Formal methods and digital systems validation for airborne systems

NASA Technical Reports Server (NTRS)

Rushby, John

1993-01-01

This report has been prepared to supplement a forthcoming chapter on formal methods in the FAA Digital Systems Validation Handbook. Its purpose is as follows: to outline the technical basis for formal methods in computer science; to explain the use of formal methods in the specification and verification of software and hardware requirements, designs, and implementations; to identify the benefits, weaknesses, and difficulties in applying these methods to digital systems used on board aircraft; and to suggest factors for consideration when formal methods are offered in support of certification. These latter factors assume the context for software development and assurance described in RTCA document DO-178B, 'Software Considerations in Airborne Systems and Equipment Certification,' Dec. 1992.

Unexpected but Most Welcome: Mixed Methods for the Validation and Revision of the Participatory Evaluation Measurement Instrument

ERIC Educational Resources Information Center

Daigneault, Pierre-Marc; Jacob, Steve

2014-01-01

Although combining methods is nothing new, more contributions about why and how to mix methods for validation purposes are needed. This article presents a case of validating the inferences drawn from the Participatory Evaluation Measurement Instrument, an instrument that purports to measure stakeholder participation in evaluation. Although the…

Validation of cleaning method for various parts fabricated at a Beryllium facility

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

Davis, Cynthia M.

This study evaluated and documented a cleaning process that is used to clean parts that are fabricated at a beryllium facility at Los Alamos National Laboratory. The purpose of evaluating this cleaning process was to validate and approve it for future use to assure beryllium surface levels are below the Department of Energy’s release limits without the need to sample all parts leaving the facility. Inhaling or coming in contact with beryllium can cause an immune response that can result in an individual becoming sensitized to beryllium, which can then lead to a disease of the lungs called chronic berylliummore » disease, and possibly lung cancer. Thirty aluminum and thirty stainless steel parts were fabricated on a lathe in the beryllium facility, as well as thirty-two beryllium parts, for the purpose of testing a parts cleaning method that involved the use of ultrasonic cleaners. A cleaning method was created, documented, validated, and approved, to reduce beryllium contamination.« less

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

PubMed

Wiegers, Ann L

2003-07-01

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

An individual and dynamic Body Segment Inertial Parameter validation method using ground reaction forces.

PubMed

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

2014-05-07

Over the last decades a variety of research has been conducted with the goal to improve the Body Segment Inertial Parameters (BSIP) estimations but to our knowledge a real validation has never been completely successful, because no ground truth is available. The aim of this paper is to propose a validation method for a BSIP identification method (IM) and to confirm the results by comparing them with recalculated contact forces using inverse dynamics to those obtained by a force plate. Furthermore, the results are compared with the recently proposed estimation method by Dumas et al. (2007). Additionally, the results are cross validated with a high velocity overarm throwing movement. Throughout conditions higher correlations, smaller metrics and smaller RMSE can be found for the proposed BSIP estimation (IM) which shows its advantage compared to recently proposed methods as of Dumas et al. (2007). The purpose of the paper is to validate an already proposed method and to show that this method can be of significant advantage compared to conventional methods. Copyright © 2014 Elsevier Ltd. All rights reserved.

Validity Argument for Assessing L2 Pragmatics in Interaction Using Mixed Methods

ERIC Educational Resources Information Center

Youn, Soo Jung

2015-01-01

This study investigates the validity of assessing L2 pragmatics in interaction using mixed methods, focusing on the evaluation inference. Open role-plays that are meaningful and relevant to the stakeholders in an English for Academic Purposes context were developed for classroom assessment. For meaningful score interpretations and accurate…

Experimental validation of structural optimization methods

NASA Technical Reports Server (NTRS)

Adelman, Howard M.

1992-01-01

The topic of validating structural optimization methods by use of experimental results is addressed. The need for validating the methods as a way of effecting a greater and an accelerated acceptance of formal optimization methods by practicing engineering designers is described. The range of validation strategies is defined which includes comparison of optimization results with more traditional design approaches, establishing the accuracy of analyses used, and finally experimental validation of the optimization results. Examples of the use of experimental results to validate optimization techniques are described. The examples include experimental validation of the following: optimum design of a trussed beam; combined control-structure design of a cable-supported beam simulating an actively controlled space structure; minimum weight design of a beam with frequency constraints; minimization of the vibration response of helicopter rotor blade; minimum weight design of a turbine blade disk; aeroelastic optimization of an aircraft vertical fin; airfoil shape optimization for drag minimization; optimization of the shape of a hole in a plate for stress minimization; optimization to minimize beam dynamic response; and structural optimization of a low vibration helicopter rotor.

A Model-Based Method for Content Validation of Automatically Generated Test Items

ERIC Educational Resources Information Center

Zhang, Xinxin; Gierl, Mark

2016-01-01

The purpose of this study is to describe a methodology to recover the item model used to generate multiple-choice test items with a novel graph theory approach. Beginning with the generated test items and working backward to recover the original item model provides a model-based method for validating the content used to automatically generate test…

Further assessment of a method to estimate reliability and validity of qualitative research findings.

PubMed

Hinds, P S; Scandrett-Hibden, S; McAulay, L S

1990-04-01

The reliability and validity of qualitative research findings are viewed with scepticism by some scientists. This scepticism is derived from the belief that qualitative researchers give insufficient attention to estimating reliability and validity of data, and the differences between quantitative and qualitative methods in assessing data. The danger of this scepticism is that relevant and applicable research findings will not be used. Our purpose is to describe an evaluative strategy for use with qualitative data, a strategy that is a synthesis of quantitative and qualitative assessment methods. Results of the strategy and factors that influence its use are also described.

Validation of catchment models for predicting land-use and climate change impacts. 1. Method

NASA Astrophysics Data System (ADS)

Ewen, J.; Parkin, G.

1996-02-01

Computer simulation models are increasingly being proposed as tools capable of giving water resource managers accurate predictions of the impact of changes in land-use and climate. Previous validation testing of catchment models is reviewed, and it is concluded that the methods used do not clearly test a model's fitness for such a purpose. A new generally applicable method is proposed. This involves the direct testing of fitness for purpose, uses established scientific techniques, and may be implemented within a quality assured programme of work. The new method is applied in Part 2 of this study (Parkin et al., J. Hydrol., 175:595-613, 1996).

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

PubMed

Shirasaki, Osamu; Asou, Yosuke; Takahashi, Yukio

2007-12-01

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

Initial interlaboratory validation of an analytical method for the determination of lead in canned tuna to be used for monitoring and regulatory purposes.

PubMed

Santiago, E C; Bello, F B B

2003-06-01

The Association of Official Analytical Chemists (AOAC) Standard Method 972.23 (dry ashing and flame atomic absorption spectrophotometry (FAAS)), applied to the analysis of lead in tuna, was validated in three selected local laboratories to determine the acceptability of the method to both the Codex Alimentarius Commission (Codex) and the European Union (EU) Commission for monitoring lead in canned tuna. Initial validation showed that the standard AOAC method as performed in the three participating laboratories cannot satisfy the Codex/EU proposed criteria for the method detection limit for monitoring lead in fish at the present regulation level of 0.5 mg x kg(-1). Modification of the standard method by chelation/concentration of the digest solution before FAAS analysis showed that the modified method has the potential to meet Codex/EU criteria on sensitivity, accuracy and precision at the specified regulation level.

[Validation and verfication of microbiology methods].

PubMed

Camaró-Sala, María Luisa; Martínez-García, Rosana; Olmos-Martínez, Piedad; Catalá-Cuenca, Vicente; Ocete-Mochón, María Dolores; Gimeno-Cardona, Concepción

2015-01-01

Clinical microbiologists should ensure, to the maximum level allowed by the scientific and technical development, the reliability of the results. This implies that, in addition to meeting the technical criteria to ensure their validity, they must be performed with a number of conditions that allows comparable results to be obtained, regardless of the laboratory that performs the test. In this sense, the use of recognized and accepted reference methodsis the most effective tool for these guarantees. The activities related to verification and validation of analytical methods has become very important, as there is continuous development, as well as updating techniques and increasingly complex analytical equipment, and an interest of professionals to ensure quality processes and results. The definitions of validation and verification are described, along with the different types of validation/verification, and the types of methods, and the level of validation necessary depending on the degree of standardization. The situations in which validation/verification is mandatory and/or recommended is discussed, including those particularly related to validation in Microbiology. It stresses the importance of promoting the use of reference strains as controls in Microbiology and the use of standard controls, as well as the importance of participation in External Quality Assessment programs to demonstrate technical competence. The emphasis is on how to calculate some of the parameters required for validation/verification, such as the accuracy and precision. The development of these concepts can be found in the microbiological process SEIMC number 48: «Validation and verification of microbiological methods» www.seimc.org/protocols/microbiology. Copyright © 2013 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Development and Validation of High Performance Liquid Chromatography Method for Determination Atorvastatin in Tablet

NASA Astrophysics Data System (ADS)

Yugatama, A.; Rohmani, S.; Dewangga, A.

2018-03-01

Atorvastatin is the primary choice for dyslipidemia treatment. Due to patent expiration of atorvastatin, the pharmaceutical industry makes copy of the drug. Therefore, the development methods for tablet quality tests involving atorvastatin concentration on tablets needs to be performed. The purpose of this research was to develop and validate the simple atorvastatin tablet analytical method by HPLC. HPLC system used in this experiment consisted of column Cosmosil C18 (150 x 4,6 mm, 5 µm) as the stationary reverse phase chomatography, a mixture of methanol-water at pH 3 (80:20 v/v) as the mobile phase, flow rate of 1 mL/min, and UV detector at wavelength of 245 nm. Validation methods were including: selectivity, linearity, accuracy, precision, limit of detection (LOD), and limit of quantitation (LOQ). The results of this study indicate that the developed method had good validation including selectivity, linearity, accuracy, precision, LOD, and LOQ for analysis of atorvastatin tablet content. LOD and LOQ were 0.2 and 0.7 ng/mL, and the linearity range were 20 - 120 ng/mL.

The Bland-Altman Method Should Not Be Used in Regression Cross-Validation Studies

ERIC Educational Resources Information Center

O'Connor, Daniel P.; Mahar, Matthew T.; Laughlin, Mitzi S.; Jackson, Andrew S.

2011-01-01

The purpose of this study was to demonstrate the bias in the Bland-Altman (BA) limits of agreement method when it is used to validate regression models. Data from 1,158 men were used to develop three regression equations to estimate maximum oxygen uptake (R[superscript 2] = 0.40, 0.61, and 0.82, respectively). The equations were evaluated in a…

Trusting Teachers' Judgement: Research Evidence of the Reliability and Validity of Teachers' Assessment Used for Summative Purposes

ERIC Educational Resources Information Center

Harlen, Wynne

2005-01-01

This paper summarizes the findings of a systematic review of research on the reliability and validity of teachers' assessment used for summative purposes. In addition to the main question, the review also addressed the question "What conditions affect the reliability and validity of teachers' summative assessment?" The initial search for studies…

Brazilian Center for the Validation of Alternative Methods (BraCVAM) and the process of validation in Brazil.

PubMed

Presgrave, Octavio; Moura, Wlamir; Caldeira, Cristiane; Pereira, Elisabete; Bôas, Maria H Villas; Eskes, Chantra

2016-03-01

The need for the creation of a Brazilian centre for the validation of alternative methods was recognised in 2008, and members of academia, industry and existing international validation centres immediately engaged with the idea. In 2012, co-operation between the Oswaldo Cruz Foundation (FIOCRUZ) and the Brazilian Health Surveillance Agency (ANVISA) instigated the establishment of the Brazilian Center for the Validation of Alternative Methods (BraCVAM), which was officially launched in 2013. The Brazilian validation process follows OECD Guidance Document No. 34, where BraCVAM functions as the focal point to identify and/or receive requests from parties interested in submitting tests for validation. BraCVAM then informs the Brazilian National Network on Alternative Methods (RENaMA) of promising assays, which helps with prioritisation and contributes to the validation studies of selected assays. A Validation Management Group supervises the validation study, and the results obtained are peer-reviewed by an ad hoc Scientific Review Committee, organised under the auspices of BraCVAM. Based on the peer-review outcome, BraCVAM will prepare recommendations on the validated test method, which will be sent to the National Council for the Control of Animal Experimentation (CONCEA). CONCEA is in charge of the regulatory adoption of all validated test methods in Brazil, following an open public consultation. 2016 FRAME.

An Investigation of Pre-Service Middle School Mathematics Teachers' Ability to Conduct Valid Proofs, Methods Used, and Reasons for Invalid Arguments

ERIC Educational Resources Information Center

Demiray, Esra; Isiksal Bostan, Mine

2017-01-01

The purposes of this study are to investigate Turkish pre-service middle school mathematics teachers' ability in conducting valid proofs for statements regarding numbers and algebra in terms of their year of enrollment in a teacher education program, to determine the proof methods used in their valid proofs, and to examine the reasons for their…

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.

Statistical Methods for Rapid Aerothermal Analysis and Design Technology: Validation

NASA Technical Reports Server (NTRS)

DePriest, Douglas; Morgan, Carolyn

2003-01-01

The cost and safety goals for NASA s next generation of reusable launch vehicle (RLV) will require that rapid high-fidelity aerothermodynamic design tools be used early in the design cycle. To meet these requirements, it is desirable to identify adequate statistical models that quantify and improve the accuracy, extend the applicability, and enable combined analyses using existing prediction tools. The initial research work focused on establishing suitable candidate models for these purposes. The second phase is focused on assessing the performance of these models to accurately predict the heat rate for a given candidate data set. This validation work compared models and methods that may be useful in predicting the heat rate.

Formal methods and their role in digital systems validation for airborne systems

NASA Technical Reports Server (NTRS)

Rushby, John

1995-01-01

This report is based on one prepared as a chapter for the FAA Digital Systems Validation Handbook (a guide to assist FAA certification specialists with advanced technology issues). Its purpose is to explain the use of formal methods in the specification and verification of software and hardware requirements, designs, and implementations; to identify the benefits, weaknesses, and difficulties in applying these methods to digital systems used in critical applications; and to suggest factors for consideration when formal methods are offered in support of certification. The presentation concentrates on the rationale for formal methods and on their contribution to assurance for critical applications within a context such as that provided by DO-178B (the guidelines for software used on board civil aircraft); it is intended as an introduction for those to whom these topics are new.

ASTM Validates Air Pollution Test Methods

ERIC Educational Resources Information Center

Chemical and Engineering News, 1973

1973-01-01

The American Society for Testing and Materials (ASTM) has validated six basic methods for measuring pollutants in ambient air as the first part of its Project Threshold. Aim of the project is to establish nationwide consistency in measuring pollutants; determining precision, accuracy and reproducibility of 35 standard measuring methods. (BL)

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

PubMed

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

2018-03-01

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

Validity evidence based on test content.

PubMed

Sireci, Stephen; Faulkner-Bond, Molly

2014-01-01

Validity evidence based on test content is one of the five forms of validity evidence stipulated in the Standards for Educational and Psychological Testing developed by the American Educational Research Association, American Psychological Association, and National Council on Measurement in Education. In this paper, we describe the logic and theory underlying such evidence and describe traditional and modern methods for gathering and analyzing content validity data. A comprehensive review of the literature and of the aforementioned Standards is presented. For educational tests and other assessments targeting knowledge and skill possessed by examinees, validity evidence based on test content is necessary for building a validity argument to support the use of a test for a particular purpose. By following the methods described in this article, practitioners have a wide arsenal of tools available for determining how well the content of an assessment is congruent with and appropriate for the specific testing purposes.

Investigation of the accuracy of breast tissue segmentation methods for the purpose of developing breast deformation models for use in adaptive radiotherapy

NASA Astrophysics Data System (ADS)

Juneja, P.; Harris, E. J.; Evans, P. M.

2014-03-01

Realistic modelling of breast deformation requires the breast tissue to be segmented into fibroglandular and fatty tissue and assigned suitable material properties. There are a number of breast tissue segmentation methods proposed and used in the literature. The purpose of this study was to validate and compare the accuracy of various segmentation methods and to investigate the effect of the tissue distribution on the segmentation accuracy. Computed tomography (CT) data for 24 patients, both in supine and prone positions were segmented into fibroglandular and fatty tissue. The segmentation methods explored were: physical density thresholding; interactive thresholding; fuzzy c-means clustering (FCM) with three classes (FCM3) and four classes (FCM4); and k-means clustering. Validation was done in two-stages: firstly, a new approach, supine-prone validation based on the assumption that the breast composition should appear the same in the supine and prone scans was used. Secondly, outlines from three experts were used for validation. This study found that FCM3 gave the most accurate segmentation of breast tissue from CT data and that the segmentation accuracy is adversely affected by the sparseness of the fibroglandular tissue distribution.

Testing alternative ground water models using cross-validation and other methods

USGS Publications Warehouse

Foglia, L.; Mehl, S.W.; Hill, M.C.; Perona, P.; Burlando, P.

2007-01-01

Many methods can be used to test alternative ground water models. Of concern in this work are methods able to (1) rank alternative models (also called model discrimination) and (2) identify observations important to parameter estimates and predictions (equivalent to the purpose served by some types of sensitivity analysis). Some of the measures investigated are computationally efficient; others are computationally demanding. The latter are generally needed to account for model nonlinearity. The efficient model discrimination methods investigated include the information criteria: the corrected Akaike information criterion, Bayesian information criterion, and generalized cross-validation. The efficient sensitivity analysis measures used are dimensionless scaled sensitivity (DSS), composite scaled sensitivity, and parameter correlation coefficient (PCC); the other statistics are DFBETAS, Cook's D, and observation-prediction statistic. Acronyms are explained in the introduction. Cross-validation (CV) is a computationally intensive nonlinear method that is used for both model discrimination and sensitivity analysis. The methods are tested using up to five alternative parsimoniously constructed models of the ground water system of the Maggia Valley in southern Switzerland. The alternative models differ in their representation of hydraulic conductivity. A new method for graphically representing CV and sensitivity analysis results for complex models is presented and used to evaluate the utility of the efficient statistics. The results indicate that for model selection, the information criteria produce similar results at much smaller computational cost than CV. For identifying important observations, the only obviously inferior linear measure is DSS; the poor performance was expected because DSS does not include the effects of parameter correlation and PCC reveals large parameter correlations. ?? 2007 National Ground Water Association.

Software phantom with realistic speckle modeling for validation of image analysis methods in echocardiography

NASA Astrophysics Data System (ADS)

Law, Yuen C.; Tenbrinck, Daniel; Jiang, Xiaoyi; Kuhlen, Torsten

2014-03-01

Computer-assisted processing and interpretation of medical ultrasound images is one of the most challenging tasks within image analysis. Physical phenomena in ultrasonographic images, e.g., the characteristic speckle noise and shadowing effects, make the majority of standard methods from image analysis non optimal. Furthermore, validation of adapted computer vision methods proves to be difficult due to missing ground truth information. There is no widely accepted software phantom in the community and existing software phantoms are not exible enough to support the use of specific speckle models for different tissue types, e.g., muscle and fat tissue. In this work we propose an anatomical software phantom with a realistic speckle pattern simulation to _ll this gap and provide a exible tool for validation purposes in medical ultrasound image analysis. We discuss the generation of speckle patterns and perform statistical analysis of the simulated textures to obtain quantitative measures of the realism and accuracy regarding the resulting textures.

Nonclinical dose formulation analysis method validation and sample analysis.

PubMed

Whitmire, Monica Lee; Bryan, Peter; Henry, Teresa R; Holbrook, John; Lehmann, Paul; Mollitor, Thomas; Ohorodnik, Susan; Reed, David; Wietgrefe, Holly D

2010-12-01

Nonclinical dose formulation analysis methods are used to confirm test article concentration and homogeneity in formulations and determine formulation stability in support of regulated nonclinical studies. There is currently no regulatory guidance for nonclinical dose formulation analysis method validation or sample analysis. Regulatory guidance for the validation of analytical procedures has been developed for drug product/formulation testing; however, verification of the formulation concentrations falls under the framework of GLP regulations (not GMP). The only current related regulatory guidance is the bioanalytical guidance for method validation. The fundamental parameters for bioanalysis and formulation analysis validations that overlap include: recovery, accuracy, precision, specificity, selectivity, carryover, sensitivity, and stability. Divergence in bioanalytical and drug product validations typically center around the acceptance criteria used. As the dose formulation samples are not true "unknowns", the concept of quality control samples that cover the entire range of the standard curve serving as the indication for the confidence in the data generated from the "unknown" study samples may not always be necessary. Also, the standard bioanalytical acceptance criteria may not be directly applicable, especially when the determined concentration does not match the target concentration. This paper attempts to reconcile the different practices being performed in the community and to provide recommendations of best practices and proposed acceptance criteria for nonclinical dose formulation method validation and sample analysis.

VALIDATION OF ANALYTICAL METHODS AND INSTRUMENTATION FOR BERYLLIUM MEASUREMENT: REVIEW AND SUMMARY OF AVAILABLE GUIDES, PROCEDURES, AND PROTOCOLS

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

Ekechukwu, A

Method validation is the process of evaluating whether an analytical method is acceptable for its intended purpose. For pharmaceutical methods, guidelines from the United States Pharmacopeia (USP), International Conference on Harmonisation (ICH), and the United States Food and Drug Administration (USFDA) provide a framework for performing such valications. In general, methods for regulatory compliance must include studies on specificity, linearity, accuracy, precision, range, detection limit, quantitation limit, and robustness. Elements of these guidelines are readily adapted to the issue of validation for beryllium sampling and analysis. This document provides a listing of available sources which can be used to validatemore » analytical methods and/or instrumentation for beryllium determination. A literature review was conducted of available standard methods and publications used for method validation and/or quality control. A comprehensive listing of the articles, papers and books reviewed is given in the Appendix. Available validation documents and guides are listed therein; each has a brief description of application and use. In the referenced sources, there are varying approches to validation and varying descriptions of the valication process at different stages in method development. This discussion focuses on valication and verification of fully developed methods and instrumentation that have been offered up for use or approval by other laboratories or official consensus bodies such as ASTM International, the International Standards Organization (ISO) and the Association of Official Analytical Chemists (AOAC). This review was conducted as part of a collaborative effort to investigate and improve the state of validation for measuring beryllium in the workplace and the environment. Documents and publications from the United States and Europe are included. Unless otherwise specified, all referenced documents were published in English.« less

Model-Based Method for Sensor Validation

NASA Technical Reports Server (NTRS)

Vatan, Farrokh

2012-01-01

Fault detection, diagnosis, and prognosis are essential tasks in the operation of autonomous spacecraft, instruments, and in situ platforms. One of NASA s key mission requirements is robust state estimation. Sensing, using a wide range of sensors and sensor fusion approaches, plays a central role in robust state estimation, and there is a need to diagnose sensor failure as well as component failure. Sensor validation can be considered to be part of the larger effort of improving reliability and safety. The standard methods for solving the sensor validation problem are based on probabilistic analysis of the system, from which the method based on Bayesian networks is most popular. Therefore, these methods can only predict the most probable faulty sensors, which are subject to the initial probabilities defined for the failures. The method developed in this work is based on a model-based approach and provides the faulty sensors (if any), which can be logically inferred from the model of the system and the sensor readings (observations). The method is also more suitable for the systems when it is hard, or even impossible, to find the probability functions of the system. The method starts by a new mathematical description of the problem and develops a very efficient and systematic algorithm for its solution. The method builds on the concepts of analytical redundant relations (ARRs).

External validation of a Cox prognostic model: principles and methods

PubMed Central

2013-01-01

Background A prognostic model should not enter clinical practice unless it has been demonstrated that it performs a useful role. External validation denotes evaluation of model performance in a sample independent of that used to develop the model. Unlike for logistic regression models, external validation of Cox models is sparsely treated in the literature. Successful validation of a model means achieving satisfactory discrimination and calibration (prediction accuracy) in the validation sample. Validating Cox models is not straightforward because event probabilities are estimated relative to an unspecified baseline function. Methods We describe statistical approaches to external validation of a published Cox model according to the level of published information, specifically (1) the prognostic index only, (2) the prognostic index together with Kaplan-Meier curves for risk groups, and (3) the first two plus the baseline survival curve (the estimated survival function at the mean prognostic index across the sample). The most challenging task, requiring level 3 information, is assessing calibration, for which we suggest a method of approximating the baseline survival function. Results We apply the methods to two comparable datasets in primary breast cancer, treating one as derivation and the other as validation sample. Results are presented for discrimination and calibration. We demonstrate plots of survival probabilities that can assist model evaluation. Conclusions Our validation methods are applicable to a wide range of prognostic studies and provide researchers with a toolkit for external validation of a published Cox model. PMID:23496923

76 FR 28664 - Method 301-Field Validation of Pollutant Measurement Methods From Various Waste Media

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-18

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 63 [OAR-2004-0080, FRL-9306-8] RIN 2060-AF00 Method 301--Field Validation of Pollutant Measurement Methods From Various Waste Media AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This action amends EPA's Method 301, Field Validation...

Establishing survey validity and reliability for American Indians through "think aloud" and test-retest methods.

PubMed

Hauge, Cindy Horst; Jacobs-Knight, Jacque; Jensen, Jamie L; Burgess, Katherine M; Puumala, Susan E; Wilton, Georgiana; Hanson, Jessica D

2015-06-01

The purpose of this study was to use a mixed-methods approach to determine the validity and reliability of measurements used within an alcohol-exposed pregnancy prevention program for American Indian women. To develop validity, content experts provided input into the survey measures, and a "think aloud" methodology was conducted with 23 American Indian women. After revising the measurements based on this input, a test-retest was conducted with 79 American Indian women who were randomized to complete either the original measurements or the new, modified measurements. The test-retest revealed that some of the questions performed better for the modified version, whereas others appeared to be more reliable for the original version. The mixed-methods approach was a useful methodology for gathering feedback on survey measurements from American Indian participants and in indicating specific survey questions that needed to be modified for this population. © The Author(s) 2015.

Cross-Validation of Survival Bump Hunting by Recursive Peeling Methods.

PubMed

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

2014-08-01

We introduce a survival/risk bump hunting framework to build a bump hunting model with a possibly censored time-to-event type of response and to validate model estimates. First, we describe the use of adequate survival peeling criteria to build a survival/risk bump hunting model based on recursive peeling methods. Our method called "Patient Recursive Survival Peeling" is a rule-induction method that makes use of specific peeling criteria such as hazard ratio or log-rank statistics. Second, to validate our model estimates and improve survival prediction accuracy, we describe a resampling-based validation technique specifically designed for the joint task of decision rule making by recursive peeling (i.e. decision-box) and survival estimation. This alternative technique, called "combined" cross-validation is done by combining test samples over the cross-validation loops, a design allowing for bump hunting by recursive peeling in a survival setting. We provide empirical results showing the importance of cross-validation and replication.

Cross-Validation of Survival Bump Hunting by Recursive Peeling Methods

PubMed Central

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

2015-01-01

We introduce a survival/risk bump hunting framework to build a bump hunting model with a possibly censored time-to-event type of response and to validate model estimates. First, we describe the use of adequate survival peeling criteria to build a survival/risk bump hunting model based on recursive peeling methods. Our method called “Patient Recursive Survival Peeling” is a rule-induction method that makes use of specific peeling criteria such as hazard ratio or log-rank statistics. Second, to validate our model estimates and improve survival prediction accuracy, we describe a resampling-based validation technique specifically designed for the joint task of decision rule making by recursive peeling (i.e. decision-box) and survival estimation. This alternative technique, called “combined” cross-validation is done by combining test samples over the cross-validation loops, a design allowing for bump hunting by recursive peeling in a survival setting. We provide empirical results showing the importance of cross-validation and replication. PMID:26997922

RELIABILITY AND VALIDITY OF A BIOMECHANICALLY BASED ANALYSIS METHOD FOR THE TENNIS SERVE

PubMed Central

Kibler, W. Ben; Lamborn, Leah; Smith, Belinda J.; English, Tony; Jacobs, Cale; Uhl, Tim L.

2017-01-01

Background An observational tennis serve analysis (OTSA) tool was developed using previously established body positions from three-dimensional kinematic motion analysis studies. These positions, defined as nodes, have been associated with efficient force production and minimal joint loading. However, the tool has yet to be examined scientifically. Purpose The primary purpose of this investigation was to determine the inter-observer reliability for each node between two health care professionals (HCPs) that developed the OTSA, and secondarily to investigate the validity of the OTSA. Methods Two separate studies were performed to meet these objectives. An inter-observer reliability study preceded the validity study by examining 28 videos of players serving. Two HCPs graded each video and scored the presence or absence of obtaining each node. Discriminant validity was determined in 33 tennis players using video taped records of three first serves. Serve mechanics were graded using the OSTA and categorized players into those with good ( ≥ 5) and poor ( ≤ 4) mechanics. Participants performed a series of field tests to evaluate trunk flexibility, lower extremity and trunk power, and dynamic balance. Results The group with good mechanics demonstrated greater backward trunk flexibility (p=0.02), greater rotational power (p=0.02), and higher single leg countermovement jump (p=0.05). Reliability of the OTSA ranged from K = 0.36-1.0, with the majority of all the nodes displaying substantial reliability (K>0.61). Conclusion This study provides HCPs with a valid and reliable field tool used to assess serve mechanics. Physical characteristics of trunk mobility and power appear to discriminate serve mechanics between players. Future intervention studies are needed to determine if improvement in physical function contribute to improved serve mechanics. Level of Evidence 3 PMID:28593098

Fit for purpose? Validation of a conceptual framework for personal recovery with current mental health consumers.

PubMed

Bird, Victoria; Leamy, Mary; Tew, Jerry; Le Boutillier, Clair; Williams, Julie; Slade, Mike

2014-07-01

Mental health services in the UK, Australia and other Anglophone countries have moved towards supporting personal recovery as a primary orientation. To provide an empirically grounded foundation to identify and evaluate recovery-oriented interventions, we previously published a conceptual framework of personal recovery based on a systematic review and narrative synthesis of existing models. Our objective was to test the validity and relevance of this framework for people currently using mental health services. Seven focus groups were conducted with 48 current mental health consumers in three NHS trusts across England, as part of the REFOCUS Trial. Consumers were asked about the meaning and their experience of personal recovery. Deductive and inductive thematic analysis applying a constant comparison approach was used to analyse the data. The analysis aimed to explore the validity of the categories within the conceptual framework, and to highlight any areas of difference between the conceptual framework and the themes generated from new data collected from the focus groups. Both the inductive and deductive analysis broadly validated the conceptual framework, with the super-ordinate categories Connectedness, Hope and optimism, Identity, Meaning and purpose, and Empowerment (CHIME) evident in the analysis. Three areas of difference were, however, apparent in the inductive analysis. These included practical support; a greater emphasis on issues around diagnosis and medication; and scepticism surrounding recovery. This study suggests that the conceptual framework of personal recovery provides a defensible theoretical base for clinical and research purposes which is valid for use with current consumers. However, the three areas of difference further stress the individual nature of recovery and the need for an understanding of the population and context under investigation. © The Royal Australian and New Zealand College of Psychiatrists 2014.

fMRI capture of auditory hallucinations: Validation of the two-steps method.

PubMed

Leroy, Arnaud; Foucher, Jack R; Pins, Delphine; Delmaire, Christine; Thomas, Pierre; Roser, Mathilde M; Lefebvre, Stéphanie; Amad, Ali; Fovet, Thomas; Jaafari, Nemat; Jardri, Renaud

2017-10-01

Our purpose was to validate a reliable method to capture brain activity concomitant with hallucinatory events, which constitute frequent and disabling experiences in schizophrenia. Capturing hallucinations using functional magnetic resonance imaging (fMRI) remains very challenging. We previously developed a method based on a two-steps strategy including (1) multivariate data-driven analysis of per-hallucinatory fMRI recording and (2) selection of the components of interest based on a post-fMRI interview. However, two tests still need to be conducted to rule out critical pitfalls of conventional fMRI capture methods before this two-steps strategy can be adopted in hallucination research: replication of these findings on an independent sample and assessment of the reliability of the hallucination-related patterns at the subject level. To do so, we recruited a sample of 45 schizophrenia patients suffering from frequent hallucinations, 20 schizophrenia patients without hallucinations and 20 matched healthy volunteers; all participants underwent four different experiments. The main findings are (1) high accuracy in reporting unexpected sensory stimuli in an MRI setting; (2) good detection concordance between hypothesis-driven and data-driven analysis methods (as used in the two-steps strategy) when controlled unexpected sensory stimuli are presented; (3) good agreement of the two-steps method with the online button-press approach to capture hallucinatory events; (4) high spatial consistency of hallucinatory-related networks detected using the two-steps method on two independent samples. By validating the two-steps method, we advance toward the possible transfer of such technology to new image-based therapies for hallucinations. Hum Brain Mapp 38:4966-4979, 2017. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

78 FR 56718 - Draft Guidance for Industry on Bioanalytical Method Validation; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-13

...] Draft Guidance for Industry on Bioanalytical Method Validation; Availability AGENCY: Food and Drug... availability of a draft guidance for industry entitled ``Bioanalytical Method Validation.'' The draft guidance is intended to provide recommendations regarding analytical method development and validation for the...

The Value of Qualitative Methods in Social Validity Research

ERIC Educational Resources Information Center

Leko, Melinda M.

2014-01-01

One quality indicator of intervention research is the extent to which the intervention has a high degree of social validity, or practicality. In this study, I drew on Wolf's framework for social validity and used qualitative methods to ascertain five middle schoolteachers' perceptions of the social validity of System 44®--a phonics-based reading…

Performance Ratings: Designs for Evaluating Their Validity and Accuracy.

DTIC Science & Technology

1986-07-01

ratees with substantial validity and with little bias due to the ethod for rating. Convergent validity and discriminant validity account for approximately...The expanded research design suggests that purpose for the ratings has little influence on the multitrait-multimethod properties of the ratings...Convergent and discriminant validity again account for substantial differences in the ratings of performance. Little method bias is present; both methods of

State of the art in the validation of screening methods for the control of antibiotic residues: is there a need for further development?

PubMed

Gaudin, Valérie

2017-09-01

Screening methods are used as a first-line approach to detect the presence of antibiotic residues in food of animal origin. The validation process guarantees that the method is fit-for-purpose, suited to regulatory requirements, and provides evidence of its performance. This article is focused on intra-laboratory validation. The first step in validation is characterisation of performance, and the second step is the validation itself with regard to pre-established criteria. The validation approaches can be absolute (a single method) or relative (comparison of methods), overall (combination of several characteristics in one) or criterion-by-criterion. Various approaches to validation, in the form of regulations, guidelines or standards, are presented and discussed to draw conclusions on their potential application for different residue screening methods, and to determine whether or not they reach the same conclusions. The approach by comparison of methods is not suitable for screening methods for antibiotic residues. The overall approaches, such as probability of detection (POD) and accuracy profile, are increasingly used in other fields of application. They may be of interest for screening methods for antibiotic residues. Finally, the criterion-by-criterion approach (Decision 2002/657/EC and of European guideline for the validation of screening methods), usually applied to the screening methods for antibiotic residues, introduced a major characteristic and an improvement in the validation, i.e. the detection capability (CCβ). In conclusion, screening methods are constantly evolving, thanks to the development of new biosensors or liquid chromatography coupled to tandem-mass spectrometry (LC-MS/MS) methods. There have been clear changes in validation approaches these last 20 years. Continued progress is required and perspectives for future development of guidelines, regulations and standards for validation are presented here.

Development and validation of a reading-related assessment battery in Malay for the purpose of dyslexia assessment.

PubMed

Lee, Lay Wah

2008-06-01

Malay is an alphabetic language with transparent orthography. A Malay reading-related assessment battery which was conceptualised based on the International Dyslexia Association definition of dyslexia was developed and validated for the purpose of dyslexia assessment. The battery consisted of ten tests: Letter Naming, Word Reading, Non-word Reading, Spelling, Passage Reading, Reading Comprehension, Listening Comprehension, Elision, Rapid Letter Naming and Digit Span. Content validity was established by expert judgment. Concurrent validity was obtained using the schools' language tests as criterion. Evidence of predictive and construct validity was obtained through regression analyses and factor analyses. Phonological awareness was the most significant predictor of word-level literacy skills in Malay, with rapid naming making independent secondary contributions. Decoding and listening comprehension made separate contributions to reading comprehension, with decoding as the more prominent predictor. Factor analysis revealed four factors: phonological decoding, phonological naming, comprehension and verbal short-term memory. In conclusion, despite differences in orthography, there are striking similarities in the theoretical constructs of reading-related tasks in Malay and in English.

Teaching method validation in the clinical laboratory science curriculum.

PubMed

Moon, Tara C; Legrys, Vicky A

2008-01-01

With the Clinical Laboratory Improvement Amendment's (CLIA) final rule, the ability of the Clinical Laboratory Scientist (CLS) to perform method validation has become increasingly important. Knowledge of the statistical methods and procedures used in method validation is imperative for clinical laboratory scientists. However, incorporating these concepts in a CLS curriculum can be challenging, especially at a time of limited resources. This paper provides an outline of one approach to addressing these topics in lecture courses and integrating them in the student laboratory and the clinical practicum for direct application.

Applied Chaos Level Test for Validation of Signal Conditions Underlying Optimal Performance of Voice Classification Methods.

PubMed

Liu, Boquan; Polce, Evan; Sprott, Julien C; Jiang, Jack J

2018-05-17

The purpose of this study is to introduce a chaos level test to evaluate linear and nonlinear voice type classification method performances under varying signal chaos conditions without subjective impression. Voice signals were constructed with differing degrees of noise to model signal chaos. Within each noise power, 100 Monte Carlo experiments were applied to analyze the output of jitter, shimmer, correlation dimension, and spectrum convergence ratio. The computational output of the 4 classifiers was then plotted against signal chaos level to investigate the performance of these acoustic analysis methods under varying degrees of signal chaos. A diffusive behavior detection-based chaos level test was used to investigate the performances of different voice classification methods. Voice signals were constructed by varying the signal-to-noise ratio to establish differing signal chaos conditions. Chaos level increased sigmoidally with increasing noise power. Jitter and shimmer performed optimally when the chaos level was less than or equal to 0.01, whereas correlation dimension was capable of analyzing signals with chaos levels of less than or equal to 0.0179. Spectrum convergence ratio demonstrated proficiency in analyzing voice signals with all chaos levels investigated in this study. The results of this study corroborate the performance relationships observed in previous studies and, therefore, demonstrate the validity of the validation test method. The presented chaos level validation test could be broadly utilized to evaluate acoustic analysis methods and establish the most appropriate methodology for objective voice analysis in clinical practice.

An integrated bioanalytical method development and validation approach: case studies.

PubMed

Xue, Y-J; Melo, Brian; Vallejo, Martha; Zhao, Yuwen; Tang, Lina; Chen, Yuan-Shek; Keller, Karin M

2012-10-01

We proposed an integrated bioanalytical method development and validation approach: (1) method screening based on analyte's physicochemical properties and metabolism information to determine the most appropriate extraction/analysis conditions; (2) preliminary stability evaluation using both quality control and incurred samples to establish sample collection, storage and processing conditions; (3) mock validation to examine method accuracy and precision and incurred sample reproducibility; and (4) method validation to confirm the results obtained during method development. This integrated approach was applied to the determination of compound I in rat plasma and compound II in rat and dog plasma. The effectiveness of the approach was demonstrated by the superior quality of three method validations: (1) a zero run failure rate; (2) >93% of quality control results within 10% of nominal values; and (3) 99% incurred sample within 9.2% of the original values. In addition, rat and dog plasma methods for compound II were successfully applied to analyze more than 900 plasma samples obtained from Investigational New Drug (IND) toxicology studies in rats and dogs with near perfect results: (1) a zero run failure rate; (2) excellent accuracy and precision for standards and quality controls; and (3) 98% incurred samples within 15% of the original values. Copyright © 2011 John Wiley & Sons, Ltd.

A special purpose knowledge-based face localization method

NASA Astrophysics Data System (ADS)

Hassanat, Ahmad; Jassim, Sabah

2008-04-01

This paper is concerned with face localization for visual speech recognition (VSR) system. Face detection and localization have got a great deal of attention in the last few years, because it is an essential pre-processing step in many techniques that handle or deal with faces, (e.g. age, face, gender, race and visual speech recognition). We shall present an efficient method for localization human's faces in video images captured on mobile constrained devices, under a wide variation in lighting conditions. We use a multiphase method that may include all or some of the following steps starting with image pre-processing, followed by a special purpose edge detection, then an image refinement step. The output image will be passed through a discrete wavelet decomposition procedure, and the computed LL sub-band at a certain level will be transformed into a binary image that will be scanned by using a special template to select a number of possible candidate locations. Finally, we fuse the scores from the wavelet step with scores determined by color information for the candidate location and employ a form of fuzzy logic to distinguish face from non-face locations. We shall present results of large number of experiments to demonstrate that the proposed face localization method is efficient and achieve high level of accuracy that outperforms existing general-purpose face detection methods.

International Harmonization and Cooperation in the Validation of Alternative Methods.

PubMed

Barroso, João; Ahn, Il Young; Caldeira, Cristiane; Carmichael, Paul L; Casey, Warren; Coecke, Sandra; Curren, Rodger; Desprez, Bertrand; Eskes, Chantra; Griesinger, Claudius; Guo, Jiabin; Hill, Erin; Roi, Annett Janusch; Kojima, Hajime; Li, Jin; Lim, Chae Hyung; Moura, Wlamir; Nishikawa, Akiyoshi; Park, HyeKyung; Peng, Shuangqing; Presgrave, Octavio; Singer, Tim; Sohn, Soo Jung; Westmoreland, Carl; Whelan, Maurice; Yang, Xingfen; Yang, Ying; Zuang, Valérie

The development and validation of scientific alternatives to animal testing is important not only from an ethical perspective (implementation of 3Rs), but also to improve safety assessment decision making with the use of mechanistic information of higher relevance to humans. To be effective in these efforts, it is however imperative that validation centres, industry, regulatory bodies, academia and other interested parties ensure a strong international cooperation, cross-sector collaboration and intense communication in the design, execution, and peer review of validation studies. Such an approach is critical to achieve harmonized and more transparent approaches to method validation, peer-review and recommendation, which will ultimately expedite the international acceptance of valid alternative methods or strategies by regulatory authorities and their implementation and use by stakeholders. It also allows achieving greater efficiency and effectiveness by avoiding duplication of effort and leveraging limited resources. In view of achieving these goals, the International Cooperation on Alternative Test Methods (ICATM) was established in 2009 by validation centres from Europe, USA, Canada and Japan. ICATM was later joined by Korea in 2011 and currently also counts with Brazil and China as observers. This chapter describes the existing differences across world regions and major efforts carried out for achieving consistent international cooperation and harmonization in the validation and adoption of alternative approaches to animal testing.

