Medicine and Health Sciences Commons^™

Evidence-Based Toxicology For The 21st Century: Opportunities And Challenges, Martin L. Stephens, Melvin E. Andersen, Richard A. Becker, Kellyn Betts, Kim Boekelheide, Ed Carney, Robert Chapin, Dennis Devlin, Suzanne C. Fitzpatrick, John R. Fowle Iii, Patricia Harlow, Thomas Hartung, Sebastian Hoffman, Michael P. Holsapple, Abigail Jacobs, Richard Judson, Olga Naidenko, Tim Pastoor, Grace Patlewicz, Andrew Rowan, Roberta Scherer, Rashid Shaikh, Ted Simon, Douglas Wolf, Joanne Zurlo

Martin Stephens, PhD

The Evidence-based Toxicology Collaboration (EBTC) was established recently to translate evidence-based approaches from medicine and health care to toxicology in an organized and sustained effort. The EBTC held a workshop on “Evidence-based Toxicology for the 21st Century: Opportunities and Challenges” in Research Triangle Park, North Carolina, USA on January 24-25, 2012. The presentations largely reflected two EBTC priorities: to apply evidence-based methods to assessing the performance of emerging pathwaybased testing methods consistent with the 2007 National Research Council report on “Toxicity Testing in the 21st Century” as well as to adopt a governance structure and work processes to move that …

Food For Thought … Mechanistic Validation, Thomas Hartung, Sebastian Hoffman, Martin Stephens

Martin Stephens, PhD

Validation of new approaches in regulatory toxicology is commonly defined as the independent assessment of the reproducibility and relevance (the scientific basis and predictive capacity) of a test for a particular purpose. In large ring trials, the emphasis to date has been mainly on reproducibility and predictive capacity (comparison to the traditional test) with less attention given to the scientific or mechanistic basis. Assessing predictive capacity is difficult for novel approaches (which are based on mechanism), such as pathways of toxicity or the complex networks within the organism (systems toxicology). This is highly relevant for implementing Toxicology for the 21st …

Animal Model Research: The Apples And Oranges Quandary, Kenneth J. Shapiro

Kenneth J. Shapiro, PhD

In this paper, I explore the premises underlying the problem of the evaluation of animal models. I argue that the presence of similarities and differences between the model and the modelled, although historically and currently a dominant antinomy framing evaluation, is not a bottom-line consideration. What is critical is 1) whether we learn and 2) whether we improve treatment through the animal model research. Similarity between model and modelled and the closely related concept of validity are not coterminus with these critical evaluative measures. In fact, differences between the model and modelled also can provide impetus to new understanding and …

Validity Of A Food Frequency Questionnaire To Assess Nutritional Intake Among Sri Lankan Adults, Ranil Jayawardena, Nuala Byrne, Mario Soares, Prasad Katulanda, Andrew P. Hills

Nuala Byrne

Sri Lanka is undergoing nutritional transition and diet-related chronic diseases are emerging as an important health problem. Currently, no validated food frequency questionnaire (FFQ) exists to measure habitual dietary intake of Sri Lankan adults. The purpose of the study is to assess the validity of a semi-quantitative FFQ and 7-day weighed-intake dietary records (7DWR), designed to assess dietary intake among Sri Lankan adults. Dietary intake was measured using both a FFQ and 7DWR. The FFQ consisted of 8 food groups containing the main foods comprising the diet of Sri Lankan adults, a total of 85 items and 12 color photographs …

Relations Between Social And Emotional Competence And Mental Health: A Construct Validation Study, Joseph Ciarrochi, Gregory Scott, Frank Deane, Patrick Heaven

joseph Ciarrochi

Researchers working fairly independently of each other have created numerous measures of social and emotional competence (SEC). These measures tend to correlate (sometimes highly) with each other and with measures of stressful events, suggesting potential redundancy. We evaluated which, if any, SEC variables predicted unique variance in social and mental health after controlling for other SEC variables in the study and the impact of stressful events. Three-hundred and thirty-one university students participated in an anonymous, cross-sectional study. We measured stressful events, and a wide variety of SECs, including: social problem solving skill (effective problem orientation, automatic processing, and problem solving), …

