Development, reliability, and validity of the My Child's Play (MCP) questionnaire.

PubMed

Schneider, Eleanor; Rosenblum, Sara

2014-01-01

This article describes the development, reliability, and validity of My Child's Play (MCP), a parent questionnaire designed to evaluate the play of children ages 3-9 yr. The first phase of the study determined the questionnaire's content and face validity. Subsequently, the internal reliability consistency and construct and concurrent validity were demonstrated using 334 completed questionnaires. The MCP showed good internal consistency (α = .86). The factor analysis revealed four distinct factors with acceptable levels of internal reliability (Cronbach's αs = .63-.81) and gender- and age-related differences in play characteristics; both findings attest to the tool's construct validity. Significant correlations (r = .33, p < .0001) with the Parent as a Teacher Inventory demonstrate the MCP's concurrent validity. The MCP demonstrated acceptable reliability and validity. It appears to be a promising standardized assessment tool for use in research and practice to promote understanding of a child's play. Copyright © 2014 by the American Occupational Therapy Association, Inc.

What Counts as Validity Evidence? Examples and Prevalence in a Systematic Review of Simulation-Based Assessment

ERIC Educational Resources Information Center

Cook, David A.; Zendejas, Benjamin; Hamstra, Stanley J.; Hatala, Rose; Brydges, Ryan

2014-01-01

Ongoing transformations in health professions education underscore the need for valid and reliable assessment. The current standard for assessment validation requires evidence from five sources: content, response process, internal structure, relations with other variables, and consequences. However, researchers remain uncertain regarding the types…

Education Technology Standards Self-Efficacy (ETSSE) Scale: A Validity and Reliability Study

ERIC Educational Resources Information Center

Simsek, Omer; Yazar, Taha

2016-01-01

Problem Statement: The educational technology standards for teachers set by the International Society for Technology in Education (the ISTE Standards-T) represent an important framework for using technology effectively in teaching and learning processes. These standards are widely used by universities, educational institutions, and schools. The…

Concurrent validation of CHIRP, a new instrument for measuring healthcare student attitudes towards interdisciplinary teamwork.

PubMed

Hollar, David; Hobgood, Cherri; Foster, Beverly; Aleman, Marco; Sawning, Susan

2012-01-01

Positive attitudes towards teamwork among health care professionals are critical to patient safety. The purpose of this study is to describe the development and concurrent validation of a new instrument to measure attitudes towards healthcare teamwork that is generalizable across various populations of healthcare students. The Collaborative Healthcare Interdisciplinary Planning (CHIRP) scale was validated against the Readiness for Inter-Professional Learning Scale (RIPLS). Analyses included student (n = 266) demographics, ANOVA, internal consistency, factor analysis, and Rasch analysis. The two instruments correlated at r = .582. The CHIRP showed a multifactorial structure having excellent internal consistency (alpha = .850), with 25 of the 36 scale items loading onto a single Teamwork Attitudes factor. The RIPLS likewise had strong internal consistency (alpha = .796) and a three-factor structure, supporting previous studies of the instrument. However, Rasch analyses showed 14 (38.9%) of the 36 CHIRP items, but only four (21.1%) of the 19 RIPLS items remaining within the satisfactory standardized OUTFIT zone of 2.0 standard deviation units. We propose the 14 fitting items as a new, validated teamwork attitudes scale.

Development and pilot of an internationally standardized measure of cardiovascular risk management in European primary care

PubMed Central

2011-01-01

Background Primary care can play an important role in providing cardiovascular risk management in patients with established Cardiovascular Diseases (CVD), patients with a known high risk of developing CVD, and potentially for individuals with a low risk of developing CVD, but who have unhealthy lifestyles. To describe and compare cardiovascular risk management, internationally valid quality indicators and standardized measures are needed. As part of a large project in 9 European countries (EPA-Cardio), we have developed and tested a set of standardized measures, linked to previously developed quality indicators. Methods A structured stepwise procedure was followed to develop measures. First, the research team allocated 106 validated quality indicators to one of the three target populations (established CVD, at high risk, at low risk) and to different data-collection methods (data abstraction from the medical records, a patient survey, an interview with lead practice GP/a practice survey). Secondly, we selected a number of other validated measures to enrich the assessment. A pilot study was performed to test the feasibility. Finally, we revised the measures based on the findings. Results The EPA-Cardio measures consisted of abstraction forms from the medical-records data of established Coronary Heart Disease (CHD)-patients - and high-risk groups, a patient questionnaire for each of the 3 groups, an interview questionnaire for the lead GP and a questionnaire for practice teams. The measures were feasible and accepted by general practices from different countries. Conclusions An internationally standardized measure of cardiovascular risk management, linked to validated quality indicators and tested for feasibility in general practice, is now available. Careful development and pilot testing of the measures are crucial in international studies of quality of healthcare. PMID:21473758

Standard addition with internal standardisation as an alternative to using stable isotope labelled internal standards to correct for matrix effects-Comparison and validation using liquid chromatography-​tandem mass spectrometric assay of vitamin D.

PubMed

Hewavitharana, Amitha K; Abu Kassim, Nur Sofiah; Shaw, Paul Nicholas

2018-06-08

With mass spectrometric detection in liquid chromatography, co-eluting impurities affect the analyte response due to ion suppression/enhancement. Internal standard calibration method, using co-eluting stable isotope labelled analogue of each analyte as the internal standard, is the most appropriate technique available to correct for these matrix effects. However, this technique is not without drawbacks, proved to be expensive because separate internal standard for each analyte is required, and the labelled compounds are expensive or require synthesising. Traditionally, standard addition method has been used to overcome the matrix effects in atomic spectroscopy and was a well-established method. This paper proposes the same for mass spectrometric detection, and demonstrates that the results are comparable to those with the internal standard method using labelled analogues, for vitamin D assay. As conventional standard addition procedure does not address procedural errors, we propose the inclusion of an additional internal standard (not co-eluting). Recoveries determined on human serum samples show that the proposed method of standard addition yields more accurate results than the internal standardisation using stable isotope labelled analogues. The precision of the proposed method of standard addition is superior to the conventional standard addition method. Copyright © 2018 Elsevier B.V. All rights reserved.

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

Quantitative determination and validation of octreotide acetate using 1 H-NMR spectroscopy with internal standard method.

PubMed

Yu, Chen; Zhang, Qian; Xu, Peng-Yao; Bai, Yin; Shen, Wen-Bin; Di, Bin; Su, Meng-Xiang

2018-01-01

Quantitative nuclear magnetic resonance (qNMR) is a well-established technique in quantitative analysis. We presented a validated 1 H-qNMR method for assay of octreotide acetate, a kind of cyclic octopeptide. Deuterium oxide was used to remove the undesired exchangeable peaks, which was referred to as proton exchange, in order to make the quantitative signals isolated in the crowded spectrum of the peptide and ensure precise quantitative analysis. Gemcitabine hydrochloride was chosen as the suitable internal standard. Experimental conditions, including relaxation delay time, the numbers of scans, and pulse angle, were optimized first. Then method validation was carried out in terms of selectivity, stability, linearity, precision, and robustness. The assay result was compared with that by means of high performance liquid chromatography, which is provided by Chinese Pharmacopoeia. The statistical F test, Student's t test, and nonparametric test at 95% confidence level indicate that there was no significant difference between these two methods. qNMR is a simple and accurate quantitative tool with no need for specific corresponding reference standards. It has the potential of the quantitative analysis of other peptide drugs and standardization of the corresponding reference standards. Copyright © 2017 John Wiley & Sons, Ltd.

Viability of Construct Validity of the Speaking Modules of International Language Examinations (IELTS vs. TOEFL iBT): Evidence from Iranian Test-Takers

ERIC Educational Resources Information Center

Zahedi, Keivan; Shamsaee, Saeedeh

2012-01-01

The aim of the present research is to examine the viability of the construct validity of the speaking modules of two internationally recognized language proficiency examinations, namely IELTS and TOEFL iBT. High-stake standardized tests play a crucial and decisive role in determining the future academic life of many people. Overall obtained scores…

INCLEN Diagnostic Tool for Autism Spectrum Disorder (INDT-ASD): development and validation.

PubMed

Juneja, Monica; Mishra, Devendra; Russell, Paul S S; Gulati, Sheffali; Deshmukh, Vaishali; Tudu, Poma; Sagar, Rajesh; Silberberg, Donald; Bhutani, Vinod K; Pinto, Jennifer M; Durkin, Maureen; Pandey, Ravindra M; Nair, M K C; Arora, Narendra K

2014-05-01

To develop and validate INCLEN Diagnostic Tool for Autism Spectrum Disorder (INDT-ASD). Diagnostic test evaluation by cross sectional design. Four tertiary pediatric neurology centers in Delhi and Thiruvanthapuram, India. Children aged 2-9 years were enrolled in the study. INDT-ASD and Childhood Autism Rating Scale (CARS) were administered in a randomly decided sequence by trained psychologist, followed by an expert evaluation by DSM-IV TR diagnostic criteria (gold standard). Psychometric parameters of diagnostic accuracy, validity (construct, criterion and convergent) and internal consistency. 154 children (110 boys, mean age 64.2 mo) were enrolled. The overall diagnostic accuracy (AUC=0.97, 95% CI 0.93, 0.99; P<0.001) and validity (sensitivity 98%, specificity 95%, positive predictive value 91%, negative predictive value 99%) of INDT-ASD for Autism spectrum disorder were high, taking expert diagnosis using DSM-IV-TR as gold standard. The concordance rate between the INDT-ASD and expert diagnosis for 'ASD group' was 82.52% [Cohen's k=0.89; 95% CI (0.82, 0.97); P=0.001]. The internal consistency of INDT-ASD was 0.96. The convergent validity with CARS (r = 0.73, P= 0.001) and divergent validity with Binet-Kamat Test of intelligence (r = -0.37; P=0.004) were significantly high. INDT-ASD has a 4-factor structure explaining 85.3% of the variance. INDT-ASD has high diagnostic accuracy, adequate content validity, good internal consistency high criterion validity and high to moderate convergent validity and 4-factor construct validity for diagnosis of Autistm spectrum disorder.

[The validation of kit of reagents for quantitative detection of DNA of human cytomegalovirus in biological material using polymerase chain reaction technique in real time operation mode].

PubMed

Sil'veĭstrova, O Iu; Domonova, É A; Shipulina, O Iu

2014-04-01

The validation of kit of reagents destined to detection and quantitative evaluation of DNA of human cytomegalovirus in biological material using polymerase chain reaction technique in real time operation mode was implemented. The comparison was made against international WHO standard--The first WHO international standard for human cytomegalovirus to implement measures the kit of reagents "AmpliSens CMV-screen/monitor-FL" and standard sample of enterprise DNA HCMV (The central research institute of epidemiology of Rospotrebnadzor) was applied. The fivefold dilution of international WHO standard and standard sample of enterprise were carried out in concentrations of DNA HCMV from 106 to 102. The arrangement of polymerase chain reaction and analysis of results were implemented using programed amplifier with system of detection of fluorescent signal in real-time mode "Rotor-Gene Q" ("Qiagen", Germany). In the total of three series of experiments, all stages of polymerase chain reaction study included, the coefficient of translation of quantitative evaluation of DNA HCMV from copy/ml to ME/ml equal to 0.6 was introduced for this kit of reagents.

Quantitative determination of galantamine in human plasma by sensitive liquid chromatography-tandem mass spectrometry using loratadine as an internal standard.

PubMed

Nirogi, Ramakrishna V S; Kandikere, Vishwottam N; Mudigonda, Koteshwara; Maurya, Santosh

2007-02-01

A simple, rapid, sensitive, and selective liquid chromatography-tandem mass spectrometry method is developed and validated for the quantitation of galantamine, an acetylcholinesterase inhibitor in human plasma, using a commercially available compound, loratadine, as the internal standard. Following liquid-liquid extraction, the analytes are separated using an isocratic mobile phase on a reverse-phase C18 column and analyzed by mass spectrometry in the multiple reaction monitoring mode using the respective (M+H)+ ions, m/z 288 to 213 for galantamine and m/z 383 and 337 for the internal standard. The assay exhibit a linear dynamic range of 0.5-100 ng/mL for galantamine in human plasma. The lower limit of quantitation is 0.5 ng/mL, with a relative standard deviation of less than 8%. Acceptable precision and accuracy are obtained for concentrations over the standard curve range. A run time of 2.5 min for each sample makes it possible to analyze more than 400 human plasma samples per day. The validated method is successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability, or bioequivalence studies.

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.

25 CFR 543.7 - What are the minimum internal control standards for bingo?

Code of Federal Regulations, 2010 CFR

2010-04-01

... information technology security standards can be found in § 543.16 of this part.) (2) The game software... applicable voucher system, player interface or other transaction history records to verify the validity of...

The International Index of Erectile Function: a methodological critique and suggestions for improvement.

PubMed

Yule, Morag; Davison, Joyce; Brotto, Lori

2011-01-01

The International Index of Erectile Function is a well-worded and psychometrically valid self-report questionnaire widely used as the standard for the evaluation of male sexual function. However, some conceptual and statistical problems arise when using the measure with men who are not sexually active. These problems are illustrated using 2 empirical examples, and the authors provide recommended solutions to further strengthen the efficacy and validity of this measure.

Updated Design Standards and Guidance from the What Works Clearinghouse: Regression Discontinuity Designs and Cluster Designs

ERIC Educational Resources Information Center

Cole, Russell; Deke, John; Seftor, Neil

2016-01-01

The What Works Clearinghouse (WWC) maintains design standards to identify rigorous, internally valid education research. As education researchers advance new methodologies, the WWC must revise its standards to include an assessment of the new designs. Recently, the WWC has revised standards for two emerging study designs: regression discontinuity…

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

PubMed

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

2013-06-01

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

An Internationally Consented Standard for Nursing Process-Clinical Decision Support Systems in Electronic Health Records.

PubMed

Müller-Staub, Maria; de Graaf-Waar, Helen; Paans, Wolter

2016-11-01

Nurses are accountable to apply the nursing process, which is key for patient care: It is a problem-solving process providing the structure for care plans and documentation. The state-of-the art nursing process is based on classifications that contain standardized concepts, and therefore, it is named Advanced Nursing Process. It contains valid assessments, nursing diagnoses, interventions, and nursing-sensitive patient outcomes. Electronic decision support systems can assist nurses to apply the Advanced Nursing Process. However, nursing decision support systems are missing, and no "gold standard" is available. The study aim is to develop a valid Nursing Process-Clinical Decision Support System Standard to guide future developments of clinical decision support systems. In a multistep approach, a Nursing Process-Clinical Decision Support System Standard with 28 criteria was developed. After pilot testing (N = 29 nurses), the criteria were reduced to 25. The Nursing Process-Clinical Decision Support System Standard was then presented to eight internationally known experts, who performed qualitative interviews according to Mayring. Fourteen categories demonstrate expert consensus on the Nursing Process-Clinical Decision Support System Standard and its content validity. All experts agreed the Advanced Nursing Process should be the centerpiece for the Nursing Process-Clinical Decision Support System and should suggest research-based, predefined nursing diagnoses and correct linkages between diagnoses, evidence-based interventions, and patient outcomes.

Validation of the Medisana MTP Plus upper arm blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Erdem, Emre; Aydogdu, Türkan; Akpolat, Tekin

2011-02-01

Standard validation protocols are objective guides for healthcare providers, physicians, and patients. The purpose of this study was to test validation of the Medisana MTP Plus upper arm blood pressure (BP) measuring monitor for self-measurement according to the European Society of Hypertension International Protocol (ESH-IP2) in adults. The Medisana MTP Plus monitor is an automated and oscillometric upper arm device for home BP monitoring. Nine consecutive measurements were made according to the ESH-IP2. Overseen by an independent supervisor, measurements were recorded by two observers blinded from both each other's readings and from the device readings. The Medisana MTP Plus device fulfills the validation criteria of the ESH-IP2 for the general population. The mean (standard deviation) of the difference between the observers and the device measurements was 0.6 mmHg (5.1 mmHg) for systolic and 2.7 mmHg (3.4 mmHg) for diastolic pressures, respectively. As the Medisana MTP Plus device has achieved the required standards, it is recommended for home BP monitoring in an adult population.

Evidence Regarding the Internal Structure: Confirmatory Factor Analysis

ERIC Educational Resources Information Center

Lewis, Todd F.

2017-01-01

American Educational Research Association (AERA) standards stipulate that researchers show evidence of the internal structure of instruments. Confirmatory factor analysis (CFA) is one structural equation modeling procedure designed to assess construct validity of assessments that has broad applicability for counselors interested in instrument…

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.

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

PubMed Central

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

2012-01-01

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

Validation of the international labour office digitized standard images for recognition and classification of radiographs of pneumoconiosis.

PubMed

Halldin, Cara N; Petsonk, Edward L; Laney, A Scott

2014-03-01

Chest radiographs are recommended for prevention and detection of pneumoconiosis. In 2011, the International Labour Office (ILO) released a revision of the International Classification of Radiographs of Pneumoconioses that included a digitized standard images set. The present study compared results of classifications of digital chest images performed using the new ILO 2011 digitized standard images to classification approaches used in the past. Underground coal miners (N = 172) were examined using both digital and film-screen radiography (FSR) on the same day. Seven National Institute for Occupational Safety and Health-certified B Readers independently classified all 172 digital radiographs, once using the ILO 2011 digitized standard images (DRILO2011-D) and once using digitized standard images used in the previous research (DRRES). The same seven B Readers classified all the miners' chest films using the ILO film-based standards. Agreement between classifications of FSR and digital radiography was identical, using a standard image set (either DRILO2011-D or DRRES). The overall weighted κ value was 0.58. Some specific differences in the results were seen and noted. However, intrareader variability in this study was similar to the published values and did not appear to be affected by the use of the new ILO 2011 digitized standard images. These findings validate the use of the ILO digitized standard images for classification of small pneumoconiotic opacities. When digital chest radiographs are obtained and displayed appropriately, results of pneumoconiosis classifications using the 2011 ILO digitized standards are comparable to film-based ILO classifications and to classifications using earlier research standards. Published by Elsevier Inc.

Validation of a reversed-phase high-performance liquid chromatographic method for the determination of free amino acids in rice using l-theanine as the internal standard.

PubMed

Liyanaarachchi, G V V; Mahanama, K R R; Somasiri, H P P S; Punyasiri, P A N

2018-02-01

The study presents the validation results of the method carried out for analysis of free amino acids (FAAs) in rice using l-theanine as the internal standard (IS) with o-phthalaldehyde (OPA) reagent using high-performance liquid chromatography-fluorescence detection. The detection and quantification limits of the method were in the range 2-16μmol/kg and 3-19μmol/kg respectively. The method had a wide working range from 25 to 600μmol/kg for each individual amino acid, and good linearity with regression coefficients greater than 0.999. Precision measured in terms of repeatability and reproducibility, expressed as percentage relative standard deviation (% RSD) was below 9% for all the amino acids analyzed. The recoveries obtained after fortification at three concentration levels were in the range 75-105%. In comparison to l-norvaline, findings revealed that l-theanine is suitable as an IS and the validated method can be used for FAA determination in rice. Copyright © 2017 Elsevier Ltd. All rights reserved.

Validation of the Grandway MD2301 digital automatic blood pressure monitor according to the European Society of Hypertension International Protocol.

PubMed

Chen, Wan; Zeng, Zhao-Lin; Bing, Sen; Li, Lin-Yi; Wang, Rui; Wan, Yi

2016-08-01

The aim of the present study was to validate the Grandway MD2301 digital automatic blood pressure monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010. The ESH-IP revision 2010 for the validation of blood pressure-measuring devices in adults was followed precisely. Systolic and diastolic blood pressure (SBP and DBP, respectively) were measured sequentially in 33 adult patients and compared with a standard mercury sphygmomanometer (two observers). A total of 99 comparison pairs were obtained. The device produced 78, 95 and 99 measurements within 5, 10, and 15 mmHg for SBP and 83, 96, and 99 for DBP, respectively. The average device-observer difference was -1.81±4.22 mmHg for SBP and -0.15±3.93 mmHg for DBP. All of the data were within the standards requirements to pass the testing. The Grandway MD2301 digital automatic blood pressure monitor meets the standards of the ESH-IP revision 2010 and can be recommended for self/home measurement in the general population.

Translation and Validation of the Korean Version of the International Knee Documentation Committee Subjective Knee Form

PubMed Central

Kim, Jin Goo; Lee, Joong Yub; Seo, Seung Suk; Choi, Choong Hyeok; Lee, Myung Chul

2013-01-01

Purpose To perform a cross-cultural adaptation and to test the measurement properties of the Korean version of International Knee Documentation Committee (K-IKDC) Subjective Knee Form. Materials and Methods According to the guidelines for cross-cultural adaptation, translation and backward translation of the English version of the IKDC Subjective Knee Form were performed. After translation into the Korean version, 150 patients who had knee-related problems were asked to complete the K-IKDC, Lysholm score, and Short Form-36 (SF-36). Of these patients, 126 were retested 2 weeks later to evaluate test-retest reliability, and 104 were recruited 3 months later to evaluate responsiveness. Construct validity was analyzed by investigating the correlation with Lysholm score and SF-36; content validity was also evaluated. Standardized mean response was calculated for evaluating responsiveness. Results The test-retest reliability proved excellent with a high value for the intraclass correlation coefficient (r=0.94). The internal consistency was strong (Cronbach's α=0.91). Good content validity with absence of floor not ceiling effects and good convergent and divergent validity were observed. Moderate responsiveness was shown (standardized mean response=0.689). Conclusions The K-IKDC demonstrated good measurement properties. We suggest that this instrument is an excellent evaluation instrument that can be used for Korean patients with knee-related injuries. PMID:24032098

Anthropometric protocols for the construction of new international fetal and newborn growth standards: the INTERGROWTH-21st Project.

PubMed

Cheikh Ismail, L; Knight, H E; Bhutta, Z; Chumlea, W C

2013-09-01

The primary aim of the INTERGROWTH-21(st) Project is to construct new, prescriptive standards describing optimal fetal and preterm postnatal growth. The anthropometric measurements include the head circumference, recumbent length and weight of the infants, and the stature and weight of the parents. In such a large, international, multicentre project, it is critical that all study sites follow standardised protocols to ensure maximal validity of the growth and nutrition indicators used. This paper describes, in detail, the selection of anthropometric personnel, equipment, and measurement and calibration protocols used to construct the new standards. Implementing these protocols at each study site ensures that the anthropometric data are of the highest quality to construct the international standards. © 2013 Royal College of Obstetricians and Gynaecologists.

Scientific Reporting: Raising the Standards

ERIC Educational Resources Information Center

McLeroy, Kenneth R.; Garney, Whitney; Mayo-Wilson, Evan; Grant, Sean

2016-01-01

This article is based on a presentation that was made at the 2014 annual meeting of the editorial board of "Health Education & Behavior." The article addresses critical issues related to standards of scientific reporting in journals, including concerns about external and internal validity and reporting bias. It reviews current…

INTERNATIONAL STANDARDS ON FOOD AND ENVIRONMENTAL RADIOACTIVITY MEASUREMENT FOR RADIOLOGICAL PROTECTION: STATUS AND PERSPECTIVES.

PubMed

Calmet, D; Ameon, R; Bombard, A; Brun, S; Byrde, F; Chen, J; Duda, J-M; Forte, M; Fournier, M; Fronka, A; Haug, T; Herranz, M; Husain, A; Jerome, S; Jiranek, M; Judge, S; Kim, S B; Kwakman, P; Loyen, J; LLaurado, M; Michel, R; Porterfield, D; Ratsirahonana, A; Richards, A; Rovenska, K; Sanada, T; Schuler, C; Thomas, L; Tokonami, S; Tsapalov, A; Yamada, T

2017-04-01

Radiological protection is a matter of concern for members of the public and thus national authorities are more likely to trust the quality of radioactivity data provided by accredited laboratories using common standards. Normative approach based on international standards aims to ensure the accuracy or validity of the test result through calibrations and measurements traceable to the International System of Units. This approach guarantees that radioactivity test results on the same types of samples are comparable over time and space as well as between different testing laboratories. Today, testing laboratories involved in radioactivity measurement have a set of more than 150 international standards to help them perform their work. Most of them are published by the International Standardization Organization (ISO) and the International Electrotechnical Commission (IEC). This paper reviews the most essential ISO standards that give guidance to testing laboratories at different stages from sampling planning to the transmission of the test report to their customers, summarizes recent activities and achievements and present the perspectives on new standards under development by the ISO Working Groups dealing with radioactivity measurement in connection with radiological protection. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Improving the psychometric properties of dot-probe attention measures using response-based computation.

PubMed

Evans, Travis C; Britton, Jennifer C

2018-09-01

Abnormal threat-related attention in anxiety disorders is most commonly assessed and modified using the dot-probe paradigm; however, poor psychometric properties of reaction-time measures may contribute to inconsistencies across studies. Typically, standard attention measures are derived using average reaction-times obtained in experimentally-defined conditions. However, current approaches based on experimentally-defined conditions are limited. In this study, the psychometric properties of a novel response-based computation approach to analyze dot-probe data are compared to standard measures of attention. 148 adults (19.19 ± 1.42 years, 84 women) completed a standardized dot-probe task including threatening and neutral faces. We generated both standard and response-based measures of attention bias, attentional orientation, and attentional disengagement. We compared overall internal consistency, number of trials necessary to reach internal consistency, test-retest reliability (n = 72), and criterion validity obtained using each approach. Compared to standard attention measures, response-based measures demonstrated uniformly high levels of internal consistency with relatively few trials and varying improvements in test-retest reliability. Additionally, response-based measures demonstrated specific evidence of anxiety-related associations above and beyond both standard attention measures and other confounds. Future studies are necessary to validate this approach in clinical samples. Response-based attention measures demonstrate superior psychometric properties compared to standard attention measures, which may improve the detection of anxiety-related associations and treatment-related changes in clinical samples. Copyright © 2018 Elsevier Ltd. All rights reserved.

Standards for testing and clinical validation of seizure detection devices.

PubMed

Beniczky, Sándor; Ryvlin, Philippe

2018-06-01

To increase the quality of studies on seizure detection devices, we propose standards for testing and clinical validation of such devices. We identified 4 key features that are important for studies on seizure detection devices: subjects, recordings, data analysis and alarms, and reference standard. For each of these features, we list the specific aspects that need to be addressed in the studies, and depending on these, studies are classified into 5 phases (0-4). We propose a set of outcome measures that need to be reported, and we propose standards for reporting the results. These standards will help in designing and reporting studies on seizure detection devices, they will give readers clear information on the level of evidence provided by the studies, and they will help regulatory bodies in assessing the quality of the validation studies. These standards are flexible, allowing classification of the studies into one of the 5 phases. We propose actions that can facilitate development of novel methods and devices. Wiley Periodicals, Inc. © 2018 International League Against Epilepsy.

Determination of low intrinsic clearance in vitro: the benefit of a novel internal standard in human hepatocyte incubations.

PubMed

Zanelli, Ugo; Michna, Thomas; Petersson, Carl

2018-03-26

1. A novel method utilizing an internal standard in hepatocytes incubations has been developed and demonstrated to decrease the variability in the determination of intrinsic clearance (CL int ) in this system. The reduced variability was shown to allow differentiation of lower elimination rate constants from noise. 2. The suggested method was able to compensate for a small but systematic error (0.5 µL/min/10 6 cells) caused by an evaporation of approximately 15% of the volume during the incubation time. 3. The approach was validated using six commercial drugs (ketoprofen, tolbutamide, phenacetin, etodolac and quinidine) which were metabolized by different pathways. 4. The suggested internal standard, MSC1815677, was extensively characterized and the acquired data suggest that it fulfills the requirements of an internal standard present during the incubation. The proposed internal standard was stable during the incubation and showed a low potential to inhibit drug metabolizing enzymes and transporters. With MSC1815677 we propose a novel simple, robust and cost-effective method to address the challenges in the estimation of low clearance in hepatocyte incubations.

Using the U.S. "Test of Financial Literacy" in Germany--Adaptation and Validation

ERIC Educational Resources Information Center

Förster, Manuel; Happ, Roland; Molerov, Dimitar

2017-01-01

In this article, the authors present the adaptation and validation processes conducted to render the American "Test of Financial Literacy" (TFL) suitable for use in Germany (TFL-G). First, they outline the translation procedure followed and the various cultural adjustments made in line with international standards. Next, they present…

Drug and herb induced liver injury: Council for International Organizations of Medical Sciences scale for causality assessment

PubMed Central

Teschke, Rolf; Wolff, Albrecht; Frenzel, Christian; Schwarzenboeck, Alexander; Schulze, Johannes; Eickhoff, Axel

2014-01-01

Causality assessment of suspected drug induced liver injury (DILI) and herb induced liver injury (HILI) is hampered by the lack of a standardized approach to be used by attending physicians and at various subsequent evaluating levels. The aim of this review was to analyze the suitability of the liver specific Council for International Organizations of Medical Sciences (CIOMS) scale as a standard tool for causality assessment in DILI and HILI cases. PubMed database was searched for the following terms: drug induced liver injury; herb induced liver injury; DILI causality assessment; and HILI causality assessment. The strength of the CIOMS lies in its potential as a standardized scale for DILI and HILI causality assessment. Other advantages include its liver specificity and its validation for hepatotoxicity with excellent sensitivity, specificity and predictive validity, based on cases with a positive reexposure test. This scale allows prospective collection of all relevant data required for a valid causality assessment. It does not require expert knowledge in hepatotoxicity and its results may subsequently be refined. Weaknesses of the CIOMS scale include the limited exclusion of alternative causes and qualitatively graded risk factors. In conclusion, CIOMS appears to be suitable as a standard scale for attending physicians, regulatory agencies, expert panels and other scientists to provide a standardized, reproducible causality assessment in suspected DILI and HILI cases, applicable primarily at all assessing levels involved. PMID:24653791

A Student Assessment Tool for Standardized Patient Simulations (SAT-SPS): Psychometric analysis.

PubMed

Castro-Yuste, Cristina; García-Cabanillas, María José; Rodríguez-Cornejo, María Jesús; Carnicer-Fuentes, Concepción; Paloma-Castro, Olga; Moreno-Corral, Luis Javier

2018-05-01

The evaluation of the level of clinical competence acquired by the student is a complex process that must meet various requirements to ensure its quality. The psychometric analysis of the data collected by the assessment tools used is a fundamental aspect to guarantee the student's competence level. To conduct a psychometric analysis of an instrument which assesses clinical competence in nursing students at simulation stations with standardized patients in OSCE-format tests. The construct of clinical competence was operationalized as a set of observable and measurable behaviors, measured by the newly-created Student Assessment Tool for Standardized Patient Simulations (SAT-SPS), which was comprised of 27 items. The categories assigned to the items were 'incorrect or not performed' (0), 'acceptable' (1), and 'correct' (2). 499 nursing students. Data were collected by two independent observers during the assessment of the students' performance at a four-station OSCE with standardized patients. Descriptive statistics were used to summarize the variables. The difficulty levels and floor and ceiling effects were determined for each item. Reliability was analyzed using internal consistency and inter-observer reliability. The validity analysis was performed considering face validity, content and construct validity (through exploratory factor analysis), and criterion validity. Internal reliability and inter-observer reliability were higher than 0.80. The construct validity analysis suggested a three-factor model accounting for 37.1% of the variance. These three factors were named 'Nursing process', 'Communication skills', and 'Safe practice'. A significant correlation was found between the scores obtained and the students' grades in general, as well as with the grades obtained in subjects with clinical content. The assessment tool has proven to be sufficiently reliable and valid for the assessment of the clinical competence of nursing students using standardized patients. This tool has three main components: the nursing process, communication skills, and safety management. Copyright © 2018 Elsevier Ltd. All rights reserved.

Validation studies of Karl Fisher reference method for moisture in cotton

USDA-ARS?s Scientific Manuscript database

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

Qualitative Analysis on Stage: Making the Research Process More Public.

ERIC Educational Resources Information Center

Anfara, Vincent A., Jr.; Brown, Kathleen M.

The increased use of qualitative research methods has spurred interest in developing formal standards for assessing its validity. These standards, however, fall short if they do not include public disclosure of methods as a criterion. The researcher must be accountable in documenting the actions associated with establishing internal validity…

New HPV Serology Laboratory Aims to Standardize Assays and Contribute to Vaccine Implementation and Access | Frederick National Laboratory for Cancer Research

Cancer.gov

A new international initiative, led by scientists at the Frederick National Laboratory for Cancer Research and several other institutions, is being launched to provide expertise and leadership on the development, validation, and standardization of hu

Building Better Courses: Examining the Content Validity of the iNACOL National Standards for Quality Online Courses

ERIC Educational Resources Information Center

Adelstein, David; Barbour, Michael

2016-01-01

In 2011, the International Association for K-12 Online Learning released the second iteration of the "National Standards for Quality Online Courses." These standards have been used by numerous institutions and states around the country to help design and create K-12 online courses. However, there has been no reported research on the…

Validation of a Russian Language Oswestry Disability Index Questionnaire.

PubMed

Yu, Elizabeth M; Nosova, Emily V; Falkenstein, Yuri; Prasad, Priya; Leasure, Jeremi M; Kondrashov, Dimitriy G

2016-11-01

Study Design  Retrospective reliability and validity study. Objective  To validate a recently translated Russian language version of the Oswestry Disability Index (R-ODI) using standardized methods detailed from previous validations in other languages. Methods  We included all subjects who were seen in our spine surgery clinic, over the age of 18, and fluent in the Russian language. R-ODI was translated by six bilingual people and combined into a consensus version. R-ODI and visual analog scale (VAS) questionnaires for leg and back pain were distributed to subjects during both their initial and follow-up visits. Test validity, stability, and internal consistency were measured using standardized psychometric methods. Results Ninety-seven subjects participated in the study. No change in the meaning of the questions on R-ODI was noted with translation from English to Russian. There was a significant positive correlation between R-ODI and VAS scores for both the leg and back during both the initial and follow-up visits ( p  < 0.01 for all). The instrument was shown to have high internal consistency (Cronbach α = 0.82) and moderate test-retest stability (interclass correlation coefficient = 0.70). Conclusions  The R-ODI is both valid and reliable for use among the Russian-speaking population in the United States.

Development of a primary standard for absorbed dose from unsealed radionuclide solutions

NASA Astrophysics Data System (ADS)

Billas, I.; Shipley, D.; Galer, S.; Bass, G.; Sander, T.; Fenwick, A.; Smyth, V.

2016-12-01

Currently, the determination of the internal absorbed dose to tissue from an administered radionuclide solution relies on Monte Carlo (MC) calculations based on published nuclear decay data, such as emission probabilities and energies. In order to validate these methods with measurements, it is necessary to achieve the required traceability of the internal absorbed dose measurements of a radionuclide solution to a primary standard of absorbed dose. The purpose of this work was to develop a suitable primary standard. A comparison between measurements and calculations of absorbed dose allows the validation of the internal radiation dose assessment methods. The absorbed dose from an yttrium-90 chloride (90YCl) solution was measured with an extrapolation chamber. A phantom was developed at the National Physical Laboratory (NPL), the UK’s National Measurement Institute, to position the extrapolation chamber as closely as possible to the surface of the solution. The performance of the extrapolation chamber was characterised and a full uncertainty budget for the absorbed dose determination was obtained. Absorbed dose to air in the collecting volume of the chamber was converted to absorbed dose at the centre of the radionuclide solution by applying a MC calculated correction factor. This allowed a direct comparison of the analytically calculated and experimentally determined absorbed dose of an 90YCl solution. The relative standard uncertainty in the measurement of absorbed dose at the centre of an 90YCl solution with the extrapolation chamber was found to be 1.6% (k  =  1). The calculated 90Y absorbed doses from published medical internal radiation dose (MIRD) and radiation dose assessment resource (RADAR) data agreed with measurements to within 1.5% and 1.4%, respectively. This study has shown that it is feasible to use an extrapolation chamber for performing primary standard absorbed dose measurements of an unsealed radionuclide solution. Internal radiation dose assessment methods based on MIRD and RADAR data for 90Y have been validated with experimental absorbed dose determination and they agree within the stated expanded uncertainty (k  =  2).

A pan-European ring trial to validate an International Standard for detection of Vibrio cholerae, Vibrio parahaemolyticus and Vibrio vulnificus in seafoods.

PubMed

Hartnell, R E; Stockley, L; Keay, W; Rosec, J-P; Hervio-Heath, D; Van den Berg, H; Leoni, F; Ottaviani, D; Henigman, U; Denayer, S; Serbruyns, B; Georgsson, F; Krumova-Valcheva, G; Gyurova, E; Blanco, C; Copin, S; Strauch, E; Wieczorek, K; Lopatek, M; Britova, A; Hardouin, G; Lombard, B; In't Veld, P; Leclercq, A; Baker-Austin, C

2018-02-10

Globally, vibrios represent an important and well-established group of bacterial foodborne pathogens. The European Commission (EC) mandated the Comite de European Normalisation (CEN) to undertake work to provide validation data for 15 methods in microbiology to support EC legislation. As part of this mandated work programme, merging of ISO/TS 21872-1:2007, which specifies a horizontal method for the detection of V. parahaemolyticus and V. cholerae, and ISO/TS 21872-2:2007, a similar horizontal method for the detection of potentially pathogenic vibrios other than V. cholerae and V. parahaemolyticus was proposed. Both parts of ISO/TS 21872 utilized classical culture-based isolation techniques coupled with biochemical confirmation steps. The work also considered simplification of the biochemical confirmation steps. In addition, because of advances in molecular based methods for identification of human pathogenic Vibrio spp. classical and real-time PCR options were also included within the scope of the validation. These considerations formed the basis of a multi-laboratory validation study with the aim of improving the precision of this ISO technical specification and providing a single ISO standard method to enable detection of these important foodborne Vibrio spp.. To achieve this aim, an international validation study involving 13 laboratories from 9 countries in Europe was conducted in 2013. The results of this validation have enabled integration of the two existing technical specifications targeting the detection of the major foodborne Vibrio spp., simplification of the suite of recommended biochemical identification tests and the introduction of molecular procedures that provide both species level identification and discrimination of putatively pathogenic strains of V. parahaemolyticus by the determination of the presence of theromostable direct and direct related haemolysins. The method performance characteristics generated in this have been included in revised international standard, ISO 21872:2017, published in July 2017. Copyright © 2018. Published by Elsevier B.V.

Admitting international graduate nursing students: what faculty need to know.

PubMed

Genovese, S Kim; Schmidt, Nola A; Brown, Janet M

2015-01-01

The number of international applicants to US nursing graduate programs is increasing. Modifying standard admission criteria, such as RN licensure, graduate record examination, validation of BSN degree, criminal background check, letters of recommendation, and personal statements, is necessary because of unique complexities. Addressing admission requirements unique to international students, such as English proficiency, visas, and proof of financial resources, is critical. Managing complexities of admitting international students is necessary to facilitate their success.

Validation and long-term evaluation of a modified on-line chiral analytical method for therapeutic drug monitoring of (R,S)-methadone in clinical samples.

PubMed

Ansermot, Nicolas; Rudaz, Serge; Brawand-Amey, Marlyse; Fleury-Souverain, Sandrine; Veuthey, Jean-Luc; Eap, Chin B

2009-08-01

Matrix effects, which represent an important issue in liquid chromatography coupled to mass spectrometry or tandem mass spectrometry detection, should be closely assessed during method development. In the case of quantitative analysis, the use of stable isotope-labelled internal standard with physico-chemical properties and ionization behaviour similar to the analyte is recommended. In this paper, an example of the choice of a co-eluting deuterated internal standard to compensate for short-term and long-term matrix effect in the case of chiral (R,S)-methadone plasma quantification is reported. The method was fully validated over a concentration range of 5-800 ng/mL for each methadone enantiomer with satisfactory relative bias (-1.0 to 1.0%), repeatability (0.9-4.9%) and intermediate precision (1.4-12.0%). From the results obtained during validation, a control chart process during 52 series of routine analysis was established using both intermediate precision standard deviation and FDA acceptance criteria. The results of routine quality control samples were generally included in the +/-15% variability around the target value and mainly in the two standard deviation interval illustrating the long-term stability of the method. The intermediate precision variability estimated in method validation was found to be coherent with the routine use of the method. During this period, 257 trough concentration and 54 peak concentration plasma samples of patients undergoing (R,S)-methadone treatment were successfully analysed for routine therapeutic drug monitoring.

Validation of Calculations in a Digital Thermometer Firmware

NASA Astrophysics Data System (ADS)

Batagelj, V.; Miklavec, A.; Bojkovski, J.

2014-04-01

State-of-the-art digital thermometers are arguably remarkable measurement instruments, measuring outputs from resistance thermometers and/or thermocouples. Not only that they can readily achieve measuring accuracies in the parts-per-million range, but they also incorporate sophisticated algorithms for the transformation calculation of the measured resistance or voltage to temperature. These algorithms often include high-order polynomials, exponentials and logarithms, and must be performed using both standard coefficients and particular calibration coefficients. The numerical accuracy of these calculations and the associated uncertainty component must be much better than the accuracy of the raw measurement in order to be negligible in the total measurement uncertainty. In order for the end-user to gain confidence in these calculations as well as to conform to formal requirements of ISO/IEC 17025 and other standards, a way of validation of these numerical procedures performed in the firmware of the instrument is required. A software architecture which allows a simple validation of internal measuring instrument calculations is suggested. The digital thermometer should be able to expose all its internal calculation functions to the communication interface, so the end-user can compare the results of the internal measuring instrument calculation with reference results. The method can be regarded as a variation of the black-box software validation. Validation results on a thermometer prototype with implemented validation ability show that the calculation error of basic arithmetic operations is within the expected rounding error. For conversion functions, the calculation error is at least ten times smaller than the thermometer effective resolution for the particular probe type.

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

PubMed

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

2007-06-01

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

Method development for gypenosides fingerprint by high performance liquid chromatography with diode-array detection and the addition of internal standard.

PubMed

Liu, Fang; Ren, Dequan; Guo, De-an; Pan, Yifeng; Zhang, Huzhe; Hu, Ping

2008-03-01

In this paper, a new method for liquid chromatographic fingerprint of saponins in Gynostemma pentaphyllum (THUNB.) MAKINO was developed. The G. pentaphyllum powder was defatted by Soxhlet extraction with petroleum ether and then gypenosides were extracted from the residue with methanol by sonicating. Column chromatography with macro pore resin was then used to separate and enrich gypenosides. HPLC fingerprint analysis of gypenosides fraction was performed on a C18 column, with an isocratic elution of 34% acetonitrile for 60 min at 0.8 ml/min, sample injection volume was 20 microl and the wavelength was 203 nm. To cover the lack of standard compounds, the addition of an internal standard of ginsenoside Rb2 was employed in the gypenosides fingerprint profile. The relative retention time (RRT) and relative peak area (RPA) of the gypenosides peaks in the fingerprint were calculated by setting the ginsenoside Rb2 as the marker compound. The relative standard deviation (RSDs) of RRT of five common peaks vs. ginsenoside Rb2 in precision, repeatability and stability test were less than 1%, and the RSDs of RPA were less than 5%. The method validation data proved that the proposed method for the fingerprint with internal standard of G. pentaphyllum saponins is adequate, valid and applicable. Finally, three batches of crude drug samples collected from Shanxi province were tested by following the established method.

An international collaboration to standardize HIV-2 viral load assays: results from the 2009 ACHI(E)V(2E) quality control study.

PubMed

Damond, F; Benard, A; Balotta, Claudia; Böni, Jürg; Cotten, Matthew; Duque, Vitor; Ferns, Bridget; Garson, Jeremy; Gomes, Perpetua; Gonçalves, Fátima; Gottlieb, Geoffrey; Kupfer, Bernd; Ruelle, Jean; Rodes, Berta; Soriano, Vicente; Wainberg, Mark; Taieb, Audrey; Matheron, Sophie; Chene, Genevieve; Brun-Vezinet, Francoise

2011-10-01

Accurate HIV-2 plasma viral load quantification is crucial for adequate HIV-2 patient management and for the proper conduct of clinical trials and international cohort collaborations. This study compared the homogeneity of HIV-2 RNA quantification when using HIV-2 assays from ACHI(E)V(2E) study sites and either in-house PCR calibration standards or common viral load standards supplied to all collaborators. Each of the 12 participating laboratories quantified blinded HIV-2 samples, using its own HIV-2 viral load assay and standard as well as centrally validated and distributed common HIV-2 group A and B standards (http://www.hiv.lanl.gov/content/sequence/HelpDocs/subtypes-more.html). Aliquots of HIV-2 group A and B strains, each at 2 theoretical concentrations (2.7 and 3.7 log(10) copies/ml), were tested. Intralaboratory, interlaboratory, and overall variances of quantification results obtained with both standards were compared using F tests. For HIV-2 group A quantifications, overall and interlaboratory and/or intralaboratory variances were significantly lower when using the common standard than when using in-house standards at the concentration levels of 2.7 log(10) copies/ml and 3.7 log(10) copies/ml, respectively. For HIV-2 group B, a high heterogeneity was observed and the variances did not differ according to the type of standard used. In this international collaboration, the use of a common standard improved the homogeneity of HIV-2 group A RNA quantification only. The diversity of HIV-2 group B, particularly in PCR primer-binding regions, may explain the heterogeneity in quantification of this strain. Development of a validated HIV-2 viral load assay that accurately quantifies distinct circulating strains is needed.

An International Collaboration To Standardize HIV-2 Viral Load Assays: Results from the 2009 ACHIEV2E Quality Control Study▿

PubMed Central

Damond, F.; Benard, A.; Balotta, Claudia; Böni, Jürg; Cotten, Matthew; Duque, Vitor; Ferns, Bridget; Garson, Jeremy; Gomes, Perpetua; Gonçalves, Fátima; Gottlieb, Geoffrey; Kupfer, Bernd; Ruelle, Jean; Rodes, Berta; Soriano, Vicente; Wainberg, Mark; Taieb, Audrey; Matheron, Sophie; Chene, Genevieve; Brun-Vezinet, Francoise

2011-01-01

Accurate HIV-2 plasma viral load quantification is crucial for adequate HIV-2 patient management and for the proper conduct of clinical trials and international cohort collaborations. This study compared the homogeneity of HIV-2 RNA quantification when using HIV-2 assays from ACHIEV2E study sites and either in-house PCR calibration standards or common viral load standards supplied to all collaborators. Each of the 12 participating laboratories quantified blinded HIV-2 samples, using its own HIV-2 viral load assay and standard as well as centrally validated and distributed common HIV-2 group A and B standards (http://www.hiv.lanl.gov/content/sequence/HelpDocs/subtypes-more.html). Aliquots of HIV-2 group A and B strains, each at 2 theoretical concentrations (2.7 and 3.7 log10 copies/ml), were tested. Intralaboratory, interlaboratory, and overall variances of quantification results obtained with both standards were compared using F tests. For HIV-2 group A quantifications, overall and interlaboratory and/or intralaboratory variances were significantly lower when using the common standard than when using in-house standards at the concentration levels of 2.7 log10 copies/ml and 3.7 log10 copies/ml, respectively. For HIV-2 group B, a high heterogeneity was observed and the variances did not differ according to the type of standard used. In this international collaboration, the use of a common standard improved the homogeneity of HIV-2 group A RNA quantification only. The diversity of HIV-2 group B, particularly in PCR primer-binding regions, may explain the heterogeneity in quantification of this strain. Development of a validated HIV-2 viral load assay that accurately quantifies distinct circulating strains is needed. PMID:21813718

Development and applicability of Hospital Survey on Patient Safety Culture (HSOPS) in Japan.

PubMed

Ito, Shinya; Seto, Kanako; Kigawa, Mika; Fujita, Shigeru; Hasegawa, Toshihiko; Hasegawa, Tomonori

2011-02-07

Patient safety culture at healthcare organizations plays an important role in guaranteeing, improving and promoting overall patient safety. Although several conceptual frameworks have been proposed in the past, no standard measurement tool has yet been developed for Japan. In order to examine possibilities to introduce the Hospital Survey on Patient Safety Culture (HSOPS) in Japan, the authors of this study translated the HSOPS into Japanese, and evaluated its factor structure, internal consistency, and construct validity. Healthcare workers (n = 6,395) from 13 acute care general hospitals in Japan participated in this survey. Confirmatory factor analysis indicated that the Japanese HSOPS' 12-factor model was selected as the most pertinent, and showed a sufficiently high standard partial regression coefficient. The internal reliability of the subscale scores was 0.46-0.88. The construct validity of each safety culture sub-dimension was confirmed by polychoric correlation, and by an ordered probit analysis. The results of the present study indicate that the factor structures of the Japanese and the American HSOPS are almost identical, and that the Japanese HSOPS has acceptable levels of internal reliability and construct validity. This shows that the HSOPS can be introduced in Japan.

Protocol for the validation of microbiological control of cellular products according to German regulators recommendations--Boon and Bane for the manufacturer.

PubMed

Störmer, M; Radojska, S; Hos, N J; Gathof, B S

2015-04-01

In order to generate standardized conditions for the microbiological control of HPCs, the PEI recommended defined steps for validation that will lead to extensive validation as shown in this study, where a possible validation principle for the microbiological control of allogeneic SCPs is presented. Although it could be demonstrated that automated culture improves microbial safety of cellular products, the requirement for extensive validation studies needs to be considered. © 2014 International Society of Blood Transfusion.

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

Validation of the conceptual research utilization scale: an application of the standards for educational and psychological testing in healthcare.

PubMed

Squires, Janet E; Estabrooks, Carole A; Newburn-Cook, Christine V; Gierl, Mark

2011-05-19

There is a lack of acceptable, reliable, and valid survey instruments to measure conceptual research utilization (CRU). In this study, we investigated the psychometric properties of a newly developed scale (the CRU Scale). We used the Standards for Educational and Psychological Testing as a validation framework to assess four sources of validity evidence: content, response processes, internal structure, and relations to other variables. A panel of nine international research utilization experts performed a formal content validity assessment. To determine response process validity, we conducted a series of one-on-one scale administration sessions with 10 healthcare aides. Internal structure and relations to other variables validity was examined using CRU Scale response data from a sample of 707 healthcare aides working in 30 urban Canadian nursing homes. Principal components analysis and confirmatory factor analyses were conducted to determine internal structure. Relations to other variables were examined using: (1) bivariate correlations; (2) change in mean values of CRU with increasing levels of other kinds of research utilization; and (3) multivariate linear regression. Content validity index scores for the five items ranged from 0.55 to 1.00. The principal components analysis predicted a 5-item 1-factor model. This was inconsistent with the findings from the confirmatory factor analysis, which showed best fit for a 4-item 1-factor model. Bivariate associations between CRU and other kinds of research utilization were statistically significant (p < 0.01) for the latent CRU scale score and all five CRU items. The CRU scale score was also shown to be significant predictor of overall research utilization in multivariate linear regression. The CRU scale showed acceptable initial psychometric properties with respect to responses from healthcare aides in nursing homes. Based on our validity, reliability, and acceptability analyses, we recommend using a reduced (four-item) version of the CRU scale to yield sound assessments of CRU by healthcare aides. Refinement to the wording of one item is also needed. Planned future research will include: latent scale scoring, identification of variables that predict and are outcomes to conceptual research use, and longitudinal work to determine CRU Scale sensitivity to change.

DNA Commission of the International Society for Forensic Genetics: Recommendations on the validation of software programs performing biostatistical calculations for forensic genetics applications.

PubMed

Coble, M D; Buckleton, J; Butler, J M; Egeland, T; Fimmers, R; Gill, P; Gusmão, L; Guttman, B; Krawczak, M; Morling, N; Parson, W; Pinto, N; Schneider, P M; Sherry, S T; Willuweit, S; Prinz, M

2016-11-01

The use of biostatistical software programs to assist in data interpretation and calculate likelihood ratios is essential to forensic geneticists and part of the daily case work flow for both kinship and DNA identification laboratories. Previous recommendations issued by the DNA Commission of the International Society for Forensic Genetics (ISFG) covered the application of bio-statistical evaluations for STR typing results in identification and kinship cases, and this is now being expanded to provide best practices regarding validation and verification of the software required for these calculations. With larger multiplexes, more complex mixtures, and increasing requests for extended family testing, laboratories are relying more than ever on specific software solutions and sufficient validation, training and extensive documentation are of upmost importance. Here, we present recommendations for the minimum requirements to validate bio-statistical software to be used in forensic genetics. We distinguish between developmental validation and the responsibilities of the software developer or provider, and the internal validation studies to be performed by the end user. Recommendations for the software provider address, for example, the documentation of the underlying models used by the software, validation data expectations, version control, implementation and training support, as well as continuity and user notifications. For the internal validations the recommendations include: creating a validation plan, requirements for the range of samples to be tested, Standard Operating Procedure development, and internal laboratory training and education. To ensure that all laboratories have access to a wide range of samples for validation and training purposes the ISFG DNA commission encourages collaborative studies and public repositories of STR typing results. Published by Elsevier Ireland Ltd.

Validity Evidence for the Neuro-Endoscopic Ventriculostomy Assessment Tool (NEVAT).

PubMed

Breimer, Gerben E; Haji, Faizal A; Cinalli, Giuseppe; Hoving, Eelco W; Drake, James M

2017-02-01

Growing demand for transparent and standardized methods for evaluating surgical competence prompted the construction of the Neuro-Endoscopic Ventriculostomy Assessment Tool (NEVAT). To provide validity evidence of the NEVAT by reporting on the tool's internal structure and its relationship with surgical expertise during simulation-based training. The NEVAT was used to assess performance of trainees and faculty at an international neuroendoscopy workshop. All participants performed an endoscopic third ventriculostomy (ETV) on a synthetic simulator. Participants were simultaneously scored by 2 raters using the NEVAT procedural checklist and global rating scale (GRS). Evidence of internal structure was collected by calculating interrater reliability and internal consistency of raters' scores. Evidence of relationships with other variables was collected by comparing the ETV performance of experts, experienced trainees, and novices using Jonckheere's test (evidence of construct validity). Thirteen experts, 11 experienced trainees, and 10 novices participated. The interrater reliability by the intraclass correlation coefficient for the checklist and GRS was 0.82 and 0.94, respectively. Internal consistency (Cronbach's α) for the checklist and the GRS was 0.74 and 0.97, respectively. Median scores with interquartile range on the checklist and GRS for novices, experienced trainees, and experts were 0.69 (0.58-0.86), 0.85 (0.63-0.89), and 0.85 (0.81-0.91) and 3.1 (2.5-3.8), 3.7 (2.2-4.3) and 4.6 (4.4-4.9), respectively. Jonckheere's test showed that the median checklist and GRS score increased with performer expertise ( P = .04 and .002, respectively). This study provides validity evidence for the NEVAT to support its use as a standardized method of evaluating neuroendoscopic competence during simulation-based training. Copyright © 2016 by the Congress of Neurological Surgeons

Confirmatory Factor Analysis of the TerraNova Comprehensive Tests of Basic Skills/5

ERIC Educational Resources Information Center

Stevens, Joseph J.; Zvoch, Keith

2007-01-01

Confirmatory factor analysis was used to explore the internal validity of scores on the TerraNova Comprehensive Tests of Basic Skills/5 using samples from a southwestern school district and standardization samples reported by the publisher. One of the strengths claimed for battery-type achievement tests is provision of reliable and valid samples…

Construction and validation of a Tamil logMAR chart.

PubMed

Varadharajan, Srinivasa; Srinivasan, Krithica; Kumaresan, Brindha

2009-09-01

To design, construct and validate a new Tamil logMAR visual acuity chart based on current recommendations. Ten Tamil letters of equal legibility were identified experimentally and were used in the chart. Two charts, one internally illuminated and one externally illuminated, were constructed for testing at 4 m distance. The repeatability of the two charts was tested. For validation, the two charts were compared with a standard English logMAR chart (ETDRS). When compared to the ETDRS chart, a difference of 0.06 +/- 0.07 and 0.07 +/- 0.07 logMAR was found for the internally and externally illuminated charts respectively. Limits of agreement between the internally illuminated Tamil logMAR chart and ETDRS chart were found to be (-0.08, 0.19), and (-0.07, 0.20) for the externally illuminated chart. The test - retest results showed a difference of 0.02 +/- 0.04 and 0.02 +/- 0.06 logMAR for the internally and externally illuminated charts respectively. Limits of agreement for repeated measurements for the internally illuminated Tamil logMAR chart were found to be (-0.06, 0.10), and (-0.10, 0.14) for the externally illuminated chart. The newly constructed Tamil logMAR charts have good repeatability. The difference in visual acuity scores between the newly constructed Tamil logMAR chart and the standard English logMAR chart was within acceptable limits. This new chart can be used for measuring visual acuity in the literate Tamil population.

Global Land Product Validation Protocols: An Initiative of the CEOS Working Group on Calibration and Validation to Evaluate Satellite-derived Essential Climate Variables

NASA Astrophysics Data System (ADS)

Guillevic, P. C.; Nickeson, J. E.; Roman, M. O.; camacho De Coca, F.; Wang, Z.; Schaepman-Strub, G.

2016-12-01

The Global Climate Observing System (GCOS) has specified the need to systematically produce and validate Essential Climate Variables (ECVs). The Committee on Earth Observation Satellites (CEOS) Working Group on Calibration and Validation (WGCV) and in particular its subgroup on Land Product Validation (LPV) is playing a key coordination role leveraging the international expertise required to address actions related to the validation of global land ECVs. The primary objective of the LPV subgroup is to set standards for validation methods and reporting in order to provide traceable and reliable uncertainty estimates for scientists and stakeholders. The Subgroup is comprised of 9 focus areas that encompass 10 land surface variables. The activities of each focus area are coordinated by two international co-leads and currently include leaf area index (LAI) and fraction of absorbed photosynthetically active radiation (FAPAR), vegetation phenology, surface albedo, fire disturbance, snow cover, land cover and land use change, soil moisture, land surface temperature (LST) and emissivity. Recent additions to the focus areas include vegetation indices and biomass. The development of best practice validation protocols is a core activity of CEOS LPV with the objective to standardize the evaluation of land surface products. LPV has identified four validation levels corresponding to increasing spatial and temporal representativeness of reference samples used to perform validation. Best practice validation protocols (1) provide the definition of variables, ancillary information and uncertainty metrics, (2) describe available data sources and methods to establish reference validation datasets with SI traceability, and (3) describe evaluation methods and reporting. An overview on validation best practice components will be presented based on the LAI and LST protocol efforts to date.

A validated high-performance liquid chromatographic method for the determination of glibenclamide in human plasma and its application to pharmacokinetic studies.

PubMed

Niopas, Ioannis; Daftsios, Athanasios C

2002-05-15

Glibenclamide is a potent second generation oral sulfonylurea antidiabetic agent widely used for the treatment of type II diabetes melitus. A rapid, sensitive, precise, accurate and specific HPLC assay for the determination of glibenclamide in human plasma was developed and validated. After addition of flufenamic acid as internal standard, the analytes were isolated from human plasma by liquid-liquid extraction. The method was linear in the 10-400 ng/ml concentration range (r > 0.999). Recovery for glibenclamide was greater than 91.5% and for internal standard was 93.5%. Within-day and between-day precision, expressed as the relative standard deviation (RSD%), ranged from 1.4 to 5.9% and 5.8 to 6.6%, respectively. Assay accuracy was better than 93.4%. The assay was used to estimate the pharmacokinetics of glibenclamide after oral administration of a 5 mg tablet of glibenclamide to 18 healthy volunteers.

Living with chronic illness scale: international validation of a new self-report measure in Parkinson’s disease

PubMed Central

Ambrosio, Leire; Portillo, Mari Carmen; Rodríguez-Blázquez, Carmen; Rodriguez-Violante, Mayela; Castrillo, Juan Carlos Martínez; Arillo, Víctor Campos; Garretto, Nélida Susana; Arakaki, Tomoko; Dueñas, Marcos Serrano; Álvarez, Mario; Ibáñez, Ivonne Pedroso; Carvajal, Ana; Martínez-Martín, Pablo

2016-01-01

Understanding how a person lives with a chronic illness, such as Parkinson’s disease (PD), is necessary to provide individualized care and professionals role in person-centered care at clinical and community levels is paramount. The present study was aimed to analyze the psychometric properties of the Living with Chronic Illness-PD Scale (EC-PC) in a wide Spanish-speaking population with PD. International cross-sectional study with retest was carried out with 324 patients from four Latin American countries and Spain. Feasibility, acceptability, scaling assumptions, reliability, precision, and construct validity were tested. The study included 324 patients, with age (mean±s.d.) 66.67±10.68 years. None of the EC-PC items had missing values and all acceptability parameters fulfilled the standard criteria. Around two-third of the items (61.54%) met scaling assumptions standards. Concerning internal consistency, Cronbach’s alpha values were 0.68–0.88; item-total correlation was >0.30, except for two items; item homogeneity index was >0.30, and inter-item correlation values 0.14–0.76. Intraclass correlation coefficient for EC-PC stability was 0.76 and standard error of measurement (s.e.m.) for precision was 8.60 (for a EC-PC s.d.=18.57). EC-PC presented strong correlation with social support (rS=0.61) and moderate correlation with life satisfaction (rS=0.46). Weak and negligible correlations were found with the other scales. Internal validity correlations ranged from 0.46 to 0.78. EC-PC total scores were significantly different for each severity level based on Hoehn and Yahr and Clinical Impression of Severity Index, but not for Patient Global Impression of Severity. The EC-PC has satisfactory acceptability, reliability, precision, and validity to evaluate living with PD. PMID:28725703

Translation of the Neck Disability Index and validation of the Greek version in a sample of neck pain patients.

PubMed

Trouli, Marianna N; Vernon, Howard T; Kakavelakis, Kyriakos N; Antonopoulou, Maria D; Paganas, Aristofanis N; Lionis, Christos D

2008-07-22

Neck pain is a highly prevalent condition resulting in major disability. Standard scales for measuring disability in patients with neck pain have a pivotal role in research and clinical settings. The Neck Disability Index (NDI) is a valid and reliable tool, designed to measure disability in activities of daily living due to neck pain. The purpose of our study was the translation and validation of the NDI in a Greek primary care population with neck complaints. The original version of the questionnaire was used. Based on international standards, the translation strategy comprised forward translations, reconciliation, backward translation and pre-testing steps. The validation procedure concerned the exploration of internal consistency (Cronbach alpha), test-retest reliability (Intraclass Correlation Coefficient, Bland and Altman method), construct validity (exploratory factor analysis) and responsiveness (Spearman correlation coefficient, Standard Error of Measurement and Minimal Detectable Change) of the questionnaire. Data quality was also assessed through completeness of data and floor/ceiling effects. The translation procedure resulted in the Greek modified version of the NDI. The latter was culturally adapted through the pre-testing phase. The validation procedure raised a large amount of missing data due to low applicability, which were assessed with two methods. Floor or ceiling effects were not observed. Cronbach alpha was calculated as 0.85, which was interpreted as good internal consistency. Intraclass correlation coefficient was found to be 0.93 (95% CI 0.84-0.97), which was considered as very good test-retest reliability. Factor analysis yielded one factor with Eigenvalue 4.48 explaining 44.77% of variance. The Spearman correlation coefficient (0.3; P = 0.02) revealed some relation between the change score in the NDI and Global Rating of Change (GROC). The SEM and MDC were calculated as 0.64 and 1.78 respectively. The Greek version of the NDI measures disability in patients with neck pain in a reliable, valid and responsive manner. It is considered a useful tool for research and clinical settings in Greek Primary Health Care.

Translation of the Neck Disability Index and validation of the Greek version in a sample of neck pain patients

PubMed Central

Trouli, Marianna N; Vernon, Howard T; Kakavelakis, Kyriakos N; Antonopoulou, Maria D; Paganas, Aristofanis N; Lionis, Christos D

2008-01-01

Background Neck pain is a highly prevalent condition resulting in major disability. Standard scales for measuring disability in patients with neck pain have a pivotal role in research and clinical settings. The Neck Disability Index (NDI) is a valid and reliable tool, designed to measure disability in activities of daily living due to neck pain. The purpose of our study was the translation and validation of the NDI in a Greek primary care population with neck complaints. Methods The original version of the questionnaire was used. Based on international standards, the translation strategy comprised forward translations, reconciliation, backward translation and pre-testing steps. The validation procedure concerned the exploration of internal consistency (Cronbach alpha), test-retest reliability (Intraclass Correlation Coefficient, Bland and Altman method), construct validity (exploratory factor analysis) and responsiveness (Spearman correlation coefficient, Standard Error of Measurement and Minimal Detectable Change) of the questionnaire. Data quality was also assessed through completeness of data and floor/ceiling effects. Results The translation procedure resulted in the Greek modified version of the NDI. The latter was culturally adapted through the pre-testing phase. The validation procedure raised a large amount of missing data due to low applicability, which were assessed with two methods. Floor or ceiling effects were not observed. Cronbach alpha was calculated as 0.85, which was interpreted as good internal consistency. Intraclass correlation coefficient was found to be 0.93 (95% CI 0.84–0.97), which was considered as very good test-retest reliability. Factor analysis yielded one factor with Eigenvalue 4.48 explaining 44.77% of variance. The Spearman correlation coefficient (0.3; P = 0.02) revealed some relation between the change score in the NDI and Global Rating of Change (GROC). The SEM and MDC were calculated as 0.64 and 1.78 respectively. Conclusion The Greek version of the NDI measures disability in patients with neck pain in a reliable, valid and responsive manner. It is considered a useful tool for research and clinical settings in Greek Primary Health Care. PMID:18647393

Validity evidence for procedural competency in virtual reality robotic simulation, establishing a credible pass/fail standard for the vaginal cuff closure procedure.

PubMed

Hovgaard, Lisette Hvid; Andersen, Steven Arild Wuyts; Konge, Lars; Dalsgaard, Torur; Larsen, Christian Rifbjerg

2018-03-30

The use of robotic surgery for minimally invasive procedures has increased considerably over the last decade. Robotic surgery has potential advantages compared to laparoscopic surgery but also requires new skills. Using virtual reality (VR) simulation to facilitate the acquisition of these new skills could potentially benefit training of robotic surgical skills and also be a crucial step in developing a robotic surgical training curriculum. The study's objective was to establish validity evidence for a simulation-based test for procedural competency for the vaginal cuff closure procedure that can be used in a future simulation-based, mastery learning training curriculum. Eleven novice gynaecological surgeons without prior robotic experience and 11 experienced gynaecological robotic surgeons (> 30 robotic procedures) were recruited. After familiarization with the VR simulator, participants completed the module 'Guided Vaginal Cuff Closure' six times. Validity evidence was investigated for 18 preselected simulator metrics. The internal consistency was assessed using Cronbach's alpha and a composite score was calculated based on metrics with significant discriminative ability between the two groups. Finally, a pass/fail standard was established using the contrasting groups' method. The experienced surgeons significantly outperformed the novice surgeons on 6 of the 18 metrics. The internal consistency was 0.58 (Cronbach's alpha). The experienced surgeons' mean composite score for all six repetitions were significantly better than the novice surgeons' (76.1 vs. 63.0, respectively, p < 0.001). A pass/fail standard of 75/100 was established. Four novice surgeons passed this standard (false positives) and three experienced surgeons failed (false negatives). Our study has gathered validity evidence for a simulation-based test for procedural robotic surgical competency in the vaginal cuff closure procedure and established a credible pass/fail standard for future proficiency-based training.

Fibrinolysis standards: a review of the current status.

PubMed

Thelwell, C

2010-07-01

Biological standards are used to calibrate measurements of components of the fibrinolytic system, either for assigning potency values to therapeutic products, or to determine levels in human plasma as an indicator of thrombotic risk. Traditionally WHO International Standards are calibrated in International Units based on consensus values from collaborative studies. The International Unit is defined by the response activity of a given amount of the standard in a bioassay, independent of the method used. Assay validity is based on the assumption that both standard and test preparation contain the same analyte, and the response in an assay is a true function of this analyte. This principle is reflected in the diversity of source materials used to prepare fibrinolysis standards, which has depended on the contemporary preparations they were employed to measure. With advancing recombinant technology, and improved analytical techniques, a reference system based on reference materials and associated reference methods has been recommended for future fibrinolysis standards. Careful consideration and scientific judgement must however be applied when deciding on an approach to develop a new standard, with decisions based on the suitability of a standard to serve its purpose, and not just to satisfy a metrological ideal. 2010 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

Nucleic acid tests for the detection of alpha human papillomaviruses.

PubMed

Poljak, Mario; Cuzick, Jack; Kocjan, Boštjan J; Iftner, Thomas; Dillner, Joakim; Arbyn, Marc

2012-11-20

Testing for high-risk types of alpha human papillomaviruses (HPV) is an invaluable part of clinical guidelines for cervical carcinoma screening, management and treatment. In this comprehensive inventory of commercial tests for detection of alpha-HPV, we identified at least 125 distinct HPV tests and at least 84 variants of the original tests. However, only a small subset of HPV tests has documented clinical performance for any of the standard HPV testing indications. For more than 75% of HPV tests currently on the market, no single publication in peer-reviewed literature can be identified. HPV tests that have not been validated and lack proof of reliability, reproducibility and accuracy should not be used in clinical management. Once incorporated in the lab, it is essential that the whole procedure of HPV testing is subject to continuous and rigorous quality assurance to avoid sub-optimal, potentially harmful practices. Manufacturers of HPV tests are urged to put more effort into evaluating their current and future products analytically, using international standards, and for clinical applications, using clinically validated endpoints. To assist with analytical validation, the World Health Organization is developing international standards for HPV types other than HPV16 and HPV18 and is planning development of external quality control panels specifically designed to be used for performance evaluation of current and future HPV tests. There is a need for more competitively priced HPV tests, especially for resource-poor countries, and uniform test validation criteria based on international standards should enable issuing more competitive and fair tender notices for purchasing. Automation systems allowing large-scale testing, as well as further increases in clinical performance, are the main needs in the further improvement of HPV tests. This article forms part of a special supplement entitled "Comprehensive Control of HPV Infections and Related Diseases" Vaccine Volume 30, Supplement 5, 2012. Copyright © 2012 Elsevier Ltd. All rights reserved.

IPDA PDS4 Project: Towards an International Planetary Data Standard

NASA Astrophysics Data System (ADS)

Martinez, Santa; Roatsch, Thomas; Capria, Maria Teresa; Heather, David; Yamamoto, Yukio; Hughes, Steven; Stein, Thomas; Cecconi, Baptiste; Prashar, Ajay; Batanov, Oleg; Gopala Krishna, Barla

2016-07-01

The International Planetary Data Alliance (IPDA) is an international collaboration of space agencies with the main objective of facilitating discovery, access and use of planetary data managed across international boundaries. For this purpose, the IPDA has adopted the NASA's Planetary Data System (PDS) standard as the de-facto archiving standard, and is working towards the internationalisation of the new generation of the standards, called PDS4. PDS4 is the largest upgrade in the history of the PDS, and is a significant step towards an online, distributed, model-driven and service-oriented architecture international archive. Following the successful deployment of PDS4 to support NASA's LADEE and MAVEN missions, PDS4 was endorsed by IPDA in 2014. This has led to the adoption of PDS4 by a number of international space agencies (ESA, JAXA, ISRO and Roscosmos, among others) for their upcoming missions. In order to closely follow the development of the PDS4 standards and to coordinate the international contribution and participation in its evolution, a group of experts from each international agency is dedicated to review different aspects of the standards and to capture recommendations and requirements to ensure the international needs are met. The activities performed by this group cover the assessment and implementation of all aspects of PDS4, including its use, documentation, tools, validation strategies and information model. This contribution will present the activities carried out by this group and how this partnership between PDS and IPDA provides an excellent foundation towards an international platform for planetary science research.

Hydrogen Fuel Quality

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

Rockward, Tommy

2012-07-16

For the past 6 years, open discussions and/or meetings have been held and are still on-going with OEM, Hydrogen Suppliers, other test facilities from the North America Team and International collaborators regarding experimental results, fuel clean-up cost, modeling, and analytical techniques to help determine levels of constituents for the development of an international standard for hydrogen fuel quality (ISO TC197 WG-12). Significant progress has been made. The process for the fuel standard is entering final stages as a result of the technical accomplishments. The objectives are to: (1) Determine the allowable levels of hydrogen fuel contaminants in support of themore » development of science-based international standards for hydrogen fuel quality (ISO TC197 WG-12); and (2) Validate the ASTM test method for determining low levels of non-hydrogen constituents.« less

Serum apolipoprotein A-1 quantification by LC–MS with a SILAC internal standard reveals reduced levels in smokers

PubMed Central

Wang, Qingqing; Zhang, Suhong; Guo, Lili; Busch, Christine M; Jian, Wenying; Weng, Naidong; Snyder, Nathaniel W; Rangiah, Kannan; Mesaros, Clementina; Blair, Ian A

2015-01-01

Background: Absolute quantification of protein biomarkers such as serum apolipoprotein A1 by both immunoassays and LC–MS can provide misleading results. Results: Recombinant ApoA-1 internal standard was prepared using stable isotope labeling by amino acids in cell culture with [13C615N2]-lysine and [13C915N1]-tyrosine in human cells. A stable isotope dilution LC–MS method for serum ApoA-1 was validated and levels analyzed for 50 nonsmokers and 50 smokers. Conclusion: The concentration of ApoA-1 in nonsmokers was 169.4 mg/dl with an 18.4% reduction to 138.2 mg/dl in smokers. The validated assay will have clinical utility for assessing effects of smoking cessation and therapeutic or dietary interventions in high-risk populations. PMID:26394123

Validation of neural spike sorting algorithms without ground-truth information.

PubMed

Barnett, Alex H; Magland, Jeremy F; Greengard, Leslie F

2016-05-01

The throughput of electrophysiological recording is growing rapidly, allowing thousands of simultaneous channels, and there is a growing variety of spike sorting algorithms designed to extract neural firing events from such data. This creates an urgent need for standardized, automatic evaluation of the quality of neural units output by such algorithms. We introduce a suite of validation metrics that assess the credibility of a given automatic spike sorting algorithm applied to a given dataset. By rerunning the spike sorter two or more times, the metrics measure stability under various perturbations consistent with variations in the data itself, making no assumptions about the internal workings of the algorithm, and minimal assumptions about the noise. We illustrate the new metrics on standard sorting algorithms applied to both in vivo and ex vivo recordings, including a time series with overlapping spikes. We compare the metrics to existing quality measures, and to ground-truth accuracy in simulated time series. We provide a software implementation. Metrics have until now relied on ground-truth, simulated data, internal algorithm variables (e.g. cluster separation), or refractory violations. By contrast, by standardizing the interface, our metrics assess the reliability of any automatic algorithm without reference to internal variables (e.g. feature space) or physiological criteria. Stability is a prerequisite for reproducibility of results. Such metrics could reduce the significant human labor currently spent on validation, and should form an essential part of large-scale automated spike sorting and systematic benchmarking of algorithms. Copyright © 2016 Elsevier B.V. All rights reserved.

Validation of the RisingSun RS-651 Blood Pressure Monitor Based on Auscultation in Adults According to the ANSI/AAMI/ISO 81060-2:2013 Standard.

PubMed

She, Jin; Guan, Xizhou; Liu, Yanyong; Xiang, Haiyan

2016-12-01

This study validated the RisingSun RS-651 blood pressure (BP) monitor based on auscultation in adults according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 standard. The RS-651 device was evaluated in a study of 97 participants. The same arm simultaneous method, as defined in the ANSI/AAMI/ISO standard, was used. The mean differences±standard deviation for criterion 1 were 0.8±2.3 mm Hg for systolic BP (SBP) and -0.1±2.9 mm Hg for diastolic BP (DBP). Analysis for criterion 2 resulted in values of 0.8±1.5 mm Hg for SBP and -0.1±2.1 mm Hg for DBP. All of the data fulfilled the ANSI/AAMI/ISO 81060-2:2013 standard requirements to pass the validation. The RisingSun RS-651 device can be recommended for both clinical and self/home use in adults according to the ANSI/AAMI/ISO 81060-2:2013 standard. © 2016 The Authors. The Journal of Clinical Hypertension Published by Wiley Periodicals, Inc.

Cross-cultural adaptation and validation of the Protective Nursing Advocacy Scale for Brazilian nurses 1

PubMed Central

Tomaschewski-Barlem, Jamila Geri; Lunardi, Valéria Lerch; Barlem, Edison Luiz Devos; da Silveira, Rosemary Silva; Dalmolin, Graziele de Lima; Ramos, Aline Marcelino

2015-01-01

Abstract Objective: to adapt culturally and validate the Protective Nursing Advocacy Scale for Brazilian nurses. Method: methodological study carried out with 153 nurses from two hospitals in the South region of Brazil, one public and the other philanthropic. The cross-cultural adaptation of the Protective Nursing Advocacy Scale was performed according to international standards, and its validation was carried out for use in the Brazilian context, by means of factor analysis and Cronbach's alpha as measure of internal consistency. Results: by means of evaluation by a committee of experts and application of pre-test, face validity and content validity of the instrument were considered satisfactory. From the factor analysis, five constructs were identified: negative implications of the advocacy practice, advocacy actions, facilitators of the advocacy practice, perceptions that favor practice advocacy and barriers to advocacy practice. The instrument showed satisfactory internal consistency, with Cronbach's alpha values ranging from 0.70 to 0.87. Conclusion: it was concluded that the Protective Nursing Advocacy Scale - Brazilian version, is a valid and reliable instrument for use in the evaluation of beliefs and actions of health advocacy, performed by Brazilian nurses in their professional practice environment. PMID:26444169

Standardization of Brief Inventory of Social Support Exchange Network (BISSEN) in Japan.

PubMed

Aiba, Miyuki; Tachikawa, Hirokazu; Fukuoka, Yoshiharu; Lebowitz, Adam; Shiratori, Yuki; Doi, Nagafumi; Matsui, Yutaka

2017-07-01

This study describes the Brief Inventory of Social Support Exchange Network (BISSEN) as a standardized brief inventory measuring various aspects of social support. We confirmed the reliability and validity for function and direction of support and standardized the BISSEN. For Sample 1, a stratified random sampling method was used to select 5200 residents in Japan. We conducted mail surveys and responses were retrieved from 2274 participants (collection rate 43.7%). Participants completed a questionnaire packet that included BISSEN, suicidal ideation, depression, support seeking, and Multidimensional Scale of Perceived Social Support (MSPSS). Sample 2 surveys for test-retest reliability were conducted on 23 residents at approximately two-week intervals. Participants were asked about gender, age, and BISSEN. First, we assessed the internal consistency, test-retest reliability, construct, convergent, and concurrent validity. McDonald's omega (.73-.92) and test-retest correlations (.78-.85) demonstrated adequate internal consistency and test-retest reliability. Depression, support seeking, and MSPSS were significantly correlated with all scores of BISSEN. The non-suicidal ideation group had significantly more support compared to the suicidal ideation group. Therefore, function and direction of support in BISSEN had sufficient reliability and validity. Next, we standardized BISSEN using Z-scores and percentile rank with respect to each 12 norm groups by age and gender. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

[Spanish validation of the MacArthur Competence Assessment Tool for Treatment interview to assess patients competence to consent treatment].

