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…

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.

Embedded performance validity testing in neuropsychological assessment: Potential clinical tools.

PubMed

Rickards, Tyler A; Cranston, Christopher C; Touradji, Pegah; Bechtold, Kathleen T

2018-01-01

The article aims to suggest clinically-useful tools in neuropsychological assessment for efficient use of embedded measures of performance validity. To accomplish this, we integrated available validity-related and statistical research from the literature, consensus statements, and survey-based data from practicing neuropsychologists. We provide recommendations for use of 1) Cutoffs for embedded performance validity tests including Reliable Digit Span, California Verbal Learning Test (Second Edition) Forced Choice Recognition, Rey-Osterrieth Complex Figure Test Combination Score, Wisconsin Card Sorting Test Failure to Maintain Set, and the Finger Tapping Test; 2) Selecting number of performance validity measures to administer in an assessment; and 3) Hypothetical clinical decision-making models for use of performance validity testing in a neuropsychological assessment collectively considering behavior, patient reporting, and data indicating invalid or noncredible performance. Performance validity testing helps inform the clinician about an individual's general approach to tasks: response to failure, task engagement and persistence, compliance with task demands. Data-driven clinical suggestions provide a resource to clinicians and to instigate conversation within the field to make more uniform, testable decisions to further the discussion, and guide future research in this area.

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.

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.

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.

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.

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.

Development and validation of a Clinical Assessment Tool for Nursing Education (CAT-NE).

PubMed

Skúladóttir, Hafdís; Svavarsdóttir, Margrét Hrönn

2016-09-01

The aim of this study was to develop a valid assessment tool to guide clinical education and evaluate students' performance in clinical nursing education. The development of the Clinical Assessment Tool for Nursing Education (CAT-NE) was based on the theory of nursing as professional caring and the Bologna learning outcomes. Benson and Clark's four steps of instrument development and validation guided the development and assessment of the tool. A mixed-methods approach with individual structured cognitive interviewing and quantitative assessments was used to validate the tool. Supervisory teachers, a pedagogical consultant, clinical expert teachers, clinical teachers, and nursing students at the University of Akureyri in Iceland participated in the process. This assessment tool is valid to assess the clinical performance of nursing students; it consists of rubrics that list the criteria for the students' expected performance. According to the students and their clinical teachers, the assessment tool clarified learning objectives, enhanced the focus of the assessment process, and made evaluation more objective. Training clinical teachers on how to assess students' performances in clinical studies and use the tool enhanced the quality of clinical assessment in nursing education. Copyright © 2016 Elsevier Ltd. All rights reserved.

Fluorescence In Situ Hybridization Probe Validation for Clinical Use.

PubMed

Gu, Jun; Smith, Janice L; Dowling, Patricia K

2017-01-01

In this chapter, we provide a systematic overview of the published guidelines and validation procedures for fluorescence in situ hybridization (FISH) probes for clinical diagnostic use. FISH probes-which are classified as molecular probes or analyte-specific reagents (ASRs)-have been extensively used in vitro for both clinical diagnosis and research. Most commercially available FISH probes in the United States are strictly regulated by the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS) the Clinical Laboratory Improvement Amendments (CLIA), and the College of American Pathologists (CAP). Although home-brewed FISH probes-defined as probes made in-house or acquired from a source that does not supply them to other laboratories-are not regulated by these agencies, they too must undergo the same individual validation process prior to clinical use as their commercial counterparts. Validation of a FISH probe involves initial validation and ongoing verification of the test system. Initial validation includes assessment of a probe's technical specifications, establishment of its standard operational procedure (SOP), determination of its clinical sensitivity and specificity, development of its cutoff, baseline, and normal reference ranges, gathering of analytics, confirmation of its applicability to a specific research or clinical setting, testing of samples with or without the abnormalities that the probe is meant to detect, staff training, and report building. Ongoing verification of the test system involves testing additional normal and abnormal samples using the same method employed during the initial validation of the probe.

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.

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.

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…

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 for cancer immunotherapy. To illustrate the requirements for validation, we discuss examples of biomarker assays that have shown preliminary evidence of an association with clinical benefit from immunotherapeutic interventions. The scope includes only those assays and technologies that have established a certain level of validation for clinical use (fit-for-purpose). Recommendations to meet challenges and strategies to guide the choice of analytical and clinical validation design for specific assays are also provided.

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 and clinical utility of purging disorder.

PubMed

Keel, Pamela K; Striegel-Moore, Ruth H

2009-12-01

To review evidence of the validity and clinical utility of Purging Disorder and examine options for the Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-V). Articles were identified by computerized and manual searches and reviewed to address five questions about Purging Disorder: Is there "ample" literature? Is the syndrome clearly defined? Can it be measured and diagnosed reliably? Can it be differentiated from other eating disorders? Is there evidence of syndrome validity? Although empirical classification and concurrent validity studies provide emerging support for the distinctiveness of Purging Disorder, questions remain about definition, diagnostic reliability in clinical settings, and clinical utility (i.e., prognostic validity). We discuss strengths and weaknesses associated with various options for the status of Purging Disorder in the DSM-V ranging from making no changes from DSM-IV to designating Purging Disorder a diagnosis on equal footing with Anorexia Nervosa and Bulimia Nervosa.

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.

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.

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.

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.

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…

Validation of a Plasma-Based Comprehensive Cancer Genotyping Assay Utilizing Orthogonal Tissue- and Plasma-Based Methodologies.

PubMed

Odegaard, Justin I; Vincent, John J; Mortimer, Stefanie; Vowles, James V; Ulrich, Bryan C; Banks, Kimberly C; Fairclough, Stephen R; Zill, Oliver A; Sikora, Marcin; Mokhtari, Reza; Abdueva, Diana; Nagy, Rebecca J; Lee, Christine E; Kiedrowski, Lesli A; Paweletz, Cloud P; Eltoukhy, Helmy; Lanman, Richard B; Chudova, Darya I; Talasaz, AmirAli

2018-04-24

Purpose: To analytically and clinically validate a circulating cell-free tumor DNA sequencing test for comprehensive tumor genotyping and demonstrate its clinical feasibility. Experimental Design: Analytic validation was conducted according to established principles and guidelines. Blood-to-blood clinical validation comprised blinded external comparison with clinical droplet digital PCR across 222 consecutive biomarker-positive clinical samples. Blood-to-tissue clinical validation comprised comparison of digital sequencing calls to those documented in the medical record of 543 consecutive lung cancer patients. Clinical experience was reported from 10,593 consecutive clinical samples. Results: Digital sequencing technology enabled variant detection down to 0.02% to 0.04% allelic fraction/2.12 copies with ≤0.3%/2.24-2.76 copies 95% limits of detection while maintaining high specificity [prevalence-adjusted positive predictive values (PPV) >98%]. Clinical validation using orthogonal plasma- and tissue-based clinical genotyping across >750 patients demonstrated high accuracy and specificity [positive percent agreement (PPAs) and negative percent agreement (NPAs) >99% and PPVs 92%-100%]. Clinical use in 10,593 advanced adult solid tumor patients demonstrated high feasibility (>99.6% technical success rate) and clinical sensitivity (85.9%), with high potential actionability (16.7% with FDA-approved on-label treatment options; 72.0% with treatment or trial recommendations), particularly in non-small cell lung cancer, where 34.5% of patient samples comprised a directly targetable standard-of-care biomarker. Conclusions: High concordance with orthogonal clinical plasma- and tissue-based genotyping methods supports the clinical accuracy of digital sequencing across all four types of targetable genomic alterations. Digital sequencing's clinical applicability is further supported by high rates of technical success and biomarker target discovery. Clin Cancer Res; 1-11. ©2018 AACR. ©2018 American Association for Cancer Research.

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.

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.

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.

Teaching method validation in the clinical laboratory science curriculum.

PubMed

Moon, Tara C; Legrys, Vicky A

2008-01-01

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

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.

Development and psychometric properties rating scale of “clinical competency evaluation in mental health nurses”: Exploratory factor analysis

PubMed Central

Moskoei, Sara; Mohtashami, Jamileh; Ghalenoeei, Mahdie; Nasiri, Maliheh; Tafreshi, Mansoreh Zaghari

2017-01-01

Introduction Evaluation of clinical competency in nurses has a distinct importance in healthcare due to its significant impact on improving the quality of patient care and creation of opportunities for professional promotion. This is a psychometric study for development of the “Clinical Competency of Mental Health Nursing”(CCMHN) rating scale. Methods In this methodological research that was conducted in 2015, in Tehran, Iran, the main items were developed after literature review and the validity and reliability of the tool were identified. The face, content (content validity ratio and content validity index) and construct validities were calculated. For face and content validity, experts’ comments were used. Exploratory factor analysis was used to determine the construct validity. The reliability of scale was determined by the internal consistency and inter-rater correlation. The collected data were analyzed by SPSS version 16, using descriptive statistical analysis. Results A scale with 45 items in two parts including Emotional/Moral and Specific Care competencies was developed. Content validity ratio and content validity index were 0.88, 0.97 respectively. Exploratory factor analysis indicated two factors: The first factor with 23.93 eigenvalue and second factor with eigenvalue 2.58. Cronbach’s alpha coefficient for determination of internal consistency was 0.98 and the ICC for confirmation inter-rater correlation was 0.98. Conclusion A scale with 45 items and two areas was developed with appropriate validity and reliability. This scale can be used to assess the clinical competency in nursing students and mental health nurses. PMID:28607650

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.

The Added Value of the Combined Use of the Autism Diagnostic Interview-Revised and the Autism Diagnostic Observation Schedule: Diagnostic Validity in a Clinical Swedish Sample of Toddlers and Young Preschoolers

ERIC Educational Resources Information Center

Zander, Eric; Sturm, Harald; Bölte, Sven

2015-01-01

The diagnostic validity of the new research algorithms of the Autism Diagnostic Interview-Revised and the revised algorithms of the Autism Diagnostic Observation Schedule was examined in a clinical sample of children aged 18-47 months. Validity was determined for each instrument separately and their combination against a clinical consensus…

Development and psychometric testing of a Clinical Reasoning Evaluation Simulation Tool (CREST) for assessing nursing students' abilities to recognize and respond to clinical deterioration.

PubMed

Liaw, Sok Ying; Rashasegaran, Ahtherai; Wong, Lai Fun; Deneen, Christopher Charles; Cooper, Simon; Levett-Jones, Tracy; Goh, Hongli Sam; Ignacio, Jeanette

2018-03-01

The development of clinical reasoning skills in recognising and responding to clinical deterioration is essential in pre-registration nursing education. Simulation has been increasingly used by educators to develop this skill. To develop and evaluate the psychometric properties of a Clinical Reasoning Evaluation Simulation Tool (CREST) for measuring clinical reasoning skills in recognising and responding to clinical deterioration in a simulated environment. A scale development with psychometric testing and mixed methods study. Nursing students and academic staff were recruited at a university. A three-phase prospective study was conducted. Phase 1 involved the development and content validation of the CREST; Phase 2 included the psychometric testing of the tool with 15 second-year and 15 third-year nursing students who undertook the simulation-based assessment; Phase 3 involved the usability testing of the tool with nine academic staff through a survey questionnaire and focus group discussion. A 10-item CREST was developed based on a model of clinical reasoning. A content validity of 0.93 was obtained from the validation of 15 international experts. The construct validity was supported as the third-year students demonstrated significantly higher (p<0.001) clinical reasoning scores than the second-year students. The concurrent validity was also supported with significant positive correlations between global rating scores and almost all subscale scores, and the total scores. The predictive validity was supported with an existing tool. The internal consistency was high with a Cronbach's alpha of 0.92. A high inter-rater reliability was demonstrated with an intraclass correlation coefficient of 0.88. The usability of the tool was rated positively by the nurse educators but the need to ease the scoring process was highlighted. A valid and reliable tool was developed to measure the effectiveness of simulation in developing clinical reasoning skills for recognising and responding to clinical deterioration. Copyright © 2017. Published by Elsevier Ltd.

Validation of biomarkers to predict response to immunotherapy in cancer: Volume II - clinical validation and regulatory considerations.

PubMed

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

2016-01-01

There is growing recognition that immunotherapy is likely to significantly improve health outcomes for cancer patients in the coming years. Currently, while a subset of patients experience substantial clinical benefit in response to different immunotherapeutic approaches, the majority of patients do not but are still exposed to the significant drug toxicities. Therefore, a growing need for the development and clinical use of predictive biomarkers exists in the field of cancer immunotherapy. Predictive cancer biomarkers can be used to identify the patients who are or who are not likely to derive benefit from specific therapeutic approaches. In order to be applicable in a clinical setting, predictive biomarkers must be carefully shepherded through a step-wise, highly regulated developmental process. Volume I of this two-volume document focused on the pre-analytical and analytical phases of the biomarker development process, by providing background, examples and "good practice" recommendations. In the current Volume II, the focus is on the clinical validation, validation of clinical utility and regulatory considerations for biomarker development. Together, this two volume series is meant to provide guidance on the entire biomarker development process, with a particular focus on the unique aspects of developing immune-based biomarkers. Specifically, knowledge about the challenges to clinical validation of predictive biomarkers, which has been gained from numerous successes and failures in other contexts, will be reviewed together with statistical methodological issues related to bias and overfitting. The different trial designs used for the clinical validation of biomarkers will also be discussed, as the selection of clinical metrics and endpoints becomes critical to establish the clinical utility of the biomarker during the clinical validation phase of the biomarker development. Finally, the regulatory aspects of submission of biomarker assays to the U.S. Food and Drug Administration as well as regulatory considerations in the European Union will be covered.

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.

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.

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.

[Computerized system validation of clinical researches].

PubMed

Yan, Charles; Chen, Feng; Xia, Jia-lai; Zheng, Qing-shan; Liu, Daniel

2015-11-01

Validation is a documented process that provides a high degree of assurance. The computer system does exactly and consistently what it is designed to do in a controlled manner throughout the life. The validation process begins with the system proposal/requirements definition, and continues application and maintenance until system retirement and retention of the e-records based on regulatory rules. The objective to do so is to clearly specify that each application of information technology fulfills its purpose. The computer system validation (CSV) is essential in clinical studies according to the GCP standard, meeting product's pre-determined attributes of the specifications, quality, safety and traceability. This paper describes how to perform the validation process and determine relevant stakeholders within an organization in the light of validation SOPs. Although a specific accountability in the implementation of the validation process might be outsourced, the ultimate responsibility of the CSV remains on the shoulder of the business process owner-sponsor. In order to show that the compliance of the system validation has been properly attained, it is essential to set up comprehensive validation procedures and maintain adequate documentations as well as training records. Quality of the system validation should be controlled using both QC and QA means.

Circulating Tumor DNA Analysis in Patients With Cancer: American Society of Clinical Oncology and College of American Pathologists Joint Review.