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

PubMed Central

Kluger, Yuval

2011-01-01

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

Validation of an Instrument to Measure High School Students' Attitudes toward Fitness Testing

ERIC Educational Resources Information Center

Mercier, Kevin; Silverman, Stephen

2014-01-01

Purpose: The purpose of this investigation was to develop an instrument that has scores that are valid and reliable for measuring students' attitudes toward fitness testing. Method: The method involved the following steps: (a) an elicitation study, (b) item development, (c) a pilot study, and (d) a validation study. The pilot study included 427…

Italian validation of the Purpose In Life (PIL) test and the Seeking Of Noetic Goals (SONG) test in a population of cancer patients.

PubMed

Brunelli, C; Bianchi, E; Murru, L; Monformoso, P; Bosisio, M; Gangeri, L; Miccinesi, G; Scrignaro, M; Ripamonti, C; Borreani, C

2012-11-01

The first instruments developed to evaluate specific logotherapeutic dimensions were the Purpose In Life (PIL) and the Seeking Of Noetic Goals (SONG) tests, designed to reflect Frankl's concepts of, respectively, meaning in life attainment and will to meaning. This study aims to perform the Italian cultural adaptation and the psychometric validation of the PIL and SONG questionnaires. We administered the PIL and SONG, culturally adapted into the Italian language, to 266 cancer patients. The psychometric validation appraised construct validity, internal consistency, test-retest reliability, known-group validity, and convergent validity of the two questionnaires with respect to one another. The factorial analysis indicates that the original single-factor solution can be maintained for both instruments (proportion of variance explained by the first factor 77% and 71% for the PIL and SONG, respectively). The results show excellent internal consistency (Cronbach's alpha of 0.91 for the PIL and 0.90 for the SONG) and test-retest reliability (intraclass correlation coefficient of 0.92 for the PIL and 0.81 for the SONG). As expected, males, believers, patients nearer to the diagnosis, and patients not undergoing psychological therapy have higher PIL and lower SONG scores, while expectations for age were not confirmed. The average level for the PIL was 107.3, while for the SONG, it was 66.1, and a negative correlation (-0.47) between PIL and SONG scores indicates good convergent validity of the two instruments. Italian versions of the PIL and SONG are adequate and reliable self-report instruments for evaluating purpose in life and the motivation to find purpose for cancer patient populations.

A validated LC method for determination of 2,3-dichlorobenzoic acid and its associated regio isomers.

PubMed

Krishnaiah, Ch; Sri, Khagga Bhavya

2012-05-01

A simple, selective and sensitive gradient reversed-phase liquid chromatography method has been developed for the separation and determination of 2,3-dichlorobenzoic acid, which is an intermediate of the lamotrizine drug substance, and its regio isomers. The separation was achieved on a reversed-phase United States Pharmacopeia L1 (C-18) column using 0.01 M ammonium acetate buffer at pH 2.5 and methanol (50:50 v/v) mixture as mobile phase A and a methanol and water mixture (80:20 v/v) as mobile phase B in a gradient elution at flow rate 1.2 mL/min with ultraviolet detection at 210 nm. The method is found to be selective, precise, linear, accurate and robust. It was used for quality assurance and monitoring the synthetic reactions involved in the process development of lamotrizine. The method is found to be simple, rapid, specific and reliable for the determination of unreacted levels of raw materials and isomers in reaction mixtures and finished product lamotrizine. The method was fully validated as per International Conference of Harmonization guidelines and results from validation confirm that the method is highly suitable for its intended purpose. © The Author [2012]. Published by Oxford University Press. All rights reserved.

Field validation of the dnph method for aldehydes and ketones. Final report

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

Workman, G.S.; Steger, J.L.

1996-04-01

A stationary source emission test method for selected aldehydes and ketones has been validated. The method employs a sampling train with impingers containing 2,4-dinitrophenylhydrazine (DNPH) to derivatize the analytes. The resulting hydrazones are recovered and analyzed by high performance liquid chromatography. Nine analytes were studied; the method was validated for formaldehyde, acetaldehyde, propionaldehyde, acetophenone and isophorone. Acrolein, menthyl ethyl ketone, menthyl isobutyl ketone, and quinone did not meet the validation criteria. The study employed the validation techniques described in EPA method 301, which uses train spiking to determine bias, and collocated sampling trains to determine precision. The studies were carriedmore » out at a plywood veneer dryer and a polyester manufacturing plant.« less

Testing and Validation of Computational Methods for Mass Spectrometry.

PubMed

Gatto, Laurent; Hansen, Kasper D; Hoopmann, Michael R; Hermjakob, Henning; Kohlbacher, Oliver; Beyer, Andreas

2016-03-04

High-throughput methods based on mass spectrometry (proteomics, metabolomics, lipidomics, etc.) produce a wealth of data that cannot be analyzed without computational methods. The impact of the choice of method on the overall result of a biological study is often underappreciated, but different methods can result in very different biological findings. It is thus essential to evaluate and compare the correctness and relative performance of computational methods. The volume of the data as well as the complexity of the algorithms render unbiased comparisons challenging. This paper discusses some problems and challenges in testing and validation of computational methods. We discuss the different types of data (simulated and experimental validation data) as well as different metrics to compare methods. We also introduce a new public repository for mass spectrometric reference data sets ( http://compms.org/RefData ) that contains a collection of publicly available data sets for performance evaluation for a wide range of different methods.

Single Lab Validation of a LC/UV/FLD/MS Method for Simultaneous Determination of Water-soluble Vitamins in Multi-Vitamin Dietary Supplements

USDA-ARS?s Scientific Manuscript database

The purpose of this study was to develop a Single-Lab Validated Method using high-performance liquid chromatography (HPLC) with different detectors (diode array detector - DAD, fluorescence detector - FLD, and mass spectrometer - MS) for determination of seven B-complex vitamins (B1 - thiamin, B2 – ...

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

PubMed

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

2005-03-09

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

Moving beyond Traditional Methods of Survey Validation

ERIC Educational Resources Information Center

Maul, Andrew

2017-01-01

In his focus article, "Rethinking Traditional Methods of Survey Validation," published in this issue of "Measurement: Interdisciplinary Research and Perspectives," Andrew Maul wrote that it is commonly believed that self-report, survey-based instruments can be used to measure a wide range of psychological attributes, such as…

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 Process Methods

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

Lewis, John E.; English, Christine M.; Gesick, Joshua C.

This report documents the validation process as applied to projects awarded through Funding Opportunity Announcements (FOAs) within the U.S. Department of Energy Bioenergy Technologies Office (DOE-BETO). It describes the procedures used to protect and verify project data, as well as the systematic framework used to evaluate and track performance metrics throughout the life of the project. This report also describes the procedures used to validate the proposed process design, cost data, analysis methodologies, and supporting documentation provided by the recipients.

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

PubMed

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

2016-03-01

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

Accuracy and generalizability of using automated methods for identifying adverse events from electronic health record data: a validation study protocol.

PubMed

Rochefort, Christian M; Buckeridge, David L; Tanguay, Andréanne; Biron, Alain; D'Aragon, Frédérick; Wang, Shengrui; Gallix, Benoit; Valiquette, Louis; Audet, Li-Anne; Lee, Todd C; Jayaraman, Dev; Petrucci, Bruno; Lefebvre, Patricia

2017-02-16

Adverse events (AEs) in acute care hospitals are frequent and associated with significant morbidity, mortality, and costs. Measuring AEs is necessary for quality improvement and benchmarking purposes, but current detection methods lack in accuracy, efficiency, and generalizability. The growing availability of electronic health records (EHR) and the development of natural language processing techniques for encoding narrative data offer an opportunity to develop potentially better methods. The purpose of this study is to determine the accuracy and generalizability of using automated methods for detecting three high-incidence and high-impact AEs from EHR data: a) hospital-acquired pneumonia, b) ventilator-associated event and, c) central line-associated bloodstream infection. This validation study will be conducted among medical, surgical and ICU patients admitted between 2013 and 2016 to the Centre hospitalier universitaire de Sherbrooke (CHUS) and the McGill University Health Centre (MUHC), which has both French and English sites. A random 60% sample of CHUS patients will be used for model development purposes (cohort 1, development set). Using a random sample of these patients, a reference standard assessment of their medical chart will be performed. Multivariate logistic regression and the area under the curve (AUC) will be employed to iteratively develop and optimize three automated AE detection models (i.e., one per AE of interest) using EHR data from the CHUS. These models will then be validated on a random sample of the remaining 40% of CHUS patients (cohort 1, internal validation set) using chart review to assess accuracy. The most accurate models developed and validated at the CHUS will then be applied to EHR data from a random sample of patients admitted to the MUHC French site (cohort 2) and English site (cohort 3)-a critical requirement given the use of narrative data -, and accuracy will be assessed using chart review. Generalizability will be determined

Pesticide applicators questionnaire content validation: A fuzzy delphi method.

PubMed

Manakandan, S K; Rosnah, I; Mohd Ridhuan, J; Priya, R

2017-08-01

The most crucial step in forming a set of survey questionnaire is deciding the appropriate items in a construct. Retaining irrelevant items and removing important items will certainly mislead the direction of a particular study. This article demonstrates Fuzzy Delphi method as one of the scientific analysis technique to consolidate consensus agreement within a panel of experts pertaining to each item's appropriateness. This method reduces the ambiguity, diversity, and discrepancy of the opinions among the experts hence enhances the quality of the selected items. The main purpose of this study was to obtain experts' consensus on the suitability of the preselected items on the questionnaire. The panel consists of sixteen experts from the Occupational and Environmental Health Unit of Ministry of Health, Vector-borne Disease Control Unit of Ministry of Health and Occupational and Safety Health Unit of both public and private universities. A set of questionnaires related to noise and chemical exposure were compiled based on the literature search. There was a total of six constructs with 60 items in which three constructs for knowledge, attitude, and practice of noise exposure and three constructs for knowledge, attitude, and practice of chemical exposure. The validation process replicated recent Fuzzy Delphi method that using a concept of Triangular Fuzzy Numbers and Defuzzification process. A 100% response rate was obtained from all the sixteen experts with an average Likert scoring of four to five. Post FDM analysis, the first prerequisite was fulfilled with a threshold value (d) ≤ 0.2, hence all the six constructs were accepted. For the second prerequisite, three items (21%) from noise-attitude construct and four items (40%) from chemical-practice construct had expert consensus lesser than 75%, which giving rise to about 12% from the total items in the questionnaire. The third prerequisite was used to rank the items within the constructs by calculating the average

Comparing Thermal Process Validation Methods for Salmonella Inactivation on Almond Kernels.

PubMed

Jeong, Sanghyup; Marks, Bradley P; James, Michael K

2017-01-01

Ongoing regulatory changes are increasing the need for reliable process validation methods for pathogen reduction processes involving low-moisture products; however, the reliability of various validation methods has not been evaluated. Therefore, the objective was to quantify accuracy and repeatability of four validation methods (two biologically based and two based on time-temperature models) for thermal pasteurization of almonds. Almond kernels were inoculated with Salmonella Enteritidis phage type 30 or Enterococcus faecium (NRRL B-2354) at ~10 8 CFU/g, equilibrated to 0.24, 0.45, 0.58, or 0.78 water activity (a w ), and then heated in a pilot-scale, moist-air impingement oven (dry bulb 121, 149, or 177°C; dew point <33.0, 69.4, 81.6, or 90.6°C; v air = 2.7 m/s) to a target lethality of ~4 log. Almond surface temperatures were measured in two ways, and those temperatures were used to calculate Salmonella inactivation using a traditional (D, z) model and a modified model accounting for process humidity. Among the process validation methods, both methods based on time-temperature models had better repeatability, with replication errors approximately half those of the surrogate ( E. faecium ). Additionally, the modified model yielded the lowest root mean squared error in predicting Salmonella inactivation (1.1 to 1.5 log CFU/g); in contrast, E. faecium yielded a root mean squared error of 1.2 to 1.6 log CFU/g, and the traditional model yielded an unacceptably high error (3.4 to 4.4 log CFU/g). Importantly, the surrogate and modified model both yielded lethality predictions that were statistically equivalent (α = 0.05) to actual Salmonella lethality. The results demonstrate the importance of methodology, a w , and process humidity when validating thermal pasteurization processes for low-moisture foods, which should help processors select and interpret validation methods to ensure product safety.

12 CFR 313.2 - Purpose.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 4 2011-01-01 2011-01-01 false Purpose. 313.2 Section 313.2 Banks and Banking... COLLECTION Scope, Purpose, Definitions and Delegations of Authority § 313.2 Purpose. (a) The purpose of this... the manner in which federal agencies should proceed to establish the existence and validity of debts...

12 CFR 313.2 - Purpose.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Purpose. 313.2 Section 313.2 Banks and Banking... COLLECTION Scope, Purpose, Definitions and Delegations of Authority § 313.2 Purpose. (a) The purpose of this... the manner in which federal agencies should proceed to establish the existence and validity of debts...

Forward ultrasonic model validation using wavefield imaging methods

NASA Astrophysics Data System (ADS)

Blackshire, James L.

2018-04-01

The validation of forward ultrasonic wave propagation models in a complex titanium polycrystalline material system is accomplished using wavefield imaging methods. An innovative measurement approach is described that permits the visualization and quantitative evaluation of bulk elastic wave propagation and scattering behaviors in the titanium material for a typical focused immersion ultrasound measurement process. Results are provided for the determination and direct comparison of the ultrasonic beam's focal properties, mode-converted shear wave position and angle, and scattering and reflection from millimeter-sized microtexture regions (MTRs) within the titanium material. The approach and results are important with respect to understanding the root-cause backscatter signal responses generated in aerospace engine materials, where model-assisted methods are being used to understand the probabilistic nature of the backscatter signal content. Wavefield imaging methods are shown to be an effective means for corroborating and validating important forward model predictions in a direct manner using time- and spatially-resolved displacement field amplitude measurements.

Content validity across methods of malnutrition assessment in patients with cancer is limited.

PubMed

Sealy, Martine J; Nijholt, Willemke; Stuiver, Martijn M; van der Berg, Marit M; Roodenburg, Jan L N; van der Schans, Cees P; Ottery, Faith D; Jager-Wittenaar, Harriët

2016-08-01

To identify malnutrition assessment methods in cancer patients and assess their content validity based on internationally accepted definitions for malnutrition. Systematic review of studies in cancer patients that operationalized malnutrition as a variable, published since 1998. Eleven key concepts, within the three domains reflected by the malnutrition definitions acknowledged by European Society for Clinical Nutrition and Metabolism (ESPEN) and the American Society for Parenteral and Enteral Nutrition (ASPEN): A: nutrient balance; B: changes in body shape, body area and body composition; and C: function, were used to classify content validity of methods to assess malnutrition. Content validity indices (M-CVIA-C) were calculated per assessment method. Acceptable content validity was defined as M-CVIA-C ≥ 0.80. Thirty-seven assessment methods were identified in the 160 included articles. Mini Nutritional Assessment (M-CVIA-C = 0.72), Scored Patient-Generated Subjective Global Assessment (M-CVIA-C = 0.61), and Subjective Global Assessment (M-CVIA-C = 0.53) scored highest M-CVIA-C. A large number of malnutrition assessment methods are used in cancer research. Content validity of these methods varies widely. None of these assessment methods has acceptable content validity, when compared against a construct based on ESPEN and ASPEN definitions of malnutrition. Copyright © 2016 Elsevier Inc. All rights reserved.

Content Validity of National Post Marriage Educational Program Using Mixed Methods

PubMed Central

MOHAJER RAHBARI, Masoumeh; SHARIATI, Mohammad; KERAMAT, Afsaneh; YUNESIAN, Masoud; ESLAMI, Mohammad; MOUSAVI, Seyed Abbas; MONTAZERI, Ali

2015-01-01

Background: Although the validity of content of program is mostly conducted with qualitative methods, this study used both qualitative and quantitative methods for the validation of content of post marriage training program provided for newly married couples. Content validity is a preliminary step of obtaining authorization required to install the program in country's health care system. Methods: This mixed methodological content validation study carried out in four steps with forming three expert panels. Altogether 24 expert panelists were involved in 3 qualitative and quantitative panels; 6 in the first item development one; 12 in the reduction kind, 4 of them were common with the first panel, and 10 executive experts in the last one organized to evaluate psychometric properties of CVR and CVI and Face validity of 57 educational objectives. Results: The raw data of post marriage program had been written by professional experts of Ministry of Health, using qualitative expert panel, the content was more developed by generating 3 topics and refining one topic and its respective content. In the second panel, totally six other objectives were deleted, three for being out of agreement cut of point and three on experts' consensus. The validity of all items was above 0.8 and their content validity indices (0.8–1) were completely appropriate in quantitative assessment. Conclusion: This study provided a good evidence for validation and accreditation of national post marriage program planned for newly married couples in health centers of the country in the near future. PMID:26056672

A validated UPLC-MS/MS method for flibanserin in plasma and its pharmacokinetic interaction with bosentan in rats.

PubMed

Iqbal, Muzaffar; Ezzeldin, Essam; Rezk, Naser L; Bajrai, Amal A; Al-Rashood, Khalid A

2018-04-25

The purpose of this study was development, validation and application of ultra-performance liquid chromatography (UPLC)-ESI-MS/MS method for quantitation of flibanserin in plasma samples. After extraction of analyte from plasma by diethyl ether, separation was performed on UPLC C 18 column using mobile phase composition of 10 mM ammonium formate-acetonitrile (30:70, v/v) by isocratic elution of 0.3 ml/min. The multiple reaction monitoring transitions of m/z 391.13→ 161.04 and 384.20→ 253.06 were used for detection of analyte and internal standard (quetiapine), respectively. The calibration curves were linear (r ≥0.995) between 0.22 and 555 ng/ml concentration and all validation results were within the acceptable range as per US FDA guidelines. The assay procedure was fully validated and successfully applied in pharmacokinetic interaction study of flibanserin with bosentan in rats.

Adolescent Personality: A Five-Factor Model Construct Validation

ERIC Educational Resources Information Center

Baker, Spencer T.; Victor, James B.; Chambers, Anthony L.; Halverson, Jr., Charles F.

2004-01-01

The purpose of this study was to investigate convergent and discriminant validity of the five-factor model of adolescent personality in a school setting using three different raters (methods): self-ratings, peer ratings, and teacher ratings. The authors investigated validity through a multitrait-multimethod matrix and a confirmatory factor…

An Engineering Method of Civil Jet Requirements Validation Based on Requirements Project Principle

NASA Astrophysics Data System (ADS)

Wang, Yue; Gao, Dan; Mao, Xuming

2018-03-01

A method of requirements validation is developed and defined to meet the needs of civil jet requirements validation in product development. Based on requirements project principle, this method will not affect the conventional design elements, and can effectively connect the requirements with design. It realizes the modern civil jet development concept, which is “requirement is the origin, design is the basis”. So far, the method has been successfully applied in civil jet aircraft development in China. Taking takeoff field length as an example, the validation process and the validation method of the requirements are detailed introduced in the study, with the hope of providing the experiences to other civil jet product design.

Objectivity and validity of EMG method in estimating anaerobic threshold.

PubMed

Kang, S-K; Kim, J; Kwon, M; Eom, H

2014-08-01

The purposes of this study were to verify and compare the performances of anaerobic threshold (AT) point estimates among different filtering intervals (9, 15, 20, 25, 30 s) and to investigate the interrelationships of AT point estimates obtained by ventilatory threshold (VT) and muscle fatigue thresholds using electromyographic (EMG) activity during incremental exercise on a cycle ergometer. 69 untrained male university students, yet pursuing regular exercise voluntarily participated in this study. The incremental exercise protocol was applied with a consistent stepwise increase in power output of 20 watts per minute until exhaustion. AT point was also estimated in the same manner using V-slope program with gas exchange parameters. In general, the estimated values of AT point-time computed by EMG method were more consistent across 5 filtering intervals and demonstrated higher correlations among themselves when compared with those values obtained by VT method. The results found in the present study suggest that the EMG signals could be used as an alternative or a new option in estimating AT point. Also the proposed computing procedure implemented in Matlab for the analysis of EMG signals appeared to be valid and reliable as it produced nearly identical values and high correlations with VT estimates. © Georg Thieme Verlag KG Stuttgart · New York.

Validated spectrofluorimetric method for the determination of clonazepam in pharmaceutical preparations.

PubMed

Ibrahim, Fawzia; El-Enany, Nahed; Shalan, Shereen; Elsharawy, Rasha

2016-05-01

A simple, highly sensitive and validated spectrofluorimetric method was applied in the determination of clonazepam (CLZ). The method is based on reduction of the nitro group of clonazepam with zinc/CaCl2, and the product is then reacted with 2-cyanoacetamide (2-CNA) in the presence of ammonia (25%) yielding a highly fluorescent product. The produced fluorophore exhibits strong fluorescence intensity at ʎ(em) = 383 nm after excitation at ʎ(ex) = 333 nm. The method was rectilinear over a concentration range of 0.1-0.5 ng/mL with a limit of detection (LOD) of 0.0057 ng/mL and a limit of quantification (LOQ) of 0.017 ng/mL. The method was fully validated and successfully applied to the determination of CLZ in its tablets with a mean percentage recovery of 100.10 ± 0.75%. Method validation according to ICH Guidelines was evaluated. Statistical analysis of the results obtained using the proposed method was successfully compared with those obtained using a reference method, and there was no significance difference between the two methods in terms of accuracy and precision. Copyright © 2015 John Wiley & Sons, Ltd.

Reliability and validity of the AutoCAD software method in lumbar lordosis measurement

PubMed Central

Letafatkar, Amir; Amirsasan, Ramin; Abdolvahabi, Zahra; Hadadnezhad, Malihe

2011-01-01

Objective The aim of this study was to determine the reliability and validity of the AutoCAD software method in lumbar lordosis measurement. Methods Fifty healthy volunteers with a mean age of 23 ± 1.80 years were enrolled. A lumbar lateral radiograph was taken on all participants, and the lordosis was measured according to the Cobb method. Afterward, the lumbar lordosis degree was measured via AutoCAD software and flexible ruler methods. The current study is accomplished in 2 parts: intratester and intertester evaluations of reliability as well as the validity of the flexible ruler and software methods. Results Based on the intraclass correlation coefficient, AutoCAD's reliability and validity in measuring lumbar lordosis were 0.984 and 0.962, respectively. Conclusions AutoCAD showed to be a reliable and valid method to measure lordosis. It is suggested that this method may replace those that are costly and involve health risks, such as radiography, in evaluating lumbar lordosis. PMID:22654681

Dynamic Time Warping compared to established methods for validation of musculoskeletal models.

PubMed

Gaspar, Martin; Welke, Bastian; Seehaus, Frank; Hurschler, Christof; Schwarze, Michael

2017-04-11

By means of Multi-Body musculoskeletal simulation, important variables such as internal joint forces and moments can be estimated which cannot be measured directly. Validation can ensued by qualitative or by quantitative methods. Especially when comparing time-dependent signals, many methods do not perform well and validation is often limited to qualitative approaches. The aim of the present study was to investigate the capabilities of the Dynamic Time Warping (DTW) algorithm for comparing time series, which can quantify phase as well as amplitude errors. We contrast the sensitivity of DTW with other established metrics: the Pearson correlation coefficient, cross-correlation, the metric according to Geers, RMSE and normalized RMSE. This study is based on two data sets, where one data set represents direct validation and the other represents indirect validation. Direct validation was performed in the context of clinical gait-analysis on trans-femoral amputees fitted with a 6 component force-moment sensor. Measured forces and moments from amputees' socket-prosthesis are compared to simulated forces and moments. Indirect validation was performed in the context of surface EMG measurements on a cohort of healthy subjects with measurements taken of seven muscles of the leg, which were compared to simulated muscle activations. Regarding direct validation, a positive linear relation between results of RMSE and nRMSE to DTW can be seen. For indirect validation, a negative linear relation exists between Pearson correlation and cross-correlation. We propose the DTW algorithm for use in both direct and indirect quantitative validation as it correlates well with methods that are most suitable for one of the tasks. However, in DV it should be used together with methods resulting in a dimensional error value, in order to be able to interpret results more comprehensible. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

PubMed

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

2010-02-01

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

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

PubMed

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

2013-01-01

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

Voltammetric determination of copper in selected pharmaceutical preparations--validation of the method.

PubMed

Lutka, Anna; Maruszewska, Małgorzata

2011-01-01

It were established and validated the conditions of voltammetric determination of copper in pharmaceutical preparations. The three selected preparations: Zincuprim (A), Wapń, cynk, miedź z wit. C (B), Vigor complete (V) contained different salts and different quantity of copper (II) and increasing number of accompanied ingredients. For the purpose to transfer copper into solution, the samples of powdered tablets of the first and second preparation were undergone extraction and of the third the mineralization procedures. The concentration of copper in solution was determined by differential pulse voltammetry (DP) using comparison with standard technique. In the validation process, the selectivity, accuracy, precision and linearity of DP determination of copper in three preparations were estimated. Copper was determined within the concentration range of 1-9 ppm (1-9 microg/mL): the mean recoveries approached 102% (A), 100% (B), 102% (V); the relative standard deviations of determinations (RSD) were 0.79-1.59% (A), 0.62-0.85% (B) and 1.68-2.28% (V), respectively. The mean recoveries and the RSDs of determination satisfied the requirements for the analyte concentration at the level 1-10 ppm. The statistical verification confirmed that the tested voltammetric method is suitable for determination of copper in pharmaceutical preparation.

Purposes and methods of scoring earthquake forecasts

NASA Astrophysics Data System (ADS)

Zhuang, J.

2010-12-01

There are two kinds of purposes in the studies on earthquake prediction or forecasts: one is to give a systematic estimation of earthquake risks in some particular region and period in order to give advice to governments and enterprises for the use of reducing disasters, the other one is to search for reliable precursors that can be used to improve earthquake prediction or forecasts. For the first case, a complete score is necessary, while for the latter case, a partial score, which can be used to evaluate whether the forecasts or predictions have some advantages than a well know model, is necessary. This study reviews different scoring methods for evaluating the performance of earthquake prediction and forecasts. Especially, the gambling scoring method, which is developed recently, shows its capacity in finding good points in an earthquake prediction algorithm or model that are not in a reference model, even if its overall performance is no better than the reference model.

Method development and validation of potent pyrimidine derivative by UV-VIS spectrophotometer.

PubMed

Chaudhary, Anshu; Singh, Anoop; Verma, Prabhakar Kumar

2014-12-01

A rapid and sensitive ultraviolet-visible (UV-VIS) spectroscopic method was developed for the estimation of pyrimidine derivative 6-Bromo-3-(6-(2,6-dichlorophenyl)-2-(morpolinomethylamino) pyrimidine4-yl) -2H-chromen-2-one (BT10M) in bulk form. Pyrimidine derivative was monitored at 275 nm with UV detection, and there is no interference of diluents at 275 nm. The method was found to be linear in the range of 50 to 150 μg/ml. The accuracy and precision were determined and validated statistically. The method was validated as a guideline. The results showed that the proposed method is suitable for the accurate, precise, and rapid determination of pyrimidine derivative. Graphical Abstract Method development and validation of potent pyrimidine derivative by UV spectroscopy.

A photographic method to measure food item intake. Validation in geriatric institutions.

PubMed

Pouyet, Virginie; Cuvelier, Gérard; Benattar, Linda; Giboreau, Agnès

2015-01-01

From both a clinical and research perspective, measuring food intake is an important issue in geriatric institutions. However, weighing food in this context can be complex, particularly when the items remaining on a plate (side dish, meat or fish and sauce) need to be weighed separately following consumption. A method based on photography that involves taking photographs after a meal to determine food intake consequently seems to be a good alternative. This method enables the storage of raw data so that unhurried analyses can be performed to distinguish the food items present in the images. Therefore, the aim of this paper was to validate a photographic method to measure food intake in terms of differentiating food item intake in the context of a geriatric institution. Sixty-six elderly residents took part in this study, which was performed in four French nursing homes. Four dishes of standardized portions were offered to the residents during 16 different lunchtimes. Three non-trained assessors then independently estimated both the total and specific food item intakes of the participants using images of their plates taken after the meal (photographic method) and a reference image of one plate taken before the meal. Total food intakes were also recorded by weighing the food. To test the reliability of the photographic method, agreements between different assessors and agreements among various estimates made by the same assessor were evaluated. To test the accuracy and specificity of this method, food intake estimates for the four dishes were compared with the food intakes determined using the weighed food method. To illustrate the added value of the photographic method, food consumption differences between the dishes were explained by investigating the intakes of specific food items. Although they were not specifically trained for this purpose, the results demonstrated that the assessor estimates agreed between assessors and among various estimates made by the same

A long-term validation of the modernised DC-ARC-OES solid-sample method.

PubMed

Flórián, K; Hassler, J; Förster, O

2001-12-01

The validation procedure based on ISO 17025 standard has been used to study and illustrate both the longterm stability of the calibration process of the DC-ARC solid sample spectrometric method and the main validation criteria of the method. In the calculation of the validation characteristics depending on the linearity(calibration), also the fulfilment of predetermining criteria such as normality and homoscedasticity was checked. In order to decide whether there are any trends in the time-variation of the analytical signal or not, also the Neumann test of trend was applied and evaluated. Finally, a comparison with similar validation data of the ETV-ICP-OES method was carried out.

Reliability and validity of the AutoCAD software method in lumbar lordosis measurement.

PubMed

Letafatkar, Amir; Amirsasan, Ramin; Abdolvahabi, Zahra; Hadadnezhad, Malihe

2011-12-01

The aim of this study was to determine the reliability and validity of the AutoCAD software method in lumbar lordosis measurement. Fifty healthy volunteers with a mean age of 23 ± 1.80 years were enrolled. A lumbar lateral radiograph was taken on all participants, and the lordosis was measured according to the Cobb method. Afterward, the lumbar lordosis degree was measured via AutoCAD software and flexible ruler methods. The current study is accomplished in 2 parts: intratester and intertester evaluations of reliability as well as the validity of the flexible ruler and software methods. Based on the intraclass correlation coefficient, AutoCAD's reliability and validity in measuring lumbar lordosis were 0.984 and 0.962, respectively. AutoCAD showed to be a reliable and valid method to measure lordosis. It is suggested that this method may replace those that are costly and involve health risks, such as radiography, in evaluating lumbar lordosis.

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

PubMed

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

2010-03-01

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

Validity in Mixed Methods Research in Education: The Application of Habermas' Critical Theory

ERIC Educational Resources Information Center

Long, Haiying

2017-01-01

Mixed methods approach has developed into the third methodological movement in educational research. Validity in mixed methods research as an important issue, however, has not been examined as extensively as that of quantitative and qualitative research. Additionally, the previous discussions of validity in mixed methods research focus on research…

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

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

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

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

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

PubMed

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

2018-05-04

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

Determination of free sulphydryl groups in wheat gluten under the influence of different time and temperature of incubation: method validation.

PubMed

Rakita, Slađana; Pojić, Milica; Tomić, Jelena; Torbica, Aleksandra

2014-05-01

The aim of the present study was to determine the characteristics of an analytical method for determination of free sulphydryl (SH) groups of wheat gluten performed with previous gluten incubation for variable times (45, 90 and 135min) at variable temperatures (30 and 37°C), in order to determine its fitness-for-purpose. It was observed that the increase in temperature and gluten incubation time caused the increase in the amount of free SH groups, with more dynamic changes at 37°C. The method characteristics identified as relevant were: linearity, limit of detection, limit of quantification, precision (repeatability and reproducibility) and measurement uncertainty, which were checked within the validation protocol, while the method performance was monitored by X- and R-control charts. Identified method characteristics demonstrated its acceptable fitness-for-purpose, when assay included previous gluten incubation at 30°C. Although the method repeatability at 37°C was acceptable, the corresponding reproducibility did not meet the performance criterion on the basis of HORRAT value (HORRAT<2). Copyright © 2013 Elsevier Ltd. All rights reserved.

Quality control of colonoscopy procedures: a prospective validated method for the evaluation of professional practices applicable to all endoscopic units.

PubMed

Coriat, R; Pommaret, E; Chryssostalis, A; Viennot, S; Gaudric, M; Brezault, C; Lamarque, D; Roche, H; Verdier, D; Parlier, D; Prat, F; Chaussade, S

2009-02-01

To produce valid information, an evaluation of professional practices has to assess the quality of all practices before, during and after the procedure under study. Several auditing techniques have been proposed for colonoscopy. The purpose of this work is to describe a straightforward original validated method for the prospective evaluation of professional practices in the field of colonoscopy applicable in all endoscopy units without increasing the staff work load. Pertinent quality-control criteria (14 items) were identified by the endoscopists at the Cochin Hospital and were compatible with: findings in the available literature; guidelines proposed by the Superior Health Authority; and application in any endoscopy unit. Prospective routine data were collected and the methodology validated by evaluating 50 colonoscopies every quarter for one year. The relevance of the criteria was assessed using data collected during four separate periods. The standard checklist was complete for 57% of the colonoscopy procedures. The colonoscopy procedure was appropriate according to national guidelines in 94% of cases. These observations were particularly noteworthy: the quality of the colonic preparation was insufficient for 9% of the procedures; complete colonoscopy was achieved for 93% of patients; and 0.38 adenomas and 0.045 carcinomas were identified per colonoscopy. This simple and reproducible method can be used for valid quality-control audits in all endoscopy units. In France, unit-wide application of this method enables endoscopists to validate 100 of the 250 points required for continuous medical training. This is a quality-control tool that can be applied annually, using a random month to evaluate any changes in routine practices.

External Validity in Policy Evaluations That Choose Sites Purposively

ERIC Educational Resources Information Center

Olsen, Robert B.; Orr, Larry L.; Bell, Stephen H.; Stuart, Elizabeth A.

2013-01-01

Evaluations of the impact of social programs are often carried out in multiple sites, such as school districts, housing authorities, local TANF offices, or One-Stop Career Centers. Most evaluations select sites purposively following a process that is nonrandom. Unfortunately, purposive site selection can produce a sample of sites that is not…

A Systematic Review of Validated Methods for Identifying Cerebrovascular Accident or Transient Ischemic Attack Using Administrative Data

PubMed Central

Andrade, Susan E.; Harrold, Leslie R.; Tjia, Jennifer; Cutrona, Sarah L.; Saczynski, Jane S.; Dodd, Katherine S.; Goldberg, Robert J.; Gurwitz, Jerry H.

2012-01-01

Purpose To perform a systematic review of the validity of algorithms for identifying cerebrovascular accidents (CVAs) or transient ischemic attacks (TIAs) using administrative and claims data. Methods PubMed and Iowa Drug Information Service (IDIS) searches of the English language literature were performed to identify studies published between 1990 and 2010 that evaluated the validity of algorithms for identifying CVAs (ischemic and hemorrhagic strokes, intracranial hemorrhage and subarachnoid hemorrhage) and/or TIAs in administrative data. Two study investigators independently reviewed the abstracts and articles to determine relevant studies according to pre-specified criteria. Results A total of 35 articles met the criteria for evaluation. Of these, 26 articles provided data to evaluate the validity of stroke, 7 reported the validity of TIA, 5 reported the validity of intracranial bleeds (intracerebral hemorrhage and subarachnoid hemorrhage), and 10 studies reported the validity of algorithms to identify the composite endpoints of stroke/TIA or cerebrovascular disease. Positive predictive values (PPVs) varied depending on the specific outcomes and algorithms evaluated. Specific algorithms to evaluate the presence of stroke and intracranial bleeds were found to have high PPVs (80% or greater). Algorithms to evaluate TIAs in adult populations were generally found to have PPVs of 70% or greater. Conclusions The algorithms and definitions to identify CVAs and TIAs using administrative and claims data differ greatly in the published literature. The choice of the algorithm employed should be determined by the stroke subtype of interest. PMID:22262598

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

PubMed

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

2007-06-01

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

E-Flux2 and SPOT: Validated Methods for Inferring Intracellular Metabolic Flux Distributions from Transcriptomic Data.

PubMed

Kim, Min Kyung; Lane, Anatoliy; Kelley, James J; Lun, Desmond S

2016-01-01

Several methods have been developed to predict system-wide and condition-specific intracellular metabolic fluxes by integrating transcriptomic data with genome-scale metabolic models. While powerful in many settings, existing methods have several shortcomings, and it is unclear which method has the best accuracy in general because of limited validation against experimentally measured intracellular fluxes. We present a general optimization strategy for inferring intracellular metabolic flux distributions from transcriptomic data coupled with genome-scale metabolic reconstructions. It consists of two different template models called DC (determined carbon source model) and AC (all possible carbon sources model) and two different new methods called E-Flux2 (E-Flux method combined with minimization of l2 norm) and SPOT (Simplified Pearson cOrrelation with Transcriptomic data), which can be chosen and combined depending on the availability of knowledge on carbon source or objective function. This enables us to simulate a broad range of experimental conditions. We examined E. coli and S. cerevisiae as representative prokaryotic and eukaryotic microorganisms respectively. The predictive accuracy of our algorithm was validated by calculating the uncentered Pearson correlation between predicted fluxes and measured fluxes. To this end, we compiled 20 experimental conditions (11 in E. coli and 9 in S. cerevisiae), of transcriptome measurements coupled with corresponding central carbon metabolism intracellular flux measurements determined by 13C metabolic flux analysis (13C-MFA), which is the largest dataset assembled to date for the purpose of validating inference methods for predicting intracellular fluxes. In both organisms, our method achieves an average correlation coefficient ranging from 0.59 to 0.87, outperforming a representative sample of competing methods. Easy-to-use implementations of E-Flux2 and SPOT are available as part of the open-source package MOST (http

A guideline for the validation of likelihood ratio methods used for forensic evidence evaluation.

PubMed

Meuwly, Didier; Ramos, Daniel; Haraksim, Rudolf

2017-07-01

This Guideline proposes a protocol for the validation of forensic evaluation methods at the source level, using the Likelihood Ratio framework as defined within the Bayes' inference model. In the context of the inference of identity of source, the Likelihood Ratio is used to evaluate the strength of the evidence for a trace specimen, e.g. a fingermark, and a reference specimen, e.g. a fingerprint, to originate from common or different sources. Some theoretical aspects of probabilities necessary for this Guideline were discussed prior to its elaboration, which started after a workshop of forensic researchers and practitioners involved in this topic. In the workshop, the following questions were addressed: "which aspects of a forensic evaluation scenario need to be validated?", "what is the role of the LR as part of a decision process?" and "how to deal with uncertainty in the LR calculation?". The questions: "what to validate?" focuses on the validation methods and criteria and "how to validate?" deals with the implementation of the validation protocol. Answers to these questions were deemed necessary with several objectives. First, concepts typical for validation standards [1], such as performance characteristics, performance metrics and validation criteria, will be adapted or applied by analogy to the LR framework. Second, a validation strategy will be defined. Third, validation methods will be described. Finally, a validation protocol and an example of validation report will be proposed, which can be applied to the forensic fields developing and validating LR methods for the evaluation of the strength of evidence at source level under the following propositions. Copyright © 2016. Published by Elsevier B.V.

Design, development and method validation of a novel multi-resonance microwave sensor for moisture measurement.

PubMed

Peters, Johanna; Taute, Wolfgang; Bartscher, Kathrin; Döscher, Claas; Höft, Michael; Knöchel, Reinhard; Breitkreutz, Jörg

2017-04-08

Microwave sensor systems using resonance technology at a single resonance in the range of 2-3 GHz have been shown to be a rapid and reliable tool for moisture determination in solid materials including pharmaceutical granules. So far, their application is limited to lower moisture ranges or limitations above certain moisture contents had to be accepted. Aim of the present study was to develop a novel multi-resonance sensor system in order to expand the measurement range. Therefore, a novel sensor using additional resonances over a wide frequency band was designed and used to investigate inherent limitations of first generation sensor systems and material-related limits. Using granule samples with different moisture contents, an experimental protocol for calibration and validation of the method was established. Pursuant to this protocol, a multiple linear regression (MLR) prediction model built by correlating microwave moisture values to the moisture determined by Karl Fischer titration was chosen and rated using conventional criteria such as coefficient of determination (R 2 ) and root mean square error of calibration (RMSEC). Using different operators, different analysis dates and different ambient conditions the method was fully validated following the guidance of ICH Q2(R1). The study clearly showed explanations for measurement uncertainties of first generation sensor systems which confirmed the approach to overcome these by using additional resonances. The established prediction model could be validated in the range of 7.6-19.6%, demonstrating its fit for its future purpose, the moisture content determination during wet granulations. Copyright © 2017 Elsevier B.V. All rights reserved.

Methods for Geometric Data Validation of 3d City Models

NASA Astrophysics Data System (ADS)

Wagner, D.; Alam, N.; Wewetzer, M.; Pries, M.; Coors, V.