PubMed

Alvarez Marrodán, Ignacio; Baón Pérez, Beatriz; Navío Acosta, Mercedes; López-Antón, Raul; Lobo Escolar, Elena; Ventura Faci, Tirso

2014-09-09

To validate the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) Spanish version, which assesses the mental capacity of patients to consent treatment, by examining 4 areas (Understanding, Appreciation, Reasoning and Expressing a choice). 160 subjects (80 Internal Medicine inpatients, 40 Psychiatric inpatients and 40 healthy controls). MacCAT-T, Mini-Mental Status Examination (MMSE). Feasibility study, reliability and validity calculations (against to gold standard of clinical expert). Mean duration of the MacCAT-T interview was 18min. Inter-rater reliability: Intraclass correlation coefficient for Understanding=0.98, Appreciation=0.97, Reasoning=0.98, Expressing a choice=0.91. Internal consistency (Cronbach's alpha): Understanding=0.87, for Appreciation=0.76, for Reasoning=0.86. Patients considered to be incapable (gold standard) scored lower in all the MacCAT-T areas. Poor performance on the MacCAT-T was related to cognitive impairment assessed by MMSE. Spanish version of the MacCAT-T is feasible, reliable, and valid for assessing the capacity of patients to consent treatment. Copyright © 2013 Elsevier España, S.L. All rights reserved.

Validation of the XDP-MDSP rating scale for the evaluation of patients with X-linked dystonia-parkinsonism.

PubMed

Pasco, Paul Matthew D; Jamora, Roland Dominic G; Rosales, Raymond L; Diesta, Cid Czarina E; Ng, Arlene R; Teleg, Rosalia A; Go, Criscely L; Lee, Lillian; Fernandez, Hubert H

2017-01-01

X-linked dystonia-parkinsonism(XDP) is a neurodegenerative disorder endemic to the Philippines. A rating scale was developed by the authors under the guidance of the Movement Disorder Society of the Philippines (MDSP) to assess XDP severity and progression, functional impact, and response to treatment in future clinical trials. Our main objective was to validate our new scale, the XDP-MDSP scale. The initial validation process included pragmatic testing to XDP patients followed by a modified Delphi procedure with an international advisory panel of dystonia, parkinsonism and scale development experts. Pearson correlation was used to assess construct validity of our new scale versus the assess construct validity of our new scale versus standard dystonia, parkinsonism, non-motor and functional scales; and also to assess divergent validity against behavioral and cognitive scales. The 37-item XDP-MDSP scale has five parts: I-dystonia, II-parkinsonism, III-non-motor features, IV-ADL, and V-global impression. After initial validation, the scale was administered to 204 XDP patients. Inter-domain correlation for the first four parts was acceptable. The correlation between these domains and the global rating was slightly lower. Correlations between Parts I, II, III, and IV versus standard dystonia, parkinsonism, non-motor and functional scales were acceptable with values ranging from 0.323 to 0.428. For divergent validity, a significant correlation was seen with behavioral scales. No significant correlation was noted with the cognitive scale. The proposed XDP-MDSP scale is internally valid but the global rating subscale may need to be modified or eliminated. While there is convergent validity, divergent validation was successful only on cognitive and not behavioral scales. The frequent co-occurrence of anxiety and depression, and its effect on the motor and functional state, may explain this finding.

Validity and reliability of Arabic MOS social support survey.

PubMed

Dafaalla, Mohamed; Farah, Abdulraheem; Bashir, Sheima; Khalil, Ammar; Abdulhamid, Rabab; Mokhtar, Mousab; Mahadi, Mohamed; Omer, Zulfa; Suliman, Asgad; Elkhalifa, Mohammed; Abdelgadir, Hanin; Kheir, Abdelmoneim E M; Abdalrahman, Ihab

2016-01-01

We aimed to generate a valid reliable Arabic version of MOS social support survey (MOS-SSS). We did a cross sectional study in medical students of Faculty of Medicine in Khartoum, Sudan. We did a clustered random sampling in 500 students of which 487 were suitable for analysis. We followed the standard translation process for translating the MOS-SSS. We accomplished factor analysis to assess construct validity, and generated item-scales correlations to evaluate the convergent and discriminant validity. We extracted the Cronbach's α and Spearman Brown coefficient of spit half method to determine internal consistency. We measured stability by correlation between the scores of the MOS survey taken at two different occasions with ten days apart in 252 participants. All items correlated highly (0.788 or greater) with their hypothesized scales. All items in subscales correlated higher by two standard errors with their own scale than with any other scale. Principle component analysis with varimax rotation was conducted on the 19 items and examination of scree plot graphically suggested 4 predominant factors that account for 72 % of variance. It showed high loadings, ranging from 0.720 to 0.84 for items of emotional support, 0.699-0.845 for tangible support, 0.518-0.823 for affectionate support, and 0.740-0.816 for positive social interaction. Cronbach's alpha for overall MOS scale and subscales indicated high internal consistency. The test-retest correlation showed weak correlation between the test and retest (ranges from 0.04 to 0.104). The Arabic MOS-SSS had high validity and internal consistency.

Validation of an isotope dilution, ICP-MS method based on internal mass bias correction for the determination of trace concentrations of Hg in sediment cores.

PubMed

Ciceri, E; Recchia, S; Dossi, C; Yang, L; Sturgeon, R E

2008-01-15

The development and validation of a method for the determination of mercury in sediments using a sector field inductively coupled plasma mass spectrometer (SF-ICP-MS) for detection is described. The utilization of isotope dilution (ID) calibration is shown to solve analytical problems related to matrix composition. Mass bias is corrected using an internal mass bias correction technique, validated against the traditional standard bracketing method. The overall analytical protocol is validated against NRCC PACS-2 marine sediment CRM. The estimated limit of detection is 12ng/g. The proposed procedure was applied to the analysis of a real sediment core sampled to a depth of 160m in Lake Como, where Hg concentrations ranged from 66 to 750ng/g.

Simple shoulder test and Oxford Shoulder Score: Persian translation and cross-cultural validation.

PubMed

Naghdi, Soofia; Nakhostin Ansari, Noureddin; Rustaie, Nilufar; Akbari, Mohammad; Ebadi, Safoora; Senobari, Maryam; Hasson, Scott

2015-12-01

To translate, culturally adapt, and validate the simple shoulder test (SST) and Oxford Shoulder Score (OSS) into Persian language using a cross-sectional and prospective cohort design. A standard forward and backward translation was followed to culturally adapt the SST and the OSS into Persian language. Psychometric properties of floor and ceiling effects, construct convergent validity, discriminant validity, internal consistency reliability, test-retest reliability, standard error of the measurement (SEM), smallest detectable change (SDC), and factor structure were determined. One hundred patients with shoulder disorders and 50 healthy subjects participated in the study. The PSST and the POSS showed no missing responses. No floor or ceiling effects were observed. Both the PSST and POSS detected differences between patients and healthy subjects supporting their discriminant validity. Construct convergent validity was confirmed by a very good correlation between the PSST and POSS (r = 0.68). There was high internal consistency for both the PSST (α = 0.73) and the POSS (α = 0.91 and 0.92). Test-retest reliability with 1-week interval was excellent (ICCagreement = 0.94 for PSST and 0.90 for POSS). Factor analyses demonstrated a three-factor solution for the PSST (49.7 % of variance) and a two-factor solution for the POSS (61.6 % of variance). The SEM/SDC was satisfactory for PSST (5.5/15.3) and POSS (6.8/18.8). The PSST and POSS are valid and reliable outcome measures for assessing functional limitations in Persian-speaking patients with shoulder disorders.

International collaborative study for the calibration of proposed International Standards for thromboplastin, rabbit, plain, and for thromboplastin, recombinant, human, plain.

PubMed

van den Besselaar, A M H P; Chantarangkul, V; Angeloni, F; Binder, N B; Byrne, M; Dauer, R; Gudmundsdottir, B R; Jespersen, J; Kitchen, S; Legnani, C; Lindahl, T L; Manning, R A; Martinuzzo, M; Panes, O; Pengo, V; Riddell, A; Subramanian, S; Szederjesi, A; Tantanate, C; Herbel, P; Tripodi, A

2018-01-01

Essentials Two candidate International Standards for thromboplastin (coded RBT/16 and rTF/16) are proposed. International Sensitivity Index (ISI) of proposed standards was assessed in a 20-centre study. The mean ISI for RBT/16 was 1.21 with a between-centre coefficient of variation of 4.6%. The mean ISI for rTF/16 was 1.11 with a between-centre coefficient of variation of 5.7%. Background The availability of International Standards for thromboplastin is essential for the calibration of routine reagents and hence the calculation of the International Normalized Ratio (INR). Stocks of the current Fourth International Standards are running low. Candidate replacement materials have been prepared. This article describes the calibration of the proposed Fifth International Standards for thromboplastin, rabbit, plain (coded RBT/16) and for thromboplastin, recombinant, human, plain (coded rTF/16). Methods An international collaborative study was carried out for the assignment of International Sensitivity Indexes (ISIs) to the candidate materials, according to the World Health Organization (WHO) guidelines for thromboplastins and plasma used to control oral anticoagulant therapy with vitamin K antagonists. Results Results were obtained from 20 laboratories. In several cases, deviations from the ISI calibration model were observed, but the average INR deviation attributabled to the model was not greater than 10%. Only valid ISI assessments were used to calculate the mean ISI for each candidate. The mean ISI for RBT/16 was 1.21 (between-laboratory coefficient of variation [CV]: 4.6%), and the mean ISI for rTF/16 was 1.11 (between-laboratory CV: 5.7%). Conclusions The between-laboratory variation of the ISI for candidate material RBT/16 was similar to that of the Fourth International Standard (RBT/05), and the between-laboratory variation of the ISI for candidate material rTF/16 was slightly higher than that of the Fourth International Standard (rTF/09). The candidate materials have been accepted by WHO as the Fifth International Standards for thromboplastin, rabbit plain, and thromboplastin, recombinant, human, plain. © 2017 International Society on Thrombosis and Haemostasis.

Reliability and construct validity of the Spanish version of the 6-item CTS symptoms scale for outcomes assessment in carpal tunnel syndrome.

PubMed

Rosales, Roberto S; Martin-Hidalgo, Yolanda; Reboso-Morales, Luis; Atroshi, Isam

2016-03-03

The purpose of this study was to assess the reliability and construct validity of the Spanish version of the 6-item carpal tunnel syndrome (CTS) symptoms scale (CTS-6). In this cross-sectional study 40 patients diagnosed with CTS based on clinical and neurophysiologic criteria, completed the standard Spanish versions of the CTS-6 and the disabilities of the arm, shoulder and hand (QuickDASH) scales on two occasions with a 1-week interval. Internal-consistency reliability was assessed with the Cronbach alpha coefficient and test-retest reliability with the intraclass correlation coefficient, two way random effect model and absolute agreement definition (ICC2,1). Cross-sectional precision was analyzed with the Standard Error of the Measurement (SEM). Longitudinal precision for test-retest reliability coefficient was assessed with the Standard Error of the Measurement difference (SEMdiff) and the Minimal Detectable Change at 95 % confidence level (MDC95). For assessing construct validity it was hypothesized that the CTS-6 would have a strong positive correlation with the QuickDASH, analyzed with the Pearson correlation coefficient (r). The standard Spanish version of the CTS-6 presented a Cronbach alpha of 0.81 with a SEM of 0.3. Test-retest reliability showed an ICC of 0.85 with a SRMdiff of 0.36 and a MDC95 of 0.7. The correlation between CTS-6 and the QuickDASH was concordant with the a priori formulated construct hypothesis (r 0.69) CONCLUSIONS: The standard Spanish version of the 6-item CTS symptoms scale showed good internal consistency, test-retest reliability and construct validity for outcomes assessment in CTS. The CTS-6 will be useful to clinicians and researchers in Spanish speaking parts of the world. The use of standardized outcome measures across countries also will facilitate comparison of research results in carpal tunnel syndrome.

Assay of free captopril in human plasma as monobromobimane derivative, using RPLC/(+)ESI/MS/MS: validation aspects and bioequivalence evaluation.

PubMed

Medvedovici, Andrei; Albu, Florin; Sora, Iuliana Daniela; Udrescu, Stefan; Galaon, Toma; David, Victor

2009-10-01

A sensitive method for determination of free captopril as monobromobimane derivative in plasma samples is discussed. The internal standard (IS) was 5-methoxy-1H-benzimidazole-2-thiol. Derivatization with monobromobimane immediately after blood collection and plasma preparation prevents oxidation of captopril to the corresponding disulfide compound and enhances the ionization yield. Consequently, derivatization enhances sample stability and detection sensitivity. Addition of the internal standard was made immediately after plasma preparation. The internal standard was also derivatized by monobromobimane, as it contains a thiol functional group. Preparation of plasma samples containing captopril and IS derivatives was based upon protein precipitation through addition of acetonitrile, in a volumetric ratio 1:2. The reversed-phase liquid chromatographic separation was achieved on a rapid resolution cartridge Zorbax SB-C(18), monitored through positive electrospray ionization and tandem MS detection using the multiple-reaction monitoring mode. Transitions were 408-362 amu for the captopril derivative and 371-260 amu for the internal standard derivative. The kinetics of captopril oxidation to the corresponding disulfide compound in plasma matrix was also studied using the proposed method. A linear log-log calibration was obtained over the concentration interval 2.5-750 ng/mL. A low limit of quantitation in the 2.5 ng/mL range was obtained. The analytical method was fully validated and successfully applied in a three-way, three-period, single-dose (50 mg), block-randomized bioequivalence study for two pharmaceutical formulations (captopril LPH 25 and 50 mg) against the comparator Capoten 50 mg. Copyright (c) 2009 John Wiley & Sons, Ltd.

Validation of an analytical method for nitrous oxide (N2O) laughing gas by headspace gas chromatography coupled to mass spectrometry (HS-GC-MS): forensic application to a lethal intoxication.

PubMed

Giuliani, N; Beyer, J; Augsburger, M; Varlet, V

2015-03-01

Drug abuse is a widespread problem affecting both teenagers and adults. Nitrous oxide is becoming increasingly popular as an inhalation drug, causing harmful neurological and hematological effects. Some gas chromatography-mass spectrometry (GC-MS) methods for nitrous oxide measurement have been previously described. The main drawbacks of these methods include a lack of sensitivity for forensic applications; including an inability to quantitatively determine the concentration of gas present. The following study provides a validated method using HS-GC-MS which incorporates hydrogen sulfide as a suitable internal standard allowing the quantification of nitrous oxide. Upon analysis, sample and internal standard have similar retention times and are eluted quickly from the molecular sieve 5Å PLOT capillary column and the Porabond Q column therefore providing rapid data collection whilst preserving well defined peaks. After validation, the method has been applied to a real case of N2O intoxication indicating concentrations in a mono-intoxication. Copyright © 2015 Elsevier B.V. All rights reserved.

Validation of the Intelligibility in Context Scale for school students in Fiji.

PubMed

Hopf, Suzanne C; McLeod, Sharynne; McDonagh, Sarah H

2017-01-01

Fiji is a multilingual nation with few assessment tools addressing children's communication. This article describes the validation of the Intelligibility in Context Scale for Fiji English, Standard Fijian, and Fiji Hindi. Informants were caregivers of 65 typically developing multilingual children (aged 5;3-10;5) attending a Fiji primary school. The students spoke an average of 2.9 languages (range = 1-5). Their main language was Standard Fijian (41.5%), Fiji Hindi (23.1%), Fiji English (20.0%), or Fijian dialect (15.4%). An ICS mean score of 4.6 was obtained for main language (ICS-ML) and 4.4 for Fiji English (ICS-FE) indicating that students were usually to always intelligible. There were no significant differences between main language, number of languages spoken, gender, age, or socio-economic status. Both scales had good internal consistency, but were not correlated with speech accuracy measures possibly due to ceiling effects. Further validation with younger children is recommended. The ICS may be a useful tool for Fiji with comparative results to other international studies.

Validation of the conceptual research utilization scale: an application of the standards for educational and psychological testing in healthcare

PubMed Central

2011-01-01

Background There is a lack of acceptable, reliable, and valid survey instruments to measure conceptual research utilization (CRU). In this study, we investigated the psychometric properties of a newly developed scale (the CRU Scale). Methods We used the Standards for Educational and Psychological Testing as a validation framework to assess four sources of validity evidence: content, response processes, internal structure, and relations to other variables. A panel of nine international research utilization experts performed a formal content validity assessment. To determine response process validity, we conducted a series of one-on-one scale administration sessions with 10 healthcare aides. Internal structure and relations to other variables validity was examined using CRU Scale response data from a sample of 707 healthcare aides working in 30 urban Canadian nursing homes. Principal components analysis and confirmatory factor analyses were conducted to determine internal structure. Relations to other variables were examined using: (1) bivariate correlations; (2) change in mean values of CRU with increasing levels of other kinds of research utilization; and (3) multivariate linear regression. Results Content validity index scores for the five items ranged from 0.55 to 1.00. The principal components analysis predicted a 5-item 1-factor model. This was inconsistent with the findings from the confirmatory factor analysis, which showed best fit for a 4-item 1-factor model. Bivariate associations between CRU and other kinds of research utilization were statistically significant (p < 0.01) for the latent CRU scale score and all five CRU items. The CRU scale score was also shown to be significant predictor of overall research utilization in multivariate linear regression. Conclusions The CRU scale showed acceptable initial psychometric properties with respect to responses from healthcare aides in nursing homes. Based on our validity, reliability, and acceptability analyses, we recommend using a reduced (four-item) version of the CRU scale to yield sound assessments of CRU by healthcare aides. Refinement to the wording of one item is also needed. Planned future research will include: latent scale scoring, identification of variables that predict and are outcomes to conceptual research use, and longitudinal work to determine CRU Scale sensitivity to change. PMID:21595888

WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-ninth report.

PubMed

2015-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use. Revised procedure for the development of monographs and other texts for The International Pharmacopoeia; Revised updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia; Revision of the supplementary guidelines on good manufacturing practices: validation, Appendix 7: non-sterile process validation; General guidance for inspectors on hold-time studies; 16 technical supplements to Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products; Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients; Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability: revision; Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products: revision; and Good review practices: guidelines for national and regional regulatory authorities.

Standard methods for sampling freshwater fishes: Opportunities for international collaboration

USGS Publications Warehouse

Bonar, Scott A.; Mercado-Silva, Norman; Hubert, Wayne A.; Beard, Douglas; Dave, Göran; Kubečka, Jan; Graeb, Brian D. S.; Lester, Nigel P.; Porath, Mark T.; Winfield, Ian J.

2017-01-01

With publication of Standard Methods for Sampling North American Freshwater Fishes in 2009, the American Fisheries Society (AFS) recommended standard procedures for North America. To explore interest in standardizing at intercontinental scales, a symposium attended by international specialists in freshwater fish sampling was convened at the 145th Annual AFS Meeting in Portland, Oregon, in August 2015. Participants represented all continents except Australia and Antarctica and were employed by state and federal agencies, universities, nongovernmental organizations, and consulting businesses. Currently, standardization is practiced mostly in North America and Europe. Participants described how standardization has been important for management of long-term data sets, promoting fundamental scientific understanding, and assessing efficacy of large spatial scale management strategies. Academics indicated that standardization has been useful in fisheries education because time previously used to teach how sampling methods are developed is now more devoted to diagnosis and treatment of problem fish communities. Researchers reported that standardization allowed increased sample size for method validation and calibration. Group consensus was to retain continental standards where they currently exist but to further explore international and intercontinental standardization, specifically identifying where synergies and bridges exist, and identify means to collaborate with scientists where standardization is limited but interest and need occur.

Potential reliability and validity of a modified version of the Unified Parkinson’s Disease Rating Scale that could be administered remotely

PubMed Central

Abdolahi, Amir; Scoglio, Nicholas; Killoran, Annie; Dorsey, Ray; Biglan, Kevin M.

2013-01-01

Background By permitting remote assessments of patients and research participants, telemedicine has the potential to reshape clinical care and clinical trials for Parkinson disease. While the majority of the motor Unified Parkinson’s Disease Rating Scale (UPDRS) items can be conducted visually, rigidity and retropulsion pull testing require hands-on assessment by the rater and are less feasible to perform remotely in patients' homes. Methods In a secondary data analysis of the Comparison of the Agonist pramipexole vs. Levodopa on Motor complications in Parkinson’s Disease (CALM-PD) study, a randomized clinical trial, we assessed the cross-sectional (baseline and 2 years) and longitudinal (change from baseline to 2 years) reliability of a modified motor UPDRS (removing rigidity and retropulsion items) compared to the standard motor UPDRS (all items) using intraclass correlation coefficients (ICC), stratified by treatment group. Internal consistency of the modified UPDRS (mUPDRS) was measured using Cronbach’s alpha, and concurrent validity was assessed using Pearson’s correlation coefficient (r) between the standard motor UPDRS and mUPDRS. Results The mUPDRS versus standard motor UPDRS is cross-sectionally (ICC ≥ 0.92) and longitudinally (ICC ≥ 0.92) reliable for both treatment groups. High internal consistencies were also observed (α ≥ 0.96). The mUPDRS had high concurrent validity with the standard UPDRS at both time points and longitudinally (r ≥ 0.93, p < 0.0001). Conclusions A modified version of the motor UPDRS without rigidity and retropulsion pull testing is reliable and valid and may lay the foundation for its use in remote assessments of patients and research participants. PMID:23102808

Potential reliability and validity of a modified version of the Unified Parkinson's Disease Rating Scale that could be administered remotely.

PubMed

Abdolahi, Amir; Scoglio, Nicholas; Killoran, Annie; Dorsey, E Ray; Biglan, Kevin M

2013-02-01

By permitting remote assessments of patients and research participants, telemedicine has the potential to reshape clinical care and clinical trials for Parkinson disease. While the majority of the motor Unified Parkinson's Disease Rating Scale (UPDRS) items can be conducted visually, rigidity and retropulsion pull testing require hands-on assessment by the rater and are less feasible to perform remotely in patients' homes. In a secondary data analysis of the Comparison of the Agonist pramipexole vs. Levodopa on Motor complications in Parkinson's Disease (CALM-PD) study, a randomized clinical trial, we assessed the cross-sectional (baseline and 2 years) and longitudinal (change from baseline to 2 years) reliability of a modified motor UPDRS (removing rigidity and retropulsion items) compared to the standard motor UPDRS (all items) using intraclass correlation coefficients (ICC), stratified by treatment group. Internal consistency of the modified UPDRS (mUPDRS) was measured using Cronbach's alpha, and concurrent validity was assessed using Pearson's correlation coefficient (r) between the standard motor UPDRS and mUPDRS. The mUPDRS versus standard motor UPDRS is cross-sectionally (ICC ≥ 0.92) and longitudinally (ICC ≥ 0.92) reliable for both treatment groups. High internal consistencies were also observed (α ≥ 0.96). The mUPDRS had high concurrent validity with the standard UPDRS at both time points and longitudinally (r ≥ 0.93, p < 0.0001). A modified version of the motor UPDRS without rigidity and retropulsion pull testing is reliable and valid and may lay the foundation for its use in remote assessments of patients and research participants. Copyright © 2012 Elsevier Ltd. All rights reserved.

Use of the kalamazoo essential elements communication checklist (adapted) in an institutional interpersonal and communication skills curriculum.

PubMed

Joyce, Barbara L; Steenbergh, Timothy; Scher, Eric

2010-06-01

This study examined the psychometric properties of the Kalamazoo Essential Elements Communication Checklist (Adapted) (KEECC-A), which addresses 7 key elements of physician communication identified in the Kalamazoo Consensus Statement, in a sample of 135 residents in multiple specialties at a large urban medical center in 2008-2009. The KEECC-A was used by residents, standardized patients, and faculty as the assessment tool in a broader institutional curriculum initiative. Three separate KEECC-A scores (self-ratings, faculty ratings, and standardized patient ratings) were calculated for each resident to assess the internal consistency and factor structure of the checklist. In addition, we analyzed KEECC-A ratings by gender and US versus international medical graduates, and collected American Board of Internal Medicine Patient Satisfaction Questionnaire (PSQ) scores for a subsample of internal medicine residents (n  =  28) to examine the relationship between this measure and the KEECC-A ratings to provide evidence of convergent validity. The KEECC-A ratings generated by faculty, standardized patients, and the residents themselves demonstrated a high degree of internal consistency. Factor analyses of the 3 different sets of KEECC-A ratings produced a consistent single-factor structure. We could not examine the relationship between KEECC-A and the PSQ because of substantial range restriction in PSQ scores. No differences were seen in the communication scores of men versus women. Faculty rated US graduates significantly higher than international medical graduates. Our study provides evidence for the reliability and validity of the KEECC-A as a measure of physician communication skills. The KEECC-A appears to be a psychometrically sound, user-friendly communication tool, linked to an expert consensus statement, that can be quickly and accurately completed by multiple raters across diverse specialties.

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.

Cross-cultural adaptation and validation of Persian Achilles tendon Total Rupture Score.

PubMed

Ansari, Noureddin Nakhostin; Naghdi, Soofia; Hasanvand, Sahar; Fakhari, Zahra; Kordi, Ramin; Nilsson-Helander, Katarina

2016-04-01

To cross-culturally adapt the Achilles tendon Total Rupture Score (ATRS) to Persian language and to preliminary evaluate the reliability and validity of a Persian ATRS. A cross-sectional and prospective cohort study was conducted to translate and cross-culturally adapt the ATRS to Persian language (ATRS-Persian) following steps described in guidelines. Thirty patients with total Achilles tendon rupture and 30 healthy subjects participated in this study. Psychometric properties of floor/ceiling effects (responsiveness), internal consistency reliability, test-retest reliability, standard error of measurement (SEM), smallest detectable change (SDC), construct validity, and discriminant validity were tested. Factor analysis was performed to determine the ATRS-Persian structure. There were no floor or ceiling effects that indicate the content and responsiveness of ATRS-Persian. Internal consistency was high (Cronbach's α 0.95). Item-total correlations exceeded acceptable standard of 0.3 for the all items (0.58-0.95). The test-retest reliability was excellent [(ICC)agreement 0.98]. SEM and SDC were 3.57 and 9.9, respectively. Construct validity was supported by a significant correlation between the ATRS-Persian total score and the Persian Foot and Ankle Outcome Score (PFAOS) total score and PFAOS subscales (r = 0.55-0.83). The ATRS-Persian significantly discriminated between patients and healthy subjects. Explanatory factor analysis revealed 1 component. The ATRS was cross-culturally adapted to Persian and demonstrated to be a reliable and valid instrument to measure functional outcomes in Persian patients with Achilles tendon rupture. II.

Meta-audit of laboratory ISO accreditation inspections: measuring the old emperor's clothes.

PubMed

Wilson, Ian G; Smye, Michael; Wallace, Ian J C

2016-02-01

Accreditation to ISO/IEC 17025 is required for EC official food control and veterinary laboratories by Regulation (EC) No. 882/2004. Measurements in hospital laboratories and clinics are increasingly accredited to ISO/IEC 15189. Both of these management standards arose from command and control military standards for factory inspection during World War II. They rely on auditing of compliance and have not been validated internally as assessment bodies require of those they accredit. Neither have they been validated to criteria outside their own ideology such as the Cochrane principles of evidence-based medicine which might establish whether any benefit exceeds their cost. We undertook a retrospective meta-audit over 14 years of internal and external laboratory audits that checked compliance with ISO 17025 in a public health laboratory. Most noncompliances arose solely from clauses in the standard and would not affect users. No effect was likely from 91% of these. Fewer than 1% of noncompliances were likely to have consequences for the validity of results or quality of service. The ISO system of compliance auditing has the performance characteristics of a poor screening test. It adds substantially to costs and generates more noise (false positives) than informative signal. Ethical use of resources indicates that management standards should not be used unless proven to deliver the efficacy, effectiveness, and value required of modern healthcare interventions. © 2015 The Authors. MicrobiologyOpen published by John Wiley & Sons Ltd.

The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study.

PubMed

Mokkink, Lidwine B; Terwee, Caroline B; Patrick, Donald L; Alonso, Jordi; Stratford, Paul W; Knol, Dirk L; Bouter, Lex M; de Vet, Henrica C W

2010-05-01

Aim of the COSMIN study (COnsensus-based Standards for the selection of health status Measurement INstruments) was to develop a consensus-based checklist to evaluate the methodological quality of studies on measurement properties. We present the COSMIN checklist and the agreement of the panel on the items of the checklist. A four-round Delphi study was performed with international experts (psychologists, epidemiologists, statisticians and clinicians). Of the 91 invited experts, 57 agreed to participate (63%). Panel members were asked to rate their (dis)agreement with each proposal on a five-point scale. Consensus was considered to be reached when at least 67% of the panel members indicated 'agree' or 'strongly agree'. Consensus was reached on the inclusion of the following measurement properties: internal consistency, reliability, measurement error, content validity (including face validity), construct validity (including structural validity, hypotheses testing and cross-cultural validity), criterion validity, responsiveness, and interpretability. The latter was not considered a measurement property. The panel also reached consensus on how these properties should be assessed. The resulting COSMIN checklist could be useful when selecting a measurement instrument, peer-reviewing a manuscript, designing or reporting a study on measurement properties, or for educational purposes.

The Determination of Sugars in Dairy Products: Development of a New Standard Method for the International Dairy Federation and the Internal Organization for Standardization.

PubMed

Sanders, Peter; Ernste-Nota, Veronica; Visser, Klaas; van Soest, Jeroen; Brunt, Kommer

2017-09-01

A method using high-performance anion-exchange chromatography (HPAEC) with a pulsed amperometric detector (PAD) for the determination of mono- and disaccharides is described. The method was accepted by the International Dairy Federation and the Internal Organization for Standardization as a new work item for the determination of sugars in dairy matrixes, and the Milk and Milk Products technical committee of ISO/TC 34/SC 5 accepted the topic "Milk and milk products - Determination of the sugar contents - High-performance anion-exchange chromatographic method (HPAEC-PAD)" as a new work item. The proposed method consists of an aqueous ethanol extraction of the sugars in the dairy sample, followed by clarification with Carrez I and II reagents. The clarified filtrate is diluted and then directly introduced in the HPAEC-PAD system for quantification of the sugars. A single-laboratory validation of the proposed method has been scheduled for spring 2017.

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

PubMed

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

2014-03-01

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

Educational Testing and Validity of Conclusions in the Scholarship of Teaching and Learning

PubMed Central

Beltyukova, Svetlana A.; Martin, Beth A.

2013-01-01

Validity and its integral evidence of reliability are fundamentals for educational and psychological measurement, and standards of educational testing. Herein, we describe these standards of educational testing, along with their subtypes including internal consistency, inter-rater reliability, and inter-rater agreement. Next, related issues of measurement error and effect size are discussed. This article concludes with a call for future authors to improve reporting of psychometrics and practical significance with educational testing in the pharmacy education literature. By increasing the scientific rigor of educational research and reporting, the overall quality and meaningfulness of SoTL will be improved. PMID:24249848

Proposed Reference Spectral Irradiance Standards to Improve Photovoltaic Concentrating System Design and Performance Evaluation: Preprint

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

Myers, D. R.; Emery, K. E.; Gueymard, C.

2002-05-01

This conference paper describes the American Society for Testing and Materials (ASTM), the International Electrotechnical Commission (IEC), and the International Standards Organization (ISO) standard solar terrestrial spectra (ASTM G-159, IEC-904-3, ISO 9845-1) provide standard spectra for photovoltaic performance applications. Modern terrestrial spectral radiation models and knowledge of atmospheric physics are applied to develop suggested revisions to update the reference spectra. We use a moderately complex radiative transfer model (SMARTS2) to produce the revised spectra. SMARTS2 has been validated against the complex MODTRAN radiative transfer code and spectral measurements. The model is proposed as an adjunct standard to reproduce the referencemore » spectra. The proposed spectra represent typical clear sky spectral conditions associated with sites representing reasonable photovoltaic energy production and weathering and durability climates. The proposed spectra are under consideration by ASTM.« less

Bioanalytical method development and validation for the determination of glycine in human cerebrospinal fluid by ion-pair reversed-phase liquid chromatography-tandem mass spectrometry.

PubMed

Jiang, Jian; James, Christopher A; Wong, Philip

2016-09-05

A LC-MS/MS method has been developed and validated for the determination of glycine in human cerebrospinal fluid (CSF). The validated method used artificial cerebrospinal fluid as a surrogate matrix for calibration standards. The calibration curve range for the assay was 100-10,000ng/mL and (13)C2, (15)N-glycine was used as an internal standard (IS). Pre-validation experiments were performed to demonstrate parallelism with surrogate matrix and standard addition methods. The mean endogenous glycine concentration in a pooled human CSF determined on three days by using artificial CSF as a surrogate matrix and the method of standard addition was found to be 748±30.6 and 768±18.1ng/mL, respectively. A percentage difference of -2.6% indicated that artificial CSF could be used as a surrogate calibration matrix for the determination of glycine in human CSF. Quality control (QC) samples, except the lower limit of quantitation (LLOQ) QC and low QC samples, were prepared by spiking glycine into aliquots of pooled human CSF sample. The low QC sample was prepared from a separate pooled human CSF sample containing low endogenous glycine concentrations, while the LLOQ QC sample was prepared in artificial CSF. Standard addition was used extensively to evaluate matrix effects during validation. The validated method was used to determine the endogenous glycine concentrations in human CSF samples. Incurred sample reanalysis demonstrated reproducibility of the method. Copyright © 2016 Elsevier B.V. All rights reserved.

Validation of lipolysis product extraction from aqueous/biological samples, separation and quantification by thin-layer chromatography with flame ionization detection analysis using O-cholesteryl ethylene glycol as a new internal standard.

PubMed

Cavalier, Jean-François; Lafont, Dominique; Boullanger, Paul; Houisse, David; Giallo, Jacqueline; Ballester, Jean-Michel; Carrière, Frédéric

2009-09-11

A general and easily accessible method for the extraction followed by the simultaneous separation and quantitative determination of triacylglycerols, diacylglycerols, monoacylglycerols and free fatty acids has been improved and optimized based on existing protocols using liquid-phase extraction and thin-layer chromatography coupled to flame ionization detection (TLC/FID Iatroscan). After lipid extraction in the presence of a suitable new synthetic internal standard, namely CholE1, a single elution step using n-heptane/diethyl ether/formic acid (55:45:1, v/v/v) was applied. This method was validated in line with international bioanalytical method validation guidelines using two different matrix systems: purified water and human gastro-intestinal fluid. Overall, the assay was found to have high levels of precision with coefficients of variation ranging from 1.48% to 11.0% and accuracy ranging from -13.3% to +5.79% RE. The confidence limits of the lipid mean recovery rates varied between 89.9% and 104%. This method is therefore highly suitable for quantifying the lipolysis products generated in vitro during the hydrolysis of various fats and oils by digestive lipases, as well as those collected from the gastro-intestinal tract in the course of human clinical studies on lipid digestion.

Validation of the G.LAB MD2200 wrist blood pressure monitor according to the European Society of Hypertension, the British Hypertension Society, and the International Organization for Standardization Protocols.

PubMed

Liu, Ze-Yu; Zhang, Qing-Han; Ye, Xiao-Lei; Liu, Da-Peng; Cheng, Kang; Zhang, Chun-Hai; Wan, Yi

2017-04-01

To validate the G.LAB MD2200 automated wrist blood pressure (BP) monitors according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010, the British Hypertension Society (BHS), and the International Organization for Standardization (ISO) 81060-2:2013 protocols. The device was assessed on 33 participants according to the ESH requirements and was then tested on 85 participants according to the BHS and ISO 81060-2:2013 criteria. The validation procedures and data analysis followed the protocols precisely. The G.LAB MD2200 devices passed all parts of ESH-IP revision 2010 for both systolic and diastolic BP, with a device-observer difference of 2.15±5.51 and 1.51±5.16 mmHg, respectively. The device achieved A/A grading for the BHS protocol and it also fulfilled the criteria of ISO 81060-2:2013, with mean differences of systolic and diastolic BP between the device and the observer of 2.19±5.21 and 2.11±4.70 mmHg, respectively. The G.LAB MD2200 automated wrist BP monitor passed the ESH-IP revision 2010 and the ISO 81060-2:2013 protocol, and achieved the A/A grade of the BHS protocol, which can be recommended for self-measurement in the general population.

Transcultural and psychometric validation of the Dispositional Resilience Scale (DRS-15) in Chinese adult women.

PubMed

Wong, Janet Yuen-Ha; Fong, Daniel Yee-Tak; Choi, Anna Wai-Man; Chan, Claudia Kor-Yee; Tiwari, Agnes; Chan, Ko Ling; Lai, Vincent; Logan, Tk; Bartone, Paul

2014-11-01

The aim of this study was to report translation and transcultural adaptation of the 15-item Dispositional Resilience Scale in traditional Chinese (C-DRS-15) and evaluate its psychometric properties. The DRS is a self-report instrument that measures psychological hardiness. We followed an international standard of cross-cultural translation and validation of patient-reported outcome measures to create the Chinese version. Then, the translated C-DRS-15 was validated on 542 Chinese women from a population-based sample in Hong Kong. The internal consistency and criterion-related validity were investigated. Exploratory and confirmatory factor analysis revealed that the C-DRS-15 was supported by a modified three-factor structure in our Chinese sample (RMSEA = .06, CFI = .94, TLI = .92, and SRMR = .06). The reliability (Cronbach's α coefficient = .78) and validity were satisfactory. Total resilience score was negatively correlated with depression (p < .001), with non-depressed women scoring higher on the C-DRS-15. The C-DRS-15 was demonstrated to be a reliable and valid measurement to assess hardiness in Chinese women.

Comparative assessment of three standardized robotic surgery training methods.

PubMed

Hung, Andrew J; Jayaratna, Isuru S; Teruya, Kara; Desai, Mihir M; Gill, Inderbir S; Goh, Alvin C

2013-10-01

To evaluate three standardized robotic surgery training methods, inanimate, virtual reality and in vivo, for their construct validity. To explore the concept of cross-method validity, where the relative performance of each method is compared. Robotic surgical skills were prospectively assessed in 49 participating surgeons who were classified as follows: 'novice/trainee': urology residents, previous experience <30 cases (n = 38) and 'experts': faculty surgeons, previous experience ≥30 cases (n = 11). Three standardized, validated training methods were used: (i) structured inanimate tasks; (ii) virtual reality exercises on the da Vinci Skills Simulator (Intuitive Surgical, Sunnyvale, CA, USA); and (iii) a standardized robotic surgical task in a live porcine model with performance graded by the Global Evaluative Assessment of Robotic Skills (GEARS) tool. A Kruskal-Wallis test was used to evaluate performance differences between novices and experts (construct validity). Spearman's correlation coefficient (ρ) was used to measure the association of performance across inanimate, simulation and in vivo methods (cross-method validity). Novice and expert surgeons had previously performed a median (range) of 0 (0-20) and 300 (30-2000) robotic cases, respectively (P < 0.001). Construct validity: experts consistently outperformed residents with all three methods (P < 0.001). Cross-method validity: overall performance of inanimate tasks significantly correlated with virtual reality robotic performance (ρ = -0.7, P < 0.001) and in vivo robotic performance based on GEARS (ρ = -0.8, P < 0.0001). Virtual reality performance and in vivo tissue performance were also found to be strongly correlated (ρ = 0.6, P < 0.001). We propose the novel concept of cross-method validity, which may provide a method of evaluating the relative value of various forms of skills education and assessment. We externally confirmed the construct validity of each featured training tool. © 2013 BJU International.

Validity and reliability of the Questionnaire for Compliance with Standard Precaution

PubMed Central

Valim, Marília Duarte; Marziale, Maria Helena Palucci; Hayashida, Miyeko; Rocha, Fernanda Ludmilla Rossi; Santos, Jair Lício Ferreira

2015-01-01

ABSTRACT OBJECTIVE : To evaluate the validity and reliability of the Questionnaire for Compliance with Standard Precaution for nurses. METHODS : This methodological study was conducted with 121 nurses from health care facilities in Sao Paulo’s countryside, who were represented by two high-complexity and by three average-complexity health care facilities. Internal consistency was calculated using Cronbach’s alpha and stability was calculated by the intraclass correlation coefficient, through test-retest. Convergent, discriminant, and known-groups construct validity techniques were conducted. RESULTS : The questionnaire was found to be reliable (Cronbach’s alpha: 0.80; intraclass correlation coefficient: (0.97) In regards to the convergent and discriminant construct validity, strong correlation was found between compliance to standard precautions, the perception of a safe environment, and the smaller perception of obstacles to follow such precautions (r = 0.614 and r = 0.537, respectively). The nurses who were trained on the standard precautions and worked on the health care facilities of higher complexity were shown to comply more (p = 0.028 and p = 0.006, respectively). CONCLUSIONS : The Brazilian version of the Questionnaire for Compliance with Standard Precaution was shown to be valid and reliable. Further investigation must be conducted with nurse samples that are more representative of the Brazilian reality. The use of the questionnaire may support the creation of educational measures considering the possible gaps that can be identified, focusing on the workers’ health and on the patients’ safety. PMID:26759967

Clinical audit project in undergraduate medical education curriculum: an assessment validation study

PubMed Central

Steketee, Carole; Mak, Donna

2016-01-01

Objectives To evaluate the merit of the Clinical Audit Project (CAP) in an assessment program for undergraduate medical education using a systematic assessment validation framework. Methods A cross-sectional assessment validation study at one medical school in Western Australia, with retrospective qualitative analysis of the design, development, implementation and outcomes of the CAP, and quantitative analysis of assessment data from four cohorts of medical students (2011- 2014). Results The CAP is fit for purpose with clear external and internal alignment to expected medical graduate outcomes.  Substantive validity in students’ and examiners’ response processes is ensured through relevant methodological and cognitive processes. Multiple validity features are built-in to the design, planning and implementation process of the CAP.  There is evidence of high internal consistency reliability of CAP scores (Cronbach’s alpha > 0.8) and inter-examiner consistency reliability (intra-class correlation>0.7). Aggregation of CAP scores is psychometrically sound, with high internal consistency indicating one common underlying construct.  Significant but moderate correlations between CAP scores and scores from other assessment modalities indicate validity of extrapolation and alignment between the CAP and the overall target outcomes of medical graduates.  Standard setting, score equating and fair decision rules justify consequential validity of CAP scores interpretation and use. Conclusions This study provides evidence demonstrating that the CAP is a meaningful and valid component in the assessment program. This systematic framework of validation can be adopted for all levels of assessment in medical education, from individual assessment modality, to the validation of an assessment program as a whole.  PMID:27716612

Clinical audit project in undergraduate medical education curriculum: an assessment validation study.

PubMed

Tor, Elina; Steketee, Carole; Mak, Donna

2016-09-24

To evaluate the merit of the Clinical Audit Project (CAP) in an assessment program for undergraduate medical education using a systematic assessment validation framework. A cross-sectional assessment validation study at one medical school in Western Australia, with retrospective qualitative analysis of the design, development, implementation and outcomes of the CAP, and quantitative analysis of assessment data from four cohorts of medical students (2011- 2014). The CAP is fit for purpose with clear external and internal alignment to expected medical graduate outcomes.  Substantive validity in students' and examiners' response processes is ensured through relevant methodological and cognitive processes. Multiple validity features are built-in to the design, planning and implementation process of the CAP.  There is evidence of high internal consistency reliability of CAP scores (Cronbach's alpha > 0.8) and inter-examiner consistency reliability (intra-class correlation>0.7). Aggregation of CAP scores is psychometrically sound, with high internal consistency indicating one common underlying construct.  Significant but moderate correlations between CAP scores and scores from other assessment modalities indicate validity of extrapolation and alignment between the CAP and the overall target outcomes of medical graduates.  Standard setting, score equating and fair decision rules justify consequential validity of CAP scores interpretation and use. This study provides evidence demonstrating that the CAP is a meaningful and valid component in the assessment program. This systematic framework of validation can be adopted for all levels of assessment in medical education, from individual assessment modality, to the validation of an assessment program as a whole.

Construct validity of the items on the Stroke Specific Quality of Life (SS-QOL) questionnaire that evaluate the participation component of the International Classification of Functioning, Disability and Health.

PubMed

Silva, Soraia Micaela; Corrêa, Fernanda Ishida; Pereira, Gabriela Santos; Faria, Christina Danielli Coelho de Morais; Corrêa, João Carlos Ferrari

2018-01-01

Analyze the construct validity and internal consistency of the Stroke Specific Quality of Life (SS-QOL) items that address the participation component of the ICF as well as analyze the ceiling and floor effects. One hundred subjects were analyzed: 85 community-dwelling and 15 institutionalized individuals. The analysis of construct validity was performed using classic psychometrics: (1) the comparison of known groups (individuals without restriction to participation vs. those with restriction to participation) using the Mann-Whitney test and (2) convergent validity - correlation between the scores on the SS-QOL items that address participation and the subscale scores of measures used to evaluate the similar constructs and concepts [the Short-Form Health Survey (SF-36), Functional Independence Measure (FIM) and grip strength test]. Spearman's correlation coefficients were calculated for this analysis. Cronbach's α was used for the analysis of internal consistency and both the ceiling and floor effects were analyzed. The level of significance for all analyses was α = 0.05. The a priori hypotheses regarding construct validity were partially demonstrated, as only five of the eight domains exhibited positive moderate to strong correlations (r > 0.40) with measures that address constructs similar to those addressed on the SS-QOL questionnaire. The items demonstrated adequate internal consistency and are capable of differentiating individuals with and without restriction to participation. The ceiling and floor effects were considered adequate for the total SS-QOL score, but beyond acceptable standards for some domains. The 26 items of the SS-QOL questionnaire measure a multidimensional construct and therefore do not only address participation. However, the items demonstrated adequate internal consistency and are capable of differentiating individuals with and without restriction to participation. Implications for rehabilitation The 26 items of the SS-QOL questionnaire demonstrated adequate internal consistency and are capable of differentiating individuals with and without restriction to participation. The present findings can guide healthcare professionals regarding the selection of an assessment tool for the evaluation of post-stroke participation. The findings can lead to consistent and standardization evaluations, which facilitates comparisons and discussion on functional health and social participation after stroke.

Validation of an optimized method for the determination of iodine in human breast milk by inductively coupled plasma mass spectrometry (ICPMS) after tetramethylammonium hydroxide extraction.

PubMed

Huynh, Dao; Zhou, Shao Jia; Gibson, Robert; Palmer, Lyndon; Muhlhausler, Beverly

2015-01-01

In this study a novel method to determine iodine concentrations in human breast milk was developed and validated. The iodine was analyzed by inductively coupled plasma mass spectrometry (ICPMS) following tetramethylammonium hydroxide (TMAH) extraction at 90°C in disposable polypropylene tubes. While similar approaches have been used previously, this method adopted a shorter extraction time (1h vs. 3h) and used antimony (Sb) as the internal standard, which exhibited greater stability in breast milk and milk powder matrices compared to tellurium (Te). Method validation included: defining iodine linearity up to 200μgL(-1); confirming recovery of iodine from NIST 1549 milk powder. A recovery of 94-98% was also achieved for the NIST 1549 milk powder and human breast milk samples spiked with sodium iodide and thyroxine (T4) solutions. The method quantitation limit (MQL) for human breast milk was 1.6μgL(-1). The intra-assay and inter-assay coefficient of variation for the breast milk samples and NIST powder were <1% and <3.5%, respectively. NIST 1549 milk powder, human breast milk samples and calibration standards spiked with the internal standard were all stable for at least 2.5 months after extraction. The results of the validation process confirmed that this newly developed method provides greater accuracy and precision in the assessment of iodine concentrations in human breast milk than previous methods and therefore offers a more reliable approach for assessing iodine concentrations in human breast milk. Copyright © 2014 Elsevier GmbH. All rights reserved.

The Ritvo Autism Asperger Diagnostic Scale-Revised (RAADS-R): A Scale to Assist the Diagnosis of Autism Spectrum Disorder in Adults--An International Validation Study

ERIC Educational Resources Information Center

Ritvo, Riva Ariella; Ritvo, Edward R.; Guthrie, Donald; Ritvo, Max J.; Hufnagel, Demetra H.; McMahon, William; Tonge, Bruce; Mataix-Cols, David; Jassi, Amita; Attwood, Tony; Eloff, Johann

2011-01-01

The Ritvo Autism Asperger Diagnostic Scale-Revised (RAADS-R) is a valid and reliable instrument to assist the diagnosis of adults with Autism Spectrum Disorders (ASD). The 80-question scale was administered to 779 subjects (201 ASD and 578 comparisons). All ASD subjects met inclusion criteria: DSM-IV-TR, ADI/ADOS diagnoses and standardized IQ…

Portfolio Evaluation for Professional Competence: Credentialing in Genetics for Nurses.

ERIC Educational Resources Information Center

Cook, Sarah Sheets; Kase, Ron; Middelton, Lindsay; Monsen, Rita Black

2003-01-01

Describes the process used by the Credentialing Committee of the International Society of Nurses in Genetics to validate evaluation criteria for nursing portfolios using neural network programs. Illustrates how standards are translated into measurable competencies and provides a scoring guide. (SK)

[Italian translation and validation of the Nordic IRSST standardized questionnaire for the analysis of musculoskeletal symptoms].

PubMed

Gobba, F; Ghersi, R; Martinelli, Simona; Richeldi, Arianna; Clerici, Piera; Grazioli, P

2008-01-01

Data on self-reported symptoms and/or functional impairments are important in research on work-related musculoskeletal disorders (WRMSDs). In such cases the availability of international standardized questionnaires is extremely important since they permit comparison of studies performed in different Countries. Translation into Italian and validation of the Nordic Musculoskeletal Questionnaire (NMQ), a tool which is widely used in studies on WRMSDs in the international scientific literature. The extended Canadian version of the NMQ was translated into Italian. As per the current guidelines, the cross-cultural adaptation was performed by translation of the items from French, back-translation by independent mother-tongue translators and committee review. The resulting version of the questionnaire underwent pre-testing in 3 independent groups of subjects. The comprehensibility, reliability (internal consistency and reproducibility) and sensitivity were evaluated. After translation/back-translation and review of the items the comprehensibility of the Italian version of the questionnaire was judged good in a group of 40 workers. The internal consistency was evaluated using the Cronbach's Alpha test in the same group and in another 98 engineering workers: the results were on the whole acceptable. The reproducibility, which was tested with Cohen's Kappa test in the 40 workers, was good/excellent. In a preliminary evaluation, performed in 30 outpatients of a of Rehabilitation Service, sensitivity was very good. The results show that the Italian version of the Nordic Musculoskeletal Questionnaire is valid for self-administration and can be applied in 'field" studies on self-reported musculoskeletal symptoms and functional impairments in group of workers.

Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part II - preanalytical issues.

PubMed

Davis, Bruce H; Dasgupta, Amar; Kussick, Steven; Han, Jin-Yeong; Estrellado, Annalee

2013-01-01

Flow cytometry and other technologies of cell-based fluorescence assays are as a matter of good laboratory practice required to validate all assays, which when in clinical practice may pass through regulatory review processes using criteria often defined with a soluble analyte in plasma or serum samples in mind. Recently the U.S. Food and Drug Administration (FDA) has entered into a public dialogue in the U.S. regarding their regulatory interest in laboratory developed tests (LDTs) or so-called "home brew" assays performed in clinical laboratories. The absence of well-defined guidelines for validation of cell-based assays using fluorescence detection has thus become a subject of concern for the International Council for Standardization of Haematology (ICSH) and International Clinical Cytometry Society (ICCS). Accordingly, a group of over 40 international experts in the areas of test development, test validation, and clinical practice of a variety of assay types using flow cytometry and/or morphologic image analysis were invited to develop a set of practical guidelines useful to in vitro diagnostic (IVD) innovators, clinical laboratories, regulatory scientists, and laboratory inspectors. The focus of the group was restricted to fluorescence reporter reagents, although some common principles are shared by immunohistochemistry or immunocytochemistry techniques and noted where appropriate. The work product of this two year effort is the content of this special issue of this journal, which is published as 5 separate articles, this being Validation of Cell-based Fluorescence Assays: Practice Guidelines from the ICSH and ICCS - Part II - Preanalytical issues. © 2013 International Clinical Cytometry Society. © 2013 International Clinical Cytometry Society.

Validity of a questionnaire measuring motives for choosing foods including sustainable concerns.

PubMed

Sautron, Valérie; Péneau, Sandrine; Camilleri, Géraldine M; Muller, Laurent; Ruffieux, Bernard; Hercberg, Serge; Méjean, Caroline

2015-04-01

Since the 1990s, sustainability of diet has become an increasingly important concern for consumers. However, there is no validated multidimensional measurement of motivation in the choice of foods including a concern for sustainability currently available. In the present study, we developed a questionnaire that measures food choice motives during purchasing, and we tested its psychometric properties. The questionnaire included 104 items divided into four predefined dimensions (environmental, health and well-being, economic and miscellaneous). It was administered to 1000 randomly selected subjects participating in the Nutrinet-Santé cohort study. Among 637 responders, one-third found the questionnaire complex or too long, while one-quarter found it difficult to fill in. Its underlying structure was determined by exploratory factor analysis and then internally validated by confirmatory factor analysis. Reliability was also assessed by internal consistency of selected dimensions and test-retest repeatability. After selecting the most relevant items, first-order analysis highlighted nine main dimensions: labeled ethics and environment, local and traditional production, taste, price, environmental limitations, health, convenience, innovation and absence of contaminants. The model demonstrated excellent internal validity (adjusted goodness of fit index = 0.97; standardized root mean square residuals = 0.07) and satisfactory reliability (internal consistency = 0.96, test-retest repeatability coefficient ranged between 0.31 and 0.68 over a mean 4-week period). This study enabled precise identification of the various dimensions in food choice motives and proposed an original, internally valid tool applicable to large populations for assessing consumer food motivation during purchasing, particularly in terms of sustainability. Copyright © 2014 Elsevier Ltd. All rights reserved.

Ada Compiler Validation Summary Report: Certificate Number: 880318W1. 09043 International Business Machines Corporation IBM Development System for the Ada Language, Version 2.1.0 IBM 4381 under VM/HPO, Host IBM 4381 under MVS/XA, Target

DTIC Science & Technology

1988-03-28

International Business Machines Corporation IBM Development System for the Ada Language, Version 2.1.0 IBM 4381 under VM/HPO, host IBM 4381 under MVS/XA, target...Program Office, AJPO 20. ABSTRACT (Continue on reverse side if necessary and identify by block number) International Business Machines Corporation, IBM...Standard ANSI/MIL-STD-1815A in the compiler listed in this declaration. I declare that International Business Machines Corporation is the owner of record

Determination of chloramphenicol residues in meat, seafood, egg, honey, milk, plasma and urine with liquid chromatography-tandem mass spectrometry, and the validation of the method based on 2002/657/EC.

PubMed

Rønning, Helene Thorsen; Einarsen, Kristin; Asp, Tone Normann

2006-06-23

A simple and rapid method for the determination and confirmation of chloramphenicol in several food matrices with LC-MS/MS was developed. Following addition of d5-chloramphenicol as internal standard, meat, seafood, egg, honey and milk samples were extracted with acetonitrile. Chloroform was then added to remove water. After evaporation, the residues were reconstituted in methanol/water (3+4) before injection. The urine and plasma samples were after addition of internal standard applied to a Chem Elut extraction cartridge, eluted with ethyl acetate, and hexane washed. Also these samples were reconstituted in methanol/water (3+4) after evaporation. By using an MRM acquisition method in negative ionization mode, the transitions 321-->152, 321-->194 and 326-->157 were used for quantification, confirmation and internal standard, respectively. Quantification of chloramphenicol positive samples regardless of matrix could be achieved with a common water based calibration curve. The validation of the method was based on EU-decision 2002/657 and different ways of calculating CCalpha and CCbeta were evaluated. The common CCalpha and CCbeta for all matrices were 0.02 and 0.04 microg/kg for the 321-->152 ion transition, and 0.02 and 0.03 microg/kg for the 321-->194 ion transition. At fortification level 0.1 microg/kg the within-laboratory reproducibility is below 25%.

Psychometric Properties of the Japanese Version of the STarT Back Tool in Patients with Low Back Pain.

PubMed

Matsudaira, Ko; Oka, Hiroyuki; Kikuchi, Norimasa; Haga, Yuri; Sawada, Takayuki; Tanaka, Sakae

2016-01-01

The STarT Back Tool uses prognostic indicators to classify patients with low back pain into three risk groups to guide early secondary prevention in primary care. The present study aimed to evaluate the psychometric properties of the Japanese version of the tool (STarT-J). An online survey was conducted among Japanese patients with low back pain aged 20-64 years. Reliability was assessed by examining the internal consistency of the overall and psychosocial subscales using Cronbach's alpha coefficients. Spearman's correlation coefficients were used to evaluate the concurrent validity between the STarT-J total score/psychosocial subscore and standard reference questionnaires. Discriminant validity was evaluated by calculating the area under the curves (AUCs) for the total and psychosocial subscale scores against standard reference cases. Known-groups validity was assessed by examining the relationship between low back pain-related disability and STarT-J scores. The analysis included data for 2000 Japanese patients with low back pain; the mean (standard deviation [SD]) age was 47.7 (9.3) years, and 54.1% were male. The mean (SD) STarT-J score was 2.2 (2.1). The Cronbach's alpha coefficient was 0.75 for the overall scale and 0.66 for the psychosocial subscale. Spearman's correlation coefficients ranged from 0.30 to 0.59, demonstrating moderate to strong concurrent validity. The AUCs for the total score ranged from 0.65 to 0.83, mostly demonstrating acceptable discriminative ability. For known-groups validity, participants with more somatic symptoms had higher total scores. Those in higher STarT-J risk groups had experienced more low back pain-related absences. The overall STarT-J scale was internally consistent and had acceptable concurrent, discriminant, and known-groups validity. The STarT-J can be used with Japanese patients with low back pain.

[Measurement properties of self-report questionnaires published in Korean nursing journals].

PubMed

Lee, Eun-Hyun; Kim, Chun-Ja; Kim, Eun Jung; Chae, Hyun-Ju; Cho, Soo-Yeon

2013-02-01

The purpose of this study was to evaluate measurement properties of self-report questionnaires for studies published in Korean nursing journals. Of 424 Korean nursing articles initially identified, 168 articles met the inclusion criteria. The methodological quality of the measurements used in the studies and interpretability were assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. It consists of items on internal consistency, reliability, measurement error, content validity, construct validity including structural validity, hypothesis testing, cross-cultural validity, and criterion validity, and responsiveness. For each item of the COSMIN checklist, measurement properties are rated on a four-point scale: excellent, good, fair, and poor. Each measurement property is scored with worst score counts. All articles used the classical test theory for measurement properties. Internal consistency (72.6%), construct validity (56.5%), and content validity (38.2%) were most frequently reported properties being rated as 'excellent' by COSMIN checklist, whereas other measurement properties were rarely reported. A systematic review of measurement properties including interpretability of most instruments warrants further research and nursing-focused checklists assessing measurement properties should be developed to facilitate intervention outcomes across Korean studies.

Reliability and Validity of the Sensory Component of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI): A Systematic Review.

PubMed

Hales, M; Biros, E; Reznik, J E

2015-01-01

Since 1982, the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) has been used to classify sensation of spinal cord injury (SCI) through pinprick and light touch scores. The absence of proprioception, pain, and temperature within this scale creates questions about its validity and accuracy. To assess whether the sensory component of the ISNCSCI represents a reliable and valid measure of classification of SCI. A systematic review of studies examining the reliability and validity of the sensory component of the ISNCSCI published between 1982 and February 2013 was conducted. The electronic databases MEDLINE via Ovid, CINAHL, PEDro, and Scopus were searched for relevant articles. A secondary search of reference lists was also completed. Chosen articles were assessed according to the Oxford Centre for Evidence-Based Medicine hierarchy of evidence and critically appraised using the McMasters Critical Review Form. A statistical analysis was conducted to investigate the variability of the results given by reliability studies. Twelve studies were identified: 9 reviewed reliability and 3 reviewed validity. All studies demonstrated low levels of evidence and moderate critical appraisal scores. The majority of the articles (~67%; 6/9) assessing the reliability suggested that training was positively associated with better posttest results. The results of the 3 studies that assessed the validity of the ISNCSCI scale were confounding. Due to the low to moderate quality of the current literature, the sensory component of the ISNCSCI requires further revision and investigation if it is to be a useful tool in clinical trials.

Reliability and Validity of the Sensory Component of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI): A Systematic Review

PubMed Central

Hales, M.; Biros, E.

2015-01-01

Background: Since 1982, the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) has been used to classify sensation of spinal cord injury (SCI) through pinprick and light touch scores. The absence of proprioception, pain, and temperature within this scale creates questions about its validity and accuracy. Objectives: To assess whether the sensory component of the ISNCSCI represents a reliable and valid measure of classification of SCI. Methods: A systematic review of studies examining the reliability and validity of the sensory component of the ISNCSCI published between 1982 and February 2013 was conducted. The electronic databases MEDLINE via Ovid, CINAHL, PEDro, and Scopus were searched for relevant articles. A secondary search of reference lists was also completed. Chosen articles were assessed according to the Oxford Centre for Evidence-Based Medicine hierarchy of evidence and critically appraised using the McMasters Critical Review Form. A statistical analysis was conducted to investigate the variability of the results given by reliability studies. Results: Twelve studies were identified: 9 reviewed reliability and 3 reviewed validity. All studies demonstrated low levels of evidence and moderate critical appraisal scores. The majority of the articles (~67%; 6/9) assessing the reliability suggested that training was positively associated with better posttest results. The results of the 3 studies that assessed the validity of the ISNCSCI scale were confounding. Conclusions: Due to the low to moderate quality of the current literature, the sensory component of the ISNCSCI requires further revision and investigation if it is to be a useful tool in clinical trials. PMID:26363591

A strategy for extending the applicability of a validated plasma calibration curve to quantitative measurements in multiple tissue homogenate samples: a case study from a rat tissue distribution study of JI-101, a triple kinase inhibitor.

PubMed

Gurav, Sandip Dhondiram; Jeniffer, Sherine; Punde, Ravindra; Gilibili, Ravindranath Reddy; Giri, Sanjeev; Srinivas, Nuggehally R; Mullangi, Ramesh

2012-04-01

A general practice in bioanalysis is that, whatever the biological matrix the analyte is being quantified in, the validation is performed in the same matrix as per regulatory guidelines. In this paper, we are presenting the applicability of a validated LC-MS/MS method in rat plasma for JI-101, to estimate the concentrations of JI-101 in various tissues that were harvested in a rat tissue distribution study. A simple protein precipitation technique was used to extract JI-101 and internal standard from the tissue homogenates. The recovery of JI-101 in all the matrices was found to be >70%. Chromatographic separation was achieved using a binary gradient using mobile phase A (acetonitrile) and B (0.2% formic acid in water) at a flow rate of 0.30 mL/min on a Prodigy ODS column with a total run time of 4.0 min. The MS/MS ion transitions monitored were 466.1 → 265 for JI-101 and 180.1 → 110.1 for internal standard. The linearity range was 5.02-4017 ng/mL. The JI-101 levels were quantifiable in the various tissue samples harvested in this study. Therefore, the use of a previously validated JI-101 assay in plasma circumvented the tedious process of method development/validation in various tissue matrices. Copyright © 2011 John Wiley & Sons, Ltd.

Validity and Reliability of Baseline Testing in a Standardized Environment.

PubMed

Higgins, Kathryn L; Caze, Todd; Maerlender, Arthur

2017-08-11

The Immediate Postconcussion Assessment and Cognitive Testing (ImPACT) is a computerized neuropsychological test battery commonly used to determine cognitive recovery from concussion based on comparing post-injury scores to baseline scores. This model is based on the premise that ImPACT baseline test scores are a valid and reliable measure of optimal cognitive function at baseline. Growing evidence suggests that this premise may not be accurate and a large contributor to invalid and unreliable baseline test scores may be the protocol and environment in which baseline tests are administered. This study examined the effects of a standardized environment and administration protocol on the reliability and performance validity of athletes' baseline test scores on ImPACT by comparing scores obtained in two different group-testing settings. Three hundred-sixty one Division 1 cohort-matched collegiate athletes' baseline data were assessed using a variety of indicators of potential performance invalidity; internal reliability was also examined. Thirty-one to thirty-nine percent of the baseline cases had at least one indicator of low performance validity, but there were no significant differences in validity indicators based on environment in which the testing was conducted. Internal consistency reliability scores were in the acceptable to good range, with no significant differences between administration conditions. These results suggest that athletes may be reliably performing at levels lower than their best effort would produce. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

True communication skills assessment in interdepartmental OSCE stations: Standard setting using the MAAS-Global and EduG.

PubMed

Setyonugroho, Winny; Kropmans, Thomas; Murphy, Ruth; Hayes, Peter; van Dalen, Jan; Kennedy, Kieran M

2018-01-01

Comparing outcome of clinical skills assessment is challenging. This study proposes reliable and valid comparison of communication skills (1) assessment as practiced in Objective Structured Clinical Examinations (2). The aim of the present study is to compare CS assessment, as standardized according to the MAAS Global, between stations in a single undergraduate medical year. An OSCE delivered in an Irish undergraduate curriculum was studied. We chose the MAAS-Global as an internationally recognized and validated instrument to calibrate the OSCE station items. The MAAS-Global proportion is the percentage of station checklist items that can be considered as 'true' CS. The reliability of the OSCE was calculated with G-Theory analysis and nested ANOVA was used to compare mean scores of all years. MAAS-Global scores in psychiatry stations were significantly higher than those in other disciplines (p<0.03) and above the initial pass mark of 50%. The higher students' scores in psychiatry stations were related to higher MAAS-Global proportions when compared to the general practice stations. Comparison of outcome measurements, using the MAAS Global as a standardization instrument, between interdisciplinary station checklists was valid and reliable. The MAAS-Global was used as a single validated instrument and is suggested as gold standard. Copyright © 2017. Published by Elsevier B.V.

Validation of IRDFF in 252Cf standard and IRDF-2002 reference neutron fields

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

Simakov, Stanislav; Capote Noy, Roberto; Greenwood, Lawrence R.

The results of validation of the latest release of International Reactor Dosimetry and Fusion File, IRDFF-1.03, in the standard 252Cf(s.f.) and reference 235U(nth,f) neutron benchmark fields are presented. The spectrum-averaged cross sections were shown to confirm the recommended spectrum for 252Cf spontaneous fission source; that was not the case for the current recommended spectra for 235U(nth,f). IRDFF was also validated in the spectra of the research reactor facilities ISNF, Sigma-Sigma and YAYOI, which are available in the IRDF- 2002 collection. Before this analysis, the ISFN spectrum was resimulated to remove unphysical oscillations in spectrum. IRDFF-1.03 was shown to reasonably reproducemore » the spectrum-averaged data measured in these fields except for the case of YAYOI.« less

Development and Validation of a Taiwanese Communication Progression in Science Education

ERIC Educational Resources Information Center

Hsin, Ming-Chin; Chien, Sung-pei; Hsu, Yin-Shao; Lin, Chen-Yung; Yore, Larry D.

2016-01-01

Common core standards, interdisciplinary education, and discipline-specific literacy are common international education reforms. The constructive-interpretative language arts pairs (speaking-listening, writing-reading, representing-viewing) and the communication, construction, and persuasion functions of language are central in these movements.…

Structured assessment of current mental state in clinical practice: an international study of the reliability and validity of the Current Psychiatric State interview, CPS-50.

PubMed

Falloon, I R H; Mizuno, M; Murakami, M; Roncone, R; Unoka, Z; Harangozo, J; Pullman, J; Gedye, R; Held, T; Hager, B; Erickson, D; Burnett, K

2005-01-01

To develop a reliable standardized assessment of psychiatric symptoms for use in clinical practice. A 50-item interview, the Current Psychiatric State 50 (CPS-50), was used to assess 237 patients with a range of psychiatric diagnoses. Ratings were made by interviewers after a 2-day training. Comparisons of inter-rater reliability on each item and on eight clinical subscales were made across four international centres and between psychiatrists and non-psychiatrists. A principal components analysis was used to validate these clinical scales. Acceptable inter-rater reliability (intra-class coefficient > 0.80) was found for 46 of the 50 items, and for all eight subscales. There was no difference between centres or between psychiatrists and non-psychiatrists. The principal components analysis factors were similar to the clinical scales. The CPS-50 is a reliable standardized assessment of current mental status that can be used in clinical practice by all mental health professionals after brief training. Blackwell Munksgaard 2004

Application of Multivariable Analysis and FTIR-ATR Spectroscopy to the Prediction of Properties in Campeche Honey

PubMed Central

Pat, Lucio; Ali, Bassam; Guerrero, Armando; Córdova, Atl V.; Garduza, José P.

2016-01-01

Attenuated total reflectance-Fourier transform infrared spectrometry and chemometrics model was used for determination of physicochemical properties (pH, redox potential, free acidity, electrical conductivity, moisture, total soluble solids (TSS), ash, and HMF) in honey samples. The reference values of 189 honey samples of different botanical origin were determined using Association Official Analytical Chemists, (AOAC), 1990; Codex Alimentarius, 2001, International Honey Commission, 2002, methods. Multivariate calibration models were built using partial least squares (PLS) for the measurands studied. The developed models were validated using cross-validation and external validation; several statistical parameters were obtained to determine the robustness of the calibration models: (PCs) optimum number of components principal, (SECV) standard error of cross-validation, (R 2 cal) coefficient of determination of cross-validation, (SEP) standard error of validation, and (R 2 val) coefficient of determination for external validation and coefficient of variation (CV). The prediction accuracy for pH, redox potential, electrical conductivity, moisture, TSS, and ash was good, while for free acidity and HMF it was poor. The results demonstrate that attenuated total reflectance-Fourier transform infrared spectrometry is a valuable, rapid, and nondestructive tool for the quantification of physicochemical properties of honey. PMID:28070445

Safer Conception Methods and Counseling: Psychometric Evaluation of New Measures of Attitudes and Beliefs Among HIV Clients and Providers.

PubMed

Woldetsadik, Mahlet Atakilt; Goggin, Kathy; Staggs, Vincent S; Wanyenze, Rhoda K; Beyeza-Kashesya, Jolly; Mindry, Deborah; Finocchario-Kessler, Sarah; Khanakwa, Sarah; Wagner, Glenn J

2016-06-01

With data from 400 HIV clients with fertility intentions and 57 HIV providers in Uganda, we evaluated the psychometrics of new client and provider scales measuring constructs related to safer conception methods (SCM) and safer conception counselling (SCC). Several forms of validity (i.e., content, face, and construct validity) were examined using standard methods including exploratory and confirmatory factor analysis. Internal consistency was established using Cronbach's alpha correlation coefficient. The final scales consisted of measures of attitudes towards use of SCM and delivery of SCC, including measures of self-efficacy and motivation to use SCM, and perceived community stigma towards childbearing. Most client and all provider measures had moderate to high internal consistency (alphas 0.60-0.94), most had convergent validity (associations with other SCM or SCC-related measures), and client measures had divergent validity (poor associations with depression). These findings establish preliminary psychometric properties of these scales and should facilitate future studies of SCM and SCC.

Screening for social phobia in medical in- and outpatients with the German version of the Social Phobia Inventory (SPIN).

PubMed

Sosic, Z; Gieler, U; Stangier, U

2008-06-01

To evaluate the German version of the Social Phobia Inventory (SPIN) as a screening device and to report corresponding cut-off scores for different populations. In Study 1, 2043 subjects from a representative sample completed the SPIN. Cut-off values were established on the basis of means and standard deviations. In Study 2, different aspects of validity were examined in a clinical sample comprising 164 subjects, including social phobic individuals, individuals with other anxiety disorders and depression, and non-clinical control subjects. Internal consistency was evaluated. Convergent and divergent validity were explored using several established measures. Finally, the sensitivity and specificity of the German SPIN with regard to social anxiety classification were investigated by means of receiver operating characteristics (ROC) analyses. In Study 1, mean scores and standard deviations were used to determine cut-off scores for the German SPIN. In Study 2, excellent internal consistency and good convergent and divergent validity were obtained. ROC analyses revealed that the German SPIN performed well in discriminating between social phobic individuals on the one hand and psychiatric and non-psychiatric controls on the other. A cut-off score of 25 represented the best balance between sensitivity and specificity. Comparable to the original version, the German SPIN demonstrates solid psychometric properties and shows promise as an economic, reliable, and valid screening device.

An internationally standardized species identification test for use on suspected seized rhinoceros horn in the illegal wildlife trade.

PubMed

Ewart, Kyle M; Frankham, Greta J; McEwing, Ross; Webster, Lucy M I; Ciavaglia, Sherryn A; Linacre, Adrian M T; The, Dang Tat; Ovouthan, Kanitia; Johnson, Rebecca N

2018-01-01

Rhinoceros (rhino) numbers have dwindled substantially over the past century. As a result, three of the five species are now considered to be critically endangered, one species is vulnerable and one species is near-threatened. Poaching has increased dramatically over the past decade due to a growing demand for rhino horn products, primarily in Asia. Improved wildlife forensic techniques, such as validated tests for species identification of seized horns, are critical to aid current enforcement and prosecution efforts and provide a deterrent to future rhino horn trafficking. Here, we present an internationally standardized species identification test based on a 230 base pair cytochrome-b region. This test improves on previous nested PCR protocols and can be used for the discrimination of samples with <20pg of template DNA, thus suitable for DNA extracted from horn products. The assay was designed to amplify water buffalo samples, a common 'rhino horn' substitute, but to exclude human DNA, a common contaminant. Phylogenetic analyses using this partial cytochrome-b region resolved the five extant rhino species. Testing successfully returned a sequence and correct identification for all of the known rhino horn samples and vouchered rhino samples from museum and zoo collections, and provided species level identification for 47 out of 52 unknown samples from seizures. Validation and standardization was carried out across five different laboratories, in four different countries, demonstrating it to be an effective and reproducible test, robust to inter laboratory variation in equipment and consumables (such as PCR reagents). This is one of the first species identification tests to be internationally standardized to produce data for evidential proceedings and the first published validated test for rhinos, one of the flagship species groups of the illegal wildlife trade and for which forensic tools are urgently required. This study serves as a model for how species identification tests should be standardized and disseminated for wildlife forensic testing. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Determination of Indonesian palm-oil-based bioenergy sustainability indicators using fuzzy inference system

NASA Astrophysics Data System (ADS)

Arkeman, Y.; Rizkyanti, R. A.; Hambali, E.

2017-05-01

Development of Indonesian palm-oil-based bioenergy faces an international challenge regarding to sustainability issue, indicated by the establishment of standards on sustainable bioenergy. Currently, Indonesia has sustainability standards limited to palm-oil cultivation, while other standards are lacking appropriateness for Indonesian palm-oil-based bioenergy sustainability regarding to real condition in Indonesia. Thus, Indonesia requires sustainability indicators for Indonesian palm-oil-based bioenergy to gain recognition and easiness in marketing it. Determination of sustainability indicators was accomplished through three stages, which were preliminary analysis, indicator assessment (using fuzzy inference system), and system validation. Global Bioenergy partnership (GBEP) was used as the standard for the assessment because of its general for use, internationally accepted, and it contained balanced proportion between environment, economic, and social aspects. Result showed that the number of sustainability indicators using FIS method are 21 indicators. The system developed has an accuracy of 85%.

The Validity of Reliability Assessments.

ERIC Educational Resources Information Center

Basch, Charles E.; Gold, Robert S.

1985-01-01

Reliability guides research design and is used as a standard for judging the credibility of findings and inferences. Using data gathered in a school health education curriculum evaluation as an example, possible errors in hypothesis testing are examined. Appropriateness of internal consistency as a measure of reliability is discussed and…

Validation of the Konsung QD217A for clinical use and self-measurement according to the European Society of Hypertension International Protocol.

PubMed

Wu, Ning; Zhang, Xuezhong; Wang, Wen; Zhang, Hongye

2015-08-01

This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure (BP) monitor Konsung QD217A for home BP monitoring according to the European Society of Hypertension International Protocol revision 2010. Three trained observers validated the performance of these devices by comparing the measurements obtained from these devices with those taken using a standard mercury sphygmomanometer. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were sequentially measured in 33 participants using a standard mercury sphygmomanometer and the Konsung QD217A device. A total of 99 pairs of comparisons were obtained from 33 participants. The QD217A device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and the observers within a range of 5, 10 and 15 mmHg was 70/99, 92/99 and 96/99, respectively, for SBP and 80/99, 94/99 and 99/99, respectively, for DBP. The device also achieved the targets in part 2 of the validation study. A total of 27 and 31 participants for SBP and DBP, respectively, showed at least two of the three device-observers differences within 5 mmHg (required≥24). The number of participants without device-observer difference within 5 mmHg was one for SBP and one for DBP (required≤3). The Konsung upper arm BP monitor QD217A has passed the International Protocol requirements and it can be recommended for clinical use and self-measurement in adults. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.

Understanding the use of standardized nursing terminology and classification systems in published research: A case study using the International Classification for Nursing Practice(®).