PubMed

Merker, Jason D; Oxnard, Geoffrey R; Compton, Carolyn; Diehn, Maximilian; Hurley, Patricia; Lazar, Alexander J; Lindeman, Neal; Lockwood, Christina M; Rai, Alex J; Schilsky, Richard L; Tsimberidou, Apostolia M; Vasalos, Patricia; Billman, Brooke L; Oliver, Thomas K; Bruinooge, Suanna S; Hayes, Daniel F; Turner, Nicholas C

2018-06-01

Purpose Clinical use of analytical tests to assess genomic variants in circulating tumor DNA (ctDNA) is increasing. This joint review from ASCO and the College of American Pathologists summarizes current information about clinical ctDNA assays and provides a framework for future research. Methods An Expert Panel conducted a literature review on the use of ctDNA assays for solid tumors, including pre-analytical variables, analytical validity, interpretation and reporting, and clinical validity and utility. Results The literature search identified 1,338 references. Of those, 390, plus 31 references supplied by the Expert Panel, were selected for full-text review. There were 77 articles selected for inclusion. Conclusion The evidence indicates that testing for ctDNA is optimally performed on plasma collected in cell stabilization or EDTA tubes, with EDTA tubes processed within 6 hours of collection. Some ctDNA assays have demonstrated clinical validity and utility with certain types of advanced cancer; however, there is insufficient evidence of clinical validity and utility for the majority of ctDNA assays in advanced cancer. Evidence shows discordance between the results of ctDNA assays and genotyping tumor specimens and supports tumor tissue genotyping to confirm undetected results from ctDNA tests. There is no evidence of clinical utility and little evidence of clinical validity of ctDNA assays in early-stage cancer, treatment monitoring, or residual disease detection. There is no evidence of clinical validity and clinical utility to suggest that ctDNA assays are useful for cancer screening, outside of a clinical trial. Given the rapid pace of research, re-evaluation of the literature will shortly be required, along with the development of tools and guidance for clinical practice.

Methodology Series Module 9: Designing Questionnaires and Clinical Record Forms - Part II.

PubMed

Setia, Maninder Singh

2017-01-01

This article is a continuation of the previous module on designing questionnaires and clinical record form in which we have discussed some basic points about designing the questionnaire and clinical record forms. In this section, we will discuss the reliability and validity of questionnaires. The different types of validity are face validity, content validity, criterion validity, and construct validity. The different types of reliability are test-retest reliability, inter-rater reliability, and intra-rater reliability. Some of these parameters are assessed by subject area experts. However, statistical tests should be used for evaluation of other parameters. Once the questionnaire has been designed, the researcher should pilot test the questionnaire. The items in the questionnaire should be changed based on the feedback from the pilot study participants and the researcher's experience. After the basic structure of the questionnaire has been finalized, the researcher should assess the validity and reliability of the questionnaire or the scale. If an existing standard questionnaire is translated in the local language, the researcher should assess the reliability and validity of the translated questionnaire, and these values should be presented in the manuscript. The decision to use a self- or interviewer-administered, paper- or computer-based questionnaire depends on the nature of the questions, literacy levels of the target population, and resources.

Methodology Series Module 9: Designing Questionnaires and Clinical Record Forms – Part II

PubMed Central

Setia, Maninder Singh

2017-01-01

This article is a continuation of the previous module on designing questionnaires and clinical record form in which we have discussed some basic points about designing the questionnaire and clinical record forms. In this section, we will discuss the reliability and validity of questionnaires. The different types of validity are face validity, content validity, criterion validity, and construct validity. The different types of reliability are test-retest reliability, inter-rater reliability, and intra-rater reliability. Some of these parameters are assessed by subject area experts. However, statistical tests should be used for evaluation of other parameters. Once the questionnaire has been designed, the researcher should pilot test the questionnaire. The items in the questionnaire should be changed based on the feedback from the pilot study participants and the researcher's experience. After the basic structure of the questionnaire has been finalized, the researcher should assess the validity and reliability of the questionnaire or the scale. If an existing standard questionnaire is translated in the local language, the researcher should assess the reliability and validity of the translated questionnaire, and these values should be presented in the manuscript. The decision to use a self- or interviewer-administered, paper- or computer-based questionnaire depends on the nature of the questions, literacy levels of the target population, and resources. PMID:28584367

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.

Development and Validation of a Photonumeric Scale for Evaluation of Volume Deficit of the Hand

PubMed Central

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

2016-01-01

BACKGROUND A validated scale is needed for objective and reproducible comparisons of hand appearance before and after treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Hand Volume Deficit 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 = 296) completed during 2 sessions occurring 3 weeks apart. RESULTS A score difference of ≥1 point was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.12 [0.99–1.26] for clinically different image pairs and 0.45 [0.33–0.57] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (mean weighted kappa = 0.83). Interrater agreement was almost perfect during the second session (0.82, primary end point). CONCLUSION The Allergan Hand Volume Deficit Scale is a validated and reliable scale for physician rating of hand volume deficit. PMID:27661741

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

Development and Validation of a Photonumeric Scale for Evaluation of Volume Deficit of the Temple

PubMed Central

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

2016-01-01

BACKGROUND A validated scale is needed for objective and reproducible comparisons of temple appearance before and after aesthetic treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Temple Hollowing 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 = 298) completed during 2 sessions occurring 3 weeks apart. RESULTS A score difference of ≥1 point was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.1 [0.94–1.26] for clinically different image pairs and 0.67 [0.51–0.83] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (mean weighted kappa = 0.86). Interrater agreement was almost perfect during the second session (0.81, primary endpoint). CONCLUSION The Allergan Temple Hollowing Scale is a validated and reliable scale for physician rating of temple volume deficit. PMID:27661742

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.

Development and testing of the CALDs and CLES+T scales for international nursing students' clinical learning environments.

PubMed

Mikkonen, Kristina; Elo, Satu; Miettunen, Jouko; Saarikoski, Mikko; Kääriäinen, Maria

2017-08-01

The purpose of this study was to develop and test the psychometric properties of the new Cultural and Linguistic Diversity scale, which is designed to be used with the newly validated Clinical Learning Environment, Supervision and Nurse Teacher scale for assessing international nursing students' clinical learning environments. In various developed countries, clinical placements are known to present challenges in the professional development of international nursing students. A cross-sectional survey. Data were collected from eight Finnish universities of applied sciences offering nursing degree courses taught in English during 2015-2016. All the relevant students (N = 664) were invited and 50% chose to participate. Of the total data submitted by the participants, 28% were used for scale validation. The construct validity of the two scales was tested by exploratory factor analysis, while their validity with respect to convergence and discriminability was assessed using Spearman's correlation. Construct validation of the Clinical Learning Environment, Supervision and Nurse Teacher scale yielded an eight-factor model with 34 items, while validation of the Cultural and Linguistic Diversity scale yielded a five-factor model with 21 items. A new scale was developed to improve evidence-based mentorship of international nursing students in clinical learning environments. The instrument will be useful to educators seeking to identify factors that affect the learning of international students. © 2017 John Wiley & Sons Ltd.

[Design and validation of an instrument to assess families at risk for health problems].

PubMed

Puschel, Klaus; Repetto, Paula; Solar, María Olga; Soto, Gabriela; González, Karla

2012-04-01

There is a paucity of screening instruments with a high clinical predictive value to identify families at risk and therefore, develop focused interventions in primary care. To develop an easy to apply screening instrument with a high clinical predictive value to identify families with a higher health vulnerability. In the first stage of the study an instrument with a high content validity was designed through a review of existent instruments, qualitative interviews with families and expert opinions following a Delphi approach of three rounds. In the second stage, concurrent validity was tested through a comparative analysis between the pilot instrument and a family clinical interview conducted to 300 families randomly selected from a population registered at a primary care clinic in Santiago. The sampling was blocked based on the presence of diabetes, depression, child asthma, behavioral disorders, presence of an older person or the lack of previous conditions among family members. The third stage, was directed to test the clinical predictive validity of the instrument by comparing the baseline vulnerability obtained by the instrument and the change in clinical status and health related quality of life perceptions of the family members after nine months of follow-up. The final SALUFAM instrument included 13 items and had a high internal consistency (Cronbach's alpha: 0.821), high test re-test reproducibility (Pearson correlation: 0.84) and a high clinical predictive value for clinical deterioration (Odds ratio: 1.826; 95% confidence intervals: 1.101-3.029). SALUFAM instrument is applicable, replicable, has a high content validity, concurrent validity and clinical predictive value.

Oncology biomarkers: discovery, validation, and clinical use.

PubMed

Heckman-Stoddard, Brandy M

2012-05-01

To discuss the discovery, validation, and clinical use of multiple types of biomarkers. Medical literature and published guidelines. Formal validation of biomarkers should include both retrospective analyses of well-characterized samples as well as a prospective clinical trial in which the biomarker is tested for its ability to predict the presence of disease or the efficacy of a cancer therapy. Biomarker development is complicated, with very few biomarker discoveries leading to clinically useful tests. Nurses should understand how a biomarker was developed, including the sensitivity and specificity before applying new biomarkers in the clinical setting. Copyright © 2012. Published by Elsevier Inc.

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.

[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 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 Argument-Based Approach to the Validation of UHTRUST: Can We Measure How Recent Graduates Can Be Trusted with Unfamiliar Tasks?

ERIC Educational Resources Information Center

Wijnen-Meijer, M.; Van der Schaaf, M.; Booij, E.; Harendza, S.; Boscardin, C.; Wijngaarden, J. Van; Ten Cate, Th. J.

2013-01-01

There is a need for valid methods to assess the readiness for clinical practice of medical graduates. This study evaluates the validity of Utrecht Hamburg Trainee Responsibility for Unfamiliar Situations Test (UHTRUST), an authentic simulation procedure to assess whether medical trainees are ready to be entrusted with unfamiliar clinical tasks…

Validating EHR clinical models using ontology patterns.

PubMed

Martínez-Costa, Catalina; Schulz, Stefan

2017-12-01

Clinical models are artefacts that specify how information is structured in electronic health records (EHRs). However, the makeup of clinical models is not guided by any formal constraint beyond a semantically vague information model. We address this gap by advocating ontology design patterns as a mechanism that makes the semantics of clinical models explicit. This paper demonstrates how ontology design patterns can validate existing clinical models using SHACL. Based on the Clinical Information Modelling Initiative (CIMI), we show how ontology patterns detect both modeling and terminology binding errors in CIMI models. SHACL, a W3C constraint language for the validation of RDF graphs, builds on the concept of "Shape", a description of data in terms of expected cardinalities, datatypes and other restrictions. SHACL, as opposed to OWL, subscribes to the Closed World Assumption (CWA) and is therefore more suitable for the validation of clinical models. We have demonstrated the feasibility of the approach by manually describing the correspondences between six CIMI clinical models represented in RDF and two SHACL ontology design patterns. Using a Java-based SHACL implementation, we found at least eleven modeling and binding errors within these CIMI models. This demonstrates the usefulness of ontology design patterns not only as a modeling tool but also as a tool for validation. Copyright © 2017 Elsevier Inc. All rights reserved.

Biomarkers and Surrogate Endpoints: Lessons Learned From Glaucoma

PubMed Central

Medeiros, Felipe A.

2017-01-01

With the recent progress in imaging technologies for assessment of structural damage in glaucoma, a debate has emerged on whether these measurements can be used as valid surrogate endpoints in clinical trials evaluating new therapies for the disease. A discussion of surrogates should be grounded on knowledge acquired from their use in other areas of medicine as well as regulatory requirements. This article reviews the conditions for valid surrogacy in the context of glaucoma clinical trials and critically evaluates the role of biomarkers such as IOP and imaging measurements as potential surrogates for clinically relevant outcomes. Valid surrogate endpoints must be able to predict a clinically relevant endpoint, such as loss of vision or decrease in quality of life. In addition, the effect of a proposed treatment on the surrogate must capture the effect of the treatment on the clinically relevant endpoint. Despite its widespread use in clinical trials, no proper validation of IOP as a surrogate endpoint has yet been conducted for any class of IOP-lowering treatments. Although strong evidence has accumulated about imaging measurements as predictors of relevant functional outcomes in glaucoma, there is still insufficient evidence to support their use as valid surrogate endpoints. However, imaging biomarkers could potentially be used as part of composite endpoints in glaucoma trials, overcoming weaknesses of the use of structural or functional endpoints in isolation. Efforts should be taken to properly design and conduct studies that can provide proper validation of potential biomarkers in glaucoma clinical trials. PMID:28475699

Biomarkers and Surrogate Endpoints: Lessons Learned From Glaucoma.

PubMed

Medeiros, Felipe A

2017-05-01

With the recent progress in imaging technologies for assessment of structural damage in glaucoma, a debate has emerged on whether these measurements can be used as valid surrogate endpoints in clinical trials evaluating new therapies for the disease. A discussion of surrogates should be grounded on knowledge acquired from their use in other areas of medicine as well as regulatory requirements. This article reviews the conditions for valid surrogacy in the context of glaucoma clinical trials and critically evaluates the role of biomarkers such as IOP and imaging measurements as potential surrogates for clinically relevant outcomes. Valid surrogate endpoints must be able to predict a clinically relevant endpoint, such as loss of vision or decrease in quality of life. In addition, the effect of a proposed treatment on the surrogate must capture the effect of the treatment on the clinically relevant endpoint. Despite its widespread use in clinical trials, no proper validation of IOP as a surrogate endpoint has yet been conducted for any class of IOP-lowering treatments. Although strong evidence has accumulated about imaging measurements as predictors of relevant functional outcomes in glaucoma, there is still insufficient evidence to support their use as valid surrogate endpoints. However, imaging biomarkers could potentially be used as part of composite endpoints in glaucoma trials, overcoming weaknesses of the use of structural or functional endpoints in isolation. Efforts should be taken to properly design and conduct studies that can provide proper validation of potential biomarkers in glaucoma clinical trials.

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).

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.

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.

[Clinical and empirical findings with the OPD-CA].

PubMed

Winter, Sibylle; Jelen, Anna; Pressel, Christine; Lenz, Klaus; Lehmkuhl, Ulrike

2011-01-01

60 clinical patients (5-17 years) were diagnosed with an interview-manual of OPD-CA (Winter, 2004). For clinical validity a comparison of patients with internal (N=17) and external disorders (N=19) was shown. References for clinical validity resulted from the comparison of the groups, especially for the axes "conflict" and "prerequisites for treatment". Patients with internal disorders showed the conflict desire for care versus autarchy significantly more often than patients with external disorders. On the other hand patients with external disorders displayed the conflict submission versus control significantly more often. Significant differences were also found for the axis "prerequisites for treatment". Patients with internal disorders had better "prerequisites for treatment" in the domains experience of illness and the prerequisites for therapy. For the axes "interpersonal relation", "structure" and "prerequisites for treatment" satisfactory data for validity and reliability were found. The clinical validity points to the usefulness of OPD-CA-manual for psychodynamic diagnostics in childhood and adolescence.

