The Clinical Interview Schedule-Revised (CIS-R)-Malay Version, Clinical Validation.

PubMed

Subramaniam, Kavitha; Krishnaswamy, Saroja; Jemain, Abdul Aziz; Hamid, Abdul; Patel, Vikram

2006-01-01

Use of instruments or questionnaires in different cultural settings without proper validation can result in inaccurate results. Issues like reliability, validity, feasibility and acceptability should be considered in the use of an instrument. The study aims to determine the usefulness of the CIS-R Malay version in detecting common mental health problems specifically to establish the validity. The CIS-R instrument (PROQSY* format) was translated through the back translation process into Malay. Inter rater reliability was established for raters who were medical students. Cases and controls for the study were psychiatric in patients, out patient and relatives or friends accompanying the patients to the clinic or visiting the inpatients. The Malay version of CIS-R was administered to all cases and controls. All cases and controls involved in the study were rated by psychiatrists for psychiatric morbidity using the SCID as a guideline. Specificity and sensitivity of the CIS-R to the assessment by the psychiatrist were determined. The Malay version of CIS-R showed 100% sensitivity and 96.15% specificity at a cut off score of 9. The CIS-R can be a useful instrument for clinical and research use in the Malaysian population for diagnosing common mental disorders like depression and anxiety.

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

PubMed

McKown, Clark

2007-03-01

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

Exploring the validity and reliability of a questionnaire for evaluating veterinary clinical teachers' supervisory skills during clinical rotations.

PubMed

Boerboom, T B B; Dolmans, D H J M; Jaarsma, A D C; Muijtjens, A M M; Van Beukelen, P; Scherpbier, A J J A

2011-01-01

Feedback to aid teachers in improving their teaching requires validated evaluation instruments. When implementing an evaluation instrument in a different context, it is important to collect validity evidence from multiple sources. We examined the validity and reliability of the Maastricht Clinical Teaching Questionnaire (MCTQ) as an instrument to evaluate individual clinical teachers during short clinical rotations in veterinary education. We examined four sources of validity evidence: (1) Content was examined based on theory of effective learning. (2) Response process was explored in a pilot study. (3) Internal structure was assessed by confirmatory factor analysis using 1086 student evaluations and reliability was examined utilizing generalizability analysis. (4) Relations with other relevant variables were examined by comparing factor scores with other outcomes. Content validity was supported by theory underlying the cognitive apprenticeship model on which the instrument is based. The pilot study resulted in an additional question about supervision time. A five-factor model showed a good fit with the data. Acceptable reliability was achievable with 10-12 questionnaires per teacher. Correlations between the factors and overall teacher judgement were strong. The MCTQ appears to be a valid and reliable instrument to evaluate clinical teachers' performance during short rotations.

Validation of the Clinical Learning Environment Inventory.

PubMed

Chan, Dominic S

2003-08-01

One hundred eight preregistration nursing students took part in this survey study, which assessed their perceptions of the clinical learning environment. Statistical data based on the sample confirmed the reliability and validity of the Clinical Learning Environment Inventory (CLEI), which was developed using the concept of classroom learning environment studies. The study also found that there were significant differences between students' actual and preferred perceptions of the clinical learning environments. In terms of the CLEI scales, students preferred a more positive and favorable clinical environment than they perceived as being actually present. The achievement of certain outcomes of clinical field placements might be enhanced by attempting to change the actual clinical environment in ways that make it more congruent with that preferred by the students.

Criterion Validity of the Mood and Feelings Questionnaire for Depressive Episodes in Clinic and Non-Clinic Subjects

ERIC Educational Resources Information Center

Daviss, W. Burleson; Birmaher, Boris; Melhem, Nadine A.; Axelson, David A.; Michaels, Shana M.; Brent, David A.

2006-01-01

Background: Previous measures of pediatric depression have shown inconsistent validity in groups with differing demographics, comorbid diagnoses, and clinic or non-clinic origins. The current study re-examines the criterion validity of child- and parent-versions of the Mood and Feelings Questionnaire (MFQ-C, MFQ-P) in a heterogeneous sample of…

Validation of Immunohistochemical Assays for Integral Biomarkers in the NCI-MATCH EAY131 Clinical Trial.

PubMed

Khoury, Joseph D; Wang, Wei-Lien; Prieto, Victor G; Medeiros, L Jeffrey; Kalhor, Neda; Hameed, Meera; Broaddus, Russell; Hamilton, Stanley R

2018-02-01

Biomarkers that guide therapy selection are gaining unprecedented importance as targeted therapy options increase in scope and complexity. In conjunction with high-throughput molecular techniques, therapy-guiding biomarker assays based upon immunohistochemistry (IHC) have a critical role in cancer care in that they inform about the expression status of a protein target. Here, we describe the validation procedures for four clinical IHC biomarker assays-PTEN, RB, MLH1, and MSH2-for use as integral biomarkers in the nationwide NCI-Molecular Analysis for Therapy Choice (NCI-MATCH) EAY131 clinical trial. Validation procedures were developed through an iterative process based on collective experience and adaptation of broad guidelines from the FDA. The steps included primary antibody selection; assay optimization; development of assay interpretation criteria incorporating biological considerations; and expected staining patterns, including indeterminate results, orthogonal validation, and tissue validation. Following assay lockdown, patient samples and cell lines were used for analytic and clinical validation. The assays were then approved as laboratory-developed tests and used for clinical trial decisions for treatment selection. Calculations of sensitivity and specificity were undertaken using various definitions of gold-standard references, and external validation was required for the PTEN IHC assay. In conclusion, validation of IHC biomarker assays critical for guiding therapy in clinical trials is feasible using comprehensive preanalytic, analytic, and postanalytic steps. Implementation of standardized guidelines provides a useful framework for validating IHC biomarker assays that allow for reproducibility across institutions for routine clinical use. Clin Cancer Res; 24(3); 521-31. ©2017 AACR . ©2017 American Association for Cancer Research.

Clinical validity of prototype personality disorder ratings in adolescents.

PubMed

Defife, Jared A; Haggerty, Greg; Smith, Scott W; Betancourt, Luis; Ahmed, Zain; Ditkowsky, Keith

2015-01-01

A growing body of research shows that personality pathology in adolescents is clinically distinctive and frequently stable into adulthood. A reliable and useful method for rating personality pathology in adolescent patients has the potential to enhance conceptualization, dissemination, and treatment effectiveness. The aim of this study is to examine the clinical validity of a prototype matching approach (derived from the Shedler Westen Assessment Procedure-Adolescent Version) for quantifying personality pathology in an adolescent inpatient sample. Sixty-six adolescent inpatients and their parents or legal guardians completed forms of the Child Behavior Checklist (CBCL) assessing emotional and behavioral problems. Clinical criterion variables including suicide history, substance use, and fights with peers were also assessed. Patients' individual and group therapists on the inpatient unit completed personality prototype ratings. Prototype diagnoses demonstrated substantial reliability (median intraclass correlation coefficient =.75) across independent ratings from individual and group therapists. Personality prototype ratings correlated with the CBCL scales and clinical criterion variables in anticipated and meaningful ways. As seen in prior research with adult samples, prototype personality ratings show clinical validity across independent clinician raters previously unfamiliar with the approach, and they are meaningfully related to clinical symptoms, behavioral problems, and adaptive functioning.

Clinical Validity of Prototype Personality Disorder Ratings in Adolescents

PubMed Central

DeFife, Jared A.; Haggerty, Greg; Smith, Scott W.; Betancourt, Luis; Ahmed, Zain; Ditkowsky, Keith

2015-01-01

A growing body of research shows that personality pathology in adolescents is clinically distinctive and frequently stable into adulthood. A reliable and useful method for rating personality pathology in adolescent patients has the potential to enhance conceptualization, dissemination, and treatment effectiveness. The aim of this study is to examine the clinical validity of a prototype matching approach (derived from the Shedler Westen Assessment Procedure – Adolescent Version) for quantifying personality pathology in an adolescent inpatient sample. Sixty-six adolescent inpatients and their parents or legal guardians completed forms of the Child Behavior Checklist (CBCL) assessing emotional and behavioral problems. Clinical criterion variables including suicide history, substance use, and fights with peers were also assessed. Patients’ individual and group therapists on the inpatient unit completed personality prototype ratings. Prototype diagnoses demonstrated substantial reliability (median ICC = .75) across independent ratings from individual and group therapists. Personality prototype ratings correlated with the CBCL scales and clinical criterion variables in anticipated and meaningful ways. As seen in prior research with adult samples, prototype personality ratings show clinical validity across independent clinician raters previously unfamiliar with the approach, and they are meaningfully related to clinical symptoms, behavioral problems, and adaptive functioning. PMID:25457971

Validation in the clinical process: four settings for objectification of the subjectivity of understanding.

PubMed

Beland, H

1994-12-01

Clinical material is presented for discussion with the aim of exemplifying the author's conceptions of validation in a number of sessions and in psychoanalytic research and of making them verifiable, susceptible to consensus and/or falsifiable. Since Freud's postscript to the Dora case, the first clinical validation in the history of psychoanalysis, validation has been group-related and society-related, that is to say, it combines the evidence of subjectivity with the consensus of the research community (the scientific community). Validation verifies the conformity of the unconscious transference meaning with the analyst's understanding. The deciding criterion is the patient's reaction to the interpretation. In terms of the theory of science, validation in the clinical process corresponds to experimental testing of truth in the sphere of inanimate nature. Four settings of validation can be distinguished: the analyst's self-supervision during the process of understanding, which goes from incomprehension to comprehension (container-contained, PS-->D, selected fact); the patient's reaction to the interpretation (insight) and the analyst's assessment of the reaction; supervision and second thoughts; and discussion in groups and publications leading to consensus. It is a peculiarity of psychoanalytic research that in the event of positive validation the three criteria of truth (evidence, consensus and utility) coincide.

Preanalytical management: serum vacuum tubes validation for routine clinical chemistry.

PubMed

Lima-Oliveira, Gabriel; Lippi, Giuseppe; Salvagno, Gian Luca; Montagnana, Martina; Picheth, Geraldo; Guidi, Gian Cesare

2012-01-01

The validation process is essential in accredited clinical laboratories. Aim of this study was to validate five kinds of serum vacuum tubes for routine clinical chemistry laboratory testing. Blood specimens from 100 volunteers in five different serum vacuum tubes (Tube I: VACUETTE, Tube II: LABOR IMPORT, Tube III: S-Monovette, Tube IV: SST and Tube V: SST II) were collected by a single, expert phlebotomist. The routine clinical chemistry tests were analyzed on cobas 6000 module. The significance of the differences between samples was assessed by paired Student's t-test after checking for normality. The level of statistical significance was set at P < 0.005. Finally, the biases from Tube I, Tube II, Tube III, Tube IV and Tube V were compared with the current desirable quality specifications for bias (B), derived from biological variation. Basically, our validation will permit the laboratory or hospital managers to select the brand's vacuum tubes validated according him/her technical or economical reasons, in order to perform the following laboratory tests: glucose, total cholesterol, high density lipoprotein-cholesterol, triglycerides, total protein, albumin, blood urea nitrogen, uric acid, alkaline phosphatise, aspartate aminotransferase, gamma-glutamyltransferase, lactate dehydrogenase, creatine kinase, total bilirubin, direct bilirubin, calcium, iron, sodium and potassium. On the contrary special attention will be required if the laboratory already performs creatinine, amylase, phosphate and magnesium determinations and the quality laboratory manager intend to change the serum tubes. We suggest that laboratory management should both standardize the procedures and frequently evaluate the quality of in vitro diagnostic devices.

Methodological challenges of validating a clinical decision-making tool in the practice environment.

PubMed

Brennan, Caitlin W; Daly, Barbara J

2015-04-01

Validating a measurement tool intended for use in the practice environment poses challenges that may not be present when validating a tool intended solely for research purposes. The aim of this article is to describe the methodological challenges of validating a clinical decision-making tool, the Oncology Acuity Tool, which nurses use to make nurse assignment and staffing decisions prospectively each shift. Data were derived from a larger validation study, during which several methodological challenges arose. Revisions to the tool, including conducting iterative feedback cycles with end users, were necessary before the validation study was initiated. The "true" value of patient acuity is unknown, and thus, two approaches to inter-rater reliability assessment were used. Discordant perspectives existed between experts and end users. Balancing psychometric rigor with clinical relevance may be achieved through establishing research-practice partnerships, seeking active and continuous feedback with end users, and weighing traditional statistical rules of thumb with practical considerations. © The Author(s) 2014.

What should we mean by empirical validation in hypnotherapy: evidence-based practice in clinical hypnosis.

PubMed

Alladin, Assen; Sabatini, Linda; Amundson, Jon K

2007-04-01

This paper briefly surveys the trend of and controversy surrounding empirical validation in psychotherapy. Empirical validation of hypnotherapy has paralleled the practice of validation in psychotherapy and the professionalization of clinical psychology, in general. This evolution in determining what counts as evidence for bona fide clinical practice has gone from theory-driven clinical approaches in the 1960s and 1970s through critical attempts at categorization of empirically supported therapies in the 1990s on to the concept of evidence-based practice in 2006. Implications of this progression in professional psychology are discussed in the light of hypnosis's current quest for validation and empirical accreditation.

Validation of Clinical Testing for Warfarin Sensitivity

PubMed Central

Langley, Michael R.; Booker, Jessica K.; Evans, James P.; McLeod, Howard L.; Weck, Karen E.

2009-01-01

Responses to warfarin (Coumadin) anticoagulation therapy are affected by genetic variability in both the CYP2C9 and VKORC1 genes. Validation of pharmacogenetic testing for warfarin responses includes demonstration of analytical validity of testing platforms and of the clinical validity of testing. We compared four platforms for determining the relevant single nucleotide polymorphisms (SNPs) in both CYP2C9 and VKORC1 that are associated with warfarin sensitivity (Third Wave Invader Plus, ParagonDx/Cepheid Smart Cycler, Idaho Technology LightCycler, and AutoGenomics Infiniti). Each method was examined for accuracy, cost, and turnaround time. All genotyping methods demonstrated greater than 95% accuracy for identifying the relevant SNPs (CYP2C9 *2 and *3; VKORC1 −1639 or 1173). The ParagonDx and Idaho Technology assays had the shortest turnaround and hands-on times. The Third Wave assay was readily scalable to higher test volumes but had the longest hands-on time. The AutoGenomics assay interrogated the largest number of SNPs but had the longest turnaround time. Four published warfarin-dosing algorithms (Washington University, UCSF, Louisville, and Newcastle) were compared for accuracy for predicting warfarin dose in a retrospective analysis of a local patient population on long-term, stable warfarin therapy. The predicted doses from both the Washington University and UCSF algorithms demonstrated the best correlation with actual warfarin doses. PMID:19324988

'Mechanical restraint-confounders, risk, alliance score': testing the clinical validity of a new risk assessment instrument.

PubMed

Deichmann Nielsen, Lea; Bech, Per; Hounsgaard, Lise; Alkier Gildberg, Frederik

2017-08-01

Unstructured risk assessment, as well as confounders (underlying reasons for the patient's risk behaviour and alliance), risk behaviour, and parameters of alliance, have been identified as factors that prolong the duration of mechanical restraint among forensic mental health inpatients. To clinically validate a new, structured short-term risk assessment instrument called the Mechanical Restraint-Confounders, Risk, Alliance Score (MR-CRAS), with the intended purpose of supporting the clinicians' observation and assessment of the patient's readiness to be released from mechanical restraint. The content and layout of MR-CRAS and its user manual were evaluated using face validation by forensic mental health clinicians, content validation by an expert panel, and pilot testing within two, closed forensic mental health inpatient units. The three sub-scales (Confounders, Risk, and a parameter of Alliance) showed excellent content validity. The clinical validations also showed that MR-CRAS was perceived and experienced as a comprehensible, relevant, comprehensive, and useable risk assessment instrument. MR-CRAS contains 18 clinically valid items, and the instrument can be used to support the clinical decision-making regarding the possibility of releasing the patient from mechanical restraint. The present three studies have clinically validated a short MR-CRAS scale that is currently being psychometrically tested in a larger study.

Validation of the tool assessment of clinical education (AssCE): A study using Delphi method and clinical experts.

PubMed

Löfmark, Anna; Mårtensson, Gunilla

2017-03-01

The aim of the present study was to establish the validity of the tool Assessment of Clinical Education (AssCE). The tool is widely used in Sweden and some Nordic countries for assessing nursing students' performance in clinical education. It is important that the tools in use be subjected to regular audit and critical reviews. The validation process, performed in two stages, was concluded with a high level of congruence. In the first stage, Delphi technique was used to elaborate the AssCE tool using a group of 35 clinical nurse lecturers. After three rounds, we reached consensus. In the second stage, a group of 46 clinical nurse lecturers representing 12 universities in Sweden and Norway audited the revised version of the AssCE in relation to learning outcomes from the last clinical course at their respective institutions. Validation of the revised AssCE was established with high congruence between the factors in the AssCE and examined learning outcomes. The revised AssCE tool seems to meet its objective to be a validated assessment tool for use in clinical nursing education. Copyright © 2016 Elsevier Ltd. All rights reserved.

Preanalytical management: serum vacuum tubes validation for routine clinical chemistry

PubMed Central

Lima-Oliveira, Gabriel; Lippi, Giuseppe; Salvagno, Gian Luca; Montagnana, Martina; Picheth, Geraldo; Guidi, Gian Cesare

2012-01-01

Introduction The validation process is essential in accredited clinical laboratories. Aim of this study was to validate five kinds of serum vacuum tubes for routine clinical chemistry laboratory testing. Materials and methods: Blood specimens from 100 volunteers in five diff erent serum vacuum tubes (Tube I: VACUETTE®, Tube II: LABOR IMPORT®, Tube III: S-Monovette®, Tube IV: SST® and Tube V: SST II®) were collected by a single, expert phlebotomist. The routine clinical chemistry tests were analyzed on cobas® 6000 module. The significance of the diff erences between samples was assessed by paired Student’s t-test after checking for normality. The level of statistical significance was set at P < 0.005. Finally, the biases from Tube I, Tube II, Tube III, Tube IV and Tube V were compared with the current desirable quality specifications for bias (B), derived from biological variation. Results and conclusions: Basically, our validation will permit the laboratory or hospital managers to select the brand’s vacuum tubes validated according him/her technical or economical reasons, in order to perform the following laboratory tests: glucose, total cholesterol, high density lipoprotein-cholesterol, triglycerides, total protein, albumin, blood urea nitrogen, uric acid, alkaline phosphatise, aspartate aminotransferase, gamma-glutamyltransferase, lactate dehydrogenase, creatine kinase, total bilirubin, direct bilirubin, calcium, iron, sodium and potassium. On the contrary special attention will be required if the laboratory already performs creatinine, amylase, phosphate and magnesium determinations and the quality laboratory manager intend to change the serum tubes. We suggest that laboratory management should both standardize the procedures and frequently evaluate the quality of in vitro diagnostic devices. PMID:22838184

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

PubMed

Greher, Michael R; Wodushek, Thomas R

2017-03-01

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

External model validation of binary clinical risk prediction models in cardiovascular and thoracic surgery.

PubMed

Hickey, Graeme L; Blackstone, Eugene H

2016-08-01

Clinical risk-prediction models serve an important role in healthcare. They are used for clinical decision-making and measuring the performance of healthcare providers. To establish confidence in a model, external model validation is imperative. When designing such an external model validation study, thought must be given to patient selection, risk factor and outcome definitions, missing data, and the transparent reporting of the analysis. In addition, there are a number of statistical methods available for external model validation. Execution of a rigorous external validation study rests in proper study design, application of suitable statistical methods, and transparent reporting. Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Refining and validating a conceptual model of Clinical Nurse Leader integrated care delivery.

PubMed

Bender, Miriam; Williams, Marjory; Su, Wei; Hites, Lisle

2017-02-01

To empirically validate a conceptual model of Clinical Nurse Leader integrated care delivery. There is limited evidence of frontline care delivery models that consistently achieve quality patient outcomes. Clinical Nurse Leader integrated care delivery is a promising nursing model with a growing record of success. However, theoretical clarity is necessary to generate causal evidence of effectiveness. Sequential mixed methods. A preliminary Clinical Nurse Leader practice model was refined and survey items developed to correspond with model domains, using focus groups and a Delphi process with a multi-professional expert panel. The survey was administered in 2015 to clinicians and administrators involved in Clinical Nurse Leader initiatives. Confirmatory factor analysis and structural equation modelling were used to validate the measurement and model structure. Final sample n = 518. The model incorporates 13 components organized into five conceptual domains: 'Readiness for Clinical Nurse Leader integrated care delivery'; 'Structuring Clinical Nurse Leader integrated care delivery'; 'Clinical Nurse Leader Practice: Continuous Clinical Leadership'; 'Outcomes of Clinical Nurse Leader integrated care delivery'; and 'Value'. Sample data had good fit with specified model and two-level measurement structure. All hypothesized pathways were significant, with strong coefficients suggesting good fit between theorized and observed path relationships. The validated model articulates an explanatory pathway of Clinical Nurse Leader integrated care delivery, including Clinical Nurse Leader practices that result in improved care dynamics and patient outcomes. The validated model provides a basis for testing in practice to generate evidence that can be deployed across the healthcare spectrum. © 2016 John Wiley & Sons Ltd.

Fit for purpose and modern validity theory in clinical outcomes assessment.

PubMed

Edwards, Michael C; Slagle, Ashley; Rubright, Jonathan D; Wirth, R J

2018-07-01

The US Food and Drug Administration (FDA), as part of its regulatory mission, is charged with determining whether a clinical outcome assessment (COA) is "fit for purpose" when used in clinical trials to support drug approval and product labeling. In this paper, we will provide a review (and some commentary) on the current state of affairs in COA development/evaluation/use with a focus on one aspect: How do you know you are measuring the right thing? In the psychometric literature, this concept is referred to broadly as validity and has itself evolved over many years of research and application. After a brief introduction, the first section will review current ideas about "fit for purpose" and how it has been viewed by FDA. This section will also describe some of the unique challenges to COA development/evaluation/use in the clinical trials space. Following this, we provide an overview of modern validity theory as it is currently understood in the psychometric tradition. This overview will focus primarily on the perspective of validity theorists such as Messick and Kane whose work forms the backbone for the bulk of high-stakes assessment in areas such as education, psychology, and health outcomes. We situate the concept of fit for purpose within the broader context of validity. By comparing and contrasting the approaches and the situations where they have traditionally been applied, we identify areas of conceptual overlap as well as areas where more discussion and research are needed.

[Systemic validation of clinical practice guidelines: the AGREE network].

PubMed

Hannes, K; Van Royen, P; Aertgeerts, B; Buntinx, F; Ramaekers, D; Chevalier, P

2005-12-01

Over recent decades, the number of available clinical practice guidelines has enormously grown. Guidelines should meet specific quality criteria to ensure good quality. There is a growing need for the developement of a set of criteria to ensure that potential biases inherent in guideline development have been properly addressed and that the recommendations for practice are valid and reliable. The AGREE-collaboration is an international network that developed an instrument to critically appraise the methodological quality of guidelines. AGREE promotes a clear strategy to produce, disseminate and evaluate guidelines of high quality. In the first phase of the international project the AGREE-instrument was tested in 11 different countries. Based on this experience the instrument was refined and optimised. In the second phase it was disseminated, promoted and evaluated in 18 participating countries. Belgium was one of them. The Belgian partner in the AGREE-project developed 3 workshops and established 13 validation committees to validate guidelines from Belgian developer groups. We collected 33 questionnaires from participants of the workshops and the validation committees, in which we asked for primary experiences and information on the usefulness and applicability of the instrument. We were also interested in the shortcomings of the instrument and potential strategies to bridge them. More efforts should be made to train methodological experts to gain certain skills for a critical appraisal of clinical practice guidelines. Promoting the AGREE-instrument will lead to a broader knowledge and use of quality criteria in guideline development and appraisal. The development and dissemination of an international list of criteria to appraise the quality of guidelines will stimulate the development of methodologically sound guidelines. International comparisons between existing guidelines will lead to a better collaboration between guideline developers throughout the world.

Development, validity and responsiveness of the Clinical COPD Questionnaire.

PubMed

van der Molen, Thys; Willemse, Brigitte W M; Schokker, Siebrig; ten Hacken, Nick H T; Postma, Dirkje S; Juniper, Elizabeth F

2003-04-28

The new Global Obstructive Lung Disease (GOLD) guidelines advice to focus treatment in Chronic Obstructive Pulmonary Disease (COPD) on improvement of functional state, prevention of disease progression and minimization of symptoms. So far no validated questionnaires are available to measure symptom and functional state in daily clinical practice. The aim of this study was to develop and validate the Clinical COPD Questionnaire (CCQ). Qualitative research with patients and clinicians was performed to generate possible items to evaluate clinical COPD control. Thereafter, an item reduction questionnaire was sent to 77 international experts. Sixty-seven experts responded and the 10 most important items, divided into 3 domains (symptoms, functional and mental state) were included in the CCQ (scale: 0 = best, 6 = worst). Cross-sectional data were collected from 119 subjects (57 COPD, GOLD stage I-III; 18 GOLD stage 0 and 44 (ex)smokers). Cronbach's alpha was high (0.91). The CCQ scores in patients (GOLD 0-III) were significantly higher than in healthy (ex)smokers. Furthermore, significant correlations were found between the CCQ total score and domains of the SF-36 (rho = 0.48 to rho = 0.69) and the SGRQ (rho = 0.67 to rho = 0.72). In patients with COPD, the correlation between the CCQ and FEV1%pred was rho =-0.49. Test-retest reliability was determined in 20 subjects in a 2-week interval (Intra Class Coefficient = 0.94). Thirty-six smokers with and without COPD showed significant improvement in the CCQ after 2 months smoking cessation, indicating the responsiveness of the CCQ. The CCQ is a self-administered questionnaire specially developed to measure clinical control in patients with COPD. Data support the validity, reliability and responsiveness of this short and easy to administer questionnaire.

Development, validity and responsiveness of the Clinical COPD Questionnaire

PubMed Central

van der Molen, Thys; Willemse, Brigitte WM; Schokker, Siebrig; ten Hacken, Nick HT; Postma, Dirkje S; Juniper, Elizabeth F

2003-01-01

Background The new Global Obstructive Lung Disease (GOLD) guidelines advice to focus treatment in Chronic Obstructive Pulmonary Disease (COPD) on improvement of functional state, prevention of disease progression and minimization of symptoms. So far no validated questionnaires are available to measure symptom and functional state in daily clinical practice. The aim of this study was to develop and validate the Clinical COPD Questionnaire (CCQ). Methods Qualitative research with patients and clinicians was performed to generate possible items to evaluate clinical COPD control. Thereafter, an item reduction questionnaire was sent to 77 international experts. Sixty-seven experts responded and the 10 most important items, divided into 3 domains (symptoms, functional and mental state) were included in the CCQ (scale: 0 = best, 6 = worst). Results Cross-sectional data were collected from 119 subjects (57 COPD, GOLD stage I-III; 18 GOLD stage 0 and 44 (ex)smokers). Cronbach's α was high (0.91). The CCQ scores in patients (GOLD 0-III) were significantly higher than in healthy (ex)smokers. Furthermore, significant correlations were found between the CCQ total score and domains of the SF-36 (ρ = 0.48 to ρ = 0.69) and the SGRQ (ρ = 0.67 to ρ = 0.72). In patients with COPD, the correlation between the CCQ and FEV1%pred was ρ =-0.49. Test-retest reliability was determined in 20 subjects in a 2-week interval (Intra Class Coefficient = 0.94). Thirty-six smokers with and without COPD showed significant improvement in the CCQ after 2 months smoking cessation, indicating the responsiveness of the CCQ. Conclusion The CCQ is a self-administered questionnaire specially developed to measure clinical control in patients with COPD. Data support the validity, reliability and responsiveness of this short and easy to administer questionnaire. PMID:12773199

Evidence for the Criterion Validity and Clinical Utility of the Pathological Narcissism Inventory

ERIC Educational Resources Information Center

Thomas, Katherine M.; Wright, Aidan G. C.; Lukowitsky, Mark R.; Donnellan, M. Brent; Hopwood, Christopher J.

2012-01-01

In this study, the authors evaluated aspects of criterion validity and clinical utility of the grandiosity and vulnerability components of the Pathological Narcissism Inventory (PNI) using two undergraduate samples (N = 299 and 500). Criterion validity was assessed by evaluating the correlations of narcissistic grandiosity and narcissistic…

Content Validation of Athletic Therapy Clinical Presentations in Canada

ERIC Educational Resources Information Center

Lafave, Mark R.; Yeo, Michelle; Westbrook, Khatija; Valdez, Dennis; Eubank, Breda; McAllister, Jenelle

2016-01-01

Context: Competency-based education requires strong planning and a vehicle to deliver and track students' progress across their undergraduate programs. Clinical presentations (CPs) are proposed as 1 method to deliver a competency-based curriculum in a Canadian undergraduate athletic therapy program. Objective: Validation of 253 CPs. Setting:…

Validation of the Novaco Anger Scale-Provocation Inventory (Danish) With Nonclinical, Clinical, and Offender Samples.

PubMed

Moeller, Stine Bjerrum; Novaco, Raymond W; Heinola-Nielsen, Vivian; Hougaard, Helle

2016-10-01

Anger has high prevalence in clinical and forensic settings, and it is associated with aggressive behavior and ward atmosphere on psychiatric units. Dysregulated anger is a clinical problem in Danish mental health care systems, but no anger assessment instruments have been validated in Danish. Because the Novaco Anger Scale and Provocation Inventory (NAS-PI) has been extensively validated with different clinical populations and lends itself to clinical case formulation, it was selected for translation and evaluation in the present multistudy project. Psychometric properties of the NAS-PI were investigated with samples of 477 nonclinical, 250 clinical, 167 male prisoner, and 64 male forensic participants. Anger prevalence and its relationship with other anger measures, anxiety/depression, and aggression were examined. NAS-PI was found to have high reliability, concurrent validity, and discriminant validity, and its scores discriminated the samples. High scores in the offender group demonstrated the feasibility of obtaining self-report assessments of anger with this population. Retrospective and prospective validity of the NAS were tested with the forensic patient sample regarding physically aggressive behavior in hospital. Regression analyses showed that higher scores on NAS increase the risk of having acted aggressively in the past and of acting aggressively in the future. © The Author(s) 2015.

Validation of Clinical Observations of Mastication in Persons with ALS.

PubMed

Simione, Meg; Wilson, Erin M; Yunusova, Yana; Green, Jordan R

2016-06-01

Amyotrophic lateral sclerosis (ALS) is a progressive neurological disease that can result in difficulties with mastication leading to malnutrition, choking or aspiration, and reduced quality of life. When evaluating mastication, clinicians primarily observe spatial and temporal aspects of jaw motion. The reliability and validity of clinical observations for detecting jaw movement abnormalities is unknown. The purpose of this study is to determine the reliability and validity of clinician-based ratings of chewing performance in neuro-typical controls and persons with varying degrees of chewing impairments due to ALS. Adults chewed a solid food consistency while full-face video were recorded along with jaw kinematic data using a 3D optical motion capture system. Five experienced speech-language pathologists watched the videos and rated the spatial and temporal aspects of chewing performance. The jaw kinematic data served as the gold-standard for validating the clinicians' ratings. Results showed that the clinician-based rating of temporal aspects of chewing performance had strong inter-rater reliability and correlated well with comparable kinematic measures. In contrast, the reliability of rating the spatial and spatiotemporal aspects of chewing (i.e., range of motion of the jaw, consistency of the chewing pattern) was mixed. Specifically, ratings of range of motion were at best only moderately reliable. Ratings of chewing movement consistency were reliable but only weakly correlated with comparable measures of jaw kinematics. These findings suggest that clinician ratings of temporal aspects of chewing are appropriate for clinical use, whereas ratings of the spatial and spatiotemporal aspects of chewing may not be reliable or valid.

Development and validation of an instrument to measure nurse educator perceived confidence in clinical teaching.

PubMed

Nguyen, Van N B; Forbes, Helen; Mohebbi, Mohammadreza; Duke, Maxine

2017-12-01

Teaching nursing in clinical environments is considered complex and multi-faceted. Little is known about the role of the clinical nurse educator, specifically the challenges related to transition from clinician, or in some cases, from newly-graduated nurse to that of clinical nurse educator, as occurs in developing countries. Confidence in the clinical educator role has been associated with successful transition and the development of role competence. There is currently no valid and reliable instrument to measure clinical nurse educator confidence. This study was conducted to develop and psychometrically test an instrument to measure perceived confidence among clinical nurse educators. A multi-phase, multi-setting survey design was used. A total of 468 surveys were distributed, and 363 were returned. Data were analyzed using exploratory and confirmatory factor analyses. The instrument was successfully tested and modified in phase 1, and factorial validity was subsequently confirmed in phase 2. There was strong evidence of internal consistency, reliability, content, and convergent validity of the Clinical Nurse Educator Skill Acquisition Assessment instrument. The resulting instrument is applicable in similar contexts due to its rigorous development and validation process. © 2017 The Authors. Nursing & Health Sciences published by John Wiley & Sons Australia, Ltd.

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

Elbow-specific clinical rating systems: extent of established validity, reliability, and responsiveness.

PubMed

The, Bertram; Reininga, Inge H F; El Moumni, Mostafa; Eygendaal, Denise

2013-10-01

The modern standard of evaluating treatment results includes the use of rating systems. Elbow-specific rating systems are frequently used in studies aiming at elbow-specific pathology. However, proper validation studies seem to be relatively sparse. In addition, these scoring systems might not always be used for appropriate populations of interest. Both of these issues might give rise to invalid conclusions being reported in the literature. Our aim was to investigate the extent to which the available elbow-specific outcome measurement tools have been validated and the quality of the validation itself. We also aimed to provide characteristics of the populations used for validation of these scales to enable clinicians to use them appropriately. A literature search identified 17 studies of 12 different elbow-specific scoring systems. These were assessed for validity, reliability, and responsiveness characteristics. The quality of these assessments was rated according to the Consensus Based Standards for the Selection of Health Measurement Instruments (COSMIN) checklist criteria, a standardized and validated tool developed specifically for this purpose. Currently, the only elbow-specific rating system that is validated using high-quality methodology is the Oxford Elbow Score, a patient-administered outcome measure tool that has been validated on heterogeneous study populations. Other rating systems still have to be proven in the future to be as good as the Oxford Elbow Score for clinical or research purposes. Additional validation studies are needed. Copyright © 2013 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

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.

Validation of the Portuguese version of the Brief Multidimensional Measure of Religiousness/Spirituality (BMMRS-P) in clinical and non-clinical samples.

PubMed

Curcio, Cristiane Schumann Silva; Lucchetti, Giancarlo; Moreira-Almeida, Alexander

2015-04-01

Despite Brazil's high levels of religious involvement, there is a scarcity of validated religiousness/spirituality (R/S) measures in Portuguese, particularly multidimensional ones. This study presents the validation of the Portuguese version of the "Brief Multidimensional Measure in Religiousness and Spirituality" (BMMRS) within the Brazilian context. Inpatients (262) and caregivers (389) at two hospitals of Brazil answered the BMMRS, the DUREL-p, and a sociodemographic questionnaire. The internal and convergent validity and test-retest reliability for major dimensions were good. Discriminant validity was high (except for the Forgiveness dimension). The Portuguese version of the BMMRS is a reliable and valid instrument to assess multiple R/S dimensions in clinical and non-clinical samples.

Validation of a next-generation sequencing assay for clinical molecular oncology.

PubMed

Cottrell, Catherine E; Al-Kateb, Hussam; Bredemeyer, Andrew J; Duncavage, Eric J; Spencer, David H; Abel, Haley J; Lockwood, Christina M; Hagemann, Ian S; O'Guin, Stephanie M; Burcea, Lauren C; Sawyer, Christopher S; Oschwald, Dayna M; Stratman, Jennifer L; Sher, Dorie A; Johnson, Mark R; Brown, Justin T; Cliften, Paul F; George, Bijoy; McIntosh, Leslie D; Shrivastava, Savita; Nguyen, Tudung T; Payton, Jacqueline E; Watson, Mark A; Crosby, Seth D; Head, Richard D; Mitra, Robi D; Nagarajan, Rakesh; Kulkarni, Shashikant; Seibert, Karen; Virgin, Herbert W; Milbrandt, Jeffrey; Pfeifer, John D

2014-01-01

Currently, oncology testing includes molecular studies and cytogenetic analysis to detect genetic aberrations of clinical significance. Next-generation sequencing (NGS) allows rapid analysis of multiple genes for clinically actionable somatic variants. The WUCaMP assay uses targeted capture for NGS analysis of 25 cancer-associated genes to detect mutations at actionable loci. We present clinical validation of the assay and a detailed framework for design and validation of similar clinical assays. Deep sequencing of 78 tumor specimens (≥ 1000× average unique coverage across the capture region) achieved high sensitivity for detecting somatic variants at low allele fraction (AF). Validation revealed sensitivities and specificities of 100% for detection of single-nucleotide variants (SNVs) within coding regions, compared with SNP array sequence data (95% CI = 83.4-100.0 for sensitivity and 94.2-100.0 for specificity) or whole-genome sequencing (95% CI = 89.1-100.0 for sensitivity and 99.9-100.0 for specificity) of HapMap samples. Sensitivity for detecting variants at an observed 10% AF was 100% (95% CI = 93.2-100.0) in HapMap mixes. Analysis of 15 masked specimens harboring clinically reported variants yielded concordant calls for 13/13 variants at AF of ≥ 15%. The WUCaMP assay is a robust and sensitive method to detect somatic variants of clinical significance in molecular oncology laboratories, with reduced time and cost of genetic analysis allowing for strategic patient management. Copyright © 2014 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

Validity of a computerized population registry of dementia based on clinical databases.

PubMed

Mar, J; Arrospide, A; Soto-Gordoa, M; Machón, M; Iruin, Á; Martinez-Lage, P; Gabilondo, A; Moreno-Izco, F; Gabilondo, A; Arriola, L

2018-05-08

The handling of information through digital media allows innovative approaches for identifying cases of dementia through computerized searches within the clinical databases that include systems for coding diagnoses. The aim of this study was to analyze the validity of a dementia registry in Gipuzkoa based on the administrative and clinical databases existing in the Basque Health Service. This is a descriptive study based on the evaluation of available data sources. First, through review of medical records, the diagnostic validity was evaluated in 2 samples of cases identified and not identified as dementia. The sensitivity, specificity and positive and negative predictive value of the diagnosis of dementia were measured. Subsequently, the cases of living dementia in December 31, 2016 were searched in the entire Gipuzkoa population to collect sociodemographic and clinical variables. The validation samples included 986 cases and 327 no cases. The calculated sensitivity was 80.2% and the specificity was 99.9%. The negative predictive value was 99.4% and positive value was 95.1%. The cases in Gipuzkoa were 10,551, representing 65% of the cases predicted according to the literature. Antipsychotic medication were taken by a 40% and a 25% of the cases were institutionalized. A registry of dementias based on clinical and administrative databases is valid and feasible. Its main contribution is to show the dimension of dementia in the health system. Copyright © 2018 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

Validation of a clinical critical thinking skills test in nursing.

PubMed

Shin, Sujin; Jung, Dukyoo; Kim, Sungeun

2015-01-27

The purpose of this study was to develop a revised version of the clinical critical thinking skills test (CCTS) and to subsequently validate its performance. This study is a secondary analysis of the CCTS. Data were obtained from a convenience sample of 284 college students in June 2011. Thirty items were analyzed using item response theory and test reliability was assessed. Test-retest reliability was measured using the results of 20 nursing college and graduate school students in July 2013. The content validity of the revised items was analyzed by calculating the degree of agreement between instrument developer intention in item development and the judgments of six experts. To analyze response process validity, qualitative data related to the response processes of nine nursing college students obtained through cognitive interviews were analyzed. Out of initial 30 items, 11 items were excluded after the analysis of difficulty and discrimination parameter. When the 19 items of the revised version of the CCTS were analyzed, levels of item difficulty were found to be relatively low and levels of discrimination were found to be appropriate or high. The degree of agreement between item developer intention and expert judgments equaled or exceeded 50%. From above results, evidence of the response process validity was demonstrated, indicating that subjects respondeds as intended by the test developer. The revised 19-item CCTS was found to have sufficient reliability and validity and will therefore represents a more convenient measurement of critical thinking ability.

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.

Validity and Reliability of the Clinical Competency Evaluation Instrument for Use among Physiotherapy Students: Pilot study.

PubMed

Muhamad, Zailani; Ramli, Ayiesah; Amat, Salleh

2015-05-01

The aim of this study was to determine the content validity, internal consistency, test-retest reliability and inter-rater reliability of the Clinical Competency Evaluation Instrument (CCEVI) in assessing the clinical performance of physiotherapy students. This study was carried out between June and September 2013 at University Kebangsaan Malaysia (UKM), Kuala Lumpur, Malaysia. A panel of 10 experts were identified to establish content validity by evaluating and rating each of the items used in the CCEVI with regards to their relevance in measuring students' clinical competency. A total of 50 UKM undergraduate physiotherapy students were assessed throughout their clinical placement to determine the construct validity of these items. The instrument's reliability was determined through a cross-sectional study involving a clinical performance assessment of 14 final-year undergraduate physiotherapy students. The content validity index of the entire CCEVI was 0.91, while the proportion of agreement on the content validity indices ranged from 0.83-1.00. The CCEVI construct validity was established with factor loading of ≥0.6, while internal consistency (Cronbach's alpha) overall was 0.97. Test-retest reliability of the CCEVI was confirmed with a Pearson's correlation range of 0.91-0.97 and an intraclass coefficient correlation range of 0.95-0.98. Inter-rater reliability of the CCEVI domains ranged from 0.59 to 0.97 on initial and subsequent assessments. This pilot study confirmed the content validity of the CCEVI. It showed high internal consistency, thereby providing evidence that the CCEVI has moderate to excellent inter-rater reliability. However, additional refinement in the wording of the CCEVI items, particularly in the domains of safety and documentation, is recommended to further improve the validity and reliability of the instrument.

Understanding Interrater Reliability and Validity of Risk Assessment Tools Used to Predict Adverse Clinical Events.

PubMed

Siedlecki, Sandra L; Albert, Nancy M

This article will describe how to assess interrater reliability and validity of risk assessment tools, using easy-to-follow formulas, and to provide calculations that demonstrate principles discussed. Clinical nurse specialists should be able to identify risk assessment tools that provide high-quality interrater reliability and the highest validity for predicting true events of importance to clinical settings. Making best practice recommendations for assessment tool use is critical to high-quality patient care and safe practices that impact patient outcomes and nursing resources. Optimal risk assessment tool selection requires knowledge about interrater reliability and tool validity. The clinical nurse specialist will understand the reliability and validity issues associated with risk assessment tools, and be able to evaluate tools using basic calculations. Risk assessment tools are developed to objectively predict quality and safety events and ultimately reduce the risk of event occurrence through preventive interventions. To ensure high-quality tool use, clinical nurse specialists must critically assess tool properties. The better the tool's ability to predict adverse events, the more likely that event risk is mediated. Interrater reliability and validity assessment is relatively an easy skill to master and will result in better decisions when selecting or making recommendations for risk assessment tool use.

The Clinical Impression of Severity Index for Parkinson's Disease: international validation study.

PubMed

Martínez-Martín, Pablo; Rodríguez-Blázquez, Carmen; Forjaz, Maria João; de Pedro, Jesús

2009-01-30

This study sought to provide further information about the psychometric properties of the Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD), in a large, international, cross-culturally diverse sample. Six hundred and fourteen patients with PD participated in the study. Apart from the CISI-PD, assessments were based on Hoehn & Yahr (HY) staging, the Scales for Outcomes in PD-Motor (SCOPA-M), -Cognition (SCOPA-COG) and -Psychosocial (SCOPA-PS), the Cumulative Illness Rating Scale-Geriatrics, and the Hospital Anxiety and Depression Scale. The total CISI-PD score displayed no floor or ceiling effects. Internal consistency was 0.81, the test-retest intraclass correlation coefficient was 0.84, and item homogeneity was 0.52. Exploratory and confirmatory factor analysis (CFI = 0.99, RMSEA = 0.07) confirmed CISI-PD's unifactorial structure. The CISI-PD showed adequate convergent validity with SCOPA-COG and SCOPA-M (r(S) = 0.46-0.85, respectively) and discriminative validity for HY stages and disease duration (P < 0.0001). In a multiple regression model, main CISI-PD predictors were SCOPA-M, disease duration, and depression. The results obtained were not only comparable to but also extended those yielded by the preliminary validation study, thus showing that the CISI-PD is a valid instrument to measure clinical impression of severity in PD. Its simplicity and easy application make it an attractive and useful tool for clinical practice and research.

DEVELOPMENT OF MOTIVATION SCALE - CLINICAL VALIDATION WITH ALCOHOL DEPENDENTS

PubMed Central

Neeliyara, Teresa; Nagalakshmi, S.V.

1994-01-01

This study focusses on the development of a comprehensive multi-dimensional scale for assessing motivation for change in the alcohol dependent population. After establishing face validity, the items evolved were administered to a normal sample of 600 male subjects in whom psychiatric illness was ruled out. The data thus obtained was subjected to factor analysis. Six factors were obtained which accounted for 55.2% of variance. These together formed a 80 item five point scale and norms were established on a sample of 600 normal subjects. Further clinical validation was established on 30 alcohol dependent subjects and 30 normals. The status of motivation was found to be inadequate in alcohol dependent individuals as compared to the normals. Split-half reliability was carried out and the tool was found to be highly reliable. PMID:21743674

Validation of a clinical critical thinking skills test in nursing

PubMed Central

2015-01-01

Purpose: The purpose of this study was to develop a revised version of the clinical critical thinking skills test (CCTS) and to subsequently validate its performance. Methods: This study is a secondary analysis of the CCTS. Data were obtained from a convenience sample of 284 college students in June 2011. Thirty items were analyzed using item response theory and test reliability was assessed. Test-retest reliability was measured using the results of 20 nursing college and graduate school students in July 2013. The content validity of the revised items was analyzed by calculating the degree of agreement between instrument developer intention in item development and the judgments of six experts. To analyze response process validity, qualitative data related to the response processes of nine nursing college students obtained through cognitive interviews were analyzed. Results: Out of initial 30 items, 11 items were excluded after the analysis of difficulty and discrimination parameter. When the 19 items of the revised version of the CCTS were analyzed, levels of item difficulty were found to be relatively low and levels of discrimination were found to be appropriate or high. The degree of agreement between item developer intention and expert judgments equaled or exceeded 50%. Conclusion: From above results, evidence of the response process validity was demonstrated, indicating that subjects respondeds as intended by the test developer. The revised 19-item CCTS was found to have sufficient reliability and validity and will therefore represents a more convenient measurement of critical thinking ability. PMID:25622716

Clinical validation of the nursing diagnosis of ineffective protection in haemodialysis patients.

PubMed

de Sá Tinôco, Jéssica Dantas; de Paiva, Maria das Graças Mariano Nunes; de Queiroz Frazão, Cecília Maria Farias; Lucio, Kadyjina Daiane Batista; Fernandes, Maria Isabel da Conceição Dias; de Oliveira Lopes, Marcos Venicios; de Carvalho Lira, Ana Luisa Brandão

2018-01-01

To evaluate the clinical validity of indicators of the nursing diagnosis of "ineffective protection" in haemodialysis patients. Haemodialysis patients have reduced protection. Studies on the nursing diagnosis of "ineffective protection" are scarce in the literature. The use of indicators to diagnose "ineffective protection" could improve the care of haemodialysis patients. The clinical usefulness of the indicators requires clinical validation. This was a diagnostic accuracy study. This study assessed a sample of 200 patients undergoing haemodialysis in a reference clinic for nephrology during the first half of 2015. Operational definitions were created for each clinical indicator based on concept analysis and content validation by experts for these indicators. Diagnostic accuracy measurement was performed with latent class analysis with randomised effects. The clinical indicator of "fatigue" had high sensitivity (p = .999) and specificity (p = 1.000) for the identification of "ineffective protection." Additionally, "maladaptive response to stress" (p = .711) and "coagulation change" (p = .653) were sensitive indicators. The main indicators that showed high specificity were "fever" (p = .987), "increased number of hospitalisations" (p = .911), "weakness" (p = .937), "infected vascular access" (p = .962) and "vascular access dysfunction" (p = .722). A set of nine clinical indicators of "ineffective protection" were accurate and statistically significant for haemodialysis patients. Three clinical indicators showed sensitivity, and six indicators showed specificity. Accurate measures for nursing diagnoses can help nurses confirm or rule out the probability of the occurrence of "ineffective protection" in patients undergoing haemodialysis. © 2017 John Wiley & Sons Ltd.

Incremental Validity in the Clinical Assessment of Early Childhood Development

ERIC Educational Resources Information Center

Liu, Xin; Zhou, Xiaobin; Lackaff, Julie

2013-01-01

The authors demonstrate the increment of clinical validity in early childhood assessment of physical impairment (PI), developmental delay (DD), and autism (AUT) using multiple standardized developmental screening measures such as performance measures and parent and teacher rating scales. Hierarchical regression and sensitivity/specificity analyses…

Inertial Measurement Units for Clinical Movement Analysis: Reliability and Concurrent Validity

PubMed Central

Nicholas, Kevin; Sparkes, Valerie; Sheeran, Liba; Davies, Jennifer L

2018-01-01

The aim of this study was to investigate the reliability and concurrent validity of a commercially available Xsens MVN BIOMECH inertial-sensor-based motion capture system during clinically relevant functional activities. A clinician with no prior experience of motion capture technologies and an experienced clinical movement scientist each assessed 26 healthy participants within each of two sessions using a camera-based motion capture system and the MVN BIOMECH system. Participants performed overground walking, squatting, and jumping. Sessions were separated by 4 ± 3 days. Reliability was evaluated using intraclass correlation coefficient and standard error of measurement, and validity was evaluated using the coefficient of multiple correlation and the linear fit method. Day-to-day reliability was generally fair-to-excellent in all three planes for hip, knee, and ankle joint angles in all three tasks. Within-day (between-rater) reliability was fair-to-excellent in all three planes during walking and squatting, and poor-to-high during jumping. Validity was excellent in the sagittal plane for hip, knee, and ankle joint angles in all three tasks and acceptable in frontal and transverse planes in squat and jump activity across joints. Our results suggest that the MVN BIOMECH system can be used by a clinician to quantify lower-limb joint angles in clinically relevant movements. PMID:29495600

Applying Kane's Validity Framework to a Simulation Based Assessment of Clinical Competence

ERIC Educational Resources Information Center

Tavares, Walter; Brydges, Ryan; Myre, Paul; Prpic, Jason; Turner, Linda; Yelle, Richard; Huiskamp, Maud

2018-01-01

Assessment of clinical competence is complex and inference based. Trustworthy and defensible assessment processes must have favourable evidence of validity, particularly where decisions are considered high stakes. We aimed to organize, collect and interpret validity evidence for a high stakes simulation based assessment strategy for certifying…

A critical evaluation of the validity of episodic future thinking: A clinical neuropsychology perspective.

PubMed

Ward, Amanda M

2016-11-01

Episodic future thinking is defined as the ability to mentally simulate a future event. Although episodic future thinking has been studied extensively in neuroscience, this construct has not been explored in depth from the perspective of clinical neuropsychology. The aim of this critical narrative review is to assess the validity and clinical implications of episodic future thinking. A systematic review of episodic future thinking literature was conducted. PubMed and PsycInfo were searched through July 2015 for review and empirical articles with the following search terms: "episodic future thinking," "future mental simulation," "imagining the future," "imagining new experiences," "future mental time travel," "future autobiographical experience," and "prospection." The review discusses evidence that episodic future thinking is important for adaptive functioning, which has implications for neurological populations. To determine the validity of episodic future thinking, the construct is evaluated with respect to related constructs, such as imagination, episodic memory, autobiographical memory, prospective memory, narrative construction, and working memory. Although it has been minimally investigated, there is evidence of convergent and discriminant validity for episodic future thinking. Research has not addressed the incremental validity of episodic future thinking. Practical considerations of episodic future thinking tasks and related constructs in a clinical neuropsychological setting are considered. The utility of episodic future thinking is currently unknown due to the lack of research investigating the validity of episodic future thinking. Future work is discussed, which could determine whether episodic future thinking is an important missing piece in standard clinical neuropsychological assessment. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Development and validation of Dutch version of Lasater Clinical Judgment Rubric in hospital practice: An instrument design study.

PubMed

Vreugdenhil, Jettie; Spek, Bea

2018-03-01

Clinical reasoning in patient care is a skill that cannot be observed directly. So far, no reliable, valid instrument exists for the assessment of nursing students' clinical reasoning skills in hospital practice. Lasater's clinical judgment rubric (LCJR), based on Tanner's model "Thinking like a nurse" has been tested, mainly in academic simulation settings. The aim is to develop a Dutch version of the LCJR (D-LCJR) and to test its psychometric properties when used in a hospital traineeship context. A mixed-model approach was used to develop and to validate the instrument. Ten dedicated educational units in a university hospital. A well-mixed group of 52 nursing students, nurse coaches and nurse educators. A Delphi panel developed the D-LCJR. Students' clinical reasoning skills were assessed "live" by nurse coaches, nurse educators and students who rated themselves. The psychometric properties tested during the assessment process are reliability, reproducibility, content validity and construct validity by testing two hypothesis: 1) a positive correlation between assessed and self-reported sum scores (convergent validity) and 2) a linear relation between experience and sum score (clinical validity). The obtained D-LCJR was found to be internally consistent, Cronbach's alpha 0.93. The rubric is also reproducible with intraclass correlations between 0.69 and 0.78. Experts judged it to be content valid. The two hypothesis were both tested significant, supporting evidence for construct validity. The translated and modified LCJR, is a promising tool for the evaluation of nursing students' development in clinical reasoning in hospital traineeships, by students, nurse coaches and nurse educators. More evidence on construct validity is necessary, in particular for students at the end of their hospital traineeship. Based on our research, the D-LCJR applied in hospital traineeships is a usable and reliable tool. Copyright © 2017 Elsevier Ltd. All rights reserved.

Construct Validity: Advances in Theory and Methodology

PubMed Central

Strauss, Milton E.; Smith, Gregory T.

2008-01-01

Measures of psychological constructs are validated by testing whether they relate to measures of other constructs as specified by theory. Each test of relations between measures reflects on the validity of both the measures and the theory driving the test. Construct validation concerns the simultaneous process of measure and theory validation. In this chapter, we review the recent history of validation efforts in clinical psychological science that has led to this perspective, and we review five recent advances in validation theory and methodology of importance for clinical researchers. These are: the emergence of nonjustificationist philosophy of science; an increasing appreciation for theory and the need for informative tests of construct validity; valid construct representation in experimental psychopathology; the need to avoid representing multidimensional constructs with a single score; and the emergence of effective new statistical tools for the evaluation of convergent and discriminant validity. PMID:19086835

Development, Validation, and Implementation of a Clinic Nurse Staffing Guideline.

PubMed

Deeken, Debra Jean; Wakefield, Douglas; Kite, Cora; Linebaugh, Jeanette; Mitchell, Blair; Parkinson, Deidre; Misra, Madhukar

2017-10-01

Ensuring that the level of nurse staffing used to care for patients is appropriate to the setting and service intensity is essential for high-quality and cost-effective care. This article describes the development, validation, and implementation of the clinic technical skills permission list developed specifically to guide nurse staffing decisions in physician clinics of an academic medical center. Results and lessons learned in using this staffing guideline are presented.

Adapting Social Neuroscience Measures for Schizophrenia Clinical Trials, Part 3: Fathoming External Validity

PubMed Central

Olbert, Charles M.

2013-01-01

It is unknown whether measures adapted from social neuroscience linked to specific neural systems will demonstrate relationships to external variables. Four paradigms adapted from social neuroscience were administered to 173 clinically stable outpatients with schizophrenia to determine their relationships to functionally meaningful variables and to investigate their incremental validity beyond standard measures of social and nonsocial cognition. The 4 paradigms included 2 that assess perception of nonverbal social and action cues (basic biological motion and emotion in biological motion) and 2 that involve higher level inferences about self and others’ mental states (self- referential memory and empathic accuracy). Overall, social neuroscience paradigms showed significant relationships to functional capacity but weak relationships to community functioning; the paradigms also showed weak correlations to clinical symptoms. Evidence for incremental validity beyond standard measures of social and nonsocial cognition was mixed with additional predictive power shown for functional capacity but not community functioning. Of the newly adapted paradigms, the empathic accuracy task had the broadest external validity. These results underscore the difficulty of translating developments from neuroscience into clinically useful tasks with functional significance. PMID:24072806

Adapting social neuroscience measures for schizophrenia clinical trials, part 3: fathoming external validity.