Validation Of Lc-Tof/Ms Screening For Drugs, Metabolites, And Collateral Compounds In Forensic Toxicology Specimens, Fessessework Guale, Shahriar Shahreza, Jeffrey Walterscheid, Hsin-Hung Chen, Crystal Arndt, Anna Kelly, Ashraf Mozayani

Ashraf Mozayani, Ph.D., PharmD

Liquid chromatography time-of-flight mass spectrometry (LC-TOF-MS) analysis provides an expansive technique for identifying many known and unknown analytes. This study developed a screening method that utilizes automated solid-phase extraction to purify a wide array of analytes involving stimulants, benzodiazepines, opiates, muscle relaxants, hypnotics, antihistamines, antidepressants and newer synthetic "Spice/K2" cannabinoids and cathinone "bath salt" designer drugs. The extract was applied to LC-TOF-MS analysis, implementing a 13 min chromatography gradient with mobile phases of ammonium formate and methanol using positive mode electrospray. Several common drugs and metabolites can share the same mass and chemical formula among unrelated compounds, but they are …

The Development Of New Concepts For Assessing Reproductive Toxicity Applicable To Large Scale Toxicological Programmes, S. Bremer, C. Pellizzer, S. Hoffmann, T. Seidle, T. Hartung

Troy Seidle, PhD

Large scale toxicological testing programmes which are currently ongoing such as the new European chemical legislation REACH require the development of new integrated testing strategies rather than applying traditional testing schemes to thousands of chemicals. The current practice of requiring in vivo testing for every possible adverse effect endanger the success of these programmes due (i) to limited testing facilities and sufficient capacity of scientific/technical knowledge for reproductive toxicity; (ii) an unacceptable number of laboratory animals involved (iii) an intolerable number of chemicals classified as false positive.

A key aspect of the implementation of new testing strategies is the determination …

Dietary Validation Of A New Australian Food-Frequency Questionnaire That Estimates Long-Chain N-3 Polyunsaturated Fatty Acids, Bethany L. Sullivan, Janelle Brown, Peter Williams, Barbara Meyer

Peter Williams

Currently, there is no FFQ designed to capture the intakes of the long-chain (LC) n-3 PUFA. The objectives of this study were to validate a new LC n-3 PUFA FFQ by comparison with 3 d weighed food records (FR) and to determine its reproducibility assessed 4 to 6 weeks apart. Healthy male and female subjects (n 53) were recruited from Wollongong and the Australian Capital Territory, Australia. The FFQ and FR were analysed for LC n-3 PUFA intakes using a nutrient analysis software package and these intakes were compared using Wilcoxon signed rank tests and Spearman correlation coefficients. Bland–Altman analysis …

Development And Validation Of An Australian Database For Estimating The Seafood Content Of Canned Products, Elizabeth Neale, Yasmine Probst, Marijka Batterham, Linda C. Tapsell

Dr Marijka Batterham

Canned fish products are of increasing popularity in Australia; however current Australian nutrient databases do not include data on the percentage fish in these products. The objective of this study was to develop and validate a database of the percentage fish and seafood contained in common canned fish and seafood products, for use in clinical trials. Six major supermarkets in the Illawarra region, NSW were audited for canned seafood products, and a database of re-ported percentage fish and seafood was developed. Mean + SD of each type of product was then determined. To vali-date the database, a representative sample of …

Validation Of The Differentiated Transformational Leadership Inventory As A Measure Of Coach Leadership In Youth Soccer, Stewart A. Vella, Lindsay G. Oades, Trevor P. Crowe

Trevor Crowe

This paper describes the validation of The Differentiated Transformational Leadership Inventory (DTLI) within a participation youth sports context. Three hundred and twenty-two athletes aged between 11 and 18 years completed the DTLI. Using a confirmatory factor analysis, the DTLI yielded an underlying factor structure that fell short of cut-off criteria for adjudging model fit. Subsequent theory-driven changes were made to the DTLI by removing the 'high performance expectations' subscale. Further data-driven changes were also made on the basis of high item-factor cross-loadings. The revised version of the DTLI was subjected to confirmatory factor analysis and proved to be a good …

Erythrocyte Biomarker-Based Validation Of A Diet History Method Used In A Dietary Intervention Trial, Craig S. Patch, Karen J Murphy, Jackie Mansour, Linda C. Tapsell, Barbara J. Meyer, Trevor A Mori, Manny Noakes, P Clifton, I Puddey, P Howe

L. C. Tapsell

No abstract provided.