PubMed

Strudwick, Gillian; Hardiker, Nicholas R

2016-10-01

In the era of evidenced based healthcare, nursing is required to demonstrate that care provided by nurses is associated with optimal patient outcomes, and a high degree of quality and safety. The use of standardized nursing terminologies and classification systems are a way that nursing documentation can be leveraged to generate evidence related to nursing practice. Several widely-reported nursing specific terminologies and classifications systems currently exist including the Clinical Care Classification System, International Classification for Nursing Practice(®), Nursing Intervention Classification, Nursing Outcome Classification, Omaha System, Perioperative Nursing Data Set and NANDA International. However, the influence of these systems on demonstrating the value of nursing and the professions' impact on quality, safety and patient outcomes in published research is relatively unknown. This paper seeks to understand the use of standardized nursing terminology and classification systems in published research, using the International Classification for Nursing Practice(®) as a case study. A systematic review of international published empirical studies on, or using, the International Classification for Nursing Practice(®) were completed using Medline and the Cumulative Index for Nursing and Allied Health Literature. Since 2006, 38 studies have been published on the International Classification for Nursing Practice(®). The main objectives of the published studies have been to validate the appropriateness of the classification system for particular care areas or populations, further develop the classification system, or utilize it to support the generation of new nursing knowledge. To date, most studies have focused on the classification system itself, and a lesser number of studies have used the system to generate information about the outcomes of nursing practice. Based on the published literature that features the International Classification for Nursing Practice, standardized nursing terminology and classification systems appear to be well developed for various populations, settings and to harmonize with other health-related terminology systems. However, the use of the systems to generate new nursing knowledge, and to validate nursing practice is still in its infancy. There is an opportunity now to utilize the well-developed systems in their current state to further what is know about nursing practice, and how best to demonstrate improvements in patient outcomes through nursing care. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

[Workplace Violence in the health sector: validation of the Italian version of the WHO questionnaire].

PubMed

La Torre, G; Sestili, C; Iavazzo, E; Mannocci, A

2017-01-01

The phenomenon of violence and aggression in the workplace is frequent and constantly increasing. Healthcare professionals are most exposed to this phenomenon, especially those who work in urgent and psychiatric emergency departments. To validate the Italian version of the questionnaire "Workplace Violence in the Health Sector Case Study Research Instruments Survey Questionnaire", conducted by WHO. 55 randomly selected workers took part in the validation of the questionnaire among physicians, nurses and nursing trainees. The internal consistency analysis of the demand of 5 dichotomous variables on binary values ​​for violence levels suggests that Cronbach's alpha is 0.61, and Cronbach's alpha calculated on standardized elements is 0.69, which means that Reliability shows sufficient levels. The Italian translation carried out in this WHO questionnaire study shows good internal reliability and consistency and could be considered a useful tool in assessing and preventing aggression and violence against health professionals.

The Chinese version of monitoring and evaluation system strengthening tool for human immunodeficiency virus (HIV) capacity building: Development and evaluation.

PubMed

Zhao, Ran; Chen, Ren; Zhang, Bing; Ma, Ying; Qin, Xia; Hu, Zhi

2015-08-01

Monitoring and evaluation (M&E) for human immunodeficiency virus (HIV) capacity building has become a significant step for HIV prevention and control. The M&E system strengthening tool published by the United Nations Joint Programme on HIV/AIDS (UNAIDS) was intended to be the most authoritative assessment tool internationally. Facing the fact that the M&E system in China did not function at an optimum level, we considered taking the international standards for reference. By linguistic validating and different stages' discussions and revisions, we came up with the Chinese version of the capacity diagnosis tool with at least 12 components and tested its validity and reliability. The tool turned out to have a sufficiently linguistic validation and proved to be a scientific and feasible instrument which was suitable for China's national conditions.

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

PubMed

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

2017-05-01

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

Validity and reliability of the NAB Naming Test.

PubMed

Sachs, Bonnie C; Rush, Beth K; Pedraza, Otto

2016-05-01

Confrontation naming is commonly assessed in neuropsychological practice, but few standardized measures of naming exist and those that do are susceptible to the effects of education and culture. The Neuropsychological Assessment Battery (NAB) Naming Test is a 31-item measure used to assess confrontation naming. Despite adequate psychometric information provided by the test publisher, there has been limited independent validation of the test. In this study, we investigated the convergent and discriminant validity, internal consistency, and alternate forms reliability of the NAB Naming Test in a sample of adults (Form 1: n = 247, Form 2: n = 151) clinically referred for neuropsychological evaluation. Results indicate adequate-to-good internal consistency and alternate forms reliability. We also found strong convergent validity as demonstrated by relationships with other neurocognitive measures. We found preliminary evidence that the NAB Naming Test demonstrates a more pronounced ceiling effect than other commonly used measures of naming. To our knowledge, this represents the largest published independent validation study of the NAB Naming Test in a clinical sample. Our findings suggest that the NAB Naming Test demonstrates adequate validity and reliability and merits consideration in the test arsenal of clinical neuropsychologists.

Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part I - rationale and aims.

PubMed

Davis, Bruce H; Wood, Brent; Oldaker, Teri; Barnett, David

2013-01-01

Flow cytometry and other technologies of cell-based fluorescence assays are as a matter of good laboratory practice required to validate all assays, which when in clinical practice may pass through regulatory review processes using criteria often defined with a soluble analyte in plasma or serum samples in mind. Recently the U.S. Food and Drug Administration (FDA) has entered into a public dialogue in the U.S. regarding their regulatory interest in laboratory developed tests (LDTs) or so-called "home brew" assays performed in clinical laboratories. The absence of well-defined guidelines for validation of cell-based assays using fluorescence detection has thus become a subject of concern for the International Council for Standardization of Haematology (ICSH) and International Clinical Cytometry Society (ICCS). Accordingly, a group of over 40 international experts in the areas of test development, test validation, and clinical practice of a variety of assay types using flow cytometry and/or morphologic image analysis were invited to develop a set of practical guidelines useful to in vitro diagnostic (IVD) innovators, clinical laboratories, regulatory scientists, and laboratory inspectors. The focus of the group was restricted to fluorescence reporter reagents, although some common principles are shared by immunohistochemistry or immunocytochemistry techniques and noted where appropriate. The work product of this two year effort is the content of this special issue of this journal, which is published as 5 separate articles, this being Validation of Cell-based Fluorescence Assays: Practice Guidelines from the ICSH and ICCS - Part I - Rationale and aims. © 2013 International Clinical Cytometry Society. © 2013 International Clinical Cytometry Society.

[Implementation of the technical requirements of the UNE-EN-ISO 15189 quality standard in a mycobacterial laboratory].

PubMed

Guna Serrano, M del Remedio; Ocete Mochón, M Dolores; Lahiguera, M José; Bresó, M Carmen; Gimeno Cardona, Concepción

2013-02-01

The UNE-EN-ISO 15189:2007 standard defines the requirements for quality and competence that must be met by medical laboratories. These laboratories should use this international standard to develop their own quality management systems and to evaluate their own competencies; in turn, this standard will be used by accreditation bodies to confirm or recognize the laboratories' competence. In clinical microbiology laboratories, application of the standard implies the implementation of the technical and specific management requirements that must be met to achieve optimal quality when carrying out microbiological tests. In Spain, accreditation is granted by the Spanish Accreditation Body (Entidad Nacional de Acreditación). This review aims to discuss the practical application of the standard's technical requirements in mycobacterial laboratory. Firstly, we define the scope of accreditation. Secondly, we specify how the items of the standard on personnel management, control of equipment, environmental facilities, method validation, internal controls and customer satisfaction surveys were developed and implemented in our laboratory. Copyright © 2013 Elsevier España, S.L. All rights reserved.

Comprehensive list of names of plant pathogenic bacteria, 1980-2007.

USDA-ARS?s Scientific Manuscript database

This list contains the names of all plant pathogenic bacteria which have been effectively and validly published in terms of the International Code of Nomenclature of Bacteria and the Standards for Naming Pathovars and their revisions. Included are species names from the Approved Lists of Bacterial N...

The reliability and validity of a portfolio designed as a programmatic assessment of performance in an integrated clinical placement.

PubMed

Roberts, Chris; Shadbolt, Narelle; Clark, Tyler; Simpson, Phillip

2014-09-20

Little is known about the technical adequacy of portfolios in reporting multiple complex academic and performance-based assessments. We explored, first, the influencing factors on the precision of scoring within a programmatic assessment of student learning outcomes within an integrated clinical placement. Second, the degree to which validity evidence supported interpretation of student scores. Within generalisability theory, we estimated the contribution that each wanted factor (i.e. student capability) and unwanted factors (e.g. the impact of assessors) made to the variation in portfolio task scores. Relative and absolute standard errors of measurement provided a confidence interval around a pre-determined pass/fail standard for all six tasks. Validity evidence was sought through demonstrating the internal consistency of the portfolio and exploring the relationship of student scores with clinical experience. The mean portfolio mark for 257 students, across 372 raters, based on six tasks, was 75.56 (SD, 6.68). For a single student on one assessment task, 11% of the variance in scores was due to true differences in student capability. The most significant interaction was context specificity (49%), the tendency for one student to engage with one task and not engage with another task. Rater subjectivity was 29%. An absolute standard error of measurement of 4.74%, gave a 95% CI of +/- 9.30%, and a 68% CI of +/- 4.74% around a pass/fail score of 57%. Construct validity was supported by demonstration of an assessment framework, the internal consistency of the portfolio tasks, and higher scores for students who did the clinical placement later in the academic year. A portfolio designed as a programmatic assessment of an integrated clinical placement has sufficient evidence of validity to support a specific interpretation of student scores around passing a clinical placement. It has modest precision in assessing students' achievement of a competency standard. There were identifiable areas for reducing measurement error and providing more certainty around decision-making. Reducing the measurement error would require engaging with the student body on the value of the tasks, more focussed academic and clinical supervisor training, and revisiting the rubric of the assessment in the light of feedback.

A comparison of in-air and in-saline focimeter measurement of the back vertex power of spherical soft contact lenses.

PubMed

Pearson, Richard M; Evans, Bruce J W

2012-11-01

To compare the repeatability and validity of measurements of the back vertex power (BVP) of spherical soft contact lenses made in-air using the method specified in the International Standard (ISO 18369-3:2006) with the corresponding values when BVP was calculated from measurements made using a wet cell and focimeter method that is not approved by this Standard. The BVP of 20 hydrogel and 20 silicone hydrogel lenses, with labelled powers ranging from +8.00 to -12.00 D, were measured with a focimeter by two operators on two occasions in-air in accordance with the relevant International Standard. Equivalent sets of measurements were made with the lenses immersed in-saline within a wet cell and their BVPs in-air were calculated. The validity of each method was assessed by comparing their results with an instrument that used the Hartmann method. The reliability results were generally a little better for the in-saline measurements than for the in-air measurements, although all reliability data demonstrated absolute values of mean errors (inter-operator and inter-session) that were <0.05 D for hydrogel lenses and <0.07 D for silicone hydrogel lenses. The in-air 95% confidence intervals were <0.45 D and <0.40 D for hydrogel and silicone hydrogel lenses, respectively and in-saline <0.39 and <0.31 D for hydrogel and silicone hydrogel lenses, respectively. The validity data revealed a relationship between measurement error and BVP for the in-air data (the focimeter overestimates the power of high plus and high minus lenses compared with the Hartmann instrument) and possibly a more complex relationship for the in-saline data. The 95% limits of agreement indicate better agreement for the in-saline validity data (-0.55 to +0.48 D for hydrogel lenses and -0.42 to +0.54 D for silicone hydrogel lenses) than those obtained in-air (-0.64 to +0.68 D for hydrogel lenses and -0.57 to +0.44 D for silicone hydrogel lenses). Using equipment readily available in a clinical setting, the wet cell method of measurement of the BVP of spherical soft contact lenses has been shown to provide results for reliability and validity that were at least as good as those obtained with the in-air method approved by the International Standard. Ophthalmic & Physiological Optics © 2012 The College of Optometrists.

Translation and cross-cultural adaptation of the lower extremity functional scale into a Brazilian Portuguese version and validation on patients with knee injuries.

PubMed

Metsavaht, Leonardo; Leporace, Gustavo; Riberto, Marcelo; Sposito, Maria Matilde M; Del Castillo, Letícia N C; Oliveira, Liszt P; Batista, Luiz Alberto

2012-11-01

Clinical measurement. To translate and culturally adapt the Lower Extremity Functional Scale (LEFS) into a Brazilian Portuguese version, and to test the construct and content validity and reliability of this version in patients with knee injuries. There is no Brazilian Portuguese version of an instrument to assess the function of the lower extremity after orthopaedic injury. The translation of the original English version of the LEFS into a Brazilian Portuguese version was accomplished using standard guidelines and tested in 31 patients with knee injuries. Subsequently, 87 patients with a variety of knee disorders completed the Brazilian Portuguese LEFS, the Medical Outcomes Study 36-Item Short-Form Health Survey, the Western Ontario and McMaster Universities Osteoarthritis Index, and the International Knee Documentation Committee Subjective Knee Evaluation Form and a visual analog scale for pain. All patients were retested within 2 days to determine reliability of these measures. Validation was assessed by determining the level of association between the Brazilian Portuguese LEFS and the other outcome measures. Reliability was documented by calculating internal consistency, test-retest reliability, and standard error of measurement. The Brazilian Portuguese LEFS had a high level of association with the physical component of the Medical Outcomes Study 36-Item Short-Form Health Survey (r = 0.82), the Western Ontario and McMaster Universities Osteoarthritis Index (r = 0.87), the International Knee Documentation Committee Subjective Knee Evaluation Form (r = 0.82), and the pain visual analog scale (r = -0.60) (all, P<.05). The Brazilian Portuguese LEFS had a low level of association with the mental component of the Medical Outcomes Study 36-Item Short-Form Health Survey (r = 0.38, P<.05). The internal consistency (Cronbach α = .952) and test-retest reliability (intraclass correlation coefficient = 0.957) of the Brazilian Portuguese version of the LEFS were high. The standard error of measurement was low (3.6) and the agreement was considered high, demonstrated by the small differences between test and retest and the narrow limit of agreement, as observed in Bland-Altman and survival-agreement plots. The translation of the LEFS into a Brazilian Portuguese version was successful in preserving the semantic and measurement properties of the original version and was shown to be valid and reliable in a Brazilian population with knee injuries.

The CIPM list of recommended frequency standard values: guidelines and procedures

NASA Astrophysics Data System (ADS)

Riehle, Fritz; Gill, Patrick; Arias, Felicitas; Robertsson, Lennart

2018-04-01

A list of standard reference frequency values (LoF) of quantum transitions from the microwave to the optical regime has been recommended by the International Committee for Weights and Measures (Comité international des poids et mesures, CIPM) for use in basic research, technology, and for the metrology of time, frequency and length. The CIPM LoF contains entries that are recommended as secondary representations of the second in the International System of Units, and entries that can be used to serve as realizations of the definition of the metre. The historical perspective that led to the CIPM LoF is outlined. Procedures have been developed for updating existing, and validating new, entries into the CIPM LoF. The CIPM LoF might serve as an entry for a future redefinition of the second by an optical transition.

Critical Need for Plutonium and Uranium Isotopic Standards with Lower Uncertainties

DOE PAGES

Mathew, Kattathu Joseph; Stanley, Floyd E.; Thomas, Mariam R.; ...

2016-09-23

Certified reference materials (CRMs) traceable to national and international safeguards database are a critical prerequisite for ensuring that nuclear measurement systems are free of systematic biases. CRMs are used to validate measurement processes associated with nuclear analytical laboratories. Diverse areas related to nuclear safeguards are impacted by the quality of the CRM standards available to analytical laboratories. These include: nuclear forensics, radio-chronometry, national and international safeguards, stockpile stewardship, nuclear weapons infrastructure and nonproliferation, fuel fabrication, waste processing, radiation protection, and environmental monitoring. For the past three decades the nuclear community is confronted with the strange situation that improvements in measurementmore » data quality resulting from the improved accuracy and precision achievable with modern multi-collector mass spectrometers could not be fully exploited due to large uncertainties associated with CRMs available from New Brunswick Laboratory (NBL) that are used for instrument calibration and measurement control. Similar conditions prevail for both plutonium and uranium isotopic standards and for impurity element standards in uranium matrices. Herein, the current status of U and Pu isotopic standards available from NBL is reviewed. Critical areas requiring improvement in the quality of the nuclear standards to enable the U. S. and international safeguards community to utilize the full potential of modern multi-collector mass spectrometer instruments are highlighted.« less

Critical Need for Plutonium and Uranium Isotopic Standards with Lower Uncertainties

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

Mathew, Kattathu Joseph; Stanley, Floyd E.; Thomas, Mariam R.

Certified reference materials (CRMs) traceable to national and international safeguards database are a critical prerequisite for ensuring that nuclear measurement systems are free of systematic biases. CRMs are used to validate measurement processes associated with nuclear analytical laboratories. Diverse areas related to nuclear safeguards are impacted by the quality of the CRM standards available to analytical laboratories. These include: nuclear forensics, radio-chronometry, national and international safeguards, stockpile stewardship, nuclear weapons infrastructure and nonproliferation, fuel fabrication, waste processing, radiation protection, and environmental monitoring. For the past three decades the nuclear community is confronted with the strange situation that improvements in measurementmore » data quality resulting from the improved accuracy and precision achievable with modern multi-collector mass spectrometers could not be fully exploited due to large uncertainties associated with CRMs available from New Brunswick Laboratory (NBL) that are used for instrument calibration and measurement control. Similar conditions prevail for both plutonium and uranium isotopic standards and for impurity element standards in uranium matrices. Herein, the current status of U and Pu isotopic standards available from NBL is reviewed. Critical areas requiring improvement in the quality of the nuclear standards to enable the U. S. and international safeguards community to utilize the full potential of modern multi-collector mass spectrometer instruments are highlighted.« less

Development and validation of the brief esophageal dysphagia questionnaire.

PubMed

Taft, T H; Riehl, M; Sodikoff, J B; Kahrilas, P J; Keefer, L; Doerfler, B; Pandolfino, J E

2016-12-01

Esophageal dysphagia is common in gastroenterology practice and has multiple etiologies. A complication for some patients with dysphagia is food impaction. A valid and reliable questionnaire to rapidly evaluate esophageal dysphagia and impaction symptoms can aid the gastroenterologist in gathering information to inform treatment approach and further evaluation, including endoscopy. 1638 patients participated over two study phases. 744 participants completed the Brief Esophageal Dysphagia Questionnaire (BEDQ) for phase 1; 869 completed the BEDQ, Visceral Sensitivity Index, Gastroesophageal Reflux Disease Questionnaire, and Hospital Anxiety and Depression Scale for phase 2. Demographic and clinical data were obtained via the electronic medical record. The BEDQ was evaluated for internal consistency, split-half reliability, ceiling and floor effects, and construct validity. The BEDQ demonstrated excellent internal consistency, reliability, and construct validity. The symptom frequency and severity scales scored above the standard acceptable cutoffs for reliability while the impaction subscale yielded poor internal consistency and split-half reliability; thus the impaction items were deemed qualifiers only and removed from the total score. No significant ceiling or floor effects were found with the exception of 1 item, and inter-item correlations fell within accepted ranges. Construct validity was supported by moderate yet significant correlations with other measures. The predictive ability of the BEDQ was small but significant. The BEDQ represents a rapid, reliable, and valid assessment tool for esophageal dysphagia with food impaction for clinical practice that differentiates between patients with major motor dysfunction and mechanical obstruction. © 2016 John Wiley & Sons Ltd.

Development and Validation of the Brief Esophageal Dysphagia Questionnaire

PubMed Central

Taft, Tiffany H.; Riehl, Megan; Sodikoff, Jamie B.; Kahrilas, Peter J.; Keefer, Laurie; Doerfler, Bethany; Pandolfino, John E.

2017-01-01

Background Esophageal dysphagia is common in gastroenterology practice and has multiple etiologies. A complication for some patients with dysphagia is food impaction. A valid and reliable questionnaire to rapidly evaluate esophageal dysphagia and impaction symptoms can aid the gastroenterologist in gathering information to inform treatment approach and further evaluation, including endoscopy. Methods 1,638 patients participated over two study phases. 744 participants completed the Brief Esophageal Dysphagia Questionnaire (BEDQ) for phase 1; 869 completed the BEDQ, Visceral Sensitivity Index, Gastroesophageal Reflux Disease Questionnaire, and Hospital Anxiety and Depression Scale for phase 2. Demographic and clinical data were obtained via the electronic medical record. The BEDQ was evaluated for internal consistency, split-half reliability, ceiling and floor effects, and construct validity. Key Results The BEDQ demonstrated excellent internal consistency, reliability, and construct validity. The symptom frequency and severity scales scored above the standard acceptable cutoffs for reliability while the impaction subscale yielded poor internal consistency and split-half reliability; thus the impaction items were deemed qualifiers only and removed from the total score. No significant ceiling or floor effects were found with the exception of 1 item, and inter-item correlations fell within accepted ranges. Construct validity was supported by moderate yet significant correlations with other measures. The predictive ability of the BEDQ was small but significant. Conclusions & Inferences The BEDQ represents a rapid, reliable and valid assessment tool for esophageal dysphagia with food impaction for clinical practice that differentiates between patients with major motor dysfunction and mechanical obstruction. PMID:27380834

Validity and reliability of the Cohen 10-item Perceived Stress Scale in patients with chronic headache: Persian version.

PubMed

Khalili, Robabe; Sirati Nir, Masoud; Ebadi, Abbas; Tavallai, Abbas; Habibi, Mehdi

2017-04-01

The Cohen Perceived Stress Scale is being used widely in various countries. The present study evaluated the validity and reliability of the Cohen 10-item Perceived Stress Scale (PSS-10) in assessing tension headache, migraine, and stress-related diseases in Iran. This study is a methodological and cross-sectional descriptive investigation of 100 patients with chronic headache admitted to the pain clinic of Baqiyatallah Educational and Therapeutic Center. Convenience sampling was used for subject selection. PSS psychometric properties were evaluated in two stages. First, the standard scale was translated. Then, the face validity, content, and construct of the translated version were determined. The average age of participants was 38 years with a standard deviation (SD) of 13.2. As for stress levels, 12% were within the normal range, 36% had an intermediate level, and 52% had a high level of stress. The face validity and scale content were remarkable, and the KMO coefficient was 0.82. Bartlett's test yielded 0.327 which was statistically significant (p<0.0001) representing the quality of the sample. In factor analysis of the scale, the two elements of "coping" and "distress" were determined. A Cronbach's Alpha coefficient of 0.72 was obtained. This confirmed the remarkable internal consistency and stability of the scale through repeated measure tests (0.93). The Persian PSS-10 has good internal consistency and reliability. The availability of a validated Persian PSS-10 would indicate a link between stress and chronic headache. Copyright © 2017 Elsevier B.V. All rights reserved.

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

PubMed

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

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

An analytical method to screen for six thyreostatic drug residues in the thyroid gland and muscle tissues of food producing animals by liquid chromatography with ultraviolet absorption detection and liquid chromatography/mass spectrometry.

PubMed

Asea, Philip E; MacNeil, James D; Boison, Joe O

2006-01-01

A method was developed and validated to screen for residues of the thyreostatic drugs, tapazole (TAP), mercaptobenzimidazole (MBI), thiouracil (TU), methylthiouracil (MTU), propylthiouracil (PrTU), and phenylthiouracil (PhTU) in bovine, equine, ovine, and porcine thyroid and muscle tissues at concentrations > or = 5 ng/g using 2-methoxy-mercaptobenzimidazole (MeMBI) and dimethylthiouracil (DMTU) as internal standards. In this method, the drugs were solvent extracted from thyroid and muscle tissue and cleaned up on an amino-propyl solid-phase extraction (SPE) cartridge. The unretained fraction containing TAP and MBI and the internal standard, MeMBI, was collected as Fraction 1. The retained fraction containing TU, MTU, PrTU, PhTU, and the internal standard, DMTU, was eluted with 3% acetic acid-isopropanol as Fraction 2. Fraction 1 was further cleaned up on an alumina B SPE cartridge and analyzed by gradient elution on a C18 high-performance liquid chromatography (HPLC) column with ultraviolet detection at wavelengths of 255 and 300 nm. Fraction 2 was taken to dryness, derivatized with 4-chloro-7-nitrobenzo-2-furazan at pH 8, and analyzed by gradient elution on a C18 LC column with mass spectrometry (MS) detection. Any "presumptive positive" test results were submitted for further analysis by LC/MS/MS. The validated method was applied to the analysis of over 300 thyroid tissue samples.

Health and Safety Checklist for Early Care and Education Programs to Assess Key National Health and Safety Standards.

PubMed

Alkon, Abbey; Rose, Roberta; Wolff, Mimi; Kotch, Jonathan B; Aronson, Susan S

2016-01-01

The project aims were to (1) develop an observational Health and Safety Checklist to assess health and safety practices and conditions in early care and education (ECE) programs using Stepping Stones To Caring For Our Children, 3rd Edition national standards, (2) pilot test the Checklist, completed by nurse child care health consultants, to assess feasibility, ease of completion, objectivity, validity, and reliability, and (3) revise the Checklist based on the qualitative and quantitative results of the pilot study. The observable national health and safety standards were identified and then rated by health, safety, and child care experts using a Delphi technique to validate the standards as essential to prevent harm and promote health. Then, child care health consultants recruited ECE centers and pilot tested the 124-item Checklist. The pilot study was conducted in Arizona, California and North Carolina. The psychometric properties of the Checklist were assessed. The 37 participating ECE centers had 2627 children from ethnically-diverse backgrounds and primarily low-income families. The child care health consultants found the Checklist easy to complete, objective, and useful for planning health and safety interventions. The Checklist had content and face validity, inter-rater reliability, internal consistency, and concurrent validity. Based on the child care health consultant feedback and psychometric properties of the Checklist, the Checklist was revised and re-written at an 8th grade literacy level. The Health and Safety Checklist provides a standardized instrument of observable, selected national standards to assess the quality of health and safety in ECE centers.

Validation of chronic obstructive pulmonary disease (COPD) diagnoses in healthcare databases: a systematic review protocol.

PubMed

Rimland, Joseph M; Abraha, Iosief; Luchetta, Maria Laura; Cozzolino, Francesco; Orso, Massimiliano; Cherubini, Antonio; Dell'Aquila, Giuseppina; Chiatti, Carlos; Ambrosio, Giuseppe; Montedori, Alessandro

2016-06-01

Healthcare databases are useful sources to investigate the epidemiology of chronic obstructive pulmonary disease (COPD), to assess longitudinal outcomes in patients with COPD, and to develop disease management strategies. However, in order to constitute a reliable source for research, healthcare databases need to be validated. The aim of this protocol is to perform the first systematic review of studies reporting the validation of codes related to COPD diagnoses in healthcare databases. MEDLINE, EMBASE, Web of Science and the Cochrane Library databases will be searched using appropriate search strategies. Studies that evaluated the validity of COPD codes (such as the International Classification of Diseases 9th Revision and 10th Revision system; the Real codes system or the International Classification of Primary Care) in healthcare databases will be included. Inclusion criteria will be: (1) the presence of a reference standard case definition for COPD; (2) the presence of at least one test measure (eg, sensitivity, positive predictive values, etc); and (3) the use of a healthcare database (including administrative claims databases, electronic healthcare databases or COPD registries) as a data source. Pairs of reviewers will independently abstract data using standardised forms and will assess quality using a checklist based on the Standards for Reporting of Diagnostic accuracy (STARD) criteria. This systematic review protocol has been produced in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) 2015 statement. Ethics approval is not required. Results of this study will be submitted to a peer-reviewed journal for publication. The results from this systematic review will be used for outcome research on COPD and will serve as a guide to identify appropriate case definitions of COPD, and reference standards, for researchers involved in validating healthcare databases. CRD42015029204. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Validation of Omron RS8, RS6, and RS3 home blood pressure monitoring devices, in accordance with the European Society of Hypertension International Protocol revision 2010.

PubMed

Takahashi, Hakuo; Yoshika, Masamichi; Yokoi, Toyohiko

2013-01-01

Allowing patients to measure their blood pressure at home is recognized as being of clinical value. However, it is not known how often these measurements are taken correctly. Blood pressure monitors for home use fall into two types based on the position of the cuff, ie, at the upper arm or the wrist. The latter is particularly convenient, as measurements can be taken fully clothed. This study aimed to evaluate the performance of the wrist-type blood pressure monitors Omron RS8 (HEM-6310F-E), Omron RS6 (HEM-6221-E), and Omron RS3 (HEM-6130-E). A team of three trained doctors validated the performance of these devices by comparing the measurements obtained from these devices with those taken using a standard mercury sphygmomanometer. All the devices met the validation requirements of the European Society of Hypertension International Protocol revision 2010. The difference in blood pressure readings between the tested device and the standard mercury sphygmomanometer was within 3 mmHg, which is acceptable according to the European Society of Hypertension guidelines. All the home devices tested were found to be suitable for measuring blood pressure at home because their performance fulfilled the requirement of the guidelines.

Development and validation of a sensitive HPLC method for the quantification of HI-6 in guinea pig plasma and evaluated in domestic swine.

PubMed

Bohnert, Sara; Vair, Cory; Mikler, John

2010-05-15

A rapid and small volume assay to quantify HI-6 in plasma was developed to further the development and licensing of an intravenous formulation of HI-6. The objective of this method was to develop a sensitive and rapid assay that clearly resolved HI-6 and an internal standard in saline and plasma matrices. A fully validated method using ion-pair HPLC and 2-PAM as the internal standard fulfilled these requirements. Small plasma samples of 35 microL were extracted using acidification, filtration and neutralization. Linearity was shown for over 4 microg/mL to 1mg/mL with accuracy and precision within 6% relative error at the lower limit of detection. This method was utilized in the pharmacokinetic analysis HI-6 dichloride (2Cl) and HI-6 dimethane sulfonate (DMS) in anaesthetized guinea pigs and domestic swine following an intravenous bolus administration. From the resultant pharmacokinetic parameters a target plasma concentration of 100 microM was established and maintained in guinea pigs receiving an intravenous infusion. This validated method allows for the analysis of low volume samples, increased sample numbers and is applicable to the determination of pharmacokinetic profiles and parameters. Copyright (c) 2010. Published by Elsevier B.V.

Rapid sensitive validated UPLC-MS method for determination of venlafaxine and its metabolite in rat plasma: Application to pharmacokinetic study.

PubMed

Dubey, Sunil Kumar; Saha, R N; Jangala, Hemanth; Pasha, S

2013-12-01

A new ultra-performance liquid chromatography-electrospray ionization mass spectrometry (UPLC-MS/ESI) method for simultaneous determination of venlafaxine (VEN) and its metabolite O-desmethylvenlafaxine (ODV) in rat plasma has been developed and validated using Venlafaxine d6 as the internal standard. The compounds and internal standard were extracted from plasma by solid phase extraction. The UPLC separation of the analytes was performed on ACQUITY UPLC ® BEH Shield RP18 (1.7 µm, 100 mm×2.1 mm) column, using isocratic elution with mobile phase constituted of water (containing 2 mM ammonium acetate): acetonitrile (20:80, v/v) at a flow rate of 0.3 mL/min. All of the analytes were eluted within 1.5 min. The compounds were ionized in the electrospray ionization (ESI) ion source of the mass spectrometer, operating in multiple reaction monitoring (MRM) and positive ion mode. The precursor to product ion transitions monitored for VEN, ODV and Venlafaxine d6 were m / z 278.3→121.08, 264.2→107.1 and 284.4→121.0, respectively. The developed and validated method was used for the pharmacokinetic study of VEN in rats.

HPLC-ESI-MS/MS validated method for simultaneous quantification of zopiclone and its metabolites, N-desmethyl zopiclone and zopiclone-N-oxide in human plasma.

PubMed

Mistri, Hiren N; Jangid, Arvind G; Pudage, Ashutosh; Shrivastav, Pranav

2008-03-15

A simple, selective and sensitive isocratic HPLC method with triple quadrupole mass spectrometry detection has been developed and validated for simultaneous quantification of zopiclone and its metabolites in human plasma. The analytes were extracted using solid phase extraction, separated on Symmetry shield RP8 column (150 mm x 4.6 mm i.d., 3.5 microm particle size) and detected by tandem mass spectrometry with a turbo ion spray interface. Metaxalone was used as an internal standard. The method had a chromatographic run time of 4.5 min and linear calibration curves over the concentration range of 0.5-150 ng/mL for both zopiclone and N-desmethyl zopiclone and 1-150 ng/mL for zopiclone-N-oxide. The intra-batch and inter-batch accuracy and precision evaluated at lower limit of quantification and quality control levels were within 89.5-109.1% and 3.0-14.7%, respectively, for all the analytes. The recoveries calculated for the analytes and internal standard were > or = 90% from spiked plasma samples. The validated method was successfully employed for a comparative bioavailability study after oral administration of 7.5 mg zopiclone (test and reference) to 16 healthy volunteers under fasted condition.

Results in standardization of FOS to support the use of SHM systems

NASA Astrophysics Data System (ADS)

Habel, Wolfgang R.; Krebber, Katerina; Daum, Werner

2016-05-01

Measurement and data recording systems are important parts of a holistic Structural Health Monitoring (SHM) system. New sensor technologies such as fiber-optic sensors are often used; however, standards (or at least guidelines) are not yet available or internationally approved. This lack in standardization makes the acceptance of FOS technologies in complex SHM systems substantially difficult. A standard family for different FOS technologies is therefore being developed that should help to design SHM systems in an optimal way. International standardization activities take place in several standardization bodies such as IEC and ASTM, and within SHM societies such as ISHMII. The paper reports on activities in standardization of fiber-optic sensors, on results already achieved, and on newly started projects. Combined activities of fiber sensor experts and SHM experts from Civil Engineering are presented. These contributions should help owners of structures as well as developers of sensors and monitoring systems to select effective and validated sensing technologies. Using these standards, both parties find recommendations how to proceed in development of SHM systems to evaluate the structural behavior based on e.g. standardized fiber optic sensors, and to derive necessary measures, e.g. the optimal maintenance strategy.

Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part IV - postanalytic considerations.

PubMed

Barnett, David; Louzao, Raaul; Gambell, Peter; De, Jitakshi; Oldaker, Teri; Hanson, Curtis A

2013-01-01

Flow cytometry and other technologies of cell-based fluorescence assays are as a matter of good laboratory practice required to validate all assays, which when in clinical practice may pass through regulatory review processes using criteria often defined with a soluble analyte in plasma or serum samples in mind. Recently the U.S. Food and Drug Administration (FDA) has entered into a public dialogue in the U.S. regarding their regulatory interest in laboratory developed tests (LDTs) or so-called home brew assays performed in clinical laboratories. The absence of well-defined guidelines for validation of cell-based assays using fluorescence detection has thus become a subject of concern for the International Council for Standardization of Haematology (ICSH) and International Clinical Cytometry Society (ICCS). Accordingly, a group of over 40 international experts in the areas of test development, test validation, and clinical practice of a variety of assay types using flow cytometry and/or morphologic image analysis were invited to develop a set of practical guidelines useful to in vitro diagnostic (IVD) innovators, clinical laboratories, regulatory scientists, and laboratory inspectors. The focus of the group was restricted to fluorescence reporter reagents, although some common principles are shared by immunohistochemistry or immunocytochemistry techniques and noted where appropriate. The work product of this two year effort is the content of this special issue of this journal, which is published as 5 separate articles, this being Validation of Cell-based Fluorescence Assays: Practice Guidelines from the ICSH and ICCS - Part IV - Postanalytic considerations. © 2013 International Clinical Cytometry Society.

Reliability and validity of the Wolfram Unified Rating Scale (WURS)

PubMed Central

2012-01-01

Background Wolfram syndrome (WFS) is a rare, neurodegenerative disease that typically presents with childhood onset insulin dependent diabetes mellitus, followed by optic atrophy, diabetes insipidus, deafness, and neurological and psychiatric dysfunction. There is no cure for the disease, but recent advances in research have improved understanding of the disease course. Measuring disease severity and progression with reliable and validated tools is a prerequisite for clinical trials of any new intervention for neurodegenerative conditions. To this end, we developed the Wolfram Unified Rating Scale (WURS) to measure the severity and individual variability of WFS symptoms. The aim of this study is to develop and test the reliability and validity of the Wolfram Unified Rating Scale (WURS). Methods A rating scale of disease severity in WFS was developed by modifying a standardized assessment for another neurodegenerative condition (Batten disease). WFS experts scored the representativeness of WURS items for the disease. The WURS was administered to 13 individuals with WFS (6-25 years of age). Motor, balance, mood and quality of life were also evaluated with standard instruments. Inter-rater reliability, internal consistency reliability, concurrent, predictive and content validity of the WURS were calculated. Results The WURS had high inter-rater reliability (ICCs>.93), moderate to high internal consistency reliability (Cronbach’s α = 0.78-0.91) and demonstrated good concurrent and predictive validity. There were significant correlations between the WURS Physical Assessment and motor and balance tests (rs>.67, p<.03), between the WURS Behavioral Scale and reports of mood and behavior (rs>.76, p<.04) and between WURS Total scores and quality of life (rs=-.86, p=.001). The WURS demonstrated acceptable content validity (Scale-Content Validity Index=0.83). Conclusions These preliminary findings demonstrate that the WURS has acceptable reliability and validity and captures individual differences in disease severity in children and young adults with WFS. PMID:23148655

Static headspace gas chromatographic method for quantitative determination of residual solvents in pharmaceutical drug substances according to european pharmacopoeia requirements.

PubMed

Otero, Raquel; Carrera, Guillem; Dulsat, Joan Francesc; Fábregas, José Luís; Claramunt, Juan

2004-11-19

A static headspace (HS) gas chromatographic method for quantitative determination of residual solvents in a drug substance has been developed according to European Pharmacopoeia general procedure. A water-dimethylformamide mixture is proposed as sample solvent to obtain good sensitivity and recovery. The standard addition technique with internal standard quantitation was used for ethanol, tetrahydrofuran and toluene determination. Validation was performed within the requirements of ICH validation guidelines Q2A and Q2B. Selectivity was tested for 36 solvents, and system suitability requirements described in the European Pharmacopoeia were checked. Limits of detection and quantitation, precision, linearity, accuracy, intermediate precision and robustness were determined, and excellent results were obtained.

Cross-Cultural Validation of the Patient Perception of Integrated Care Survey.

PubMed

Tietschert, Maike V; Angeli, Federica; van Raak, Arno J A; Ruwaard, Dirk; Singer, Sara J

2017-07-20

To test the cross-cultural validity of the U.S. Patient Perception of Integrated Care (PPIC) Survey in a Dutch sample using a standardized procedure. Primary data collected from patients of five primary care centers in the south of the Netherlands, through survey research from 2014 to 2015. Cross-sectional data collected from patients who saw multiple health care providers during 6 months preceding data collection. The PPIC survey includes 59 questions that measure patient perceived care integration across providers, settings, and time. Data analysis followed a standardized procedure guiding data preparation, psychometric analysis, and included invariance testing with the U.S. dataset. Latent scale structures of the Dutch and U.S. survey were highly comparable. Factor "Integration with specialist" had lower reliability scores and noninvariance. For the remaining factors, internal consistency and invariance estimates were strong. The standardized cross-cultural validation procedure produced strong support for comparable psychometric characteristics of the Dutch and U.S. surveys. Future research should examine the usability of the proposed procedure for contexts with greater cultural differences. © Health Research and Educational Trust.

PedsQLTM 4.0 Generic Core Scales for adolescents in the Yoruba language: translation and general psychometric properties.

PubMed

Atilola, Olayinka; Stevanović, Dejan

2014-04-01

Quality of life (QOL) is a universally accepted concept for measuring the impact of different aspects of life on general well-being. Adaptation of existing QOL instruments to local cultures has been identified as a better strategy than development of new ones. To translate and adapt the Paediatric Quality of Life Inventory™ Version 4.0 Generic Core Scales (PedsQL™) to the Yoruba language and culture and to test the psychometric properties of the adapted instrument among adolescents. Psychometric properties including internal consistency reliability, construct and factorial validity of the Yoruba version of PedsQL™ were evaluated using standard procedures. The self report and proxy scales of the Yoruba PedsQL™ were developed with good cultural relevance and semantic/conceptual equivalence. Results from 527 adolescents revealed a Cronbach's coefficient which exceeded 0.7 for internal consistency reliability for all scores. The healthy subjects reported higher PedsQL™ scores than those with mental health and physical problems, which confirmed construct validity. Confirmatory factor analysis revealed a good model fit for the Psychosocial Health score, but not for the other measures. The Yoruba PedsQL™ is culturally appropriate and with good internal consistency, reliability and construct validity. More work is needed regarding its factorial validity.

A low-cost acoustic permeameter

NASA Astrophysics Data System (ADS)

Drake, Stephen A.; Selker, John S.; Higgins, Chad W.

2017-04-01

Intrinsic permeability is an important parameter that regulates air exchange through porous media such as snow. Standard methods of measuring snow permeability are inconvenient to perform outdoors, are fraught with sampling errors, and require specialized equipment, while bringing intact samples back to the laboratory is also challenging. To address these issues, we designed, built, and tested a low-cost acoustic permeameter that allows computation of volume-averaged intrinsic permeability for a homogenous medium. In this paper, we validate acoustically derived permeability of homogenous, reticulated foam samples by comparison with results derived using a standard flow-through permeameter. Acoustic permeameter elements were designed for use in snow, but the measurement methods are not snow-specific. The electronic components - consisting of a signal generator, amplifier, speaker, microphone, and oscilloscope - are inexpensive and easily obtainable. The system is suitable for outdoor use when it is not precipitating, but the electrical components require protection from the elements in inclement weather. The permeameter can be operated with a microphone either internally mounted or buried a known depth in the medium. The calibration method depends on choice of microphone positioning. For an externally located microphone, calibration was based on a low-frequency approximation applied at 500 Hz that provided an estimate of both intrinsic permeability and tortuosity. The low-frequency approximation that we used is valid up to 2 kHz, but we chose 500 Hz because data reproducibility was maximized at this frequency. For an internally mounted microphone, calibration was based on attenuation at 50 Hz and returned only intrinsic permeability. We found that 50 Hz corresponded to a wavelength that minimized resonance frequencies in the acoustic tube and was also within the response limitations of the microphone. We used reticulated foam of known permeability (ranging from 2 × 10-7 to 3 × 10-9 m2) and estimated tortuosity of 1.05 to validate both methods. For the externally mounted microphone the mean normalized standard deviation was 6 % for permeability and 2 % for tortuosity. The mean relative error from known measurements was 17 % for permeability and 2 % for tortuosity. For the internally mounted microphone the mean normalized standard deviation for permeability was 10 % and the relative error was also 10 %. Permeability determination for an externally mounted microphone is less sensitive to environmental noise than is the internally mounted microphone and is therefore the recommended method. The approximation using the internally mounted microphone was developed as an alternative for circumstances in which placing the microphone in the medium was not feasible. Environmental noise degrades precision of both methods and is recognizable as increased scatter for replicate data points.

Spanish version of the screening Örebro musculoskeletal pain questionnaire: a cross-cultural adaptation and validation.

PubMed

Cuesta-Vargas, Antonio Ignacio; González-Sánchez, Manuel

2014-10-29

Spanish is one of the five most spoken languages in the world. There is currently no published Spanish version of the Örebro Musculoskeletal Pain Questionnaire (OMPQ). The aim of the present study is to describe the process of translating the OMPQ into Spanish and to perform an analysis of reliability, internal structure, internal consistency and concurrent criterion-related validity. Translation and psychometric testing. Two independent translators translated the OMPQ into Spanish. From both translations a consensus version was achieved. A backward translation was made to verify and resolve any semantic or conceptual problems. A total of 104 patients (67 men/37 women) with a mean age of 53.48 (±11.63), suffering from chronic musculoskeletal disorders, twice completed a Spanish version of the OMPQ. Statistical analysis was performed to evaluate the reliability, the internal structure, internal consistency and concurrent criterion-related validity with reference to the gold standard questionnaire SF-12v2. All variables except "Coping" showed a rate above 0.85 on reliability. The internal structure calculation through exploratory factor analysis indicated that 75.2% of the variance can be explained with six components with an eigenvalue higher than 1 and 52.1% with only three components higher than 10% of variance explained. In the concurrent criterion-related validity, several significant correlations were seen close to 0.6, exceeding that value in the correlation between general health and total value of the OMPQ. The Spanish version of the screening questionnaire OMPQ can be used to identify Spanish patients with musculoskeletal pain at risk of developing a chronic disability.

[The seventieth anniversary of Medicina (Buenos Aires)].

PubMed

Kantor, Isabel N; Kotsias, Basilio A

2010-01-01

The historical trajectory of Medicina (Buenos Aires) and the current challenges accompanying its seventieth birthday are briefly described. The initial objectives at its foundation were to contribute to the advance of medicine, and support both clinical and experimental research in Argentina. These objectives continue to be valid. The editorial presence of the journal continues to be necessary. It is published following the international quality standards, the peer review system, and it is indexed in the main international data bases for scientific journals.

Cultural competence in mental health nursing: validity and internal consistency of the Portuguese version of the multicultural mental health awareness scale-MMHAS.

PubMed

de Almeida Vieira Monteiro, Ana Paula Teixeira; Fernandes, Alexandre Bastos

2016-05-17

Cultural competence is an essential component in rendering effective and culturally responsive services to culturally and ethnically diverse clients. Still, great difficulty exists in assessing the cultural competence of mental health nurses. There are no Portuguese validated measurement instruments to assess cultural competence in mental health nurses. This paper reports a study testing the reliability and validity of the Portuguese version of the Multicultural Mental Health Awareness Scale-MMHAS in a sample of Portuguese nurses. Following a standard forward/backward translation into Portuguese, the adapted version of MMHAS, along with a sociodemographic questionnaire, were applied to a sample of 306 Portuguese nurses (299 males, 77 females; ages 21-68 years, M = 35.43, SD = 9.85 years). A psychometric research design was used with content and construct validity and reliability. Reliability was assessed using internal consistency and item-total correlations. Construct validity was determined using factor analysis. The factor analysis confirmed that the Portuguese version of MMHAS has a three-factor structure of multicultural competencies (Awareness, Knowledge, and Skills) explaining 59.51% of the total variance. Strong content validity and reliability correlations were demonstrated. The Portuguese version of MMHAS has a strong internal consistency, with a Cronbach's alpha of 0.958 for the total scale. The results supported the construct validity and reliability of the Portuguese version of MMHAS, proving that is a reliable and valid measure of multicultural counselling competencies in mental health nursing. The MMHAS Portuguese version can be used to evaluate the effectiveness of multicultural competency training programs in Portuguese-speaking mental health nurses. The scale can also be a useful in future studies of multicultural competencies in Portuguese-speaking nurses.

The case for an international patient-reported outcomes measurement information system (PROMIS®) initiative

PubMed Central

2013-01-01

Patient-reported outcomes (PROs) play an increasingly important role in clinical practice and research. Modern psychometric methods such as item response theory (IRT) enable the creation of item banks that support fixed-length forms as well as computerized adaptive testing (CAT), often resulting in improved measurement precision and responsiveness. Here we describe and discuss the case for developing an international core set of PROs building from the US PROMIS® network. PROMIS is a U.S.-based cooperative group of research sites and centers of excellence convened to develop and standardize PRO measures across studies and settings. If extended to a global collaboration, PROMIS has the potential to transform PRO measurement by creating a shared, unifying terminology and metric for reporting of common symptoms and functional life domains. Extending a common set of standardized PRO measures to the international community offers great potential for improving patient-centered research, clinical trials reporting, population monitoring, and health care worldwide. Benefits of such standardization include the possibility of: international syntheses (such as meta-analyses) of research findings; international population monitoring and policy development; health services administrators and planners access to relevant information on the populations they serve; better assessment and monitoring of patients by providers; and improved shared decision making. The goal of the current PROMIS International initiative is to ensure that item banks are translated and culturally adapted for use in adults and children in as many countries as possible. The process includes 3 key steps: translation/cultural adaptation, calibration, and validation. A universal translation, an approach focusing on commonalities, rather than differences across versions developed in regions or countries speaking the same language, is proposed to ensure conceptual equivalence for all items. International item calibration using nationally representative samples of adults and children within countries is essential to demonstrate that all items possess expected strong measurement properties. Finally, it is important to demonstrate that the PROMIS measures are valid, reliable and responsive to change when used in an international context. IRT item banking will allow for tailoring within countries and facilitate growth and evolution of PROs through contributions from the international measurement community. A number of opportunities and challenges of international development of PROs item banks are discussed. PMID:24359143

The case for an international patient-reported outcomes measurement information system (PROMIS®) initiative.

PubMed

Alonso, Jordi; Bartlett, Susan J; Rose, Matthias; Aaronson, Neil K; Chaplin, John E; Efficace, Fabio; Leplège, Alain; Lu, Aiping; Tulsky, David S; Raat, Hein; Ravens-Sieberer, Ulrike; Revicki, Dennis; Terwee, Caroline B; Valderas, Jose M; Cella, David; Forrest, Christopher B

2013-12-20

Patient-reported outcomes (PROs) play an increasingly important role in clinical practice and research. Modern psychometric methods such as item response theory (IRT) enable the creation of item banks that support fixed-length forms as well as computerized adaptive testing (CAT), often resulting in improved measurement precision and responsiveness. Here we describe and discuss the case for developing an international core set of PROs building from the US PROMIS® network.PROMIS is a U.S.-based cooperative group of research sites and centers of excellence convened to develop and standardize PRO measures across studies and settings. If extended to a global collaboration, PROMIS has the potential to transform PRO measurement by creating a shared, unifying terminology and metric for reporting of common symptoms and functional life domains. Extending a common set of standardized PRO measures to the international community offers great potential for improving patient-centered research, clinical trials reporting, population monitoring, and health care worldwide. Benefits of such standardization include the possibility of: international syntheses (such as meta-analyses) of research findings; international population monitoring and policy development; health services administrators and planners access to relevant information on the populations they serve; better assessment and monitoring of patients by providers; and improved shared decision making.The goal of the current PROMIS International initiative is to ensure that item banks are translated and culturally adapted for use in adults and children in as many countries as possible. The process includes 3 key steps: translation/cultural adaptation, calibration, and validation. A universal translation, an approach focusing on commonalities, rather than differences across versions developed in regions or countries speaking the same language, is proposed to ensure conceptual equivalence for all items. International item calibration using nationally representative samples of adults and children within countries is essential to demonstrate that all items possess expected strong measurement properties. Finally, it is important to demonstrate that the PROMIS measures are valid, reliable and responsive to change when used in an international context.IRT item banking will allow for tailoring within countries and facilitate growth and evolution of PROs through contributions from the international measurement community. A number of opportunities and challenges of international development of PROs item banks are discussed.

77 FR 31515 - Validation of Merchant Mariners' Vital Information and Issuance of Coast Guard Merchant Mariner's...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-29

... III. Basis and Purpose IV. Background V. Discussion of Comments and Changes VI. Regulatory Analyses A...) Implementation of the 1995 Amendments to the International Convention on Standards of Training, Certification and... 11216) and implemented changes to the other definitions listed within the section. The Coast Guard is...

What Works Clearinghouse Standards and Generalization of Single-Case Design Evidence

ERIC Educational Resources Information Center

Hitchcock, John H.; Kratochwill, Thomas R.; Chezan, Laura C.

2015-01-01

A recent review of existing rubrics designed to help researchers evaluate the internal and external validity of single-case design (SCD) studies found that the various options yield consistent results when examining causal arguments. The authors of the review, however, noted considerable differences across the rubrics when addressing the…

Towards a Risk-Based Typology for Transnational Education

ERIC Educational Resources Information Center

Healey, Nigel Martin

2015-01-01

Transnational education (TNE) has been a growth area for UK universities over the last decade. The standard typology classifies TNE by the nature of the activity (i.e., distance learning, international branch campus, franchise, and validation). By analysing a large number of TNE partnerships around the world, this study reveals that the current…

Multi-Criteria Decision Analysis of Test Endpoints for Detecting the Effects of Endocrine Active Substances in Fish Full Life Cycle Tests

EPA Science Inventory

Fish full life cycle (FFLC) tests are increasingly required in the ecotoxicological assessment of endocrine active substances. However, FFLC tests have not been internationally standardized or validated, and it is currently unclear how such tests should best be designed to provid...

Converging Transnational Financial Reporting Standards: Validating the Joint FASB/IASB Concept of Information Quality

ERIC Educational Resources Information Center

Watkins, Jim

2012-01-01

Accelerating cross-border investing activity transformed global financial markets during the latter part of the 20th century. Due to lack of trans-cultural consistency comparability in financial reporting was compromised hindering multinational investment. In light thereof there is a movement afoot among international authorities to converge…

Item Specification in the Development of a Diagnostic Gambling Instrument: A Focus Group Approach

ERIC Educational Resources Information Center

Cunningham-Williams, Renee M.; Zayas, Luis E.; Books, Samantha J.; Cottler, Linda B.

2008-01-01

Pathological Gambling Disorder (PGD) is internationally prevalent and contributes to significant disruption and impairment in a gambler's life. For accurate diagnosis and treatment planning, clinicians require standardized criteria as in commonly used DSM and ICD-10 taxonomies, which are conceptually clear, valid, and culturally appropriate. We…

Measuring Waist Circumference in Disabled Adults

ERIC Educational Resources Information Center

Waninge, A.; Ligthart, K. A. M.; Kramer, J.; Hoeve, S.; van der Schans, C. P.; Haisma, H. H.

2010-01-01

To date, it is unknown whether waist circumference can be measured validly and reliably when a subject is in a supine position. This issue is relevant when international standards for healthy participants are applied to persons with severe intellectual, sensory, and motor disabilities. Thus, the aims of our study were (1) to determine the validity…

Current state-of-art of STR sequencing in forensic genetics.

PubMed

Alonso, Antonio; Barrio, Pedro A; Müller, Petra; Köcher, Steffi; Berger, Burkhard; Martin, Pablo; Bodner, Martin; Willuweit, Sascha; Parson, Walther; Roewer, Lutz; Budowle, Bruce

2018-05-11

The current state of validation and implementation strategies of MPS technology for the analysis of STR markers for forensic genetics use is described, covering the topics of the current catalogue of commercial MPS-STR panels, leading MPS-platforms, and MPS-STR data analysis tools. In addition, the developmental and internal validation studies carried out to date to evaluate reliability, sensitivity, mixture analysis, concordance, and the ability to analyze challenged samples are summarized. The results of various MPS-STR population studies that showed a large number of new STR sequence variants that increase the power of discrimination in several forensically-relevant loci are also presented. Finally, various initiatives developed by several international projects and standardization (or guidelines) groups to facilitate application of MPS technology for STR marker analyses are discussed in regard to promoting a standard STR sequence nomenclature, performing population studies to detect sequence variants, and developing a universal system to translate sequence variants into a simple STR nomenclature (numbers and letters) compatible with national STR databases. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

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

PubMed

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

2016-09-01

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

THE CHALLENGE OF CIEMAT INTERNAL DOSIMETRY SERVICE FOR ACCREDITATION ACCORDING TO ISO/IEC 17025 STANDARD, FOR IN VIVO AND IN VITRO MONITORING AND DOSE ASSESSMENT OF INTERNAL EXPOSURES.

PubMed

Lopez, M A; Martin, R; Hernandez, C; Navarro, J F; Navarro, T; Perez, B; Sierra, I

2016-09-01

The accreditation of an Internal Dosimetry Service (IDS) according to ISO/IEC 17025 Standard is a challenge. The aim of this process is to guarantee the technical competence for the monitoring of radionuclides incorporated in the body and for the evaluation of the associated committed effective dose E(50). This publication describes the main accreditation issues addressed by CIEMAT IDS regarding all the procedures involving good practice in internal dosimetry, focussing in the difficulties to ensure the traceability in the whole process, the appropriate calculation of detection limit of measurement techniques, the validation of methods (monitoring and dose assessments), the description of all the uncertainty sources and the interpretation of monitoring data to evaluate the intake and the committed effective dose. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Standard International prognostic index remains a valid predictor of outcome for patients with aggressive CD20+ B-cell lymphoma in the rituximab era.

PubMed

Ziepert, Marita; Hasenclever, Dirk; Kuhnt, Evelyn; Glass, Bertram; Schmitz, Norbert; Pfreundschuh, Michael; Loeffler, Markus

2010-05-10

The International Prognostic Index (IPI) is widely used for risk stratification of patients with aggressive B-cell lymphoma. The introduction of rituximab has markedly improved outcome, and R-CHOP (rituximab + cyclophosphamide, doxorubicin, vincristine, prednisone) has become the standard treatment for CD20(+) diffuse large B-cell lymphoma. To investigate whether the IPI has maintained its power for risk stratification when rituximab is combined with CHOP, we analyzed the prognostic relevance of IPI in three prospective clinical trials. In total, 1,062 patients treated with rituximab were included (MabThera International Trial [MInT], 380 patients; dose-escalated regimen of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone (MegaCHOEP) trial, 72 patients; CHOP + rituximab for patients older than age 60 years [RICOVER-60] trial, 610 patients). A multivariate proportional hazards modeling was performed for single IPI factors under rituximab on event-free, progression-free, and overall survival. IPI score was significant for all three end points. Rituximab significantly improved treatment outcome within each IPI group resulting in a quenching of the Kaplan-Meier estimators. However, IPI was a significant prognostic factor in all three end points and the ordering of the IPI groups remained valid. The relative risk estimates of single IPI factors and their order in patients treated with R-CHOP were similar to those found with CHOP. The effects of rituximab were superimposed on the effects of CHOP with no interactions between chemotherapy and antibody therapy. These results demonstrate that the IPI is still valid in the R-CHOP era.

The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials.

PubMed

Schmitt, Jochen; Spuls, Phyllis I; Thomas, Kim S; Simpson, Eric; Furue, Masutaka; Deckert, Stefanie; Dohil, Magdalene; Apfelbacher, Christian; Singh, Jasvinder A; Chalmers, Joanne; Williams, Hywel C

2014-10-01

The lack of core outcome sets for atopic eczema (AE) is a major obstacle for advancing evidence-based treatment. The global Harmonising Outcome Measures for Eczema (HOME) initiative has already defined clinical signs, symptoms, quality of life, and long-term control of flares as core outcome domains for AE trials. This article deals with the standardization of measurement instruments to assess clinical signs of AE. To resolve the current lack of standardization of the assessment of clinical signs of AE, we followed a structured process of systematic reviews and international consensus sessions to identify 1 core outcome measurement instrument for assessment of clinical signs in all future AE trials. Systematic reviews indicated that from 16 different instruments identified to assess clinical signs of AE, only the Eczema Area and Severity Index (EASI) and the objective Scoring Atopic Dermatitis (SCORAD) index were identified as extensively validated. The EASI has adequate validity, responsiveness, internal consistency, and intraobserver reliability. The objective SCORAD index has adequate validity, responsiveness, and interobserver reliability but unclear intraobserver reliability to measure clinical signs of AE. In an international consensus study, patients, physicians, nurses, methodologists, and pharmaceutical industry representatives agreed that the EASI is the preferred core instrument to measure clinical signs in all future AE trials. All stakeholders involved in designing, reporting, and using clinical trials on AE are asked to comply with this consensus to enable better evidence-based decision making, clearer scientific communication, and improved patient care. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

PA.NET International Quality Certification Protocol for blood pressure monitors.

PubMed

Omboni, Stefano; Costantini, Carlo; Pini, Claudio; Bulegato, Roberto; Manfellotto, Dario; Rizzoni, Damiano; Palatini, Paolo; O'brien, Eoin; Parati, Gianfranco

2008-10-01

Although standard validation protocols provide assurance of the accuracy of blood pressure monitors (BPMs), there is no guidance for the consumer as to the overall quality of a device. The PA.NET International Quality Certification Protocol, developed by the Association for Research and Development of Biomedical Technologies and for Continuing Medical Education (ARSMED), a nonprofit organization, with the support of the Italian Society of Hypertension-Italian Hypertension League, and the dabl Educational Trust denotes additional criteria of quality for BPMs that fulfilled basic validation criteria, published in full in peer-reviewed medical journals. The certification is characterized by three phases: (i) to determine that the device fulfilled standard validation criteria; (ii) to determine the technical and functional characteristics of the device (e.g. operativity, display dimension, accessory functions, memory availability, etc.) and (iii) to determine the commercial characteristics (e.g. price-quality ratio, after-sale service, guarantee, etc.). At the end of the certification process, ARSMED attributes a quality index to the device, based on a scale ranging from 1 to 100, and a quality seal with four different grades (bronze, silver, gold and diamond) according to the achieved score. The seal is identified by a unique alphanumeric code. The quality seal may be used on the packaging of the appliance or in advertising. A quality certification is released to the manufacturer and published on www.pressionearteriosa.net and www.dableducational.org. The PA.NET International Quality Certification Protocol represents the first attempt to provide health care personnel and consumers with an independent and objective assessment of BPMs based on their quality.

Analytical method for the identification and assay of 12 phthalates in cosmetic products: application of the ISO 12787 international standard "Cosmetics-Analytical methods-Validation criteria for analytical results using chromatographic techniques".

PubMed

Gimeno, Pascal; Maggio, Annie-Françoise; Bousquet, Claudine; Quoirez, Audrey; Civade, Corinne; Bonnet, Pierre-Antoine

2012-08-31

Esters of phthalic acid, more commonly named phthalates, may be present in cosmetic products as ingredients or contaminants. Their presence as contaminant can be due to the manufacturing process, to raw materials used or to the migration of phthalates from packaging when plastic (polyvinyl chloride--PVC) is used. 8 phthalates (DBP, DEHP, BBP, DMEP, DnPP, DiPP, DPP, and DiBP), classified H360 or H361, are forbidden in cosmetics according to the European regulation on cosmetics 1223/2009. A GC/MS method was developed for the assay of 12 phthalates in cosmetics, including the 8 phthalates regulated. Analyses are carried out on a GC/MS system with electron impact ionization mode (EI). The separation of phthalates is obtained on a cross-linked 5%-phenyl/95%-dimethylpolysiloxane capillary column 30 m × 0.25 mm (i.d.) × 0.25 mm film thickness using a temperature gradient. Phthalate quantification is performed by external calibration using an internal standard. Validation elements obtained on standard solutions, highlight a satisfactory system conformity (resolution>1.5), a common quantification limit at 0.25 ng injected, an acceptable linearity between 0.5 μg mL⁻¹ and 5.0 μg mL⁻¹ as well as a precision and an accuracy in agreement with in-house specifications. Cosmetic samples ready for analytical injection are analyzed after a dilution in ethanol whereas more complex cosmetic matrices, like milks and creams, are assayed after a liquid/liquid extraction using ter-butyl methyl ether (TBME). Depending on the type of cosmetics analyzed, the common limits of quantification for the 12 phthalates were set at 0.5 or 2.5 μg g⁻¹. All samples were assayed using the analytical approach described in the ISO 12787 international standard "Cosmetics-Analytical methods-Validation criteria for analytical results using chromatographic techniques". This analytical protocol is particularly adapted when it is not possible to make reconstituted sample matrices. Copyright © 2012 Elsevier B.V. All rights reserved.

Changes to publication requirements made at the XVIII International Botanical Congress in Melbourne - what does e-publication mean for you?

PubMed Central

2011-01-01

Changes to the International Code of Botanical Nomenclature are decided on every 6 years at Nomenclature Sections associated with International Botanical Congresses (IBC). The XVIII IBC was held in Melbourne, Australia; the Nomenclature Section met on 18-22 July 2011 and its decisions were accepted by the Congress at its plenary session on 30 July. Several important changes were made to the Code as a result of this meeting that will affect publication of new names. Two of these changes will come into effect on 1 January 2012, some months before the Melbourne Code is published. Electronic material published online in Portable Document Format (PDF) with an International Standard Serial Number (ISSN) or an International Standard Book Number (ISBN) will constitute effective publication, and the requirement for a Latin description or diagnosis for names of new taxa will be changed to a requirement for a description or diagnosis in either Latin or English. In addition, effective from 1 January 2013, new names of organisms treated as fungi must, in order to be validly published, include in the protologue (everything associated with a name at its valid publication) the citation of an identifier issued by a recognized repository (such as MycoBank). Draft text of the new articles dealing with electronic publication is provided and best practice is outlined. To encourage dissemination of the changes made to the International Code of Nomenclature for algae, fungi, and plants, this article will be published in BMC Evolutionary Biology, Botanical Journal of the Linnean Society, Brittonia, Cladistics, MycoKeys, Mycotaxon, New Phytologist, North American Fungi, Novon, Opuscula Philolichenum, PhytoKeys, Phytoneuron, Phytotaxa, Plant Diversity and Resources, Systematic Botany and Taxon. PMID:21917189

Changes to publication requirements made at the XVIII International Botanical Congress in Melbourne - what does e-publication mean for you?

PubMed Central

Knapp, Sandra; McNeill, John; Turland, Nicholas J.

2011-01-01

Abstract Changes to the International Code of Botanical Nomenclature are decided on every 6 years at Nomenclature Sections associated with International Botanical Congresses (IBC). The XVIII IBC was held in Melbourne, Australia; the Nomenclature Section met on 18-22 July 2011 and its decisions were accepted by the Congress at its plenary session on 30 July. Several important changes were made to the Code as a result of this meeting that will affect publication of new names. Two of these changes will come into effect on 1 January 2012, some months before the Melbourne Code is published. Electronic material published online in Portable Document Format (PDF) with an International Standard Serial Number (ISSN) or an International Standard Book Number (ISBN) will constitute effective publication, and the requirement for a Latin description or diagnosis for names of new taxa will be changed to a requirement for a description or diagnosis in either Latin or English. In addition, effective from 1 January 2013, new names of organisms treated as fungi must, in order to be validly published, include in the protologue (everything associated with a name at its valid publication) the citation of an identifier issued by a recognized repository (such as MycoBank). Draft text of the new articles dealing with electronic publication is provided and best practice is outlined. To encourage dissemination of the changes made to the International Code of Nomenclature for algae, fungi, and plants, this article will be published in BMC Evolutionary Biology, Botanical Journal of the Linnean Society, Brittonia, Cladistics, MycoKeys, Mycotaxon, New Phytologist, North American Fungi, Novon, Opuscula Philolichenum, PhytoKeys, Phytoneuron, Phytotaxa, Plant Diversity and Resources, Systematic Botany and Taxon. PMID:22287918

Anthropometric standardisation and quality control protocols for the construction of new, international, fetal and newborn growth standards: the INTERGROWTH-21st Project.

PubMed

Cheikh Ismail, L; Knight, H E; Ohuma, E O; Hoch, L; Chumlea, W C

2013-09-01

The primary aim of the INTERGROWTH-21(st) Project is to construct new, prescriptive standards describing optimal fetal and preterm postnatal growth. The anthropometric measurements include the head circumference, recumbent length and weight of the infants, and the stature and weight of the parents. In such a large, international, multicentre project, it is critical that all study sites follow standardised protocols to ensure maximal validity of the growth and nutrition indicators used. This paper describes in detail the anthropometric training, standardisation and quality control procedures used to collect data for these new standards. The initial standardisation session was in Nairobi, Kenya, using newborns, which was followed by similar sessions in the eight participating study sites in Brazil, China, India, Italy, Kenya, Oman, UK and USA. The intraobserver and inter-observer technical error of measurement values for head circumference range from 0.3 to 0.4 cm, and for recumbent length from 0.3 to 0.5 cm. These standardisation protocols implemented at each study site worldwide ensure that the anthropometric data collected are of the highest quality to construct international growth standards. © 2013 Royal College of Obstetricians and Gynaecologists.

Simultaneous determination of ascorbic acid and caffeine in commercial soft drinks using reversed-phase ultraperformance liquid chromatography.

PubMed

Turak, Fatma; Güzel, Remziye; Dinç, Erdal

2017-04-01

A new reversed-phase ultraperformance liquid chromatography method with a photodiode array detector was developed for the quantification of ascorbic acid (AA) and caffeine (CAF) in 11 different commercial drinks consisting of one energy drink and 10 ice tea drinks. Separation of the analyzed AA and CAF with an internal standard, caffeic acid, was performed on a Waters BEH C 18 column (100 mm × 2.1 mm, 1.7 μm i.d.), using a mobile phase consisting of acetonitrile and 0.2M H 3 PO 4 (11:89, v/v) with a flow rate of 0.25 mL/min and an injection volume of 1.0 μL. Calibration graphs for AA and CAF were computed from the peak area ratio of AA/internal standard and CAF/internal standard detected at 244.0 nm and 273.6 nm, respectively. The developed reversed-phase ultraperformance liquid chromatography method was validated by analyzing standard addition samples. The proposed reversed-phase ultraperformance liquid chromatography method gave us successful results for the quantitative analysis of commercial drinks containing AA and CAF substances. Copyright © 2016. Published by Elsevier B.V.

Extended internal standard method for quantitative 1H NMR assisted by chromatography (EIC) for analyte overlapping impurity on 1H NMR spectra.

PubMed

Saito, Naoki; Kitamaki, Yuko; Otsuka, Satoko; Yamanaka, Noriko; Nishizaki, Yuzo; Sugimoto, Naoki; Imura, Hisanori; Ihara, Toshihide

2018-07-01

We devised a novel extended internal standard method of quantitative 1 H NMR (qNMR) assisted by chromatography (EIC) that accurately quantifies 1 H signal areas of analytes, even when the chemical shifts of the impurity and analyte signals overlap completely. When impurity and analyte signals overlap in the 1 H NMR spectrum but can be separated in a chromatogram, the response ratio of the impurity and an internal standard (IS) can be obtained from the chromatogram. If the response ratio can be converted into the 1 H signal area ratio of the impurity and the IS, the 1 H signal area of the analyte can be evaluated accurately by mathematically correcting the contributions of the 1 H signal area of the impurity overlapping the analyte in the 1 H NMR spectrum. In this study, gas chromatography and liquid chromatography were used. We used 2-chlorophenol and 4-chlorophenol containing phenol as an impurity as examples in which impurity and analyte signals overlap to validate and demonstrate the EIC, respectively. Because the 1 H signals of 2-chlorophenol and phenol can be separated in specific alkaline solutions, 2-chlorophenol is suitable to validate the EIC by comparing analytical value obtained by the EIC with that by only qNMR under the alkaline condition. By the EIC, the purity of 2-chlorophenol was obtained with a relative expanded uncertainty (k = 2) of 0.24%. The purity matched that obtained under the alkaline condition. Furthermore, the EIC was also validated by evaluating the phenol content with the absolute calibration curve method by gas chromatography. Finally, we demonstrated that the EIC was possible to evaluate the purity of 4-chlorophenol, with a relative expanded uncertainty (k = 2) of 0.22%, which was not able to be separated from the 1 H signal of phenol under any condition. Copyright © 2018 Elsevier B.V. All rights reserved.

The JaCVAM international validation study on the in vivo comet assay: Selection of test chemicals.

PubMed

Morita, Takeshi; Uno, Yoshifumi; Honma, Masamitsu; Kojima, Hajime; Hayashi, Makoto; Tice, Raymond R; Corvi, Raffaella; Schechtman, Leonard

2015-07-01

The Japanese Center for the Validation of Alternative Methods (JaCVAM) sponsored an international prevalidation and validation study of the in vivo rat alkaline pH comet assay. The main objective of the study was to assess the sensitivity and specificity of the assay for correctly identifying genotoxic carcinogens, as compared with the traditional rat liver unscheduled DNA synthesis assay. Based on existing carcinogenicity and genotoxicity data and chemical class information, 90 chemicals were identified as primary candidates for use in the validation study. From these 90 chemicals, 46 secondary candidates and then 40 final chemicals were selected based on a sufficiency of carcinogenic and genotoxic data, differences in chemical class or genotoxic or carcinogenic mode of action (MOA), availability, price, and ease of handling. These 40 chemicals included 19 genotoxic carcinogens, 6 genotoxic non-carcinogens, 7 non-genotoxic carcinogens and 8 non-genotoxic non-carcinogens. "Genotoxicity" was defined as positive in the Ames mutagenicity test or in one of the standard in vivo genotoxicity tests (primarily the erythrocyte micronucleus assay). These chemicals covered various chemicals classes, MOAs, and genotoxicity profiles and were considered to be suitable for the purpose of the validation study. General principles of chemical selection for validation studies are discussed. Copyright © 2015 Elsevier B.V. All rights reserved.

Ten years of the International Patient Decision Aid Standards Collaboration: evolution of the core dimensions for assessing the quality of patient decision aids

PubMed Central

2013-01-01

In 2003, the International Patient Decision Aid Standards (IPDAS) Collaboration was established to enhance the quality and effectiveness of patient decision aids by establishing an evidence-informed framework for improving their content, development, implementation, and evaluation. Over this 10 year period, the Collaboration has established: a) the background document on 12 core dimensions to inform the original modified Delphi process to establish the IPDAS checklist (74 items); b) the valid and reliable IPDAS instrument (47 items); and c) the IPDAS qualifying (6 items), certifying (6 items + 4 items for screening), and quality criteria (28 items). The objective of this paper is to describe the evolution of the IPDAS Collaboration and discuss the standardized process used to update the background documents on the theoretical rationales, evidence and emerging issues underlying the 12 core dimensions for assessing the quality of patient decision aids. PMID:24624947

Validity, reliability and Norwegian adaptation of the Stroke-Specific Quality of Life (SS-QOL) scale

PubMed Central

Pedersen, Synne Garder; Heiberg, Guri Anita; Nielsen, Jørgen Feldbæk; Friborg, Oddgeir; Stabel, Henriette Holm; Anke, Audny; Arntzen, Cathrine

2018-01-01

Background: There is a paucity of stroke-specific instruments to assess health-related quality of life in the Norwegian language. The objective was to examine the validity and reliability of a Norwegian version of the 12-domain Stroke-Specific Quality of Life scale. Methods: A total of 125 stroke survivors were prospectively recruited. Questionnaires were administered at 3 months; 36 test–retests were performed at 12 months post stroke. The translation was conducted according to guidelines. The internal consistency was assessed with Cronbach’s alpha; convergent validity, with item-to-subscale correlations; and test–retest, with Spearman’s correlations. Scaling validity was explored by calculating both floor and ceiling effects. A priori hypotheses regarding the associations between the Stroke-Specific Quality of Life domain scores and scores of established measures were tested. Standard error of measurement was assessed. Results: The Norwegian version revealed no major changes in back translations. The internal consistency values of the domains were Cronbach’s alpha = 0.79–0.93. Rates of missing items were small, and the item-to-subscale correlation coefficients supported convergent validity (0.48–0.87). The observed floor effects were generally small, whereas the ceiling effects had moderate or high values (16%–63%). Test–retest reliability indicated stability in most domains, with Spearman’s rho = 0.67–0.94 (all p < 0.001), whereas the rho was 0.35 (p < 0.05) for the ‘Vision’ domain. Hypothesis testing supported the construct validity of the scale. Standard error of measurement values for each domain were generated to indicate the required magnitudes of detectable change. Conclusions: The Norwegian version of the Stroke-Specific Quality of Life scale is a reliable and valid instrument with good psychometric properties. It is suited for use in health research as well as in individual assessments of persons with stroke. PMID:29344360

Validity, reliability and Norwegian adaptation of the Stroke-Specific Quality of Life (SS-QOL) scale.

PubMed

Pedersen, Synne Garder; Heiberg, Guri Anita; Nielsen, Jørgen Feldbæk; Friborg, Oddgeir; Stabel, Henriette Holm; Anke, Audny; Arntzen, Cathrine

2018-01-01

There is a paucity of stroke-specific instruments to assess health-related quality of life in the Norwegian language. The objective was to examine the validity and reliability of a Norwegian version of the 12-domain Stroke-Specific Quality of Life scale. A total of 125 stroke survivors were prospectively recruited. Questionnaires were administered at 3 months; 36 test-retests were performed at 12 months post stroke. The translation was conducted according to guidelines. The internal consistency was assessed with Cronbach's alpha; convergent validity, with item-to-subscale correlations; and test-retest, with Spearman's correlations. Scaling validity was explored by calculating both floor and ceiling effects. A priori hypotheses regarding the associations between the Stroke-Specific Quality of Life domain scores and scores of established measures were tested. Standard error of measurement was assessed. The Norwegian version revealed no major changes in back translations. The internal consistency values of the domains were Cronbach's alpha = 0.79-0.93. Rates of missing items were small, and the item-to-subscale correlation coefficients supported convergent validity (0.48-0.87). The observed floor effects were generally small, whereas the ceiling effects had moderate or high values (16%-63%). Test-retest reliability indicated stability in most domains, with Spearman's rho = 0.67-0.94 (all p < 0.001), whereas the rho was 0.35 (p < 0.05) for the 'Vision' domain. Hypothesis testing supported the construct validity of the scale. Standard error of measurement values for each domain were generated to indicate the required magnitudes of detectable change. The Norwegian version of the Stroke-Specific Quality of Life scale is a reliable and valid instrument with good psychometric properties. It is suited for use in health research as well as in individual assessments of persons with stroke.

Standard values and relationship-specific validity of the Bielefeld Relationship Expectations Questionnaire (BFPE).

PubMed

Petrowski, Katja; Berth, Hendrik; Paul, Sören; Grande, Gesine; Stöbel-Richter, Yve; Brähler, Elmar

2010-10-13

The Bielefeld Partnership Expectations Questionnaire (BFPE) is a tool to assess attachment in the romantic relationships of adults. The attachment styles are operationalized as configuration patterns of scale scores. While convergent validity has already been investigated, discriminant validity is still lacking confirmation. The present sample (n = 1509) is representative for the German population aged 18 to 50. The mean age was 34.6 years. Most of the participants lived in a relationship (77.3 %). Discriminant validity was analyzed using a marital quality questionnaire (PFB), a social support questionnaire (F-Soz-U K-14), and a life satisfaction questionnaire (FLZ). All the BFPE scales have a satisfying internal consistency between r = .79 and .86. Those individuals who showed a secure pattern, i.e. increased "Readiness for Self-Disclosure" and "Conscious Need for Care" as well as reduced "Fear of Rejection" experienced their partner as socially supportive, reported higher marital quality in all of its facets, and were more satisfied within the life-domains "family/children" and "relationship/sexuality". Standard values for each scale are presented. The BFPE has repeatedly been verified as a short, reliable, and valid instrument applicable to research practice with healthy individuals as well as within clinical contexts.

Software for imaging phase-shift interference microscope

NASA Astrophysics Data System (ADS)

Malinovski, I.; França, R. S.; Couceiro, I. B.

2018-03-01

In recent years absolute interference microscope was created at National Metrology Institute of Brazil (INMETRO). The instrument by principle of operation is imaging phase-shifting interferometer (PSI) equipped with two stabilized lasers of different colour as traceable reference wavelength sources. We report here some progress in development of the software for this instrument. The status of undergoing internal validation and verification of the software is also reported. In contrast with standard PSI method, different methodology of phase evaluation is applied. Therefore, instrument specific procedures for software validation and verification are adapted and discussed.

Gross alpha and beta activity analyses in urine-a routine laboratory method for internal human radioactivity detection.