PubMed

Olbert, Charles M; Penn, David L; Kern, Robert S; Lee, Junghee; Horan, William P; Reise, Steven P; Ochsner, Kevin N; Marder, Stephen R; Green, Michael F

2013-11-01

It is unknown whether measures adapted from social neuroscience linked to specific neural systems will demonstrate relationships to external variables. Four paradigms adapted from social neuroscience were administered to 173 clinically stable outpatients with schizophrenia to determine their relationships to functionally meaningful variables and to investigate their incremental validity beyond standard measures of social and nonsocial cognition. The 4 paradigms included 2 that assess perception of nonverbal social and action cues (basic biological motion and emotion in biological motion) and 2 that involve higher level inferences about self and others' mental states (self-referential memory and empathic accuracy). Overall, social neuroscience paradigms showed significant relationships to functional capacity but weak relationships to community functioning; the paradigms also showed weak correlations to clinical symptoms. Evidence for incremental validity beyond standard measures of social and nonsocial cognition was mixed with additional predictive power shown for functional capacity but not community functioning. Of the newly adapted paradigms, the empathic accuracy task had the broadest external validity. These results underscore the difficulty of translating developments from neuroscience into clinically useful tasks with functional significance.

Construction and validation of clinical contents for development of learning objects.

PubMed

Hortense, Flávia Tatiana Pedrolo; Bergerot, Cristiane Decat; Domenico, Edvane Birelo Lopes de

2018-01-01

to describe the process of construction and validation of clinical contents for health learning objects, aimed at patients in the treatment of head and neck cancer. descriptive, methodological study. The development of the script and the storyboard were based on scientific evidence and submitted to the appreciation of specialists for validation of content. The agreement index was checked quantitatively and the suggestions were qualitatively evaluated. The items described in the roadmap were approved by 99% of expert experts. The suggestions for adjustments were inserted in their entirety in the final version. The free-marginal kappa statistical test, for multiple evaluators, presented value equal to 0.68%, granting a substantial agreement. The steps taken in the construction and validation of the content for the production of educational material for patients with head and neck cancer were adequate, relevant and suitable for use in other subjects.

Clinical validation of nursing outcome mobility in patients with cerebrovascular accidents.

PubMed

Moreira, Rafaella Pessoa; Araujo, Thelma Leite de; Lopes, Marcos Venicios de Oliveira; Cavalcante, Tahissa Frota; Guedes, Nirla Gomes; Chaves, Emília Soares; Portela, Regiane Campos; Holanda, Rose-Eloise

2016-12-15

To clinically validate the nursing outcome Mobility in patients with cerebrovascular accidents. Descriptive study, conducted in July 2011, with 38 outpatients, in northeastern Brazil. Data collection took place by evaluating two pairs of specialist nurses, where one pair used the instrument containing the constitutive and operational definitions of the indicators and magnitudes of the Mobility Outcome and the other pair without such definitions. When analyzing the evaluations among nurses, all indicators showed significant differences by the Friedman test (p <0.05). The constitutive and operational definitions submitted to the validation process provide greater accuracy in assessing the cerebrovascular accident patient's mobility state.

Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine. Part 3: Technical Validation of Immunohistochemistry (IHC) Assays in Clinical IHC Laboratories.

PubMed

Torlakovic, Emina E; Cheung, Carol C; D'Arrigo, Corrado; Dietel, Manfred; Francis, Glenn D; Gilks, C Blake; Hall, Jacqueline A; Hornick, Jason L; Ibrahim, Merdol; Marchetti, Antonio; Miller, Keith; van Krieken, J Han; Nielsen, Soren; Swanson, Paul E; Vyberg, Mogens; Zhou, Xiaoge; Taylor, Clive R

2017-03-01

Validation of immunohistochemistry (IHC) assays is a subject that is of great importance to clinical practice as well as basic research and clinical trials. When applied to clinical practice and focused on patient safety, validation of IHC assays creates objective evidence that IHC assays used for patient care are "fit-for-purpose." Validation of IHC assays needs to be properly informed by and modeled to assess the purpose of the IHC assay, which will further determine what sphere of validation is required, as well as the scope, type, and tier of technical validation. These concepts will be defined in this review, part 3 of the 4-part series "Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine."

Reliability and validity in a nutshell.

PubMed

Bannigan, Katrina; Watson, Roger

2009-12-01

To explore and explain the different concepts of reliability and validity as they are related to measurement instruments in social science and health care. There are different concepts contained in the terms reliability and validity and these are often explained poorly and there is often confusion between them. To develop some clarity about reliability and validity a conceptual framework was built based on the existing literature. The concepts of reliability, validity and utility are explored and explained. Reliability contains the concepts of internal consistency and stability and equivalence. Validity contains the concepts of content, face, criterion, concurrent, predictive, construct, convergent (and divergent), factorial and discriminant. In addition, for clinical practice and research, it is essential to establish the utility of a measurement instrument. To use measurement instruments appropriately in clinical practice, the extent to which they are reliable, valid and usable must be established.

Development and validation of a survey to measure features of clinical networks.

PubMed

Brown, Bernadette Bea; Haines, Mary; Middleton, Sandy; Paul, Christine; D'Este, Catherine; Klineberg, Emily; Elliott, Elizabeth

2016-09-30

Networks of clinical experts are increasingly being implemented as a strategy to improve health care processes and outcomes and achieve change in the health system. Few are ever formally evaluated and, when this is done, not all networks are equally successful in their efforts. There is a need to formatively assess the strategic and operational management and leadership of networks to identify where functioning could be improved to maximise impact. This paper outlines the development and psychometric evaluation of an Internet survey to measure features of clinical networks and provides descriptive results from a sample of members of 19 diverse clinical networks responsible for evidence-based quality improvement across a large geographical region. Instrument development was based on: a review of published and grey literature; a qualitative study of clinical network members; a program logic framework; and consultation with stakeholders. The resulting domain structure was validated for a sample of 592 clinical network members using confirmatory factor analysis. Scale reliability was assessed using Cronbach's alpha. A summary score was calculated for each domain and aggregate level means and ranges are reported. The instrument was shown to have good construct validity across seven domains as demonstrated by a high level of internal consistency, and all Cronbach's α coefficients were equal to or above 0.75. In the survey sample of network members there was strong reported commitment and belief in network-led quality improvement initiatives, which were perceived to have improved quality of care (72.8 %) and patient outcomes (63.2 %). Network managers were perceived to be effective leaders and clinical co-chairs were perceived as champions for change. Perceived external support had the lowest summary score across the seven domains. This survey, which has good construct validity and internal reliability, provides a valid instrument to use in future research related to

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

PubMed

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

2016-11-01

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

Clinical validation of the nursing diagnosis of dysfunctional family processes related to alcoholism.

PubMed

Mangueira, Suzana de Oliveira; Lopes, Marcos Venícios de Oliveira

2016-10-01

To evaluate the clinical validity indicators for the nursing diagnosis of dysfunctional family processes related to alcohol abuse. Alcoholism is a chronic disease that negatively affects family relationships. Studies on the nursing diagnosis of dysfunctional family processes are scarce in the literature. This diagnosis is currently composed of 115 defining characteristics, hindering their use in practice and highlighting the need for clinical validation. This was a diagnostic accuracy study. A sample of 110 alcoholics admitted to a reference centre for alcohol treatment was assessed during the second half of 2013 for the presence or absence of the defining characteristics of the diagnosis. Operational definitions were created for each defining characteristic based on concept analysis and experts evaluated the content of these definitions. Diagnostic accuracy measures were calculated from latent class models with random effects. All 89 clinical indicators were found in the sample and a set of 24 clinical indicators was identified as clinically valid for a diagnostic screening for family dysfunction from the report of alcoholics. Main clinical indicators with high specificity included sexual abuse, disturbance in academic performance in children and manipulation. The main indicators that showed high sensitivity values were distress, loss, anxiety, low self-esteem, confusion, embarrassment, insecurity, anger, loneliness, deterioration in family relationships and disturbance in family dynamics. Eighteen clinical indicators showed a high capacity for diagnostic screening for alcoholics (high sensitivity) and six indicators can be used for confirmatory diagnosis (high specificity). © 2016 John Wiley & Sons Ltd.

Comparing Parent-Child Interactions in the Clinic and at Home: An Exploration of the Validity of Clinical Behavior Observations Using Sequential Analysis

ERIC Educational Resources Information Center

Shriver, Mark D.; Frerichs, Lynae J.; Williams, Melissa; Lancaster, Blake M.

2013-01-01

Direct observation is often considered the "gold standard" for assessing the function, frequency, and intensity of problem behavior. Currently, the literature investigating the construct validity of direct observation conducted in the clinic setting reveals conflicting results. Previous studies on the construct validity of clinic-based…

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

ERIC Educational Resources Information Center

Baig, Lubna; Violato, Claudio; Crutcher, Rodney

2010-01-01

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

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

PubMed

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

2018-06-01

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

ClinicalCodes: an online clinical codes repository to improve the validity and reproducibility of research using electronic medical records.

PubMed

Springate, David A; Kontopantelis, Evangelos; Ashcroft, Darren M; Olier, Ivan; Parisi, Rosa; Chamapiwa, Edmore; Reeves, David

2014-01-01

Lists of clinical codes are the foundation for research undertaken using electronic medical records (EMRs). If clinical code lists are not available, reviewers are unable to determine the validity of research, full study replication is impossible, researchers are unable to make effective comparisons between studies, and the construction of new code lists is subject to much duplication of effort. Despite this, the publication of clinical codes is rarely if ever a requirement for obtaining grants, validating protocols, or publishing research. In a representative sample of 450 EMR primary research articles indexed on PubMed, we found that only 19 (5.1%) were accompanied by a full set of published clinical codes and 32 (8.6%) stated that code lists were available on request. To help address these problems, we have built an online repository where researchers using EMRs can upload and download lists of clinical codes. The repository will enable clinical researchers to better validate EMR studies, build on previous code lists and compare disease definitions across studies. It will also assist health informaticians in replicating database studies, tracking changes in disease definitions or clinical coding practice through time and sharing clinical code information across platforms and data sources as research objects.

ClinicalCodes: An Online Clinical Codes Repository to Improve the Validity and Reproducibility of Research Using Electronic Medical Records

PubMed Central

Springate, David A.; Kontopantelis, Evangelos; Ashcroft, Darren M.; Olier, Ivan; Parisi, Rosa; Chamapiwa, Edmore; Reeves, David

2014-01-01

Lists of clinical codes are the foundation for research undertaken using electronic medical records (EMRs). If clinical code lists are not available, reviewers are unable to determine the validity of research, full study replication is impossible, researchers are unable to make effective comparisons between studies, and the construction of new code lists is subject to much duplication of effort. Despite this, the publication of clinical codes is rarely if ever a requirement for obtaining grants, validating protocols, or publishing research. In a representative sample of 450 EMR primary research articles indexed on PubMed, we found that only 19 (5.1%) were accompanied by a full set of published clinical codes and 32 (8.6%) stated that code lists were available on request. To help address these problems, we have built an online repository where researchers using EMRs can upload and download lists of clinical codes. The repository will enable clinical researchers to better validate EMR studies, build on previous code lists and compare disease definitions across studies. It will also assist health informaticians in replicating database studies, tracking changes in disease definitions or clinical coding practice through time and sharing clinical code information across platforms and data sources as research objects. PMID:24941260

[Validation of a questionnaire to evaluate patient safety in clinical laboratories].

PubMed

Giménez Marín, Ángeles; Rivas-Ruiz, Francisco

2012-01-01

The aim of this study was to prepare, pilot and validate a questionnaire to evaluate patient safety in the specific context of clinical laboratories. A specific questionnaire on patient safety in the laboratory, with 62 items grouped into six areas, was developed, taking into consideration the diverse human and laboratory contextual factors which may contribute to producing errors. A pilot study of 30 interviews was carried out, including validity and reliability analyses using principal components factor analysis and Cronbach's alpha. Subsequently, 240 questionnaires were sent to 21 hospitals, followed by a test-retest of 41 questionnaires with the definitive version. The sample analyzed was composed of 225 questionnaires (an overall response rate of 80%). Of the 62 items initially assessed, 17 were eliminated due to non-compliance with the criteria established before the principal components factor analysis was performed. For the 45 remaining items, 12 components were identified, with an cumulative variance of 69.5%. In seven of the 10 components with two or more items, Cronbach's alpha was higher than 0.7. The questionnaire items assessed in the test-retest were found to be stable. We present the first questionnaire with sufficiently proven validity and reliability for evaluating patient safety in the specific context of clinical laboratories. This questionnaire provides a useful instrument to perform a subsequent macrostudy of hospital clinical laboratories in Spain. The questionnaire can also be used to monitor and promote commitment to patient safety within the search for continuous quality improvement. Copyright © 2011 SESPAS. Published by Elsevier Espana. All rights reserved.

Validity of faculty and resident global assessment of medical students' clinical knowledge during their pediatrics clerkship.

PubMed

Dudas, Robert A; Colbert, Jorie M; Goldstein, Seth; Barone, Michael A

2012-01-01

Medical knowledge is one of six core competencies in medicine. Medical student assessments should be valid and reliable. We assessed the relationship between faculty and resident global assessment of pediatric medical student knowledge and performance on a standardized test in medical knowledge. Retrospective cross-sectional study of medical students on a pediatric clerkship in academic year 2008-2009 at one academic health center. Faculty and residents rated students' clinical knowledge on a 5-point Likert scale. The inter-rater reliability of clinical knowledge ratings was assessed by calculating the intra-class correlation coefficient (ICC) for residents' ratings, faculty ratings, and both rating types combined. Convergent validity between clinical knowledge ratings and scores on the National Board of Medical Examiners (NBME) clinical subject examination in pediatrics was assessed with Pearson product moment correlation correction and the coefficient of the determination. There was moderate agreement for global clinical knowledge ratings by faculty and moderate agreement for ratings by residents. The agreement was also moderate when faculty and resident ratings were combined. Global ratings of clinical knowledge had high convergent validity with pediatric examination scores when students were rated by both residents and faculty. Our findings provide evidence for convergent validity of global assessment of medical students' clinical knowledge with NBME subject examination scores in pediatrics. Copyright © 2012 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

Automated validation of patient safety clinical incident classification: macro analysis.

PubMed

Gupta, Jaiprakash; Patrick, Jon

2013-01-01

Patient safety is the buzz word in healthcare. Incident Information Management System (IIMS) is electronic software that stores clinical mishaps narratives in places where patients are treated. It is estimated that in one state alone over one million electronic text documents are available in IIMS. In this paper we investigate the data density available in the fields entered to notify an incident and the validity of the built in classification used by clinician to categories the incidents. Waikato Environment for Knowledge Analysis (WEKA) software was used to test the classes. Four statistical classifier based on J48, Naïve Bayes (NB), Naïve Bayes Multinominal (NBM) and Support Vector Machine using radial basis function (SVM_RBF) algorithms were used to validate the classes. The data pool was 10,000 clinical incidents drawn from 7 hospitals in one state in Australia. In first part of the study 1000 clinical incidents were selected to determine type and number of fields worth investigating and in the second part another 5448 clinical incidents were randomly selected to validate 13 clinical incident types. Result shows 74.6% of the cells were empty and only 23 fields had content over 70% of the time. The percentage correctly classified classes on four algorithms using categorical dataset ranged from 42 to 49%, using free-text datasets from 65% to 77% and using both datasets from 72% to 79%. Kappa statistic ranged from 0.36 to 0.4. for categorical data, from 0.61 to 0.74. for free-text and from 0.67 to 0.77 for both datasets. Similar increases in performance in the 3 experiments was noted on true positive rate, precision, F-measure and area under curve (AUC) of receiver operating characteristics (ROC) scores. The study demonstrates only 14 of 73 fields in IIMS have data that is usable for machine learning experiments. Irrespective of the type of algorithms used when all datasets are used performance was better. Classifier NBM showed best performance. We think the

Validation of biomarkers to predict response to immunotherapy in cancer: Volume I - pre-analytical and analytical validation.

PubMed

Masucci, Giuseppe V; Cesano, Alessandra; Hawtin, Rachael; Janetzki, Sylvia; Zhang, Jenny; Kirsch, Ilan; Dobbin, Kevin K; Alvarez, John; Robbins, Paul B; Selvan, Senthamil R; Streicher, Howard Z; Butterfield, Lisa H; Thurin, Magdalena

2016-01-01

Immunotherapies have emerged as one of the most promising approaches to treat patients with cancer. Recently, there have been many clinical successes using checkpoint receptor blockade, including T cell inhibitory receptors such as cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) and programmed cell death-1 (PD-1). Despite demonstrated successes in a variety of malignancies, responses only typically occur in a minority of patients in any given histology. Additionally, treatment is associated with inflammatory toxicity and high cost. Therefore, determining which patients would derive clinical benefit from immunotherapy is a compelling clinical question. Although numerous candidate biomarkers have been described, there are currently three FDA-approved assays based on PD-1 ligand expression (PD-L1) that have been clinically validated to identify patients who are more likely to benefit from a single-agent anti-PD-1/PD-L1 therapy. Because of the complexity of the immune response and tumor biology, it is unlikely that a single biomarker will be sufficient to predict clinical outcomes in response to immune-targeted therapy. Rather, the integration of multiple tumor and immune response parameters, such as protein expression, genomics, and transcriptomics, may be necessary for accurate prediction of clinical benefit. Before a candidate biomarker and/or new technology can be used in a clinical setting, several steps are necessary to demonstrate its clinical validity. Although regulatory guidelines provide general roadmaps for the validation process, their applicability to biomarkers in the cancer immunotherapy field is somewhat limited. Thus, Working Group 1 (WG1) of the Society for Immunotherapy of Cancer (SITC) Immune Biomarkers Task Force convened to address this need. In this two volume series, we discuss pre-analytical and analytical (Volume I) as well as clinical and regulatory (Volume II) aspects of the validation process as applied to predictive biomarkers

The DSM-5 social anxiety disorder severity scale: Evidence of validity and reliability in a clinical sample.

PubMed

LeBeau, Richard T; Mesri, Bita; Craske, Michelle G

2016-10-30

With DSM-5, the APA began providing guidelines for anxiety disorder severity assessment that incorporates newly developed self-report scales. The scales share a common template, are brief, and are free of copyright restrictions. Initial validation studies have been promising, but the English-language versions of the scales have not been formally validated in clinical samples. Forty-seven individuals with a principal diagnosis of Social Anxiety Disorder (SAD) completed a diagnostic assessment, as well as the DSM-5 SAD severity scale and several previously validated measures. The scale demonstrated internal consistency, convergent validity, and discriminant validity. The next steps in the validation process are outlined. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Assessing Discriminative Performance at External Validation of Clinical Prediction Models

PubMed Central

Nieboer, Daan; van der Ploeg, Tjeerd; Steyerberg, Ewout W.

2016-01-01

Introduction External validation studies are essential to study the generalizability of prediction models. Recently a permutation test, focusing on discrimination as quantified by the c-statistic, was proposed to judge whether a prediction model is transportable to a new setting. We aimed to evaluate this test and compare it to previously proposed procedures to judge any changes in c-statistic from development to external validation setting. Methods We compared the use of the permutation test to the use of benchmark values of the c-statistic following from a previously proposed framework to judge transportability of a prediction model. In a simulation study we developed a prediction model with logistic regression on a development set and validated them in the validation set. We concentrated on two scenarios: 1) the case-mix was more heterogeneous and predictor effects were weaker in the validation set compared to the development set, and 2) the case-mix was less heterogeneous in the validation set and predictor effects were identical in the validation and development set. Furthermore we illustrated the methods in a case study using 15 datasets of patients suffering from traumatic brain injury. Results The permutation test indicated that the validation and development set were homogenous in scenario 1 (in almost all simulated samples) and heterogeneous in scenario 2 (in 17%-39% of simulated samples). Previously proposed benchmark values of the c-statistic and the standard deviation of the linear predictors correctly pointed at the more heterogeneous case-mix in scenario 1 and the less heterogeneous case-mix in scenario 2. Conclusion The recently proposed permutation test may provide misleading results when externally validating prediction models in the presence of case-mix differences between the development and validation population. To correctly interpret the c-statistic found at external validation it is crucial to disentangle case-mix differences from incorrect

Assessing Discriminative Performance at External Validation of Clinical Prediction Models.

PubMed

Nieboer, Daan; van der Ploeg, Tjeerd; Steyerberg, Ewout W

2016-01-01

External validation studies are essential to study the generalizability of prediction models. Recently a permutation test, focusing on discrimination as quantified by the c-statistic, was proposed to judge whether a prediction model is transportable to a new setting. We aimed to evaluate this test and compare it to previously proposed procedures to judge any changes in c-statistic from development to external validation setting. We compared the use of the permutation test to the use of benchmark values of the c-statistic following from a previously proposed framework to judge transportability of a prediction model. In a simulation study we developed a prediction model with logistic regression on a development set and validated them in the validation set. We concentrated on two scenarios: 1) the case-mix was more heterogeneous and predictor effects were weaker in the validation set compared to the development set, and 2) the case-mix was less heterogeneous in the validation set and predictor effects were identical in the validation and development set. Furthermore we illustrated the methods in a case study using 15 datasets of patients suffering from traumatic brain injury. The permutation test indicated that the validation and development set were homogenous in scenario 1 (in almost all simulated samples) and heterogeneous in scenario 2 (in 17%-39% of simulated samples). Previously proposed benchmark values of the c-statistic and the standard deviation of the linear predictors correctly pointed at the more heterogeneous case-mix in scenario 1 and the less heterogeneous case-mix in scenario 2. The recently proposed permutation test may provide misleading results when externally validating prediction models in the presence of case-mix differences between the development and validation population. To correctly interpret the c-statistic found at external validation it is crucial to disentangle case-mix differences from incorrect regression coefficients.

Construct Validity of the Anxiety Sensitivity Index-3 in Clinical Samples

ERIC Educational Resources Information Center

Kemper, Christoph J.; Lutz, Johannes; Bahr, Tobias; Ruddel, Heinz; Hock, Michael

2012-01-01

Using two clinical samples of patients, the presented studies examined the construct validity of the recently revised Anxiety Sensitivity Index-3 (ASI-3). Confirmatory factor analyses established a clear three-factor structure that corresponds to the postulated subdivision of the construct into correlated somatic, social, and cognitive components.…

Performance validity testing in neuropsychology: a clinical guide, critical review, and update on a rapidly evolving literature.

PubMed

Lippa, Sara M

2018-04-01

Over the past two decades, there has been much research on measures of response bias and myriad measures have been validated in a variety of clinical and research samples. This critical review aims to guide clinicians through the use of performance validity tests (PVTs) from test selection and administration through test interpretation and feedback. Recommended cutoffs and relevant test operating characteristics are presented. Other important issues to consider during test selection, administration, interpretation, and feedback are discussed including order effects, coaching, impact on test data, and methods to combine measures and improve predictive power. When interpreting performance validity measures, neuropsychologists must use particular caution in cases of dementia, low intelligence, English as a second language/minority cultures, or low education. PVTs provide valuable information regarding response bias and, under the right circumstances, can provide excellent evidence of response bias. Only after consideration of the entire clinical picture, including validity test performance, can concrete determinations regarding the validity of test data be made.

Validity of the Aberrant Behavior Checklist in a Clinical Sample of Toddlers

ERIC Educational Resources Information Center

Karabekiroglu, Koray; Aman, Michael G.

2009-01-01

We investigated the congruent and criterion validity of the Aberrant Behavior Checklist (ABC) in a clinical sample of toddlers seen over 1 year in Turkey. All consecutive patients (N = 93), 14-43 months old (mean, 30.6 mos.), in a child psychiatry outpatient clinic were included. The ABC, Autism Behavior Checklist (AuBC), and Child Behavior…

Anger Assessment in Clinical and Nonclinical Populations: Further Validation of the State-Trait Anger Expression Inventory-2.

PubMed

Lievaart, Marien; Franken, Ingmar H A; Hovens, Johannes E

2016-03-01

The most commonly used instrument for measuring anger is the State-Trait Anger Expression Inventory-2 (STAXI-2; Spielberger, 1999). This study further examines the validity of the STAXI-2 and compares anger scores between several clinical and nonclinical samples. Reliability, concurrent, and construct validity were investigated in Dutch undergraduate students (N = 764), a general population sample (N = 1211), and psychiatric outpatients (N = 226). The results support the reliability and validity of the STAXI-2. Concurrent validity was strong, with meaningful correlations between the STAXI-2 scales and anger-related constructs in both clinical and nonclinical samples. Importantly, patients showed higher experience and expression of anger than the general population sample. Additionally, forensic outpatients with addiction problems reported higher Anger Expression-Out than general psychiatric outpatients. Our conclusion is that the STAXI-2 is a suitable instrument to measure both the experience and the expression of anger in both general and clinical populations. © 2016 Wiley Periodicals, Inc.

The development and validation of the clinicians' awareness towards cognitive errors (CATChES) in clinical decision making questionnaire tool.

PubMed

Chew, Keng Sheng; Kueh, Yee Cheng; Abdul Aziz, Adlihafizi

2017-03-21

Despite their importance on diagnostic accuracy, there is a paucity of literature on questionnaire tools to assess clinicians' awareness toward cognitive errors. A validation study was conducted to develop a questionnaire tool to evaluate the Clinician's Awareness Towards Cognitive Errors (CATChES) in clinical decision making. This questionnaire is divided into two parts. Part A is to evaluate the clinicians' awareness towards cognitive errors in clinical decision making while Part B is to evaluate their perception towards specific cognitive errors. Content validation for both parts was first determined followed by construct validation for Part A. Construct validation for Part B was not determined as the responses were set in a dichotomous format. For content validation, all items in both Part A and Part B were rated as "excellent" in terms of their relevance in clinical settings. For construct validation using exploratory factor analysis (EFA) for Part A, a two-factor model with total variance extraction of 60% was determined. Two items were deleted. Then, the EFA was repeated showing that all factor loadings are above the cut-off value of >0.5. The Cronbach's alpha for both factors are above 0.6. The CATChES questionnaire tool is a valid questionnaire tool aimed to evaluate the awareness among clinicians toward cognitive errors in clinical decision making.

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

PubMed

Shirasaki, Osamu; Asou, Yosuke; Takahashi, Yukio

2007-12-01

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

Clinical utility of the Neurobehavioral Symptom Inventory validity scales to screen for symptom exaggeration following traumatic brain injury.

PubMed

Lange, Rael T; Brickell, Tracey A; Lippa, Sara M; French, Louis M

2015-01-01

The purpose of this study was to examine the clinical utility of three recently developed validity scales (Validity-10, NIM5, and LOW6) designed to screen for symptom exaggeration using the Neurobehavioral Symptom Inventory (NSI). Participants were 272 U.S. military service members who sustained a mild, moderate, severe, or penetrating traumatic brain injury (TBI) and who were evaluated by the neuropsychology service at Walter Reed Army Medical Center within 199 weeks post injury. Participants were divided into two groups based on the Negative Impression Management scale of the Personality Assessment Inventory: (a) those who failed symptom validity testing (SVT-fail; n = 27) and (b) those who passed symptom validity testing (SVT-pass; n = 245). Participants in the SVT-fail group had significantly higher scores (p<.001) on the Validity-10, NIM5, LOW6, NSI total, and Personality Assessment Inventory (PAI) clinical scales (range: d = 0.76 to 2.34). Similarly high sensitivity, specificity, positive predictive power (PPP), and negative predictive (NPP) values were found when using all three validity scales to differentiate SVT-fail versus SVT-pass groups. However, the Validity-10 scale consistently had the highest overall values. The optimal cutoff score for the Validity-10 scale to identify possible symptom exaggeration was ≥19 (sensitivity = .59, specificity = .89, PPP = .74, NPP = .80). For the majority of people, these findings provide support for the use of the Validity-10 scale as a screening tool for possible symptom exaggeration. When scores on the Validity-10 exceed the cutoff score, it is recommended that (a) researchers and clinicians do not interpret responses on the NSI, and (b) clinicians follow up with a more detailed evaluation, using well-validated symptom validity measures (e.g., Minnesota Multiphasic Personality Inventory-2 Restructured Form, MMPI-2-RF, validity scales), to seek confirmatory evidence to support an hypothesis of symptom exaggeration.

Design for validation: An approach to systems validation

NASA Technical Reports Server (NTRS)

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

1989-01-01

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

Psychometric instrumentation: reliability and validity of instruments used for clinical practice, evidence-based practice projects and research studies.

PubMed

Mayo, Ann M

2015-01-01

It is important for CNSs and other APNs to consider the reliability and validity of instruments chosen for clinical practice, evidence-based practice projects, or research studies. Psychometric testing uses specific research methods to evaluate the amount of error associated with any particular instrument. Reliability estimates explain more about how well the instrument is designed, whereas validity estimates explain more about scores that are produced by the instrument. An instrument may be architecturally sound overall (reliable), but the same instrument may not be valid. For example, if a specific group does not understand certain well-constructed items, then the instrument does not produce valid scores when used with that group. Many instrument developers may conduct reliability testing only once, yet continue validity testing in different populations over many years. All CNSs should be advocating for the use of reliable instruments that produce valid results. Clinical nurse specialists may find themselves in situations where reliability and validity estimates for some instruments that are being utilized are unknown. In such cases, CNSs should engage key stakeholders to sponsor nursing researchers to pursue this most important work.

The Clinical Validation of the Athlete Sleep Screening Questionnaire: an Instrument to Identify Athletes that Need Further Sleep Assessment.

PubMed

Bender, Amy M; Lawson, Doug; Werthner, Penny; Samuels, Charles H

2018-06-04

Previous research has established that general sleep screening questionnaires are not valid and reliable in an athlete population. The Athlete Sleep Screening Questionnaire (ASSQ) was developed to address this need. While the initial validation of the ASSQ has been established, the clinical validity of the ASSQ has yet to be determined. The main objective of the current study was to evaluate the clinical validity of the ASSQ. Canadian National Team athletes (N = 199; mean age 24.0 ± 4.2 years, 62% females; from 23 sports) completed the ASSQ. A subset of athletes (N = 46) were randomized to the clinical validation sub-study which required subjects to complete an ASSQ at times 2 and 3 and to have a clinical sleep interview by a sleep medicine physician (SMP) who rated each subjects' category of clinical sleep problem and provided recommendations to improve sleep. To assess clinical validity, the SMP category of clinical sleep problem was compared to the ASSQ. The internal consistency (Cronbach's alpha = 0.74) and test-retest reliability (r = 0.86) of the ASSQ were acceptable. The ASSQ demonstrated good agreement with the SMP (Cohen's kappa = 0.84) which yielded a diagnostic sensitivity of 81%, specificity of 93%, positive predictive value of 87%, and negative predictive value of 90%. There were 25.1% of athletes identified to have clinically relevant sleep disturbances that required further clinical sleep assessment. Sleep improved from time 1 at baseline to after the recommendations at time 3. Sleep screening athletes with the ASSQ provides a method of accurately determining which athletes would benefit from preventative measures and which athletes suffer from clinically significant sleep problems. The process of sleep screening athletes and providing recommendations improves sleep and offers a clinical intervention output that is simple and efficient for teams and athletes to implement.

Behavioral Indicators on a Mobile Sensing Platform Predict Clinically Validated Psychiatric Symptoms of Mood and Anxiety Disorders

PubMed Central

Place, Skyler; Rubin, Channah; Gorrostieta, Cristina; Mead, Caroline; Kane, John; Marx, Brian P; Feast, Joshua; Deckersbach, Thilo; Pentland, Alex “Sandy”; Nierenberg, Andrew; Azarbayejani, Ali

2017-01-01

Background There is a critical need for real-time tracking of behavioral indicators of mental disorders. Mobile sensing platforms that objectively and noninvasively collect, store, and analyze behavioral indicators have not yet been clinically validated or scalable. Objective The aim of our study was to report on models of clinical symptoms for post-traumatic stress disorder (PTSD) and depression derived from a scalable mobile sensing platform. Methods A total of 73 participants (67% [49/73] male, 48% [35/73] non-Hispanic white, 33% [24/73] veteran status) who reported at least one symptom of PTSD or depression completed a 12-week field trial. Behavioral indicators were collected through the noninvasive mobile sensing platform on participants’ mobile phones. Clinical symptoms were measured through validated clinical interviews with a licensed clinical social worker. A combination hypothesis and data-driven approach was used to derive key features for modeling symptoms, including the sum of outgoing calls, count of unique numbers texted, absolute distance traveled, dynamic variation of the voice, speaking rate, and voice quality. Participants also reported ease of use and data sharing concerns. Results Behavioral indicators predicted clinically assessed symptoms of depression and PTSD (cross-validated area under the curve [AUC] for depressed mood=.74, fatigue=.56, interest in activities=.75, and social connectedness=.83). Participants reported comfort sharing individual data with physicians (Mean 3.08, SD 1.22), mental health providers (Mean 3.25, SD 1.39), and medical researchers (Mean 3.03, SD 1.36). Conclusions Behavioral indicators passively collected through a mobile sensing platform predicted symptoms of depression and PTSD. The use of mobile sensing platforms can provide clinically validated behavioral indicators in real time; however, further validation of these models and this platform in large clinical samples is needed. PMID:28302595

A Serious Game for Clinical Assessment of Cognitive Status: Validation Study.

PubMed

Tong, Tiffany; Chignell, Mark; Tierney, Mary C; Lee, Jacques

2016-05-27

We propose the use of serious games to screen for abnormal cognitive status in situations where it may be too costly or impractical to use standard cognitive assessments (eg, emergency departments). If validated, serious games in health care could enable broader availability of efficient and engaging cognitive screening. The objective of this work is to demonstrate the feasibility of a game-based cognitive assessment delivered on tablet technology to a clinical sample and to conduct preliminary validation against standard mental status tools commonly used in elderly populations. We carried out a feasibility study in a hospital emergency department to evaluate the use of a serious game by elderly adults (N=146; age: mean 80.59, SD 6.00, range 70-94 years). We correlated game performance against a number of standard assessments, including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and the Confusion Assessment Method (CAM). After a series of modifications, the game could be used by a wide range of elderly patients in the emergency department demonstrating its feasibility for use with these users. Of 146 patients, 141 (96.6%) consented to participate and played our serious game. Refusals to play the game were typically due to concerns of family members rather than unwillingness of the patient to play the game. Performance on the serious game correlated significantly with the MoCA (r=-.339, P <.001) and MMSE (r=-.558, P <.001), and correlated (point-biserial correlation) with the CAM (r=.565, P <.001) and with other cognitive assessments. This research demonstrates the feasibility of using serious games in a clinical setting. Further research is required to demonstrate the validity and reliability of game-based assessments for clinical decision making.

A Serious Game for Clinical Assessment of Cognitive Status: Validation Study

PubMed Central

Chignell, Mark; Tierney, Mary C.; Lee, Jacques

2016-01-01

Background We propose the use of serious games to screen for abnormal cognitive status in situations where it may be too costly or impractical to use standard cognitive assessments (eg, emergency departments). If validated, serious games in health care could enable broader availability of efficient and engaging cognitive screening. Objective The objective of this work is to demonstrate the feasibility of a game-based cognitive assessment delivered on tablet technology to a clinical sample and to conduct preliminary validation against standard mental status tools commonly used in elderly populations. Methods We carried out a feasibility study in a hospital emergency department to evaluate the use of a serious game by elderly adults (N=146; age: mean 80.59, SD 6.00, range 70-94 years). We correlated game performance against a number of standard assessments, including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and the Confusion Assessment Method (CAM). Results After a series of modifications, the game could be used by a wide range of elderly patients in the emergency department demonstrating its feasibility for use with these users. Of 146 patients, 141 (96.6%) consented to participate and played our serious game. Refusals to play the game were typically due to concerns of family members rather than unwillingness of the patient to play the game. Performance on the serious game correlated significantly with the MoCA (r=–.339, P <.001) and MMSE (r=–.558, P <.001), and correlated (point-biserial correlation) with the CAM (r=.565, P <.001) and with other cognitive assessments. Conclusions This research demonstrates the feasibility of using serious games in a clinical setting. Further research is required to demonstrate the validity and reliability of game-based assessments for clinical decision making. PMID:27234145

Validation of the clinical dehydration scale for children with acute gastroenteritis.

PubMed

Goldman, Ran D; Friedman, Jeremy N; Parkin, Patricia C

2008-09-01

We previously created a clinical dehydration scale. Our objective was to validate the clinical dehydration scale with a new cohort of patients with acute gastroenteritis who were assessed in a tertiary emergency department in a developed country. A prospective observational study was performed in an emergency department at a large pediatric tertiary center in Canada. Children 1 month to 5 years of age with symptoms of acute gastroenteritis who were assessed in the emergency department were enrolled consecutively during a 4-month period. The main outcome measures were length of stay, proportion of children receiving intravenous fluid rehydration, and proportions of children with abnormal serum pH values or bicarbonate levels. A total of 205 children were enrolled, with a mean age of 22.4 +/- 14.9 months; 103 (50%) were male. The distribution of severity categories was as follows: no dehydration (score of 0), n = 117 (57%); some dehydration (score of 1-4), n = 83 (41%); moderate/severe dehydration (score of 5-8), n = 5 (2%). The 3 dehydration categories were significantly different with respect to the validation hypotheses (length of stay, mean +/- SD: none, 245 +/- 181 minutes; some, 397 +/- 302 minutes; moderate/severe, 501 +/- 389 minutes; treatment with intravenous fluids: none, n =17, 15%; some, n = 41, 49%; moderate/severe, n = 4, 80%; number of vomiting episodes in the 7 days before the emergency department visit: none, 8.4 +/- 7.7 episodes; some, 13 +/- 10.7 episodes; moderate/severe, 30.2 +/- 14.8 episodes). The clinical dehydration scale and the 3 severity categories were valid for a prospectively enrolled cohort of patients who were assessed in our tertiary emergency department. The scoring system was valuable in predicting a longer length of stay and the need for intravenous fluid rehydration for children with symptoms of acute gastroenteritis.

Screening for postdeployment conditions: development and cross-validation of an embedded validity scale in the neurobehavioral symptom inventory.

PubMed

Vanderploeg, Rodney D; Cooper, Douglas B; Belanger, Heather G; Donnell, Alison J; Kennedy, Jan E; Hopewell, Clifford A; Scott, Steven G

2014-01-01

To develop and cross-validate internal validity scales for the Neurobehavioral Symptom Inventory (NSI). Four existing data sets were used: (1) outpatient clinical traumatic brain injury (TBI)/neurorehabilitation database from a military site (n = 403), (2) National Department of Veterans Affairs TBI evaluation database (n = 48 175), (3) Florida National Guard nonclinical TBI survey database (n = 3098), and (4) a cross-validation outpatient clinical TBI/neurorehabilitation database combined across 2 military medical centers (n = 206). Secondary analysis of existing cohort data to develop (study 1) and cross-validate (study 2) internal validity scales for the NSI. The NSI, Mild Brain Injury Atypical Symptoms, and Personality Assessment Inventory scores. Study 1: Three NSI validity scales were developed, composed of 5 unusual items (Negative Impression Management [NIM5]), 6 low-frequency items (LOW6), and the combination of 10 nonoverlapping items (Validity-10). Cut scores maximizing sensitivity and specificity on these measures were determined, using a Mild Brain Injury Atypical Symptoms score of 8 or more as the criterion for invalidity. Study 2: The same validity scale cut scores again resulted in the highest classification accuracy and optimal balance between sensitivity and specificity in the cross-validation sample, using a Personality Assessment Inventory Negative Impression Management scale with a T score of 75 or higher as the criterion for invalidity. The NSI is widely used in the Department of Defense and Veterans Affairs as a symptom-severity assessment following TBI, but is subject to symptom overreporting or exaggeration. This study developed embedded NSI validity scales to facilitate the detection of invalid response styles. The NSI Validity-10 scale appears to hold considerable promise for validity assessment when the NSI is used as a population-screening tool.

Language-based Measures of Mindfulness: Initial Validity and Clinical Utility

PubMed Central

Collins, Susan E.; Chawla, Neharika; Hsu, Sharon H.; Grow, Joel; Otto, Jacqueline M.; Marlatt, G. Alan

2009-01-01

This study examined relationships among language use, mindfulness, and substance-use treatment outcomes in the context of an efficacy trial of mindfulness-based relapse prevention (MBRP) for adults with alcohol and other drug use (AOD) disorders (see Bowen, Chawla, Collins et al., in press). An expert panel generated two categories of mindfulness language (ML) describing the mindfulness state and the more encompassing “mindfulness journey,” which included words describing challenges of developing a mindfulness practice. MBRP participants (n=48) completed baseline sociodemographic and AOD measures, and participated in the 8-week MBRP program. AOD data were collected during the 4-month follow-up. A word count program assessed the frequency of ML and other linguistic markers in participants’ responses to open-ended questions about their postintervention impressions of mindfulness practice and MBRP. Findings supported concurrent validity of ML categories: ML words appeared more frequently in the MBRP manual compared to the 12-step Big Book. Further, ML categories correlated with other linguistic variables related to the mindfulness construct. Finally, predictive validity was supported: greater use of ML predicted fewer AOD use days during the 4-month follow-up. This study provided initial support for ML as a valid, clinically useful mindfulness measure. If future studies replicate these findings, ML could be used in conjunction with self-report to provide a more complete picture of the mindfulness experience. PMID:20025383

World Workshop on Oral Medicine VI: an international validation study of clinical competencies for advanced training in oral medicine.

PubMed

Steele, John C; Clark, Hadleigh J; Hong, Catherine H L; Jurge, Sabine; Muthukrishnan, Arvind; Kerr, A Ross; Wray, David; Prescott-Clements, Linda; Felix, David H; Sollecito, Thomas P

2015-08-01

To explore international consensus for the validation of clinical competencies for advanced training in Oral Medicine. An electronic survey of clinical competencies was designed. The survey was sent to and completed by identified international stakeholders during a 10-week period. To be validated, an individual competency had to achieve 90% or greater consensus to keep it in its current format. Stakeholders from 31 countries responded. High consensus agreement was achieved with 93 of 101 (92%) competencies exceeding the benchmark for agreement. Only 8 warranted further attention and were reviewed by a focus group. No additional competencies were suggested. This is the first international validated study of clinical competencies for advanced training in Oral Medicine. These validated clinical competencies could provide a model for countries developing an advanced training curriculum for Oral Medicine and also inform review of existing curricula. Copyright © 2015 Elsevier Inc. All rights reserved.

General Health Questionnaire-12 validity in Colombia and factorial equivalence between clinical and nonclinical participants.

PubMed

Ruiz, Francisco J; García-Beltrán, Diana M; Suárez-Falcón, Juan C

2017-10-01

The General Health Questionnaire - 12 (GHQ-12) is a widely used screening self-report for emotional disorders among adults. However, there is little evidence concerning the validity of the GHQ-12 in Colombia and its factorial invariance between nonclinical and clinical samples. Accordingly, the current study aims to explore the GHQ-12 validity in Colombian nonclinical and clinical samples. The GHQ-12 was administered to a total of 1641 participants, including a sample of undergraduates, one of general population, and a clinical sample. The internal consistency of the GHQ-12 across samples was good (overall alpha of .90). The one-factor model showed a good fit to the data and was considered theoretically more coherent than the two-factor model with positive and negative items loading in separate factors. Metric and scalar invariance were observed across nonclinical and clinical samples. The GHQ-12 scores were strongly and positively related to emotional symptoms and experiential avoidance, and negatively related to life satisfaction. According to the receiver operating characteristic (ROC) curves, a threshold score of 11/12 was optimal to identify emotional disorders. In conclusion, the GHQ-12 is a valid screening self-report in Colombia that provides scores that can be compared across clinical and nonclinical participants. Copyright © 2017 Elsevier B.V. All rights reserved.

Clinical Validation of the "Sedentary Lifestyle" Nursing Diagnosis in Secondary School Students

ERIC Educational Resources Information Center

de Oliveira, Marcos Renato; da Silva, Viviane Martins; Guedes, Nirla Gomes; de Oliveira Lopes, Marcos Venícios

2016-01-01

This study clinically validated the nursing diagnosis of "sedentary lifestyle" (SL) among 564 Brazilian adolescents. Measures of diagnostic accuracy were calculated for defining characteristics, and Mantel--Haenszel analysis was used to identify related factors. The measures of diagnostic accuracy showed that the following defining…

Criteria for the validity of clinical trials of treatments of cohorts of cancer patients based on the Hardin Jones principle.

PubMed Central

Pauling, L; Herman, Z S

1989-01-01

With the assumption of the validity of the Hardin Jones principle that the death rate of members of a homogeneous cohort of cancer patients is constant, three criteria for the validity of clinical trials of cancer treatments are formulated. These criteria are satisfied by most published clinical trials, but one trial was found to violate all three, rendering the validity of its reported results uncertain. PMID:2780542

Clinical utility and validation of the Couple's Communicative Evaluation Scale.

PubMed

West, Craig E

2005-10-01

This study assessed the validity and clinical utility of a new test, the Couple's Communicative Evaluation Scale. With 24 couples from a variety of resources, e.g., churches, newspaper, and colleges, a discriminant analysis using the Dyadic Adjustment Scale, indicated that satisfied couples could be discriminated from issatisfied couples with 91-96% accuracy. Significant differences on the scale were found for means between 7 distressed and 16 nondistressed couples using the satisfaction/dissatisfaction cutoff score of 200 on the Dyadic Adjustment Scale and significant differences on the individual scales were found for means between 16 distressed and 31 nondistressed individuals using the satisfaction/dissatisfaction cutoff score of 100 on the Dyadic Adjustment Scale. Demographic variables, e.g., age, marriage length, were statistically significant. Scale scores were highly correlated with those on the Dyadic Adjustment Scale, indicating good validity. Using all 400 items, an alpha of .99 indicated good internal consistency for the verbal, nonverbal, and listening communication scores.

Computer simulation of Cerebral Arteriovenous Malformation-validation analysis of hemodynamics parameters.

PubMed

Kumar, Y Kiran; Mehta, Shashi Bhushan; Ramachandra, Manjunath

2017-01-01

The purpose of this work is to provide some validation methods for evaluating the hemodynamic assessment of Cerebral Arteriovenous Malformation (CAVM). This article emphasizes the importance of validating noninvasive measurements for CAVM patients, which are designed using lumped models for complex vessel structure. The validation of the hemodynamics assessment is based on invasive clinical measurements and cross-validation techniques with the Philips proprietary validated software's Qflow and 2D Perfursion. The modeling results are validated for 30 CAVM patients for 150 vessel locations. Mean flow, diameter, and pressure were compared between modeling results and with clinical/cross validation measurements, using an independent two-tailed Student t test. Exponential regression analysis was used to assess the relationship between blood flow, vessel diameter, and pressure between them. Univariate analysis is used to assess the relationship between vessel diameter, vessel cross-sectional area, AVM volume, AVM pressure, and AVM flow results were performed with linear or exponential regression. Modeling results were compared with clinical measurements from vessel locations of cerebral regions. Also, the model is cross validated with Philips proprietary validated software's Qflow and 2D Perfursion. Our results shows that modeling results and clinical results are nearly matching with a small deviation. In this article, we have validated our modeling results with clinical measurements. The new approach for cross-validation is proposed by demonstrating the accuracy of our results with a validated product in a clinical environment.

A Structured Clinical Interview for Kleptomania (SCI-K): preliminary validity and reliability testing.

PubMed

Grant, Jon E; Kim, Suck Won; McCabe, James S

2006-06-01

Kleptomania presents difficulties in diagnosis for clinicians. This study aimed to develop and test a DSM-IV-based diagnostic instrument for kleptomania. To assess for current kleptomania the Structured Clinical Interview for Kleptomania (SCI-K) was administered to 112 consecutive subjects requesting psychiatric outpatient treatment for a variety of disorders. Reliability and validity were determined. Classification accuracy was examined using the longitudinal course of illness. The SCI-K demonstrated excellent test-retest (Phi coefficient = 0.956 (95% CI = 0.937, 0.970)) and inter-rater reliability (phi coefficient = 0.718 (95% CI = 0.506, 0.848)) in the diagnosis of kleptomania. Concurrent validity was observed with a self-report measure using DSM-IV kleptomania criteria (phi coefficient = 0.769 (95% CI = 0.653, 0.850)). Discriminant validity was observed with a measure of depression (point biserial coefficient = -0.020 (95% CI = -0.205, 0.166)). The SCI-K demonstrated both high sensitivity and specificity based on longitudinal assessment. The SCI-K demonstrated excellent reliability and validity in diagnosing kleptomania in subjects presenting with various psychiatric problems. These findings require replication in larger groups, including non-psychiatric populations, to examine their generalizability. Copyright (c) 2006 John Wiley & Sons, Ltd.

Factorial Validity and Invariance of the GHQ-12 among Clinical and Nonclinical Samples

ERIC Educational Resources Information Center

Fernandes, Helder Miguel; Vasconcelos-Raposo, Jose

2013-01-01

The purpose of this study was to examine the internal reliability, factorial validity, and measurement invariance of a Brazilian-Portuguese version of the General Health Questionnaire-12 (GHQ-12) across clinical and nonclinical groups. The clinical sample consisted of 228 chronic hemodialysis patients (41.7% female), with a mean age of 48.23 (SD =…

Validation by simulation of a clinical trial model using the standardized mean and variance criteria.

PubMed

Abbas, Ismail; Rovira, Joan; Casanovas, Josep

2006-12-01

To develop and validate a model of a clinical trial that evaluates the changes in cholesterol level as a surrogate marker for lipodystrophy in HIV subjects under alternative antiretroviral regimes, i.e., treatment with Protease Inhibitors vs. a combination of nevirapine and other antiretroviral drugs. Five simulation models were developed based on different assumptions, on treatment variability and pattern of cholesterol reduction over time. The last recorded cholesterol level, the difference from the baseline, the average difference from the baseline and level evolution, are the considered endpoints. Specific validation criteria based on a 10% minus or plus standardized distance in means and variances were used to compare the real and the simulated data. The validity criterion was met by all models for considered endpoints. However, only two models met the validity criterion when all endpoints were considered. The model based on the assumption that within-subjects variability of cholesterol levels changes over time is the one that minimizes the validity criterion, standardized distance equal to or less than 1% minus or plus. Simulation is a useful technique for calibration, estimation, and evaluation of models, which allows us to relax the often overly restrictive assumptions regarding parameters required by analytical approaches. The validity criterion can also be used to select the preferred model for design optimization, until additional data are obtained allowing an external validation of the model.

Validation of clinic weights from electronic health records against standardized weight measurements in weight loss trials.

PubMed

Xiao, Lan; Lv, Nan; Rosas, Lisa G; Au, David; Ma, Jun

2017-02-01

To validate clinic weights in electronic health records against researcher-measured weights for outcome assessment in weight loss trials. Clinic and researcher-measured weights from a published trial (BE WELL) were compared using Lin's concordance correlation coefficient, Bland and Altman's limits of agreement, and polynomial regression model. Changes in clinic and researcher-measured weights in BE WELL and another trial, E-LITE, were analyzed using growth curve modeling. Among BE WELL (n = 330) and E-LITE (n = 241) participants, 96% and 90% had clinic weights (mean [SD] of 5.8 [6.1] and 3.7 [3.9] records) over 12 and 15 months of follow-up, respectively. The concordance correlation coefficient was 0.99, and limits of agreement plots showed no pattern between or within treatment groups, suggesting overall good agreement between researcher-measured and nearest-in-time clinic weights up to 3 months. The 95% confidence intervals for predicted percent differences fell within ±3% for clinic weights within 3 months of the researcher-measured weights. Furthermore, the growth curve slopes for clinic and researcher-measured weights by treatment group did not differ significantly, suggesting similar inferences about treatment effects over time, in both trials. Compared with researcher-measured weights, close-in-time clinic weights showed high agreement and inference validity. Clinic weights could be a valid pragmatic outcome measure in weight loss studies. © 2017 The Obesity Society.

Measuring clinical management by physicians and nurses in European hospitals: development and validation of two scales.

PubMed

Plochg, Thomas; Arah, Onyebuchi A; Botje, Daan; Thompson, Caroline A; Klazinga, Niek S; Wagner, Cordula; Mannion, Russell; Lombarts, Kiki

2014-04-01

Clinical management is hypothesized to be critical for hospital management and hospital performance. The aims of this study were to develop and validate professional involvement scales for measuring the level of clinical management by physicians and nurses in European hospitals. Testing of validity and reliability of scales derived from a questionnaire of 21 items was developed on the basis of a previous study and expert opinion and administered in a cross-sectional seven-country research project 'Deepening our Understanding of Quality improvement in Europe' (DUQuE). A sample of 3386 leading physicians and nurses working in 188 hospitals located in Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey. Validity and reliability of professional involvement scales and subscales. Psychometric analysis yielded four subscales for leading physicians: (i) Administration and budgeting, (ii) Managing medical practice, (iii) Strategic management and (iv) Managing nursing practice. Only the first three factors applied well to the nurses. Cronbach's alpha for internal consistency ranged from 0.74 to 0.86 for the physicians, and from 0.61 to 0.81 for the nurses. Except for the 0.74 correlation between 'Administration and budgeting' and 'Managing medical practice' among physicians, all inter-scale correlations were <0.70 (range 0.43-0.61). Under testing for construct validity, the subscales were positively correlated with 'formal management roles' of physicians and nurses. The professional involvement scales appear to yield reliable and valid data in European hospital settings, but the scale 'Managing medical practice' for nurses needs further exploration. The measurement instrument can be used for international research on clinical management.

Validation workflow for a clinical Bayesian network model in multidisciplinary decision making in head and neck oncology treatment.

PubMed

Cypko, Mario A; Stoehr, Matthaeus; Kozniewski, Marcin; Druzdzel, Marek J; Dietz, Andreas; Berliner, Leonard; Lemke, Heinz U

2017-11-01

Oncological treatment is being increasingly complex, and therefore, decision making in multidisciplinary teams is becoming the key activity in the clinical pathways. The increased complexity is related to the number and variability of possible treatment decisions that may be relevant to a patient. In this paper, we describe validation of a multidisciplinary cancer treatment decision in the clinical domain of head and neck oncology. Probabilistic graphical models and corresponding inference algorithms, in the form of Bayesian networks, can support complex decision-making processes by providing a mathematically reproducible and transparent advice. The quality of BN-based advice depends on the quality of the model. Therefore, it is vital to validate the model before it is applied in practice. For an example BN subnetwork of laryngeal cancer with 303 variables, we evaluated 66 patient records. To validate the model on this dataset, a validation workflow was applied in combination with quantitative and qualitative analyses. In the subsequent analyses, we observed four sources of imprecise predictions: incorrect data, incomplete patient data, outvoting relevant observations, and incorrect model. Finally, the four problems were solved by modifying the data and the model. The presented validation effort is related to the model complexity. For simpler models, the validation workflow is the same, although it may require fewer validation methods. The validation success is related to the model's well-founded knowledge base. The remaining laryngeal cancer model may disclose additional sources of imprecise predictions.

Behavioral Indicators on a Mobile Sensing Platform Predict Clinically Validated Psychiatric Symptoms of Mood and Anxiety Disorders.

PubMed

Place, Skyler; Blanch-Hartigan, Danielle; Rubin, Channah; Gorrostieta, Cristina; Mead, Caroline; Kane, John; Marx, Brian P; Feast, Joshua; Deckersbach, Thilo; Pentland, Alex Sandy; Nierenberg, Andrew; Azarbayejani, Ali

2017-03-16

There is a critical need for real-time tracking of behavioral indicators of mental disorders. Mobile sensing platforms that objectively and noninvasively collect, store, and analyze behavioral indicators have not yet been clinically validated or scalable. The aim of our study was to report on models of clinical symptoms for post-traumatic stress disorder (PTSD) and depression derived from a scalable mobile sensing platform. A total of 73 participants (67% [49/73] male, 48% [35/73] non-Hispanic white, 33% [24/73] veteran status) who reported at least one symptom of PTSD or depression completed a 12-week field trial. Behavioral indicators were collected through the noninvasive mobile sensing platform on participants' mobile phones. Clinical symptoms were measured through validated clinical interviews with a licensed clinical social worker. A combination hypothesis and data-driven approach was used to derive key features for modeling symptoms, including the sum of outgoing calls, count of unique numbers texted, absolute distance traveled, dynamic variation of the voice, speaking rate, and voice quality. Participants also reported ease of use and data sharing concerns. Behavioral indicators predicted clinically assessed symptoms of depression and PTSD (cross-validated area under the curve [AUC] for depressed mood=.74, fatigue=.56, interest in activities=.75, and social connectedness=.83). Participants reported comfort sharing individual data with physicians (Mean 3.08, SD 1.22), mental health providers (Mean 3.25, SD 1.39), and medical researchers (Mean 3.03, SD 1.36). Behavioral indicators passively collected through a mobile sensing platform predicted symptoms of depression and PTSD. The use of mobile sensing platforms can provide clinically validated behavioral indicators in real time; however, further validation of these models and this platform in large clinical samples is needed. ©Skyler Place, Danielle Blanch-Hartigan, Channah Rubin, Cristina Gorrostieta

Construction and Validation of the Clinical Judgment Skill Inventory: Clinical Judgment Skill Competencies That Measure Counselor Debiasing Techniques

ERIC Educational Resources Information Center

Austin, Bryan S.; Leahy, Michael J.