Assessing Clinical Reasoning (ASCLIRE): Instrument Development and Validation

ERIC Educational Resources Information Center

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

2015-01-01

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…

Integrating Validity Theory with Use of Measurement Instruments in Clinical Settings

PubMed Central

Kelly, P Adam; O'Malley, Kimberly J; Kallen, Michael A; Ford, Marvella E

2005-01-01

Objective To present validity concepts in a conceptual framework useful for research in clinical settings. Principal Findings We present a three-level decision rubric for validating measurement instruments, to guide health services researchers step-by-step in gathering and evaluating validity evidence within their specific situation. We address construct precision, the capacity of an instrument to measure constructs it purports to measure and differentiate from other, unrelated constructs; quantification precision, the reliability of the instrument; and translation precision, the ability to generalize scores from an instrument across subjects from the same or similar populations. We illustrate with specific examples, such as an approach to validating a measurement instrument for veterans when prior evidence of instrument validity for this population does not exist. Conclusions Validity should be viewed as a property of the interpretations and uses of scores from an instrument, not of the instrument itself: how scores are used and the consequences of this use are integral to validity. Our advice is to liken validation to building a court case, including discovering evidence, weighing the evidence, and recognizing when the evidence is weak and more evidence is needed. PMID:16178998

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…

Imaging biomarker roadmap for cancer studies

PubMed Central

O’Connor, James P. B.; Aboagye, Eric O.; Adams, Judith E.; Aerts, Hugo J. W. L.; Barrington, Sally F.; Beer, Ambros J.; Boellaard, Ronald; Bohndiek, Sarah E.; Brady, Michael; Brown, Gina; Buckley, David L.; Chenevert, Thomas L.; Clarke, Laurence P.; Collette, Sandra; Cook, Gary J.; deSouza, Nandita M.; Dickson, John C.; Dive, Caroline; Evelhoch, Jeffrey L.; Faivre-Finn, Corinne; Gallagher, Ferdia A.; Gilbert, Fiona J.; Gillies, Robert J.; Goh, Vicky; Griffiths, John R.; Groves, Ashley M.; Halligan, Steve; Harris, Adrian L.; Hawkes, David J.; Hoekstra, Otto S.; Huang, Erich P.; Hutton, Brian F.; Jackson, Edward F.; Jayson, Gordon C.; Jones, Andrew; Koh, Dow-Mu; Lacombe, Denis; Lambin, Philippe; Lassau, Nathalie; Leach, Martin O.; Lee, Ting-Yim; Leen, Edward L.; Lewis, Jason S.; Liu, Yan; Lythgoe, Mark F.; Manoharan, Prakash; Maxwell, Ross J.; Miles, Kenneth A.; Morgan, Bruno; Morris, Steve; Ng, Tony; Padhani, Anwar R.; Parker, Geoff J. M.; Partridge, Mike; Pathak, Arvind P.; Peet, Andrew C.; Punwani, Shonit; Reynolds, Andrew R.; Robinson, Simon P.; Shankar, Lalitha K.; Sharma, Ricky A.; Soloviev, Dmitry; Stroobants, Sigrid; Sullivan, Daniel C.; Taylor, Stuart A.; Tofts, Paul S.; Tozer, Gillian M.; van Herk, Marcel; Walker-Samuel, Simon; Wason, James; Williams, Kaye J.; Workman, Paul; Yankeelov, Thomas E.; Brindle, Kevin M.; McShane, Lisa M.; Jackson, Alan; Waterton, John C.

2017-01-01

Imaging biomarkers (IBs) are integral to the routine management of patients with cancer. IBs used daily in oncology include clinical TNM stage, objective response and left ventricular ejection fraction. Other CT, MRI, PET and ultrasonography biomarkers are used extensively in cancer research and drug development. New IBs need to be established either as useful tools for testing research hypotheses in clinical trials and research studies, or as clinical decision-making tools for use in healthcare, by crossing ‘translational gaps’ through validation and qualification. Important differences exist between IBs and biospecimen-derived biomarkers and, therefore, the development of IBs requires a tailored ‘roadmap’. Recognizing this need, Cancer Research UK (CRUK) and the European Organisation for Research and Treatment of Cancer (EORTC) assembled experts to review, debate and summarize the challenges of IB validation and qualification. This consensus group has produced 14 key recommendations for accelerating the clinical translation of IBs, which highlight the role of parallel (rather than sequential) tracks of technical (assay) validation, biological/clinical validation and assessment of cost-effectiveness; the need for IB standardization and accreditation systems; the need to continually revisit IB precision; an alternative framework for biological/clinical validation of IBs; and the essential requirements for multicentre studies to qualify IBs for clinical use. PMID:27725679

Decision analysis. Clinical art or Clinical Science

DTIC Science & Technology

1977-05-01

having helped some clients. Over the past half century, psychotherapy has faced a series of crises concerned with its transformation from an art to a...clinical science . These include validation of the effectiveness of various forms of therapy, validating elements of treatment programs and

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.

Validation of modified forms of the PedsQL generic core scales and cancer module scales for adolescents and young adults (AYA) with cancer or a blood disorder.

PubMed

Ewing, Jane E; King, Madeleine T; Smith, Narelle F

2009-03-01

To validate two health-related quality of life (HRQOL) measures, the PedsQL Generic Core and Cancer Module adolescent forms (13-18 years), after modification for 16-25-year-old adolescents and young adults (AYA) with cancer or a blood disorder. AYA patients and nominated proxies were recruited from three Sydney hospitals. Modified forms were administered by telephone or in clinics/wards. Analyses included correlations, factor analysis, and analysis of variance of known-groups (defined by the Memorial Symptom Assessment Scale). Eighty-eight patients and 79 proxies completed questionnaires. Factor structures consistent with those of the unmodified forms confirmed construct validity. Cronbach's alpha ranged 0.81-0.98. Inter-scale correlations were as hypothesized, confirming discriminant validity. Statistically significant differences between groups with mild, moderate, and severe symptoms (P < 0.05) confirmed clinical validity. These modified forms provide reliable and valid measures of HRQOL in AYA with cancer or a blood disorder, suitable for clinical trials, research, and practice.

[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.

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

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

Nomogram predicting response after chemoradiotherapy in rectal cancer using sequential PETCT imaging: a multicentric prospective study with external validation.

PubMed

van Stiphout, Ruud G P M; Valentini, Vincenzo; Buijsen, Jeroen; Lammering, Guido; Meldolesi, Elisa; van Soest, Johan; Leccisotti, Lucia; Giordano, Alessandro; Gambacorta, Maria A; Dekker, Andre; Lambin, Philippe

2014-11-01

To develop and externally validate a predictive model for pathologic complete response (pCR) for locally advanced rectal cancer (LARC) based on clinical features and early sequential (18)F-FDG PETCT imaging. Prospective data (i.a. THUNDER trial) were used to train (N=112, MAASTRO Clinic) and validate (N=78, Università Cattolica del S. Cuore) the model for pCR (ypT0N0). All patients received long-course chemoradiotherapy (CRT) and surgery. Clinical parameters were age, gender, clinical tumour (cT) stage and clinical nodal (cN) stage. PET parameters were SUVmax, SUVmean, metabolic tumour volume (MTV) and maximal tumour diameter, for which response indices between pre-treatment and intermediate scan were calculated. Using multivariate logistic regression, three probability groups for pCR were defined. The pCR rates were 21.4% (training) and 23.1% (validation). The selected predictive features for pCR were cT-stage, cN-stage, response index of SUVmean and maximal tumour diameter during treatment. The models' performances (AUC) were 0.78 (training) and 0.70 (validation). The high probability group for pCR resulted in 100% correct predictions for training and 67% for validation. The model is available on the website www.predictcancer.org. The developed predictive model for pCR is accurate and externally validated. This model may assist in treatment decisions during CRT to select complete responders for a wait-and-see policy, good responders for extra RT boost and bad responders for additional chemotherapy. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Development and psychometric validation of a self-administered questionnaire assessing the acceptance of influenza vaccination: the Vaccinees' Perception of Injection (VAPI©) questionnaire

PubMed Central

Chevat, Catherine; Viala-Danten, Muriel; Dias-Barbosa, Carla; Nguyen, Van Hung

2009-01-01

Background Influenza is among the most common infectious diseases. The main protection against influenza is vaccination. A self-administered questionnaire was developed and validated for use in clinical trials to assess subjects' perception and acceptance of influenza vaccination and its subsequent injection site reactions (ISR). Methods The VAPI questionnaire was developed based on interviews with vaccinees. The initial version was administered to subjects in international clinical trials comparing intradermal with intramuscular influenza vaccination. Item reduction and scale construction were carried out using principal component and multitrait analyses (n = 549). Psychometric validation of the final version was conducted per country (n = 5,543) and included construct and clinical validity and internal consistency reliability. All subjects gave their written informed consent before being interviewed or included in the clinical studies. Results The final questionnaire comprised 4 dimensions ("bother from ISR"; "arm movement"; "sleep"; "acceptability") grouping 16 items, and 5 individual items (anxiety before vaccination; bother from pain during vaccination; satisfaction with injection system; willingness to be vaccinated next year; anxiety about vaccination next year). Construct validity was confirmed for all scales in most of the countries. Internal consistency reliability was good for all versions (Cronbach's alpha ranging from 0.68 to 0.94), as was clinical validity: scores were positively correlated with the severity of ISR and pain. Conclusion The VAPI questionnaire is a valid and reliable tool, assessing the acceptance of vaccine injection and reactions following vaccination. Trial registration NCT00258934, NCT00383526, NCT00383539. PMID:19261173

Validity of three clinical performance assessments of internal medicine clerks.

PubMed

Hull, A L; Hodder, S; Berger, B; Ginsberg, D; Lindheim, N; Quan, J; Kleinhenz, M E

1995-06-01

To analyze the construct validity of three methods to assess the clinical performances of internal medicine clerks. A multitrait-multimethod (MTMM) study was conducted at the Case Western Reserve University School of Medicine to determine the convergent and divergent validity of a clinical evaluation form (CEF) completed by faculty and residents, an objective structured clinical examination (OSCE), and the medicine subject test of the National Board of Medical Examiners. Three traits were involved in the analysis: clinical skills, knowledge, and personal characteristics. A correlation matrix was computed for 410 third-year students who completed the clerkship between August 1988 and July 1991. There was a significant (p < .01) convergence of the four correlations that assessed the same traits by using different methods. However, the four convergent correlations were of moderate magnitude (ranging from .29 to .47). Divergent validity was assessed by comparing the magnitudes of the convergence correlations with the magnitudes of correlations among unrelated assessments (i.e., different traits by different methods). Seven of nine possible coefficients were smaller than the convergent coefficients, suggesting evidence of divergent validity. A significant CEF method effect was identified. There was convergent validity and some evidence of divergent validity with a significant method effect. The findings were similar for correlations corrected for attenuation. Four conclusions were reached: (1) the reliability of the OSCE must be improved, (2) the CEF ratings must be redesigned to further discriminate among the specific traits assessed, (3) additional methods to assess personal characteristics must be instituted, and (4) several assessment methods should be used to evaluate individual student performances.

Discovery and Validation of Novel Expression Signature for Postcystectomy Recurrence in High-Risk Bladder Cancer

PubMed Central

Lam, Lucia L.; Ghadessi, Mercedeh; Erho, Nicholas; Vergara, Ismael A.; Alshalalfa, Mohammed; Buerki, Christine; Haddad, Zaid; Sierocinski, Thomas; Triche, Timothy J.; Skinner, Eila C.; Davicioni, Elai; Daneshmand, Siamak; Black, Peter C.

2014-01-01

Background Nearly half of muscle-invasive bladder cancer patients succumb to their disease following cystectomy. Selecting candidates for adjuvant therapy is currently based on clinical parameters with limited predictive power. This study aimed to develop and validate genomic-based signatures that can better identify patients at risk for recurrence than clinical models alone. Methods Transcriptome-wide expression profiles were generated using 1.4 million feature-arrays on archival tumors from 225 patients who underwent radical cystectomy and had muscle-invasive and/or node-positive bladder cancer. Genomic (GC) and clinical (CC) classifiers for predicting recurrence were developed on a discovery set (n = 133). Performances of GC, CC, an independent clinical nomogram (IBCNC), and genomic-clinicopathologic classifiers (G-CC, G-IBCNC) were assessed in the discovery and independent validation (n = 66) sets. GC was further validated on four external datasets (n = 341). Discrimination and prognostic abilities of classifiers were compared using area under receiver-operating characteristic curves (AUCs). All statistical tests were two-sided. Results A 15-feature GC was developed on the discovery set with area under curve (AUC) of 0.77 in the validation set. This was higher than individual clinical variables, IBCNC (AUC = 0.73), and comparable to CC (AUC = 0.78). Performance was improved upon combining GC with clinical nomograms (G-IBCNC, AUC = 0.82; G-CC, AUC = 0.86). G-CC high-risk patients had elevated recurrence probabilities (P < .001), with GC being the best predictor by multivariable analysis (P = .005). Genomic-clinicopathologic classifiers outperformed clinical nomograms by decision curve and reclassification analyses. GC performed the best in validation compared with seven prior signatures. GC markers remained prognostic across four independent datasets. Conclusions The validated genomic-based classifiers outperform clinical models for predicting postcystectomy bladder cancer recurrence. This may be used to better identify patients who need more aggressive management. PMID:25344601

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.

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.

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…

ICCS/ESCCA consensus guidelines to detect GPI-deficient cells in paroxysmal nocturnal hemoglobinuria (PNH) and related disorders part 4 - assay validation and quality assurance.

PubMed

Oldaker, Teri; Whitby, Liam; Saber, Maryam; Holden, Jeannine; Wallace, Paul K; Litwin, Virginia

2018-01-01

Over the past six years, a diverse group of stakeholders have put forth recommendations regarding the analytical validation of flow cytometric methods and described in detail the differences between cell-based and traditional soluble analyte assay validations. This manuscript is based on these general recommendations as well as the published experience of experts in the area of PNH testing. The goal is to provide practical assay-specific guidelines for the validation of high-sensitivity flow cytometric PNH assays. Examples of the reports and validation data described herein are provided in Supporting Information. © 2017 International Clinical Cytometry Society. © 2017 International Clinical Cytometry Society.

Idiopathic Pulmonary Fibrosis: Clinically Meaningful Primary Endpoints in Phase 3 Clinical Trials

PubMed Central

Collard, Harold R.; Anstrom, Kevin J.; Flaherty, Kevin R.; Fleming, Thomas R.; King, Talmadge E.; Martinez, Fernando J.; Brown, Kevin K.