PubMed

Chen, Xiaowen; Zhao, Luqian; Qin, Hongran; Zhao, Meijia; Zhou, Yirui; Yang, Shuqiang; Su, Xu; Xu, Xiaohua

2014-05-01

The aim of this work was to develop a method to provide rapid results for humans with internal radioactive contamination. The authors hypothesized that valuable information could be obtained from gas proportional counter techniques by screening urine samples from potentially exposed individuals rapidly. Recommended gross alpha and beta activity screening methods generally employ gas proportional counting techniques. Based on International Standards Organization (ISO) methods, improvements were made in the evaporation process to develop a method to provide rapid results, adequate sensitivity, and minimum sample preparation and operator intervention for humans with internal radioactive contamination. The method described by an American National Standards Institute publication was used to calibrate the gas proportional counter, and urine samples from patients with or without radionuclide treatment were measured to validate the method. By improving the evaporation process, the time required to perform the assay was reduced dramatically. Compared with the reference data, the results of the validation samples were very satisfactory with respect to gross-alpha and gross-beta activities. The gas flow proportional counting method described here has the potential for radioactivity monitoring in the body. This method was easy, efficient, and fast, and its application is of great utility in determining whether a sample should be analyzed by a more complicated method, for example radiochemical and/or γ-spectroscopy. In the future, it may be used commonly in medical examination and nuclear emergency treatment.Health Phys. 106(5):000-000; 2014.

Liquid-liquid extraction of strongly protein bound BMS-299897 from human plasma and cerebrospinal fluid, followed by high-performance liquid chromatography/tandem mass spectrometry.

PubMed

Xue, Y J; Pursley, Janice; Arnold, Mark

2007-04-11

BMS-299897 is a gamma-secretase inhibitor that is being developed for the treatment of Alzheimer's disease. Liquid-liquid extraction (LLE), chromatographic/tandem mass spectrometry (LC/MS/MS) methods have been developed and validated for the quantitation of BMS-299897 in human plasma and cerebrospinal fluid (CSF). Both methods utilized (13)C6-BMS-299897, the stable label isotope analog, as the internal standard. For the human plasma extraction method, two incubation steps were required after the addition of 5 mM ammonium acetate and the internal standard in acetonitrile to release the analyte bound to proteins prior to LLE with toluene. For the human CSF extraction method, after the addition of 0.5 N HCl and the internal standard, CSF samples were extracted with toluene and no incubation was required. The organic layers obtained from both extraction methods were removed and evaporated to dryness. The residues were reconstituted and injected into the LC/MS/MS system. Chromatographic separation was achieved isocratically on a MetaChem C18 Hypersil BDS column (2.0 mm x 50 mm, 3 microm). The mobile phase contained 10 mM ammonium acetate pH 5 and acetonitrile. Detection was by negative ion electrospray tandem mass spectrometry. The standard curves ranged from 1 to 1000 ng/ml for human plasma and 0.25-100 ng/ml for human CSF. Both standard curves were fitted to a 1/x weighted quadratic regression model. For both methods, the intra-assay precision was within 8.2% CV, the inter-assay precision was within 5.4% CV, and assay accuracy was within +/-7.4% of the nominal values. The validation and sample analysis results demonstrated that both methods had acceptable precision and accuracy across the calibration ranges.

Nurses' knowledge and attitudes towards aged sexuality: validity and internal consistency of the Dutch version of the Aging Sexual Knowledge and Attitudes Scale.

PubMed

Mahieu, Lieslot; de Casterlé, Bernadette Dierckx; Van Elssen, Kim; Gastmans, Chris

2013-11-01

This paper reports a study testing the content and face validity and internal consistency of the Dutch version of the Aging Sexual Knowledge and Attitudes Scale. The ability of older residents to sexually express themselves is known to be influenced by the knowledge and attitudes of nursing home staff towards later-life sexuality. Although the Aging Sexual Knowledge and Attitudes Scale is a widely used instrument to measure this, there is no validated, Dutch translation available. Instrument development. Following a standard forward/backward translation into Dutch, the scale was further adapted for use in Flemish nursing home settings. Content and face validity and user-friendliness were assessed. The psychometric properties were determined by means of an exploratory study. Data were collected from March-April 2011 at eight Flemish nursing homes. Reliability was assessed using internal consistency and item-total correlations. Both subscales of the Flemish adaptation showed acceptable content validity. The face validity and user-friendliness were deemed favourable with hardly any remarks given by the expert panel. The Cronbach's α was 0.80 and 0.88 for the knowledge and attitude subscales, respectively. The item-total correlations ranged from 0.21-0.48 for the knowledge section and from 0.09-0.68 for the attitude subscale. We conclude from our study that the Dutch version of the scale has acceptable to good psychometric properties. The Flemish adaptation therefore seems to be a valuable instrument for studying nursing staff's knowledge and attitudes towards aged sexuality in Flanders. © 2013 Blackwell Publishing Ltd.

Rating scales for dystonia in cerebral palsy: reliability and validity.

PubMed

Monbaliu, E; Ortibus, E; Roelens, F; Desloovere, K; Deklerck, J; Prinzie, P; de Cock, P; Feys, H

2010-06-01

This study investigated the reliability and validity of the Barry-Albright Dystonia Scale (BADS), the Burke-Fahn-Marsden Movement Scale (BFMMS), and the Unified Dystonia Rating Scale (UDRS) in patients with bilateral dystonic cerebral palsy (CP). Three raters independently scored videotapes of 10 patients (five males, five females; mean age 13 y 3 mo, SD 5 y 2 mo, range 5-22 y). One patient each was classified at levels I-IV in the Gross Motor Function Classification System and six patients were classified at level V. Reliability was measured by (1) intraclass correlation coefficient (ICC) for interrater reliability, (2) standard error of measurement (SEM) and smallest detectable difference (SDD), and (3) Cronbach's alpha for internal consistency. Validity was assessed by Pearson's correlations among the three scales used and by content analysis. Moderate to good interrater reliability was found for total scores of the three scales (ICC: BADS=0.87; BFMMS=0.86; UDRS=0.79). However, many subitems showed low reliability, in particular for the UDRS. SEM and SDD were respectively 6.36% and 17.72% for the BADS, 9.88% and 27.39% for the BFMMS, and 8.89% and 24.63% for the UDRS. High internal consistency was found. Pearson's correlations were high. Content validity showed insufficient accordance with the new CP definition and classification. Our results support the internal consistency and concurrent validity of the scales; however, taking into consideration the limitations in reliability, including the large SDD values and the content validity, further research on methods of assessment of dystonia is warranted.

Community validation of the IDEA study cognitive screen in rural Tanzania.

PubMed

Gray, William K; Paddick, Stella Maria; Collingwood, Cecilia; Kisoli, Aloyce; Mbowe, Godfrey; Mkenda, Sarah; Lissu, Carolyn; Rogathi, Jane; Kissima, John; Walker, Richard W; Mushi, Declare; Chaote, Paul; Ogunniyi, Adesola; Dotchin, Catherine L

2016-11-01

The dementia diagnosis gap in sub-Saharan Africa (SSA) is large, partly because of difficulties in screening for cognitive impairment in the community. As part of the Identification and Intervention for Dementia in Elderly Africans (IDEA) study, we aimed to validate the IDEA cognitive screen in a community-based sample in rural Tanzania METHODS: Study participants were recruited from people who attended screening days held in villages within the rural Hai district of Tanzania. Criterion validity was assessed against the gold standard clinical dementia diagnosis using DSM-IV criteria. Construct validity was assessed against, age, education, sex and grip strength and instrumental activities of daily living (IADLs). Internal consistency and floor and ceiling effects were also examined. During community screening, the IDEA cognitive screen had high criterion validity, with an area under the receiver operating characteristic curve of 0.855 (95% CI 0.794 to 0.915). Higher scores on the screen were significantly correlated with lower age, male sex, having attended school, better grip strength and improved performance in activities of daily living. Factor analysis revealed a single factor with an eigenvalue greater than one, although internal consistency was only moderate (Cronbach's alpha = 0.534). The IDEA cognitive screen had high criterion and construct validity and is suitable for use as a cognitive screening instrument in a community setting in SSA. Only moderate internal consistency may partly reflect the multi-domain nature of dementia as diagnosed clinically. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

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

PubMed Central

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

2017-01-01

With increasing awareness regarding biorisk management worldwide, many biosafety laboratories are being setup in India. It is important for the facility users, project managers and the executing agencies to understand the process of validation and certification of such biosafety laboratories. There are some international guidelines available, but there are no national guidelines or reference standards available in India on certification and validation of biosafety laboratories. There is no accredited government/private agency available in India to undertake validation and certification of biosafety laboratories. Therefore, the reliance is mostly on indigenous experience, talent and expertise available, which is in short supply. This article elucidates the process of certification and validation of biosafety laboratories in a concise manner for the understanding of the concerned users and suggests the important parameters and criteria that should be considered and addressed during the laboratory certification and validation process. PMID:29434059

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

PubMed

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

2017-10-01

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

German National Proficiency Scales in Biology: Internal Structure, Relations to General Cognitive Abilities and Verbal Skills

PubMed Central

KÖLLER, OLAF

2016-01-01

ABSTRACT National and international large‐scale assessments (LSA) have a major impact on educational systems, which raises fundamental questions about the validity of the measures regarding their internal structure and their relations to relevant covariates. Given its importance, research on the validity of instruments specifically developed for LSA is still sparse, especially in science and its subdomains biology, chemistry, and physics. However, policy decisions for the improvement of educational quality based on LSA can only be helpful if valid information on students’ achievement levels is provided. In the present study, the nature of the measurement instruments based on the German Educational Standards in Biology is examined. On the basis of data from 3,165 students in Grade 10, we present dimensional analyses and report the relationship between different subdimensions of biology literacy and cognitive covariates such as general cognitive abilities and verbal skills. A theory‐driven two‐dimensional model fitted the data best. Content knowledge and scientific inquiry, two subdimensions of biology literacy, are highly correlated and show differential correlational patterns to the covariates. We argue that the underlying structure of biology should be incorporated into curricula, teacher training and future assessments. PMID:27818532

A New Standard in Dementia Knowledge Measurement: Comparative Validation of the Dementia Knowledge Assessment Scale and the Alzheimer's Disease Knowledge Scale.

PubMed

Annear, Michael J; Eccleston, Claire E; McInerney, Frances J; Elliott, Kate-Ellen J; Toye, Christine M; Tranter, Bruce K; Robinson, Andrew L

2016-06-01

To compare the psychometric performance of the Dementia Knowledge Assessment Scale (DKAS) and the Alzheimer's Disease Knowledge Scale (ADKS) when administered to a large international cohort before and after online dementia education. Comparative psychometric analysis with pre- and posteducation scale responses. The setting for this research encompassed 7,909 individuals from 124 countries who completed the 9-week Understanding Dementia Massive Open Online Course (MOOC). Volunteer respondents who completed the DKAS and ADKS before (n = 3,649) and after (n = 878) completion of the Understanding Dementia MOOC. Assessment and comparison of the DKAS and ADKS included evaluation of scale development procedures, interscale correlations, response distribution, internal consistency, and construct validity. The DKAS had superior internal consistency, wider response distribution with less ceiling effect, and better discrimination between pre- and posteducation scores and occupational cohorts than the ADKS. The 27-item DKAS is a reliable and preliminarily valid measure of dementia knowledge that is psychometrically and conceptually sound, overcomes limitations of existing instruments, and can be administered to diverse cohorts to measure baseline understanding and knowledge change. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

German National Proficiency Scales in Biology: Internal Structure, Relations to General Cognitive Abilities and Verbal Skills.

PubMed

Kampa, Nele; Köller, Olaf

2016-09-01

National and international large-scale assessments (LSA) have a major impact on educational systems, which raises fundamental questions about the validity of the measures regarding their internal structure and their relations to relevant covariates. Given its importance, research on the validity of instruments specifically developed for LSA is still sparse, especially in science and its subdomains biology, chemistry, and physics. However, policy decisions for the improvement of educational quality based on LSA can only be helpful if valid information on students' achievement levels is provided. In the present study, the nature of the measurement instruments based on the German Educational Standards in Biology is examined. On the basis of data from 3,165 students in Grade 10, we present dimensional analyses and report the relationship between different subdimensions of biology literacy and cognitive covariates such as general cognitive abilities and verbal skills. A theory-driven two-dimensional model fitted the data best. Content knowledge and scientific inquiry, two subdimensions of biology literacy, are highly correlated and show differential correlational patterns to the covariates. We argue that the underlying structure of biology should be incorporated into curricula, teacher training and future assessments.

Performance of a Blood Pressure Smartphone App in Pregnant Women: The iPARR Trial (iPhone App Compared With Standard RR Measurement).

PubMed

Raichle, Christina J; Eckstein, Jens; Lapaire, Olav; Leonardi, Licia; Brasier, Noé; Vischer, Annina S; Burkard, Thilo

2018-06-01

Hypertensive disorders are one of the leading causes of maternal death worldwide. Several smartphone apps claim to measure blood pressure (BP) using photoplethysmographic signals recorded by smartphone cameras. However, no single app has been validated for this use to date. We aimed to validate a new, promising smartphone algorithm. In this subgroup analysis of the iPARR trial (iPhone App Compared With Standard RR Measurement), we tested the Preventicus BP smartphone algorithm on 32 pregnant women. The trial was conducted based on the European Society of Hypertension International Protocol revision 2010 for validation of BP measuring devices in adults. Each individual received 7 sequential BP measurements starting with the reference device (Omron-HBP-1300) and followed by the smartphone measurement, resulting in 96 BP comparisons. Validation requirements of the European Society of Hypertension International Protocol revision 2010 were not fulfilled. Mean (±SD) systolic BP disagreement between the test and reference devices was 5.0 (±14.5) mm Hg. The number of absolute differences between test and reference device within 5, 10, and 15 mm Hg was 31, 53, and 64 of 96, respectively. A Bland-Altman plot showed an overestimation of smartphone-determined systolic BP in comparison with reference systolic BP in low range but an underestimation in medium-range BP. The Preventicus BP smartphone algorithm failed the accuracy criteria for estimating BP in pregnant women and was thus not commercialized. Pregnant women should be discouraged from using BP smartphone apps, unless there are algorithms specifically validated according to common protocols. URL: https://www.clinicaltrials.gov. Unique identifier: NCT02552030. © 2018 American Heart Association, Inc.

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

PubMed Central

2012-01-01

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

Standard operating procedures for serum and plasma collection: early detection research network consensus statement standard operating procedure integration working group.

PubMed

Tuck, Melissa K; Chan, Daniel W; Chia, David; Godwin, Andrew K; Grizzle, William E; Krueger, Karl E; Rom, William; Sanda, Martin; Sorbara, Lynn; Stass, Sanford; Wang, Wendy; Brenner, Dean E

2009-01-01

Specimen collection is an integral component of clinical research. Specimens from subjects with various stages of cancers or other conditions, as well as those without disease, are critical tools in the hunt for biomarkers, predictors, or tests that will detect serious diseases earlier or more readily than currently possible. Analytic methodologies evolve quickly. Access to high-quality specimens, collected and handled in standardized ways that minimize potential bias or confounding factors, is key to the "bench to bedside" aim of translational research. It is essential that standard operating procedures, "the how" of creating the repositories, be defined prospectively when designing clinical trials. Small differences in the processing or handling of a specimen can have dramatic effects in analytical reliability and reproducibility, especially when multiplex methods are used. A representative working group, Standard Operating Procedures Internal Working Group (SOPIWG), comprised of members from across Early Detection Research Network (EDRN) was formed to develop standard operating procedures (SOPs) for various types of specimens collected and managed for our biomarker discovery and validation work. This report presents our consensus on SOPs for the collection, processing, handling, and storage of serum and plasma for biomarker discovery and validation.

International consensus on a complications list after gastrectomy for cancer.

PubMed

Baiocchi, Gian Luca; Giacopuzzi, Simone; Marrelli, Daniele; Reim, Daniel; Piessen, Guillaume; Matos da Costa, Paulo; Reynolds, John V; Meyer, Hans-Joachim; Morgagni, Paolo; Gockel, Ines; Lara Santos, Lucio; Jensen, Lone Susanne; Murphy, Thomas; Preston, Shaun R; Ter-Ovanesov, Mikhail; Fumagalli Romario, Uberto; Degiuli, Maurizio; Kielan, Wojciech; Mönig, Stefan; Kołodziejczyk, Piotr; Polkowski, Wojciech; Hardwick, Richard; Pera, Manuel; Johansson, Jan; Schneider, Paul M; de Steur, Wobbe O; Gisbertz, Suzanne S; Hartgrink, Henk; van Sandick, Joanna W; Portolani, Nazario; Hölscher, Arnulf H; Botticini, Maristella; Roviello, Franco; Mariette, Christophe; Allum, William; De Manzoni, Giovanni

2018-05-30

Perioperative complications can affect outcomes after gastrectomy for cancer, with high mortality and morbidity rates ranging between 10 and 40%. The absence of a standardized system for recording complications generates wide variation in evaluating their impacts on outcomes and hinders proposals of quality-improvement projects. The aim of this study was to provide a list of defined gastrectomy complications approved through international consensus. The Gastrectomy Complications Consensus Group consists of 34 European gastric cancer experts who are members of the International Gastric Cancer Association. A group meeting established the work plan for study implementation through Delphi surveys. A consensus was reached regarding a set of standardized methods to define gastrectomy complications. A standardized list of 27 defined complications (grouped into 3 intraoperative, 14 postoperative general, and 10 postoperative surgical complications) was created to provide a simple but accurate template for recording individual gastrectomy complications. A consensus was reached for both the list of complications that should be considered major adverse events after gastrectomy for cancer and their specific definitions. The study group also agreed that an assessment of each surgical case should be completed at patient discharge and 90 days postoperatively using a Complication Recording Sheet. The list of defined complications (soon to be validated in an international multicenter study) and the ongoing development of an electronic datasheet app to record them provide the basic infrastructure to reach the ultimate goals of standardized international data collection, establishment of benchmark results, and fostering of quality-improvement projects.

Reliability and Validity of the Chinese (Mandarin) Tinnitus Handicap Inventory

PubMed Central

Meng, Zhaoli; Zheng, Yun; Wang, Kai; Kong, Xiudan; Tao, Yong; Xu, Ke; Liu, Guanjian

2012-01-01

Objectives The Tinnitus Handicap Inventory (THI) is a commonly used self-reporting tinnitus questionnaire. We undertook this study to determine the reliability and validity of the Chinese-Mandarin version of the Tinnitus Handicap Inventory (THI-CM) for measuring tinnitus-related handicaps. Methods We tested the test-retest reliability, internal reliability, and construct validity of the THI-CM. Two-hundred patients seeking treatment for primary or secondary tinnitus in Southwest China were asked to complete THI-CM prior to clinical evaluation. Patients were evaluated by a clinician using standard methods, and 40 patients were asked to complete THI-CM a second time 14±3 days after the initial interview. Results The test-retest reliability of THI-CM was high (Pearson correlation, 0.98), as was the internal reliability (Cronbach's α, 0.93). Factor analysis indicated that THI-CM has a unifactorial structure. Conclusion The THI-CM version is reliable. The total score in THI-CM can be used to measure tinnitus-related handicaps in Mandarin-speaking populations. PMID:22468196

Construct validity of the Thai version of the job content questionnaire in a large population of heterogeneous occupations.

PubMed

Phakthongsuk, Pitchaya

2009-04-01

To test the construct validity of the Thai version of the job content questionnaire (TJCQ). The present descriptive study recruited 10415 participants from all occupations according to the International Standard Classification of Occupations. The instrument consisted of a 48-item of the job content questionnaire. Eight items newly developed by the authors from in-depth interviews were added. Exploratory factor analysis showed six factor models of work hazards, decision latitude, psychological demand, social support, physical demand, and job security. However, supervisor and co-worker support were not distinguished into two factors and some items distributed differently along the factors extracted. Confirmatory factor analysis supported the construct of six latent factors, although the overall fit was moderately acceptable. Cronbach's alpha coefficients higher than 0.7, supported the internal consistency of TJCQ scales except for job security (0.55). These findings suggest that TJCQ is valid and reliable for assessing job stress among Thai populations.

Comparison of consumer perception and acceptability for steaks cooked to different endpoints: validation of photographic approach.

PubMed

Chan, Sheung-Hang; Moss, Bruce W; Farmer, Linda J; Gordon, Alan; Cuskelly, Geraldine J

2013-02-15

Photographs have been used to enhance consumer reporting of preference of meat doneness, however, the use of photographs has not been validated for this purpose. This study used standard cooking methods to produce steaks of five different degrees of doneness (rare medium, medium well, well done and very well done) to study the consumer's perception of doneness, from both the external and internal surface of the cooked steak and also from corresponding photographs of each sample. Consumers evaluated each surface of the cooked steaks in relation to doneness for acceptability, 'just about right' and perception of doneness. Data were analysed using a split plot ANOVA and least significant test. Perception scores (for both external and internal surfaces) between different presentation methods (steak samples and corresponding photos), were not significantly different (p>0.05). The result indicates that photographs can be used as a valid approach for assessing preference for meat doneness. Copyright © 2012 Elsevier Ltd. All rights reserved.

Measuring quality of life in low-income, Spanish-speaking Puerto Ricans with type 2 diabetes residing in the mainland U.S.

PubMed

Lemon, Stephenie C; Rosal, Milagros C; Welch, Garry

2011-11-01

This study assessed the psychometric properties of the Audit of Diabetes-Dependent Quality of Life (ADDQoL) modified for low-income, low-education, Spanish-speaking Puerto Ricans with type 2 diabetes residing in the northeastern United States. Cross-sectional data from 226 patients were analyzed. Scale modifications included simplification of instructions, question wording and response format, and oral administration. Reliability was assessed with Cronbach's alpha coefficient and internal structure by exploratory factor analysis. Criterion validity was assessed using correlation analysis and linear and logistic regression models assessing the association of the ADDQoL with standardized physical health status, mental health status, depression, and comorbidity indices. Two ADDQoL items were dropped. The modified scale had excellent internal consistency and supported the original scale factor structure. Criterion validity results supported the validity of this measure. The modified ADDQoL showed psychometric properties that support its use in low-income, Spanish-speaking Puerto Ricans with type 2 diabetes who reside in mainland U.S.

[Caregiver's health: adaption and validation in a Spanish population of the Experience of Caregiving Inventory (ECI)].

PubMed

Crespo-Maraver, Mariacruz; Doval, Eduardo; Fernández-Castro, Jordi; Giménez-Salinas, Jordi; Prat, Gemma; Bonet, Pere

2018-04-04

To adapt and to validate the Experience of Caregiving Inventory (ECI) in a Spanish population, providing empirical evidence of its internal consistency, internal structure and validity. Psychometric validation of the adapted version of the ECI. One hundred and seventy-two caregivers (69.2% women), mean age 57.51 years (range: 21-89) participated. Demographic and clinical data, standardized measures (ECI, suffering scale of SCL-90-R, Zarit burden scale) were used. The two scales of negative evaluation of the ECI most related to serious mental disorders (disruptive behaviours [DB] and negative symptoms [NS]) and the two scales of positive appreciation (positive personal experiences [PPE], and good aspects of the relationship [GAR]) were analyzed. Exploratory structural equation modelling was used to analyze the internal structure. The relationship between the ECI scales and the SCL-90-R and Zarit scores was also studied. The four-factor model presented a good fit. Cronbach's alpha (DB: 0.873; NS: 0.825; PPE: 0.720; GAR: 0.578) showed a higher homogeneity in the negative scales. The SCL-90-R scores correlated with the negative ECI scales, and none of the ECI scales correlated with the Zarit scale. The Spanish version of the ECI can be considered a valid, reliable, understandable and feasible self-report measure for its administration in the health and community context. Copyright © 2018 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

International Council for Standardization in Haematology (ICSH) Recommendations for Laboratory Measurement of Direct Oral Anticoagulants.

PubMed

Gosselin, Robert C; Adcock, Dorothy M; Bates, Shannon M; Douxfils, Jonathan; Favaloro, Emmanuel J; Gouin-Thibault, Isabelle; Guillermo, Cecilia; Kawai, Yohko; Lindhoff-Last, Edelgard; Kitchen, Steve

2018-03-01

This guidance document was prepared on behalf of the International Council for Standardization in Haematology (ICSH) for providing haemostasis-related guidance documents for clinical laboratories. This inaugural coagulation ICSH document was developed by an ad hoc committee, comprised of international clinical and laboratory direct acting oral anticoagulant (DOAC) experts. The committee developed consensus recommendations for laboratory measurement of DOACs (dabigatran, rivaroxaban, apixaban and edoxaban), which would be germane for laboratories assessing DOAC anticoagulation. This guidance document addresses all phases of laboratory DOAC measurements, including pre-analytical (e.g. preferred time sample collection, preferred sample type, sample stability), analytical (gold standard method, screening and quantifying methods) and post analytical (e.g. reporting units, quality assurance). The committee addressed the use and limitations of screening tests such as prothrombin time, activated partial thromboplastin time as well as viscoelastic measurements of clotting blood and point of care methods. Additionally, the committee provided recommendations for the proper validation or verification of performance of laboratory assays prior to implementation for clinical use, and external quality assurance to provide continuous assessment of testing and reporting method. Schattauer GmbH Stuttgart.

Evaluating Mobile Survey Tools (MSTs) for Field-Level Monitoring and Data Collection: Development of a Novel Evaluation Framework, and Application to MSTs for Rural Water and Sanitation Monitoring

PubMed Central

Fisher, Michael B.; Mann, Benjamin H.; Cronk, Ryan D.; Shields, Katherine F.; Klug, Tori L.; Ramaswamy, Rohit

2016-01-01

Information and communications technologies (ICTs) such as mobile survey tools (MSTs) can facilitate field-level data collection to drive improvements in national and international development programs. MSTs allow users to gather and transmit field data in real time, standardize data storage and management, automate routine analyses, and visualize data. Dozens of diverse MST options are available, and users may struggle to select suitable options. We developed a systematic MST Evaluation Framework (EF), based on International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) software quality modeling standards, to objectively assess MSTs and assist program implementers in identifying suitable MST options. The EF is applicable to MSTs for a broad variety of applications. We also conducted an MST user survey to elucidate needs and priorities of current MST users. Finally, the EF was used to assess seven MSTs currently used for water and sanitation monitoring, as a validation exercise. The results suggest that the EF is a promising method for evaluating MSTs. PMID:27563916

Evaluating Mobile Survey Tools (MSTs) for Field-Level Monitoring and Data Collection: Development of a Novel Evaluation Framework, and Application to MSTs for Rural Water and Sanitation Monitoring.

PubMed

Fisher, Michael B; Mann, Benjamin H; Cronk, Ryan D; Shields, Katherine F; Klug, Tori L; Ramaswamy, Rohit

2016-08-23

Information and communications technologies (ICTs) such as mobile survey tools (MSTs) can facilitate field-level data collection to drive improvements in national and international development programs. MSTs allow users to gather and transmit field data in real time, standardize data storage and management, automate routine analyses, and visualize data. Dozens of diverse MST options are available, and users may struggle to select suitable options. We developed a systematic MST Evaluation Framework (EF), based on International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) software quality modeling standards, to objectively assess MSTs and assist program implementers in identifying suitable MST options. The EF is applicable to MSTs for a broad variety of applications. We also conducted an MST user survey to elucidate needs and priorities of current MST users. Finally, the EF was used to assess seven MSTs currently used for water and sanitation monitoring, as a validation exercise. The results suggest that the EF is a promising method for evaluating MSTs.

Transcultural Adaptation and Validation of the German Version of the Vocal Tract Discomfort Scale.

PubMed

Lukaschyk, Julia; Brockmann-Bauser, Meike; Beushausen, Ulla

2017-03-01

Currently, there is no standardized German questionnaire to assess vocal tract discomfort in voice patients. The aim of this study was to evaluate the internal consistency, reliability, and validity of the German version of the Vocal Tract Discomfort (VTD) Scale. This is a cross-sectional study. First, a cross-cultural translation and adaptation from English to German was performed. One hundred seven patients between the ages of 18 and 76 with voice disorders were divided into two different diagnosis-related groups (organic and functional voice disorder) and 50 vocally healthy adults were included. All participants completed the VTD Scale and the Voice Handicap Index (VHI). The internal consistency of the VTD Scale was analyzed through Cronbach's α coefficient. Pearson correlation between the VDT Scale and VHI total scores was used to determine criterion validity. The VDT Scale score differences related to diagnosis groups were assessed with analysis of variance. Excellent internal consistency was found (α = 0.919, P < 0.05), and criterion validity was confirmed by a high correlation between the total VTD Scale and VHI (r = 0.674). There was a significant difference between the diagnosis groups' total VTD Scale score (F[4.135] = 15.114, P = 0.000). Furthermore, the vocally healthy adults had significantly lower values than the two diagnosis groups (x¯: 11.48, s = 8.340). The German version of the VTD Scale has an excellent internal consistency and reliability, and shows high clinical validity. Thus, it is a useful instrument in voice diagnostics. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Quantification of Paclitaxel and Polyaspartate Paclitaxel Conjugate in Beagle Plasma: Application to a Pharmacokinetic Study.

PubMed

Gao, Yangyang; Chen, Junying; Zhang, Xiqian; Xie, Huiru; Wang, Yanran; Guo, Shuquan

2017-03-01

An LC-MS/MS method for the determination of polyaspartate paclitaxel conjugate (PASP-PTX) and paclitaxel (PTX) in dog plasma with cephalomannine (Internal Standard for PASP-PTX, IS-I) and clopidogrel bisulfate (Internal Standard for PTX, IS-II) as the internal standards was developed and validated. Plasma samples of PASP-PTX were extracted by ethyl acetate following the hydrolysis reaction, while protein precipitation was used for the extraction of PTX using acetonitrile. Analytes were separated by a CAPCELL PAK C18 MG II column using a gradient elution with the mobile phase (A) 5 mM ammonium containing 0.1% formic acid, and (B) acetonitrile. Quantification was performed by monitoring the m/z transitions of 286.2/105.0 for PASP-PTX, 264.2/83.0 for IS-I, 854.4/286.0 for PTX, and 322.1/184.1 for IS-II in the ESI positive mode. This method was validated in terms of specificity, linearity, precision, accuracy, and stability. The lower limit of quantification was 0.15 µg/mL for PASP-PTX and 0.01 µg/mL for PTX, and the calibration curves were linear over 0.15-300 µg/mL for PASP-PTX and over 0.01-10 µg/mL for PTX. The samples were stable under all the tested conditions. The method was successfully applied to study the pharmacokinetic profiles of PASP-PTX and PTX in beagles following intravenous administration of PASP-PTX. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Development and validation of the Chinese version of dry eye related quality of life scale.

PubMed

Zheng, Bang; Liu, Xiao-Jing; Sun, Yue-Qian Fiona; Su, Jia-Zeng; Zhao, Yang; Xie, Zheng; Yu, Guang-Yan

2017-07-17

To develop the Chinese version of quality of life scale for dry eye patients based on the Impact of Dry Eye on Everyday Life (IDEEL) questionnaire and to assess the reliability and validity of the developed scale. The original IDEEL was adapted cross-culturally to Chinese language and further developed following standard procedures. A total of 100 Chinese patients diagnosed with dry eye syndrome were included to investigate the psychometric properties of the Chinese version of scale. Psychometric tests included internal consistency (Cronbach's ɑ coefficients), construct validity (exploratory factor analysis), and known-groups validity (the analysis of variance). The Chinese version of Dry Eye Related Quality of Life (CDERQOL) Scale contains 45 items classified into 5 domains. Good to excellent internal consistency reliability was demonstrated for all 5 domains (Cronbach's ɑ coefficients range from 0.716 to 0.913). Construct validity assessment indicated a consistent factorial structure of the CDERQOL scale with hypothesized construct, with the exception of "Dry Eye Symptom-Bother" domain. All domain scores were detected with significant difference across three severity groups of dry eye patients (P < 0.05) except for "Satisfaction with Treatment" domain, indicating good known-groups validity. The results indicated that the CDERQOL scale is a reliable and valid instrument for patients with dry eye syndrome among Chinese population, and could be used as a supplementary diagnostic and treatment-effectiveness measure.

International Society for the Advancement of Cytometry Cell Sorter Biosafety Standards

PubMed Central

Holmes, Kevin L.; Fontes, Benjamin; Hogarth, Philip; Konz, Richard; Monard, Simon; Pletcher, Charles H.; Wadley, Robert B.; Schmid, Ingrid; Perfetto, Stephen P.

2014-01-01

Flow cytometric cell sorting of biological specimens has become prevalent in basic and clinical research laboratories. These specimens may contain known or unknown infectious agents, necessitating precautions to protect instrument operators and the environment from biohazards arising from the use of sorters. To this end the International Society of Analytical Cytology (ISAC) was proactive in establishing biosafety guidelines in 1997 (Schmid et al., Cytometry 1997;28:99–117) and subsequently published revised biosafety standards for cell sorting of unfixed samples in 2007 (Schmid et al., Cytometry Part A J Int Soc Anal Cytol 2007;71A:414–437). Since their publication, these documents have become recognized worldwide as the standard of practice and safety precautions for laboratories performing cell sorting experiments. However, the field of cytometry has progressed since 2007, and the document requires an update. The new Standards provides guidance: (1) for laboratory design for cell sorter laboratories; (2) for the creation of laboratory or instrument specific Standard Operating Procedures (SOP); and (3) on procedures for the safe operation of cell sorters, including personal protective equipment (PPE) and validation of aerosol containment. PMID:24634405

The performance of single and multi-collector ICP-MS instruments for fast and reliable 34S/32S isotope ratio measurements†

PubMed Central

Pröfrock, Daniel; Irrgeher, Johanna; Prohaska, Thomas

2016-01-01

The performance and validation characteristics of different single collector inductively coupled plasma mass spectrometers based on different technical principles (ICP-SFMS, ICP-QMS in reaction and collision modes, and ICP-MS/MS) were evaluated in comparison to the performance of MC ICP-MS for fast and reliable S isotope ratio measurements. The validation included the determination of LOD, BEC, measurement repeatability, within-lab reproducibility and deviation from certified values as well as a study on instrumental isotopic fractionation (IIF) and the calculation of the combined standard measurement uncertainty. Different approaches of correction for IIF applying external intra-elemental IIF correction (aka standard-sample bracketing) using certified S reference materials and internal inter-elemental IIF (aka internal standardization) correction using Si isotope ratios in MC ICP-MS are explained and compared. The resulting combined standard uncertainties of examined ICP-QMS systems were not better than 0.3–0.5% (uc,rel), which is in general insufficient to differentiate natural S isotope variations. Although the performance of the single collector ICP-SFMS is better (single measurement uc,rel = 0.08%), the measurement reproducibility (>0.2%) is the major limit of this system and leaves room for improvement. MC ICP-MS operated in the edge mass resolution mode, applying bracketing for correction of IIF, provided isotope ratio values with the highest quality (relative combined measurement uncertainty: 0.02%; deviation from the certified value: <0.002%). PMID:27812369

The performance of single and multi-collector ICP-MS instruments for fast and reliable 34S/32S isotope ratio measurements.

PubMed

Hanousek, Ondrej; Brunner, Marion; Pröfrock, Daniel; Irrgeher, Johanna; Prohaska, Thomas

2016-11-14

The performance and validation characteristics of different single collector inductively coupled plasma mass spectrometers based on different technical principles (ICP-SFMS, ICP-QMS in reaction and collision modes, and ICP-MS/MS) were evaluated in comparison to the performance of MC ICP-MS for fast and reliable S isotope ratio measurements. The validation included the determination of LOD, BEC, measurement repeatability, within-lab reproducibility and deviation from certified values as well as a study on instrumental isotopic fractionation (IIF) and the calculation of the combined standard measurement uncertainty. Different approaches of correction for IIF applying external intra-elemental IIF correction (aka standard-sample bracketing) using certified S reference materials and internal inter-elemental IIF (aka internal standardization) correction using Si isotope ratios in MC ICP-MS are explained and compared. The resulting combined standard uncertainties of examined ICP-QMS systems were not better than 0.3-0.5% ( u c,rel ), which is in general insufficient to differentiate natural S isotope variations. Although the performance of the single collector ICP-SFMS is better (single measurement u c,rel = 0.08%), the measurement reproducibility (>0.2%) is the major limit of this system and leaves room for improvement. MC ICP-MS operated in the edge mass resolution mode, applying bracketing for correction of IIF, provided isotope ratio values with the highest quality (relative combined measurement uncertainty: 0.02%; deviation from the certified value: <0.002%).

Safety, Codes, and Standards | Hydrogen and Fuel Cells | NREL

Science.gov Websites

to develop and test hydrogen sensor technologies. In addition to partnering with organizations in the and Validation of Prototype Hydrogen Sensors, P.K. Sekhar, J. Zhou, M.B. Post, L. Woo, W.J. Buttner , M.B. Post, C. Rivkin, R. Burgess, and W.J. Buttner, International Journal of Hydrogen Energy (March

49 CFR Appendix F to Part 236 - Minimum Requirements of FRA Directed Independent Third-Party Assessment of PTC System Safety...

Code of Federal Regulations, 2010 CFR

2010-10-01

..., national, or international standards. (f) The reviewer shall analyze all Fault Tree Analyses (FTA), Failure... cited by the reviewer; (4) Identification of any documentation or information sought by the reviewer...) Identification of the hardware and software verification and validation procedures for the PTC system's safety...

46 CFR 199.03 - Relationship to international standards.

Code of Federal Regulations, 2012 CFR

2012-10-01

... supplemented by a Record of Equipment, or a valid Cargo Ship Safety Equipment Certificate supplemented by a... lifejackets, if carried, must be of the same or similar design as required by § 199.70(b). (5) Containers for... appliance in accordance with § 199.170(c)(2). (13) Immersion suits must be carried on all cargo vessels...

46 CFR 199.03 - Relationship to international standards.

Code of Federal Regulations, 2013 CFR

2013-10-01

... supplemented by a Record of Equipment, or a valid Cargo Ship Safety Equipment Certificate supplemented by a... lifejackets, if carried, must be of the same or similar design as required by § 199.70(b). (5) Containers for... appliance in accordance with § 199.170(c)(2). (13) Immersion suits must be carried on all cargo vessels...

46 CFR 199.03 - Relationship to international standards.

Code of Federal Regulations, 2014 CFR

2014-10-01

... supplemented by a Record of Equipment, or a valid Cargo Ship Safety Equipment Certificate supplemented by a... lifejackets, if carried, must be of the same or similar design as required by § 199.70(b). (5) Containers for... appliance in accordance with § 199.170(c)(2). (13) Immersion suits must be carried on all cargo vessels...

46 CFR 199.03 - Relationship to international standards.

Code of Federal Regulations, 2010 CFR

2010-10-01

... supplemented by a Record of Equipment, or a valid Cargo Ship Safety Equipment Certificate supplemented by a... lifejackets, if carried, must be of the same or similar design as required by § 199.70(b). (5) Containers for... appliance in accordance with § 199.170(c)(2). (13) Immersion suits must be carried on all cargo vessels...

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

PubMed

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

2014-01-01

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

International ranking systems for universities and institutions: a critical appraisal

PubMed Central

Ioannidis, John PA; Patsopoulos, Nikolaos A; Kavvoura, Fotini K; Tatsioni, Athina; Evangelou, Evangelos; Kouri, Ioanna; Contopoulos-Ioannidis, Despina G; Liberopoulos, George

2007-01-01

Background Ranking of universities and institutions has attracted wide attention recently. Several systems have been proposed that attempt to rank academic institutions worldwide. Methods We review the two most publicly visible ranking systems, the Shanghai Jiao Tong University 'Academic Ranking of World Universities' and the Times Higher Education Supplement 'World University Rankings' and also briefly review other ranking systems that use different criteria. We assess the construct validity for educational and research excellence and the measurement validity of each of the proposed ranking criteria, and try to identify generic challenges in international ranking of universities and institutions. Results None of the reviewed criteria for international ranking seems to have very good construct validity for both educational and research excellence, and most don't have very good construct validity even for just one of these two aspects of excellence. Measurement error for many items is also considerable or is not possible to determine due to lack of publication of the relevant data and methodology details. The concordance between the 2006 rankings by Shanghai and Times is modest at best, with only 133 universities shared in their top 200 lists. The examination of the existing international ranking systems suggests that generic challenges include adjustment for institutional size, definition of institutions, implications of average measurements of excellence versus measurements of extremes, adjustments for scientific field, time frame of measurement and allocation of credit for excellence. Conclusion Naïve lists of international institutional rankings that do not address these fundamental challenges with transparent methods are misleading and should be abandoned. We make some suggestions on how focused and standardized evaluations of excellence could be improved and placed in proper context. PMID:17961208

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.

Assessing local instrument reliability and validity: a field-based example from northern Uganda.

PubMed

Betancourt, Theresa S; Bass, Judith; Borisova, Ivelina; Neugebauer, Richard; Speelman, Liesbeth; Onyango, Grace; Bolton, Paul

2009-08-01

This paper presents an approach for evaluating the reliability and validity of mental health measures in non-Western field settings. We describe this approach using the example of our development of the Acholi psychosocial assessment instrument (APAI), which is designed to assess depression-like (two tam, par and kumu), anxiety-like (ma lwor) and conduct problems (kwo maraco) among war-affected adolescents in northern Uganda. To examine the criterion validity of this measure in the absence of a traditional gold standard, we derived local syndrome terms from qualitative data and used self reports of these syndromes by indigenous people as a reference point for determining caseness. Reliability was examined using standard test-retest and inter-rater methods. Each of the subscale scores for the depression-like syndromes exhibited strong internal reliability ranging from alpha = 0.84-0.87. Internal reliability was good for anxiety (0.70), conduct problems (0.83), and the pro-social attitudes and behaviors (0.70) subscales. Combined inter-rater reliability and test-retest reliability were good for most subscales except for the conduct problem scale and prosocial scales. The pattern of significant mean differences in the corresponding APAI problem scale score between self-reported cases vs. noncases on local syndrome terms was confirmed in the data for all of the three depression-like syndromes, but not for the anxiety-like syndrome ma lwor or the conduct problem kwo maraco.

Development and validation of reversed-phase HPLC gradient method for the estimation of efavirenz in plasma.

PubMed

Gupta, Shweta; Kesarla, Rajesh; Chotai, Narendra; Omri, Abdelwahab

2017-01-01

Efavirenz is an anti-viral agent of non-nucleoside reverse transcriptase inhibitor category used as a part of highly active retroviral therapy for the treatment of infections of human immune deficiency virus type-1. A simple, sensitive and rapid reversed-phase high performance liquid chromatographic gradient method was developed and validated for the determination of efavirenz in plasma. The method was developed with high performance liquid chromatography using Waters X-Terra Shield, RP18 50 x 4.6 mm, 3.5 μm column and a mobile phase consisting of phosphate buffer pH 3.5 and Acetonitrile. The elute was monitored with the UV-Visible detector at 260 nm with a flow rate of 1.5 mL/min. Tenofovir disoproxil fumarate was used as internal standard. The method was validated for linearity, precision, accuracy, specificity, robustness and data obtained were statistically analyzed. Calibration curve was found to be linear over the concentration range of 1-300 μg/mL. The retention times of efavirenz and tenofovir disoproxil fumarate (internal standard) were 5.941 min and 4.356 min respectively. The regression coefficient value was found to be 0.999. The limit of detection and the limit of quantification obtained were 0.03 and 0.1 μg/mL respectively. The developed HPLC method can be useful for quantitative pharmacokinetic parameters determination of efavirenz in plasma.

Design of a Competency Evaluation Model for Clinical Nursing Practicum, Based on Standardized Language Systems: Psychometric Validation Study.

PubMed

Iglesias-Parra, Maria Rosa; García-Guerrero, Alfonso; García-Mayor, Silvia; Kaknani-Uttumchandani, Shakira; León-Campos, Álvaro; Morales-Asencio, José Miguel

2015-07-01

To develop an evaluation system of clinical competencies for the practicum of nursing students based on the Nursing Interventions Classification (NIC). Psychometric validation study: the first two phases addressed definition and content validation, and the third phase consisted of a cross-sectional study for analyzing reliability. The study population was undergraduate nursing students and clinical tutors. Through the Delphi technique, 26 competencies and 91 interventions were isolated. Cronbach's α was 0.96. Factor analysis yielded 18 factors that explained 68.82% of the variance. Overall inter-item correlation was 0.26, and total-item correlation ranged between 0.66 and 0.19. A competency system for the nursing practicum, structured on the NIC, is a reliable method for assessing and evaluating clinical competencies. Further evaluations in other contexts are needed. The availability of standardized language systems in the nursing discipline supposes an ideal framework to develop the nursing curricula. © 2015 Sigma Theta Tau International.

Extended Finite Element Method with Simplified Spherical Harmonics Approximation for the Forward Model of Optical Molecular Imaging

PubMed Central

Li, Wei; Yi, Huangjian; Zhang, Qitan; Chen, Duofang; Liang, Jimin

2012-01-01

An extended finite element method (XFEM) for the forward model of 3D optical molecular imaging is developed with simplified spherical harmonics approximation (SPN). In XFEM scheme of SPN equations, the signed distance function is employed to accurately represent the internal tissue boundary, and then it is used to construct the enriched basis function of the finite element scheme. Therefore, the finite element calculation can be carried out without the time-consuming internal boundary mesh generation. Moreover, the required overly fine mesh conforming to the complex tissue boundary which leads to excess time cost can be avoided. XFEM conveniences its application to tissues with complex internal structure and improves the computational efficiency. Phantom and digital mouse experiments were carried out to validate the efficiency of the proposed method. Compared with standard finite element method and classical Monte Carlo (MC) method, the validation results show the merits and potential of the XFEM for optical imaging. PMID:23227108

Extended finite element method with simplified spherical harmonics approximation for the forward model of optical molecular imaging.

PubMed

Li, Wei; Yi, Huangjian; Zhang, Qitan; Chen, Duofang; Liang, Jimin

2012-01-01

An extended finite element method (XFEM) for the forward model of 3D optical molecular imaging is developed with simplified spherical harmonics approximation (SP(N)). In XFEM scheme of SP(N) equations, the signed distance function is employed to accurately represent the internal tissue boundary, and then it is used to construct the enriched basis function of the finite element scheme. Therefore, the finite element calculation can be carried out without the time-consuming internal boundary mesh generation. Moreover, the required overly fine mesh conforming to the complex tissue boundary which leads to excess time cost can be avoided. XFEM conveniences its application to tissues with complex internal structure and improves the computational efficiency. Phantom and digital mouse experiments were carried out to validate the efficiency of the proposed method. Compared with standard finite element method and classical Monte Carlo (MC) method, the validation results show the merits and potential of the XFEM for optical imaging.

Contributing to the ICNP: validating the term 'informal settlement'.

PubMed

Geyer, N; Mmuwe-Hlahane, S; Shongwe-Magongo, R G; Uys, E

2005-12-01

The specific aims of this study were to propose a definition of the term informal settlement, validate the term informal settlement, and submit a term and definition for international utilization to the International Council of Nurses (ICN) for consideration for inclusion in the International Classification of Nursing Practice (ICNP). South Africa was one of four African countries (Botswana, South Africa, Swaziland and Zimbabwe) funded by the WK Kellogg Foundation to participate in the ICNP project. South Africa had two research groups. One of the research groups identified the term informal settlement to define. This was a qualitative study where a philosophical perspective was used to explore, explain and describe nursing practice. The combined method proposed by the ICN was utilized to define and validate the term informal settlement. Validation and literature review provided sufficient support for the defined characteristics and the term was finally defined and submitted to ICN on 12 April 2001 as informal settlement is a type of residential development with the specific characteristics--temporary residential structures, erected with limited or no formal infrastructure, densely populated, no secure tenure for occupants, no property demarcations, often associated with overcrowding/limited or no privacy, and low standard of living, being situated in high risk areas with an increased risk for disease and disasters. The ICNP Evaluation Committee recommended inclusion in the ICNP with minor changes in February 2003.

Systematic Review of Childhood Sedentary Behavior Questionnaires: What do We Know and What is Next?

PubMed

Hidding, Lisan M; Altenburg, Teatske M; Mokkink, Lidwine B; Terwee, Caroline B; Chinapaw, Mai J M

2017-04-01

Accurate measurement of child sedentary behavior is necessary for monitoring trends, examining health effects, and evaluating the effectiveness of interventions. We therefore aimed to summarize studies examining the measurement properties of self-report or proxy-report sedentary behavior questionnaires for children and adolescents under the age of 18 years. Additionally, we provided an overview of the characteristics of the evaluated questionnaires. We performed systematic literature searches in the EMBASE, PubMed, and SPORTDiscus electronic databases. Studies had to report on at least one measurement property of a questionnaire assessing sedentary behavior. Questionnaire data were extracted using a standardized checklist, i.e. the Quality Assessment of Physical Activity Questionnaire (QAPAQ) checklist, and the methodological quality of the included studies was rated using a standardized tool, i.e. the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Forty-six studies on 46 questionnaires met our inclusion criteria, of which 33 examined test-retest reliability, nine examined measurement error, two examined internal consistency, 22 examined construct validity, eight examined content validity, and two examined structural validity. The majority of the included studies were of fair or poor methodological quality. Of the studies with at least a fair methodological quality, six scored positive on test-retest reliability, and two scored positive on construct validity. None of the questionnaires included in this review were considered as both valid and reliable. High-quality studies on the most promising questionnaires are required, with more attention to the content validity of the questionnaires. PROSPERO registration number: CRD42016035963.

Reproducibility, validity, and responsiveness of the hip outcome score in patients with end-stage hip osteoarthritis.

PubMed

Naal, Florian D; Impellizzeri, Franco M; von Eisenhart-Rothe, Rüdiger; Mannion, Anne F; Leunig, Michael

2012-11-01

To evaluate reproducibility, validity, and responsiveness of the Hip Outcome Score (HOS) in patients with end-stage hip osteoarthritis. In a cohort of 157 consecutive patients (mean age 66 years; 79 women) undergoing total hip replacement, the HOS was tested for the following measurement properties: feasibility (percentage of evaluable questionnaires), reproducibility (intraclass correlation coefficient [ICC] and standard error of measurement [SEM]), construct validity (correlation with the Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC], Oxford Hip Score [OHS], Short Form 12 health survey, and University of California, Los Angeles activity scale), internal consistency (Cronbach's alpha), factorial validity (factor analysis), floor and ceiling effects, and internal and external responsiveness at 6 months after surgery (standardized response mean and change score correlations). Missing items occurred frequently. Five percent to 6% of the HOS activities of daily living (ADL) subscales and 20-32% of the sport subscales could not be scored. ICCs were 0.92 for both subscales. SEMs were 1.8 points (ADL subscale) and 2.3 points (sport subscale). Highest correlations were found with the OHS (r = 0.81 for ADL subscale and r = 0.58 for sport subscale) and the WOMAC physical function subscale (r = 0.83 for ADL subscale and r = 0.56 for sport subscale). Cronbach's alpha was 0.93 and 0.88 for the ADL and sport subscales, respectively. Neither unidimensionality of the subscales nor the 2-factor structure was supported by factor analysis. Both subscales showed good internal and external responsiveness. The HOS is reproducible and responsive when assessing patients with end-stage hip osteoarthritis in whom the items are relevant. However, based on the large proportion of missing data and the findings of the factor analysis, we cannot recommend this questionnaire for routine use in this target group. Copyright © 2012 by the American College of Rheumatology.

De novo synthesis of trideuteromethyl esters of amino acids for use in GC-MS and GC-tandem MS exemplified for ADMA in human plasma and urine: standardization, validation, comparison and proof of evidence for their aptitude as internal standards.

PubMed

Tsikas, Dimitrios

2009-08-01

Asymmetric dimethylarginine (ADMA, N(G),N(G)-dimethyl-L-arginine) is an endogenous inhibitor of nitric oxide (NO) synthesis, a potential risk factor for cardiovascular diseases and a powerful biochemical parameter in clinical studies. In our previous work we have reported on a GC-tandem MS method for the accurate and precise quantification of ADMA in biological fluids using de novo synthesized [(2)H(3)]-methyl ester ADMA (d(3)Me-ADMA) as internal standard (IS). This method provides basal ADMA concentrations in biological fluids that agree with those obtained by other groups using other validated methods for ADMA. Unanimously, de novo synthesized stable-isotope labeled analogues are considered not ideal IS, because they must be prepared in a matrix different from the biological sample. Recently, [2,3,3,4,4,5,5-(2)H(7)]-ADMA (d(7)-ADMA) has become commercially available and we took this opportunity to test the reliability of the de novo synthesized d(3)Me-ADMA as an IS for ADMA in GC-tandem MS. In this article, we report on the re-validation of the previously reported GC-tandem MS method for ADMA in human plasma and urine using d(7)-ADMA as IS, and on comparative quantitative analyses of ADMA by GC-tandem MS using d(7)-ADMA and d(3)Me-ADMA. After thorough standardization of d(7)-ADMA and methods validation, we obtained by GC-tandem MS very similar ADMA concentrations in plasma and urine using d(7)-ADMA and d(3)Me-ADMA. The present study gives a proof of evidence for the aptitude of (2)H(3)-ADMA as IS in GC-tandem MS and suggests that de novo synthesis of stable-isotope labeled alkyl esters of amino acids and amino acid derivates may be a generally applicable method in mass spectrometry-based methods for amino acids. This approach is especially useful for amino acids for which no stable-isotope labeled analogues are commercially available.

Measuring severe maternal morbidity: validation of potential measures.

PubMed

Main, Elliott K; Abreo, Anisha; McNulty, Jennifer; Gilbert, William; McNally, Colleen; Poeltler, Debra; Lanner-Cusin, Katarina; Fenton, Douglas; Gipps, Theresa; Melsop, Kathryn; Greene, Naomi; Gould, Jeffrey B; Kilpatrick, Sarah

2016-05-01

Both maternal mortality rate and severe maternal morbidity rate have risen significantly in the United Sates. Recently, the Centers for Disease Control and Prevention introduced International Classification of Diseases, 9th revision, criteria for defining severe maternal morbidity with the use of administrative data sources; however, those criteria have not been validated with the use of chart reviews. The primary aim of the current study was to validate the Centers for Disease Control and Prevention International Classification of Diseases, 9th revision, criteria for the identification of severe maternal morbidity. This analysis initially required the development of a reproducible set of clinical conditions that were judged to be consistent with severe maternal morbidity to be used as the clinical gold standard for validation. Alternative criteria for severe maternal morbidity were also examined. The 67,468 deliveries that occurred during a 12-month period from 16 participating California hospitals were screened initially for severe maternal morbidity with the presence of any of 4 criteria: (1) Centers for Disease Control and Prevention International Classification of Diseases, 9th revision, diagnosis and procedure codes; (2) prolonged postpartum length of stay (>3 standard deviations beyond the mean length of stay for the California population); (3) any maternal intensive care unit admissions (with the use of hospital billing sources); and (4) the administration of any blood product (with the use of transfusion service data). Complete medical records for all screen-positive cases were examined to determine whether they satisfied the criteria for the clinical gold standard (determined by 4 rounds of a modified Delphi technique). Descriptive and statistical analyses that included area under the receiver operating characteristic curve and C-statistic were performed. The Centers for Disease Control and Prevention International Classification of Diseases, 9th revision, criteria had a reasonably high sensitivity of 0.77 and a positive predictive value of 0.44 with a C-statistic of 0.87. The most important source of false-positive cases were mothers whose only criterion was 1-2 units of blood products. The Centers for Disease Control and Prevention International Classification of Diseases, 9th revision, criteria screen rate ranged from 0.51-2.45% among hospitals. True positive severe maternal morbidity ranged from 0.05-1.13%. When hospitals were grouped by their neonatal intensive care unit level of care, severe maternal morbidity rates were statistically lower at facilities with lower level neonatal intensive care units (P < .0001). The Centers for Disease Control and Prevention International Classification of Diseases, 9th revision, criteria can serve as a reasonable administrative metric for measuring severe maternal morbidity at population levels. Caution should be used with the use of these criteria for individual hospitals, because case-mix effects appear to be strong. Copyright © 2016 Elsevier Inc. All rights reserved.

A novel cuffless device for self-measurement of blood pressure: concept, performance and clinical validation.

PubMed

Boubouchairopoulou, N; Kollias, A; Chiu, B; Chen, B; Lagou, S; Anestis, P; Stergiou, G S

2017-07-01

A pocket-size cuffless electronic device for self-measurement of blood pressure (BP) has been developed (Freescan, Maisense Inc., Zhubei, Taiwan). The device estimates BP within 10 s using three embedded electrodes and one force sensor that is applied over the radial pulse to evaluate the pulse wave. Before use, basic anthropometric characteristics are recorded on the device, and individualized initial calibration is required based on a standard BP measurement performed using an upper-arm BP monitor. The device performance in providing valid BP readings was evaluated in 313 normotensive and hypertensive adults in three study phases during which the device sensor was upgraded. A formal validation study of a prototype device against mercury sphygmomanometer was performed according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 2013 protocol. The test device succeeded in obtaining a valid BP measurement (three successful readings within up to five attempts) in 55-72% of the participants, which reached 87% with device sensor upgrade. For the validation study, 125 adults were recruited and 85 met the protocol requirements for inclusion. The mean device-observers BP difference was 3.2±6.7 (s.d.) mm Hg for systolic and 2.6±4.6 mm Hg for diastolic BP (criterion 1). The estimated s.d. (inter-subject variability) were 5.83 and 4.17 mm Hg respectively (criterion 2). These data suggest that this prototype cuffless BP monitor provides valid self-measurements in the vast majority of adults, and satisfies the BP measurement accuracy criteria of the ANSI/AAMI/ISO 2013 validation protocol.

Psychometric properties and cross-cultural adaptation of the Brazilian Quebec back pain disability scale questionnaire.

PubMed

Rodrigues, Marcelo F; Michel-Crosato, Edgard; Cardoso, Jefferson R; Traebert, Jefferson

2009-06-01

Cross-cultural translation and psychometric testing. To translate and cross-culturally adapt the Quebec Back Pain Disability Scale (QDS) to Brazilian Portuguese and to examine its validity and reliability. Current literature shows the need to adopt reliable and internationally standardized methods for the analysis of low back pain. To our knowledge, this specific questionnaire has not been translated and validated for Portuguese-speaking patients. The translation and cross-cultural adaptation of the QDS were developed in agreement with internationally recommended methodology, and the resulting product was evaluated in this study with 54 consecutive patients. Internal consistency was obtained through Cronbach's alpha; reliability was estimated through the intraclass correlation coefficient and the Bland and Altman agreement (d = mean difference). Validity was determined by correlating the scores of the Brazil-QDS with the Brazilian version of the Roland-Morris Questionnaire and Visual Analogue Pain Scale by means of the Spearman rank correlation coefficient. The internal consistency obtained was excellent (Cronbach's alpha = 0.97). Intraobserver and interobserver reliability were considered strong (ICC = 0.93-d = 0.68 and 0.96-d = 0.57, respectively). The correlation with Brazilian Roland-Morris Questionnaire and with the Visual Analogue Scale was high (r = 0.857; r = 0.758, respectively). The data showed that the process of translation and cross-cultural adaptation were successful and that the adapted instrument demonstrated excellent psychometric properties.

Sample sizes needed for specified margins of relative error in the estimates of the repeatability and reproducibility standard deviations.

PubMed

McClure, Foster D; Lee, Jung K

2005-01-01

Sample size formulas are developed to estimate the repeatability and reproducibility standard deviations (Sr and S(R)) such that the actual error in (Sr and S(R)) relative to their respective true values, sigmar and sigmaR, are at predefined levels. The statistical consequences associated with AOAC INTERNATIONAL required sample size to validate an analytical method are discussed. In addition, formulas to estimate the uncertainties of (Sr and S(R)) were derived and are provided as supporting documentation. Formula for the Number of Replicates Required for a Specified Margin of Relative Error in the Estimate of the Repeatability Standard Deviation.

Establishing the 1st Chinese National Standard for inactivated hepatitis A vaccine.

PubMed

Gao, Fan; Mao, Qun-Ying; Wang, Yi-Ping; Chen, Pan; Liang, Zheng-Lun

2016-07-01

A reference standard calibrated in the International Units is needed for the quality control of hepatitis A vaccine. Thus, National Institutes for Food and Drug Control launched a project to establish a non-adsorbed inactivated hepatitis A vaccine reference as the working standard calibrated against the 1st International Standard (IS). Two national standard candidates (NSCs) were obtained from two manufacturers, and designated as NSC A (lyophilized form) and NSC B (liquid form). Six laboratories participated in the collaborative study and were asked to use their in-house validated enzyme-linked immunosorbent assay methods to detect hepatitis A vaccine antigen content. Although both exhibited good parallelism and linear relationship with IS, NSC B showed a better agreement among laboratories than NSC A. And based on suitability of the candidates, NSC B was selected. The accelerated degradation study showed that NSC B was stable at the storage temperature (≤-70 °C). Therefore NSC B was approved as the first Chinese national antigen standard for inactivated hepatitis A vaccine, with an assigned antigen content of 70 IU/ml. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

PROMIS GH (Patient-Reported Outcomes Measurement Information System Global Health) Scale in Stroke: A Validation Study.

PubMed

Katzan, Irene L; Lapin, Brittany

2018-01-01

The International Consortium for Health Outcomes Measurement recently included the 10-item PROMIS GH (Patient-Reported Outcomes Measurement Information System Global Health) scale as part of their recommended Standard Set of Stroke Outcome Measures. Before collection of PROMIS GH is broadly implemented, it is necessary to assess its performance in the stroke population. The objective of this study was to evaluate the psychometric properties of PROMIS GH in patients with ischemic stroke and intracerebral hemorrhage. PROMIS GH and 6 PROMIS domain scales measuring same/similar constructs were electronically collected on 1102 patients with ischemic and hemorrhagic strokes at various stages of recovery from their stroke who were seen in a cerebrovascular clinic from October 12, 2015, through June 2, 2017. Confirmatory factor analysis was performed to evaluate the adequacy of 2-factor structure of component scores. Test-retest reliability and convergent validity of PROMIS GH items and component scores were assessed. Discriminant validity and responsiveness were compared between PROMIS GH and PROMIS domain scales measuring the same or related constructs. Analyses were repeated stratified by stroke subtype and modified Rankin Scale score <2 versus ≥2. There was moderate internal reliability (ordinal α, 0.82-0.88) and marginal model fit for the 2-factor solution for component scores (root mean square error of approximation, 0.11). Convergent validity was good with significant correlations between all PROMIS GH items and PROMIS domain scales ( P <0.001 for all). There was excellent discrimination for all PROMIS GH items and component scores across modified Rankin Scale levels. Good responsiveness (effect size, >0.5) was demonstrated for 8 of the 10 PROMIS GH items. Reliability and validity remained consistent across stroke subtype and disability level (modified Rankin Scale, <2 versus ≥2). PROMIS GH exhibits acceptable performance in patients with stroke. Our findings support International Consortium for Health Outcomes Measurement recommendation to use PROMIS GH as part of the standard set of outcome measures in stroke. © 2017 American Heart Association, Inc.

Forensic analysis of explosives using isotope ratio mass spectrometry (IRMS)--part 1: instrument validation of the DELTAplusXP IRMS for bulk nitrogen isotope ratio measurements.

PubMed

Benson, Sarah J; Lennard, Christopher J; Hill, David M; Maynard, Philip; Roux, Claude

2010-01-01

A significant amount of research has been conducted into the use of stable isotopes to assist in determining the origin of various materials. The research conducted in the forensic field shows the potential of isotope ratio mass spectrometry (IRMS) to provide a level of discrimination not achievable utilizing traditional forensic techniques. Despite the research there have been few, if any, publications addressing the validation and measurement uncertainty of the technique for forensic applications. This study, the first in a planned series, presents validation data for the measurement of bulk nitrogen isotope ratios in ammonium nitrate (AN) using the DELTA(plus)XP (Thermo Finnigan) IRMS instrument equipped with a ConFlo III interface and FlashEA 1112 elemental analyzer (EA). Appropriate laboratory standards, analytical methods and correction calculations were developed and evaluated. A validation protocol was developed in line with the guidelines provided by the National Association of Testing Authorities, Australia (NATA). Performance characteristics including: accuracy, precision/repeatability, reproducibility/ruggedness, robustness, linear range, and measurement uncertainty were evaluated for the measurement of nitrogen isotope ratios in AN. AN (99.5%) and ammonium thiocyanate (99.99+%) were determined to be the most suitable laboratory standards and were calibrated against international standards (certified reference materials). All performance characteristics were within an acceptable range when potential uncertainties, including the manufacturer's uncertainty of the technique and standards, were taken into account. The experiments described in this article could be used as a model for validation of other instruments for similar purposes. Later studies in this series will address the more general issue of demonstrating that the IRMS technique is scientifically sound and fit-for-purpose in the forensic explosives analysis field.

SEALDH-II-An Autonomous, Holistically Controlled, First Principles TDLAS Hygrometer for Field and Airborne Applications: Design-Setup-Accuracy/Stability Stress Test.

PubMed

Buchholz, Bernhard; Kallweit, Sören; Ebert, Volker

2016-12-30

Instrument operation in harsh environments often significantly impacts the trust level of measurement data. While commercial instrument manufacturers clearly define the deployment conditions to achieve trustworthy data in typical standard applications, it is frequently unavoidable in scientific field applications to operate instruments outside these commercial standard application specifications. Scientific instrumentation, however, is employing cutting-edge technology and often highly optimized but also lacks long-term field tests to assess the field vs. laboratory performance. Recently, we developed the Selective Extractive Laser Diode Hygrometer (SEALDH-II), which addresses field and especially airborne applications as well as metrological laboratory validations. SEALDH-II targets reducing deviations between airborne hygrometers (currently up to 20% between the most advanced hygrometers) with a new holistic, internal control and validation concept, which guarantees the transfer of the laboratory performance into a field scenario by capturing more than 80 instrument internal "housekeeping" data to nearly perfectly control SEALDH-II's health status. SEALDH-II uses a calibration-free, first principles based, direct Tuneable Diode Laser Absorption Spectroscopy (dTDLAS) approach, to cover the entire atmospheric humidity measurement range from about 3 to 40,000 ppmv with a calculated maximum uncertainty of 4.3% ± 3 ppmv. This is achieved not only by innovations in internal instrument monitoring and design, but also by active control algorithms such as a high resolution spectral stabilization. This paper describes the setup, working principles, and instrument stabilization, as well as its precision validation and long-term stress tests in an environmental chamber over an environmental temperature and humidity range of ΔT = 50 K and ΔRH = 80% RH, respectively.

SEALDH-II—An Autonomous, Holistically Controlled, First Principles TDLAS Hygrometer for Field and Airborne Applications: Design–Setup–Accuracy/Stability Stress Test

PubMed Central

Buchholz, Bernhard; Kallweit, Sören; Ebert, Volker

2016-01-01

Instrument operation in harsh environments often significantly impacts the trust level of measurement data. While commercial instrument manufacturers clearly define the deployment conditions to achieve trustworthy data in typical standard applications, it is frequently unavoidable in scientific field applications to operate instruments outside these commercial standard application specifications. Scientific instrumentation, however, is employing cutting-edge technology and often highly optimized but also lacks long-term field tests to assess the field vs. laboratory performance. Recently, we developed the Selective Extractive Laser Diode Hygrometer (SEALDH-II), which addresses field and especially airborne applications as well as metrological laboratory validations. SEALDH-II targets reducing deviations between airborne hygrometers (currently up to 20% between the most advanced hygrometers) with a new holistic, internal control and validation concept, which guarantees the transfer of the laboratory performance into a field scenario by capturing more than 80 instrument internal “housekeeping” data to nearly perfectly control SEALDH-II’s health status. SEALDH-II uses a calibration-free, first principles based, direct Tuneable Diode Laser Absorption Spectroscopy (dTDLAS) approach, to cover the entire atmospheric humidity measurement range from about 3 to 40,000 ppmv with a calculated maximum uncertainty of 4.3% ± 3 ppmv. This is achieved not only by innovations in internal instrument monitoring and design, but also by active control algorithms such as a high resolution spectral stabilization. This paper describes the setup, working principles, and instrument stabilization, as well as its precision validation and long-term stress tests in an environmental chamber over an environmental temperature and humidity range of ΔT = 50 K and ΔRH = 80% RH, respectively. PMID:28042844

The Development of a Clinical Screening Instrument For Tumour Predisposition Syndromes In Childhood Cancer Patients

PubMed Central

Hopman, Saskia M. J.; Merks, Johannes H. M.; de Borgie, Corianne A. J. M.; Aalfs, C. M.; Biesecker, Leslie G.; Cole, Trevor; Eng, Charis; Legius, Eric; Maher, Eamonn R.; van Noesel, Max M.; Verloes, Alain; Viskochil, David H.; Wagner, Anja; Weksberg, Rosanna; Caron, Huib N.; Hennekam, Raoul C. M.

2014-01-01

Background Identification of tumour predisposition syndromes in patients who have cancer in childhood is paramount for optimal care. A screening instrument that can help to identify such patients will facilitate physicians caring for children with cancer. The complete screening instrument should consist of a standardized series of pictures and a screening form for manifestations not visible in the pictures. Here we describe the development of such a screening form based on an international two-stage Delphi process and an initial validation of the complete instrument. Patients and Methods We identified manifestations that may contribute to the diagnosis of a tumour predisposition syndrome through the Winter-Baraitser Dysmorphology Database and the textbook “Gorlin's Syndromes of the Head and Neck”. In a two-round Delphi process, eight international content-experts scored the contribution of each of these manifestations. We performed a clinical validation of the instrument in a selected cohort of ten paediatric cancer patients from another centre. Results In total, 49 manifestations were found to contribute to the diagnosis of a tumour predisposition syndrome and were included in the screening form. The pilot validation study showed that patients suspect for having a tumour predisposition syndrome were recognized. Excellent correlation for indication for referral of a patient between the screening instrument and the reference standard (personal evaluation by an experienced clinical geneticist) was found.). Conclusions The Delphi process performed by international specialists with a function as opinion leaders in their field of expertise has led to a screening form and instrument with which those childhood cancer patients can be identified who may have a tumour predisposition syndrome and thus have an indication to be referred for further genetic analysis. PMID:23855994

Multiple internal standard normalization for improving HS-SPME-GC-MS quantitation in virgin olive oil volatile organic compounds (VOO-VOCs) profile.

PubMed

Fortini, Martina; Migliorini, Marzia; Cherubini, Chiara; Cecchi, Lorenzo; Calamai, Luca

2017-04-01

The commercial value of virgin olive oils (VOOs) strongly depends on their classification, also based on the aroma of the oils, usually evaluated by a panel test. Nowadays, a reliable analytical method is still needed to evaluate the volatile organic compounds (VOCs) and support the standard panel test method. To date, the use of HS-SPME sampling coupled to GC-MS is generally accepted for the analysis of VOCs in VOOs. However, VOO is a challenging matrix due to the simultaneous presence of: i) compounds at ppm and ppb concentrations; ii) molecules belonging to different chemical classes and iii) analytes with a wide range of molecular mass. Therefore, HS-SPME-GC-MS quantitation based upon the use of external standard method or of only a single internal standard (ISTD) for data normalization in an internal standard method, may be troublesome. In this work a multiple internal standard normalization is proposed to overcome these problems and improving quantitation of VOO-VOCs. As many as 11 ISTDs were used for quantitation of 71 VOCs. For each of them the most suitable ISTD was selected and a good linearity in a wide range of calibration was obtained. Except for E-2-hexenal, without ISTD or with an unsuitable ISTD, the linear range of calibration was narrower with respect to that obtained by a suitable ISTD, confirming the usefulness of multiple internal standard normalization for the correct quantitation of VOCs profile in VOOs. The method was validated for 71 VOCs, and then applied to a series of lampante virgin olive oils and extra virgin olive oils. In light of our results, we propose the application of this analytical approach for routine quantitative analyses and to support sensorial analysis for the evaluation of positive and negative VOOs attributes. Copyright © 2017 Elsevier B.V. All rights reserved.

Use of high-resolution mass spectrometry to investigate a metabolite interference during liquid chromatography/tandem mass spectrometric quantification of a small molecule in toxicokinetic study samples.

PubMed

Furlong, Michael; Bessire, Andrew; Song, Wei; Huntington, Christopher; Groeber, Elizabeth

2010-07-15

During routine liquid chromatography/tandem mass spectrometric (LC/MS/MS) bioanalysis of a small molecule analyte in rat serum samples from a toxicokinetic study, an unexpected interfering peak was observed in the extracted ion chromatogram of the internal standard. No interfering peaks were observed in the extracted ion chromatogram of the analyte. The dose-dependent peak area response and peak area response versus time profiles of the interfering peak suggested that it might have been related to a metabolite of the dosed compound. Further investigation using high-resolution mass spectrometry led to unequivocal identification of the interfering peak as an N-desmethyl metabolite of the parent analyte. High-resolution mass spectrometry (HRMS) was also used to demonstrate that the interfering response of the metabolite in the multiple reaction monitoring (MRM) channel of the internal standard was due to an isobaric relationship between the (13)C-isotope of the metabolite and the internal standard (i.e., common precursor ion mass), coupled with a metabolite product ion with identical mass to the product ion used in the MRM transition of the internal standard. These results emphasize (1) the need to carefully evaluate internal standard candidates with regard to potential interferences from metabolites during LC/MS/MS method development, validation and bioanalysis of small molecule analytes in biological matrices; (2) the value of HRMS as a tool to investigate unexpected interferences encountered during LC/MS/MS analysis of small molecules in biological matrices; and (3) the potential for interference regardless of choice of IS and therefore the importance of conducting assay robustness on incurred in vitro or in vivo study samples. Copyright 2010 John Wiley & Sons, Ltd.

Scientific Reporting: Raising the Standards.

PubMed

McLeroy, Kenneth R; Garney, Whitney; Mayo-Wilson, Evan; Grant, Sean

2016-10-01

This article is based on a presentation that was made at the 2014 annual meeting of the editorial board of Health Education & Behavior. The article addresses critical issues related to standards of scientific reporting in journals, including concerns about external and internal validity and reporting bias. It reviews current reporting guidelines, effects of adopting guidelines, and offers suggestions for improving reporting. The evidence about the effects of guideline adoption and implementation is briefly reviewed. Recommendations for adoption and implementation of appropriate guidelines, including considerations for journals, are provided. © 2016 Society for Public Health Education.

Instruments to assess patients with rotator cuff pathology: a systematic review of measurement properties.

PubMed

Longo, Umile Giuseppe; Saris, Daniël; Poolman, Rudolf W; Berton, Alessandra; Denaro, Vincenzo

2012-10-01

The aims of this study were to obtain an overview of the methodological quality of studies on the measurement properties of rotator cuff questionnaires and to describe how well various aspects of the design and statistical analyses of studies on measurement properties are performed. A systematic review of published studies on the measurement properties of rotator cuff questionnaires was performed. Two investigators independently rated the quality of the studies using the Consensus-based Standards for the selection of health Measurement Instruments checklist. This checklist was developed in an international Delphi consensus study. Sixteen studies were included, in which two measurement instruments were evaluated, namely the Western Ontario Rotator Cuff Index and the Rotator Cuff Quality-of-Life Measure. The methodological quality of the included studies was adequate on some properties (construct validity, reliability, responsiveness, internal consistency, and translation) but need to be improved on other aspects. The most important methodological aspects that need to be developed are as follows: measurement error, content validity, structural validity, cross-cultural validity, criterion validity, and interpretability. Considering the importance of adequate measurement properties, it is concluded that, in the field of rotator cuff pathology, there is room for improvement in the methodological quality of studies measurement properties. II.

Cross-cultural adaptation and validation of the Turkish version of the pain catastrophizing scale among patients with ankylosing spondylitis

PubMed Central

İlçin, Nursen; Gürpınar, Barış; Bayraktar, Deniz; Savcı, Sema; Çetin, Pınar; Sarı, İsmail; Akkoç, Nurullah

2016-01-01

[Purpose] This study describes the cultural adaptation, validation, and reliability of the Turkish version of the Pain Catastrophizing Scale in patients with ankylosing spondylitis. [Methods] The validity of the Turkish version of the Pain Catastrophizing Scale was assessed by evaluating data quality (missing data and floor and ceiling effects), principal components analysis, internal consistency (Cronbach’s alpha), and construct validity (Spearman’s rho). Reproducibility analyses included standard measurement error, minimum detectable change, limits of agreement, and intraclass correlation coefficients. [Results] Sixty-four adult patients with ankylosing spondylitis with a mean age of 42.2 years completed the study. Factor analysis revealed that all questionnaire items could be grouped into two factors. Excellent internal consistency was found, with a Chronbach’s alpha value of 0.95. Reliability analyses showed an intraclass correlation coefficient (95% confidence interval) of 0.96 for the total score. There was a low correlation coefficient between the Turkish version of the Pain Catastrophizing Scale and body mass index, pain levels at rest and during activity, health-related quality of life, and fear and avoidance behaviors. [Conclusion] The results of this study indicate that the Turkish version of the Pain Catastrophizing Scale is a valid and reliable clinical and research tool for patients with ankylosing spondylitis. PMID:26957778

Validation of a Persian version of the Fibromyalgia Impact Questionnaire (FIQ-P).

PubMed

Bidari, Ali; Hassanzadeh, Morteza; Mohabat, Mohamad-Farzam; Talachian, Elham; Khoei, Effat Merghati

2014-02-01

The aim of this study is to translate, adapt, and validate a Persian version of the Fibromyalgia (FM) Impact Questionnaire (FIQ-P). The FIQ-P was adapted following the translation and back-translation approach; then, it was administered to thirty females with FM. Participants also completed two other validated questionnaires, the Medical Outcome Survey Short Form-36 (SF-36) and the Beck Depression Inventory (BDI). Internal consistency within the FIQ-P items and its test-retest reliability were assessed with Cronbach's alpha and Spearman's correlation coefficient, respectively. Construct validity was analyzed by Spearman's r when correlating the FIQ-P to other questionnaires. The translated version was concordant. Adaptation affected two sub-items of physical function. Participants' mean age ± standard deviation was 40.4 ± 9.0 years. Internal consistency proved good with α = 0.80. Test-retest coefficient ranged from 0.50 for the item "work days missed" to 0.79 for all FIQ-P items. Fair and statistically significant (P < 0.01) correlations were found between the FIQ-P items and two other questionnaires, SF-36 (r = -0.57) and BDI (r = 0.53). We concluded that the FIQ-P is a valid and reliable instrument for measuring health status of Persian-speaking FM patients.