2015-01-01

Purpose: To construct and validate a new self-report instrument, the Clinical Judgment Skill Inventory (CJSI), inclusive of clinical judgment skill competencies that address counselor biases and evidence-based strategies. Method: An Internet-based survey design was used and an exploratory factor analysis was performed on a sample of rehabilitation…

The predictive validity of the BioMedical Admissions Test for pre-clinical examination performance.

PubMed

Emery, Joanne L; Bell, John F

2009-06-01

Some medical courses in the UK have many more applicants than places and almost all applicants have the highest possible previous and predicted examination grades. The BioMedical Admissions Test (BMAT) was designed to assist in the student selection process specifically for a number of 'traditional' medical courses with clear pre-clinical and clinical phases and a strong focus on science teaching in the early years. It is intended to supplement the information provided by examination results, interviews and personal statements. This paper reports on the predictive validity of the BMAT and its predecessor, the Medical and Veterinary Admissions Test. Results from the earliest 4 years of the test (2000-2003) were matched to the pre-clinical examination results of those accepted onto the medical course at the University of Cambridge. Correlation and logistic regression analyses were performed for each cohort. Section 2 of the test ('Scientific Knowledge') correlated more strongly with examination marks than did Section 1 ('Aptitude and Skills'). It also had a stronger relationship with the probability of achieving the highest examination class. The BMAT and its predecessor demonstrate predictive validity for the pre-clinical years of the medical course at the University of Cambridge. The test identifies important differences in skills and knowledge between candidates, not shown by their previous attainment, which predict their examination performance. It is thus a valid source of additional admissions information for medical courses with a strong scientific emphasis when previous attainment is very high.

The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI): Revision for Clinical Use, Content Validation, and Inter-rater Reliability.

PubMed

Rosenson, Robert S; Miller, Kate; Bayliss, Martha; Sanchez, Robert J; Baccara-Dinet, Marie T; Chibedi-De-Roche, Daniela; Taylor, Beth; Khan, Irfan; Manvelian, Garen; White, Michelle; Jacobson, Terry A

2017-04-01

The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) is a method for assessing the likelihood that a patient's muscle symptoms (e.g., myalgia or myopathy) were caused or worsened by statin use. The objectives of this study were to prepare the SAMS-CI for clinical use, estimate its inter-rater reliability, and collect feedback from physicians on its practical application. For content validity, we conducted structured in-depth interviews with its original authors as well as with a panel of independent physicians. Estimation of inter-rater reliability involved an analysis of 30 written clinical cases which were scored by a sample of physicians. A separate group of physicians provided feedback on the clinical use of the SAMS-CI and its potential utility in practice. Qualitative interviews with providers supported the content validity of the SAMS-CI. Feedback on the clinical use of the SAMS-CI included several perceived benefits (such as brevity, clear wording, and simple scoring process) and some possible concerns (workflow issues and applicability in primary care). The inter-rater reliability of the SAMS-CI was estimated to be 0.77 (confidence interval 0.66-0.85), indicating high concordance between raters. With additional provider feedback, a revised SAMS-CI instrument was created suitable for further testing, both in the clinical setting and in prospective validation studies. With standardized questions, vetted language, easily interpreted scores, and demonstrated reliability, the SAMS aims to estimate the likelihood that a patient's muscle symptoms were attributable to statins. The SAMS-CI may support better detection of statin-associated muscle symptoms in clinical practice, optimize treatment for patients experiencing muscle symptoms, and provide a useful tool for further clinical research.

Explicating Validity

ERIC Educational Resources Information Center

Kane, Michael T.

2016-01-01

How we choose to use a term depends on what we want to do with it. If "validity" is to be used to support a score interpretation, validation would require an analysis of the plausibility of that interpretation. If validity is to be used to support score uses, validation would require an analysis of the appropriateness of the proposed…

Assessment of validity with polytrauma Veteran populations.

PubMed

Bush, Shane S; Bass, Carmela

2015-01-01

Veterans with polytrauma have suffered injuries to multiple body parts and organs systems, including the brain. The injuries can generate a triad of physical, neurologic/cognitive, and emotional symptoms. Accurate diagnosis is essential for the treatment of these conditions and for fair allocation of benefits. To accurately diagnose polytrauma disorders and their related problems, clinicians take into account the validity of reported history and symptoms, as well as clinical presentations. The purpose of this article is to describe the assessment of validity with polytrauma Veteran populations. Review of scholarly and other relevant literature and clinical experience are utilized. A multimethod approach to validity assessment that includes objective, standardized measures increases the confidence that can be placed in the accuracy of self-reported symptoms and physical, cognitive, and emotional test results. Due to the multivariate nature of polytrauma and the multiple disciplines that play a role in diagnosis and treatment, an ideal model of validity assessment with polytrauma Veteran populations utilizes neurocognitive, neurological, neuropsychiatric, and behavioral measures of validity. An overview of these validity assessment approaches as applied to polytrauma Veteran populations is presented. Veterans, the VA, and society are best served when accurate diagnoses are made.

Cross-Cultural Adaptation, Reliability and Validity Study of the Persian Version of the Clinical COPD Questionnaire.

PubMed

Hasanpour, Neda; Attarbashi Moghadam, Behrouz; Sami, Ramin; Tavakol, Kamran

2016-08-01

The clinical COPD questionnaire (CCQ) has been developed to measure the health status of COPD patients. The aim of this study was to translate CCQ into the Persian language and assess the validity and reliability of the translated version. We used a forward-backward procedure to translate the questionnaire. In a cross-sectional study 100 COPD patients and 50 healthy subjects over 40 years old were selected to assess the reliability and construct validity of the instrument. The face and content validity were used for the questionnaire validity. Validity was examined in a population of patients with COPD, using the Persian validated version of the St George's Respiratory Questionnaire (PSGRQ). In order to assess the questionnaire's reliability, the Intraclass correlation coefficient (ICC) and Cronbach's alpha were calculated. Test-retest reliability was tested by re-administering the Persian version of the CCQ (PCCQ) after 1 week. Test-retest carry out of data demonstrates that the PCCQ has excellent reliability (ICC for all 3 domains were higher than 0.9). Internal consistency was found by Cronbach's alpha to be 0.96, 0.94, 0.97, and 0.98 for the symptom, mental state, functional state and total scores respectively. In addition, the correlation between the components of PCCQ and PSGRQ showed satisfactory construct validity. Analyzing the data from healthy subjects and patients divulged that the PCCQ has acceptable discriminant validity. In general, the PCCQ had satisfactory reliability and validity for assessing health-related quality of life status of Iranian COPD patients.

The Reliability, Validity, and Evaluation of the Objective Structured Clinical Examination in Podiatry (Chiropody).

ERIC Educational Resources Information Center

Woodburn, Jim; Sutcliffe, Nick

1996-01-01

The Objective Structured Clinical Examination (OSCE), initially developed for undergraduate medical education, has been adapted for assessment of clinical skills in podiatry students. A 12-month pilot study found the test had relatively low levels of reliability, high construct and criterion validity, and good stability of performance over time.…

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.

Validity and concordance between self-reported and clinical diagnosis of hypertension among elderly residents in northeastern Brazil.

PubMed

de Menezes, Tarciana Nobre; Oliveira, Elaine Cristina Tôrres; de Sousa Fischer, Milena Abreu Tavares

2014-02-01

Self-reported information has been used as an easy and quick method to estimate the prevalence of systemic hypertension in populations. However, verification of whether self-reports of the disease are consistent with clinical diagnosis is essential for proper use of this information. This study aimed to verify the validity and concordance between self-reported and clinical diagnosis of hypertension in the elderly population of a city in northeastern Brazil. This was a cross-sectional and population-based study. The prevalence of diagnosed and self-reported hypertension and the validity and concordance between self-reported and clinical diagnosis and their distribution according to demographic and socioeconomic variables were assessed. The validity of self-reported hypertension was determined by sensitivity, specificity, and positive and negative predictive value. Overall, 795 elderly patients were evaluated (69.1% women). There was a high prevalence of hypertension among the elderly (diagnosed: 75.1%, 95% confidence interval (CI) = 71.1%-77.9%; self-reported: 59.7%, 95% CI = 56.3%-63.1%). For self-reported hypertension, sensitivity was substantial (77.1%), specificity was excellent (93.4%), positive predictive value was excellent (97.3%), and negative predictive value was moderate (57.2%). There was a moderate concordance between self-reported and clinical diagnosis of hypertension (kappa = 0.59; P < 0.001). Reasonable validity and moderate concordance of self-reported information on hypertension was observed, which reinforces the idea that this information can be used as strategy for detecting the disease prevalence in this population. However, because of nonachievement of excellence in the validity and reliability of the measured blood pressure, this information should be carefully considered for the strategic planning of health services.

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

PubMed Central

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

2017-01-01

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

The validity of a professional competence tool for physiotherapy students in simulation-based clinical education: a Rasch analysis.

PubMed

Judd, Belinda K; Scanlan, Justin N; Alison, Jennifer A; Waters, Donna; Gordon, Christopher J

2016-08-05

Despite the recent widespread adoption of simulation in clinical education in physiotherapy, there is a lack of validated tools for assessment in this setting. The Assessment of Physiotherapy Practice (APP) is a comprehensive tool used in clinical placement settings in Australia to measure professional competence of physiotherapy students. The aim of the study was to evaluate the validity of the APP for student assessment in simulation settings. A total of 1260 APPs were collected, 971 from students in simulation and 289 from students in clinical placements. Rasch analysis was used to examine the construct validity of the APP tool in three different simulation assessment formats: longitudinal assessment over 1 week of simulation; longitudinal assessment over 2 weeks; and a short-form (25 min) assessment of a single simulation scenario. Comparison with APPs from 5 week clinical placements in hospital and clinic-based settings were also conducted. The APP demonstrated acceptable fit to the expectations of the Rasch model for the 1 and 2 week clinical simulations, exhibiting unidimensional properties that were able to distinguish different levels of student performance. For the short-form simulation, nine of the 20 items recorded greater than 25 % of scores as 'not-assessed' by clinical educators which impacted on the suitability of the APP tool in this simulation format. The APP was a valid assessment tool when used in longitudinal simulation formats. A revised APP may be required for assessment in short-form simulation scenarios.

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

PubMed

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

2015-01-01

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

Validation of the German version of the Clinical Assessment Interview for Negative Symptoms (CAINS).

PubMed

Engel, Maike; Fritzsche, Anja; Lincoln, Tania Marie

2014-12-15

Validated assessment instruments could contribute to a better understanding and assessment of negative symptoms and advance treatment research. The aim of this study was to examine the psychometric properties of a German version of the Clinical Assessment Interview for Negative Symptoms (CAINS). In- and outpatients (N=53) with schizophrenia or schizoaffective disorder were assessed with standardized interviews and questionnaires on negative and positive symptoms and general psychopathology in schizophrenia, depression, the ability to experience anticipatory and consummatory pleasure, and global functioning. The results indicated good psychometric properties, high internal consistency and promising inter-rater agreement for the German version of the CAINS. The two-factor solution of the original version of the CAINS was confirmed, indicating good construct validity. Convergent validity was supported by significant correlations between the CAINS subscales with the negative symptom scale of the Positive and Negative Syndrome Scale, and with consummatory pleasure. The CAINS also exhibited discriminant validity indicated by its non-significant correlations with positive symptoms, general psychopathology and depression that are in line with the findings for the original version of the CAINS. In addition, the CAINS correlated moderately with global functioning. The German version of the CAINS appears to be a valid and suitable diagnostic tool for measuring negative symptoms in schizophrenia. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Six-minute-walk test in idiopathic pulmonary fibrosis: test validation and minimal clinically important difference.

PubMed

du Bois, Roland M; Weycker, Derek; Albera, Carlo; Bradford, Williamson Z; Costabel, Ulrich; Kartashov, Alex; Lancaster, Lisa; Noble, Paul W; Sahn, Steven A; Szwarcberg, Javier; Thomeer, Michiel; Valeyre, Dominique; King, Talmadge E

2011-05-01

The 6-minute-walk test (6MWT) is a practical and clinically meaningful measure of exercise tolerance with favorable performance characteristics in various cardiac and pulmonary diseases. Performance characteristics in patients with idiopathic pulmonary fibrosis (IPF) have not been systematically evaluated. To assess the reliability, validity, and responsiveness of the 6MWT and estimate the minimal clinically important difference (MCID) in patients with IPF. The study population included all subjects completing a 6MWT in a clinical trial evaluating interferon gamma-1b (n = 822). Six-minute walk distance (6MWD) and other parameters were measured at baseline and at 24-week intervals using a standardized protocol. Parametric and distribution-independent correlation coefficients were used to assess the strength of the relationships between 6MWD and measures of pulmonary function, dyspnea, and health-related quality of life. Both distribution-based and anchor-based methods were used to estimate the MCID. Comparison of two proximal measures of 6MWD (mean interval, 24 d) demonstrated good reliability (coefficient = 0.83; P < 0.001). 6MWD was weakly correlated with measures of physiologic function and health-related quality of life; however, values were consistently and significantly lower for patients with the poorest functional status, suggesting good construct validity. Importantly, change in 6MWD was highly predictive of mortality; a 24-week decline of greater than 50 m was associated with a fourfold increase in risk of death at 1 year (hazard ratio, 4.27; 95% confidence interval, 2.57- 7.10; P < 0.001). The estimated MCID was 24-45 m. The 6MWT is a reliable, valid, and responsive measure of disease status and a valid endpoint for clinical trials in IPF.

Cultural adaptation and validation of the Lasater Clinical Judgment Rubric in nursing students in Spain.

PubMed

Román-Cereto, Montserrat; García-Mayor, Silvia; Kaknani-Uttumchandani, Shakira; García-Gámez, Marina; León-Campos, Alvaro; Fernández-Ordóñez, Eloisa; Ruiz-García, Maria Luisa; Martí-García, C; López-Leiva, Inmaculada; Lasater, Kathie; Morales-Asencio, José Miguel

2018-05-01

The clinical judgment and decision-making abilities of nurses can influence many health outcomes, hence the importance of addressing these qualities in university studies. In this respect, clinical simulation is a commonly employed teaching method. The evaluation of simulation activities requires standardised instruments, such as the Lasater Clinical Judgment Rubric, which is widely used for this purpose, although a culturally adapted and validated version in Spain is not available. To obtain a Spanish culturally adapted and validated version of the rubric for undergraduate students of nursing. Cultural adaptation and psychometric validation study carried out with undergraduate nursing students in the simulation laboratories at the University of Málaga (Spain). A process of translation/back-translation and cultural adaptation was carried out in accordance with international standards. The rubric was empirically evaluated in standardised scenarios with high and medium-fidelity simulators. Each student took part in two different simulation sessions, led by two instructors. In each simulation, the data were collected by two independent observers. 152 observations were obtained from 76 students. The interobserver reliability was high, with an intraclass correlation coefficient of 0.93 (95% CI 0.92-0.95) (p = 0.0001) and Cronbach's alpha of 0.93. According to the confirmatory factor analysis, the fit of the model was satisfactory in all indices, with a χ 2 /df value of 1.08, GFI 0.96, TLI 0.99, NFI 0.97 and RMSEA 0.24 (90% CI 0.000-0.066). The rubric obtained is culturally adapted to the Spanish educational context, and is valid and reliable for nursing students. Further prospective studies should be undertaken to evaluate the responsiveness, potential for transfer to clinical practice and cost-benefit ratios of different simulation designs. Copyright © 2018 Elsevier Ltd. All rights reserved.

Discovery and Validation of Biomarkers to Guide Clinical Management of Pneumonia in African Children

PubMed Central

Huang, Honglei; Ideh, Readon C.; Gitau, Evelyn; Thézénas, Marie L.; Jallow, Muminatou; Ebruke, Bernard; Chimah, Osaretin; Oluwalana, Claire; Karanja, Henri; Mackenzie, Grant; Adegbola, Richard A.; Kwiatkowski, Dominic; Kessler, Benedikt M.; Berkley, James A.; Howie, Stephen R. C.; Casals-Pascual, Climent

2014-01-01

Background. Pneumonia is the leading cause of death in children globally. Clinical algorithms remain suboptimal for distinguishing severe pneumonia from other causes of respiratory distress such as malaria or distinguishing bacterial pneumonia and pneumonia from others causes, such as viruses. Molecular tools could improve diagnosis and management. Methods. We conducted a mass spectrometry–based proteomic study to identify and validate markers of severity in 390 Gambian children with pneumonia (n = 204) and age-, sex-, and neighborhood-matched controls (n = 186). Independent validation was conducted in 293 Kenyan children with respiratory distress (238 with pneumonia, 41 with Plasmodium falciparum malaria, and 14 with both). Predictive value was estimated by the area under the receiver operating characteristic curve (AUC). Results. Lipocalin 2 (Lpc-2) was the best protein biomarker of severe pneumonia (AUC, 0.71 [95% confidence interval, .64–.79]) and highly predictive of bacteremia (78% [64%–92%]), pneumococcal bacteremia (84% [71%–98%]), and “probable bacterial etiology” (91% [84%–98%]). These results were validated in Kenyan children with severe malaria and respiratory distress who also met the World Health Organization definition of pneumonia. The combination of Lpc-2 and haptoglobin distinguished bacterial versus malaria origin of respiratory distress with high sensitivity and specificity in Gambian children (AUC, 99% [95% confidence interval, 99%–100%]) and Kenyan children (82% [74%–91%]). Conclusions. Lpc-2 and haptoglobin can help discriminate the etiology of clinically defined pneumonia and could be used to improve clinical management. These biomarkers should be further evaluated in prospective clinical studies. PMID:24696240

Concurrent Validation of the Clinical Opiate Withdrawal Scale (COWS) and Single-Item Indices against the Clinical Institute Narcotic Assessment (CINA) Opioid Withdrawal Instrument

PubMed Central

Tompkins, D. Andrew; Bigelow, George E.; Harrison, Joseph A.; Johnson, Rolley E.; Fudala, Paul J.; Strain, Eric C.

2009-01-01

Introduction The Clinical Opiate Withdrawal Scale (COWS) is an 11-item clinician-administered scale assessing opioid withdrawal. Though commonly used in clinical practice, it has not been systematically validated. The present study validated the COWS in comparison to the validated Clinical Institute Narcotic Assessment (CINA) scale. Method Opioid-dependent volunteers were enrolled in a residential trial and stabilized on morphine 30 mg given subcutaneously four times daily. Subjects then underwent double-blind, randomized challenges of intramuscularly administered placebo and naloxone (0.4 mg) on separate days, during which the COWS, CINA, and visual analog scale (VAS) assessments were concurrently obtained. Subjects completing both challenges were included (N=46). Correlations between mean peak COWS and CINA scores as well as self-report VAS questions were calculated. Results Mean peak COWS and CINA scores of 7.6 and 24.4, respectively, occurred on average 30 minutes post-injection of naloxone. Mean COWS and CINA scores 30 minutes after placebo injection were 1.3 and 18.9, respectively. The Pearson correlation coefficient for peak COWS and CINA scores during the naloxone challenge session was 0.85 (p<0.001). Peak COWS scores also correlated well with peak VAS self-report scores of bad drug effect (r=0.57, p<0.001) and feeling sick (r=0.57, p<0.001), providing additional evidence of concurrent validity. Placebo was not associated with any significant elevation of COWS, CINA, or VAS scores, indicating discriminant validity. Cronbach’s alpha for the COWS was 0.78, indicating good internal consistency (reliability). Discussion COWS, CINA, and certain VAS items are all valid measurement tools for acute opiate withdrawal. PMID:19647958

Validity of a quantitative clinical measurement tool of trunk posture in idiopathic scoliosis.

PubMed

Fortin, Carole; Feldman, Debbie E; Cheriet, Farida; Labelle, Hubert

2010-09-01

Concurrent validity between postural indices obtained from digital photographs (two-dimensional [2D]), surface topography imaging (three-dimensional [3D]), and radiographs. To assess the validity of a quantitative clinical postural assessment tool of the trunk based on photographs (2D) as compared to a surface topography system (3D) as well as indices calculated from radiographs. To monitor progression of scoliosis or change in posture over time in young persons with idiopathic scoliosis (IS), noninvasive and nonionizing methods are recommended. In a clinical setting, posture can be quite easily assessed by calculating key postural indices from photographs. Quantitative postural indices of 70 subjects aged 10 to 20 years old with IS (Cobb angle, 15 degrees -60 degrees) were measured from photographs and from 3D trunk surface images taken in the standing position. Shoulder, scapula, trunk list, pelvis, scoliosis, and waist angles indices were calculated with specially designed software. Frontal and sagittal Cobb angles and trunk list were also calculated on radiographs. The Pearson correlation coefficients (r) was used to estimate concurrent validity of the 2D clinical postural tool of the trunk with indices extracted from the 3D system and with those obtained from radiographs. The correlation between 2D and 3D indices was good to excellent for shoulder, pelvis, trunk list, and thoracic scoliosis (0.81>r<0.97; P<0.01) but fair to moderate for thoracic kyphosis, lumbar lordosis, and thoracolumbar or lumbar scoliosis (0.30>r<0.56; P<0.05). The correlation between 2D and radiograph spinal indices was fair to good (-0.33 to -0.80 with Cobb angles and 0.76 for trunk list; P<0.05). This tool will facilitate clinical practice by monitoring trunk posture among persons with IS. Further, it may contribute to a reduction in the use of radiographs to monitor scoliosis progression.

Validation of the 4P's Plus screen for substance use in pregnancy validation of the 4P's Plus.

PubMed

Chasnoff, I J; Wells, A M; McGourty, R F; Bailey, L K

2007-12-01

The purpose of this study is to validate the 4P's Plus screen for substance use in pregnancy. A total of 228 pregnant women enrolled in prenatal care underwent screening with the 4P's Plus and received a follow-up clinical assessment for substance use. Statistical analyses regarding reliability, sensitivity, specificity, and positive and negative predictive validity of the 4Ps Plus were conducted. The overall reliability for the five-item measure was 0.62. Seventy-four (32.5%) of the women had a positive screen. Sensitivity and specificity were very good, at 87 and 76%, respectively. Positive predictive validity was low (36%), but negative predictive validity was quite high (97%). Of the 31 women who had a positive clinical assessment, 45% were using less than 1 day per week. The 4P's Plus reliably and effectively screens pregnant women for risk of substance use, including those women typically missed by other perinatal screening methodologies.

The Reliability, Validity, and Usefulness of the Objective Structured Clinical Examination (OSCE) in Dental Education

ERIC Educational Resources Information Center

Graham, Roseanna

2010-01-01

This study evaluated the reliability, validity, and educational usefulness of a comprehensive, multidisciplinary Objective Structured Clinical Examination (OSCE) in dental education. The OSCE was administered to dental students at the Columbia University College of Dental Medicine (CDM) before they entered clinical training. Participants in this…

Translation, adaptation, and validation of the Stanford Hypnotic Clinical Scale in Puerto Rico.

PubMed

Deynes-Exclusa, Yazmin; Sayers-Montalvo, Sean K; Martinez-Taboas, Alfonso

2011-04-01

The only hypnotizability scale that has been translated and validated for the Puerto Rican population is the Barber Suggestibility Scale (BSS). In this article, the Stanford Hypnotic Clinical Scale (SHCS) was translated and validated for this population. The translated SHCS ("Escala Stanford de Hipnosis Clinica" [ESHC]) was administered individually to 100 Puerto Rican college students. There were no significant differences found between the norms of the original SHCS samples and the Spanish version of the SHCS. Both samples showed similar distributions. The Spanish version's internal reliability as well as the item discrimination index were adequate. The authors conclude that the ESHC is an adequate instrument to measure hypnotizability in the Puerto Rican population.

SU-E-T-50: Automatic Validation of Megavoltage Beams Modeled for Clinical Use in Radiation Therapy

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

Melchior, M; Salinas Aranda, F; 21st Century Oncology, Ft. Myers, FL

2014-06-01

Purpose: To automatically validate megavoltage beams modeled in XiO™ 4.50 (Elekta, Stockholm, Sweden) and Varian Eclipse™ Treatment Planning Systems (TPS) (Varian Associates, Palo Alto, CA, USA), reducing validation time before beam-on for clinical use. Methods: A software application that can automatically read and analyze DICOM RT Dose and W2CAD files was developed using MatLab integrated development environment.TPS calculated dose distributions, in DICOM RT Dose format, and dose values measured in different Varian Clinac beams, in W2CAD format, were compared. Experimental beam data used were those acquired for beam commissioning, collected on a water phantom with a 2D automatic beam scanningmore » system.Two methods were chosen to evaluate dose distributions fitting: gamma analysis and point tests described in Appendix E of IAEA TECDOC-1583. Depth dose curves and beam profiles were evaluated for both open and wedged beams. Tolerance parameters chosen for gamma analysis are 3% and 3 mm dose and distance, respectively.Absolute dose was measured independently at points proposed in Appendix E of TECDOC-1583 to validate software results. Results: TPS calculated depth dose distributions agree with measured beam data under fixed precision values at all depths analyzed. Measured beam dose profiles match TPS calculated doses with high accuracy in both open and wedged beams. Depth and profile dose distributions fitting analysis show gamma values < 1. Relative errors at points proposed in Appendix E of TECDOC-1583 meet therein recommended tolerances.Independent absolute dose measurements at points proposed in Appendix E of TECDOC-1583 confirm software results. Conclusion: Automatic validation of megavoltage beams modeled for their use in the clinic was accomplished. The software tool developed proved efficient, giving users a convenient and reliable environment to decide whether to accept or not a beam model for clinical use. Validation time before beam-on for

Noninvasive assessment of mitral inertness: clinical results with numerical model validation

NASA Technical Reports Server (NTRS)

Firstenberg, M. S.; Greenberg, N. L.; Smedira, N. G.; McCarthy, P. M.; Garcia, M. J.; Thomas, J. D.

2001-01-01

Inertial forces (Mdv/dt) are a significant component of transmitral flow, but cannot be measured with Doppler echo. We validated a method of estimating Mdv/dt. Ten patients had a dual sensor transmitral (TM) catheter placed during cardiac surgery. Doppler and 2D echo was performed while acquiring LA and LV pressures. Mdv/dt was determined from the Bernoulli equation using Doppler velocities and TM gradients. Results were compared with numerical modeling. TM gradients (range: 1.04-14.24 mmHg) consisted of 74.0 +/- 11.0% inertial forcers (range: 0.6-12.9 mmHg). Multivariate analysis predicted Mdv/dt = -4.171(S/D (RATIO)) + 0.063(LAvolume-max) + 5. Using this equation, a strong relationship was obtained for the clinical dataset (y=0.98x - 0.045, r=0.90) and the results of numerical modeling (y=0.96x - 0.16, r=0.84). TM gradients are mainly inertial and, as validated by modeling, can be estimated with echocardiography.

On Validity Theory and Test Validation

ERIC Educational Resources Information Center

Sireci, Stephen G.

2007-01-01

Lissitz and Samuelsen (2007) propose a new framework for conceptualizing test validity that separates analysis of test properties from analysis of the construct measured. In response, the author of this article reviews fundamental characteristics of test validity, drawing largely from seminal writings as well as from the accepted standards. He…

Millon Clinical Multiaxial Inventory-III Subtypes of Opioid Dependence: Validity and Matching to Behavioral Therapies

ERIC Educational Resources Information Center

Ball, Samuel A.; Nich, Charla; Rounsaville, Bruce J.; Eagan, Dorothy; Carroll, Kathleen M.

2004-01-01

The concurrent and predictive validity of 2 different methods of Millon Clinical Multiaxial Inventory-III subtyping (protocol sorting, cluster analysis) was evaluated in 125 recently detoxified opioid-dependent outpatients in a 12-week randomized clinical trial. Participants received naltrexone and relapse prevention group counseling and were…

Measuring the statistical validity of summary meta-analysis and meta-regression results for use in clinical practice.

PubMed

Willis, Brian H; Riley, Richard D

2017-09-20

An important question for clinicians appraising a meta-analysis is: are the findings likely to be valid in their own practice-does the reported effect accurately represent the effect that would occur in their own clinical population? To this end we advance the concept of statistical validity-where the parameter being estimated equals the corresponding parameter for a new independent study. Using a simple ('leave-one-out') cross-validation technique, we demonstrate how we may test meta-analysis estimates for statistical validity using a new validation statistic, Vn, and derive its distribution. We compare this with the usual approach of investigating heterogeneity in meta-analyses and demonstrate the link between statistical validity and homogeneity. Using a simulation study, the properties of Vn and the Q statistic are compared for univariate random effects meta-analysis and a tailored meta-regression model, where information from the setting (included as model covariates) is used to calibrate the summary estimate to the setting of application. Their properties are found to be similar when there are 50 studies or more, but for fewer studies Vn has greater power but a higher type 1 error rate than Q. The power and type 1 error rate of Vn are also shown to depend on the within-study variance, between-study variance, study sample size, and the number of studies in the meta-analysis. Finally, we apply Vn to two published meta-analyses and conclude that it usefully augments standard methods when deciding upon the likely validity of summary meta-analysis estimates in clinical practice. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.

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.

Symptom validity testing in memory clinics: Hippocampal-memory associations and relevance for diagnosing mild cognitive impairment.

PubMed

Rienstra, Anne; Groot, Paul F C; Spaan, Pauline E J; Majoie, Charles B L M; Nederveen, Aart J; Walstra, Gerard J M; de Jonghe, Jos F M; van Gool, Willem A; Olabarriaga, Silvia D; Korkhov, Vladimir V; Schmand, Ben

2013-01-01

Patients with mild cognitive impairment (MCI) do not always convert to dementia. In such cases, abnormal neuropsychological test results may not validly reflect cognitive symptoms due to brain disease, and the usual brain-behavior relationships may be absent. This study examined symptom validity in a memory clinic sample and its effect on the associations between hippocampal volume and memory performance. Eleven of 170 consecutive patients (6.5%; 13% of patients younger than 65 years) referred to memory clinics showed noncredible performance on symptom validity tests (SVTs, viz. Word Memory Test and Test of Memory Malingering). They were compared to a demographically matched group (n = 57) selected from the remaining patients. Hippocampal volume, measured by an automated volumetric method (Freesurfer), was correlated with scores on six verbal memory tests. The median correlation was r = .49 in the matched group. However, the relation was absent (median r = -.11) in patients who failed SVTs. Memory clinic samples may include patients who show noncredible performance, which invalidates their MCI diagnosis. This underscores the importance of applying SVTs in evaluating patients with cognitive complaints that may signify a predementia stage, especially when these patients are relatively young.

The Growing Need for Validated Biomarkers and Endpoints for Dry Eye Clinical Research.

PubMed

Roy, Neeta S; Wei, Yi; Kuklinski, Eric; Asbell, Penny A

2017-05-01

Biomarkers with minimally invasive and reproducible objective metrics provide the key to future paradigm shifts in understanding of the underlying causes of dry eye disease (DED) and approaches to treatment of DED. We review biomarkers and their validity in providing objective metrics for DED clinical research and patient care. The English-language literature in PubMed primarily over the last decade was surveyed for studies related to identification of biomarkers of DED: (1) inflammation, (2) point-of-care, (3) ocular imaging, and (4) genetics. Relevant studies in each group were individually evaluated for (1) methodological and analytical details, (2) data and concordance with other similar studies, and (3) potential to serve as validated biomarkers with objective metrics. Significant work has been done to identify biomarkers for DED clinical trials and for patient care. Interstudy variation among studies dealing with the same biomarker type was high. This could be attributed to biologic variations and/or differences in processing, and data analysis. Correlation with other signs and symptoms of DED was not always clear or present. Many of the biomarkers reviewed show the potential to serve as validated and objective metrics for clinical research and patient care in DED. Interstudy variation for a given biomarker emphasizes the need for detailed reporting of study methodology, including information on subject characteristics, quality control, processing, and analysis methods to optimize development of nonsubjective metrics. Biomarker development offers a rich opportunity to significantly move forward clinical research and patient care in DED. DED is an unmet medical need - a chronic pain syndrome associated with variable vision that affects quality of life, is common with advancing age, interferes with the comfortable use of contact lenses, and can diminish results of eye surgeries, such as cataract extraction, LASIK, and glaucoma procedures. It is a worldwide

Clinical validity of a disease-specific health status questionnaire: the peripheral artery questionnaire.

PubMed

Hoeks, Sanne E; Smolderen, Kim G; Scholte Op Reimer, Wilma J M; Verhagen, Hence J M; Spertus, John A; Poldermans, Don

2009-02-01

Measuring patient-centered outcomes is becoming increasingly important in patients with peripheral arterial disease (PAD), both as a means of determining the benefits of treatment and as an aid for disease management. In order to monitor health status in a reliable and sensitive way, the disease-specific measure Peripheral Artery Questionnaire (PAQ) was developed. However, to date, its correlation with traditional clinical indices is unknown. The primary aim of this study was to better establish the clinical validity of the PAQ by examining its association with functional indices related to PAD. Furthermore, we hypothesized that the clinical validity of this disease-specific measure is better as compared with the EuroQol-5-dimensional (EQ-5D), a standardized generic instrument. Data on 711 consecutive PAD patients undergoing surgery were collected from 11 Dutch hospitals in 2004. At 3-year follow-up, questionnaires including the PAQ, EQ-5D, and EuroQol-Visual Analogue Scale (EQ VAS) were completed in 84% of survivors. The PAQ was analyzed according to three domains, as established by a factor analyses in the Dutch population, and the summary score. Baseline clinical indices included the presence and severity of claudication intermittent (CI) and the Lee Cardiac Risk Index. All three PAQ domains (Physical Function, Perceived Disability, and Treatment Satisfaction) were significantly associated with CI symptoms (P values < .001-.008). Patients with claudication had significant lower PAQ summary scores as compared with asymptomatic patients (58.6 +/- 27.8 vs 68.6 +/- 27.8, P = < .001). Furthermore, the PAQ summary score and the subscale scores for Physical Functioning and Perceived Disability demonstrated a clear dose-response relation for walking distance and the Lee Risk Index (P values < .001-.031). With respect to the generic EQ-5D, the summary EQ-5D index was associated with CI (0.81 +/- 0.20 vs 0.76 +/- 0.24, P = .031) but not with walking distance (P = .128

Clinical Validity, Understandability, and Actionability of Online Cardiovascular Disease Risk Calculators: Systematic Review.

PubMed

Bonner, Carissa; Fajardo, Michael Anthony; Hui, Samuel; Stubbs, Renee; Trevena, Lyndal

2018-02-01

Online health information is particularly important for cardiovascular disease (CVD) prevention, where lifestyle changes are recommended until risk becomes high enough to warrant pharmacological intervention. Online information is abundant, but the quality is often poor and many people do not have adequate health literacy to access, understand, and use it effectively. This project aimed to review and evaluate the suitability of online CVD risk calculators for use by low health literate consumers in terms of clinical validity, understandability, and actionability. This systematic review of public websites from August to November 2016 used evaluation of clinical validity based on a high-risk patient profile and assessment of understandability and actionability using Patient Education Material Evaluation Tool for Print Materials. A total of 67 unique webpages and 73 unique CVD risk calculators were identified. The same high-risk patient profile produced widely variable CVD risk estimates, ranging from as little as 3% to as high as a 43% risk of a CVD event over the next 10 years. One-quarter (25%) of risk calculators did not specify what model these estimates were based on. The most common clinical model was Framingham (44%), and most calculators (77%) provided a 10-year CVD risk estimate. The calculators scored moderately on understandability (mean score 64%) and poorly on actionability (mean score 19%). The absolute percentage risk was stated in most (but not all) calculators (79%), and only 18% included graphical formats consistent with recommended risk communication guidelines. There is a plethora of online CVD risk calculators available, but they are not readily understandable and their actionability is poor. Entering the same clinical information produces widely varying results with little explanation. Developers need to address actionability as well as clinical validity and understandability to improve usefulness to consumers with low health literacy. �

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

PubMed

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

2017-08-25

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

The development and validation of a questionnaire to measure the clinical learning environment for undergraduate dental students (DECLEI).

PubMed

Kossioni, A E; Lyrakos, G; Ntinalexi, I; Varela, R; Economu, I

2014-05-01

The aim of this study was to develop and validate according to psychometric standards a self-administered instrument to measure the students' self-perceptions of the undergraduate clinical dental environment (DECLEI). The initial questionnaire was developed using feedback from dental students, experts' opinion and an extensive literature review. Critical incident technique (CIT) analysis was used to generate items and identify domains. Thirty clinical dental students participated in a pilot validation that generated a 67-item questionnaire. To develop a shorter and more practical version of the instrument, DECLEI-67 was distributed to 153 clinical students at the University of Athens and its English version to 51 students from various dental schools, attending the 2012 European Dental Students Association meeting. This final procedure aimed to select items, identify subscales and measure internal consistency and discriminant validity. A total of 202 students returned the questionnaires (response rate 99%). The final instrument included 24 items divided into three subscales: (i) organisation and learning opportunities, (ii) professionalism and communication and (iii) satisfaction and commitment to the dental studies. Cronbach's α for the total questionnaire was 0.89. The interscale correlations ranged from 0.39 to 0.48. The instrument identified differences related to school of origin, age and duration of clinical experience. An interpretation of the scores (range 0–100) has been proposed. The 24-item DECLEI seemed to be a practical and valid instrument to measure a dental school's undergraduate clinical learning environment.

Clinical Validation of Targeted Next Generation Sequencing for Colon and Lung Cancers

PubMed Central

D’Haene, Nicky; Le Mercier, Marie; De Nève, Nancy; Blanchard, Oriane; Delaunoy, Mélanie; El Housni, Hakim; Dessars, Barbara; Heimann, Pierre; Remmelink, Myriam; Demetter, Pieter; Tejpar, Sabine; Salmon, Isabelle

2015-01-01

Objective Recently, Next Generation Sequencing (NGS) has begun to supplant other technologies for gene mutation testing that is now required for targeted therapies. However, transfer of NGS technology to clinical daily practice requires validation. Methods We validated the Ion Torrent AmpliSeq Colon and Lung cancer panel interrogating 1850 hotspots in 22 genes using the Ion Torrent Personal Genome Machine. First, we used commercial reference standards that carry mutations at defined allelic frequency (AF). Then, 51 colorectal adenocarcinomas (CRC) and 39 non small cell lung carcinomas (NSCLC) were retrospectively analyzed. Results Sensitivity and accuracy for detecting variants at an AF >4% was 100% for commercial reference standards. Among the 90 cases, 89 (98.9%) were successfully sequenced. Among the 86 samples for which NGS and the reference test were both informative, 83 showed concordant results between NGS and the reference test; i.e. KRAS and BRAF for CRC and EGFR for NSCLC, with the 3 discordant cases each characterized by an AF <10%. Conclusions Overall, the AmpliSeq colon/lung cancer panel was specific and sensitive for mutation analysis of gene panels and can be incorporated into clinical daily practice. PMID:26366557

Concurrent Criterion Validity of the Ausburg Multidimensional Personality Instrument (AMPI) Clinical Scales among College Students

ERIC Educational Resources Information Center

Kelly, William E.; Lutz, Daniel

2014-01-01

The concurrent criterion validity of the Ausburg Multidimensional Personality Instrument (AMPI) clinical scales was examined. The AMPI and several scales purportedly measuring the same or similar constructs as those of the AMPI clinical scales were administered to two samples of college students (N = 134 and N = 118). The correlations between the…

Development and validation of a clinical prediction rule to identify suspected breast cancer: a prospective cohort study.

PubMed

Galvin, Rose; Joyce, Doireann; Downey, Eithne; Boland, Fiona; Fahey, Tom; Hill, Arnold K

2014-10-03

The number of primary care referrals of women with breast symptoms to symptomatic breast units (SBUs) has increased exponentially in the past decade in Ireland. The aim of this study is to develop and validate a clinical prediction rule (CPR) to identify women with breast cancer so that a more evidence based approach to referral from primary care to these SBUs can be developed. We analysed routine data from a prospective cohort of consecutive women reviewed at a SBU with breast symptoms. The dataset was split into a derivation and validation cohort. Regression analysis was used to derive a CPR from the patient's history and clinical findings. Validation of the CPR consisted of estimating the number of breast cancers predicted to occur compared with the actual number of observed breast cancers across deciles of risk. A total of 6,590 patients were included in the derivation study and 4.9% were diagnosed with breast cancer. Independent clinical predictors for breast cancer were: increasing age by year (adjusted odds ratio 1.08, 95% CI 1.07-1.09); presence of a lump (5.63, 95% CI 4.2-7.56); nipple change (2.77, 95% CI 1.68-4.58) and nipple discharge (2.09, 95% CI 1.1-3.97). Validation of the rule (n = 911) demonstrated that the probability of breast cancer was higher with an increasing number of these independent variables. The Hosmer-Lemeshow goodness of fit showed no overall significant difference between the expected and the observed numbers of breast cancer (χ(2)HL: 6.74, p-value: 0.56). This study derived and validated a CPR for breast cancer in women attending an Irish national SBU. We found that increasing age, presence of a lump, nipple discharge and nipple change are all associated with increased risk of breast cancer. Further validation of the rule is necessary as well as an assessment of its impact on referral practice.

Validating archetypes for the Multiple Sclerosis Functional Composite.

PubMed

Braun, Michael; Brandt, Alexander Ulrich; Schulz, Stefan; Boeker, Martin

2014-08-03

Numerous information models for electronic health records, such as openEHR archetypes are available. The quality of such clinical models is important to guarantee standardised semantics and to facilitate their interoperability. However, validation aspects are not regarded sufficiently yet. The objective of this report is to investigate the feasibility of archetype development and its community-based validation process, presuming that this review process is a practical way to ensure high-quality information models amending the formal reference model definitions. A standard archetype development approach was applied on a case set of three clinical tests for multiple sclerosis assessment: After an analysis of the tests, the obtained data elements were organised and structured. The appropriate archetype class was selected and the data elements were implemented in an iterative refinement process. Clinical and information modelling experts validated the models in a structured review process. Four new archetypes were developed and publicly deployed in the openEHR Clinical Knowledge Manager, an online platform provided by the openEHR Foundation. Afterwards, these four archetypes were validated by domain experts in a team review. The review was a formalised process, organised in the Clinical Knowledge Manager. Both, development and review process turned out to be time-consuming tasks, mostly due to difficult selection processes between alternative modelling approaches. The archetype review was a straightforward team process with the goal to validate archetypes pragmatically. The quality of medical information models is crucial to guarantee standardised semantic representation in order to improve interoperability. The validation process is a practical way to better harmonise models that diverge due to necessary flexibility left open by the underlying formal reference model definitions.This case study provides evidence that both community- and tool-enabled review processes

Validating archetypes for the Multiple Sclerosis Functional Composite

PubMed Central

2014-01-01

Background Numerous information models for electronic health records, such as openEHR archetypes are available. The quality of such clinical models is important to guarantee standardised semantics and to facilitate their interoperability. However, validation aspects are not regarded sufficiently yet. The objective of this report is to investigate the feasibility of archetype development and its community-based validation process, presuming that this review process is a practical way to ensure high-quality information models amending the formal reference model definitions. Methods A standard archetype development approach was applied on a case set of three clinical tests for multiple sclerosis assessment: After an analysis of the tests, the obtained data elements were organised and structured. The appropriate archetype class was selected and the data elements were implemented in an iterative refinement process. Clinical and information modelling experts validated the models in a structured review process. Results Four new archetypes were developed and publicly deployed in the openEHR Clinical Knowledge Manager, an online platform provided by the openEHR Foundation. Afterwards, these four archetypes were validated by domain experts in a team review. The review was a formalised process, organised in the Clinical Knowledge Manager. Both, development and review process turned out to be time-consuming tasks, mostly due to difficult selection processes between alternative modelling approaches. The archetype review was a straightforward team process with the goal to validate archetypes pragmatically. Conclusions The quality of medical information models is crucial to guarantee standardised semantic representation in order to improve interoperability. The validation process is a practical way to better harmonise models that diverge due to necessary flexibility left open by the underlying formal reference model definitions. This case study provides evidence that both

Measuring the statistical validity of summary meta‐analysis and meta‐regression results for use in clinical practice

PubMed Central

Riley, Richard D.

2017-01-01

An important question for clinicians appraising a meta‐analysis is: are the findings likely to be valid in their own practice—does the reported effect accurately represent the effect that would occur in their own clinical population? To this end we advance the concept of statistical validity—where the parameter being estimated equals the corresponding parameter for a new independent study. Using a simple (‘leave‐one‐out’) cross‐validation technique, we demonstrate how we may test meta‐analysis estimates for statistical validity using a new validation statistic, Vn, and derive its distribution. We compare this with the usual approach of investigating heterogeneity in meta‐analyses and demonstrate the link between statistical validity and homogeneity. Using a simulation study, the properties of Vn and the Q statistic are compared for univariate random effects meta‐analysis and a tailored meta‐regression model, where information from the setting (included as model covariates) is used to calibrate the summary estimate to the setting of application. Their properties are found to be similar when there are 50 studies or more, but for fewer studies Vn has greater power but a higher type 1 error rate than Q. The power and type 1 error rate of Vn are also shown to depend on the within‐study variance, between‐study variance, study sample size, and the number of studies in the meta‐analysis. Finally, we apply Vn to two published meta‐analyses and conclude that it usefully augments standard methods when deciding upon the likely validity of summary meta‐analysis estimates in clinical practice. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. PMID:28620945

Assessing clinical reasoning (ASCLIRE): Instrument development and validation.

PubMed

Kunina-Habenicht, Olga; Hautz, Wolf E; Knigge, Michel; Spies, Claudia; Ahlers, Olaf

2015-12-01

Clinical reasoning is an essential competency in medical education. This study aimed at developing and validating a test to assess diagnostic accuracy, collected information, and diagnostic decision time in clinical reasoning. A norm-referenced computer-based test for the assessment of clinical reasoning (ASCLIRE) was developed, integrating the entire clinical decision process. In a cross-sectional study participants were asked to choose as many diagnostic measures as they deemed necessary to diagnose the underlying disease of six different cases with acute or sub-acute dyspnea and provide a diagnosis. 283 students and 20 content experts participated. In addition to diagnostic accuracy, respective decision time and number of used relevant diagnostic measures were documented as distinct performance indicators. The empirical structure of the test was investigated using a structural equation modeling approach. Experts showed higher accuracy rates and lower decision times than students. In a cross-sectional comparison, the diagnostic accuracy of students improved with the year of study. Wrong diagnoses provided by our sample were comparable to wrong diagnoses in practice. We found an excellent fit for a model with three latent factors-diagnostic accuracy, decision time, and choice of relevant diagnostic information-with diagnostic accuracy showing no significant correlation with decision time. ASCLIRE considers decision time as an important performance indicator beneath diagnostic accuracy and provides evidence that clinical reasoning is a complex ability comprising diagnostic accuracy, decision time, and choice of relevant diagnostic information as three partly correlated but still distinct aspects.

Are validated outcome measures used in distal radial fractures truly valid?

PubMed Central

Nienhuis, R. W.; Bhandari, M.; Goslings, J. C.; Poolman, R. W.; Scholtes, V. A. B.

2016-01-01

validity on hypothesis testing are good. There is no evidence for the other measurement properties. Conclusion According to this systematic review, there is, at best, moderate evidence that the responsiveness of the PRWE and DASH are good, as are the reliability and validity of the PRWE. We recommend these PROMs in clinical studies in patients with distal radial fractures; however, more clinimetric studies of higher methodological quality are needed to adequately determine the other measurement properties. Cite this article: Dr Y. V. Kleinlugtenbelt. Are validated outcome measures used in distal radial fractures truly valid?: A critical assessment using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Bone Joint Res 2016;5:153–161. DOI: 10.1302/2046-3758.54.2000462. PMID:27132246

Clinical prediction rule for delayed hemothorax after minor thoracic injury: a multicentre derivation and validation study

PubMed Central

Émond, Marcel; Guimont, Chantal; Chauny, Jean-Marc; Daoust, Raoul; Bergeron, Éric; Vanier, Laurent; Moore, Lynne; Plourde, Miville; Kuimi, Batomen; Boucher, Valérie; Allain-Boulé, Nadine; Le Sage, Natalie

2017-01-01

Background: About 75% of patients with minor thoracic injury are discharged after an emergency department visit. However, complications such as delayed hemothorax can occur. We sought to derive and validate a clinical decision rule to predict hemothorax in patients discharged from the emergency department. Methods: We conducted a 6-year prospective cohort study in 4 university-affiliated emergency departments. Patients aged 16 years or older presenting with a minor thoracic injury were assessed at 5 time points (initial visit and 7, 14, 30 and 90 d after the injury). Radiologists' reports were reviewed for the presence of hemothorax. We used log-binomial regression models to identify predictors of hemothorax. Results: A total of 1382 patients were included: 830 in the derivation phase and 552 in the validation phase. Of these, 151 (10.9%) had hemothorax at the 14-day follow-up. Patients 65 years of age or older represented 25.3% (210/830) and 23.7% (131/552) of the derivation and validation cohorts, respectively. The final clinical decision rule included a combination of age (> 70 yr, 2 points; 45-70 yr, 1 point), fracture of any high to mid thorax rib (ribs 3-9, 2 points) and presence of 3 or more rib fractures (1 point). Twenty (30.8%) of the 65 high-risk patients (score ≥ 4) experienced hemothorax during the follow-up period. The clinical decision rule had a high specificity (90.7%, 95% confidence interval 87.7%-93.1%) in this high-risk group, thus guiding appropriate post-emergency care. Interpretation: One patient out of every 10 presented with delayed hemothorax after discharge from the emergency department. Implementation of this validated clinical decision rule for minor thoracic injury could guide emergency discharge plans. PMID:28611156

Thiopurine pharmacogenomics: association of SNPs with clinical response and functional validation of candidate genes

PubMed Central

Matimba, Alice; Li, Fang; Livshits, Alina; Cartwright, Cher S; Scully, Stephen; Fridley, Brooke L; Jenkins, Gregory; Batzler, Anthony; Wang, Liewei; Weinshilboum, Richard; Lennard, Lynne

2014-01-01

Aim We investigated candidate genes associated with thiopurine metabolism and clinical response in childhood acute lymphoblastic leukemia. Materials & methods We performed genome-wide SNP association studies of 6-thioguanine and 6-mercaptopurine cytotoxicity using lymphoblastoid cell lines. We then genotyped the top SNPs associated with lymphoblastoid cell line cytotoxicity, together with tagSNPs for genes in the ‘thiopurine pathway’ (686 total SNPs), in DNA from 589 Caucasian UK ALL97 patients. Functional validation studies were performed by siRNA knockdown in cancer cell lines. Results SNPs in the thiopurine pathway genes ABCC4, ABCC5, IMPDH1, ITPA, SLC28A3 and XDH, and SNPs located within or near ATP6AP2, FRMD4B, GNG2, KCNMA1 and NME1, were associated with clinical response and measures of thiopurine metabolism. Functional validation showed shifts in cytotoxicity for these genes. Conclusion The clinical response to thiopurines may be regulated by variation in known thiopurine pathway genes and additional novel genes outside of the thiopurine pathway. PMID:24624911

Construct Validity of an Objective Structured Clinical Examination (OSCE) in Psychiatry: Associations with the Clinical Skills Examination and Other Indicators

ERIC Educational Resources Information Center

Park, Robin S.; Chibnall, John T.; Blaskiewicz, Robert J.; Furman, Gail E.; Powell, Jill K.; Mohr, Clinton J.

2004-01-01

Objective: The construct validity of checklist and global process scores for an objective structured clinical examination (OSCE) in psychiatry was assessed. Multiple regression analysis was used to predict psychiatry OSCE scores from the clinical skills examination, an obstetrics/gynecology (OB/GYN) OSCE, and the National Board of Medical…

Clinical Validation of 4-Dimensional Computed Tomography Ventilation With Pulmonary Function Test Data

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

Brennan, Douglas; Schubert, Leah; Diot, Quentin

Purpose: A new form of functional imaging has been proposed in the form of 4-dimensional computed tomography (4DCT) ventilation. Because 4DCTs are acquired as part of routine care for lung cancer patients, calculating ventilation maps from 4DCTs provides spatial lung function information without added dosimetric or monetary cost to the patient. Before 4DCT-ventilation is implemented it needs to be clinically validated. Pulmonary function tests (PFTs) provide a clinically established way of evaluating lung function. The purpose of our work was to perform a clinical validation by comparing 4DCT-ventilation metrics with PFT data. Methods and Materials: Ninety-eight lung cancer patients withmore » pretreatment 4DCT and PFT data were included in the study. Pulmonary function test metrics used to diagnose obstructive lung disease were recorded: forced expiratory volume in 1 second (FEV1) and FEV1/forced vital capacity. Four-dimensional CT data sets and spatial registration were used to compute 4DCT-ventilation images using a density change–based and a Jacobian-based model. The ventilation maps were reduced to single metrics intended to reflect the degree of ventilation obstruction. Specifically, we computed the coefficient of variation (SD/mean), ventilation V20 (volume of lung ≤20% ventilation), and correlated the ventilation metrics with PFT data. Regression analysis was used to determine whether 4DCT ventilation data could predict for normal versus abnormal lung function using PFT thresholds. Results: Correlation coefficients comparing 4DCT-ventilation with PFT data ranged from 0.63 to 0.72, with the best agreement between FEV1 and coefficient of variation. Four-dimensional CT ventilation metrics were able to significantly delineate between clinically normal versus abnormal PFT results. Conclusions: Validation of 4DCT ventilation with clinically relevant metrics is essential. We demonstrate good global agreement between PFTs and 4DCT-ventilation, indicating

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

PubMed

Hansson, Oskar; Gill, Peter; Egeland, Thore

2014-11-01

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

Validity threats: overcoming interference with proposed interpretations of assessment data.

PubMed

Downing, Steven M; Haladyna, Thomas M

2004-03-01

Factors that interfere with the ability to interpret assessment scores or ratings in the proposed manner threaten validity. To be interpreted in a meaningful manner, all assessments in medical education require sound, scientific evidence of validity. The purpose of this essay is to discuss 2 major threats to validity: construct under-representation (CU) and construct-irrelevant variance (CIV). Examples of each type of threat for written, performance and clinical performance examinations are provided. The CU threat to validity refers to undersampling the content domain. Using too few items, cases or clinical performance observations to adequately generalise to the domain represents CU. Variables that systematically (rather than randomly) interfere with the ability to meaningfully interpret scores or ratings represent CIV. Issues such as flawed test items written at inappropriate reading levels or statistically biased questions represent CIV in written tests. For performance examinations, such as standardised patient examinations, flawed cases or cases that are too difficult for student ability contribute CIV to the assessment. For clinical performance data, systematic rater error, such as halo or central tendency error, represents CIV. The term face validity is rejected as representative of any type of legitimate validity evidence, although the fact that the appearance of the assessment may be an important characteristic other than validity is acknowledged. There are multiple threats to validity in all types of assessment in medical education. Methods to eliminate or control validity threats are suggested.

The Validity of a New Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) for Evaluating Symptoms in the Clinical Setting.