2015-12-01

Geometric quality of 3D city models is crucial for data analysis and simulation tasks, which are part of modern applications of the data (e.g. potential heating energy consumption of city quarters, solar potential, etc.). Geometric quality in these contexts is however a different concept as it is for 2D maps. In the latter case, aspects such as positional or temporal accuracy and correctness represent typical quality metrics of the data. They are defined in ISO 19157 and should be mentioned as part of the metadata. 3D data has a far wider range of aspects which influence their quality, plus the idea of quality itself is application dependent. Thus, concepts for definition of quality are needed, including methods to validate these definitions. Quality on this sense means internal validation and detection of inconsistent or wrong geometry according to a predefined set of rules. A useful starting point would be to have correct geometry in accordance with ISO 19107. A valid solid should consist of planar faces which touch their neighbours exclusively in defined corner points and edges. No gaps between them are allowed, and the whole feature must be 2-manifold. In this paper, we present methods to validate common geometric requirements for building geometry. Different checks based on several algorithms have been implemented to validate a set of rules derived from the solid definition mentioned above (e.g. water tightness of the solid or planarity of its polygons), as they were developed for the software tool CityDoctor. The method of each check is specified, with a special focus on the discussion of tolerance values where they are necessary. The checks include polygon level checks to validate the correctness of each polygon, i.e. closeness of the bounding linear ring and planarity. On the solid level, which is only validated if the polygons have passed validation, correct polygon orientation is checked, after self-intersections outside of defined corner points and edges

Empirical Performance of Cross-Validation With Oracle Methods in a Genomics Context

PubMed Central

Martinez, Josue G.; Carroll, Raymond J.; Müller, Samuel; Sampson, Joshua N.; Chatterjee, Nilanjan

2012-01-01

When employing model selection methods with oracle properties such as the smoothly clipped absolute deviation (SCAD) and the Adaptive Lasso, it is typical to estimate the smoothing parameter by m-fold cross-validation, for example, m = 10. In problems where the true regression function is sparse and the signals large, such cross-validation typically works well. However, in regression modeling of genomic studies involving Single Nucleotide Polymorphisms (SNP), the true regression functions, while thought to be sparse, do not have large signals. We demonstrate empirically that in such problems, the number of selected variables using SCAD and the Adaptive Lasso, with 10-fold cross-validation, is a random variable that has considerable and surprising variation. Similar remarks apply to non-oracle methods such as the Lasso. Our study strongly questions the suitability of performing only a single run of m-fold cross-validation with any oracle method, and not just the SCAD and Adaptive Lasso. PMID:22347720

Empirical Performance of Cross-Validation With Oracle Methods in a Genomics Context.

PubMed

Martinez, Josue G; Carroll, Raymond J; Müller, Samuel; Sampson, Joshua N; Chatterjee, Nilanjan

2011-11-01

When employing model selection methods with oracle properties such as the smoothly clipped absolute deviation (SCAD) and the Adaptive Lasso, it is typical to estimate the smoothing parameter by m-fold cross-validation, for example, m = 10. In problems where the true regression function is sparse and the signals large, such cross-validation typically works well. However, in regression modeling of genomic studies involving Single Nucleotide Polymorphisms (SNP), the true regression functions, while thought to be sparse, do not have large signals. We demonstrate empirically that in such problems, the number of selected variables using SCAD and the Adaptive Lasso, with 10-fold cross-validation, is a random variable that has considerable and surprising variation. Similar remarks apply to non-oracle methods such as the Lasso. Our study strongly questions the suitability of performing only a single run of m-fold cross-validation with any oracle method, and not just the SCAD and Adaptive Lasso.

Determination of vitamin C in foods: current state of method validation.

PubMed

Spínola, Vítor; Llorent-Martínez, Eulogio J; Castilho, Paula C

2014-11-21

Vitamin C is one of the most important vitamins, so reliable information about its content in foodstuffs is a concern to both consumers and quality control agencies. However, the heterogeneity of food matrixes and the potential degradation of this vitamin during its analysis create enormous challenges. This review addresses the development and validation of high-performance liquid chromatography methods for vitamin C analysis in food commodities, during the period 2000-2014. The main characteristics of vitamin C are mentioned, along with the strategies adopted by most authors during sample preparation (freezing and acidification) to avoid vitamin oxidation. After that, the advantages and handicaps of different analytical methods are discussed. Finally, the main aspects concerning method validation for vitamin C analysis are critically discussed. Parameters such as selectivity, linearity, limit of quantification, and accuracy were studied by most authors. Recovery experiments during accuracy evaluation were in general satisfactory, with usual values between 81 and 109%. However, few methods considered vitamin C stability during the analytical process, and the study of the precision was not always clear or complete. Potential future improvements regarding proper method validation are indicated to conclude this review. Copyright © 2014. Published by Elsevier B.V.

Development and Validation of New Discriminative Dissolution Method for Carvedilol Tablets

PubMed Central

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

2011-01-01

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

Validation of model-based deformation correction in image-guided liver surgery via tracked intraoperative ultrasound: preliminary method and results

NASA Astrophysics Data System (ADS)

Clements, Logan W.; Collins, Jarrod A.; Wu, Yifei; Simpson, Amber L.; Jarnagin, William R.; Miga, Michael I.

2015-03-01

Soft tissue deformation represents a significant error source in current surgical navigation systems used for open hepatic procedures. While numerous algorithms have been proposed to rectify the tissue deformation that is encountered during open liver surgery, clinical validation of the proposed methods has been limited to surface based metrics and sub-surface validation has largely been performed via phantom experiments. Tracked intraoperative ultrasound (iUS) provides a means to digitize sub-surface anatomical landmarks during clinical procedures. The proposed method involves the validation of a deformation correction algorithm for open hepatic image-guided surgery systems via sub-surface targets digitized with tracked iUS. Intraoperative surface digitizations were acquired via a laser range scanner and an optically tracked stylus for the purposes of computing the physical-to-image space registration within the guidance system and for use in retrospective deformation correction. Upon completion of surface digitization, the organ was interrogated with a tracked iUS transducer where the iUS images and corresponding tracked locations were recorded. After the procedure, the clinician reviewed the iUS images to delineate contours of anatomical target features for use in the validation procedure. Mean closest point distances between the feature contours delineated in the iUS images and corresponding 3-D anatomical model generated from the preoperative tomograms were computed to quantify the extent to which the deformation correction algorithm improved registration accuracy. The preliminary results for two patients indicate that the deformation correction method resulted in a reduction in target error of approximately 50%.

Evaluation of email alerts in practice: Part 2. Validation of the information assessment method.

PubMed

Pluye, Pierre; Grad, Roland M; Johnson-Lafleur, Janique; Bambrick, Tara; Burnand, Bernard; Mercer, Jay; Marlow, Bernard; Campbell, Craig

2010-12-01

The information assessment method (IAM) permits health professionals to systematically document the relevance, cognitive impact, use and health outcomes of information objects delivered by or retrieved from electronic knowledge resources. The companion review paper (Part 1) critically examined the literature, and proposed a 'Push-Pull-Acquisition-Cognition-Application' evaluation framework, which is operationalized by IAM. The purpose of the present paper (Part 2) is to examine the content validity of the IAM cognitive checklist when linked to email alerts. A qualitative component of a mixed methods study was conducted with 46 doctors reading and rating research-based synopses sent on email. The unit of analysis was a doctor's explanation of a rating of one item regarding one synopsis. Interviews with participants provided 253 units that were analysed to assess concordance with item definitions. The content relevance of seven items was supported. For three items, revisions were needed. Interviews suggested one new item. This study has yielded a 2008 version of IAM. © 2010 Blackwell Publishing Ltd.

VALUE - Validating and Integrating Downscaling Methods for Climate Change Research

NASA Astrophysics Data System (ADS)

Maraun, Douglas; Widmann, Martin; Benestad, Rasmus; Kotlarski, Sven; Huth, Radan; Hertig, Elke; Wibig, Joanna; Gutierrez, Jose

2013-04-01

Our understanding of global climate change is mainly based on General Circulation Models (GCMs) with a relatively coarse resolution. Since climate change impacts are mainly experienced on regional scales, high-resolution climate change scenarios need to be derived from GCM simulations by downscaling. Several projects have been carried out over the last years to validate the performance of statistical and dynamical downscaling, yet several aspects have not been systematically addressed: variability on sub-daily, decadal and longer time-scales, extreme events, spatial variability and inter-variable relationships. Different downscaling approaches such as dynamical downscaling, statistical downscaling and bias correction approaches have not been systematically compared. Furthermore, collaboration between different communities, in particular regional climate modellers, statistical downscalers and statisticians has been limited. To address these gaps, the EU Cooperation in Science and Technology (COST) action VALUE (www.value-cost.eu) has been brought into life. VALUE is a research network with participants from currently 23 European countries running from 2012 to 2015. Its main aim is to systematically validate and develop downscaling methods for climate change research in order to improve regional climate change scenarios for use in climate impact studies. Inspired by the co-design idea of the international research initiative "future earth", stakeholders of climate change information have been involved in the definition of research questions to be addressed and are actively participating in the network. The key idea of VALUE is to identify the relevant weather and climate characteristics required as input for a wide range of impact models and to define an open framework to systematically validate these characteristics. Based on a range of benchmark data sets, in principle every downscaling method can be validated and compared with competing methods. The results of

Analyzing the Validity of the Adult-Adolescent Parenting Inventory for Low-Income Populations

ERIC Educational Resources Information Center

Lawson, Michael A.; Alameda-Lawson, Tania; Byrnes, Edward

2017-01-01

Objectives: The purpose of this study was to examine the construct and predictive validity of the Adult-Adolescent Parenting Inventory (AAPI-2). Methods: The validity of the AAPI-2 was evaluated using multiple statistical methods, including exploratory factor analysis, confirmatory factor analysis, and latent class analysis. These analyses were…

ePortfolios: The Method of Choice for Validation

ERIC Educational Resources Information Center

Scott, Ken; Kim, Jichul

2015-01-01

Community colleges have long been institutions of higher education in the arenas of technical education and training, as well as preparing students for transfer to universities. While students are engaged in their student learning outcomes, projects, research, and community service, how have these students validated their work? One method of…

Validation of a spectrophotometric assay method for bisoprolol using picric acid.

PubMed

Panainte, Alina-Diana; Bibire, Nela; Tântaru, Gladiola; Apostu, M; Vieriu, Mădălina

2013-01-01

Bisoprolol is a drug belonging to beta blockers drugs used primarily for the treatment of cardiovascular diseases. A spectrophotometric method for quantitative determination of bisoprolol was developed based on the formation of a complex combination between bisoprolol and picric acid. The complex combination of bisoprolol and picric acid has a maximum absorbance peak at 420 nm. Optimum working conditions were established and the method was validated. The method presented a good linearity in the concentration range 5-120 microg/ml (regression coefficient r2 = 0.9992). The RSD for the precision of the method was 1.74 and for the intermediate precision 1.43, and recovery values ranged between 98.25-101.48%. The proposed and validated spectrophotometric method for the determination of bisoprolol is simple and cost effective.

Validation of "Teaching and Learning Guiding Principles Instrument" for Malaysian Higher Learning Institutions

ERIC Educational Resources Information Center

Rahman, Nurulhuda Abd; Masuwai, Azwani; Tajudin, Nor'ain Mohd; Tek, Ong Eng; Adnan, Mazlini

2016-01-01

Purpose: This study was aimed at establishing, through the validation of the "Teaching and Learning Guiding Principles Instrument" (TLGPI), the validity and reliability of the underlying factor structure of the Teaching and Learning Guiding Principles (TLGP) generated by a previous study. Method: A survey method was used to collect data…

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

PubMed

Barrett, Eva; McCreesh, Karen; Lewis, Jeremy

2014-02-01

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

Prognostics of Power Electronics, Methods and Validation Experiments

NASA Technical Reports Server (NTRS)

Kulkarni, Chetan S.; Celaya, Jose R.; Biswas, Gautam; Goebel, Kai

2012-01-01

Abstract Failure of electronic devices is a concern for future electric aircrafts that will see an increase of electronics to drive and control safety-critical equipment throughout the aircraft. As a result, investigation of precursors to failure in electronics and prediction of remaining life of electronic components is of key importance. DC-DC power converters are power electronics systems employed typically as sourcing elements for avionics equipment. Current research efforts in prognostics for these power systems focuses on the identification of failure mechanisms and the development of accelerated aging methodologies and systems to accelerate the aging process of test devices, while continuously measuring key electrical and thermal parameters. Preliminary model-based prognostics algorithms have been developed making use of empirical degradation models and physics-inspired degradation model with focus on key components like electrolytic capacitors and power MOSFETs (metal-oxide-semiconductor-field-effect-transistor). This paper presents current results on the development of validation methods for prognostics algorithms of power electrolytic capacitors. Particularly, in the use of accelerated aging systems for algorithm validation. Validation of prognostics algorithms present difficulties in practice due to the lack of run-to-failure experiments in deployed systems. By using accelerated experiments, we circumvent this problem in order to define initial validation activities.

Simple validated LC-MS/MS method for the determination of atropine and scopolamine in plasma for clinical and forensic toxicological purposes.

PubMed

Koželj, Gordana; Perharič, Lucija; Stanovnik, Lovro; Prosen, Helena

2014-08-05

A liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the determination of atropine and scopolamine in 100μL human plasma was developed and validated. Sample pretreatment consisted of protein precipitation with acetonitrile followed by a concentration step. Analytes and levobupivacaine (internal standard) were separated on a Zorbax XDB-CN column (75mm×4.6mm i.d., 3.5μm) with gradient elution (purified water, acetonitrile, formic acid). The triple quadrupole MS was operated in ESI positive mode. Matrix effect was estimated for deproteinised plasma samples. Selected reaction monitoring (SRM) was used for quantification in the range of 0.10-50.00ng/mL. Interday precision for both tropanes and intraday precision for atropine was <10%, intraday precision for scopolamine was <14% and <18% at lower limit of quantification (LLOQ). Mean interday and intraday accuracies for atropine were within ±7% and for scopolamine within ±11%. The method can be used for determination of therapeutic and toxic levels of both compounds and has been successfully applied to a study of pharmacodynamic and pharmacokinetic properties of tropanes, where plasma samples of volunteers were collected at fixed time intervals after ingestion of a buckwheat meal, spiked with five low doses of tropanes. Copyright © 2014 Elsevier B.V. All rights reserved.

Specification and Preliminary Validation of IAT (Integrated Analysis Techniques) Methods: Executive Summary.

DTIC Science & Technology

1985-03-01

conceptual framwork , and preliminary validation of IAT concepts. Planned work for FY85, including more extensive validation, is also described. 20...Developments: Required Capabilities .... ......... 10 2-1 IAT Conceptual Framework - FY85 (FEO) ..... ........... 11 2-2 Recursive Nature of Decomposition...approach: 1) Identify needs & requirements for IAT. 2) Develop IAT conceptual framework. 3) Validate IAT methods. 4) Develop applications materials. To

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

PubMed

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

2018-02-01

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

Cross validation issues in multiobjective clustering

PubMed Central

Brusco, Michael J.; Steinley, Douglas

2018-01-01

The implementation of multiobjective programming methods in combinatorial data analysis is an emergent area of study with a variety of pragmatic applications in the behavioural sciences. Most notably, multiobjective programming provides a tool for analysts to model trade offs among competing criteria in clustering, seriation, and unidimensional scaling tasks. Although multiobjective programming has considerable promise, the technique can produce numerically appealing results that lack empirical validity. With this issue in mind, the purpose of this paper is to briefly review viable areas of application for multiobjective programming and, more importantly, to outline the importance of cross-validation when using this method in cluster analysis. PMID:19055857

Validation of a high performance liquid chromatography method for the stabilization of epigallocatechin gallate.

PubMed

Fangueiro, Joana F; Parra, Alexander; Silva, Amélia M; Egea, Maria A; Souto, Eliana B; Garcia, Maria L; Calpena, Ana C

2014-11-20

Epigallocatechin gallate (EGCG) is a green tea catechin with potential health benefits, such as anti-oxidant, anti-carcinogenic and anti-inflammatory effects. In general, EGCG is highly susceptible to degradation, therefore presenting stability problems. The present paper was focused on the study of EGCG stability in HEPES (N-2-hydroxyethylpiperazine-N'-2-ethanesulfonic acid) medium regarding the pH dependency, storage temperature and in the presence of ascorbic acid a reducing agent. The evaluation of EGCG in HEPES buffer has demonstrated that this molecule is not able of maintaining its physicochemical properties and potential beneficial effects, since it is partially or completely degraded, depending on the EGCG concentration. The storage temperature of EGCG most suitable to maintain its structure was shown to be the lower values (4 or -20 °C). The pH 3.5 was able to provide greater stability than pH 7.4. However, the presence of a reducing agent (i.e., ascorbic acid) was shown to provide greater protection against degradation of EGCG. A validation method based on RP-HPLC with UV-vis detection was carried out for two media: water and a biocompatible physiological medium composed of Transcutol®P, ethanol and ascorbic acid. The quantification of EGCG for purposes, using pure EGCG, requires a validated HPLC method which could be possible to apply in pharmacokinetic and pharmacodynamics studies. Copyright © 2014. Published by Elsevier B.V.

Verification and Validation Studies for the LAVA CFD Solver

NASA Technical Reports Server (NTRS)

Moini-Yekta, Shayan; Barad, Michael F; Sozer, Emre; Brehm, Christoph; Housman, Jeffrey A.; Kiris, Cetin C.

2013-01-01

The verification and validation of the Launch Ascent and Vehicle Aerodynamics (LAVA) computational fluid dynamics (CFD) solver is presented. A modern strategy for verification and validation is described incorporating verification tests, validation benchmarks, continuous integration and version control methods for automated testing in a collaborative development environment. The purpose of the approach is to integrate the verification and validation process into the development of the solver and improve productivity. This paper uses the Method of Manufactured Solutions (MMS) for the verification of 2D Euler equations, 3D Navier-Stokes equations as well as turbulence models. A method for systematic refinement of unstructured grids is also presented. Verification using inviscid vortex propagation and flow over a flat plate is highlighted. Simulation results using laminar and turbulent flow past a NACA 0012 airfoil and ONERA M6 wing are validated against experimental and numerical data.

A collaborative design method to support integrated care. An ICT development method containing continuous user validation improves the entire care process and the individual work situation

PubMed Central

Scandurra, Isabella; Hägglund, Maria

2009-01-01

Introduction Integrated care involves different professionals, belonging to different care provider organizations and requires immediate and ubiquitous access to patient-oriented information, supporting an integrated view on the care process [1]. Purpose To present a method for development of usable and work process-oriented information and communication technology (ICT) systems for integrated care. Theory and method Based on Human-computer Interaction Science and in particular Participatory Design [2], we present a new collaborative design method in the context of health information systems (HIS) development [3]. This method implies a thorough analysis of the entire interdisciplinary cooperative work and a transformation of the results into technical specifications, via user validated scenarios, prototypes and use cases, ultimately leading to the development of appropriate ICT for the variety of occurring work situations for different user groups, or professions, in integrated care. Results and conclusions Application of the method in homecare of the elderly resulted in an HIS that was well adapted to the intended user groups. Conducted in multi-disciplinary seminars, the method captured and validated user needs and system requirements for different professionals, work situations, and environments not only for current work; it also aimed to improve collaboration in future (ICT supported) work processes. A holistic view of the entire care process was obtained and supported through different views of the HIS for different user groups, resulting in improved work in the entire care process as well as for each collaborating profession [4].

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

NASA Technical Reports Server (NTRS)

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

1991-01-01

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

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.

Validity and reliability of a method for assessment of cervical vertebral maturation.

PubMed

Zhao, Xiao-Guang; Lin, Jiuxiang; Jiang, Jiu-Hui; Wang, Qingzhu; Ng, Sut Hong

2012-03-01

To evaluate the validity and reliability of the cervical vertebral maturation (CVM) method with a longitudinal sample. Eighty-six cephalograms from 18 subjects (5 males and 13 females) were selected from the longitudinal database. Total mandibular length was measured on each film; an increased rate served as the gold standard in examination of the validity of the CVM method. Eleven orthodontists, after receiving intensive training in the CVM method, evaluated all films twice. Kendall's W and the weighted kappa statistic were employed. Kendall's W values were higher than 0.8 at both times, indicating strong interobserver reproducibility, but interobserver agreement was documented twice at less than 50%. A wide range of intraobserver agreement was noted (40.7%-79.1%), and substantial intraobserver reproducibility was proved by kappa values (0.53-0.86). With regard to validity, moderate agreement was reported between the gold standard and observer staging at the initial time (kappa values 0.44-0.61). However, agreement seemed to be unacceptable for clinical use, especially in cervical stage 3 (26.8%). Even though the validity and reliability of the CVM method proved statistically acceptable, we suggest that many other growth indicators should be taken into consideration in evaluating adolescent skeletal maturation.

Update of Standard Practices for New Method Validation in Forensic Toxicology.

PubMed

Wille, Sarah M R; Coucke, Wim; De Baere, Thierry; Peters, Frank T

2017-01-01

International agreement concerning validation guidelines is important to obtain quality forensic bioanalytical research and routine applications as it all starts with the reporting of reliable analytical data. Standards for fundamental validation parameters are provided in guidelines as those from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the German speaking Gesellschaft fur Toxikologie und Forensische Chemie (GTFCH) and the Scientific Working Group of Forensic Toxicology (SWGTOX). These validation parameters include selectivity, matrix effects, method limits, calibration, accuracy and stability, as well as other parameters such as carryover, dilution integrity and incurred sample reanalysis. It is, however, not easy for laboratories to implement these guidelines into practice as these international guidelines remain nonbinding protocols, that depend on the applied analytical technique, and that need to be updated according the analyst's method requirements and the application type. In this manuscript, a review of the current guidelines and literature concerning bioanalytical validation parameters in a forensic context is given and discussed. In addition, suggestions for the experimental set-up, the pros and cons of statistical approaches and adequate acceptance criteria for the validation of bioanalytical applications are given. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

MetaKTSP: a meta-analytic top scoring pair method for robust cross-study validation of omics prediction analysis.

PubMed

Kim, SungHwan; Lin, Chien-Wei; Tseng, George C

2016-07-01

Supervised machine learning is widely applied to transcriptomic data to predict disease diagnosis, prognosis or survival. Robust and interpretable classifiers with high accuracy are usually favored for their clinical and translational potential. The top scoring pair (TSP) algorithm is an example that applies a simple rank-based algorithm to identify rank-altered gene pairs for classifier construction. Although many classification methods perform well in cross-validation of single expression profile, the performance usually greatly reduces in cross-study validation (i.e. the prediction model is established in the training study and applied to an independent test study) for all machine learning methods, including TSP. The failure of cross-study validation has largely diminished the potential translational and clinical values of the models. The purpose of this article is to develop a meta-analytic top scoring pair (MetaKTSP) framework that combines multiple transcriptomic studies and generates a robust prediction model applicable to independent test studies. We proposed two frameworks, by averaging TSP scores or by combining P-values from individual studies, to select the top gene pairs for model construction. We applied the proposed methods in simulated data sets and three large-scale real applications in breast cancer, idiopathic pulmonary fibrosis and pan-cancer methylation. The result showed superior performance of cross-study validation accuracy and biomarker selection for the new meta-analytic framework. In conclusion, combining multiple omics data sets in the public domain increases robustness and accuracy of the classification model that will ultimately improve disease understanding and clinical treatment decisions to benefit patients. An R package MetaKTSP is available online. (http://tsenglab.biostat.pitt.edu/software.htm). ctseng@pitt.edu Supplementary data are available at Bioinformatics online. © The Author 2016. Published by Oxford University Press. All

Validation Methods for Fault-Tolerant avionics and control systems, working group meeting 1

NASA Technical Reports Server (NTRS)

1979-01-01

The proceedings of the first working group meeting on validation methods for fault tolerant computer design are presented. The state of the art in fault tolerant computer validation was examined in order to provide a framework for future discussions concerning research issues for the validation of fault tolerant avionics and flight control systems. The development of positions concerning critical aspects of the validation process are given.

Triangulation, Respondent Validation, and Democratic Participation in Mixed Methods Research

ERIC Educational Resources Information Center

Torrance, Harry

2012-01-01

Over the past 10 years or so the "Field" of "Mixed Methods Research" (MMR) has increasingly been exerting itself as something separate, novel, and significant, with some advocates claiming paradigmatic status. Triangulation is an important component of mixed methods designs. Triangulation has its origins in attempts to validate research findings…

When Educational Material Is Delivered: A Mixed Methods Content Validation Study of the Information Assessment Method

PubMed Central

2017-01-01

Background The Information Assessment Method (IAM) allows clinicians to report the cognitive impact, clinical relevance, intention to use, and expected patient health benefits associated with clinical information received by email. More than 15,000 Canadian physicians and pharmacists use the IAM in continuing education programs. In addition, information providers can use IAM ratings and feedback comments from clinicians to improve their products. Objective Our general objective was to validate the IAM questionnaire for the delivery of educational material (ecological and logical content validity). Our specific objectives were to measure the relevance and evaluate the representativeness of IAM items for assessing information received by email. Methods A 3-part mixed methods study was conducted (convergent design). In part 1 (quantitative longitudinal study), the relevance of IAM items was measured. Participants were 5596 physician members of the Canadian Medical Association who used the IAM. A total of 234,196 ratings were collected in 2012. The relevance of IAM items with respect to their main construct was calculated using descriptive statistics (relevance ratio R). In part 2 (qualitative descriptive study), the representativeness of IAM items was evaluated. A total of 15 family physicians completed semistructured face-to-face interviews. For each construct, we evaluated the representativeness of IAM items using a deductive-inductive thematic qualitative data analysis. In part 3 (mixing quantitative and qualitative parts), results from quantitative and qualitative analyses were reviewed, juxtaposed in a table, discussed with experts, and integrated. Thus, our final results are derived from the views of users (ecological content validation) and experts (logical content validation). Results Of the 23 IAM items, 21 were validated for content, while 2 were removed. In part 1 (quantitative results), 21 items were deemed relevant, while 2 items were deemed not relevant

Validation of the Seating and Mobility Script Concordance Test

ERIC Educational Resources Information Center

Cohen, Laura J.; Fitzgerald, Shirley G.; Lane, Suzanne; Boninger, Michael L.; Minkel, Jean; McCue, Michael

2009-01-01

The purpose of this study was to develop the scoring system for the Seating and Mobility Script Concordance Test (SMSCT), obtain and appraise internal and external structure evidence, and assess the validity of the SMSCT. The SMSCT purpose is to provide a method for testing knowledge of seating and mobility prescription. A sample of 106 therapists…

Validation of a Cost-Efficient Multi-Purpose SNP Panel for Disease Based Research

PubMed Central

Hou, Liping; Phillips, Christopher; Azaro, Marco; Brzustowicz, Linda M.; Bartlett, Christopher W.

2011-01-01

Background Here we present convergent methodologies using theoretical calculations, empirical assessment on in-house and publicly available datasets as well as in silico simulations, that validate a panel of SNPs for a variety of necessary tasks in human genetics disease research before resources are committed to larger-scale genotyping studies on those samples. While large-scale well-funded human genetic studies routinely have up to a million SNP genotypes, samples in a human genetics laboratory that are not yet part of such studies may be productively utilized in pilot projects or as part of targeted follow-up work though such smaller scale applications require at least some genome-wide genotype data for quality control purposes such as DNA “barcoding” to detect swaps or contamination issues, determining familial relationships between samples and correcting biases due to population effects such as population stratification in pilot studies. Principal Findings Empirical performance in classification of relative types for any two given DNA samples (e.g., full siblings, parental, etc) indicated that for outbred populations the panel performs sufficiently to classify relationship in extended families and therefore also for smaller structures such as trios and for twin zygosity testing. Additionally, familial relationships do not significantly diminish the (mean match) probability of sharing SNP genotypes in pedigrees, further indicating the uniqueness of the “barcode.” Simulation using these SNPs for an African American case-control disease association study demonstrated that population stratification, even in complex admixed samples, can be adequately corrected under a range of disease models using the SNP panel. Conclusion The panel has been validated for use in a variety of human disease genetics research tasks including sample barcoding, relationship verification, population substructure detection and statistical correction. Given the ease of genotyping

Variety and Drift in the Functions and Purposes of Assessment in K-12 Education

ERIC Educational Resources Information Center

Ho, Andrew D.

2014-01-01

Background/Context: The target of assessment validation is not an assessment but the use of an assessment for a purpose. Although the validation literature often provides examples of assessment purposes, comprehensive reviews of these purposes are rare. Additionally, assessment purposes posed for validation are generally described as discrete and…

Experimental Validation of Model Updating and Damage Detection via Eigenvalue Sensitivity Methods with Artificial Boundary Conditions

DTIC Science & Technology

2017-09-01

VALIDATION OF MODEL UPDATING AND DAMAGE DETECTION VIA EIGENVALUE SENSITIVITY METHODS WITH ARTIFICIAL BOUNDARY CONDITIONS by Matthew D. Bouwense...VALIDATION OF MODEL UPDATING AND DAMAGE DETECTION VIA EIGENVALUE SENSITIVITY METHODS WITH ARTIFICIAL BOUNDARY CONDITIONS 5. FUNDING NUMBERS 6. AUTHOR...unlimited. EXPERIMENTAL VALIDATION OF MODEL UPDATING AND DAMAGE DETECTION VIA EIGENVALUE SENSITIVITY METHODS WITH ARTIFICIAL BOUNDARY

Purposeful sampling for qualitative data collection and analysis in mixed method implementation research

PubMed Central

Palinkas, Lawrence A.; Horwitz, Sarah M.; Green, Carla A.; Wisdom, Jennifer P.; Duan, Naihua; Hoagwood, Kimberly

2013-01-01

Purposeful sampling is widely used in qualitative research for the identification and selection of information-rich cases related to the phenomenon of interest. Although there are several different purposeful sampling strategies, criterion sampling appears to be used most commonly in implementation research. However, combining sampling strategies may be more appropriate to the aims of implementation research and more consistent with recent developments in quantitative methods. This paper reviews the principles and practice of purposeful sampling in implementation research, summarizes types and categories of purposeful sampling strategies and provides a set of recommendations for use of single strategy or multistage strategy designs, particularly for state implementation research. PMID:24193818

Purposeful Sampling for Qualitative Data Collection and Analysis in Mixed Method Implementation Research.

PubMed

Palinkas, Lawrence A; Horwitz, Sarah M; Green, Carla A; Wisdom, Jennifer P; Duan, Naihua; Hoagwood, Kimberly

2015-09-01

Purposeful sampling is widely used in qualitative research for the identification and selection of information-rich cases related to the phenomenon of interest. Although there are several different purposeful sampling strategies, criterion sampling appears to be used most commonly in implementation research. However, combining sampling strategies may be more appropriate to the aims of implementation research and more consistent with recent developments in quantitative methods. This paper reviews the principles and practice of purposeful sampling in implementation research, summarizes types and categories of purposeful sampling strategies and provides a set of recommendations for use of single strategy or multistage strategy designs, particularly for state implementation research.

Relationship between isometric shoulder strength and arms-only swimming power among male collegiate swimmers: study of valid clinical assessment methods.

PubMed

Awatani, Takenori; Morikita, Ikuhiro; Mori, Seigo; Shinohara, Junji; Tatsumi, Yasutaka

2018-04-01

[Purpose] The purpose of the present study was to confirm the relationships between shoulder strength (extensor strength and internal rotator strength) of the abducted position and swimming power during arm-only swimming. [Subjects and Methods] Fourteen healthy male collegiate swimmers participated in the study. Main measures were shoulder strength (strength using torque that was calculated from the upper extremity length and the isometric force of the abducted position) and swimming power. [Results] Internal rotation torque of the dominant side in the abducted external rotated position (r=0.85) was significantly correlated with maximum swimming power. The rate of bilateral difference in extension torque in the maximum abducted position (r=-0.728) was significantly correlated with the swimming velocity-to-swimming power ratio. [Conclusion] The results of this study suggest that internal rotator strength measurement in the abducted external rotated position and extensor strength measurement in the maximum abducted position are valid assessment methods for swimmers.

78 FR 20695 - Walk-Through Metal Detectors and Hand-Held Metal Detectors Test Method Validation

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-05

... Detectors and Hand-Held Metal Detectors Test Method Validation AGENCY: National Institute of Justice, DOJ... ensure that the test methods in the standards are properly documented, NIJ is requesting proposals (including price quotes) for test method validation efforts from testing laboratories. NIJ is also seeking...

Validity of body composition methods across ethnic population groups.

PubMed

Deurenberg, P; Deurenberg-Yap, M

2003-10-01

Most in vivo body composition methods rely on assumptions that may vary among different population groups as well as within the same population group. The assumptions are based on in vitro body composition (carcass) analyses. The majority of body composition studies were performed on Caucasians and much of the information on validity methods and assumptions were available only for this ethnic group. It is assumed that these assumptions are also valid for other ethnic groups. However, if apparent differences across ethnic groups in body composition 'constants' and body composition 'rules' are not taken into account, biased information on body composition will be the result. This in turn may lead to misclassification of obesity or underweight at an individual as well as a population level. There is a need for more cross-ethnic population studies on body composition. Those studies should be carried out carefully, with adequate methodology and standardization for the obtained information to be valuable.

The Importance of Method Selection in Determining Product Integrity for Nutrition Research1234

PubMed Central

Mudge, Elizabeth M; Brown, Paula N

2016-01-01

The American Herbal Products Association estimates that there as many as 3000 plant species in commerce. The FDA estimates that there are about 85,000 dietary supplement products in the marketplace. The pace of product innovation far exceeds that of analytical methods development and validation, with new ingredients, matrixes, and combinations resulting in an analytical community that has been unable to keep up. This has led to a lack of validated analytical methods for dietary supplements and to inappropriate method selection where methods do exist. Only after rigorous validation procedures to ensure that methods are fit for purpose should they be used in a routine setting to verify product authenticity and quality. By following systematic procedures and establishing performance requirements for analytical methods before method development and validation, methods can be developed that are both valid and fit for purpose. This review summarizes advances in method selection, development, and validation regarding herbal supplement analysis and provides several documented examples of inappropriate method selection and application. PMID:26980823

Validity of a digital diet estimation method for use with preschool children

USDA-ARS?s Scientific Manuscript database

The validity of using the Remote Food Photography Method (RFPM) for measuring food intake of minority preschool children's intake is not well documented. The aim of the study was to determine the validity of intake estimations made by human raters using the RFPM compared with those obtained by weigh...

Developing and validating a nutrition knowledge questionnaire: key methods and considerations.

PubMed

Trakman, Gina Louise; Forsyth, Adrienne; Hoye, Russell; Belski, Regina

2017-10-01

To outline key statistical considerations and detailed methodologies for the development and evaluation of a valid and reliable nutrition knowledge questionnaire. Literature on questionnaire development in a range of fields was reviewed and a set of evidence-based guidelines specific to the creation of a nutrition knowledge questionnaire have been developed. The recommendations describe key qualitative methods and statistical considerations, and include relevant examples from previous papers and existing nutrition knowledge questionnaires. Where details have been omitted for the sake of brevity, the reader has been directed to suitable references. We recommend an eight-step methodology for nutrition knowledge questionnaire development as follows: (i) definition of the construct and development of a test plan; (ii) generation of the item pool; (iii) choice of the scoring system and response format; (iv) assessment of content validity; (v) assessment of face validity; (vi) purification of the scale using item analysis, including item characteristics, difficulty and discrimination; (vii) evaluation of the scale including its factor structure and internal reliability, or Rasch analysis, including assessment of dimensionality and internal reliability; and (viii) gathering of data to re-examine the questionnaire's properties, assess temporal stability and confirm construct validity. Several of these methods have previously been overlooked. The measurement of nutrition knowledge is an important consideration for individuals working in the nutrition field. Improved methods in the development of nutrition knowledge questionnaires, such as the use of factor analysis or Rasch analysis, will enable more confidence in reported measures of nutrition knowledge.

VALIDATION OF A METHOD FOR ESTIMATING LONG-TERM EXPOSURES BASED ON SHORT-TERM MEASUREMENTS

EPA Science Inventory

A method for estimating long-term exposures from short-term measurements is validated using data from a recent EPA study of exposure to fine particles. The method was developed a decade ago but data to validate it did not exist until recently. In this paper, data from repeated ...

VALIDATION OF A METHOD FOR ESTIMATING LONG-TERM EXPOSURES BASED ON SHORT-TERM MEASUREMENTS

EPA Science Inventory

A method for estimating long-term exposures from short-term measurements is validated using data from a recent EPA study of exposure to fine particles. The method was developed a decade ago but long-term exposure data to validate it did not exist until recently. In this paper, ...

Validity Evidence in Scale Development: The Application of Cross Validation and Classification-Sequencing Validation

ERIC Educational Resources Information Center

Acar, Tu¨lin

2014-01-01

In literature, it has been observed that many enhanced criteria are limited by factor analysis techniques. Besides examinations of statistical structure and/or psychological structure, such validity studies as cross validation and classification-sequencing studies should be performed frequently. The purpose of this study is to examine cross…

Validation of chemistry models employed in a particle simulation method

NASA Technical Reports Server (NTRS)

Haas, Brian L.; Mcdonald, Jeffrey D.

1991-01-01

The chemistry models employed in a statistical particle simulation method, as implemented in the Intel iPSC/860 multiprocessor computer, are validated and applied. Chemical relaxation of five-species air in these reservoirs involves 34 simultaneous dissociation, recombination, and atomic-exchange reactions. The reaction rates employed in the analytic solutions are obtained from Arrhenius experimental correlations as functions of temperature for adiabatic gas reservoirs in thermal equilibrium. Favorable agreement with the analytic solutions validates the simulation when applied to relaxation of O2 toward equilibrium in reservoirs dominated by dissociation and recombination, respectively, and when applied to relaxation of air in the temperature range 5000 to 30,000 K. A flow of O2 over a circular cylinder at high Mach number is simulated to demonstrate application of the method to multidimensional reactive flows.

Adapting CEF-Descriptors for Rating Purposes: Validation by a Combined Rater Training and Scale Revision Approach

ERIC Educational Resources Information Center

Harsch, Claudia; Martin, Guido

2012-01-01

We explore how a local rating scale can be based on the Common European Framework CEF-proficiency scales. As part of the scale validation (Alderson, 1991; Lumley, 2002), we examine which adaptations are needed to turn CEF-proficiency descriptors into a rating scale for a local context, and to establish a practicable method to revise the initial…

Validation of selected analytical methods using accuracy profiles to assess the impact of a Tobacco Heating System on indoor air quality.

PubMed

Mottier, Nicolas; Tharin, Manuel; Cluse, Camille; Crudo, Jean-René; Lueso, María Gómez; Goujon-Ginglinger, Catherine G; Jaquier, Anne; Mitova, Maya I; Rouget, Emmanuel G R; Schaller, Mathieu; Solioz, Jennifer

2016-09-01

Studies in environmentally controlled rooms have been used over the years to assess the impact of environmental tobacco smoke on indoor air quality. As new tobacco products are developed, it is important to determine their impact on air quality when used indoors. Before such an assessment can take place it is essential that the analytical methods used to assess indoor air quality are validated and shown to be fit for their intended purpose. Consequently, for this assessment, an environmentally controlled room was built and seven analytical methods, representing eighteen analytes, were validated. The validations were carried out with smoking machines using a matrix-based approach applying the accuracy profile procedure. The performances of the methods were compared for all three matrices under investigation: background air samples, the environmental aerosol of Tobacco Heating System THS 2.2, a heat-not-burn tobacco product developed by Philip Morris International, and the environmental tobacco smoke of a cigarette. The environmental aerosol generated by the THS 2.2 device did not have any appreciable impact on the performances of the methods. The comparison between the background and THS 2.2 environmental aerosol samples generated by smoking machines showed that only five compounds were higher when THS 2.2 was used in the environmentally controlled room. Regarding environmental tobacco smoke from cigarettes, the yields of all analytes were clearly above those obtained with the other two air sample types. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

The Development and Validation of the Age-Based Rejection Sensitivity Questionnaire

ERIC Educational Resources Information Center

Kang, Sonia K.; Chasteen, Alison L.

2009-01-01

Purpose: There is much evidence suggesting that older adults are often negatively affected by aging stereotypes; however, no method to identify individual differences in vulnerability to these effects has yet been developed. The purpose of this study was to develop a reliable and valid questionnaire to measure individual differences in the…

The Importance of Method Selection in Determining Product Integrity for Nutrition Research.

PubMed

Mudge, Elizabeth M; Betz, Joseph M; Brown, Paula N

2016-03-01

The American Herbal Products Association estimates that there as many as 3000 plant species in commerce. The FDA estimates that there are about 85,000 dietary supplement products in the marketplace. The pace of product innovation far exceeds that of analytical methods development and validation, with new ingredients, matrixes, and combinations resulting in an analytical community that has been unable to keep up. This has led to a lack of validated analytical methods for dietary supplements and to inappropriate method selection where methods do exist. Only after rigorous validation procedures to ensure that methods are fit for purpose should they be used in a routine setting to verify product authenticity and quality. By following systematic procedures and establishing performance requirements for analytical methods before method development and validation, methods can be developed that are both valid and fit for purpose. This review summarizes advances in method selection, development, and validation regarding herbal supplement analysis and provides several documented examples of inappropriate method selection and application. © 2016 American Society for Nutrition.

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

PubMed

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

2015-05-01

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

Objectifying Content Validity: Conducting a Content Validity Study in Social Work Research.

ERIC Educational Resources Information Center

Rubio, Doris McGartland; Berg-Weger, Marla; Tebb, Susan S.; Lee, E. Suzanne; Rauch, Shannon

2003-01-01

The purpose of this article is to demonstrate how to conduct a content validity study. Instructions on how to calculate a content validity index, factorial validity index, and an interrater reliability index and guide for interpreting these indices are included. Implications regarding the value of conducting a content validity study for…

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.

Standard Setting Methods for Pass/Fail Decisions on High-Stakes Objective Structured Clinical Examinations: A Validity Study.

PubMed

Yousuf, Naveed; Violato, Claudio; Zuberi, Rukhsana W

2015-01-01

CONSTRUCT: Authentic standard setting methods will demonstrate high convergent validity evidence of their outcomes, that is, cutoff scores and pass/fail decisions, with most other methods when compared with each other. The objective structured clinical examination (OSCE) was established for valid, reliable, and objective assessment of clinical skills in health professions education. Various standard setting methods have been proposed to identify objective, reliable, and valid cutoff scores on OSCEs. These methods may identify different cutoff scores for the same examinations. Identification of valid and reliable cutoff scores for OSCEs remains an important issue and a challenge. Thirty OSCE stations administered at least twice in the years 2010-2012 to 393 medical students in Years 2 and 3 at Aga Khan University are included. Psychometric properties of the scores are determined. Cutoff scores and pass/fail decisions of Wijnen, Cohen, Mean-1.5SD, Mean-1SD, Angoff, borderline group and borderline regression (BL-R) methods are compared with each other and with three variants of cluster analysis using repeated measures analysis of variance and Cohen's kappa. The mean psychometric indices on the 30 OSCE stations are reliability coefficient = 0.76 (SD = 0.12); standard error of measurement = 5.66 (SD = 1.38); coefficient of determination = 0.47 (SD = 0.19), and intergrade discrimination = 7.19 (SD = 1.89). BL-R and Wijnen methods show the highest convergent validity evidence among other methods on the defined criteria. Angoff and Mean-1.5SD demonstrated least convergent validity evidence. The three cluster variants showed substantial convergent validity with borderline methods. Although there was a high level of convergent validity of Wijnen method, it lacks the theoretical strength to be used for competency-based assessments. The BL-R method is found to show the highest convergent validity evidences for OSCEs with other standard setting methods used in the present study

Validating silicon polytrodes with paired juxtacellular recordings: method and dataset.