Measuring activity in children and adolescents using self-report: PAQ-C and PAQ-A.

PubMed

Janz, Kathleen F; Lutuchy, Elena M; Wenthe, Phyllis; Levy, Steven M

2008-04-01

This study examined the psychometric properties of two versions of a commonly used physical activity 7-d self-report, the Physical Activity Questionnaire for Older Children (PAQ-C) and Physical Activity Questionnaire for Adolescents (PAQ-A). We longitudinally examined the internal consistency, stability, and situational effects of the PAQ-C and PAQ-A in a cohort of children (N = 210) at ages 11 and 13 yr. Statistical analysis included factor loading and standardized Cronbach coefficient alphas. We cross-sectionally examined concurrent validity of the PAQ-A in a subsample of our cohort (N = 49) at age 13 by comparing it with concurrently measured physical activity using an activity monitor (Actigraph). Spearman correlation coefficients were used for this analysis. Standardized Cronbach alphas ranged from 0.72 to 0.88. A subsample analysis suggested that completing the questionnaires during the summer months slightly reduced the standardized alpha for the PAQ-C, but not the PAQ-A. Associations between the PAQ-A (revised) summary score and activity monitor variables were rho = 0.56 for total PA and rho = 0.63 for moderate through vigorous activity (P < 0.05). Associations between individual PAQ-A questions and activity monitor variables for the same time frame ranged from rho = 0.41 to 0.62 (P < 0.05). The PAQ-C and PAQ-A show good internal consistency. The PAQ-A has acceptable validity.

Sensitive and selective liquid chromatography-tandem mass spectrometry method for the quantification of aniracetam in human plasma.

PubMed

Zhang, Jingjing; Liang, Jiabi; Tian, Yuan; Zhang, Zunjian; Chen, Yun

2007-10-15

A rapid, sensitive and selective LC-MS/MS method was developed and validated for the quantification of aniracetam in human plasma using estazolam as internal standard (IS). Following liquid-liquid extraction, the analytes were separated using a mobile phase of methanol-water (60:40, v/v) on a reverse phase C18 column and analyzed by a triple-quadrupole mass spectrometer in the selected reaction monitoring (SRM) mode using the respective [M+H]+ ions, m/z 220-->135 for aniracetam and m/z 295-->205 for the IS. The assay exhibited a linear dynamic range of 0.2-100 ng/mL for aniracetam in human plasma. The lower limit of quantification (LLOQ) was 0.2 ng/mL with a relative standard deviation of less than 15%. Acceptable precision and accuracy were obtained for concentrations over the standard curve range. The validated LC-MS/MS method has been successfully applied to study the pharmacokinetics of aniracetam in healthy male Chinese volunteers.

Assessment and certification of neonatal incubator sensors through an inferential neural network.

PubMed

de Araújo, José Medeiros; de Menezes, José Maria Pires; Moura de Albuquerque, Alberto Alexandre; da Mota Almeida, Otacílio; Ugulino de Araújo, Fábio Meneghetti

2013-11-15

Measurement and diagnostic systems based on electronic sensors have been increasingly essential in the standardization of hospital equipment. The technical standard IEC (International Electrotechnical Commission) 60601-2-19 establishes requirements for neonatal incubators and specifies the calibration procedure and validation tests for such devices using sensors systems. This paper proposes a new procedure based on an inferential neural network to evaluate and calibrate a neonatal incubator. The proposal presents significant advantages over the standard calibration process, i.e., the number of sensors is drastically reduced, and it runs with the incubator under operation. Since the sensors used in the new calibration process are already installed in the commercial incubator, no additional hardware is necessary; and the calibration necessity can be diagnosed in real time without the presence of technical professionals in the neonatal intensive care unit (NICU). Experimental tests involving the aforementioned calibration system are carried out in a commercial incubator in order to validate the proposal.

Assessment and Certification of Neonatal Incubator Sensors through an Inferential Neural Network

PubMed Central

de Araújo Júnior, José Medeiros; de Menezes Júnior, José Maria Pires; de Albuquerque, Alberto Alexandre Moura; Almeida, Otacílio da Mota; de Araújo, Fábio Meneghetti Ugulino

2013-01-01

Measurement and diagnostic systems based on electronic sensors have been increasingly essential in the standardization of hospital equipment. The technical standard IEC (International Electrotechnical Commission) 60601-2-19 establishes requirements for neonatal incubators and specifies the calibration procedure and validation tests for such devices using sensors systems. This paper proposes a new procedure based on an inferential neural network to evaluate and calibrate a neonatal incubator. The proposal presents significant advantages over the standard calibration process, i.e., the number of sensors is drastically reduced, and it runs with the incubator under operation. Since the sensors used in the new calibration process are already installed in the commercial incubator, no additional hardware is necessary; and the calibration necessity can be diagnosed in real time without the presence of technical professionals in the neonatal intensive care unit (NICU). Experimental tests involving the aforementioned calibration system are carried out in a commercial incubator in order to validate the proposal. PMID:24248278

Corsica: A Multi-Mission Absolute Calibration Site

NASA Astrophysics Data System (ADS)

Bonnefond, P.; Exertier, P.; Laurain, O.; Guinle, T.; Femenias, P.

2013-09-01

In collaboration with the CNES and NASA oceanographic projects (TOPEX/Poseidon and Jason), the OCA (Observatoire de la Côte d'Azur) developed a verification site in Corsica since 1996, operational since 1998. CALibration/VALidation embraces a wide variety of activities, ranging from the interpretation of information from internal-calibration modes of the sensors to validation of the fully corrected estimates of the reflector heights using in situ data. Now, Corsica is, like the Harvest platform (NASA side) [14], an operating calibration site able to support a continuous monitoring with a high level of accuracy: a 'point calibration' which yields instantaneous bias estimates with a 10-day repeatability of 30 mm (standard deviation) and mean errors of 4 mm (standard error). For a 35-day repeatability (ERS, Envisat), due to a smaller time series, the standard error is about the double ( 7 mm).In this paper, we will present updated results of the absolute Sea Surface Height (SSH) biases for TOPEX/Poseidon (T/P), Jason-1, Jason-2, ERS-2 and Envisat.

Linguistic validation of stigmatisation degree, self-esteem and knowledge questionnaire among asthma patients using Rasch analysis.

PubMed

Ahmad, Sohail; Ismail, Ahmad Izuanuddin; Khan, Tahir Mehmood; Akram, Waqas; Mohd Zim, Mohd Arif; Ismail, Nahlah Elkudssiah

2017-04-01

The stigmatisation degree, self-esteem and knowledge either directly or indirectly influence the control and self-management of asthma. To date, there is no valid and reliable instrument that can assess these key issues collectively. The main aim of this study was to test the reliability and validity of the newly devised and translated "Stigmatisation Degree, Self-Esteem and Knowledge Questionnaire" among adult asthma patients using the Rasch measurement model. This cross-sectional study recruited thirty adult asthma patients from two respiratory specialist clinics in Selangor, Malaysia. The newly devised self-administered questionnaire was adapted from relevant publications and translated into the Malay language using international standard translation guidelines. Content and face validation was done. The data were extracted and analysed for real item reliability and construct validation using the Rasch model. The translated "Stigmatisation Degree, Self-Esteem and Knowledge Questionnaire" showed high real item reliability values of 0.90, 0.86 and 0.89 for stigmatisation degree, self-esteem, and knowledge of asthma, respectively. Furthermore, all values of point measure correlation (PTMEA Corr) analysis were within the acceptable specified range of the Rasch model. Infit/outfit mean square values and Z standard (ZSTD) values of each item verified the construct validity and suggested retaining all the items in the questionnaire. The reliability analyses and output tables of item measures for construct validation proved the translated Malaysian version of "Stigmatisation Degree, Self-Esteem and Knowledge Questionnaire" as a valid and highly reliable questionnaire.

Author Response to Sabour (2018), "Comment on Hall et al. (2017), 'How to Choose Between Measures of Tinnitus Loudness for Clinical Research? A Report on the Reliability and Validity of an Investigator-Administered Test and a Patient-Reported Measure Using Baseline Data Collected in a Phase IIa Drug Trial'".

PubMed

Hall, Deborah A; Mehta, Rajnikant L; Fackrell, Kathryn

2018-03-08

The authors respond to a letter to the editor (Sabour, 2018) concerning the interpretation of validity in the context of evaluating treatment-related change in tinnitus loudness over time. The authors refer to several landmark methodological publications and an international standard concerning the validity of patient-reported outcome measurement instruments. The tinnitus loudness rating performed better against our reported acceptability criteria for (face and convergent) validity than did the tinnitus loudness matching test. It is important to distinguish between tests that evaluate the validity of measuring treatment-related change over time and tests that quantify the accuracy of diagnosing tinnitus as a case and non-case.

Development, validation and utilisation of food-frequency questionnaires - a review.

PubMed

Cade, Janet; Thompson, Rachel; Burley, Victoria; Warm, Daniel

2002-08-01

The purpose of this review is to provide guidance on the development, validation and use of food-frequency questionnaires (FFQs) for different study designs. It does not include any recommendations about the most appropriate method for dietary assessment (e.g. food-frequency questionnaire versus weighed record). A comprehensive search of electronic databases was carried out for publications from 1980 to 1999. Findings from the review were then commented upon and added to by a group of international experts. Recommendations have been developed to aid in the design, validation and use of FFQs. Specific details of each of these areas are discussed in the text. FFQs are being used in a variety of ways and different study designs. There is no gold standard for directly assessing the validity of FFQs. Nevertheless, the outcome of this review should help those wishing to develop or adapt an FFQ to validate it for its intended use.

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

PubMed

Brown, K; Stokes, W

2012-01-01

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

Performance in normal subjects on a novel battery of driving-related sensory-motor and cognitive tests.

PubMed

Innes, Carrie R H; Jones, Richard D; Anderson, Tim J; Hollobon, Susan G; Dalrymple-Alford, John C

2009-05-01

Currently, there is no international standard for the assessment of fitness to drive for cognitively or physically impaired persons. A computerized battery of driving-related sensory-motor and cognitive tests (SMCTests) has been developed, comprising tests of visuoperception, visuomotor ability, complex attention, visual search, decision making, impulse control, planning, and divided attention. Construct validity analysis was conducted in 60 normal, healthy subjects and showed that, overall, the novel cognitive tests assessed cognitive functions similar to a set of standard neuropsychological tests. The novel tests were found to have greater perceived face validity for predicting on-road driving ability than was found in the equivalent standard tests. Test-retest stability and reliability of SMCTests measures, as well as correlations between SMCTests and on-road driving, were determined in a subset of 12 subjects. The majority of test measures were stable and reliable across two sessions, and significant correlations were found between on-road driving scores and measures from ballistic movement, footbrake reaction, hand-control reaction, and complex attention. The substantial face validity, construct validity, stability, and reliability of SMCTests, together with the battery's level of correlation with on-road driving in normal subjects, strengthen our confidence in the ability of SMCTests to detect and identify sensory-motor and cognitive deficits related to unsafe driving and increased risk of accidents.

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

PubMed Central

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

2017-01-01

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

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

PubMed

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

2017-01-01

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

The Geoscience Spaceborne Imaging Spectroscopy Technical Committees Calibration and Validation Workshop

NASA Technical Reports Server (NTRS)

Ong, Cindy; Mueller, Andreas; Thome, Kurtis; Pierce, Leland E.; Malthus, Timothy

2016-01-01

Calibration is the process of quantitatively defining a system's responses to known, controlled signal inputs, and validation is the process of assessing, by independent means, the quality of the data products derived from those system outputs [1]. Similar to other Earth observation (EO) sensors, the calibration and validation of spaceborne imaging spectroscopy sensors is a fundamental underpinning activity. Calibration and validation determine the quality and integrity of the data provided by spaceborne imaging spectroscopy sensors and have enormous downstream impacts on the accuracy and reliability of products generated from these sensors. At least five imaging spectroscopy satellites are planned to be launched within the next five years, with the two most advanced scheduled to be launched in the next two years [2]. The launch of these sensors requires the establishment of suitable, standardized, and harmonized calibration and validation strategies to ensure that high-quality data are acquired and comparable between these sensor systems. Such activities are extremely important for the community of imaging spectroscopy users. Recognizing the need to focus on this underpinning topic, the Geoscience Spaceborne Imaging Spectroscopy (previously, the International Spaceborne Imaging Spectroscopy) Technical Committee launched a calibration and validation initiative at the 2013 International Geoscience and Remote Sensing Symposium (IGARSS) in Melbourne, Australia, and a post-conference activity of a vicarious calibration field trip at Lake Lefroy in Western Australia.

Development, pilot testing and psychometric validation of a short version of the coronary artery disease education questionnaire: The CADE-Q SV.

PubMed

Ghisi, Gabriela Lima de Melo; Sandison, Nicole; Oh, Paul

2016-03-01

To develop, pilot test and psychometrically validate a shorter version of the coronary artery disease education questionnaire (CADE-Q), called CADE-Q SV. Based on previous versions of the CADE-Q, cardiac rehabilitation (CR) experts developed 20 items divided into 5 knowledge domains to comprise the first version of the CADE-Q SV. To establish content validity, they were reviewed by an expert panel (N=12). Refined items were pilot-tested in 20 patients, in which clarity was provided. A final version was generated and psychometrically-tested in 132CR patients. Test-retest reliability was assessed via the intraclass correlation coefficient (ICC), the internal consistency using Cronbach's alpha, and criterion validity with regard to patients' education and duration in CR. All ICC coefficients meet the minimum recommended standard. All domains were considered internally consistent (α>0.7). Criterion validity was supported by significant differences in mean scores by educational level (p<0.01) and duration in CR (p<0.05). Knowledge about exercise and nutrition was higher than knowledge about medical condition. The CADE-Q SV was demonstrated to have good reliability and validity. This is a short, quick and appropriate tool for application in clinical and research settings, assessing patients' knowledge during CR and as part of education programming. Copyright © 2015. Published by Elsevier Ireland Ltd.

Translation and Validation of the Dutch Western Ontario Meniscal Evaluation Tool.

PubMed

van der Wal, Robert J P; Heemskerk, Bastiaan T J; van Arkel, Ewoud R A; Mokkink, Lidwine B; Thomassen, Bregje J W

2017-05-01

The aim of this study was to translate the Western Ontario Meniscal Evaluation Tool (WOMET) into Dutch, to evaluate the content validity, construct validity, reliability, and responsiveness, and to determine the minimal important change (MIC) of the Dutch version. The WOMET was translated into Dutch according to a standardized forward-backward translation protocol. A total of 86 patients (51 males, 35 females, median age 52 years [interquartile range, 43-60 years]) with isolated meniscal pathology were included. The WOMET was completed three times; at baseline, around 2 weeks, and after 3 months from the baseline. Knee injury and osteoarthritis outcome score, International Knee Documentation Committee subjective knee form, short-form 36, and an anchor question were also answered. There were good results for content validity (floor and ceiling effects [< 15%]), construct validity (79% of the predefined hypotheses were confirmed), internal consistency (Cronbach α = 0.87, 0.79, and 0.86 for each subscale score), test-retest reliability (intraclass correlation coefficient = 0.78 for total WOMET score), and responsiveness (79% of the predefined hypotheses were confirmed). The smallest detectable change and MIC for the Dutch WOMET are 20.5 and 14.7, respectively. The Dutch version of the WOMET is valid and reliable for assessing health-related quality of life in patients with meniscal pathology. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Validation of the Arab Youth Mental Health scale as a screening tool for depression/anxiety in Lebanese children

PubMed Central

2011-01-01

Background Early detection of common mental disorders, such as depression and anxiety, among children and adolescents requires the use of validated, culturally sensitive, and developmentally appropriate screening instruments. The Arab region has a high proportion of youth, yet Arabic-language screening instruments for mental disorders among this age group are virtually absent. Methods We carried out construct and clinical validation on the recently-developed Arab Youth Mental Health (AYMH) scale as a screening tool for depression/anxiety. The scale was administered with 10-14 year old children attending a social service center in Beirut, Lebanon (N = 153). The clinical assessment was conducted by a child and adolescent clinical psychiatrist employing the DSM IV criteria. We tested the scale's sensitivity, specificity, and internal consistency. Results Scale scores were generally significantly associated with how participants responded to standard questions on health, mental health, and happiness, indicating good construct validity. The results revealed that the scale exhibited good internal consistency (Cronbach's alpha = 0.86) and specificity (79%). However, it exhibited moderate sensitivity for girls (71%) and poor sensitivity for boys (50%). Conclusions The AYMH scale is useful as a screening tool for general mental health states and a valid screening instrument for common mental disorders among girls. It is not a valid instrument for detecting depression and anxiety among boys in an Arab culture. PMID:21435213

Determination of lipophilic toxins by LC/MS/MS: single-laboratory validation.

PubMed

Villar-González, Adriano; Rodríguez-Velasco, María Luisa; Gago-Martínez, Ana

2011-01-01

An LC/MS/MS method has been developed, assessed, and intralaboratory-validated for the analysis of the lipophilic toxins currently regulated by European Union legislation: okadaic acid (OA) and dinophysistoxins 1 and 2, including their ester forms; azaspiracids 1, 2, and 3; pectenotoxins 1 and 2; yessotoxin (YTX), and the analogs 45 OH-YTX, Homo YTX, and 45 OH-Homo YTX; as well as for the analysis of 13-desmetil-spirolide C. The method consists of duplicate sample extraction with methanol and direct analysis of the crude extract without further cleanup or concentration. Ester forms of OA and dinophysistoxins are detected as the parent ions after alkaline hydrolysis of the extract. The validation process of this method was performed using both fortified and naturally contaminated samples, and experiments were designed according to International Organization for Standardization, International Union of Pure and Applied Chemistry, and AOAC guidelines. With the exception of YTX in fortified samples, RSDr below 15% and RSDR were below 25%. Recovery values were between 77 and 95%, and LOQs were below 60 microg/kg. These data together with validation experiments for recovery, selectivity, robustness, traceability, and linearity, as well as uncertainty calculations, are presented in this paper.

Cross-cultural adaptation, reliability and validity of the Turkish version of the Hospital for Special Surgery (HSS) Knee Score.

PubMed

Narin, Selnur; Unver, Bayram; Bakırhan, Serkan; Bozan, Ozgür; Karatosun, Vasfi

2014-01-01

The purpose of this study was to adapt the English version of the Hospital for Special Surgery (HSS) knee score for use in a Turkish population and to evaluate its validity, reliability and cultural adaptation. Standard forward-back translation of the HSS knee score was performed and the Turkish version was applied in 73 patients. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Mini-Mental State Examination and sit-to-stand test were also performed and analyzed. Internal consistency reliability was tested using Cronbach's alpha. The intraclass correlation coefficient (ICC) was used to calculate the test-retest reliability at one-week intervals. Validity was assessed by calculating the Pearson correlation between the HSS, WOMAC and sit-to-stand test scores. The ICC ranged from 0.98 to 0.99 with high internal consistency (Cronbach's alpha: 0.87). The WOMAC score correlated with total HSS score (r: -0.80, p<0.001) and sit-to-stand score (r: 0.12, p: 0.312). The Turkish version of the HSS knee score is reliable and valid in evaluating the total knee arthroplasty in Turkish patients.

Evaluating the Risk of Nonresponse Bias in Educational Large-Scale Assessments with School Nonresponse Questionnaires: A Theoretical Study

ERIC Educational Resources Information Center

Meinck, Sabine; Cortes, Diego; Tieck, Sabine

2017-01-01

Survey participation rates can have a direct impact on the validity of the data collected since nonresponse always holds the risk of bias. Therefore, the International Association for the Evaluation of Educational Achievement (IEA) has set very high standards for minimum survey participation rates. Nonresponse in IEA studies varies between studies…

Nueva investigacion sobre kindergarten de dia completo (Recent Research on All-Day Kindergarten). ERIC Digest.

ERIC Educational Resources Information Center

Clark, Patricia

Noting that much of the early research on the effects of all-day kindergarten had serious problems with internal and external validity due to inadequate methodological standards, this Spanish-language digest reviews research conducted in the 1990s. The digest discusses the academic, social, and behavioral effects of all-day kindergarten, as well…

The Japanese version of the questionnaire about the process of recovery: development and validity and reliability testing.

PubMed

Kanehara, Akiko; Kotake, Risa; Miyamoto, Yuki; Kumakura, Yousuke; Morita, Kentaro; Ishiura, Tomoko; Shimizu, Kimiko; Fujieda, Yumiko; Ando, Shuntaro; Kondo, Shinsuke; Kasai, Kiyoto

2017-11-07

Personal recovery is increasingly recognised as an important outcome measure in mental health services. This study aimed to develop a Japanese version of the Questionnaire about the Process of Recovery (QPR-J) and test its validity and reliability. The study comprised two stages that employed the cross-sectional and prospective cohort designs, respectively. We translated the questionnaire using a standard translation/back-translation method. Convergent validity was examined by calculating Pearson's correlation coefficients with scores on the Recovery Assessment Scale (RAS) and the Short-Form-8 Health Survey (SF-8). An exploratory factor analysis (EFA) was conducted to examine factorial validity. We used intraclass correlation and Cronbach's alpha to examine the test-retest and internal consistency reliability of the QPR-J's 22-item full scale, 17-item intrapersonal and 5-item interpersonal subscales. We conducted an EFA along with a confirmatory factor analysis (CFA). Data were obtained from 197 users of mental health services (mean age: 42.0 years; 61.9% female; 49.2% diagnosed with schizophrenia). The QPR-J showed adequate convergent validity, exhibiting significant, positive correlations with the RAS and SF-8 scores. The QPR-J's full version, subscales, showed excellent test-retest and internal consistency reliability, with the exception of acceptable but relatively low internal consistency reliability for the interpersonal subscale. Based on the results of the CFA and EFA, we adopted the factor structure extracted from the original 2-factor model based on the present CFA. The QPR-J is an adequately valid and reliable measure of the process of recovery among Japanese users with mental health services.

Translation and validation of the Rhinosinusitis Disability Index for use in Nigeria.

PubMed

Asoegwu, C N; Nwawolo, C C; Okubadejo, N U

2017-07-01

The Rhinosinusitis Disability Index (RSDI) is a validated and reliable measure of severity of chronic rhinosinusitis. The objective of this study was to translate and validate the instrument for use in Nigeria. This is a methodological study. 71 patients with chronic rhinosinusitis attending two Otolaryngology clinics in Lagos, Nigeria. Using standardized methods and trained translators, the RSDI was translated to vernacular (Yoruba language) and back-translated to culturally appropriate English. Data analysis comprised of assessment of the item quality, content validity and internal consistency of the back-translated Rhinosinusitis Disability Index (bRSDI), and correlation to the original RSDI. Content validity (floor and ceiling effects) showed 0% floor and ceiling effects for the total scores, 0% ceiling effects for all domains and floor effect for physical domain, and 9.9 and 8.5% floor effects for functional and emotional domains, respectively. The mean item-own correlation for physical domain was 0.54 ± 0.08, 0.72 ± 0.08 for functional domain and 0.74 ± 0.07 for emotional domain. All domain item-own correlations were higher than item-other domain correlations. The total Cronbach's alpha was 0.936 and was higher than 0.70 for all the domains representing good internal consistency. Pearson correlation analysis showed strong correlation of RSDI to bRSDI (total score 0.881; p = 0.000, and domain subscores-physical: 0.788; p = 0.000, functional: 0.830; p = 0.000, and emotional: 0.888; p = 0.000). The back-translated Rhinosinusitis Disability Index shows good face and content validity with good internal consistency while correlating linearly and significantly with the original Rhinosinusitis Disability Index and is recommended for use in Nigeria.

Developing the Polish Educational Needs Assessment Tool (Pol-ENAT) in rheumatoid arthritis and systemic sclerosis: a cross-cultural validation study using Rasch analysis.

PubMed

Sierakowska, Matylda; Sierakowski, Stanisław; Sierakowska, Justyna; Horton, Mike; Ndosi, Mwidimi

2015-03-01

To undertake cross-cultural adaptation and validation of the educational needs assessment tool (ENAT) for use with people with rheumatoid arthritis (RA) and systemic sclerosis (SSc) in Poland. The study involved two main phases: (1) cross-cultural adaptation of the ENAT from English into Polish and (2) Cross-cultural validation of Polish Educational Needs Assessment Tool (Pol-ENAT). The first phase followed an established process of cross-cultural adaptation of self-report measures. The second phase involved completion of the Pol-ENAT by patients and subjecting the data to Rasch analysis to assess the construct validity, unidimensionality, internal consistency and cross-cultural invariance. An adequate conceptual equivalence was achieved following the adaptation process. The dataset for validation comprised a total of 278 patients, 237 (85.3 %) of which were female. In each disease group (145, RA and 133, SSc), the 7 domains of the Pol-ENAT were found to fit the Rasch model, X (2)(df) = 16.953(14), p = 0.259 and 8.132(14), p = 0.882 for RA and SSc, respectively. Internal consistency of the Pol-ENAT was high (patient separation index = 0.85 and 0.89 for SSc and RA, respectively), and unidimensionality was confirmed. Cross-cultural differential item functioning (DIF) was detected in some subscales, and DIF-adjusted conversion tables were calibrated to enable cross-cultural comparison of data between Poland and the UK. Using a standard process in cross-cultural adaptation, conceptual equivalence was achieved between the original (UK) ENAT and the adapted Pol-ENAT. Fit to the Rasch model, confirmed that the construct validity, unidimensionality and internal consistency of the ENAT have been preserved.

The Specific Level of Functioning Scale: construct validity, internal consistency and factor structure in a large Italian sample of people with schizophrenia living in the community.

PubMed

Mucci, Armida; Rucci, Paola; Rocca, Paola; Bucci, Paola; Gibertoni, Dino; Merlotti, Eleonora; Galderisi, Silvana; Maj, Mario

2014-10-01

The study aimed to assess the construct validity, internal consistency and factor structure of the Specific Levels of Functioning Scale (SLOF), a multidimensional instrument assessing real life functioning. The study was carried out in 895 Italian people with schizophrenia, all living in the community and attending the outpatient units of 26 university psychiatric clinics and/or community mental health departments. The construct validity of the SLOF was analyzed by means of the multitrait-multimethod approach, using the Personal and Social Performance (PSP) Scale as the gold standard. The factor structure of the SLOF was examined using both an exploratory principal component analysis and a confirmatory factor analysis. The six factors identified using exploratory principal component analysis explained 57.1% of the item variance. The examination of the multitrait-multimethod matrix revealed that the SLOF factors had high correlations with PSP factors measuring the same constructs and low correlations with PSP factors measuring different constructs. The confirmatory factor analysis (CFA) corroborated the 6-factor structure reported in the original validation study. Loadings were all significant and ranged from a minimum of 0.299 to a maximum of 0.803. The CFA model was adequately powered and had satisfactory goodness of fit indices (comparative fit index=0.927, Tucker-Lewis index=0.920 and root mean square error of approximation=0.047, 95% CI 0.045-0.049). The present study confirms, in a large sample of Italian people with schizophrenia living in the community, that the SLOF is a reliable and valid instrument for the assessment of social functioning. It has good construct validity and internal consistency, and a well-defined factor structure. Copyright © 2014 Elsevier B.V. All rights reserved.

A validated HPLC determination of the flavone aglycone diosmetin in human plasma.

PubMed

Kanaze, Feras Imad; Bounartzi, Melpomeni I; Niopas, Ioannis

2004-12-01

Diosmetin, 3',5,7-trihydroxy-4'-methoxy flavone, is the aglycone of the flavonoid glycoside diosmin that occurs naturally in foods of plant origin. Diosmin exhibits antioxidant and anti-inflammatory activities, improves venous tone and it is used for the treatment of chronic venous insufficiency. Diosmin is hydrolyzed by enzymes of intestinal micro flora before absorption of its aglycone diosmetin. A specific, sensitive, precise, accurate and robust HPLC assay for the determination of diosmetin in human plasma was developed and validated. Diosmetin and the internal standard 7-ethoxycoumarin were isolated from plasma by liquid-liquid extraction and separated on a C8 reversed-phase column with methanol-water-acetic acid (55:43:2, v/v/v) as the mobile phase at 43 degrees C. Peaks were monitored at 344 nm. The method was linear in the 10-300 ng/mL concentration range (r > 0.999). Recovery for diosmetin and internal standard was greater than 89.7 and 86.8%, respectively. Intra-day and inter-day precision for diosmetin ranged from 1.6 to 4.6 and from 2.2 to 5.3%, respectively, and accuracy was better than 97.9%. Copyright 2004 John Wiley & Sons, Ltd.

Methane–oxygen electrochemical coupling in an ionic liquid: a robust sensor for simultaneous quantification†

PubMed Central

Wang, Zhe; Guo, Min; Baker, Gary A.; Stetter, Joseph R.; Lin, Lu; Mason, Andrew J.

2017-01-01

Current sensor devices for the detection of methane or natural gas emission are either expensive and have high power requirements or fail to provide a rapid response. This report describes an electrochemical methane sensor utilizing a non-volatile and conductive pyrrolidinium-based ionic liquid (IL) electrolyte and an innovative internal standard method for methane and oxygen dual-gas detection with high sensitivity, selectivity, and stability. At a platinum electrode in bis(trifluoromethylsulfonyl)imide (NTf2)-based ILs, methane is electro-oxidized to produce CO2 and water when an oxygen reduction process is included. The in situ generated CO2 arising from methane oxidation was shown to provide an excellent internal standard for quantification of the electrochemical oxygen sensor signal. The simultaneous quantification of both methane and oxygen in real time strengthens the reliability of the measurements by cross-validation of two ambient gases occurring within a single sample matrix and allows for the elimination of several types of random and systematic errors in the detection. We have also validated this IL-based methane sensor employing both conventional solid macroelectrodes and flexible microfabricated electrodes using single- and double-potential step chronoamperometry. PMID:25093213

[Legal relevance of guidelines : Contextualization exemplified by international recommendations for treatment of inguinal hernia in adults].

PubMed

Weyhe, D; Uslar, V N; Mählmeyer, C; Oehlers, H

2018-06-21

Guidelines aim to standardize treatment concepts based on evidence from the literature and may thus be viewed as collegial support; however, there is a lack of clarity about the legal relevance and legal validity of international guidelines compared to the Association of the Scientific Medical Societies in Germany (AWMF) recommendations. A literature search was conducted on German AWMF guidelines and on international guidelines for inguinal hernia in adults. Differences in the structure of the guidelines were analyzed and legal terms, such as the medical standard, the Patients' Rights Act and the current legal literature are defined and commented on with respect to guideline-compliant treatment. Since 2003 a total of 15 guidelines and recommendations for the treatment of inguinal hernia have been published. There are no AWMF guidelines on one of the procedures most frequently performed in Germany. Among the relevant judgments and laws passed from 1994 onwards, § 630 of the German Civil Code (BGB) passed in 2013 seems to be particularly significant, since it standardizes the term "medical standard" and explicitly allows values falling short of the standard after clarification. From a legal point of view, the basic prerequisites for medical treatment are patient consent and intervention education. In principle, a non-guideline-compliant treatment procedure can be agreed. The patient must be informed about the treatment options that are relevant to the medical standard, the procedure must be indicated according to the medical standard and the operation must be performed in accordance with the national medical specialist standard. Thus, international guidelines cannot a priori claim to be followed unobserved and are therefore not legally comparable to the German S3 guidelines of the AWMF. It is strongly advised to expressly point out and explicitly explain anything falling short of the standard, individual healing attempts and so-called outsider methods.

Approaches to quality management and accreditation in a genetic testing laboratory

PubMed Central

Berwouts, Sarah; Morris, Michael A; Dequeker, Elisabeth

2010-01-01

Medical laboratories, and specifically genetic testing laboratories, provide vital medical services to different clients: clinicians requesting a test, patients from whom the sample was collected, public health and medical-legal instances, referral laboratories and authoritative bodies. All expect results that are accurate and obtained in an efficient and effective manner, within a suitable time frame and at acceptable cost. There are different ways of achieving the end results, but compliance with International Organization for Standardization (ISO) 15189, the international standard for the accreditation of medical laboratories, is becoming progressively accepted as the optimal approach to assuring quality in medical testing. We present recommendations and strategies designed to aid genetic testing laboratories with the implementation of a quality management system, including key aspects such as document control, external quality assessment, internal quality control, internal audit, management review, validation, as well as managing the human side of change. The focus is on pragmatic approaches to attain the levels of quality management and quality assurance required for accreditation according to ISO 15189, within the context of genetic testing. Attention is also given to implementing efficient and effective quality improvement. PMID:20720559

[On the way to national reference system of laboratory medicine].

PubMed

Muravskaia, N P; Men'shikov, V V

2014-10-01

The application of standard samples and reference techniques of implementation of measurements is needed for a valid support of reliability of analyses applied in clinical diagnostic laboratories. They play role of landmarks under metrologic monitoring, calibration of devices and control of quality of results. The article presents analysis of shortcomings interfering with formation of national reference system in Russia harmonized with possibilities provided by international organizations. Among them are the joint Committee on metrologic monitoring in laboratory medicine under the auspices of the International Bureau of Weights and Measures, the International Federation of clinical chemistry and laboratory medicine, etc. The results of the recent development of national normative documents, standard samples and techniques assisted by the authors of article are considered. They are the first steps to organization of national reference system which would comprise all range of modern analytical technologies of laboratory medicine. The national and international measures are proposed to enhance the promptest resolving of task of organization of national reference system for laboratory medicine in the interests of increasing of effectiveness of medical care to citizen of Russia.

[Methodological quality of an article on the treatment of gastric cancer adopted as protocol by some Chilean hospitals].

PubMed

Manterola, Carlos; Torres, Rodrigo; Burgos, Luis; Vial, Manuel; Pineda, Viviana

2006-07-01

Surgery is a curative treatment for gastric cancer (GC). As relapse is frequent, adjuvant therapies such as postoperative chemo radiotherapy have been tried. In Chile, some hospitals adopted Macdonald's study as a protocol for the treatment of GC. To determine methodological quality and internal and external validity of the Macdonald study. Three instruments were applied that assess methodological quality. A critical appraisal was done and the internal and external validity of the methodological quality was analyzed with two scales: MINCIR (Methodology and Research in Surgery), valid for therapy studies and CONSORT (Consolidated Standards of Reporting Trials), valid for randomized controlled trials (RCT). Guides and scales were applied by 5 researchers with training in clinical epidemiology. The reader's guide verified that the Macdonald study was not directed to answer a clearly defined question. There was random assignment, but the method used is not described and the patients were not considered until the end of the study (36% of the group with surgery plus chemo radiotherapy did not complete treatment). MINCIR scale confirmed a multicentric RCT, not blinded, with an unclear randomized sequence, erroneous sample size estimation, vague objectives and no exclusion criteria. CONSORT system proved the lack of working hypothesis and specific objectives as well as an absence of exclusion criteria and identification of the primary variable, an imprecise estimation of sample size, ambiguities in the randomization process, no blinding, an absence of statistical adjustment and the omission of a subgroup analysis. The instruments applied demonstrated methodological shortcomings that compromise the internal and external validity of the.

A systematic review of the measurement properties of the Body Image Scale (BIS) in cancer patients.

PubMed

Melissant, Heleen C; Neijenhuijs, Koen I; Jansen, Femke; Aaronson, Neil K; Groenvold, Mogens; Holzner, Bernhard; Terwee, Caroline B; van Uden-Kraan, Cornelia F; Cuijpers, Pim; Verdonck-de Leeuw, Irma M

2018-06-01

Body image is acknowledged as an important aspect of health-related quality of life in cancer patients. The Body Image Scale (BIS) is a patient-reported outcome measure (PROM) to evaluate body image in cancer patients. The aim of this study was to systematically review measurement properties of the BIS among cancer patients. A search in Embase, MEDLINE, PsycINFO, and Web of Science was performed to identify studies that investigated measurement properties of the BIS (Prospero ID 42017057237). Study quality was assessed (excellent, good, fair, poor), and data were extracted and analyzed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology on structural validity, internal consistency, reliability, measurement error, hypothesis testing for construct validity, and responsiveness. Evidence was categorized into sufficient, insufficient, inconsistent, or indeterminate. Nine studies were included. Evidence was sufficient for structural validity (one factor solution), internal consistency (α = 0.86-0.96), and reliability (r > 0.70); indeterminate for measurement error (information on minimal important change lacked) and responsiveness (increasing body image disturbance in only one study); and inconsistent for hypothesis testing (conflicting results). Quality of the evidence was moderate to low. No studies reported on cross-cultural validity. The BIS is a PROM with good structural validity, internal consistency, and test-retest reliability, but good quality studies on the other measurement properties are needed to optimize evidence. It is recommended to include a wider variety of cancer diagnoses and treatment modalities in these future studies.

Absolute, pressure-dependent validation of a calibration-free, airborne laser hygrometer transfer standard (SEALDH-II) from 5 to 1200 ppmv using a metrological humidity generator

NASA Astrophysics Data System (ADS)

Buchholz, Bernhard; Ebert, Volker

2018-01-01

Highly accurate water vapor measurements are indispensable for understanding a variety of scientific questions as well as industrial processes. While in metrology water vapor concentrations can be defined, generated, and measured with relative uncertainties in the single percentage range, field-deployable airborne instruments deviate even under quasistatic laboratory conditions up to 10-20 %. The novel SEALDH-II hygrometer, a calibration-free, tuneable diode laser spectrometer, bridges this gap by implementing a new holistic concept to achieve higher accuracy levels in the field. We present in this paper the absolute validation of SEALDH-II at a traceable humidity generator during 23 days of permanent operation at 15 different H2O mole fraction levels between 5 and 1200 ppmv. At each mole fraction level, we studied the pressure dependence at six different gas pressures between 65 and 950 hPa. Further, we describe the setup for this metrological validation, the challenges to overcome when assessing water vapor measurements on a high accuracy level, and the comparison results. With this validation, SEALDH-II is the first airborne, metrologically validated humidity transfer standard which links several scientific airborne and laboratory measurement campaigns to the international metrological water vapor scale.

Progress, innovation and regulatory science in drug development: the politics of international standard-setting.

PubMed

Abraham, John; Reed, Tim

2002-06-01

This paper examines international standard-setting in the toxicology of pharmaceuticals during the 1990s, which has involved both the pharmaceutical industry and regulatory agencies in an organization known as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The analysis shows that the relationships between innovation, regulatory science and 'progress' may be more complex and controversial than is often assumed. An assessment of the ICH's claims about the implications of 'technical' harmonization of drug-testing standards for the maintenance of drug safety, via toxicological testing, and the delivery of therapeutic progress, via innovation, is presented. By demonstrating that there is not a technoscientific validity for these claims, it is argued that, within the ICH, a discourse of technological innovation and scientific progress has been used by regulatory agencies and prominent parts of the transnational pharmaceutical industry to legitimize the lowering and loosening of toxicological standards for drug testing. The mobilization and acceptance of this discourse are shown to be pivotal to the ICH's transformation of reductions in safety standards, which are apparently against the interests of patients and public health, into supposed therapeutic benefits derived from promises of greater access to more innovative drug products. The evidence suggests that it is highly implausible that these reductions in the standards of regulatory toxicology are consistent with therapeutic progress for patients, and highlights a worrying aspect embedded in the 'technical trajectories' of regulatory science.

Cross-cultural adaptation and validation of the Patient-Rated Tennis Elbow Evaluation Questionnaire on lateral elbow tendinopathy for French-speaking patients.

PubMed

Kaux, Jean-François; Delvaux, François; Schaus, Jean; Demoulin, Christophe; Locquet, Médéa; Buckinx, Fanny; Beaudart, Charlotte; Dardenne, Nadia; Van Beveren, Julien; Croisier, Jean-Louis; Forthomme, Bénédicte; Bruyère, Olivier

Translation and validation of algo-functional questionnaire. The lateral elbow tendinopathy is a common injury in tennis players and physical workers. The Patient-Rated Tennis Elbow Evaluation (PRTEE) Questionnaire was specifically designed to measure pain and functional limitations in patients with lateral epicondylitis (tennis elbow). First developed in English, this questionnaire has since been translated into several languages. The aims of the study were to translate and cross-culturally adapt the PRTEE questionnaire into French and to evaluate the reliability and validity of this translated version of the questionnaire (PRTEE-F). The PRTEE was translated and cross-culturally adapted into French according to international guidelines. To assess the reliability and validity of the PRTEE-F, 115 participants were asked twice to fill in the PRTEE-F, and once the Disabilities of Arm, Shoulder and Hand Questionnaire (DASH) and the Short Form Health Survey (SF-36). Internal consistency (using Cronbach's alpha), test-retest reliability (using intraclass correlation coefficient (ICC), standard error of measurement and minimal detectable change), and convergent and divergent validity (using the Spearman's correlation coefficients respectively with the DASH and with some subscales of the SF-36) were assessed. The PRTEE was translated into French without any problems. PRTEE-F showed a good test-retest reliability for the overall score (ICC 0.86) and for each item (ICC 0.8-0.96) and a high internal consistency (Cronbach's alpha = 0.98). The correlation analyses revealed high correlation coefficients between PRTEE-F and DASH (convergent validity) and, as expected, a low or moderate correlation with the divergent subscales of the SF-36 (discriminant validity). There was no floor or ceiling effect. The PRTEE questionnaire was successfully cross-culturally adapted into French. The PRTEE-F is reliable and valid for evaluating French-speaking patients with lateral elbow tendinopathy. Copyright © 2016 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Comparative analysis of international standards for the fatigue testing of posterior spinal fixation systems: the importance of preload in ISO 12189.

PubMed

La Barbera, Luigi; Ottardi, Claudia; Villa, Tomaso

2015-10-01

Preclinical evaluation of the mechanical reliability of fixation devices is a mandatory activity before their introduction into market. There are two standardized protocols for preclinical testing of spinal implants. The American Society for Testing Materials (ASTM) recommends the F1717 standard, which describes a vertebrectomy condition that is relatively simple to implement, whereas the International Organization for Standardization (ISO) suggests the 12189 standard, which describes a more complex physiological anterior support-based setup. Moreover, ASTM F1717 is nowadays well established, whereas ISO 12189 has received little attention: A few studies tried to accurately describe the ISO experimental procedure through numeric models, but these studies totally neglect the recommended precompression step. This study aimed to build up a reliable, validated numeric model capable of describing the stress on the rods of a spinal fixator assembled according to ISO 12189 standard procedure. Such a model would more adequately represent the in vitro testing condition. This study used finite element (FE) simulations and experimental validation testing. An FE model of the ISO setup was built to calculate the stress on the rods. Simulation was validated by comparison with experimental strain gauges measurements. The same fixator has been previously virtually mounted in an L2-L4 FE model of the lumbar spine, and stresses in the rods were calculated when the spine was subjected to physiological forces and moments. The comparison between the FE predictions and experimental measurements is in good agreement, thus confirming the suitability of the FE method to evaluate the stresses in the device. The initial precompression induces a significant extension of the assembled construct. As the applied load increases, the initial extension is gradually compensated, so that at peak load the rods are bent in flexion: The final stress value predicted is thus reduced to about 50%, if compared with the previous model where the precompression was not considered. Neglecting the initial preload due to the assembly of the overall construct according to ISO 12189 standard could lead to an overestimation of the stress on the rods up to 50%. To correctly describe the state of stress on the posterior spinal fixator, tested according to the ISO procedure, it is important to take into account the initial preload due to the assembly of the overall construct. Copyright © 2015 Elsevier Inc. All rights reserved.

[Revalidation and standardization of the cognition mini-exam (first Spanish version of the Mini-Mental Status Examination) in the general geriatric population].

PubMed

Lobo, A; Saz, P; Marcos, G; Día, J L; de la Cámara, C; Ventura, T; Morales Asín, F; Fernando Pascual, L; Montañés, J A; Aznar, S

1999-06-05

The revalidation of the Mini Examen Cognoscitivo (MEC), first Spanish version (1978) of the Mini-Mental Status Examination (MMSE) and documentation of "population-based norms" should clarify the potential confusion induced by later versions of MMSE. The Zaragoza Study on the prevalence of dementia and depression in a representative sample of the elderly community (N = 1,080). MEC-35 and MEC-30 points, and validated, Spanish versions of Geriatric Mental State (GMS), History and Aetiology Schedule (HAS) and Social Status Schedule (SSS). a) validation of MEC (standardized lay interviewers) against the gold standard of psychiatric diagnosis (DSM-III-R), two months later; b) "population-based norms" in the "healthy" population, and c) comparison with other MMSE versions. The instrument fulfills criteria of "feasibility", "content", "procedural" and "construct validity". Test-retest reliability: weighted kappa = 0.637. MEC-30 (cut-off point 23/24), sensitivity = 89.8%, specificity = 75.1% (80.8% with the cut-off at 22/23), and ROC curve, AUC = 0.920. The coefficients of individual items were satisfactory and the specificity increases in MEC-35 (83.9%). Other MMSE Spanish versions have not improved these coefficients. "Population-based norms" confirm the hypothesized influence of age and education level. MEC-30 is the version with most comparable results with the MMSE in USA. The validity of MEC is confirmed in the elderly population, with the same cut-off points recommended in the original standardization. MEC-30 is the best version for international comparisons.

Measuring safety climate in health care.

PubMed

Flin, R; Burns, C; Mearns, K; Yule, S; Robertson, E M

2006-04-01

To review quantitative studies of safety climate in health care to examine the psychometric properties of the questionnaires designed to measure this construct. A systematic literature review was undertaken to study sample and questionnaire design characteristics (source, no of items, scale type), construct validity (content validity, factor structure and internal reliability, concurrent validity), within group agreement, and level of analysis. Twelve studies were examined. There was a lack of explicit theoretical underpinning for most questionnaires and some instruments did not report standard psychometric criteria. Where this information was available, several questionnaires appeared to have limitations. More consideration should be given to psychometric factors in the design of healthcare safety climate instruments, especially as these are beginning to be used in large scale surveys across healthcare organisations.

The FIRE Project

NASA Technical Reports Server (NTRS)

Mcdougal, D.

1986-01-01

The International Satellite Cloud Climatology Project's (ISCCP) First ISCCP Regional Experiment (FIRE) project is a program to validate the cloud parameters derived by the ISCCP. The 4- to 5-year program will concentrate on clouds in the continental United States, particularly cirrus and marine stratocumulus clouds. As part of the validation process, FIRE will acquire satellite, aircraft, balloon, and surface data. These data (except for the satellite data) will be amalgamated into one common data set. Plans are to generate a standardized format structure for use in the PCDS. Data collection will begin in April 1986, but will not be available to the general scientific community until 1987 or 1988. Additional pertinent data sets already reside in the PCDS. Other qualifications of the PCDS for use in this validation program were enumerated.

Reliability and validity of the Euthanasia Attitude Scale (EAS) for Hong Kong medical doctors.

PubMed

Tang, Wai-Kiu; Mak, Kwok-Kei; Kam, Philip Ming-Ho; Ho, Joanna Wing-Kiu; Chan, Denise Che-Ying; Suen, To-Lam; Lau, Michael Chak-Kwan; Cheng, Adrian Ka-Chun; Wan, Yuen-Ting; Wan, Ho-Yan; Hussain, Assad

2010-08-01

This study aimed to examine the reliability and validity of the Euthanasia Attitude Scale (EAS) in Hong Kong medical doctors. A total of 107 medical doctors (61.7% men) participated in a survey at clinical settings in 2008. The 21-item EAS was used to assess their attitudes toward euthanasia. The mean (standard deviation) and median of the EAS were 63.60 (60.31) and 63.00. Total EAS scores correlated well with ''Ethical Considerations,'' ''Practical Considerations,'' and ''Treasuring Life'' (Spearman rho =.37-.96, P < .001) but not ''Naturalistic Beliefs.'' The construct validity of the 3-factor model was appropriate (Kaiser-Meyer-Olkin [KMO] value = 0.90) and showed high internal consistency (Cronbach alpha =.79-.92). Euthanasia Attitude Scale may be a reliable and valid measure for assessing the attitudes toward euthanasia in medical professionals.

Identifying dyspepsia in the Greek population: translation and validation of a questionnaire.

PubMed

Anastasiou, Foteini; Antonakis, Nikos; Chaireti, Georgia; Theodorakis, Pavlos N; Lionis, Christos

2006-03-04

Studies on clinical issues, including diagnostic strategies, are considered to be the core content of general practice research. The use of standardised instruments is regarded as an important component for the development of Primary Health Care research capacity. Demand for epidemiological cross-cultural comparisons in the international setting and the use of common instruments and definitions valid to each culture is bigger than ever. Dyspepsia is a common complaint in primary practice but little is known with respect to its incidence in Greece. There are some references about the Helicobacter Pylori infection in patients with functional dyspepsia or gastric ulcer in Greece but there is no specific instrument for the identification of dyspepsia. This paper reports on the validation and translation into Greek, of an English questionnaire for the identification of dyspepsia in the general population and discusses several possibilities of its use in the Greek primary care. The selected English postal questionnaire for the identification of people with dyspepsia in the general population consists of 30 items and was developed in 1995. The translation and cultural adaptation of the questionnaire has been performed according to international standards. For the validation of the instrument the internal consistency of the items was established using the alpha coefficient of Chronbach, the reproducibility (test - retest reliability) was measured by kappa correlation coefficient and the criterion validity was calculated against the diagnosis of the patients' records using also kappa correlation coefficient. The final Greek version of the postal questionnaire for the identification of dyspepsia in the general population was reliably translated. The internal consistency of the questionnaire was good, Chronbach's alpha was found to be 0.88 (95% CI: 0.81-0.93), suggesting that all items were appropriate to measure. Kappa coefficient for reproducibility (test - retest reliability) was found 0.66 (95% CI: 0.62-0.71), whereas the kappa analysis for criterion validity was 0.63 (95% CI: 0.36-0.89). This study indicates that the Greek translation is comparable with the English-language version in terms of validity and reliability, and is suitable for epidemiological research within the Greek primary health care setting.

Validation of a smartphone auscultatory blood pressure kit Accutension XYZ-110 in adults according to the ANSI/AAMI/ISO 81060-2: 2013 standard.

PubMed

Chu, Guang; Zhang, Zhi; Xu, Mengdan; Huang, Daini; Dai, Qiuyan

2017-10-01

The aim of this study was to validate the accuracy of the Accutension XYZ-110 blood pressure (BP) kit according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 standard. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured simultaneously on the same arm in 85 Chinese adults (female : male=48 : 37) with a mean age of 43.2 years using the mercury sphygmomanometer (two observers) and the Accutension XYZ-110 device (one supervisor). The ANSI/AAMI/ISO 81060-2:2013 standard for the validation of BP-measuring devices in adults was followed precisely. A total of 255 comparison pairs were obtained for analysis. The mean device-observer difference in the 255 separate BP data pairs was 2.45±2.24 mmHg for SBP and 0.69±2.09 mmHg for DBP. The data were in accordance with the criterion 1 of the ANSI/AAMI/ISO 81060-2:2013 standard requirements (≤5±8 mmHg). In addition, the mean device-observer difference of the 85 participants was 2.45±1.47 mmHg for SBP and 0.69±1.36 mmHg for DBP. The device accuracy also fulfilled the criterion 2 with the SD of less than or equal to 6.47 for SBP and less than or equal to 6.90 mmHg for DBP. The Accutension XYZ-110 BP kit fulfilled the requirements of the ANSI/AAMI/ISO 81060-2:2013 standard, and hence could be recommended for both clinical and self/home BP measurement in adults.

Guidelines for the standardization of preanalytic variables for blood-based biomarker studies in Alzheimer’s disease research

PubMed Central

Gupta, Veer; Henriksen, Kim; Edwards, Melissa; Jeromin, Andreas; Lista, Simone; Bazenet, Chantal; Soares, Holly; Lovestone, Simon; Hampel, Harald; Montine, Thomas; Blennow, Kaj; Foroud, Tatiana; Carrillo, Maria; Graff-Radford, Neill; Laske, Christoph; Breteler, Monique; Shaw, Leslie; Trojanowski, John Q.; Schupf, Nicole; Rissman, Robert A.; Fagan, Anne M.; Oberoi, Pankaj; Umek, Robert; Weiner, Michael W.; Grammas, Paula; Posner, Holly; Martins, Ralph

2015-01-01

The lack of readily available biomarkers is a significant hindrance towards progressing to effective therapeutic and preventative strategies for Alzheimer’s disease (AD). Blood-based biomarkers have potential to overcome access and cost barriers and greatly facilitate advanced neuroimaging and cerebrospinal fluid biomarker approaches. Despite the fact that preanalytical processing is the largest source of variability in laboratory testing, there are no currently available standardized preanalytical guidelines. The current international working group provides the initial starting point for such guidelines for standardized operating procedures (SOPs). It is anticipated that these guidelines will be updated as additional research findings become available. The statement provides (1) a synopsis of selected preanalytical methods utilized in many international AD cohort studies, (2) initial draft guidelines/SOPs for preanalytical methods, and (3) a list of required methodological information and protocols to be made available for publications in the field in order to foster cross-validation across cohorts and laboratories. PMID:25282381

International Society for the Advancement of Cytometry cell sorter biosafety standards.

PubMed

Holmes, Kevin L; Fontes, Benjamin; Hogarth, Philip; Konz, Richard; Monard, Simon; Pletcher, Charles H; Wadley, Robert B; Schmid, Ingrid; Perfetto, Stephen P

2014-05-01

Flow cytometric cell sorting of biological specimens has become prevalent in basic and clinical research laboratories. These specimens may contain known or unknown infectious agents, necessitating precautions to protect instrument operators and the environment from biohazards arising from the use of sorters. To this end the International Society of Analytical Cytology (ISAC) was proactive in establishing biosafety guidelines in 1997 (Schmid et al., Cytometry 1997;28:99-117) and subsequently published revised biosafety standards for cell sorting of unfixed samples in 2007 (Schmid et al., Cytometry Part A J Int Soc Anal Cytol 2007;71A:414-437). Since their publication, these documents have become recognized worldwide as the standard of practice and safety precautions for laboratories performing cell sorting experiments. However, the field of cytometry has progressed since 2007, and the document requires an update. The new Standards provides guidance: (1) for laboratory design for cell sorter laboratories; (2) for the creation of laboratory or instrument specific Standard Operating Procedures (SOP); and (3) on procedures for the safe operation of cell sorters, including personal protective equipment (PPE) and validation of aerosol containment. Published © 2014 Wiley Periodicals Inc.

Roadmap for Testing and Validation of Electric Vehicle Communication Standards

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

Pratt, Richard M.; Tuffner, Francis K.; Gowri, Krishnan

Vehicle to grid communication standards are critical to the charge management and interoperability among plug-in electric vehicles (PEVs), charging stations and utility providers. The Society of Automobile Engineers (SAE), International Organization for Standardization (ISO), International Electrotechnical Commission (IEC) and the ZigBee Alliance are developing requirements for communication messages and protocols. While interoperability standards development has been in progress for more than two years, no definitive guidelines are available for the automobile manufacturers, charging station manufacturers or utility backhaul network systems. At present, there is a wide range of proprietary communication options developed and supported in the industry. Recent work bymore » the Electric Power Research Institute (EPRI), in collaboration with SAE and automobile manufacturers, has identified performance requirements and developed a test plan based on possible communication pathways using power line communication (PLC). Though the communication pathways and power line communication technology options are identified, much work needs to be done in developing application software and testing of communication modules before these can be deployed in production vehicles. This paper presents a roadmap and results from testing power line communication modules developed to meet the requirements of SAE J2847/1 standard.« less

Life-Space Assessment questionnaire: Novel measurement properties for Brazilian community-dwelling older adults.

PubMed

Simões, Maria do Socorro Mp; Garcia, Isabel Ff; Costa, Lucíola da Cm; Lunardi, Adriana C

2018-05-01

The Life-Space Assessment (LSA) assesses mobility from the spaces that older adults go, and how often and how independent they move. Despite its increased use, LSA measurement properties remain unclear. The aim of the present study was to analyze the content validity, reliability, construct validity and interpretability of the LSA for Brazilian community-dwelling older adults. In this clinimetric study we analyzed the measurement properties (content validity, reliability, construct validity and interpretability) of the LSA administered to 80 Brazilian community-dwelling older adults. Reliability was analyzed by Cronbach's alpha (internal consistency), intraclass correlation coefficients and 95% confidence interval (reproducibility), and standard error of measurement (measurement error). Construct validity was analyzed by Pearson's correlations between the LSA and accelerometry (time in inactivity and moderate-to-vigorous activities), and interpretability was analyzed by determination of the minimal detectable change, and floor and ceiling effects. The LSA met the criteria for content validity. The Cronbach's alpha was 0.92, intraclass correlation coefficient was 0.97 (95% confidence interval 0.95-0.98) and standard error of measurement was 4.12. The LSA showed convergence with accelerometry (negative correlation with time in inactivity and positive correlation with time in moderate to vigorous activities), the minimal detectable change was 0.36 and we observed no floor or ceiling effects. The LSA showed adequate reliability, validity and interpretability for life-space mobility assessment of Brazilian community-dwelling older adults. Geriatr Gerontol Int 2018; 18: 783-789. © 2018 Japan Geriatrics Society.

On-Orbit Prospective Echocardiography on International Space Station

NASA Technical Reports Server (NTRS)

Hamilton, Douglas R.; Sargsyan, Ashot E.; Martin, David; Garcia, Kathleen M.; Melton, Shannon; Feiverson, Alan; Dulchavsky, Scott A.

2010-01-01

A number of echocardiographic research projects and experiments have been flown on almost every space vehicle since 1970, but validation of standard methods and the determination of Space Normal cardiac function has not been reported to date. Advanced Diagnostics in Microgravity (ADUM) -remote guided echocardiographic technique provides a novel and effective approach to on-board assessment of cardiac physiology and structure using a just-in-time training algorithm and real-time remote guidance aboard the International Space Station (ISS). The validation of remotely guided echocardiographic techniques provides the procedures and protocols to perform scientific and clinical echocardiography on the ISS and the Moon. The objectives of this study were: 1.To confirm the ability of non-physician astronaut/cosmonaut crewmembers to perform clinically relevant remotely guided echocardiography using the Human Research Facility on board the ISS. 2.To compare the preflight, postflight and in-flight echocardiographic parameters commonly used in clinical medicine.

The Korean version of the Carpal Tunnel Questionnaire. Cross cultural adaptation, reliability, validity and responsiveness.

PubMed

Kim, J K; Lim, H M

2015-02-01

The purpose of this study was to translate and culturally adapt the Carpal Tunnel Questionnaire to produce an equivalent Korean version. A total of 53 patients completed the Korean version of the Carpal Tunnel Questionnaire pre-operatively and 3 months after open carpal tunnel release. All 53 also completed the Korean version of the Disabilities of Arm, Shoulder, and Hand questionnaire pre-operatively and 3 months post-operatively. Reliability was measured by determining the test-retest reliability and internal consistency. Test-retest reliability was assessed using intraclass correlation coefficients and paired t-tests, and internal consistency using Cronbach's alpha coefficients. Pearson correlation analysis was carried out on the Korean version of the Carpal Tunnel Questionnaire scores and the Korean version of the Disabilities of Arm, Shoulder, and Hand scores to assess construct validity. Responsiveness was evaluated using effect sizes and standardized response means. The reliability of the Korean version of the Carpal Tunnel Questionnaire was good. The scores in the Korean version of the Disabilities of Arm, Shoulder, and Hand strongly correlated with the scores in the Korean version of the Carpal Tunnel Questionnaire. Standardized response mean and effect size were both large for the Korean version of the Carpal Tunnel Questionnaire. The study shows that the Korean version of the Carpal Tunnel Questionnaire is a reliable, valid and responsive instrument for measuring outcomes in carpal tunnel syndrome. © The Author(s) 2014.

A sensitive and specific liquid chromatography mass spectrometry method for simultaneous determination of berberine, palmatine, coptisine, epiberberine and jatrorrhizine from Coptidis Rhizoma in rat plasma

NASA Astrophysics Data System (ADS)

Yu, Sen; Pang, Xiaoyan; Deng, Yuanxiong; Liu, Li; Liang, Yan; Liu, Xiaodong; Xie, Lin; Wang, Guangji; Wang, Xinting

2007-11-01

A sensitive and specific liquid chromatography-electrospray ionization-mass spectrometry (LC-ESI-MS) method has been developed and validated for the identification and quantification of five protoberberine alkaloids, which are berberine, palmatine, coptisine, epiberberine and jatrorrhizine, in rat plasma using tetrahydroberberine as an internal standard. Following solid-phase extraction, the analytes were separated by linear gradient elution on a Shim-pack ODS (4.6 [mu]m, 150 mm × 2.0 mm i.d.) column and analyzed in selected ion monitoring (SIM) mode with a positive electrospray ionization (ESI) interface using the respective [M]+ and [M + H]+ ions, [M]+ = 336 for berberine; 320 for coptisine; 336 for epiberberine; 338 for jatrorrhizine; 352 for palmatine and [M + H]+ = 340 for the internal standard. The method was validated over the concentration range of 0.31-20 ng mL-1 for all the five protoberberine alkaloids. Within-batch and between-batch precisions (R.S.D.%) were all within 15% and accuracy (%Er) ranged from -5 to 5%. The lower limits of quantification were 0.31 ng mL-1 for all analytes. The extraction recoveries were on average 80.8% for berberine, 67E0% for coptisine, 66.2% for epiberberine, 71.8% for jatrorrhizine and 73E2% for palmatine. The validated method was used to study the pharmacokinetic profile of the five protoberberine alkaloids in rat plasma after oral administration of Coptidis Rhizoma extract.

Validation of a sensitive LC/MS/MS method for the determination of telaprevir and its R-isomer in human plasma.

PubMed

Chen, Xinhui; Bushman, Lane R; McAllister, Kevin J; Anderson, Peter L; Kiser, Jennifer J

2014-12-01

The purpose of this study was to validate a reversed-phase high-performance liquid chromatographic (HPLC), tandem mass spectrometry (MS/MS) assay for the determination of telaprevir and its R-diastereomer (VRT-127394) in acidified and nonacidified human plasma. The chromatographic baseline separation of telaprevir and telaprevir-R was performed on a Waters XBridge(TM) BEH Shield C18 , 2.1 × 75 mm column with a 2.5 µm particle size, under isocratic conditions consisting of a mobile phase of 50:45:5 water-acetonitrile-isopropanol with 1% ammonia at 0.2 mL/min. This method utilized a stable isotope internal standard with 11 deuterium atoms on the structure of the telaprevir molecule (telaprevir-d11). An internal standard for the telaprevir-R (telaprevir-R-d11) was also prepared by incubating telaprevir-d11 in basic solution, which facilitated isomer inter-conversion. The detection and quantitation of telaprevir, telaprevir-R, telaprevir-IS and telaprevir-R-IS was achieved by positive ion electrospray (ESI+) MS/MS detection. The assay quantifiable limit was 5.0 ng/mL when 0.100 mL of acidified human plasma was extracted. Accuracy and precision were validated over the calibration range of 5.0-5000 ng/mL. It was demonstrated using patient samples that, contrary to previous recommendations, quantitation of telaprevir does not require acidified plasma. Copyright © 2014 John Wiley & Sons, Ltd.

A Protocol for Advanced Psychometric Assessment of Surveys

PubMed Central

Squires, Janet E.; Hayduk, Leslie; Hutchinson, Alison M.; Cranley, Lisa A.; Gierl, Mark; Cummings, Greta G.; Norton, Peter G.; Estabrooks, Carole A.

2013-01-01

Background and Purpose. In this paper, we present a protocol for advanced psychometric assessments of surveys based on the Standards for Educational and Psychological Testing. We use the Alberta Context Tool (ACT) as an exemplar survey to which this protocol can be applied. Methods. Data mapping, acceptability, reliability, and validity are addressed. Acceptability is assessed with missing data frequencies and the time required to complete the survey. Reliability is assessed with internal consistency coefficients and information functions. A unitary approach to validity consisting of accumulating evidence based on instrument content, response processes, internal structure, and relations to other variables is taken. We also address assessing performance of survey data when aggregated to higher levels (e.g., nursing unit). Discussion. In this paper we present a protocol for advanced psychometric assessment of survey data using the Alberta Context Tool (ACT) as an exemplar survey; application of the protocol to the ACT survey is underway. Psychometric assessment of any survey is essential to obtaining reliable and valid research findings. This protocol can be adapted for use with any nursing survey. PMID:23401759

Measuring participation as defined by the World Health Organization in the International Classification of Functioning, Disability and Health. Psychometric properties of the Ghent Participation Scale.

PubMed

Van de Velde, Dominique; Coorevits, Pascal; Sabbe, Lode; De Baets, Stijn; Bracke, Piet; Van Hove, Geert; Josephsson, Staffan; Ilsbroukx, Stephan; Vanderstraeten, Guy

2017-03-01

To examine the internal consistency, test-retest reliability, construct validity, discriminant validity and responsiveness of the Ghent Participation Scale. Cross-sectional study with a test-retest sample. Six outpatient rehabilitation centres in Belgium. A total of 365 outpatients from eight diagnostic groups. The Ghent Participation Scale, the Impact on Participation and Autonomy, the Utrecht Scale for Evaluation of Rehabilitation-Participation and the Medical outcome study Short Form SF-36. The Ghent Participation Scale was found to have good internal consistency (Cronbach's α between 0.75 and 0.83). At item level, the test-retest reliability was good; weighted kappas ranged between 0.57 and 0.88. On the dimension level intraclass correlation coefficients ranged between 0.80 and 0.90. Evidence for construct validity came from high correlations between the subscales of the Ghent Participation Scale and four subscales of the Impact on Participation and Autonomy (range, r = -0.71 to -0.87) and two subscales of the Utrecht Scale for Evaluation of Rehabilitation-Participation (range, r = 0.54 to 0.72). Standardized response mean ranged between 0.23 and 0.68 and the area under the curve ranged between 68% and 88%. The Ghent Participation Scale appears to be a valid and reliable method of assessing participation irrespective of the respondent's health condition. The Ghent Participation Scale is responsive and is able to detect changes over time.

Reliability and Validity of Composite Scores from the NIH Toolbox Cognition Battery in Adults

PubMed Central

Heaton, Robert K.; Akshoomoff, Natacha; Tulsky, David; Mungas, Dan; Weintraub, Sandra; Dikmen, Sureyya; Beaumont, Jennifer; Casaletto, Kaitlin B.; Conway, Kevin; Slotkin, Jerry; Gershon, Richard

2014-01-01

This study describes psychometric properties of the NIH Toolbox Cognition Battery (NIHTB-CB) Composite Scores in an adult sample. The NIHTB-CB was designed for use in epidemiologic studies and clinical trials for ages 3 to 85. A total of 268 self-described healthy adults were recruited at four university-based sites, using stratified sampling guidelines to target demographic variability for age (20–85 years), gender, education, and ethnicity. The NIHTB-CB contains seven computer-based instruments assessing five cognitive sub-domains: Language, Executive Function, Episodic Memory, Processing Speed, and Working Memory. Participants completed the NIHTB-CB, corresponding gold standard validation measures selected to tap the same cognitive abilities, and sociodemographic questionnaires. Three Composite Scores were derived for both the NIHTB-CB and gold standard batteries: “Crystallized Cognition Composite,” “Fluid Cognition Composite,” and “Total Cognition Composite” scores. NIHTB Composite Scores showed acceptable internal consistency (Cronbach’s alphas = 0.84 Crystallized, 0.83 Fluid, 0.77 Total), excellent test–retest reliability (r: 0.86–0.92), strong convergent (r: 0.78–0.90) and discriminant (r: 0.19–0.39) validities versus gold standard composites, and expected age effects (r = 0.18 crystallized, r = − 0.68 fluid, r = − 0.26 total). Significant relationships with self-reported prior school difficulties and current health status, employment, and presence of a disability provided evidence of external validity. The NIH Toolbox Cognition Battery Composite Scores have excellent reliability and validity, suggesting they can be used effectively in epidemiologic and clinical studies. PMID:24960398

The reliability and validity of the standardized Mensendieck test in relation to disability in patients with chronic pain.

PubMed

Keessen, Paul; Maaskant, Jolanda; Visser, Bart

2018-08-01

The standardized Mensendieck test (SMT) was developed to quantify posture, movement, gait, and respiration. In the hands of an experienced therapist, the SMT is proven to be a reliable tool. It is unclear whether posture, movement, gait, and respiration are related to the degree of functional disability in patients with chronic pain. The objective of this study was to assess the reliability and convergent validity of the SMT in a heterogeneous sample of 50 patients with chronic pain. Internal consistency was determined by Cronbach's α and interrater reliability by the intraclass correlation coefficient (ICC). Convergent validity was assessed by determining the Spearman rank correlation coefficient between the movement quality measured in the SMT and functional limitation measured on the disability rating index (DRI). The internal consistency was Cronbach's α 0.91. Substantial reliability was found for the items: movement (ICC = 0.68), gait (ICC = 0.69), sitting posture (ICC = 0.63), and respiration (ICC = 0.64). Insufficient reliability was found for standing posture (ICC = 0.23). A moderate correlation was found between average test score SMT and the DRI (r = -0.37) and respiration and DRI (r = -0.45). The SMT is a reasonably reliable tool to assess movement, gait, sitting posture, and respiration. None of the items in the domain standing posture has sufficient reliability. A thorough study of this domain should be considered. The results show little evidence for convergent validity. Several items of the SMT correlated moderately with functional limitation with the DRI. These items were global movement, hip flexion, pelvis rotation, and all respiration items.

Assessing patient-centered care: one approach to health disparities education.

PubMed

Wilkerson, LuAnn; Fung, Cha-Chi; May, Win; Elliott, Donna

2010-05-01

Patient-centered care has been described as one approach to cultural competency education that could reduce racial and ethnic health disparities by preparing providers to deliver care that is respectful and responsive to the preferences of each patient. In order to evaluate the effectiveness of a curriculum in teaching patient-centered care (PCC) behaviors to medical students, we drew on the work of Kleinman, Eisenberg, and Good to develop a scale that could be embedded across cases in an objective structured clinical examination (OSCE). To compare the reliability, validity, and feasibility of an embedded patient-centered care scale with the use of a single culturally challenging case in measuring students' use of PCC behaviors as part of a comprehensive OSCE. A total of 322 students from two California medical schools participated in the OSCE as beginning seniors. Cronbach's alpha was used to assess the internal consistency of each approach. Construct validity was addressed by establishing convergent and divergent validity using the cultural challenge case total score and OSCE component scores. Feasibility assessment considered cost and training needs for the standardized patients (SPs). Medical students demonstrated a moderate level of patient-centered skill (mean = 63%, SD = 11%). The PCC Scale demonstrated an acceptable level of internal consistency (alpha = 0.68) over the single case scale (alpha = 0.60). Both convergent and divergent validities were established through low to moderate correlation coefficients. The insertion of PCC items across multiple cases in a comprehensive OSCE can provide a reliable estimate of students' use of PCC behaviors without incurring extra costs associated with implementing a special cross-cultural OSCE. This approach is particularly feasible when an OSCE is already part of the standard assessment of clinical skills. Reliability may be increased with an additional investment in SP training.

The effects of normal aging on multiple aspects of financial decision-making.

PubMed

Bangma, Dorien F; Fuermaier, Anselm B M; Tucha, Lara; Tucha, Oliver; Koerts, Janneke

2017-01-01

Financial decision-making (FDM) is crucial for independent living. Due to cognitive decline that accompanies normal aging, older adults might have difficulties in some aspects of FDM. However, an improved knowledge, personal experience and affective decision-making, which are also related to normal aging, may lead to a stable or even improved age-related performance in some other aspects of FDM. Therefore, the present explorative study examines the effects of normal aging on multiple aspects of FDM. One-hundred and eighty participants (range 18-87 years) were assessed with eight FDM tests and several standard neuropsychological tests. Age effects were evaluated using hierarchical multiple regression analyses. The validity of the prediction models was examined by internal validation (i.e. bootstrap resampling procedure) as well as external validation on another, independent, sample of participants (n = 124). Multiple regression and correlation analyses were applied to investigate the mediation effect of standard measures of cognition on the observed effects of age on FDM. On a relatively basic level of FDM (e.g., paying bills or using FDM styles) no significant effects of aging were found. However more complex FDM, such as making decisions in accordance with specific rules, becomes more difficult with advancing age. Furthermore, an older age was found to be related to a decreased sensitivity for impulsive buying. These results were confirmed by the internal and external validation analyses. Mediation effects of numeracy and planning were found to explain parts of the association between one aspect of FDM (i.e. Competence in decision rules) and age; however, these cognitive domains were not able to completely explain the relation between age and FDM. Normal aging has a negative influence on a complex aspect of FDM, however, other aspects appear to be unaffected by normal aging or improve.

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

PubMed Central

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

2014-01-01

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

Substance use disorders: Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) and International Classification of Diseases, tenth edition (ICD-10).

PubMed

Hasin, Deborah; Hatzenbuehler, Mark L; Keyes, Katherine; Ogburn, Elizabeth

2006-09-01

Two major nomenclatures, Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) and International Classification of Diseases, tenth edition (ICD-10), currently define substance use disorders for broad audiences of users with different training, experience and interests. A comparison of these definitions and their implications for DSM-V and ICD-11 has not been available. The background for the dependence concept and abuse, harmful use, withdrawal, substance-induced disorders and remission and other substance-related conditions is reviewed. Reliability evidence is presented, as is validity evidence from approaches including psychometric, genetic and animal studies. The relevance of the DSM-IV and ICD-10 compared to alternative systems (e.g. the Addiction Severity Index) is considered. Reliability and psychometric validity evidence for substance dependence is consistently strong, but more mixed for abuse and harmful use. Findings on the genetics of alcohol disorders support the validity of the dependence concept, while animal studies underscore the centrality of continued use despite negative consequences to the concept of dependence. While few studies on substance-induced disorders have been conducted, those published show good reliability and validity when elements of DSM-IV and ICD-10 are combined. Dependence in DSM-V and ICD-11 should be retained, standardizing both criteria sets and adding a severity measure. The consequences of heavy use should be measured independently of dependence; add cannabis withdrawal if further research supports existing evidence; conduct further studies of the substance-induced psychiatric categories; standardize their criteria across DSM-V and ICD-11; develop a theoretical basis for better remission criteria; consider changing substance 'abuse' to substance 'dysfunction disorder'; and conduct clinician education on the value of the diagnostic criteria.

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).

The Vocal Cord Dysfunction Questionnaire: Validity and Reliability of the Persian Version.

PubMed

Ghaemi, Hamide; Khoddami, Seyyedeh Maryam; Soleymani, Zahra; Zandieh, Fariborz; Jalaie, Shohreh; Ahanchian, Hamid; Khadivi, Ehsan

2017-12-25

The aim of this study was to develop, validate, and assess the reliability of the Persian version of Vocal Cord Dysfunction Questionnaire (VCDQ P ). The study design was cross-sectional or cultural survey. Forty-four patients with vocal fold dysfunction (VFD) and 40 healthy volunteers were recruited for the study. To assess the content validity, the prefinal questions were given to 15 experts to comment on its essential. Ten patients with VFD rated the importance of VCDQ P in detecting face validity. Eighteen of the patients with VFD completed the VCDQ 1 week later for test-retest reliability. To detect absolute reliability, standard error of measurement and smallest detected change were calculated. Concurrent validity was assessed by completing the Persian Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) by 34 patients with VFD. Discriminant validity was measured from 34 participants. The VCDQ was further validated by administering the questionnaire to 40 healthy volunteers. Validation of the VCDQ as a treatment outcome tool was conducted in 18 patients with VFD using pre- and posttreatment scores. The internal consistency was confirmed (Cronbach α = 0.78). The test-retest reliability was excellent (intraclass correlation coefficient = 0.97). The standard error of measurement and smallest detected change values were acceptable (0.39 and 1.08, respectively). There was a significant correlation between the VCDQ P and the CAT total scores (P < 0.05). Discriminative validity was significantly different. The VCDQ scores in patients with VFD before and after treatment was significantly different (P < 0.001). The VCDQ was cross-culturally adapted to Persian and demonstrated to be a valid and reliable self-administered questionnaire in Persian-speaking population. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Determination of calcium, magnesium, sodium, and potassium in foodstuffs by using a microsampling flame atomic absorption spectrometric method after closed-vessel microwave digestion: method validation.

PubMed

Chekri, Rachida; Noël, Laurent; Vastel, Christelle; Millour, Sandrine; Kadar, Ali; Guérin, Thierry

2010-01-01

This paper describes a validation process in compliance with the NFIEN ISO/IEC 17025 standard for the determination of the macrominerals calcium, magnesium, sodium, and potassium in foodstuffs by microsampling with flame atomic absorption spectrometry after closed-vessel microwave digestion. The French Standards Commission (Agence Francaise de Normalisation) standards NF V03-110, NF EN V03-115, and XP T-90-210 were used to evaluate this method. The method was validated in the context of an analysis of the 1322 food samples of the second French Total Diet Study (TDS). Several performance criteria (linearity, LOQ, specificity, trueness, precision under repeatability conditions, and intermediate precision reproducibility) were evaluated. Furthermore, the method was monitored by several internal quality controls. The LOQ values obtained (25, 5, 8.3, and 8.3 mg/kg for Ca, Mg, Na, and K, respectively) were in compliance with the needs of the TDS. The method provided accurate results as demonstrated by a repeatability CV (CVr) of < 7% and a reproducibility CV (CVR) of < 12% for all the elements. Therefore, the results indicated that this method could be used in the laboratory for the routine determination of these four elements in foodstuffs with acceptable analytical performance.

Short version of the Depression Anxiety Stress Scale-21: is it valid for Brazilian adolescents?