PubMed

Koloski, N A; Jones, M; Hammer, J; von Wulffen, M; Shah, A; Hoelz, H; Kutyla, M; Burger, D; Martin, N; Gurusamy, S R; Talley, N J; Holtmann, G

2017-08-01

The clinical assessments of patients with gastrointestinal symptoms can be time-consuming, and the symptoms captured during the consultation may be influenced by a variety of patient and non-patient factors. To facilitate standardized symptom assessment in the routine clinical setting, we developed the Structured Assessment of Gastrointestinal Symptom (SAGIS) instrument to precisely characterize symptoms in a routine clinical setting. We aimed to validate SAGIS including its reliability, construct and discriminant validity, and utility in the clinical setting. Development of the SAGIS consisted of initial interviews with patients referred for the diagnostic work-up of digestive symptoms and relevant complaints identified. The final instrument consisted of 22 items as well as questions on extra intestinal symptoms and was given to 1120 consecutive patients attending a gastroenterology clinic randomly split into derivation (n = 596) and validation datasets (n = 551). Discriminant validity along with test-retest reliability was assessed. The time taken to perform a clinical assessment with and without the SAGIS was recorded along with doctor satisfaction with this tool. Exploratory factor analysis conducted on the derivation sample suggested five symptom constructs labeled as abdominal pain/discomfort (seven items), gastroesophageal reflux disease/regurgitation symptoms (four items), nausea/vomiting (three items), diarrhea/incontinence (five items), and difficult defecation and constipation (2 items). Confirmatory factor analysis conducted on the validation sample supported the initially developed five-factor measurement model ([Formula: see text], p < 0.0001, χ 2 /df = 4.6, CFI = 0.90, TLI = 0.88, RMSEA = 0.08). All symptom groups demonstrated differentiation between disease groups. The SAGIS was shown to be reliable over time and resulted in a 38% reduction of the time required for clinical assessment. The SAGIS instrument has excellent

Validation of Medicaid claims-based diagnosis of myocardial infarction using an HIV clinical cohort

PubMed Central

Brouwer, Emily S.; Napravnik, Sonia; Eron, Joseph J; Simpson, Ross J; Brookhart, M. Alan; Stalzer, Brant; Vinikoor, Michael; Floris-Moore, Michelle; Stürmer, Til

2014-01-01

Background In non-experimental comparative effectiveness research using healthcare databases, outcome measurements must be validated to evaluate and potentially adjust for misclassification bias. We aimed to validate claims-based myocardial infarction algorithms in a Medicaid population using an HIV clinical cohort as the gold standard. Methods Medicaid administrative data were obtained for the years 2002–2008 and linked to the UNC CFAR HIV Clinical Cohort based on social security number, first name and last name and myocardial infarction were adjudicated. Sensitivity, specificity, positive predictive value, and negative predictive value were calculated. Results There were 1,063 individuals included. Over a median observed time of 2.5 years, 17 had a myocardial infarction. Specificity ranged from 0.979–0.993 with the highest specificity obtained using criteria with the ICD-9 code in the primary and secondary position and a length of stay ≥ 3 days. Sensitivity of myocardial infarction ascertainment varied from 0.588–0.824 depending on algorithm. Conclusion: Specificities of varying claims-based myocardial infarction ascertainment criteria are high but small changes impact positive predictive value in a cohort with low incidence. Sensitivities vary based on ascertainment criteria. Type of algorithm used should be prioritized based on study question and maximization of specific validation parameters that will minimize bias while also considering precision. PMID:23604043

Clinical decision making in response to performance validity test failure in a psychiatric setting.

PubMed

Marcopulos, Bernice A; Caillouet, Beth A; Bailey, Christopher M; Tussey, Chriscelyn; Kent, Julie-Ann; Frederick, Richard

2014-01-01

This study examined the clinical utility of a performance validity test (PVT) for screening consecutive referrals (N = 436) to a neuropsychology service at a state psychiatric hospital treating both civilly committed and forensic patients. We created a contingency table with Test of Memory Malingering (TOMM) pass/fail (355/81) and secondary gain present/absent (181/255) to examine pass rates associated with patient demographic, clinical and forensic status characteristics. Of the 81 failed PVTs, 48 had secondary gain defined as active criminal legal charges; 33 failed PVTs with no secondary gain. These individuals tended to be older, female, Caucasian, and civilly committed compared with the group with secondary gain who failed. From estimations of TOMM False Positive Rate and True Positive Rate we estimated base rates of neurocognitive malingering for our clinical population using the Test Validation Summary (TVS; Frederick & Bowden, 2009 ). Although PVT failure is clearly more common in a group with secondary gain (31%), there were a number of false positives (11%). Clinical ratings of patients without gain who failed suggested cognitive deficits, behavioral issues, and inattention. Low scores on PVTs in the absence of secondary gain provide useful information on test engagement and can inform clinical decisions about testing.

Clinical utility and validity of minoxidil response testing in androgenetic alopecia.

PubMed

Goren, Andy; Shapiro, Jerry; Roberts, Janet; McCoy, John; Desai, Nisha; Zarrab, Zoulikha; Pietrzak, Aldona; Lotti, Torello

2015-01-01

Clinical response to 5% topical minoxidil for the treatment of androgenetic alopecia (AGA) is typically observed after 3-6 months. Approximately 40% of patients will regrow hair. Given the prolonged treatment time required to elicit a response, a diagnostic test for ruling out nonresponders would have significant clinical utility. Two studies have previously reported that sulfotransferase enzyme activity in plucked hair follicles predicts a patient's response to topical minoxidil therapy. The aim of this study was to assess the clinical utility and validity of minoxidil response testing. In this communication, the present authors conducted an analysis of completed and ongoing studies of minoxidil response testing. The analysis confirmed the clinical utility of a sulfotransferase enzyme test in successfully ruling out 95.9% of nonresponders to topical minoxidil for the treatment of AGA. © 2014 Wiley Periodicals, Inc.

Spanish Translation and Cross-Language Validation of a Sleep Habits Questionnaire for Use in Clinical and Research Settings

PubMed Central

Baldwin, Carol M.; Choi, Myunghan; McClain, Darya Bonds; Celaya, Alma; Quan, Stuart F.

2012-01-01

Study Objectives: To translate, back-translate and cross-language validate (English/Spanish) the Sleep Heart Health Study Sleep Habits Questionnaire for use with Spanish-speakers in clinical and research settings. Methods: Following rigorous translation and back-translation, this cross-sectional cross-language validation study recruited bilingual participants from academic, clinic, and community-based settings (N = 50; 52% women; mean age 38.8 ± 12 years; 90% of Mexican heritage). Participants completed English and Spanish versions of the Sleep Habits Questionnaire, the Epworth Sleepiness Scale, and the Acculturation Rating Scale for Mexican Americans II one week apart in randomized order. Psychometric properties were assessed, including internal consistency, convergent validity, scale equivalence, language version intercorrelations, and exploratory factor analysis using PASW (Version18) software. Grade level readability of the sleep measure was evaluated. Results: All sleep categories (duration, snoring, apnea, insomnia symptoms, other sleep symptoms, sleep disruptors, restless legs syndrome) showed Cronbach α, Spearman-Brown coefficients and intercorrelations ≥ 0.700, suggesting robust internal consistency, correlation, and agreement between language versions. The Epworth correlated significantly with snoring, apnea, sleep symptoms, restless legs, and sleep disruptors) on both versions, supporting convergent validity. Items loaded on 4 factors accounted for 68% and 67% of the variance on the English and Spanish versions, respectively. Conclusions: The Spanish-language Sleep Habits Questionnaire demonstrates conceptual and content equivalency. It has appropriate measurement properties and should be useful for assessing sleep health in community-based clinics and intervention studies among Spanish-speaking Mexican Americans. Both language versions showed readability at the fifth grade level. Further testing is needed with larger samples. Citation: Baldwin CM

Validation of a virtual reality balance module for use in clinical concussion assessment and management.

PubMed

Teel, Elizabeth F; Slobounov, Semyon M

2015-03-01

To determine the criterion and content validity of a virtual reality (VR) balance module for use in clinical practice. Retrospective, VR balance module completed by participants during concussion baseline or assessment testing session. A Pennsylvania State University research laboratory. A total of 60 control and 28 concussed students and athletes from the Pennsylvania State University. None. This study examined: (1) the relationship between VR composite balance scores (final, stationary, yaw, pitch, and roll) and area of the center-of-pressure (eyes open and closed) scores and (2) group differences (normal volunteers and concussed student-athletes) on VR composite balance scores. With the exception of the stationary composite score, all other VR balance composite scores were significantly correlated with the center of pressure data obtained from a force platform. Significant correlations ranged from r = -0.273 to -0.704 for the eyes open conditions and from r = -0.353 to -0.876 for the eyes closed condition. When examining group differences on the VR balance composite modules, the concussed group did significantly (P < 0.01) worse on all measures compared with the control group. The VR balance module met or exceeded the criterion and content validity standard set by the current balance tools and may be appropriate for use in a clinical concussion setting. Virtual reality balance module is a valid tool for concussion assessment in clinical settings. This novel type of balance assessment may be more sensitive to concussion diagnoses, especially later (7-10 days) in the recovery phase than current clinical balance tools.

The Professionalism Assessment of Clinical Teachers (PACT): The Reliability and Validity of a Novel Tool to Evaluate Professional and Clinical Teaching Behaviors

ERIC Educational Resources Information Center

Young, Meredith E.; Cruess, Sylvia R.; Cruess, Richard L.; Steinert, Yvonne

2014-01-01

Physicians function as clinicians, teachers, and role models within the clinical environment. Negative learning environments have been shown to be due to many factors, including the presence of unprofessional behaviors among clinical teachers. Reliable and valid assessments of clinical teacher performance, including professional behaviors, may…

[Validity and Reliability of the Korean Version Scale of the Clinical Learning Environment, Supervision and Nurse Teacher Evaluation Scale (CLES+T)].

PubMed

Kim, Sun Hee; Yoo, So Yeon; Kim, Yae Young

2018-02-01

This study was conducted to evaluate the validity and reliability of the Korean version of the clinical learning environment, supervision and nurse teacher evaluation scale (CLES+T) that measures the clinical learning environment and the conditions associated with supervision and nurse teachers. The English CLES+T was translated into Korean with forward and back translation. Survey data were collected from 434 nursing students who had more than four days of clinical practice in Korean hospitals. Internal consistency reliability and construct validity using confirmatory and exploratory factor analysis were conducted. SPSS 20.0 and AMOS 22.0 programs were used for data analysis. The exploratory factor analysis revealed seven factors for the thirty three-item scale. Confirmatory factor analysis supported good convergent and discriminant validities. The Cronbach's alpha for the overall scale was .94 and for the seven subscales ranged from .78 to .94. The findings suggest that the 33-items Korean CLES+T is an appropriate instrument to measure Korean nursing students'clinical learning environment with good validity and reliability. © 2018 Korean Society of Nursing Science.

Validation of Gujarati Version of ABILOCO-Kids Questionnaire

PubMed Central

Diwan, Jasmin; Patel, Pankaj; Bansal, Ankita B.

2015-01-01

Background ABILOCO-Kids is a measure of locomotion ability for children with cerebral palsy (CP) aged 6 to 15 years & is available in English & French. Aim To validate the Gujarati version of ABILOCO-Kids questionnaire to be used in clinical research on Gujarati population. Materials and Methods ABILOCO-Kids questionnaire was translated into Gujarati from English using forward-backward-forward method. To ensure face & content validity of Gujarati version using group consensus method, each item was examined by group of experts having mean experience of 24.62 years in field of paediatric and paediatric physiotherapy. Each item was analysed for content, meaning, wording, format, ease of administration & scoring. Each item was scored by expert group as either accepted, rejected or accepted with modification. Procedure was continued until 80% of consensus for all items. Concurrent validity was examined on 55 children with Cerebral Palsy (6-15 years) of all Gross Motor Functional Classification System (GMFCS) level & all clinical types by correlating score of ABILOCO-Kids with Gross Motor Functional Measure & GMFCS. Result In phase 1 of validation, 16 items were accepted as it is; 22 items accepted with modification & 3 items went for phase 2 validation. For concurrent validity, highly significant positive correlation was found between score of ABILOCO-Kids & total GMFM (r=0.713, p<0.005) & highly significant negative correlation with GMFCS (r= -0.778, p<0.005). Conclusion Gujarati translated version of ABILOCO-Kids questionnaire has good face & content validity as well as concurrent validity which can be used to measure caregiver reported locomotion ability in children with CP. PMID:26557603

Validation of Gujarati Version of ABILOCO-Kids Questionnaire.

PubMed

Diwan, Shraddha; Diwan, Jasmin; Patel, Pankaj; Bansal, Ankita B

2015-10-01

ABILOCO-Kids is a measure of locomotion ability for children with cerebral palsy (CP) aged 6 to 15 years & is available in English & French. To validate the Gujarati version of ABILOCO-Kids questionnaire to be used in clinical research on Gujarati population. ABILOCO-Kids questionnaire was translated into Gujarati from English using forward-backward-forward method. To ensure face & content validity of Gujarati version using group consensus method, each item was examined by group of experts having mean experience of 24.62 years in field of paediatric and paediatric physiotherapy. Each item was analysed for content, meaning, wording, format, ease of administration & scoring. Each item was scored by expert group as either accepted, rejected or accepted with modification. Procedure was continued until 80% of consensus for all items. Concurrent validity was examined on 55 children with Cerebral Palsy (6-15 years) of all Gross Motor Functional Classification System (GMFCS) level & all clinical types by correlating score of ABILOCO-Kids with Gross Motor Functional Measure & GMFCS. In phase 1 of validation, 16 items were accepted as it is; 22 items accepted with modification & 3 items went for phase 2 validation. For concurrent validity, highly significant positive correlation was found between score of ABILOCO-Kids & total GMFM (r=0.713, p<0.005) & highly significant negative correlation with GMFCS (r= -0.778, p<0.005). Gujarati translated version of ABILOCO-Kids questionnaire has good face & content validity as well as concurrent validity which can be used to measure caregiver reported locomotion ability in children with CP.

The analytical validation of the Oncotype DX Recurrence Score assay

PubMed Central

Baehner, Frederick L

2016-01-01

In vitro diagnostic multivariate index assays are highly complex molecular assays that can provide clinically actionable information regarding the underlying tumour biology and facilitate personalised treatment. These assays are only useful in clinical practice if all of the following are established: analytical validation (i.e., how accurately/reliably the assay measures the molecular characteristics), clinical validation (i.e., how consistently/accurately the test detects/predicts the outcomes of interest), and clinical utility (i.e., how likely the test is to significantly improve patient outcomes). In considering the use of these assays, clinicians often focus primarily on the clinical validity/utility; however, the analytical validity of an assay (e.g., its accuracy, reproducibility, and standardisation) should also be evaluated and carefully considered. This review focuses on the rigorous analytical validation and performance of the Oncotype DX® Breast Cancer Assay, which is performed at the Central Clinical Reference Laboratory of Genomic Health, Inc. The assay process includes tumour tissue enrichment (if needed), RNA extraction, gene expression quantitation (using a gene panel consisting of 16 cancer genes plus 5 reference genes and quantitative real-time RT-PCR), and an automated computer algorithm to produce a Recurrence Score® result (scale: 0–100). This review presents evidence showing that the Recurrence Score result reported for each patient falls within a tight clinically relevant confidence interval. Specifically, the review discusses how the development of the assay was designed to optimise assay performance, presents data supporting its analytical validity, and describes the quality control and assurance programmes that ensure optimal test performance over time. PMID:27729940

The analytical validation of the Oncotype DX Recurrence Score assay.

PubMed

Baehner, Frederick L

2016-01-01

In vitro diagnostic multivariate index assays are highly complex molecular assays that can provide clinically actionable information regarding the underlying tumour biology and facilitate personalised treatment. These assays are only useful in clinical practice if all of the following are established: analytical validation (i.e., how accurately/reliably the assay measures the molecular characteristics), clinical validation (i.e., how consistently/accurately the test detects/predicts the outcomes of interest), and clinical utility (i.e., how likely the test is to significantly improve patient outcomes). In considering the use of these assays, clinicians often focus primarily on the clinical validity/utility; however, the analytical validity of an assay (e.g., its accuracy, reproducibility, and standardisation) should also be evaluated and carefully considered. This review focuses on the rigorous analytical validation and performance of the Oncotype DX ® Breast Cancer Assay, which is performed at the Central Clinical Reference Laboratory of Genomic Health, Inc. The assay process includes tumour tissue enrichment (if needed), RNA extraction, gene expression quantitation (using a gene panel consisting of 16 cancer genes plus 5 reference genes and quantitative real-time RT-PCR), and an automated computer algorithm to produce a Recurrence Score ® result (scale: 0-100). This review presents evidence showing that the Recurrence Score result reported for each patient falls within a tight clinically relevant confidence interval. Specifically, the review discusses how the development of the assay was designed to optimise assay performance, presents data supporting its analytical validity, and describes the quality control and assurance programmes that ensure optimal test performance over time.

Are You "Tilting at Windmills" or Undertaking a Valid Clinical Trial?

PubMed Central

Zariffa, Jose; Kramer, John L.K.

2011-01-01

In this review, several aspects surrounding the choice of a therapeutic intervention and the conduct of clinical trials are discussed. Some of the background for why human studies have evolved to their current state is also included. Specifically, the following questions have been addressed: 1) What criteria should be used to determine whether a scientific discovery or invention is worthy of translation to human application? 2) What recent scientific advance warrants a deeper understanding of clinical trials by everyone? 3) What are the different types and phases of a clinical trial? 4) What characteristics of a human disorder should be noted, tracked, or stratified for a clinical trial and what inclusion /exclusion criteria are important to enrolling appropriate trial subjects? 5) What are the different study designs that can be used in a clinical trial program? 6) What confounding factors can alter the accurate interpretation of clinical trial outcomes? 7) What are the success rates of clinical trials and what can we learn from previous clinical trials? 8) What are the essential principles for the conduct of valid clinical trials? PMID:21786433

Validation of the SETOC Instrument--Student Evaluation of Teaching in Outpatient Clinics

ERIC Educational Resources Information Center

Zuberi, Rukhsana W.; Bordage, Georges; Norman, Geoffrey R.

2007-01-01

Purpose: There is a paucity of evaluation forms specifically developed and validated for outpatient settings. The purpose of this study was to develop and validate an instrument specifically for evaluating outpatient teaching, to provide reliable and valid ratings for individual and group feedback to faculty, and to identify outstanding teachers…

MO-B-BRB-03: 3D Dosimetry in the Clinic: Validating Special Techniques

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

Juang, T.

Full three-dimensional (3D) dosimetry using volumetric chemical dosimeters probed by 3D imaging systems has long been a promising technique for the radiation therapy clinic, since it provides a unique methodology for dose measurements in the volume irradiated using complex conformal delivery techniques such as IMRT and VMAT. To date true 3D dosimetry is still not widely practiced in the community; it has been confined to centres of specialized expertise especially for quality assurance or commissioning roles where other dosimetry techniques are difficult to implement. The potential for improved clinical applicability has been advanced considerably in the last decade by themore » development of improved 3D dosimeters (e.g., radiochromic plastics, radiochromic gel dosimeters and normoxic polymer gel systems) and by improved readout protocols using optical computed tomography or magnetic resonance imaging. In this session, established users of some current 3D chemical dosimeters will briefly review the current status of 3D dosimetry, describe several dosimeters and their appropriate imaging for dose readout, present workflow procedures required for good dosimetry, and analyze some limitations for applications in select settings. We will review the application of 3D dosimetry to various clinical situations describing how 3D approaches can complement other dose delivery validation approaches already available in the clinic. The applications presented will be selected to inform attendees of the unique features provided by full 3D techniques. Learning Objectives: L. John Schreiner: Background and Motivation Understand recent developments enabling clinically practical 3D dosimetry, Appreciate 3D dosimetry workflow and dosimetry procedures, and Observe select examples from the clinic. Sofie Ceberg: Application to dynamic radiotherapy Observe full dosimetry under dynamic radiotherapy during respiratory motion, and Understand how the measurement of high resolution dose data

Validity and validation of expert (Q)SAR systems.

PubMed

Hulzebos, E; Sijm, D; Traas, T; Posthumus, R; Maslankiewicz, L

2005-08-01

At a recent workshop in Setubal (Portugal) principles were drafted to assess the suitability of (quantitative) structure-activity relationships ((Q)SARs) for assessing the hazards and risks of chemicals. In the present study we applied some of the Setubal principles to test the validity of three (Q)SAR expert systems and validate the results. These principles include a mechanistic basis, the availability of a training set and validation. ECOSAR, BIOWIN and DEREK for Windows have a mechanistic or empirical basis. ECOSAR has a training set for each QSAR. For half of the structural fragments the number of chemicals in the training set is >4. Based on structural fragments and log Kow, ECOSAR uses linear regression to predict ecotoxicity. Validating ECOSAR for three 'valid' classes results in predictivity of > or = 64%. BIOWIN uses (non-)linear regressions to predict the probability of biodegradability based on fragments and molecular weight. It has a large training set and predicts non-ready biodegradability well. DEREK for Windows predictions are supported by a mechanistic rationale and literature references. The structural alerts in this program have been developed with a training set of positive and negative toxicity data. However, to support the prediction only a limited number of chemicals in the training set is presented to the user. DEREK for Windows predicts effects by 'if-then' reasoning. The program predicts best for mutagenicity and carcinogenicity. Each structural fragment in ECOSAR and DEREK for Windows needs to be evaluated and validated separately.

Statistical validation of normal tissue complication probability models.

PubMed

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

2012-09-01

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

Millon Clinical Multiaxial Inventory–III Subtypes of Opioid Dependence: Validity and Matching to Behavioral Therapies

PubMed Central

Ball, Samuel A.; Nich, Charla; Rounsaville, Bruce J.; Eagan, Dorothy; Carroll, Kathleen M.

2013-01-01

The concurrent and predictive validity of 2 different methods of Millon Clinical Multiaxial Inventory–III subtyping (protocol sorting, cluster analysis) was evaluated in 125 recently detoxified opioid-dependent outpatients in a 12-week randomized clinical trial. Participants received naltrexone and relapse prevention group counseling and were assigned to 1 of 3 intervention conditions: (a) no-incentive vouchers, (b) incentive vouchers alone, or (c) incentive vouchers plus relationship counseling. Affective disturbance was the most common Axis I protocol-sorted subtype (66%), antisocial–narcissistic was the most common Axis II subtype (46%), and cluster analysis suggested that a 2-cluster solution (high vs. low psychiatric severity) was optimal. Predictive validity analyses indicated less symptom improvement for the higher problem subtypes, and patient treatment matching analyses indicated that some subtypes had better outcomes in the no-incentive voucher conditions. PMID:15301655

Clinical validation of the CHRONIOUS wearable system in patients with chronic disease.

PubMed

Bellos, Christos; Papadopoulos, Athanassios; Rosso, Roberto; Fotiadis, Dimitrios I

2013-01-01

The CHRONIOUS system defines a powerful and easy to use framework which has been designed to provide services to clinicians and their patients suffering from chronic diseases. The system is composed of a wearable shirt that integrate several body sensors, a portable smart device and a central sub-system that is responsible for the long term storage of the collected patient's data. A multi-parametric expert system is developed for the analysis of the collected data using intelligent algorithms and complex techniques. Apart for the vital signals, dietary habits, drug intake, activity data, environmental and biochemical parameters are recorded. The CHRONIOUS platform is validated through clinical trials in several medical centers and patient's home environments recruiting patients suffering from Chronic Obstructive pulmonary disease (COPD) and Chronic Kidney Disease (CKD) diseases. The clinical trials contribute in improving the system's accuracy, while Pulmonologists and Nephrologists experts utilized the CHRONIOUS platform to evaluate its efficiency and performance. The results of the utilization of the system were very encouraging. The CHRONIOUS system has been proven to be a well-validated real-time patient monitoring and supervision platform, providing a useful tool for the clinician and the patient that would contribute to the more effective management of chronic diseases.

Linguistic and psychometric validation of the Malaysian version of Diabetes Quality of Life-Brief Clinical Inventory (DQoL-BCI).

PubMed

Samah, Syamimi; Neoh, Chin Fen; Wong, Yuet Yen; Hassali, Mohamed Azmi; Shafie, Asrul Akmal; Lim, Siong Meng; Ramasamy, Kalavathy; Mat Nasir, Nafiza; Han, Yung Wen; Burroughs, Thomas

2017-11-01

Quality of life (QoL) assessment provides valuable outcome to support clinical decision-making, particularly for patients with chronic diseases that are incurable. A brief, 15-item diabetes-specific tool [i.e. Diabetes Quality of Life-Brief Clinical Inventory (DQoL-BCI)] is known to be developed in English and validated for use in clinical practice. This simplified tool, however, is not readily available for use in the Malaysian setting. To translate the DQoL-BCI into a Malaysian version and to assess its construct validity (factorial validity, convergent validity and discriminant validity), reliability (internal consistency) and floor and ceiling effects among the Malaysian diabetic population. A forward-backward translation, involving professional translators and experts with vast experience in translation of patient reported outcome measures, was conducted. A total of 202 patients with Type 2 diabetes mellitus (T2DM) who fulfilled the inclusion criteria were invited to complete the translated DQoL-BCI. Data were analysed using SPSS for exploratory factor analysis (EFA), convergent and discriminant validity, reliability and test-retest, and AMOS software for confirmatory factor analysis (CFA). Findings from EFA indicated that the 4-factor structure of the Malaysian version of DQoL-BCI was optimal and explained 50.9% of the variance; CFA confirmed the 4-factor model fit. There was negative, moderate correlation between the scores of DQoL-BCI (Malaysian version) and EQ-5D-3L utility score (r = -0.329, p = 0.003). Patients with higher glycated haemoglobin levels (p = 0.008), diabetes macrovascular (p = 0.017) and microvascular (p = 0.013) complications reported poorer QoL. Cronbach's alpha coefficient and intraclass coefficient correlations (range) obtained were 0.703 and 0.86 (0.734-0.934), indicating good reliability and stability of the translated DQoL-BCI. This study had validated the linguistic and psychometric properties of DQoL-BCI (Malaysian

Review of the Reported Measures of Clinical Validity and Clinical Utility as Arguments for the Implementation of Pharmacogenetic Testing: A Case Study of Statin-Induced Muscle Toxicity.

PubMed

Jansen, Marleen E; Rigter, T; Rodenburg, W; Fleur, T M C; Houwink, E J F; Weda, M; Cornel, Martina C

2017-01-01

Advances from pharmacogenetics (PGx) have not been implemented into health care to the expected extent. One gap that will be addressed in this study is a lack of reporting on clinical validity and clinical utility of PGx-tests. A systematic review of current reporting in scientific literature was conducted on publications addressing PGx in the context of statins and muscle toxicity. Eighty-nine publications were included and information was selected on reported measures of effect, arguments, and accompanying conclusions. Most authors report associations to quantify the relationship between a genetic variation an outcome, such as adverse drug responses. Conclusions on the implementation of a PGx-test are generally based on these associations, without explicit mention of other measures relevant to evaluate the test's clinical validity and clinical utility. To gain insight in the clinical impact and select useful tests, additional outcomes are needed to estimate the clinical validity and utility, such as cost-effectiveness.

[Validation and verfication of microbiology methods].

PubMed

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

2015-01-01

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

Clinical Validation of Non-Invasive Cardiac Output Monitoring in Healthy Pregnant Women.

PubMed

McLaughlin, Kelsey; Wright, Stephen P; Kingdom, John C P; Parker, John D

2017-11-01

Non-invasive hemodynamic monitoring has the potential to be a valuable clinical tool for the screening and management of hypertensive disorders of pregnancy. The objective of this study was to validate the clinical utility of the non-invasive cardiac output monitoring (NICOM) system in pregnant women. Twenty healthy pregnant women with a singleton pregnancy at 22 to 26 weeks' gestation were enrolled in this study. Measures of heart rate, stroke volume, and cardiac output were obtained through NICOM and compared with Doppler echocardiography. NICOM significantly overestimated measures of both stroke volume and cardiac output compared with Doppler echocardiography (95 ± 4 vs. 73 ± 4 mL, P < 0.0001; and 7.4 ± 0.2 vs. 5.6 ± 0.2 L/min, P < 0.0001; respectively). There is no gold standard for the measurement of cardiac output in the setting of pregnancy. However, once normal values have been established, NICOM has the potential to be a useful clinical tool for monitoring maternal hemodynamics in pregnant women. Further investigation regarding the validity of NICOM is required in larger populations of healthy and hypertensive pregnant women to determine whether this device is appropriate for maternal hemodynamic assessment during pregnancy. Copyright © 2017 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.

Development and Validation of a Practical Two-Step Prediction Model and Clinical Risk Score for Post-Thrombotic Syndrome.

PubMed

Amin, Elham E; van Kuijk, Sander M J; Joore, Manuela A; Prandoni, Paolo; Cate, Hugo Ten; Cate-Hoek, Arina J Ten

2018-06-04

 Post-thrombotic syndrome (PTS) is a common chronic consequence of deep vein thrombosis that affects the quality of life and is associated with substantial costs. In clinical practice, it is not possible to predict the individual patient risk. We develop and validate a practical two-step prediction tool for PTS in the acute and sub-acute phase of deep vein thrombosis.  Multivariable regression modelling with data from two prospective cohorts in which 479 (derivation) and 1,107 (validation) consecutive patients with objectively confirmed deep vein thrombosis of the leg, from thrombosis outpatient clinic of Maastricht University Medical Centre, the Netherlands (derivation) and Padua University hospital in Italy (validation), were included. PTS was defined as a Villalta score of ≥ 5 at least 6 months after acute thrombosis.  Variables in the baseline model in the acute phase were: age, body mass index, sex, varicose veins, history of venous thrombosis, smoking status, provoked thrombosis and thrombus location. For the secondary model, the additional variable was residual vein obstruction. Optimism-corrected area under the receiver operating characteristic curves (AUCs) were 0.71 for the baseline model and 0.60 for the secondary model. Calibration plots showed well-calibrated predictions. External validation of the derived clinical risk scores was successful: AUC, 0.66 (95% confidence interval [CI], 0.63-0.70) and 0.64 (95% CI, 0.60-0.69).  Individual risk for PTS in the acute phase of deep vein thrombosis can be predicted based on readily accessible baseline clinical and demographic characteristics. The individual risk in the sub-acute phase can be predicted with limited additional clinical characteristics. Schattauer GmbH Stuttgart.

Connecting Technological Innovation in Artificial Intelligence to Real-world Medical Practice through Rigorous Clinical Validation: What Peer-reviewed Medical Journals Could Do

PubMed Central

2018-01-01

Artificial intelligence (AI) is projected to substantially influence clinical practice in the foreseeable future. However, despite the excitement around the technologies, it is yet rare to see examples of robust clinical validation of the technologies and, as a result, very few are currently in clinical use. A thorough, systematic validation of AI technologies using adequately designed clinical research studies before their integration into clinical practice is critical to ensure patient benefit and safety while avoiding any inadvertent harms. We would like to suggest several specific points regarding the role that peer-reviewed medical journals can play, in terms of study design, registration, and reporting, to help achieve proper and meaningful clinical validation of AI technologies designed to make medical diagnosis and prediction, focusing on the evaluation of diagnostic accuracy efficacy. Peer-reviewed medical journals can encourage investigators who wish to validate the performance of AI systems for medical diagnosis and prediction to pay closer attention to the factors listed in this article by emphasizing their importance. Thereby, peer-reviewed medical journals can ultimately facilitate translating the technological innovations into real-world practice while securing patient safety and benefit. PMID:29805337

Connecting Technological Innovation in Artificial Intelligence to Real-world Medical Practice through Rigorous Clinical Validation: What Peer-reviewed Medical Journals Could Do.

PubMed

Park, Seong Ho; Kressel, Herbert Y

2018-05-28

Artificial intelligence (AI) is projected to substantially influence clinical practice in the foreseeable future. However, despite the excitement around the technologies, it is yet rare to see examples of robust clinical validation of the technologies and, as a result, very few are currently in clinical use. A thorough, systematic validation of AI technologies using adequately designed clinical research studies before their integration into clinical practice is critical to ensure patient benefit and safety while avoiding any inadvertent harms. We would like to suggest several specific points regarding the role that peer-reviewed medical journals can play, in terms of study design, registration, and reporting, to help achieve proper and meaningful clinical validation of AI technologies designed to make medical diagnosis and prediction, focusing on the evaluation of diagnostic accuracy efficacy. Peer-reviewed medical journals can encourage investigators who wish to validate the performance of AI systems for medical diagnosis and prediction to pay closer attention to the factors listed in this article by emphasizing their importance. Thereby, peer-reviewed medical journals can ultimately facilitate translating the technological innovations into real-world practice while securing patient safety and benefit.

Clinical validity of a relocation stress scale for the families of patients transferred from intensive care units.

PubMed

Oh, HyunSoo; Lee, Seul; Kim, JiSun; Lee, EunJu; Min, HyoNam; Cho, OkJa; Seo, WhaSook

2015-07-01

This study was conducted to develop a family relocation stress scale by modifying the Son's Relocation Stress Syndrome Scale, to examine its clinical validity and reliability and to confirm its suitability for measuring family relocation stress. The transfer of ICU patients to general wards is a significant anxiety-producing event for family members. However, no relocation stress scale has been developed specifically for families. A nonexperimental, correlation design was adopted. The study subjects were 95 family members of 95 ICU patients at a university hospital located in Incheon, South Korea. Face and construct validities of the devised family relocation stress scale were examined. Construct validity was examined using factor analysis and by using a nomological validity test. Reliability was also examined. Face and content validity of the scale were verified by confirming that its items adequately measured family relocation stress. Factor analysis yielded four components, and the total variance explained by these four components was 63·0%, which is acceptable. Nomological validity was well supported by significant relationships between relocation stress and degree of preparation for relocation, patient self-care ability, family burden and satisfaction with the relocation process. The devised scale was also found to have good reliability. The family relocation stress scale devised in this study was found to have good validity and reliability, and thus, is believed to offer a means of assessing family relocation stress. The findings of this study provide a reliable and valid assessment tool when nurses prepare families for patient transfer from an ICU to a ward setting, and may also provide useful information to those developing an intervention programme for family relocation stress management. © 2015 John Wiley & Sons Ltd.

Validation of electronic systems to collect patient-reported outcome (PRO) data-recommendations for clinical trial teams: report of the ISPOR ePRO systems validation good research practices task force.

PubMed

Zbrozek, Arthur; Hebert, Joy; Gogates, Gregory; Thorell, Rod; Dell, Christopher; Molsen, Elizabeth; Craig, Gretchen; Grice, Kenneth; Kern, Scottie; Hines, Sheldon

2013-06-01

Outcomes research literature has many examples of high-quality, reliable patient-reported outcome (PRO) data entered directly by electronic means, ePRO, compared to data entered from original results on paper. Clinical trial managers are increasingly using ePRO data collection for PRO-based end points. Regulatory review dictates the rules to follow with ePRO data collection for medical label claims. A critical component for regulatory compliance is evidence of the validation of these electronic data collection systems. Validation of electronic systems is a process versus a focused activity that finishes at a single point in time. Eight steps need to be described and undertaken to qualify the validation of the data collection software in its target environment: requirements definition, design, coding, testing, tracing, user acceptance testing, installation and configuration, and decommissioning. These elements are consistent with recent regulatory guidance for systems validation. This report was written to explain how the validation process works for sponsors, trial teams, and other users of electronic data collection devices responsible for verifying the quality of the data entered into relational databases from such devices. It is a guide on the requirements and documentation needed from a data collection systems provider to demonstrate systems validation. It is a practical source of information for study teams to ensure that ePRO providers are using system validation and implementation processes that will ensure the systems and services: operate reliably when in practical use; produce accurate and complete data and data files; support management control and comply with any existing regulations. Furthermore, this short report will increase user understanding of the requirements for a technology review leading to more informed and balanced recommendations or decisions on electronic data collection methods. Copyright © 2013 International Society for

Clinical Validity of the ADI-R in a US-Based Latino Population

ERIC Educational Resources Information Center

Vanegas, Sandra B.; Magaña, Sandra; Morales, Miguel; McNamara, Ellyn

2016-01-01

The Autism Diagnostic Interview-Revised (ADI-R) has been validated as a tool to aid in the diagnosis of Autism; however, given the growing diversity in the United States, the ADI-R must be validated for different languages and cultures. This study evaluates the validity of the ADI-R in a US-based Latino, Spanish-speaking population of 50 children…

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

ERIC Educational Resources Information Center

Acar, Tu¨lin

2014-01-01

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

Reconceptualising the external validity of discrete choice experiments.

PubMed

Lancsar, Emily; Swait, Joffre

2014-10-01

External validity is a crucial but under-researched topic when considering using discrete choice experiment (DCE) results to inform decision making in clinical, commercial or policy contexts. We present the theory and tests traditionally used to explore external validity that focus on a comparison of final outcomes and review how this traditional definition has been empirically tested in health economics and other sectors (such as transport, environment and marketing) in which DCE methods are applied. While an important component, we argue that the investigation of external validity should be much broader than a comparison of final outcomes. In doing so, we introduce a new and more comprehensive conceptualisation of external validity, closely linked to process validity, that moves us from the simple characterisation of a model as being or not being externally valid on the basis of predictive performance, to the concept that external validity should be an objective pursued from the initial conceptualisation and design of any DCE. We discuss how such a broader definition of external validity can be fruitfully used and suggest innovative ways in which it can be explored in practice.

Assessing decentering: validation, psychometric properties, and clinical usefulness of the Experiences Questionnaire in a Spanish sample.

PubMed

Soler, Joaquim; Franquesa, Alba; Feliu-Soler, Albert; Cebolla, Ausias; García-Campayo, Javier; Tejedor, Rosa; Demarzo, Marcelo; Baños, Rosa; Pascual, Juan Carlos; Portella, Maria J

2014-11-01

Decentering is defined as the ability to observe one's thoughts and feelings in a detached manner. The Experiences Questionnaire (EQ) is a self-report instrument that originally assessed decentering and rumination. The purpose of this study was to evaluate the psychometric properties of the Spanish version of EQ-Decentering and to explore its clinical usefulness. The 11-item EQ-Decentering subscale was translated into Spanish and psychometric properties were examined in a sample of 921 adult individuals, 231 with psychiatric disorders and 690 without. The subsample of nonpsychiatric participants was also split according to their previous meditative experience (meditative participants, n=341; and nonmeditative participants, n=349). Additionally, differences among these three subgroups were explored to determine clinical validity of the scale. Finally, EQ-Decentering was administered twice in a group of borderline personality disorder, before and after a 10-week mindfulness intervention. Confirmatory factor analysis indicated acceptable model fit, sbχ(2)=243.8836 (p<.001), CFI=.939, GFI=.936, SRMR=.040, and RMSEA=.06 (.060-.077), and psychometric properties were found to be satisfactory (reliability: Cronbach's α=.893; convergent validity: r>.46; and divergent validity: r<-.35). The scale detected changes in decentering after a 10-session intervention in mindfulness (t=-4.692, p<.00001). Differences among groups were significant (F=134.8, p<.000001), where psychiatric participants showed the lowest scores compared to nonpsychiatric meditative and nonmeditative participants. The Spanish version of the EQ-Decentering is a valid and reliable instrument to assess decentering either in clinical and nonclinical samples. In addition, the findings show that EQ-Decentering seems an adequate outcome instrument to detect changes after mindfulness-based interventions. Copyright © 2014. Published by Elsevier Ltd.

Random Qualitative Validation: A Mixed-Methods Approach to Survey Validation

ERIC Educational Resources Information Center

Van Duzer, Eric

2012-01-01

The purpose of this paper is to introduce the process and value of Random Qualitative Validation (RQV) in the development and interpretation of survey data. RQV is a method of gathering clarifying qualitative data that improves the validity of the quantitative analysis. This paper is concerned with validity in relation to the participants'…

Criterion Validation Testing of Clinical Metrology Instruments for Measuring Degenerative Joint Disease Associated Mobility Impairment in Cats

PubMed Central

Gruen, Margaret E.; Griffith, Emily H.; Thomson, Andrea E.; Simpson, Wendy; Lascelles, B. Duncan X.

2015-01-01

Introduction Degenerative joint disease and associated pain are common in cats, particularly in older cats. There is a need for treatment options, however evaluation of putative therapies is limited by a lack of suitable, validated outcome measures that can be used in the target population of client owned cats. The objectives of this study were to evaluate low-dose daily meloxicam for the treatment of pain associated with degenerative joint disease in cats, and further validate two clinical metrology instruments, the Feline Musculoskeletal Pain Index (FMPI) and the Client Specific Outcome Measures (CSOM). Methods Sixty-six client owned cats with degenerative joint disease and owner-reported impairments in mobility were screened and enrolled into a double-masked, placebo-controlled, randomized clinical trial. Following a run-in baseline period, cats were given either placebo or meloxicam for 21 days, then in a masked washout, cats were all given placebo for 21 days. Subsequently, cats were given the opposite treatment, placebo or meloxicam, for 21 days. Cats wore activity monitors throughout the study, owners completed clinical metrology instruments following each period. Results Activity counts were increased in cats during treatment with daily meloxicam (p<0.0001) compared to baseline. The FMPI results and activity count data offer concurrent validation for the FMPI, though the relationship between baseline activity counts and FMPI scores at baseline was poor (R2=0.034). The CSOM did not show responsiveness for improvement in this study, and the relationship between baseline activity counts and CSOM scores at baseline was similarly poor (R2=0.042). Conclusions Refinements to the FMPI, including abbreviation of the instrument and scoring as percent of possible score are recommended. This study offered further validation of the FMPI as a clinical metrology instrument for use in detecting therapeutic efficacy in cats with degenerative joint disease. PMID:26162101

PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions.

PubMed

Cook, Karon F; Jensen, Sally E; Schalet, Benjamin D; Beaumont, Jennifer L; Amtmann, Dagmar; Czajkowski, Susan; Dewalt, Darren A; Fries, James F; Pilkonis, Paul A; Reeve, Bryce B; Stone, Arthur A; Weinfurt, Kevin P; Cella, David

2016-05-01

To present an overview of a series of studies in which the clinical validity of the National Institutes of Health's Patient Reported Outcome Measurement Information System (NIH; PROMIS) measures was evaluated, by domain, across six clinical populations. Approximately 1,500 individuals at baseline and 1,300 at follow-up completed PROMIS measures. The analyses reported in this issue were conducted post hoc, pooling data across six previous studies, and accommodating the different designs of the six, within-condition, parent studies. Changes in T-scores, standardized response means, and effect sizes were calculated in each study. When a parent study design allowed, known groups validity was calculated using a linear mixed model. The results provide substantial support for the clinical validity of nine PROMIS measures in a range of chronic conditions. The cross-condition focus of the analyses provided a unique and multifaceted perspective on how PROMIS measures function in "real-world" clinical settings and provides external anchors that can support comparative effectiveness research. The current body of clinical validity evidence for the nine PROMIS measures indicates the success of NIH PROMIS in developing measures that are effective across a range of chronic conditions. Copyright © 2016 Elsevier Inc. All rights reserved.

Continuous leg dyskinesia assessment in Parkinson's disease -clinical validity and ecological effect.

PubMed

Ramsperger, Robert; Meckler, Stefan; Heger, Tanja; van Uem, Janet; Hucker, Svenja; Braatz, Ulrike; Graessner, Holm; Berg, Daniela; Manoli, Yiannos; Serrano, J Artur; Ferreira, Joaquim J; Hobert, Markus A; Maetzler, Walter

2016-05-01

Dyskinesias in Parkinson's disease (PD) patients are a common side effect of long-term dopaminergic therapy and are associated with motor dysfunctions, including gait and balance deficits. Although promising compounds have been developed to treat these symptoms, clinical trials have failed. This failure may, at least partly, be explained by the lack of objective and continuous assessment strategies. This study tested the clinical validity and ecological effect of an algorithm that detects and quantifies dyskinesias of the legs using a single ankle-worn sensor. Twenty-three PD patients (seven with leg dyskinesias) and 13 control subjects were investigated in the lab. Participants performed purposeful daily activity-like tasks while being video-taped. Clinical evaluation was performed using the leg dyskinesia item of the Unified Dyskinesia Rating Scale. The ecological effect of the developed algorithm was investigated in a multi-center, 12-week, home-based sub-study that included three patients with and seven without dyskinesias. In the lab-based sub-study, the sensor-based algorithm exhibited a specificity of 98%, a sensitivity of 85%, and an accuracy of 0.96 for the detection of dyskinesias and a correlation level of 0.61 (p < 0.001) with the clinical severity score. In the home-based sub-study, all patients could be correctly classified regarding the presence or absence of leg dyskinesias, supporting the ecological relevance of the algorithm. This study provides evidence of clinical validity and ecological effect of an algorithm derived from a single sensor on the ankle for detecting leg dyskinesias in PD patients. These results should motivate the investigation of leg dyskinesias in larger studies using wearable sensors. Copyright © 2016 Elsevier Ltd. All rights reserved.

Statistical Validation for Clinical Measures: Repeatability and Agreement of Kinect™-Based Software

PubMed Central

Tello, Emanuel; Rodrigo, Alejandro; Valentinuzzi, Max E.

2018-01-01

Background The rehabilitation process is a fundamental stage for recovery of people's capabilities. However, the evaluation of the process is performed by physiatrists and medical doctors, mostly based on their observations, that is, a subjective appreciation of the patient's evolution. This paper proposes a tracking platform of the movement made by an individual's upper limb using Kinect sensor(s) to be applied for the patient during the rehabilitation process. The main contribution is the development of quantifying software and the statistical validation of its performance, repeatability, and clinical use in the rehabilitation process. Methods The software determines joint angles and upper limb trajectories for the construction of a specific rehabilitation protocol and quantifies the treatment evolution. In turn, the information is presented via a graphical interface that allows the recording, storage, and report of the patient's data. For clinical purposes, the software information is statistically validated with three different methodologies, comparing the measures with a goniometer in terms of agreement and repeatability. Results The agreement of joint angles measured with the proposed software and goniometer is evaluated with Bland-Altman plots; all measurements fell well within the limits of agreement, meaning interchangeability of both techniques. Additionally, the results of Bland-Altman analysis of repeatability show 95% confidence. Finally, the physiotherapists' qualitative assessment shows encouraging results for the clinical use. Conclusion The main conclusion is that the software is capable of offering a clinical history of the patient and is useful for quantification of the rehabilitation success. The simplicity, low cost, and visualization possibilities enhance the use of the software Kinect for rehabilitation and other applications, and the expert's opinion endorses the choice of our approach for clinical practice. Comparison of the new measurement

Statistical Validation for Clinical Measures: Repeatability and Agreement of Kinect™-Based Software.

PubMed

Lopez, Natalia; Perez, Elisa; Tello, Emanuel; Rodrigo, Alejandro; Valentinuzzi, Max E

2018-01-01

The rehabilitation process is a fundamental stage for recovery of people's capabilities. However, the evaluation of the process is performed by physiatrists and medical doctors, mostly based on their observations, that is, a subjective appreciation of the patient's evolution. This paper proposes a tracking platform of the movement made by an individual's upper limb using Kinect sensor(s) to be applied for the patient during the rehabilitation process. The main contribution is the development of quantifying software and the statistical validation of its performance, repeatability, and clinical use in the rehabilitation process. The software determines joint angles and upper limb trajectories for the construction of a specific rehabilitation protocol and quantifies the treatment evolution. In turn, the information is presented via a graphical interface that allows the recording, storage, and report of the patient's data. For clinical purposes, the software information is statistically validated with three different methodologies, comparing the measures with a goniometer in terms of agreement and repeatability. The agreement of joint angles measured with the proposed software and goniometer is evaluated with Bland-Altman plots; all measurements fell well within the limits of agreement, meaning interchangeability of both techniques. Additionally, the results of Bland-Altman analysis of repeatability show 95% confidence. Finally, the physiotherapists' qualitative assessment shows encouraging results for the clinical use. The main conclusion is that the software is capable of offering a clinical history of the patient and is useful for quantification of the rehabilitation success. The simplicity, low cost, and visualization possibilities enhance the use of the software Kinect for rehabilitation and other applications, and the expert's opinion endorses the choice of our approach for clinical practice. Comparison of the new measurement technique with established

Clinical validity of new genetic biomarkers of irinotecan neutropenia: an independent replication study.

PubMed

Crona, D J; Ramirez, J; Qiao, W; de Graan, A-J; Ratain, M J; van Schaik, R H N; Mathijssen, R H J; Rosner, G L; Innocenti, F

2016-02-01

The overall goal of this study was to provide evidence for the clinical validity of nine genetic variants in five genes previously associated with irinotecan neutropenia and pharmacokinetics. Variants associated with absolute neutrophil count (ANC) nadir and/or irinotecan pharmacokinetics in a discovery cohort of cancer patients were genotyped in an independent replication cohort of 108 cancer patients. Patients received single-agent irinotecan every 3 weeks. For ANC nadir, we replicated UGT1A1*28, UGT1A1*93 and SLCO1B1*1b in univariate analyses. For irinotecan area under the concentration-time curve (AUC0-24), we replicated ABCC2 -24C>T; however, ABCC2 -24C>T only predicted a small fraction of the variance. For SN-38 AUC0-24 and the glucuronidation ratio, we replicated UGT1A1*28 and UGT1A1*93. In addition to UGT1A1*28, this study independently validated UGT1A1*93 and SLCO1B1*1b as new predictors of irinotecan neutropenia. Further demonstration of their clinical utility will optimize irinotecan therapy in cancer patients.

A combined pre-clinical meta-analysis and randomized confirmatory trial approach to improve data validity for therapeutic target validation.

PubMed

Kleikers, Pamela W M; Hooijmans, Carlijn; Göb, Eva; Langhauser, Friederike; Rewell, Sarah S J; Radermacher, Kim; Ritskes-Hoitinga, Merel; Howells, David W; Kleinschnitz, Christoph; Schmidt, Harald H H W

2015-08-27

Biomedical research suffers from a dramatically poor translational success. For example, in ischemic stroke, a condition with a high medical need, over a thousand experimental drug targets were unsuccessful. Here, we adopt methods from clinical research for a late-stage pre-clinical meta-analysis (MA) and randomized confirmatory trial (pRCT) approach. A profound body of literature suggests NOX2 to be a major therapeutic target in stroke. Systematic review and MA of all available NOX2(-/y) studies revealed a positive publication bias and lack of statistical power to detect a relevant reduction in infarct size. A fully powered multi-center pRCT rejects NOX2 as a target to improve neurofunctional outcomes or achieve a translationally relevant infarct size reduction. Thus stringent statistical thresholds, reporting negative data and a MA-pRCT approach can ensure biomedical data validity and overcome risks of bias.

The FORGE AHEAD clinical readiness consultation tool: a validated tool to assess clinical readiness for chronic disease care mobilization in Canada's First Nations.

PubMed

Hayward, Mariam Naqshbandi; Mequanint, Selam; Paquette-Warren, Jann; Bailie, Ross; Chirila, Alexandra; Dyck, Roland; Green, Michael; Hanley, Anthony; Tompkins, Jordan; Harris, Stewart

2017-03-23

Given the astounding rates of diabetes and related complications, and the barriers to providing care present in Indigenous communities in Canada, intervention strategies that take into account contextual factors such as readiness to mobilize are needed to maximize improvements and increase the likelihood of success and sustainment. As part of the national FORGE AHEAD Program, we sought to develop, test and validate a clinical readiness consultation tool aimed at assessing the readiness of clinical teams working on-reserve in First Nations communities to participate in quality improvement (QI) to enhance diabetes care in Canada. A literature review was conducted to identify existing readiness tools. The ABCD - SAT was adapted using a consensus approach that emphasized a community-based participatory approach and prioritized the knowledge and wisdom held by community members. The tool was piloted with a group of 16 people from 7 provinces and 11 partnering communities to assess language use, clarity, relevance, format, and ease of completion using examples. Internal reliability analysis and convergence validity were conducted with data from 53 clinical team members from 11 First Nations communities (3-5 per community) who have participated in the FORGE AHEAD program. The 27-page Clinical Readiness Consultation Tool (CRCT) consists of five main components, 21 sub-components, and 74 items that are aligned with the Expanded Chronic Care Model. Five-point Likert scale feedback from the pilot ranged from 3.25 to 4.5. Length of the tool was reported as a drawback but respondents noted that all the items were needed to provide a comprehensive picture of the healthcare system. Results for internal consistency showed that all sub-components except for two were within acceptable ranges (0.77-0.93). The Team Structure and Function sub-component scale had a moderately significant positive correlation with the validated Team Climate Inventory, r = 0.45, p < 0.05. The

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

ERIC Educational Resources Information Center

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

2003-01-01

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

Cross-cultural validation of Lupus Impact Tracker in five European clinical practice settings.

PubMed

Schneider, Matthias; Mosca, Marta; Pego-Reigosa, José-Maria; Gunnarsson, Iva; Maurel, Frédérique; Garofano, Anna; Perna, Alessandra; Porcasi, Rolando; Devilliers, Hervé

2017-05-01

The aim was to evaluate the cross-cultural validity of the Lupus Impact Tracker (LIT) in five European countries and to assess its acceptability and feasibility from the patient and physician perspectives. A prospective, observational, cross-sectional and multicentre validation study was conducted in clinical settings. Before the visit, patients completed LIT, Short Form 36 (SF-36) and care satisfaction questionnaires. During the visit, physicians assessed disease activity [Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI], organ damage [SLICC/ACR damage index (SDI)] and flare occurrence. Cross-cultural validity was assessed using the Differential Item Functioning method. Five hundred and sixty-nine SLE patients were included by 25 specialists; 91.7% were outpatients and 89.9% female, with mean age 43.5 (13.0) years. Disease profile was as follows: 18.3% experienced flares; mean SELENA-SLEDAI score 3.4 (4.5); mean SDI score 0.8 (1.4); and SF-36 mean physical and mental component summary scores: physical component summary 42.8 (10.8) and mental component summary 43.0 (12.3). Mean LIT score was 34.2 (22.3) (median: 32.5), indicating that lupus moderately impacted patients' daily life. A cultural Differential Item Functioning of negligible magnitude was detected across countries (pseudo- R 2 difference of 0.01-0.04). Differences were observed between LIT scores and Physician Global Assessment, SELENA-SLEDAI, SDI scores = 0 (P < 0.035) and absence of flares (P = 0.004). The LIT showed a strong association with SF-36 physical and social role functioning, vitality, bodily pain and mental health (P < 0.001). The LIT was well accepted by patients and physicians. It was reliable, with Cronbach α coefficients ranging from 0.89 to 0.92 among countries. The LIT is validated in the five participating European countries. The results show its reliability and cultural invariability across countries. They suggest that LIT can be used in routine

A clinical reasoning model focused on clients' behaviour change with reference to physiotherapists: its multiphase development and validation.

PubMed

Elvén, Maria; Hochwälder, Jacek; Dean, Elizabeth; Söderlund, Anne

2015-05-01

A biopsychosocial approach and behaviour change strategies have long been proposed to serve as a basis for addressing current multifaceted health problems. This emphasis has implications for clinical reasoning of health professionals. This study's aim was to develop and validate a conceptual model to guide physiotherapists' clinical reasoning focused on clients' behaviour change. Phase 1 consisted of the exploration of existing research and the research team's experiences and knowledge. Phases 2a and 2b consisted of validation and refinement of the model based on input from physiotherapy students in two focus groups (n = 5 per group) and from experts in behavioural medicine (n = 9). Phase 1 generated theoretical and evidence bases for the first version of a model. Phases 2a and 2b established the validity and value of the model. The final model described clinical reasoning focused on clients' behaviour change as a cognitive, reflective, collaborative and iterative process with multiple interrelated levels that included input from the client and physiotherapist, a functional behavioural analysis of the activity-related target behaviour and the selection of strategies for behaviour change. This unique model, theory- and evidence-informed, has been developed to help physiotherapists to apply clinical reasoning systematically in the process of behaviour change with their clients.

Validation of Clinical Scoring Systems ART and ABCR after Transarterial Chemoembolization of Hepatocellular Carcinoma.