Development And Validation Of An Australian Database For Estimating The Seafood Content Of Canned Products, Elizabeth Neale, Yasmine Probst, Marijka Batterham, Linda C. Tapsell

L. C. Tapsell

Canned fish products are of increasing popularity in Australia; however current Australian nutrient databases do not include data on the percentage fish in these products. The objective of this study was to develop and validate a database of the percentage fish and seafood contained in common canned fish and seafood products, for use in clinical trials. Six major supermarkets in the Illawarra region, NSW were audited for canned seafood products, and a database of re-ported percentage fish and seafood was developed. Mean + SD of each type of product was then determined. To vali-date the database, a representative sample of …

Qualification Versus Validation Of Biomarkers, Jenny Doust

Jenny Doust

The phases of research used to evaluate new drugs provide a useful reference point for determining the studies that need to be conducted to evaluate new biomarkers. However, biomarkers do not have a single pathway for changing health outcomes and may be used for a variety of purposes, such as improving diagnostic criteria, improving prognosis, improving the monitoring of disease or as a measurement of health outcomes. The impact on health outcomes is also less direct and is dependent on the sequence of actions taken as a consequence of the test results. The different purposes of biomarkers and the less …

Author Guidelines For Reporting Scale Development And Validation Results In The Journal Of The Society For Social Work And Research, Peter Cabrera-Nguyen

Elián P. Cabrera-Nguyen

In this invited article, Cabrera-Nguyen provides guidelines for reporting scale development and validation results. Authors' attention to these guidelines will help ensure the research reported in JSSWR is rigorous and of high quality. This article provides guidance for those using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). In addition, the article provides helpful links to resources addressing structural equation modeling, multiple imputation for missing data, and a general resource for quantitative data analysis.

Obstructive Lung Disease Models: What Is Valid, Jill M. Ferdinands, David M. Mannino

David M. Mannino

Use of disease simulation models has led to scrutiny of model methods and demand for evidence that models credibly simulate health outcomes. We sought to describe recent obstructive lung disease simulation models and their validation. Medline and EMBASE were used to identify obstructive lung disease simulation models published from January 2000 to June 2006. Publications were reviewed to assess model attributes and four types of validation: first-order (verification/debugging), second-order (comparison with studies used in model development), third-order (comparison with studies not used in model development), and predictive validity. Six asthma and seven chronic obstructive pulmonary disease models were identified. Seven …

Validation Of Cone Beam Ct Scan For Measurement Of Palatal Depth In Study Casts, Radzi Z., Yahya N. A., Abu Kasim N. H., Abu Osman N. A., Yusof Z. Y. M., Mohd F. N., Noor N. H. M., Jamaludin M., Othman S. A., Obaidellah U. H., Mohamed N. H., Kadir R., Nambiar P.

Siti Adibah Othman

The purpose of this study was to validate the use of digital dental study casts obtained from Cone beam CT Scan (CBCT) against gold standard; that is traditional dental study cast measured with digital caliper. Thirty-four study casts of Malaysian Aborigines were selected from Centre of Malaysian Pribumi Studies Databank. Palatal depth of each study casts were measured using Mitutoyo digital caliper. Subsequently, all the study models were scanned using i-CAT CBCT and the palatal depth were measured using i-CAT software. Data were analysed using SPSS version 12.0 where Intraclass correlation and paired T-test were employed. There was no significant …

Validation Of The Caregiving At Life’S End Questionnaire, Jennifer R. Salmon, Jung Kwak, Kimberly D. Acquaviva, Kathleen A. Egan, Katherine E. Brandt

Kimberly D. Acquaviva, PhD, MSW

The researchers in this study developed and validated a questionnaire to measure the needs of end-of-life (EOL) caregivers. The model is used to facilitate meaningful and supportive experiences for both the patient and caregiver. The questionnaire was developed using existing scales of meaning, self acceptance, burden, and gain as well as new scales of caregiver comfort, importance of caregiving tasks, and caregiver closure. The sample included 34 current and 17 bereaved caregivers affiliated with The Hospice Institute of the Florida Suncoast. The scales performed well in terms of concurrent validity, internal consistency, and reliability.