PubMed

Neto, Joana P; Lopes, Gonçalo; Frazão, João; Nogueira, Joana; Lacerda, Pedro; Baião, Pedro; Aarts, Arno; Andrei, Alexandru; Musa, Silke; Fortunato, Elvira; Barquinha, Pedro; Kampff, Adam R

2016-08-01

Cross-validating new methods for recording neural activity is necessary to accurately interpret and compare the signals they measure. Here we describe a procedure for precisely aligning two probes for in vivo "paired-recordings" such that the spiking activity of a single neuron is monitored with both a dense extracellular silicon polytrode and a juxtacellular micropipette. Our new method allows for efficient, reliable, and automated guidance of both probes to the same neural structure with micrometer resolution. We also describe a new dataset of paired-recordings, which is available online. We propose that our novel targeting system, and ever expanding cross-validation dataset, will be vital to the development of new algorithms for automatically detecting/sorting single-units, characterizing new electrode materials/designs, and resolving nagging questions regarding the origin and nature of extracellular neural signals. Copyright © 2016 the American Physiological Society.

Validating silicon polytrodes with paired juxtacellular recordings: method and dataset

PubMed Central

Lopes, Gonçalo; Frazão, João; Nogueira, Joana; Lacerda, Pedro; Baião, Pedro; Aarts, Arno; Andrei, Alexandru; Musa, Silke; Fortunato, Elvira; Barquinha, Pedro; Kampff, Adam R.

2016-01-01

Cross-validating new methods for recording neural activity is necessary to accurately interpret and compare the signals they measure. Here we describe a procedure for precisely aligning two probes for in vivo “paired-recordings” such that the spiking activity of a single neuron is monitored with both a dense extracellular silicon polytrode and a juxtacellular micropipette. Our new method allows for efficient, reliable, and automated guidance of both probes to the same neural structure with micrometer resolution. We also describe a new dataset of paired-recordings, which is available online. We propose that our novel targeting system, and ever expanding cross-validation dataset, will be vital to the development of new algorithms for automatically detecting/sorting single-units, characterizing new electrode materials/designs, and resolving nagging questions regarding the origin and nature of extracellular neural signals. PMID:27306671

Cross-Validation of FITNESSGRAM® Health-Related Fitness Standards in Hungarian Youth

ERIC Educational Resources Information Center

Laurson, Kelly R.; Saint-Maurice, Pedro F.; Karsai, István; Csányi, Tamás

2015-01-01

Purpose: The purpose of this study was to cross-validate FITNESSGRAM® aerobic and body composition standards in a representative sample of Hungarian youth. Method: A nationally representative sample (N = 405) of Hungarian adolescents from the Hungarian National Youth Fitness Study (ages 12-18.9 years) participated in an aerobic capacity assessment…

JaCVAM-organized international validation study of the in vivo rodent alkaline comet assay for the detection of genotoxic carcinogens: I. Summary of pre-validation study results.

PubMed

Uno, Yoshifumi; Kojima, Hajime; Omori, Takashi; Corvi, Raffaella; Honma, Masamistu; Schechtman, Leonard M; Tice, Raymond R; Burlinson, Brian; Escobar, Patricia A; Kraynak, Andrew R; Nakagawa, Yuzuki; Nakajima, Madoka; Pant, Kamala; Asano, Norihide; Lovell, David; Morita, Takeshi; 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 validation effort was to establish an Organisation for Economic Co-operation and Development (OECD) test guideline. The purpose of the pre-validation studies (i.e., Phase 1 through 3), conducted in four or five laboratories with extensive comet assay experience, was to optimize the protocol to be used during the definitive validation study. Copyright © 2015 Elsevier B.V. All rights reserved.

An investigation of new toxicity test method performance in validation studies: 1. Toxicity test methods that have predictive capacity no greater than chance.

PubMed

Bruner, L H; Carr, G J; Harbell, J W; Curren, R D

2002-06-01

An approach commonly used to measure new toxicity test method (NTM) performance in validation studies is to divide toxicity results into positive and negative classifications, and the identify true positive (TP), true negative (TN), false positive (FP) and false negative (FN) results. After this step is completed, the contingent probability statistics (CPS), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) are calculated. Although these statistics are widely used and often the only statistics used to assess the performance of toxicity test methods, there is little specific guidance in the validation literature on what values for these statistics indicate adequate performance. The purpose of this study was to begin developing data-based answers to this question by characterizing the CPS obtained from an NTM whose data have a completely random association with a reference test method (RTM). Determining the CPS of this worst-case scenario is useful because it provides a lower baseline from which the performance of an NTM can be judged in future validation studies. It also provides an indication of relationships in the CPS that help identify random or near-random relationships in the data. The results from this study of randomly associated tests show that the values obtained for the statistics vary significantly depending on the cut-offs chosen, that high values can be obtained for individual statistics, and that the different measures cannot be considered independently when evaluating the performance of an NTM. When the association between results of an NTM and RTM is random the sum of the complementary pairs of statistics (sensitivity + specificity, NPV + PPV) is approximately 1, and the prevalence (i.e., the proportion of toxic chemicals in the population of chemicals) and PPV are equal. Given that combinations of high sensitivity-low specificity or low specificity-high sensitivity (i.e., the sum of the sensitivity and

Working towards accreditation by the International Standards Organization 15189 Standard: how to validate an in-house developed method an example of lead determination in whole blood by electrothermal atomic absorption spectrometry.

PubMed

Garcia Hejl, Carine; Ramirez, Jose Manuel; Vest, Philippe; Chianea, Denis; Renard, Christophe

2014-09-01

Laboratories working towards accreditation by the International Standards Organization (ISO) 15189 standard are required to demonstrate the validity of their analytical methods. The different guidelines set by various accreditation organizations make it difficult to provide objective evidence that an in-house method is fit for the intended purpose. Besides, the required performance characteristics tests and acceptance criteria are not always detailed. The laboratory must choose the most suitable validation protocol and set the acceptance criteria. Therefore, we propose a validation protocol to evaluate the performance of an in-house method. As an example, we validated the process for the detection and quantification of lead in whole blood by electrothermal absorption spectrometry. The fundamental parameters tested were, selectivity, calibration model, precision, accuracy (and uncertainty of measurement), contamination, stability of the sample, reference interval, and analytical interference. We have developed a protocol that has been applied successfully to quantify lead in whole blood by electrothermal atomic absorption spectrometry (ETAAS). In particular, our method is selective, linear, accurate, and precise, making it suitable for use in routine diagnostics.

MR Imaging Anatomy in Neurodegeneration: A Robust Volumetric Parcellation Method of the Frontal Lobe Gyri with Quantitative Validation in Patients with Dementia

PubMed Central

Iordanova, B.; Rosenbaum, D.; Norman, D.; Weiner, M.; Studholme, C.

2007-01-01

BACKGROUND AND PURPOSE Brain volumetry is widely used for evaluating tissue degeneration; however, the parcellation methods are rarely validated and use arbitrary planes to mark boundaries of brain regions. The goal of this study was to develop, validate, and apply an MR imaging tracing method for the parcellation of 3 major gyri of the frontal lobe, which uses only local landmarks intrinsic to the structures of interest, without the need for global reorientation or the use of dividing planes or lines. METHODS Studies were performed on 25 subjects—healthy controls and subjects diagnosed with Lewy body dementia and Alzheimer disease—with significant variation in the underlying gyral anatomy and state of atrophy. The protocol was evaluated by using multiple observers tracing scans of subjects diagnosed with neurodegenerative disease and those aging normally, and the results were compared by spatial overlap agreement. To confirm the results, observers marked the same locations in different brains. We illustrated the variabilities of the key boundaries that pose the greatest challenge to defining consistent parcellations across subjects. RESULTS The resulting gyral volumes were evaluated, and their consistency across raters was used as an additional assessment of the validity of our marking method. The agreement on a scale of 0–1 was found to be 0.83 spatial and 0.90 volumetric for the same rater and 0.85 spatial and 0.90 volumetric for 2 different raters. The results revealed that the protocol remained consistent across different neurodegenerative conditions. CONCLUSION Our method provides a simple and reliable way for the volumetric evaluation of frontal lobe neurodegeneration and can be used as a resource for larger comparative studies as well as a validation procedure of automated algorithms. PMID:16971629

Critical Values for Lawshe's Content Validity Ratio: Revisiting the Original Methods of Calculation

ERIC Educational Resources Information Center

Ayre, Colin; Scally, Andrew John

2014-01-01

The content validity ratio originally proposed by Lawshe is widely used to quantify content validity and yet methods used to calculate the original critical values were never reported. Methods for original calculation of critical values are suggested along with tables of exact binomial probabilities.

Methods for Trustworthy Design of On-Chip Bus Interconnect for General-Purpose Processors

DTIC Science & Technology

2012-03-01

Technology Andrew Huang, was able to test the security properties of HyperTransport bus protocol on an Xbox [20]. In his research, he was able to...TRUSTWORTHY DESIGN OF ON -CHIP BUS INTERCONNECT FOR GENERAL-PURPOSE PROCESSORS by Jay F. Elson March 2012 Thesis Advisor: Ted Huffmire Second...AND DATES COVERED Master’s Thesis 4. TITLE AND SUBTITLE Methods for Trustworthy Design of On -Chip Bus Interconnect for General-Purpose Processors 5

Enhanced high-performance liquid chromatography method for the determination of retinoic acid in plasma. Development, optimization and validation.

PubMed

Teglia, Carla M; Gil García, María D; Galera, María Martínez; Goicoechea, Héctor C

2014-08-01

When determining endogenous compounds in biological samples, the lack of blank or analyte-free matrix samples involves the use of alternative strategies for calibration and quantitation. This article deals with the development, optimization and validation of a high performance liquid chromatography method for the determination of retinoic acid in plasma, obtaining at the same time information about its isomers, taking into account the basal concentration of these endobiotica. An experimental design was used for the optimization of three variables: mobile phase composition, flow rate and column temperature through a central composite design. Four responses were selected for optimization purposes (area under the peaks, quantity of peaks, analysis time and resolution between the first principal peak and the following one). The optimum conditions resulted in a mobile phase consisting of methanol 83.4% (v/v), acetonitrile 0.6% (v/v) and acid aqueous solution 16.0% (v/v); flow rate of 0.68 mL min(-1) and an column temperature of 37.10 °C. Detection was performed at 350 nm by a diode array detector. The method was validated following a holistic approach that included not only the classical parameters related to method performance but also the robustness and the expected proportion of acceptable results lying inside predefined acceptability intervals, i.e., the uncertainty of measurements. The method validation results indicated a high selectivity and good precision characteristics that were studied at four concentration levels, with RSD less than 5.0% for retinoic acid (less than 7.5% for the LOQ concentration level), in intra and inter-assay precision studies. Linearity was proved for a range from 0.00489 to 15.109 ng mL(-1) of retinoic acid and the recovery, which was studied at four different fortification levels in phuman plasma samples, varied from 99.5% to 106.5% for retinoic acid. The applicability of the method was demonstrated by determining retinoic acid and

Automatic liver segmentation in computed tomography using general-purpose shape modeling methods.

PubMed

Spinczyk, Dominik; Krasoń, Agata

2018-05-29

Liver segmentation in computed tomography is required in many clinical applications. The segmentation methods used can be classified according to a number of criteria. One important criterion for method selection is the shape representation of the segmented organ. The aim of the work is automatic liver segmentation using general purpose shape modeling methods. As part of the research, methods based on shape information at various levels of advancement were used. The single atlas based segmentation method was used as the simplest shape-based method. This method is derived from a single atlas using the deformable free-form deformation of the control point curves. Subsequently, the classic and modified Active Shape Model (ASM) was used, using medium body shape models. As the most advanced and main method generalized statistical shape models, Gaussian Process Morphable Models was used, which are based on multi-dimensional Gaussian distributions of the shape deformation field. Mutual information and sum os square distance were used as similarity measures. The poorest results were obtained for the single atlas method. For the ASM method in 10 analyzed cases for seven test images, the Dice coefficient was above 55[Formula: see text], of which for three of them the coefficient was over 70[Formula: see text], which placed the method in second place. The best results were obtained for the method of generalized statistical distribution of the deformation field. The DICE coefficient for this method was 88.5[Formula: see text] CONCLUSIONS: This value of 88.5 [Formula: see text] Dice coefficient can be explained by the use of general-purpose shape modeling methods with a large variance of the shape of the modeled object-the liver and limitations on the size of our training data set, which was limited to 10 cases. The obtained results in presented fully automatic method are comparable with dedicated methods for liver segmentation. In addition, the deforamtion features of the

Factor analysis methods and validity evidence: A systematic review of instrument development across the continuum of medical education

NASA Astrophysics Data System (ADS)

Wetzel, Angela Payne

Previous systematic reviews indicate a lack of reporting of reliability and validity evidence in subsets of the medical education literature. Psychology and general education reviews of factor analysis also indicate gaps between current and best practices; yet, a comprehensive review of exploratory factor analysis in instrument development across the continuum of medical education had not been previously identified. Therefore, the purpose for this study was critical review of instrument development articles employing exploratory factor or principal component analysis published in medical education (2006--2010) to describe and assess the reporting of methods and validity evidence based on the Standards for Educational and Psychological Testing and factor analysis best practices. Data extraction of 64 articles measuring a variety of constructs that have been published throughout the peer-reviewed medical education literature indicate significant errors in the translation of exploratory factor analysis best practices to current practice. Further, techniques for establishing validity evidence tend to derive from a limited scope of methods including reliability statistics to support internal structure and support for test content. Instruments reviewed for this study lacked supporting evidence based on relationships with other variables and response process, and evidence based on consequences of testing was not evident. Findings suggest a need for further professional development within the medical education researcher community related to (1) appropriate factor analysis methodology and reporting and (2) the importance of pursuing multiple sources of reliability and validity evidence to construct a well-supported argument for the inferences made from the instrument. Medical education researchers and educators should be cautious in adopting instruments from the literature and carefully review available evidence. Finally, editors and reviewers are encouraged to recognize

Best Practices in Stability Indicating Method Development and Validation for Non-clinical Dose Formulations.

PubMed

Henry, Teresa R; Penn, Lara D; Conerty, Jason R; Wright, Francesca E; Gorman, Gregory; Pack, Brian W

2016-11-01

Non-clinical dose formulations (also known as pre-clinical or GLP formulations) play a key role in early drug development. These formulations are used to introduce active pharmaceutical ingredients (APIs) into test organisms for both pharmacokinetic and toxicological studies. Since these studies are ultimately used to support dose and safety ranges in human studies, it is important to understand not only the concentration and PK/PD of the active ingredient but also to generate safety data for likely process impurities and degradation products of the active ingredient. As such, many in the industry have chosen to develop and validate methods which can accurately detect and quantify the active ingredient along with impurities and degradation products. Such methods often provide trendable results which are predictive of stability, thus leading to the name; stability indicating methods. This document provides an overview of best practices for those choosing to include development and validation of such methods as part of their non-clinical drug development program. This document is intended to support teams who are either new to stability indicating method development and validation or who are less familiar with the requirements of validation due to their position within the product development life cycle.

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

NASA Astrophysics Data System (ADS)

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

2017-09-01

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

Developmental and internal validation of a novel 13 loci STR multiplex method for Cannabis sativa DNA profiling.

PubMed

Houston, Rachel; Birck, Matthew; Hughes-Stamm, Sheree; Gangitano, David

2017-05-01

Marijuana (Cannabis sativa L.) is a plant cultivated and trafficked worldwide as a source of fiber (hemp), medicine, and intoxicant. The development of a validated method using molecular techniques such as short tandem repeats (STRs) could serve as an intelligence tool to link multiple cases by means of genetic individualization or association of cannabis samples. For this purpose, a 13 loci STR multiplex method was developed, optimized, and validated according to relevant ISFG and SWGDAM guidelines. The STR multiplex consists of 13 previously described C. sativa STR loci: ANUCS501, 9269, 4910, 5159, ANUCS305, 9043, B05, 1528, 3735, CS1, D02, C11, and H06. A sequenced allelic ladder consisting of 56 alleles was designed to accurately genotype 101 C. sativa samples from three seizures provided by a U.S. Customs and Border Protection crime lab. Using an optimal range of DNA (0.5-1.0ng), validation studies revealed well-balanced electropherograms (inter-locus balance range: 0.500-1.296), relatively balanced heterozygous peaks (mean peak height ratio of 0.83 across all loci) with minimal artifacts and stutter ratio (mean stutter of 0.021 across all loci). This multi-locus system is relatively sensitive (0.13ng of template DNA) with a combined power of discrimination of 1 in 55 million. The 13 STR panel was found to be species specific for C. sativa; however, non-specific peaks were produced with Humulus lupulus. The results of this research demonstrate the robustness and applicability of this 13 loci STR system for forensic DNA profiling of marijuana samples. Copyright © 2017 Elsevier B.V. All rights reserved.

Comparison of on-site field measured inorganic arsenic in rice with laboratory measurements using a field deployable method: Method validation.

PubMed

Mlangeni, Angstone Thembachako; Vecchi, Valeria; Norton, Gareth J; Raab, Andrea; Krupp, Eva M; Feldmann, Joerg

2018-10-15

A commercial arsenic field kit designed to measure inorganic arsenic (iAs) in water was modified into a field deployable method (FDM) to measure iAs in rice. While the method has been validated to give precise and accurate results in the laboratory, its on-site field performance has not been evaluated. This study was designed to test the method on-site in Malawi in order to evaluate its accuracy and precision in determination of iAs on-site by comparing with a validated reference method and giving original data on inorganic arsenic in Malawian rice and rice-based products. The method was validated by using the established laboratory-based HPLC-ICPMS. Statistical tests indicated there were no significant differences between on-site and laboratory iAs measurements determined using the FDM (p = 0.263, ά = 0.05) and between on-site measurements and measurements determined using HPLC-ICP-MS (p = 0.299, ά = 0.05). This method allows quick (within 1 h) and efficient screening of rice containing iAs concentrations on-site. Copyright © 2018 Elsevier Ltd. All rights reserved.

When Educational Material Is Delivered: A Mixed Methods Content Validation Study of the Information Assessment Method.

PubMed

Badran, Hani; Pluye, Pierre; Grad, Roland

2017-03-14

The Information Assessment Method (IAM) allows clinicians to report the cognitive impact, clinical relevance, intention to use, and expected patient health benefits associated with clinical information received by email. More than 15,000 Canadian physicians and pharmacists use the IAM in continuing education programs. In addition, information providers can use IAM ratings and feedback comments from clinicians to improve their products. Our general objective was to validate the IAM questionnaire for the delivery of educational material (ecological and logical content validity). Our specific objectives were to measure the relevance and evaluate the representativeness of IAM items for assessing information received by email. A 3-part mixed methods study was conducted (convergent design). In part 1 (quantitative longitudinal study), the relevance of IAM items was measured. Participants were 5596 physician members of the Canadian Medical Association who used the IAM. A total of 234,196 ratings were collected in 2012. The relevance of IAM items with respect to their main construct was calculated using descriptive statistics (relevance ratio R). In part 2 (qualitative descriptive study), the representativeness of IAM items was evaluated. A total of 15 family physicians completed semistructured face-to-face interviews. For each construct, we evaluated the representativeness of IAM items using a deductive-inductive thematic qualitative data analysis. In part 3 (mixing quantitative and qualitative parts), results from quantitative and qualitative analyses were reviewed, juxtaposed in a table, discussed with experts, and integrated. Thus, our final results are derived from the views of users (ecological content validation) and experts (logical content validation). Of the 23 IAM items, 21 were validated for content, while 2 were removed. In part 1 (quantitative results), 21 items were deemed relevant, while 2 items were deemed not relevant (R=4.86% [N=234,196] and R=3.04% [n

Method for Pre-Conditioning a Measured Surface Height Map for Model Validation

NASA Technical Reports Server (NTRS)

Sidick, Erkin

2012-01-01

This software allows one to up-sample or down-sample a measured surface map for model validation, not only without introducing any re-sampling errors, but also eliminating the existing measurement noise and measurement errors. Because the re-sampling of a surface map is accomplished based on the analytical expressions of Zernike-polynomials and a power spectral density model, such re-sampling does not introduce any aliasing and interpolation errors as is done by the conventional interpolation and FFT-based (fast-Fourier-transform-based) spatial-filtering method. Also, this new method automatically eliminates the measurement noise and other measurement errors such as artificial discontinuity. The developmental cycle of an optical system, such as a space telescope, includes, but is not limited to, the following two steps: (1) deriving requirements or specs on the optical quality of individual optics before they are fabricated through optical modeling and simulations, and (2) validating the optical model using the measured surface height maps after all optics are fabricated. There are a number of computational issues related to model validation, one of which is the "pre-conditioning" or pre-processing of the measured surface maps before using them in a model validation software tool. This software addresses the following issues: (1) up- or down-sampling a measured surface map to match it with the gridded data format of a model validation tool, and (2) eliminating the surface measurement noise or measurement errors such that the resulted surface height map is continuous or smoothly-varying. So far, the preferred method used for re-sampling a surface map is two-dimensional interpolation. The main problem of this method is that the same pixel can take different values when the method of interpolation is changed among the different methods such as the "nearest," "linear," "cubic," and "spline" fitting in Matlab. The conventional, FFT-based spatial filtering method used to

Effective data validation of high-frequency data: time-point-, time-interval-, and trend-based methods.

PubMed

Horn, W; Miksch, S; Egghart, G; Popow, C; Paky, F

1997-09-01

Real-time systems for monitoring and therapy planning, which receive their data from on-line monitoring equipment and computer-based patient records, require reliable data. Data validation has to utilize and combine a set of fast methods to detect, eliminate, and repair faulty data, which may lead to life-threatening conclusions. The strength of data validation results from the combination of numerical and knowledge-based methods applied to both continuously-assessed high-frequency data and discontinuously-assessed data. Dealing with high-frequency data, examining single measurements is not sufficient. It is essential to take into account the behavior of parameters over time. We present time-point-, time-interval-, and trend-based methods for validation and repair. These are complemented by time-independent methods for determining an overall reliability of measurements. The data validation benefits from the temporal data-abstraction process, which provides automatically derived qualitative values and patterns. The temporal abstraction is oriented on a context-sensitive and expectation-guided principle. Additional knowledge derived from domain experts forms an essential part for all of these methods. The methods are applied in the field of artificial ventilation of newborn infants. Examples from the real-time monitoring and therapy-planning system VIE-VENT illustrate the usefulness and effectiveness of the methods.

Teaching Analytical Method Transfer through Developing and Validating Then Transferring Dissolution Testing Methods for Pharmaceuticals

ERIC Educational Resources Information Center

Kimaru, Irene; Koether, Marina; Chichester, Kimberly; Eaton, Lafayette

2017-01-01

Analytical method transfer (AMT) and dissolution testing are important topics required in industry that should be taught in analytical chemistry courses. Undergraduate students in senior level analytical chemistry laboratory courses at Kennesaw State University (KSU) and St. John Fisher College (SJFC) participated in development, validation, and…

Validate or falsify: Lessons learned from a microscopy method claimed to be useful for detecting Borrelia and Babesia organisms in human blood.

PubMed

Aase, Audun; Hajdusek, Ondrej; Øines, Øivind; Quarsten, Hanne; Wilhelmsson, Peter; Herstad, Tove K; Kjelland, Vivian; Sima, Radek; Jalovecka, Marie; Lindgren, Per-Eric; Aaberge, Ingeborg S

2016-01-01

A modified microscopy protocol (the LM-method) was used to demonstrate what was interpreted as Borrelia spirochetes and later also Babesia sp., in peripheral blood from patients. The method gained much publicity, but was not validated prior to publication, which became the purpose of this study using appropriate scientific methodology, including a control group. Blood from 21 patients previously interpreted as positive for Borrelia and/or Babesia infection by the LM-method and 41 healthy controls without known history of tick bite were collected, blinded and analysed for these pathogens by microscopy in two laboratories by the LM-method and conventional method, respectively, by PCR methods in five laboratories and by serology in one laboratory. Microscopy by the LM-method identified structures claimed to be Borrelia- and/or Babesia in 66% of the blood samples of the patient group and in 85% in the healthy control group. Microscopy by the conventional method for Babesia only did not identify Babesia in any samples. PCR analysis detected Borrelia DNA in one sample of the patient group and in eight samples of the control group; whereas Babesia DNA was not detected in any of the blood samples using molecular methods. The structures interpreted as Borrelia and Babesia by the LM-method could not be verified by PCR. The method was, thus, falsified. This study underlines the importance of doing proper test validation before new or modified assays are introduced.

A Comparison of Three Methods for the Analysis of Skin Flap Viability: Reliability and Validity.

PubMed

Tim, Carla Roberta; Martignago, Cintia Cristina Santi; da Silva, Viviane Ribeiro; Dos Santos, Estefany Camila Bonfim; Vieira, Fabiana Nascimento; Parizotto, Nivaldo Antonio; Liebano, Richard Eloin

2018-05-01

Objective: Technological advances have provided new alternatives to the analysis of skin flap viability in animal models; however, the interrater validity and reliability of these techniques have yet to be analyzed. The present study aimed to evaluate the interrater validity and reliability of three different methods: weight of paper template (WPT), paper template area (PTA), and photographic analysis. Approach: Sixteen male Wistar rats had their cranially based dorsal skin flap elevated. On the seventh postoperative day, the viable tissue area and the necrotic area of the skin flap were recorded using the paper template method and photo image. The evaluation of the percentage of viable tissue was performed using three methods, simultaneously and independently by two raters. The analysis of interrater reliability and viability was performed using the intraclass correlation coefficient and Bland Altman Plot Analysis was used to visualize the presence or absence of systematic bias in the evaluations of data validity. Results: The results showed that interrater reliability for WPT, measurement of PTA, and photographic analysis were 0.995, 0.990, and 0.982, respectively. For data validity, a correlation >0.90 was observed for all comparisons made between the three methods. In addition, Bland Altman Plot Analysis showed agreement between the comparisons of the methods and the presence of systematic bias was not observed. Innovation: Digital methods are an excellent choice for assessing skin flap viability; moreover, they make data use and storage easier. Conclusion: Independently from the method used, the interrater reliability and validity proved to be excellent for the analysis of skin flaps' viability.

Introduction to Validation of Analytical Methods: Potentiometric Determination of CO[subscript 2

ERIC Educational Resources Information Center

Hipólito-Nájera, A. Ricardo; Moya-Hernandez, M. Rosario; Gomez-Balderas, Rodolfo; Rojas-Hernandez, Alberto; Romero-Romo, Mario

2017-01-01

Validation of analytical methods is a fundamental subject for chemical analysts working in chemical industries. These methods are also relevant for pharmaceutical enterprises, biotechnology firms, analytical service laboratories, government departments, and regulatory agencies. Therefore, for undergraduate students enrolled in majors in the field…

Development and validation of a discriminative dissolution method for atorvastatin calcium tablets using in vivo data by LC and UV methods.

PubMed

Machado, J C; Lange, A D; Todeschini, V; Volpato, N M

2014-02-01

A dissolution method to analyze atorvastatin tablets using in vivo data for RP and test pilot (PB) was developed and validated. The appropriate conditions were determined after solubility tests using different media, and sink conditions were established. The conditions used were equipment paddle at 50 rpm and 900 mL of potassium phosphate buffer pH 6.0 as dissolution medium. In vivo release profiles were obtained from the bioequivalence study of RP and the generic candidate PB. The fraction of dose absorbed was calculated using the Loo-Riegelman method. It was necessary to use a scale factor of time similar to 6.0, to associate the values of absorbed fraction and dissolved fraction, obtaining an in vivo-in vitro correlation level A. The dissolution method to quantify the amount of drug dissolved was validated using high-performance liquid chromatography and ultraviolet spectrophotometry, and validated according to the USP protocol. The discriminative power of dissolution conditions was assessed using two different pilot batches of atorvastatin tablets (PA and PB) and RP. The dissolution test was validated and may be used as a discriminating method in quality control and in the development of the new formulations.

Clinical Validation of Heart Rate Apps: Mixed-Methods Evaluation Study

PubMed Central

Stans, Jelle; Mortelmans, Christophe; Van Haelst, Ruth; Van Schelvergem, Gertjan; Pelckmans, Caroline; Smeets, Christophe JP; Lanssens, Dorien; De Cannière, Hélène; Storms, Valerie; Thijs, Inge M; Vaes, Bert; Vandervoort, Pieter M

2017-01-01

Background Photoplethysmography (PPG) is a proven way to measure heart rate (HR). This technology is already available in smartphones, which allows measuring HR only by using the smartphone. Given the widespread availability of smartphones, this creates a scalable way to enable mobile HR monitoring. An essential precondition is that these technologies are as reliable and accurate as the current clinical (gold) standards. At this moment, there is no consensus on a gold standard method for the validation of HR apps. This results in different validation processes that do not always reflect the veracious outcome of comparison. Objective The aim of this paper was to investigate and describe the necessary elements in validating and comparing HR apps versus standard technology. Methods The FibriCheck (Qompium) app was used in two separate prospective nonrandomized studies. In the first study, the HR of the FibriCheck app was consecutively compared with 2 different Food and Drug Administration (FDA)-cleared HR devices: the Nonin oximeter and the AliveCor Mobile ECG. In the second study, a next step in validation was performed by comparing the beat-to-beat intervals of the FibriCheck app to a synchronized ECG recording. Results In the first study, the HR (BPM, beats per minute) of 88 random subjects consecutively measured with the 3 devices showed a correlation coefficient of .834 between FibriCheck and Nonin, .88 between FibriCheck and AliveCor, and .897 between Nonin and AliveCor. A single way analysis of variance (ANOVA; P=.61 was executed to test the hypothesis that there were no significant differences between the HRs as measured by the 3 devices. In the second study, 20,298 (ms) R-R intervals (RRI)–peak-to-peak intervals (PPI) from 229 subjects were analyzed. This resulted in a positive correlation (rs=.993, root mean square deviation [RMSE]=23.04 ms, and normalized root mean square error [NRMSE]=0.012) between the PPI from FibriCheck and the RRI from the wearable

Validation of laboratory-scale recycling test method of paper PSA label products

Treesearch

Carl Houtman; Karen Scallon; Richard Oldack

2008-01-01

Starting with test methods and a specification developed by the U.S. Postal Service (USPS) Environmentally Benign Pressure Sensitive Adhesive Postage Stamp Program, a laboratory-scale test method and a specification were developed and validated for pressure-sensitive adhesive labels, By comparing results from this new test method and pilot-scale tests, which have been...

External Standards or Standard Addition? Selecting and Validating a Method of Standardization

NASA Astrophysics Data System (ADS)

Harvey, David T.

2002-05-01

A common feature of many problem-based laboratories in analytical chemistry is a lengthy independent project involving the analysis of "real-world" samples. Students research the literature, adapting and developing a method suitable for their analyte, sample matrix, and problem scenario. Because these projects encompass the complete analytical process, students must consider issues such as obtaining a representative sample, selecting a method of analysis, developing a suitable standardization, validating results, and implementing appropriate quality assessment/quality control practices. Most textbooks and monographs suitable for an undergraduate course in analytical chemistry, however, provide only limited coverage of these important topics. The need for short laboratory experiments emphasizing important facets of method development, such as selecting a method of standardization, is evident. The experiment reported here, which is suitable for an introductory course in analytical chemistry, illustrates the importance of matrix effects when selecting a method of standardization. Students also learn how a spike recovery is used to validate an analytical method, and obtain a practical experience in the difference between performing an external standardization and a standard addition.

Development and Validation of Coaches' Interpersonal Style Questionnaire

ERIC Educational Resources Information Center

Pulido, Juan J.; Sánchez-Oliva, David; Leo, Francisco M.; Sánchez-Cano, Jorge; García-Calvo, Tomás

2018-01-01

Purpose: The objectives were to develop and validate the Coaches' Interpersonal Style Questionnaire. The Coaches' Interpersonal Style Questionnaire analyzes the interpersonal style adopted by coaches when implementing their strategy of supporting or thwarting athletes' basic psychological needs. Method: In Study 1, an exploratory factor analysis…

[Selection of risk and diagnosis in diabetic polyneuropathy. Validation of method of new systems].

PubMed

Jurado, Jerónimo; Caula, Jacinto; Pou i Torelló, Josep Maria

2006-06-30

In a previous study we developed a specific algorithm, the polyneuropathy selection method (PSM) with 4 parameters (age, HDL-C, HbA1c, and retinopathy), to select patients at risk of diabetic polyneuropathy (DPN). We also developed a simplified method for DPN diagnosis: outpatient polyneuropathy diagnosis (OPD), with 4 variables (symptoms and 3 objective tests). To confirm the validity of conventional tests for DPN diagnosis; to validate the discriminatory power of the PSM and the diagnostic value of OPD by evaluating their relationship to electrodiagnosis studies and objective clinical neurological assessment; and to evaluate the correlation of DPN and pro-inflammatory status. Cross-sectional, crossed association for PSM validation. Paired samples for OPD validation. Primary care in 3 counties. Random sample of 75 subjects from the type-2 diabetes census for PSM evaluation. Thirty DPN patients and 30 non-DPN patients (from 2 DM2 sub-groups in our earlier study) for OPD evaluation. The gold standard for DPN diagnosis will be studied by means of a clinical neurological study (symptoms, physical examination, and sensitivity tests) and electrodiagnosis studies (sensitivity and motor EMG). Risks of neuropathy, macroangiopathy and pro-inflammatory status (PCR, TNF soluble fraction and total TGF-beta1) will be studied in every subject. Electrodiagnosis studies should confirm the validity of conventional tests for DPN diagnosis. PSM and OPD will be valid methods for selecting patients at risk and diagnosing DPN. There will be a significant relationship between DPN and pro-inflammatory tests.

Validity and Feasibility of a Digital Diet Estimation Method for Use with Preschool Children: A Pilot Study

ERIC Educational Resources Information Center

Nicklas, Theresa A.; O'Neil, Carol E.; Stuff, Janice; Goodell, Lora Suzanne; Liu, Yan; Martin, Corby K.

2012-01-01

Objective: The goal of the study was to assess the validity and feasibility of a digital diet estimation method for use with preschool children in "Head Start." Methods: Preschool children and their caregivers participated in validation (n = 22) and feasibility (n = 24) pilot studies. Validity was determined in the metabolic research unit using…

PRN 96-1: Tolerance Enforcement Methods - Independent Laboratory Validation by Petitioner

EPA Pesticide Factsheets

This notice is intended to clarify the requirements for submission of an Independent Laboratory Validation to accompany new pesticide analytical methods and does not contain additional data requirements.This notice supersedes PR Notice 88-5.

Pinaverium Bromide: Development and Validation of Spectrophotometric Methods for Assay and Dissolution Studies.

PubMed

Martins, Danielly da Fonte Carvalho; Florindo, Lorena Coimbra; Machado, Anna Karolina Mouzer da Silva; Todeschini, Vítor; Sangoi, Maximiliano da Silva

2017-11-01

This study presents the development and validation of UV spectrophotometric methods for the determination of pinaverium bromide (PB) in tablet assay and dissolution studies. The methods were satisfactorily validated according to International Conference on Harmonization guidelines. The response was linear (r2 > 0.99) in the concentration ranges of 2-14 μg/mL at 213 nm and 10-70 μg/mL at 243 nm. The LOD and LOQ were 0.39 and 1.31 μg/mL, respectively, at 213 nm. For the 243 nm method, the LOD and LOQ were 2.93 and 9.77 μg/mL, respectively. Precision was evaluated by RSD, and the obtained results were lower than 2%. Adequate accuracy was also obtained. The methods proved to be robust using a full factorial design evaluation. For PB dissolution studies, the best conditions were achieved using a United States Pharmacopeia Dissolution Apparatus 2 (paddle) at 50 rpm and with 900 mL 0.1 M hydrochloric acid as the dissolution medium, presenting satisfactory results during the validation tests. In addition, the kinetic parameters of drug release were investigated using model-dependent methods, and the dissolution profiles were best described by the first-order model. Therefore, the proposed methods were successfully applied for the assay and dissolution analysis of PB in commercial tablets.

Pressure ulcer prevention algorithm content validation: a mixed-methods, quantitative study.

PubMed

van Rijswijk, Lia; Beitz, Janice M

2015-04-01

Translating pressure ulcer prevention (PUP) evidence-based recommendations into practice remains challenging for a variety of reasons, including the perceived quality, validity, and usability of the research or the guideline itself. Following the development and face validation testing of an evidence-based PUP algorithm, additional stakeholder input and testing were needed. Using convenience sampling methods, wound care experts attending a national wound care conference and a regional wound ostomy continence nursing (WOCN) conference and/or graduates of a WOCN program were invited to participate in an Internal Review Board-approved, mixed-methods quantitative survey with qualitative components to examine algorithm content validity. After participants provided written informed consent, demographic variables were collected and participants were asked to comment on and rate the relevance and appropriateness of each of the 26 algorithm decision points/steps using standard content validation study procedures. All responses were anonymous. Descriptive summary statistics, mean relevance/appropriateness scores, and the content validity index (CVI) were calculated. Qualitative comments were transcribed and thematically analyzed. Of the 553 wound care experts invited, 79 (average age 52.9 years, SD 10.1; range 23-73) consented to participate and completed the study (a response rate of 14%). Most (67, 85%) were female, registered (49, 62%) or advanced practice (12, 15%) nurses, and had > 10 years of health care experience (88, 92%). Other health disciplines included medical doctors, physical therapists, nurse practitioners, and certified nurse specialists. Almost all had received formal wound care education (75, 95%). On a Likert-type scale of 1 (not relevant/appropriate) to 4 (very relevant and appropriate), the average score for the entire algorithm/all decision points (N = 1,912) was 3.72 with an overall CVI of 0.94 (out of 1). The only decision point/step recommendation

VALIDATION OF ANALYTICAL METHODS AND INSTRUMENTATION FOR BERYLLIUM MEASUREMENT: REVIEW AND SUMMARY OF AVAILABLE GUIDES, PROCEDURES, AND PROTOCOLS

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

Ekechukwu, A.

This document proposes to provide a listing of available sources which can be used to validate analytical methods and/or instrumentation for beryllium determination. A literature review was conducted of available standard methods and publications used for method validation and/or quality control. A comprehensive listing of the articles, papers, and books reviewed is given in Appendix 1. Available validation documents and guides are listed in the appendix; each has a brief description of application and use. In the referenced sources, there are varying approaches to validation and varying descriptions of validation at different stages in method development. This discussion focuses onmore » validation and verification of fully developed methods and instrumentation that have been offered up for use or approval by other laboratories or official consensus bodies such as ASTM International, the International Standards Organization (ISO) and the Association of Official Analytical Chemists (AOAC). This review was conducted as part of a collaborative effort to investigate and improve the state of validation for measuring beryllium in the workplace and the environment. Documents and publications from the United States and Europe are included. Unless otherwise specified, all documents were published in English.« less

Use of multiple cluster analysis methods to explore the validity of a community outcomes concept map.

PubMed

Orsi, Rebecca

2017-02-01

Concept mapping is now a commonly-used technique for articulating and evaluating programmatic outcomes. However, research regarding validity of knowledge and outcomes produced with concept mapping is sparse. The current study describes quantitative validity analyses using a concept mapping dataset. We sought to increase the validity of concept mapping evaluation results by running multiple cluster analysis methods and then using several metrics to choose from among solutions. We present four different clustering methods based on analyses using the R statistical software package: partitioning around medoids (PAM), fuzzy analysis (FANNY), agglomerative nesting (AGNES) and divisive analysis (DIANA). We then used the Dunn and Davies-Bouldin indices to assist in choosing a valid cluster solution for a concept mapping outcomes evaluation. We conclude that the validity of the outcomes map is high, based on the analyses described. Finally, we discuss areas for further concept mapping methods research. Copyright © 2016 Elsevier Ltd. All rights reserved.

Validity of Eye Movement Methods and Indices for Capturing Semantic (Associative) Priming Effects

ERIC Educational Resources Information Center

Odekar, Anshula; Hallowell, Brooke; Kruse, Hans; Moates, Danny; Lee, Chao-Yang

2009-01-01

Purpose: The purpose of this investigation was to evaluate the usefulness of eye movement methods and indices as a tool for studying priming effects by verifying whether eye movement indices capture semantic (associative) priming effects in a visual cross-format (written word to semantically related picture) priming paradigm. Method: In the…

TH-CD-202-06: A Method for Characterizing and Validating Dynamic Lung Density Change During Quiet Respiration

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

Dou, T; Ruan, D; Heinrich, M

2016-06-15

Purpose: To obtain a functional relationship that calibrates the lung tissue density change under free breathing conditions through correlating Jacobian values to the Hounsfield units. Methods: Free-breathing lung computed tomography images were acquired using a fast helical CT protocol, where 25 scans were acquired per patient. Using a state-of-the-art deformable registration algorithm, a set of the deformation vector fields (DVF) was generated to provide spatial mapping from the reference image geometry to the other free-breathing scans. These DVFs were used to generate Jacobian maps, which estimate voxelwise volume change. Subsequently, the set of 25 corresponding Jacobian and voxel intensity inmore » Hounsfield units (HU) were collected and linear regression was performed based on the mass conservation relationship to correlate the volume change to density change. Based on the resulting fitting coefficients, the tissues were classified into parenchymal (Type I), vascular (Type II), and soft tissue (Type III) types. These coefficients modeled the voxelwise density variation during quiet breathing. The accuracy of the proposed method was assessed using mean absolute difference in HU between the CT scan intensities and the model predicted values. In addition, validation experiments employing a leave-five-out method were performed to evaluate the model accuracy. Results: The computed mean model errors were 23.30±9.54 HU, 29.31±10.67 HU, and 35.56±20.56 HU, respectively, for regions I, II, and III, respectively. The cross validation experiments averaged over 100 trials had mean errors of 30.02 ± 1.67 HU over the entire lung. These mean values were comparable with the estimated CT image background noise. Conclusion: The reported validation experiment statistics confirmed the lung density modeling during free breathing. The proposed technique was general and could be applied to a wide range of problem scenarios where accurate dynamic lung density information is

Validation of a Tool to Assess and Track Undergraduate Attitudes toward Those Living in Poverty

ERIC Educational Resources Information Center

Blair, Kevin D.; Brown, Marlo; Schoepflin, Todd; Taylor, David B.