2012-01-01

Definitive evidence of clinical efficacy in a Phase 3 trial is best shown by a beneficial impact on a clinically meaningful endpoint—that is, an endpoint that directly measures how a patient feels (symptoms), functions (the ability to perform activities in daily life), or survives. In idiopathic pulmonary fibrosis (IPF), we believe the endpoints that best meet these criteria are all-cause mortality and all-cause nonelective hospitalization. There are no validated measures of symptoms or broader constructs such as health status or funtional status in IPF. A surrogate endpoint is defined as an indirect measure that is intended to substitute for a clinically meaningful endpoint. Surrogate endpoints can be appropriate outcome measures if validated. However, validation requires substantial evidence that the effect of an intervention on a clinically meaningful endpoint is reliably predicted by the effect of an intervention on the surrogate endpoint. For patients with IPF, there are currently no validated surrogate endpoints. PMID:22505745

Spontaneous Swallow Frequency Compared with Clinical Screening in the Identification of Dysphagia in Acute Stroke

PubMed Central

Crary, Michael A.; Carnaby, Giselle D.; Sia, Isaac

2017-01-01

Background The aim of this study was to compare spontaneous swallow frequency analysis (SFA) with clinical screening protocols for identification of dysphagia in acute stroke. Methods In all, 62 patients with acute stroke were evaluated for spontaneous swallow frequency rates using a validated acoustic analysis technique. Independent of SFA, these same patients received a routine nurse-administered clinical dysphagia screening as part of standard stroke care. Both screening tools were compared against a validated clinical assessment of dysphagia for acute stroke. In addition, psychometric properties of SFA were compared against published, validated clinical screening protocols. Results Spontaneous SFA differentiates patients with versus without dysphagia after acute stroke. Using a previously identified cut point based on swallows per minute, spontaneous SFA demonstrated superior ability to identify dysphagia cases compared with a nurse-administered clinical screening tool. In addition, spontaneous SFA demonstrated equal or superior psychometric properties to 4 validated, published clinical dysphagia screening tools. Conclusions Spontaneous SFA has high potential to identify dysphagia in acute stroke with psychometric properties equal or superior to clinical screening protocols. PMID:25088166

Spontaneous swallow frequency compared with clinical screening in the identification of dysphagia in acute stroke.

PubMed

Crary, Michael A; Carnaby, Giselle D; Sia, Isaac

2014-09-01

The aim of this study was to compare spontaneous swallow frequency analysis (SFA) with clinical screening protocols for identification of dysphagia in acute stroke. In all, 62 patients with acute stroke were evaluated for spontaneous swallow frequency rates using a validated acoustic analysis technique. Independent of SFA, these same patients received a routine nurse-administered clinical dysphagia screening as part of standard stroke care. Both screening tools were compared against a validated clinical assessment of dysphagia for acute stroke. In addition, psychometric properties of SFA were compared against published, validated clinical screening protocols. Spontaneous SFA differentiates patients with versus without dysphagia after acute stroke. Using a previously identified cut point based on swallows per minute, spontaneous SFA demonstrated superior ability to identify dysphagia cases compared with a nurse-administered clinical screening tool. In addition, spontaneous SFA demonstrated equal or superior psychometric properties to 4 validated, published clinical dysphagia screening tools. Spontaneous SFA has high potential to identify dysphagia in acute stroke with psychometric properties equal or superior to clinical screening protocols. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. 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.

Biomarkers and surrogate endpoints in glaucoma clinical trials

PubMed Central

Medeiros, Felipe A

2015-01-01

Surrogate endpoints are often used as replacements for true clinically relevant endpoints in several areas of medicine, as they enable faster and less expensive clinical trials. However, without proper validation, the use of surrogates may lead to incorrect conclusions about the efficacy and safety of treatments. This article reviews the general requirements for validating surrogate endpoints and provides a critical assessment of the use of intraocular pressure (IOP), visual fields, and structural measurements of the optic nerve as surrogate endpoints in glaucoma clinical trials. A valid surrogate endpoint must be able to predict the clinically relevant endpoint and fully capture the effect of an intervention on that endpoint. Despite its widespread use in clinical trials, no proper validation of IOP as a surrogate endpoint has ever been conducted for any class of IOP-lowering treatments. Evidence has accumulated with regard to the role of imaging measurements of optic nerve damage as surrogate endpoints in glaucoma. These measurements are predictive of functional losses in the disease and may explain, at least in part, treatment effects on clinically relevant endpoints. The use of composite endpoints in glaucoma trials may overcome weaknesses of the use of structural or functional endpoints in isolation. Unless research is dedicated to fully develop and validate suitable endpoints that can be used in glaucoma clinical trials, we run the risk of inappropriate judgments about the value of new therapies. PMID:25034049

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

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.…

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.

The Brief Fear of Negative Evaluation Scale (BFNE): translation and validation study of the Iranian version.

PubMed

Tavoli, Azadeh; Melyani, Mahdiyeh; Bakhtiari, Maryam; Ghaedi, Gholam Hossein; Montazeri, Ali

2009-07-09

The Brief Fear of Negative Evaluation Scale (BFNE) is a commonly used instrument to measure social anxiety. This study aimed to translate and to test the reliability and validity of the BFNE in Iran. The English language version of the BFNE was translated into Persian (Iranian language) and was used in this study. The questionnaire was administered to a consecutive sample of 235 students with (n = 33, clinical group) and without social phobia (n = 202, non-clinical group). In addition to the BFNE, two standard instruments were used to measure social phobia severity: the Social Phobia Inventory (SPIN), and the Social Interaction Anxiety Scale (SIAS). All participants completed a brief background information questionnaire, the SPIN, the SIAS and the BFNE scales. Statistical analysis was performed to test the reliability and validity of the BFNE. In all 235 students were studied (111 male and 124 female). The mean age for non-clinical group was 22.2 (SD = 2.1) years and for clinical sample it was 22.4 (SD = 1.8) years. Cronbach's alpha coefficient (to test reliability) was acceptable for both non-clinical and clinical samples (alpha = 0.90 and 0.82 respectively). In addition, 3-week test-retest reliability was performed in non-clinical sample and the intraclass correlation coefficient (ICC) was quite high (ICC = 0.71). Validity as performed using convergent and discriminant validity showed satisfactory results. The questionnaire correlated well with established measures of social phobia such as the SPIN (r = 0.43, p < 0.001) and the SIAS (r = 0.54, p < 0.001). Also the BFNE discriminated well between men and women with and without social phobia in the expected direction. Factor analysis supported a two-factor solution corresponding to positive and reverse-worded items. This validation study of the Iranian version of BFNE proved that it is an acceptable, reliable and valid measure of social phobia. However, since the scale showed a two-factor structure and this does not confirm to the theoretical basis for the BFNE, thus we suggest the use of the BFNE-II when it becomes available in Iran. The validation study of the BFNE-II is in progress.

The Brief Negative Symptom Scale (BNSS): Independent validation in a large sample of Italian patients with schizophrenia.

PubMed

Mucci, A; Galderisi, S; Merlotti, E; Rossi, A; Rocca, P; Bucci, P; Piegari, G; Chieffi, M; Vignapiano, A; Maj, M

2015-07-01

The Brief Negative Symptom Scale (BNSS) was developed to address the main limitations of the existing scales for the assessment of negative symptoms of schizophrenia. The initial validation of the scale by the group involved in its development demonstrated good convergent and discriminant validity, and a factor structure confirming the two domains of negative symptoms (reduced emotional/verbal expression and anhedonia/asociality/avolition). However, only relatively small samples of patients with schizophrenia were investigated. Further independent validation in large clinical samples might be instrumental to the broad diffusion of the scale in clinical research. The present study aimed to examine the BNSS inter-rater reliability, convergent/discriminant validity and factor structure in a large Italian sample of outpatients with schizophrenia. Our results confirmed the excellent inter-rater reliability of the BNSS (the intraclass correlation coefficient ranged from 0.81 to 0.98 for individual items and was 0.98 for the total score). The convergent validity measures had r values from 0.62 to 0.77, while the divergent validity measures had r values from 0.20 to 0.28 in the main sample (n=912) and in a subsample without clinically significant levels of depression and extrapyramidal symptoms (n=496). The BNSS factor structure was supported in both groups. The study confirms that the BNSS is a promising measure for quantifying negative symptoms of schizophrenia in large multicenter clinical studies. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Measuring primary care organizational capacity for diabetes care coordination: the Diabetes Care Coordination Readiness Assessment.

PubMed

Weeks, Douglas L; Polello, Jennifer M; Hansen, Daniel T; Keeney, Benjamin J; Conrad, Douglas A

2014-01-01

Not all primary care clinics are prepared to implement care coordination services for chronic conditions, such as diabetes. Understanding true capacity to coordinate care is an important first-step toward establishing effective and efficient care coordination. Yet, we could identify no diabetes-specific instruments to systematically assess readiness and/or status of primary care clinics to engage in diabetes care coordination. This report describes the development and initial validation of the Diabetes Care Coordination Readiness Assessment (DCCRA), which is intended to measure primary care clinic readiness to coordinate care for adult patients with diabetes. The instrument was developed through iterative item generation within a framework of five domains of care coordination: Organizational Capacity, Care Coordination, Clinical Management, Quality Improvement, and Technical Infrastructure. Validation data was collected on 39 primary care clinics. Content validity, inter-rater reliability, internal consistency, and construct validity of the 49-item instrument were assessed. Inter-rater agreement indices per item ranged from 0.50 to 1.0. Cronbach's alpha of the entire instrument was 0.964, and for the five domain scales ranged from 0.688 to 0.961. Clinics with existing care coordinators were rated as more ready to support care coordination than clinics without care coordinators for the entire DCCRA and for each domain, supporting construct validity. As providers increasingly attempt to adopt patient-centered approaches, introduction of the DCCRA is timely and appropriate for assisting clinics with identifying gaps in provision of care coordination services. The DCCRA's strengths include promising psychometric properties. A valid measure of diabetes care coordination readiness should be useful in diabetes program evaluation, assistance with quality improvement initiatives, and measurement of patient-centered care in research.

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.

Initial Validation of a Comprehensive Assessment Instrument for Bereavement-Related Grief Symptoms and Risk of Complications: The Indicator of Bereavement Adaptation—Cruse Scotland (IBACS)

PubMed Central

Schut, Henk; Stroebe, Margaret S.; Wilson, Stewart; Birrell, John

2016-01-01

Objective This study assessed the validity of the Indicator of Bereavement Adaptation Cruse Scotland (IBACS). Designed for use in clinical and non-clinical settings, the IBACS measures severity of grief symptoms and risk of developing complications. Method N = 196 (44 male, 152 female) help-seeking, bereaved Scottish adults participated at two timepoints: T1 (baseline) and T2 (after 18 months). Four validated assessment instruments were administered: CORE-R, ICG-R, IES-R, SCL-90-R. Discriminative ability was assessed using ROC curve analysis. Concurrent validity was tested through correlation analysis at T1. Predictive validity was assessed using correlation analyses and ROC curve analysis. Optimal IBACS cutoff values were obtained by calculating a maximal Youden index J in ROC curve analysis. Clinical implications were compared across instruments. Results ROC curve analysis results (AUC = .84, p < .01, 95% CI between .77 and .90) indicated the IBACS is a good diagnostic instrument for assessing complicated grief. Positive correlations (p < .01, 2-tailed) with all four instruments at T1 demonstrated the IBACS' concurrent validity, strongest with complicated grief measures (r = .82). Predictive validity was shown to be fair in T2 ROC curve analysis results (n = 67, AUC = .78, 95% CI between .65 and .92; p < .01). Predictive validity was also supported by stable positive correlations between IBACS and other instruments at T2. Clinical indications were found not to differ across instruments. Conclusions The IBACS offers effective grief symptom and risk assessment for use by non-clinicians. Indications are sufficient to support intake assessment for a stepped model of bereavement intervention. PMID:27741246

Clinical validation of the Tempus xO assay

PubMed Central

Beaubier, Nike; Tell, Robert; Huether, Robert; Bontrager, Martin; Bush, Stephen; Parsons, Jerod; Shah, Kaanan; Baker, Tim; Selkov, Gene; Taxter, Tim; Thomas, Amber; Bettis, Sam; Khan, Aly; Lau, Denise; Lee, Christina; Barber, Matthew; Cieslik, Marcin; Frankenberger, Casey; Franzen, Amy; Weiner, Ali; Palmer, Gary; Lonigro, Robert; Robinson, Dan; Wu, Yi-Mi; Cao, Xuhong; Lefkofsky, Eric; Chinnaiyan, Arul; White, Kevin P.

2018-01-01

We have developed a clinically validated NGS assay that includes tumor, germline and RNA sequencing. We apply this assay to clinical specimens and cell lines, and we demonstrate a clinical sensitivity of 98.4% and positive predictive value of 100% for the clinically actionable variants measured by the assay. We also demonstrate highly accurate copy number measurements and gene rearrangement identification. PMID:29899824

Validating archetypes for the Multiple Sclerosis Functional Composite.

PubMed

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

2014-08-03

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

Validating archetypes for the Multiple Sclerosis Functional Composite

PubMed Central

2014-01-01

Background Numerous information models for electronic health records, such as openEHR archetypes are available. The quality of such clinical models is important to guarantee standardised semantics and to facilitate their interoperability. However, validation aspects are not regarded sufficiently yet. The objective of this report is to investigate the feasibility of archetype development and its community-based validation process, presuming that this review process is a practical way to ensure high-quality information models amending the formal reference model definitions. Methods A standard archetype development approach was applied on a case set of three clinical tests for multiple sclerosis assessment: After an analysis of the tests, the obtained data elements were organised and structured. The appropriate archetype class was selected and the data elements were implemented in an iterative refinement process. Clinical and information modelling experts validated the models in a structured review process. Results Four new archetypes were developed and publicly deployed in the openEHR Clinical Knowledge Manager, an online platform provided by the openEHR Foundation. Afterwards, these four archetypes were validated by domain experts in a team review. The review was a formalised process, organised in the Clinical Knowledge Manager. Both, development and review process turned out to be time-consuming tasks, mostly due to difficult selection processes between alternative modelling approaches. The archetype review was a straightforward team process with the goal to validate archetypes pragmatically. Conclusions The quality of medical information models is crucial to guarantee standardised semantic representation in order to improve interoperability. The validation process is a practical way to better harmonise models that diverge due to necessary flexibility left open by the underlying formal reference model definitions. This case study provides evidence that both community- and tool-enabled review processes, structured in the Clinical Knowledge Manager, ensure archetype quality. It offers a pragmatic but feasible way to reduce variation in the representation of clinical information models towards a more unified and interoperable model. PMID:25087081

Construct validity and internal consistency reliability of the Malay version of the 21-item depression anxiety stress scale (Malay-DASS-21) among male outpatient clinic attendees in Johor.