PubMed

Kloeckner, Roman; Pitton, Michael B; Dueber, Christoph; Schmidtmann, Irene; Galle, Peter R; Koch, Sandra; Wörns, Marcus A; Weinmann, Arndt

2017-01-01

To perform an external validation of the Assessment for Retreatment with Transarterial Chemoembolization (ART) and α-fetoprotein (AFP), Barcelona Clinic Liver Cancer (BCLC), Child-Pugh, and response (ABCR) scores and to compare them in terms of prognostic power. From 2000 to 2015, 871 patients with hepatocellular carcinoma underwent transarterial chemoembolization at a tertiary referral hospital, and 176 met all inclusion and exclusion criteria for both scores and were analyzed. Nineteen percent (n = 34) had BCLC stage A disease and 81% had stage B disease. Thirty-nine patients (22%) presented with elevated AFP levels. Overall survival was calculated. Scores were validated and compared with a Harrell C-index, integrated Brier score (IBS), and prediction error curves. Before the second chemoembolization procedure, 22 patients (12%) showed an increase of 1 point in Child-Pugh score and 51 patients (22%) had an increase of ≥ 2 points. Thirty-one patients (23%) showed a > 25% increase in aspartate aminotransferase level, and 114 (65%) showed a response to treatment. Consequently, 127 patients (72%) had a low ART score and 49 (28%) had a high ART score. One hundred fifty-eight patients (90%) had a low ABCR score, whereas 18 (10%) had a high ABCR score. Low and high ART score groups had median survival durations of 20.8 and 15.3 mo, respectively. Harrell C-indexes were 0.572 and 0.608, and IBSs were 0.135 and 0.128, for ART and ABCR, respectively. For both scores, an increase in Child-Pugh score ≥ 2 points and a radiologic response were significantly associated with survival. Both scores were of limited predictive value, and neither was sufficient to support clear-cut clinical decisions. Further effort is necessary to determine criteria for making valid clinical predictions. Copyright © 2017 SIR. Published by Elsevier Inc. All rights reserved.

Design and validation of a comprehensive fecal incontinence questionnaire.

PubMed

Macmillan, Alexandra K; Merrie, Arend E H; Marshall, Roger J; Parry, Bryan R

2008-10-01

Fecal incontinence can have a profound effect on quality of life. Its prevalence remains uncertain because of stigma, lack of consistent definition, and dearth of validated measures. This study was designed to develop a valid clinical and epidemiologic questionnaire, building on current literature and expertise. Patients and experts undertook face validity testing. Construct validity, criterion validity, and test-retest reliability was undertaken. Construct validity comprised factor analysis and internal consistency of the quality of life scale. The validity of known groups was tested against 77 control subjects by using regression models. Questionnaire results were compared with a stool diary for criterion validity. Test-retest reliability was calculated from repeated questionnaire completion. The questionnaire achieved good face validity. It was completed by 104 patients. The quality of life scale had four underlying traits (factor analysis) and high internal consistency (overall Cronbach alpha = 0.97). Patients and control subjects answered the questionnaire significantly differently (P < 0.01) in known-groups validity testing. Criterion validity assessment found mean differences close to zero. Median reliability for the whole questionnaire was 0.79 (range, 0.35-1). This questionnaire compares favorably with other available instruments, although the interpretation of stool consistency requires further research. Its sensitivity to treatment still needs to be investigated.

The development and validity of the Salford Gait Tool: an observation-based clinical gait assessment tool.

PubMed

Toro, Brigitte; Nester, Christopher J; Farren, Pauline C

2007-03-01

To develop the construct, content, and criterion validity of the Salford Gait Tool (SF-GT) and to evaluate agreement between gait observations using the SF-GT and kinematic gait data. Tool development and comparative evaluation. University in the United Kingdom. For designing construct and content validity, convenience samples of 10 children with hemiplegic, diplegic, and quadriplegic cerebral palsy (CP) and 152 physical therapy students and 4 physical therapists were recruited. For developing criterion validity, kinematic gait data of 13 gait clusters containing 56 children with hemiplegic, diplegic, and quadriplegic CP and 11 neurologically intact children was used. For clinical evaluation, a convenience sample of 23 pediatric physical therapists participated. We developed a sagittal plane observational gait assessment tool through a series of design, test, and redesign iterations. The tool's grading system was calibrated using kinematic gait data of 13 gait clusters and was evaluated by comparing the agreement of gait observations using the SF-GT with kinematic gait data. Criterion standard kinematic gait data. There was 58% mean agreement based on grading categories and 80% mean agreement based on degree estimations evaluated with the least significant difference method. The new SF-GT has good concurrent criterion validity.

Specificity rates for non-clinical, bilingual, Mexican Americans on three popular performance validity measures.

PubMed

Gasquoine, Philip G; Weimer, Amy A; Amador, Arnoldo

2017-04-01

To measure specificity as failure rates for non-clinical, bilingual, Mexican Americans on three popular performance validity measures: (a) the language format Reliable Digit Span; (b) visual-perceptual format Test of Memory Malingering; and (c) visual-perceptual format Dot Counting, using optimal/suboptimal effort cut scores developed for monolingual, English-speakers. Participants were 61 consecutive referrals, aged between 18 and 65 years, with <16 years of education who were subjectively bilingual (confirmed via formal assessment) and chose the language of assessment, Spanish or English, for the performance validity tests. Failure rates were 38% for Reliable Digit Span, 3% for the Test of Memory Malingering, and 7% for Dot Counting. For Reliable Digit Span, the failure rates for Spanish (46%) and English (31%) languages of administration did not differ significantly. Optimal/suboptimal effort cut scores derived for monolingual English-speakers can be used with Spanish/English bilinguals when using the visual-perceptual format Test of Memory Malingering and Dot Counting. The high failure rate for Reliable Digit Span suggests it should not be used as a performance validity measure with Spanish/English bilinguals, irrespective of the language of test administration, Spanish or English.

Validity and reliability of balance assessment software using the Nintendo Wii balance board: usability and validation.

PubMed

Park, Dae-Sung; Lee, GyuChang

2014-06-10

A balance test provides important information such as the standard to judge an individual's functional recovery or make the prediction of falls. The development of a tool for a balance test that is inexpensive and widely available is needed, especially in clinical settings. The Wii Balance Board (WBB) is designed to test balance, but there is little software used in balance tests, and there are few studies on reliability and validity. Thus, we developed a balance assessment software using the Nintendo Wii Balance Board, investigated its reliability and validity, and compared it with a laboratory-grade force platform. Twenty healthy adults participated in our study. The participants participated in the test for inter-rater reliability, intra-rater reliability, and concurrent validity. The tests were performed with balance assessment software using the Nintendo Wii balance board and a laboratory-grade force platform. Data such as Center of Pressure (COP) path length and COP velocity were acquired from the assessment systems. The inter-rater reliability, the intra-rater reliability, and concurrent validity were analyzed by an intraclass correlation coefficient (ICC) value and a standard error of measurement (SEM). The inter-rater reliability (ICC: 0.89-0.79, SEM in path length: 7.14-1.90, SEM in velocity: 0.74-0.07), intra-rater reliability (ICC: 0.92-0.70, SEM in path length: 7.59-2.04, SEM in velocity: 0.80-0.07), and concurrent validity (ICC: 0.87-0.73, SEM in path length: 5.94-0.32, SEM in velocity: 0.62-0.08) were high in terms of COP path length and COP velocity. The balance assessment software incorporating the Nintendo Wii balance board was used in our study and was found to be a reliable assessment device. In clinical settings, the device can be remarkably inexpensive, portable, and convenient for the balance assessment.

A Multitrait-Multimethod Analysis of the Construct Validity of Child Anxiety Disorders in a Clinical Sample

ERIC Educational Resources Information Center

Langer, David A.; Wood, Jeffrey J.; Bergman, R. Lindsey; Piacentini, John C.

2010-01-01

The present study examines the construct validity of separation anxiety disorder (SAD), social phobia (SoP), panic disorder (PD), and generalized anxiety disorder (GAD) in a clinical sample of children. Participants were 174 children, 6 to 17 years old (94 boys) who had undergone a diagnostic evaluation at a university hospital based clinic.…

Utilizing Existing Clinical and Population Biospecimen Resources for Discovery or Validation of Markers for Early Cancer Detection

Cancer.gov

Utilizing Existing Clinical and Population Biospecimen Resources for Discovery or Validation of Markers for Early Cancer Detection, a 2013 workshop sponsored by the Epidemiology and Genomics Research Program.

Utilisation, Reliability and Validity of Clinical Evaluation Exercise in Otolaryngology Training.

PubMed

Awad, Z; Hayden, L; Muthuswamy, K; Tolley, N S

2015-10-01

To investigate the utilisation, reliability and validity of clinical evaluation exercise (CEX) in otolaryngology training. Retrospective database analysis. Online assessment database. We analysed all CEXs submitted by north London core (CT) and speciality trainees (ST) in otolaryngology from 2010 to 2013. Internal consistency of the 7 CEX items rated as either O: outstanding, S: satisfactory or D: development required. Overall performance rating (pS) of 1-4 assessed against completion of training level. Receiver operating characteristic was used to describe CEX sensitivity and specificity. Overall score (cS), pS and the number of 'D'-rated items were used to investigate construct validity. One thousand one hundred and sixty CEXs from 45 trainees were included. CEX showed good internal consistency (Cronbach's alpha= 0.85). CEX was highly sensitive (99%), yet not specific (6%). cS and pS for ST was higher than CT (99.1% ± 0.4 versus 96.6% ± 0.8 and 3.06 ± 0.05 versus 1.92 ± 0.04, respectively P < 0.001). pS showed a significant stepwise increase from CT1 to ST6 (P < 0.001). In contrast, cS only showed improvement up to ST4 (P = 0.025). The most frequently utilised item 'management and follow-up planning' was found to be the best predictor of cS and pS (rs  = +0.69 and +0.21, respectively). CEX is reliable in assessing early years otolaryngology trainees in clinical examination, but not at higher level. It has the potential to be used in a summative capacity in selecting trainees for ST positions. This would also encourage trainees to master all domains of otolaryngology clinical examination by end of CT. © 2015 John Wiley & Sons Ltd.

The Depressive Experiences Questionnaire: validity and psychological correlates in a clinical sample.

PubMed

Riley, W T; McCranie, E W

1990-01-01

This study sought to compare the original and revised scoring systems of the Depressive Experiences Questionnaire (DEQ) and to assess the construct validity of the Dependent and Self-Critical subscales of the DEQ in a clinically depressed sample. Subjects were 103 depressed inpatients who completed the DEQ, the Beck Depression Inventory (BDI), the Hopelessness Scale, the Automatic Thoughts Questionnaire (ATQ), the Rathus Assertiveness Schedule (RAS), and the Minnesota Multiphasic Personality Inventory (MMPI). The original and revised scoring systems of the DEQ evidenced good concurrent validity for each factor scale, but the revised system did not sufficiently discriminate dependent and self-critical dimensions. Using the original scoring system, self-criticism was significantly and positively related to severity of depression, whereas dependency was not, particularly for males. Factor analysis of the DEQ scales and the other scales used in this study supported the dependent and self-critical dimensions. For men, the correlation of the DEQ with the MMPI scales indicated that self-criticism was associated with psychotic symptoms, hostility/conflict, and a distress/exaggerated response set, whereas dependency did not correlate significantly with any MMPI scales. Females, however, did not exhibit a differential pattern of correlations between either the Dependency or the Self-Criticism scales and the MMPI. These findings suggest possible gender differences in the clinical characteristics of male and female dependent and self-critical depressive subtypes.

Validation of a clinical leadership qualities framework for managers in aged care: a Delphi study.

PubMed

Jeon, Yun-Hee; Conway, Jane; Chenoweth, Lynn; Weise, Janelle; Thomas, Tamsin Ht; Williams, Anna

2015-04-01

To establish validity of a clinical leadership framework for aged care middle managers (The Aged care Clinical Leadership Qualities Framework). Middle managers in aged care have responsibility not only for organisational governance also and operational management but also quality service delivery. There is a need to better define clinical leadership abilities in aged care middle managers, in order to optimise their positional authority to lead others to achieve quality outcomes. A Delphi method. Sixty-nine experts in aged care were recruited, representing rural, remote and metropolitan community and residential aged care settings. Panellists were asked to rate the proposed framework in terms of the relevance and importance of each leadership quality using four-point Likert scales, and to provide comments. Three rounds of consultation were conducted. The number and corresponding percentage of the relevance and importance rating for each quality was calculated for each consultation round, as well as mean scores. Consensus was determined to be reached when a percentage score reached 70% or greater. Twenty-three panellists completed all three rounds of consultation. Following the three rounds of consultation, the acceptability and face validity of the framework was confirmed. The study confirmed the framework as useful in identifying leadership requirements for middle managers in Australian aged care settings. The framework is the first validated framework of clinical leadership attributes for middle managers in aged care and offers an initial step forward in clarifying the aged care middle manager role. The framework provides clarity in the breadth of role expectations for the middle managers and can be used to inform an aged care specific leadership program development, individuals' and organisations' performance and development processes; and policy and guidelines about the types of activities required of middle managers in aged care. © 2014 John Wiley & Sons Ltd.

Development and validation of receptor occupancy pharmacodynamic assays used in the clinical development of the monoclonal antibody vedolizumab.

PubMed

Wyant, Tim; Estevam, Jose; Yang, Lili; Rosario, Maria

2016-03-01

Vedolizumab is a monoclonal antibody approved for use in ulcerative colitis and Crohn's disease. By specifically binding to α4 β7 integrin, vedolizumab prevents trafficking of lymphocytes to the gut, thereby interfering with disease pathology. During the clinical development program, the pharmacodynamic effect of vedolizumab was evaluated by 2 flow cytometry receptor occupancy assays: act-1 (ACT-1) and mucosal addressin cell adhesion molecule-1 (MAdCAM-1). Here we describe the development and validation of these assays. The ACT-1 assay is a receptor occupancy free-site assay that uses a monoclonal antibody with the same binding epitope as vedolizumab to detect free (unbound) sites on α4 β7 integrin. The MAdCAM-1 assay used a soluble version of the natural ligand for α4 β7 integrin to detect free sites. The assays were validated using a fit-for-purpose approach throughout the clinical development of vedolizumab. Both the ACT-1 assay and the MAdCAM-1 assay demonstrated acceptable reproducibility and repeatability. The assays were sufficiently stable to allow for clinical use. During clinical testing the assays demonstrated that vedolizumab was able to saturate peripheral cells at all doses tested. Two pharmacodynamic receptor occupancy assays were developed and validated to assess the effect of vedolizumab on peripheral blood cells. The results of these assays demonstrated the practical use of flow cytometry to examine pharmacodynamic response in clinical trials. © 2015 International Clinical Cytometry Society.

Clinical Validity of the ADI-R in a US-Based Latino Population.

PubMed

Vanegas, Sandra B; Magaña, Sandra; Morales, Miguel; McNamara, Ellyn

2016-05-01

The Autism Diagnostic Interview-Revised (ADI-R) has been validated as a tool to aid in the diagnosis of Autism; however, given the growing diversity in the United States, the ADI-R must be validated for different languages and cultures. This study evaluates the validity of the ADI-R in a US-based Latino, Spanish-speaking population of 50 children and adolescents with ASD and developmental disability. Sensitivity and specificity of the ADI-R as a diagnostic tool were moderate, but lower than previously reported values. Validity of the social reciprocity and restrictive and repetitive behaviors domains was high, but low in the communication domain. Findings suggest that language discordance between caregiver and child may influence reporting of communication symptoms and contribute to lower sensitivity and specificity.

NASA Countermeasures Evaluation and Validation Project

NASA Technical Reports Server (NTRS)

Lundquist, Charlie M.; Paloski, William H. (Technical Monitor)

2000-01-01

To support its ISS and exploration class mission objectives, NASA has developed a Countermeasure Evaluation and Validation Project (CEVP). The goal of this project is to evaluate and validate the optimal complement of countermeasures required to maintain astronaut health, safety, and functional ability during and after short- and long-duration space flight missions. The CEVP is the final element of the process in which ideas and concepts emerging from basic research evolve into operational countermeasures. The CEVP is accomplishing these objectives by conducting operational/clinical research to evaluate and validate countermeasures to mitigate these maladaptive responses. Evaluation is accomplished by testing in space flight analog facilities, and validation is accomplished by space flight testing. Both will utilize a standardized complement of integrated physiological and psychological tests, termed the Integrated Testing Regimen (ITR) to examine candidate countermeasure efficacy and intersystem effects. The CEVP emphasis is currently placed on validating the initial complement of ISS countermeasures targeting bone, muscle, and aerobic fitness; followed by countermeasures for neurological, psychological, immunological, nutrition and metabolism, and radiation risks associated with space flight. This presentation will review the processes, plans, and procedures that will enable CEVP to play a vital role in transitioning promising research results into operational countermeasures necessary to maintain crew health and performance during long duration space flight.

Horizon 2020 SME-Instrument topic: clinical research for the validation of biomarkers and/or diagnostic medical devices.

PubMed

Sanne, Jean-Luc

2018-06-21

The European Commission released €130 million over 2014, 2015 and 2017 under the EU Framework Program for Research and Innovation, Horizon 2020, to support innovative small and medium-sized enterprises in the diagnostic area. The call topic focused on 'Clinical research for the validation of biomarkers and/or diagnostic medical devices'. It attracted 1194 applicants from all over Europe. The quality of the proposals was high and a large proportion of them were eligible for funding. In the majority, proposals were about in vitro diagnostics and tackled both clinical validation of new biomarkers and device optimization. The proposals dealt with various advanced technologies. One third of the proposers gave priority to the new and promising field of personalized medicine.

Modeling and validating the cost and clinical pathway of colorectal cancer.

PubMed

Joranger, Paal; Nesbakken, Arild; Hoff, Geir; Sorbye, Halfdan; Oshaug, Arne; Aas, Eline

2015-02-01

Cancer is a major cause of morbidity and mortality, and colorectal cancer (CRC) is the third most common cancer in the world. The estimated costs of CRC treatment vary considerably, and if CRC costs in a model are based on empirically estimated total costs of stage I, II, III, or IV treatments, then they lack some flexibility to capture future changes in CRC treatment. The purpose was 1) to describe how to model CRC costs and survival and 2) to validate the model in a transparent and reproducible way. We applied a semi-Markov model with 70 health states and tracked age and time since specific health states (using tunnels and 3-dimensional data matrix). The model parameters are based on an observational study at Oslo University Hospital (2049 CRC patients), the National Patient Register, literature, and expert opinion. The target population was patients diagnosed with CRC. The model followed the patients diagnosed with CRC from the age of 70 until death or 100 years. The study focused on the perspective of health care payers. The model was validated for face validity, internal and external validity, and cross-validity. The validation showed a satisfactory match with other models and empirical estimates for both cost and survival time, without any preceding calibration of the model. The model can be used to 1) address a range of CRC-related themes (general model) like survival and evaluation of the cost of treatment and prevention measures; 2) make predictions from intermediate to final outcomes; 3) estimate changes in resource use and costs due to changing guidelines; and 4) adjust for future changes in treatment and trends over time. The model is adaptable to other populations. © The Author(s) 2014.

Epistemological Dialogue of Validity: Building Validity in Educational and Social Research

ERIC Educational Resources Information Center

Cakir, Mustafa

2012-01-01

The notion of validity in the social sciences is evolving and is influenced by philosophy of science, critiques of objectivity, and epistemological debates. Methodology for validation of the knowledge claims is diverse across different philosophies of science. In other words, definition and the way to establish of validity have evolved as…

Design, Realization, and First Validation of an Immersive Web-Based Virtual Patient Simulator for Training Clinical Decisions in Surgery.

PubMed

Kleinert, Robert; Heiermann, Nadine; Wahba, Roger; Chang, De-Huan; Hölscher, Arnulf H; Stippel, Dirk L

2015-01-01

Immersive patient simulators (IPS) allow an illusionary immersion into a synthetic world where the user can freely navigate through a 3-dimensional environment similar to computer games. Playful learning with IPS allows internalization of medical workflows without harming real patients. Ideally, IPS show high student acceptance and can have positive effect on knowledge gain. Development of IPS with high technical quality is resource intensive. Therefore most of the "high-fidelity" IPS are commercially driven. Usage of IPS in the daily curriculum is still rare. There is no academic-driven simulator that is freely accessible to every student and combines high immersion grade with a profound amount of medical content. Therefore it was our aim to develop an academic-driven IPS prototype that is free to use and combines a high immersion grade with profound medical content. In addition, a first validation of the prototype was conducted. The conceptual design included definition of the following parameters: amount of curricular content, grade of technical quality, availability, and level of validation. A preliminary validation was done with 25 students. Students' opinion about acceptance was evaluated by a Likert-scale questionnaire. Effect on knowledge gain was determined by testing concordance and predictive validity. A custom-made simulator prototype (Artificial learning interface for clinical education [ALICE]) displays a virtual clinic environment that can be explored from a first-person view similar to a video game. By controlling an avatar, the user navigates through the environment, is able to treat virtual patients, and faces the consequence of different decisions. ALICE showed high students' acceptance. There was positive correlation for concordance validity and predictive validity. Simulator usage had positive effect on reproduction of trained content and declarative knowledge. We successfully developed a university-based, IPS prototype (ALICE) with profound

Reaction time as an indicator of insufficient effort: Development and validation of an embedded performance validity parameter.

PubMed

Stevens, Andreas; Bahlo, Simone; Licha, Christina; Liske, Benjamin; Vossler-Thies, Elisabeth

2016-11-30

Subnormal performance in attention tasks may result from various sources including lack of effort. In this report, the derivation and validation of a performance validity parameter for reaction time is described, using a set of malingering-indices ("Slick-criteria"), and 3 independent samples of participants (total n =893). The Slick-criteria yield an estimate of the probability of malingering based on the presence of an external incentive, evidence from neuropsychological testing, from self-report and clinical data. In study (1) a validity parameter is derived using reaction time data of a sample, composed of inpatients with recent severe brain lesions not involved in litigation and of litigants with and without brain lesion. In study (2) the validity parameter is tested in an independent sample of litigants. In study (3) the parameter is applied to an independent sample comprising cooperative and non-cooperative testees. Logistic regression analysis led to a derived validity parameter based on median reaction time and standard deviation. It performed satisfactorily in studies (2) and (3) (study 2 sensitivity=0.94, specificity=1.00; study 3 sensitivity=0.79, specificity=0.87). The findings suggest that median reaction time and standard deviation may be used as indicators of negative response bias. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The Incremental Validity and Clinical Utility of the MMPI-2 Infrequency Posttraumatic Stress Disorder Scale

ERIC Educational Resources Information Center

Marshall, Margarita B.; Bagby, R. Michael

2006-01-01

The incremental validity and clinical utility of the recently developed Minnesota Multiphasic Personality Inventory-2 (MMPI-2) Infrequency Posttraumatic Stress Disorder Scale (Fptsd) was examined in relation to the family of MMPI-2 F scales in distinguishing feigned post-traumatic stress disorder (PTSD) from disability claimants with PTSD.…

Spanish translation and cross-language validation of a sleep habits questionnaire for use in clinical and research settings.

PubMed

Baldwin, Carol M; Choi, Myunghan; McClain, Darya Bonds; Celaya, Alma; Quan, Stuart F

2012-04-15

To translate, back-translate and cross-language validate (English/Spanish) the Sleep Heart Health Study Sleep Habits Questionnaire for use with Spanish-speakers in clinical and research settings. Following rigorous translation and back-translation, this cross-sectional cross-language validation study recruited bilingual participants from academic, clinic, and community-based settings (N = 50; 52% women; mean age 38.8 ± 12 years; 90% of Mexican heritage). Participants completed English and Spanish versions of the Sleep Habits Questionnaire, the Epworth Sleepiness Scale, and the Acculturation Rating Scale for Mexican Americans II one week apart in randomized order. Psychometric properties were assessed, including internal consistency, convergent validity, scale equivalence, language version intercorrelations, and exploratory factor analysis using PASW (Version18) software. Grade level readability of the sleep measure was evaluated. All sleep categories (duration, snoring, apnea, insomnia symptoms, other sleep symptoms, sleep disruptors, restless legs syndrome) showed Cronbach α, Spearman-Brown coefficients and intercorrelations ≥ 0.700, suggesting robust internal consistency, correlation, and agreement between language versions. The Epworth correlated significantly with snoring, apnea, sleep symptoms, restless legs, and sleep disruptors) on both versions, supporting convergent validity. Items loaded on 4 factors accounted for 68% and 67% of the variance on the English and Spanish versions, respectively. The Spanish-language Sleep Habits Questionnaire demonstrates conceptual and content equivalency. It has appropriate measurement properties and should be useful for assessing sleep health in community-based clinics and intervention studies among Spanish-speaking Mexican Americans. Both language versions showed readability at the fifth grade level. Further testing is needed with larger samples.

Validation of assessment of intraoral digital photography for evaluation of dental restorations in clinical research.

PubMed

Signori, Cácia; Collares, Kauê; Cumerlato, Catarina B F; Correa, Marcos B; Opdam, Niek J M; Cenci, Maximiliano S

2018-04-01

The aim of this study was to investigate the validity of assessment of intraoral digital photography in the evaluation of dental restorations. Intraoral photographs of anterior and posterior restorations were classified based on FDI criteria according to the need for intervention: no intervention, repair and replacement. Evaluations were performed by an experienced expert in restorative dentistry (gold standard evaluator) and 3 trained dentists (consensus). The clinical inspection was the reference standard method. The prevalence of failures was explored. Cohen's kappa statistic was used. Validity was accessed by sensitivity, specificity, likelihood ratio and predictives values. Higher prevalence of failed restorations intervention was identified by the intraoral photography (17.7%) in comparison to the clinical evaluation (14.1%). Moderate agreement in the diagnosis of total failures was shown between the methods for the gold standard evaluator (kappa = 0.51) and consensus of evaluators (kappa = 0.53). Gold standard evaluator and consensus showed substantial and moderate agreement for posterior restorations (kappa = 0.61; 0.59), and fair and moderate agreement for anterior restorations (kappa = 0.36; 0.43), respectively. The accuracy was 84.8% in the assessment by intraoral photographs. Sensitivity and specificity values of 87.5% and 89.3% were found. Under the limits of this study, the assessment of digital photography performed by intraoral camera is an indirect diagnostic method valid for the evaluation of dental restorations, mainly in posterior teeth. This method should be employed taking into account the higher detection of defects provided by the images, which are not always clinically relevant. Copyright © 2018 Elsevier Ltd. All rights reserved.

[Multicenter validation of an evaluation tool for clinical training activities (SVAT) of the nursing students].

PubMed

Finotto, Sergio; Gradellini, Cinzia; Bandini, Stefania; Burrai, Francesco; Lucchi Casadei, Sandra; Villani, Carolina; Vincenzi, Simone; Mecugni, Daniela

2017-01-01

To evaluate the psychometric characteristics of the Scheda di Valutazione delle Attività di Tirocinio (SVAT). The degree courses in Nursing of the University of Modena and Reggio Emilia, site of Reggio Emilia, the University of Bologna Formative Section BO1, Imola and training center of Cesena, the University of Ferrara training centers of Ferrara and Codigoro were all enrolled in the research. For the content validation the reactive Delphi method was chosen. The panel of experts expressed a qualitative-intuitive judgment on the adequacy of language and on the stimulus material (SVAT). For internal consistency Cronbach's alpha was calculated the. The test-retest method was used for the reliability of stability. all indicators of the SVAT have achieved a degree of consensus not less than 80% demonstrating its content validity. The face validity is demonstrated by an average score equal to or greater than 7 obtained by all indicators. The reliability of internal consistency of the SVAT was appraised by Cronbach's alpha that was 0.987 for the entire instrument. The reliability of the stability has been calculated through the correlation's coefficient expressed by Pearson's r that was 0.983 (p = 1.3E-198). in Italy there is no a "gold standard" tool to evaluate the clinical performance of nursing students during and at the end of their clinical training. The SVAT proves to be a valuable and reliable tool it furthermore could stimulate the discussion and the debate among educators and nurses, so that also in our country, it may be possible develop and refine tools that support the evaluation of clinical skills of nursing students.

Modeling Clinical Outcomes in Prostate Cancer: Application and Validation of the Discrete Event Simulation Approach.

PubMed

Pan, Feng; Reifsnider, Odette; Zheng, Ying; Proskorovsky, Irina; Li, Tracy; He, Jianming; Sorensen, Sonja V

2018-04-01

Treatment landscape in prostate cancer has changed dramatically with the emergence of new medicines in the past few years. The traditional survival partition model (SPM) cannot accurately predict long-term clinical outcomes because it is limited by its ability to capture the key consequences associated with this changing treatment paradigm. The objective of this study was to introduce and validate a discrete-event simulation (DES) model for prostate cancer. A DES model was developed to simulate overall survival (OS) and other clinical outcomes based on patient characteristics, treatment received, and disease progression history. We tested and validated this model with clinical trial data from the abiraterone acetate phase III trial (COU-AA-302). The model was constructed with interim data (55% death) and validated with the final data (96% death). Predicted OS values were also compared with those from the SPM. The DES model's predicted time to chemotherapy and OS are highly consistent with the final observed data. The model accurately predicts the OS hazard ratio from the final data cut (predicted: 0.74; 95% confidence interval [CI] 0.64-0.85 and final actual: 0.74; 95% CI 0.6-0.88). The log-rank test to compare the observed and predicted OS curves indicated no statistically significant difference between observed and predicted curves. However, the predictions from the SPM based on interim data deviated significantly from the final data. Our study showed that a DES model with properly developed risk equations presents considerable improvements to the more traditional SPM in flexibility and predictive accuracy of long-term outcomes. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

MotiveValidator: interactive web-based validation of ligand and residue structure in biomolecular complexes.

PubMed

Vařeková, Radka Svobodová; Jaiswal, Deepti; Sehnal, David; Ionescu, Crina-Maria; Geidl, Stanislav; Pravda, Lukáš; Horský, Vladimír; Wimmerová, Michaela; Koča, Jaroslav

2014-07-01

Structure validation has become a major issue in the structural biology community, and an essential step is checking the ligand structure. This paper introduces MotiveValidator, a web-based application for the validation of ligands and residues in PDB or PDBx/mmCIF format files provided by the user. Specifically, MotiveValidator is able to evaluate in a straightforward manner whether the ligand or residue being studied has a correct annotation (3-letter code), i.e. if it has the same topology and stereochemistry as the model ligand or residue with this annotation. If not, MotiveValidator explicitly describes the differences. MotiveValidator offers a user-friendly, interactive and platform-independent environment for validating structures obtained by any type of experiment. The results of the validation are presented in both tabular and graphical form, facilitating their interpretation. MotiveValidator can process thousands of ligands or residues in a single validation run that takes no more than a few minutes. MotiveValidator can be used for testing single structures, or the analysis of large sets of ligands or fragments prepared for binding site analysis, docking or virtual screening. MotiveValidator is freely available via the Internet at http://ncbr.muni.cz/MotiveValidator. © The Author(s) 2014. Published by Oxford University Press on behalf of Nucleic Acids Research.

Embedded measures of performance validity using verbal fluency tests in a clinical sample.

PubMed

Sugarman, Michael A; Axelrod, Bradley N

2015-01-01

The objective of this study was to determine to what extent verbal fluency measures can be used as performance validity indicators during neuropsychological evaluation. Participants were clinically referred for neuropsychological evaluation in an urban-based Veteran's Affairs hospital. Participants were placed into 2 groups based on their objectively evaluated effort on performance validity tests (PVTs). Individuals who exhibited credible performance (n = 431) failed 0 PVTs, and those with poor effort (n = 192) failed 2 or more PVTs. All participants completed the Controlled Oral Word Association Test (COWAT) and Animals verbal fluency measures. We evaluated how well verbal fluency scores could discriminate between the 2 groups. Raw scores and T scores for Animals discriminated between the credible performance and poor-effort groups with 90% specificity and greater than 40% sensitivity. COWAT scores had lower sensitivity for detecting poor effort. A combination of FAS and Animals scores into logistic regression models yielded acceptable group classification, with 90% specificity and greater than 44% sensitivity. Verbal fluency measures can yield adequate detection of poor effort during neuropsychological evaluation. We provide suggested cut points and logistic regression models for predicting the probability of poor effort in our clinical setting and offer suggested cutoff scores to optimize sensitivity and specificity.

40 CFR 1065.550 - Gas analyzer range validation and drift validation.

Code of Federal Regulations, 2012 CFR

2012-07-01

... a dry sample measured with a CLD and the removed water is corrected based on measured CO2, CO, THC... may not validate the concentration subcomponents (e.g., THC and CH4 for NMHC) separately. For example, for NMHC measurements, perform drift validation on NMHC; do not validate THC and CH4 separately. (2...

40 CFR 1065.550 - Gas analyzer range validation and drift validation.

Code of Federal Regulations, 2013 CFR

2013-07-01

... a dry sample measured with a CLD and the removed water is corrected based on measured CO2, CO, THC... may not validate the concentration subcomponents (e.g., THC and CH4 for NMHC) separately. For example, for NMHC measurements, perform drift validation on NMHC; do not validate THC and CH4 separately. (2...

Development of a clinically validated bulk failure test for ceramic crowns.

PubMed

Kelly, J Robert; Rungruanganunt, Patchnee; Hunter, Ben; Vailati, Francesca

2010-10-01

Traditional testing of ceramic crowns creates a stress state and damage modes that differ greatly from those seen clinically. There is a need to develop and communicate an in vitro testing protocol that is clinically valid. The purpose of this study was to develop an in vitro failure test for ceramic single-unit prostheses that duplicates the failure mechanism and stress state observed in clinically failed prostheses. This article first compares characteristics of traditional load-to-failure tests of ceramic crowns with the growing body of evidence regarding failure origins and stress states at failure from the examination of clinically failed crowns, finite element analysis (FEA), and data from clinical studies. Based on this analysis, an experimental technique was systematically developed and test materials were identified to recreate key aspects of clinical failure in vitro. One potential dentin analog material (an epoxy filled with woven glass fibers; NEMA grade G10) was evaluated for elastic modulus in blunt contact and for bond strength to resin cement as compared to hydrated dentin. Two bases with different elastic moduli (nickel chrome and resin-based composite) were tested for influence on failure loads. The influence of water during storage and loading (both monotonic and cyclic) was examined. Loading piston materials (G10, aluminum, stainless steel) and piston designs were varied to eliminate Hertzian cracking and to improve performance. Testing was extended from a monolayer ceramic (leucite-filled glass) to a bilayer ceramic system (glass-infiltrated alumina). The influence of cyclic rate on mean failure loads was examined (2 Hz, 10 Hz, 20 Hz) with the extremes compared statistically (t test; α=.05). Failure loads were highly influenced by base elastic modulus (t test; P<.001). Cyclic loading while in water significantly decreased mean failure loads (1-way ANOVA; P=.003) versus wet storage/dry cycling (350 N vs. 1270 N). G10 was not significantly

The development of an instrument for evaluating clinical teachers: involving stakeholders to determine content validity.

PubMed

Stalmeijer, Renée E; Dolmans, Diana H J M; Wolfhagen, Ineke H A P; Muijtjens, Arno M M; Scherpbier, Albert J J A

2008-01-01

Research indicates that the quality of supervision strongly influences the learning of medical students in clinical practice. Clinical teachers need feedback to improve their supervisory skills. The available instruments either lack a clear theoretical framework or are not suitable for providing feedback to individual teachers. We developed an evaluation instrument based on the 'cognitive apprenticeship model'. The aim was to estimate the content validity of the developed instrument. Item relevance was rated on a five-point scale (1 = highly irrelevant, 5 = highly relevant) by three groups of stakeholders in undergraduate clinical teaching: educationalists (N = 12), doctors (N = 16) and students (N = 12). Additionally, stakeholders commented on content, wording and omission of items. The items were generally rated as very relevant (Mean = 4.3, SD = 0.38, response = 95%) and any differences between the stakeholder groups were small. The results led to elimination of 4 items, rewording of 13 items and addition of 1 item. The cognitive apprenticeship model appears to offer a useful framework for the development of an evaluation instrument aimed at providing feedback to individual clinical teachers on the quality of student supervision. Further studies in larger populations will have to establish the instrument's statistical validity and generalizability.

Blood collection tubes as medical devices: The potential to affect assays and proposed verification and validation processes for the clinical laboratory.

PubMed

Bowen, Raffick A R; Adcock, Dorothy M

2016-12-01

Blood collection tubes (BCTs) are an often under-recognized variable in the preanalytical phase of clinical laboratory testing. Unfortunately, even the best-designed and manufactured BCTs may not work well in all clinical settings. Clinical laboratories, in collaboration with healthcare providers, should carefully evaluate BCTs prior to putting them into clinical use to determine their limitations and ensure that patients are not placed at risk because of inaccuracies due to poor tube performance. Selection of the best BCTs can be achieved through comparing advertising materials, reviewing the literature, observing the device at a scientific meeting, receiving a demonstration, evaluating the device under simulated conditions, or testing the device with patient samples. Although many publications have discussed method validations, few detail how to perform experiments for tube verification and validation. This article highlights the most common and impactful variables related to BCTs and discusses the validation studies that a typical clinical laboratory should perform when selecting BCTs. We also present a brief review of how in vitro diagnostic devices, particularly BCTs, are regulated in the United States, the European Union, and Canada. The verification and validation of BCTs will help to avoid the economic and human costs associated with incorrect test results, including poor patient care, unnecessary testing, and delays in test results. We urge laboratorians, tube manufacturers, diagnostic companies, and other researchers to take all the necessary steps to protect against the adverse effects of BCT components and their additives on clinical assays. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Using wound care algorithms: a content validation study.

PubMed

Beitz, J M; van Rijswijk, L

1999-09-01

Valid and reliable heuristic devices facilitating optimal wound care are lacking. The objectives of this study were to establish content validation data for a set of wound care algorithms, to identify their associated strengths and weaknesses, and to gain insight into the wound care decision-making process. Forty-four registered nurse wound care experts were surveyed and interviewed at national and regional educational meetings. Using a cross-sectional study design and an 83-item, 4-point Likert-type scale, this purposive sample was asked to quantify the degree of validity of the algorithms' decisions and components. Participants' comments were tape-recorded, transcribed, and themes were derived. On a scale of 1 to 4, the mean score of the entire instrument was 3.47 (SD +/- 0.87), the instrument's Content Validity Index was 0.86, and the individual Content Validity Index of 34 of 44 participants was > 0.8. Item scores were lower for those related to packing deep wounds (P < .001). No other significant differences were observed. Qualitative data analysis revealed themes of difficulty associated with wound assessment and care issues, that is, the absence of valid and reliable definitions. The wound care algorithms studied proved valid. However, the lack of valid and reliable wound assessment and care definitions hinders optimal use of these instruments. Further research documenting their clinical use is warranted. Research-based practice recommendations should direct the development of future valid and reliable algorithms designed to help nurses provide optimal wound care.

10 CFR 26.131 - Cutoff levels for validity screening and initial validity tests.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Cutoff levels for validity screening and initial validity tests. 26.131 Section 26.131 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Licensee Testing Facilities § 26.131 Cutoff levels for validity screening and initial validity tests. (a) Each...

10 CFR 26.131 - Cutoff levels for validity screening and initial validity tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Cutoff levels for validity screening and initial validity tests. 26.131 Section 26.131 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Licensee Testing Facilities § 26.131 Cutoff levels for validity screening and initial validity tests. (a) Each...

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

PubMed

Winzer, Eva; Luger, Maria; Schindler, Karin

2018-06-01

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

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

PubMed

Hall, Emily A; Docherty, Carrie L

2017-07-01

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

Anxiety measures validated in perinatal populations: a systematic review.

PubMed

Meades, Rose; Ayers, Susan

2011-09-01

Research and screening of anxiety in the perinatal period is hampered by a lack of psychometric data on self-report anxiety measures used in perinatal populations. This paper aimed to review self-report measures that have been validated with perinatal women. A systematic search was carried out of four electronic databases. Additional papers were obtained through searching identified articles. Thirty studies were identified that reported validation of an anxiety measure with perinatal women. Most commonly validated self-report measures were the General Health Questionnaire (GHQ), State-Trait Anxiety Inventory (STAI), and Hospital Anxiety and Depression Scales (HADS). Of the 30 studies included, 11 used a clinical interview to provide criterion validity. Remaining studies reported one or more other forms of validity (factorial, discriminant, concurrent and predictive) or reliability. The STAI shows criterion, discriminant and predictive validity and may be most useful for research purposes as a specific measure of anxiety. The Kessler 10 (K-10) may be the best short screening measure due to its ability to differentiate anxiety disorders. The Depression Anxiety Stress Scales 21 (DASS-21) measures multiple types of distress, shows appropriate content, and remains to be validated against clinical interview in perinatal populations. Nineteen studies did not report sensitivity or specificity data. The early stages of research into perinatal anxiety, the multitude of measures in use, and methodological differences restrict comparison of measures across studies. There is a need for further validation of self-report measures of anxiety in the perinatal period to enable accurate screening and detection of anxiety symptoms and disorders. Copyright © 2010 Elsevier B.V. All rights reserved.

The Anomalous Sentences Repetition Test: Replication and Validation Study.

ERIC Educational Resources Information Center

Weeks, David J.

1986-01-01

Presents a brief clinical test, derived from earlier neuropsychological instruments, with evidence for its reliability, interscorer agreement, and validity. The latter is based upon correlations with both CAT scan measures of cortical atrophy and ventricular enlargement, as well as correlations with seven other previously validated cognitive…

Agreeing on Validity Arguments

ERIC Educational Resources Information Center

Sireci, Stephen G.

2013-01-01

Kane (this issue) presents a comprehensive review of validity theory and reminds us that the focus of validation is on test score interpretations and use. In reacting to his article, I support the argument-based approach to validity and all of the major points regarding validation made by Dr. Kane. In addition, I call for a simpler, three-step…

A clinical prognostic model compared to the newly adopted UICC staging in an independent validation cohort of P16 negative/positive head and neck cancer patients.

PubMed

Rasmussen, Jacob H; Håkansson, Katrin; Rasmussen, Gregers B; Vogelius, Ivan R; Friborg, Jeppe; Fischer, Barbara M; Bentzen, Søren M; Specht, Lena

2018-06-01

A previously published prognostic model in patients with head and neck squamous cell carcinoma (HNSCC) was validated in both a p16-negative and a p16-positive independent patient cohort and the performance was compared with the newly adopted 8th edition of the UICC staging system. Consecutive patients with HNSCC treated at a single institution from 2005 to 2012 were included. The cohort was divided in three. 1.) Training cohort, patients treated from 2005 to 2009 excluding patients with p16-positive oropharyngeal squamous cell carcinomas (OPSCC); 2.) A p16-negative validation cohort and 3.) A p16-positive validation cohort. A previously published prognostic model (clinical model) with the significant covariates (smoking status, FDG uptake, and tumor volume) was refitted in the training cohort and validated in the two validation cohorts. The clinical model was used to generate four risk groups based on the predicted risk of disease recurrence after 2 years and the performance was compared with UICC staging 8th edition using concordance index. Overall 568 patients were included. Compared to UICC the clinical model had a significantly better concordance index in the p16-negative validation cohort (AUC = 0.63 for UICC and AUC = 0.73 for the clinical model; p = 0.003) and a borderline significantly better concordance index in the p16-positive cohort (AUC = 0.63 for UICC and 0.72 for the clinical model; p = 0.088). The validated clinical model provided a better prognostication of risk of disease recurrence than UICC stage in the p16-negative validation cohort, and similar prognostication as the newly adopted 8th edition of the UICC staging in the p16-positive patient cohort. Copyright © 2018 Elsevier Ltd. All rights reserved.

Diagnosis of TIA (DOT) score--design and validation of a new clinical diagnostic tool for transient ischaemic attack.

PubMed

Dutta, Dipankar

2016-02-09

The diagnosis of Transient Ischaemic Attack (TIA) can be difficult and 50-60% of patients seen in TIA clinics turn out to be mimics. Many of these mimics have high ABCD2 scores and fill urgent TIA clinic slots inappropriately. A TIA diagnostic tool may help non-specialists make the diagnosis with greater accuracy and improve TIA clinic triage. The only available diagnostic score (Dawson et al) is limited in scope and not widely used. The Diagnosis of TIA (DOT) Score is a new and internally validated web and mobile app based diagnostic tool which encompasses both brain and retinal TIA. The score was derived retrospectively from a single centre TIA clinic database using stepwise logistic regression by backwards elimination to find the best model. An optimum cutpoint was obtained for the score. The derivation and validation cohorts were separate samples drawn from the years 2010/12 and 2013 respectively. Receiver Operating Characteristic (ROC) curves and area under the curve (AUC) were calculated and the diagnostic accuracy of DOT was compared to the Dawson score. A web and smartphone calculator were designed subsequently. The derivation cohort had 879 patients and the validation cohort 525. The final model had seventeen predictors and had an AUC of 0.91 (95% CI: 0.89-0.93). When tested on the validation cohort, the AUC for DOTS was 0.89 (0.86-0.92) while that of the Dawson score was 0.77 (0.73-0.81). The sensitivity and specificity of the DOT score were 89% (CI: 84%-93%) and 76% (70%-81%) respectively while those of the Dawson score were 83% (78%-88%) and 51% (45%-57%). Other diagnostic accuracy measures (DOT vs. Dawson) include positive predictive values (75% vs. 58%), negative predictive values (89% vs. 79%), positive likelihood ratios (3.67 vs. 1.70) and negative likelihood ratios (0.15 vs. 0.32). The DOT score shows promise as a diagnostic tool for TIA and requires independent external validation before it can be widely used. It could potentially improve the

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

PubMed Central

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

2016-01-01

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

A validation study of a clinical prediction rule for screening asymptomatic chlamydia and gonorrhoea infections among heterosexuals in British Columbia.

PubMed

Falasinnu, Titilola; Gilbert, Mark; Gustafson, Paul; Shoveller, Jean

2016-02-01

One component of effective sexually transmitted infections (STIs) control is ensuring those at highest risk of STIs have access to clinical services because terminating transmission in this group will prevent most future cases. Here, we describe the results of a validation study of a clinical prediction rule for identifying individuals at increased risk for chlamydia and gonorrhoea infection derived in Vancouver, British Columbia (BC), against a population of asymptomatic patients attending sexual health clinics in other geographical settings in BC. We examined electronic records (2000-2012) from clinic visits at seven sexual health clinics in geographical locations outside Vancouver. The model's calibration and discrimination were examined by the area under the receiver operating characteristic curve (AUC) and the Hosmer-Lemeshow (H-L) statistic, respectively. We also examined the sensitivity and proportion of patients that would need to be screened at different cut-offs of the risk score. The prevalence of infection was 5.3% (n=10 425) in the geographical validation population. The prediction rule showed good performance in this population (AUC, 0.69; H-L p=0.26). Possible risk scores ranged from -2 to 27. We identified a risk score cut-off point of ≥8 that detected cases with a sensitivity of 86% by screening 63% of the geographical validation population. The prediction rule showed good generalisability in STI clinics outside of Vancouver with improved discriminative performance compared with temporal validation. The prediction rule has the potential for augmenting triaging services in STI clinics and enhancing targeted testing in population-based screening programmes. 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/

Validity of Sensory Systems as Distinct Constructs

PubMed Central

Su, Chia-Ting

2014-01-01

This study investigated the validity of sensory systems as distinct measurable constructs as part of a larger project examining Ayres’s theory of sensory integration. Confirmatory factor analysis (CFA) was conducted to test whether sensory questionnaire items represent distinct sensory system constructs. Data were obtained from clinical records of two age groups, 2- to 5-yr-olds (n = 231) and 6- to 10-yr-olds (n = 223). With each group, we tested several CFA models for goodness of fit with the data. The accepted model was identical for each group and indicated that tactile, vestibular–proprioceptive, visual, and auditory systems form distinct, valid factors that are not age dependent. In contrast, alternative models that grouped items according to sensory processing problems (e.g., over- or underresponsiveness within or across sensory systems) did not yield valid factors. Results indicate that distinct sensory system constructs can be measured validly using questionnaire data. PMID:25184467

Further examination of embedded performance validity indicators for the Conners' Continuous Performance Test and Brief Test of Attention in a large outpatient clinical sample.

PubMed

Sharland, Michael J; Waring, Stephen C; Johnson, Brian P; Taran, Allise M; Rusin, Travis A; Pattock, Andrew M; Palcher, Jeanette A

2018-01-01

Assessing test performance validity is a standard clinical practice and although studies have examined the utility of cognitive/memory measures, few have examined attention measures as indicators of performance validity beyond the Reliable Digit Span. The current study further investigates the classification probability of embedded Performance Validity Tests (PVTs) within the Brief Test of Attention (BTA) and the Conners' Continuous Performance Test (CPT-II), in a large clinical sample. This was a retrospective study of 615 patients consecutively referred for comprehensive outpatient neuropsychological evaluation. Non-credible performance was defined two ways: failure on one or more PVTs and failure on two or more PVTs. Classification probability of the BTA and CPT-II into non-credible groups was assessed. Sensitivity, specificity, positive predictive value, and negative predictive value were derived to identify clinically relevant cut-off scores. When using failure on two or more PVTs as the indicator for non-credible responding compared to failure on one or more PVTs, highest classification probability, or area under the curve (AUC), was achieved by the BTA (AUC = .87 vs. .79). CPT-II Omission, Commission, and Total Errors exhibited higher classification probability as well. Overall, these findings corroborate previous findings, extending them to a large clinical sample. BTA and CPT-II are useful embedded performance validity indicators within a clinical battery but should not be used in isolation without other performance validity indicators.

Validation of the Intrinsic Spirituality Scale (ISS) with Muslims.

PubMed

Hodge, David R; Zidan, Tarek; Husain, Altaf

2015-12-01

This study validates an existing spirituality measure--the intrinsic spirituality scale (ISS)--for use with Muslims in the United States. A confirmatory factor analysis was conducted with a diverse sample of self-identified Muslims (N = 281). Validity and reliability were assessed along with criterion and concurrent validity. The measurement model fit the data well, normed χ2 = 2.50, CFI = 0.99, RMSEA = 0.07, and SRMR = 0.02. All 6 items that comprise the ISS demonstrated satisfactory levels of validity (λ > .70) and reliability (R2 > .50). The Cronbach's alpha obtained with the present sample was .93. Appropriate correlations with theoretically linked constructs demonstrated criterion and concurrent validity. The results suggest the ISS is a valid measure of spirituality in clinical settings with the rapidly growing Muslim population. The ISS may, for instance, provide an efficient screening tool to identify Muslims that are particularly likely to benefit from spiritually accommodative treatments. (c) 2015 APA, all rights reserved).

Development and Validation of Targeted Next-Generation Sequencing Panels for Detection of Germline Variants in Inherited Diseases.

PubMed

Santani, Avni; Murrell, Jill; Funke, Birgit; Yu, Zhenming; Hegde, Madhuri; Mao, Rong; Ferreira-Gonzalez, Andrea; Voelkerding, Karl V; Weck, Karen E

2017-06-01

- The number of targeted next-generation sequencing (NGS) panels for genetic diseases offered by clinical laboratories is rapidly increasing. Before an NGS-based test is implemented in a clinical laboratory, appropriate validation studies are needed to determine the performance characteristics of the test. - To provide examples of assay design and validation of targeted NGS gene panels for the detection of germline variants associated with inherited disorders. - The approaches used by 2 clinical laboratories for the development and validation of targeted NGS gene panels are described. Important design and validation considerations are examined. - Clinical laboratories must validate performance specifications of each test prior to implementation. Test design specifications and validation data are provided, outlining important steps in validation of targeted NGS panels by clinical diagnostic laboratories.

Official Position of the American Academy of Clinical Neuropsychology Social Security Administration Policy on Validity Testing: Guidance and Recommendations for Change.

PubMed

Chafetz, M D; Williams, M A; Ben-Porath, Y S; Bianchini, K J; Boone, K B; Kirkwood, M W; Larrabee, G J; Ord, J S

2015-01-01

The milestone publication by Slick, Sherman, and Iverson (1999) of criteria for determining malingered neurocognitive dysfunction led to extensive research on validity testing. Position statements by the National Academy of Neuropsychology and the American Academy of Clinical Neuropsychology (AACN) recommended routine validity testing in neuropsychological evaluations. Despite this widespread scientific and professional support, the Social Security Administration (SSA) continued to discourage validity testing, a stance that led to a congressional initiative for SSA to reevaluate their position. In response, SSA commissioned the Institute of Medicine (IOM) to evaluate the science concerning the validation of psychological testing. The IOM concluded that validity assessment was necessary in psychological and neuropsychological examinations (IOM, 2015 ). The AACN sought to provide independent expert guidance and recommendations concerning the use of validity testing in disability determinations. A panel of contributors to the science of validity testing and its application to the disability process was charged with describing why the disability process for SSA needs improvement, and indicating the necessity for validity testing in disability exams. This work showed how the determination of malingering is a probability proposition, described how different types of validity tests are appropriate, provided evidence concerning non-credible findings in children and low-functioning individuals, and discussed the appropriate evaluation of pain disorders typically seen outside of mental consultations. A scientific plan for validity assessment that additionally protects test security is needed in disability determinations and in research on classification accuracy of disability decisions.

Validation of the Mayo Clinic Staging System in Determining Prognoses of Patients With Perihilar Cholangiocarcinoma.

PubMed

Coelen, Robert J S; Gaspersz, Marcia P; Labeur, Tim A; van Vugt, Jeroen L A; van Dieren, Susan; Willemssen, François E J A; Nio, Chung Y; IJzermans, Jan N M; Klümpen, Heinz-Josef; Groot Koerkamp, Bas; van Gulik, Thomas M

2017-12-01

Most systems for staging perihilar cholangiocarcinoma (PHC) have been developed for the minority of patients with resectable disease. The recently developed Mayo Clinic system for staging PHC requires only clinical and radiologic variables, but has not yet been validated. We performed a retrospective study to validate the Mayo Clinic staging system. We identified consecutive patients with suspected PHC who were evaluated and treated at 2 tertiary centers in The Netherlands, from January 2002 through December 2014. Baseline characteristics (performance status, carbohydrate antigen 19-9 level) used in the staging system were collected from medical records and imaging parameters (tumor size, suspected vascular involvement, and metastatic disease) were reassessed by 2 experienced abdominal radiologists. Overall survival was analyzed using the Kaplan-Meier method and comparison of staging groups was performed using the log-rank test and Cox proportional hazard regression analysis. Discriminative performance was quantified by the concordance index and compared with the radiologic TNM staging of the American Joint Committee on Cancer (7th ed). PHCs from 600 patients were staged according to the Mayo Clinic model (23 stage I, 80 stage II, 357 stage III, and 140 stage IV). The median overall survival time was 11.6 months. The median overall survival times for patients with stages I, II, III, and IV were 33.2 months, 19.7 months, 12.1 months, and 6.0 months, respectively; with hazard ratios of 1.0 (reference), 2.02 (95% confidence interval [CI], 1.14-3.58), 2.71 (95% CI, 1.59-4.64), and 4.00 (95% CI, 2.30-6.95), respectively (P < .001). The concordance index score was 0.59 for the entire cohort (95% CI, 0.56-0.61). The Mayo Clinic model performed slightly better than the radiologic American Joint Committee on Cancer TNM system. In a retrospective study of 600 patients with PHC, we validated the Mayo Clinic system for staging PHC. This 4-tier staging system may aid

Validity and reliability of balance assessment software using the Nintendo Wii balance board: usability and validation

PubMed Central

2014-01-01

Background A balance test provides important information such as the standard to judge an individual’s functional recovery or make the prediction of falls. The development of a tool for a balance test that is inexpensive and widely available is needed, especially in clinical settings. The Wii Balance Board (WBB) is designed to test balance, but there is little software used in balance tests, and there are few studies on reliability and validity. Thus, we developed a balance assessment software using the Nintendo Wii Balance Board, investigated its reliability and validity, and compared it with a laboratory-grade force platform. Methods Twenty healthy adults participated in our study. The participants participated in the test for inter-rater reliability, intra-rater reliability, and concurrent validity. The tests were performed with balance assessment software using the Nintendo Wii balance board and a laboratory-grade force platform. Data such as Center of Pressure (COP) path length and COP velocity were acquired from the assessment systems. The inter-rater reliability, the intra-rater reliability, and concurrent validity were analyzed by an intraclass correlation coefficient (ICC) value and a standard error of measurement (SEM). Results The inter-rater reliability (ICC: 0.89-0.79, SEM in path length: 7.14-1.90, SEM in velocity: 0.74-0.07), intra-rater reliability (ICC: 0.92-0.70, SEM in path length: 7.59-2.04, SEM in velocity: 0.80-0.07), and concurrent validity (ICC: 0.87-0.73, SEM in path length: 5.94-0.32, SEM in velocity: 0.62-0.08) were high in terms of COP path length and COP velocity. Conclusion The balance assessment software incorporating the Nintendo Wii balance board was used in our study and was found to be a reliable assessment device. In clinical settings, the device can be remarkably inexpensive, portable, and convenient for the balance assessment. PMID:24912769

A new framework to enhance the interpretation of external validation studies of clinical prediction models.