2014-01-01

Purpose: This article describes the development and validation of the Undergraduate Perceptions of Poverty Tracking Survey (UPPTS). Method: Data were collected from 301 undergraduates at a small university in the Northeast and analyzed using exploratory factor analysis augmented by random qualitative validation. Results: The resulting survey…

Headspace profiling of cocaine samples for intelligence purposes.

PubMed

Dujourdy, Laurence; Besacier, Fabrice

2008-08-06

A method for determination of residual solvents in illicit hydrochloride cocaine samples using static headspace-gas chromatography (HS-GC) associated with a storage computerized procedure is described for the profiling and comparison of seizures. The system involves a gas chromatographic separation of 18 occluded solvents followed by fully automatic data analysis and transfer to a PHP/MySQL database. First, a fractional factorial design was used to evaluate the main effects of some critical method parameters (salt choice, vial agitation intensity, oven temperature, pressurization and loop equilibration) on the results with a minimum of experiments. The method was then validated for tactical intelligence purposes (batch comparison) via several studies: selection of solvents and mathematical comparison tool, reproducibility and "cutting" influence studies. The decision threshold to determine the similarity of two samples was set and false positives and negatives evaluated. Finally, application of the method to distinguish geographical origins is discussed.

Comprehensive validation scheme for in situ fiber optics dissolution method for pharmaceutical drug product testing.

PubMed

Mirza, Tahseen; Liu, Qian Julie; Vivilecchia, Richard; Joshi, Yatindra

2009-03-01

There has been a growing interest during the past decade in the use of fiber optics dissolution testing. Use of this novel technology is mainly confined to research and development laboratories. It has not yet emerged as a tool for end product release testing despite its ability to generate in situ results and efficiency improvement. One potential reason may be the lack of clear validation guidelines that can be applied for the assessment of suitability of fiber optics. This article describes a comprehensive validation scheme and development of a reliable, robust, reproducible and cost-effective dissolution test using fiber optics technology. The test was successfully applied for characterizing the dissolution behavior of a 40-mg immediate-release tablet dosage form that is under development at Novartis Pharmaceuticals, East Hanover, New Jersey. The method was validated for the following parameters: linearity, precision, accuracy, specificity, and robustness. In particular, robustness was evaluated in terms of probe sampling depth and probe orientation. The in situ fiber optic method was found to be comparable to the existing manual sampling dissolution method. Finally, the fiber optic dissolution test was successfully performed by different operators on different days, to further enhance the validity of the method. The results demonstrate that the fiber optics technology can be successfully validated for end product dissolution/release testing. (c) 2008 Wiley-Liss, Inc. and the American Pharmacists Association

Development and Testing of a Method for Validating Chemical Inactivation of Ebola Virus.

PubMed

Alfson, Kendra J; Griffiths, Anthony

2018-03-13

Complete inactivation of infectious Ebola virus (EBOV) is required before a sample may be removed from a Biosafety Level 4 laboratory. The United States Federal Select Agent Program regulations require that procedures used to demonstrate chemical inactivation must be validated in-house to confirm complete inactivation. The objective of this study was to develop a method for validating chemical inactivation of EBOV and then demonstrate the effectiveness of several commonly-used inactivation methods. Samples containing infectious EBOV ( Zaire ebolavirus ) in different matrices were treated, and the sample was diluted to limit the cytopathic effect of the inactivant. The presence of infectious virus was determined by assessing the cytopathic effect in Vero E6 cells. Crucially, this method did not result in a loss of infectivity in control samples, and we were able to detect less than five infectious units of EBOV ( Zaire ebolavirus ). We found that TRIzol LS reagent and RNA-Bee inactivated EBOV in serum; TRIzol LS reagent inactivated EBOV in clarified cell culture media; TRIzol reagent inactivated EBOV in tissue and infected Vero E6 cells; 10% neutral buffered formalin inactivated EBOV in tissue; and osmium tetroxide vapors inactivated EBOV on transmission electron microscopy grids. The methods described herein are easily performed and can be adapted to validate inactivation of viruses in various matrices and by various chemical methods.

Space Suit Joint Torque Measurement Method Validation

NASA Technical Reports Server (NTRS)

Valish, Dana; Eversley, Karina

2012-01-01

In 2009 and early 2010, a test method was developed and performed to quantify the torque required to manipulate joints in several existing operational and prototype space suits. This was done in an effort to develop joint torque requirements appropriate for a new Constellation Program space suit system. The same test method was levied on the Constellation space suit contractors to verify that their suit design met the requirements. However, because the original test was set up and conducted by a single test operator there was some question as to whether this method was repeatable enough to be considered a standard verification method for Constellation or other future development programs. In order to validate the method itself, a representative subset of the previous test was repeated, using the same information that would be available to space suit contractors, but set up and conducted by someone not familiar with the previous test. The resultant data was compared using graphical and statistical analysis; the results indicated a significant variance in values reported for a subset of the re-tested joints. Potential variables that could have affected the data were identified and a third round of testing was conducted in an attempt to eliminate and/or quantify the effects of these variables. The results of the third test effort will be used to determine whether or not the proposed joint torque methodology can be applied to future space suit development contracts.

A multivariate model and statistical method for validating tree grade lumber yield equations

Treesearch

Donald W. Seegrist

1975-01-01

Lumber yields within lumber grades can be described by a multivariate linear model. A method for validating lumber yield prediction equations when there are several tree grades is presented. The method is based on multivariate simultaneous test procedures.

Applying the Mixed Methods Instrument Development and Construct Validation Process: the Transformative Experience Questionnaire

ERIC Educational Resources Information Center

Koskey, Kristin L. K.; Sondergeld, Toni A.; Stewart, Victoria C.; Pugh, Kevin J.

2018-01-01

Onwuegbuzie and colleagues proposed the Instrument Development and Construct Validation (IDCV) process as a mixed methods framework for creating and validating measures. Examples applying IDCV are lacking. We provide an illustrative case integrating the Rasch model and cognitive interviews applied to the development of the Transformative…

Developing and validating the Youth Conduct Problems Scale-Rwanda: a mixed methods approach.

PubMed

Ng, Lauren C; Kanyanganzi, Frederick; Munyanah, Morris; Mushashi, Christine; Betancourt, Theresa S

2014-01-01

This study developed and validated the Youth Conduct Problems Scale-Rwanda (YCPS-R). Qualitative free listing (n = 74) and key informant interviews (n = 47) identified local conduct problems, which were compared to existing standardized conduct problem scales and used to develop the YCPS-R. The YCPS-R was cognitive tested by 12 youth and caregiver participants, and assessed for test-retest and inter-rater reliability in a sample of 64 youth. Finally, a purposive sample of 389 youth and their caregivers were enrolled in a validity study. Validity was assessed by comparing YCPS-R scores to conduct disorder, which was diagnosed with the Mini International Neuropsychiatric Interview for Children, and functional impairment scores on the World Health Organization Disability Assessment Schedule Child Version. ROC analyses assessed the YCPS-R's ability to discriminate between youth with and without conduct disorder. Qualitative data identified a local presentation of youth conduct problems that did not match previously standardized measures. Therefore, the YCPS-R was developed solely from local conduct problems. Cognitive testing indicated that the YCPS-R was understandable and required little modification. The YCPS-R demonstrated good reliability, construct, criterion, and discriminant validity, and fair classification accuracy. The YCPS-R is a locally-derived measure of Rwandan youth conduct problems that demonstrated good psychometric properties and could be used for further research.

Validity of two methods for estimation of vertical jump height.

PubMed

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

2011-07-01

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

Verification, Validation, and Solution Quality in Computational Physics: CFD Methods Applied to Ice Sheet Physics

NASA Technical Reports Server (NTRS)

Thompson, David E.

2005-01-01

Procedures and methods for veri.cation of coding algebra and for validations of models and calculations used in the aerospace computational fluid dynamics (CFD) community would be ef.cacious if used by the glacier dynamics modeling community. This paper presents some of those methods, and how they might be applied to uncertainty management supporting code veri.cation and model validation for glacier dynamics. The similarities and differences between their use in CFD analysis and the proposed application of these methods to glacier modeling are discussed. After establishing sources of uncertainty and methods for code veri.cation, the paper looks at a representative sampling of veri.cation and validation efforts that are underway in the glacier modeling community, and establishes a context for these within an overall solution quality assessment. Finally, a vision of a new information architecture and interactive scienti.c interface is introduced and advocated.

STATISTICAL VALIDATION OF SULFATE QUANTIFICATION METHODS USED FOR ANALYSIS OF ACID MINE DRAINAGE

EPA Science Inventory

Turbidimetric method (TM), ion chromatography (IC) and inductively coupled plasma atomic emission spectrometry (ICP-AES) with and without acid digestion have been compared and validated for the determination of sulfate in mining wastewater. Analytical methods were chosen to compa...

Validation of a partial coherence interferometry method for estimating retinal shape

PubMed Central

Verkicharla, Pavan K.; Suheimat, Marwan; Pope, James M.; Sepehrband, Farshid; Mathur, Ankit; Schmid, Katrina L.; Atchison, David A.

2015-01-01

To validate a simple partial coherence interferometry (PCI) based retinal shape method, estimates of retinal shape were determined in 60 young adults using off-axis PCI, with three stages of modeling using variants of the Le Grand model eye, and magnetic resonance imaging (MRI). Stage 1 and 2 involved a basic model eye without and with surface ray deviation, respectively and Stage 3 used model with individual ocular biometry and ray deviation at surfaces. Considering the theoretical uncertainty of MRI (12-14%), the results of the study indicate good agreement between MRI and all three stages of PCI modeling with <4% and <7% differences in retinal shapes along horizontal and vertical meridians, respectively. Stage 2 and Stage 3 gave slightly different retinal co-ordinates than Stage 1 and we recommend the intermediate Stage 2 as providing a simple and valid method of determining retinal shape from PCI data. PMID:26417496

Validation of a partial coherence interferometry method for estimating retinal shape.

PubMed

Verkicharla, Pavan K; Suheimat, Marwan; Pope, James M; Sepehrband, Farshid; Mathur, Ankit; Schmid, Katrina L; Atchison, David A

2015-09-01

To validate a simple partial coherence interferometry (PCI) based retinal shape method, estimates of retinal shape were determined in 60 young adults using off-axis PCI, with three stages of modeling using variants of the Le Grand model eye, and magnetic resonance imaging (MRI). Stage 1 and 2 involved a basic model eye without and with surface ray deviation, respectively and Stage 3 used model with individual ocular biometry and ray deviation at surfaces. Considering the theoretical uncertainty of MRI (12-14%), the results of the study indicate good agreement between MRI and all three stages of PCI modeling with <4% and <7% differences in retinal shapes along horizontal and vertical meridians, respectively. Stage 2 and Stage 3 gave slightly different retinal co-ordinates than Stage 1 and we recommend the intermediate Stage 2 as providing a simple and valid method of determining retinal shape from PCI data.

Double Cross-Validation in Multiple Regression: A Method of Estimating the Stability of Results.

ERIC Educational Resources Information Center

Rowell, R. Kevin

In multiple regression analysis, where resulting predictive equation effectiveness is subject to shrinkage, it is especially important to evaluate result replicability. Double cross-validation is an empirical method by which an estimate of invariance or stability can be obtained from research data. A procedure for double cross-validation is…

Cross-Validation of a PACER Prediction Equation for Assessing Aerobic Capacity in Hungarian Youth

ERIC Educational Resources Information Center

Saint-Maurice, Pedro F.; Welk, Gregory J.; Finn, Kevin J.; Kaj, Mónika

2015-01-01

Purpose: The purpose of this article was to evaluate the validity of the Progressive Aerobic Cardiovascular and Endurance Run (PACER) test in a sample of Hungarian youth. Method: Approximately 500 participants (aged 10-18 years old) were randomly selected across Hungary to complete both laboratory (maximal treadmill protocol) and field assessments…

Content Validity of Temporal Bone Models Printed Via Inexpensive Methods and Materials.

PubMed

Bone, T Michael; Mowry, Sarah E

2016-09-01

Computed tomographic (CT) scans of the 3-D printed temporal bone models will be within 15% accuracy of the CT scans of the cadaveric temporal bones. Previous studies have evaluated the face validity of 3-D-printed temporal bone models designed to train otolaryngology residents. The purpose of the study was to determine the content validity of temporal bone models printed using inexpensive printers and materials. Four cadaveric temporal bones were randomly selected and clinical temporal bone CT scans were obtained. Models were generated using previously described methods in acrylonitrile butadiene styrene (ABS) plastic using the Makerbot Replicator 2× and Hyrel printers. Models were radiographically scanned using the same protocol as the cadaveric bones. Four images from each cadaveric CT series and four corresponding images from the model CT series were selected, and voxel values were normalized to black or white. Scan slices were compared using PixelDiff software. Gross anatomic structures were evaluated in the model scans by four board certified otolaryngologists on a 4-point scale. Mean pixel difference between the cadaver and model scans was 14.25 ± 2.30% at the four selected CT slices. Mean cortical bone width difference and mean external auditory canal width difference were 0.58 ± 0.66 mm and 0.55 ± 0.46 mm, respectively. Expert raters felt the mastoid air cells were well represented (2.5 ± 0.5), while middle ear and otic capsule structures were not accurately rendered (all averaged <1.8). These results suggest that these models would be sufficient adjuncts to cadaver temporal bones for training residents in cortical mastoidectomies, but less effective for middle ear procedures.

Reliability and Validity Testing of the Physical Resilience Measure

ERIC Educational Resources Information Center

Resnick, Barbara; Galik, Elizabeth; Dorsey, Susan; Scheve, Ann; Gutkin, Susan

2011-01-01

Objective: The purpose of this study was to test reliability and validity of the Physical Resilience Scale. Methods: A single-group repeated measure design was used and 130 older adults from three different housing sites participated. Participants completed the Physical Resilience Scale, Hardy-Gill Resilience Scale, 14-item Resilience Scale,…

Survey of Verification and Validation Techniques for Small Satellite Software Development

NASA Technical Reports Server (NTRS)

Jacklin, Stephen A.

2015-01-01

The purpose of this paper is to provide an overview of the current trends and practices in small-satellite software verification and validation. This document is not intended to promote a specific software assurance method. Rather, it seeks to present an unbiased survey of software assurance methods used to verify and validate small satellite software and to make mention of the benefits and value of each approach. These methods include simulation and testing, verification and validation with model-based design, formal methods, and fault-tolerant software design with run-time monitoring. Although the literature reveals that simulation and testing has by far the longest legacy, model-based design methods are proving to be useful for software verification and validation. Some work in formal methods, though not widely used for any satellites, may offer new ways to improve small satellite software verification and validation. These methods need to be further advanced to deal with the state explosion problem and to make them more usable by small-satellite software engineers to be regularly applied to software verification. Last, it is explained how run-time monitoring, combined with fault-tolerant software design methods, provides an important means to detect and correct software errors that escape the verification process or those errors that are produced after launch through the effects of ionizing radiation.

Validity and Reliability of International Physical Activity Questionnaire-Short Form in Chinese Youth

ERIC Educational Resources Information Center

Wang, Chao; Chen, Peijie; Zhuang, Jie

2013-01-01

Purpose: The psychometric profiles of the widely used International Physical Activity Questionnaire-Short Form (IPAQ-SF) in Chinese youth have not been reported. The purpose of this study was to examine the validity and reliability of the IPAQ-SF using a sample of Chinese youth. Method: One thousand and twenty-one youth (M[subscript age] = 14.26 ±…

Validation of verbal autopsy methods using hospital medical records: a case study in Vietnam.

PubMed

Tran, Hong Thi; Nguyen, Hoa Phuong; Walker, Sue M; Hill, Peter S; Rao, Chalapati

2018-05-18

Information on causes of death (COD) is crucial for measuring the health outcomes of populations and progress towards the Sustainable Development Goals. In many countries such as Vietnam where the civil registration and vital statistics (CRVS) system is dysfunctional, information on vital events will continue to rely on verbal autopsy (VA) methods. This study assesses the validity of VA methods used in Vietnam, and provides recommendations on methods for implementing VA validation studies in Vietnam. This validation study was conducted on a sample of 670 deaths from a recent VA study in Quang Ninh province. The study covered 116 cases from this sample, which met three inclusion criteria: a) the death occurred within 30 days of discharge after last hospitalisation, and b) medical records (MRs) for the deceased were available from respective hospitals, and c) the medical record mentioned that the patient was terminally ill at discharge. For each death, the underlying cause of death (UCOD) identified from MRs was compared to the UCOD from VA. The validity of VA diagnoses for major causes of death was measured using sensitivity, specificity and positive predictive value (PPV). The sensitivity of VA was at least 75% in identifying some leading CODs such as stroke, road traffic accidents and several site-specific cancers. However, sensitivity was less than 50% for other important causes including ischemic heart disease, chronic obstructive pulmonary diseases, and diabetes. Overall, there was 57% agreement between UCOD from VA and MR, which increased to 76% when multiple causes from VA were compared to UCOD from MR. Our findings suggest that VA is a valid method to ascertain UCOD in contexts such as Vietnam. Furthermore, within cultural contexts in which patients prefer to die at home instead of a healthcare facility, using the available MRs as the gold standard may be meaningful to the extent that recall bias from the interval between last hospital discharge and death

Experimental validation of boundary element methods for noise prediction

NASA Technical Reports Server (NTRS)

Seybert, A. F.; Oswald, Fred B.

1992-01-01

Experimental validation of methods to predict radiated noise is presented. A combined finite element and boundary element model was used to predict the vibration and noise of a rectangular box excited by a mechanical shaker. The predicted noise was compared to sound power measured by the acoustic intensity method. Inaccuracies in the finite element model shifted the resonance frequencies by about 5 percent. The predicted and measured sound power levels agree within about 2.5 dB. In a second experiment, measured vibration data was used with a boundary element model to predict noise radiation from the top of an operating gearbox. The predicted and measured sound power for the gearbox agree within about 3 dB.

The face of pain--a pilot study to validate the measurement of facial pain expression with an improved electromyogram method.

PubMed

Wolf, Karsten; Raedler, Thomas; Henke, Kai; Kiefer, Falk; Mass, Reinhard; Quante, Markus; Wiedemann, Klaus

2005-01-01

The purpose of this pilot study was to establish the validity of an improved facial electromyogram (EMG) method for the measurement of facial pain expression. Darwin defined pain in connection with fear as a simultaneous occurrence of eye staring, brow contraction and teeth chattering. Prkachin was the first to use the video-based Facial Action Coding System to measure facial expressions while using four different types of pain triggers, identifying a group of facial muscles around the eyes. The activity of nine facial muscles in 10 healthy male subjects was analyzed. Pain was induced through a laser system with a randomized sequence of different intensities. Muscle activity was measured with a new, highly sensitive and selective facial EMG. The results indicate two groups of muscles as key for pain expression. These results are in concordance with Darwin's definition. As in Prkachin's findings, one muscle group is assembled around the orbicularis oculi muscle, initiating eye staring. The second group consists of the mentalis and depressor anguli oris muscles, which trigger mouth movements. The results demonstrate the validity of the facial EMG method for measuring facial pain expression. Further studies with psychometric measurements, a larger sample size and a female test group should be conducted.

Reference Proteome Extracts for Mass Spec Instrument Performance Validation and Method Development

PubMed Central

Rosenblatt, Mike; Urh, Marjeta; Saveliev, Sergei

2014-01-01

Biological samples of high complexity are required to test protein mass spec sample preparation procedures and validate mass spec instrument performance. Total cell protein extracts provide the needed sample complexity. However, to be compatible with mass spec applications, such extracts should meet a number of design requirements: compatibility with LC/MS (free of detergents, etc.)high protein integrity (minimal level of protein degradation and non-biological PTMs)compatibility with common sample preparation methods such as proteolysis, PTM enrichment and mass-tag labelingLot-to-lot reproducibility Here we describe total protein extracts from yeast and human cells that meet the above criteria. Two extract formats have been developed: Intact protein extracts with primary use for sample preparation method development and optimizationPre-digested extracts (peptides) with primary use for instrument validation and performance monitoring

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.

Low-cost extrapolation method for maximal LTE radio base station exposure estimation: test and validation.

PubMed

Verloock, Leen; Joseph, Wout; Gati, Azeddine; Varsier, Nadège; Flach, Björn; Wiart, Joe; Martens, Luc

2013-06-01

An experimental validation of a low-cost method for extrapolation and estimation of the maximal electromagnetic-field exposure from long-term evolution (LTE) radio base station installations are presented. No knowledge on downlink band occupation or service characteristics is required for the low-cost method. The method is applicable in situ. It only requires a basic spectrum analyser with appropriate field probes without the need of expensive dedicated LTE decoders. The method is validated both in laboratory and in situ, for a single-input single-output antenna LTE system and a 2×2 multiple-input multiple-output system, with low deviations in comparison with signals measured using dedicated LTE decoders.

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.

Blood Density Is Nearly Equal to Water Density: A Validation Study of the Gravimetric Method of Measuring Intraoperative Blood Loss

PubMed Central

Vitello, Dominic J.; Ripper, Richard M.; Fettiplace, Michael R.; Weinberg, Guy L.; Vitello, Joseph M.

2015-01-01

Purpose. The gravimetric method of weighing surgical sponges is used to quantify intraoperative blood loss. The dry mass minus the wet mass of the gauze equals the volume of blood lost. This method assumes that the density of blood is equivalent to water (1 gm/mL). This study's purpose was to validate the assumption that the density of blood is equivalent to water and to correlate density with hematocrit. Methods. 50 µL of whole blood was weighed from eighteen rats. A distilled water control was weighed for each blood sample. The averages of the blood and water were compared utilizing a Student's unpaired, one-tailed t-test. The masses of the blood samples and the hematocrits were compared using a linear regression. Results. The average mass of the eighteen blood samples was 0.0489 g and that of the distilled water controls was 0.0492 g. The t-test showed P = 0.2269 and R 2 = 0.03154. The hematocrit values ranged from 24% to 48%. The linear regression R 2 value was 0.1767. Conclusions. The R 2 value comparing the blood and distilled water masses suggests high correlation between the two populations. Linear regression showed the hematocrit was not proportional to the mass of the blood. The study confirmed that the measured density of blood is similar to water. PMID:26464949

Blood Density Is Nearly Equal to Water Density: A Validation Study of the Gravimetric Method of Measuring Intraoperative Blood Loss.

PubMed

Vitello, Dominic J; Ripper, Richard M; Fettiplace, Michael R; Weinberg, Guy L; Vitello, Joseph M

2015-01-01

Purpose. The gravimetric method of weighing surgical sponges is used to quantify intraoperative blood loss. The dry mass minus the wet mass of the gauze equals the volume of blood lost. This method assumes that the density of blood is equivalent to water (1 gm/mL). This study's purpose was to validate the assumption that the density of blood is equivalent to water and to correlate density with hematocrit. Methods. 50 µL of whole blood was weighed from eighteen rats. A distilled water control was weighed for each blood sample. The averages of the blood and water were compared utilizing a Student's unpaired, one-tailed t-test. The masses of the blood samples and the hematocrits were compared using a linear regression. Results. The average mass of the eighteen blood samples was 0.0489 g and that of the distilled water controls was 0.0492 g. The t-test showed P = 0.2269 and R (2) = 0.03154. The hematocrit values ranged from 24% to 48%. The linear regression R (2) value was 0.1767. Conclusions. The R (2) value comparing the blood and distilled water masses suggests high correlation between the two populations. Linear regression showed the hematocrit was not proportional to the mass of the blood. The study confirmed that the measured density of blood is similar to water.

Validated spectrophotometric methods for determination of some oral hypoglycemic drugs.

PubMed

Farouk, M; Abdel-Satar, O; Abdel-Aziz, O; Shaaban, M

2011-02-01

Four accurate, precise, rapid, reproducible, and simple spectrophotometric methods were validated for determination of repaglinide (RPG), pioglitazone hydrochloride (PGL) and rosiglitazone maleate (RGL). The first two methods were based on the formation of a charge-transfer purple-colored complex of chloranilic acid with RPG and RGL with a molar absorptivity 1.23 × 10³ and 8.67 × 10² l•mol^-1•cm^-1 and a Sandell's sensitivity of 0.367 and 0.412 μg•cm^-2, respectively, and an ion-pair yellow-colored complex of bromophenol blue with RPG, PGL and RGL with molar absorptivity 8.86 × 10³, 6.95 × 10³, and 7.06 × 10³ l•mol^-1•cm^-1, respectively, and a Sandell's sensitivity of 0.051 μg•cm^-2 for all ion-pair complexes. The influence of different parameters on color formation was studied to determine optimum conditions for the visible spectrophotometric methods. The other spectrophotometric methods were adopted for demtermination of the studied drugs in the presence of their acid-, alkaline- and oxidative-degradates by computing derivative and pH-induced difference spectrophotometry, as stability-indicating techniques. All the proposed methods were validated according to the International Conference on Harmonization guidelines and successfully applied for determination of the studied drugs in pure form and in pharmaceutical preparations with good extraction recovery ranges between 98.7-101.4%, 98.2-101.3%, and 99.9-101.4% for RPG, PGL, and RGL, respectively. Results of relative standard deviations did not exceed 1.6%, indicating that the proposed methods having good repeatability and reproducibility. All the obtained results were statistically compared to the official method used for RPG analysis and the manufacturers methods used for PGL and RGL analysis, respectively, where no significant differences were found.

Experimental Validation of Normalized Uniform Load Surface Curvature Method for Damage Localization

PubMed Central

Jung, Ho-Yeon; Sung, Seung-Hoon; Jung, Hyung-Jo

2015-01-01

In this study, we experimentally validated the normalized uniform load surface (NULS) curvature method, which has been developed recently to assess damage localization in beam-type structures. The normalization technique allows for the accurate assessment of damage localization with greater sensitivity irrespective of the damage location. In this study, damage to a simply supported beam was numerically and experimentally investigated on the basis of the changes in the NULS curvatures, which were estimated from the modal flexibility matrices obtained from the acceleration responses under an ambient excitation. Two damage scenarios were considered for the single damage case as well as the multiple damages case by reducing the bending stiffness (EI) of the affected element(s). Numerical simulations were performed using MATLAB as a preliminary step. During the validation experiments, a series of tests were performed. It was found that the damage locations could be identified successfully without any false-positive or false-negative detections using the proposed method. For comparison, the damage detection performances were compared with those of two other well-known methods based on the modal flexibility matrix, namely, the uniform load surface (ULS) method and the ULS curvature method. It was confirmed that the proposed method is more effective for investigating the damage locations of simply supported beams than the two conventional methods in terms of sensitivity to damage under measurement noise. PMID:26501286

Vacuum decay container closure integrity leak test method development and validation for a lyophilized product-package system.

PubMed

Patel, Jayshree; Mulhall, Brian; Wolf, Heinz; Klohr, Steven; Guazzo, Dana Morton

2011-01-01

A leak test performed according to ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method was developed and validated for container-closure integrity verification of a lyophilized product in a parenteral vial package system. This nondestructive leak test method is intended for use in manufacturing as an in-process package integrity check, and for testing product stored on stability in lieu of sterility tests. Method development and optimization challenge studies incorporated artificially defective packages representing a range of glass vial wall and sealing surface defects, as well as various elastomeric stopper defects. Method validation required 3 days of random-order replicate testing of a test sample population of negative-control, no-defect packages and positive-control, with-defect packages. Positive-control packages were prepared using vials each with a single hole laser-drilled through the glass vial wall. Hole creation and hole size certification was performed by Lenox Laser. Validation study results successfully demonstrated the vacuum decay leak test method's ability to accurately and reliably detect those packages with laser-drilled holes greater than or equal to approximately 5 μm in nominal diameter. All development and validation studies were performed at Whitehouse Analytical Laboratories in Whitehouse, NJ, under the direction of consultant Dana Guazzo of RxPax, LLC, using a VeriPac 455 Micro Leak Test System by Packaging Technologies & Inspection (Tuckahoe, NY). Bristol Myers Squibb (New Brunswick, NJ) fully subsidized all work. A leak test performed according to ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method was developed and validated to detect defects in stoppered vial packages containing lyophilized product for injection. This nondestructive leak test method is intended for use in manufacturing as an in-process package integrity

A systematic review and appraisal of methods of developing and validating lifestyle cardiovascular disease risk factors questionnaires.

PubMed

Nse, Odunaiya; Quinette, Louw; Okechukwu, Ogah

2015-09-01

Well developed and validated lifestyle cardiovascular disease (CVD) risk factors questionnaires is the key to obtaining accurate information to enable planning of CVD prevention program which is a necessity in developing countries. We conducted this review to assess methods and processes used for development and content validation of lifestyle CVD risk factors questionnaires and possibly develop an evidence based guideline for development and content validation of lifestyle CVD risk factors questionnaires. Relevant databases at the Stellenbosch University library were searched for studies conducted between 2008 and 2012, in English language and among humans. Using the following databases; pubmed, cinahl, psyc info and proquest. Search terms used were CVD risk factors, questionnaires, smoking, alcohol, physical activity and diet. Methods identified for development of lifestyle CVD risk factors were; review of literature either systematic or traditional, involvement of expert and /or target population using focus group discussion/interview, clinical experience of authors and deductive reasoning of authors. For validation, methods used were; the involvement of expert panel, the use of target population and factor analysis. Combination of methods produces questionnaires with good content validity and other psychometric properties which we consider good.

Validation of the Mass-Extraction-Window for Quantitative Methods Using Liquid Chromatography High Resolution Mass Spectrometry.

PubMed

Glauser, Gaétan; Grund, Baptiste; Gassner, Anne-Laure; Menin, Laure; Henry, Hugues; Bromirski, Maciej; Schütz, Frédéric; McMullen, Justin; Rochat, Bertrand

2016-03-15

A paradigm shift is underway in the field of quantitative liquid chromatography-mass spectrometry (LC-MS) analysis thanks to the arrival of recent high-resolution mass spectrometers (HRMS). The capability of HRMS to perform sensitive and reliable quantifications of a large variety of analytes in HR-full scan mode is showing that it is now realistic to perform quantitative and qualitative analysis with the same instrument. Moreover, HR-full scan acquisition offers a global view of sample extracts and allows retrospective investigations as virtually all ionized compounds are detected with a high sensitivity. In time, the versatility of HRMS together with the increasing need for relative quantification of hundreds of endogenous metabolites should promote a shift from triple-quadrupole MS to HRMS. However, a current "pitfall" in quantitative LC-HRMS analysis is the lack of HRMS-specific guidance for validated quantitative analyses. Indeed, false positive and false negative HRMS detections are rare, albeit possible, if inadequate parameters are used. Here, we investigated two key parameters for the validation of LC-HRMS quantitative analyses: the mass accuracy (MA) and the mass-extraction-window (MEW) that is used to construct the extracted-ion-chromatograms. We propose MA-parameters, graphs, and equations to calculate rational MEW width for the validation of quantitative LC-HRMS methods. MA measurements were performed on four different LC-HRMS platforms. Experimentally determined MEW values ranged between 5.6 and 16.5 ppm and depended on the HRMS platform, its working environment, the calibration procedure, and the analyte considered. The proposed procedure provides a fit-for-purpose MEW determination and prevents false detections.

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

Improvement of Simulation Method in Validation of Software of the Coordinate Measuring Systems

NASA Astrophysics Data System (ADS)

Nieciąg, Halina

2015-10-01

Software is used in order to accomplish various tasks at each stage of the functioning of modern measuring systems. Before metrological confirmation of measuring equipment, the system has to be validated. This paper discusses the method for conducting validation studies of a fragment of software to calculate the values of measurands. Due to the number and nature of the variables affecting the coordinate measurement results and the complex character and multi-dimensionality of measurands, the study used the Monte Carlo method of numerical simulation. The article presents an attempt of possible improvement of results obtained by classic Monte Carlo tools. The algorithm LHS (Latin Hypercube Sampling) was implemented as alternative to the simple sampling schema of classic algorithm.

A Framework for Mixing Methods in Quantitative Measurement Development, Validation, and Revision: A Case Study

ERIC Educational Resources Information Center

Luyt, Russell

2012-01-01

A framework for quantitative measurement development, validation, and revision that incorporates both qualitative and quantitative methods is introduced. It extends and adapts Adcock and Collier's work, and thus, facilitates understanding of quantitative measurement development, validation, and revision as an integrated and cyclical set of…

Methods to validate the accuracy of an indirect calorimeter in the in-vitro setting.

PubMed

Oshima, Taku; Ragusa, Marco; Graf, Séverine; Dupertuis, Yves Marc; Heidegger, Claudia-Paula; Pichard, Claude

2017-12-01

The international ICALIC initiative aims at developing a new indirect calorimeter according to the needs of the clinicians and researchers in the field of clinical nutrition and metabolism. The project initially focuses on validating the calorimeter for use in mechanically ventilated acutely ill adult patient. However, standard methods to validate the accuracy of calorimeters have not yet been established. This paper describes the procedures for the in-vitro tests to validate the accuracy of the new indirect calorimeter, and defines the ranges for the parameters to be evaluated in each test to optimize the validation for clinical and research calorimetry measurements. Two in-vitro tests have been defined to validate the accuracy of the gas analyzers and the overall function of the new calorimeter. 1) Gas composition analysis allows validating the accuracy of O 2 and CO 2 analyzers. Reference gas of known O 2 (or CO 2 ) concentration is diluted by pure nitrogen gas to achieve predefined O 2 (or CO 2 ) concentration, to be measured by the indirect calorimeter. O 2 and CO 2 concentrations to be tested were determined according to their expected ranges of concentrations during calorimetry measurements. 2) Gas exchange simulator analysis validates O 2 consumption (VO 2 ) and CO 2 production (VCO 2 ) measurements. CO 2 gas injection into artificial breath gas provided by the mechanical ventilator simulates VCO 2 . Resulting dilution of O 2 concentration in the expiratory air is analyzed by the calorimeter as VO 2 . CO 2 gas of identical concentration to the fraction of inspired O 2 (FiO 2 ) is used to simulate identical VO 2 and VCO 2 . Indirect calorimetry results from publications were analyzed to determine the VO 2 and VCO 2 values to be tested for the validation. O 2 concentration in respiratory air is highest at inspiration, and can decrease to 15% during expiration. CO 2 concentration can be as high as 5% in expired air. To validate analyzers for measurements of Fi

Comparison of validation methods for forming simulations

NASA Astrophysics Data System (ADS)

Schug, Alexander; Kapphan, Gabriel; Bardl, Georg; Hinterhölzl, Roland; Drechsler, Klaus

2018-05-01

The forming simulation of fibre reinforced thermoplastics could reduce the development time and improve the forming results. But to take advantage of the full potential of the simulations it has to be ensured that the predictions for material behaviour are correct. For that reason, a thorough validation of the material model has to be conducted after characterising the material. Relevant aspects for the validation of the simulation are for example the outer contour, the occurrence of defects and the fibre paths. To measure these features various methods are available. Most relevant and also most difficult to measure are the emerging fibre orientations. For that reason, the focus of this study was on measuring this feature. The aim was to give an overview of the properties of different measuring systems and select the most promising systems for a comparison survey. Selected were an optical, an eddy current and a computer-assisted tomography system with the focus on measuring the fibre orientations. Different formed 3D parts made of unidirectional glass fibre and carbon fibre reinforced thermoplastics were measured. Advantages and disadvantages of the tested systems were revealed. Optical measurement systems are easy to use, but are limited to the surface plies. With an eddy current system also lower plies can be measured, but it is only suitable for carbon fibres. Using a computer-assisted tomography system all plies can be measured, but the system is limited to small parts and challenging to evaluate.

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.

Performance Validity Testing in Neuropsychology: Methods for Measurement Development and Maximizing Diagnostic Accuracy.

PubMed

Wodushek, Thomas R; Greher, Michael R

2017-05-01

In the first column in this 2-part series, Performance Validity Testing in Neuropsychology: Scientific Basis and Clinical Application-A Brief Review, the authors introduced performance validity tests (PVTs) and their function, provided a justification for why they are necessary, traced their ongoing endorsement by neuropsychological organizations, and described how they are used and interpreted by ever increasing numbers of clinical neuropsychologists. To enhance readers' understanding of these measures, this second column briefly describes common detection strategies used in PVTs as well as the typical methods used to validate new PVTs and determine cut scores for valid/invalid determinations. We provide a discussion of the latest research demonstrating how neuropsychologists can combine multiple PVTs in a single battery to improve sensitivity/specificity to invalid responding. Finally, we discuss future directions for the research and application of PVTs.

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

PubMed

Charoennit, P; Lourith, N

2012-04-01

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

Hidden Populations, Online Purposive Sampling, and External Validity: Taking off the Blindfold

ERIC Educational Resources Information Center

Barratt, Monica J.; Ferris, Jason A.; Lenton, Simon

2015-01-01

Online purposive samples have unknown biases and may not strictly be used to make inferences about wider populations, yet such inferences continue to occur. We compared the demographic and drug use characteristics of Australian ecstasy users from a probability (National Drug Strategy Household Survey, n = 726) and purposive sample (online survey…

Development and validation of a multi-analyte method for the regulatory control of carotenoids used as feed additives in fish and poultry feed.

PubMed

Vincent, Ursula; Serano, Federica; von Holst, Christoph

2017-08-01

Carotenoids are used in animal nutrition mainly as sensory additives that favourably affect the colour of fish, birds and food of animal origin. Various analytical methods exist for their quantification in compound feed, reflecting the different physico-chemical characteristics of the carotenoid and the corresponding feed additives. They may be natural products or specific formulations containing the target carotenoids produced by chemical synthesis. In this study a multi-analyte method was developed that can be applied to the determination of all 10 carotenoids currently authorised within the European Union for compound feedingstuffs. The method functions regardless of whether the carotenoids have been added to the compound feed via natural products or specific formulations. It is comprised of three steps: (1) digestion of the feed sample with an enzyme; (2) pressurised liquid extraction; and (3) quantification of the analytes by reversed-phase HPLC coupled to a photodiode array detector in the visible range. The method was single-laboratory validated for poultry and fish feed covering a mass fraction range of the target analyte from 2.5 to 300 mg kg - 1 . The following method performance characteristics were obtained: the recovery rate varied from 82% to 129% and precision expressed as the relative standard deviation of intermediate precision varied from 1.6% to 15%. Based on the acceptable performance obtained in the validation study, the multi-analyte method is considered fit for the intended purpose.

A Validation Study of the Adolescent Dissociative Experiences Scale

ERIC Educational Resources Information Center

Keck Seeley, Susan. M.; Perosa, Sandra, L.; Perosa, Linda, M.

2004-01-01

Objective: The purpose of this study was to further the validation process of the Adolescent Dissociative Experiences Scale (A-DES). In this study, a 6-item Likert response format with descriptors was used when responding to the A-DES rather than the 11-item response format used in the original A-DES. Method: The internal reliability and construct…

Validation of quantitative method for azoxystrobin residues in green beans and peas.

PubMed

Abdelraheem, Ehab M H; Hassan, Sayed M; Arief, Mohamed M H; Mohammad, Somaia G

2015-09-01

This study presents a method validation for extraction and quantitative analysis of azoxystrobin residues in green beans and peas using HPLC-UV and the results confirmed by GC-MS. The employed method involved initial extraction with acetonitrile after the addition of salts (magnesium sulfate and sodium chloride), followed by a cleanup step by activated neutral carbon. Validation parameters; linearity, matrix effect, LOQ, specificity, trueness and repeatability precision were attained. The spiking levels for the trueness and the precision experiments were (0.1, 0.5, 3 mg/kg). For HPLC-UV analysis, mean recoveries ranged between 83.69% to 91.58% and 81.99% to 107.85% for green beans and peas, respectively. For GC-MS analysis, mean recoveries ranged from 76.29% to 94.56% and 80.77% to 100.91% for green beans and peas, respectively. According to these results, the method has been proven to be efficient for extraction and determination of azoxystrobin residues in green beans and peas. Copyright © 2015 Elsevier Ltd. All rights reserved.

Development and validation of a rapid multi-class method for the confirmation of fourteen prohibited medicinal additives in pig and poultry compound feed by liquid chromatography-tandem mass spectrometry.

PubMed

Cronly, Mark; Behan, P; Foley, B; Malone, E; Earley, S; Gallagher, M; Shearan, P; Regan, L

2010-12-01

A confirmatory method has been developed to allow for the analysis of fourteen prohibited medicinal additives in pig and poultry compound feed. These compounds are prohibited for use as feed additives although some are still authorised for use in medicated feed. Feed samples are extracted by acetonitrile with addition of sodium sulfate. The extracts undergo a hexane wash to aid with sample purification. The extracts are then evaporated to dryness and reconstituted in initial mobile phase. The samples undergo an ultracentrifugation step prior to injection onto the LC-MS/MS system and are analysed in a run time of 26 min. The LC-MS/MS system is run in MRM mode with both positive and negative electrospray ionisation. The method was validated over three days and is capable of quantitatively analysing for metronidazole, dimetridazole, ronidazole, ipronidazole, chloramphenicol, sulfamethazine, dinitolimide, ethopabate, carbadox and clopidol. The method is also capable of qualitatively analysing for sulfadiazine, tylosin, virginiamycin and avilamycin. A level of 100 microg kg(-1) was used for validation purposes and the method is capable of analysing to this level for all the compounds. Validation criteria of trueness, precision, repeatability and reproducibility along with measurement uncertainty are calculated for all analytes. Copyright (c) 2010 Elsevier B.V. All rights reserved.