PubMed Central

da Silva, Hítalo Andrade; dos Passos, Muana Hiandra Pereira; de Oliveira, Valéria Mayaly Alves; Palmeira, Aline Cabral; Pitangui, Ana Carolina Rodarti; de Araújo, Rodrigo Cappato

2016-01-01

ABSTRACT Objective To evaluate the interday reproducibility, agreement and validity of the construct of short version of the Depression Anxiety Stress Scale-21 applied to adolescents. Methods The sample consisted of adolescents of both sexes, aged between 10 and 19 years, who were recruited from schools and sports centers. The validity of the construct was performed by exploratory factor analysis, and reliability was calculated for each construct using the intraclass correlation coefficient, standard error of measurement and the minimum detectable change. Results The factor analysis combining the items corresponding to anxiety and stress in a single factor, and depression in a second factor, showed a better match of all 21 items, with higher factor loadings in their respective constructs. The reproducibility values for depression were intraclass correlation coefficient with 0.86, standard error of measurement with 0.80, and minimum detectable change with 2.22; and, for anxiety/stress: intraclass correlation coefficient with 0.82, standard error of measurement with 1.80, and minimum detectable change with 4.99. Conclusion The short version of the Depression Anxiety Stress Scale-21 showed excellent values of reliability, and strong internal consistency. The two-factor model with condensation of the constructs anxiety and stress in a single factor was the most acceptable for the adolescent population. PMID:28076595

[Assessing work-related stress: an Italian adaptation of the HSE Management Standards Work-Related Stress Indicator Tool].

PubMed

Marcatto, Francesco; D'Errico, Giuseppe; Di Blas, Lisa; Ferrante, Donatella

2011-01-01

The aim of this paper is to present a preliminary validation of an Italian adaptation of the HSE Management Standards Work-Related Stress Indicator Tool (IT), an instrument for assessing work-related stress at the organizational level, originally developed in Britain by the Health and Safety Executive. A scale that assesses the physical work environment has been added to the original version of the IT. 190 employees of the University of Trieste have been enrolled in the study. A confirmatory analysis showed a satisfactory fit of the eight-factors structure of the instrument. Further psychometric analysis showed adequate internal consistency of the IT scales and good criterion validity, as evidenced by the correlations with self-perception of stress, work satisfaction and motivation. In conclusion, the Indicator Tool proved to be a valid and reliable instrument for the assessment of work-related stress at the organizational level, and it is also compatible with the instructions provided by the Ministry of Labour and Social Policy (Circular letter 18/11/2010).

Analysis of SMELS and reference materials for validation of the k0-based internal monostandard NAA method using in-situ detection efficiency

NASA Astrophysics Data System (ADS)

Acharya, R.; Swain, K. K.; Reddy, A. V. R.

2010-10-01

Three synthetic multielement standards (SMELS I, II and III) and two reference materials (RMs), SL-3 and Soil-7 of IAEA were analyzed for validation of the k0-based internal monostandard neutron activation analysis (IM-NAA) method utilizing in-situ relative detection efficiency. The internal monostandards used in SMELS and RMs were Au and Sc, respectively. The samples were irradiated in Apsara and Dhruva reactors, BARC and radioactive assay was carried out using a 40% relative efficiency HPGe detector coupled to an 8 k MCA. Concentrations of 23 elements were determined in both SMELS and RMs. In the case of RMs, concentrations of a few elements, whose certified values are not available, could also be determined. The % deviations for the elements determined in SMELS with respect to the assigned values and RMs with respect to certified values were within ±8%. The Z-score values at 95% confidence level for most of the elements in both the materials were within ±1.

Electric Vehicle Communication Standards Testing and Validation Phase I: SAE J2847/1

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

Pratt, Richard M.; Tuffner, Francis K.; Gowri, Krishnan

Executive Summary Vehicle to grid communication standards are critical to the charge management and interoperability among vehicles, charging stations and utility providers. Several standards initiatives by the Society of Automobile Engineers (SAE), International Standards Organization and International Electrotechnical Commission (ISO/IEC), and ZigBee / HomePlug Alliance are developing requirements for communication messages and protocols. While the standard development is in progress for more than two years, no definitive guidelines are available for the automobile manufacturers, charging station manufacturers and utility backhaul network systems. At present, there is a wide range of proprietary communication options developed and supported in the industry. Recentmore » work by the Electric Power Research Institute (EPRI) in collaboration with SAE and automobile manufacturers has identified performance requirements and test plan based on possible communication pathways using power line communication over the control pilot and mains. Though the communication pathways and power line communication technology options are identified, much work needs to be done in developing application software and testing of communication modules before these can be deployed in production vehicles. This report presents a test plan and results from initial testing of two power line communication modules developed to meet the requirements of SAE J2847/1 standard.« less

International validation study for interim PET in ABVD-treated, advanced-stage hodgkin lymphoma: interpretation criteria and concordance rate among reviewers.

PubMed

Biggi, Alberto; Gallamini, Andrea; Chauvie, Stephane; Hutchings, Martin; Kostakoglu, Lale; Gregianin, Michele; Meignan, Michel; Malkowski, Bogdan; Hofman, Michael S; Barrington, Sally F

2013-05-01

At present, there are no standard criteria that have been validated for interim PET reporting in lymphoma. In 2009, an international workshop attended by hematologists and nuclear medicine experts in Deauville, France, proposed to develop simple and reproducible rules for interim PET reporting in lymphoma. Accordingly, an international validation study was undertaken with the primary aim of validating the prognostic role of interim PET using the Deauville 5-point score to evaluate images and with the secondary aim of measuring concordance rates among reviewers using the same 5-point score. This paper focuses on the criteria for interpretation of interim PET and on concordance rates. A cohort of advanced-stage Hodgkin lymphoma patients treated with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) were enrolled retrospectively from centers worldwide. Baseline and interim scans were reviewed by an international panel of 6 nuclear medicine experts using the 5-point score. Complete scan datasets of acceptable diagnostic quality were available for 260 of 440 (59%) enrolled patients. Independent agreement among reviewers was reached on 252 of 260 patients (97%), for whom at least 4 reviewers agreed the findings were negative (score of 1-3) or positive (score of 4-5). After discussion, consensus was reached in all cases. There were 45 of 260 patients (17%) with positive interim PET findings and 215 of 260 patients (83%) with negative interim PET findings. Thirty-three interim PET-positive scans were true-positive, and 12 were false-positive. Two hundred three interim PET-negative scans were true-negative, and 12 were false-negative. Sensitivity, specificity, and accuracy were 0.73, 0.94, and 0.91, respectively. Negative predictive value and positive predictive value were 0.94 and 0.73, respectively. The 3-y failure-free survival was 83%, 28%, and 95% for the entire population and for interim PET-positive and -negative patients, respectively (P < 0.0001). The agreement between pairs of reviewers was good or very good, ranging from 0.69 to 0.84 as measured with the Cohen kappa. Overall agreement was good at 0.76 as measured with the Krippendorf α. The 5-point score proposed at Deauville for reviewing interim PET scans in advanced Hodgkin lymphoma is accurate and reproducible enough to be accepted as a standard reporting criterion in clinical practice and for clinical trials.

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

PubMed

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

2016-02-01

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

Measurement properties of depression questionnaires in patients with diabetes: a systematic review.

PubMed

van Dijk, Susan E M; Adriaanse, Marcel C; van der Zwaan, Lennart; Bosmans, Judith E; van Marwijk, Harm W J; van Tulder, Maurits W; Terwee, Caroline B

2018-06-01

To conduct a systematic review on measurement properties of questionnaires measuring depressive symptoms in adult patients with type 1 or type 2 diabetes. A systematic review of the literature in MEDLINE, EMbase and PsycINFO was performed. Full text, original articles, published in any language up to October 2016 were included. Eligibility for inclusion was independently assessed by three reviewers who worked in pairs. Methodological quality of the studies was evaluated by two independent reviewers using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Quality of the questionnaires was rated per measurement property, based on the number and quality of the included studies and the reported results. Of 6286 unique hits, 21 studies met our criteria evaluating nine different questionnaires in multiple settings and languages. The methodological quality of the included studies was variable for the different measurement properties: 9/15 studies scored 'good' or 'excellent' on internal consistency, 2/5 on reliability, 0/1 on content validity, 10/10 on structural validity, 8/11 on hypothesis testing, 1/5 on cross-cultural validity, and 4/9 on criterion validity. For the CES-D, there was strong evidence for good internal consistency, structural validity, and construct validity; moderate evidence for good criterion validity; and limited evidence for good cross-cultural validity. The PHQ-9 and WHO-5 also performed well on several measurement properties. However, the evidence for structural validity of the PHQ-9 was inconclusive. The WHO-5 was less extensively researched and originally not developed to measure depression. Currently, the CES-D is best supported for measuring depressive symptoms in diabetes patients.

Validation of the Spanish Version of the COPD-Q Questionnaire on COPD Knowledge.

PubMed

Puente-Maestu, Luis; Chancafe-Morgan, Jorge; Calle, Myriam; Rodríguez-Hermosa, Juan L; Malo de Molina, Rosa; Ortega-González, Ángel; Fuster, Antonia; Márquez-Martín, Eduardo; Marcos, Pedro J; Ramírez, Laura; Ray, Shaunta'; Franks, Andrea

2016-01-01

Although recognition of the importance of educating chronic obstructive pulmonary disease (COPD) patients has grown in recent years, their understanding of this disease is not being measured due to a lack of specific instruments. The aim of this study was to validate the COPD-Q questionnaire, a 13-item instrument for determining COPD knowledge. The COPD-Q was translated and backtranslated, and subsequently submitted to logic and content validation by a group of COPD experts and 8 COPD patients. Reliability was studied in an independent group of 59 patients with severe COPD seen in the pulmonology ward or clinics of 6 hospitals in Spain (Andalusia, Baleares, Castilla-La Mancha, Galicia and Madrid). This sample was also used for other internal and external validations. The mean age of the group was approximately 70 years and their health awareness was low-to-medium. The number of correct answers was 8.3 (standard deviation: 1.9), median 8, range 3-13. Floor and ceiling effects were 0% and 1.5%, respectively. Internal consistency of the questionnaire was good (Cronbach's alpha=0.85) and reliability was also high, with a kappa coefficient >0.6 for all items and an intraclass correlation efficient of 0.84 for the total score. The 13-item COPD-Q is a valid, applicable and reliable instrument for determining patients' knowledge of COPD. Copyright © 2014 SEPAR. Published by Elsevier Espana. All rights reserved.

Validity of International Classification of Diseases (ICD) coding for dengue infections in hospital discharge records in Malaysia.

PubMed

Woon, Yuan-Liang; Lee, Keng-Yee; Mohd Anuar, Siti Fatimah Zahra; Goh, Pik-Pin; Lim, Teck-Onn

2018-04-20

Hospitalization due to dengue illness is an important measure of dengue morbidity. However, limited studies are based on administrative database because the validity of the diagnosis codes is unknown. We validated the International Classification of Diseases, 10th revision (ICD) diagnosis coding for dengue infections in the Malaysian Ministry of Health's (MOH) hospital discharge database. This validation study involves retrospective review of available hospital discharge records and hand-search medical records for years 2010 and 2013. We randomly selected 3219 hospital discharge records coded with dengue and non-dengue infections as their discharge diagnoses from the national hospital discharge database. We then randomly sampled 216 and 144 records for patients with and without codes for dengue respectively, in keeping with their relative frequency in the MOH database, for chart review. The ICD codes for dengue were validated against lab-based diagnostic standard (NS1 or IgM). The ICD-10-CM codes for dengue had a sensitivity of 94%, modest specificity of 83%, positive predictive value of 87% and negative predictive value 92%. These results were stable between 2010 and 2013. However, its specificity decreased substantially when patients manifested with bleeding or low platelet count. The diagnostic performance of the ICD codes for dengue in the MOH's hospital discharge database is adequate for use in health services research on dengue.

Validation of the Medipro MediCare 100f upper arm blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Yi, Jun; Wan, Yi; Pan, Feng; Yu, Xiaorong; Zhao, Huadong; Shang, Fujun; Xu, Yongyong

2011-08-01

The validation of sphygmomanometer is important in accurate blood pressure measurement. This study presents the validation results by the Medipro MediCare 100f upper arm blood pressure monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010. The ESH-IP revision 2010 for the validation of blood pressure measuring devices in adults was followed precisely. A total of 99 couples of test device and reference blood pressure measurements were obtained during the study (three pairs for each of the 33 participants). The device produced 73, 93, and 98 measurements within 5, 10, and 15 mmHg for systolic blood pressure (SBP) and 79, 93, and 96 for diastolic blood pressure (DBP), respectively. The mean standard deviation device-observer difference was 1.4 ± 5.2 mmHg for SBP and 0.02±5.8 mmHg for DBP. The number of participants with two or three of the device-observer differences within 5 mmHg was 24 for SBP and 30 for DBP, whereas there was no participant with none of the device-observer differences within 5 mmHg. According to the results of the validation study based on the ESH-IP revision 2010, the Medipro MediCare 100f can be recommended for self-measurement in an adult population.

Validation of Social Cognition Rating Tools in Indian Setting (SOCRATIS): A new test-battery to assess social cognition.

PubMed

Mehta, Urvakhsh M; Thirthalli, Jagadisha; Naveen Kumar, C; Mahadevaiah, Mahesh; Rao, Kiran; Subbakrishna, Doddaballapura K; Gangadhar, Bangalore N; Keshavan, Matcheri S

2011-09-01

Social cognition is a cognitive domain that is under substantial cultural influence. There are no culturally appropriate standardized tools in India to comprehensively test social cognition. This study describes validation of tools for three social cognition constructs: theory of mind, social perception and attributional bias. Theory of mind tests included adaptations of, (a) two first order tasks [Sally-Anne and Smarties task], (b) two second order tasks [Ice cream van and Missing cookies story], (c) two metaphor-irony tasks and (d) the faux pas recognition test. Internal, Personal, and Situational Attributions Questionnaire (IPSAQ) and Social Cue Recognition Test were adapted to assess attributional bias and social perception, respectively. These tests were first modified to suit the Indian cultural context without changing the constructs to be tested. A panel of experts then rated the tests on likert scales as to (1) whether the modified tasks tested the same construct as in the original and (2) whether they were culturally appropriate. The modified tests were then administered to groups of actively symptomatic and remitted schizophrenia patients as well as healthy comparison subjects. All tests of the Social Cognition Rating Tools in Indian Setting had good content validity and known groups validity. In addition, the social cure recognition test in Indian setting had good internal consistency and concurrent validity. Copyright © 2011 Elsevier B.V. All rights reserved.

Chinese adaptation and validation of the patellofemoral pain severity scale.

PubMed

Cheung, Roy T H; Ngai, Shirley P C; Lam, Priscillia L; Chiu, Joseph K W; Fung, Eric Y H

2013-05-01

This study validated the Patellofemoral Pain Severity Scale translated into Chinese. The Chinese Patellofemoral Pain Severity Scale was translated from the original English version following standard forward and backward translation procedures recommended by the International Society for Pharmacoeconomics and Outcomes Research. The survey was then conducted in clinical settings by a questionnaire comprising the Chinese Patellofemoral Pain Severity Scale, Kujala Scale and Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index. Eighty-four Chinese reading patients with patellofemoral pain were recruited from physical therapy clinics. Internal consistency of the translated instrument was measured by Cronbach alpha. Convergent validity was examined by Spearman rank correlation coefficient (rho) tests by comparing its score with the validated Chinese version of the Kujala Scale and the WOMAC Osteoarthritis Index while the test-retest reliability was evaluated by administering the questionnaires twice. Cronbach alpha values of individual questions and their overall value were above 0.85. Strong association was found between the Chinese Patellofemoral Pain Severity Scale and the Kujala Scale (rho = -0.72, p < 0.001). Moderate correlation was also found between Chinese Patellofemoral Pain Severity Scale with the WOMAC Osteoarthritis Index (rho = 0.63, p < 0.001). Excellent test-retest reliability (Intraclass correlation coefficient = 0.98) was demonstrated. The Chinese translated version of the Patellofemoral Pain Severity Scale is a reliable and valid instrument for patients with patellofemoral pain.

Development and Validation of the 34-Item Disability Screening Questionnaire (DSQ-34) for Use in Low and Middle Income Countries Epidemiological and Development Surveys.

PubMed

Trani, Jean-François; Babulal, Ganesh Muneshwar; Bakhshi, Parul

2015-01-01

Although 80% of persons with disabilities live in low and middle-income countries, there is still a lack of comprehensive, cross-culturally validated tools to identify persons facing activity limitations and functioning difficulties in these settings. In absence of such a tool, disability estimates vary considerably according to the methodology used, and policies are based on unreliable estimates. The Disability Screening Questionnaire composed of 27 items (DSQ-27) was initially designed by a group of international experts in survey development and disability in Afghanistan for a national survey. Items were selected based on major domains of activity limitations and functioning difficulties linked to an impairment as defined by the International Classification of Functioning, Disability and Health. Face, content and construct validity, as well as sensitivity and specificity were examined. Based on the results obtained, the tool was subsequently refined and expanded to 34 items, tested and validated in Darfur, Sudan. Internal consistency for the total DSQ-34 using a raw and standardized Cronbach's Alpha and within each domain using a standardized Cronbach's Alpha was examined in the Asian context (India and Nepal). Exploratory factor analysis (EFA) using principal axis factoring (PAF) evaluated the lowest number of factors to account for the common variance among the questions in the screen. Test-retest reliability was determined by calculating intraclass correlation (ICC) and inter-rater reliability by calculating the kappa statistic; results were checked using Bland-Altman plots. The DSQ-34 was further tested for standard error of measurement (SEM) and for the minimum detectable change (MDC). Good internal consistency was indicated by Cronbach's Alpha of 0.83/0.82 for India and 0.76/0.78 for Nepal. We confirmed our assumption for EFA using the Kaiser-Meyer-Olkin measure of sampling well above the accepted cutoff of 0.40 for India (0.82) and Nepal (0.82). The criteria for Bartlett's test of sphericity were also met for both India (< .001) and Nepal (< .001). Estimates of reliability from the two countries reached acceptable levels of ICC of 0.75 (p<0.001) for India of 0.77 for Nepal (p<0.001) and good strength of agreement for weighted kappa (respectively 0.77 and 0.79). The SEM/MDC was 0.80/2.22 for India and 0.96/2.66 for Nepal indicating a smaller amount of measurement error in the screen. In Nepal and India, the DSQ-34 shows strong psychometric properties that indicate that it effectively discriminates between persons with and without disabilities. This instrument can be used in association with other instruments for the purpose of comparing health outcomes of persons with and without disabilities in LMICs.

Development and validation of the Polish version of the Female Sexual Function Index in the Polish population of females.

PubMed

Nowosielski, Krzysztof; Wróbel, Beata; Sioma-Markowska, Urszula; Poręba, Ryszard

2013-02-01

Unlike male sexual function, which is relatively easy to assess, female sexual function is still a diagnostic challenge. Although numerous new measurements for female sexual dysfunction (FSD) have recently been developed, the Female Sexual Function Index (FSFI) remains the gold standard for screening. It has been validated in more than 30 countries. The FSFI has been used in several studies conducted in Poland, but it has never been standardized for Polish women. The aim of this study was to develop a Polish version of the FSFI (PL-FSFI). In total, 189 women aged 18-55 years were included in the study. Eighty-five were diagnosed with FSD as per the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM IV-TR) criteria; 104 women did not have FSD. All subjects completed the PL-FSFI at baseline (day 0), day 7, and day 28. Test-retest reliability was determined by Pearson's product-moment correlations. Reliability was tested using Cronbach's α coefficient. Construct validity was evaluated by principal component analysis using varimax rotation and factor analysis. Discriminant validity was assessed with between-groups analysis of variance. All domains of the PL-FSFI demonstrated satisfactory internal consistencies, with Cronbach's α value of >0.70 for the entire sample. The test-retest reliability demonstrated good-to-excellent agreement between the assessment points. Based on principal component analysis, a 5-factor model was established that explained 83.62% of the total variance. Domain intercorrelations of the PL-FSFI ranged from 0.37-0.77. The optimal PL-FSFI cutoff score was 27.50, with 87.1% sensitivity and 83.1% specificity. The PL-FSFI is a reliable questionnaire with good psychometric and discriminative validity. Therefore, it can be used as a tool for preliminary screening for FSD among Polish women. © 2012 International Society for Sexual Medicine.

Inter‐station intensity standardization for whole‐body MR data

PubMed Central

Staring, Marius; Reijnierse, Monique; Lelieveldt, Boudewijn P. F.; van der Geest, Rob J.

2016-01-01

Purpose To develop and validate a method for performing inter‐station intensity standardization in multispectral whole‐body MR data. Methods Different approaches for mapping the intensity of each acquired image stack into the reference intensity space were developed and validated. The registration strategies included: “direct” registration to the reference station (Strategy 1), “progressive” registration to the neighboring stations without (Strategy 2), and with (Strategy 3) using information from the overlap regions of the neighboring stations. For Strategy 3, two regularized modifications were proposed and validated. All methods were tested on two multispectral whole‐body MR data sets: a multiple myeloma patients data set (48 subjects) and a whole‐body MR angiography data set (33 subjects). Results For both data sets, all strategies showed significant improvement of intensity homogeneity with respect to vast majority of the validation measures (P < 0.005). Strategy 1 exhibited the best performance, closely followed by Strategy 2. Strategy 3 and its modifications were performing worse, in majority of the cases significantly (P < 0.05). Conclusions We propose several strategies for performing inter‐station intensity standardization in multispectral whole‐body MR data. All the strategies were successfully applied to two types of whole‐body MR data, and the “direct” registration strategy was concluded to perform the best. Magn Reson Med 77:422–433, 2017. © 2016 The Authors Magnetic Resonance in Medicine published by Wiley Periodicals, Inc. on behalf of International Society for Magnetic Resonance in Medicine PMID:26834001

Validation of a 4-item Negative Symptom Assessment (NSA-4): a short, practical clinical tool for the assessment of negative symptoms in schizophrenia.

PubMed

Alphs, Larry; Morlock, Robert; Coon, Cheryl; Cazorla, Pilar; Szegedi, Armin; Panagides, John

2011-06-01

The 16-item Negative Symptom Assessment (NSA-16) scale is a validated tool for evaluating negative symptoms of schizophrenia. The psychometric properties and predictive power of a four-item version (NSA-4) were compared with the NSA-16. Baseline data from 561 patients with predominant negative symptoms of schizophrenia who participated in two identically designed clinical trials were evaluated. Ordered logistic regression analysis of ratings using NSA-4 and NSA-16 were compared with ratings using several other standard tools to determine predictive validity and construct validity. Internal consistency and test--retest reliability were also analyzed. NSA-16 and NSA-4 scores were both predictive of scores on the NSA global rating (odds ratio = 0.83-0.86) and the Clinical Global Impressions--Severity scale (odds ratio = 0.91-0.93). NSA-16 and NSA-4 showed high correlation with each other (Pearson r = 0.85), similar high correlation with other measures of negative symptoms (demonstrating convergent validity), and lesser correlations with measures of other forms of psychopathology (demonstrating divergent validity). NSA-16 and NSA-4 both showed acceptable internal consistency (Cronbach α, 0.85 and 0.64, respectively) and test--retest reliability (intraclass correlation coefficient, 0.87 and 0.82). This study demonstrates that NSA-4 offers accuracy comparable to the NSA-16 in rating negative symptoms in patients with schizophrenia. Copyright © 2011 John Wiley & Sons, Ltd.

Validation of a Spanish version of the Leicester Cough Questionnaire in non-cystic fibrosis bronchiectasis.

PubMed

Muñoz, Gerard; Buxó, Maria; de Gracia, Javier; Olveira, Casilda; Martinez-Garcia, Miguel Angel; Giron, Rosa; Polverino, Eva; Alvarez, Antonio; Birring, Surinder S; Vendrell, Montserrat

2016-05-01

The Leicester Cough Questionnaire (LCQ) has been validated in non-cystic fibrosis bronchiectasis (NCFBC). The present study aimed to create and validate a Spanish version of the LCQ (LCQ-Sp) in NCFBC. The LCQ-Sp was developed following a standardized protocol. For reliability, we assessed internal consistency and the change in score over a 15-day period in stable state. For responsiveness, we assessed the change in scores between visit 1 and the first exacerbation. For validity, we evaluated convergent validity through correlation with the Saint George's Respiratory Questionnaire (SGRQ) and discriminant validity. Two hundred fifty-nine patients (118 mild bronchiectasis, 90 moderate bronchiectasis and 47 severe bronchiectasis) were included. Internal consistency was high for the total scoring and good for the different domains (Cronbach's α: 0.86-0.91). The test-retest reliability shows an intraclass correlation coefficient of 0.87 for the total score. The mean LCQ-Sp score at visit 1 decreased at the beginning of an exacerbation (15.13 ± 4.06 vs. 12.24 ± 4.64; p < 0.001). The correlation between LCQ-Sp and SGRQ scores was -0.66 (p < 0.01). The differences in the LCQ-Sp total score between the different groups of severity were significant (p < 0.001). The LCQ-Sp discriminates disease severity, is responsive to change when faced with exacerbations and is reliable for use in bronchiectasis. © The Author(s) 2016.

Validation of a Spanish version of the Leicester Cough Questionnaire in non-cystic fibrosis bronchiectasis

PubMed Central

Muñoz, Gerard; Buxó, Maria; de Gracia, Javier; Olveira, Casilda; Martinez-Garcia, Miguel Angel; Giron, Rosa; Polverino, Eva; Alvarez, Antonio; Birring, Surinder S

2016-01-01

The Leicester Cough Questionnaire (LCQ) has been validated in non-cystic fibrosis bronchiectasis (NCFBC). The present study aimed to create and validate a Spanish version of the LCQ (LCQ-Sp) in NCFBC. The LCQ-Sp was developed following a standardized protocol. For reliability, we assessed internal consistency and the change in score over a 15-day period in stable state. For responsiveness, we assessed the change in scores between visit 1 and the first exacerbation. For validity, we evaluated convergent validity through correlation with the Saint George’s Respiratory Questionnaire (SGRQ) and discriminant validity. Two hundred fifty-nine patients (118 mild bronchiectasis, 90 moderate bronchiectasis and 47 severe bronchiectasis) were included. Internal consistency was high for the total scoring and good for the different domains (Cronbach’s α: 0.86–0.91). The test–retest reliability shows an intraclass correlation coefficient of 0.87 for the total score. The mean LCQ-Sp score at visit 1 decreased at the beginning of an exacerbation (15.13 ± 4.06 vs. 12.24 ± 4.64; p < 0.001). The correlation between LCQ-Sp and SGRQ scores was −0.66 (p < 0.01). The differences in the LCQ-Sp total score between the different groups of severity were significant (p < 0.001). The LCQ-Sp discriminates disease severity, is responsive to change when faced with exacerbations and is reliable for use in bronchiectasis. PMID:26902541

The characterization and certification of a quantitative reference material for Legionella detection and quantification by qPCR.

PubMed

Baume, M; Garrelly, L; Facon, J P; Bouton, S; Fraisse, P O; Yardin, C; Reyrolle, M; Jarraud, S

2013-06-01

The characterization and certification of a Legionella DNA quantitative reference material as a primary measurement standard for Legionella qPCR. Twelve laboratories participated in a collaborative certification campaign. A candidate reference DNA material was analysed through PCR-based limiting dilution assays (LDAs). The validated data were used to statistically assign both a reference value and an associated uncertainty to the reference material. This LDA method allowed for the direct quantification of the amount of Legionella DNA per tube in genomic units (GU) and the determination of the associated uncertainties. This method could be used for the certification of all types of microbiological standards for qPCR. The use of this primary standard will improve the accuracy of Legionella qPCR measurements and the overall consistency of these measurements among different laboratories. The extensive use of this certified reference material (CRM) has been integrated in the French standard NF T90-471 (April 2010) and in the ISO Technical Specification 12 869 (Anon 2012 International Standardisation Organisation) for validating qPCR methods and ensuring the reliability of these methods. © 2013 The Society for Applied Microbiology.

Ensuring Quality in AFRINEST and SATT

PubMed Central

2013-01-01

Background: Three randomized open-label clinical trials [Simplified Antibiotic Therapy Trial (SATT) Bangladesh, SATT Pakistan and African Neonatal Sepsis Trial (AFRINEST)] were developed to test the equivalence of simplified antibiotic regimens compared with the standard regimen of 7 days of parenteral antibiotics. These trials were originally conceived and designed separately; subsequently, significant efforts were made to develop and implement a common protocol and approach. Previous articles in this supplement briefly describe the specific quality control methods used in the individual trials; this article presents additional information about the systematic approaches used to minimize threats to validity and ensure quality across the trials. Methods: A critical component of quality control for AFRINEST and SATT was striving to eliminate variation in clinical assessments and decisions regarding eligibility, enrollment and treatment outcomes. Ensuring appropriate and consistent clinical judgment was accomplished through standardized approaches applied across the trials, including training, assessment of clinical skills and refresher training. Standardized monitoring procedures were also applied across the trials, including routine (day-to-day) internal monitoring of performance and adherence to protocols, systematic external monitoring by funding agencies and external monitoring by experienced, independent trial monitors. A group of independent experts (Technical Steering Committee/Technical Advisory Group) provided regular monitoring and technical oversight for the trials. Conclusions: Harmonization of AFRINEST and SATT have helped to ensure consistency and quality of implementation, both internally and across the trials as a whole, thereby minimizing potential threats to the validity of the trials’ results. PMID:23945575

Convergent and diagnostic validity of STAVUX, a word and pseudoword spelling test for adults.

PubMed

Östberg, Per; Backlund, Charlotte; Lindström, Emma

2016-10-01

Few comprehensive spelling tests are available in Swedish, and none have been validated in adults with reading and writing disorders. The recently developed STAVUX test includes word and pseudoword spelling subtests with high internal consistency and adult norms stratified by education. This study evaluated the convergent and diagnostic validity of STAVUX in adults with dyslexia. Forty-six adults, 23 with dyslexia and 23 controls, took STAVUX together with a standard word-decoding test and a self-rated measure of spelling skills. STAVUX subtest scores showed moderate to strong correlations with word-decoding scores and predicted self-rated spelling skills. Word and pseudoword subtest scores both predicted dyslexia status. Receiver-operating characteristic (ROC) analysis showed excellent diagnostic discriminability. Sensitivity was 91% and specificity 96%. In conclusion, the results of this study support the convergent and diagnostic validity of STAVUX.

The validity and diagnostic efficiency of the Davidson Trauma Scale in military veterans who have served since September 11th, 2001.

PubMed

McDonald, Scott D; Beckham, Jean C; Morey, Rajendra A; Calhoun, Patrick S

2009-03-01

The present study examined the psychometric properties and diagnostic efficiency of the Davidson Trauma Scale (DTS), a self-report measure of posttraumatic stress disorder (PTSD) symptoms. Participants included 158 U.S. military veterans who have served since September 11, 2001 (post-9/11). Results support the DTS as a valid self-report measure of PTSD symptoms. The DTS demonstrated good internal consistency, concurrent validity, and convergent and divergent validity. Diagnostic efficiency was excellent when discriminating between veterans with PTSD and veterans with no Axis I diagnosis. However, although satisfactory by conventional standards, efficiency was substantially attenuated when discriminating between PTSD and other Axis I diagnoses. Thus, results illustrate that potency of the DTS as a diagnostic aid was highly dependent on the comparison group used for analyses. Results are discussed in terms of applications to clinical practice and research.

Verification, Validation and Credibility Assessment of a Computational Model of the Advanced Resistive Exercise Device (ARED)

NASA Technical Reports Server (NTRS)

Werner, C. R.; Humphreys, B. T.; Mulugeta, L.

2014-01-01

The Advanced Resistive Exercise Device (ARED) is the resistive exercise device used by astronauts on the International Space Station (ISS) to mitigate bone loss and muscle atrophy due to extended exposure to microgravity (micro g). The Digital Astronaut Project (DAP) has developed a multi-body dynamics model of biomechanics models for use in spaceflight exercise physiology research and operations. In an effort to advance model maturity and credibility of the ARED model, the DAP performed verification, validation and credibility (VV and C) assessment of the analyses of the model in accordance to NASA-STD-7009 'Standards for Models and Simulations'.

Adaptation and validation of the Portuguese version of the Lithium Knowledge Test (LKT) of bipolar patients treated with lithium: cross-over study

PubMed Central

2006-01-01

Objective Adherence problems are a common feature among bipolar patients. A recent study showed that lithium knowledge was the main difference between adherent and non adherents bipolar patients. The Lithium Knowledge Test (LKT), a brief questionnaire, was developed as a means of identifying aspects of patients' practical and pharmacological knowledge which are important if therapy is to be safe and effective. The original English version is validated in psychiatric population, but a validated Portuguese one is not yet available. Methods One hundred six patients selected were diagnosed with bipolar disorder (I or II) according to DSM-IV criteria and had to be on lithium treatment for at least one month. The LKT was administered on only one occasion. We analysed the internal consis tency, concurrent validity, sensitivity and specificity of the LKT for the detection of the knowledge about lithium treatment of bipolar patients. Results The internal consistency, evaluated by Cronbach's alpha was 0.596. The mean of total score LKT by bipolar patients was 9.0 (SD: 0.75) for men and 8.74 (SD: 0.44) for women. Concurrent validity based on plasma lithium concentration showed a significant correlation between the total LKT score and plasma lithium (r = 0,232; p = 0.020). The sensitivity was 84% and specificity was 81%. Conclusion LKT is a rapid, reliable instrument which appears to be as effective as a lengthier standard interview with a lithium clinic doctor, and which has a high level of acceptability to lithium patients. We found that the psychometric assessment of the Portuguese version of LKT showed good internal consistency, sensitivity and specificity. PMID:17147815

Comparison of gas chromatography-combustion-mass spectrometry and gas chromatography-flame ionization detector for the determination of fatty acid methyl esters in biodiesel without specific standards.

PubMed

Sobrado, Laura Alonso; Freije-Carrelo, Laura; Moldovan, Mariella; Encinar, Jorge Ruiz; Alonso, J Ignacio García

2016-07-29

GC-FID has been effectively used as a universal quantification technique for volatile organic compounds for a long time. In most cases, the use of the ECN allows for quantification by GC-FID without external calibration using only the response of a single internal standard. In this paper we compare the performance characteristics of GC-FID with those of post-column (13)C Isotope Dilution GC-Combustion-MS for the absolute quantification of organic compounds without the need for individual standards. For this comparison we have selected the quantification of FAMEs in biodiesel. The selection of the right internal standard was critical for GC-FID even when ECN were considered. On the other hand, the nature of the internal standard was not relevant when GC-Combustion-MS was employed. The proposed method was validated with the analysis of the certified reference material SRM 2772 and comparative data was obtained on real biodiesel samples. The analysis of the SRM 2772 biodiesel provided recoveries in the range 100.6-103.5% and 96.4-103.6% for GC-combustion-MS and GC-FID, respectively. The detection limit for GC-combustion-MS was found to be 4.2ng compound/g of injected sample. In conclusion, the quantitative performance of GC-Combustion-MS compared satisfactorily with that of GC-FID constituting a viable alternative for the quantification of organic compounds without the need for individual standards. Copyright © 2016 Elsevier B.V. All rights reserved.

Testing for purchasing power parity in 21 African countries using several unit root tests

NASA Astrophysics Data System (ADS)

Choji, Niri Martha; Sek, Siok Kun

2017-04-01

Purchasing power parity is used as a basis for international income and expenditure comparison through the exchange rate theory. However, empirical studies show disagreement on the validity of PPP. In this paper, we conduct the testing on the validity of PPP using panel data approach. We apply seven different panel unit root tests to test the validity of the purchasing power parity (PPP) hypothesis based on the quarterly data on real effective exchange rate for 21 African countries from the period 1971: Q1-2012: Q4. All the results of the seven tests rejected the hypothesis of stationarity meaning that absolute PPP does not hold in those African Countries. This result confirmed the claim from previous studies that standard panel unit tests fail to support the PPP hypothesis.

Reliability, validity, and utility of the Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF) in assessments of bariatric surgery candidates.

PubMed

Tarescavage, Anthony M; Wygant, Dustin B; Boutacoff, Lana I; Ben-Porath, Yossef S

2013-12-01

In the current study, we examined the reliability, validity, and clinical utility of Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF; Ben-Porath & Tellegen, 2011) scores in a sample of 759 bariatric surgery candidates. We provide descriptives for all scales, internal consistency and standard error of measurement estimates for all substantive scales, external correlates of substantive scales using chart review and self-report criteria, and relative risk ratios to assess the clinical utility of the instrument. Results generally support the reliability, validity, and clinical utility of MMPI-2-RF scale scores in the psychological evaluation of bariatric surgery candidates. Limitations, future directions, and practical application of these results are discussed. (c) 2013 APA, all rights reserved.

Valid internal standard technique for arson detection based on gas chromatography-mass spectrometry.

PubMed

Salgueiro, Pedro A S; Borges, Carlos M F; Bettencourt da Silva, Ricardo J N

2012-09-28

The most popular procedures for the detection of residues of accelerants in fire debris are the ones published by the American Society for Testing and Materials (ASTM E1412-07 and E1618-10). The most critical stages of these tests are the conservation of fire debris from the sampling to the laboratory, the extraction of residues of accelerants from the debris to the activated charcoal strips (ACS) and from those to the final solvent, as well as the analysis of sample extract by gas chromatography-mass spectrometry (GC-MS) and the interpretation of the instrumental signal. This work proposes a strategy for checking the quality of the sample conservation, the accelerant residues transference to final solvent and GC-MS analysis, using internal standard additions. It is used internal standards ranging from a highly volatile compound for checking debris conservation to low volatile compound for checking GC-MS repeatability. The developed quality control (QC) parameters are not affected by GC-MS sensitivity variation and, specifically, the GC-MS performance control is not affected by ACS adsorption saturation that may mask test performance deviations. The proposed QC procedure proved to be adequate to check GC-MS repeatability, ACS extraction and sample conservation since: (1) standard additions are affected by negligible uncertainty and (2) observed dispersion of QC parameters are fit for its intended use. Copyright © 2012 Elsevier B.V. All rights reserved.

Development and validation of the Survey of Organizational Research Climate (SORC).

PubMed

Martinson, Brian C; Thrush, Carol R; Lauren Crain, A

2013-09-01

Development and targeting efforts by academic organizations to effectively promote research integrity can be enhanced if they are able to collect reliable data to benchmark baseline conditions, to assess areas needing improvement, and to subsequently assess the impact of specific initiatives. To date, no standardized and validated tool has existed to serve this need. A web- and mail-based survey was administered in the second half of 2009 to 2,837 randomly selected biomedical and social science faculty and postdoctoral fellows at 40 academic health centers in top-tier research universities in the United States. Measures included the Survey of Organizational Research Climate (SORC) as well as measures of perceptions of organizational justice. Exploratory and confirmatory factor analyses yielded seven subscales of organizational research climate, all of which demonstrated acceptable internal consistency (Cronbach's α ranging from 0.81 to 0.87) and adequate test-retest reliability (Pearson r ranging from 0.72 to 0.83). A broad range of correlations between the seven subscales and five measures of organizational justice (unadjusted regression coefficients ranging from 0.13 to 0.95) document both construct and discriminant validity of the instrument. The SORC demonstrates good internal (alpha) and external reliability (test-retest) as well as both construct and discriminant validity.

Development and Validation of the Survey of Organizational Research Climate (SORC)

PubMed Central

Martinson, Brian C.; Thrush, Carol R.; Crain, A. Lauren

2012-01-01

Background Development and targeting efforts by academic organizations to effectively promote research integrity can be enhanced if they are able to collect reliable data to benchmark baseline conditions, to assess areas needing improvement, and to subsequently assess the impact of specific initiatives. To date, no standardized and validated tool has existed to serve this need. Methods A web- and mail-based survey was administered in the second half of 2009 to 2,837 randomly selected biomedical and social science faculty and postdoctoral fellows at 40 academic health centers in top-tier research universities in the United States. Measures included the Survey of Organizational Research Climate (SORC) as well as measures of perceptions of organizational justice. Results Exploratory and confirmatory factor analyses yielded seven subscales of organizational research climate, all of which demonstrated acceptable internal consistency (Cronbach’s α ranging from 0.81 to 0.87) and adequate test-retest reliability (Pearson r ranging from 0.72 to 0.83). A broad range of correlations between the seven subscales and five measures of organizational justice (unadjusted regression coefficients ranging from .13 to .95) document both construct and discriminant validity of the instrument. Conclusions The SORC demonstrates good internal (alpha) and external reliability (test-retest) as well as both construct and discriminant validity. PMID:23096775

[Diagnostic kits in parasitology: which controls?].

PubMed

Rossi, P

2004-06-01

The development of new diagnostic tools particularly for some parasitic "neglected diseases", is slowed or even hindered by limited resources assigned for basic and applied research in public institution and private sector. Even if the time-line and costs needed for developing a new In Vitro Diagnostic (IVD) test are generally lower compared to vaccines or new drugs, industry is poorly engaged in investing resources due to the perception of limited markets. To accelerate the development of diagnostics for the world's most deadly diseases, the World Health Organization's (WHO) Special Programme for Research and Training in Tropical Diseases (TDR), the United Nations Development Programme, the World Bank and the Gates Foundation, last year launched a new initiative, FIND (Foundation for Innovative New Diagnostics, www.finddiagnostics.org). The aim is to "apply the latest biotechnology innovations to develop and validate affordable diagnostic tests for diseases of the developing world". Ideally, a new diagnostic test should be accurately evaluated prior to use in medical practice. The first step would be a pre-clinical evaluation, an analytic study to determine its laboratory performance. A crucial point in this phase is the calibration of reagents (antigens, antibodies, DNA probes, etc.) against a standard reference preparation. WHO, through the WHO International Laboratories for Biological Standards, "provides International Biological Reference Preparations which serve as reference sources of defined biological activity expressed in an internationally agreed unit" (www.who.int/biologicals/IBRP/index.htm). Standardization allows "comparison of biological measurements worldwide" and ensures the reliability of diagnostic procedures. These preparations are generally intended for use in the characterization of the activity of secondary reference preparations (regional, national or in-house working standards). Unfortunately, international reference standards for parasitic diseases are not available at present, except for Toxoplasma antibodies. The first international standard reagent for Anti-Toxoplasma Serum was established in 1968 and at present, an international standard reference serum, Anti-toxoplasma serum, human TOXM is available at the National Institute for Biological Standards and Control (NIBSC) in UK. Several collaborative, multicenter studies were carried out to assess the performance of different methods and commercial tests for the diagnosis of toxoplasmosis, by providing to participating laboratories a panel of well-defined sera to be tested. A four-phase process following well-accepted methodological standards for the development of diagnostics, analogous to those internationally accepted for drugs and vaccines was recently proposed. The pre-clinical evaluation, the analytic study to assess sensitivity, specificity, predictive values in laboratory (phase I), should be followed by a proof of principle study to distinguish diseased from healthy persons in easily accessible populations (phase II). The evaluation of test performance in populations of intended use (phase III), and finally the delineation of cost-effectiveness and societal impact of new tests in comparison with existing tools (phase IV) should complete the validation procedure. In this context, national regulatory agencies play a major role in pre-market approval and post-market surveillance of IVDs. The European Community in 1998 approved a directive (Directive 98/79/EC) which rules the marketing of IVD medical devices, in order to harmonise the performance levels and standards in European countries. But, among IVDs for parasitic diseases, only those to detect congenital toxoplasmosis are submitted to defined procedures to provide the verification of products before their placing on the market and the surveillance after their marketing by a notified body, which perform appropriate examinations, tests and inspections to production facilities to verify if the device meets the requirements of the directive. In U.S.A., the Food and Drug Administration (FDA), through the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), provides a comprehensive and regulatory activity for IVDs through pre-market evaluation and post-market surveillance. In developing countries, the scarcity of resources limits the procedures through which the national control authority can assure safety, quality and efficacy of products marketed, both imported and locally manufactured.

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.

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

PubMed

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

2014-01-01

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

Polish Adult Reading Test (PART) - construction of Polish test for estimating the level of premorbid intelligence in schizophrenia.

PubMed

Karakuła-Juchnowicz, Hanna; Stecka, Mariola

2017-08-29

In view of unavailability in Poland of the standardized methods to measure PIQ, the aim of the work was to develop a Polish test to assess the premorbid level of intelligence - PART(Polish AdultReading Test) and to measureits psychometric properties, such as validity, reliability as well as standardization in the group of schizophrenia patients. The principles of PART construction were based on the idea of popular worldwide National Adult Reading Test by Hazel Nelson. The research comprised a group of 122 subjects (65 schizophrenia patients and 57 healthy people), aged 18-60 years, matched for age and gender. PART appears to be a method with high internal consistency and reliability measured by test-retest, inter-rater reliability, and the method with acceptable diagnostic and prognostic validity. The standardized procedures of PART have been investigated and described. Considering the psychometric values of PART and a short time of its performance, the test may be a useful diagnostic instrument in the assessment of premorbid level of intelligence in a group of schizophrenic patients.

Validation of a quantitative NMR method for suspected counterfeit products exemplified on determination of benzethonium chloride in grapefruit seed extracts.

PubMed

Bekiroglu, Somer; Myrberg, Olle; Ostman, Kristina; Ek, Marianne; Arvidsson, Torbjörn; Rundlöf, Torgny; Hakkarainen, Birgit

2008-08-05

A 1H-nuclear magnetic resonance (NMR) spectroscopy method for quantitative determination of benzethonium chloride (BTC) as a constituent of grapefruit seed extract was developed. The method was validated, assessing its specificity, linearity, range, and precision, as well as accuracy, limit of quantification and robustness. The method includes quantification using an internal reference standard, 1,3,5-trimethoxybenzene, and regarded as simple, rapid, and easy to implement. A commercial grapefruit seed extract was studied and the experiments were performed on spectrometers operating at two different fields, 300 and 600 MHz for proton frequencies, the former with a broad band (BB) probe and the latter equipped with both a BB probe and a CryoProbe. The concentration average for the product sample was 78.0, 77.8 and 78.4 mg/ml using the 300 BB probe, the 600MHz BB probe and CryoProbe, respectively. The standard deviation and relative standard deviation (R.S.D., in parenthesis) for the average concentrations was 0.2 (0.3%), 0.3 (0.4%) and 0.3mg/ml (0.4%), respectively.

Cultural Adaptation and Reliability of the Compliance with Standard Precautions Scale (CSPS) for Nurses in Brazil 1

PubMed Central

Pereira, Fernanda Maria Vieira; Lam, Simon Ching; Gir, Elucir

2017-01-01

ABSTRACT Objective: this study aimed to carry of the cultural adaptation and to evaluate the reliability of the Compliance with Standard Precautions Scale (CSPS) for nurses in Brazil. Method: the adaptation process entailed translation, consensus among judges, back-translation, semantic validation and pretest. The reliability was evaluated by internal consistency (Cronbach alpha) and stability (test-retest). The instrument was administered to a sample group of 300 nurses who worked in a large hospital located in the city of São Paulo/SP, Brazil. Results: through the semantic validation, the items from the scale were considered understandable and deemed important for the nurse´s clinical practice. The CSPS Brazilian Portuguese version (CSPS-PB) revealed excellent interpretability. The Cronbach`s alpha was 0.61 and the intraclass correlation coefficient was 0.85. Conclusion: the initial study showed that CSPS-PB is appropriate to assess compliance with standard precautions among nurses in Brazil. The reliability was considered acceptable. Furhter study is necessary to evaluate its comprehensive psychometric properties. PMID:28301030

The key-features approach to assess clinical decisions: validity evidence to date.

PubMed

Bordage, G; Page, G

2018-05-17

The key-features (KFs) approach to assessment was initially proposed during the First Cambridge Conference on Medical Education in 1984 as a more efficient and effective means of assessing clinical decision-making skills. Over three decades later, we conducted a comprehensive, systematic review of the validity evidence gathered since then. The evidence was compiled according to the Standards for Educational and Psychological Testing's five sources of validity evidence, namely, Content, Response process, Internal structure, Relations to other variables, and Consequences, to which we added two other types related to Cost-feasibility and Acceptability. Of the 457 publications that referred to the KFs approach between 1984 and October 2017, 164 are cited here; the remaining 293 were either redundant or the authors simply mentioned the KFs concept in relation to their work. While one set of articles reported meeting the validity standards, another set examined KFs test development choices and score interpretation. The accumulated validity evidence for the KFs approach since its inception supports the decision-making construct measured and its use to assess clinical decision-making skills at all levels of training and practice and with various types of exam formats. Recognizing that gathering validity evidence is an ongoing process, areas with limited evidence, such as item factor analyses or consequences of testing, are identified as well as new topics needing further clarification, such as the use of the KFs approach for formative assessment and its place within a program of assessment.

The Global Precipitation Measurement (GPM) Project

NASA Technical Reports Server (NTRS)

Azarbarzin, Ardeshir; Carlisle, Candace

2010-01-01

The Global Precipitation Measurement (GP!v1) mission is an international cooperative effort to advance the understanding of the physics of the Earth's water and energy cycle. Accurate and timely knowledge of global precipitation is essential for understanding the weather/climate/ecological system, for improving our ability to manage freshwater resources, and for predicting high-impact natural hazard events including floods, droughts, extreme weather events, and landslides. The GPM Core Observatory will be a reference standard to uniformly calibrate data from a constellation of spacecraft with passive microwave sensors. GPM is being developed under a partnership between the United States (US) National Aeronautics and Space Administration (NASA) and the Japanese Aerospace and Exploration Agency (JAXA). NASA's Goddard Space Flight Center (GSFC), in Greenbelt, MD is developing the Core Observatory, two GPM Microwave Imager (GMI) instruments, Ground Validation System and Precipitation Processing System for the GPM mission. JAXA will provide a Dual-frequency Precipitation Radar (DPR) for installation on the Core satellite and launch services for the Core Observatory. The second GMI instrument will be flown on a partner-provided spacecraft. Other US agencies and international partners contribute to the GPM mission by providing precipitation measurements obtained from their own spacecraft and/or providing ground-based precipitation measurements to support ground validation activities. The Precipitation Processing System will provide standard data products for the mission.

Simultaneous validation of the Grandway MD2301 digital automatic blood pressure monitor by the British Hypertension Society and the Association for the Advancement of Medical Instrumentation/the International Organization for Standardization protocols.

PubMed

Huang, Jinhua; Wang, Yun; Liu, Zhaoying; Wang, Yuling

2017-02-01

The aim of this study was to determine the accuracy of the Grandway MD2301 digital automatic blood pressure monitor by the British Hypertension Society (BHS) and the Association for the Advancement of Medical Instrumentation (AAMI)/the International Organization for Standardization (ISO) protocols. A total of 85 participants were included for evaluation based on the requirements of the BHS and the AAMI/ISO protocols. The validation procedure and data analysis followed the protocols precisely. The device achieved A/A grading for the BHS protocol and maintained A/A grading throughout the low, medium and high blood pressure ranges. The device also fulfilled the requirement of the AAMI/ISO protocol with device-observer differences of -0.9±5.6 and 0.8±5.2 mmHg for systolic and diastolic blood pressure, respectively, for criterion 1, and -0.9±4.7 and 0.8±4.2 mmHg, respectively, for criterion 2. The Grandway MD2301 digital automatic blood pressure monitor achieved A/A grade of the BHS protocol and passed the requirements of the AAMI/ISO protocol in adults.

Target analyte quantification by isotope dilution LC-MS/MS directly referring to internal standard concentrations--validation for serum cortisol measurement.

PubMed

Maier, Barbara; Vogeser, Michael

2013-04-01

Isotope dilution LC-MS/MS methods used in the clinical laboratory typically involve multi-point external calibration in each analytical series. Our aim was to test the hypothesis that determination of target analyte concentrations directly derived from the relation of the target analyte peak area to the peak area of a corresponding stable isotope labelled internal standard compound [direct isotope dilution analysis (DIDA)] may be not inferior to conventional external calibration with respect to accuracy and reproducibility. Quality control samples and human serum pools were analysed in a comparative validation protocol for cortisol as an exemplary analyte by LC-MS/MS. Accuracy and reproducibility were compared between quantification either involving a six-point external calibration function, or a result calculation merely based on peak area ratios of unlabelled and labelled analyte. Both quantification approaches resulted in similar accuracy and reproducibility. For specified analytes, reliable analyte quantification directly derived from the ratio of peak areas of labelled and unlabelled analyte without the need for a time consuming multi-point calibration series is possible. This DIDA approach is of considerable practical importance for the application of LC-MS/MS in the clinical laboratory where short turnaround times often have high priority.

[Preparation and certification of mussel reference material for organochlorine pesticides and polychlorinated biphenyls using isotope dilution-high resolution mass spectrometry].

PubMed

Lu, Xianbo; Chen, Jiping; Wang, Shuqiu; Zou, Lili; Tian, Yuzeng; Ni, Yuwen; Su, Fan

2012-09-01

A method for the preparation and certification of the reference material of organochlorine pesticides (OCPs) and polychlorinated biphenyls (PCBs) in mussel tissue is described. The mussel tissue from Dalian Bay was frozen-dried, comminuted, sieved, homogenized, packaged, and sterilized by 60Co radiation sterilization in turn. The certified values for 18 OCPs and 16 PCBs were determined by high resolution gas chromatography/high resolution mass spectrometry (HRGC/HRMS) using isotope dilution and internal standard quantitation techniques. The certified values were validated and given based on seven accredited laboratories, and these values are traceable to the SI (international system of units) through gravimetrically prepared standards of established purity and measurement intercomparisons. The certified values of PCBs and OCPs in mussel span 4 orders of magnitude with a relative uncertainty of about 10%. This material is a natural biological material with confirmed good homogeneity and stability, and it was approved as the grade "primary reference material" (GBW10069) in June 2012 in China. This reference material provided necessary quality control products for our country to implement the Stockholm Treaty on the monitoring of persistent organic pollutants (POPs). The material is intended to be used for the method validation and quality control in the determination of OCPs and PCBs in biota samples.

Bioanalytical Method for Carbocisteine in Human Plasma by Using LC-MS/MS: A Pharmacokinetic Application.

PubMed

Dhanure, Shivanand; Savalia, Atulkumar; More, Pravinkumar; Shirode, Prashant; Kapse, Kailas; Shah, Virag

2014-01-01

A simple, sensitive, and selective LC-MS/MS method was developed and validated for the quantification of carbocisteine in human plasma. Rosiglitazone was used as the internal standard and heparin was used as the anticoagulant. The chromatographic separation was performed by using the Waters Symmetry Shield RP 8, 150 × 3.9 mm, 5 μ column at 40°C with a mobile phase consisting of a mixture of methanol and 0.5% formic acid solution in a 40:60 proportion. The flow rate was 500 μl/min along with a 5 μl injection volume. Protein precipitation was used as the extraction method. Mass spectrometric data were detected in positive ion mode. The MRM mode of the ions for carbocisteine was 180.0 > 89.0 and for rosiglitazone it was 238.1 > 135.1. The method was validated in the concentration curve range of 50.000 ng/mL to 6000.000 ng/mL. The retention times of carbocisteine and the internal standard rosiglitazone were approximately 2.20 and 3.01 min, respectively. The overall run time was 4.50 min. This method was found suitable to analyze human plasma samples for the application in pharmacokinetic and BA/BE studies.

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

NASA Technical Reports Server (NTRS)

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

2014-01-01

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

Cross-cultural adaptation and validation of the Norwegian pain catastrophizing scale in patients with low back pain.

PubMed

Fernandes, Linda; Storheim, Kjersti; Lochting, Ida; Grotle, Margreth

2012-06-22

Pain catastrophizing has been found to be an important predictor of disability and days lost from work in patients with low back pain. The most commonly used outcome measure to identify pain catastrophizing is the Pain Catastrophizing Scale (PCS). To enable the use of the PCS in clinical settings and research in Norwegian speaking patients, the PCS had to be translated. The purpose of this study was therefore to translate and cross-culturally adapt the PCS into Norwegian and to test internal consistency, construct validity and reproducibility of the PCS. The PCS was translated before it was tested for psychometric properties. Patients with subacute or chronic non-specific low back pain aged 18 years or more were recruited from primary and secondary care. Validity of the PCS was assessed by evaluating data quality (missing, floor and ceiling effects), principal components analysis, internal consistency (Cronbach's alpha), and construct validity (Spearman's rho). Reproducibility analyses included standard error of measurement, minimum detectable change, limits of agreement, and intraclass correlation coefficients. A total of 38 men and 52 women (n = 90), with a mean (SD) age of 47.6 (11.7) years, were included for baseline testing. A subgroup of 61 patients was included for test-retest assessments. The Norwegian PCS was easy-to-comprehend. The principal components analysis supported a three-factor structure, internal consistency was satisfactory for the PCS total score (α 0.90) and the subscales rumination (α 0.83) and helplessness (α 0.86), but not for the subscale magnification (α 0.53). In total, 86% of the correlation analyses were in accordance with predefined hypothesis. The reliability analyses showed intraclass correlation coefficients of 0.74 - 0.87 for the PCS total score and subscales. The PCS total score (range 0-52 points) showed a standard error of measurement of 4.6 points and a 95% minimum detectable change estimate of 12.8 points. The Norwegian PCS total score showed acceptable psychometric properties in terms of comprehensibility, consistency, construct validity, and reproducibility when applied to patients with subacute or chronic LBP from different clinical settings. Our study support the use of the PCS total score for clinical or research purposes identifying or evaluating pain catastrophizing.

Measurement properties of patient-reported outcome measures (PROMs) used in adult patients with chronic kidney disease: A systematic review

PubMed Central

Kyte, Derek; Cockwell, Paul; Marshall, Tom; Gheorghe, Adrian; Keeley, Thomas; Slade, Anita; Calvert, Melanie

2017-01-01

Background Patient-reported outcome measures (PROMs) can provide valuable information which may assist with the care of patients with chronic kidney disease (CKD). However, given the large number of measures available, it is unclear which PROMs are suitable for use in research or clinical practice. To address this we comprehensively evaluated studies that assessed the measurement properties of PROMs in adults with CKD. Methods Four databases were searched; reference list and citation searching of included studies was also conducted. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was used to appraise the methodological quality of the included studies and to inform a best evidence synthesis for each PROM. Results The search strategy retrieved 3,702 titles/abstracts. After 288 duplicates were removed, 3,414 abstracts were screened and 71 full-text articles were retrieved for further review. Of these, 24 full-text articles were excluded as they did not meet the eligibility criteria. Following reference list and citation searching, 19 articles were retrieved bringing the total number of papers included in the final analysis to 66. There was strong evidence supporting internal consistency and moderate evidence supporting construct validity for the Kidney Disease Quality of Life-36 (KDQOL-36) in pre-dialysis patients. In the dialysis population, the KDQOL-Short Form (KDQOL-SF) had strong evidence for internal consistency and structural validity and moderate evidence for test-retest reliability and construct validity while the KDQOL-36 had moderate evidence of internal consistency, test-retest reliability and construct validity. The End Stage Renal Disease-Symptom Checklist Transplantation Module (ESRD-SCLTM) demonstrated strong evidence for internal consistency and moderate evidence for test-retest reliability, structural and construct validity in renal transplant recipients. Conclusions We suggest considering the KDQOL-36 for use in pre-dialysis patients; the KDQOL-SF or KDQOL-36 for dialysis patients and the ESRD-SCLTM for use in transplant recipients. However, further research is required to evaluate the measurement error, structural validity, responsiveness and patient acceptability of PROMs used in CKD. PMID:28636678

A rapid and sensitive method for the quantitation of montelukast in sheep plasma using liquid chromatography/tandem mass spectrometry.

PubMed

Papp, Robert; Luk, Pauline; Mullett, Wayne M; Kwong, Elizabeth

2007-10-15

A rapid LC-MS/MS method was developed and partially validated for the quantitation of montelukast in spiked sheep plasma. A total run time of 1.5 min was achieved using a short monolithic column and employing a rapid gradient. Sample preparation involved protein precipitation with twofold acetonitrile by volume during which a deuterated internal standard (montelukast D-6) was incorporated. The MRM transitions for montelukast and the deuterated internal standard were 586/422 and 592/427, respectively. A linear dynamic range of 0.25-500 ng/mL with a correlation coefficient of 0.9999 was achieved. Precision was below 5% at all levels except at the LOQ (0.36 ng/mL) which demonstrated an overall of R.S.D. of 8%. Post-column infusion experiments were performed with precipitated plasma matrix and showed minimal interference with the peaks of interest.

The new standard of fluids for hemodialysis in Japan.

PubMed

Kawanishi, Hideki; Masakane, Ikuto; Tomo, Tadashi

2009-01-01

The standard of fluids for hemodialysis is being evaluated by the International Organization for Standardization (ISO), and will be decided within a few years. In 2008, the Japanese Society for Dialysis Therapy (JSDT) proposed the standard of fluids for hemodialysis by taking the draft ISO standard into consideration and the circumstances in Japan. It was characteristically a standard for Japan, where the central dialysis fluid delivery system (CDDS) is routinely used. In addition, the therapeutic application of each dialysis fluid is clarified. Since high-performance dialyzers are frequently employed in Japan, the standard recommends that ultrapure dialysis fluid be used for all dialysis modalities at all dialysis facilities. It also recommends that the dialysis equipment safety management committee at each facility validate the microbiological qualities of online-prepared substitution fluid, making the responsibility of the dialysis facility clear. This standard is more rigid than those of other countries, and is expected to contribute to improvements in the survival outcome of dialysis patients. (c) 2009 S. Karger AG, Basel.

Standard on microbiological management of fluids for hemodialysis and related therapies by the Japanese Society for Dialysis Therapy 2008.

PubMed

Kawanishi, Hideki; Akiba, Takashi; Masakane, Ikuto; Tomo, Tadashi; Mineshima, Michio; Kawasaki, Tadayuki; Hirakata, Hideki; Akizawa, Tadao

2009-04-01

The Committee of Scientific Academy of the Japanese Society for Dialysis Therapy (JSDT) proposes a new standard on microbiological management of fluids for hemodialysis and related therapies. This standard is within the scope of the International Organization for Standardization (ISO), which is currently under revision. This standard is to be applied to the central dialysis fluid delivery systems (CDDS), which are widely used in Japan. In this standard, microbiological qualities for dialysis water and dialysis fluids are clearly defined by endotoxin level and bacterial count. The qualities of dialysis fluids were classified into three levels: standard, ultrapure, and online prepared substitution fluid. In addition, the therapeutic application of each dialysis fluid is clarified. Since high-performance dialyzers are frequently used in Japan, the standard recommends that ultrapure dialysis fluid be used for all dialysis modalities at all dialysis facilities. It also recommends that the dialysis equipment safety management committee at each facility should validate the microbiological qualities of online prepared substitution fluid.

A systematic review of the measurement properties of the European Organisation for Research and Treatment of Cancer In-patient Satisfaction with Care Questionnaire, the EORTC IN-PATSAT32.

PubMed

Neijenhuijs, Koen I; Jansen, Femke; Aaronson, Neil K; Brédart, Anne; Groenvold, Mogens; Holzner, Bernhard; Terwee, Caroline B; Cuijpers, Pim; Verdonck-de Leeuw, Irma M

2018-05-07

The EORTC IN-PATSAT32 is a patient-reported outcome measure (PROM) to assess cancer patients' satisfaction with in-patient health care. The aim of this study was to investigate whether the initial good measurement properties of the IN-PATSAT32 are confirmed in new studies. Within the scope of a larger systematic review study (Prospero ID 42017057237), a systematic search was performed of Embase, Medline, PsycINFO, and Web of Science for studies that investigated measurement properties of the IN-PATSAT32 up to July 2017. Study quality was assessed, data were extracted, and synthesized according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Nine studies were included in this review. The evidence on reliability and construct validity were rated as sufficient and of the quality of the evidence as moderate. The evidence on structural validity was rated as insufficient and of low quality. The evidence on internal consistency was indeterminate. Measurement error, responsiveness, criterion validity, and cross-cultural validity were not reported in the included studies. Measurement error could be calculated for two studies and was judged indeterminate. In summary, the IN-PATSAT32 performs as expected with respect to reliability and construct validity. No firm conclusions can be made yet whether the IN-PATSAT32 also performs as well with respect to structural validity and internal consistency. Further research on these measurement properties of the PROM is therefore needed as well as on measurement error, responsiveness, criterion validity, and cross-cultural validity. For future studies, it is recommended to take the COSMIN methodology into account.

Systematic review of measurement properties of questionnaires measuring somatization in primary care patients.

PubMed

Sitnikova, Kate; Dijkstra-Kersten, Sandra M A; Mokkink, Lidwine B; Terluin, Berend; van Marwijk, Harm W J; Leone, Stephanie S; van der Horst, Henriëtte E; van der Wouden, Johannes C

2017-12-01

The aim of this review is to critically appraise the evidence on measurement properties of self-report questionnaires measuring somatization in adult primary care patients and to provide recommendations about which questionnaires are most useful for this purpose. We assessed the methodological quality of included studies using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. To draw overall conclusions about the quality of the questionnaires, we conducted an evidence synthesis using predefined criteria for judging the measurement properties. We found 24 articles on 9 questionnaires. Studies on the Patient Health Questionnaire-15 (PHQ-15) and the Four-Dimensional Symptom Questionnaire (4DSQ) somatization subscale prevailed and covered the broadest range of measurement properties. These questionnaires had the best internal consistency, test-retest reliability, structural validity, and construct validity. The PHQ-15 also had good criterion validity, whereas the 4DSQ somatization subscale was validated in several languages. The Bodily Distress Syndrome (BDS) checklist had good internal consistency and structural validity. Some evidence was found for good construct validity and criterion validity of the Physical Symptom Checklist (PSC-51) and good construct validity of the Symptom Check-List (SCL-90-R) somatization subscale. However, these three questionnaires were only studied in a small number of primary care studies. Based on our findings, we recommend the use of either the PHQ-15 or 4DSQ somatization subscale for somatization in primary care. Other questionnaires, such as the BDS checklist, PSC-51 and the SCL-90-R somatization subscale show promising results but have not been studied extensively in primary care. Copyright © 2017 Elsevier Inc. All rights reserved.

Validity and reliability of the Short Form 36 Health Surveys (SF-36) among patients with spondyloarthritis in Singapore.

PubMed

Kwan, Yu Heng; Fong, Warren Weng Seng; Lui, Nai Lee; Yong, Si Ting; Cheung, Yin Bun; Malhotra, Rahul; Østbye, Truls; Thumboo, Julian

2016-12-01

The Short Form 36 Health Survey (SF-36) is a popular health-related quality of life (HrQoL) tool. However, few studies have assessed its psychometric properties in patients with spondyloarthritis (SpA). We therefore aimed to assess the reliability and validity of the SF-36 in patients with SpA in Singapore. Cross-sectional data from a registry of 196 SpA patients recruited from a dedicated tertiary referral clinic in Singapore from 2011 to 2014 was used. Analyses were guided by the COnsensus-based Standards for the selection of health Measurement INstruments framework. Internal consistency reliability was assessed using Cronbach's alpha. Construct validity was assessed through 33 a priori hypotheses by correlations of the eight subscales and two summary scores of SF-36 with other health outcomes. Known-group construct validity was assessed by comparison of the means of the subscales and summary scores of the SF-36 of SpA patients and the general population of Singapore using student's t tests. Among 196 patients (155 males (79.0 %), median (range) age: 36 (17-70), 166 Chinese (84.6 %)), SF-36 scales showed high internal consistency ranging from 0.88 to 0.90. Convergent construct validity was supported as shown by fulfillment of all hypotheses. Divergent construct validity was supported, as SF-36 MCS was not associated with PGA, pain and HAQ. Known-group construct validity showed SpA patients had lower scores of 3.8-12.5 when compared to the general population at p < 0.001. This study supports the SF-36 as a valid and reliable measure of HrQoL for use in patients with SpA at a single time point.

Validation of a proposal for evaluating hospital infection control programs.

PubMed

Silva, Cristiane Pavanello Rodrigues; Lacerda, Rúbia Aparecida

2011-02-01

To validate the construct and discriminant properties of a hospital infection prevention and control program. The program consisted of four indicators: technical-operational structure; operational prevention and control guidelines; epidemiological surveillance system; and prevention and control activities. These indicators, with previously validated content, were applied to 50 healthcare institutions in the city of São Paulo, Southeastern Brazil, in 2009. Descriptive statistics were used to characterize the hospitals and indicator scores, and Cronbach's α coefficient was used to evaluate the internal consistency. The discriminant validity was analyzed by comparing indicator scores between groups of hospitals: with versus without quality certification. The construct validity analysis was based on exploratory factor analysis with a tetrachoric correlation matrix. The indicators for the technical-operational structure and epidemiological surveillance presented almost 100% conformity in the whole sample. The indicators for the operational prevention and control guidelines and the prevention and control activities presented internal consistency ranging from 0.67 to 0.80. The discriminant validity of these indicators indicated higher and statistically significant mean conformity scores among the group of institutions with healthcare certification or accreditation processes. In the construct validation, two dimensions were identified for the operational prevention and control guidelines: recommendations for preventing hospital infection and recommendations for standardizing prophylaxis procedures, with good correlation between the analysis units that formed the guidelines. The same was found for the prevention and control activities: interfaces with treatment units and support units were identified. Validation of the measurement properties of the hospital infection prevention and control program indicators made it possible to develop a tool for evaluating these programs in an ethical and scientific manner in order to obtain a quality diagnosis in this field.

Development of an Independent Global Land Cover Validation Dataset

NASA Astrophysics Data System (ADS)

Sulla-Menashe, D. J.; Olofsson, P.; Woodcock, C. E.; Holden, C.; Metcalfe, M.; Friedl, M. A.; Stehman, S. V.; Herold, M.; Giri, C.

2012-12-01

Accurate information related to the global distribution and dynamics in global land cover is critical for a large number of global change science questions. A growing number of land cover products have been produced at regional to global scales, but the uncertainty in these products and the relative strengths and weaknesses among available products are poorly characterized. To address this limitation we are compiling a database of high spatial resolution imagery to support international land cover validation studies. Validation sites were selected based on a probability sample, and may therefore be used to estimate statistically defensible accuracy statistics and associated standard errors. Validation site locations were identified using a stratified random design based on 21 strata derived from an intersection of Koppen climate classes and a population density layer. In this way, the two major sources of global variation in land cover (climate and human activity) are explicitly included in the stratification scheme. At each site we are acquiring high spatial resolution (< 1-m) satellite imagery for 5-km x 5-km blocks. The response design uses an object-oriented hierarchical legend that is compatible with the UN FAO Land Cover Classification System. Using this response design, we are classifying each site using a semi-automated algorithm that blends image segmentation with a supervised RandomForest classification algorithm. In the long run, the validation site database is designed to support international efforts to validate land cover products. To illustrate, we use the site database to validate the MODIS Collection 4 Land Cover product, providing a prototype for validating the VIIRS Surface Type Intermediate Product scheduled to start operational production early in 2013. As part of our analysis we evaluate sources of error in coarse resolution products including semantic issues related to the class definitions, mixed pixels, and poor spectral separation between classes.

External validation of the diffuse intrinsic pontine glioma survival prediction model: a collaborative report from the International DIPG Registry and the SIOPE DIPG Registry.

PubMed

Veldhuijzen van Zanten, Sophie E M; Lane, Adam; Heymans, Martijn W; Baugh, Joshua; Chaney, Brooklyn; Hoffman, Lindsey M; Doughman, Renee; Jansen, Marc H A; Sanchez, Esther; Vandertop, William P; Kaspers, Gertjan J L; van Vuurden, Dannis G; Fouladi, Maryam; Jones, Blaise V; Leach, James

2017-08-01

We aimed to perform external validation of the recently developed survival prediction model for diffuse intrinsic pontine glioma (DIPG), and discuss its utility. The DIPG survival prediction model was developed in a cohort of patients from the Netherlands, United Kingdom and Germany, registered in the SIOPE DIPG Registry, and includes age <3 years, longer symptom duration and receipt of chemotherapy as favorable predictors, and presence of ring-enhancement on MRI as unfavorable predictor. Model performance was evaluated by analyzing the discrimination and calibration abilities. External validation was performed using an unselected cohort from the International DIPG Registry, including patients from United States, Canada, Australia and New Zealand. Basic comparison with the results of the original study was performed using descriptive statistics, and univariate- and multivariable regression analyses in the validation cohort. External validation was assessed following a variety of analyses described previously. Baseline patient characteristics and results from the regression analyses were largely comparable. Kaplan-Meier curves of the validation cohort reproduced separated groups of standard (n = 39), intermediate (n = 125), and high-risk (n = 78) patients. This discriminative ability was confirmed by similar values for the hazard ratios across these risk groups. The calibration curve in the validation cohort showed a symmetric underestimation of the predicted survival probabilities. In this external validation study, we demonstrate that the DIPG survival prediction model has acceptable cross-cohort calibration and is able to discriminate patients with short, average, and increased survival. We discuss how this clinico-radiological model may serve a useful role in current clinical practice.

Analytical Method Development and Validation for the Simultaneous Estimation of Abacavir and Lamivudine by Reversed-phase High-performance Liquid Chromatography in Bulk and Tablet Dosage Forms.

PubMed

Raees Ahmad, Sufiyan Ahmad; Patil, Lalit; Mohammed Usman, Mohammed Rageeb; Imran, Mohammad; Akhtar, Rashid

2018-01-01

A simple rapid, accurate, precise, and reproducible validated reverse phase high performance liquid chromatography (HPLC) method was developed for the determination of Abacavir (ABAC) and Lamivudine (LAMI) in bulk and tablet dosage forms. The quantification was carried out using Symmetry Premsil C18 (250 mm × 4.6 mm, 5 μm) column run in isocratic way using mobile phase comprising methanol: water (0.05% orthophosphoric acid with pH 3) 83:17 v/v and a detection wavelength of 245 nm and injection volume of 20 μl, with a flow rate of 1 ml/min. In the developed method, the retention times of ABAC and LAMI were found to be 3.5 min and 7.4 min, respectively. The method was validated in terms of linearity, precision, accuracy, limits of detection, limits of quantitation, and robustness in accordance with the International Conference on Harmonization guidelines. The assay of the proposed method was found to be 99% - 101%. The recovery studies were also carried out and mean % recovery was found to be 99% - 101%. The % relative standard deviation from reproducibility was found to be <2%. The proposed method was statistically evaluated and can be applied for routine quality control analysis of ABAC and LAMI in bulk and in tablet dosage form. Attempts were made to develop RP-HPLC method for simultaneous estimation of Abacavir and Lamivudine for the RP-HPLC method. The developed method was validated according to the ICH guidelines. The linearity, precision, range, robustness were within the limits as specified by the ICH guidelines. Hence the method was found to be simple, accurate, precise, economic and reproducible. So the proposed methods can be used for the routine quality control analysis of Abacavir and Lamivudine in bulk drug as well as in formulations. Abbreviations Used: HPLC: High-performance liquid chromatography, UV: Ultraviolet, ICH: International Conference on Harmonization, ABAC: Abacavir, LAMI: Lamivudine, HIV: Human immunodeficiency virus, AIDS: Acquired immunodeficiency syndrome, NRTI: Nucleoside reverse transcriptase inhibitors, ARV: Antiretroviral, RSD: Relative standard deviation, RT: Retention time, SD: Standard deviation.

Psychometric Validation Study of the Liebowitz Social Anxiety Scale - Self-Reported Version for Brazilian Portuguese

PubMed Central

Forni dos Santos, Larissa; Loureiro, Sonia Regina; Crippa, José Alexandre de Souza; Osório, Flávia de Lima

2013-01-01

Social Anxiety Disorder (SAD) is prevalent and rarely diagnosed due to the difficulty in recognizing its symptoms as belonging to a disorder. Therefore, the evaluation/screening scales are of great importance for its detection, with the most used being the Liebowitz Social Anxiety Scale (LSAS). Thus, this study proposed to evaluate the psychometric properties of internal consistency and convergent validity, as well as the confirmatory factorial analysis and reliability of the self-reported version of the LSAS (LSAS-SR), translated into Brazilian Portuguese, in a sample of the general population (N = 413) and in a SAD clinical sample (N = 252). The convergent validity with specific scales for the evaluation of SAD and a general anxiety scale presented correlations ranging from 0.21 to 0.84. The confirmatory factorial analysis did not replicate the previously indicated findings of the literature, with the difficulty being in obtaining a consensus factorial structure common to the diverse cultures in which the instrument was studied. The LSAS-SR presented excellent internal consistency (α = 0.90–0.96) and test-retest reliability (Intraclass Correlation Coefficient = 0.81; Pearson’s = 0.82). The present findings support those of international studies that attest to the excellent psychometric properties of the LSAS-SR, endorsing its status as the gold standard. PMID:23922961

Validation of the Andon KD5031 for clinical use and self-measurement according to the European Society of Hypertension International Protocol.

PubMed

Wu, Ning; Zhang, Xuezhong; Wang, Wen; Zhang, Hongye

2016-10-01

This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure (BP) monitor Andon KD5031 for home BP monitoring according to the European Society of Hypertension International Protocol revision 2010. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were sequentially measured in 33 participants using the standard mercury sphygmomanometer and the Andon KD5031 device. Ninety-nine pairs of comparisons were obtained from 33 participants for analysis. The KD5031 device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and the observers within a range of 5, 10, and 15 mmHg was 66/99, 93/99, and 98/99, respectively, for SBP and 72/99, 94/99, and 99/99, respectively, for DBP. The device also achieved the targets in part 2 of the validation study. Twenty-six participants for both SBP and DBP had at least two of the three device-observer differences within 5 mmHg (required ≥24). The number of participants without a device-observer difference within 5 mmHg was one for SBP and three for DBP (required ≤3). The Andon upper arm BP monitor KD5031 has passed the International Protocol requirements, and it can be recommended for clinical use and self-measurement in adults.

Validation of the Andon KD595 for clinical use and self-measurement according to the European Society of Hypertension International Protocol.

PubMed

Wu, Ning; Zhang, Xuezhong; Wang, Wen; Zhang, Hongye

2016-04-01

This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure monitor Andon KD595 for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were sequentially measured in 33 participants using the standard mercury sphygmomanometer and the Andon KD595 device. Ninety-nine pairs of comparisons were obtained from 33 participants for analysis. The KD595 device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and the observers within a range of 5, 10, and 15 mmHg was 72/99, 93/99, and 96/99, respectively, for SBP and 72/99, 96/99, and 99/99, respectively, for DBP. The device also achieved the targets in part 2 of the validation study. A total of 28 and 25 participants had at least two of the three device-observer differences within 5 mmHg (required≥24) for SBP and DBP, respectively. The number of participants without device-observer difference within 5 mmHg was two for SBP and two for DBP (required≤3). The Andon upper arm blood pressure monitor KD595 has passed the International Protocol requirements and it can be recommended for clinical use and self-measurement in adults.

Spanish adaptation of the revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R).