PubMed

Debray, Thomas P A; Vergouwe, Yvonne; Koffijberg, Hendrik; Nieboer, Daan; Steyerberg, Ewout W; Moons, Karel G M

2015-03-01

It is widely acknowledged that the performance of diagnostic and prognostic prediction models should be assessed in external validation studies with independent data from "different but related" samples as compared with that of the development sample. We developed a framework of methodological steps and statistical methods for analyzing and enhancing the interpretation of results from external validation studies of prediction models. We propose to quantify the degree of relatedness between development and validation samples on a scale ranging from reproducibility to transportability by evaluating their corresponding case-mix differences. We subsequently assess the models' performance in the validation sample and interpret the performance in view of the case-mix differences. Finally, we may adjust the model to the validation setting. We illustrate this three-step framework with a prediction model for diagnosing deep venous thrombosis using three validation samples with varying case mix. While one external validation sample merely assessed the model's reproducibility, two other samples rather assessed model transportability. The performance in all validation samples was adequate, and the model did not require extensive updating to correct for miscalibration or poor fit to the validation settings. The proposed framework enhances the interpretation of findings at external validation of prediction models. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

[Validation of interaction databases in psychopharmacotherapy].

PubMed

Hahn, M; Roll, S C

2018-03-01

Drug-drug interaction databases are an important tool to increase drug safety in polypharmacy. There are several drug interaction databases available but it is unclear which one shows the best results and therefore increases safety for the user of the databases and the patients. So far, there has been no validation of German drug interaction databases. Validation of German drug interaction databases regarding the number of hits, mechanisms of drug interaction, references, clinical advice, and severity of the interaction. A total of 36 drug interactions which were published in the last 3-5 years were checked in 5 different databases. Besides the number of hits, it was also documented if the mechanism was correct, clinical advice was given, primary literature was cited, and the severity level of the drug-drug interaction was given. All databases showed weaknesses regarding the hit rate of the tested drug interactions, with a maximum of 67.7% hits. The highest score in this validation was achieved by MediQ with 104 out of 180 points. PsiacOnline achieved 83 points, arznei-telegramm® 58, ifap index® 54 and the ABDA-database 49 points. Based on this validation MediQ seems to be the most suitable databank for the field of psychopharmacotherapy. The best results in this comparison were achieved by MediQ but this database also needs improvement with respect to the hit rate so that the users can rely on the results and therefore increase drug therapy safety.

Chronic obstructive lung disease "expert system": validation of a predictive tool for assisting diagnosis.

PubMed

Braido, Fulvio; Santus, Pierachille; Corsico, Angelo Guido; Di Marco, Fabiano; Melioli, Giovanni; Scichilone, Nicola; Solidoro, Paolo

2018-01-01

The purposes of this study were development and validation of an expert system (ES) aimed at supporting the diagnosis of chronic obstructive lung disease (COLD). A questionnaire and a WebFlex code were developed and validated in silico. An expert panel pilot validation on 60 cases and a clinical validation on 241 cases were performed. The developed questionnaire and code validated in silico resulted in a suitable tool to support the medical diagnosis. The clinical validation of the ES was performed in an academic setting that included six different reference centers for respiratory diseases. The results of the ES expressed as a score associated with the risk of suffering from COLD were matched and compared with the final clinical diagnoses. A set of 60 patients were evaluated by a pilot expert panel validation with the aim of calculating the sample size for the clinical validation study. The concordance analysis between these preliminary ES scores and diagnoses performed by the experts indicated that the accuracy was 94.7% when both experts and the system confirmed the COLD diagnosis and 86.3% when COLD was excluded. Based on these results, the sample size of the validation set was established in 240 patients. The clinical validation, performed on 241 patients, resulted in ES accuracy of 97.5%, with confirmed COLD diagnosis in 53.6% of the cases and excluded COLD diagnosis in 32% of the cases. In 11.2% of cases, a diagnosis of COLD was made by the experts, although the imaging results showed a potential concomitant disorder. The ES presented here (COLD ES ) is a safe and robust supporting tool for COLD diagnosis in primary care settings.

Initial Retrieval Validation from the Joint Airborne IASI Validation Experiment (JAIVEx)

NASA Technical Reports Server (NTRS)

Zhou, Daniel K.; Liu, Xu; Smith, WIlliam L.; Larar, Allen M.; Taylor, Jonathan P.; Revercomb, Henry E.; Mango, Stephen A.; Schluessel, Peter; Calbet, Xavier

2007-01-01

The Joint Airborne IASI Validation Experiment (JAIVEx) was conducted during April 2007 mainly for validation of the Infrared Atmospheric Sounding Interferometer (IASI) on the MetOp satellite, but also included a strong component focusing on validation of the Atmospheric InfraRed Sounder (AIRS) aboard the AQUA satellite. The cross validation of IASI and AIRS is important for the joint use of their data in the global Numerical Weather Prediction process. Initial inter-comparisons of geophysical products have been conducted from different aspects, such as using different measurements from airborne ultraspectral Fourier transform spectrometers (specifically, the NPOESS Airborne Sounder Testbed Interferometer (NAST-I) and the Scanning-High resolution Interferometer Sounder (S-HIS) aboard the NASA WB-57 aircraft), UK Facility for Airborne Atmospheric Measurements (FAAM) BAe146-301 aircraft insitu instruments, dedicated dropsondes, radiosondes, and ground based Raman Lidar. An overview of the JAIVEx retrieval validation plan and some initial results of this field campaign are presented.

Development and validation of simulated virtual patients to impart early clinical exposure in endocrine physiology.

PubMed

Gupta, Akriti; Singh, Satendra; Khaliq, Farah; Dhaliwal, Upreet; Madhu, S V

2018-03-01

In the country presently, preclinical medical students are not routinely exposed to real patients. Thus, when they start clinical postings, they are found to have poor clinical reasoning skills. Simulated virtual patients (SVPs) can improve clinical skills without endangering real patients. This pilot study describes the development of two SVPs in endocrine physiology and their validation in terms of acquisition of clinical knowledge and student engagement. Two SVPs, Nandini Sharma (unintentional weight gain) and Sunil Yadav (polyuria), were created and published on the i-Human Patients platform through an iterative, interdisciplinary, and transdisciplinary collaborative process using the conceptual framework of Kim et al. (Kim S, Phillips WR, Pinsky L, Brock D, Phillips K, Keary J. Med Educ 40: 867-876, 2006). After internal and external peer validation, the SVPs were piloted on 40 students (20 students per virtual patient) over 2 wk. A cognitive pretest was conducted before exposure, and a posttest soon after. Faculty and student feedback were collected. Faculty found SVPs authentic, helpful as teaching-learning tools, and useful for giving feedback and for assessment. Students found SVPs more engaging than paper cases and helpful in developing clinical reasoning and in imparting clinical exposure. Pretest and posttest scores indicated knowledge gain ( P < 0.01). Although challenging to create, SVPs created on the i-Human Patients platform improved learning in endocrine physiology and were well accepted by students and faculty as a means to provide early clinical exposure. More SVPs can be developed through collaboration between stakeholder departments and integrated into the curriculum for greater benefit.

External validation of the clinical dehydration scale for children with acute gastroenteritis.

PubMed

Bailey, Benoit; Gravel, Jocelyn; Goldman, Ran D; Friedman, Jeremy N; Parkin, Patricia C

2010-06-01

The objective was to validate the clinical dehydration scale (CDS) for children with gastroenteritis in a different pediatric emergency department (ED) from where it was initially derived and validated. A prospective cohort study was performed in a tertiary care pediatric ED over a 1-year period. A sample of triage nurses were trained in applying the CDS. The CDS consists of four clinical characteristics (general appearance, eyes, mucous membranes, and tears), each of which are scored 0, 1, or 2 for a total score of 0 to 8, with 0 representing no dehydration; 1 to 4, some dehydration; and 5 to 8, moderate/severe dehydration. Children 1 month to 5 years of age with vomiting and/or diarrhea who had the CDS documented at triage and a final diagnosis of gastroenteritis, gastritis, or enteritis were enrolled. Exclusion criteria included a chronic disease, treatment with intravenous (IV) rehydration within the previous 24 hours, visit to the ED for the same illness in the 7 days prior to arrival, and diarrhea of more than 10 days' duration. The primary outcome was the length of stay (LOS) in the ED from the time of seeing a physician to discharge, analyzed with a Kruskal-Wallis test. From April 2008 to March 2009, 150 patients with a mean (+/-SD) age of 22 (+/-14) months (range = 4 months to 4 years) were enrolled. Fifty-six patients had no dehydration, 74 had some dehydration, and 20 had moderate/severe dehydration. The median LOS in the ED after being seen by a physician was significantly longer as children appeared more dehydrated according to the CDS: 54 minutes (interquartile range [IQR] = 26-175 minutes), 128 minutes (IQR = 25-334 minutes), and 425 minutes (IQR = 218-673 minutes) for the no, some, and moderate/severe dehydration groups, respectively (p < 0.001). The CDS has been further validated in children with gastroenteritis in a different pediatric center than the original one where it was developed. It is a good predictor of LOS in the ED after being seen by

Groundwater Model Validation

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

Ahmed E. Hassan

2006-01-24

Models have an inherent uncertainty. The difficulty in fully characterizing the subsurface environment makes uncertainty an integral component of groundwater flow and transport models, which dictates the need for continuous monitoring and improvement. Building and sustaining confidence in closure decisions and monitoring networks based on models of subsurface conditions require developing confidence in the models through an iterative process. The definition of model validation is postulated as a confidence building and long-term iterative process (Hassan, 2004a). Model validation should be viewed as a process not an end result. Following Hassan (2004b), an approach is proposed for the validation process ofmore » stochastic groundwater models. The approach is briefly summarized herein and detailed analyses of acceptance criteria for stochastic realizations and of using validation data to reduce input parameter uncertainty are presented and applied to two case studies. During the validation process for stochastic models, a question arises as to the sufficiency of the number of acceptable model realizations (in terms of conformity with validation data). Using a hierarchical approach to make this determination is proposed. This approach is based on computing five measures or metrics and following a decision tree to determine if a sufficient number of realizations attain satisfactory scores regarding how they represent the field data used for calibration (old) and used for validation (new). The first two of these measures are applied to hypothetical scenarios using the first case study and assuming field data consistent with the model or significantly different from the model results. In both cases it is shown how the two measures would lead to the appropriate decision about the model performance. Standard statistical tests are used to evaluate these measures with the results indicating they are appropriate measures for evaluating model realizations. The use of

Does the decision in a validation process of a surrogate endpoint change with level of significance of treatment effect? A proposal on validation of surrogate endpoints.

PubMed

Sertdemir, Y; Burgut, R

2009-01-01

In recent years the use of surrogate end points (S) has become an interesting issue. In clinical trials, it is important to get treatment outcomes as early as possible. For this reason there is a need for surrogate endpoints (S) which are measured earlier than the true endpoint (T). However, before a surrogate endpoint can be used it must be validated. For a candidate surrogate endpoint, for example time to recurrence, the validation result may change dramatically between clinical trials. The aim of this study is to show how the validation criterion (R(2)(trial)) proposed by Buyse et al. are influenced by the magnitude of treatment effect with an application using real data. The criterion R(2)(trial) proposed by Buyse et al. (2000) is applied to the four data sets from colon cancer clinical trials (C-01, C-02, C-03 and C-04). Each clinical trial is analyzed separately for treatment effect on survival (true endpoint) and recurrence free survival (surrogate endpoint) and this analysis is done also for each center in each trial. Results are used for standard validation analysis. The centers were grouped by the Wald statistic in 3 equal groups. Validation criteria R(2)(trial) were 0.641 95% CI (0.432-0.782), 0.223 95% CI (0.008-0.503), 0.761 95% CI (0.550-0.872) and 0.560 95% CI (0.404-0.687) for C-01, C-02, C-03 and C-04 respectively. The R(2)(trial) criteria changed by the Wald statistics observed for the centers used in the validation process. Higher the Wald statistic groups are higher the R(2)(trial) values observed. The recurrence free survival is not a good surrogate for overall survival in clinical trials with non significant treatment effects and moderate for significant treatment effects. This shows that the level of significance of treatment effect should be taken into account in validation process of surrogate endpoints.

Construct, Concurrent and Predictive Validity of the URICA: Data from Two Multi-site Clinical Trials

PubMed Central

Field, Craig A.; Adinoff, Bryon; Harris, T. Robert; Ball, Samuel A.; Carroll, Kathleen M.

2011-01-01

Background A better understanding of how to measure motivation to change and how it relates to behavior change in patients with drug and alcohol dependence would broaden our understanding of the role of motivation in addiction treatment. Methods Two multi-site, randomized clinical trials comparing brief motivational interventions with standard care were conducted in the National Institute on Drug Abuse Clinical Trials Network. Patients with primary drug dependence and alcohol dependence entering outpatient treatment participated in a study of either Motivational Enhancement Therapy (n=431) or Motivational Interviewing (n=423). The construct, concurrent, and predictive validity of two composite measures of motivation to change derived from the University of Rhode Island Change Assessment (URICA): Readiness to Change (RTC) and Committed Action (CA) were evaluated. Results Confirmatory factor analysis confirmed the a priori factor structure of the URICA. RTC was significantly associated with measures of addiction severity at baseline (r=.12-.52, p<.05). Although statistically significant (p<.01), the correlations between treatment outcomes and RTC were low (r=-.15 and -18). Additional analyses did not support a moderating or mediating effect of motivation on treatment retention or substance use. Conclusions The construct validity of the URICA was confirmed separately in a large sample of drug- and alcohol-dependent patients. However, evidence for the predictive validity of composite scores was very limited and there were no moderating or mediating effects of either measure on treatment outcome. Thus, increased motivation to change, as measured by the composite scores of motivation derived from the URICA, does not appear to influence treatment outcome. PMID:19157723

A serious game can be a valid method to train clinical decision-making in surgery.

PubMed

Graafland, Maurits; Vollebergh, Maarten F; Lagarde, Sjoerd M; van Haperen, M; Bemelman, Willem A; Schijven, Marlies P

2014-12-01

A serious game was developed to train surgical residents in clinical decision-making regarding biliary tract disease. Serious or applied gaming is a novel educational approach to postgraduate training, combining training and assessment of clinical decision-making in a fun and challenging way. Although interest for serious games in medicine is rising, evidence on its validity is lacking. This study investigates face, content, and construct validity of this serious game. Experts structurally validated the game's medical content. Subsequently, 41 participants played the game. Decision scores and decision speed were compared among surgeons, surgical residents, interns, and medical students, determining the game's discriminatory ability between different levels of expertise. After playing, participants completed a questionnaire on the game's perceived realism and teaching ability. Surgeons solved more cases correctly (mean 77 %) than surgical residents (67 %), interns (60 %), master-degree students (50 %), and bachelor-degree students (39 % (p < 0.01). Trainees performed significantly better in their second play session than in the first (median 72 vs. 48 %, p = 0.00). Questionnaire results showed that educators and surgical trainees found the game both realistic and useful for surgical training. The majority perceived the game as fun (91.2 %), challenging (85.3 %), and would recommend the game to educate their colleagues (81.8 %). This serious game showed clear discriminatory ability between different levels of expertise in biliary tract disease management and clear teaching capability. It was perceived as appealing and realistic. Serious gaming has the potential to increase adherence to training programs in surgical residency training and medical school.

Preliminary Validation of a Screening Tool for Adolescent Panic Disorder in Pediatric Primary Care Clinics

ERIC Educational Resources Information Center

Queen, Alexander H.; Ehrenreich-May, Jill; Hershorin, Eugene R.

2012-01-01

This study examines the validity of a brief screening tool for adolescent panic disorder (PD) in a primary care setting. A total of 165 participants (ages 12-17 years) seen in two pediatric primary care clinics completed the Autonomic Nervous System Questionnaire (ANS; Stein et al. in Psychosomatic Med 61:359-364, 40). A subset of those screening…

The Validity of the Five-Factor Model Prototypes for Personality Disorders in Two Clinical Samples

ERIC Educational Resources Information Center

Miller, Joshua D.; Reynolds, Sarah K.; Pilkonis, Paul A.

2004-01-01

The authors examined the validity of D. R. Lynam and T. A. Widiger's (2001) prototypes for personality disorders (PDs) derived from the facets of the 5-factor model (FFM) of personality in 2 clinical samples. In the 1st sample (N = 94), there was good agreement between the prototypes generated by experts and the profiles reported by patients.…

Clinical utility and validity of the Functional Disability Inventory (FDI) among a multicenter sample of youth with chronic pain

PubMed Central

Kashikar-Zuck, Susmita; Flowers, Stacy R.; Claar, Robyn Lewis; Guite, Jessica W.; Logan, Deirdre E.; Lynch-Jordan, Anne M; Palermo, Tonya M.; Wilson, Anna C.

2011-01-01

The Functional Disability Inventory (FDI) is a well-established and commonly used measure of physical functioning and disability in youth with chronic pain. Further validation of the measure has been called for, in particular, examination of the clinical utility and factor structure of the measure. To address this need, we utilized a large multicenter dataset of pediatric patients with chronic pain who had completed the FDI and other measures assessing pain and emotional functioning. Clinical reference points to allow for interpretation of raw scores were developed to enhance clinical utility of the measure and exploratory factor analysis was performed to examine its factor structure. Participants included 1300 youth ages 8 to 18 years (M=14.2 years; 76% female) with chronic pain. Examination of the distribution of FDI scores and validation with measures of depressive symptoms and pain intensity yielded three distinct categories of disability: No/Minimal Disability, Moderate Disability and Severe Disability. Factor analysis of FDI scores revealed a two-factor solution representing vigorous Physical Activities and non-physically strenuous Daily Activities. The three-level classification system and factor structure were further explored via comparison across the four most commonly encountered pain conditions in clinical settings (head, back, abdominal and widespread pain). Our findings provide important new information regarding the clinical utility and validity of the FDI. This will greatly enhance the interpretability of scores for research and clinical use in a wide range of pediatric pain conditions. In particular these findings will facilitate use of the FDI as an outcome measure in future clinical trials. PMID:21458162

The Abbott RealTime High Risk HPV test is a clinically validated human papillomavirus assay for triage in the referral population and use in primary cervical cancer screening in women 30 years and older: a review of validation studies.

PubMed

Poljak, Mario; Oštrbenk, Anja

2013-01-01

Human papillomavirus (HPV) testing has become an essential part of current clinical practice in the management of cervical cancer and precancerous lesions. We reviewed the most important validation studies of a next-generation real-time polymerase chain reaction-based assay, the RealTime High Risk HPV test (RealTime)(Abbott Molecular, Des Plaines, IL, USA), for triage in referral population settings and for use in primary cervical cancer screening in women 30 years and older published in peer-reviewed journals from 2009 to 2013. RealTime is designed to detect 14 high-risk HPV genotypes with concurrent distinction of HPV-16 and HPV-18 from 12 other HPV genotypes. The test was launched on the European market in January 2009 and is currently used in many laboratories worldwide for routine detection of HPV. We concisely reviewed validation studies of a next-generation real-time polymerase chain reaction (PCR)-based assay: the Abbott RealTime High Risk HPV test. Eight validation studies of RealTime in referral settings showed its consistently high absolute clinical sensitivity for both CIN2+ (range 88.3-100%) and CIN3+ (range 93.0-100%), as well as comparative clinical sensitivity relative to the currently most widely used HPV test: the Qiagen/Digene Hybrid Capture 2 HPV DNA Test (HC2). Due to the significantly different composition of the referral populations, RealTime absolute clinical specificity for CIN2+ and CIN3+ varied greatly across studies, but was comparable relative to HC2. Four validation studies of RealTime performance in cervical cancer screening settings showed its consistently high absolute clinical sensitivity for both CIN2+ and CIN3+, as well as comparative clinical sensitivity and specificity relative to HC2 and GP5+/6+ PCR. RealTime has been extensively evaluated in the last 4 years. RealTime can be considered clinically validated for triage in referral population settings and for use in primary cervical cancer screening in women 30 years and older.

Pain assessment in children: theoretical and empirical validity.

PubMed

Villarruel, A M; Denyes, M J

1991-12-01

Valid assessment of pain in children is foundational for both the nursing practice and research domains, yet few validated methods of pain measurement are currently available for young children. This article describes an innovative research approach used in the development of photographic instruments to measure pain intensity in young African-American and Hispanic children. The instruments were designed to enable children to participate actively in their own care and to do so in ways that are congruent with their developmental and cultural heritage. Conceptualization of the instruments, methodological development, and validation processes grounded in Orem's Self-Care Deficit Theory of Nursing are described. The authors discuss the ways in which the gaps between nursing theory, research, and practice are narrowed when development of instruments to measure clinical nursing phenomena are grounded in nursing theory, validated through research and utilized in practice settings.

Validation of the Inventory of Depressive Symptomatology (IDS) in Cocaine Dependent Inmates.

ERIC Educational Resources Information Center

Suris, Alina; Kashner, T. Michael; Gillaspy, James A., Jr.; Biggs, Melanie; Rush, A. John

2001-01-01

While the reliability and validity of Inventory of Depressive Symptomatology (IDS) scores have been established with outpatient adults being treated in community psychiatric clinics, it has not been used in special or dually diagnosed populations. Establishes internal consistency, concurrent validity, and construct validity for both the clinical…

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

PubMed

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

2015-10-01

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

CosmoQuest:Using Data Validation for More Than Just Data Validation

NASA Astrophysics Data System (ADS)

Lehan, C.; Gay, P.

2016-12-01

It is often taken for granted that different scientists completing the same task (e.g. mapping geologic features) will get the same results, and data validation is often skipped or under-utilized due to time and funding constraints. Robbins et. al (2014), however, demonstrated that this is a needed step, as large variation can exist even among collaborating team members completing straight-forward tasks like marking craters. Data Validation should be much more than a simple post-project verification of results. The CosmoQuest virtual research facility employs regular data-validation for a variety of benefits, including real-time user feedback, real-time tracking to observe user activity while it's happening, and using pre-solved data to analyze users' progress and to help them retain skills. Some creativity in this area can drastically improve project results. We discuss methods of validating data in citizen science projects and outline the variety of uses for validation, which, when used properly, improves the scientific output of the project and the user experience for the citizens doing the work. More than just a tool for scientists, validation can assist users in both learning and retaining important information and skills, improving the quality and quantity of data gathered. Real-time analysis of user data can give key information in the effectiveness of the project that a broad glance would miss, and properly presenting that analysis is vital. Training users to validate their own data, or the data of others, can significantly improve the accuracy of misinformed or novice users.

An exploratory study into the effect of time-restricted internet access on face-validity, construct validity and reliability of postgraduate knowledge progress testing

PubMed Central

2013-01-01

Background Yearly formative knowledge testing (also known as progress testing) was shown to have a limited construct-validity and reliability in postgraduate medical education. One way to improve construct-validity and reliability is to improve the authenticity of a test. As easily accessible internet has become inseparably linked to daily clinical practice, we hypothesized that allowing internet access for a limited amount of time during the progress test would improve the perception of authenticity (face-validity) of the test, which would in turn improve the construct-validity and reliability of postgraduate progress testing. Methods Postgraduate trainees taking the yearly knowledge progress test were asked to participate in a study where they could access the internet for 30 minutes at the end of a traditional pen and paper test. Before and after the test they were asked to complete a short questionnaire regarding the face-validity of the test. Results Mean test scores increased significantly for all training years. Trainees indicated that the face-validity of the test improved with internet access and that they would like to continue to have internet access during future testing. Internet access did not improve the construct-validity or reliability of the test. Conclusion Improving the face-validity of postgraduate progress testing, by adding the possibility to search the internet for a limited amount of time, positively influences test performance and face-validity. However, it did not change the reliability or the construct-validity of the test. PMID:24195696

Clinical validation of robot simulation of toothbrushing--comparative plaque removal efficacy.

PubMed

Lang, Tomas; Staufer, Sebastian; Jennes, Barbara; Gaengler, Peter

2014-07-04

Clinical validation of laboratory toothbrushing tests has important advantages. It was, therefore, the aim to demonstrate correlation of tooth cleaning efficiency of a new robot brushing simulation technique with clinical plaque removal. Clinical programme: 27 subjects received dental cleaning prior to 3-day-plaque-regrowth-interval. Plaque was stained, photographically documented and scored using planimetrical index. Subjects brushed teeth 33-47 with three techniques (horizontal, rotating, vertical), each for 20s buccally and for 20s orally in 3 consecutive intervals. The force was calibrated, the brushing technique was video supported. Two different brushes were randomly assigned to the subject. Robot programme: Clinical brushing programmes were transfered to a 6-axis-robot. Artificial teeth 33-47 were covered with plaque-simulating substrate. All brushing techniques were repeated 7 times, results were scored according to clinical planimetry. All data underwent statistical analysis by t-test, U-test and multivariate analysis. The individual clinical cleaning patterns are well reproduced by the robot programmes. Differences in plaque removal are statistically significant for the two brushes, reproduced in clinical and robot data. Multivariate analysis confirms the higher cleaning efficiency for anterior teeth and for the buccal sites. The robot tooth brushing simulation programme showed good correlation with clinically standardized tooth brushing.This new robot brushing simulation programme can be used for rapid, reproducible laboratory testing of tooth cleaning.

Validation of a track repeating algorithm for intensity modulated proton therapy: clinical cases study

NASA Astrophysics Data System (ADS)

Yepes, Pablo P.; Eley, John G.; Liu, Amy; Mirkovic, Dragan; Randeniya, Sharmalee; Titt, Uwe; Mohan, Radhe

2016-04-01

Monte Carlo (MC) methods are acknowledged as the most accurate technique to calculate dose distributions. However, due its lengthy calculation times, they are difficult to utilize in the clinic or for large retrospective studies. Track-repeating algorithms, based on MC-generated particle track data in water, accelerate dose calculations substantially, while essentially preserving the accuracy of MC. In this study, we present the validation of an efficient dose calculation algorithm for intensity modulated proton therapy, the fast dose calculator (FDC), based on a track-repeating technique. We validated the FDC algorithm for 23 patients, which included 7 brain, 6 head-and-neck, 5 lung, 1 spine, 1 pelvis and 3 prostate cases. For validation, we compared FDC-generated dose distributions with those from a full-fledged Monte Carlo based on GEANT4 (G4). We compared dose-volume-histograms, 3D-gamma-indices and analyzed a series of dosimetric indices. More than 99% of the voxels in the voxelized phantoms describing the patients have a gamma-index smaller than unity for the 2%/2 mm criteria. In addition the difference relative to the prescribed dose between the dosimetric indices calculated with FDC and G4 is less than 1%. FDC reduces the calculation times from 5 ms per proton to around 5 μs.

Development and Validation of a Photonumeric Scale for Assessment of Chin Retrusion.

PubMed

Sykes, Jonathan M; Carruthers, Alastair; Hardas, Bhushan; Murphy, Diane K; Jones, Derek; Carruthers, Jean; Donofrio, Lisa; Creutz, Lela; Marx, Ann; Dill, Sara

2016-10-01

A validated scale is needed for objective and reproducible comparisons of chin appearance before and after chin augmentation in practice and clinical studies. To describe the development and validation of the 5-point photonumeric Allergan Chin Retrusion Scale. The Allergan Chin Retrusion Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 298) completed during 2 sessions occurring 3 weeks apart. A difference of ≥1 point on the scale was shown to reflect a clinically meaningful difference (mean [95% confidence interval] absolute score difference, 1.07 [0.94-1.20] for clinically different image pairs and 0.51 [0.39-0.63] for not clinically different pairs). Intrarater agreement between the 2 live-subject validation sessions was substantial (mean weighted kappa = 0.79). Interrater agreement was substantial during the second rating session (0.68, primary end point). The Allergan Chin Retrusion Scale is a validated and reliable scale for physician rating of severity of chin retrusion.

Biomarkers for Early Detection of Clinically Relevant Prostate Cancer. A Multi-Institutional Validation Trial

DTIC Science & Technology

2016-10-01

Study (PASS). We are in the process of evaluating these three biomarker panels in tissue, blood, and urine samples with well annotated clinical and...impacting both the initial choice of therapy and decision-making during AS. The objective of the study is to utilize analytically validated assays that...predict reclassification from Gleason 6 cancer to Gleason 7 or greater. The analysis plan was determined before specimens were selected for the study

Bibliometrics for Social Validation.

PubMed

Hicks, Daniel J

2016-01-01

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

Bibliometrics for Social Validation

PubMed Central

2016-01-01

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

MO-B-BRB-02: 3D Dosimetry in the Clinic: IMRT Technique Validation in Sweden

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

Ceberg, S.

Full three-dimensional (3D) dosimetry using volumetric chemical dosimeters probed by 3D imaging systems has long been a promising technique for the radiation therapy clinic, since it provides a unique methodology for dose measurements in the volume irradiated using complex conformal delivery techniques such as IMRT and VMAT. To date true 3D dosimetry is still not widely practiced in the community; it has been confined to centres of specialized expertise especially for quality assurance or commissioning roles where other dosimetry techniques are difficult to implement. The potential for improved clinical applicability has been advanced considerably in the last decade by themore » development of improved 3D dosimeters (e.g., radiochromic plastics, radiochromic gel dosimeters and normoxic polymer gel systems) and by improved readout protocols using optical computed tomography or magnetic resonance imaging. In this session, established users of some current 3D chemical dosimeters will briefly review the current status of 3D dosimetry, describe several dosimeters and their appropriate imaging for dose readout, present workflow procedures required for good dosimetry, and analyze some limitations for applications in select settings. We will review the application of 3D dosimetry to various clinical situations describing how 3D approaches can complement other dose delivery validation approaches already available in the clinic. The applications presented will be selected to inform attendees of the unique features provided by full 3D techniques. Learning Objectives: L. John Schreiner: Background and Motivation Understand recent developments enabling clinically practical 3D dosimetry, Appreciate 3D dosimetry workflow and dosimetry procedures, and Observe select examples from the clinic. Sofie Ceberg: Application to dynamic radiotherapy Observe full dosimetry under dynamic radiotherapy during respiratory motion, and Understand how the measurement of high resolution dose data

Validity, Responsibility, and Aporia

ERIC Educational Resources Information Center

Koro-Ljungberg, Mirka

2010-01-01

In this article, the author problematizes external, objectified, oversimplified, and mechanical approaches to validity in qualitative research, which endorse simplistic and reductionist views of knowledge and data. Instead of promoting one generalizable definition or operational criteria for validity, the author's "deconstructive validity work"…

Optimization and validation of sample preparation for metagenomic sequencing of viruses in clinical samples.

PubMed

Lewandowska, Dagmara W; Zagordi, Osvaldo; Geissberger, Fabienne-Desirée; Kufner, Verena; Schmutz, Stefan; Böni, Jürg; Metzner, Karin J; Trkola, Alexandra; Huber, Michael

2017-08-08

Sequence-specific PCR is the most common approach for virus identification in diagnostic laboratories. However, as specific PCR only detects pre-defined targets, novel virus strains or viruses not included in routine test panels will be missed. Recently, advances in high-throughput sequencing allow for virus-sequence-independent identification of entire virus populations in clinical samples, yet standardized protocols are needed to allow broad application in clinical diagnostics. Here, we describe a comprehensive sample preparation protocol for high-throughput metagenomic virus sequencing using random amplification of total nucleic acids from clinical samples. In order to optimize metagenomic sequencing for application in virus diagnostics, we tested different enrichment and amplification procedures on plasma samples spiked with RNA and DNA viruses. A protocol including filtration, nuclease digestion, and random amplification of RNA and DNA in separate reactions provided the best results, allowing reliable recovery of viral genomes and a good correlation of the relative number of sequencing reads with the virus input. We further validated our method by sequencing a multiplexed viral pathogen reagent containing a range of human viruses from different virus families. Our method proved successful in detecting the majority of the included viruses with high read numbers and compared well to other protocols in the field validated against the same reference reagent. Our sequencing protocol does work not only with plasma but also with other clinical samples such as urine and throat swabs. The workflow for virus metagenomic sequencing that we established proved successful in detecting a variety of viruses in different clinical samples. Our protocol supplements existing virus-specific detection strategies providing opportunities to identify atypical and novel viruses commonly not accounted for in routine diagnostic panels.

Validation of the Chronic Pain Acceptance Questionnaire-8 in an Australian pain clinic sample.

PubMed

Baranoff, John; Hanrahan, Stephanie J; Kapur, Dilip; Connor, Jason P

2014-02-01

Recently, an 8-item short-form version of the Chronic Pain Acceptance Questionnaire (CPAQ-8) was developed predominantly in an internet sample. Further investigation of the factor structure in a multidisciplinary pain clinic sample is required. Investigation of the concurrent validity of the CPAQ-8 after accounting for the effects of variables commonly measured in the pain clinic setting is also necessary. This study examines the factor structure and concurrent validity of the CPAQ-8 in a sample of treatment-seeking patients who attended a multidisciplinary pain clinic. Participants were 334 patients who attended an Australian multidisciplinary pain service. Participants completed the CPAQ, a demographic questionnaire, and measures of patient adjustment and functioning. Confirmatory factor analysis identified a two-factor 8-item model consisting of Activity Engagement and Pain Willingness factors (SRMR = 0.039, RMSEA = 0.063, CFI = 0.973, TLI = 0.960) was superior to both the CPAQ and CPAQ with an item removed. The CPAQ and CPAQ-8 total scores were highly correlated (r = 0.93). After accounting for pain intensity, the CPAQ-8 was a significant predictor of depression, anxiety, stress, and disability. The subscales of the CPAQ-8 were both unique contributors to depression and disability in regression analyses, after accounting for pain intensity and kinesiophobia, and after accounting for pain intensity and catastrophizing. The CPAQ-8 has a sound factor structure and similar psychometric properties to the CPAQ; it may have clinical utility as a measure of pain acceptance in treatment-seeking, chronic pain patients.

Psychometric Validation of the Leeds Dependence Questionnaire (LDQ) in a Young Adult Clinical Sample

PubMed Central

Kelly, John F.; Magill, Molly; Slaymaker, Valerie; Kahler, Christopher

2013-01-01

Objective Measures of substance dependence severity that are both clinically efficient and sensitive to change can facilitate assessment of clinical innovation necessary for improving current evidence-based practices. The Leeds Dependence Questionnaire (LDQ) is a 10-item, continuous, self-report measure of dependence that is not specific to any particular substance and has shown promise in preliminary psychometric research. The present study investigates its psychometric properties in a large clinical sample of young adults. Method Emerging adults (N = 300) were enrolled in a naturalistic treatment process and outcome study of residential substance dependence treatment (mean age 20.4 [1.6], range 18–25; 27% female; 95% White). Dependence severity by demographic and diagnostic groupings, factor structure and internal consistency, and criterion- and construct-related validity were examined. Results Dependence severity in this cohort of youth overall was high (M = 18.65 [8.65]). LDQ scores were highest among opiate and stimulant users, and there was a trend for higher scores among women compared to men (t = 1.869, p = .063). Factor analysis using a robust alpha factoring extraction revealed a single factor accounting for 63% of the variance in reported dependence severity. The internal consistency was also very high (alpha = .93). Concurrent and convergent validity with dependence criteria, substance use frequency, and general symptom severity, respectively, were also acceptable. Conclusions The LDQ shows considerable promise as a brief, psychometrically sound, measure of substance dependence useful across a variety of substances, that has clinical and research utility. This study supports its use among emerging adults. PMID:20004062

Quality of life in multiple myeloma: clinical validation of the Mexican-Spanish version of the QLQ-MY20 instrument.

PubMed

Espinoza-Zamora, José Ramiro; Portilla-Espinosa, César Miguel; Labardini-Méndez, Juan Rafael; Cervera, Eduardo; Niesvisky, Ruben; Oñate-Ocaña, Luis F

2015-06-01

Health-related quality of life (HRQL) has become an important outcome measurement in hematology. Our aim was to validate the quality of life questionnaire (QLQ)-MY20 instrument in patients with multiple myeloma (MM) in Mexico. The Mexican-Spanish versions of the QLQ-C30 and QLQ-MY20 instruments were applied to patients with MM at a cancer referral centre. Reliability and validity tests were performed. Test-retest was carried out in selected patients. Ninety-eight patients with MM were included in this study. Questionnaire compliance rates were high, and the instrument was well accepted; internal consistency tests demonstrated good convergent and divergent validity. Cronbach's α coefficients of seven of nine multi-item scales of the QLQ-C30 and of all three multi-item scales of the QLQ-MY20 instruments were >0.7 (range, 0.36-0.89). The scales of the QLQ-C30 and QLQ-MY20 instruments distinguished among clinically distinct groups of patients; 9 of 15 scales of the QLQ-C30 and all 4 scales of the QLQ-MY20 presented responsiveness after change over time. The Mexican-Spanish version of the QLQ-MY20 questionnaire is reliable and valid for the assessment of HRQL in patients with MM and can be used in clinical trials in the Mexican community.

Development and validation of the Child Oral Health Impact Profile - Preschool version.

PubMed

Ruff, R R; Sischo, L; Chinn, C H; Broder, H L

2017-09-01

The Child Oral Health Impact Profile (COHIP) is a validated instrument created to measure the oral health-related quality of life of school-aged children. The purpose of this study was to develop and validate a preschool version of the COHIP (COHIP-PS) for children aged 2-5. The COHIP-PS was developed and validated using a multi-stage process consisting of item selection, face validity testing, item impact testing, reliability and validity testing, and factor analysis. A cross-sectional convenience sample of caregivers having children 2-5 years old from four groups completed item clarity and impact forms. Groups were recruited from pediatric health clinics or preschools/daycare centers, speech clinics, dental clinics, or cleft/craniofacial centers. Participants had a variety of oral health-related conditions, including caries, congenital orofacial anomalies, and speech/language deficiencies such as articulation and language disorders. COHIP-PS. The COHIP-PS was found to have acceptable internal validity (a = 0.71) and high test-retest reliability (0.87), though internal validity was below the accepted threshold for the community sample. While discriminant validity results indicated significant differences across study groups, the overall magnitude of differences was modest. Results from confirmatory factor analyses support the use of a four-factor model consisting of 11 items across oral health, functional well-being, social-emotional well-being, and self-image domains. Quality of life is an integral factor in understanding and assessing children's well-being. The COHIP-PS is a validated oral health-related quality of life measure for preschool children with cleft or other oral conditions. Copyright© 2017 Dennis Barber Ltd.

Construct validity of the Iowa Gambling Task.

PubMed

Buelow, Melissa T; Suhr, Julie A

2009-03-01

The Iowa Gambling Task (IGT) was created to assess real-world decision making in a laboratory setting and has been applied to various clinical populations (i.e., substance abuse, schizophrenia, pathological gamblers) outside those with orbitofrontal cortex damage, for whom it was originally developed. The current review provides a critical examination of lesion, functional neuroimaging, developmental, and clinical studies in order to examine the construct validity of the IGT. The preponderance of evidence provides support for the use of the IGT to detect decision making deficits in clinical populations, in the context of a more comprehensive evaluation. The review includes a discussion of three critical issues affecting the validity of the IGT, as it has recently become available as a clinical instrument: the lack of a concise definition as to what aspect of decision making the IGT measures, the lack of data regarding reliability of the IGT, and the influence of personality and state mood on IGT performance.

The development and validation of the Clinical Teaching Behavior Inventory (CTBI-23): Nurse preceptors' and new graduate nurses' perceptions of precepting.

PubMed

Lee-Hsieh, Jane; O'Brien, Anthony; Liu, Chieh-Yu; Cheng, Su-Fen; Lee, Yea-Wen; Kao, Yu-Hsiu

2016-03-01

Few studies have examined the perceptions of clinical teaching behaviors among both nurse preceptors and preceptees. To develop a Clinical Teaching Behavior Inventory (CTBI) for nurse preceptors' self-evaluation, and for new graduate nurse preceptee evaluation of preceptor clinical teaching behaviors and to test the validity and reliability of the CTBI. This study used mixed research techniques in five phases. Phase I: based on a literature review, the researchers developed an instrument to measure clinical teaching behaviors. Phase II: 17 focus group interviews were conducted with 63 preceptors and 24 new graduate nurses from five hospitals across Taiwan. Clinical teaching behavior themes were extracted from the focus group data and integrated into the domains and items of the CTBI. Phase III: two rounds of an expert Delphi study were conducted to determine the content validity of the instrument. Phase IV: a total of 290 nurse preceptors and 260 new graduate nurses were recruited voluntarily in the same five hospitals in Taiwan. Of these, 521 completed questionnaires to test the construct validity of CTBI by using confirmatory factory analysis. Phase V: the internal consistency and reliability of the instrument were tested. CTBI consists of 23 items in six domains: (1) 'Committing to Teaching'; (2) 'Building a Learning Atmosphere'; (3) 'Using Appropriate Teaching Strategies'; (4) 'Guiding Inter-professional Communication'; (5) 'Providing Feedback and Evaluation'; and (6) 'Showing Concern and Support'. The confirmatory factor analysis yielded a good fit and reliable scores for the CTBI-23 model. The CTBI-23 is a valid and reliable instrument for identifying the clinical teaching behaviors of a preceptor as perceived by preceptors and new graduate preceptees. The CTBI-23 depicts clinical teaching behaviors of nurse preceptors in Taiwan. Copyright © 2015 Elsevier Ltd. All rights reserved.

Assessing the reliability, predictive and construct validity of historical, clinical and risk management-20 (HCR-20) in Mexican psychiatric inpatients.

PubMed

Sada, Andrea; Robles-García, Rebeca; Martínez-López, Nicolás; Hernández-Ramírez, Rafael; Tovilla-Zarate, Carlos-Alfonso; López-Munguía, Fernando; Suárez-Alvarez, Enrique; Ayala, Xochitl; Fresán, Ana

2016-08-01

Assessing dangerousness to gauge the likelihood of future violent behaviour has become an integral part of clinical mental health practice in forensic and non-forensic psychiatric settings, one of the most effective instruments for this being the Historical, Clinical and Risk Management-20 (HCR-20). To examine the HCR-20 factor structure in Mexican psychiatric inpatients and to obtain its predictive validity and reliability for use in this population. In total, 225 patients diagnosed with psychotic, affective or personality disorders were included. The HCR-20 was applied at hospital admission and violent behaviours were assessed during psychiatric hospitalization using the Overt Aggression Scale (OAS). Construct validity, predictive validity and internal consistency were determined. Violent behaviour remains more severe in patients classified in the high-risk group during hospitalization. Fifteen items displayed adequate communalities in the original designated domains of the HCR-20 and internal consistency of the instruments was high. The HCR-20 is a suitable instrument for predicting violence risk in Mexican psychiatric inpatients.

Noninvasive assessment of mitral inertness [correction of inertance]: clinical results with numerical model validation.

PubMed

Firstenberg, M S; Greenberg, N L; Smedira, N G; McCarthy, P M; Garcia, M J; Thomas, J D

2001-01-01

Inertial forces (Mdv/dt) are a significant component of transmitral flow, but cannot be measured with Doppler echo. We validated a method of estimating Mdv/dt. Ten patients had a dual sensor transmitral (TM) catheter placed during cardiac surgery. Doppler and 2D echo was performed while acquiring LA and LV pressures. Mdv/dt was determined from the Bernoulli equation using Doppler velocities and TM gradients. Results were compared with numerical modeling. TM gradients (range: 1.04-14.24 mmHg) consisted of 74.0 +/- 11.0% inertial forcers (range: 0.6-12.9 mmHg). Multivariate analysis predicted Mdv/dt = -4.171(S/D (RATIO)) + 0.063(LAvolume-max) + 5. Using this equation, a strong relationship was obtained for the clinical dataset (y=0.98x - 0.045, r=0.90) and the results of numerical modeling (y=0.96x - 0.16, r=0.84). TM gradients are mainly inertial and, as validated by modeling, can be estimated with echocardiography.

Cross-cultural adaptation and validation of the Italian version of the Kerlan-Jobe Orthopaedic Clinic Shoulder and Elbow score.

PubMed

Merolla, Giovanni; Corona, Katia; Zanoli, Gustavo; Cerciello, Simone; Giannotti, Stefano; Porcellini, Giuseppe

2017-12-01

The Kerlan-Jobe Orthopaedic Clinic (KJOC) Shoulder and Elbow score is a reliable and sensitive tool to measure the performance of overhead athletes. The purpose of this study was to carry out a cross-cultural adaptation and validation of the KJOC questionnaire in Italian and to assess its reliability, validity, and responsiveness. Ninety professional athletes with a painful shoulder were included in this study and were assigned to the "injury group" (n = 32) or the "overuse group" (n = 58); 65 were managed conservatively and 25 were treated by arthroscopic surgery. To assess the reliability of the KJOC score, patients were asked to fill in the questionnaire at baseline and after 2 weeks. To test the construct validity, KJOC scores were compared to those obtained with the Italian version of the Disabilities of the Arm, Shoulder, and Hand (DASH) scale, and with the DASH sports/performing arts module. To test KJOC score responsiveness, the follow-up KJOC scores of the participants treated conservatively were compared to those of the patients treated by arthroscopic surgery. Statistical analysis demonstrated that the KJOC questionnaire is reliable in terms of the single items and the overall score (ICC 0.95-0.99); that it has high construct validity (r s  = -0.697; p < 0.01); and that it is responsive to clinical differences in shoulder function (p < 0.0001). The Italian version of the KJOC Shoulder and Elbow score performed in a similar way to the English version and demonstrated good validity, reliability, and responsiveness after conservative and surgical treatment. II.

"Blue flags", development of a short clinical questionnaire on work-related psychosocial risk factors - a validation study in primary care.

PubMed

Post Sennehed, Charlotte; Gard, Gunvor; Holmberg, Sara; Stigmar, Kjerstin; Forsbrand, Malin; Grahn, Birgitta

2017-07-24

Working conditions substantially influence health, work ability and sick leave. Useful instruments to help clinicians pay attention to working conditions are lacking in primary care (PC). The aim of this study was to test the validity of a short "Blue flags" questionnaire, which focuses on work-related psychosocial risk factors and any potential need for contacts and/or actions at the workplace. From the original"The General Nordic Questionnaire" (QPS Nordic ) the research group identified five content areas with a total of 51 items which were considered to be most relevant focusing on work-related psychosocial risk factors. Fourteen items were selected from the identified QPS Nordic content areas and organised in a short questionnaire "Blue flags". These 14 items were validated towards the 51 QPS Nordic items. Content validity was reviewed by a professional panel and a patient panel. Structural and concurrent validity were also tested within a randomised clinical trial. The two panels (n = 111) considered the 14 psychosocial items to be relevant. A four-factor model was extracted with an explained variance of 25.2%, 14.9%, 10.9% and 8.3% respectively. All 14 items showed satisfactory loadings on all factors. Concerning concurrent validity the overall correlation was very strong r s  = 0.87 (p < 0.001).). Correlations were moderately strong for factor one, r s  = 0.62 (p < 0.001) and factor two, r s  = 0.74 (p < 0.001). Factor three and factor four were weaker, bur still fair and significant at r s  = 0.53 (p < 0.001) and r s  = 0.41 (p < 0.001) respectively. The internal consistency of the whole "Blue flags" was good with Cronbach's alpha of 0.76. The content, structural and concurrent validity were satisfactory in this first step of development of the "Blue flags" questionnaire. In summary, the overall validity is considered acceptable. Testing in clinical contexts and in other patient populations is recommended to ensure predictive validity

A simplified approach to the pooled analysis of calibration of clinical prediction rules for systematic reviews of validation studies

PubMed Central

Dimitrov, Borislav D; Motterlini, Nicola; Fahey, Tom

2015-01-01

Objective Estimating calibration performance of clinical prediction rules (CPRs) in systematic reviews of validation studies is not possible when predicted values are neither published nor accessible or sufficient or no individual participant or patient data are available. Our aims were to describe a simplified approach for outcomes prediction and calibration assessment and evaluate its functionality and validity. Study design and methods: Methodological study of systematic reviews of validation studies of CPRs: a) ABCD2 rule for prediction of 7 day stroke; and b) CRB-65 rule for prediction of 30 day mortality. Predicted outcomes in a sample validation study were computed by CPR distribution patterns (“derivation model”). As confirmation, a logistic regression model (with derivation study coefficients) was applied to CPR-based dummy variables in the validation study. Meta-analysis of validation studies provided pooled estimates of “predicted:observed” risk ratios (RRs), 95% confidence intervals (CIs), and indexes of heterogeneity (I2) on forest plots (fixed and random effects models), with and without adjustment of intercepts. The above approach was also applied to the CRB-65 rule. Results Our simplified method, applied to ABCD2 rule in three risk strata (low, 0–3; intermediate, 4–5; high, 6–7 points), indicated that predictions are identical to those computed by univariate, CPR-based logistic regression model. Discrimination was good (c-statistics =0.61–0.82), however, calibration in some studies was low. In such cases with miscalibration, the under-prediction (RRs =0.73–0.91, 95% CIs 0.41–1.48) could be further corrected by intercept adjustment to account for incidence differences. An improvement of both heterogeneities and P-values (Hosmer-Lemeshow goodness-of-fit test) was observed. Better calibration and improved pooled RRs (0.90–1.06), with narrower 95% CIs (0.57–1.41) were achieved. Conclusion Our results have an immediate clinical

Quality assurance of the clinical learning environment in Austria: Construct validity of the Clinical Learning Environment, Supervision and Nurse Teacher Scale (CLES+T scale).

PubMed

Mueller, Gerhard; Mylonas, Demetrius; Schumacher, Petra

2018-07-01

Within nursing education, the clinical learning environment is of a high importance in regards to the development of competencies and abilities. The organization, atmosphere, and supervision in the clinical learning environment are only a few factors that influence this development. In Austria there is currently no valid instrument available for the evaluation of influencing factors. The aim of the study was to test the construct validity with principal component analysis as well as the internal consistency of the German Clinical Learning Environment, Supervision and Teacher Scale (CLES+T scale) in Austria. The present validation study has a descriptive-quantitative cross-sectional design. The sample consisted of 385 nursing students from thirteen training institutions in Austria. The data collection was carried out online between March and April 2016. Starting with a polychoric correlation matrix, a parallel analysis with principal component extraction and promax rotation was carried out due to the ordinal data. The exploratory ordinal factor analysis supported a four-component solution and explained 73% of the total variance. The internal consistency of all 25 items reached a Cronbach's α of 0.95 and the four components ranged between 0.83 and 0.95. The German version of the CLES+T scale seems to be a useful instrument for identifying potential areas of improvement in clinical practice in order to derive specific quality measures for the practical learning environment. Copyright © 2018 Elsevier Ltd. All rights reserved.

TES Validation Reports

Atmospheric Science Data Center

2014-06-30

... Reports: TES Data Versions: TES Validation Report Version 6.0 (PDF) R13 processing version; F07_10 file versions TES Validation Report Version 5.0 (PDF) R12 processing version; F06_08, F06_09 file ...

Model Validation Status Review

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

E.L. Hardin

The primary objective for the Model Validation Status Review was to perform a one-time evaluation of model validation associated with the analysis/model reports (AMRs) containing model input to total-system performance assessment (TSPA) for the Yucca Mountain site recommendation (SR). This review was performed in response to Corrective Action Request BSC-01-C-01 (Clark 2001, Krisha 2001) pursuant to Quality Assurance review findings of an adverse trend in model validation deficiency. The review findings in this report provide the following information which defines the extent of model validation deficiency and the corrective action needed: (1) AMRs that contain or support models are identified,more » and conversely, for each model the supporting documentation is identified. (2) The use for each model is determined based on whether the output is used directly for TSPA-SR, or for screening (exclusion) of features, events, and processes (FEPs), and the nature of the model output. (3) Two approaches are used to evaluate the extent to which the validation for each model is compliant with AP-3.10Q (Analyses and Models). The approaches differ in regard to whether model validation is achieved within individual AMRs as originally intended, or whether model validation could be readily achieved by incorporating information from other sources. (4) Recommendations are presented for changes to the AMRs, and additional model development activities or data collection, that will remedy model validation review findings, in support of licensing activities. The Model Validation Status Review emphasized those AMRs that support TSPA-SR (CRWMS M&O 2000bl and 2000bm). A series of workshops and teleconferences was held to discuss and integrate the review findings. The review encompassed 125 AMRs (Table 1) plus certain other supporting documents and data needed to assess model validity. The AMRs were grouped in 21 model areas representing the modeling of processes affecting the natural

Visualizing and Validating Metadata Traceability within the CDISC Standards.

PubMed

Hume, Sam; Sarnikar, Surendra; Becnel, Lauren; Bennett, Dorine

2017-01-01

The Food & Drug Administration has begun requiring that electronic submissions of regulated clinical studies utilize the Clinical Data Information Standards Consortium data standards. Within regulated clinical research, traceability is a requirement and indicates that the analysis results can be traced back to the original source data. Current solutions for clinical research data traceability are limited in terms of querying, validation and visualization capabilities. This paper describes (1) the development of metadata models to support computable traceability and traceability visualizations that are compatible with industry data standards for the regulated clinical research domain, (2) adaptation of graph traversal algorithms to make them capable of identifying traceability gaps and validating traceability across the clinical research data lifecycle, and (3) development of a traceability query capability for retrieval and visualization of traceability information.

Visualizing and Validating Metadata Traceability within the CDISC Standards

PubMed Central

Hume, Sam; Sarnikar, Surendra; Becnel, Lauren; Bennett, Dorine

2017-01-01

The Food & Drug Administration has begun requiring that electronic submissions of regulated clinical studies utilize the Clinical Data Information Standards Consortium data standards. Within regulated clinical research, traceability is a requirement and indicates that the analysis results can be traced back to the original source data. Current solutions for clinical research data traceability are limited in terms of querying, validation and visualization capabilities. This paper describes (1) the development of metadata models to support computable traceability and traceability visualizations that are compatible with industry data standards for the regulated clinical research domain, (2) adaptation of graph traversal algorithms to make them capable of identifying traceability gaps and validating traceability across the clinical research data lifecycle, and (3) development of a traceability query capability for retrieval and visualization of traceability information. PMID:28815125

The validation index: a new metric for validation of segmentation algorithms using two or more expert outlines with application to radiotherapy planning.

PubMed

Juneja, Prabhjot; Evans, Philp M; Harris, Emma J

2013-08-01

Validation is required to ensure automated segmentation algorithms are suitable for radiotherapy target definition. In the absence of true segmentation, algorithmic segmentation is validated against expert outlining of the region of interest. Multiple experts are used to overcome inter-expert variability. Several approaches have been studied in the literature, but the most appropriate approach to combine the information from multiple expert outlines, to give a single metric for validation, is unclear. None consider a metric that can be tailored to case-specific requirements in radiotherapy planning. Validation index (VI), a new validation metric which uses experts' level of agreement was developed. A control parameter was introduced for the validation of segmentations required for different radiotherapy scenarios: for targets close to organs-at-risk and for difficult to discern targets, where large variation between experts is expected. VI was evaluated using two simulated idealized cases and data from two clinical studies. VI was compared with the commonly used Dice similarity coefficient (DSCpair - wise) and found to be more sensitive than the DSCpair - wise to the changes in agreement between experts. VI was shown to be adaptable to specific radiotherapy planning scenarios.

The Chinese Version of the Self-Report Family Inventory: Reliability and Validity.

ERIC Educational Resources Information Center

Shek, Daniel T. L.; Lai, Kelly Y. C.

2001-01-01

Reliability and validity of Chinese Self-Report Family Inventory (C-SFI) were examined in three studies. Study 1 showed C-SFI was temporally stable and internally consistent. Study 2 indicated C-SFI could discriminate between clinical and nonclinical groups. Study 3 gave support for internal consistency, concurrent validity and construct validity.…

Clinical assessment of dysphagia in neurodegeneration (CADN): development, validity and reliability of a bedside tool for dysphagia assessment.

PubMed

Vogel, Adam P; Rommel, Natalie; Sauer, Carina; Horger, Marius; Krumm, Patrick; Himmelbach, Marc; Synofzik, Matthis

2017-06-01

Screening assessments for dysphagia are essential in neurodegenerative disease. Yet there are no purpose-built tools to quantify swallowing deficits at bedside or in clinical trials. A quantifiable, brief, easy to administer assessment that measures the impact of dysphagia and predicts the presence or absence of aspiration is needed. The Clinical Assessment of Dysphagia in Neurodegeneration (CADN) was designed by a multidisciplinary team (neurology, neuropsychology, speech pathology) validated against strict methodological criteria in two neurodegenerative diseases, Parkinson's disease (PD) and degenerative ataxia (DA). CADN comprises two parts, an anamnesis (part one) and consumption (part two). Two-thirds of patients were assessed using reference tests, the SWAL-QOL symptoms subscale (part one) and videofluoroscopic assessment of swallowing (part two). CADN has 11 items and can be administered and scored in an average of 7 min. Test-retest reliability was established using correlation and Bland-Altman plots. 125 patients with a neurodegenerative disease were recruited; 60 PD and 65 DA. Validity was established using ROC graphs and correlations. CADN has sensitivity of 79 and 84% and specificity 71 and 69% for parts one and two, respectively. Significant correlations with disease severity were also observed (p < 0.001) for PD with small to large associations between disease severity and CADN scores for DA. Cutoff scores were identified that signal the presence of clinically meaningful dysphagia symptomatology and risk of aspiration. The CADN is a reliable, valid, brief, quantifiable, and easily deployed assessment of swallowing in neurodegenerative disease. It is thus ideally suited for both clinical bedside assessment and future multicentre clinical trials in neurodegenerative disease.