Some New Mathematical Methods for Variational Objective Analysis

NASA Technical Reports Server (NTRS)

Wahba, G.; Johnson, D. R.

1984-01-01

New and/or improved variational methods for simultaneously combining forecast, heterogeneous observational data, a priori climatology, and physics to obtain improved estimates of the initial state of the atmosphere for the purpose of numerical weather prediction are developed. Cross validated spline methods are applied to atmospheric data for the purpose of improved description and analysis of atmospheric phenomena such as the tropopause and frontal boundary surfaces.

Validity of a Simulation Game as a Method for History Teaching

ERIC Educational Resources Information Center

Corbeil, Pierre; Laveault, Dany

2011-01-01

The aim of this research is, first, to determine the validity of a simulation game as a method of teaching and an instrument for the development of reasoning and, second, to study the relationship between learning and students' behavior toward games. The participants were college students in a History of International Relations course, with two…

Validated spectrophotometric methods for simultaneous determination of troxerutin and carbazochrome in dosage form

NASA Astrophysics Data System (ADS)

Khattab, Fatma I.; Ramadan, Nesrin K.; Hegazy, Maha A.; Al-Ghobashy, Medhat A.; Ghoniem, Nermine S.

2015-03-01

Four simple, accurate, sensitive and precise spectrophotometric methods were developed and validated for simultaneous determination of Troxerutin (TXN) and Carbazochrome (CZM) in their bulk powders, laboratory prepared mixtures and pharmaceutical dosage forms. Method A is first derivative spectrophotometry (D1) where TXN and CZM were determined at 294 and 483.5 nm, respectively. Method B is first derivative of ratio spectra (DD1) where the peak amplitude at 248 for TXN and 439 nm for CZM were used for their determination. Method C is ratio subtraction (RS); in which TXN was determined at its λmax (352 nm) in the presence of CZM which was determined by D1 at 483.5 nm. While, method D is mean centering of the ratio spectra (MCR) in which the mean centered values at 300 nm and 340.0 nm were used for the two drugs in a respective order. The two compounds were simultaneously determined in the concentration ranges of 5.00-50.00 μg mL-1 and 0.5-10.0 μg mL-1 for TXN and CZM, respectively. The methods were validated according to the ICH guidelines and the results were statistically compared to the manufacturer's method.

Validated spectrophotometric methods for simultaneous determination of troxerutin and carbazochrome in dosage form.

PubMed

Khattab, Fatma I; Ramadan, Nesrin K; Hegazy, Maha A; Al-Ghobashy, Medhat A; Ghoniem, Nermine S

2015-03-15

Four simple, accurate, sensitive and precise spectrophotometric methods were developed and validated for simultaneous determination of Troxerutin (TXN) and Carbazochrome (CZM) in their bulk powders, laboratory prepared mixtures and pharmaceutical dosage forms. Method A is first derivative spectrophotometry (D(1)) where TXN and CZM were determined at 294 and 483.5 nm, respectively. Method B is first derivative of ratio spectra (DD(1)) where the peak amplitude at 248 for TXN and 439 nm for CZM were used for their determination. Method C is ratio subtraction (RS); in which TXN was determined at its λmax (352 nm) in the presence of CZM which was determined by D(1) at 483.5 nm. While, method D is mean centering of the ratio spectra (MCR) in which the mean centered values at 300 nm and 340.0 nm were used for the two drugs in a respective order. The two compounds were simultaneously determined in the concentration ranges of 5.00-50.00 μg mL(-1) and 0.5-10.0 μg mL(-1) for TXN and CZM, respectively. The methods were validated according to the ICH guidelines and the results were statistically compared to the manufacturer's method. Copyright © 2015 Elsevier B.V. All rights reserved.

Validation of the Abdominal Pain Index Using a Revised Scoring Method

PubMed Central

Sherman, Amanda L.; Smith, Craig A.; Walker, Lynn S.

2015-01-01

Objective Evaluate the psychometric properties of child- and parent-report versions of the four-item Abdominal Pain Index (API) in children with functional abdominal pain (FAP) and healthy controls, using a revised scoring method that facilitates comparisons of scores across samples and time. Methods Pediatric patients aged 8–18 years with FAP and controls completed the API at baseline (N = 1,967); a subset of their parents (N = 290) completed the API regarding the child’s pain. Subsets of patients completed follow-up assessments at 2 weeks (N = 231), 3 months (N = 330), and 6 months (N = 107). Subsets of both patients (N = 389) and healthy controls (N = 172) completed a long-term follow-up assessment (mean age at follow-up = 20.21 years, SD = 3.75). Results The API demonstrated good concurrent, discriminant, and construct validity, as well as good internal consistency. Conclusion We conclude that the API, using the revised scoring method, is a useful, reliable, and valid measure of abdominal pain severity. PMID:25617048

STR-validator: an open source platform for validation and process control.

PubMed

Hansson, Oskar; Gill, Peter; Egeland, Thore

2014-11-01

This paper addresses two problems faced when short tandem repeat (STR) systems are validated for forensic purposes: (1) validation is extremely time consuming and expensive, and (2) there is strong consensus about what to validate but not how. The first problem is solved by powerful data processing functions to automate calculations. Utilising an easy-to-use graphical user interface, strvalidator (hereafter referred to as STR-validator) can greatly increase the speed of validation. The second problem is exemplified by a series of analyses, and subsequent comparison with published material, highlighting the need for a common validation platform. If adopted by the forensic community STR-validator has the potential to standardise the analysis of validation data. This would not only facilitate information exchange but also increase the pace at which laboratories are able to switch to new technology. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Development and Single-Laboratory Validation of a Liquid Chromatography Tandem Mass Spectrometry Method for Quantitation of Tetrodotoxin in Mussels and Oysters.

PubMed

Turner, Andrew D; Boundy, Michael J; Rapkova, Monika Dhanji

2017-09-01

In recent years, evidence has grown for the presence of tetrodotoxin (TTX) in bivalve mollusks, leading to the potential for consumers of contaminated products to be affected by Tetrodotoxin Shellfish Poisoning (TSP). A single-laboratory validation was conducted for the hydrophilic interaction LC (HILIC) tandem MS (MS/MS) analysis of TTX in common mussels and Pacific oysters-the bivalve species that have been found to contain TTXs in the United Kingdom in recent years. The method consists of a single-step dispersive extraction in 1% acetic acid, followed by a carbon SPE cleanup step before dilution and instrumental analysis. The full method was developed as a rapid tool for the quantitation of TTX, as well as for the associated analogs 4-epi-TTX; 5,6,11-trideoxy TTX; 11-nor TTX-6-ol; 5-deoxy TTX; and 4,9-anhydro TTX. The method can also be run as the acquisition of TTX together with paralytic shellfish toxins. Results demonstrated acceptable method performance characteristics for specificity, linearity, recovery, ruggedness, repeatability, matrix variability, and within-laboratory reproducibility for the analysis of TTX. The LOD and LOQ were fit-for-purpose in comparison to the current action limit for TTX enforced in The Netherlands. In addition, aspects of method performance (LOD, LOQ, and within-laboratory reproducibility) were found to be satisfactory for three other TTX analogs (11-nor TTX-6-ol, 5-deoxy TTX, and 4,9-anhydro TTX). The method was found to be practical and suitable for use in regulatory testing, providing rapid turnaround of sample analysis. Plans currently underway on a full collaborative study to validate a HILIC-MS/MS method for paralytic shellfish poisoning toxins will be extended to include TTX in order to generate international acceptance, ultimately for use as an alternative official control testing method should regulatory controls be adopted.

Development and validity of a method for the evaluation of printed education material

PubMed Central

Castro, Mauro Silveira; Pilger, Diogo; Fuchs, Flávio Danni; Ferreira, Maria Beatriz Cardoso

Objectives To develop and study the validity of an instrument for evaluation of Printed Education Materials (PEM); to evaluate the use of acceptability indices; to identify possible influences of professional aspects. Methods An instrument for PEM evaluation was developed which included tree steps: domain identification, item generation and instrument design. A reading to easy PEM was developed for education of patient with systemic hypertension and its treatment with hydrochlorothiazide. Construct validity was measured based on previously established errors purposively introduced into the PEM, which served as extreme groups. An acceptability index was applied taking into account the rate of professionals who should approve each item. Participants were 10 physicians (9 men) and 5 nurses (all women). Results Many professionals identified intentional errors of crude character. Few participants identified errors that needed more careful evaluation, and no one detected the intentional error that required literature analysis. Physicians considered as acceptable 95.8% of the items of the PEM, and nurses 29.2%. The differences between the scoring were statistically significant in 27% of the items. In the overall evaluation, 66.6% were considered as acceptable. The analysis of each item revealed a behavioral pattern for each professional group. Conclusions The use of instruments for evaluation of printed education materials is required and may improve the quality of the PEM available for the patients. Not always are the acceptability indices totally correct or represent high quality of information. The professional experience, the practice pattern, and perhaps the gendre of the reviewers may influence their evaluation. An analysis of the PEM by professionals in communication, in drug information, and patients should be carried out to improve the quality of the proposed material. PMID:25214924

Evaluating the Social Validity of the Early Start Denver Model: A Convergent Mixed Methods Study

ERIC Educational Resources Information Center

Ogilvie, Emily; McCrudden, Matthew T.

2017-01-01

An intervention has social validity to the extent that it is socially acceptable to participants and stakeholders. This pilot convergent mixed methods study evaluated parents' perceptions of the social validity of the Early Start Denver Model (ESDM), a naturalistic behavioral intervention for children with autism. It focused on whether the parents…

Method validation for methanol quantification present in working places

NASA Astrophysics Data System (ADS)

Muna, E. D. M.; Bizarri, C. H. B.; Maciel, J. R. M.; da Rocha, G. P.; de Araújo, I. O.

2015-01-01

Given the widespread use of methanol by different industry sectors and high toxicity associated with this substance, it is necessary to use an analytical method able to determine in a sensitive, precise and accurate levels of methanol in the air of working environments. Based on the methodology established by the National Institute for Occupational Safety and Health (NIOSH), it was validated a methodology for determination of methanol in silica gel tubes which had demonstrated its effectiveness based on the participation of the international collaborative program sponsored by the American Industrial Hygiene Association (AIHA).

Patterns of Cognitive Strengths and Weaknesses: Identification Rates, Agreement, and Validity for Learning Disabilities Identification

PubMed Central

Miciak, Jeremy; Fletcher, Jack M.; Stuebing, Karla; Vaughn, Sharon; Tolar, Tammy D.

2014-01-01

Purpose Few empirical investigations have evaluated LD identification methods based on a pattern of cognitive strengths and weaknesses (PSW). This study investigated the reliability and validity of two proposed PSW methods: the concordance/discordance method (C/DM) and cross battery assessment (XBA) method. Methods Cognitive assessment data for 139 adolescents demonstrating inadequate response to intervention was utilized to empirically classify participants as meeting or not meeting PSW LD identification criteria using the two approaches, permitting an analysis of: (1) LD identification rates; (2) agreement between methods; and (3) external validity. Results LD identification rates varied between the two methods depending upon the cut point for low achievement, with low agreement for LD identification decisions. Comparisons of groups that met and did not meet LD identification criteria on external academic variables were largely null, raising questions of external validity. Conclusions This study found low agreement and little evidence of validity for LD identification decisions based on PSW methods. An alternative may be to use multiple measures of academic achievement to guide intervention. PMID:24274155

Investigation of a Sybr-Green-Based Method to Validate DNA Sequences for DNA Computing

DTIC Science & Technology

2005-05-01

OF A SYBR-GREEN-BASED METHOD TO VALIDATE DNA SEQUENCES FOR DNA COMPUTING 6. AUTHOR(S) Wendy Pogozelski, Salvatore Priore, Matthew Bernard ...simulated annealing. Biochemistry, 35, 14077-14089. 15 Pogozelski, W.K., Bernard , M.P. and Macula, A. (2004) DNA code validation using...and Clark, B.F.C. (eds) In RNA Biochemistry and Biotechnology, NATO ASI Series, Kluwer Academic Publishers. Zucker, M. and Stiegler , P. (1981

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

PubMed

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

2012-12-01

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

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

PubMed

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

1999-01-01

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

A systematic and critical review on bioanalytical method validation using the example of simultaneous quantitation of antidiabetic agents in blood.

PubMed

Fachi, Mariana Millan; Leonart, Letícia Paula; Cerqueira, Letícia Bonancio; Pontes, Flavia Lada Degaut; de Campos, Michel Leandro; Pontarolo, Roberto

2017-06-15

A systematic and critical review was conducted on bioanalytical methods validated to quantify combinations of antidiabetic agents in human blood. The aim of this article was to verify how the validation process of bioanalytical methods is performed and the quality of the published records. The validation assays were evaluated according to international guidelines. The main problems in the validation process are pointed out and discussed to help researchers to choose methods that are truly reliable and can be successfully applied for their intended use. The combination of oral antidiabetic agents was chosen as these are some of the most studied drugs and several methods are present in the literature. Moreover, this article may be applied to the validation process of all bioanalytical. Copyright © 2017 Elsevier B.V. All rights reserved.

A Self-Validation Method for High-Temperature Thermocouples Under Oxidizing Atmospheres

NASA Astrophysics Data System (ADS)

Mokdad, S.; Failleau, G.; Deuzé, T.; Briaudeau, S.; Kozlova, O.; Sadli, M.

2015-08-01

Thermocouples are prone to significant drift in use particularly when they are exposed to high temperatures. Indeed, high-temperature exposure can affect the response of a thermocouple progressively by changing the structure of the thermoelements and inducing inhomogeneities. Moreover, an oxidizing atmosphere contributes to thermocouple drift by changing the chemical nature of the metallic wires by the effect of oxidation. In general, severe uncontrolled drift of thermocouples results from these combined influences. A periodic recalibration of the thermocouple can be performed, but sometimes it is not possible to remove the sensor out of the process. Self-validation methods for thermocouples provide a solution to avoid this drawback, but there are currently no high-temperature contact thermometers with self-validation capability at temperatures up to . LNE-Cnam has developed fixed-point devices integrated to the thermocouples consisting of machined alumina-based devices for operation under oxidizing atmospheres. These devices require small amounts of pure metals (typically less than 2 g). They are suitable for self-validation of high-temperature thermocouples up to . In this paper the construction and the characterization of these integrated fixed-point devices are described. The phase-transition plateaus of gold, nickel, and palladium, which enable coverage of the temperature range between and , are assessed with this self-validation technique. Results of measurements performed at LNE-Cnam with the integrated self-validation module at several levels of temperature will be presented. The performance of the devices are assessed and discussed, in terms of robustness and metrological characteristics. Uncertainty budgets are also proposed and detailed.

Alternative methods to determine headwater benefits

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

Bao, Y.S.; Perlack, R.D.; Sale, M.J.

1997-11-10

In 1992, the Federal Energy Regulatory Commission (FERC) began using a Flow Duration Analysis (FDA) methodology to assess headwater benefits in river basins where use of the Headwater Benefits Energy Gains (HWBEG) model may not result in significant improvements in modeling accuracy. The purpose of this study is to validate the accuracy and appropriateness of the FDA method for determining energy gains in less complex basins. This report presents the results of Oak Ridge National Laboratory`s (ORNL`s) validation of the FDA method. The validation is based on a comparison of energy gains using the FDA method with energy gains calculatedmore » using the MWBEG model. Comparisons of energy gains are made on a daily and monthly basis for a complex river basin (the Alabama River Basin) and a basin that is considered relatively simple hydrologically (the Stanislaus River Basin). In addition to validating the FDA method, ORNL was asked to suggest refinements and improvements to the FDA method. Refinements and improvements to the FDA method were carried out using the James River Basin as a test case.« less

Examining Teacher Evaluation Validity and Leadership Decision Making within a Standards-Based Evaluation System

ERIC Educational Resources Information Center

Kimball, Steven M.; Milanowski, Anthony

2009-01-01

Purpose: The article reports on a study of school leader decision making that examined variation in the validity of teacher evaluation ratings in a school district that has implemented a standards-based teacher evaluation system. Research Methods: Applying mixed methods, the study used teacher evaluation ratings and value-added student achievement…

Clinical Validation of Heart Rate Apps: Mixed-Methods Evaluation Study.

PubMed

Vandenberk, Thijs; Stans, Jelle; Mortelmans, Christophe; Van Haelst, Ruth; Van Schelvergem, Gertjan; Pelckmans, Caroline; Smeets, Christophe Jp; Lanssens, Dorien; De Cannière, Hélène; Storms, Valerie; Thijs, Inge M; Vaes, Bert; Vandervoort, Pieter M

2017-08-25

Photoplethysmography (PPG) is a proven way to measure heart rate (HR). This technology is already available in smartphones, which allows measuring HR only by using the smartphone. Given the widespread availability of smartphones, this creates a scalable way to enable mobile HR monitoring. An essential precondition is that these technologies are as reliable and accurate as the current clinical (gold) standards. At this moment, there is no consensus on a gold standard method for the validation of HR apps. This results in different validation processes that do not always reflect the veracious outcome of comparison. The aim of this paper was to investigate and describe the necessary elements in validating and comparing HR apps versus standard technology. The FibriCheck (Qompium) app was used in two separate prospective nonrandomized studies. In the first study, the HR of the FibriCheck app was consecutively compared with 2 different Food and Drug Administration (FDA)-cleared HR devices: the Nonin oximeter and the AliveCor Mobile ECG. In the second study, a next step in validation was performed by comparing the beat-to-beat intervals of the FibriCheck app to a synchronized ECG recording. In the first study, the HR (BPM, beats per minute) of 88 random subjects consecutively measured with the 3 devices showed a correlation coefficient of .834 between FibriCheck and Nonin, .88 between FibriCheck and AliveCor, and .897 between Nonin and AliveCor. A single way analysis of variance (ANOVA; P=.61 was executed to test the hypothesis that there were no significant differences between the HRs as measured by the 3 devices. In the second study, 20,298 (ms) R-R intervals (RRI)-peak-to-peak intervals (PPI) from 229 subjects were analyzed. This resulted in a positive correlation (rs=.993, root mean square deviation [RMSE]=23.04 ms, and normalized root mean square error [NRMSE]=0.012) between the PPI from FibriCheck and the RRI from the wearable ECG. There was no significant difference

A novel validation and calibration method for motion capture systems based on micro-triangulation.

PubMed

Nagymáté, Gergely; Tuchband, Tamás; Kiss, Rita M

2018-06-06

Motion capture systems are widely used to measure human kinematics. Nevertheless, users must consider system errors when evaluating their results. Most validation techniques for these systems are based on relative distance and displacement measurements. In contrast, our study aimed to analyse the absolute volume accuracy of optical motion capture systems by means of engineering surveying reference measurement of the marker coordinates (uncertainty: 0.75 mm). The method is exemplified on an 18 camera OptiTrack Flex13 motion capture system. The absolute accuracy was defined by the root mean square error (RMSE) between the coordinates measured by the camera system and by engineering surveying (micro-triangulation). The original RMSE of 1.82 mm due to scaling error was managed to be reduced to 0.77 mm while the correlation of errors to their distance from the origin reduced from 0.855 to 0.209. A simply feasible but less accurate absolute accuracy compensation method using tape measure on large distances was also tested, which resulted in similar scaling compensation compared to the surveying method or direct wand size compensation by a high precision 3D scanner. The presented validation methods can be less precise in some respects as compared to previous techniques, but they address an error type, which has not been and cannot be studied with the previous validation methods. Copyright © 2018 Elsevier Ltd. All rights reserved.

Validation of a Smartphone Image-Based Dietary Assessment Method for Pregnant Women

PubMed Central

Ashman, Amy M.; Collins, Clare E.; Brown, Leanne J.; Rae, Kym M.; Rollo, Megan E.

2017-01-01

Image-based dietary records could lower participant burden associated with traditional prospective methods of dietary assessment. They have been used in children, adolescents and adults, but have not been evaluated in pregnant women. The current study evaluated relative validity of the DietBytes image-based dietary assessment method for assessing energy and nutrient intakes. Pregnant women collected image-based dietary records (via a smartphone application) of all food, drinks and supplements consumed over three non-consecutive days. Intakes from the image-based method were compared to intakes collected from three 24-h recalls, taken on random days; once per week, in the weeks following the image-based record. Data were analyzed using nutrient analysis software. Agreement between methods was ascertained using Pearson correlations and Bland-Altman plots. Twenty-five women (27 recruited, one withdrew, one incomplete), median age 29 years, 15 primiparas, eight Aboriginal Australians, completed image-based records for analysis. Significant correlations between the two methods were observed for energy, macronutrients and fiber (r = 0.58–0.84, all p < 0.05), and for micronutrients both including (r = 0.47–0.94, all p < 0.05) and excluding (r = 0.40–0.85, all p < 0.05) supplements in the analysis. Bland-Altman plots confirmed acceptable agreement with no systematic bias. The DietBytes method demonstrated acceptable relative validity for assessment of nutrient intakes of pregnant women. PMID:28106758

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

PubMed

Azemard, Sabine; Vassileva, Emilia

2015-06-01

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

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

Softcopy quality ruler method: implementation and validation

NASA Astrophysics Data System (ADS)

Jin, Elaine W.; Keelan, Brian W.; Chen, Junqing; Phillips, Jonathan B.; Chen, Ying

2009-01-01

A softcopy quality ruler method was implemented for the International Imaging Industry Association (I3A) Camera Phone Image Quality (CPIQ) Initiative. This work extends ISO 20462 Part 3 by virtue of creating reference digital images of known subjective image quality, complimenting the hardcopy Standard Reference Stimuli (SRS). The softcopy ruler method was developed using images from a Canon EOS 1Ds Mark II D-SLR digital still camera (DSC) and a Kodak P880 point-and-shoot DSC. Images were viewed on an Apple 30in Cinema Display at a viewing distance of 34 inches. Ruler images were made for 16 scenes. Thirty ruler images were generated for each scene, representing ISO 20462 Standard Quality Scale (SQS) values of approximately 2 to 31 at an increment of one just noticeable difference (JND) by adjusting the system modulation transfer function (MTF). A Matlab GUI was developed to display the ruler and test images side-by-side with a user-adjustable ruler level controlled by a slider. A validation study was performed at Kodak, Vista Point Technology, and Aptina Imaging in which all three companies set up a similar viewing lab to run the softcopy ruler method. The results show that the three sets of data are in reasonable agreement with each other, with the differences within the range expected from observer variability. Compared to previous implementations of the quality ruler, the slider-based user interface allows approximately 2x faster assessments with 21.6% better precision.

Experimental Design and Some Threats to Experimental Validity: A Primer

ERIC Educational Resources Information Center

Skidmore, Susan

2008-01-01

Experimental designs are distinguished as the best method to respond to questions involving causality. The purpose of the present paper is to explicate the logic of experimental design and why it is so vital to questions that demand causal conclusions. In addition, types of internal and external validity threats are discussed. To emphasize the…

Validity and Reliability of Internalized Stigma of Mental Illness (Cantonese)

ERIC Educational Resources Information Center

Young, Daniel Kim-Wan; Ng, Petrus Y. N.; Pan, Jia-Yan; Cheng, Daphne

2017-01-01

Purpose: This study aims to translate and test the reliability and validity of the Internalized Stigma of Mental Illness-Cantonese (ISMI-C). Methods: The original English version of ISMI is translated into the ISMI-C by going through forward and backward translation procedure. A cross-sectional research design is adopted that involved 295…

Multilaboratory Validation of First Action Method 2016.04 for Determination of Four Arsenic Species in Fruit Juice by High-Performance Liquid Chromatography-Inductively Coupled Plasma-Mass Spectrometry.

PubMed

Kubachka, Kevin; Heitkemper, Douglas T; Conklin, Sean

2017-07-01

Before being designated AOAC First Action Official MethodSM 2016.04, the U.S. Food and Drug Administration's method, EAM 4.10 High Performance Liquid Chromatography-Inductively Coupled Plasma-Mass Spectrometric Determination of Four Arsenic Species in Fruit Juice, underwent both a single-laboratory validation and a multilaboratory validation (MLV) study. Three federal and five state regulatory laboratories participated in the MLV study, which is the primary focus of this manuscript. The method was validated for inorganic arsenic (iAs) measured as the sum of the two iAs species arsenite [As(III)] and arsenate [As(V)], dimethylarsinic acid (DMA), and monomethylarsonic acid (MMA) by analyses of 13 juice samples, including three apple juice, three apple juice concentrate, four grape juice, and three pear juice samples. In addition, two water Standard Reference Materials (SRMs) were analyzed. The method LODs and LOQs obtained among the eight laboratories were approximately 0.3 and 2 ng/g, respectively, for each of the analytes and were adequate for the intended purpose of the method. Each laboratory analyzed method blanks, fortified method blanks, reference materials, triplicate portions of each juice sample, and duplicate fortified juice samples (one for each matrix type) at three fortification levels. In general, repeatability and reproducibility of the method was ≤15% RSD for each species present at a concentration >LOQ. The average recovery of fortified analytes for all laboratories ranged from 98 to 104% iAs, DMA, and MMA for all four juice sample matrixes. The average iAs results for SRMs 1640a and 1643e agreed within the range of 96-98% of certified values for total arsenic.

Do placebo based validation standards mimic real batch products behaviour? Case studies.

PubMed

Bouabidi, A; Talbi, M; Bouklouze, A; El Karbane, M; Bourichi, H; El Guezzar, M; Ziemons, E; Hubert, Ph; Rozet, E

2011-06-01

Analytical methods validation is a mandatory step to evaluate the ability of developed methods to provide accurate results for their routine application. Validation usually involves validation standards or quality control samples that are prepared in placebo or reconstituted matrix made of a mixture of all the ingredients composing the drug product except the active substance or the analyte under investigation. However, one of the main concerns that can be made with this approach is that it may lack an important source of variability that come from the manufacturing process. The question that remains at the end of the validation step is about the transferability of the quantitative performance from validation standards to real authentic drug product samples. In this work, this topic is investigated through three case studies. Three analytical methods were validated using the commonly spiked placebo validation standards at several concentration levels as well as using samples coming from authentic batch samples (tablets and syrups). The results showed that, depending on the type of response function used as calibration curve, there were various degrees of differences in the results accuracy obtained with the two types of samples. Nonetheless the use of spiked placebo validation standards was showed to mimic relatively well the quantitative behaviour of the analytical methods with authentic batch samples. Adding these authentic batch samples into the validation design may help the analyst to select and confirm the most fit for purpose calibration curve and thus increase the accuracy and reliability of the results generated by the method in routine application. Copyright © 2011 Elsevier B.V. All rights reserved.

Lead isotope ratios for bullets, a descriptive approach for investigative purposes and a new method for sampling of bullet lead.

PubMed

Sjåstad, Knut-Endre; Simonsen, Siri Lene; Andersen, Tom H

2014-11-01

To establish a link between a bullet fired from a suspected firearm, investigation of striation marks are one of the corner stones in the forensic laboratory. Nevertheless, on some occasions, the bullet may be deformed to such extent that traditional investigation of striation marks will be impossible. Fragments of lead can be investigated by lead isotope ratio determination in order to distinguish between bullets with different origin. This approach initially seems reasonable, since the abundance of lead isotopes varies significantly in nature. To make a method valid for forensic purposes, it is important to have a fundamental understanding of the variation within a box of lead bullets and the expected variation between boxes. Studies of variability within and between boxes of ammunition are imperative to perform any type of forensic interpretation, both in an investigative and evaluative context. This work presents an extensive study of variability within and between boxes of ammunition by use of multicollector inductive coupled mass spectrometry. As a first approximation to classify bullets to any given source, a simple and robust graphical method is presented. In addition, an easy-to-use sampling procedure of lead is presented. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

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

PubMed

Winzer, Eva; Luger, Maria; Schindler, Karin

2018-06-01

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

Rapid determination of residues of pesticides in honey by µGC-ECD and GC-MS/MS: Method validation and estimation of measurement uncertainty according to document No. SANCO/12571/2013.

PubMed

Paoloni, Angela; Alunni, Sabrina; Pelliccia, Alessandro; Pecorelli, Ivan

2016-01-01

A simple and straightforward method for simultaneous determination of residues of 13 pesticides in honey samples (acrinathrin, bifenthrin, bromopropylate, cyhalothrin-lambda, cypermethrin, chlorfenvinphos, chlorpyrifos, coumaphos, deltamethrin, fluvalinate-tau, malathion, permethrin and tetradifon) from different pesticide classes has been developed and validated. The analytical method provides dissolution of honey in water and an extraction of pesticide residues by n-Hexane followed by clean-up on a Florisil SPE column. The extract was evaporated and taken up by a solution of an injection internal standard (I-IS), ethion, and finally analyzed by capillary gas chromatography with electron capture detection (GC-µECD). Identification for qualitative purpose was conducted by gas chromatography with triple quadrupole mass spectrometer (GC-MS/MS). A matrix-matched calibration curve was performed for quantitative purposes by plotting the area ratio (analyte/I-IS) against concentration using a GC-µECD instrument. According to document No. SANCO/12571/2013, the method was validated by testing the following parameters: linearity, matrix effect, specificity, precision, trueness (bias) and measurement uncertainty. The analytical process was validated analyzing blank honey samples spiked at levels equal to and greater than 0.010 mg/kg (limit of quantification). All parameters were satisfactorily compared with the values established by document No. SANCO/12571/2013. The analytical performance was verified by participating in eight multi-residue proficiency tests organized by BIPEA, obtaining satisfactory z-scores in all 70 determinations. Measurement uncertainty was estimated according to the top-down approaches described in Appendix C of the SANCO document using the within-laboratory reproducibility relative standard deviation combined with laboratory bias using the proficiency test data.

A Multi-Purpose, Detector-Based Photometric Calibration System for Luminous Intensity, Illuminance and Luminance

NASA Astrophysics Data System (ADS)

Lam, Brenda H. S.; Yang, Steven S. L.; Chau, Y. C.

2018-02-01

A multi-purpose detector based calibration system for luminous intensity, illuminance and luminance has been developed at the Government of the Hong Kong Special Administrative Region, Standards and Calibration Laboratory (SCL). In this paper, the measurement system and methods are described. The measurement models and contributory uncertainties were validated using the Guide to the Expression of Uncertainty in Measurement (GUM) framework and Supplement 1 to the GUM - Propagation of distributions using a Monte Carlo method in accordance with the JCGM 100:2008 and JCGM 101:2008 at the intended precision level.

An Examination of Construct Validity for the EARLI Numeracy Skill Measures

ERIC Educational Resources Information Center

Cheng, Weiyi; Lei, Pui-Wa; DiPerna, James C.

2017-01-01

The purpose of the current study was to examine dimensionality and concurrent validity evidence of the EARLI numeracy measures (DiPerna, Morgan, & Lei, 2007), which were developed to assess key skills such as number identification, counting, and basic arithmetic. Two methods (NOHARM with approximate chi-square test and DIMTEST with DETECT…

Development and Validation of the Spanish-English Language Proficiency Scale (SELPS)

ERIC Educational Resources Information Center

Smyk, Ekaterina; Restrepo, M. Adelaida; Gorin, Joanna S.; Gray, Shelley

2013-01-01

Purpose: This study examined the development and validation of a criterion-referenced Spanish-English Language Proficiency Scale (SELPS) that was designed to assess the oral language skills of sequential bilingual children ages 4-8. This article reports results for the English proficiency portion of the scale. Method: The SELPS assesses syntactic…

Convergent and Divergent Validity of the Grammaticality and Utterance Length Instrument

ERIC Educational Resources Information Center

Castilla-Earls, Anny; Fulcher-Rood, Katrina

2018-01-01

Purpose: This feasibility study examines the convergent and divergent validity of the Grammaticality and Utterance Length Instrument (GLi), a tool designed to assess the grammaticality and average utterance length of a child's prerecorded story retell. Method: Three raters used the GLi to rate audio-recorded story retells from 100 English-speaking…

Probability of identification: a statistical model for the validation of qualitative botanical identification methods.

PubMed

LaBudde, Robert A; Harnly, James M

2012-01-01

A qualitative botanical identification method (BIM) is an analytical procedure that returns a binary result (1 = Identified, 0 = Not Identified). A BIM may be used by a buyer, manufacturer, or regulator to determine whether a botanical material being tested is the same as the target (desired) material, or whether it contains excessive nontarget (undesirable) material. The report describes the development and validation of studies for a BIM based on the proportion of replicates identified, or probability of identification (POI), as the basic observed statistic. The statistical procedures proposed for data analysis follow closely those of the probability of detection, and harmonize the statistical concepts and parameters between quantitative and qualitative method validation. Use of POI statistics also harmonizes statistical concepts for botanical, microbiological, toxin, and other analyte identification methods that produce binary results. The POI statistical model provides a tool for graphical representation of response curves for qualitative methods, reporting of descriptive statistics, and application of performance requirements. Single collaborator and multicollaborative study examples are given.

Development and Validation of an HPLC Method for Karanjin in Pongamia pinnata linn. Leaves.

PubMed

Katekhaye, S; Kale, M S; Laddha, K S

2012-01-01

A rapid, simple and specific reversed-phase HPLC method has been developed for analysis of karanjin in Pongamia pinnata Linn. leaves. HPLC analysis was performed on a C(18) column using an 85:13.5:1.5 (v/v) mixtures of methanol, water and acetic acid as isocratic mobile phase at a flow rate of 1 ml/min. UV detection was at 300 nm. The method was validated for accuracy, precision, linearity, specificity. Validation revealed the method is specific, accurate, precise, reliable and reproducible. Good linear correlation coefficients (r(2)>0.997) were obtained for calibration plots in the ranges tested. Limit of detection was 4.35 μg and limit of quantification was 16.56 μg. Intra and inter-day RSD of retention times and peak areas was less than 1.24% and recovery was between 95.05 and 101.05%. The established HPLC method is appropriate enabling efficient quantitative analysis of karanjin in Pongamia pinnata leaves.

Development and Validation of an HPLC Method for Karanjin in Pongamia pinnata linn. Leaves

PubMed Central

Katekhaye, S; Kale, M. S.; Laddha, K. S.

2012-01-01

A rapid, simple and specific reversed-phase HPLC method has been developed for analysis of karanjin in Pongamia pinnata Linn. leaves. HPLC analysis was performed on a C18 column using an 85:13.5:1.5 (v/v) mixtures of methanol, water and acetic acid as isocratic mobile phase at a flow rate of 1 ml/min. UV detection was at 300 nm. The method was validated for accuracy, precision, linearity, specificity. Validation revealed the method is specific, accurate, precise, reliable and reproducible. Good linear correlation coefficients (r2>0.997) were obtained for calibration plots in the ranges tested. Limit of detection was 4.35 μg and limit of quantification was 16.56 μg. Intra and inter-day RSD of retention times and peak areas was less than 1.24% and recovery was between 95.05 and 101.05%. The established HPLC method is appropriate enabling efficient quantitative analysis of karanjin in Pongamia pinnata leaves. PMID:23204626

Bridging the Gap Between Validation and Implementation of Non-Animal Veterinary Vaccine Potency Testing Methods.

PubMed

Dozier, Samantha; Brown, Jeffrey; Currie, Alistair

2011-11-29

In recent years, technologically advanced high-throughput techniques have been developed that replace, reduce or refine animal use in vaccine quality control tests. Following validation, these tests are slowly being accepted for use by international regulatory authorities. Because regulatory acceptance itself has not guaranteed that approved humane methods are adopted by manufacturers, various organizations have sought to foster the preferential use of validated non-animal methods by interfacing with industry and regulatory authorities. After noticing this gap between regulation and uptake by industry, we began developing a paradigm that seeks to narrow the gap and quicken implementation of new replacement, refinement or reduction guidance. A systematic analysis of our experience in promoting the transparent implementation of validated non-animal vaccine potency assays has led to the refinement of our paradigmatic process, presented here, by which interested parties can assess the local regulatory acceptance of methods that reduce animal use and integrate them into quality control testing protocols, or ensure the elimination of peripheral barriers to their use, particularly for potency and other tests carried out on production batches.

A Validation Study of the Revised Personal Safety Decision Scale

ERIC Educational Resources Information Center

Kim, HaeJung; Hopkins, Karen M.

2017-01-01

Objective: The purpose of this study is to examine the reliability and validity of an 11-item Personal Safety Decision Scale (PSDS) in a sample of child welfare workers. Methods: Data were derived from a larger cross-sectional online survey to a random stratified sample of 477 public child welfare workers in a mid-Atlantic State. An exploratory…

A validated ultra high pressure liquid chromatographic method for qualification and quantification of folic acid in pharmaceutical preparations.

PubMed

Deconinck, E; Crevits, S; Baten, P; Courselle, P; De Beer, J

2011-04-05

A fully validated UHPLC method for the identification and quantification of folic acid in pharmaceutical preparations was developed. The starting conditions for the development were calculated starting from the HPLC conditions of a validated method. These start conditions were tested on four different UHPLC columns: Grace Vision HT™ C18-P, C18, C18-HL and C18-B (2 mm × 100 mm, 1.5 μm). After selection of the stationary phase, the method was further optimised by testing two aqueous and two organic phases and by adapting to a gradient method. The obtained method was fully validated based on its measurement uncertainty (accuracy profile) and robustness tests. A UHPLC method was obtained for the identification and quantification of folic acid in pharmaceutical preparations, which will cut analysis times and solvent consumption. Copyright © 2010 Elsevier B.V. All rights reserved.

Validation of a method for the quantitation of ghrelin and unacylated ghrelin by HPLC.

PubMed

Staes, Edith; Rozet, Eric; Ucakar, Bernard; Hubert, Philippe; Préat, Véronique

2010-02-05

An HPLC/UV method was first optimized for the separation and quantitation of human acylated and unacylated (or des-acyl) ghrelin from aqueous solutions. This method was validated by an original approach using accuracy profiles based on tolerance intervals for the total error measurement. The concentration range that achieved adequate accuracy extended from 1.85 to 59.30microM and 1.93 to 61.60microM for acylated and unacylated ghrelin, respectively. Then, optimal temperature, pH and buffer for sample storage were determined. Unacylated ghrelin was found to be stable in all conditions tested. At 37 degrees C acylated ghrelin was stable at pH 4 but unstable at pH 7.4, the main degradation product was unacylated ghrelin. Finally, this validated HPLC/UV method was used to evaluate the binding of acylated and unacylated ghrelin to liposomes.

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

PubMed Central

Roumelioti, Maria; Leotsinidis, Michalis

2009-01-01

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

Reliability and validity of a brief method to assess nociceptive flexion reflex (NFR) threshold.

PubMed

Rhudy, Jamie L; France, Christopher R

2011-07-01

The nociceptive flexion reflex (NFR) is a physiological tool to study spinal nociception. However, NFR assessment can take several minutes and expose participants to repeated suprathreshold stimulations. The 4 studies reported here assessed the reliability and validity of a brief method to assess NFR threshold that uses a single ascending series of stimulations (Peak 1 NFR), by comparing it to a well-validated method that uses 3 ascending/descending staircases of stimulations (Staircase NFR). Correlations between the NFR definitions were high, were on par with test-retest correlations of Staircase NFR, and were not affected by participant sex or chronic pain status. Results also indicated the test-retest reliabilities for the 2 definitions were similar. Using larger stimulus increments (4 mAs) to assess Peak 1 NFR tended to result in higher NFR threshold estimates than using the Staircase NFR definition, whereas smaller stimulus increments (2 mAs) tended to result in lower NFR threshold estimates than the Staircase NFR definition. Neither NFR definition was correlated with anxiety, pain catastrophizing, or anxiety sensitivity. In sum, a single ascending series of electrical stimulations results in a reliable and valid estimate of NFR threshold. However, caution may be warranted when comparing NFR thresholds across studies that differ in the ascending stimulus increments. This brief method to assess NFR threshold is reliable and valid; therefore, it should be useful to clinical pain researchers interested in quickly assessing inter- and intra-individual differences in spinal nociceptive processes. Copyright © 2011 American Pain Society. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2008-01-01

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

Validation and Verification (V and V) Testing on Midscale Flame Resistant (FR) Test Method

DTIC Science & Technology

2016-12-16

Method for Evaluation of Flame Resistant Clothing for Protection against Fire Simulations Using an Instrumented Manikin. Validation and...complement (not replace) the capabilities of the ASTM F1930 Standard Test Method for Evaluation of Flame Resistant Clothing for Protection against Fire ...Engineering Center (NSRDEC) to complement the ASTM F1930 Standard Test Method for Evaluation of Flame Resistant Clothing for Protection against Fire

[Validation Study for Analytical Method of Diarrhetic Shellfish Poisons in 9 Kinds of Shellfish].

PubMed

Yamaguchi, Mizuka; Yamaguchi, Takahiro; Kakimoto, Kensaku; Nagayoshi, Haruna; Okihashi, Masahiro; Kajimura, Keiji

2016-01-01

A method was developed for the simultaneous determination of okadaic acid, dinophysistoxin-1 and dinophysistoxin-2 in shellfish using ultra performance liquid chromatography with tandem mass spectrometry. Shellfish poisons in spiked samples were extracted with methanol and 90% methanol, and were hydrolyzed with 2.5 mol/L sodium hydroxide solution. Purification was done on an HLB solid-phase extraction column. This method was validated in accordance with the notification of Ministry of Health, Labour and Welfare of Japan. As a result of the validation study in nine kinds of shellfish, the trueness, repeatability and within-laboratory reproducibility were 79-101%, less than 12 and 16%, respectively. The trueness and precision met the target values of notification.

Validity of the remote food photography method against doubly labeled water among minority preschoolers

USDA-ARS?s Scientific Manuscript database

The aim of this study was to determine the validity of energy intake (EI) estimations made using the remote food photography method (RFPM) compared to the doubly labeled water (DLW) method in minority preschool children in a free-living environment. Seven days of food intake and spot urine samples...

Validation of the Abdominal Pain Index using a revised scoring method.