PubMed

Rusli, B N; Amrina, K; Trived, S; Loh, K P; Shashi, M

2017-10-01

The 21-item English version of the Depression Anxiety Stress Scale (DASS-21) has been proposed as a method for assessing self-perceived depression, anxiety and stress over the past week in various clinical and nonclinical populations. Several Malay versions of the DASS-21 have been validated in various populations with varying success. One particular Malay version has been validated in various occupational groups (such as nurses and automotive workers) but not among male clinic outpatient attendees in Malaysia. To validate the Malay version of the DASS-21 (Malay-DASS-21) among male outpatient clinic attendees in Johor. A validation study with a random sample of 402 male respondents attending the outpatient clinic of a major public outpatient clinic in Johor Bahru and Segamat was carried out from January to March 2016. Construct validity of the Malay-DASS-21 was examined using Exploratory Factor Analysis (KMO = 0.947; Bartlett's test of sphericity is significant, p<0.001) through Principal Component Analysis and orthogonal (varimax) rotation with Kaiser Normalization to confirm the psychometric properties of the Malay-DASS- 21 and the internal consistency reliability using Cronbach's alpha. Construct validity of the Malay-DASS-21 based on eigenvalues and factor loadings to confirm the three factor structure (depression, anxiety, and stress) was acceptable. The internal consistency reliability of the factor construct was very impressive with Cronbach's alpha values in the range of 0.837 to 0.863. The present study showed that the Malay- DASS-21 has acceptable psychometric construct and high internal consistency reliability to measure self-perceived depression, anxiety and stress over the past week in male outpatient clinic attendees in Johor. Further studies are necessary to revalidate the Malay-DASS-21 across different populations and cultures, and using confirmatory factor analyses.

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.

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.

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.

Psychometric properties of the Geriatric Anxiety Inventory (GAI) and its short-form (GAI-SF) in a clinical and non-clinical sample of older adults.

PubMed

Johnco, Carly; Knight, Ashleigh; Tadic, Dusanka; Wuthrich, Viviana M

2015-07-01

The Geriatric Anxiety Inventory is a 20-item geriatric-specific measure of anxiety severity. While studies suggest good internal consistency and convergent validity, divergent validity from measures of depression are weak. Clinical cutoffs have been developed that vary across studies due to the small clinical samples used. A six-item short form (GAI-SF) has been developed, and while this scale is promising, the research assessing the psychometrics of this scale is limited. This study examined the psychometric properties of GAI and GAI-SF in a large sample of 197 clinical geriatric participants with a comorbid anxiety and unipolar mood disorder, and a non-clinical control sample (N = 59). The internal consistency and convergent validity with other measures of anxiety was adequate for GAI and GAI-SF. Divergent validity from depressive symptoms was good in the clinical sample but weak in the total and non-clinical samples. Divergent validity from cognitive functioning was good in all samples. The one-factor structure was replicated for both measures. Receiver Operating Characteristic analyses indicated that the GAI is more accurate at identifying clinical status than the GAI-SF, although the sensitivity and specificity for the recommended cutoffs was adequate for both measures. Both GAI and GAI-SF show good psychometric properties for identifying geriatric anxiety. The GAI-SF may be a useful alternative screening measure for identifying anxiety in older adults.

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

PubMed

Sabour, Siamak

2018-03-08

The purpose of this letter, in response to Hall, Mehta, and Fackrell (2017), is to provide important knowledge about methodology and statistical issues in assessing the reliability and validity of an audiologist-administered tinnitus loudness matching test and a patient-reported tinnitus loudness rating. The author uses reference textbooks and published articles regarding scientific assessment of the validity and reliability of a clinical test to discuss the statistical test and the methodological approach in assessing validity and reliability in clinical research. Depending on the type of the variable (qualitative or quantitative), well-known statistical tests can be applied to assess reliability and validity. The qualitative variables of sensitivity, specificity, positive predictive value, negative predictive value, false positive and false negative rates, likelihood ratio positive and likelihood ratio negative, as well as odds ratio (i.e., ratio of true to false results), are the most appropriate estimates to evaluate validity of a test compared to a gold standard. In the case of quantitative variables, depending on distribution of the variable, Pearson r or Spearman rho can be applied. Diagnostic accuracy (validity) and diagnostic precision (reliability or agreement) are two completely different methodological issues. Depending on the type of the variable (qualitative or quantitative), well-known statistical tests can be applied to assess validity.

Factors affecting knowledge transfer from continuing professional education to clinical practice: Development and psychometric properties of a new instrument.

PubMed

Vasli, Parvaneh; Dehghan-Nayeri, Nahid; Khosravi, Laleh

2018-01-01

Despite the emphasis placed on the implementation of continuing professional education programs in Iran, researchers or practitioners have not developed an instrument for assessing the factors that affect the knowledge transfer from such programs to clinical practice. The aim of this study was to design and validate such instrument for the Iranian context. The research used a three-stage mix method. In the first stage, in-depth interviews with nurses and content analysis were conducted, after which themes were extracted from the data. In the second stage, the findings of the content analysis and literature review were examined, and preliminary instrument options were developed. In the third stage, qualitative content validity, face validity, content validity ratio, content validity index, and construct validity using exploratory factor analysis was conducted. The reliability of the instrument was measured before and after the determination of construct validity. Primary tool instrument initially comprised 53 items, and its content validity index was 0.86. In the multi-stage factor analysis, eight questions were excluded, thereby reducing 11 factors to five and finally, to four. The final instrument with 43 items consists of the following dimensions: structure and organizational climate, personal characteristics, nature and status of professionals, and nature of educational programs. Managers can use the Iranian instrument to identify factors affecting knowledge transfer of continuing professional education to clinical practice. Copyright © 2017. Published by Elsevier Ltd.

Brief reasons for living inventory: a psychometric investigation.

PubMed

Cwik, Jan Christopher; Siegmann, Paula; Willutzki, Ulrike; Nyhuis, Peter; Wolter, Marcus; Forkmann, Thomas; Glaesmer, Heide; Teismann, Tobias

2017-11-06

The present study aimed at validating the German version of the Brief Reasons for Living inventory (BRFL). Validity and reliability were established in a community (n = 339) and a clinical sample (n = 272). Convergent and discriminant validity were investigated, and confirmatory factor analyses were conducted for the complete BRFL as well as for a 10-item version excluding conditional items on child-related concerns. Furthermore, it was assessed how BRFL scores moderate the association between depression and suicide ideation. Results indicated an adequate fit of the data to the original factor structure. The total scale and the subscales of the German version of the BRFL had sufficient internal consistency, as well as good convergent and divergent validity. The BRFL demonstrated clinical utility by differentiating between participants with vs. without suicide ideation. Reasons for living proved to moderate the association between depression and suicide ideation. Results provide preliminary evidence that the BRFL may be a reliable and valid measure of adaptive reasons for living that can be used in clinic and research settings.

Wechsler Adult Intelligence Scale-IV Dyads for Estimating Global Intelligence.

PubMed

Girard, Todd A; Axelrod, Bradley N; Patel, Ronak; Crawford, John R

2015-08-01

All possible two-subtest combinations of the core Wechsler Adult Intelligence Scale-IV (WAIS-IV) subtests were evaluated as possible viable short forms for estimating full-scale IQ (FSIQ). Validity of the dyads was evaluated relative to FSIQ in a large clinical sample (N = 482) referred for neuropsychological assessment. Sample validity measures included correlations, mean discrepancies, and levels of agreement between dyad estimates and FSIQ scores. In addition, reliability and validity coefficients were derived from WAIS-IV standardization data. The Coding + Information dyad had the strongest combination of reliability and validity data. However, several other dyads yielded comparable psychometric performance, albeit with some variability in their particular strengths. We also observed heterogeneity between validity coefficients from the clinical and standardization-based estimates for several dyads. Thus, readers are encouraged to also consider the individual psychometric attributes, their clinical or research goals, and client or sample characteristics when selecting among the dyadic short forms. © The Author(s) 2014.

Evidence-based dentistry: analysis of dental anxiety scales for children.

PubMed

Al-Namankany, A; de Souza, M; Ashley, P

2012-03-09

To review paediatric dental anxiety measures (DAMs) and assess the statistical methods used for validation and their clinical implications. A search of four computerised databases between 1960 and January 2011 associated with DAMs, using pre-specified search terms, to assess the method of validation including the reliability as intra-observer agreement 'repeatability or stability' and inter-observer agreement 'reproducibility' and all types of validity. Fourteen paediatric DAMs were predominantly validated in schools and not in the clinical setting while five of the DAMs were not validated at all. The DAMs that were validated were done so against other paediatric DAMs which may not have been validated previously. Reliability was not assessed in four of the DAMs. However, all of the validated studies assessed reliability which was usually 'good' or 'acceptable'. None of the current DAMs used a formal sample size technique. Diversity was seen between the studies ranging from a few simple pictograms to lists of questions reported by either the individual or an observer. To date there is no scale that can be considered as a gold standard, and there is a need to further develop an anxiety scale with a cognitive component for children and adolescents.

Development and validation of an automated delirium risk assessment system (Auto-DelRAS) implemented in the electronic health record system.

PubMed

Moon, Kyoung-Ja; Jin, Yinji; Jin, Taixian; Lee, Sun-Mi

2018-01-01

A key component of the delirium management is prevention and early detection. To develop an automated delirium risk assessment system (Auto-DelRAS) that automatically alerts health care providers of an intensive care unit (ICU) patient's delirium risk based only on data collected in an electronic health record (EHR) system, and to evaluate the clinical validity of this system. Cohort and system development designs were used. Medical and surgical ICUs in two university hospitals in Seoul, Korea. A total of 3284 patients for the development of Auto-DelRAS, 325 for external validation, 694 for validation after clinical applications. The 4211 data items were extracted from the EHR system and delirium was measured using CAM-ICU (Confusion Assessment Method for Intensive Care Unit). The potential predictors were selected and a logistic regression model was established to create a delirium risk scoring algorithm to construct the Auto-DelRAS. The Auto-DelRAS was evaluated at three months and one year after its application to clinical practice to establish the predictive validity of the system. Eleven predictors were finally included in the logistic regression model. The results of the Auto-DelRAS risk assessment were shown as high/moderate/low risk on a Kardex screen. The predictive validity, analyzed after the clinical application of Auto-DelRAS after one year, showed a sensitivity of 0.88, specificity of 0.72, positive predictive value of 0.53, negative predictive value of 0.94, and a Youden index of 0.59. A relatively high level of predictive validity was maintained with the Auto-DelRAS system, even one year after it was applied to clinical practice. Copyright © 2017. Published by Elsevier Ltd.

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.

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

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.

Development and feasibility of the misuse, abuse, and diversion drug event reporting system (MADDERS®).

PubMed

Treister, Roi; Trudeau, Jeremiah J; Van Inwegen, Richard; Jones, Judith K; Katz, Nathaniel P

2016-12-01

Inappropriate use of analgesic drugs has become increasingly pervasive over the past decade. Currently, drug abuse potential is primarily assessed post-marketing; no validated tools are available to assess this potential in phase II and III clinical trials. This paper describes the development and feasibility testing of a Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS), which aims to identify potentially abuse-related events and classify them according to a recently developed classification scheme, allowing the quantification of these events in clinical trials. The system was initially conceived and designed with input from experts and patients, followed by field-testing to assess its feasibility and content validity in both completed and ongoing clinical trials. The results suggest that MADDERS is a feasible system with initial validity. It showed higher rates of the triggering events in subjects taking medications with known abuse potential than in patients taking medications without abuse potential. Additionally, experts agreed on the classification of most abuse-related events in MADDERS. MADDERS is a new systematic approach to collect information on potentially abuse-related events in clinical trials and classify them. The system has demonstrated feasibility for implementation. Additional research is ongoing to further evaluate its validity. Currently, there are no validated tools to assess drug abuse potential during clinical trials. Because of its ease of implementation, its systematic approach, and its preliminary validation results, MADDERS could provide such a tool for clinical trials. (Am J Addict 2016;25:641-651). © 2016 American Academy of Addiction Psychiatry.

Instruments to identify prescription medication misuse, abuse, and related events in clinical trials: an ACTTION systematic review

PubMed Central

Smith, Shannon M.; Paillard, Florence; McKeown, Andrew; Burke, Laurie B.; Edwards, Robert R.; Katz, Nathaniel P.; Papadopoulos, Elektra J.; Rappaport, Bob A.; Slagle, Ashley; Strain, Eric C.; Wasan, Ajay D.; Turk, Dennis C.; Dworkin, Robert H.

2017-01-01

Measurement of inappropriate medication use events (e.g., abuse, misuse) in clinical trials is important in characterizing a medication’s abuse potential. However, no “gold standard” assessment of inappropriate use events in clinical trials has been identified. In this systematic review, we examine the measurement properties (i.e., content validity, cross-sectional reliability and construct validity, longitudinal construct validity, ability to detect change, and responder definitions) of instruments assessing inappropriate use of opioid and non-opioid prescription medications to identify any that meet U.S. and European regulatory agencies’ rigorous standards for outcome measures in clinical trials. Sixteen published instruments were identified, most of which were not designed for the selected concept of interest and context of use. For this reason, many instruments were found to lack adequate content validity (or documentation of content validity) to evaluate current inappropriate medication use events; for example, evaluating inappropriate use across the lifespan rather than current use, including items that did not directly assess inappropriate use (e.g., questions about anger), or failing to capture information pertinent to inappropriate use events (e.g., intention, route of administration). In addition, the psychometric data across all instruments were generally limited in scope. A further limitation is the heterogeneous, non-standardized use of inappropriate medication use terminology. These observations suggest that available instruments are not well suited for assessing current inappropriate medication use within the specific context of clinical trials. Further effort is needed to develop reliable and valid instruments to measure current inappropriate medication use events in clinical trials. PMID:25660826

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.

On the validity of the Middlesex Hospital Questionnaire: a comparison of diagnostic self-ratings in psychiatric out-patients, general practice patients, and 'normals' based on the Hebrew version.

PubMed

Dasberg, H; Shalif, I

1978-09-01

The short clinical diagnostic self-rating scale for psycho-neurotic patients (The Middlesex Hospital Questionnaire) was translated into everyday Hebrew and tested on 216 subjects for: (1) concurrent validity with clinical diagnoses; (2) discriminatory validity on a psychoneurotic gradient of psychiatric out-patients, general practice patients, and normal controls; (3) validity of subscales and discrete items using matrices of Spearman rank correlation coefficients; (4) construct validity using Guttman's smallest space analysis based on coefficients of similarity. The Hebrew MHQ was found to retain its validity and to be easily applicable in waiting-room situations. It is a useful method for generating and substantiating hypotheses on psychosomatic and psychosocial interrelationships. The MHQ seems to enable the expression of the 'neurotic load' of a general practice subpopulation as a centile on a scale, thereby corroborating previous epidemiological findings on the high prevalence of neurotic illness in general practice. There is reason to believe that the MHQ is a valid instrument for the analysis of symptom profiles of subjects involved in future drug trials.

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 reserved.

Instruments to Identify Prescription Medication Misuse, Abuse, and Related Events in Clinical Trials: An ACTTION Systematic Review.