Applicability Analysis of Validation Evidence for Biomedical Computational Models

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

Pathmanathan, Pras; Gray, Richard A.; Romero, Vicente J.

Computational modeling has the potential to revolutionize medicine the way it transformed engineering. However, despite decades of work, there has only been limited progress to successfully translate modeling research to patient care. One major difficulty which often occurs with biomedical computational models is an inability to perform validation in a setting that closely resembles how the model will be used. For example, for a biomedical model that makes in vivo clinically relevant predictions, direct validation of predictions may be impossible for ethical, technological, or financial reasons. Unavoidable limitations inherent to the validation process lead to challenges in evaluating the credibilitymore » of biomedical model predictions. Therefore, when evaluating biomedical models, it is critical to rigorously assess applicability, that is, the relevance of the computational model, and its validation evidence to the proposed context of use (COU). However, there are no well-established methods for assessing applicability. In this paper, we present a novel framework for performing applicability analysis and demonstrate its use with a medical device computational model. The framework provides a systematic, step-by-step method for breaking down the broad question of applicability into a series of focused questions, which may be addressed using supporting evidence and subject matter expertise. The framework can be used for model justification, model assessment, and validation planning. While motivated by biomedical models, it is relevant to a broad range of disciplines and underlying physics. Finally, the proposed applicability framework could help overcome some of the barriers inherent to validation of, and aid clinical implementation of, biomedical models.« less

Applicability Analysis of Validation Evidence for Biomedical Computational Models

DOE PAGES

Pathmanathan, Pras; Gray, Richard A.; Romero, Vicente J.; ...

2017-09-07

Computational modeling has the potential to revolutionize medicine the way it transformed engineering. However, despite decades of work, there has only been limited progress to successfully translate modeling research to patient care. One major difficulty which often occurs with biomedical computational models is an inability to perform validation in a setting that closely resembles how the model will be used. For example, for a biomedical model that makes in vivo clinically relevant predictions, direct validation of predictions may be impossible for ethical, technological, or financial reasons. Unavoidable limitations inherent to the validation process lead to challenges in evaluating the credibilitymore » of biomedical model predictions. Therefore, when evaluating biomedical models, it is critical to rigorously assess applicability, that is, the relevance of the computational model, and its validation evidence to the proposed context of use (COU). However, there are no well-established methods for assessing applicability. In this paper, we present a novel framework for performing applicability analysis and demonstrate its use with a medical device computational model. The framework provides a systematic, step-by-step method for breaking down the broad question of applicability into a series of focused questions, which may be addressed using supporting evidence and subject matter expertise. The framework can be used for model justification, model assessment, and validation planning. While motivated by biomedical models, it is relevant to a broad range of disciplines and underlying physics. Finally, the proposed applicability framework could help overcome some of the barriers inherent to validation of, and aid clinical implementation of, biomedical models.« less

Biomarkers for Early Detection of Clinically Relevant Prostate Cancer. A Multi-Institutional Validation Trial

DTIC Science & Technology

2016-10-01

Study (PASS). We are in the process of evaluating these three biomarker panels in tissue, blood, and urine samples with well annotated clinical and...choice of therapy and decision-making during AS. The objective of the study is to utilize analytically validated assays that take into account tumor...Gleason 6 cancer to Gleason 7 or greater. The analysis plan was determined before specimens were selected for the study , and included 7 breaking

Biomarkers for Early Detection of Clinically Relevant Prostate Cancer: A Multi-Institutional Validation Trial

DTIC Science & Technology

2017-10-01

mRNA and has been shown in many studies to improve predictive accuracy for cancer on initial biopsy,3,7-9 and to be correlated with more aggressive... Study (PASS). We are in the process of evaluating these three biomarker panels in tissue, blood, and urine samples with well annotated clinical and...during AS. The objective of the study is to utilize analytically validated assays that take into account tumor heterogeneity to measure biomarkers in

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

PubMed

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

2014-06-14

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

Validation of a [Al18F]PSMA-11 preparation for clinical applications.

PubMed

Al-Momani, Ehab; Israel, Ina; Samnick, Samuel

2017-12-01

Imaging prostate-specific membrane antigen (PSMA) using positron emission tomography (PET) has been presented so far as the most sensitive and specific with regard to prostate cancer detection, in particular in high-risk prostate cancer patients. Currently, it mainly features Gallium-68 ( 68 Ga) labeled PSMA ligands, notably [ 68 Ga]Glu-urea-Lys(Ahx)-HBED-CC ([ 68 Ga]-PSMA-11) and [ 68 Ga]DOTAGA-FFK (Sub-KuE termed ([ 68 Ga]PSMA-I&T). However, 68 Ga has several shortcomings as radionuclide including a short half-life and non-ideal energies. This has motivated consideration of 18 F-labeled analogues for PET imaging of prostate cancer. Here, we describe a simple synthesis and validation of a fluorine-18 labeled Glu-urea-Lys(Ahx)-HBED-CC ([Al 18 F]PSMA-11) for nuclear medicine applications. An efficient method for preparation of [Al 18 F]PSMA-11 was developed and validated (according to Pharm Eur) for routinely clinical applications. [Al 18 F]PSMA-11 was reproducibly obtained in radiochemical yields of 84 ± 6% (n = 15) and > 98% radiochemical purity using an improved one-step radiofluorination in aqueous solution. The total (production/preparation) time, including purification, pharmacological formulation of the isolated product and the quality control of the injectable solution was less than 60min. The [Al 18 F]PSMA-11 was stable over 4h in 1% EtOH/saline selected as injection solution. The solution was sterile, non-pyrogenic and ready for clinical applications after sterile filtration through a 0.22µm membrane filter under sterile conditions. In addition, [Al 18 F]PSMA-11 exhibited higher uptake and retention in PMSA-expressing LNCap prostate cells as compared to its clinically established 68 Ga-labeled analogues [ 68 Ga]PSMA-11 and [ 68 Ga]PSMA-I&T as well as to [ 68 Ga]NOTA-Bn-PSMA. The simple and fast preparation of [Al 18 F]PSMA-11 combined with its favorable pharmacological properties warrant its translation to a clinical setting. The facile and high

Validation and cross-cultural pilot testing of compliance with standard precautions scale: self-administered instrument for clinical nurses.

PubMed

Lam, Simon C

2014-05-01

To perform detailed psychometric testing of the compliance with standard precautions scale (CSPS) in measuring compliance with standard precautions of clinical nurses and to conduct cross-cultural pilot testing and assess the relevance of the CSPS on an international platform. A cross-sectional and correlational design with repeated measures. Nursing students from a local registered nurse training university, nurses from different hospitals in Hong Kong, and experts in an international conference. The psychometric properties of the CSPS were evaluated via internal consistency, 2-week and 3-month test-retest reliability, concurrent validation, and construct validation. The cross-cultural pilot testing and relevance check was examined by experts on infection control from various developed and developing regions. Among 453 participants, 193 were nursing students, 165 were enrolled nurses, and 95 were registered nurses. The results showed that the CSPS had satisfactory reliability (Cronbach α = 0.73; intraclass correlation coefficient, 0.79 for 2-week test-retest and 0.74 for 3-month test-retest) and validity (optimum correlation with criterion measure; r = 0.76, P < .001; satisfactory results on known-group method and hypothesis testing). A total of 19 experts from 16 countries assured that most of the CSPS findings were relevant and globally applicable. The CSPS demonstrated satisfactory results on the basis of the standard international criteria on psychometric testing, which ascertained the reliability and validity of this instrument in measuring the compliance of clinical nurses with standard precautions. The cross-cultural pilot testing further reinforced the instrument's relevance and applicability in most developed and developing regions.

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.

Validity evidence for Surgical Improvement of Clinical Knowledge Ops: a novel gaming platform to assess surgical decision making.

PubMed

Lin, Dana T; Park, Julia; Liebert, Cara A; Lau, James N

2015-01-01

Current surgical education curricula focus mainly on the acquisition of technical skill rather than clinical and operative judgment. SICKO (Surgical Improvement of Clinical Knowledge Ops) is a novel gaming platform developed to address this critical need. A pilot study was performed to collect validity evidence for SICKO as an assessment for surgical decision making. Forty-nine subjects stratified into 4 levels of expertise were recruited to play SICKO. Later, players were surveyed regarding the realism of the gaming platform as well as the clinical competencies required of them while playing SICKO. Each group of increasing expertise outperformed the less experienced groups. Mean total game scores for the novice, junior resident, senior resident, and expert groups were 5,461, 8,519, 11,404, and 13,913, respectively (P = .001). Survey results revealed high scores for realism and content. SICKO holds the potential to be not only an engaging and immersive educational tool, but also a valid assessment in the armamentarium of surgical educators. Published by Elsevier Inc.

Validation of sterilizing grade filtration.

PubMed

Jornitz, M W; Meltzer, T H

2003-01-01

Validation consideration of sterilizing grade filters, namely 0.2 micron, changed when FDA voiced concerns about the validity of Bacterial Challenge tests performed in the past. Such validation exercises are nowadays considered to be filter qualification. Filter validation requires more thorough analysis, especially Bacterial Challenge testing with the actual drug product under process conditions. To do so, viability testing is a necessity to determine the Bacterial Challenge test methodology. Additionally to these two compulsory tests, other evaluations like extractable, adsorption and chemical compatibility tests should be considered. PDA Technical Report # 26, Sterilizing Filtration of Liquids, describes all parameters and aspects required for the comprehensive validation of filters. The report is a most helpful tool for validation of liquid filters used in the biopharmaceutical industry. It sets the cornerstones of validation requirements and other filtration considerations.

Development and validation of clinical prediction models for mortality, functional outcome and cognitive impairment after stroke: a study protocol

PubMed Central

Fahey, Marion; Rudd, Anthony; Béjot, Yannick; Wolfe, Charles; Douiri, Abdel

2017-01-01

Introduction Stroke is a leading cause of adult disability and death worldwide. The neurological impairments associated with stroke prevent patients from performing basic daily activities and have enormous impact on families and caregivers. Practical and accurate tools to assist in predicting outcome after stroke at patient level can provide significant aid for patient management. Furthermore, prediction models of this kind can be useful for clinical research, health economics, policymaking and clinical decision support. Methods 2869 patients with first-ever stroke from South London Stroke Register (SLSR) (1995–2004) will be included in the development cohort. We will use information captured after baseline to construct multilevel models and a Cox proportional hazard model to predict cognitive impairment, functional outcome and mortality up to 5 years after stroke. Repeated random subsampling validation (Monte Carlo cross-validation) will be evaluated in model development. Data from participants recruited to the stroke register (2005–2014) will be used for temporal validation of the models. Data from participants recruited to the Dijon Stroke Register (1985–2015) will be used for external validation. Discrimination, calibration and clinical utility of the models will be presented. Ethics Patients, or for patients who cannot consent their relatives, gave written informed consent to participate in stroke-related studies within the SLSR. The SLSR design was approved by the ethics committees of Guy’s and St Thomas’ NHS Foundation Trust, Kings College Hospital, Queens Square and Westminster Hospitals (London). The Dijon Stroke Registry was approved by the Comité National des Registres and the InVS and has authorisation of the Commission Nationale de l’Informatique et des Libertés. PMID:28821511

Evaluating the validity of clinical codes to identify cataract and glaucoma in the UK Clinical Practice Research Datalink.

PubMed

Kang, Elizabeth M; Pinheiro, Simone P; Hammad, Tarek A; Abou-Ali, Adel

2015-01-01

The aim of this study is to determine (i) the positive predictive value (PPV) of an algorithm using clinical codes to identify incident glaucoma and cataract events in the Clinical Practice Research Datalink (CPRD) and (ii) the ability to capture the correct timing of these clinical events. A total of 21,339 and 5349 potential cataract and glaucoma cases, respectively, were identified in CPRD between 1 January 1990 and 31 December 2010. Questionnaires were sent to the general practitioners (GP) of 1169 (5.5%) cataract and 1163 (21.7%) glaucoma cases for validation. GPs were asked to verify the diagnosis and the timing of the diagnosis and to provide other supporting information. A total of 986 (84.3%) valid cataract questionnaires and 863 (74.2%) glaucoma questionnaires were completed. 92.1% and 92.4% of these used information beyond EMR to verify the diagnosis. Cataract and glaucoma diagnoses were confirmed in the large majority of the cases. The PPV (95% CI) of the cataract and glaucoma Read code algorithm were 92.0% (90.3-93.7%) and 84.1% (81.7-86.6%), respectively. However, timing of diagnosis was incorrect for a substantial proportion of the cases (20.3% and 32.8% of the cataract and glaucoma cases, respectively) among whom 30.4% and 49.2% had discrepancies in diagnosis timing greater than 1 year. High PPV suggests that the algorithms based on the clinical Read codes are sufficient to identify the cataract and glaucoma cases in CPRD. However, these codes alone may not be able to accurately identify the timing of the diagnosis of these eye disorders. Ltd. Copyright © 2014 John Wiley & Sons, Ltd.

Assessment of postprandial triglycerides in clinical practice: validation in a general population and coronary heart disease patients

USDA-ARS?s Scientific Manuscript database

BACKGROUND: Previous studies have suggested that for clinical purposes, subjects with fasting triglycerides (TGs) between 89-180 mg/dl (1-2 mmol/l) would benefit from postprandial TGs testing. OBJECTIVE: To determine the postprandial TG response in 2 independent studies and validate who should benef...

Expanding the Nomological Net of the Pathological Narcissism Inventory: German Validation and Extension in a Clinical Inpatient Sample.

PubMed

Morf, Carolyn C; Schürch, Eva; Küfner, Albrecht; Siegrist, Philip; Vater, Aline; Back, Mitja; Mestel, Robert; Schröder-Abé, Michela

2017-06-01

The Pathological Narcissism Inventory (PNI) is a multidimensional measure for assessing grandiose and vulnerable features in narcissistic pathology. The aim of the present research was to construct and validate a German translation of the PNI and to provide further information on the PNI's nomological net. Findings from a first study confirm the psychometric soundness of the PNI and replicate its seven-factor first-order structure. A second-order structure was also supported but with several equivalent models. A second study investigating associations with a broad range of measures ( DSM Axis I and II constructs, emotions, personality traits, interpersonal and dysfunctional behaviors, and well-being) supported the concurrent validity of the PNI. Discriminant validity with the Narcissistic Personality Inventory was also shown. Finally, in a third study an extension in a clinical inpatient sample provided further evidence that the PNI is a useful tool to assess the more pathological end of narcissism.

Clinical trials validate the severity of persistent Lyme disease symptoms.

PubMed

Cameron, Daniel J

2009-02-01

Persistent Lyme Disease Symptoms (PLDS) have included fatigue, headaches, poor concentration and memory, lightheadedness, joint pain, and mood disturbances. Evidence-based guidelines committees disagree over the severity of PLDS. The 2004 International Lyme and Associated Diseases Society (ILADS) concluded that PLDS are severe. The 2006 Infectious Disease Society of America (IDSA) guidelines committee concluded that PLDS are nothing more than the "aches and pains of daily living" and an ad hoc International Lyme group concluded that PLDS are "symptoms common in persons who have never had Lyme disease." Clinical trials validate the severity of persistent Lyme disease symptoms. There are 22 standardized instruments used to measure the severity of PLDS among the four published National Institutes of Health (NIH) sponsored double-blind randomized placebo-controlled trials (RCTs). VALIDATING THE HYPOTHESIS: All four NIH sponsored RCTs validate the severity of PLDS. PLDS are as severe as symptoms seen in other serious chronic illnesses, and result in a quality of life lower than for the general population as determined by 22 standardized measures of QOL, including fatigue, pain, role function, psychopathology, and cognition. None of the four RCTs support the IDSA hypothesis that PLDS are nothing more than "the aches and pains of daily living" nor the ad hoc International Lyme group conclusion that PLDS are "symptoms common in persons who have never had Lyme disease." If the QOL of life for these patients is as poor as for patients with other serious chronic diseases, their symptoms need to be addressed by their doctors. Studies differ as to the precise cause of PLDS, the most effective treatments, and whether a cure is possible. But the fact that there is disagreement is not a license for physicians to ignore or turn away patients complaining of PLDS, or to dismiss their symptoms as purely psychosomatic. For physicians, the goal or purpose of treating PLDS should be the

Cross-cultural Adaption and Validation of the Danish Voice Handicap Index.

PubMed

Sorensen, Jesper Roed; Printz, Trine; Mehlum, Camilla Slot; Heidemann, Christian Hamilton; Groentved, Aagot Moeller; Godballe, Christian

2018-02-02

We aimed to assess psychometric properties, including internal consistency, reliability, and clinical validity of the Danish version of the Voice Handicap Index (VHI). A cross-sectional survey study was carried out. For validation, the existing nonvalidated Danish version of the VHI was used. Data from 208 patients with voice disorders of different etiology (neurogenic, functional, and structural) and a control group of 85 vocally healthy individuals were included. A test-retest reliability analysis of 42 patients and 45 control persons was performed. The internal consistency, test-retest reliability, and clinical validity of the questionnaire were assessed. Internal consistency was high with a Cronbach α >0.90 for both the patient and control group. Test-retest reliability measured as intraclass correlation coefficient was good with 0.93 (95% confidence interval [95% confidence interval]: 0.87-0.96) for patients and 0.78 (95% confidence interval: 0.63-0.87) for the control group which indicates sufficient reliability of the questionnaire. The Danish VHI has good clinical validity as it has a strong correlation between patient's perception of the severity of their voice disorder and the VHI score from the Spearman correlation of 0.69. The existing Danish version of the VHI has been thoroughly validated and found to be in line with the original VHI from Jacobsen et al. It showed good internal consistency, test-retest reliability, and clinical validity. It is suitable for use in daily practice and in research projects as it is able to assess patients' perception of their voice disorder severity. Copyright © 2018 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Clinical validation of robot simulation of toothbrushing - comparative plaque removal efficacy

PubMed Central

2014-01-01

Background Clinical validation of laboratory toothbrushing tests has important advantages. It was, therefore, the aim to demonstrate correlation of tooth cleaning efficiency of a new robot brushing simulation technique with clinical plaque removal. Methods Clinical programme: 27 subjects received dental cleaning prior to 3-day-plaque-regrowth-interval. Plaque was stained, photographically documented and scored using planimetrical index. Subjects brushed teeth 33–47 with three techniques (horizontal, rotating, vertical), each for 20s buccally and for 20s orally in 3 consecutive intervals. The force was calibrated, the brushing technique was video supported. Two different brushes were randomly assigned to the subject. Robot programme: Clinical brushing programmes were transfered to a 6-axis-robot. Artificial teeth 33–47 were covered with plaque-simulating substrate. All brushing techniques were repeated 7 times, results were scored according to clinical planimetry. All data underwent statistical analysis by t-test, U-test and multivariate analysis. Results The individual clinical cleaning patterns are well reproduced by the robot programmes. Differences in plaque removal are statistically significant for the two brushes, reproduced in clinical and robot data. Multivariate analysis confirms the higher cleaning efficiency for anterior teeth and for the buccal sites. Conclusions The robot tooth brushing simulation programme showed good correlation with clinically standardized tooth brushing. This new robot brushing simulation programme can be used for rapid, reproducible laboratory testing of tooth cleaning. PMID:24996973

Reliable Digit Span: A Systematic Review and Cross-Validation Study

ERIC Educational Resources Information Center

Schroeder, Ryan W.; Twumasi-Ankrah, Philip; Baade, Lyle E.; Marshall, Paul S.

2012-01-01

Reliable Digit Span (RDS) is a heavily researched symptom validity test with a recent literature review yielding more than 20 studies ranging in dates from 1994 to 2011. Unfortunately, limitations within some of the research minimize clinical generalizability. This systematic review and cross-validation study was conducted to address these…

The Adequacy of the Q Methodology for Clinical Validation of Nursing Diagnoses Related to Subjective Foci.

PubMed

Miguel, Susana; Caldeira, Sílvia; Vieira, Margarida

2018-04-01

This article describes the adequacy of the Q methodology as a new option for the validation of nursing diagnoses related to subjective foci. Discussion paper about the characteristics of the Q methodology. This method has been used in nursing research particularly related to subjective concepts and includes both a quantitative and qualitative dimension. The Q methodology seems to be an adequate and innovative method for the clinical validation of nursing diagnoses. The validation of nursing diagnoses related to subjective foci using the Q methodology could improve the level of evidence and provide nurses with clinical indicators for clinical reasoning and for the planning of effective interventions. Descrever a adequação da metodologia Q como uma nova opção para a validação clínica de diagnósticos de enfermagem relacionados com focos subjetivos. MÉTODOS: Artigo de discussão sobre as características da metodologia Q. Este método tem sido utilizado na pesquisa em enfermagem relacionada com conceitos subjetivos e inclui em simultâneo uma vertente qualitativa e quantitativa. CONCLUSÕES: A metodologia Q parece ser uma opção metodológica adequada para a validação clínica de diagnósticos de enfermagem. IMPLICAÇÕES PARA A PRÁTICA: A utilização da metodologia Q na validação clínica de diagnósticos de enfermagem relacionados com focos subjetivos pode melhorar o nível e evidência e facilitar o raciocínio clínico dos enfermeiros, ao providenciar indicadores clínicos também necessários ao desenvolvimento de intervenções efetivas. © 2016 NANDA International, Inc.

Validation and Implementation of Clinical Laboratory Improvements Act-Compliant Whole-Genome Sequencing in the Public Health Microbiology Laboratory

PubMed Central

Kozyreva, Varvara K.; Truong, Chau-Linda; Greninger, Alexander L.; Crandall, John; Mukhopadhyay, Rituparna

2017-01-01

ABSTRACT Public health microbiology laboratories (PHLs) are on the cusp of unprecedented improvements in pathogen identification, antibiotic resistance detection, and outbreak investigation by using whole-genome sequencing (WGS). However, considerable challenges remain due to the lack of common standards. Here, we describe the validation of WGS on the Illumina platform for routine use in PHLs according to Clinical Laboratory Improvements Act (CLIA) guidelines for laboratory-developed tests (LDTs). We developed a validation panel comprising 10 Enterobacteriaceae isolates, 5 Gram-positive cocci, 5 Gram-negative nonfermenting species, 9 Mycobacterium tuberculosis isolates, and 5 miscellaneous bacteria. The genome coverage range was 15.71× to 216.4× (average, 79.72×; median, 71.55×); the limit of detection (LOD) for single nucleotide polymorphisms (SNPs) was 60×. The accuracy, reproducibility, and repeatability of base calling were >99.9%. The accuracy of phylogenetic analysis was 100%. The specificity and sensitivity inferred from multilocus sequence typing (MLST) and genome-wide SNP-based phylogenetic assays were 100%. The following objectives were accomplished: (i) the establishment of the performance specifications for WGS applications in PHLs according to CLIA guidelines, (ii) the development of quality assurance and quality control measures, (iii) the development of a reporting format for end users with or without WGS expertise, (iv) the availability of a validation set of microorganisms, and (v) the creation of a modular template for the validation of WGS processes in PHLs. The validation panel, sequencing analytics, and raw sequences could facilitate multilaboratory comparisons of WGS data. Additionally, the WGS performance specifications and modular template are adaptable for the validation of other platforms and reagent kits. PMID:28592550

Validation and Implementation of Clinical Laboratory Improvements Act-Compliant Whole-Genome Sequencing in the Public Health Microbiology Laboratory.

PubMed

Kozyreva, Varvara K; Truong, Chau-Linda; Greninger, Alexander L; Crandall, John; Mukhopadhyay, Rituparna; Chaturvedi, Vishnu

2017-08-01

Public health microbiology laboratories (PHLs) are on the cusp of unprecedented improvements in pathogen identification, antibiotic resistance detection, and outbreak investigation by using whole-genome sequencing (WGS). However, considerable challenges remain due to the lack of common standards. Here, we describe the validation of WGS on the Illumina platform for routine use in PHLs according to Clinical Laboratory Improvements Act (CLIA) guidelines for laboratory-developed tests (LDTs). We developed a validation panel comprising 10 Enterobacteriaceae isolates, 5 Gram-positive cocci, 5 Gram-negative nonfermenting species, 9 Mycobacterium tuberculosis isolates, and 5 miscellaneous bacteria. The genome coverage range was 15.71× to 216.4× (average, 79.72×; median, 71.55×); the limit of detection (LOD) for single nucleotide polymorphisms (SNPs) was 60×. The accuracy, reproducibility, and repeatability of base calling were >99.9%. The accuracy of phylogenetic analysis was 100%. The specificity and sensitivity inferred from multilocus sequence typing (MLST) and genome-wide SNP-based phylogenetic assays were 100%. The following objectives were accomplished: (i) the establishment of the performance specifications for WGS applications in PHLs according to CLIA guidelines, (ii) the development of quality assurance and quality control measures, (iii) the development of a reporting format for end users with or without WGS expertise, (iv) the availability of a validation set of microorganisms, and (v) the creation of a modular template for the validation of WGS processes in PHLs. The validation panel, sequencing analytics, and raw sequences could facilitate multilaboratory comparisons of WGS data. Additionally, the WGS performance specifications and modular template are adaptable for the validation of other platforms and reagent kits. Copyright © 2017 Kozyreva et al.

Methodology for Computational Fluid Dynamic Validation for Medical Use: Application to Intracranial Aneurysm.

PubMed

Paliwal, Nikhil; Damiano, Robert J; Varble, Nicole A; Tutino, Vincent M; Dou, Zhongwang; Siddiqui, Adnan H; Meng, Hui

2017-12-01

Computational fluid dynamics (CFD) is a promising tool to aid in clinical diagnoses of cardiovascular diseases. However, it uses assumptions that simplify the complexities of the real cardiovascular flow. Due to high-stakes in the clinical setting, it is critical to calculate the effect of these assumptions in the CFD simulation results. However, existing CFD validation approaches do not quantify error in the simulation results due to the CFD solver's modeling assumptions. Instead, they directly compare CFD simulation results against validation data. Thus, to quantify the accuracy of a CFD solver, we developed a validation methodology that calculates the CFD model error (arising from modeling assumptions). Our methodology identifies independent error sources in CFD and validation experiments, and calculates the model error by parsing out other sources of error inherent in simulation and experiments. To demonstrate the method, we simulated the flow field of a patient-specific intracranial aneurysm (IA) in the commercial CFD software star-ccm+. Particle image velocimetry (PIV) provided validation datasets for the flow field on two orthogonal planes. The average model error in the star-ccm+ solver was 5.63 ± 5.49% along the intersecting validation line of the orthogonal planes. Furthermore, we demonstrated that our validation method is superior to existing validation approaches by applying three representative existing validation techniques to our CFD and experimental dataset, and comparing the validation results. Our validation methodology offers a streamlined workflow to extract the "true" accuracy of a CFD solver.

Clinical assessment of the physical activity pattern of chronic fatigue syndrome patients: a validation of three methods.

PubMed

Scheeres, Korine; Knoop, Hans; Meer, van der Jos; Bleijenberg, Gijs

2009-04-01

Effective treatment of chronic fatigue syndrome (CFS) with cognitive behavioural therapy (CBT) relies on a correct classification of so called 'fluctuating active' versus 'passive' patients. For successful treatment with CBT is it especially important to recognise the passive patients and give them a tailored treatment protocol. In the present study it was evaluated whether CFS patient's physical activity pattern can be assessed most accurately with the 'Activity Pattern Interview' (API), the International Physical Activity Questionnaire (IPAQ) or the CFS-Activity Questionnaire (CFS-AQ). The three instruments were validated compared to actometers. Actometers are until now the best and most objective instrument to measure physical activity, but they are too expensive and time consuming for most clinical practice settings. In total 226 CFS patients enrolled for CBT therapy answered the API at intake and filled in the two questionnaires. Directly after intake they wore the actometer for two weeks. Based on receiver operating characteristic (ROC) curves the validity of the three methods were assessed and compared. Both the API and the two questionnaires had an acceptable validity (0.64 to 0.71). None of the three instruments was significantly better than the others. The proportion of false predictions was rather high for all three instrument. The IPAQ had the highest proportion of correct passive predictions (sensitivity 70.1%). The validity of all three instruments appeared to be fair, and all showed rather high proportions of false classifications. Hence in fact none of the tested instruments could really be called satisfactory. Because the IPAQ showed to be the best in correctly predicting 'passive' CFS patients, which is most essentially related to treatment results, it was concluded that the IPAQ is the preferable alternative for an actometer when treating CFS patients in clinical practice.

Derivation and Internal Validation of a Clinical Prediction Tool for 30-Day Mortality in Lower Gastrointestinal Bleeding.

PubMed

Sengupta, Neil; Tapper, Elliot B

2017-05-01

There are limited data to predict which patients with lower gastrointestinal bleeding are at risk for adverse outcomes. We aimed to develop a clinical tool based on admission variables to predict 30-day mortality in lower gastrointestinal bleeding. We used a validated machine learning algorithm to identify adult patients hospitalized with lower gastrointestinal bleeding at an academic medical center between 2008 and 2015. The cohort was split randomly into derivation and validation cohorts. In the derivation cohort, we used multiple logistic regression on all candidate admission variables to create a prediction model for 30-day mortality, using area under the receiving operator characteristic curve and misclassification rate to estimate prediction accuracy. Regression coefficients were used to derive an integer score, and mortality risk associated with point totals was assessed. In the derivation cohort (n = 4044), 8 variables were most associated with 30-day mortality: age, dementia, metastatic cancer, chronic kidney disease, chronic pulmonary disease, anticoagulant use, admission hematocrit, and albumin. The model yielded a misclassification rate of 0.06 and area under the curve of 0.81. The integer score ranged from -10 to 26 in the derivation cohort, with a misclassification rate of 0.11 and area under the curve of 0.74. In the validation cohort (n = 2060), the score had an area under the curve of 0.72 with a misclassification rate of 0.12. After dividing the score into 4 quartiles of risk, 30-day mortality in the derivation and validation sets was 3.6% and 4.4% in quartile 1, 4.9% and 7.3% in quartile 2, 9.9% and 9.1% in quartile 3, and 24% and 26% in quartile 4, respectively. A clinical tool can be used to predict 30-day mortality in patients hospitalized with lower gastrointestinal bleeding. Copyright © 2017 Elsevier Inc. All rights reserved.

Multi-analyte validation in heterogeneous solution by ELISA.

PubMed

Lakshmipriya, Thangavel; Gopinath, Subash C B; Hashim, Uda; Murugaiyah, Vikneswaran

2017-12-01

Enzyme Linked Immunosorbent Assay (ELISA) is a standard assay that has been used widely to validate the presence of analyte in the solution. With the advancement of ELISA, different strategies have shown and became a suitable immunoassay for a wide range of analytes. Herein, we attempted to provide additional evidence with ELISA, to show its suitability for multi-analyte detection. To demonstrate, three clinically relevant targets have been chosen, which include 16kDa protein from Mycobacterium tuberculosis, human blood clotting Factor IXa and a tumour marker Squamous Cell Carcinoma antigen. Indeed, we adapted the routine steps from the conventional ELISA to validate the occurrence of analytes both in homogeneous and heterogeneous solutions. With the homogeneous and heterogeneous solutions, we could attain the sensitivity of 2, 8 and 1nM for the targets 16kDa protein, FIXa and SSC antigen, respectively. Further, the specific multi-analyte validations were evidenced with the similar sensitivities in the presence of human serum. ELISA assay in this study has proven its applicability for the genuine multiple target validation in the heterogeneous solution, can be followed for other target validations. Copyright © 2017 Elsevier B.V. All rights reserved.

Convergent, discriminant, and criterion validity of DSM-5 traits.

PubMed

Yalch, Matthew M; Hopwood, Christopher J

2016-10-01

Section III of the Diagnostic and Statistical Manual of Mental Disorders (5th edi.; DSM-5; American Psychiatric Association, 2013) contains a system for diagnosing personality disorder based in part on assessing 25 maladaptive traits. Initial research suggests that this aspect of the system improves the validity and clinical utility of the Section II Model. The Computer Adaptive Test of Personality Disorder (CAT-PD; Simms et al., 2011) contains many similar traits as the DSM-5, as well as several additional traits seemingly not covered in the DSM-5. In this study we evaluate the convergent and discriminant validity between the DSM-5 traits, as assessed by the Personality Inventory for DSM-5 (PID-5; Krueger et al., 2012), and CAT-PD in an undergraduate sample, and test whether traits included in the CAT-PD but not the DSM-5 provide incremental validity in association with clinically relevant criterion variables. Results supported the convergent and discriminant validity of the PID-5 and CAT-PD scales in their assessment of 23 out of 25 DSM-5 traits. DSM-5 traits were consistently associated with 11 criterion variables, despite our having intentionally selected clinically relevant criterion constructs not directly assessed by DSM-5 traits. However, the additional CAT-PD traits provided incremental information above and beyond the DSM-5 traits for all criterion variables examined. These findings support the validity of pathological trait models in general and the DSM-5 and CAT-PD models in particular, while also suggesting that the CAT-PD may include additional traits for consideration in future iterations of the DSM-5 system. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Cultural adaptation, standardization and clinical validity of the test your memory dementia screening instrument in Greek.

PubMed

Iatraki, Eliza; Simos, Panagiotis G; Lionis, Christos; Zaganas, Ioannis; Symvoulakis, Emmanouil K; Papastefanakis, Emmanouil; Panagiotakis, Simeon; Pantelidakis, Heraklis; Papadopoulos, Konstantinos; Tziraki, Chariklia

2014-01-01

To adapt and standardize the Test Your Memory (TYM) dementia screening instrument in Greek. Normative data on the Greek version of the TYM were obtained from a community sample of 239 adults aged 21-92 years. Clinical validity was assessed in a cohort of 134 Neurology Clinic patients. Concurrent validity was examined through comparisons with the Mini-Mental State Examination (MMSE) and the Greek Everyday Function Scale. Correlations between the TYM and the MMSE were 0.73 and 0.82 in the community and patient samples, respectively. Scores on both tests were moderately associated with everyday functional capacity. Using age- and education-corrected cutoff scores ranging from 26/50 to 45/50 points, the sensitivity of the TYM for Alzheimer's disease detection was found to be higher than that of the MMSE (0.82 vs. 0.70), although its specificity was lower (0.71 vs. 0.90). Findings are consistent with previous reports in a variety of cultural settings supporting the potential utility of the TYM as a dementia screening tool.

Development and validation of the JAX Cancer Treatment Profile™ for detection of clinically actionable mutations in solid tumors

PubMed Central

Ananda, Guruprasad; Mockus, Susan; Lundquist, Micaela; Spotlow, Vanessa; Simons, Al; Mitchell, Talia; Stafford, Grace; Philip, Vivek; Stearns, Timothy; Srivastava, Anuj; Barter, Mary; Rowe, Lucy; Malcolm, Joan; Bult, Carol; Karuturi, Radha Krishna Murthy; Rasmussen, Karen; Hinerfeld, Douglas

2015-01-01

Background The continued development of targeted therapeutics for cancer treatment has required the concomitant development of more expansive methods for the molecular profiling of the patient’s tumor. We describe the validation of the JAX Cancer Treatment Profile™ (JAX-CTP™), a next generation sequencing (NGS)-based molecular diagnostic assay that detects actionable mutations in solid tumors to inform the selection of targeted therapeutics for cancer treatment. Methods NGS libraries are generated from DNA extracted from formalin fixed paraffin embedded tumors. Using hybrid capture, the genes of interest are enriched and sequenced on the Illumina HiSeq 2500 or MiSeq sequencers followed by variant detection and functional and clinical annotation for the generation of a clinical report. Results The JAX-CTP™ detects actionable variants, in the form of single nucleotide variations and small insertions and deletions (≤50bp) in 190 genes in specimens with a neoplastic cell content of ≥10%. The JAX-CTP™ is also validated for the detection of clinically actionable gene amplifications. Conclusions There is a lack of consensus in the molecular diagnostics field on the best method for the validation of NGS-based assays in oncology, thus the importance of communicating methods, as contained in this report. The growing number of targeted therapeutics and the complexity of the tumor genome necessitates continued development and refinement of advanced assays for tumor profiling to enable precision cancer treatment. PMID:25562415

Validity, responsiveness, minimal detectable change, and minimal clinically important change of the Pediatric Motor Activity Log in children with cerebral palsy.

PubMed

Lin, Keh-chung; Chen, Hui-fang; Chen, Chia-ling; Wang, Tien-ni; Wu, Ching-yi; Hsieh, Yu-wei; Wu, Li-ling

2012-01-01

This study examined criterion-related validity and clinimetric properties of the Pediatric Motor Activity Log (PMAL) in children with cerebral palsy. Study participants were 41 children (age range: 28-113 months) and their parents. Criterion-related validity was evaluated by the associations between the PMAL and criterion measures at baseline and posttreatment, including the self-care, mobility, and cognition subscale, the total performance of the Functional Independence Measure in children (WeeFIM), and the grasping and visual-motor integration of the Peabody Developmental Motor Scales. Pearson correlation coefficients were calculated. Responsiveness was examined using the paired t test and the standardized response mean, the minimal detectable change was captured at the 90% confidence level, and the minimal clinically important change was estimated using anchor-based and distribution-based approaches. The PMAL-QOM showed fair concurrent validity at pretreatment and posttreatment and predictive validity, whereas the PMAL-AOU had fair concurrent validity at posttreatment only. The PMAL-AOU and PMAL-QOM were both markedly responsive to change after treatment. Improvement of at least 0.67 points on the PMAL-AOU and 0.66 points on the PMAL-QOM can be considered as a true change, not measurement error. A mean change has to exceed the range of 0.39-0.94 on the PMAL-AOU and the range of 0.38-0.74 on the PMAL-QOM to be regarded as clinically important change. Copyright © 2011 Elsevier Ltd. All rights reserved.

Italian Validation of Homophobia Scale (HS).

PubMed

Ciocca, Giacomo; Capuano, Nicolina; Tuziak, Bogdan; Mollaioli, Daniele; Limoncin, Erika; Valsecchi, Diana; Carosa, Eleonora; Gravina, Giovanni L; Gianfrilli, Daniele; Lenzi, Andrea; Jannini, Emmanuele A

2015-09-01

The Homophobia Scale (HS) is a valid tool to assess homophobia. This test is self-reporting, composed of 25 items, which assesses a total score and three factors linked to homophobia: behavior/negative affect, affect/behavioral aggression, and negative cognition. The aim of this study was to validate the HS in the Italian context. An Italian translation of the HS was carried out by two bilingual people, after which an English native translated the test back into the English language. A psychologist and sexologist checked the translated items from a clinical point of view. We recruited 100 subjects aged18-65 for the Italian validation of the HS. The Pearson coefficient and Cronbach's α coefficient were performed to test the test-retest reliability and internal consistency. A sociodemographic questionnaire including the main information as age, geographic distribution, partnership status, education, religious orientation, and sex orientation was administrated together with the translated version of HS. The analysis of the internal consistency showed an overall Cronbach's α coefficient of 0.92. In the four domains, the Cronbach's α coefficient was 0.90 in behavior/negative affect, 0.94 in affect/behavioral aggression, and 0.92 in negative cognition, whereas in the total score was 0.86. The test-retest reliability showed the following results: the HS total score was r = 0.93 (P < 0.0001), behavior/negative affect was r = 0.79 (P < 0.0001), affect/behavioral aggression was r = 0.81 (P < 0.0001), and negative cognition was r = 0.75 (P < 0.0001). The Italian validation of the HS revealed the use of this self-report test to have good psychometric properties. This study offers a new tool to assess homophobia. In this regard, the HS can be introduced into the clinical praxis and into programs for the prevention of homophobic behavior.

Validation of the Mayo Hip Score: construct validity, reliability and responsiveness to change.

PubMed

Singh, Jasvinder A; Schleck, Cathy; Harmsen, W Scott; Lewallen, David G

2016-01-19

Previous studies have provided the initial evidence for construct validity and test-retest reliability of the Mayo Hip Score. Instruments used for Total Hip Arthroplasty (THA) outcomes assessment should be valid, reliable and responsive to change. Our main objective was to examine the responsiveness to change, association with subsequent revision and the construct validity of the Mayo hip score. Discriminant ability was assessed by calculating effect size (ES), standardized response mean (SRM) and Guyatt's responsiveness index (GRI). Minimal clinically important difference (MCII) and moderate improvement thresholds were calculated. We assessed construct validity by examining association of scores with preoperative patient characteristics and correlation with Harris hip score, and assessed association of scores with the risk of subsequent revision. Five thousand three hundred seven provided baseline data; of those with baseline data, 2,278 and 2,089 (39%) provided 2- and 5-year data, respectively. Large ES, SRM and GRI ranging 2.66-2.78, 2.42-2.61 and 1.67-1.88 were noted for Mayo hip scores with THA, respectively. The MCII and moderate improvement thresholds were 22.4-22.7 and 39.4-40.5 respectively. Hazard ratios of revision surgery were higher with lower final score or less improvement in Mayo hip score at 2-years and borderline significant/non-significant at 5-years, respectively: (1) score ≤55 with hazard ratios of 2.24 (95% CI, 1.45, 3.46; p = 0.0003) and 1.70 (95% CI, 1.00, 2.92; p = 0.05) of implant revision subsequently, compared to 72-80 points; (2) no improvement or worsening score with hazard ratios 3.94 (95% CI, 1.50, 10.30; p = 0.005) and 2.72 (95% CI, 0.85,8.70; p = 0.09), compared to improvement >50-points. Mayo hip score had significant positive correlation with younger age, male gender, lower BMI, lower ASA class and lower Deyo-Charlson index (p ≤ 0.003 for each) and with Harris hip scores (p < 0.001). Mayo Hip Score is

Measurement of Harm Outcomes in Older Adults after Hospital Discharge: Reliability and Validity

PubMed Central

Douglas, Alison; Letts, Lori; Eva, Kevin; Richardson, Julie

2012-01-01

Objectives. Defining and validating a measure of safety contributes to further validation of clinical measures. The objective was to define and examine the psychometric properties of the outcome “incidents of harm.” Methods. The Incident of Harm Caregiver Questionnaire was administered to caregivers of older adults discharged from hospital by telephone. Caregivers completed daily logs for one month and medical charts were examined. Results. Test-retest reliability (n = 38) was high for the occurrence of an incident of harm (yes/no; kappa = 1.0) and the type of incident (agreement = 100%). Validation against daily logs found no disagreement regarding occurrence or types of incidents. Validation with medical charts found no disagreement regarding incident occurrence and disagreement in half regarding incident type. Discussion. The data support the Incident of Harm Caregiver Questionnaire as a reliable and valid estimation of incidents for this sample and are important to researchers as a method to measure safety when validating clinical measures. PMID:22649728

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

Reliability and validity of the Bowel Function Index for evaluating opioid-induced constipation: translation, cultural adaptation and validation of the Portuguese version (BFI-P).

PubMed

Dueñas, María; Mendonça, Liliane; Sampaio, Rute; Gouvinhas, Cláudia; Oliveira, Daniela; Castro-Lopes, José Manuel; Azevedo, Luís Filipe

2017-03-01

The Bowel Function Index (BFI) is a simple and sound bowel function and opioid-induced constipation (OIC) screening tool. We aimed to develop the translation and cultural adaptation of this measure (BFI-P) and to assess its reliability and validity for the Portuguese language and a chronic pain population. The BFI-P was created after a process including translation, back translation and cultural adaptation. Participants (n = 226) were recruited in a chronic pain clinic and were assessed at baseline and after one week. Internal consistency, test-retest reliability, responsiveness, construct (convergent and known groups) and factorial validity were assessed. Test-retest reliability had an intra-class correlation of 0.605 for BFI mean score. Internal consistency of BFI had Cronbach's alpha of 0.865. The construct validity of BFI-P was shown to be excellent and the exploratory factor analysis confirmed its unidimensional structure. The responsiveness of BFI-P was excellent, with a suggested 17-19 point and 8-12 point change in score constituting a clinically relevant change in constipation for patients with and without previous constipation, respectively. This study had some limitations, namely, the criterion validity of BFI-P was not directly assessed; and the absence of a direct criterion for OIC precluded the assessment of the criterion based responsiveness of BFI-P. Nevertheless, BFI may importantly contribute to better OIC screening and its Portuguese version (BFI-P) has been shown to have excellent reliability, internal consistency, validity and responsiveness. Further suggestions regarding statistically and clinically important change cut-offs for this instrument are presented.

Development and Validation of a Photonumeric Scale for Evaluation of Facial Skin Texture

PubMed Central

Carruthers, Alastair; Hardas, Bhushan; Murphy, Diane K.; Carruthers, Jean; Jones, Derek; Sykes, Jonathan M.; Creutz, Lela; Marx, Ann; Dill, Sara

2016-01-01

BACKGROUND A validated scale is needed for objective and reproducible comparisons of facial skin roughness before and after aesthetic treatment in practice and in clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Skin Roughness Scale. METHODS The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 290) completed during 2 sessions occurring 3 weeks apart. RESULTS A score difference of ≥1 point was shown to reflect a clinically meaningful difference (mean [95% confidence interval] absolute score difference 1.09 [0.96–1.23] for clinically different image pairs and 0.53 [0.38–0.67] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (weighted kappa = 0.83). Interrater agreement was almost perfect during the second rating session (0.81, primary end point). CONCLUSION The Allergan Skin Roughness Scale is a validated and reliable scale for physician rating of midface skin roughness. PMID:27661744

Beware of external validation! - A Comparative Study of Several Validation Techniques used in QSAR Modelling.

PubMed

Majumdar, Subhabrata; Basak, Subhash C

2018-04-26

Proper validation is an important aspect of QSAR modelling. External validation is one of the widely used validation methods in QSAR where the model is built on a subset of the data and validated on the rest of the samples. However, its effectiveness for datasets with a small number of samples but large number of predictors remains suspect. Calculating hundreds or thousands of molecular descriptors using currently available software has become the norm in QSAR research, owing to computational advances in the past few decades. Thus, for n chemical compounds and p descriptors calculated for each molecule, the typical chemometric dataset today has high value of p but small n (i.e. n < p). Motivated by the evidence of inadequacies of external validation in estimating the true predictive capability of a statistical model in recent literature, this paper performs an extensive and comparative study of this method with several other validation techniques. We compared four validation methods: leave-one-out, K-fold, external and multi-split validation, using statistical models built using the LASSO regression, which simultaneously performs variable selection and modelling. We used 300 simulated datasets and one real dataset of 95 congeneric amine mutagens for this evaluation. External validation metrics have high variation among different random splits of the data, hence are not recommended for predictive QSAR models. LOO has the overall best performance among all validation methods applied in our scenario. Results from external validation are too unstable for the datasets we analyzed. Based on our findings, we recommend using the LOO procedure for validating QSAR predictive models built on high-dimensional small-sample data. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Longitudinal construct validity: establishment of clinical meaning in patient evaluative instruments.

PubMed

Liang, M H

2000-09-01

Although widely used and reported in research for the evaluation of groups, measures of health status and health-related quality of life have had little application in clinical practice for the assessment of individual patients. One of the principal barriers is the demonstration that these measures add clinically significant information to measures of function or symptoms alone. Here, we review the methods for evaluation of construct validity in longitudinal studies and make recommendations for nomenclature, reporting of study results, and future research agenda. Analytical review. The terms "sensitivity" and "responsiveness" have been used interchangeably, and there are few studies that evaluate the extent to which health status or health-related quality-of life measures capture clinically important changes ("responsiveness"). Current methods of evaluating responsiveness are not standardized or evaluated. Approaches for the assessment of a clinically significant or meaningful change are described; rather than normative information, however, standardized transition questions are proposed. They would be reported routinely and as separate axes of description to capture individual perceptions. Research in methods to assess the subject's evaluation of the importance and magnitude of a measured change are critical if health status and health-related quality-of-life measures are to have an impact on patient care.

Clinical endpoint adjudication in a contemporary all-comers coronary stent investigation: methodology and external validation.

PubMed

Vranckx, Pascal; McFadden, Eugene; Cutlip, Donald E; Mehran, Roxana; Swart, Michael; Kint, P P; Zijlstra, Felix; Silber, Sigmund; Windecker, Stephan; Serruys, Patrick W C J

2013-01-01

Globalisation in coronary stent research calls for harmonization of clinical endpoint definitions and event adjudication. Little has been published about the various processes used for event adjudication or their impact on outcome reporting. We performed a validation of the clinical event committee (CEC) adjudication process on 100 suspected events in the RESOLUTE All-comers trial (Resolute-AC). Two experienced Clinical Research Organisations (CRO) that had already extensive internal validation processes in place, participated in the study. After initial adjudication by the primary-CEC, events were cross-adjudicated by an external-CEC using the same definitions. Major discrepancies affecting the primary end point of target-lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically-indicated target-lesion revascularization (CI-TLR), were analysed by an independent oversight committee who provided recommendations for harmonization. Discordant adjudications were reconsidered by the primary CEC. Subsequently, the RAC database was interrogated for cases that based on these recommendations merited re-adjudication and these cases were also re-adjudicated by the primary CEC. Final discrepancies in adjudication of individual components of TLF occurred in 7 out of 100 events in 5 patients. Discrepancies for the (hierarchical) primary endpoint occurred in 5 events (2 cardiac deaths and 3 TV-MI). After application of harmonization recommendations to the overall RAC population (n=2292), the primary CEC adjudicated 3 additional clinical-TLRs and considered 1 TV-MI as no event. A harmonization process provided a high level of concordance for event adjudication and improved accuracy for final event reporting. These findings suggest it is feasible to pool clinical event outcome data across clinical trials even when different CECs are responsible for event adjudication. Copyright © 2012 Elsevier Inc. All rights reserved.

Longitudinal construct validity of the minimum data set health status index.

PubMed

Jones, Aaron; Feeny, David; Costa, Andrew P

2018-05-24

The Minimum Data Set Health Status Index (MDS-HSI) is a generic, preference-based health-related quality of life (HRQOL) measure derived by mapping items from the Resident Assessment Instrument - Minimum Data Set (RAI-MDS) assessment onto the Health Utilities Index Mark 2 classification system. While the validity of the MDS-HSI has been examined in cross-sectional settings, the longitudinal validity has not been explored. The objective of this study was to investigate the longitudinal construct validity of the MDS-HSI in a home care population. This study utilized a retrospective cohort of home care patients in the Hamilton-Niagara-Haldimand-Brant health region of Ontario, Canada with at least two RAI-MDS Home Care assessments between January 2010 and December 2014. Convergent validity was assessed by calculating Spearman rank correlations between the change in MDS-HSI and changes in six validated indices of health domains that can be calculated from the RAI-MDS assessment. Known-groups validity was investigated by fitting multivariable linear regression models to estimate the mean change in MDS-HSI associated with clinically important changes in the six health domain indices and 15 disease symptoms from the RAI-MDS Home Care assessment, controlling for age and sex. The cohort contained 25,182 patients with two RAI-MDS Home Care assessments. Spearman correlations between the MDS-HSI change and changes in the health domain indices were all statistically significant and in the hypothesized small to moderate range [0.1 < ρ < 0.5]. Clinically important changes in all of the health domain indices and 13 of the 15 disease symptoms were significantly associated with clinically important changes in the MDS-HSI. The findings of this study support the longitudinal construct validity of the MDS-HSI in home care populations. In addition to evaluating changes in HRQOL among home care patients in clinical research, economic evaluation, and health technology assessment

Ecological validity and clinical utility of Patient-Reported Outcomes Measurement Information System (PROMIS®) instruments for detecting premenstrual symptoms of depression, anger, and fatigue.

PubMed

Junghaenel, Doerte U; Schneider, Stefan; Stone, Arthur A; Christodoulou, Christopher; Broderick, Joan E

2014-04-01

This study examined the ecological validity and clinical utility of NIH Patient Reported-Outcomes Measurement Information System (PROMIS®) instruments for anger, depression, and fatigue in women with premenstrual symptoms. One-hundred women completed daily diaries and weekly PROMIS assessments over 4weeks. Weekly assessments were administered through Computerized Adaptive Testing (CAT). Weekly CATs and corresponding daily scores were compared to evaluate ecological validity. To test clinical utility, we examined if CATs could detect changes in symptom levels, if these changes mirrored those obtained from daily scores, and if CATs could identify clinically meaningful premenstrual symptom change. PROMIS CAT scores were higher in the pre-menstrual than the baseline (ps<.0001) and post-menstrual (ps<.0001) weeks. The correlations between CATs and aggregated daily scores ranged from .73 to .88 supporting ecological validity. Mean CAT scores showed systematic changes in accordance with the menstrual cycle and the magnitudes of the changes were similar to those obtained from the daily scores. Finally, Receiver Operating Characteristic (ROC) analyses demonstrated the ability of the CATs to discriminate between women with and without clinically meaningful premenstrual symptom change. PROMIS CAT instruments for anger, depression, and fatigue demonstrated validity and utility in premenstrual symptom assessment. The results provide encouraging initial evidence of the utility of PROMIS instruments for the measurement of affective premenstrual symptoms. Copyright © 2014 Elsevier Inc. All rights reserved.

Ecological Validity and Clinical Utility of Patient-Reported Outcomes Measurement Information System (PROMIS®) instruments for detecting premenstrual symptoms of depression, anger, and fatigue

PubMed Central

Junghaenel, Doerte U.; Schneider, Stefan; Stone, Arthur A.; Christodoulou, Christopher; Broderick, Joan E.

2014-01-01

Objective This study examined the ecological validity and clinical utility of NIH Patient Reported-Outcomes Measurement Information System (PROMIS®) instruments for anger, depression, and fatigue in women with premenstrual symptoms. Methods One-hundred women completed daily diaries and weekly PROMIS assessments over 4 weeks. Weekly assessments were administered through Computerized Adaptive Testing (CAT). Weekly CATs and corresponding daily scores were compared to evaluate ecological validity. To test clinical utility, we examined if CATs could detect changes in symptom levels, if these changes mirrored those obtained from daily scores, and if CATs could identify clinically meaningful premenstrual symptom change. Results PROMIS CAT scores were higher in the pre-menstrual than the baseline (ps < .0001) and post-menstrual (ps < .0001) weeks. The correlations between CATs and aggregated daily scores ranged from .73 to .88 supporting ecological validity. Mean CAT scores showed systematic changes in accordance with the menstrual cycle and the magnitudes of the changes were similar to those obtained from the daily scores. Finally, Receiver Operating Characteristic (ROC) analyses demonstrated the ability of the CATs to discriminate between women with and without clinically meaningful premenstrual symptom change. Conclusions PROMIS CAT instruments for anger, depression, and fatigue demonstrated validity and utility in premenstrual symptom assessment. The results provide encouraging initial evidence of the utility of PROMIS instruments for the measurement of affective premenstrual symptoms. PMID:24630180

Psychometric Properties and Validation of the Positive and Negative Suicide Ideation (PANSI) Inventory in an Outpatient Clinical Population in Malaysia.

PubMed

Sinniah, Aishvarya; Oei, Tian P S; Chinna, Karuthan; Shah, Shamsul A; Maniam, T; Subramaniam, Ponnusamy

2015-01-01

The PANSI is a measure designed to assess the risk and protective factors related to suicidal behaviors. The present study evaluated the psychometric properties and factor structure of the Positive and Negative Suicide Ideation (PANSI) Inventory in a sample of clinical outpatients at a major hospital in Malaysia. In this study, 283 psychiatric patients and 200 medical (non-psychiatric) patients participated. All the patients completed the PANSI and seven other self-report instruments. Confirmative factor analysis supported the 2-factor oblique model. The internal consistency of the two subscales of PANSI-Negative and the PANSI-Positive were 0.93 and 0.84, respectively. In testing construct validity, PANSI showed sizable correlation with the other seven scales. Criterion validity was supported by scores on PANSI which differentiated psychiatric patients from medical patients. Logistic regression analyses showed PANSI can be used to classify the patients into suicidal or non-suicidal. The PANSI is a reliable and valid instrument to measure the severity of suicidal ideation among clinical outpatients in Malaysia.