PubMed

Laird, Kelsey T; Sherman, Amanda L; Smith, Craig A; Walker, Lynn S

2015-06-01

Evaluate the psychometric properties of child- and parent-report versions of the four-item Abdominal Pain Index (API) in children with functional abdominal pain (FAP) and healthy controls, using a revised scoring method that facilitates comparisons of scores across samples and time. Pediatric patients aged 8-18 years with FAP and controls completed the API at baseline (N = 1,967); a subset of their parents (N = 290) completed the API regarding the child's pain. Subsets of patients completed follow-up assessments at 2 weeks (N = 231), 3 months (N = 330), and 6 months (N = 107). Subsets of both patients (N = 389) and healthy controls (N = 172) completed a long-term follow-up assessment (mean age at follow-up = 20.21 years, SD = 3.75). The API demonstrated good concurrent, discriminant, and construct validity, as well as good internal consistency. We conclude that the API, using the revised scoring method, is a useful, reliable, and valid measure of abdominal pain severity. © The Author 2015. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

MO-C-17A-03: A GPU-Based Method for Validating Deformable Image Registration in Head and Neck Radiotherapy Using Biomechanical Modeling

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

Neylon, J; Min, Y; Qi, S

2014-06-15

Purpose: Deformable image registration (DIR) plays a pivotal role in head and neck adaptive radiotherapy but a systematic validation of DIR algorithms has been limited by a lack of quantitative high-resolution groundtruth. We address this limitation by developing a GPU-based framework that provides a systematic DIR validation by generating (a) model-guided synthetic CTs representing posture and physiological changes, and (b) model-guided landmark-based validation. Method: The GPU-based framework was developed to generate massive mass-spring biomechanical models from patient simulation CTs and contoured structures. The biomechanical model represented soft tissue deformations for known rigid skeletal motion. Posture changes were simulated by articulatingmore » skeletal anatomy, which subsequently applied elastic corrective forces upon the soft tissue. Physiological changes such as tumor regression and weight loss were simulated in a biomechanically precise manner. Synthetic CT data was then generated from the deformed anatomy. The initial and final positions for one hundred randomly-chosen mass elements inside each of the internal contoured structures were recorded as ground truth data. The process was automated to create 45 synthetic CT datasets for a given patient CT. For instance, the head rotation was varied between +/− 4 degrees along each axis, and tumor volumes were systematically reduced up to 30%. Finally, the original CT and deformed synthetic CT were registered using an optical flow based DIR. Results: Each synthetic data creation took approximately 28 seconds of computation time. The number of landmarks per data set varied between two and three thousand. The validation method is able to perform sub-voxel analysis of the DIR, and report the results by structure, giving a much more in depth investigation of the error. Conclusions: We presented a GPU based high-resolution biomechanical head and neck model to validate DIR algorithms by generating CT

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

PubMed

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

2017-01-01

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

Making clinical trials more relevant: improving and validating the PRECIS tool for matching trial design decisions to trial purpose

PubMed Central

2013-01-01

Background If you want to know which of two or more healthcare interventions is most effective, the randomised controlled trial is the design of choice. Randomisation, however, does not itself promote the applicability of the results to situations other than the one in which the trial was done. A tool published in 2009, PRECIS (PRagmatic Explanatory Continuum Indicator Summaries) aimed to help trialists design trials that produced results matched to the aim of the trial, be that supporting clinical decision-making, or increasing knowledge of how an intervention works. Though generally positive, groups evaluating the tool have also found weaknesses, mainly that its inter-rater reliability is not clear, that it needs a scoring system and that some new domains might be needed. The aim of the study is to: Produce an improved and validated version of the PRECIS tool. Use this tool to compare the internal validity of, and effect estimates from, a set of explanatory and pragmatic trials matched by intervention. Methods The study has four phases. Phase 1 involves brainstorming and a two-round Delphi survey of authors who cited PRECIS. In Phase 2, the Delphi results will then be discussed and alternative versions of PRECIS-2 developed and user-tested by experienced trialists. Phase 3 will evaluate the validity and reliability of the most promising PRECIS-2 candidate using a sample of 15 to 20 trials rated by 15 international trialists. We will assess inter-rater reliability, and raters’ subjective global ratings of pragmatism compared to PRECIS-2 to assess convergent and face validity. Phase 4, to determine if pragmatic trials sacrifice internal validity in order to achieve applicability, will compare the internal validity and effect estimates of matched explanatory and pragmatic trials of the same intervention, condition and participants. Effect sizes for the trials will then be compared in a meta-regression. The Cochrane Risk of Bias scores will be compared with the

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.

Physical activity problem-solving inventory for adolescents: development and initial validation.

PubMed

Thompson, Debbe; Bhatt, Riddhi; Watson, Kathy

2013-08-01

Youth encounter physical activity barriers, often called problems. The purpose of problem solving is to generate solutions to overcome the barriers. Enhancing problem-solving ability may enable youth to be more physically active. Therefore, a method for reliably assessing physical activity problem-solving ability is needed. The purpose of this research was to report the development and initial validation of the physical activity problem-solving inventory for adolescents (PAPSIA). Qualitative and quantitative procedures were used. The social problem-solving inventory for adolescents guided the development of the PAPSIA scale. Youth (14- to 17-year-olds) were recruited using standard procedures, such as distributing flyers in the community and to organizations likely to be attended by adolescents. Cognitive interviews were conducted in person. Adolescents completed pen and paper versions of the questionnaire and/or scales assessing social desirability, self-reported physical activity, and physical activity self-efficacy. An expert panel review, cognitive interviews, and a pilot study (n = 129) established content validity. Construct, concurrent, and predictive validity were also established (n = 520 youth). PAPSIA is a promising measure for assessing youth physical activity problem-solving ability. Future research will assess its validity with objectively measured physical activity.

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

PubMed Central

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

2016-01-01

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

Assessing College Student-Athletes' Life Stress: Initial Measurement Development and Validation

ERIC Educational Resources Information Center

Lu, Frank Jing-Horng; Hsu, Ya-Wen; Chan, Yuan-Shuo; Cheen, Jang-Rong; Kao, Kuei-Tsu

2012-01-01

College student-athletes have unique life stress that warrants close attention. The purpose of this study was to develop a reliable and valid measurement assessing college student-athletes' life stress. In Study 1, a focus group discussion and Delphi method produced a questionnaire draft, termed the College Student-Athletes' Life Stress Scale. In…

25 CFR 309.8 - For marketing purposes, what is the recommended method of identifying authentic Indian products?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 25 Indians 2 2011-04-01 2011-04-01 false For marketing purposes, what is the recommended method of identifying authentic Indian products? 309.8 Section 309.8 Indians INDIAN ARTS AND CRAFTS BOARD, DEPARTMENT OF THE INTERIOR PROTECTION OF INDIAN ARTS AND CRAFTS PRODUCTS § 309.8 For marketing purposes, what is the...

25 CFR 309.8 - For marketing purposes, what is the recommended method of identifying authentic Indian products?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 25 Indians 2 2010-04-01 2010-04-01 false For marketing purposes, what is the recommended method of identifying authentic Indian products? 309.8 Section 309.8 Indians INDIAN ARTS AND CRAFTS BOARD, DEPARTMENT OF THE INTERIOR PROTECTION OF INDIAN ARTS AND CRAFTS PRODUCTS § 309.8 For marketing purposes, what is the...

Knowledge Transmission versus Social Transformation: A Critical Analysis of Purpose in Elementary Social Studies Methods Textbooks

ERIC Educational Resources Information Center

Butler, Brandon M.; Suh, Yonghee; Scott, Wendy

2015-01-01

In this article, the authors investigate the extent to which 9 elementary social studies methods textbooks present the purpose of teaching and learning social studies. Using Stanley's three perspectives of teaching social studies for knowledge transmission, method of intelligence, and social transformation; we analyze how these texts prepare…

Reliability and validity in measurement of true humeral retroversion by a three-dimensional cylinder fitting method.

PubMed

Saka, Masayuki; Yamauchi, Hiroki; Hoshi, Kenji; Yoshioka, Toru; Hamada, Hidetoshi; Gamada, Kazuyoshi

2015-05-01

Humeral retroversion is defined as the orientation of the humeral head relative to the distal humerus. Because none of the previous methods used to measure humeral retroversion strictly follow this definition, values obtained by these techniques vary and may be biased by morphologic variations of the humerus. The purpose of this study was 2-fold: to validate a method to define the axis of the distal humerus with a virtual cylinder and to establish the reliability of 3-dimensional (3D) measurement of humeral retroversion by this cylinder fitting method. Humeral retroversion in 14 baseball players (28 humeri) was measured by the 3D cylinder fitting method. The root mean square error was calculated to compare values obtained by a single tester and by 2 different testers using the embedded coordinate system. To establish the reliability, intraclass correlation coefficient (ICC) and precision (standard error of measurement [SEM]) were calculated. The root mean square errors for the humeral coordinate system were <1.0 mm/1.0° for comparison of all translations/rotations obtained by a single tester and <1.0 mm/2.0° for comparison obtained by 2 different testers. Assessment of reliability and precision of the 3D measurement of retroversion yielded an intratester ICC of 0.99 (SEM, 1.0°) and intertester ICC of 0.96 (SEM, 2.8°). The error in measurements obtained by a distal humerus cylinder fitting method was small enough not to affect retroversion measurement. The 3D measurement of retroversion by this method provides excellent intratester and intertester reliability. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Testing and Validation of the Dynamic Inertia Measurement Method

NASA Technical Reports Server (NTRS)

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

2015-01-01

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

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 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

Evidence flow graph methods for validation and verification of expert systems

NASA Technical Reports Server (NTRS)

Becker, Lee A.; Green, Peter G.; Bhatnagar, Jayant

1989-01-01

The results of an investigation into the use of evidence flow graph techniques for performing validation and verification of expert systems are given. A translator to convert horn-clause rule bases into evidence flow graphs, a simulation program, and methods of analysis were developed. These tools were then applied to a simple rule base which contained errors. It was found that the method was capable of identifying a variety of problems, for example that the order of presentation of input data or small changes in critical parameters could affect the output from a set of rules.

Evidence flow graph methods for validation and verification of expert systems

NASA Technical Reports Server (NTRS)

Becker, Lee A.; Green, Peter G.; Bhatnagar, Jayant

1988-01-01

This final report describes the results of an investigation into the use of evidence flow graph techniques for performing validation and verification of expert systems. This was approached by developing a translator to convert horn-clause rule bases into evidence flow graphs, a simulation program, and methods of analysis. These tools were then applied to a simple rule base which contained errors. It was found that the method was capable of identifying a variety of problems, for example that the order of presentation of input data or small changes in critical parameters could effect the output from a set of rules.

40 CFR Appendix D to Part 63 - Alternative Validation Procedure for EPA Waste and Wastewater Methods

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 14 2010-07-01 2010-07-01 false Alternative Validation Procedure for EPA Waste and Wastewater Methods D Appendix D to Part 63 Protection of Environment ENVIRONMENTAL... POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED) Pt. 63, App. D Appendix D to Part 63—Alternative Validation...

40 CFR Appendix D to Part 63 - Alternative Validation Procedure for EPA Waste and Wastewater Methods

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 14 2011-07-01 2011-07-01 false Alternative Validation Procedure for EPA Waste and Wastewater Methods D Appendix D to Part 63 Protection of Environment ENVIRONMENTAL... POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED) Pt. 63, App. D Appendix D to Part 63—Alternative Validation...

40 CFR Appendix D to Part 63 - Alternative Validation Procedure for EPA Waste and Wastewater Methods

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 15 2014-07-01 2014-07-01 false Alternative Validation Procedure for EPA Waste and Wastewater Methods D Appendix D to Part 63 Protection of Environment ENVIRONMENTAL... POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED) Pt. 63, App. D Appendix D to Part 63—Alternative Validation...

40 CFR Appendix D to Part 63 - Alternative Validation Procedure for EPA Waste and Wastewater Methods

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 15 2013-07-01 2013-07-01 false Alternative Validation Procedure for EPA Waste and Wastewater Methods D Appendix D to Part 63 Protection of Environment ENVIRONMENTAL... POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED) Pt. 63, App. D Appendix D to Part 63—Alternative Validation...

40 CFR Appendix D to Part 63 - Alternative Validation Procedure for EPA Waste and Wastewater Methods

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 15 2012-07-01 2012-07-01 false Alternative Validation Procedure for EPA Waste and Wastewater Methods D Appendix D to Part 63 Protection of Environment ENVIRONMENTAL... POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED) Pt. 63, App. D Appendix D to Part 63—Alternative Validation...

Validation of a Teachers' Achievement Goal Instrument for Teaching Physical Education

ERIC Educational Resources Information Center

Wang, Jian; Shen, Bo; Luo, Xiaobin; Hu, Qingshan; Garn, Alex C.

2018-01-01

Purpose: Using Butler's teacher achievement goal orientation as a conceptual framework, we developed this study to validate a teachers' achievement goal instrument for teaching physical education. Methods: A sample of 322 Chinese physical education teachers participated in this study and completed measures of achievement goal orientations and job…

A Construct Validity Study of Clinical Competence: A Multitrait Multimethod Matrix Approach

ERIC Educational Resources Information Center

Baig, Lubna; Violato, Claudio; Crutcher, Rodney

2010-01-01

Introduction: The purpose of the study was to adduce evidence for estimating the construct validity of clinical competence measured through assessment instruments used for high-stakes examinations. Methods: Thirty-nine international physicians (mean age = 41 + 6.5 y) participated in high-stakes examination and 3-month supervised clinical practice…

Seeking a Valid Gold Standard for an Innovative, Dialect-Neutral Language Test

ERIC Educational Resources Information Center

Pearson, Barbara Zurer; Jackson, Janice E.; Wu, Haotian

2014-01-01

Purpose: In this study, the authors explored alternative gold standards to validate an innovative, dialect-neutral language assessment. Method: Participants were 78 African American children, ages 5;0 (years;months) to 6;11. Twenty participants had previously been identified as having language impairment. The Diagnostic Evaluation of Language…

A validation framework for brain tumor segmentation.

PubMed

Archip, Neculai; Jolesz, Ferenc A; Warfield, Simon K

2007-10-01

We introduce a validation framework for the segmentation of brain tumors from magnetic resonance (MR) images. A novel unsupervised semiautomatic brain tumor segmentation algorithm is also presented. The proposed framework consists of 1) T1-weighted MR images of patients with brain tumors, 2) segmentation of brain tumors performed by four independent experts, 3) segmentation of brain tumors generated by a semiautomatic algorithm, and 4) a software tool that estimates the performance of segmentation algorithms. We demonstrate the validation of the novel segmentation algorithm within the proposed framework. We show its performance and compare it with existent segmentation. The image datasets and software are available at http://www.brain-tumor-repository.org/. We present an Internet resource that provides access to MR brain tumor image data and segmentation that can be openly used by the research community. Its purpose is to encourage the development and evaluation of segmentation methods by providing raw test and image data, human expert segmentation results, and methods for comparing segmentation results.

Enhanced data validation strategy of air quality monitoring network.

PubMed

Harkat, Mohamed-Faouzi; Mansouri, Majdi; Nounou, Mohamed; Nounou, Hazem

2018-01-01

Quick validation and detection of faults in measured air quality data is a crucial step towards achieving the objectives of air quality networks. Therefore, the objectives of this paper are threefold: (i) to develop a modeling technique that can be used to predict the normal behavior of air quality variables and help provide accurate reference for monitoring purposes; (ii) to develop fault detection method that can effectively and quickly detect any anomalies in measured air quality data. For this purpose, a new fault detection method that is based on the combination of generalized likelihood ratio test (GLRT) and exponentially weighted moving average (EWMA) will be developed. GLRT is a well-known statistical fault detection method that relies on maximizing the detection probability for a given false alarm rate. In this paper, we propose to develop GLRT-based EWMA fault detection method that will be able to detect the changes in the values of certain air quality variables; (iii) to develop fault isolation and identification method that allows defining the fault source(s) in order to properly apply appropriate corrective actions. In this paper, reconstruction approach that is based on Midpoint-Radii Principal Component Analysis (MRPCA) model will be developed to handle the types of data and models associated with air quality monitoring networks. All air quality modeling, fault detection, fault isolation and reconstruction methods developed in this paper will be validated using real air quality data (such as particulate matter, ozone, nitrogen and carbon oxides measurement). Copyright © 2017 Elsevier Inc. All rights reserved.

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

PubMed

Kolokitha, Olga-Elpis

2007-10-01

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

Validity and reliability of the session-RPE method for quantifying training in Australian football: a comparison of the CR10 and CR100 scales.

PubMed

Scott, Tannath J; Black, Cameron R; Quinn, John; Coutts, Aaron J

2013-01-01

The purpose of this study was to examine and compare the criterion validity and test-retest reliability of the CR10 and CR100 rating of perceived exertion (RPE) scales for team sport athletes that undertake high-intensity, intermittent exercise. Twenty-one male Australian football (AF) players (age: 19.0 ± 1.8 years, body mass: 83.92 ± 7.88 kg) participated the first part (part A) of this study, which examined the construct validity of the session-RPE (sRPE) method for quantifying training load in AF. Ten male athletes (age: 16.1 ± 0.5 years) participated in the second part of the study (part B), which compared the test-retest reliability of the CR10 and CR100 RPE scales. In part A, the validity of the sRPE method was assessed by examining the relationships between sRPE, and objective measures of internal (i.e., heart rate) and external training load (i.e., distance traveled), collected from AF training sessions. Part B of the study assessed the reliability of sRPE through examining the test-retest reliability of sRPE during 3 different intensities of controlled intermittent running (10, 11.5, and 13 km·h(-1)). Results from part A demonstrated strong correlations for CR10- and CR100-derived sRPE with measures of internal training load (Banisters TRIMP and Edwards TRIMP) (CR10: r = 0.83 and 0.83, and CR100: r = 0.80 and 0.81, p < 0.05). Correlations between sRPE and external training load (distance, higher speed running and player load) for both the CR10 (r = 0.81, 0.71, and 0.83) and CR100 (r = 0.78, 0.69, and 0.80) were significant (p < 0.05). Results from part B demonstrated poor reliability for both the CR10 (31.9% CV) and CR100 (38.6% CV) RPE scales after short bouts of intermittent running. Collectively, these results suggest both CR10- and CR100-derived sRPE methods have good construct validity for assessing training load in AF. The poor levels of reliability revealed under field testing indicate that the sRPE method may not be sensible to detecting small

Method validation for control determination of mercury in fresh fish and shrimp samples by solid sampling thermal decomposition/amalgamation atomic absorption spectrometry.

PubMed

Torres, Daiane Placido; Martins-Teixeira, Maristela Braga; Cadore, Solange; Queiroz, Helena Müller

2015-01-01

A method for the determination of total mercury in fresh fish and shrimp samples by solid sampling thermal decomposition/amalgamation atomic absorption spectrometry (TDA AAS) has been validated following international foodstuff protocols in order to fulfill the Brazilian National Residue Control Plan. The experimental parameters have been previously studied and optimized according to specific legislation on validation and inorganic contaminants in foodstuff. Linearity, sensitivity, specificity, detection and quantification limits, precision (repeatability and within-laboratory reproducibility), robustness as well as accuracy of the method have been evaluated. Linearity of response was satisfactory for the two range concentrations available on the TDA AAS equipment, between approximately 25.0 and 200.0 μg kg(-1) (square regression) and 250.0 and 2000.0 μg kg(-1) (linear regression) of mercury. The residues for both ranges were homoscedastic and independent, with normal distribution. Correlation coefficients obtained for these ranges were higher than 0.995. Limits of quantification (LOQ) and of detection of the method (LDM), based on signal standard deviation (SD) for a low-in-mercury sample, were 3.0 and 1.0 μg kg(-1), respectively. Repeatability of the method was better than 4%. Within-laboratory reproducibility achieved a relative SD better than 6%. Robustness of the current method was evaluated and pointed sample mass as a significant factor. Accuracy (assessed as the analyte recovery) was calculated on basis of the repeatability, and ranged from 89% to 99%. The obtained results showed the suitability of the present method for direct mercury measurement in fresh fish and shrimp samples and the importance of monitoring the analysis conditions for food control purposes. Additionally, the competence of this method was recognized by accreditation under the standard ISO/IEC 17025.

Student mathematical imagination instruments: construction, cultural adaptation and validity

NASA Astrophysics Data System (ADS)

Dwijayanti, I.; Budayasa, I. K.; Siswono, T. Y. E.

2018-03-01

Imagination has an important role as the center of sensorimotor activity of the students. The purpose of this research is to construct the instrument of students’ mathematical imagination in understanding concept of algebraic expression. The researcher performs validity using questionnaire and test technique and data analysis using descriptive method. Stages performed include: 1) the construction of the embodiment of the imagination; 2) determine the learning style questionnaire; 3) construct instruments; 4) translate to Indonesian as well as adaptation of learning style questionnaire content to student culture; 5) perform content validation. The results stated that the constructed instrument is valid by content validation and empirical validation so that it can be used with revisions. Content validation involves Indonesian linguists, english linguists and mathematics material experts. Empirical validation is done through a legibility test (10 students) and shows that in general the language used can be understood. In addition, a questionnaire test (86 students) was analyzed using a biserial point correlation technique resulting in 16 valid items with a reliability test using KR 20 with medium reability criteria. While the test instrument test (32 students) to find all items are valid and reliability test using KR 21 with reability is 0,62.

Verification and Validation Process for Progressive Damage and Failure Analysis Methods in the NASA Advanced Composites Consortium

NASA Technical Reports Server (NTRS)

Wanthal, Steven; Schaefer, Joseph; Justusson, Brian; Hyder, Imran; Engelstad, Stephen; Rose, Cheryl

2017-01-01

The Advanced Composites Consortium is a US Government/Industry partnership supporting technologies to enable timeline and cost reduction in the development of certified composite aerospace structures. A key component of the consortium's approach is the development and validation of improved progressive damage and failure analysis methods for composite structures. These methods will enable increased use of simulations in design trade studies and detailed design development, and thereby enable more targeted physical test programs to validate designs. To accomplish this goal with confidence, a rigorous verification and validation process was developed. The process was used to evaluate analysis methods and associated implementation requirements to ensure calculation accuracy and to gage predictability for composite failure modes of interest. This paper introduces the verification and validation process developed by the consortium during the Phase I effort of the Advanced Composites Project. Specific structural failure modes of interest are first identified, and a subset of standard composite test articles are proposed to interrogate a progressive damage analysis method's ability to predict each failure mode of interest. Test articles are designed to capture the underlying composite material constitutive response as well as the interaction of failure modes representing typical failure patterns observed in aerospace structures.

The effect of adopting new storage methods for extending product validity periods on manufacturers expected inventory costs.

PubMed

Chen, Po-Yu

2014-01-01

The validness of the expiration dates (validity period) that manufacturers provide on food product labels is a crucial food safety problem. Governments must study how to use their authority by implementing fair awards and punishments to prompt manufacturers into adopting rigorous considerations, such as the effect of adopting new storage methods for extending product validity periods on expected costs. Assuming that a manufacturer sells fresh food or drugs, this manufacturer must respond to current stochastic demands at each unit of time to determine the purchase amount of products for sale. If this decision maker is capable and an opportunity arises, new packaging methods (e.g., aluminum foil packaging, vacuum packaging, high-temperature sterilization after glass packaging, or packaging with various degrees of dryness) or storage methods (i.e., adding desiccants or various antioxidants) can be chosen to extend the validity periods of products. To minimize expected costs, this decision maker must be aware of the processing costs of new storage methods, inventory standards, inventory cycle lengths, and changes in relationships between factors such as stochastic demand functions in a cycle. Based on these changes in relationships, this study established a mathematical model as a basis for discussing the aforementioned topics.

Construct Validity and Scoring Methods of the World Health Organization: Health and Work Performance Questionnaire Among Workers With Arthritis and Rheumatological Conditions.

PubMed

AlHeresh, Rawan; LaValley, Michael P; Coster, Wendy; Keysor, Julie J

2017-06-01

To evaluate construct validity and scoring methods of the world health organization-health and work performance questionnaire (HPQ) for people with arthritis. Construct validity was examined through hypothesis testing using the recommended guidelines of the consensus-based standards for the selection of health measurement instruments (COSMIN). The HPQ using the absolute scoring method showed moderate construct validity as four of the seven hypotheses were met. The HPQ using the relative scoring method had weak construct validity as only one of the seven hypotheses were met. The absolute scoring method for the HPQ is superior in construct validity to the relative scoring method in assessing work performance among people with arthritis and related rheumatic conditions; however, more research is needed to further explore other psychometric properties of the HPQ.

Validation of rapid descriptive sensory methods against conventional descriptive analyses: A systematic review.

PubMed

Aguiar, Lorena Andrade de; Melo, Lauro; de Lacerda de Oliveira, Lívia

2018-04-03

A major drawback of conventional descriptive profile (CDP) in sensory evaluation is the long time spent in panel training. Rapid descriptive methods (RDM) have increased significantly. Some of them have been compared with CDP for validation. In Health Sciences, systematic reviews (SR) are performed to evaluate validation of diagnostic tests in relation to a gold standard method. SR present a well-defined protocol to summarize research evidence and to evaluate the quality of the studies with determined criteria. We adapted SR protocol to evaluate the validation of RDM against CDP as satisfactory procedures to obtain food characterization. We used "Population Intervention Comparison Outcome Study - PICOS" framework to design the research in which "Population" was food/ beverages; "intervention" were RDM, "Comparison" was CDP as gold standard, "Outcome" was the ability of RDM to generate similar descriptive profiles in comparison with CDP and "Studies" was sensory descriptive analyses. The proportion of studies concluding for similarity of the RDM with CDP ranged from 0% to 100%. Low and moderate risk of bias were reached by 87% and 13% of the studies, respectively, supporting the conclusions of SR. RDM with semi-trained assessors and evaluation of individual attributes presented higher percentages of concordance with CDP.

Validity and reliability assessment of a peer evaluation method in team-based learning classes.

PubMed

Yoon, Hyun Bae; Park, Wan Beom; Myung, Sun-Jung; Moon, Sang Hui; Park, Jun-Bean

2018-03-01

Team-based learning (TBL) is increasingly employed in medical education because of its potential to promote active group learning. In TBL, learners are usually asked to assess the contributions of peers within their group to ensure accountability. The purpose of this study is to assess the validity and reliability of a peer evaluation instrument that was used in TBL classes in a single medical school. A total of 141 students were divided into 18 groups in 11 TBL classes. The students were asked to evaluate their peers in the group based on evaluation criteria that were provided to them. We analyzed the comments that were written for the highest and lowest achievers to assess the validity of the peer evaluation instrument. The reliability of the instrument was assessed by examining the agreement among peer ratings within each group of students via intraclass correlation coefficient (ICC) analysis. Most of the students provided reasonable and understandable comments for the high and low achievers within their group, and most of those comments were compatible with the evaluation criteria. The average ICC of each group ranged from 0.390 to 0.863, and the overall average was 0.659. There was no significant difference in inter-rater reliability according to the number of members in the group or the timing of the evaluation within the course. The peer evaluation instrument that was used in the TBL classes was valid and reliable. Providing evaluation criteria and rules seemed to improve the validity and reliability of the instrument.

A Validated Method for the Quality Control of Andrographis paniculata Preparations.

PubMed

Karioti, Anastasia; Timoteo, Patricia; Bergonzi, Maria Camilla; Bilia, Anna Rita

2017-10-01

Andrographis paniculata is a herbal drug of Asian traditional medicine largely employed for the treatment of several diseases. Recently, it has been introduced in Europe for the prophylactic and symptomatic treatment of common cold and as an ingredient of dietary supplements. The active principles are diterpenes with andrographolide as the main representative. In the present study, an analytical protocol was developed for the determination of the main constituents in the herb and preparations of A. paniculata . Three different extraction protocols (methanol extraction using a modified Soxhlet procedure, maceration under ultrasonication, and decoction) were tested. Ultrasonication achieved the highest content of analytes. HPLC conditions were optimized in terms of solvent mixtures, time course, and temperature. A reversed phase C18 column eluted with a gradient system consisting of acetonitrile and acidified water and including an isocratic step at 30 °C was used. The HPLC method was validated for linearity, limits of quantitation and detection, repeatability, precision, and accuracy. The overall method was validated for precision and accuracy over at least three different concentration levels. Relative standard deviation was less than 1.13%, whereas recovery was between 95.50% and 97.19%. The method also proved to be suitable for the determination of a large number of commercial samples and was proposed to the European Pharmacopoeia for the quality control of Andrographidis herba. Georg Thieme Verlag KG Stuttgart · New York.

Validation of a two-dimensional liquid chromatography method for quality control testing of pharmaceutical materials.

PubMed

Yang, Samuel H; Wang, Jenny; Zhang, Kelly

2017-04-07

Despite the advantages of 2D-LC, there is currently little to no work in demonstrating the suitability of these 2D-LC methods for use in a quality control (QC) environment for good manufacturing practice (GMP) tests. This lack of information becomes more critical as the availability of commercial 2D-LC instrumentation has significantly increased, and more testing facilities begin to acquire these 2D-LC capabilities. It is increasingly important that the transferability of developed 2D-LC methods be assessed in terms of reproducibility, robustness and performance across different laboratories worldwide. The work presented here focuses on the evaluation of a heart-cutting 2D-LC method used for the analysis of a pharmaceutical material, where a key, co-eluting impurity in the first dimension ( 1 D) is resolved from the main peak and analyzed in the second dimension ( 2 D). A design-of-experiments (DOE) approach was taken in the collection of the data, and the results were then modeled in order to evaluate method robustness using statistical modeling software. This quality by design (QBD) approach gives a deeper understanding of the impact of these 2D-LC critical method attributes (CMAs) and how they affect overall method performance. Although there are multiple parameters that may be critical from method development point of view, a special focus of this work is devoted towards evaluation of unique 2D-LC critical method attributes from method validation perspective that transcend conventional method development and validation. The 2D-LC method attributes are evaluated for their recovery, peak shape, and resolution of the two co-eluting compounds in question on the 2 D. In the method, linearity, accuracy, precision, repeatability, and sensitivity are assessed along with day-to-day, analyst-to-analyst, and lab-to-lab (instrument-to-instrument) assessments. The results of this validation study demonstrate that the 2D-LC method is accurate, sensitive, and robust and is

Validation of the OMNI RPE Seven Day Exertional Recall Questionnaire

ERIC Educational Resources Information Center

Schafer, Mark A.; Robertson, Robert J.; Thekkada, Savitha J.; Gallagher, Michael, Jr.; Hunt, Sarah E.; Goss, Fredric L.; Aaron, Deborah J.

2013-01-01

Purpose: The present study examined the validity of the Seven Day Recall Questionnaire among recreationally active men and women. Method: Initially, participants completed a level walk (2.5 mph [4.0 kph]), hill walk (3.5 mph [5.6 kph], 5% grade), and run (5.0 mph [8.0 kph], 2.5% grade). Seven days later, participants were given the Seven Day…

Validation methodology in publications describing epidemiological registration methods of dental caries: a systematic review.

PubMed

Sjögren, P; Ordell, S; Halling, A

2003-12-01

The aim was to describe and systematically review the methodology and reporting of validation in publications describing epidemiological registration methods for dental caries. BASIC RESEARCH METHODOLOGY: Literature searches were conducted in six scientific databases. All publications fulfilling the predetermined inclusion criteria were assessed for methodology and reporting of validation using a checklist including items described previously as well as new items. The frequency of endorsement of the assessed items was analysed. Moreover, the type and strength of evidence, was evaluated. Reporting of predetermined items relating to methodology of validation and the frequency of endorsement of the assessed items were of primary interest. Initially 588 publications were located. 74 eligible publications were obtained, 23 of which fulfilled the inclusion criteria and remained throughout the analyses. A majority of the studies reported the methodology of validation. The reported methodology of validation was generally inadequate, according to the recommendations of evidence-based medicine. The frequencies of reporting the assessed items (frequencies of endorsement) ranged from four to 84 per cent. A majority of the publications contributed to a low strength of evidence. There seems to be a need to improve the methodology and the reporting of validation in publications describing professionally registered caries epidemiology. Four of the items assessed in this study are potentially discriminative for quality assessments of reported validation.

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

NASA Technical Reports Server (NTRS)

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

2001-01-01

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

Development and validation of RP HPLC method to determine nandrolone phenylpropionate in different pharmaceutical formulations.

PubMed

Mukherjee, Jayanti; Das, Ayan; Chakrabarty, Uday Sankar; Sahoo, Bijay Kumar; Dey, Goutam; Choudhury, Hira; Pal, Tapan Kumar

2011-01-01

This study describes development and subsequent validation of a reversed phase high performance liquid chromatographic (RP-HPLC) method for the estimation of nandrolone phenylpropionate, an anabolic steroid, in bulk drug, in conventional parenteral dosage formulation and in prepared nanoparticle dosage form. The chromatographic system consisted of a Luna Phenomenex, CN (250 mm x 4.6 mm, 5 microm) column, an isocratic mobile phase comprising 10 mM phosphate buffer and acetonitrile (50:50, v/v) and UV detection at 240 nm. Nandrolone phenylpropionate was eluted about 6.3 min with no interfering peaks of excipients used for the preparation of dosage forms. The method was linear over the range from 0.050 to 25 microg/mL in raw drug (r2 = 0.9994). The intra-day and inter-day precision values were in the range of 0.219-0.609% and 0.441-0.875%, respectively. Limits of detection and quantitation were 0.010 microg/mL and 0.050 microg/mL, respectively. The results were validated according to International Conference on Harmonization (ICH) guidelines in parenteral and prepared nanoparticle formulation. The validated HPLC method is simple, sensitive, precise, accurate and reproducible.

Estimating Rooftop Suitability for PV: A Review of Methods, Patents, and Validation Techniques

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

Melius, J.; Margolis, R.; Ong, S.

2013-12-01

A number of methods have been developed using remote sensing data to estimate rooftop area suitable for the installation of photovoltaics (PV) at various geospatial resolutions. This report reviews the literature and patents on methods for estimating rooftop-area appropriate for PV, including constant-value methods, manual selection methods, and GIS-based methods. This report also presents NREL's proposed method for estimating suitable rooftop area for PV using Light Detection and Ranging (LiDAR) data in conjunction with a GIS model to predict areas with appropriate slope, orientation, and sunlight. NREL's method is validated against solar installation data from New Jersey, Colorado, and Californiamore » to compare modeled results to actual on-the-ground measurements.« less

Optimization and validation of FePro cell labeling method.

PubMed

Janic, Branislava; Rad, Ali M; Jordan, Elaine K; Iskander, A S M; Ali, Md M; Varma, N Ravi S; Frank, Joseph A; Arbab, Ali S

2009-06-11

Current method to magnetically label cells using ferumoxides (Fe)-protamine (Pro) sulfate (FePro) is based on generating FePro complexes in a serum free media that are then incubated overnight with cells for the efficient labeling. However, this labeling technique requires long (>12-16 hours) incubation time and uses relatively high dose of Pro (5-6 microg/ml) that makes large extracellular FePro complexes. These complexes can be difficult to clean with simple cell washes and may create low signal intensity on T2* weighted MRI that is not desirable. The purpose of this study was to revise the current labeling method by using low dose of Pro and adding Fe and Pro directly to the cells before generating any FePro complexes. Human tumor glioma (U251) and human monocytic leukemia cell (THP-1) lines were used as model systems for attached and suspension cell types, respectively and dose dependent (Fe 25 to 100 microg/ml and Pro 0.75 to 3 microg/ml) and time dependent (2 to 48 h) labeling experiments were performed. Labeling efficiency and cell viability of these cells were assessed. Prussian blue staining revealed that more than 95% of cells were labeled. Intracellular iron concentration in U251 cells reached approximately 30-35 pg-iron/cell at 24 h when labeled with 100 microg/ml of Fe and 3 microg/ml of Pro. However, comparable labeling was observed after 4 h across the described FePro concentrations. Similarly, THP-1 cells achieved approximately 10 pg-iron/cell at 48 h when labeled with 100 microg/ml of Fe and 3 microg/ml of Pro. Again, comparable labeling was observed after 4 h for the described FePro concentrations. FePro labeling did not significantly affect cell viability. There was almost no extracellular FePro complexes observed after simple cell washes. To validate and to determine the effectiveness of the revised technique, human T-cells, human hematopoietic stem cells (hHSC), human bone marrow stromal cells (hMSC) and mouse neuronal stem cells (mNSC C17

Reflectance Estimation from Urban Terrestrial Images: Validation of a Symbolic Ray-Tracing Method on Synthetic Data

NASA Astrophysics Data System (ADS)

Coubard, F.; Brédif, M.; Paparoditis, N.; Briottet, X.

2011-04-01

Terrestrial geolocalized images are nowadays widely used on the Internet, mainly in urban areas, through immersion services such as Google Street View. On the long run, we seek to enhance the visualization of these images; for that purpose, radiometric corrections must be performed to free them from illumination conditions at the time of acquisition. Given the simultaneously acquired 3D geometric model of the scene with LIDAR or vision techniques, we face an inverse problem where the illumination and the geometry of the scene are known and the reflectance of the scene is to be estimated. Our main contribution is the introduction of a symbolic ray-tracing rendering to generate parametric images, for quick evaluation and comparison with the acquired images. The proposed approach is then based on an iterative estimation of the reflectance parameters of the materials, using a single rendering pre-processing. We validate the method on synthetic data with linear BRDF models and discuss the limitations of the proposed approach with more general non-linear BRDF models.

The concurrent validity and reliability of a low-cost, high-speed camera-based method for measuring the flight time of vertical jumps.

PubMed

Balsalobre-Fernández, Carlos; Tejero-González, Carlos M; del Campo-Vecino, Juan; Bavaresco, Nicolás

2014-02-01

Flight time is the most accurate and frequently used variable when assessing the height of vertical jumps. The purpose of this study was to analyze the validity and reliability of an alternative method (i.e., the HSC-Kinovea method) for measuring the flight time and height of vertical jumping using a low-cost high-speed Casio Exilim FH-25 camera (HSC). To this end, 25 subjects performed a total of 125 vertical jumps on an infrared (IR) platform while simultaneously being recorded with a HSC at 240 fps. Subsequently, 2 observers with no experience in video analysis analyzed the 125 videos independently using the open-license Kinovea 0.8.15 software. The flight times obtained were then converted into vertical jump heights, and the intraclass correlation coefficient (ICC), Bland-Altman plot, and Pearson correlation coefficient were calculated for those variables. The results showed a perfect correlation agreement (ICC = 1, p < 0.0001) between both observers' measurements of flight time and jump height and a highly reliable agreement (ICC = 0.997, p < 0.0001) between the observers' measurements of flight time and jump height using the HSC-Kinovea method and those obtained using the IR system, thus explaining 99.5% (p < 0.0001) of the differences (shared variance) obtained using the IR platform. As a result, besides requiring no previous experience in the use of this technology, the HSC-Kinovea method can be considered to provide similarly valid and reliable measurements of flight time and vertical jump height as more expensive equipment (i.e., IR). As such, coaches from many sports could use the HSC-Kinovea method to measure the flight time and height of their athlete's vertical jumps.

Development and Validation of a UHPLC UV Method for the In-Process Control of Bosentan Monohydrate Synthesis.

PubMed

Jatczak, Marta; Sidoryk, Katarzyna; Kossykowska, Magdalena; Łuniewski, Wojciech; Zagrodzka, Joanna; Lipiec-Abramska, Elżbieta

2016-01-01

Bosentan monohydrate (4- tert -butyl- N -[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl) pyrimidin-4-yl]benzene-1-sulfonamide monohydrate) is a dual endothelin receptor antagonist (ERA) applied in the treatment of pulmonary arterial hypertension. To achieve effective process control of the bosentan monohydrate synthesis, it was necessary to develop a selective and not highly time-consuming method for ultra-high performance liquid chromatography (UHPLC). The method is characterized by adequate sensitivity, reproducibility and selectivity for the determination of bosentan monohydrate and related compounds from all synthetic stages. The UHPLC separation was carried out by reversed phase chromatography on the Acquity BEH C18 column (100 mm × 2.1 mm, 1.7 µm) with a mobile phase composed of solvent A (0.1 %, v/v, acetic acid in water) and solvent B (methanol), in the gradient mode at the flow rate of 0.4 mL min -1 . Limits of detection and quantification for the compounds were ≤0.1 µg mL -1 and 0.3 µg mL -1 , respectively. The linearity for all related compounds was investigated as in the range for the active pharmaceutical ingredient (API) and as in the range for the in-process control. The developed method was validated according to the current guidelines, proving the suitability of the method for its intended purpose.

Validation of newly developed and redesigned key indicator methods for assessment of different working conditions with physical workloads based on mixed-methods design: a study protocol

PubMed Central

Liebers, Falk; Brandstädt, Felix; Schust, Marianne; Serafin, Patrick; Schäfer, Andreas; Gebhardt, Hansjürgen; Hartmann, Bernd; Steinberg, Ulf

2017-01-01

Introduction The impact of work-related musculoskeletal disorders is considerable. The assessment of work tasks with physical workloads is crucial to estimate the work-related health risks of exposed employees. Three key indicator methods are available for risk assessment regarding manual lifting, holding and carrying of loads; manual pulling and pushing of loads; and manual handling operations. Three further KIMs for risk assessment regarding whole-body forces, awkward body postures and body movement have been developed de novo. In addition, the development of a newly drafted combined method for mixed exposures is planned. All methods will be validated regarding face validity, reliability, convergent validity, criterion validity and further aspects of utility under practical conditions. Methods and analysis As part of the joint project MEGAPHYS (multilevel risk assessment of physical workloads), a mixed-methods study is being designed for the validation of KIMs and conducted in companies of different sizes and branches in Germany. Workplaces are documented and analysed by observations, applying KIMs, interviews and assessment of environmental conditions. Furthermore, a survey among the employees at the respective workplaces takes place with standardised questionnaires, interviews and physical examinations. It is intended to include 1200 employees at 120 different workplaces. For analysis of the quality criteria, recommendations of the COSMIN checklist (COnsensus-based Standards for the selection of health Measurement INstruments) will be taken into account. Ethics and dissemination The study was planned and conducted in accordance with the German Medical Professional Code and the Declaration of Helsinki as well as the German Federal Data Protection Act. The design of the study was approved by ethics committees. We intend to publish the validated KIMs in 2018. Results will be published in peer-reviewed journals, presented at international meetings and disseminated

Development and Preliminary Validation of the Drinking Expectancy Sexual Vulnerabilities Questionnaire (DESV-Q): A Purpose-Specific Instrument for Rape-Perception Research.