PubMed

Smith, Shannon M; Paillard, Florence; McKeown, Andrew; Burke, Laurie B; Edwards, Robert R; Katz, Nathaniel P; Papadopoulos, Elektra J; Rappaport, Bob A; Slagle, Ashley; Strain, Eric C; Wasan, Ajay D; Turk, Dennis C; Dworkin, Robert H

2015-05-01

Measurement of inappropriate medication use events (eg, abuse or misuse) in clinical trials is important in characterizing a medication's abuse potential. However, no gold standard assessment of inappropriate use events in clinical trials has been identified. In this systematic review, we examine the measurement properties (ie, content validity, cross-sectional reliability and construct validity, longitudinal construct validity, ability to detect change, and responder definitions) of instruments assessing inappropriate use of opioid and nonopioid prescription medications to identify any that meet U.S. and European regulatory agencies' rigorous standards for outcome measures in clinical trials. Sixteen published instruments were identified, most of which were not designed for the selected concept of interest and context of use. For this reason, many instruments were found to lack adequate content validity (or documentation of content validity) to evaluate current inappropriate medication use events; for example, evaluating inappropriate use across the life span rather than current use, including items that did not directly assess inappropriate use (eg, questions about anger), or failing to capture information pertinent to inappropriate use events (eg, intention and route of administration). In addition, the psychometric data across all instruments were generally limited in scope. A further limitation is the heterogeneous, nonstandardized use of inappropriate medication use terminology. These observations suggest that available instruments are not well suited for assessing current inappropriate medication use within the specific context of clinical trials. Further effort is needed to develop reliable and valid instruments to measure current inappropriate medication use events in clinical trials. This systematic review evaluates the measurement properties of inappropriate medication use (eg, abuse or misuse) instruments to determine whether any meet regulatory standards for clinical trial outcome measures to assess abuse potential. Copyright © 2015 American Pain Society. All rights reserved.

Development and psychometric testing of Holistic Clinical Assessment Tool (HCAT) for undergraduate nursing students.

PubMed

Wu, Xi Vivien; Enskär, Karin; Pua, Lay Hoon; Heng, Doreen Gek Noi; Wang, Wenru

2016-09-22

A major focus in nursing education is on the judgement of clinical performance, and it is a complex process due to the diverse nature of nursing practice. A holistic approach in assessment of competency is advocated. Difficulties in the development of valid and reliable assessment measures in nursing competency have resulted in the development of assessment instruments with an increase in face and content validity, but few studies have tested these instruments psychometrically. It is essential to develop a holistic assessment tool to meet the needs of the clinical education. The study aims to develop a Holistic Clinical Assessment Tool (HCAT) and test its psychometric properties. The HCAT was developed based on the systematic literature review and the findings of qualitative studies. An expert panel was invited to evaluate the content validity of the tool. A total of 130 final-year nursing undergraduate students were recruited to evaluate the psychometric properties (i.e. factor structure, internal consistency and test-retest reliability) of the tool. The HCAT has good content validity with content validity index of .979. The exploratory factor analysis reveals a four-factor structure of the tool. The internal consistency and test-retest reliability of the HCAT are satisfactory with Cronbach alpha ranging from .789 to .965 and Intraclass Correlation Coefficient ranging from .881 to .979 for the four subscales and total scale. HCAT has the potential to be used as a valid measure to evaluate clinical competence in nursing students, and provide specific and ongoing feedback to enhance the holistic clinical learning experience. In addition, HCAT functions as a tool for self-reflection, peer-assessment and guides preceptors in clinical teaching and assessment.

Validity and usability of a professional association's web-based knowledge translation portal: American Physical Therapy Association's PTNow.org.

PubMed

Deutsch, Judith E; Romney, Wendy; Reynolds, Jan; Manal, Tara Jo

2015-10-08

PTNow.org is an evidence-based, on-line portal created by a professional membership association to promote use of evidence in practice and to help decrease unwarranted variation in practice. The site contains synthesis documents designed to promote efficient clinical reasoning. These documents were written and peer-reviewed by teams of content experts and master clinicians. The purpose of this paper is to report on the content and construct validity as well as usability of the site. Physical therapist participants used clinical summaries (available in 3 formats--as a full summary with hyperlinks, "quick takes" with hyperlinks, and a portable two-page version) on the PTNow.org site to answer knowledge acquisition and clinical reasoning questions related to four patient scenarios. They also responded to questions about ease of use related to website navigation and about format and completeness of information using a 1-5 Likert scale. Responses were coded to reflect how participants used the site and then were summarized descriptively. Preferences for clinical summary format were analyzed using an analysis of variance (ANOVA) and a Dunnett T3 post hoc analysis. Seventeen participants completed the study. Clinical relevance and completeness ratings by experienced clinicians, which were used as the measure of content validity, ranged from 3.1 to 4.6 on a 5 point scale. Construct validity based on the information on the PTNow.org site was supported for knowledge acquisition questions 66 % of the time and for clinical reasoning questions 40 % of the time. Usability ratings for the full clinical summary were 4.6 (1.2); for the quick takes, 3.5 (.98); and for the portable clinical summary, 4.0 (.45). Participants preferred the full clinical summary over the other two formats (F = 5.908, P = 0.007). One hundred percent of the participants stated that they would recommend the PTNow site to their colleagues. Prelimary evidence supported both content validity and construct validity of knowledge acquisition, and partially supported construct validity of clinical reasoning for the clinical summaries on the PTNow.org site. Usability was supported, with users preferring the full clinical summary over the other two formats. Iterative design is ongoing.

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.

[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 implementation study will further reveal the impact of the Amsterdam Wrist Rules on the anticipated reduction of X-rays requested, missed fractures, Emergency Department waiting times and health care costs.

Clinimetrics and clinical psychometrics: macro- and micro-analysis.

PubMed

Tomba, Elena; Bech, Per

2012-01-01

Clinimetrics was introduced three decades ago to specify the domain of clinical markers in clinical medicine (indexes or rating scales). In this perspective, clinical validity is the platform for selecting the various indexes or rating scales (macro-analysis). Psychometric validation of these indexes or rating scales is the measuring aspect (micro-analysis). Clinical judgment analysis by experienced psychiatrists is included in the macro-analysis and the item response theory models are especially preferred in the micro-analysis when using the total score as a sufficient statistic. Clinical assessment tools covering severity of illness scales, prognostic measures, issues of co-morbidity, longitudinal assessments, recovery, stressors, lifestyle, psychological well-being, and illness behavior have been identified. The constructive dialogue in clinimetrics between clinical judgment and psychometric validation procedures is outlined for generating developments of clinical practice in psychiatry. Copyright © 2012 S. Karger AG, Basel.

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…

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…

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 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…

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…

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…

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

Identification and validation of loss of function variants in clinical contexts.

PubMed

Lescai, Francesco; Marasco, Elena; Bacchelli, Chiara; Stanier, Philip; Mantovani, Vilma; Beales, Philip

2014-01-01

The choice of an appropriate variant calling pipeline for exome sequencing data is becoming increasingly more important in translational medicine projects and clinical contexts. Within GOSgene, which facilitates genetic analysis as part of a joint effort of the University College London and the Great Ormond Street Hospital, we aimed to optimize a variant calling pipeline suitable for our clinical context. We implemented the GATK/Queue framework and evaluated the performance of its two callers: the classical UnifiedGenotyper and the new variant discovery tool HaplotypeCaller. We performed an experimental validation of the loss-of-function (LoF) variants called by the two methods using Sequenom technology. UnifiedGenotyper showed a total validation rate of 97.6% for LoF single-nucleotide polymorphisms (SNPs) and 92.0% for insertions or deletions (INDELs), whereas HaplotypeCaller was 91.7% for SNPs and 55.9% for INDELs. We confirm that GATK/Queue is a reliable pipeline in translational medicine and clinical context. We conclude that in our working environment, UnifiedGenotyper is the caller of choice, being an accurate method, with a high validation rate of error-prone calls like LoF variants. We finally highlight the importance of experimental validation, especially for INDELs, as part of a standard pipeline in clinical environments.

Development and Validation of a Natural Language Processing Tool to Identify Patients Treated for Pneumonia across VA Emergency Departments.

PubMed

Jones, B E; South, B R; Shao, Y; Lu, C C; Leng, J; Sauer, B C; Gundlapalli, A V; Samore, M H; Zeng, Q

2018-01-01

Identifying pneumonia using diagnosis codes alone may be insufficient for research on clinical decision making. Natural language processing (NLP) may enable the inclusion of cases missed by diagnosis codes. This article (1) develops a NLP tool that identifies the clinical assertion of pneumonia from physician emergency department (ED) notes, and (2) compares classification methods using diagnosis codes versus NLP against a gold standard of manual chart review to identify patients initially treated for pneumonia. Among a national population of ED visits occurring between 2006 and 2012 across the Veterans Affairs health system, we extracted 811 physician documents containing search terms for pneumonia for training, and 100 random documents for validation. Two reviewers annotated span- and document-level classifications of the clinical assertion of pneumonia. An NLP tool using a support vector machine was trained on the enriched documents. We extracted diagnosis codes assigned in the ED and upon hospital discharge and calculated performance characteristics for diagnosis codes, NLP, and NLP plus diagnosis codes against manual review in training and validation sets. Among the training documents, 51% contained clinical assertions of pneumonia; in the validation set, 9% were classified with pneumonia, of which 100% contained pneumonia search terms. After enriching with search terms, the NLP system alone demonstrated a recall/sensitivity of 0.72 (training) and 0.55 (validation), and a precision/positive predictive value (PPV) of 0.89 (training) and 0.71 (validation). ED-assigned diagnostic codes demonstrated lower recall/sensitivity (0.48 and 0.44) but higher precision/PPV (0.95 in training, 1.0 in validation); the NLP system identified more "possible-treated" cases than diagnostic coding. An approach combining NLP and ED-assigned diagnostic coding classification achieved the best performance (sensitivity 0.89 and PPV 0.80). System-wide application of NLP to clinical text can increase capture of initial diagnostic hypotheses, an important inclusion when studying diagnosis and clinical decision-making under uncertainty. Schattauer GmbH Stuttgart.

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.

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.

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.

Development and Validation of Personality Disorder Spectra Scales for the MMPI-2-RF.

PubMed

Sellbom, Martin; Waugh, Mark H; Hopwood, Christopher J

2018-01-01

The purpose of this study was to develop and validate a set of MMPI-2-RF (Ben-Porath & Tellegen, 2008/2011) personality disorder (PD) spectra scales. These scales could serve the purpose of assisting with DSM-5 PD diagnosis and help link categorical and dimensional conceptions of personality pathology within the MMPI-2-RF. We developed and provided initial validity results for scales corresponding to the 10 PD constructs listed in the DSM-5 using data from student, community, clinical, and correctional samples. Initial validation efforts indicated good support for criterion validity with an external PD measure as well as with dimensional personality traits included in the DSM-5 alternative model for PDs. Construct validity results using psychosocial history and therapists' ratings in a large clinical sample were generally supportive as well. Overall, these brief scales provide clinicians using MMPI-2-RF data with estimates of DSM-5 PD constructs that can support cross-model connections between categorical and dimensional assessment approaches.

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.

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

PubMed

Wodushek, Thomas R; Greher, Michael R

2017-05-01

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

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.

First-in-human Phase 1 CRISPR Gene Editing Cancer Trials: Are We Ready?

PubMed

Baylis, Francoise; McLeod, Marcus

2017-01-01

A prospective first-in-human Phase 1 CRISPR gene editing trial in the United States for patients with melanoma, synovial sarcoma, and multiple myeloma offers hope that gene editing tools may usefully treat human disease. An overarching ethical challenge with first-in-human Phase 1 clinical trials, however, is knowing when it is ethically acceptable to initiate such trials on the basis of safety and efficacy data obtained from pre-clinical studies. If the pre-clinical studies that inform trial design are themselves poorly designed - as a result of which the quality of pre-clinical evidence is deficient - then the ethical requirement of scientific validity for clinical research may not be satisfied. In turn, this could mean that the Phase 1 clinical trial will be unsafe and that trial participants will be exposed to risk for no potential benefit. To assist sponsors, researchers, clinical investigators and reviewers in deciding when it is ethically acceptable to initiate first-in-human Phase 1 CRISPR gene editing clinical trials, structured processes have been developed to assess and minimize translational distance between pre-clinical and clinical research. These processes draw attention to various features of internal validity, construct validity, and external validity. As well, the credibility of supporting evidence is to be critically assessed with particular attention to optimism bias, financial conflicts of interest and publication bias. We critically examine the pre-clinical evidence used to justify the first-inhuman Phase 1 CRISPR gene editing cancer trial in the United States using these tools. We conclude that the proposed trial cannot satisfy the ethical requirement of scientific validity because the supporting pre-clinical evidence used to inform trial design is deficient. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Validation of electronic medical record-based phenotyping algorithms: results and lessons learned from the eMERGE network.

PubMed

Newton, Katherine M; Peissig, Peggy L; Kho, Abel Ngo; Bielinski, Suzette J; Berg, Richard L; Choudhary, Vidhu; Basford, Melissa; Chute, Christopher G; Kullo, Iftikhar J; Li, Rongling; Pacheco, Jennifer A; Rasmussen, Luke V; Spangler, Leslie; Denny, Joshua C

2013-06-01

Genetic studies require precise phenotype definitions, but electronic medical record (EMR) phenotype data are recorded inconsistently and in a variety of formats. To present lessons learned about validation of EMR-based phenotypes from the Electronic Medical Records and Genomics (eMERGE) studies. The eMERGE network created and validated 13 EMR-derived phenotype algorithms. Network sites are Group Health, Marshfield Clinic, Mayo Clinic, Northwestern University, and Vanderbilt University. By validating EMR-derived phenotypes we learned that: (1) multisite validation improves phenotype algorithm accuracy; (2) targets for validation should be carefully considered and defined; (3) specifying time frames for review of variables eases validation time and improves accuracy; (4) using repeated measures requires defining the relevant time period and specifying the most meaningful value to be studied; (5) patient movement in and out of the health plan (transience) can result in incomplete or fragmented data; (6) the review scope should be defined carefully; (7) particular care is required in combining EMR and research data; (8) medication data can be assessed using claims, medications dispensed, or medications prescribed; (9) algorithm development and validation work best as an iterative process; and (10) validation by content experts or structured chart review can provide accurate results. Despite the diverse structure of the five EMRs of the eMERGE sites, we developed, validated, and successfully deployed 13 electronic phenotype algorithms. Validation is a worthwhile process that not only measures phenotype performance but also strengthens phenotype algorithm definitions and enhances their inter-institutional sharing.

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 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 psychometric properties and supports the clinical assessment of and symptom-based categorization of patients with a wide spectrum of gastrointestinal symptoms.

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.

Validation of the Chinese version of functional assessment of anorexia-cachexia therapy (FAACT) scale for measuring quality of life in cancer patients with cachexia.