Psychometric Properties and Validation of the Positive and Negative Suicide Ideation (PANSI) Inventory in an Outpatient Clinical Population in Malaysia

PubMed Central

Sinniah, Aishvarya; Oei, Tian P. S.; Chinna, Karuthan; Shah, Shamsul A.; Maniam, T.; Subramaniam, Ponnusamy

2015-01-01

The PANSI is a measure designed to assess the risk and protective factors related to suicidal behaviors. The present study evaluated the psychometric properties and factor structure of the Positive and Negative Suicide Ideation (PANSI) Inventory in a sample of clinical outpatients at a major hospital in Malaysia. In this study, 283 psychiatric patients and 200 medical (non-psychiatric) patients participated. All the patients completed the PANSI and seven other self-report instruments. Confirmative factor analysis supported the 2-factor oblique model. The internal consistency of the two subscales of PANSI-Negative and the PANSI-Positive were 0.93 and 0.84, respectively. In testing construct validity, PANSI showed sizable correlation with the other seven scales. Criterion validity was supported by scores on PANSI which differentiated psychiatric patients from medical patients. Logistic regression analyses showed PANSI can be used to classify the patients into suicidal or non-suicidal. The PANSI is a reliable and valid instrument to measure the severity of suicidal ideation among clinical outpatients in Malaysia. PMID:26733920

Validation of learning assessments: A primer.

PubMed

Peeters, Michael J; Martin, Beth A

2017-09-01

The Accreditation Council for Pharmacy Education's Standards 2016 has placed greater emphasis on validating educational assessments. In this paper, we describe validity, reliability, and validation principles, drawing attention to the conceptual change that highlights one validity with multiple evidence sources; to this end, we recommend abandoning historical (confusing) terminology associated with the term validity. Further, we describe and apply Kane's framework (scoring, generalization, extrapolation, and implications) for the process of validation, with its inferences and conclusions from varied uses of assessment instruments by different colleges and schools of pharmacy. We then offer five practical recommendations that can improve reporting of validation evidence in pharmacy education literature. We describe application of these recommendations, including examples of validation evidence in the context of pharmacy education. After reading this article, the reader should be able to understand the current concept of validation, and use a framework as they validate and communicate their own institution's learning assessments. Copyright © 2017 Elsevier Inc. All rights reserved.

Only complementary voices tell the truth: a reevaluation of validity in multi-informant approaches of child and adolescent clinical assessments.

PubMed

Kaurin, Aleksandra; Egloff, Boris; Stringaris, Argyris; Wessa, Michèle

2016-08-01

Multi-informant approaches are thought to be key to clinical assessment. Classical theories of psychological measurements assume that only convergence among different informants' reports allows for an estimate of the true nature and causes of clinical presentations. However, the integration of multiple accounts is fraught with problems because findings in child and adolescent psychiatry do not conform to the fundamental expectation of convergence. Indeed, reports provided by different sources (self, parents, teachers, peers) share little variance. Moreover, in some cases informant divergence may be meaningful and not error variance. In this review, we give an overview of conceptual and theoretical foundations of valid multi-informant assessment and discuss why our common concepts of validity need revaluation.

Development and initial validity of the in-hand manipulation assessment.

PubMed

Klymenko, Gabrielle; Liu, Karen P Y; Bissett, Michelle; Fong, Kenneth N K; Welage, Nandana; Wong, Rebecca S M

2018-04-01

A review of the literature related to in-hand manipulation (IHM) revealed that there is no assessment which specifically measures this construct in the adult population. This study reports the face and content validity of an IHM assessment for adults with impaired hand function based on expert opinion. The definition of IHM skills, assessment tasks and scoring methods identified from literature was discussed in a focus group (n = 4) to establish face validity. An expert panel (n = 16) reviewed the content validity of the proposed assessment; evaluating the representativeness and relevance of encompassing the IHM skills in the proposed assessment tasks, the clarity and importance to daily life of the task and the clarity and applicability to clinical environment of the scoring method. The content validity was calculated using the content validity index for both the individual task and all tasks together (I-CVI and S-CVI). Feedback was incorporated to create the assessment. The focus group members agreed to include 10 assessment tasks that covered all IHM skills. In the expert panel review, all tasks received an I-CVI above 0.78 and S-CVI above 0.80 in representativeness and relevance ratings, representing good content validity. With the comments from the expert panel, tasks were modified to improve the clarity and importance to daily life. A four-point Likert scale was identified for assessing both the completion of the assessment tasks and the quality of IHM skills within the task performance. Face and content validity were established in this new IHM assessment. Further studies to examine psychometric properties and use within clinical practice are recommended. © 2018 Occupational Therapy Australia.

Validation of Digital Spiral Analysis as Outcome Parameter for Clinical Trials in Essential Tremor

PubMed Central

Haubenberger, Dietrich; Kalowitz, Daniel; Nahab, Fatta B.; Toro, Camilo; Ippolito, Dominic; Luckenbaugh, David A.; Wittevrongel, Loretta; Hallett, Mark

2014-01-01

Essential tremor, one of the most prevalent movement disorders, is characterized by kinetic and postural tremor affecting activities of daily living. Spiral drawing is commonly used to visually rate tremor intensity, as part of the routine clinical assessment of tremor and as a tool in clinical trials. We present a strategy to quantify tremor severity from spirals drawn on a digitizing tablet. We validate our method against a well-established visual spiral rating method and compare both methods on their capacity to capture a therapeutic effect, as defined by the change in clinical essential tremor rating scale after an ethanol challenge. Fifty-four Archimedes spirals were drawn using a digitizing tablet by nine ethanol-responsive patients with essential tremor before and at five consecutive time points after the administration of ethanol in a standardized treatment intervention. Quantitative spiral tremor severity was estimated from the velocity tremor peak amplitude after numerical derivation and Fourier transformation of pen-tip positions. In randomly ordered sets, spirals were scored by seven trained raters, using Bain and Findley’s 0 to 10 rating scale. Computerized scores correlated with visual ratings (P < 0.0001). The correlation was significant at each time point before and after ethanol (P < 0.005). Quantitative ratings provided better sensitivity than visual rating to capture the effects of an ethanol challenge (P < 0.05). Using a standardized treatment approach, we were able to demonstrate that spirography time-series analysis is a valid, reliable method to document tremor intensity and a more sensitive measure for small effects than currently available visual spiral rating methods. PMID:21714004

Development and validation of clinical prediction models for mortality, functional outcome and cognitive impairment after stroke: a study protocol.

PubMed

Fahey, Marion; Rudd, Anthony; Béjot, Yannick; Wolfe, Charles; Douiri, Abdel

2017-08-18

Stroke is a leading cause of adult disability and death worldwide. The neurological impairments associated with stroke prevent patients from performing basic daily activities and have enormous impact on families and caregivers. Practical and accurate tools to assist in predicting outcome after stroke at patient level can provide significant aid for patient management. Furthermore, prediction models of this kind can be useful for clinical research, health economics, policymaking and clinical decision support. 2869 patients with first-ever stroke from South London Stroke Register (SLSR) (1995-2004) will be included in the development cohort. We will use information captured after baseline to construct multilevel models and a Cox proportional hazard model to predict cognitive impairment, functional outcome and mortality up to 5 years after stroke. Repeated random subsampling validation (Monte Carlo cross-validation) will be evaluated in model development. Data from participants recruited to the stroke register (2005-2014) will be used for temporal validation of the models. Data from participants recruited to the Dijon Stroke Register (1985-2015) will be used for external validation. Discrimination, calibration and clinical utility of the models will be presented. Patients, or for patients who cannot consent their relatives, gave written informed consent to participate in stroke-related studies within the SLSR. The SLSR design was approved by the ethics committees of Guy's and St Thomas' NHS Foundation Trust, Kings College Hospital, Queens Square and Westminster Hospitals (London). The Dijon Stroke Registry was approved by the Comité National des Registres and the InVS and has authorisation of the Commission Nationale de l'Informatique et des Libertés. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

External validation and comparison of three pediatric clinical dehydration scales.

PubMed

Jauregui, Joshua; Nelson, Daniel; Choo, Esther; Stearns, Branden; Levine, Adam C; Liebmann, Otto; Shah, Sachita P

2014-01-01

To prospectively validate three popular clinical dehydration scales and overall physician gestalt in children with vomiting or diarrhea relative to the criterion standard of percent weight change with rehydration. We prospectively enrolled a non-consecutive cohort of children ≤ 18 years of age with an acute episode of diarrhea or vomiting. Patient weight, clinical scale variables and physician clinical impression, or gestalt, were recorded before and after fluid resuscitation in the emergency department and upon hospital discharge. The percent weight change from presentation to discharge was used to calculate the degree of dehydration, with a weight change of ≥ 5% considered significant dehydration. Receiver operating characteristics (ROC) curves were constructed for each of the three clinical scales and physician gestalt. Sensitivity and specificity were calculated based on the best cut-points of the ROC curve. We approached 209 patients, and of those, 148 were enrolled and 113 patients had complete data for analysis. Of these, 10.6% had significant dehydration based on our criterion standard. The Clinical Dehydration Scale (CDS) and Gorelick scales both had an area under the ROC curve (AUC) statistically different from the reference line with AUCs of 0.72 (95% CI 0.60, 0.84) and 0.71 (95% CI 0.57, 0.85) respectively. The World Health Organization (WHO) scale and physician gestalt had AUCs of 0.61 (95% CI 0.45, 0.77) and 0.61 (0.44, 0.78) respectively, which were not statistically significant. The Gorelick scale and Clinical Dehydration Scale were fair predictors of dehydration in children with diarrhea or vomiting. The World Health Organization scale and physician gestalt were not helpful predictors of dehydration in our cohort.

Validating Analytical Methods

ERIC Educational Resources Information Center

Ember, Lois R.

1977-01-01

The procedures utilized by the Association of Official Analytical Chemists (AOAC) to develop, evaluate, and validate analytical methods for the analysis of chemical pollutants are detailed. Methods validated by AOAC are used by the EPA and FDA in their enforcement programs and are granted preferential treatment by the courts. (BT)

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 a premature ejaculation diagnostic tool.

PubMed

Symonds, Tara; Perelman, Michael A; Althof, Stanley; Giuliano, François; Martin, Mona; May, Kathryn; Abraham, Lucy; Crossland, Anna; Morris, Mark

2007-08-01

Diagnosis of premature ejaculation (PE) for clinical trial purposes has typically relied on intravaginal ejaculation latency time (IELT) for entry, but this parameter does not capture the multidimensional nature of PE. Therefore, the aim was to develop a brief, multidimensional, psychometrically validated instrument for diagnosing PE status. The questionnaire development involved three stages: (1) Five focus groups and six individual interviews were conducted to develop the content; (2) psychometric validation using three different groups of men; and (3) generation of a scoring system. For psychometric validation/scoring system development, data was collected from (1) men with PE based on clinician diagnosis, using DSM-IV-TR, who also had IELTs < or =2 min (n=292); (2) men self-reporting PE (n=309); and (3) men self-reporting no-PE (n=701). Standard psychometric analyses were conducted to produce the final questionnaire. Sensitivity/specificity analysis was used to determine an appropriate scoring system. The qualitative research identified 9 items to capture the essence of DSM-IV-TR PE classification. The psychometric validation resulted in a 5-item, unidimensional, measure, which captures the essence of DSM-IV-TR: control, frequency, minimal stimulation, distress, and interpersonal difficulty. Sensitivity/specificity analyses suggested a score of < or =8 indicated no-PE, 9 and 10 probable PE, and > or =11 PE. The development and validation of this new PE diagnostic tool has resulted in a new, user-friendly, and brief self-report questionnaire for use in clinical trials to diagnose PE.

A test of the validity of the motivational interviewing treatment integrity code.

PubMed

Forsberg, Lars; Berman, Anne H; Kallmén, Håkan; Hermansson, Ulric; Helgason, Asgeir R

2008-01-01

To evaluate the Swedish version of the Motivational Interviewing Treatment Code (MITI), MITI coding was applied to tape-recorded counseling sessions. Construct validity was assessed using factor analysis on 120 MITI-coded sessions. Discriminant validity was assessed by comparing MITI coding of motivational interviewing (MI) sessions with information- and advice-giving sessions as well as by comparing MI-trained practitioners with untrained practitioners. A principal-axis factoring analysis yielded some evidence for MITI construct validity. MITI differentiated between practitioners with different levels of MI training as well as between MI practitioners and advice-giving counselors, thus supporting discriminant validity. MITI may be used as a training tool together with supervision to confirm and enhance MI practice in clinical settings. MITI can also serve as a tool for evaluating MI integrity in clinical research.

Descriptive analysis of the verbal behavior of a therapist: a known-group validity analysis of the putative behavioral functions involved in clinical interaction.

PubMed

Virues-Ortega, Javier; Montaño-Fidalgo, Montserrat; Froján-Parga, María Xesús; Calero-Elvira, Ana

2011-12-01

This study analyzes the interobserver agreement and hypothesis-based known-group validity of the Therapist's Verbal Behavior Category System (SISC-INTER). The SISC-INTER is a behavioral observation protocol comprised of a set of verbal categories representing putative behavioral functions of the in-session verbal behavior of a therapist (e.g., discriminative, reinforcing, punishing, and motivational operations). The complete therapeutic process of a clinical case of an individual with marital problems was recorded (10 sessions, 8 hours), and data were arranged in a temporal sequence using 10-min periods. Hypotheses based on the expected performance of the putative behavioral functions portrayed by the SISC-INTER codes across prevalent clinical activities (i.e., assessing, explaining, Socratic method, providing clinical guidance) were tested using autoregressive integrated moving average (ARIMA) models. Known-group validity analyses provided support to all hypotheses. The SISC-INTER may be a useful tool to describe therapist-client interaction in operant terms. The utility of reliable and valid protocols for the descriptive analysis of clinical practice in terms of verbal behavior is discussed. Copyright © 2011. Published by Elsevier Ltd.

Validity, responsiveness, and minimal clinically important difference of EQ-5D-5L in stroke patients undergoing rehabilitation.

PubMed

Chen, Poyu; Lin, Keh-Chung; Liing, Rong-Jiuan; Wu, Ching-Yi; Chen, Chia-Ling; Chang, Ku-Chou

2016-06-01

To examine the criterion validity, responsiveness, and minimal clinically important difference (MCID) of the EuroQoL 5-Dimensions Questionnaire (EQ-5D-5L) and visual analog scale (EQ-VAS) in people receiving rehabilitation after stroke. The EQ-5D-5L, along with four criterion measures-the Medical Research Council scales for muscle strength, the Fugl-Meyer assessment, the functional independence measure, and the Stroke Impact Scale-was administered to 65 patients with stroke before and after 3- to 4-week therapy. Criterion validity was estimated using the Spearman correlation coefficient. Responsiveness was analyzed by the effect size, standardized response mean (SRM), and criterion responsiveness. The MCID was determined by anchor-based and distribution-based approaches. The percentage of patients exceeding the MCID was also reported. Concurrent validity of the EQ-Index was better compared with the EQ-VAS. The EQ-Index has better power for predicting the rehabilitation outcome in the activities of daily living than other motor-related outcome measures. The EQ-Index was moderately responsive to change (SRM = 0.63), whereas the EQ-VAS was only mildly responsive to change. The MCID estimation of the EQ-Index (the percentage of patients exceeding the MCID) was 0.10 (33.8 %) and 0.10 (33.8 %) based on the anchor-based and distribution-based approaches, respectively, and the estimation of EQ-VAS was 8.61 (41.5 %) and 10.82 (32.3 %). The EQ-Index has shown reasonable concurrent validity, limited predictive validity, and acceptable responsiveness for detecting the health-related quality of life in stroke patients undergoing rehabilitation, but not for EQ-VAS. Future research considering different recovery stages after stroke is warranted to validate these estimations.

EOS Terra Validation Program

NASA Technical Reports Server (NTRS)

Starr, David

1999-01-01

The EOS Terra mission will be launched in July 1999. This mission has great relevance to the atmospheric radiation community and global change issues. Terra instruments include ASTER, CERES, MISR, MODIS and MOPITT. In addition to the fundamental radiance data sets, numerous global science data products will be generated, including various Earth radiation budget, cloud and aerosol parameters, as well as land surface, terrestrial ecology, ocean color, and atmospheric chemistry parameters. Significant investments have been made in on-board calibration to ensure the quality of the radiance observations. A key component of the Terra mission is the validation of the science data products. This is essential for a mission focused on global change issues and the underlying processes. The Terra algorithms have been subject to extensive pre-launch testing with field data whenever possible. Intensive efforts will be made to validate the Terra data products after launch. These include validation of instrument calibration (vicarious calibration) experiments, instrument and cross-platform comparisons, routine collection of high quality correlative data from ground-based networks, such as AERONET, and intensive sites, such as the SGP ARM site, as well as a variety field experiments, cruises, etc. Airborne simulator instruments have been developed for the field experiment and underflight activities including the MODIS Airborne Simulator (MAS), AirMISR, MASTER (MODIS-ASTER), and MOPITT-A. All are integrated on the NASA ER-2, though low altitude platforms are more typically used for MASTER. MATR is an additional sensor used for MOPITT algorithm development and validation. The intensive validation activities planned for the first year of the Terra mission will be described with emphasis on derived geophysical parameters of most relevance to the atmospheric radiation community. Detailed information about the EOS Terra validation Program can be found on the EOS Validation program

Measurement-based Treatment of Residual Symptoms Using Clinically Useful Depression Outcome Scale: Korean Validation Study

PubMed Central

Jeon, Sang Won; Han, Changsu; Ko, Young-Hoon; Yoon, Seo Young; Pae, Chi-Un; Choi, Joonho; Park, Yong Chon; Kim, Jong-Woo; Yoon, Ho-Kyoung; Ko, Seung-Duk; Patkar, Ashwin A.; Zimmerman, Mark

2017-01-01

Objective This study was aimed at evaluating the diagnostic validity of the Korean version of the Clinically Useful Depression Outcome Scale (CUDOS) with varying follow-up in a typical clinical setting in multiple centers. Methods In total, 891 psychiatric outpatients were enrolled at the time of their intake appointment. Current diagnostic characteristics were examined using the Structured Clinical Interview for DSM-IV (41% major depressive disorder). The CUDOS was measured and compared with three clinician rating scales and four self-report scales. Results The CUDOS showed excellent results for internal consistency (Cronbach’s α, 0.91), test-retest reliability (patients at intake, r=0.81; depressed patients in ongoing treatment, r=0.89), and convergent and discriminant validity (measures of depression, r=0.80; measures of anxiety and somatization, r=0.42). The CUDOS had a high ability to discriminate between different levels of depression severity based on the rating of Clinical Global Impression for depression severity and the diagnostic classification of major depression, minor depression, and non-depression. The ability of the CUDOS to identify patients with major depression was high (area under the receiver operating characteristic curve=0.867). A score of 20 as the optimal cutoff point was suggested when screening for major depression using the CUDOS (sensitivity=89.9%, specificity=69.5%). The CUDOS was sensitive to change after antidepressant treatment: patients with greater improvement showed a greater decrease in CUDOS scores (p<0.001). Conclusion The results of this multi-site outpatient study found that the Korean version of the CUDOS is a very useful measurement for research and for clinical practice. PMID:28138107

The validity and clinical utility of the Disabilities of the Arm Shoulder and Hand questionnaire for hand injuries in developing country contexts: A systematic review.

PubMed

de Klerk, Susan; Buchanan, Helen; Jerosch-Herold, Christina

Systematic review. The Disabilities of the Arm Shoulder and Hand Questionnaire has multiple language versions from many countries around the world. In addition there is extensive research evidence of its psychometric properties. The purpose of this study was to systematically review the evidence available on the validity and clinical utility of the Disabilities of the Arm Shoulder and Hand as a measure of activity and participation in patients with musculoskeletal hand injuries in developing country contexts. We registered the review with international prospective register of systematic reviews prior to conducting a comprehensive literature search and extracting descriptive data. Two reviewers independently assessed methodological quality with the Consensus-Based Standards for the Selection of Health Measurement Instruments critical appraisal tool, the checklist to operationalize measurement characteristics of patient-rated outcome measures and the multidimensional model of clinical utility. Fourteen studies reporting 12 language versions met the eligibility criteria. Two language versions (Persian and Turkish) had an overall rating of good, and one (Thai) had an overall rating of excellent for cross-cultural validity. The remaining 9 language versions had an overall poor rating for cross-cultural validity. Content and construct validity and clinical utility yielded similar results. Poor quality ratings for validity and clinical utility were due to insufficient documentation of results and inadequate psychometric testing. With the increase in migration and globalization, hand therapists are likely to require a range of culturally adapted and translated versions of the Disabilities of the Arm Shoulder and Hand. Recommendations include rigorous application and reporting of cross-cultural adaptation, appropriate psychometric testing, and testing of clinical utility in routine clinical practice. Copyright © 2017 Hanley & Belfus. Published by Elsevier Inc. All rights

TMATS/ IHAL/ DDML Schema Validation

DTIC Science & Technology

2017-02-01

task was to create a method for performing IRIG eXtensible Markup Language (XML) schema validation. As opposed to XML instance document validation...TMATS / IHAL / DDML Schema Validation, RCC 126-17, February 2017 vii Acronyms DDML Data Display Markup Language HUD heads-up display iNET...system XML eXtensible Markup Language TMATS / IHAL / DDML Schema Validation, RCC 126-17, February 2017 viii This page intentionally left blank

Validating Retinal Fundus Image Analysis Algorithms: Issues and a Proposal

PubMed Central

Trucco, Emanuele; Ruggeri, Alfredo; Karnowski, Thomas; Giancardo, Luca; Chaum, Edward; Hubschman, Jean Pierre; al-Diri, Bashir; Cheung, Carol Y.; Wong, Damon; Abràmoff, Michael; Lim, Gilbert; Kumar, Dinesh; Burlina, Philippe; Bressler, Neil M.; Jelinek, Herbert F.; Meriaudeau, Fabrice; Quellec, Gwénolé; MacGillivray, Tom; Dhillon, Bal

2013-01-01

This paper concerns the validation of automatic retinal image analysis (ARIA) algorithms. For reasons of space and consistency, we concentrate on the validation of algorithms processing color fundus camera images, currently the largest section of the ARIA literature. We sketch the context (imaging instruments and target tasks) of ARIA validation, summarizing the main image analysis and validation techniques. We then present a list of recommendations focusing on the creation of large repositories of test data created by international consortia, easily accessible via moderated Web sites, including multicenter annotations by multiple experts, specific to clinical tasks, and capable of running submitted software automatically on the data stored, with clear and widely agreed-on performance criteria, to provide a fair comparison. PMID:23794433

Validity evidence and reliability of a simulated patient feedback instrument

PubMed Central

2012-01-01

Background In the training of healthcare professionals, one of the advantages of communication training with simulated patients (SPs) is the SP's ability to provide direct feedback to students after a simulated clinical encounter. The quality of SP feedback must be monitored, especially because it is well known that feedback can have a profound effect on student performance. Due to the current lack of valid and reliable instruments to assess the quality of SP feedback, our study examined the validity and reliability of one potential instrument, the 'modified Quality of Simulated Patient Feedback Form' (mQSF). Methods Content validity of the mQSF was assessed by inviting experts in the area of simulated clinical encounters to rate the importance of the mQSF items. Moreover, generalizability theory was used to examine the reliability of the mQSF. Our data came from videotapes of clinical encounters between six simulated patients and six students and the ensuing feedback from the SPs to the students. Ten faculty members judged the SP feedback according to the items on the mQSF. Three weeks later, this procedure was repeated with the same faculty members and recordings. Results All but two items of the mQSF received importance ratings of > 2.5 on a four-point rating scale. A generalizability coefficient of 0.77 was established with two judges observing one encounter. Conclusions The findings for content validity and reliability with two judges suggest that the mQSF is a valid and reliable instrument to assess the quality of feedback provided by simulated patients. PMID:22284898

Validity evidence and reliability of a simulated patient feedback instrument.

PubMed

Schlegel, Claudia; Woermann, Ulrich; Rethans, Jan-Joost; van der Vleuten, Cees

2012-01-27

In the training of healthcare professionals, one of the advantages of communication training with simulated patients (SPs) is the SP's ability to provide direct feedback to students after a simulated clinical encounter. The quality of SP feedback must be monitored, especially because it is well known that feedback can have a profound effect on student performance. Due to the current lack of valid and reliable instruments to assess the quality of SP feedback, our study examined the validity and reliability of one potential instrument, the 'modified Quality of Simulated Patient Feedback Form' (mQSF). Content validity of the mQSF was assessed by inviting experts in the area of simulated clinical encounters to rate the importance of the mQSF items. Moreover, generalizability theory was used to examine the reliability of the mQSF. Our data came from videotapes of clinical encounters between six simulated patients and six students and the ensuing feedback from the SPs to the students. Ten faculty members judged the SP feedback according to the items on the mQSF. Three weeks later, this procedure was repeated with the same faculty members and recordings. All but two items of the mQSF received importance ratings of > 2.5 on a four-point rating scale. A generalizability coefficient of 0.77 was established with two judges observing one encounter. The findings for content validity and reliability with two judges suggest that the mQSF is a valid and reliable instrument to assess the quality of feedback provided by simulated patients.

The Danish Neuro-Oncology Registry: establishment, completeness and validity.

PubMed

Hansen, Steinbjørn; Nielsen, Jan; Laursen, René J; Rasmussen, Birthe Krogh; Nørgård, Bente Mertz; Gradel, Kim Oren; Guldberg, Rikke

2016-08-30

The Danish Neuro-Oncology Registry (DNOR) is a nationwide clinical cancer database that has prospectively registered data on patients with gliomas since January 2009. The purpose of this study was to describe the establishment of the DNOR and further to evaluate the database completeness of patient registration and validity of data. The completeness of the number of patients registered in the database was evaluated in the study period from January 2009 through December 2014 by comparing cases reported to the DNOR with the Danish National Patient Registry and the Danish Pathology Registry. The data validity of important clinical variables was evaluated by a random sample of 100 patients from the DNOR using the medical records as reference. A total of 2241 patients were registered in the DNOR by December 2014 with an overall patient completeness of 92 %, which increased during the study period (from 78 % in 2009 to 96 % in 2014). Medical records were available for all patients in the validity analyses. Most variables showed a high agreement proportion (56-100 %), with a fair to good chance-corrected agreement (k = 0.43-1.0). The completeness of patient registration was very high (92 %) and the validity of the most important patient data was good. The DNOR is a newly established national database, which is a reliable source for future scientific studies and clinical quality assessments among patients with gliomas.

Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis.

PubMed

Banks, Jamie L; Marotta, Charles A

2007-03-01

The modified Rankin scale (mRS), a clinician-reported measure of global disability, is widely applied for evaluating stroke patient outcomes and as an end point in randomized clinical trials. Extensive evidence on the validity of the mRS exists across a large but fragmented literature. As new treatments for acute ischemic stroke are submitted for agency approval, an appreciation of the mRS's attributes, specifically its relationship to other stroke evaluation scales, would be valuable for decision-makers to properly assess the impact of a new drug on treatment paradigms. The purpose of this report is to assemble and systematically assess the properties of the mRS to provide decision-makers with pertinent evaluative information. A Medline search was conducted to identify reports in the peer-reviewed medical literature (1957-2006) that provide information on the structure, validation, scoring, and psychometric properties of the mRS and its use in clinical trials. The selection of articles was based on defined criteria that included relevance, study design and use of appropriate statistical methods. Of 224 articles identified by the literature search, 50 were selected for detailed assessment. Inter-rater reliability with the mRS is moderate and improves with structured interviews (kappa 0.56 versus 0.78); strong test-re-test reliability (kappa=0.81 to 0.95) has been reported. Numerous studies demonstrate the construct validity of the mRS by its relationships to physiological indicators such as stroke type, lesion size, perfusion and neurological impairment. Convergent validity between the mRS and other disability scales is well documented. Patient comorbidities and socioeconomic factors should be considered in properly applying and interpreting the mRS. Recent analyses suggest that randomized clinical trials of acute stroke treatments may require a smaller sample size if the mRS is used as a primary end point rather than the Barthel Index. Multiple types of evidence

External validation and clinical utility of a prediction model for 6-month mortality in patients undergoing hemodialysis for end-stage kidney disease.

PubMed

Forzley, Brian; Er, Lee; Chiu, Helen Hl; Djurdjev, Ognjenka; Martinusen, Dan; Carson, Rachel C; Hargrove, Gaylene; Levin, Adeera; Karim, Mohamud

2018-02-01

End-stage kidney disease is associated with poor prognosis. Health care professionals must be prepared to address end-of-life issues and identify those at high risk for dying. A 6-month mortality prediction model for patients on dialysis derived in the United States is used but has not been externally validated. We aimed to assess the external validity and clinical utility in an independent cohort in Canada. We examined the performance of the published 6-month mortality prediction model, using discrimination, calibration, and decision curve analyses. Data were derived from a cohort of 374 prevalent dialysis patients in two regions of British Columbia, Canada, which included serum albumin, age, peripheral vascular disease, dementia, and answers to the "the surprise question" ("Would I be surprised if this patient died within the next year?"). The observed mortality in the validation cohort was 11.5% at 6 months. The prediction model had reasonable discrimination (c-stat = 0.70) but poor calibration (calibration-in-the-large = -0.53 (95% confidence interval: -0.88, -0.18); calibration slope = 0.57 (95% confidence interval: 0.31, 0.83)) in our data. Decision curve analysis showed the model only has added value in guiding clinical decision in a small range of threshold probabilities: 8%-20%. Despite reasonable discrimination, the prediction model has poor calibration in this external study cohort; thus, it may have limited clinical utility in settings outside of where it was derived. Decision curve analysis clarifies limitations in clinical utility not apparent by receiver operating characteristic curve analysis. This study highlights the importance of external validation of prediction models prior to routine use in clinical practice.

Validation of the Communication Skills Questionnaire (CSQ) in people with schizophrenia.

PubMed

Prat, Gemma; Casas-Anguera, Emma; Garcia-Franco, Mar; Escandell, Maria José; Martin, José Ramón; Vilamala, Sonia; Villalta-Gil, Victoria; Gimenez-Salinas, Jordi; Hernández-Rambla, Carla; Ochoa, Susana

2014-12-15

This present study describes the validation of the Communication Skills Questionnaire (CSQ) in people with schizophrenia. A total of 125 clinically stable people in rehabilitation treatment who were diagnosed with schizophrenia were included. For convergent and discriminant validity the following tests were administered; the Gambrill and Richie (GR) Assertiveness Inventory, the Social Functioning Scale (SFS), Life Skills Profile (LSP), Clinical Global Impression scale for schizophrenia (CGI-S) and the Global Assessment of Functioning (GAF) scale. Internal consistency of the CSQ had a Cronbach׳s alpha of 0.96. Test-retest reliability showed coefficients between 0.60 and 0.70. Convergent validity showed significant relations at p<0.0001 for all instruments assessed. None of the subscales used for assessing discriminant validity showed a significant correlation with the CSQ except for the CGI-S depression subscale. The instrument shows good psychometric properties and demonstrates that it is a useful instrument for evaluating communication skills in people with schizophrenia. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Preliminary validation of the Yale Food Addiction Scale.

PubMed

Gearhardt, Ashley N; Corbin, William R; Brownell, Kelly D

2009-04-01

Previous research has found similarities between addiction to psychoactive substances and excessive food consumption. Further exploration is needed to evaluate the concept of "food addiction," as there is currently a lack of psychometrically validated measurement tools in this area. The current study represents a preliminary exploration of the Yale Food Addiction Scale (YFAS), designed to identify those exhibiting signs of addiction towards certain types of foods (e.g., high fat and high sugar). Survey data were collected from 353 respondents from a stratified random sample of young adults. In addition to the YFAS, the survey assessed eating pathology, alcohol consumption and other health behaviors. The YFAS exhibited adequate internal reliability, and showed good convergent validity with measures of similar constructs and good discriminant validity relative to related but dissimilar constructs. Additionally, the YFAS predicted binge-eating behavior above and beyond existing measures of eating pathology, demonstrating incremental validity. The YFAS is a sound tool for identifying eating patterns that are similar to behaviors seen in classic areas of addiction. Further evaluation of the scale is needed, especially due to a low response rate of 24.5% and a non-clinical sample, but confirmation of the reliability and validity of the scale has the potential to facilitate empirical research on the concept of "food addiction".

Brazilian validation of the Alberta Infant Motor Scale.

PubMed

Valentini, Nadia Cristina; Saccani, Raquel

2012-03-01

The Alberta Infant Motor Scale (AIMS) is a well-known motor assessment tool used to identify potential delays in infants' motor development. Although Brazilian researchers and practitioners have used the AIMS in laboratories and clinical settings, its translation to Portuguese and validation for the Brazilian population is yet to be investigated. This study aimed to translate and validate all AIMS items with respect to internal consistency and content, criterion, and construct validity. A cross-sectional and longitudinal design was used. A cross-cultural translation was used to generate a Brazilian-Portuguese version of the AIMS. In addition, a validation process was conducted involving 22 professionals and 766 Brazilian infants (aged 0-18 months). The results demonstrated language clarity and internal consistency for the motor criteria (motor development score, α=.90; prone, α=.85; supine, α=.92; sitting, α=.84; and standing, α=.86). The analysis also revealed high discriminative power to identify typical and atypical development (motor development score, P<.001; percentile, P=.04; classification criterion, χ(2)=6.03; P=.05). Temporal stability (P=.07) (rho=.85, P<.001) was observed, and predictive power (P<.001) was limited to the group of infants aged from 3 months to 9 months. Limited predictive validity was observed, which may have been due to the restricted time that the groups were followed longitudinally. In sum, the translated version of AIMS presented adequate validity and reliability.

The Predictive Validity of Projective Measures.

ERIC Educational Resources Information Center

Suinn, Richard M.; Oskamp, Stuart

Written for use by clinical practitioners as well as psychological researchers, this book surveys recent literature (1950-1965) on projective test validity by reviewing and critically evaluating studies which shed light on what may reliably be predicted from projective test results. Two major instruments are covered: the Rorschach and the Thematic…

External validation of a Cox prognostic model: principles and methods

PubMed Central

2013-01-01

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

Cross-validation of clinical characteristics and treatment patterns associated with phenotypes for lithium response defined by the Alda scale.

PubMed

Scott, Jan; Geoffroy, Pierre Alexis; Sportiche, Sarah; Brichant-Petit-Jean, Clara; Gard, Sebastien; Kahn, Jean-Pierre; Azorin, Jean-Michel; Henry, Chantal; Etain, Bruno; Bellivier, Frank

2017-01-15

It is increasingly recognised that reliable and valid assessments of lithium response are needed in order to target more efficiently the use of this medication in bipolar disorders (BD) and to identify genotypes, endophenotypes and biomarkers of response. In a large, multi-centre, clinically representative sample of 300 cases of BD, we assess external clinical validators of lithium response phenotypes as defined using three different recommended approaches to scoring the Alda lithium response scale. The scale comprises an A scale (rating lithium response) and a B scale (assessing confounders). Analysis of the two continuous scoring methods (A scale score minus the B scale score, or A scale score in those with a low B scale score) demonstrated that 21-23% of the explained variance in lithium response was accounted for by a positive family history of BD I and the early introduction of lithium. Categorical definitions of response suggest poor response is also associated with a positive history of alcohol and/or substance use comorbidities. High B scale scores were significantly associated with longer duration of illness prior to receiving lithium and the presence of psychotic symptoms. The original sample was not recruited specifically to study lithium response. The Alda scale is designed to assess response retrospectively. This cross-validation study identifies different clinical phenotypes of lithium response when defined by continuous or categorical measures. Future clinical, genetic and biomarker studies should report both the findings and the method employed to assess lithium response according to the Alda scale. Copyright © 2016 Elsevier B.V. All rights reserved.

Validation of NOViSE.

PubMed

Korzeniowski, Przemyslaw; Brown, Daniel C; Sodergren, Mikael H; Barrow, Alastair; Bello, Fernando

2017-02-01

The goal of this study was to establish face, content, and construct validity of NOViSE-the first force-feedback enabled virtual reality (VR) simulator for natural orifice transluminal endoscopic surgery (NOTES). Fourteen surgeons and surgical trainees performed 3 simulated hybrid transgastric cholecystectomies using a flexible endoscope on NOViSE. Four of them were classified as "NOTES experts" who had independently performed 10 or more simulated or human NOTES procedures. Seven participants were classified as "Novices" and 3 as "Gastroenterologists" with no or minimal NOTES experience. A standardized 5-point Likert-type scale questionnaire was administered to assess the face and content validity. NOViSE showed good overall face and content validity. In 14 out of 15 statements pertaining to face validity (graphical appearance, endoscope and tissue behavior, overall realism), ≥50% of responses were "agree" or "strongly agree." In terms of content validity, 85.7% of participants agreed or strongly agreed that NOViSE is a useful training tool for NOTES and 71.4% that they would recommend it to others. Construct validity was established by comparing a number of performance metrics such as task completion times, path lengths, applied forces, and so on. NOViSE demonstrated early signs of construct validity. Experts were faster and used a shorter endoscopic path length than novices in all but one task. The results indicate that NOViSE authentically recreates a transgastric hybrid cholecystectomy and sets promising foundations for the further development of a VR training curriculum for NOTES without compromising patient safety or requiring expensive animal facilities.

NCI-FDA Interagency Oncology Task Force Workshop Provides Guidance for Analytical Validation of Protein-based Multiplex Assays | Office of Cancer Clinical Proteomics Research

Cancer.gov

An NCI-FDA Interagency Oncology Task Force (IOTF) Molecular Diagnostics Workshop was held on October 30, 2008 in Cambridge, MA, to discuss requirements for analytical validation of protein-based multiplex technologies in the context of its intended use. This workshop developed through NCI's Clinical Proteomic Technologies for Cancer initiative and the FDA focused on technology-specific analytical validation processes to be addressed prior to use in clinical settings. In making this workshop unique, a case study approach was used to discuss issues related to

Validation of the Social Appearance Anxiety Scale: factor, convergent, and divergent validity.

PubMed

Levinson, Cheri A; Rodebaugh, Thomas L

2011-09-01

The Social Appearance Anxiety Scale (SAAS) was created to assess fear of overall appearance evaluation. Initial psychometric work indicated that the measure had a single-factor structure and exhibited excellent internal consistency, test-retest reliability, and convergent validity. In the current study, the authors further examined the factor, convergent, and divergent validity of the SAAS in two samples of undergraduates. In Study 1 (N = 323), the authors tested the factor structure, convergent, and divergent validity of the SAAS with measures of the Big Five personality traits, negative affect, fear of negative evaluation, and social interaction anxiety. In Study 2 (N = 118), participants completed a body evaluation that included measurements of height, weight, and body fat content. The SAAS exhibited excellent convergent and divergent validity with self-report measures (i.e., self-esteem, trait anxiety, ethnic identity, and sympathy), predicted state anxiety experienced during the body evaluation, and predicted body fat content. In both studies, results confirmed a single-factor structure as the best fit to the data. These results lend additional support for the use of the SAAS as a valid measure of social appearance anxiety.

[Validity 'and Utilities' clinic of a grid observation (PACSLAC-F) to evaluate the pain in seniors with dementia's living in the Long-Term Care ].

PubMed

Aubin, Michèle; Verreault, René; Savoie, Maryse; LeMay, Sylvie; Hadjistavropoulos, Thomas; Fillion, Lise; Beaulieu, Marie; Viens, Chantal; Bergeron, Rénald; Vézina, Lucie; Misson, Lucie; Fuchs-Lacelle, Shannon

2008-01-01

This study presents the validation of the French Canadian version (PACLSAC-F) of the Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC). Unlike the published validation of the English version of the PACSLAC, which was validated retrospectively, the French version was validated prospectively. The PACSLAC-F was completed by nurses working in long-term care facilities after observing 86 seniors, with severe cognitive impairment, in calm, painful or distressing but non-painful situations. The test-retest and inter-observer reliability, the internal consistency, and the discriminent validity were found to be satisfactory. To evaluate the convergent validity with the DOLOPLUS-2 and the clinical relevance of the PACSLAC, it was also completed by nurses during their work shift, with 26 additional patients, for three days per week during a period of four weeks. These results encourage us to test the PACSLAC in a comprehensive program of pain management targeting this population.

Incremental Criterion Validity of the WJ-III COG Clinical Clusters: Marginal Predictive Effects beyond the General Factor

ERIC Educational Resources Information Center

McGill, Ryan J.

2015-01-01

The current study examined the incremental validity of the clinical clusters from the Woodcock-Johnson III Tests of Cognitive Abilities (WJ-III COG) for predicting scores on the Woodcock-Johnson III Tests of Achievement (WJ-III ACH). All participants were children and adolescents (N = 4,722) drawn from the nationally representative WJ-III…

Development and psychometric validation of a cystic fibrosis knowledge scale.

PubMed

Balfour, Louise; Armstrong, Michael; Holly, Crystal; Gaudet, Ena; Aaron, Shawn; Tasca, George; Cameron, William; Pakhale, Smita

2014-11-01

Well-developed and validated measures of cystic fibrosis (CF) knowledge are scarce. The purpose of the present study is to develop and validate a CF knowledge scale that is brief, easy to use, self-administered and demonstrates clinical utility. A comprehensive literature search generated a pool of scale items; an expert panel of CF team members reviewed and provided recommendations for item inclusion. A focus group of CF patients and family members (n = 12) then reviewed the items for face validity and reading clarity. To evaluate the validity and reliability of the newly developed CF knowledge scale, it was administered to several different samples including CF patients (n = 45), respirology patients (n = 100), health-care providers (n = 74) and university student samples (psychology students, n = 71; medical students, n = 36). Internal consistency of the scale was high, with an alpha coefficient for the overall sample of .95 (n = 326). The scale also demonstrated excellent construct validity. This study is an important first step in a line of research that aims to develop and empirically validate a psycho-educational adherence intervention for improving quality of life and treatment outcomes among adult CF patients. The CF knowledge scale has potential applications as a clinical teaching tool with patients and health-care providers and could be used as an outcome measure in CF educational intervention studies aimed at optimizing CF treatment knowledge, adherence and quality of life among CF patients. © 2014 Asian Pacific Society of Respirology.

The Myotonometer: Not a Valid Measurement Tool for Active Hamstring Musculotendinous Stiffness.

PubMed

Pamukoff, Derek N; Bell, Sarah E; Ryan, Eric D; Blackburn, J Troy

2016-05-01

Hamstring musculotendinous stiffness (MTS) is associated with lower-extremity injury risk (ie, hamstring strain, anterior cruciate ligament injury) and is commonly assessed using the damped oscillatory technique. However, despite a preponderance of studies that measure MTS reliably in laboratory settings, there are no valid clinical measurement tools. A valid clinical measurement technique is needed to assess MTS and permit identification of individuals at heightened risk of injury and track rehabilitation progress. To determine the validity and reliability of the Myotonometer for measuring active hamstring MTS. Descriptive laboratory study. Laboratory. 33 healthy participants (15 men, age 21.33 ± 2.94 y, height 172.03 ± 16.36 cm, mass 74.21 ± 16.36 kg). Hamstring MTS was assessed using the damped oscillatory technique and the Myotonometer. Intraclass correlations were used to determine the intrasession, intersession, and interrater reliability of the Myotonometer. Criterion validity was assessed via Pearson product-moment correlation between MTS measures obtained from the Myotonometer and from the damped oscillatory technique. The Myotonometer demonstrated good intrasession (ICC3,1 = .807) and interrater reliability (ICC2,k = .830) and moderate intersession reliability (ICC2,k = .693). However, it did not provide a valid measurement of MTS compared with the damped oscillatory technique (r = .346, P = .061). The Myotonometer does not provide a valid measure of active hamstring MTS. Although the Myotonometer does not measure active MTS, it possesses good reliability and portability and could be used clinically to measure tissue compliance, muscle tone, or spasticity associated with multiple musculoskeletal disorders. Future research should focus on portable and clinically applicable tools to measure active hamstring MTS in efforts to prevent and monitor injuries.

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

PubMed

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

2015-12-18

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

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

PubMed

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

2016-01-01

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

Lesson 6: Signature Validation

EPA Pesticide Factsheets

Checklist items 13 through 17 are grouped under the Signature Validation Process, and represent CROMERR requirements that the system must satisfy as part of ensuring that electronic signatures it receives are valid.

Identification and Validation of Established and Novel Biomarkers for Infections in Burns

DTIC Science & Technology

2017-10-01

in burn patients have been proposed, but not validated. In our four site study , we are enrolling severely burned adults and children , and...identify the early stages of infection prior to clinical detection. This multicenter study will enable us to identify novel biomarkers, validate whether...a multicenter study 3. Develop a model of prediction of infection using clinical data and proteomic information. Relevance: 5% of combat-sustained

Validation of the secretion severity rating scale.

PubMed

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

2016-10-01

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

External Validation and Comparison of Three Pediatric Clinical Dehydration Scales

PubMed Central

Jauregui, Joshua; Nelson, Daniel; Choo, Esther; Stearns, Branden; Levine, Adam C.; Liebmann, Otto; Shah, Sachita P.

2014-01-01

Objective To prospectively validate three popular clinical dehydration scales and overall physician gestalt in children with vomiting or diarrhea relative to the criterion standard of percent weight change with rehydration. Methods We prospectively enrolled a non-consecutive cohort of children ≤ 18 years of age with an acute episode of diarrhea or vomiting. Patient weight, clinical scale variables and physician clinical impression, or gestalt, were recorded before and after fluid resuscitation in the emergency department and upon hospital discharge. The percent weight change from presentation to discharge was used to calculate the degree of dehydration, with a weight change of ≥ 5% considered significant dehydration. Receiver operating characteristics (ROC) curves were constructed for each of the three clinical scales and physician gestalt. Sensitivity and specificity were calculated based on the best cut-points of the ROC curve. Results We approached 209 patients, and of those, 148 were enrolled and 113 patients had complete data for analysis. Of these, 10.6% had significant dehydration based on our criterion standard. The Clinical Dehydration Scale (CDS) and Gorelick scales both had an area under the ROC curve (AUC) statistically different from the reference line with AUCs of 0.72 (95% CI 0.60, 0.84) and 0.71 (95% CI 0.57, 0.85) respectively. The World Health Organization (WHO) scale and physician gestalt had AUCs of 0.61 (95% CI 0.45, 0.77) and 0.61 (0.44, 0.78) respectively, which were not statistically significant. Conclusion The Gorelick scale and Clinical Dehydration Scale were fair predictors of dehydration in children with diarrhea or vomiting. The World Health Organization scale and physician gestalt were not helpful predictors of dehydration in our cohort. PMID:24788134

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 Psychosocial Factors Related to Breast Cancer Screening.

ERIC Educational Resources Information Center

Zapka, Jane G.; And Others

1991-01-01

The construct validity of hypothesized survey items and data reduction procedures for selected psychosocial constructs frequently used in breast cancer screening research were investigated in telephone interviews with randomly selected samples of 1,184 and 903 women and a sample of 169 Hispanic clinic clients. Validity of the constructs is…

Application of validity theory and methodology to patient-reported outcome measures (PROMs): building an argument for validity.

PubMed

Hawkins, Melanie; Elsworth, Gerald R; Osborne, Richard H

2018-07-01

Data from subjective patient-reported outcome measures (PROMs) are now being used in the health sector to make or support decisions about individuals, groups and populations. Contemporary validity theorists define validity not as a statistical property of the test but as the extent to which empirical evidence supports the interpretation of test scores for an intended use. However, validity testing theory and methodology are rarely evident in the PROM validation literature. Application of this theory and methodology would provide structure for comprehensive validation planning to support improved PROM development and sound arguments for the validity of PROM score interpretation and use in each new context. This paper proposes the application of contemporary validity theory and methodology to PROM validity testing. The validity testing principles will be applied to a hypothetical case study with a focus on the interpretation and use of scores from a translated PROM that measures health literacy (the Health Literacy Questionnaire or HLQ). Although robust psychometric properties of a PROM are a pre-condition to its use, a PROM's validity lies in the sound argument that a network of empirical evidence supports the intended interpretation and use of PROM scores for decision making in a particular context. The health sector is yet to apply contemporary theory and methodology to PROM development and validation. The theoretical and methodological processes in this paper are offered as an advancement of the theory and practice of PROM validity testing in the health sector.

49 CFR 1522.117 - Qualifications of validators.

Code of Federal Regulations, 2010 CFR

2010-10-01

...-APPROVED VALIDATION FIRMS AND VALIDATORS TSA-Approved Validation Firms and Validators for the Certified... that address his or her abilities in inspection, validation, and written communications. (4) The...

Validity and Reliability of Clinical Examination in the Diagnosis of Myofascial Pain Syndrome and Myofascial Trigger Points in Upper Quarter Muscles.

PubMed

Mayoral Del Moral, Orlando; Torres Lacomba, María; Russell, I Jon; Sánchez Méndez, Óscar; Sánchez Sánchez, Beatriz

2017-12-15

To determine whether two independent examiners can agree on a diagnosis of myofascial pain syndrome (MPS). To evaluate interexaminer reliability in identifying myofascial trigger points in upper quarter muscles. To evaluate the reliability of clinical diagnostic criteria for the diagnosis of MPS. To evaluate the validity of clinical diagnostic criteria for the diagnosis of MPS. Validity and reliability study. Provincial Hospital. Toledo, Spain. Twenty myofascial pain syndrome patients and 20 healthy, normal control subjects, enrolled by a trained and experienced examiner. Ten bilateral muscles from the upper quarter were evaluated by two experienced examiners. The second examiner was blinded to the diagnosis group. The MPS diagnosis required at least one muscle to have an active myofascial trigger point. Three to four days separated the two examinations. The primary outcome measure was the frequency with which the two examiners agreed on the classification of the subjects as patients or as healthy controls. The kappa statistic (K) was used to determine the level of agreement between both examinations, interpreted as very good (0.81-1.00), good (0.61-0.80), moderate (0.41-0.60), fair (0.21-0.40), or poor (≤0.20). Interexaminer reliability for identifying subjects with MPS was very good (K = 1.0). Interexaminer reliability for identifying muscles leading to a diagnosis of MPS was also very good (K = 0.81). Sensitivity and specificity showed high values for most examination tests in all muscles, which confirms the validity of clinical diagnostic criteria in the diagnosis of MPS. Interrater reliability between two expert examiners identifying subjects with MPS involving upper quarter muscles exhibited substantial agreement. These results suggest that clinical criteria can be valid and reliable in the diagnosis of this condition. © 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Minnesota Impulse Disorders Interview (MIDI): Validation of a structured diagnostic clinical interview for impulse control disorders in an enriched community sample.

PubMed

Chamberlain, Samuel R; Grant, Jon E

2018-07-01

Disorders of impulsivity are common, functionally impairing, and highly relevant across different clinical and research settings. Few structured clinical interviews for the identification and diagnosis of impulse control disorders exist, and none have been validated in a community sample in terms of psychometric properties. The Minnesota Impulse control disorders Interview (MIDI v2.0) was administered to an enriched sample of 293 non-treatment seeking adults aged 18-35 years, recruited using media advertisements in two large US cities. In addition to the MIDI, participants undertook extended clinical interview for other mental disorders, the Barratt impulsiveness questionnaire, and the Padua obsessive-compulsive inventory. The psychometric properties of the MIDI were characterized. In logistic regression, the MIDI showed good concurrent validity against the reference measures (versus gambling disorder interview, p < 0.001; Barratt impulsiveness attentional and non-planning scores p < 0.05), and good discriminant validity versus primarily non-impulsive symptoms, including against anxiety, depression, and obsessive-compulsive symptoms (all p > 0.05). Test re-test reliability was excellent (0.95). The MIDI has good psychometric properties and thus may be a valuable interview tool for clinical and research studies involving impulse control disorders. Further research is needed to better understanding the optimal diagnostic classification and neurobiology of these neglected disorders. Crown Copyright © 2018. Published by Elsevier B.V. All rights reserved.

Performance of a Cartridge-Based Assay for Detection of Clinically Significant Human Papillomavirus (HPV) Infection: Lessons from VALGENT (Validation of HPV Genotyping Tests)

PubMed Central

Geraets, Daan; Cuzick, Jack; Cadman, Louise; Moore, Catherine; Vanden Broeck, Davy; Padalko, Elisaveta; Quint, Wim; Arbyn, Marc

2016-01-01

The Validation of Human Papillomavirus (HPV) Genotyping Tests (VALGENT) studies offer an opportunity to clinically validate HPV assays for use in primary screening for cervical cancer and also provide a framework for the comparison of analytical and type-specific performance. Through VALGENT, we assessed the performance of the cartridge-based Xpert HPV assay (Xpert HPV), which detects 14 high-risk (HR) types and resolves HPV16 and HPV18/45. Samples from women attending the United Kingdom cervical screening program enriched with cytologically abnormal samples were collated. All had been previously tested by a clinically validated standard comparator test (SCT), the GP5+/6+ enzyme immunoassay (EIA). The clinical sensitivity and specificity of the Xpert HPV for the detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) and CIN3+ relative to those of the SCT were assessed as were the inter- and intralaboratory reproducibilities according to international criteria for test validation. Type concordance for HPV16 and HPV18/45 between the Xpert HPV and the SCT was also analyzed. The Xpert HPV detected 94% of CIN2+ and 98% of CIN3+ lesions among all screened women and 90% of CIN2+ and 96% of CIN3+ lesions in women 30 years and older. The specificity for CIN1 or less (≤CIN1) was 83% (95% confidence interval [CI], 80 to 85%) in all women and 88% (95% CI, 86 to 91%) in women 30 years and older. Inter- and intralaboratory agreements for the Xpert HPV were 98% and 97%, respectively. The kappa agreements for HPV16 and HPV18/45 between the clinically validated reference test (GP5+/6+ LMNX) and the Xpert HPV were 0.92 and 0.91, respectively. The clinical performance and reproducibility of the Xpert HPV are comparable to those of well-established HPV assays and fulfill the criteria for use in primary cervical cancer screening. PMID:27385707

Designing and validation of a yoga-based intervention for schizophrenia.

PubMed

Govindaraj, Ramajayam; Varambally, Shivarama; Sharma, Manjunath; Gangadhar, Bangalore Nanjundaiah

2016-06-01

Schizophrenia is a chronic mental illness which causes significant distress and dysfunction. Yoga has been found to be effective as an add-on therapy in schizophrenia. Modules of yoga used in previous studies were based on individual researcher's experience. This study aimed to develop and validate a specific generic yoga-based intervention module for patients with schizophrenia. The study was conducted at NIMHANS Integrated Centre for Yoga (NICY). A yoga module was designed based on traditional and contemporary yoga literature as well as published studies. The yoga module along with three case vignettes of adult patients with schizophrenia was sent to 10 yoga experts for their validation. Experts (n = 10) gave their opinion on the usefulness of a yoga module for patients with schizophrenia with some modifications. In total, 87% (13 of 15 items) of the items in the initial module were retained, with modification in the remainder as suggested by the experts. A specific yoga-based module for schizophrenia was designed and validated by experts. Further studies are needed to confirm efficacy and clinical utility of the module. Additional clinical validation is suggested.

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

Validation of a quality-of-life instrument for patients with nonmelanoma skin cancer.

PubMed

Rhee, John S; Matthews, B Alex; Neuburg, Marcy; Logan, Brent R; Burzynski, Mary; Nattinger, Ann B

2006-01-01

To validate a disease-specific quality-of-life instrument--the Skin Cancer Index--intended to measure quality-of-life issues relevant to patients with nonmelanoma skin cancer. Internal reliability, convergent and divergent validity with existing scales, and factor analyses were performed in a cross-sectional study of 211 patients presenting with cervicofacial nonmelanoma skin cancer to a dermatologic surgery clinic. Factor analyses of the Skin Cancer Index confirmed a multidimensional scale with 3 distinct subscales-emotional, social, and appearance. Excellent internal validity of the 3 subscales was demonstrated. Substantial evidence was observed for convergent validity with the Dermatology Life Quality Index, Rosenberg Self-Esteem Scale, Lerman's Cancer Worry Scale, and Medical Outcomes Survey Short-Form 12 domains for vitality, emotion, social function, and mental health. These findings validate a new disease-specific quality-of-life instrument for patients with cervicofacial nonmelanoma skin cancer. Studies on the responsiveness of the Skin Cancer Index to clinical intervention are currently under way.