PubMed

Starfelt, Louise Charlotte; Young, Ross McD; White, Katherine M; Palk, Gavan

2016-01-01

Alcohol expectancies likely play a role in people's perceptions of alcohol-involved sexual violence. However, no appropriate measure exists to examine this link comprehensively. The aim of this research was to develop an alcohol expectancy measure which captures young adults' beliefs about alcohol's role in sexual aggression and victimization. Two cross-sectional samples of young Australian adults (18-25 years) were recruited for scale development (Phase 1) and scale validation (Phase 2). In Phase 1, participants (N = 201; 38.3% males) completed an online survey with an initial pool of alcohol expectancy items stated in terms of three targets (self, men, women) to identify the scale's factor structure and most effective items. A revised alcohol expectancy scale was then administered online to 322 young adults (39.6% males) in Phase 2. To assess the predictive, convergent, and discriminant validity of the scale, participants also completed established measures of personality, social desirability, alcohol use, general and context-specific alcohol expectancies, and impulsiveness. Principal axis factoring (Phase 1) and confirmatory factor analysis (Phase 2) resulted in a target-equivalent five-factor structure for the final 66-item Drinking Expectancy Sexual Vulnerabilities Questionnaire (DESV-Q). The factors were labeled (1) Sexual Coercion, (2) Sexual Vulnerability, (3) Confidence, (4) Self-Centeredness, and (5) Negative Cognitive and Behavioral Changes. The measure demonstrated effective items, high internal consistency, and satisfactory predictive, convergent, and discriminant validity. The DESV-Q is a purpose-specific instrument that could be used in future research to elucidate people's attributions for alcohol-involved sexual aggression and victimization.

Validation of quantitative and qualitative methods for detecting allergenic ingredients in processed foods in Japan.

PubMed

Sakai, Shinobu; Adachi, Reiko; Akiyama, Hiroshi; Teshima, Reiko

2013-06-19

A labeling system for food allergenic ingredients was established in Japan in April 2002. To monitor the labeling, the Japanese government announced official methods for detecting allergens in processed foods in November 2002. The official methods consist of quantitative screening tests using enzyme-linked immunosorbent assays (ELISAs) and qualitative confirmation tests using Western blotting or polymerase chain reactions (PCR). In addition, the Japanese government designated 10 μg protein/g food (the corresponding allergenic ingredient soluble protein weight/food weight), determined by ELISA, as the labeling threshold. To standardize the official methods, the criteria for the validation protocol were described in the official guidelines. This paper, which was presented at the Advances in Food Allergen Detection Symposium, ACS National Meeting and Expo, San Diego, CA, Spring 2012, describes the validation protocol outlined in the official Japanese guidelines, the results of interlaboratory studies for the quantitative detection method (ELISA for crustacean proteins) and the qualitative detection method (PCR for shrimp and crab DNAs), and the reliability of the detection methods.

Reliability and validity of the adolescent health profile-types.

PubMed

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

1998-08-01

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

Experimental comparison and validation of hot-ball method with guarded hot plate method on polyurethane foams

NASA Astrophysics Data System (ADS)

Hudec, Ján; Glorieux, Christ; Dieška, Peter; Kubičár, Ľudovít

2016-07-01

The Hot-ball method is an innovative transient method for measuring thermophysical properties. The principle is based on heating of a small ball, incorporated in measured medium, by constant heating power and simultaneous measuring of the ball's temperature response since the heating was initiated. The shape of the temperature response depends on thermophysical properties of the medium, where the sensor is placed. This method is patented by Institute of Physics, SAS, where the method and sensors based on this method are being developed. At the beginning of the development of sensors for this method we were oriented on monitoring applications, where relative precision is much more important than accuracy. Meanwhile, the quality of sensors was improved good enough to be used for a new application - absolute measuring of thermophysical parameters of low thermally conductive materials. This paper describes experimental verification and validation of measurement by hot-ball method. Thanks to cooperation with Laboratory of Soft Matter and Biophysics of Catholic University of Leuven in Belgium, established Guarded Hot Plate method was used as a reference. Details about measuring setups, description of the experiments and results of the comparison are presented.

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

PubMed Central

Kolokitha, Olga-Elpis

2007-01-01

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

Initial Validation Study for a Scale Used to Determine Service Intensity for Itinerant Teachers of Students with Visual Impairments

ERIC Educational Resources Information Center

Pogrund, Rona L.; Darst, Shannon; Munro, Michael P.

2015-01-01

Introduction: The purpose of this study was to begin validation of a scale that will be used by teachers of students with visual impairments to determine appropriate recommended type and frequency of services for their students based on identified student need. Methods: Validity and reliability of the Visual Impairment Scale of Service Intensity…

[Validation of measurement methods and estimation of uncertainty of measurement of chemical agents in the air at workstations].

PubMed

Dobecki, Marek

2012-01-01

This paper reviews the requirements for measurement methods of chemical agents in the air at workstations. European standards, which have a status of Polish standards, comprise some requirements and information on sampling strategy, measuring techniques, type of samplers, sampling pumps and methods of occupational exposure evaluation at a given technological process. Measurement methods, including air sampling and analytical procedure in a laboratory, should be appropriately validated before intended use. In the validation process, selected methods are tested and budget of uncertainty is set up. The validation procedure that should be implemented in the laboratory together with suitable statistical tools and major components of uncertainity to be taken into consideration, were presented in this paper. Methods of quality control, including sampling and laboratory analyses were discussed. Relative expanded uncertainty for each measurement expressed as a percentage, should not exceed the limit of values set depending on the type of occupational exposure (short-term or long-term) and the magnitude of exposure to chemical agents in the work environment.

Estimating body fat in NCAA Division I female athletes: a five-compartment model validation of laboratory methods.

PubMed

Moon, Jordan R; Eckerson, Joan M; Tobkin, Sarah E; Smith, Abbie E; Lockwood, Christopher M; Walter, Ashley A; Cramer, Joel T; Beck, Travis W; Stout, Jeffrey R

2009-01-01

The purpose of the present study was to determine the validity of various laboratory methods for estimating percent body fat (%fat) in NCAA Division I college female athletes (n = 29; 20 +/- 1 year). Body composition was assessed via hydrostatic weighing (HW), air displacement plethysmography (ADP), and dual-energy X-ray absorptiometry (DXA), and estimates of %fat derived using 4-compartment (C), 3C, and 2C models were compared to a criterion 5C model that included bone mineral content, body volume (BV), total body water, and soft tissue mineral. The Wang-4C and the Siri-3C models produced nearly identical values compared to the 5C model (r > 0.99, total error (TE) < 0.40%fat). For the remaining laboratory methods, constant error values (CE) ranged from -0.04%fat (HW-Siri) to -3.71%fat (DXA); r values ranged from 0.89 (ADP-Siri, ADP-Brozek) to 0.93 (DXA); standard error of estimate values ranged from 1.78%fat (DXA) to 2.19%fat (ADP-Siri, ADP-Brozek); and TE values ranged from 2.22%fat (HW-Brozek) to 4.90%fat (DXA). The limits of agreement for DXA (-10.10 to 2.68%fat) were the largest with a significant trend of -0.43 (P < 0.05). With the exception of DXA, all of the equations resulted in acceptable TE values (<3.08%fat). However, the results for individual estimates of %fat using the Brozek equation indicated that the 2C models that derived BV from ADP and HW overestimated (5.38, 3.65%) and underestimated (5.19, 4.88%) %fat, respectively. The acceptable TE values for both HW and ADP suggest that these methods are valid for estimating %fat in college female athletes; however, the Wang-4C and Siri-3C models should be used to identify individual estimates of %fat in this population.

Performance Validity Testing in Neuropsychology: Scientific Basis and Clinical Application-A Brief Review.

PubMed

Greher, Michael R; Wodushek, Thomas R

2017-03-01

Performance validity testing refers to neuropsychologists' methodology for determining whether neuropsychological test performances completed in the course of an evaluation are valid (ie, the results of true neurocognitive function) or invalid (ie, overly impacted by the patient's effort/engagement in testing). This determination relies upon the use of either standalone tests designed for this sole purpose, or specific scores/indicators embedded within traditional neuropsychological measures that have demonstrated this utility. In response to a greater appreciation for the critical role that performance validity issues play in neuropsychological testing and the need to measure this variable to the best of our ability, the scientific base for performance validity testing has expanded greatly over the last 20 to 30 years. As such, the majority of current day neuropsychologists in the United States use a variety of measures for the purpose of performance validity testing as part of everyday forensic and clinical practice and address this issue directly in their evaluations. The following is the first article of a 2-part series that will address the evolution of performance validity testing in the field of neuropsychology, both in terms of the science as well as the clinical application of this measurement technique. The second article of this series will review performance validity tests in terms of methods for development of these measures, and maximizing of diagnostic accuracy.

Improving the Validity and Reliability of a Health Promotion Survey for Physical Therapists

PubMed Central

Stephens, Jaca L.; Lowman, John D.; Graham, Cecilia L.; Morris, David M.; Kohler, Connie L.; Waugh, Jonathan B.

2013-01-01

Purpose Physical therapists (PTs) have a unique opportunity to intervene in the area of health promotion. However, no instrument has been validated to measure PTs’ views on health promotion in physical therapy practice. The purpose of this study was to evaluate the content validity and test-retest reliability of a health promotion survey designed for PTs. Methods An expert panel of PTs assessed the content validity of “The Role of Health Promotion in Physical Therapy Survey” and provided suggestions for revision. Item content validity was assessed using the content validity ratio (CVR) as well as the modified kappa statistic. Therapists then participated in the test-retest reliability assessment of the revised health promotion survey, which was assessed using a weighted kappa statistic. Results Based on feedback from the expert panelists, significant revisions were made to the original survey. The expert panel reached at least a majority consensus agreement for all items in the revised survey and the survey-CVR improved from 0.44 to 0.66. Only one item on the revised survey had substantial test-retest agreement, with 55% of the items having moderate agreement and 43% poor agreement. Conclusions All items on the revised health promotion survey demonstrated at least fair validity, but few items had reasonable test-retest reliability. Further modifications should be made to strengthen the validity and improve the reliability of this survey. PMID:23754935

Establishing high resolution melting analysis: method validation and evaluation for c-RET proto-oncogene mutation screening.

PubMed

Benej, Martin; Bendlova, Bela; Vaclavikova, Eliska; Poturnajova, Martina

2011-10-06

Reliable and effective primary screening of mutation carriers is the key condition for common diagnostic use. The objective of this study is to validate the method high resolution melting (HRM) analysis for routine primary mutation screening and accomplish its optimization, evaluation and validation. Due to their heterozygous nature, germline point mutations of c-RET proto-oncogene, associated to multiple endocrine neoplasia type 2 (MEN2), are suitable for HRM analysis. Early identification of mutation carriers has a major impact on patients' survival due to early onset of medullary thyroid carcinoma (MTC) and resistance to conventional therapy. The authors performed a series of validation assays according to International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines for validation of analytical procedures, along with appropriate design and optimization experiments. After validated evaluation of HRM, the method was utilized for primary screening of 28 pathogenic c-RET mutations distributed among nine exons of c-RET gene. Validation experiments confirm the repeatability, robustness, accuracy and reproducibility of HRM. All c-RET gene pathogenic variants were detected with no occurrence of false-positive/false-negative results. The data provide basic information about design, establishment and validation of HRM for primary screening of genetic variants in order to distinguish heterozygous point mutation carriers among the wild-type sequence carriers. HRM analysis is a powerful and reliable tool for rapid and cost-effective primary screening, e.g., of c-RET gene germline and/or sporadic mutations and can be used as a first line potential diagnostic tool.

Drug Target Validation Methods in Malaria - Protein Interference Assay (PIA) as a Tool for Highly Specific Drug Target Validation.

PubMed

Meissner, Kamila A; Lunev, Sergey; Wang, Yuan-Ze; Linzke, Marleen; de Assis Batista, Fernando; Wrenger, Carsten; Groves, Matthew R

2017-01-01

The validation of drug targets in malaria and other human diseases remains a highly difficult and laborious process. In the vast majority of cases, highly specific small molecule tools to inhibit a proteins function in vivo are simply not available. Additionally, the use of genetic tools in the analysis of malarial pathways is challenging. These issues result in difficulties in specifically modulating a hypothetical drug target's function in vivo. The current "toolbox" of various methods and techniques to identify a protein's function in vivo remains very limited and there is a pressing need for expansion. New approaches are urgently required to support target validation in the drug discovery process. Oligomerisation is the natural assembly of multiple copies of a single protein into one object and this self-assembly is present in more than half of all protein structures. Thus, oligomerisation plays a central role in the generation of functional biomolecules. A key feature of oligomerisation is that the oligomeric interfaces between the individual parts of the final assembly are highly specific. However, these interfaces have not yet been systematically explored or exploited to dissect biochemical pathways in vivo. This mini review will describe the current state of the antimalarial toolset as well as the potentially druggable malarial pathways. A specific focus is drawn to the initial efforts to exploit oligomerisation surfaces in drug target validation. As alternative to the conventional methods, Protein Interference Assay (PIA) can be used for specific distortion of the target protein function and pathway assessment in vivo. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

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

PubMed

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

2008-09-29

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

Validated method for the analysis of goji berry, a rich source of zeaxanthin dipalmitate.

PubMed

Karioti, Anastasia; Bergonzi, Maria Camilla; Vincieri, Franco F; Bilia, Anna Rita

2014-12-31

In the present study an HPLC-DAD method was developed for the determination of the main carotenoid, zeaxanthin dipalmitate, in the fruits of Lycium barbarum. The aim was to develop and optimize an extraction protocol to allow fast, exhaustive, and repeatable extraction, suitable for labile carotenoid content. Use of liquid N2 allowed the grinding of the fruit. A step of ultrasonication with water removed efficiently the polysaccharides and enabled the exhaustive extraction of carotenoids by hexane/acetone 50:50. The assay was fast and simple and permitted the quality control of a large number of commercial samples including fruits, juices, and a jam. The HPLC method was validated according to ICH guidelines and satisfied the requirements. Finally, the overall method was validated for precision (% RSD ranging between 3.81 and 4.13) and accuracy at three concentration levels. The recovery was between 94 and 107% with RSD values <2%, within the acceptable limits, especially if the difficulty of the matrix is taken into consideration.

A statistical method (cross-validation) for bone loss region detection after spaceflight

PubMed Central

Zhao, Qian; Li, Wenjun; Li, Caixia; Chu, Philip W.; Kornak, John; Lang, Thomas F.

2010-01-01

Astronauts experience bone loss after the long spaceflight missions. Identifying specific regions that undergo the greatest losses (e.g. the proximal femur) could reveal information about the processes of bone loss in disuse and disease. Methods for detecting such regions, however, remains an open problem. This paper focuses on statistical methods to detect such regions. We perform statistical parametric mapping to get t-maps of changes in images, and propose a new cross-validation method to select an optimum suprathreshold for forming clusters of pixels. Once these candidate clusters are formed, we use permutation testing of longitudinal labels to derive significant changes. PMID:20632144

Workshop Report: Crystal City VI-Bioanalytical Method Validation for Biomarkers.

PubMed

Arnold, Mark E; Booth, Brian; King, Lindsay; Ray, Chad

2016-11-01

With the growing focus on translational research and the use of biomarkers to drive drug development and approvals, biomarkers have become a significant area of research within the pharmaceutical industry. However, until the US Food and Drug Administration's (FDA) 2013 draft guidance on bioanalytical method validation included consideration of biomarker assays using LC-MS and LBA, those assays were created, validated, and used without standards of performance. This lack of expectations resulted in the FDA receiving data from assays of varying quality in support of efficacy and safety claims. The AAPS Crystal City VI (CC VI) Workshop in 2015 was held as the first forum for industry-FDA discussion around the general issues of biomarker measurements (e.g., endogenous levels) and specific technology strengths and weaknesses. The 2-day workshop served to develop a common understanding among the industrial scientific community of the issues around biomarkers, informed the FDA of the current state of the science, and will serve as a basis for further dialogue as experience with biomarkers expands with both groups.

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

PubMed

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

2017-04-01

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

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

PubMed

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

2018-02-01

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

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

PubMed

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

2016-07-15

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

When Assessment Data Are Words: Validity Evidence for Qualitative Educational Assessments.

PubMed

Cook, David A; Kuper, Ayelet; Hatala, Rose; Ginsburg, Shiphra

2016-10-01

Quantitative scores fail to capture all important features of learner performance. This awareness has led to increased use of qualitative data when assessing health professionals. Yet the use of qualitative assessments is hampered by incomplete understanding of their role in forming judgments, and lack of consensus in how to appraise the rigor of judgments therein derived. The authors articulate the role of qualitative assessment as part of a comprehensive program of assessment, and translate the concept of validity to apply to judgments arising from qualitative assessments. They first identify standards for rigor in qualitative research, and then use two contemporary assessment validity frameworks to reorganize these standards for application to qualitative assessment.Standards for rigor in qualitative research include responsiveness, reflexivity, purposive sampling, thick description, triangulation, transparency, and transferability. These standards can be reframed using Messick's five sources of validity evidence (content, response process, internal structure, relationships with other variables, and consequences) and Kane's four inferences in validation (scoring, generalization, extrapolation, and implications). Evidence can be collected and evaluated for each evidence source or inference. The authors illustrate this approach using published research on learning portfolios.The authors advocate a "methods-neutral" approach to assessment, in which a clearly stated purpose determines the nature of and approach to data collection and analysis. Increased use of qualitative assessments will necessitate more rigorous judgments of the defensibility (validity) of inferences and decisions. Evidence should be strategically sought to inform a coherent validity argument.

29 CFR 1607.5 - General standards for validity studies.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 4 2010-07-01 2010-07-01 false General standards for validity studies. 1607.5 Section 1607... studies. A. Acceptable types of validity studies. For the purposes of satisfying these guidelines, users may rely upon criterion-related validity studies, content validity studies or construct validity...

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.

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

PubMed Central

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

2014-01-01

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

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

PubMed

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

2018-01-01

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

Evaluation of the confusion matrix method in the validation of an automated system for measuring feeding behaviour of cattle.

PubMed

Ruuska, Salla; Hämäläinen, Wilhelmiina; Kajava, Sari; Mughal, Mikaela; Matilainen, Pekka; Mononen, Jaakko

2018-03-01

The aim of the present study was to evaluate empirically confusion matrices in device validation. We compared the confusion matrix method to linear regression and error indices in the validation of a device measuring feeding behaviour of dairy cattle. In addition, we studied how to extract additional information on classification errors with confusion probabilities. The data consisted of 12 h behaviour measurements from five dairy cows; feeding and other behaviour were detected simultaneously with a device and from video recordings. The resulting 216 000 pairs of classifications were used to construct confusion matrices and calculate performance measures. In addition, hourly durations of each behaviour were calculated and the accuracy of measurements was evaluated with linear regression and error indices. All three validation methods agreed when the behaviour was detected very accurately or inaccurately. Otherwise, in the intermediate cases, the confusion matrix method and error indices produced relatively concordant results, but the linear regression method often disagreed with them. Our study supports the use of confusion matrix analysis in validation since it is robust to any data distribution and type of relationship, it makes a stringent evaluation of validity, and it offers extra information on the type and sources of errors. Copyright © 2018 Elsevier B.V. All rights reserved.

A Diagnostic Marker to Discriminate Childhood Apraxia of Speech from Speech Delay: II. Validity Studies of the Pause Marker

ERIC Educational Resources Information Center

Shriberg, Lawrence D.; Strand, Edythe A.; Fourakis, Marios; Jakielski, Kathy J.; Hall, Sheryl D.; Karlsson, Heather B.; Mabie, Heather L.; McSweeny, Jane L.; Tilkens, Christie M.; Wilson, David L.

2017-01-01

Purpose: The purpose of this 2nd article in this supplement is to report validity support findings for the Pause Marker (PM), a proposed single-sign diagnostic marker of childhood apraxia of speech (CAS). Method: PM scores and additional perceptual and acoustic measures were obtained from 296 participants in cohorts with idiopathic and…

Validation of finite element and boundary element methods for predicting structural vibration and radiated noise

NASA Technical Reports Server (NTRS)

Seybert, A. F.; Wu, X. F.; Oswald, Fred B.

1992-01-01

Analytical and experimental validation of methods to predict structural vibration and radiated noise are presented. A rectangular box excited by a mechanical shaker was used as a vibrating structure. Combined finite element method (FEM) and boundary element method (BEM) models of the apparatus were used to predict the noise radiated from the box. The FEM was used to predict the vibration, and the surface vibration was used as input to the BEM to predict the sound intensity and sound power. Vibration predicted by the FEM model was validated by experimental modal analysis. Noise predicted by the BEM was validated by sound intensity measurements. Three types of results are presented for the total radiated sound power: (1) sound power predicted by the BEM modeling using vibration data measured on the surface of the box; (2) sound power predicted by the FEM/BEM model; and (3) sound power measured by a sound intensity scan. The sound power predicted from the BEM model using measured vibration data yields an excellent prediction of radiated noise. The sound power predicted by the combined FEM/BEM model also gives a good prediction of radiated noise except for a shift of the natural frequencies that are due to limitations in the FEM model.

Comparative Study in Laboratory Rats to Validate Sperm Quality Methods and Endpoints

NASA Technical Reports Server (NTRS)

Price, W. A.; Briggs, G. B.; Alexander, W. K.; Still, K. R.; Grasman, K. A.

2000-01-01

Abstract The Naval Health Research Center, Detachment (Toxicology) performs toxicity studies in laboratory animals to characterize the risk of exposure to chemicals of Navy interest. Research was conducted at the Toxicology Detachment at WPAFB, OH in collaboration with Wright State University, Department of Biological Sciences for the validation of new bioassay methods for evaluating reproductive toxicity. The Hamilton Thorne sperm analyzer was used to evaluate sperm damage produced by exposure to a known testicular toxic agent, methoxyacetic acid and by inhalation exposure to JP-8 and JP-5 in laboratory rats. Sperm quality parameters were evaluated (sperm concentration, motility, and morphology) to provide evidence of sperm damage. The Hamilton Thorne sperm analyzer utilizes a DNA specific fluorescent stain (similar to flow cytometry) and digitized optical computer analysis to detect sperm cell damage. The computer assisted sperm analysis (CASA) is a more rapid, robust, predictive and sensitive method for characterizing reproductive toxicity. The results presented in this poster report validation information showing exposure to methoxyacetic acid causes reproductive toxicity and inhalation exposure to JP-8 and JP-5 had no significant effects. The CASA method detects early changes that result in reproductive deficits and these data will be used in a continuing program to characterize the toxicity of chemicals, and combinations of chemicals, of military interest to formulate permissible exposure limits.

Validation of the Child Sport Cohesion Questionnaire

ERIC Educational Resources Information Center

Martin, Luc J.; Carron, Albert V.; Eys, Mark A.; Loughead, Todd

2013-01-01

The purpose of the present study was to test the validity evidence of the Child Sport Cohesion Questionnaire (CSCQ). To accomplish this task, convergent, discriminant, and known-group difference validity were examined, along with factorial validity via confirmatory factor analysis (CFA). Child athletes (N = 290, M[subscript age] = 10.73 plus or…

FDIR Strategy Validation with the B Method

NASA Astrophysics Data System (ADS)

Sabatier, D.; Dellandrea, B.; Chemouil, D.

2008-08-01

In a formation flying satellite system, the FDIR strategy (Failure Detection, Isolation and Recovery) is paramount. When a failure occurs, satellites should be able to take appropriate reconfiguration actions to obtain the best possible results given the failure, ranging from avoiding satellite-to-satellite collision to continuing the mission without disturbance if possible. To achieve this goal, each satellite in the formation has an implemented FDIR strategy that governs how it detects failures (from tests or by deduction) and how it reacts (reconfiguration using redundant equipments, avoidance manoeuvres, etc.). The goal is to protect the satellites first and the mission as much as possible. In a project initiated by the CNES, ClearSy experiments the B Method to validate the FDIR strategies developed by Thales Alenia Space, of the inter satellite positioning and communication devices that will be used for the SIMBOL-X (2 satellite configuration) and the PEGASE (3 satellite configuration) missions and potentially for other missions afterward. These radio frequency metrology sensor devices provide satellite positioning and inter satellite communication in formation flying. This article presents the results of this experience.

A method for validation of finite element forming simulation on basis of a pointwise comparison of distance and curvature

NASA Astrophysics Data System (ADS)

Dörr, Dominik; Joppich, Tobias; Schirmaier, Fabian; Mosthaf, Tobias; Kärger, Luise; Henning, Frank

2016-10-01

Thermoforming of continuously fiber reinforced thermoplastics (CFRTP) is ideally suited to thin walled and complex shaped products. By means of forming simulation, an initial validation of the producibility of a specific geometry, an optimization of the forming process and the prediction of fiber-reorientation due to forming is possible. Nevertheless, applied methods need to be validated. Therefor a method is presented, which enables the calculation of error measures for the mismatch between simulation results and experimental tests, based on measurements with a conventional coordinate measuring device. As a quantitative measure, describing the curvature is provided, the presented method is also suitable for numerical or experimental sensitivity studies on wrinkling behavior. The applied methods for forming simulation, implemented in Abaqus explicit, are presented and applied to a generic geometry. The same geometry is tested experimentally and simulation and test results are compared by the proposed validation method.

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

PubMed

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

2005-07-01

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

Predicting Chinese Children and Youth's Energy Expenditure Using ActiGraph Accelerometers: A Calibration and Cross-Validation Study

ERIC Educational Resources Information Center

Zhu, Zheng; Chen, Peijie; Zhuang, Jie

2013-01-01

Purpose: The purpose of this study was to develop and cross-validate an equation based on ActiGraph accelerometer GT3X output to predict children and youth's energy expenditure (EE) of physical activity (PA). Method: Participants were 367 Chinese children and youth (179 boys and 188 girls, aged 9 to 17 years old) who wore 1 ActiGraph GT3X…

Identifying areas with vitamin A deficiency: the validity of a semiquantitative food frequency method.

PubMed

Sloan, N L; Rosen, D; de la Paz, T; Arita, M; Temalilwa, C; Solomons, N W

1997-02-01

The prevalence of vitamin A deficiency has traditionally been assessed through xerophthalmia or biochemical surveys. The cost and complexity of implementing these methods limits the ability of nonresearch organizations to identify vitamin A deficiency. This study examined the validity of a simple, inexpensive food frequency method to identify areas with a high prevalence of vitamin A deficiency. The validity of the method was tested in 15 communities, 5 each from the Philippines, Guatemala, and Tanzania. Serum retinol concentrations of less than 20 micrograms/dL defined vitamin A deficiency. Weighted measures of vitamin A intake six or fewer times per week and unweighted measures of consumption of animal sources of vitamin A four or fewer times per week correctly classified seven of eight communities as having a high prevalence of vitamin A deficiency (i.e., 15% or more preschool-aged children in the community had the deficiency) (sensitivity = 87.5%) and four of seven communities as having a low prevalence (specificity = 57.1%). This method correctly classified the vitamin A deficiency status of 73.3% of the communities but demonstrated a high false-positive rate (42.9%).

Validation and Recommendation of Methods to Measure Biogas Production Potential of Animal Manure

PubMed Central

Pham, C. H.; Triolo, J. M.; Cu, T. T. T.; Pedersen, L.; Sommer, S. G.

2013-01-01

In developing countries, biogas energy production is seen as a technology that can provide clean energy in poor regions and reduce pollution caused by animal manure. Laboratories in these countries have little access to advanced gas measuring equipment, which may limit research aimed at improving local adapted biogas production. They may also be unable to produce valid estimates of an international standard that can be used for articles published in international peer-reviewed science journals. This study tested and validated methods for measuring total biogas and methane (CH4) production using batch fermentation and for characterizing the biomass. The biochemical methane potential (BMP) (CH4 NL kg−1 VS) of pig manure, cow manure and cellulose determined with the Moller and VDI methods was not significantly different in this test (p>0.05). The biodegradability using a ratio of BMP and theoretical BMP (TBMP) was slightly higher using the Hansen method, but differences were not significant. Degradation rate assessed by methane formation rate showed wide variation within the batch method tested. The first-order kinetics constant k for the cumulative methane production curve was highest when two animal manures were fermented using the VDI 4630 method, indicating that this method was able to reach steady conditions in a shorter time, reducing fermentation duration. In precision tests, the repeatability of the relative standard deviation (RSDr) for all batch methods was very low (4.8 to 8.1%), while the reproducibility of the relative standard deviation (RSDR) varied widely, from 7.3 to 19.8%. In determination of biomethane concentration, the values obtained using the liquid replacement method (LRM) were comparable to those obtained using gas chromatography (GC). This indicates that the LRM method could be used to determine biomethane concentration in biogas in laboratories with limited access to GC. PMID:25049861

Intensity non-uniformity correction in MRI: existing methods and their validation.

PubMed

Belaroussi, Boubakeur; Milles, Julien; Carme, Sabin; Zhu, Yue Min; Benoit-Cattin, Hugues

2006-04-01

Magnetic resonance imaging is a popular and powerful non-invasive imaging technique. Automated analysis has become mandatory to efficiently cope with the large amount of data generated using this modality. However, several artifacts, such as intensity non-uniformity, can degrade the quality of acquired data. Intensity non-uniformity consists in anatomically irrelevant intensity variation throughout data. It can be induced by the choice of the radio-frequency coil, the acquisition pulse sequence and by the nature and geometry of the sample itself. Numerous methods have been proposed to correct this artifact. In this paper, we propose an overview of existing methods. We first sort them according to their location in the acquisition/processing pipeline. Sorting is then refined based on the assumptions those methods rely on. Next, we present the validation protocols used to evaluate these different correction schemes both from a qualitative and a quantitative point of view. Finally, availability and usability of the presented methods is discussed.

Comparison of Methods for Estimating Prevalence of Chronic Diseases and Health Behaviors for Small Geographic Areas: Boston Validation Study, 2013

PubMed Central

Holt, James B.; Zhang, Xingyou; Lu, Hua; Shah, Snehal N.; Dooley, Daniel P.; Matthews, Kevin A.; Croft, Janet B.

2017-01-01

Introduction Local health authorities need small-area estimates for prevalence of chronic diseases and health behaviors for multiple purposes. We generated city-level and census-tract–level prevalence estimates of 27 measures for the 500 largest US cities. Methods To validate the methodology, we constructed multilevel logistic regressions to predict 10 selected health indicators among adults aged 18 years or older by using 2013 Behavioral Risk Factor Surveillance System (BRFSS) data; we applied their predicted probabilities to census population data to generate city-level, neighborhood-level, and zip-code–level estimates for the city of Boston, Massachusetts. Results By comparing the predicted estimates with their corresponding direct estimates from a locally administered survey (Boston BRFSS 2010 and 2013), we found that our model-based estimates for most of the selected health indicators at the city level were close to the direct estimates from the local survey. We also found strong correlation between the model-based estimates and direct survey estimates at neighborhood and zip code levels for most indicators. Conclusion Findings suggest that our model-based estimates are reliable and valid at the city level for certain health outcomes. Local health authorities can use the neighborhood-level estimates if high quality local health survey data are not otherwise available. PMID:29049020

Program to analyze aquifer test data and check for validity with the jacob method

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

Field, M.S.

1993-01-01

The Jacob straight-line method of aquifer analysis deals with the late-time data and small radius of the Theis type curve which plot as a straight line if the drawdown data are plotted on an arithmetic scale and the time data on a logarithmic (base 10) scale. Correct analysis with the Jacob method normally assumes that (1) the data lie on a straight line, (2) the value of the dimensionless time factor is less than 0.01, and (3) the site's hydrogeology conforms to the method's assumptions and limiting conditions. Items 1 and 2 are usually considered for the Jacob method, butmore » item 3 is often ignored, which can lead to incorrect calculations of aquifer parameters. A BASIC computer program was developed to analyze aquifer test data with the Jacob method to test the validity of its use. Aquifer test data are entered into the program and manipulated so that a slope and time intercept of the straight line drawn through the data (excluding early-time and late-time data) can be used to calculate transmissivity and storage coefficient. Late-time data are excluded to eliminate the effects of positive and negative boundaries. The time-drawdown data then are converted into dimensionless units to determine if the Jacob method's assumptions are valid for the hydrogeologic conditions under which the test was conducted.« less

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

PubMed

Kulikov, A U; Zinchenko, A A

2007-02-19

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

Principles and Methods to Guide Education for Purpose: A Brazilian Experience

ERIC Educational Resources Information Center

Araujo, Ulisses F.; Arantes, Valeria Amorim; Danza, Hanna Cebel; Pinheiro, Viviane Potenza Guimarães; Garbin, Monica

2016-01-01

This article presents a Brazilian experience in training teachers to educate for purpose. Understanding that purpose is a value to be constructed through real-world and contextualised experiences, the authors discuss some psychological processes that underlie purpose development. Then the authors show how these processes are used in a purpose…

Validation of an improved method to calculate the orientation and magnitude of pedicle screw bending moments.

PubMed

Freeman, Andrew L; Fahim, Mina S; Bechtold, Joan E

2012-10-01

Previous methods of pedicle screw strain measurement have utilized complex, time consuming methods of strain gauge application, experience high failure rates, do not effectively measure resultant bending moments, and cannot predict moment orientation. The purpose of this biomechanical study was to validate an improved method of quantifying pedicle screw bending moment orientation and magnitude. Pedicle screws were instrumented to measure biplanar screw bending moments by positioning four strain gauges on flat, machined surfaces below the screw head. Screws were calibrated to measure bending moments by hanging certified weights a known distance from the strain gauges. Loads were applied in 30 deg increments at 12 different angles while recording data from two independent strain channels. The data were then analyzed to calculate the predicted orientation and magnitude of the resultant bending moment. Finally, flexibility tests were performed on a cadaveric motion segment implanted with the instrumented screws to demonstrate the implementation of this technique. The difference between the applied and calculated orientation of the bending moments averaged (±standard error of the mean (SEM)) 0.3 ± 0.1 deg across the four screws for all rotations and loading conditions. The calculated resultant bending moments deviated from the actual magnitudes by an average of 0.00 ± 0.00 Nm for all loading conditions. During cadaveric testing, the bending moment orientations were medial/lateral in flexion-extension, variable in lateral bending, and diagonal in axial torsion. The technique developed in this study provides an accurate method of calculating the orientation and magnitude of screw bending moments and can be utilized with any pedicle screw fixation system.

Improvement and validation of the method to determine neutral detergent fiber in feed.

PubMed

Hiraoka, Hisaaki; Fukunaka, Rie; Ishikuro, Eiichi; Enishi, Osamu; Goto, Tetsuhisa

2012-10-01

To improve the performance of the analytical method for neutral detergent fiber in feed with heat-stable α-amylase treatment (aNDFom), the process of adding heat-stable α-amylase, as well as other analytical conditions, were examined. In this new process, the starch in the samples was removed by adding amylase to neutral detergent (ND) solution twice, just after the start of heating and immediately after refluxing. We also examined the effects of the use of sodium sulfite, and drying and ashing conditions for aNDFom analysis by this modified amylase addition method. A collaborative study to validate this new method was carried out with 15 laboratories. These laboratories analyzed two samples, alfalfa pellet and dairy mixed feed, with blind duplicates. Ten laboratories used a conventional apparatus and five used a Fibertec(®) type apparatus. There were no significant differences in aNDFom values between these two refluxing apparatuses. The aNDFom values in alfalfa pellet and dairy mixed feed were 388 g/kg and 145 g/kg, the coefficients of variation for the repeatability and reproducibility (CV(r) and CV(R) ) were 1.3% and 2.9%, and the HorRat values were 0.8 and 1.1, respectively. This new method was validated with 5.8% uncertainty (k = 2) from the collaborative study. © 2012 The Authors. Animal Science Journal © 2012 Japanese Society of Animal Science.

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

PubMed Central

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

2015-01-01

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

A program needs-driven approach to selecting dietary assessment methods for decision-making in food fortification programs.

PubMed

Coates, Jennifer; Colaiezzi, Brooke; Fiedler, John L; Wirth, James; Lividini, Keith; Rogers, Beatrice

2012-09-01

Dietary assessment data are essential for designing, monitoring, and evaluating food fortification and other food-based nutrition programs. Planners and managers must understand the validity, usefulness, and cost tradeoffs of employing alternative dietary assessment methods, but little guidance exists. To identify and apply criteria to assess the tradeoffs of using alternative dietary methods for meeting fortification programming needs. Twenty-five semistructured expert interviews were conducted and literature was reviewed for information on the validity, usefulness, and cost of using 24-hour recalls, Food Frequency Questionnaires/Fortification Rapid Assessment Tool (FFQ/FRAT), Food Balance Sheets (FBS), and Household Consumption and Expenditures Surveys (HCES) for program stage-specific information needs. Criteria were developed and applied to construct relative rankings of the four methods. Needs assessment: HCES offers the greatest suitability at the lowest cost for estimating the risk of inadequate intakes, but relative to 24-hour recall compromises validity. HCES should be used to identify vehicles and to estimate coverage and likely impact due to its low cost and moderate-to-high validity. Baseline assessment: 24-hour recall should be applied using a representative sample. Monitoring: A simple, low-cost FFQ can be used to monitor coverage. Impact evaluation: 24-hour recall should be used to assess changes in nutrient intakes. FBS have low validity relative to other methods for all programmatic purposes. Each dietary assessment method has strengths and weaknesses that vary by context and purpose. Method selection must be driven by the program's data needs, the suitability of the methods for the purpose, and a clear understanding of the tradeoffs involved.

Elaboration and validation of the method for the quantification of the emetic toxin of Bacillus cereus as described in EN-ISO 18465 - Microbiology of the food chain - Quantitative determination of emetic toxin (cereulide) using LC-MS/MS.

PubMed

In 't Veld, P H; van der Laak, L F J; van Zon, M; Biesta-Peters, E G

2018-04-12

A method for the quantification of the Bacillus cereus emetic toxin (cereulide) was developed and validated. The method principle is based on LC-MS as this is the most sensitive and specific method for cereulide. Therefore the study design is different from the microbiological methods validated under this mandate. As the method had to be developed a two stage validation study approach was used. The first stage (pre-study) focussed on the method applicability and the experience of the laboratories with the method. Based on the outcome of the pre-study and comments received during voting at CEN and ISO level a final method was agreed to be used for the second stage the (final) validation of the method. In the final (validation) study samples of cooked rice (both artificially contaminated with cereulide or contaminated with B. cereus for production of cereulide in the rice) and 6 other food matrices (fried rice dish, cream pastry with chocolate, hotdog sausage, mini pancakes, vanilla custard and infant formula) were used. All these samples were spiked by the participating laboratories using standard solutions of cereulide supplied by the organising laboratory. The results of the study indicate that the method is fit for purpose. Repeatability values were obtained of 0.6 μg/kg at low level spike (ca. 5 μg/kg) and 7 to 9.6 μg/kg at high level spike (ca. 75 μg/kg). Reproducibility at low spike level ranged from 0.6 to 0.9 μg/kg and from 8.7 to 14.5 μg/kg at high spike level. Recovery from the spiked samples ranged between 96.5% for mini-pancakes to 99.3% for fries rice dish. Copyright © 2018. Published by Elsevier B.V.

Validity and relative validity of a novel digital approach for 24-h dietary recall in athletes.

PubMed

Baker, Lindsay B; Heaton, Lisa E; Stein, Kimberly W; Nuccio, Ryan P; Jeukendrup, Asker E

2014-04-30

We developed a digital dietary analysis tool for athletes (DATA) using a modified 24-h recall method and an integrated, customized nutrient database. The purpose of this study was to assess DATA's validity and relative validity by measuring its agreement with registered dietitians' (RDs) direct observations (OBSERVATION) and 24-h dietary recall interviews using the USDA 5-step multiple-pass method (INTERVIEW), respectively. Fifty-six athletes (14-20 y) completed DATA and INTERVIEW in randomized counter-balanced order. OBSERVATION (n = 26) consisted of RDs recording participants' food/drink intake in a 24-h period and were completed the day prior to DATA and INTERVIEW. Agreement among methods was estimated using a repeated measures t-test and Bland-Altman analysis. The paired differences (with 95% confidence intervals) between DATA and OBSERVATION were not significant for carbohydrate (10.1%, -1.2-22.7%) and protein (14.1%, -3.2-34.5%) but was significant for energy (14.4%, 1.2-29.3%). There were no differences between DATA and INTERVIEW for energy (-1.1%, -9.1-7.7%), carbohydrate (0.2%, -7.1-8.0%) or protein (-2.7%, -11.3-6.7%). Bland-Altman analysis indicated significant positive correlations between absolute values of the differences and the means for OBSERVATION vs. DATA (r = 0.40 and r = 0.47 for energy and carbohydrate, respectively) and INTERVIEW vs. DATA (r = 0.52, r = 0.29, and r = 0.61 for energy, carbohydrate, and protein, respectively). There were also wide 95% limits of agreement (LOA) for most method comparisons. The mean bias ratio (with 95% LOA) for OBSERVATION vs. DATA was 0.874 (0.551-1.385) for energy, 0.906 (0.522-1.575) for carbohydrate, and 0.895(0.395-2.031) for protein. The mean bias ratio (with 95% LOA) for INTERVIEW vs. DATA was 1.016 (0.538-1.919) for energy, 0.995 (0.563-1.757) for carbohydrate, and 1.031 (0.514-2.068) for protein. DATA has good relative validity for group-level comparisons in athletes. However, there are large variations

Validation of the SETOC Instrument--Student Evaluation of Teaching in Outpatient Clinics

ERIC Educational Resources Information Center

Zuberi, Rukhsana W.; Bordage, Georges; Norman, Geoffrey R.

2007-01-01

Purpose: There is a paucity of evaluation forms specifically developed and validated for outpatient settings. The purpose of this study was to develop and validate an instrument specifically for evaluating outpatient teaching, to provide reliable and valid ratings for individual and group feedback to faculty, and to identify outstanding teachers…