PubMed

Zhou, Ting; Yang, Kaixiang; Thapa, Sudip; Fu, Qiang; Jiang, Yongsheng; Yu, Shiying

2017-04-01

The assessment of quality of life (QOL) is an important part of cachexia management for cancer patients. Functional assessment of anorexia-cachexia therapy (FAACT), a specific QOL instrument for cachexia patients, has not been validated in Chinese population. The aim of this study was to validate the FAACT scale in Chinese cancer patients for its future use. Eligible cancer patients were included in our study. Patients' demographic and clinical characteristics were collected from the electronic medical records. Patients were asked to complete the Chinese version of FAACT scale and the MD Anderson symptom inventory (MDASI), and then the reliability and validity were analyzed. A total of 285 patients were enrolled in our study, data of 241 patients were evaluated. Coefficients of Cronbach's alpha, test-retest and split-half analyses were all greater than 0.8, which indicated an excellent reliability for FAACT scale. In item-subscale correlation analysis and factor analysis, good construct validity for FAACT scale was found. The correlation between FAACT and MDASI interference subscale showed reasonable criterion-related validity, and for further clinical validation, the FAACT scale showed excellent discriminative validity for distinguishing patients in different cachexia status and in different performance status. The Chinese version of FAACT scale has good reliability and validity and is suitable for measuring QOL of cachexia patients in Chinese population.

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

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.

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…

The Brief Fear of Negative Evaluation Scale (BFNE): translation and validation study of the Iranian version

PubMed Central

Tavoli, Azadeh; Melyani, Mahdiyeh; Bakhtiari, Maryam; Ghaedi, Gholam Hossein; Montazeri, Ali

2009-01-01

Background The Brief Fear of Negative Evaluation Scale (BFNE) is a commonly used instrument to measure social anxiety. This study aimed to translate and to test the reliability and validity of the BFNE in Iran. Methods The English language version of the BFNE was translated into Persian (Iranian language) and was used in this study. The questionnaire was administered to a consecutive sample of 235 students with (n = 33, clinical group) and without social phobia (n = 202, non-clinical group). In addition to the BFNE, two standard instruments were used to measure social phobia severity: the Social Phobia Inventory (SPIN), and the Social Interaction Anxiety Scale (SIAS). All participants completed a brief background information questionnaire, the SPIN, the SIAS and the BFNE scales. Statistical analysis was performed to test the reliability and validity of the BFNE. Results In all 235 students were studied (111 male and 124 female). The mean age for non-clinical group was 22.2 (SD = 2.1) years and for clinical sample it was 22.4 (SD = 1.8) years. Cronbach's alpha coefficient (to test reliability) was acceptable for both non-clinical and clinical samples (α = 0.90 and 0.82 respectively). In addition, 3-week test-retest reliability was performed in non-clinical sample and the intraclass correlation coefficient (ICC) was quite high (ICC = 0.71). Validity as performed using convergent and discriminant validity showed satisfactory results. The questionnaire correlated well with established measures of social phobia such as the SPIN (r = 0.43, p < 0.001) and the SIAS (r = 0.54, p < 0.001). Also the BFNE discriminated well between men and women with and without social phobia in the expected direction. Factor analysis supported a two-factor solution corresponding to positive and reverse-worded items. Conclusion This validation study of the Iranian version of BFNE proved that it is an acceptable, reliable and valid measure of social phobia. However, since the scale showed a two-factor structure and this does not confirm to the theoretical basis for the BFNE, thus we suggest the use of the BFNE-II when it becomes available in Iran. The validation study of the BFNE-II is in progress. PMID:19589161

Selecting postoperative adjuvant systemic therapy for early stage breast cancer: A critical assessment of commercially available gene expression assays

PubMed Central

Schuur, Eric; Angel Aristizabal, Javier; Bargallo Rocha, Juan Enrique; Cabello, Cesar; Elizalde, Roberto; García‐Estévez, Laura; Gomez, Henry L.; Katz, Artur; Nuñez De Pierro, Aníbal

2017-01-01

Risk stratification of patients with early stage breast cancer may support adjuvant chemotherapy decision‐making. This review details the development and validation of six multi‐gene classifiers, each of which claims to provide useful prognostic and possibly predictive information for early stage breast cancer patients. A careful assessment is presented of each test's analytical validity, clinical validity, and clinical utility, as well as the quality of evidence supporting its use. PMID:28211064

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).

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.…

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…

Psychometric Properties of the Arabic Version of the Drug Use Disorders Identification Test (DUDIT) in Clinical, Prison Inmate, and Student Samples.

PubMed

Sfendla, Anis; Zouini, Btissame; Lemrani, Dina; Berman, Anne H; Senhaji, Meftaha; Kerekes, Nóra

2017-04-01

The study aimed to validate the Arabic version of the Drug Use Disorders Identification Test (DUDIT) by (1) assessing its factor structure, (2) determining structural validity, (3) evaluating item-total and inter-item correlation, and (4) assessing its predictive validity. The study population included 169 prison inmates, 51 patients with clinical diagnosis of substance used disorder, and 53 students (N = 273). All participants completed the self-report version of the Arabic DUDIT. After exploratory factor analysis, internal consistency of the Arabic DUDIT was determined and external validation was performed. Principal factor analysis showed that Arabic DUDIT exhibited only one factor, which explained 66.9% of the variance. Reliability based on Cronbach's alpha was .95. When compared to the DSM-IV substance use disorder diagnosis in a clinical sample, DUDIT had an area under the curve (AUC) of .98, with a sensitivity of .98 and a specificity of .90. The Arabic version of DUDIT is a valid and reliable tool for screening for drug use in Arabic-speaking countries.

Validation of Self-Reported Cognitive Problems with Objective Neuropsychological Performance in Manganese-Exposed Residents

EPA Science Inventory

There is a lack of validation of self-reported cognitive problems with objective neuropsychological measures. The validity of four self-reported cognitive items from a health questionnaire (HQ) and the Symptoms Checklist 90-Revised (SCL-90-R) was examined with objective clinical ...

Developing an instrument to measure effective factors on Clinical Learning.

PubMed

Dadgaran, Ideh; Shirazi, Mandana; Mohammadi, Aeen; Ravari, Ali

2016-07-01

Although nursing students spend a large part of their learning period in the clinical environment, clinical learning has not been perceived by its nature yet. To develop an instrument to measure effective factors on clinical learning in nursing students. This is a mixed methods study performed in 2 steps. First, the researchers defined "clinical learning" in nursing students through qualitative content analysis and designed items of the questionnaire based on semi-structured individual interviews with nursing students. Then, as the second step, psychometric properties of the questionnaire were evaluated using the face validity, content validity, construct validity, and internal consistency evaluated on 227 students from fourth or higher semesters. All the interviews were recorded and transcribed, and then, they were analyzed using Max Qualitative Data Analysis and all of qualitative data were analyzed using SPSS 14. To do the study, we constructed the preliminary questionnaire containing 102 expressions. After determination of face and content validities by qualitative and quantitative approaches, the expressions of the questionnaire were reduced to 45. To determine the construct validity, exploratory factor analysis was applied. The results indicated that the maximum variance percentage (40.55%) was defined by the first 3 factors while the rest of the total variance percentage (59.45%) was determined by the other 42 factors. Results of exploratory factor analysis of this questionnaire indicated the presence of 3 instructor-staff, students, and educational related factors. Finally, 41 expressions were kept in 3 factor groups. The α-Cronbach coefficient (0.93) confirmed the high internal consistency of the questionnaire. Results indicated that the prepared questionnaire was an efficient instrument in the study of the effective factors on clinical learning as viewed by nursing students since it involves 41 expressions and properties such as instrument design based on perception and experiences of the nursing students about effective factors on clinical learning, definition of facilitator and preventive factors of the clinical learning, simple scoring, suitable validity and reliability, and applicability in different occasions.

Validation of an Arabic Version of the Obesity-Related Wellbeing (ORWELL 97) Questionnaire in Adults with Obesity.

PubMed

Itani, Leila; Calugi, Simona; Kreidieh, Dima; El Kassas, Germine; El Masri, Dana; Tannir, Hana; Dalle Grave, Riccardo; Harfoush, Aya; El Ghoch, Marwan

2018-01-10

No specific questionnaire that evaluates Health-Related Quality Of Life (HRQOL) in individuals with obesity is available in the Arabic language. The aim of this study was therefore to propose and examine the validity and reliability of an Arabic language version of the ORWELL 97, a validated obesity-related HRQOL questionnaire. The ORWELL 97 questionnaire was translated from English to Arabic language and administered to 318 Arabic-speaking participants (106 from clinical and 212 from community samples), and underwent internal consistency, test-retest reliability, construct and discriminative validity analysis. Internal consistency and the test-retest reliability were excellent for ORWELL 97 global scores in the clinical sample. Participants with obesity displayed significantly higher ORWELL 97 scores than participants from the community sample, confirming the good discriminant validity of the questionnaire. Confirmatory factor analysis in the clinical sample revealed a good fit for a modified two-factor structure. Overall, the Arabic version of the ORWELL 97 can be considered validated in Arabic adult patients with obesity, paving the way to further assessment of its responsiveness in measuring changes in health-related quality of life associated with obesity treatment. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Biomarkers and surrogate endpoints in glaucoma clinical trials.

PubMed

Medeiros, Felipe A

2015-05-01

Surrogate endpoints are often used as replacements for true clinically relevant endpoints in several areas of medicine, as they enable faster and less expensive clinical trials. However, without proper validation, the use of surrogates may lead to incorrect conclusions about the efficacy and safety of treatments. This article reviews the general requirements for validating surrogate endpoints and provides a critical assessment of the use of intraocular pressure (IOP), visual fields, and structural measurements of the optic nerve as surrogate endpoints in glaucoma clinical trials. A valid surrogate endpoint must be able to predict the clinically relevant endpoint and fully capture the effect of an intervention on that endpoint. Despite its widespread use in clinical trials, no proper validation of IOP as a surrogate endpoint has ever been conducted for any class of IOP-lowering treatments. Evidence has accumulated with regard to the role of imaging measurements of optic nerve damage as surrogate endpoints in glaucoma. These measurements are predictive of functional losses in the disease and may explain, at least in part, treatment effects on clinically relevant endpoints. The use of composite endpoints in glaucoma trials may overcome weaknesses of the use of structural or functional endpoints in isolation. Unless research is dedicated to fully develop and validate suitable endpoints that can be used in glaucoma clinical trials, we run the risk of inappropriate judgments about the value of new therapies. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

"Clinical brain profiling": a neuroscientific diagnostic approach for mental disorders.

PubMed

Peled, Abraham; Geva, Amir B

2014-10-01

Clinical brain profiling is an attempt to map a descriptive nosology in psychiatry to underlying constructs in neurobiology and brain dynamics. This paper briefly reviews the motivation behind clinical brain profiling (CBP) and presents some provisional validation using clinical assessments and meta-analyses of neuroscientific publications. The paper has four sections. In the first, we review the nature and motivation for clinical brain profiling. This involves a description of the key aspects of functional anatomy that can lead to psychopathology. These features constitute the dimensions or categories for a profile of brain disorders based upon pathophysiology. The second section describes a mapping or translation matrix that maps from symptoms and signs, of a descriptive sort, to the CBP dimensions that provide a more mechanistic explanation. We will describe how this mapping engenders archetypal diagnoses, referring readers to tables and figures. The third section addresses the construct validity of clinical brain profiling by establishing correlations between profiles based on clinical ratings of symptoms and signs under classical diagnostic categories with the corresponding profiles generated automatically using archetypal diagnoses. We then provide further validation by performing a cluster analysis on the symptoms and signs and showing how they correspond to the equivalent brain profiles based upon clinical and automatic diagnosis. In the fourth section, we address the construct validity of clinical brain profiling by looking for associations between pathophysiological mechanisms (such as connectivity and plasticity) and nosological diagnoses (such as schizophrenia and depression). Based upon the mechanistic perspective offered in the first section, we test some particular hypotheses about double dissociations using a meta-analysis of PubMed searches. The final section concludes with perspectives for the future and outstanding validation issues for clinical brain profiling. Copyright © 2014 Elsevier Ltd. All rights reserved.

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.

Cognitive assessment: A challenge for occupational therapists in Brazil

PubMed Central

Conti, Juliana

2017-01-01

Cognitive impairment is a common dysfunction after neurological injury. Cognitive assessment tools can help the therapist understand how impairments are affecting functional status and quality of life. Objective The aim of the study was to identify instruments for cognitive assessment that Occupational Therapists (OT) can use in clinical practice. Methods The instruments published in English and Portuguese between 1999 and 2016 were systematically reviewed. Results The search identified 17 specific instruments for OT not validated in Brazilian Portuguese, 10 non-specific instruments for OT not validated in Brazilian Portuguese, and 25 instruments validated for Portuguese, only one of which was specific for OT (Lowenstein Occupational Therapy Cognitive Assessment). Conclusion There are few assessment cognitive tools validated for use in the Brazilian culture and language. The majority of the instruments appear not to be validated for use by OT in clinical practice. PMID:29213503

The use of video clips in teleconsultation for preschool children with movement disorders.

PubMed

Gorter, Hetty; Lucas, Cees; Groothuis-Oudshoorn, Karin; Maathuis, Carel; van Wijlen-Hempel, Rietje; Elvers, Hans

2013-01-01

To investigate the reliability and validity of video clips in assessing movement disorders in preschool children. The study group included 27 children with neuromotor concerns. The explorative validity group included children with motor problems (n = 21) or with typical development (n = 9). Hempel screening was used for live observation of the child, full recording, and short video clips. The explorative study tested the validity of the clinical classifications "typical" or "suspect." Agreement between live observation and the full recording was almost perfect; Agreement for the clinical classification "typical" or "suspect" was substantial. Agreement between the full recording and short video clips was substantial to moderate. The explorative validity study, based on short video clips and the presence of a neuromotor developmental disorder, showed substantial agreement. Hempel screening enables reliable and valid observation of video clips, but further research is necessary to demonstrate the predictive value.

[Psychometric Characteristics of the Clinical Nursing Mentors' Behavior Scale].

PubMed

Zhao, Rong; Chen, Yan-Hua; Yu, Hui-Ting; Xiao, Lu; Wen, Jing; Yeh, Tzu-Pei

2017-08-01

The behavior of mentors impacts the quality and experience of nursing students who are studying in clinical placement. Accurately assessing the behavior of mentors is fundamental to training, regulating, guiding, and improving their behavior and quality of teaching. To test the validity and reliability of the Clinical Nursing Mentors' Behavior Scale (CNMBS) among mentors. This study included three stages. During the first stage, seven Chinese experts were invited to evaluate content validity. During the second stage, the test-retest reliability was examined with 63 mentors. During the third stage, a cross-sectional study was conducted. Seven hundred and sixty-six nursing mentors from five hospitals in Beijing, Shenzhen, and Sichuan completed the survey either online or in hard copy form. The data collected from the questionnaire were analyzed using item analysis, construct validity, internal consistency and discriminant validity, with the results used to determine the psychometric characteristics of the CNMBS. The content validity index for the CNMBS was .91. The intra-class correlation coefficient was .89; the range of the item discrimination critical ratio was 9.42-22.43 (p < .001), and the item-total correlation was .35- .70 (p < .001). The three factors of "guiding personal growth", "promoting professional development", and "providing psychosocial support" and a total of 23 items were identified, with item factor loadings ranging from .51 to .79. The three factors explained 50.99% of total variance. The internal consistency of the CNMBS earned a Cronbach's α coefficient of .92, while those of the three subscales were .89, .86 and .75, respectively. The Clinical Nursing Mentors' Behavior Scale demonstrated high validity and reliability, supporting the CNMBS as a valid tool for assessing the teaching behavior of mentors.