PubMed

Campos, Teresa Salas; Rodríguez-Santos, Francisco; Esteban, Jesus; Vázquez, Pilar Cordero; Mora Pardina, Jesus S; Carmona, Alejandra Cano

2010-10-01

ALSFRS-R is a tool designed to measure disease progress in ALS patients. It consists of 12 items grouped into four functions designed to assess disabilities according to the Activities of daily living (ADL). Our objective was to validate the Spanish version of ALSFRS-R based on the original version. Four examiners assessed 73 ALS patients, applying the ALSFRS-R, ALSAQ-40 and the respiratory function variable assessed by the SRI scale, which measures respiratory insufficiency. Internal consistency and test-retest correlations were measured using Cronbach's alpha and Spearman's Rho tests. Factor analysis was performed by applying Varimax rotation and Kaiser standardization. Validity was analysed based on correlations between items in the ALSFRS-R scales and equivalents in the ALSAQ-40 and SRI questionnaires. The results showed high internal consistency (0.77-0.95) and a good test-retest correlation (0.80-0.95). Factor analysis showed a 73.3% principal component contribution; the weight of each item regarding their corresponding factors was 0.7-0.9. High correlations were observed (rs >0.60) between corresponding factors of ALSFRS-R/ALSAQ-40 and ALSFRS-R/SRI. We conclude that the version obtained from the ALSFRS-R maintains the internal consistency and validity of the construct of the original scale. The Spanish version of ALSFRS-R is available for readers at http://www.fundela.es/verOtras.php.

Field validation of protocols developed to evaluate in-line mastitis detection systems.

PubMed

Kamphuis, C; Dela Rue, B T; Eastwood, C R

2016-02-01

This paper reports on a field validation of previously developed protocols for evaluating the performance of in-line mastitis-detection systems. The protocols outlined 2 requirements of these systems: (1) to detect cows with clinical mastitis (CM) promptly and accurately to enable timely and appropriate treatment and (2) to identify cows with high somatic cell count (SCC) to manage bulk milk SCC levels. Gold standard measures, evaluation tests, performance measures, and performance targets were proposed. The current study validated the protocols on commercial dairy farms with automated in-line mastitis-detection systems using both electrical conductivity (EC) and SCC sensor systems that both monitor at whole-udder level. The protocol for requirement 1 was applied on 3 commercial farms. For requirement 2, the protocol was applied on 6 farms; 3 of them had low bulk milk SCC (128×10(3) cells/mL) and were the same farms as used for field evaluation of requirement 1. Three farms with high bulk milk SCC (270×10(3) cells/mL) were additionally enrolled. The field evaluation methodology and results were presented at a workshop including representation from 7 international suppliers of in-line mastitis-detection systems. Feedback was sought on the acceptance of standardized performance evaluation protocols and recommended refinements to the protocols. Although the methodology for requirement 1 was relatively labor intensive and required organizational skills over an extended period, no major issues were encountered during the field validation of both protocols. The validation, thus, proved the protocols to be practical. Also, no changes to the data collection process were recommended by the technology supplier representatives. However, 4 recommendations were made to refine the protocols: inclusion of an additional analysis that ignores small (low-density) clot observations in the definition of CM, extension of the time window from 4 to 5 milkings for timely alerts for CM, setting a maximum number of 10 milkings for the time window to detect a CM episode, and presentation of sensitivity for a larger range of false alerts per 1,000 milkings replacing minimum performance targets. The recommended refinements are discussed with suggested changes to the original protocols. The information presented is intended to inform further debate toward achieving international agreement on standard protocols to evaluate performance of in-line mastitis-detection systems. Copyright © 2016 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Standards of care for obsessive–compulsive disorder centres

PubMed Central

Menchón, José M.; van Ameringen, Michael; Dell’Osso, Bernardo; Denys, Damiaan; Figee, Martijn; Grant, Jon E.; Hollander, Eric; Marazziti, Donatella; Nicolini, Humberto; Pallanti, Stefano; Ruck, Christian; Shavitt, Roseli; Stein, Dan J.; Andersson, Erik; Bipeta, Rajshekhar; Cath, Danielle C.; Drummond, Lynne; Feusner, Jamie; Geller, Daniel A.; Hranov, Georgi; Lochner, Christine; Matsunaga, Hisato; McCabe, Randy E.; Mpavaenda, Davis; Nakamae, Takashi; O'Kearney, Richard; Pasquini, Massimo; Pérez Rivera, Ricardo; Poyurovsky, Michael; Real, Eva; do Rosário, Maria Conceição; Soreni, Noam; Swinson, Richard P.; Vulink, Nienke; Zohar, Joseph; Fineberg, Naomi

2016-01-01

Abstract In recent years, many assessment and care units for obsessive–compulsive disorder (OCD) have been set up in order to detect, diagnose and to properly manage this complex disorder, but there is no consensus regarding the key functions that these units should perform. The International College of Obsessive-Compulsive Spectrum Disorders (ICOCS) together with the Obsessive Compulsive and Related Disorders Network (OCRN) of the European College of Neuropsychopharmacology (ECNP) and the Anxiety and Obsessive Compulsive Disorders Section of the World Psychiaric Association (WPA) has developed a standards of care programme for OCD centres. The goals of this collaborative initiative are promoting basic standards, improving the quality of clinical care and enhance the validity and reliability of research results provided by different facilities and countries. PMID:27359333

Translation, Cultural Adaptation, and Validation of Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) and Self-Complete Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) Questionnaires into the Greek Language.

PubMed

Batistaki, Chrysanthi; Lyrakos, George; Drachtidi, Kalliopi; Stamatiou, Georgia; Kitsou, Maria-Chrysanthi; Kostopanagiotou, Georgia

2016-06-01

The LANSS and S-LANSS questionnaires represent two widely accepted and validated instruments used to assist the identification of neuropathic pain worldwide. The aim of this study was to translate, culturally adapt, and validate the LANSS and S-LANSS questionnaires into the Greek language. Forward and backward translations of both questionnaires were performed from the English to Greek language. The final versions were assessed by a committee of clinical experts, and they were then pilot-tested in 20 patients with chronic pain. Both questionnaires were validated in 200 patients with chronic pain (100 patients for each questionnaire), using as the "gold standard" the diagnosis of a clinical expert in pain management. Sensitivity and specificity of questionnaires were assessed, as well as the internal consistency (using Cronbach's alpha coefficient) and correlation with the "gold standard" diagnosis (using Pearson correlation coefficient). Sensitivity and specificity of the LANSS questionnaire were calculated to be 82.76% and 95.24%, while for the S-LANSS 86.21% and 95.24%, respectively. Positive predictive value for neuropathic pain was 96% for the LANSS and 96.15% for the S-LANSS. Cronbach's alpha was revealed to be acceptable for both questionnaires (0.65 for LANSS and 0.67 for the S-LANSS), while a significant correlation was observed compared to the "gold standard" diagnosis (rLANSS   = 0.79 και tSLANSS   = 0.77, respectively, P = 0.01). The LANSS and the S-LANSS diagnostic tools have been translated and validated into the Greek language and can be adequately used to assist the identification of neuropathic pain in everyday clinical practice. © 2015 World Institute of Pain.

Translation, Cross-cultural Adaptation and Validation of the Farsi Version of NIH Task Force's Recommended Multidimensional Minimal Dataset for Research on Chronic Low Back Pain.

PubMed

Noormohammadpour, Pardis; Tavana, Bahareh; Mansournia, Mohammad Ali; Zeinalizadeh, Mehdi; Mirzashahi, Babak; Rostami, Mohsen; Kordi, Ramin

2018-05-01

Translation and cultural adaptation of the National Institutes of Health (NIH) Task Force's minimal dataset. The purpose of this study was to evaluate validity and reliability of the Farsi version of NIH Task Force's recommended multidimensional minimal dataset for research on chronic low back pain (CLBP). Considering the high treatment cost of CLBP and its increasing prevalence, NIH Pain Consortium developed research standards (including recommendations for definitions, a minimum dataset, and outcomes' report) for studies regarding CLBP. Application of these recommendations could standardize research and improve comparability of different studies in CLBP. This study has three phases: translation of dataset into Farsi and its cultural adaptation, assessment of pre-final version of dataset's comprehensibility via a pilot study, and investigation of the reliability and validity of final version of translated dataset. Subjects were 250 patients with CLBP. Test-retest reliability, content validity, and convergent validity (correlations among different dimensions of dataset and Farsi versions of Oswestry Disability Index, Roland Morris Disability Questionnaire, Fear-Avoidance Belief Questionnaire, and Beck Depression Inventory-II) were assessed. The Farsi version demonstrated good/excellent convergent validity (the correlation coefficient between impact dimension and ODI was r = 0.75 [P < 0.001], between impact dimension and Roland-Morris Disability Questionnaire was r = 0.80 [P < 0.001], and between psychological dimension and BDI was r = 0.62 [P < 0.001]). The test-retest reliability was also strong (intraclass correlation coefficient value ranged between 0.70 and 0.95) and the internal consistency was good/excellent (Chronbach's alpha coefficients' value for two main dimensions including impact dimension and psychological dimension were 0.91 and 0.82 [P < 0.001], respectively). In addition, its face validity and content validity were acceptable. The Farsi version of minimal dataset for research on CLBP is a reliable and valid instrument for data gathering in patients with CLBP. This minimum dataset can be a step toward standardization of research regarding CLBP. 3.

Procedure-specific assessment tool for flexible pharyngo-laryngoscopy: gathering validity evidence and setting pass-fail standards.

PubMed

Melchiors, Jacob; Petersen, K; Todsen, T; Bohr, A; Konge, Lars; von Buchwald, Christian

2018-06-01

The attainment of specific identifiable competencies is the primary measure of progress in the modern medical education system. The system, therefore, requires a method for accurately assessing competence to be feasible. Evidence of validity needs to be gathered before an assessment tool can be implemented in the training and assessment of physicians. This evidence of validity must according to the contemporary theory on validity be gathered from specific sources in a structured and rigorous manner. The flexible pharyngo-laryngoscopy (FPL) is central to the otorhinolaryngologist. We aim to evaluate the flexible pharyngo-laryngoscopy assessment tool (FLEXPAT) created in a previous study and to establish a pass-fail level for proficiency. Eighteen physicians with different levels of experience (novices, intermediates, and experienced) were recruited to the study. Each performed an FPL on two patients. These procedures were video recorded, blinded, and assessed by two specialists. The score was expressed as the percentage of a possible max score. Cronbach's α was used to analyze internal consistency of the data, and a generalizability analysis was performed. The scores of the three different groups were explored, and a pass-fail level was determined using the contrasting groups' standard setting method. Internal consistency was strong with a Cronbach's α of 0.86. We found a generalizability coefficient of 0.72 sufficient for moderate stakes assessment. We found a significant difference between the novice and experienced groups (p < 0.001) and strong correlation between experience and score (Pearson's r = 0.75). The pass/fail level was established at 72% of the maximum score. Applying this pass-fail level in the test population resulted in half of the intermediary group receiving a failing score. We gathered validity evidence for the FLEXPAT according to the contemporary framework as described by Messick. Our results support a claim of validity and are comparable to other studies exploring clinical assessment tools. The high rate of physicians underperforming in the intermediary group demonstrates the need for continued educational intervention. Based on our work, we recommend the use of the FLEXPAT in clinical assessment of FPL and the application of a pass-fail level of 72% for proficiency.

Tinnitus functional index: validation of the German version for Switzerland.

PubMed

Peter, Nicole; Kleinjung, Tobias; Jeker, Raphael; Meyer, Martin; Klaghofer, Richard; Weidt, Steffi

2017-05-05

Different standardized questionnaires are used to assess tinnitus severity, making comparisons across studies difficult. These questionnaires are also used to measure treatment-related changes in tinnitus although they were not designed for this purpose. To solve these problems, a new questionnaire - the Tinnitus Functional Index (TFI) - has been established. The TFI is highly responsive to treatment-related change and promises to be the new gold standard in tinnitus evaluation. The aim of the current study was to validate a German version of the TFI for a German-speaking population in Switzerland. At the ENT department of the University Hospital Zurich, 264 subjects completed an online survey including the German version for Switzerland of TFI, Tinnitus Handicap Inventory (THI), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) and sociodemographic variables. Internal consistency of the TFI was calculated with Cronbach's alpha coefficient. Pearson correlation coefficients were used for the test-retest reliability of the TFI and to investigate convergent and discriminant validity between the THI and the BDI and BAI, respectively. Factor analysis was assessed using a principal component analysis with oblique rotation. The different factors extracted were then compared with the original questionnaire. The German version of the TFI for Switzerland showed an excellent internal consistency (Cronbach's alpha of 0.97) and an excellent test-retest reliability of 0.91. The convergent validity with THI was high (r = 0.86). The discriminant validity with BAI and BDI showed moderate results (BAI: r = 0.60 and BDI: r = 0.65). In the factor analysis only five factors with one main factor could be extracted instead of eight factors as described in the original version. Nevertheless, relations to the original eight subscales could be demonstrated. The German version of the TFI for Switzerland is a suitable instrument for measuring the impact of tinnitus. The reliability and validity of this version are comparable with the original version of the TFI. Although this study showed only five factors in the factor analysis, relations to the original eight subscales were identified. Therefore, the German version of the TFI for Switzerland can deliver relevant information regarding the different tinnitus domains. Clinical trial registration number on clinicaltrial.gov: NCT01837368 .

Development and validation of the functional assessment of chronic illness therapy treatment satisfaction (FACIT TS) measures.

PubMed

Peipert, John D; Beaumont, Jennifer L; Bode, Rita; Cella, Dave; Garcia, Sofia F; Hahn, Elizabeth A

2014-04-01

To develop and validate a new functional assessment of chronic illness therapy (FACIT) measure of satisfaction with treatment for chronic illnesses such as cancer and HIV/AIDS. To define domains and generate items, a literature review informed creation of semi-structured interview guides for patients and an international expert panel of clinicians and researchers. Patients and experts also rated 15 areas of satisfaction for relevance. The final list of items underwent further refinement by the original expert panel and a new group of clinical experts. Items were tested in four studies (primarily lung cancer) and data were pooled for analysis. Exploratory and confirmatory factor analyses (CFA), and item response theory modeling were conducted to evaluate dimensionality. Internal consistency reliability and test-retest reliability were both evaluated. Validity was evaluated by correlating the FACIT subscale scores and measures of comparable concepts and by testing the scales' ability to distinguish people according to their overall treatment satisfaction. Two instruments were created: the FACIT TS-general (G), an overall evaluation of current treatment, and the FACIT TS-patient satisfaction (PS), a measure of patient satisfaction. CFA results were not optimal for a five-factor solution for PS. Internal consistency reliability met psychometric standards (≥0.70) for all PS subscales. Construct validity was established for the PS subscales: Physician Communication, Treatment Staff Communication, Technical Competence, Confidence and Trust, and Nurse Communication. The two instruments generated here offer a new way to assess several key dimensions of patient satisfaction with treatment, especially for people with lung cancer.

Extensive validation of the pain disability index in 3 groups of patients with musculoskeletal pain.

PubMed

Soer, Remko; Köke, Albère J A; Vroomen, Patrick C A J; Stegeman, Patrick; Smeets, Rob J E M; Coppes, Maarten H; Reneman, Michiel F

2013-04-20

A cross-sectional study design was performed. To validate the pain disability index (PDI) extensively in 3 groups of patients with musculoskeletal pain. The PDI is a widely used and studied instrument for disability related to various pain syndromes, although there is conflicting evidence concerning factor structure, test-retest reliability, and missing items. Additionally, an official translation of the Dutch language version has never been performed. For reliability, internal consistency, factor structure, test-retest reliability and measurement error were calculated. Validity was tested with hypothesized correlations with pain intensity, kinesiophobia, Rand-36 subscales, Depression, Roland-Morris Disability Questionnaire, Quality of Life, and Work Status. Structural validity was tested with independent backward translation and approval from the original authors. One hundred seventy-eight patients with acute back pain, 425 patients with chronic low back pain and 365 with widespread pain were included. Internal consistency of the PDI was good. One factor was identified with factor analyses. Test-retest reliability was good for the PDI (intraclass correlation coefficient, 0.76). Standard error of measurement was 6.5 points and smallest detectable change was 17.9 points. Little correlations between the PDI were observed with kinesiophobia and depression, fair correlations with pain intensity, work status, and vitality and moderate correlations with the Rand-36 subscales and the Roland-Morris Disability Questionnaire. The PDI-Dutch language version is internally consistent as a 1-factor structure, and test-retest reliable. Missing items seem high in sexual and professional items. Using the PDI as a 2-factor questionnaire has no additional value and is unreliable.

Use of laser ablation-inductively coupled plasma-time of flight-mass spectrometry to identify the elemental composition of vanilla and determine the geographic origin by discriminant function analysis.

PubMed

Hondrogiannis, Ellen M; Ehrlinger, Erin; Poplaski, Alyssa; Lisle, Meredith

2013-11-27

A total of 11 elements found in 25 vanilla samples from Uganda, Madagascar, Indonesia, and Papua New Guinea were measured by laser ablation-inductively coupled plasma-time-of-flight-mass spectrometry (LA-ICP-TOF-MS) for the purpose of collecting data that could be used to discriminate among the origins. Pellets were prepared of the samples, and elemental concentrations were obtained on the basis of external calibration curves created using five National Institute of Standards and Technology (NIST) standards and one Chinese standard with (13)C internal standardization. These curves were validated using NIST 1573a (tomato leaves) as a check standard. Discriminant analysis was used to successfully classify the vanilla samples by their origin. Our method illustrates the feasibility of using LA-ICP-TOF-MS with an external calibration curve for high-throughput screening of spice screening analysis.

Report of the panel on international programs

NASA Technical Reports Server (NTRS)

Anderson, Allen Joel; Fuchs, Karl W.; Ganeka, Yasuhiro; Gaur, Vinod; Green, Andrew A.; Siegfried, W.; Lambert, Anthony; Rais, Jacub; Reighber, Christopher; Seeger, Herman

1991-01-01

The panel recommends that NASA participate and take an active role in the continuous monitoring of existing regional networks, the realization of high resolution geopotential and topographic missions, the establishment of interconnection of the reference frames as defined by different space techniques, the development and implementation of automation for all ground-to-space observing systems, calibration and validation experiments for measuring techniques and data, the establishment of international space-based networks for real-time transmission of high density space data in standardized formats, tracking and support for non-NASA missions, and the extension of state-of-the art observing and analysis techniques to developing nations.

Cross-cultural Adaptation and Validation of the Simplified Chinese Version of the Knee Outcome Survey Activities of Daily Living Scale.

PubMed

Jia, Zhen-Yu; Wang, Wei; Nian, Xin-Wen; Zhang, Xiao-Xi; Huang, Zhi-Ping; Cui, Jin; Xu, Wei-Dong

2016-10-01

To perform a cross-cultural adaptation and translation of the original version of the Activities of Daily Living Scale of the Knee Outcome Survey into Simplified Chinese and validate of the Simplified Chinese version. The original version was translated and cross-culturally adapted into Simplified Chinese according to the guidelines and the recommendations of the American Academy of Orthopaedic Surgeons Outcome Committee. A total of 213 patients (96 male, 117 female) were selected to participate in our investigation. The inclusion criteria were as follows: 18 years of age and older, able to speak Chinese Mandarin and read Simplified Chinese, and referred to physical therapy for evaluation and treatment for a knee disorder. The exclusion criteria were as follows: patients who had disorders or impairments involving both knees, patients who had other conditions that could affect lower extremity function, patients with physical therapy related to the knee in the previous 1 month, and patients with psychological problems. Each participant was asked to complete the Knee Outcome Survey Activities of Daily Living Scale (KOS-ADLS), International Knee Documentation Committee Subjective Knee Form, Western Ontario and McMaster Universities Osteoarthritis Index, and Short Form 36 forms and to provide baseline demographic data. Each participant completed the KOS-ADLS twice on 2 nonconsecutive days for reliability evaluation. A portion of the participants (n = 161) finished the KOS-ADLS a third time 4 weeks after physical treatment to test responsiveness. The original version of the KOS-ADLS was well adapted and translated into Simplified Chinese. Simplified Chinese of KOS-ADLS was shown to have good internal consistency (Cronbach's alpha = 0.855 to 0.929), great test-retest reliability (intraclass correlation coefficient = 0.935 to 0.961), high construct validity as we hypothesized (significant correlations with Short Form 36 subscales, Western Ontario and McMaster Universities Osteoarthritis Index, and International Knee Documentation Committee Subjective Knee Form), and high responsiveness (standard response means = 0.97 to 1.23, standard effect size = 0.81 to 0.91). Simplified Chinese of KOS-ADLS was shown to have good reliability, validity, and responsiveness for use in patients with knee disorders in China. Level II, testing of previously developed diagnostic criteria in a series of consecutive patients with universally applied gold standard. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Validated UPLC-MS/MS method for determination of moclobemide in human brain cell supernatant and its application to bidirectional transport study.

PubMed

Li-Bo, Dai; Miao, Yan; Huan-De, Li; Ping-Fei, Fang; Feng, Wang; Yang, Deng

2013-09-01

A simple and sensitive analytical method based on ultraperformance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) has been developed for determination of moclobemide in human brain cell monolayer as an in vitro model of blood-brain barrier. Brucine was employed as the internal standard. Moclobemide and internal standard were extracted from cell supernatant by ethyl acetate after alkalinizing with sodium hydroxide. The UPLC separation was performed on an Acquity UPLC(TM) BEH C18 column (50 × 2.1 mm, 1.7 µm, Waters, USA) with a mobile phase consisting of methanol-water (29.5:70.5, v/v); the water in the mobile phase contained 0.05% ammonium acetate and 0.1% formic acid. Detection of the analytes was achieved using positive ion electrospray via multiple reaction monitoring mode. The mass transitions were m/z 269.16 → 182.01 for moclobemide and m/z 395.24 → 324.15 for brucine. The extraction recovery was 83.0-83.4% and the lower limit of quantitation (LLOQ) was 1.0 ng/mL for moclobemide. The method was validated from LLOQ to 1980 ng/mL with a coefficient of determination greater than 0.999. Intra- and inter-day accuracies of the method at three concentrations ranged from 89.1 to 100.9% for moclobemide with precision of 1.1-9.6%. This validated method was successfully applied to bidirectional transport study of moclobemide blood-brain barrier permeability. Copyright © 2013 John Wiley & Sons, Ltd.

Validity, Reliability and Acceptability of the Team Standardized Assessment of Clinical Encounter Report*

PubMed Central

Wong, Camilla L.; Norris, Mireille; Sinha, Samir S.; Zorzitto, Maria L.; Madala, Sushma; Hamid, Jemila S.

2016-01-01

Background The Team Standardized Assessment of a Clinical Encounter Report (StACER) was designed for use in Geriatric Medicine residency programs to evaluate Communicator and Collaborator competencies. Methods The Team StACER was completed by two geriatricians and interdisciplinary team members based on observations during a geriatric medicine team meeting. Postgraduate trainees were recruited from July 2010–November 2013. Inter-rater reliability between two geriatricians and between all team members was determined. Internal consistency of items for the constructs Communicator and Collaborator competencies was calculated. Raters completed a survey previously administered to Canadian geriatricians to assess face validity. Trainees completed a survey to determine the usefulness of this instrument as a feedback tool. Results Thirty postgraduate trainees participated. The prevalence-adjusted bias-adjusted kappa range inter-rater reliability for Communicator and Collaborator items were 0.87–1.00 and 0.86–1.00, respectively. The Cronbach’s alpha coefficient for Communicator and Collaborator items was 0.997 (95% CI: 0.993–1.00) and 0.997 (95% CI: 0.997–1.00), respectively. The instrument lacked discriminatory power, as all trainees scored “meets requirements” in the overall assessment. Niney-three per cent and 86% of trainees found feedback useful for developing Communicator and Collaborator competencies, respectively. Conclusions The Team StACER has adequate inter-rater reliability and internal consistency. Poor discriminatory power and face validity challenge the merit of using this evaluation tool. Trainees felt the tool provided useful feedback on Collaborator and Communicator competencies. PMID:28050222

UHPLC-MS/MS method for the quantitation of penicillin G and metabolites in citrus fruit using internal standards.

PubMed

Canzani, Daniele; Hsieh, Kevin; Standland, Matthew; Hammack, Walter; Aldeek, Fadi

2017-02-15

Penicillin G has been applied to citrus trees as a potential treatment in the fight against Huanglongbing (HLB). Here, we have developed and validated a method to identify and quantitate penicillin G and two of its metabolites, penillic acid and penilloic acid, in citrus fruit using ultra high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS). This method improves upon a previous method by incorporating isotopically labeled internal standards, namely, penillic acid-D 5 , and penilloic acid-D 5 . These standards greatly enhanced the accuracy and precision of our measurements by compensating for recovery losses, degradation, and matrix effects. When 2g of citrus fruit sample is extracted, the limits of detection (LOD) were determined to be 0.1ng/g for penicillin G and penilloic acid, and 0.25ng/g for penillic acid. At fortification levels of 0.1, 0.25, 1, and 10ng/g, absolute recoveries for penillic and penilloic acids were generally between 50-70%. Recoveries corrected with the isotopically labeled standards were approximately 90-110%. This method will be useful for the identification and quantitation of drug residues and their degradation products using isotopically labeled standards and UHPLC-MS/MS. Published by Elsevier B.V.

Development and evaluation of an instrument for assessing brief behavioral change interventions.

PubMed

Strayer, Scott M; Martindale, James R; Pelletier, Sandra L; Rais, Salehin; Powell, Jon; Schorling, John B

2011-04-01

To develop an observational coding instrument for evaluating the fidelity and quality of brief behavioral change interventions based on the behavioral theories of the 5 A's, Stages of Change and Motivational Interviewing. Content and face validity were assessed prior to an intervention where psychometric properties were evaluated with a prospective cohort of 116 medical students. Properties assessed included the inter-rater reliability of the instrument, internal consistency of the full scale and sub-scales and descriptive statistics of the instrument. Construct validity was assessed based on student's scores. Inter-rater reliability for the instrument was 0.82 (intraclass correlation). Internal consistency for the full scale was 0.70 (KR20). Internal consistencies for the sub-scales were as follows: MI intervention component (KR20=.7); stage-appropriate MI-based intervention (KR20=.55); MI spirit (KR20=.5); appropriate assessment (KR20=.45) and appropriate assisting (KR20=.56). The instrument demonstrated good inter-rater reliability and moderate overall internal consistency when used to assess performing brief behavioral change interventions by medical students. This practical instrument can be used with minimal training and demonstrates promising psychometric properties when evaluated with medical students counseling standardized patients. Further testing is required to evaluate its usefulness in clinical settings. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Validation of Spectra and Phase in Sub-1 cm-1 Resolution Sum-Frequency Generation Vibrational Spectroscopy through Internal Heterodyne Phase-Resolved Measurement

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

Fu, Li; Chen, Shunli; Wang, Hongfei

2016-03-03

Reliably determination of the spectral features and their phases in sum-frequency generation vibrational spectroscopy (SFG-VS) for surfaces with closely overlapping peaks has been a standing issue. Here we present two approaches towards resolving such issue. The first utilizes the high resolution and accurate lineshape from the recently developed sub-wavenumber high resolution broadband SFG-VS (HR-BB-SFG-VS), from which the detail spectral parameters, including relative spectral phases, of overlapping peaks can be determined through reliable spectral fitting. These results are further validated by using the second method that utilizes the azimuthal angle phase dependence of the z-cut α-quartz crystal, a common phase standard,more » through the spectral interference between the SFG fields of the quartz surface, as the internal phase reference, and the adsorbed molecular layer. Even though this approach is limited to molecular layers that can be transferred or deposited onto the quartz surface, it is simple and straightforward, as it requires only an internal phase standard with a single measurement that is free of phase drifts. More importantly, it provides unambiguous SFG spectral phase information of such surfaces. Using this method, the absolute phase of the molecular susceptibility tensors of the CH3, CH2 and chiral C-H groups in different Langmuir-Blodgett (LB) molecular monolayers and drop-cast peptide films are determined. These two approaches are fully consistent with and complement to each other, making both easily applicable tools in SFG-VS studies. More importantly, as the HR-BB-SFG-VS technique can be easily applied to various surfaces and interfaces, such validation of the spectral and phase information from HR-BB-SFG-VS measurement demonstrates it as one most promising tool for interrogating the detailed structure and interactions of complex molecular interfaces.« less

Development and initial validation of primary care provider mental illness management and team-based care self-efficacy scales.

PubMed

Loeb, Danielle F; Crane, Lori A; Leister, Erin; Bayliss, Elizabeth A; Ludman, Evette; Binswanger, Ingrid A; Kline, Danielle M; Smith, Meredith; deGruy, Frank V; Nease, Donald E; Dickinson, L Miriam

Develop and validate self-efficacy scales for primary care provider (PCP) mental illness management and team-based care participation. We developed three self-efficacy scales: team-based care (TBC), mental illness management (MIM), and chronic medical illness (CMI). We developed the scales using Bandura's Social Cognitive Theory as a guide. The survey instrument included items from previously validated scales on team-based care and mental illness management. We administered a mail survey to 900 randomly selected Colorado physicians. We conducted exploratory principal factor analysis with oblique rotation. We constructed self-efficacy scales and calculated standardized Cronbach's alpha coefficients to test internal consistency. We calculated correlation coefficients between the MIM and TBC scales and previously validated measures related to each scale to evaluate convergent validity. We tested correlations between the TBC and the measures expected to correlate with the MIM scale and vice versa to evaluate discriminant validity. PCPs (n=402, response rate=49%) from diverse practice settings completed surveys. Items grouped into factors as expected. Cronbach's alphas were 0.94, 0.88, and 0.83 for TBC, MIM, and CMI scales respectively. In convergent validity testing, the TBC scale was correlated as predicted with scales assessing communications strategies, attitudes toward teams, and other teamwork indicators (r=0.25 to 0.40, all statistically significant). Likewise, the MIM scale was significantly correlated with several items about knowledge and experience managing mental illness (r=0.24 to 41, all statistically significant). As expected in discriminant validity testing, the TBC scale had only very weak correlations with the mental illness knowledge and experience managing mental illness items (r=0.03 to 0.12). Likewise, the MIM scale was only weakly correlated with measures of team-based care (r=0.09 to.17). This validation study of MIM and TBC self-efficacy scales showed high internal validity and good construct validity. Copyright © 2016 Elsevier Inc. All rights reserved.

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

PubMed

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

2018-05-01

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

Translation and validation of the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) version 4 quality of life instrument into Arabic language.

PubMed

Soudy, Hussein; Maghfoor, Irfan; Elhassan, Tusneem Ahmed M; Abdullah, Eman; Rauf, Shahzad M; Al Zahrani, Ahmed; Akhtar, Saad

2018-03-12

Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) has been translated from English into several languages. Currently, there is no validated translation of FACT-BMT in Arabic. Here, we are reporting the first Arabic translation and validation of the FACT-BMT. The study was approved by the Institutional Research Advisory Council. The Arabic translation followed the standard Functional Assessment of Chronic Illness Therapy (FACIT.org) translation methodology (with permission). Arabic FACT-BMT (50- items) was statistically validated. Cronbach's alpha for internal consistency, Spearman's rank correlation coefficients method for Inter-scale correlations and Principal Component Analysis for factorial construct validity was used. One hundred and eight consecutive relapsed /refractory lymphoma patients who underwent high dose chemotherapy and autologous stem cell transplant were enrolled. There were 68 males (63%) and 40 females (37%) with a median age of 29 years (range 14-62). After Arabic questionnaire pre-testing (Cronbach's alpha 0.744), the study included 108 patients. Cronbach's alpha for the entire FACT-BMT indicated an excellent internal consistency (0.90); range (0.67 to 0.91). Cronbach's alpha for sub-groups of social (0.78), emotional (0.67) and functional wellbeing was (0.88). Cronbach's alpha for bone marrow transplant (0.81), FACT-General (0.89), and FACT- Trial Outcome Index (TOI); (0.91) also revealed excellent internal consistency. Patients had high scores in all domains of quality of life, indicating that most patients were leading a normal life. This translation of FACT-BMT in Arabic was reviewed and approved for submission by the FACIT.org. Our data reports the first translated, validated and approved Arabic version of FACT-BMT. This will help large numbers of Arabic speaking patients undergoing stem cell/bone marrow transplantation, across the globe.

Is the Berg Balance Scale an effective tool for the measurement of early postural control impairments in patients with Parkinson's disease? Evidence from Rasch analysis.

PubMed

La Porta, F; Giordano, A; Caselli, S; Foti, C; Franchignoni, F

2015-12-01

It is unclear whether the BBS is an effective tool for the measurement of early postural control impairments in patients with Parkinson's disease (PD). The aim of this paper was to evaluate BBS' content validity, internal construct validity, reliability and targeting in patients with PD within the Rasch analysis framework. Observational, cross-sectional study. Outpatient Rehabilitation Unit. A sample of 285 outpatients with PD. The content validity of the BBS was assessed using standard linking techniques. The BBS was administered by trained physiotherapists. The data collected then underwent Rasch analysis. Content validity analysis showed a lack of items assessing postural responses to tripping and slips and stability during walking. On Rasch analysis, the BBS failed the requirements of monotonicity, local independence, unidimensionality and invariance. After rescoring 7 items, grouping of locally dependent items into testlets, and deletion of the static sitting balance item because mistargeted and underdiscriminating, the Rasch-modified BBS for PD (BBS-PD) showed adequate internal construct validity (χ(2)24=39.693; P=0.023), including absence of differential item functioning (DIF) across gender and age, and was, as a whole, sufficiently precise for individual person measurement (PSI=0.894). However, the scale was not well targeted to the sample in view of the prevalence of higher scores. This study demonstrated the internal construct validity and reliability of the BBS-PD as a measurement tool for patients with PD within the Rasch analysis framework. However, the lack of items critical to the assessment of postural control impairments typical of PD, affected negatively the targeting, so that a significant percentage of patients was located in the higher ability range of the measurement continuum, where precision of measurement is reduced. These findings suggest that the BBS, even if modified, may not be an effective tool for the measurement of early postural control in patients with PD.

Greek cultural adaption and validation of the Kujala anterior knee pain scale in patients with patellofemoral pain syndrome.

PubMed

Papadopoulos, Costas; Constantinou, Antonis; Cheimonidou, Areti-Zoi; Stasinopoulos, Dimitrios

2017-04-01

To cross-culturally adapt and validate the Greek version of the Kujala anterior knee pain scale (KAKPS). The Greek KAKPS was translated from the original English version following standard forward and backward translation procedures. The survey was then conducted in clinical settings by a questionnaire comprising the Greek KAKPS and patellofemoral pain syndrome (PFPS) severity scale. A total of 130 (62 women and 68 men) Greek-reading patients between 18 and 45 years old with anterior knee pain (AKP) for at least four weeks were recruited from physical therapy clinics. To establish test-retest reliability, the patients were asked to complete the KAKPS at initial visit and 2-3 days after the initial visit. The Greek version of the PFPS severity scale was also administered once at initial visit. Internal consistency of the translated instrument was measured using Cronbach's α. An intraclass correlation coefficient was used to assess the test-retest reliability of the KAKPS. Concurrent validity was measured by correlating the KAKPS with the PFPS severity scale using Pearson's correlation coefficient. The results showed that the Greek KAKPS has good internal consistency (Cronbach's α = 0.942), test-retest reliability (ICC = 0.921) and concurrent validity (r > 0.7). This study has shown that the Greek KAKPS has good internal consistency, test-retest reliability and concurrent validity when correlated with the PFPS severity scale in adult patients with AKP for at least four weeks. Implications for rehabilitation The Greek version of the KAKPS has been found to be reliable and valid when used in adult patients with AKP for at least four weeks. The results of the psychometric characteristics were compatible with those of the original English version. The KAKPS could be applied in a Greek-speaking population to assess functional limitations and symptoms in patients aged 18-45 years old with AKP for at least four weeks.

Cross-cultural adaptation, reliability and validity of the Turkish version of the Lower Limb Functional Index.

PubMed

Duruturk, Neslihan; Tonga, Eda; Gabel, Charles Philip; Acar, Manolya; Tekindal, Agah

2015-07-26

This study aims to adapt culturally a Turkish version of the Lower Limb Functional Index (LLFI) and to determine its validity, reliability, internal consistency, measurement sensitivity and factor structure in lower limb problems. The LLFI was translated into Turkish and cross-culturally adapted with a double forward-backward protocol that determined face and content validity. Individuals (n = 120) with lower limb musculoskeletal disorders completed the LLFI and Short Form-36 questionnaires and the Timed Up and Go physical test. The psychometric properties were evaluated for the all participants from patient-reported outcome measures made at baseline and repeated at day 3 to determine criterion between scores (Pearson's r), internal consistency (Cronbachs α) and test-retest reliability (intraclass correlation coefficient - ICC 2.1 ). Error was determined using standard error of the measurement (SEM) and minimal detectable change at the 90% level (MDC 90 ), while factor structure was determined using exploratory factor analysis with maximum likelihood extraction and Varimax rotation. The psychometric characteristics showed strong criterion validity (r = 0.74-0.76), high internal consistency (α = 0.82) and high test-retest reability (ICC 2.1  = 0.97). The SEM of 3.2% gave an MDC 90  = 5.8%. The factor structure was uni-dimensional. Turkish version of LLFI was found to be valid and reliable for the measurement of lower limb function in a Turkish population. Implications for Rehabilitation Lower extremity musculoskeletal disorders are common and greatly impact activities among the affected individuals pertaining to daily living, work, leisure and quality of life. Patient-reported outcome (PRO) measures have advantages as they are practical, cost-effective and clinically convenient for use in patient-centered care. The Lower Limb Functional Index is a recently validated PRO measure shown to have strong clinimetric properties.

The EORTC information questionnaire, EORTC QLQ-INFO25. Validation study for Spanish patients.

PubMed

Arraras, Juan Ignacio; Manterola, Ana; Hernández, Berta; Arias de la Vega, Fernando; Martínez, Maite; Vila, Meritxell; Eito, Clara; Vera, Ruth; Domínguez, Miguel Ángel

2011-06-01

The EORTC QLQ-INFO25 evaluates the information received by cancer patients. This study assesses the psychometric properties of the QLQ-INFO25 when applied to a sample of Spanish patients. A total of 169 patients with different cancers and stages of disease completed the EORTC QLQINFO25, the EORTC QLQ-C30 and the information scales of the inpatient satisfaction module EORTC IN-PATSAT32 on two occasions during the patients' treatment and follow- up period. Psychometric evaluation of the structure, reliability, validity and responsiveness to changes was conducted. Patient acceptability was assessed with a debriefing questionnaire. Multi-trait scaling confirmed the 4 multi-item scales (information about disease, medical tests, treatment and other services) and eight single items. All items met the standards for convergent validity and all except one met the standards of item discriminant validity. Internal consistency for all scales (α>0.70) and the whole questionnaire (α>0.90) was adequate in the three measurements, except information about the disease (0.67) and other services (0.68) in the first measurement, as was test-retest reliability (intraclass correlations >0.70). Correlations with related areas of IN-PATSAT32 (r>0.40) supported convergent validity. Divergent validity was confirmed through low correlations with EORTC QLQ-C30 scales (r<0.30). The EORTC QLQ-INFO-25 discriminated among groups based on gender, age, education, levels of anxiety and depression, treatment line, wish for information and satisfaction. One scale and an item showed changes over time. The EORTC QLQ-INFO 25 is a reliable and valid instrument when applied to a sample of Spanish cancer patients. These results are in line with those of the EORTC validation study.

Prediction of two month modified Rankin Scale with an ordinal prediction model in patients with aneurysmal subarachnoid haemorrhage

PubMed Central

2010-01-01

Background Aneurysmal subarachnoid haemorrhage (aSAH) is a devastating event with a frequently disabling outcome. Our aim was to develop a prognostic model to predict an ordinal clinical outcome at two months in patients with aSAH. Methods We studied patients enrolled in the International Subarachnoid Aneurysm Trial (ISAT), a randomized multicentre trial to compare coiling and clipping in aSAH patients. Several models were explored to estimate a patient's outcome according to the modified Rankin Scale (mRS) at two months after aSAH. Our final model was validated internally with bootstrapping techniques. Results The study population comprised of 2,128 patients of whom 159 patients died within 2 months (8%). Multivariable proportional odds analysis identified World Federation of Neurosurgical Societies (WFNS) grade as the most important predictor, followed by age, sex, lumen size of the aneurysm, Fisher grade, vasospasm on angiography, and treatment modality. The model discriminated moderately between those with poor and good mRS scores (c statistic = 0.65), with minor optimism according to bootstrap re-sampling (optimism corrected c statistic = 0.64). Conclusion We presented a calibrated and internally validated ordinal prognostic model to predict two month mRS in aSAH patients who survived the early stage up till a treatment decision. Although generalizability of the model is limited due to the selected population in which it was developed, this model could eventually be used to support clinical decision making after external validation. Trial Registration International Standard Randomised Controlled Trial, Number ISRCTN49866681 PMID:20920243

ASTM Committee C28: International Standards for Properties and Performance of Advanced Ceramics, Three Decades of High-quality, Technically-rigorous Normalization

NASA Technical Reports Server (NTRS)

Jenkins, Michael G.; Salem, Jonathan A.

2016-01-01

Physical and mechanical properties and performance of advanced ceramics and glasses are difficult to measure correctly without the proper techniques. For over three decades, ASTM Committee C28 on Advanced Ceramics, has developed high quality, rigorous, full-consensus standards (e.g., test methods, practices, guides, terminology) to measure properties and performance of monolithic and composite ceramics that may be applied to glasses in some cases. These standards testing particulars for many mechanical, physical, thermal, properties and performance of these materials. As a result these standards provide accurate, reliable, repeatable and complete data. Within Committee C28 users, producers, researchers, designers, academicians, etc. have written, continually updated, and validated through round-robin test programs, nearly 50 standards since the Committees founding in 1986. This paper provides a retrospective review of the 30 years of ASTM Committee C28 including a graphical pictogram listing of C28 standards along with examples of the tangible benefits of advanced ceramics standards to demonstrate their practical applications.

Evaluation and cross-validation of Environmental Models

NASA Astrophysics Data System (ADS)

Lemaire, Joseph

Before scientific models (statistical or empirical models based on experimental measurements; physical or mathematical models) can be proposed and selected as ISO Environmental Standards, a Commission of professional experts appointed by an established International Union or Association (e.g. IAGA for Geomagnetism and Aeronomy, . . . ) should have been able to study, document, evaluate and validate the best alternative models available at a given epoch. Examples will be given, indicating that different values for the Earth radius have been employed in different data processing laboratories, institutes or agencies, to process, analyse or retrieve series of experimental observations. Furthermore, invariant magnetic coordinates like B and L, commonly used in the study of Earth's radiation belts fluxes and for their mapping, differ from one space mission data center to the other, from team to team, and from country to country. Worse, users of empirical models generally fail to use the original magnetic model which had been employed to compile B and L , and thus to build these environmental models. These are just some flagrant examples of inconsistencies and misuses identified so far; there are probably more of them to be uncovered by careful, independent examination and benchmarking. A meter prototype, the standard unit length that has been determined on 20 May 1875, during the Diplomatic Conference of the Meter, and deposited at the BIPM (Bureau International des Poids et Mesures). In the same token, to coordinate and safeguard progress in the field of Space Weather, similar initiatives need to be undertaken, to prevent wild, uncontrolled dissemination of pseudo Environmental Models and Standards. Indeed, unless validation tests have been performed, there is guaranty, a priori, that all models on the market place have been built consistently with the same units system, and that they are based on identical definitions for the coordinates systems, etc... Therefore, preliminary analyses should be carried out under the control and authority of an established international professional Organization or Association, before any final political decision is made by ISO to select a specific Environmental Models, like for example IGRF and DGRF. Of course, Commissions responsible for checking the consistency of definitions, methods and algorithms for data processing might consider to delegate specific tasks (e.g. bench-marking the technical tools, the calibration procedures, the methods of data analysis, and the software algorithms employed in building the different types of models, as well as their usage) to private, intergovernmental or international organization/agencies (e.g.: NASA, ESA, AGU, EGU, COSPAR, . . . ); eventually, the latter should report conclusions to the Commissions members appointed by IAGA or any established authority like IUGG.

Validated HPLC-UV method for determination of naproxen in human plasma with proven selectivity against ibuprofen and paracetamol.

PubMed

Filist, Monika; Szlaska, Iwona; Kaza, Michał; Pawiński, Tomasz

2016-06-01

Estimating the influence of interfering compounds present in the biological matrix on the determination of an analyte is one of the most important tasks during bioanalytical method development and validation. Interferences from endogenous components and, if necessary, from major metabolites as well as possible co-administered medications should be evaluated during a selectivity test. This paper describes a simple, rapid and cost-effective HPLC-UV method for the determination of naproxen in human plasma in the presence of two other analgesics, ibuprofen and paracetamol. Sample preparation is based on a simple liquid-liquid extraction procedure with a short, 5 s mixing time. Fenoprofen, which is characterized by a similar structure and properties to naproxen, was first used as the internal standard. The calibration curve is linear in the concentration range of 0.5-80.0 µg/mL, which is suitable for pharmacokinetic studies following a single 220 mg oral dose of naproxen sodium. The method was fully validated according to international guidelines and was successfully applied in a bioequivalence study in humans. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Adaptation and Validation of the Kannada Version of the Singing Voice Handicap Index.

PubMed

Gunjawate, Dhanshree R; Aithal, Venkataraja U; Guddattu, Vasudeva; Bellur, Rajashekhar

2017-07-01

The present study aimed to adapt and validate the Singing Voice Handicap Index (SVHI) into Kannada language using standard procedures. This is a cross-sectional study. The original English version of SVHI was translated into Kannada. It was administered on 106 Indian classical singers, of whom 22 complained of voice problems. Its internal consistency was determined using Cronbach's alpha coefficient (α), test-retest reliability using Pearson's product moment correlation and paired t test, and the difference in mean scores by independent sample t test. The results revealed that the Kannada SVHI exhibited an excellent internal consistency (α = 0.96) with a high item-to-total correlation. Further, excellent test-retest reliability (r = 0.99) and significant differences in SVHI scores were also obtained by singers with and without a voice problem (t = 12.93, df = 104, P = 0.005). The Kannada SVHI is a valid and reliable tool for self-reported assessment of singers with voice problems. It will provide a valuable insight into the singing-related voice problems as perceived by the singers themselves. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Psychometric Evaluation of the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).

PubMed

Duncan, Laura; Georgiades, Kathy; Wang, Li; Van Lieshout, Ryan J; MacMillan, Harriet L; Ferro, Mark A; Lipman, Ellen L; Szatmari, Peter; Bennett, Kathryn; Kata, Anna; Janus, Magdalena; Boyle, Michael H

2017-12-04

The goals of the study were to examine test-retest reliability, informant agreement and convergent and discriminant validity of nine DSM-IV-TR psychiatric disorders classified by parent and youth versions of the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). Using samples drawn from the general population and child mental health outpatient clinics, 283 youth aged 9 to 18 years and their parents separately completed the MINI-KID with trained lay interviewers on two occasions 7 to 14 days apart. Test-retest reliability estimates based on kappa (κ) went from 0.33 to 0.79 across disorders, samples and informants. Parent-youth agreement on disorders was low (average κ = 0.20). Confirmatory factor analysis provided evidence supporting convergent and discriminant validity. The MINI-KID disorder classifications yielded estimates of test-retest reliability and validity comparable to other standardized diagnostic interviews in both general population and clinic samples. These findings, in addition to the brevity and low administration cost, make the MINI-KID a good candidate for use in epidemiological research and clinical practice. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Persian language version of the "Tinnitus Handicap Inventory": translation, standardization, validity and reliability.

PubMed

Mahmoudian, Saeid; Shahmiri, Elaheh; Rouzbahani, Masoumeh; Jafari, Zahra; Keyhani, Mohammad; Rahimi, Farzad; Mahmoudian, Guiti; Akbarvand, Leila; Barzegar, Gholamreza; Farhadi, Mohammad

2011-01-01

Tinnitus is a debilitating condition that is widespread yet difficult to successfully diagnose and treat. This symptom can seriously affect the individual's life quality. The aim of current study was to compose and validate a Persian version of the Tinnitus Handicap Inventory (THI-P). The linguistic validation of the original version of THI into Persian version (THI-P) included translation, back translation and data gathering. The THI-P was administered to 112 tinnitus subjects. Age, gender, medical history and tinnitus characteristics were recorded as baseline information. All participants complained of chronic unilateral or bilateral subjective idiopathic tinnitus lasting for at least 6 months before consulting about their tinnitus. There was no significant difference between gender, age, hearing impairment and total score and subscales of THI-P. Pearson product-moment correlations revealed adequate test-retest reliability for the THI-P (r = 0.96). Cronbach's-alpha coefficient indicated adequate internal stability of the THI-P (r= 0.943), with a total item correction varying between r=0.939 and r=0.944, indicating its reproducibility. The present study proved the internal consistency/ coherency of the Persian version of THI (THI-P). This provides satisfactory application in clinical/research environments.

Quantification of seven β-lactam antibiotics and two β-lactamase inhibitors in human plasma using a validated UPLC-MS/MS method.

PubMed

Carlier, Mieke; Stove, Veronique; Roberts, Jason A; Van de Velde, Eric; De Waele, Jan J; Verstraete, Alain G

2012-11-01

There is an increasing interest in monitoring plasma concentrations of β-lactam antibiotics. The objective of this work was to develop and validate a rapid ultra-performance liquid chromatographic method with tandem mass spectrometric detection (UPLC-MS/MS) for simultaneous quantification of amoxicillin, ampicillin, cefuroxime, cefazolin, ceftazidime, meropenem, piperacillin, clavulanic acid and tazobactam. Sample clean-up included protein precipitation with acetonitrile and back-extraction of acetonitrile with dichloromethane. Six deuterated β-lactam antibiotics were used as internal standards. Chromatographic separation was performed on a Waters ACQUITY UPLC system using a BEH C(18) column (1.7 μm, 100 mm×2.1 mm) applying a binary gradient elution of water and acetonitrile both containing 0.1% formic acid. The total run time was 5.5 min. The developed method was validated in terms of precision, accuracy, linearity, matrix effect and recovery. The assay has now been successfully used to determine concentrations of amoxicillin/clavulanic acid, cefuroxime and meropenem in plasma samples from intensive care patients. Copyright © 2012 Elsevier B.V. and the International Society of Chemotherapy. All rights reserved.

The psychometric properties of the Perceived Stress Scale-10 among patients with systemic lupus erythematosus.

PubMed

Mills, S D; Azizoddin, D; Racaza, G Z; Wallace, D J; Weisman, M H; Nicassio, P M

2017-10-01

Objective Systemic lupus erythematosus (SLE) is a chronic, multisystem autoimmune disease characterized by periods of remission and recurrent flares, which have been associated with stress. Despite the significance of stress in this disease, the Perceived Stress Scale-10 has yet to be psychometrically evaluated in patients with SLE. Methods Exploratory factor analysis was used to examine the structural validity of the Perceived Stress Scale-10 among patients with SLE ( N = 138) receiving medical care at Cedars Sinai Medical Center. Cronbach's coefficient alpha was used to examine internal consistency reliability, and Pearson product-moment correlations were used to examine convergent validity with measures of anxiety, depression, helplessness, and disease activity. Results Exploratory factor analysis provided support for a two-factor structure (comparative fit index = .95; standardized root mean residual = .04; root mean square error of approximation = .08). Internal consistency reliability was good for both factors (α = .84 and .86). Convergent validity was evidenced via significant correlations with measures of anxiety, depression, and helplessness. There were no significant correlations with the measure of disease activity. Conclusion The Perceived Stress Scale-10 can be used to examine perceived stress among patients with SLE.

Novel rapid liquid chromatography tandem masspectrometry method for vemurafenib and metabolites in human plasma, including metabolite concentrations at steady state.

PubMed

Vikingsson, Svante; Strömqvist, Malin; Svedberg, Anna; Hansson, Johan; Höiom, Veronica; Gréen, Henrik

2016-08-01

A novel, rapid and sensitive liquid chromatography tandem-mass spectrometry method for quantification of vemurafenib in human plasma, that also for the first time allows for metabolite semi-quantification, was developed and validated to support clinical trials and therapeutic drug monitoring. Vemurafenib was analysed by precipitation with methanol followed by a 1.9 min isocratic liquid chromatography tandem masspectrometry analysis using an Acquity BEH C18 column with methanol and formic acid using isotope labelled internal standards. Analytes were detected in multireaction monitoring mode on a Xevo TQ. Semi-quantification of vemurafenib metabolites was performed using the same analytical system and sample preparation with gradient elution. The vemurafenib method was successfully validated in the range 0.5-100 μg/mL according to international guidelines. The metabolite method was partially validated owing to the lack of commercially available reference materials. For the first time concentration levels at steady state for melanoma patients treated with vemurafenib is presented. The low abundance of vemurafenib metabolites suggests that they lack clinical significance. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Identifying dyspepsia in the Greek population: translation and validation of a questionnaire

PubMed Central

Anastasiou, Foteini; Antonakis, Nikos; Chaireti, Georgia; Theodorakis, Pavlos N; Lionis, Christos

2006-01-01

Background Studies on clinical issues, including diagnostic strategies, are considered to be the core content of general practice research. The use of standardised instruments is regarded as an important component for the development of Primary Health Care research capacity. Demand for epidemiological cross-cultural comparisons in the international setting and the use of common instruments and definitions valid to each culture is bigger than ever. Dyspepsia is a common complaint in primary practice but little is known with respect to its incidence in Greece. There are some references about the Helicobacter Pylori infection in patients with functional dyspepsia or gastric ulcer in Greece but there is no specific instrument for the identification of dyspepsia. This paper reports on the validation and translation into Greek, of an English questionnaire for the identification of dyspepsia in the general population and discusses several possibilities of its use in the Greek primary care. Methods The selected English postal questionnaire for the identification of people with dyspepsia in the general population consists of 30 items and was developed in 1995. The translation and cultural adaptation of the questionnaire has been performed according to international standards. For the validation of the instrument the internal consistency of the items was established using the alpha coefficient of Chronbach, the reproducibility (test – retest reliability) was measured by kappa correlation coefficient and the criterion validity was calculated against the diagnosis of the patients' records using also kappa correlation coefficient. Results The final Greek version of the postal questionnaire for the identification of dyspepsia in the general population was reliably translated. The internal consistency of the questionnaire was good, Chronbach's alpha was found to be 0.88 (95% CI: 0.81–0.93), suggesting that all items were appropriate to measure. Kappa coefficient for reproducibility (test – retest reliability) was found 0.66 (95% CI: 0.62–0.71), whereas the kappa analysis for criterion validity was 0.63 (95% CI: 0.36–0.89). Conclusion This study indicates that the Greek translation is comparable with the English-language version in terms of validity and reliability, and is suitable for epidemiological research within the Greek primary health care setting. PMID:16515708

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

Recent Work in Hybrid Radiation Transport Methods with Applications to Commercial Nuclear Power

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

Kulesza, Joel A.

This talk will begin with an overview of hybrid radiation transport methods followed by a discussion of the author’s work to advance current capabilities. The talk will then describe applications for these methods in commercial nuclear power reactor analyses and techniques for experimental validation. When discussing these analytical and experimental activities, the importance of technical standards such as those created and maintained by ASTM International will be demonstrated.

Development and validation of a UPLC-MS/MS method for the simultaneous determination of paritaprevir and ritonavir in rat liver.

PubMed

Ocque, Andrew J; Hagler, Colleen E; Difrancesco, Robin; Woolwine-Cunningham, Yvonne; Bednasz, Cindy J; Morse, Gene D; Talal, Andrew H

2016-07-01

Determination of paritaprevir and ritonavir in rat liver tissue samples. We successfully validated a UPLC-MS/MS method to measure paritaprevir and ritonavir in rat liver using deuterated internal standards (d8-paritapervir and d6-ritonavir). The method is linear from 20 to 20,000 and 5 to 10,000 pg on column for paritaprevir and ritonavir, respectively, and is normalized per milligram tissue. Interday and intraday variability ranged from 0.591 to 5.33% and accuracy ranged from -6.68 to 10.1% for quality control samples. The method was then applied to the measurement of paritaprevir and ritonavir in rat liver tissue samples from a pilot study. The validated method is suitable for measurement of paritaprevir and ritonavir within rat liver tissue samples for PK studies.

Determination of some phenolic compounds in red wine by RP-HPLC: method development and validation.

PubMed

Burin, Vívian Maria; Arcari, Stefany Grützmann; Costa, Léa Luzia Freitas; Bordignon-Luiz, Marilde T

2011-09-01

A methodology employing reversed-phase high-performance liquid chromatography (RP-HPLC) was developed and validated for simultaneous determination of five phenolic compounds in red wine. The chromatographic separation was carried out in a C(18) column with water acidify with acetic acid (pH 2.6) (solvent A) and 20% solvent A and 80% acetonitrile (solvent B) as the mobile phase. The validation parameters included: selectivity, linearity, range, limits of detection and quantitation, precision and accuracy, using an internal standard. All calibration curves were linear (R(2) > 0.999) within the range, and good precision (RSD < 2.6%) and recovery (80-120%) was obtained for all compounds. This method was applied to quantify phenolics in red wine samples from Santa Catarina State, Brazil, and good separation peaks for phenolic compounds in these wines were observed.

Using routine Haemophilia Joint Health Score for international comparisons of haemophilia outcome: standardization is needed.

PubMed

Nijdam, A; Bladen, M; Hubert, N; Pettersson, M; Bartels, B; van der Net, J; Liesner, R; Petrini, P; Kurnik, K; Fischer, K

2016-01-01

Haemophilia Joint Health Score (HJHS) is the most sensitive validated score for physical examination of joint health in haemophilia. HJHS performed at regular intervals can be used for clinical monitoring as well as for comparative outcomes research. To determine whether routinely collected HJHS could be used to compare outcome of three different prophylactic regimens in children with severe haemophilia A (primary) and which parameters caused variability in HJHS (secondary). International retrospective observational multi-centre study comparing routine HJHS in 127 children with severe haemophilia A born from 1995 to 2009, from London, Stockholm and Utrecht centres. Patient and treatment data were collected from the European Paediatric Network for Haemophilia Management registry and patient files. The independent effects of regimens, physiotherapists, age and inhibitor status on HJHS were explored, using multivariable regression analysis. Prophylaxis varied across participating centres, with differences in initial frequency of infusions (1× per week vs. 3× per week), age at reaching infusions ≥3× per week, and dose kg(-1) week(-1) at HJHS assessment. Evaluation at median age of 11 years showed an illogical association of HJHS with treatment regimen: the least intensive regimen had the lowest HJHS. The HJHS increased with age and history of inhibitor, as expected (internal validity). But the comparison of prophylactic regimens was obscured by systematic differences in assessment between physiotherapists, both within and between centres. Inter-physiotherapist discrepancies in routine HJHS hamper comparison of scores between treatment regimens. For multi-centre research, additional inter-observer standardization for HJHS scoring is needed. © 2015 John Wiley & Sons Ltd.

Antibiotic stewardship through the EU project "ABS International".

PubMed

Allerberger, Franz; Frank, Annegret; Gareis, Roland

2008-01-01

The increasing problem of antimicrobial resistance requires implementation of antibiotic stewardship (ABS) programs. The project "ABS International--implementing antibiotic strategies for appropriate use of antibiotics in hospitals in member states of the European Union" was started in September 2006 in Austria, Belgium, the Czech Republic, Germany, Hungary, Italy, Poland, Slovenia and Slovakia. A training program for national ABS trainers was prepared and standard templates for ABS tools (antibiotic list, guides for antibiotic treatment and surgical prophylaxis, antibiotic-related organization) and valid process measures, as well as quality indicators for antibiotic use were developed. Specific ABS tools are being implemented in up to five healthcare facilities in each country. Although ABS International clearly focuses on healthcare institutions, future antimicrobial stewardship programs must also cover public education and antibiotic prescribing in primary care.

Measuring verbal and non-verbal communication in aphasia: reliability, validity, and sensitivity to change of the Scenario Test.

PubMed

van der Meulen, Ineke; van de Sandt-Koenderman, W Mieke E; Duivenvoorden, Hugo J; Ribbers, Gerard M

2010-01-01

This study explores the psychometric qualities of the Scenario Test, a new test to assess daily-life communication in severe aphasia. The test is innovative in that it: (1) examines the effectiveness of verbal and non-verbal communication; and (2) assesses patients' communication in an interactive setting, with a supportive communication partner. To determine the reliability, validity, and sensitivity to change of the Scenario Test and discuss its clinical value. The Scenario Test was administered to 122 persons with aphasia after stroke and to 25 non-aphasic controls. Analyses were performed for the entire group of persons with aphasia, as well as for a subgroup of persons unable to communicate verbally (n = 43). Reliability (internal consistency, test-retest reliability, inter-judge, and intra-judge reliability) and validity (internal validity, convergent validity, known-groups validity) and sensitivity to change were examined using standard psychometric methods. The Scenario Test showed high levels of reliability. Internal consistency (Cronbach's alpha = 0.96; item-rest correlations = 0.58-0.82) and test-retest reliability (ICC = 0.98) were high. Agreement between judges in total scores was good, as indicated by the high inter- and intra-judge reliability (ICC = 0.86-1.00). Agreement in scores on the individual items was also good (square-weighted kappa values 0.61-0.92). The test demonstrated good levels of validity. A principal component analysis for categorical data identified two dimensions, interpreted as general communication and communicative creativity. Correlations with three other instruments measuring communication in aphasia, that is, Spontaneous Speech interview from the Aachen Aphasia Test (AAT), Amsterdam-Nijmegen Everyday Language Test (ANELT), and Communicative Effectiveness Index (CETI), were moderate to strong (0.50-0.85) suggesting good convergent validity. Group differences were observed between persons with aphasia and non-aphasic controls, as well as between persons with aphasia unable to use speech to convey information and those able to communicate verbally; this indicates good known-groups validity. The test was sensitive to changes in performance, measured over a period of 6 months. The data support the reliability and validity of the Scenario Test as an instrument for examining daily-life communication in aphasia. The test focuses on multimodal communication; its psychometric qualities enable future studies on the effect of Alternative and Augmentative Communication (AAC) training in aphasia.

Psychometric properties including reliability, validity and responsiveness of the Majeed pelvic score in patients with chronic sacroiliac joint pain.

PubMed

Bajada, Stefan; Mohanty, Khitish

2016-06-01

The Majeed scoring system is a disease-specific outcome measure that was originally designed to assess pelvic injuries. The aim of this study was to determine the psychometric properties of the Majeed scoring system for chronic sacroiliac joint pain. Internal consistency, content validity, criterion validity, construct validity and responsiveness to change was assessed prospectively for the Majeed scoring system in a cohort of 60 patients diagnosed with sacroiliac joint pain. This diagnosis was confirmed with CT-guided sacroiliac joint anaesthetic block. The overall Majeed score showed acceptable internal consistency (Cronbach alpha = 0.63). Similarly, it showed acceptable floor (0 %) and ceiling (0 %) effects. On the other hand, the domains of pain, work, sitting and sexual intercourse had high (>30 %) floor effects. Significant correlation with the physical component of the Short Form-36 (p = 0.005) and Oswestry disability index (p ≤ 0.001) was found indicating acceptable criterion validity. The overall Majeed score showed acceptable construct validity with all five developed hypotheses showing significance (p ≤ 0.05). The overall Majeed score showed acceptable responsiveness to change with a large (≥0.80) effect size and standardized response mean. Overall the Majeed scoring system demonstrated acceptable psychometric properties for outcome assessment in chronic sacroiliac joint pain. Thus, its use in this condition is adequate. However, some domains demonstrated suboptimal performance indicating that improvement might be achieved with the development of an outcome measure specific for sacroiliac joint dysfunction and degeneration.

Psychometric Properties of the Multidimensional Pain Inventory Applied to Brazilian Patients with Orofacial Pain.

PubMed

Zucoloto, Miriane Lucindo; Maroco, João; Duarte Bonini Campos, Juliana Alvares

2015-01-01

To evaluate the psychometric properties of the Multidimensional Pain Inventory (MPI) in a Brazilian sample of patients with orofacial pain. A total of 1,925 adult patients, who sought dental care in the School of Dentistry of São Paulo State University's Araraquara campus, were invited to participate; 62.5% (n=1,203) agreed to participate. Of these, 436 presented with orofacial pain and were included. The mean age was 39.9 (SD=13.6) years and 74.5% were female. Confirmatory factor analysis was conducted using χ²/df, comparative fit index, goodness of fit index, and root mean square error of approximation as indices of goodness of fit. Convergent validity was estimated by the average variance extracted and composite reliability, and internal consistency by Cronbach's alpha standardized coefficient (α). The stability of the models was tested in independent samples (test and validation; dental pain and orofacial pain). The factorial invariance was estimated by multigroup analysis (Δχ²). Factorial, convergent validity, and internal consistency were adequate in all three parts of the MPI. To achieve this adequate fit for Part 1, item 15 needed to be deleted (λ=0.13). Discriminant validity was compromised between the factors "activities outside the home" and "social activities" of Part 3 of the MPI in the total sample, validation sample, and in patients with dental pain and with orofacial pain. A strong invariance between different subsamples from the three parts of the MPI was detected. The MPI produced valid, reliable, and stable data for pain assessment among Brazilian patients with orofacial pain.

Development, validation and psychometric properties of the Arabic version of the Orofacial Esthetic Scale: OES-Ar.

PubMed

Alhajj, Mohammed Nasser; Amran, Abdullah Ghalib; Halboub, Esam; Al-Basmi, Abdulghani Ali; Al-Ghabri, Fawaz Abdullah

2017-07-01

This study aimed at developing the Arabic version of the Orofacial Esthetic Scale (OES-Ar) and to investigate its psychometric properties among Arabic-speaking population with and without esthetic impairments. Translation and cross-cultural adaptation was done according to the standard guidelines. Internal consistency was assessed on 230 participants. For test-retest reliability, 50 subjects with natural teeth were recalled within a period of 2 weeks. Validity of the OES-Ar was tested by construct, convergent, and discriminant validity tests. Responsiveness to esthetic changes was assessed in 60 patients. The results showed excellent internal consistency with Cronbach's alpha value of 0.92 and inter-item correlation average value of 0.60. The ICC values ranged from 0.87 to 0.96 which indicated excellent agreement. Construct validity of the OES-Ar was confirmed to be one-factor structure (one-dimensional). For convergent validity, a significant correlation was found between OES summary score and overall impression of the orofacial esthetic as well as between OES summary score and the summary score of the three questions of the OHIP-49Ar related to esthetic. The discriminant validity test revealed significant differences between different study groups (P<0.001). Responsiveness to treatment was confirmed by significant differences between pre- and post-treatment OES total summary score (P<0.001). The OES-Ar has excellent psychometric properties making it valuable instrument to assess orofacial esthetics in Arabic-speaking patients. Copyright © 2016 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

Validation of the urgency questionnaire in Portuguese: A new instrument to assess overactive bladder syndrome.

PubMed

Moraes, Rodolfo Pacheco de; Silva, Jonas Lopes da; Calado, Adriano Almeida; Cavalcanti, Geraldo de Aguiar

2018-01-01

Overactive Bladder (OAB) is a clinical condition characterized by symptoms reported by patients. Therefore, measurement instruments based on reported information are important for understanding its impact and treatment benefits. The aim of this study was to translate, culturally adapt and validate the Urgency Questionnaire (UQ) in Portuguese. Initially, the UQ was translated and culturally adapted to Portuguese. Sixty-three volunteers were enrolled in the study and were interviewed for responding the Portuguese version of the UQ and the validated Portuguese version of the Overactive Bladder Questionnaire short-form (OABq-SF), used as the gold standard measurement for the validation process. Psychometric properties such as criterion validity, stability, and reliability were tested. Forty-six subjects were included in the symptomatic group (presence of "urgency"), and seventeen were included in the asymptomatic group (control group). There was difference between symptomatic and asymptomatic subjects on all of the subscales (p≤0.001). The UQ subscales correlated with the OABq-SF subscales (p≤0.01), except the subscale "time to control urgency" and the item "impact" from the visual analog scales (VAS). However, these scales correlated with the OABq-SF - Symptom Bother Scale. The UQ subscales demonstrated stability over time (p<0.05), but the subscale "fear of incontinence" and the item "severity" of the VAS did not. All of the UQ subscales showed internal consistencies that were considered to be good or excellent. The Portuguese version of the UQ proved to be a valid tool for the evaluation of OAB in individuals whose native language is Portuguese. Copyright® by the International Brazilian Journal of Urology.

Validity Evidence and Scoring Guidelines for Standardized Patient Encounters and Patient Notes From a Multisite Study of Clinical Performance Examinations in Seven Medical Schools.

PubMed

Park, Yoon Soo; Hyderi, Abbas; Heine, Nancy; May, Win; Nevins, Andrew; Lee, Ming; Bordage, Georges; Yudkowsky, Rachel

2017-11-01

To examine validity evidence of local graduation competency examination scores from seven medical schools using shared cases and to provide rater training protocols and guidelines for scoring patient notes (PNs). Between May and August 2016, clinical cases were developed, shared, and administered across seven medical schools (990 students participated). Raters were calibrated using training protocols, and guidelines were developed collaboratively across sites to standardize scoring. Data included scores from standardized patient encounters for history taking, physical examination, and PNs. Descriptive statistics were used to examine scores from the different assessment components. Generalizability studies (G-studies) using variance components were conducted to estimate reliability for composite scores. Validity evidence was collected for response process (rater perception), internal structure (variance components, reliability), relations to other variables (interassessment correlations), and consequences (composite score). Student performance varied by case and task. In the PNs, justification of differential diagnosis was the most discriminating task. G-studies showed that schools accounted for less than 1% of total variance; however, for the PNs, there were differences in scores for varying cases and tasks across schools, indicating a school effect. Composite score reliability was maximized when the PN was weighted between 30% and 40%. Raters preferred using case-specific scoring guidelines with clear point-scoring systems. This multisite study presents validity evidence for PN scores based on scoring rubric and case-specific scoring guidelines that offer rigor and feedback for learners. Variability in PN scores across participating sites may signal different approaches to teaching clinical reasoning among medical schools.

Simultaneous validation of the SunTech CT40 automated blood pressure measurement device by the 1993 British Hypertension Society protocol and the Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2: 2013 standard.

PubMed

Polo Friz, Hernan; Punzi, Veronica; Petri, Francesco; Orlandi, Riccardo; Maggiolini, Daniele; Polo Friz, Melisa; Primitz, Laura; Vighi, Giuseppe

2017-10-01

This study aimed to perform a simultaneous, third-party, independent validation of the oscillometric SunTech CT40 device for blood pressure (BP) measurement, according to the 1993 protocol of the British Hypertension Society and the standard of the Association for the Advancement of Medical Instrumentation (AAMI)/the International Organization for Standardization (ISO) 81060-2:2013. Patient recruitment, study procedures, and data analysis followed the recommendations stated by the protocols. The study was approved by the institutional review board. A total of 94 participants were included, 52 (55.3%) women, mean±SD age: 63.1±18.0 years, mean±SD arm circumference: 35.0±9.0 cm. The average of observers' entry BPs was 146.9±37.2 mmHg for systolic blood pressure (SBP) and 82.2±22.1 mmHg for diastolic blood pressure (DBP). Differences between the standard measurement and the test device within 5, 10, and 15 mmHg, for the better observer, were 79.4, 96.5, and 100.0% for SBP and 82.6, 97.5, and 100.0% for DBP, respectively. The mean±SD differences between the readings obtained using the test device and those obtained by the observers (AAMI/ISO 81060-2:2013 standard criterion 1) were 0.3±5.0 mmHg (SBP) and -0.8±4.3 mmHg (DBP), and the mean±SD differences between average of reference readings and average of test device readings in each patient (criterion 2) were 0.3±3.9 and -0.8±3.5 mmHg for SBP and DBP, respectively. The CT40 BP device achieved A/A grade of the British Hypertension Society protocol and fulfilled the requirements (criteria 1 and 2) of the AAMI/ISO standard. CT40 can be recommended for BP measurement in adults.

Causation and Validation of Nursing Diagnoses: A Middle Range Theory.

PubMed

de Oliveira Lopes, Marcos Venícios; da Silva, Viviane Martins; Herdman, T Heather

2017-01-01

To describe a predictive middle range theory (MRT) that provides a process for validation and incorporation of nursing diagnoses in clinical practice. Literature review. The MRT includes definitions, a pictorial scheme, propositions, causal relationships, and translation to nursing practice. The MRT can be a useful alternative for education, research, and translation of this knowledge into practice. This MRT can assist clinicians in understanding clinical reasoning, based on temporal logic and spectral interaction among elements of nursing classifications. In turn, this understanding will improve the use and accuracy of nursing diagnosis, which is a critical component of the nursing process that forms a basis for nursing practice standards worldwide. © 2015 NANDA International, Inc.

Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols.

PubMed

Reveiz, Ludovic; Haby, Michelle M; Martínez-Vega, Ruth; Pinzón-Flores, Carlos E; Elias, Vanessa; Smith, Emma; Pinart, Mariona; Broutet, Nathalie; Becerra-Posada, Francisco; Aldighieri, Sylvain; Van Kerkhove, Maria D

2017-01-01

Given the severity and impact of the current Zika virus (ZIKV) outbreak in the Americas, numerous countries have rushed to develop research studies to assess ZIKV and its potential health consequences. In an effort to ensure that studies are comprehensive, both internally and externally valid, and with reliable results, the World Health Organization, the Pan American Health Organization, Institut Pasteur, the networks of Fiocruz, the Consortia for the Standardization of Influenza Seroepidemiology (CONSISE) and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) have generated six standardized clinical and epidemiological research protocols and questionnaires to address key public health questions on ZIKV. We conducted a systematic search of ongoing study protocols related to ZIKV research. We analyzed the content of protocols of 32 cohort studies and 13 case control studies for systematic bias that could produce erroneous results. Additionally we aimed to characterize the risks of bias and confounding in observational studies related to ZIKV and to propose ways to minimize them, including the use of six newly standardized research protocols. Observational studies of ZIKV face an array of challenges, including measurement of exposure and outcomes (microcephaly and Guillain-Barré Syndrome). Potential confounders need to be measured where known and controlled for in the analysis. Selection bias due to non-random selection is a significant issue, particularly in the case-control design, and losses to follow-up is equally important for the cohort design. Observational research seeking to answer key questions on the ZIKV should consider these restrictions and take precautions to minimize bias in an effort to provide reliable and valid results. Utilization of the standardized research protocols developed by the WHO, PAHO, Institut Pasteur, and CONSISE will harmonize the key methodological aspects of each study design to minimize bias at different stages of the study. Biases need to be considered by researchers implementing the standardized protocols as well as by users of observational epidemiological studies of ZIKV.

Validated LC–MS-MS Method for Multiresidual Analysis of 13 Illicit Phenethylamines in Amniotic Fluid

PubMed Central

Burrai, Lucia; Nieddu, Maria; Carta, Antonio; Trignano, Claudia; Sanna, Raimonda; Boatto, Gianpiero

2016-01-01

A multi-residue analytical method was developed for the determination in amniotic fluid (AF) of 13 illicit phenethylamines, including 12 compounds never investigated in this matrix before. Samples were subject to solid-phase extraction using; hydrophilic–lipophilic balance cartridges which gave good recoveries and low matrix effects on analysis of the extracts. The quantification was performed by liquid chromatography electrospray tandem mass spectrometry. The water–acetonitrile mobile phase containing 0.1% formic acid, used with a C18 reversed phase column, provided adequate separation, resolution and signal-to-noise ratio for the analytes and the internal standard. The final optimized method was validated according to international guidelines. A monitoring campaign to assess fetal exposure to these 13 substances of abuse has been performed on AF test samples obtained from pregnant women. All mothers (n = 194) reported no use of drugs of abuse during pregnancy, and this was confirmed by the analytical data. PMID:26755540

Validity and reliability of the Dutch version of the Copenhagen Hip And Groin Outcome Score (HAGOS-NL) in patients with hip pathology.

PubMed

Giezen, Hilde; Stevens, Martin; van den Akker-Scheek, Inge; Reininga, Inge H F

2017-01-01

The Copenhagen Hip And Groin Outcome Score (HAGOS) was developed to assess disease-specific consequences in young to middle-aged, physically active hip and/or groin patients. The study aimed to determine validity and reliability of the Dutch version of the HAGOS (HAGOS-NL) for middle-aged patients with hip complaints. To assess validity, 117 participants completed five questionnaires: HAGOS-NL, international Hip Outcome Tool (iHOT-12NL), Hip disability and Osteoarthritis Outcome Score (HOOS), RAND-36 Health Survey and Tegner activity scale. Structural validity was determined by conducting confirmatory factor analysis. Construct validity was analyzed by formulating predefined hypotheses regarding relationships between the HAGOS-NL and subscales of the iHOT-12NL, HOOS, RAND-36 and Tegner activity scale. The HAGOS-NL was filled out again by 67 patients to explore test-retest reliability. Reliability was assessed in terms of Cronbach's alpha, Intraclass Correlation Coefficient (ICC), Standard Error of Measurement (SEM) and Minimal Detectable Change (MDC). The Bland and Altman method was used to explore absolute agreement. Factor analysis confirmed that the HAGOS-NL consists of six subscales. All hypotheses were confirmed, indicating good construct validity. Internal consistency was good, with Cronbach's alpha values ranging from 0.89 to 0.98. Test-retest reliability was considered good, with ICC values of 0.80 and higher. The SEM ranged from 6.6 to 12.3, and MDC at individual level from 18.3 to 34.1 and at group level from 2.3 to 4.4. Bland and Altman analyses showed no bias. The HAGOS-NL is a reliable and valid instrument for measuring pain, physical functioning and quality of life in middle-aged patients with hip complaints.

Measurement Properties of the Persian Translated Version of Graves Orbitopathy Quality of Life Questionnaire: A Validation Study.

PubMed

Kashkouli, Mohsen Bahmani; Karimi, Nasser; Aghamirsalim, Mohamadreza; Abtahi, Mohammad Bagher; Nojomi, Marzieh; Shahrad-Bejestani, Hadi; Salehi, Masoud

2017-02-01

To determine the measurement properties of the Persian language version of the Graves orbitopathy quality of life questionnaire (GO-QOL). Following a systematic translation and cultural adaptation process, 141 consecutive unselected thyroid eye disease (TED) patients answered the Persian GO-QOL and underwent complete ophthalmic examination. The questionnaire was again completed by 60 patients on the second visit, 2-4 weeks later. Construct validity (cross-cultural validity, structural validity and hypotheses testing), reliability (internal consistency and test-retest reliability), and floor and ceiling effects of the Persian version of the GO-QOL were evaluated. Furthermore, Rasch analysis was used to assess its psychometric properties. Cross-cultural validity was established by back-translation techniques, committee review and pretesting techniques. Bi-dimensionality of the questionnaire was confirmed by factor analysis. Construct validity was also supported through confirmation of 6 out of 8 predefined hypotheses. Cronbach's α and intraclass correlation coefficient (ICC) were 0.650 and 0.859 for visual functioning and 0.875 and 0.896 for appearance subscale, respectively. Mean quality of life (QOL) scores for visual functioning and appearance were 78.18 (standard deviation, SD, 21.57) and 56.25 (SD 26.87), respectively. Person reliabilities from the Rasch rating scale model for both visual functioning and appearance revealed an acceptable internal consistency for the Persian GO-QOL. The Persian GO-QOL questionnaire is a valid and reliable tool with good psychometric properties in evaluation of Persian-speaking patients with TED. Applying Rasch analysis to future versions of the GO-QOL is recommended in order to perform tests for linearity between the estimated item measures in different versions.

Patient-reported outcome instruments that evaluate adherence behaviours in adults with asthma: A systematic review of measurement properties.

PubMed

Gagné, Myriam; Boulet, Louis-Philippe; Pérez, Norma; Moisan, Jocelyne

2018-04-30

To systematically identify the measurement properties of patient-reported outcome instruments (PROs) that evaluate adherence to inhaled maintenance medication in adults with asthma. We conducted a systematic review of six databases. Two reviewers independently included studies on the measurement properties of PROs that evaluated adherence in asthmatic participants aged ≥18 years. Based on the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), the reviewers (1) extracted data on internal consistency, reliability, measurement error, content validity, structural validity, hypotheses testing, cross-cultural validity, criterion validity, and responsiveness; (2) assessed the methodological quality of the included studies; (3) assessed the quality of the measurement properties (positive or negative); and (4) summarised the level of evidence (limited, moderate, or strong). We screened 6,068 records and included 15 studies (14 PROs). No studies evaluated measurement error or responsiveness. Based on methodological and measurement property quality assessments, we found limited positive evidence of: (a) internal consistency of the Adherence Questionnaire, Refined Medication Adherence Reason Scale (MAR-Scale), Medication Adherence Report Scale for Asthma (MARS-A), and Test of the Adherence to Inhalers (TAI); (b) reliability of the TAI; and (c) structural validity of the Adherence Questionnaire, MAR-Scale, MARS-A, and TAI. We also found limited negative evidence of: (d) hypotheses testing of Adherence Questionnaire; (e) reliability of the MARS-A; and (f) criterion validity of the MARS-A and TAI. Our results highlighted the need to conduct further high-quality studies that will positively evaluate the reliability, validity, and responsiveness of the available PROs. This article is protected by copyright. All rights reserved.

Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema (Lymph-ICF-LL): reliability and validity.

PubMed

Devoogdt, Nele; De Groef, An; Hendrickx, Ad; Damstra, Robert; Christiaansen, Anke; Geraerts, Inge; Vervloesem, Nele; Vergote, Ignace; Van Kampen, Marijke

2014-05-01

Patients may develop primary (congenital) or secondary (acquired) lymphedema, causing significant physical and psychosocial problems. To plan treatment for lymphedema and monitor a patient's progress, swelling, and problems in functioning associated with lymphedema development should be assessed at baseline and follow-up. The purpose of this study was to investigate the reliability (test-retest, internal consistency, and measurement variability) and validity (content and construct) of data obtained with the Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema (Lymph-ICF-LL). This was a multicenter, cross-sectional study. The Lymph-ICF-LL is a descriptive, evaluative tool containing 28 questions about impairments in function, activity limitations, and participation restrictions in patients with lower limb lymphedema. The questionnaire has 5 domains: physical function, mental function, general tasks/household activities, mobility activities, and life domains/social life. The reliability and validity of the Lymph-ICF-LL were examined in 30 participants with objective lower limb lymphedema. Intraclass correlation coefficients for test-retest reliability ranged from .69 to .94, and Cronbach alpha coefficients for internal consistency ranged from .82 to .97. Measurement variability was acceptable (standard error of measurement=5.9-12.6). Content validity was good because all questions were understandable for 93% of participants, the scoring system (visual analog scale) was clear, and the questionnaire was comprehensive for 90% of participants. Construct validity was good. All hypotheses for assessing convergent validity and divergent validity were accepted. The known-groups validity and responsiveness of the Dutch Lymph-ICF-LL and the cross-cultural validity of the English version of the Lymph-ICF-LL were not investigated. The Lymph-ICF-LL is a Dutch questionnaire with evidence of reliability and validity for assessing impairments in function, activity limitations, and participation restrictions in people with primary or secondary lower limb lymphedema.

Improved quality monitoring of multi-center acupuncture clinical trials in China

PubMed Central

2009-01-01

Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs). Methods A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture. PMID:20035630

Big Data in Designing Clinical Trials: Opportunities and Challenges

PubMed Central

Mayo, Charles S.; Matuszak, Martha M.; Schipper, Matthew J.; Jolly, Shruti; Hayman, James A.; Ten Haken, Randall K.

2017-01-01

Emergence of big data analytics resource systems (BDARSs) as a part of routine practice in Radiation Oncology is on the horizon. Gradually, individual researchers, vendors, and professional societies are leading initiatives to create and demonstrate use of automated systems. What are the implications for design of clinical trials, as these systems emerge? Gold standard, randomized controlled trials (RCTs) have high internal validity for the patients and settings fitting constraints of the trial, but also have limitations including: reproducibility, generalizability to routine practice, infrequent external validation, selection bias, characterization of confounding factors, ethics, and use for rare events. BDARS present opportunities to augment and extend RCTs. Preliminary modeling using single- and muti-institutional BDARS may lead to better design and less cost. Standardizations in data elements, clinical processes, and nomenclatures used to decrease variability and increase veracity needed for automation and multi-institutional data pooling in BDARS also support ability to add clinical validation phases to clinical trial design and increase participation. However, volume and variety in BDARS present other technical, policy, and conceptual challenges including applicable statistical concepts, cloud-based technologies. In this summary, we will examine both the opportunities and the challenges for use of big data in design of clinical trials. PMID:28913177

Big Data in Designing Clinical Trials: Opportunities and Challenges.

PubMed

Mayo, Charles S; Matuszak, Martha M; Schipper, Matthew J; Jolly, Shruti; Hayman, James A; Ten Haken, Randall K

2017-01-01

Emergence of big data analytics resource systems (BDARSs) as a part of routine practice in Radiation Oncology is on the horizon. Gradually, individual researchers, vendors, and professional societies are leading initiatives to create and demonstrate use of automated systems. What are the implications for design of clinical trials, as these systems emerge? Gold standard, randomized controlled trials (RCTs) have high internal validity for the patients and settings fitting constraints of the trial, but also have limitations including: reproducibility, generalizability to routine practice, infrequent external validation, selection bias, characterization of confounding factors, ethics, and use for rare events. BDARS present opportunities to augment and extend RCTs. Preliminary modeling using single- and muti-institutional BDARS may lead to better design and less cost. Standardizations in data elements, clinical processes, and nomenclatures used to decrease variability and increase veracity needed for automation and multi-institutional data pooling in BDARS also support ability to add clinical validation phases to clinical trial design and increase participation. However, volume and variety in BDARS present other technical, policy, and conceptual challenges including applicable statistical concepts, cloud-based technologies. In this summary, we will examine both the opportunities and the challenges for use of big data in design of clinical trials.

Interns' compliance with accreditation council for graduate medical education work-hour limits.

PubMed

Landrigan, Christopher P; Barger, Laura K; Cade, Brian E; Ayas, Najib T; Czeisler, Charles A

2006-09-06

Sleep deprivation is associated with increased risk of serious medical errors and motor vehicle crashes among interns. The Accreditation Council for Graduate Medical Education (ACGME) introduced duty-hour standards in 2003 to reduce work hours. To estimate compliance with the ACGME duty-hour standards among interns. National prospective cohort study with monthly Web-based survey assessment of intern work and sleep hours using a validated instrument, conducted preimplementation (July 2002 through May 2003) and postimplementation (July 2003 through May 2004) of ACGME standards. Participants were 4015 of the approximately 37 253 interns in US residency programs in all specialties during this time; they completed 29 477 reports of their work and sleep hours. Overall and monthly rates of compliance with the ACGME standards. Postimplementation, 1068 (83.6%; 95% confidence interval [CI], 81.4%-85.5%) of 1278 of interns reported work hours in violation of the standards during 1 or more months. Working shifts greater than 30 consecutive hours was reported by 67.4% (95% CI, 64.8%-70.0%). Averaged over 4 weeks, 43.0% (95% CI, 40.3%-45.7%) reported working more than 80 hours weekly, and 43.7% (95% CI, 41.0%-46.5%) reported not having 1 day in 7 off work duties. Violations were reported during 3765 (44.0%; 95% CI, 43.0%-45.1%) of the 8553 intern-months assessed postimplementation (including vacation and ambulatory rotations), and during 2660 (61.5%; 95% CI, 60.0%-62.9%) of 4327 intern-months during which interns worked exclusively in inpatient settings. Postimplementation, 29.0% (95% CI, 28.7%-29.7%) of reported work weeks were more than 80 hours per week, 12.1% (95% CI, 11.8%-12.6%) were 90 or more hours per week, and 3.9% (95% CI, 3.7%-4.2%) were 100 or more hours per week. Comparing preimplementation to postimplementation responses, reported mean work duration decreased 5.8% from 70.7 (95% CI, 70.5-70.9) hours to 66.6 (95% CI, 66.3-66.9) hours per week (P<.001), and reported mean sleep duration increased 6.1% (22 minutes) from 5.91 (95% CI, 5.88-5.94) hours to 6.27 (95% CI, 6.23-6.31) hours per night (P<.001). However, reported mean sleep during extended shifts decreased 4.5%, from 2.69 (95% CI, 2.66-2.73) hours to 2.57 (95% CI, 2.52-2.62) hours (P<.001). In the first year following implementation of the ACGME duty-hour standards, interns commonly reported noncompliance with these requirements.

Validation of the A&D BP UA-651 device for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Benetti, Elisabetta; Fania, Claudio; Palatini, Paolo

2014-02-01

The objective of this study was to determine the accuracy of the A&D BP UA-651 device for home blood pressure (BP) measurement according to the International Protocol of the European Society of Hypertension. Device evaluation was carried out in 33 patients. The mean age of the patients was 48.3±15.5 years, the mean systolic BP was 138.3±24.9 mmHg (range 90-180), the mean diastolic BP was 88.3±13.8 mmHg (range 60-108), and the mean arm circumference was 28.6±3.4 cm (range 23-36). The protocol requirements were followed precisely. The device passed all requirements, fulfilling the standards of the protocol. On average, the device underestimated the systolic BP by 0.4±4.4 mmHg and diastolic BP by 1.3±3.5 mmHg. The device-observer discrepancies were unrelated to patients' clinical characteristics. These data show that the A&D BP UA-651 device fulfilled the requirements for validation by the International Protocol and can be recommended for clinical use in the adult population.

Development and validation of a high throughput assay for the quantification of multiple green tea-derived catechins in human plasma.

PubMed

Mawson, Deborah H; Jeffrey, Keon L; Teale, Philip; Grace, Philip B

2018-06-19

A rapid, accurate and robust method for the determination of catechin (C), epicatechin (EC), gallocatechin (GC), epigallocatechin (EGC), catechin gallate (Cg), epicatechin gallate (ECg), gallocatechin gallate (GCg) and epigallocatechin gallate (EGCg) concentrations in human plasma has been developed. The method utilises protein precipitation following enzyme hydrolysis, with chromatographic separation and detection using reversed-phase liquid chromatography - tandem mass spectrometry (LC-MS/MS). Traditional issues such as lengthy chromatographic run times, sample and extract stability, and lack of suitable internal standards have been addressed. The method has been evaluated using a comprehensive validation procedure, confirming linearity over appropriate concentration ranges, and inter/intra batch precision and accuracies within suitable thresholds (precisions within 13.8% and accuracies within 12.4%). Recoveries of analytes were found to be consistent between different matrix samples, compensated for using suitable internal markers and within the performance of the instrumentation used. Similarly, chromatographic interferences have been corrected using the internal markers selected. Stability of all analytes in matrix is demonstrated over 32 days and throughout extraction conditions. This method is suitable for high throughput sample analysis studies. This article is protected by copyright. All rights reserved.

Fully Automated Quantification of Cytomegalovirus (CMV) in Whole Blood with the New Sensitive Abbott RealTime CMV Assay in the Era of the CMV International Standard

PubMed Central

Schnepf, Nathalie; Scieux, Catherine; Resche-Riggon, Matthieu; Feghoul, Linda; Xhaard, Alienor; Gallien, Sébastien; Molina, Jean-Michel; Socié, Gérard; Viglietti, Denis; Simon, François; Mazeron, Marie-Christine

2013-01-01

Fully standardized reproducible and sensitive quantification assays for cytomegalovirus (CMV) are needed to better define thresholds for antiviral therapy initiation and interruption. We evaluated the newly released Abbott RealTime CMV assay for CMV quantification in whole blood (WB) that includes automated extraction and amplification (m2000 RealTime system). Sensitivity, accuracy, linearity, and intra- and interassay variability were validated in a WB matrix using Quality Control for Molecular Diagnostics (QCMD) panels and the WHO international standard (IS). The intra- and interassay coefficients of variation were 1.37% and 2.09% at 5 log10 copies/ml and 2.41% and 3.80% at 3 log10 copies/ml, respectively. According to expected values for the QCMD and Abbott RealTime CMV methods, the lower limits of quantification were 104 and <50 copies/ml, respectively. The conversion factor between international units and copies (2.18), determined from serial dilutions of the WHO IS in WB, was significantly different from the factor provided by the manufacturer (1.56) (P = 0.001). Results from 302 clinical samples were compared with those from the Qiagen artus CMV assay on the same m2000 RealTime system. The two assays provided highly concordant results (concordance correlation coefficient, 0.92), but the Abbott RealTime CMV assay detected and quantified, respectively, 20.6% and 47.8% more samples than the Qiagen/artus CMV assay. The sensitivity and reproducibility of the results, along with the automation, fulfilled the quality requirements for implementation of the Abbott RealTime CMV assay in clinical settings. Our results highlight the need for careful validation of conversion factors provided by the manufacturers for the WHO IS in WB to allow future comparison of results obtained with different assays. PMID:23616450

The new agreement of the international RIGA consensus conference on nasal airway function tests.

PubMed

Vogt, K; Bachmann-Harildstad, G; Lintermann, A; Nechyporenko, A; Peters, F; Wernecke, K D

2018-01-21

The report reflects an agreement based on the consensus conference of the International Standardization Committee on the Objective Assessment of the Nasal Airway in Riga, 2nd Nov. 2016. The aim of the conference was to address the existing nasal airway function tests and to take into account physical, mathematical and technical correctness as a base of international standardization as well as the requirements of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Rhinomanometry, acoustic rhinometry, peak nasal inspiratory flow, Odiosoft-Rhino, optical rhinometry, 24-h measurements, computational fluid dynamics, nasometry and the mirrow test were evaluated for important diagnostic criteria, which are the precision of the equipment including calibration and the software applied; validity with sensitivity, specificity, positive and negative predictive values, reliability with intra-individual and inter-individual reproducibility and responsiveness in clinical studies. For rhinomanometry, the logarithmic effective resistance was set as the parameter of high diagnostic relevance. In acoustic rhinometry, the area of interest for the minimal cross-sectional area will need further standardization. Peak nasal inspiratory flow is a reproducible and fast test, which showed a high range of mean values in different studies. The state of the art with computational fluid dynamics for the simulation of the airway still depends on high performance computing hardware and will, after standardization of the software and both the software and hardware for imaging protocols, certainly deliver a better understanding of the nasal airway flux.

Validation of standard ASTM F2732 and comparison with ISO 11079 with respect to comfort temperature ratings for cold protective clothing.

PubMed

Gao, Chuansi; Lin, Li-Yen; Halder, Amitava; Kuklane, Kalev; Holmér, Ingvar

2015-01-01

American standard ASTM F2732 estimates the lowest environmental temperature for thermal comfort for cold weather protective clothing. International standard ISO 11079 serves the same purpose but expresses cold stress in terms of required clothing insulation for a given cold climate. The objective of this study was to validate and compare the temperature ratings using human subject tests at two levels of metabolic rates (2 and 4 MET corresponding to 116.4 and 232.8 W/m(2)). Nine young and healthy male subjects participated in the cold exposure at 3.4 and -30.6 °C. The results showed that both standards predict similar temperature ratings for an intrinsic clothing insulation of 1.89 clo and for 2 MET activity. The predicted temperature rating for 2 MET activity is consistent with test subjects' thermophysiological responses, perceived thermal sensation and thermal comfort. For 4 MET activity, however, the whole body responses were on the cold side, particularly the responses of the extremities. ASTM F2732 is also limited due to its omission and simplification of three climatic variables (air velocity, radiant temperature and relative humidity) and exposure time in the cold which are of practical importance. Copyright © 2014 Elsevier Ltd and The Ergonomics Society. All rights reserved.

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

PubMed

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

2014-03-01

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

Development, validation, and implementation of a patient-specific Monte Carlo 3D internal dosimetry platform

NASA Astrophysics Data System (ADS)

Besemer, Abigail E.

Targeted radionuclide therapy is emerging as an attractive treatment option for a broad spectrum of tumor types because it has the potential to simultaneously eradicate both the primary tumor site as well as the metastatic disease throughout the body. Patient-specific absorbed dose calculations for radionuclide therapies are important for reducing the risk of normal tissue complications and optimizing tumor response. However, the only FDA approved software for internal dosimetry calculates doses based on the MIRD methodology which estimates mean organ doses using activity-to-dose scaling factors tabulated from standard phantom geometries. Despite the improved dosimetric accuracy afforded by direct Monte Carlo dosimetry methods these methods are not widely used in routine clinical practice because of the complexity of implementation, lack of relevant standard protocols, and longer dose calculation times. The main goal of this work was to develop a Monte Carlo internal dosimetry platform in order to (1) calculate patient-specific voxelized dose distributions in a clinically feasible time frame, (2) examine and quantify the dosimetric impact of various parameters and methodologies used in 3D internal dosimetry methods, and (3) develop a multi-criteria treatment planning optimization framework for multi-radiopharmaceutical combination therapies. This platform utilizes serial PET/CT or SPECT/CT images to calculate voxelized 3D internal dose distributions with the Monte Carlo code Geant4. Dosimetry can be computed for any diagnostic or therapeutic radiopharmaceutical and for both pre-clinical and clinical applications. In this work, the platform's dosimetry calculations were successfully validated against previously published reference doses values calculated in standard phantoms for a variety of radionuclides, over a wide range of photon and electron energies, and for many different organs and tumor sizes. Retrospective dosimetry was also calculated for various pre-clinical and clinical patients and large dosimetric differences resulted when using conventional organ-level methods and the patient-specific voxelized methods described in this work. The dosimetric impact of various steps in the 3D voxelized dosimetry process were evaluated including quantitative imaging acquisition, image coregistration, voxel resampling, ROI contouring, CT-based material segmentation, and pharmacokinetic fitting. Finally, a multi-objective treatment planning optimization framework was developed for multi-radiopharmaceutical combination therapies.

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

PubMed

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

2013-11-01

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

Development and validation of a stability-indicating gas chromatographic method for quality control of residual solvents in blonanserin: a novel atypical antipsychotic agent.

PubMed

Peng, Ming; Liu, Jin; Lu, Dan; Yang, Yong-Jian

2012-09-01

Blonanserin is a novel atypical antipsychotic agent for the treatment of schizophrenia. Ethyl alcohol, isopropyl alcohol and toluene are utilized in the synthesis route of this bulk drug. A new validated gas chromatographic (GC) method for the simultaneous determination of residual solvents in blonanserin is described in this paper. Blonanserin was dissolved in N, N-dimethylformamide to make a sample solution that was directly injected into a DB-624 column. A postrun oven temperature at 240°C for approximately 2 h after the analysis cycle was performed to wash out blonanserin residue in the GC column. Quantitation was performed by external standard analyses and the validation was carried out according to International Conference on Harmonization validation guidelines Q2A and Q2B. The method was shown to be specific (no interference in the blank solution), linear (correlation coefficients ≥0.99998, n = 10), accurate (average recoveries between 94.1 and 101.7%), precise (intra-day and inter-day precision ≤2.6%), sensitive (limit of detection ≤0.2 ng, and limit of quantitation ≤0.7 ng), robust (small variations of carrier gas flow, initial oven temperature, temperature ramping rate, injector and detector temperatures did not significantly affect the system suitability test parameters and peak areas) and stable (reference standard and sample solutions were stable over 48 h). This extensively validated method is ready to be used for the quality control of blonanserin.

Concurrent validation of a neurocognitive assessment protocol for clients with mental illness in job matching as shop sales in supported employment.

PubMed

Ng, S S W; Lak, D C C; Lee, S C K; Ng, P P K

2015-03-01

Occupational therapists play a major role in the assessment and referral of clients with severe mental illness for supported employment. Nonetheless, there is scarce literature about the content and predictive validity of the process. In addition, the criteria of successful job matching have not been analysed and job supervisors have relied on experience rather than objective standards in recruitment. This study aimed to explore the profile of successful clients working in 'shop sales' in a supportive environment using a neurocognitive assessment protocol, and to validate the protocol against 'internal standards' of the job supervisors. This was a concurrent validation study of criterion-related scales for a single job type. The subjective ratings from the supervisors were concurrently validated against the results of neurocognitive assessment of intellectual function and work-related cognitive behaviour. A regression model was established for clients who succeeded and failed in employment using supervisor's ratings and a cutoff value of 10.5 for the Performance Fitness Rating Scale (R(2) = 0.918, F[41] = 3.794, p = 0.003). Classification And Regression Tree was also plotted to identify the profile of cases, with an overall accuracy of 0.861 (relative error, 0.26). Use of both inference statistics and data mining techniques enables the decision tree of neurocognitive assessments to be more readily applied by therapists in vocational rehabilitation, and thus directly improve the efficiency and efficacy of the process.

Development of a Research Participants’ Perception Survey to Improve Clinical Research

PubMed Central

Yessis, Jennifer L.; Kost, Rhonda G.; Lee, Laura M.; Coller, Barry S.; Henderson, David K.

2012-01-01

Abstract Introduction: Clinical research participants’ perceptions regarding their experiences during research protocols provide outcome‐based insights into the effectiveness of efforts to protect rights and safety, and opportunities to enhance participants’ clinical research experiences. Use of validated surveys measuring patient‐centered outcomes is standard in hospitals, yet no instruments exist to assess outcomes of clinical research processes. Methods: We derived survey questions from data obtained from focus groups comprised of research participants and professionals. We assessed the survey for face/content validity, and privacy/confidentiality protections and fielded it to research participants at 15 centers. We conducted analyses of response rates, sample characteristics, and psychometrics, including survey and item completion and analysis, internal consistency, item internal consistency, criterion‐related validity, and item usefulness. Responses were tested for fit into existing patient‐centered dimensions of care and new clinical research dimensions using Cronbach's alpha coefficient. Results: Surveys were mailed to 18,890 individuals; 4,961 were returned (29%). Survey completion was 89% overall; completion rates exceeded 90% for 88 of 93 evaluable items. Questions fit into three dimensions of patient‐centered care and two novel clinical research dimensions (Cronbach's alpha for dimensions: 0.69–0.85). Conclusions: The validated survey offers a new method for assessing and improving outcomes of clinical research processes. Clin Trans Sci 2012; Volume 5: 452–460 PMID:23253666

Assessment of reliability, validity, responsiveness and minimally important change of the German Hip dysfunction and osteoarthritis outcome score (HOOS) in patients with osteoarthritis of the hip.

PubMed

Arbab, Dariusch; van Ochten, Johannes H M; Schnurr, Christoph; Bouillon, Bertil; König, Dietmar

2017-12-01

Patient-reported outcome measures are a critical tool in evaluating the efficacy of orthopedic procedures. The intention of this study was to evaluate reliability, validity, responsiveness and minimally important change of the German version of the Hip dysfunction and osteoarthritis outcome score (HOOS). The German HOOS was investigated in 251 consecutive patients before and 6 months after total hip arthroplasty. All patients completed HOOS, Oxford-Hip Score, Short-Form (SF-36) and numeric scales for pain and disability. Test-retest reliability, internal consistency, floor and ceiling effects, construct validity and minimal important change were analyzed. The German HOOS demonstrated excellent test-retest reliability with intraclass correlation coefficient values > 0.7. Cronbach´s alpha values demonstrated strong internal consistency. As hypothesized, HOOS subscales strongly correlated with corresponding OHS and SF-36 domains. All subscales showed excellent (effect size/standardized response means > 0.8) responsiveness between preoperative assessment and postoperative follow-up. The HOOS and all subdomains showed higher changes than the minimal detectable change which indicates true changes. The German version of the HOOS demonstrated good psychometric properties. It proved to be valid, reliable and responsive to the changes instrument for use in patients with hip osteoarthritis undergoing total hip replacement.

Reliability and validity of the Turkish version of the situational self-efficacy scale for fruit and vegetable consumption in adolescents.

PubMed

Kadioglu, Hasibe; Erol, Saime; Ergun, Ayse

2015-01-01

The purpose of this research was to examine the psychometric properties of the Turkish version of the situational self-efficacy scale for vegetable and fruit consumption in adolescents. This was a methodological study. The study was conducted in four public secondary schools in Istanbul, Turkey. Subjects were 1586 adolescents. Content and construct validity were assessed to test the validity of the scale. The reliability was assessed in terms of internal consistency and test-retest reliability. For confirmatory factor analysis, χ(2) statistics plus other fit indices were used, including the goodness-of-fit index, the adjusted goodness-of-fit index, the nonnormed fit index, the comparative fit index, the standardized root mean residual, and the root mean square error of approximation. Pearson's correlation was used for test-retest reliability and item total correlation. The internal consistency was assessed by using Cronbach α. Confirmatory factor analysis strongly supported the three-component structure representing positive social situations (α = .81), negative effect situations (α = .93), and difficult situations (α = .78). Psychometric analyses of the Turkish version of the situational self-efficacy scale indicate high reliability and good content and construct validity. Researchers and health professionals will find it useful to employ the Turkish situational self-efficacy scale in evaluating situational self-efficacy for fruit and vegetable consumption in Turkish adolescents.

Uterine Fibroid Symptom - Quality of Life questionnaire translation and validation into Brazilian Portuguese.

PubMed

Silva, Rita Oliveira da; Gomes, Mariano Tamura Vieira; Castro, Rodrigo de Aquino; Bonduki, Cláudio Emílio; Girão, Manoel João Batista Castello

2016-10-01

Purpose  To translate into Portuguese, culturally adapt and validate the Uterine Fibroid Symptom - Quality of Life (UFS-QoL) questionnaire for Brazilian women with uterine leiomyoma. Methods  Initially, the UFS-QoL questionnaire was translated into Brazilian Portuguese in accordance with international standards, with subsequent cultural, structural, conceptual and semantic adaptations, so that patients were able to properly answer the questionnaire. Fifty patients with uterine leiomyoma and 19 patients without the disease, confirmed by abdominal pelvic examination and/or transvaginal ultrasound, were selected at the outpatient clinics of the Department of Gynecology of the Universidade Federal de São Paulo (Unifesp). The UFS-QoL questionnaire was administered to all women twice on the same day, with two different interviewers, with an interval of 15 minutes between interviews. After 15 days, the questionnaire was re-administered by the first interviewer. Reliability (internal consistency and test-retest), construct and discriminative validity were tested to ratify the questionnaire. Results  The reliability of the instrument was assessed by Cronbach's α coefficient with an overall result of 0.97, indicating high reliability. The survey results showed a high correlation ( p  = 0.94; p  ≤ 0.001). Conclusion  The UFS-QoL questionnaire was successfully adapted to the Brazilian Portuguese language and Brazilian culture, showing reliability and validity. Thieme Publicações Ltda Rio de Janeiro, Brazil.

LC-MS/MS-based approach for obtaining exposure estimates of metabolites in early clinical trials using radioactive metabolites as reference standards.

PubMed

Zhang, Donglu; Raghavan, Nirmala; Chando, Theodore; Gambardella, Janice; Fu, Yunlin; Zhang, Duxi; Unger, Steve E; Humphreys, W Griffith

2007-12-01

An LC-MS/MS-based approach that employs authentic radioactive metabolites as reference standards was developed to estimate metabolite exposures in early drug development studies. This method is useful to estimate metabolite levels in studies done with non-radiolabeled compounds where metabolite standards are not available to allow standard LC-MS/MS assay development. A metabolite mixture obtained from an in vivo source treated with a radiolabeled compound was partially purified, quantified, and spiked into human plasma to provide metabolite standard curves. Metabolites were analyzed by LC-MS/MS using the specific mass transitions and an internal standard. The metabolite concentrations determined by this approach were found to be comparable to those determined by valid LC-MS/MS assays. This approach does not requires synthesis of authentic metabolites or the knowledge of exact structures of metabolites, and therefore should provide a useful method to obtain early estimates of circulating metabolites in early clinical or toxicological studies.

Optimized, Fast-Throughput UHPLC-DAD Based Method for Carotenoid Quantification in Spinach, Serum, Chylomicrons, and Feces.

PubMed

Eriksen, Jane N; Madsen, Pia L; Dragsted, Lars O; Arrigoni, Eva

2017-02-01

An improved UHPLC-DAD-based method was developed and validated for quantification of major carotenoids present in spinach, serum, chylomicrons, and feces. Separation was achieved with gradient elution within 12.5 min for six dietary carotenoids and the internal standard, echinenone. The proposed method provides, for all standard components, resolution > 1.1, linearity covering the target range (R > 0.99), LOQ < 0.035 mg/L, and intraday and interday RSDs < 2 and 10%, respectively. Suitability of the method was tested on biological matrices. Method precision (RSD%) for carotenoid quantification in serum, chylomicrons, and feces was below 10% for intra- and interday analysis, except for lycopene. Method accuracy was consistent with mean recoveries ranging from 78.8 to 96.9% and from 57.2 to 96.9% for all carotenoids, except for lycopene, in serum and feces, respectively. Additionally, an interlaboratory validation study on spinach at two institutions showed no significant differences in lutein or β-carotene content, when evaluated on four occasions.

Multiplex cDNA quantification method that facilitates the standardization of gene expression data

PubMed Central

Gotoh, Osamu; Murakami, Yasufumi; Suyama, Akira

2011-01-01

Microarray-based gene expression measurement is one of the major methods for transcriptome analysis. However, current microarray data are substantially affected by microarray platforms and RNA references because of the microarray method can provide merely the relative amounts of gene expression levels. Therefore, valid comparisons of the microarray data require standardized platforms, internal and/or external controls and complicated normalizations. These requirements impose limitations on the extensive comparison of gene expression data. Here, we report an effective approach to removing the unfavorable limitations by measuring the absolute amounts of gene expression levels on common DNA microarrays. We have developed a multiplex cDNA quantification method called GEP-DEAN (Gene expression profiling by DCN-encoding-based analysis). The method was validated by using chemically synthesized DNA strands of known quantities and cDNA samples prepared from mouse liver, demonstrating that the absolute amounts of cDNA strands were successfully measured with a sensitivity of 18 zmol in a highly multiplexed manner in 7 h. PMID:21415008

Method of analysis at the U.S. Geological Survey California Water Science Center, Sacramento Laboratory - determination of haloacetic acid formation potential, method validation, and quality-control practices

USGS Publications Warehouse

Zazzi, Barbara C.; Crepeau, Kathryn L.; Fram, Miranda S.; Bergamaschi, Brian A.

2005-01-01

An analytical method for the determination of haloacetic acid formation potential of water samples has been developed by the U.S. Geological Survey California Water Science Center Sacramento Laboratory. The haloacetic acid formation potential is measured by dosing water samples with chlorine under specified conditions of pH, temperature, incubation time, darkness, and residual-free chlorine. The haloacetic acids formed are bromochloroacetic acid, bromodichloroacetic acid, dibromochloroacetic acid, dibromoacetic acid, dichloroacetic acid, monobromoacetic acid, monochloroacetic acid, tribromoacetic acid, and trichloroacetic acid. They are extracted, methylated, and then analyzed using a gas chromatograph equipped with an electron capture detector. Method validation experiments were performed to determine the method accuracy, precision, and detection limit for each of the compounds. Method detection limits for these nine haloacetic acids ranged from 0.11 to 0.45 microgram per liter. Quality-control practices include the use of blanks, quality-control samples, calibration verification standards, surrogate recovery, internal standard, matrix spikes, and duplicates.

Determination of the neuropharmacological drug nodakenin in rat plasma and brain tissues by liquid chromatography tandem mass spectrometry: Application to pharmacokinetic studies.

PubMed

Song, Yingshi; Yan, Huiyu; Xu, Jingbo; Ma, Hongxi

2017-09-01

A rapid and sensitive liquid chromatography tandem mass spectrometry detection using selected reaction monitoring in positive ionization mode was developed and validated for the quantification of nodakenin in rat plasma and brain. Pareruptorin A was used as internal standard. A single step liquid-liquid extraction was used for plasma and brain sample preparation. The method was validated with respect to selectivity, precision, accuracy, linearity, limit of quantification, recovery, matrix effect and stability. Lower limit of quantification of nodakenin was 2.0 ng/mL in plasma and brain tissue homogenates. Linear calibration curves were obtained over concentration ranges of 2.0-1000 ng/mL in plasma and brain tissue homogenates for nodakenin. Intra-day and inter-day precisions (relative standard deviation, RSD) were <15% in both biological media. This assay was successfully applied to plasma and brain pharmacokinetic studies of nodakenin in rats after intravenous administration. Copyright © 2017 John Wiley & Sons, Ltd.

Development of short-form measures to assess four types of elder mistreatment: Findings from an evidence-based study of APS elder abuse substantiation decisions.

PubMed

Beach, Scott R; Liu, Pi-Ju; DeLiema, Marguerite; Iris, Madelyn; Howe, Melissa J K; Conrad, Kendon J

2017-01-01

Improving the standardization and efficiency of adult protective services (APS) investigations is a top priority in APS practice. Using data from the Elder Abuse Decision Support System (EADSS), we developed short-form measures of four types of elder abuse: financial, emotional/psychological, physical, and neglect. The EADSS data set contains 948 elder abuse cases (age 60+) with yes/no abuse substantiation decisions for each abuse type following a 30-day investigation. Item sensitivity/specificity analyses were conducted on long-form items with the substantiation decision for each abuse type as the criterion. Validity was further tested using receiver-operator characteristic (ROC) curve analysis, correlation with long forms and internal consistency. The four resulting short-form measures, containing 36 of the 82 original items, have validity similar to the original long forms. These short forms can be used to standardize and increase efficiency of APS investigations, and may also offer researchers new options for brief elder abuse assessments.

Development of short-form measures to assess four types of elder mistreatment: Findings from an evidence-based study of APS elder abuse substantiation decisions

PubMed Central

Beach, Scott R.; Liu, Pi-Ju; DeLiema, Marguerite; Iris, Madelyn; Howe, Melissa J.K.; Conrad, Kendon J.

2018-01-01

Improving the standardization and efficiency of adult protective services (APS) investigations is a top priority in APS practice. Using data from the Elder Abuse Decision Support System (EADSS), we developed short-form measures of four types of elder abuse: financial, emotional/psychological, physical, and neglect. The EADSS data set contains 948 elder abuse cases (age 60+) with yes/no abuse substantiation decisions for each abuse type following a 30-day investigation. Item sensitivity/specificity analyses were conducted on long-form items with the substantiation decision for each abuse type as the criterion. Validity was further tested using receiver–operator characteristic (ROC) curve analysis, correlation with long forms and internal consistency. The four resulting short-form measures, containing 36 of the 82 original items, have validity similar to the original long forms. These short forms can be used to standardize and increase efficiency of APS investigations, and may also offer researchers new options for brief elder abuse assessments. PMID:28590799

Development and Validation of the 34-Item Disability Screening Questionnaire (DSQ-34) for Use in Low and Middle Income Countries Epidemiological and Development Surveys

PubMed Central

Trani, Jean-François; Babulal, Ganesh Muneshwar; Bakhshi, Parul

2015-01-01

Background Although 80% of persons with disabilities live in low and middle-income countries, there is still a lack of comprehensive, cross-culturally validated tools to identify persons facing activity limitations and functioning difficulties in these settings. In absence of such a tool, disability estimates vary considerably according to the methodology used, and policies are based on unreliable estimates. Methods and Findings The Disability Screening Questionnaire composed of 27 items (DSQ-27) was initially designed by a group of international experts in survey development and disability in Afghanistan for a national survey. Items were selected based on major domains of activity limitations and functioning difficulties linked to an impairment as defined by the International Classification of Functioning, Disability and Health. Face, content and construct validity, as well as sensitivity and specificity were examined. Based on the results obtained, the tool was subsequently refined and expanded to 34 items, tested and validated in Darfur, Sudan. Internal consistency for the total DSQ-34 using a raw and standardized Cronbach’s Alpha and within each domain using a standardized Cronbach’s Alpha was examined in the Asian context (India and Nepal). Exploratory factor analysis (EFA) using principal axis factoring (PAF) evaluated the lowest number of factors to account for the common variance among the questions in the screen. Test-retest reliability was determined by calculating intraclass correlation (ICC) and inter-rater reliability by calculating the kappa statistic; results were checked using Bland-Altman plots. The DSQ-34 was further tested for standard error of measurement (SEM) and for the minimum detectable change (MDC). Good internal consistency was indicated by Cronbach’s Alpha of 0.83/0.82 for India and 0.76/0.78 for Nepal. We confirmed our assumption for EFA using the Kaiser-Meyer-Olkin measure of sampling well above the accepted cutoff of 0.40 for India (0.82) and Nepal (0.82). The criteria for Bartlett’s test of sphericity were also met for both India (< .001) and Nepal (< .001). Estimates of reliability from the two countries reached acceptable levels of ICC of 0.75 (p<0.001) for India of 0.77 for Nepal (p<0.001) and good strength of agreement for weighted kappa (respectively 0.77 and 0.79). The SEM/MDC was 0.80/2.22 for India and 0.96/2.66 for Nepal indicating a smaller amount of measurement error in the screen. Conclusions In Nepal and India, the DSQ-34 shows strong psychometric properties that indicate that it effectively discriminates between persons with and without disabilities. This instrument can be used in association with other instruments for the purpose of comparing health outcomes of persons with and without disabilities in LMICs. PMID:26630668

Validity of brief screening questionnaires to detect depression in primary care in Ethiopia.

PubMed

Hanlon, Charlotte; Medhin, Girmay; Selamu, Medhin; Breuer, Erica; Worku, Benyam; Hailemariam, Maji; Lund, Crick; Prince, Martin; Fekadu, Abebaw

2015-11-01

Brief depression screening questionnaires may increase detection of depression in primary care settings but there have been few validation studies carried out in typical populations in low-income countries. Cultural validation of the Patient Health Questionnaire (PHQ-9/PHQ-2), the 20-item Self-Reporting Questionnaire (SRQ-20) and the Kessler scales (K6/K10) was carried out in 306 adults consecutively attending primary care facilities in small towns in Ethiopia. To assess criterion validity, the gold standard assessment for presence of Major Depressive Disorder (MDD) was made by Ethiopian psychiatric nurses using the Mini International Neuropsychiatric Interview. The prevalence of gold standard MDD was 5.9%, with irritability more common than depressed mood or anhedonia. The area under the receiver operating characteristic curve indicated good performance of the PHQ-9, SRQ-20, K6 and K10 (0.83-0.85) but only fair for the PHQ-2 (0.78). No cut-off score had acceptable sensitivity combined with adequate positive predictive value. All screening questionnaires were associated with disability and the PHQ-9 and SRQ-20 were associated with higher health service contacts, indicating convergent validity. Construct validity of all scales was indicated by unidimensionality on exploratory factor analysis. Test-retest reliability was not assessed. Brief depression screening questionnaires were found to be valid in primary care in this low-income country. However, these questionnaires do not have immediate applicability in routine clinical settings. Further studies should evaluate utility of indicated screening embedded within health system changes that support MDD detection. Investigation of irritability as a core depression symptom is warranted. Copyright © 2015 Elsevier B.V. All rights reserved.

Principles to Consider in Defining New Directions in Internal Medicine Training and Certification

PubMed Central

Turner, Barbara J; Centor, Robert M; Rosenthal, Gary E

2006-01-01

SGIM endoreses seven principles related to current thinking about internal medicine training: 1) internal medicine requires a full three years of residency training before subspecialization; 2) internal medicine residency programs must dramatically increase support for training in the ambulatory setting and offer equivalent opportunities for training in both inpatient and outpatient medicine; 3) in settings where adequate support and time are devoted to ambulatory training, the third year of residency could offer an opportunity to develop further expertise or mastery in a specific type or setting of care; 4) further certification in specific specialties within internal medicine requires the completion of an approved fellowship program; 5) areas of mastery in internal medicine can be demonstrated through modified board certification and recertification examinations; 6) certification processes throughout internal medicine should focus increasingly on demonstration of clinical competence through adherence to validated standards of care within and across practice settings; and 7) regardless of the setting in which General Internists practice, we should unite to promote the critical role that this specialty serves in patient care. PMID:16637826

Comparative analysis of international standards for the fatigue testing of posterior spinal fixation systems.

PubMed

Villa, Tomaso; La Barbera, Luigi; Galbusera, Fabio

2014-04-01

Preclinical evaluation of the long-term reliability of devices for lumbar fixation is a mandatory activity before they are put into market. The experimental setups are described in two different standards edited by the International Organization for Standardization (ISO) and the American Society for Testing Materials (ASTM), but the evaluation of the suitability of such tests to simulate the actual loading with in vivo situations has never been performed. To calculate through finite element (FE) simulations the stress in the rods of the fixator when subjected to ASTM and ISO standards. To compare the calculated stresses arising in the same fixator once it has been virtually mounted in a physiological environment and loaded with physiological forces and moments. FE simulations and validation experimental tests. FE models of the ISO and ASTM setups were created to conduct simulations of the tests prescribed by standards and calculate stresses in the rods. Validation of the simulations were performed through experimental tests; the same fixator was virtually mounted in an L2-L4 FE model of the lumbar spine and stresses in the rods were calculated when the spine was subjected to physiological forces and moments. The comparison between FE simulations and experimental tests showed good agreement between results obtained using the two methodologies, thus confirming the suitability of the FE method to evaluate stresses in the device in different loading situations. The usage of a physiological load with ASTM standard is impossible due to the extreme severity of the ASTM configuration; in this circumstance, the presence of an anterior support is suggested. Also, ISO prescriptions, although the choice of the setup correctly simulates the mechanical contribution of the discs, seem to overstress the device as compared with a physiological loading condition. Some daily activities, other than walking, can induce a further state of stress in the device that should be taken into account in setting up new experimental procedures. ISO standard loading prescriptions seems to be more severe than the expected physiological ones. The ASTM standard should be completed by including some anterior supporting device and declaring the value of the load to be imposed. Moreover, a further enhancement of standards would be simulating other movements representative of daily activities different from walking. Copyright © 2014 Elsevier Inc. All rights reserved.

Design and validation of standardized clinical and functional remission criteria in schizophrenia

PubMed Central

Mosolov, Sergey N; Potapov, Andrey V; Ushakov, Uriy V; Shafarenko, Aleksey A; Kostyukova, Anastasiya B

2014-01-01

Background International Remission Criteria (IRC) for schizophrenia were developed recently by a group of internationally known experts. The IRC detect only 10%–30% of cases and do not cover the diversity of forms and social functioning. Our aim was to design a more applicable tool and validate its use – the Standardized Clinical and Functional Remission Criteria (SCFRC). Methods We used a 6-month follow-up study of 203 outpatients from two Moscow centers and another further sample of stable patients from a 1-year controlled trial of atypical versus typical medication. Diagnosis was confirmed by International Classification of Diseases Version 10 (ICD10) criteria and the Mini-International Neuropsychiatric Interview (MINI). Patients were assessed by the Positive and Negative Syndrome Scale, including intensity threshold, and further classified using the Russian domestic remission criteria and the level of social and personal functioning, according to the Personal and Social Performance Scale (PSP). The SCFRC were formulated and were validated by a data reanalysis on the first population sample and on a second independent sample (104 patients) and in an open-label prospective randomized 12-month comparative study of risperidone long-acting injectable (RLAI) versus olanzapine. Results Only 64 of the 203 outpatients (31.5%) initially met the IRC, and 53 patients (26.1%) met the IRC after 6 months, without a change in treatment. Patients who were in remission had episodic and progressive deficit (39.6%), or remittent (15%) paranoid schizophrenia, or schizoaffective disorder (17%). In addition, 105 patients of 139 (51.7%), who did not meet symptomatic IRC, remained stable within the period. Reanalysis of data revealed that 65.5% of the patients met the SCFRC. In the controlled trial, 70% of patients in the RLAI group met the SCFRC and only 19% the IRC. In the routine treatment group, 55.9% met the SCFRC and only 5.7% the IRC. Results of the further independent sample demonstrated that 35% met the IRC, 65% the SCFRC, and 56% of patients met both the symptomatic and functional criteria. In the controlled trial of RLAI and olanzapine, 40% and 35% of patients, respectively, met the IRC, while 70% and 55%, respectively, met the SCFRC. Conclusion In schizophrenia outpatients, a greater proportion of stable cases is detected in remission by SCFRC in comparison with IRC. The SCFRC were more sensitive to the full spectrum of schizophrenia. The SCFRC appear to be valid as a tool and clinically useful as they produce a comprehensive assessment of treatment effectiveness for a wide range of patients. PMID:24511232

Development of a valid Simplified Chinese version of the International Hip Outcome Tool (SC-iHOT-33) in young patients having total hip arthroplasty.

PubMed

Li, D H; Wang, W; Li, X; Gao, Y L; Liu, D H; Liu, D L; Xu, W D

2017-01-01

The International Hip Outcome Tool (iHOT-33) is a questionnaire designed for young, active patients with hip disorders. It has proven to be a highly reliable and valid questionnaire. The main purpose of our study was to adapt the iHOT-33 questionnaire into simplified Chinese and to assess its psychometric properties in Chinese patients. The iHOT-33 was cross culturally adapted into Chinese and 138 patients completed the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the EuroQol-5D (EQ-5D), and the Chinese version of the iHOT-33(SC-iHOT-33) pre- or postoperatively within 6 months' follow-up. The Cronbach's alpha, intraclass correlation coefficient (ICC), Pearson's correlation coefficient (r), effect size (ES), and standardized response mean (SRM) were calculated to assess the reliability, validity, and responsiveness of the SC-iHOT-33, respectively. Total Cronbach's alpha was 0.965, which represented excellent internal consistency of the SC-iHOT-33. The ICC ranges from 0.866 to 0.929, which shows excellent test-retest reliability. The subscales of SC-iHOT-33 had the highest correlation coefficient (r = 0.812) with the physical function subscales of the WOMAC, as well as good correlation between the social/emotional subscale of the SC-iHOT-33 and the EQ-5D (r = 0.740, r = 0.743). No floor or ceiling effects were found. The ES and SRM values indicated good responsiveness of 2.44 and 2.67, respectively. The SC-iHOT-33 questionnaire is reliable, valid, and responsive for the evaluation of young, Chinese, active patients with hip disorders. Copyright © 2016 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

International BMI-for-age references underestimate thinness and overestimate overweight and obesity in Bolivian adolescents.

PubMed

Baya Botti, A; Pérez-Cueto, F J A; Vasquez Monllor, P A; Kolsteren, P W

2010-01-01

Since no growth standards for adolescents exist and a single reference applicable everywhere is still in debate, it is recognized that the best reference should be derived from the growth pattern of the healthy population that will use it. In 2007 a study developed references for body mass index for 12th to 18th y Bolivian school adolescent (BAP. To compare nutritional status outcomes applying BMI references from the BAP, the Center for Disease Control and Prevention CDC 2000, the International Task Force (IOTF), and the 2007 WHO, to determine appropriateness of use in Bolivian adolescents. References were applied in 3306 adolescents, 45.0% male, 55% female, 12th to 18th y selected from a nationally representative sample. Main findings reveal that the CDC and the 2007 WHO underestimate underweight (p<0.001) and the three international references overestimate overweight (p<0.001) with variation between ages and gender. Bolivian health providers are advised to replace CDC, OITF and 2007 WHO references for the use of BAP in Bolivia which reflects its healthy adolescent population growth pattern. International references may lead to incorrect conclusions when applied on Bolivian adolescents. They could deflect efforts from population which need prompt intervention and mislead treatments and budget to unnecessary ones. We recommend validation of international references where appropriate until a standard is released.

PubMed

Steagall, Paulo V M; Monteiro, Beatriz P; Lavoie, Anne-Marie; Frank, Diane; Troncy, Eric; Luna, Stelio P L; Brondani, Juliana T

2017-01-01

Validation of the French version of the UNESP-Botucatu multidimensional composite pain scale for assessing postoperative pain in cats. The aim of this study was to validate the French version of the UNESP-Botucatu multidimensional composite pain scale (MCPS-Fr) to assess postoperative pain in cats. Two veterinarians and one DVM student identified three domains of behavior based on video analyses: "psychomotor change", "protection of the painful area" and "physiological variables". Internal consistency was excellent (Cronbach's alpha coefficient of 0.94, 0.90 and 0.61, respectively). Criterion validity was good to very good when evaluations from the three observers were compared with a "gold standard". Inter- and intra-rater reliability for each scale item were good to very good. The optimal cut-off point identified with a ROC curve was > 7 (scale range 0-30 points), with a sensitivity of 97.8% and specificity of 99.1%. The MCPS-Fr is a valid, reliable and responsive instrument for assessing acute pain in cats undergoing ovariohysterectomy.(Translated by Dr. Beatriz Monteiro).

Working towards a consensus for antibody validation.

PubMed

Reiss, Peter D; Min, Danxi; Leung, Mei Y

2014-01-01

Commercial research antibodies are the most commonly used product in the life science tools market, and their applications represent a significant investment of time and resources for researchers. Frequently however, the quality of antibodies does not meet the expectations of consumers, causing loss of valuable time and money. This can delay research efforts and scientific discovery, or even lead to false, irreproducible results to be published in the scientific literature. This raises the question of whether there should be universal standards for validating antibodies.   During the 1 (st) International Antibody Validation Forum, hosted by St John's Laboratory Ltd on October 15 (th) 2014 at Queen Mary University of London, scientists from academia and industry presented data highlighting quality issues arising from lack of antibody validation. While the forum identified significant current problems in the antibody market, it also discussed future opportunities for improved quality and transparency by encouraging data disclosure and data sharing. This article highlights the key issues and conclusions reached at the forum.

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.

Minimal clinically important difference of the Modified Fatigue Impact Scale in Parkinson's disease.

PubMed

Kluger, Benzi M; Garimella, Sanjana; Garvan, Cynthia

2017-10-01

Fatigue is a common and debilitating symptom of Parkinson's disease (PD) with no evidence-based treatments. While several fatigue scales are partially validated in PD the minimal clinically important difference (MCID) is unknown for any scale but is an important psychometric value to design and interpret therapeutic trials. We thus sought to determine the MCID for the Modified Fatigue Impact Scale (MFIS). This is a secondary data analysis from 94 PD participants in an acupuncture trial for PD fatigue. Standard psychometric approaches were used to establish validity and an anchor-based approach was used to determine the MCID. The MFIS demonstrated good concurrent validity with other outcome measures and high internal consistency. MCIDs values were found to be 13.8, 6.8 and 6.2 for the MFIS total, MFIS cognitive, and MFIS physical subscores respectively. The MFIS is a valid multidimensional measure of fatigue in PD with demonstrable MCID. Copyright © 2017 Elsevier Ltd. All rights reserved.

Translation and Initial Validation of the Japanese Version of the Self-Beliefs Related to Social Anxiety Scale.

PubMed

Maeda, Shunta; Shimada, Hironori; Sato, Tomoya; Tashiro, Kyoko; Tanaka, Yuki

2017-04-01

Cognitive models of social anxiety posit that there are several types of maladaptive beliefs responsible for persistent social anxiety. Although these beliefs are theoretically important, currently there is no validated measure of these beliefs in Japan. In the present study, we translated into Japanese a well-validated measure of these beliefs, the Self-Beliefs Related to Social Anxiety (SBSA) Scale. The psychometric properties of the scale were also examined in two nonclinical samples ( ns = 401 and 30). Using confirmatory factor analysis, the Japanese version of the SBSA was found to have a correlated three-factor structure that consisted of "conditional beliefs," "unconditional beliefs," and "high standard beliefs." In addition, the Japanese version of the SBSA and its subscales demonstrated good internal consistency reliability and test-retest reliability. The Japanese version of the SBSA also demonstrated good convergent and divergent validity. Future applications of the Japanese version of the SBSA are discussed.

The effects of normal aging on multiple aspects of financial decision-making

PubMed Central

Bangma, Dorien F.; Fuermaier, Anselm B. M.; Tucha, Lara; Tucha, Oliver; Koerts, Janneke

2017-01-01

Objectives Financial decision-making (FDM) is crucial for independent living. Due to cognitive decline that accompanies normal aging, older adults might have difficulties in some aspects of FDM. However, an improved knowledge, personal experience and affective decision-making, which are also related to normal aging, may lead to a stable or even improved age-related performance in some other aspects of FDM. Therefore, the present explorative study examines the effects of normal aging on multiple aspects of FDM. Methods One-hundred and eighty participants (range 18–87 years) were assessed with eight FDM tests and several standard neuropsychological tests. Age effects were evaluated using hierarchical multiple regression analyses. The validity of the prediction models was examined by internal validation (i.e. bootstrap resampling procedure) as well as external validation on another, independent, sample of participants (n = 124). Multiple regression and correlation analyses were applied to investigate the mediation effect of standard measures of cognition on the observed effects of age on FDM. Results On a relatively basic level of FDM (e.g., paying bills or using FDM styles) no significant effects of aging were found. However more complex FDM, such as making decisions in accordance with specific rules, becomes more difficult with advancing age. Furthermore, an older age was found to be related to a decreased sensitivity for impulsive buying. These results were confirmed by the internal and external validation analyses. Mediation effects of numeracy and planning were found to explain parts of the association between one aspect of FDM (i.e. Competence in decision rules) and age; however, these cognitive domains were not able to completely explain the relation between age and FDM. Conclusion Normal aging has a negative influence on a complex aspect of FDM, however, other aspects appear to be unaffected by normal aging or improve. PMID:28792973

Investigating the Criterion-Related Validity of the TOEFL® Speaking Scores for ITA Screening and Setting Standards for ITAS. TOEFL iBT Research Report. TOEFL iBT-03. ETS RR-08-02

ERIC Educational Resources Information Center

Xi, Xiaoming

2008-01-01

Although the primary use of the speaking section of the Test of English as a Foreign Language™ Internet-based test (TOEFL® iBT Speaking test) is to inform admissions decisions at English medium universities, it may also be useful as an initial screening measure for international teaching assistants (ITAs). This study provides criterion-related…

Demonstration and Validation of a Waste-to-Energy Conversion System for Fixed DoD Installations

DTIC Science & Technology

2013-09-01

hydrocarbon HVAC heating, ventilation , and air conditioning HX heat exchanger I/O input/output ISO International Organization for Standardization...DEMONSTRATION In 2011, renewable energy accounted for just 9% of total energy consumption in the United States, and just 5% (or 0.45% overall) of that (477...operations and facilities.3 Facility energy costs accounted for ~21% ($4.1 billion). DoD has made great progress in reducing its energy consumption for

Simultaneous quantification of fentanyl, sufentanil, cefazolin, doxapram and keto-doxapram in plasma using liquid chromatography - tandem mass spectrometry.

PubMed

Flint, Robert B; Bahmany, Soma; van der Nagel, Bart C H; Koch, Birgit C P

2018-05-16

A simple and specific UPLC-MS/MS method was developed and validated for simultaneous quantification of fentanyl, sufentanil, cefazolin, doxapram and its active metabolite keto-doxapram. The internal standard was fentanyl-d5 for all analytes. Chromatographic separation was achieved with a reversed phase Acquity UPLC HSS T3 column with a run-time of only 5.0 minutes per injected sample. Gradient elution was performed with a mobile phase consisting of ammonium acetate, formic acid in Milli-Q ultrapure water or in methanol with a total flow rate of 0.4 mL minute -1 . A plasma volume of only 50 μL was required to achieve both adequate accuracy and precision. Calibration curves of all 5 analytes were linear. All analytes were stable for at least 48 hours in the autosampler. The method was validated according to US Food and Drug Administration guidelines. This method allows quantification of fentanyl, sufentanil, cefazolin, doxapram and keto-doxapram, which serves purposes for research, as well as therapeutic drug monitoring, if applicable. The strength of this method is the combination of a small sample volume, a short run-time, a deuterated internal standard, an easy sample preparation method and the ability to simultaneously quantify all analytes in one run. This article is protected by copyright. All rights reserved.

Validated method for determination of bromopride in human plasma by liquid chromatography--electrospray tandem mass spectrometry: application to the bioequivalence study.

PubMed

Nazare, P; Massaroti, P; Duarte, L F; Campos, D R; Marchioretto, M A M; Bernasconi, G; Calafatti, S; Barros, F A P; Meurer, E C; Pedrazzoli, J; Moraes, L A B

2005-09-01

A simple, sensitive and specific liquid chromatography-tandem mass spectrometry method for the quantification of bromopride I in human plasma is presented. Sample preparation consisted of the addition of procainamide II as the internal standard, liquid-liquid extraction in alkaline conditions using hexane-ethyl acetate (1 : 1, v/v) as the extracting solvent, followed by centrifugation, evaporation of the solvent and sample reconstitution in acetonitrile. Both I and II (internal standard, IS) were analyzed using a C18 column and the mobile-phase acetonitrile-water (formic acid 0.1%). The eluted compounds were monitored using electrospray tandem mass spectrometry. The analyses were carried out by multiple reaction monitoring (MRM) using the parent-to-daughter combinations of m/z 344.20 > 271.00 and m/z 236.30 > 163.10. The areas of peaks from analyte and IS were used for quantification of I. The achieved limit of quantification was 1.0 ng/ml and the assay exhibited a linear dynamic range of 1-100.0 ng/ml and gave a correlation coefficient (r) of 0.995 or better. Validation results on linearity, specificity, accuracy, precision and stability, as well as application to the analysis of samples taken up to 24 h after oral administration of 10 mg of I in healthy volunteers demonstrated the applicability to bioequivalence studies.

Validated high-performance liquid chromatographic method utilizing solid-phase extraction for the simultaneous determination of naringenin and hesperetin in human plasma.

PubMed

Kanaze, Feras Imad; Kokkalou, Eugene; Georgarakis, Manolis; Niopas, Ioannis

2004-03-05

Naringenin and hesperetin, the aglycones of the flavanone glucosides naringin and hesperidin occur naturally in citrus fruits. They exert a variety of pharmacological effects such as antioxidant, blood lipid-lowering, anticarcinogenic and inhibit selected cytochrome P-450 enzymes resulting in drug interactions. A specific, sensitive, precise, and accurate solid-phase extraction high-performance liquid chromatographic (HPLC) assay for the simultaneous determination of naringenin and hesperetin in human plasma was developed and validated. After addition of 7-ethoxycoumarin as internal standard, plasma samples were incubated with beta-glucuronidase/sulphatase, and the analytes were isolated from plasma by solid-phase extraction using C(18) cartridges and separated on a C(8) reversed phase column with methanol/water/acetic acid (40:58:2, v/v/v) as the eluent at 45 degrees C. The method was linear in the 10-300 ng/ml concentration range for both naringenin and hesperetin (r>0.999). Recovery for naringenin, hesperetin and internal standard was greater than 76.7%. Intra- and inter-day precision for naringenin ranged from 1.4 to 4.2% and from 1.9 to 5.2%, respectively, and for hesperetin ranged from 1.3 to 4.1% and from 1.7 to 5.1%, respectively. Accuracy was better than 91.5 and 91.3% for naringenin and hesperetin, respectively.

Validation of an LC-MS/MS Method for Urinary Lactulose and Mannitol Quantification: Results in Patients with Irritable Bowel Syndrome.

PubMed

Gervasoni, Jacopo; Schiattarella, Arcangelo; Giorgio, Valentina; Primiano, Aniello; Russo, Consuelo; Tesori, Valentina; Scaldaferri, Franco; Urbani, Andrea; Zuppi, Cecilia; Persichilli, Silvia

2016-01-01

Aim . Lactulose/mannitol ratio is used to assess intestinal barrier function. Aim of this work was to develop a robust and rapid method for the analysis of lactulose and mannitol in urine by liquid chromatography coupled to tandem mass spectrometry. Lactulose/mannitol ratio has been measured in pediatric patients suffering from irritable bowel syndrome. Methods . Calibration curves and raffinose, used as internal standard, were prepared in water : acetonitrile 20 : 80. Fifty μ L of urine sample was added to 450  μ L of internal standard solution. The chromatographic separation was performed using a Luna NH 2 column operating at a flow rate of 200  μ L/min and eluted with a linear gradient from 20% to 80% water in acetonitrile. Total run time is 9 minutes. The mass spectrometry operates in electrospray negative mode. Method was fully validated according to European Medicine Agency guidelines. Results and Conclusions . Linearity ranged from 10 to 1000 mg/L for mannitol and 2.5 to 1000 mg/L for lactulose. Imprecision in intra- and interassay was lower than 15% for both analytes. Accuracy was higher than 85%. Lactulose/mannitol ratio in pediatric patients is significantly higher than that measured in controls. The presented method, rapid and sensitive, is suitable in a clinical laboratory.

A systematic approach to designing reliable VV optimization methodology: assessment of internal validity of echocardiographic, electrocardiographic and haemodynamic optimization of cardiac resynchronization therapy.

PubMed

Kyriacou, Andreas; Li Kam Wa, Matthew E; Pabari, Punam A; Unsworth, Beth; Baruah, Resham; Willson, Keith; Peters, Nicholas S; Kanagaratnam, Prapa; Hughes, Alun D; Mayet, Jamil; Whinnett, Zachary I; Francis, Darrel P

2013-08-10

In atrial fibrillation (AF), VV optimization of biventricular pacemakers can be examined in isolation. We used this approach to evaluate internal validity of three VV optimization methods by three criteria. Twenty patients (16 men, age 75 ± 7) in AF were optimized, at two paced heart rates, by LVOT VTI (flow), non-invasive arterial pressure, and ECG (minimizing QRS duration). Each optimization method was evaluated for: singularity (unique peak of function), reproducibility of optimum, and biological plausibility of the distribution of optima. The reproducibility (standard deviation of the difference, SDD) of the optimal VV delay was 10 ms for pressure, versus 8 ms (p=ns) for QRS and 34 ms (p<0.01) for flow. Singularity of optimum was 85% for pressure, 63% for ECG and 45% for flow (Chi(2)=10.9, p<0.005). The distribution of pressure optima was biologically plausible, with 80% LV pre-excited (p=0.007). The distributions of ECG (55% LV pre-excitation) and flow (45% LV pre-excitation) optima were no different to random (p=ns). The pressure-derived optimal VV delay is unaffected by the paced rate: SDD between slow and fast heart rate is 9 ms, no different from the reproducibility SDD at both heart rates. Using non-invasive arterial pressure, VV delay optimization by parabolic fitting is achievable with good precision, satisfying all 3 criteria of internal validity. VV optimum is unaffected by heart rate. Neither QRS minimization nor LVOT VTI satisfy all validity criteria, and therefore seem weaker candidate modalities for VV optimization. AF, unlinking interventricular from atrioventricular delay, uniquely exposes resynchronization concepts to experimental scrutiny. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Beliefs about penis size: validation of a scale for men ashamed about their penis size.

PubMed

Veale, David; Eshkevari, Ertimiss; Read, Julie; Miles, Sarah; Troglia, Andrea; Phillips, Rachael; Echeverria, Lina Maria Carmona; Fiorito, Chiara; Wylie, Kevan; Muir, Gordon

2014-01-01

No measures are available for understanding beliefs in men who experience shame about the perceived size of their penis. Such a measure might be helpful for treatment planning, and measuring outcome after any psychological or physical intervention. Our aim was to validate a newly developed measure called the Beliefs about Penis Size Scale (BAPS). One hundred seventy-three male participants completed a new questionnaire consisting of 18 items to be validated and developed into the BAPS, as well as various other standardized measures. A urologist also measured actual penis size. The BAPS was validated against six psychosexual self-report questionnaires as well as penile size measurements. Exploratory factor analysis reduced the number of items in the BAPS from 18 to 10, which was best explained by one factor. The 10-item BAPS had good internal consistency and correlated significantly with measures of depression, anxiety, body image quality of life, social anxiety, erectile function, overall satisfaction, and the importance attached to penis size. The BAPS was not found to correlate with actual penis size. It was able to discriminate between those who had concerns or were dissatisfied about their penis size and those who were not. This is the first study to develop a scale for measurement of beliefs about penis size. It may be used as part of an assessment for men who experience shame about the perceived size of their penis and as an outcome measure after treatment. The BAPS measures various manifestations of masculinity and shame about their perceived penis size including internal self-evaluative beliefs; negative evaluation by others; anticipated consequences of a perceived small penis, and extreme self-consciousness. © 2013 International Society for Sexual Medicine.

A clinician-administered observation and corresponding caregiver interview capturing DSM-5 sensory reactivity symptoms in children with ASD.

PubMed

Siper, Paige M; Kolevzon, Alexander; Wang, A Ting; Buxbaum, Joseph D; Tavassoli, Teresa

2017-06-01

Sensory reactivity is a new criterion for autism spectrum disorder (ASD) in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). However, there is no consensus on how to reliably measure sensory reactivity, particularly in minimally verbal individuals. The current study is an initial validation of the Sensory Assessment for Neurodevelopmental Disorders (SAND), a novel clinician-administered observation and corresponding caregiver interview that captures sensory symptoms based on DSM-5 criteria for ASD. Eighty children between the ages of 2 and 12 participated in this study; 44 children with ASD and 36 typically developing (TD) children. Sensory reactivity symptoms were measured using the SAND and the already validated Short Sensory Profile (SSP). Initial psychometric properties of the SAND were examined including reliability, validity, sensitivity and specificity. Children with ASD showed significantly more sensory reactivity symptoms compared to TD children across sensory domains (visual, tactile, and auditory) and within sensory subtypes (hyperreactivity, hyporeactivity and seeking). The SAND showed strong internal consistency, inter-rater reliability and test-retest reliability, high sensitivity (95.5%) and specificity (91.7%), and strong convergent validity with the SSP. The SAND provides a novel method to characterize sensory reactivity symptoms based on DSM-5 criteria for ASD. This is the first known sensory assessment that combines a clinician-administered observation and caregiver interview to optimally capture sensory phenotypes characteristic of individuals with neurodevelopmental disorders. The SAND offers a beneficial new tool for both research and clinical purposes and has the potential to meaningfully enhance gold-standard assessment of ASD. Autism Res 2017, 10: 1133-1140. © 2017 International Society for Autism Research, Wiley Periodicals, Inc. © 2017 International Society for Autism Research, Wiley Periodicals, Inc.

Development of the adult PedsQL™ neurofibromatosis type 1 module: initial feasibility, reliability and validity.

PubMed

Nutakki, Kavitha; Hingtgen, Cynthia M; Monahan, Patrick; Varni, James W; Swigonski, Nancy L

2013-02-21

Neurofibromatosis type 1 (NF1) is a common autosomal dominant genetic disorder with significant impact on health-related quality of life (HRQOL). Research in understanding the pathogenetic mechanisms of neurofibroma development has led to the use of new clinical trials for the treatment of NF1. One of the most important outcomes of a trial is improvement in quality of life, however, no condition specific HRQOL instrument for NF1 exists. The objective of this study was to develop an NF1 HRQOL instrument as a module of PedsQL™ and to test for its initial feasibility, internal consistency reliability and validity in adults with NF1. The NF1 specific HRQOL instrument was developed using a standard method of PedsQL™ module development - literature review, focus group/semi-structured interviews, cognitive interviews and experts' review of initial draft, pilot testing and field testing. Field testing involved 134 adults with NF1. Feasibility was measured by the percentage of missing responses, internal consistency reliability was measured with Cronbach's alpha and validity was measured by the known-groups method. Feasibility, measured by the percentage of missing responses was 4.8% for all subscales on the adult version of the NF1-specific instrument. Internal consistency reliability for the Total Score (alpha =0.97) and subscale reliabilities ranging from 0.72 to 0.96 were acceptable for group comparisons. The PedsQL™ NF1 module distinguished between NF1 adults with excellent to very good, good, and fair to poor health status. The results demonstrate the initial feasibility, reliability and validity of the PedsQL™ NF1 module in adult patients. The PedsQL™ NF1 Module can be used to understand the multidimensional nature of NF1 on the HRQOL patients with this disorder.

Validation of the prognostic gene portfolio, ClinicoMolecular Triad Classification, using an independent prospective breast cancer cohort and external patient populations.

PubMed

Wang, Dong-Yu; Done, Susan J; Mc Cready, David R; Leong, Wey L

2014-07-04

Using genome-wide expression profiles of a prospective training cohort of breast cancer patients, ClinicoMolecular Triad Classification (CMTC) was recently developed to classify breast cancers into three clinically relevant groups to aid treatment decisions. CMTC was found to be both prognostic and predictive in a large external breast cancer cohort in that study. This study serves to validate the reproducibility of CMTC and its prognostic value using independent patient cohorts. An independent internal cohort (n = 284) and a new external cohort (n = 2,181) were used to validate the association of CMTC between clinicopathological factors, 12 known gene signatures, two molecular subtype classifiers, and 19 oncogenic signalling pathway activities, and to reproduce the abilities of CMTC to predict clinical outcomes of breast cancer. In addition, we also updated the outcome data of the original training cohort (n = 147). The original training cohort reached a statistically significant difference (p < 0.05) in disease-free survivals between the three CMTC groups after an additional two years of follow-up (median = 55 months). The prognostic value of the triad classification was reproduced in the second independent internal cohort and the new external validation cohort. CMTC achieved even higher prognostic significance when all available patients were analyzed (n = 4,851). Oncogenic pathways Myc, E2F1, Ras and β-catenin were again implicated in the high-risk groups. Both prospective internal cohorts and the independent external cohorts reproduced the triad classification of CMTC and its prognostic significance. CMTC is an independent prognostic predictor, and it outperformed 12 other known prognostic gene signatures, molecular subtype classifications, and all other standard prognostic clinicopathological factors. Our results support further development of CMTC portfolio into a guide for personalized breast cancer treatments.

Is a controlled randomised trial the non-plus-ultra design? A contribution to discussion on comparative, controlled, non-randomised trials.

PubMed

Gaus, Wilhelm; Muche, Rainer

2013-05-01

Clinical studies provide formalised experience for evidence-based medicine (EBM). Many people consider a controlled randomised trial (CRT, identical to a randomised controlled trial RCT) to be the non-plus-ultra design. However, CRTs also have limitations. The problem is not randomisation itself but informed consent for randomisation and masking of therapies according to today's legal and ethical standards. We do not want to de-rate CRTs, but we would like to contribute to the discussion on clinical research methodology. Informed consent to a CRT and masking of therapies plainly select patients. The excellent internal validity of CRTs can be counterbalanced by poor external validity, because internal and external validity act as antagonists. In a CRT, patients may feel like guinea pigs, this can decrease compliance, cause protocol violations, reduce self-healing properties, suppress unspecific therapeutic effects and possibly even modify specific efficacy. A control group (comparative study) is most important for the degree of evidence achieved by a trial. Study control by detailed protocol and good clinical practice (controlled study) is second in importance and randomisation and masking is third (thus the sequence CRT instead of RCT). Controlled non-randomised trials are just as ambitious and detailed as CRTs. We recommend clinicians and biometricians to take high quality controlled non-randomised trials into consideration more often. They combine good internal and external validity, better suit daily medical practice, show better patient compliance and fewer protocol violations, deliver estimators unbiased by alienated patients, and perhaps provide a clearer explanation of the achieved success. Copyright © 2013 Elsevier Inc. All rights reserved.

Consensus on Recording Deep Endometriosis Surgery: the CORDES statement.

PubMed

Vanhie, A; Meuleman, C; Tomassetti, C; Timmerman, D; D'Hoore, A; Wolthuis, A; Van Cleynenbreugel, B; Dancet, E; Van den Broeck, U; Tsaltas, J; Renner, S P; Ebert, A D; Carmona, F; Abbott, J; Stepniewska, A; Taylor, H; Saridogan, E; Mueller, M; Keckstein, J; Pluchino, N; Janik, G; Zupi, E; Minelli, L; Cooper, M; Dunselman, G; Koh, C; Abrao, M S; Chapron, C; D'Hooghe, T

2016-06-01

Which essential items should be recorded before, during and after endometriosis surgery and in clinical outcome based surgical trials in patients with deep endometriosis (DE)? A DE surgical sheet (DESS) was developed for standardized reporting of the surgical treatment of DE and an international expert consensus proposal on relevant items that should be recorded in surgical outcome trials in women with DE. Surgery is an important treatment for symptomatic DE. So far, data have been reported in such a way that comparison of different surgical techniques is impossible. Therefore, we present an international expert proposal for standardized reporting of surgical treatment and surgical outcome trials in women with DE. International expert consensus based on a systematic review of literature. Taking into account recommendations from Consolidated Standards of Reporting Trials (CONSORT), the Innovation Development Exploration Assessment and Long-term Study (IDEAL), the Initiative on Methods, Measurement and Pain Assessment in Clinical trials (IMMPACT) and the World Endometriosis Research Foundation Phenome and Biobanking Harmonisation Project (WERF EPHect), a systematic literature review on surgical treatment of DE was performed and resulted in a proposal for standardized reporting, adapted by contributions from eight members of the multidisciplinary Leuven University Hospitals Endometriosis Care Program, from 18 international experts and from audience feedback during three international meetings. We have developed the DESS to record in detail the surgical procedures for DE, and an international consensus on pre-, intra- and post-operative data that should be recorded in surgical outcome trials on DE. The recommendations in this paper represent a consensus among international experts based on a systematic review of the literature. For several items and recommendations, high-quality RCTs were not available. Further research is needed to validate and evaluate the recommendations presented here. This international expert consensus for standardized reporting of surgical treatment in women with DE, based on a systematic literature review and international consensus, can be used as a guideline to record and report surgical management of patients with DE and as a guideline to design, execute, interpret and compare clinical trials in this patient population. None of the authors received funding for the development of this paper. M.A. reports personal fees and non-financial support from Bayer Pharma outside the submitted work; H.T. reports a grant from Pfizer and personal fees for being on the advisory board of Perrigo, Abbvie, Allergan and SPD. N/A. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Derivation and external validation of a case mix model for the standardized reporting of 30-day stroke mortality rates.

PubMed

Bray, Benjamin D; Campbell, James; Cloud, Geoffrey C; Hoffman, Alex; James, Martin; Tyrrell, Pippa J; Wolfe, Charles D A; Rudd, Anthony G

2014-11-01

Case mix adjustment is required to allow valid comparison of outcomes across care providers. However, there is a lack of externally validated models suitable for use in unselected stroke admissions. We therefore aimed to develop and externally validate prediction models to enable comparison of 30-day post-stroke mortality outcomes using routine clinical data. Models were derived (n=9000 patients) and internally validated (n=18 169 patients) using data from the Sentinel Stroke National Audit Program, the national register of acute stroke in England and Wales. External validation (n=1470 patients) was performed in the South London Stroke Register, a population-based longitudinal study. Models were fitted using general estimating equations. Discrimination and calibration were assessed using receiver operating characteristic curve analysis and correlation plots. Two final models were derived. Model A included age (<60, 60-69, 70-79, 80-89, and ≥90 years), National Institutes of Health Stroke Severity Score (NIHSS) on admission, presence of atrial fibrillation on admission, and stroke type (ischemic versus primary intracerebral hemorrhage). Model B was similar but included only the consciousness component of the NIHSS in place of the full NIHSS. Both models showed excellent discrimination and calibration in internal and external validation. The c-statistics in external validation were 0.87 (95% confidence interval, 0.84-0.89) and 0.86 (95% confidence interval, 0.83-0.89) for models A and B, respectively. We have derived and externally validated 2 models to predict mortality in unselected patients with acute stroke using commonly collected clinical variables. In settings where the ability to record the full NIHSS on admission is limited, the level of consciousness component of the NIHSS provides a good approximation of the full NIHSS for mortality prediction. © 2014 American Heart Association, Inc.

A new extranodal scoring system based on the prognostically relevant extranodal sites in diffuse large B-cell lymphoma, not otherwise specified treated with chemoimmunotherapy.

PubMed

Hwang, Hee Sang; Yoon, Dok Hyun; Suh, Cheolwon; Huh, Jooryung

2016-08-01

Extranodal involvement is a well-known prognostic factor in patients with diffuse large B-cell lymphomas (DLBCL). Nevertheless, the prognostic impact of the extranodal scoring system included in the conventional international prognostic index (IPI) has been questioned in an era where rituximab treatment has become widespread. We investigated the prognostic impacts of individual sites of extranodal involvement in 761 patients with DLBCL who received rituximab-based chemoimmunotherapy. Subsequently, we established a new extranodal scoring system based on extranodal sites, showing significant prognostic correlation, and compared this system with conventional scoring systems, such as the IPI and the National Comprehensive Cancer Network-IPI (NCCN-IPI). An internal validation procedure, using bootstrapped samples, was also performed for both univariate and multivariate models. Using multivariate analysis with a backward variable selection, we found nine extranodal sites (the liver, lung, spleen, central nervous system, bone marrow, kidney, skin, adrenal glands, and peritoneum) that remained significant for use in the final model. Our newly established extranodal scoring system, based on these sites, was better correlated with patient survival than standard scoring systems, such as the IPI and the NCCN-IPI. Internal validation by bootstrapping demonstrated an improvement in model performance of our modified extranodal scoring system. Our new extranodal scoring system, based on the prognostically relevant sites, may improve the performance of conventional prognostic models of DLBCL in the rituximab era and warrants further external validation using large study populations.