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.

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.

Screening for potential child maltreatment in parents of a newborn baby: The predictive validity of an Instrument for early identification of Parents At Risk for child Abuse and Neglect (IPARAN).

PubMed

van der Put, Claudia E; Bouwmeester-Landweer, Merian B R; Landsmeer-Beker, Eleonore A; Wit, Jan M; Dekker, Friedo W; Kousemaker, N Pieter J; Baartman, Herman E M

2017-08-01

For preventive purposes it is important to be able to identify families with a high risk of child maltreatment at an early stage. Therefore we developed an actuarial instrument for screening families with a newborn baby, the Instrument for identification of Parents At Risk for child Abuse and Neglect (IPARAN). The aim of this study was to assess the predictive validity of the IPARAN and to examine whether combining actuarial and clinical methods leads to an improvement of the predictive validity. We examined the predictive validity by calculating several performance indicators (i.e., sensitivity, specificity and the Area Under the receiver operating characteristic Curve [AUC]) in a sample of 4692 Dutch families with newborns. The outcome measure was a report of child maltreatment at Child Protection Services during a follow-up of 3 years. For 17 children (.4%) a report of maltreatment was registered. The predictive validity of the IPARAN was significantly better than chance (AUC=.700, 95% CI [.567-.832]), in contrast to a low value for clinical judgement of nurses of the Youth Health Care Centers (AUC=.591, 95% CI [.422-.759]). The combination of the IPARAN and clinical judgement resulted in the highest predictive validity (AUC=.720, 95% CI [.593-.847]), however, the difference between the methods did not reach statistical significance. The good predictive validity of the IPARAN in combination with clinical judgment of the nurse enables professionals to assess risks at an early stage and to make referrals to early intervention programs. Copyright © 2017 Elsevier Ltd. All rights reserved.

Psychometric properties of the Persian version of the Ambulatory Care Learning Educational Environment Measure (ACLEEM) questionnaire, Shiraz, Iran

PubMed Central

Parvizi, Mohammad Mahdi; Amini, Mitra; Dehghani, Mohammad Reza; Jafari, Peyman; Parvizi, Zahra

2016-01-01

Purpose Evaluation is the main component in design and implementation of educational activities and rapid growth of educational institution programs. Outpatient medical education and clinical training environment is one of the most important parts of training of medical residents. This study aimed to determine the validity and reliability of the Persian version of Ambulatory Care Learning Educational Environment Measure (ACLEEM) questionnaire, as an instrument for assessment of educational environments in residency medical clinics. Materials and methods This study was performed on 180 residents in Shiraz University of Medical Sciences, Shiraz, Iran, in 2014–2015. The questionnaire designers’ electronic permission (by email) and the residents’ verbal consent were obtained before distributing the questionnaires. The study data were gathered using ACLEEM questionnaire developed by Arnoldo Riquelme in 2013. The data were analyzed using the SPSS statistical software, version 14, and MedCalc® software. Then, the construct validity, including convergent and discriminant validities, of the Persian version of ACLEEM questionnaire was assessed. Its internal consistency was also checked by Cronbach’s alpha coefficient. Results Five team members who were experts in medical education were consulted to test the cultural adaptation, linguistic equivalency, and content validity of the Persian version of the questionnaire. Content validity indexes were >0.9 in all items. In factor analysis of the instrument, the Kaiser–Meyer–Olkin index was 0.928 and Barlett’s sphericity test yielded the following results: X2=6,717.551, df =1,225, and P≤0.001. Besides, Cronbach’s alpha coefficient of ACLEEM questionnaire was 0.964. Cronbach’s alpha coefficients were also >0.80 in all the three domains of the questionnaire. Overall, the Persian version of ACLEEM showed excellent convergent validity and acceptable discriminant validity, except for the clinical training domain. Conclusion According to the results, the Persian version of ACLEEM questionnaire was a valid and reliable instrument for Iranian residents to assess specialized clinics and residency ambulatory settings. PMID:27729824

Psychometric properties of the Persian version of the Ambulatory Care Learning Educational Environment Measure (ACLEEM) questionnaire, Shiraz, Iran.

PubMed

Parvizi, Mohammad Mahdi; Amini, Mitra; Dehghani, Mohammad Reza; Jafari, Peyman; Parvizi, Zahra

2016-01-01

Evaluation is the main component in design and implementation of educational activities and rapid growth of educational institution programs. Outpatient medical education and clinical training environment is one of the most important parts of training of medical residents. This study aimed to determine the validity and reliability of the Persian version of Ambulatory Care Learning Educational Environment Measure (ACLEEM) questionnaire, as an instrument for assessment of educational environments in residency medical clinics. This study was performed on 180 residents in Shiraz University of Medical Sciences, Shiraz, Iran, in 2014-2015. The questionnaire designers' electronic permission (by email) and the residents' verbal consent were obtained before distributing the questionnaires. The study data were gathered using ACLEEM questionnaire developed by Arnoldo Riquelme in 2013. The data were analyzed using the SPSS statistical software, version 14, and MedCalc ® software. Then, the construct validity, including convergent and discriminant validities, of the Persian version of ACLEEM questionnaire was assessed. Its internal consistency was also checked by Cronbach's alpha coefficient. Five team members who were experts in medical education were consulted to test the cultural adaptation, linguistic equivalency, and content validity of the Persian version of the questionnaire. Content validity indexes were >0.9 in all items. In factor analysis of the instrument, the Kaiser-Meyer-Olkin index was 0.928 and Barlett's sphericity test yielded the following results: X 2 =6,717.551, df =1,225, and P ≤0.001. Besides, Cronbach's alpha coefficient of ACLEEM questionnaire was 0.964. Cronbach's alpha coefficients were also >0.80 in all the three domains of the questionnaire. Overall, the Persian version of ACLEEM showed excellent convergent validity and acceptable discriminant validity, except for the clinical training domain. According to the results, the Persian version of ACLEEM questionnaire was a valid and reliable instrument for Iranian residents to assess specialized clinics and residency ambulatory settings.

Development and validation of electronic surveillance tool for acute kidney injury: A retrospective analysis.

PubMed

Ahmed, Adil; Vairavan, Srinivasan; Akhoundi, Abbasali; Wilson, Gregory; Chiofolo, Caitlyn; Chbat, Nicolas; Cartin-Ceba, Rodrigo; Li, Guangxi; Kashani, Kianoush

2015-10-01

Timely detection of acute kidney injury (AKI) facilitates prevention of its progress and potentially therapeutic interventions. The study objective is to develop and validate an electronic surveillance tool (AKI sniffer) to detect AKI in 2 independent retrospective cohorts of intensive care unit (ICU) patients. The primary aim is to compare the sensitivity, specificity, and positive and negative predictive values of AKI sniffer performance against a reference standard. This study is conducted in the ICUs of a tertiary care center. The derivation cohort study subjects were Olmsted County, MN, residents admitted to all Mayo Clinic ICUs from July 1, 2010, through December 31, 2010, and the validation cohort study subjects were all patients admitted to a Mayo Clinic, Rochester, campus medical/surgical ICU on January 12, 2010, through March 23, 2010. All included records were reviewed by 2 independent investigators who adjudicated AKI using the Acute Kidney Injury Network criteria; disagreements were resolved by a third reviewer. This constituted the reference standard. An electronic algorithm was developed; its precision and reliability were assessed in comparison with the reference standard in 2 separate cohorts, derivation and validation. Of 1466 screened patients, a total of 944 patients were included in the study: 482 for derivation and 462 for validation. Compared with the reference standard in the validation cohort, the sensitivity and specificity of the AKI sniffer were 88% and 96%, respectively. The Cohen κ (95% confidence interval) agreement between the electronic and the reference standard was 0.84 (0.78-0.89) and 0.85 (0.80-0.90) in the derivation and validation cohorts. Acute kidney injury can reliably and accurately be detected electronically in ICU patients. The presented method is applicable for both clinical (decision support) and research (enrollment for clinical trials) settings. Prospective validation is required. Copyright © 2015 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, the MDS-HSI may be used in system-level applications using routinely collected population-level data.

A critical analysis of test-retest reliability in instrument validation studies of cancer patients under palliative care: a systematic review

PubMed Central

2014-01-01

Background Patient-reported outcome validation needs to achieve validity and reliability standards. Among reliability analysis parameters, test-retest reliability is an important psychometric property. Retested patients must be in a clinically stable condition. This is particularly problematic in palliative care (PC) settings because advanced cancer patients are prone to a faster rate of clinical deterioration. The aim of this study was to evaluate the methods by which multi-symptom and health-related qualities of life (HRQoL) based on patient-reported outcomes (PROs) have been validated in oncological PC settings with regards to test-retest reliability. Methods A systematic search of PubMed (1966 to June 2013), EMBASE (1980 to June 2013), PsychInfo (1806 to June 2013), CINAHL (1980 to June 2013), and SCIELO (1998 to June 2013), and specific PRO databases was performed. Studies were included if they described a set of validation studies. Studies were included if they described a set of validation studies for an instrument developed to measure multi-symptom or multidimensional HRQoL in advanced cancer patients under PC. The COSMIN checklist was used to rate the methodological quality of the study designs. Results We identified 89 validation studies from 746 potentially relevant articles. From those 89 articles, 31 measured test-retest reliability and were included in this review. Upon critical analysis of the overall quality of the criteria used to determine the test-retest reliability, 6 (19.4%), 17 (54.8%), and 8 (25.8%) of these articles were rated as good, fair, or poor, respectively, and no article was classified as excellent. Multi-symptom instruments were retested over a shortened interval when compared to the HRQoL instruments (median values 24 hours and 168 hours, respectively; p = 0.001). Validation studies that included objective confirmation of clinical stability in their design yielded better results for the test-retest analysis with regard to both pain and global HRQoL scores (p < 0.05). The quality of the statistical analysis and its description were of great concern. Conclusion Test-retest reliability has been infrequently and poorly evaluated. The confirmation of clinical stability was an important factor in our analysis, and we suggest that special attention be focused on clinical stability when designing a PRO validation study that includes advanced cancer patients under PC. PMID:24447633

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 version), thus providing a valid and reliable brief tool for assessing the QoL of Malaysian T2DM patients. Copyright © 2016 Elsevier Inc. All rights reserved.

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…

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

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.

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.

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

The Pittsburgh sleep quality index as a screening tool for sleep dysfunction in clinical and non-clinical samples: A systematic review and meta-analysis.

PubMed

Mollayeva, Tatyana; Thurairajah, Pravheen; Burton, Kirsteen; Mollayeva, Shirin; Shapiro, Colin M; Colantonio, Angela

2016-02-01

This review appraises the process of development and the measurement properties of the Pittsburgh sleep quality index (PSQI), gauging its potential as a screening tool for sleep dysfunction in non-clinical and clinical samples; it also compares non-clinical and clinical populations in terms of PSQI scores. MEDLINE, Embase, PsycINFO, and HAPI databases were searched. Critical appraisal of studies of measurement properties was performed using COSMIN. Of 37 reviewed studies, 22 examined construct validity, 19 - known-group validity, 15 - internal consistency, and three - test-retest reliability. Study quality ranged from poor to excellent, with the majority designated fair. Internal consistency, based on Cronbach's alpha, was good. Discrepancies were observed in factor analytic studies. In non-clinical and clinical samples with known differences in sleep quality, the PSQI global scores and all subscale scores, with the exception of sleep disturbance, differed significantly. The best evidence synthesis for the PSQI showed strong reliability and validity, and moderate structural validity in a variety of samples, suggesting the tool fulfills its intended utility. A taxonometric analysis can contribute to better understanding of sleep dysfunction as either a dichotomous or continuous construct. Copyright © 2015 Elsevier Ltd. All rights reserved.

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.

Development and validation of response markers to predict survival and pleurodesis success in patients with malignant pleural effusion (PROMISE): a multicohort analysis.

PubMed

Psallidas, Ioannis; Kanellakis, Nikolaos I; Gerry, Stephen; Thézénas, Marie Laëtitia; Charles, Philip D; Samsonova, Anastasia; Schiller, Herbert B; Fischer, Roman; Asciak, Rachelle; Hallifax, Robert J; Mercer, Rachel; Dobson, Melissa; Dong, Tao; Pavord, Ian D; Collins, Gary S; Kessler, Benedikt M; Pass, Harvey I; Maskell, Nick; Stathopoulos, Georgios T; Rahman, Najib M

2018-06-13

The prevalence of malignant pleural effusion is increasing worldwide, but prognostic biomarkers to plan treatment and to understand the underlying mechanisms of disease progression remain unidentified. The PROMISE study was designed with the objectives to discover, validate, and prospectively assess biomarkers of survival and pleurodesis response in malignant pleural effusion and build a score that predicts survival. In this multicohort study, we used five separate and independent datasets from randomised controlled trials to investigate potential biomarkers of survival and pleurodesis. Mass spectrometry-based discovery was used to investigate pleural fluid samples for differential protein expression in patients from the discovery group with different survival and pleurodesis outcomes. Clinical, radiological, and biological variables were entered into least absolute shrinkage and selection operator regression to build a model that predicts 3-month mortality. We evaluated the model using internal and external validation. 17 biomarker candidates of survival and seven of pleurodesis were identified in the discovery dataset. Three independent datasets (n=502) were used for biomarker validation. All pleurodesis biomarkers failed, and gelsolin, macrophage migration inhibitory factor, versican, and tissue inhibitor of metalloproteinases 1 (TIMP1) emerged as accurate predictors of survival. Eight variables (haemoglobin, C-reactive protein, white blood cell count, Eastern Cooperative Oncology Group performance status, cancer type, pleural fluid TIMP1 concentrations, and previous chemotherapy or radiotherapy) were validated and used to develop a survival score. Internal validation with bootstrap resampling and external validation with 162 patients from two independent datasets showed good discrimination (C statistic values of 0·78 [95% CI 0·72-0·83] for internal validation and 0·89 [0·84-0·93] for external validation of the clinical PROMISE score). To our knowledge, the PROMISE score is the first prospectively validated prognostic model for malignant pleural effusion that combines biological and clinical parameters to accurately estimate 3-month mortality. It is a robust, clinically relevant prognostic score that can be applied immediately, provide important information on patient prognosis, and guide the selection of appropriate management strategies. European Respiratory Society, Medical Research Funding-University of Oxford, Slater & Gordon Research Fund, and Oxfordshire Health Services Research Committee Research Grants. Copyright © 2018 Elsevier Ltd. All rights reserved.

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.…

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 =…

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…

Development and validation of a nursing professionalism evaluation model in a career ladder system.

PubMed

Kim, Yeon Hee; Jung, Young Sun; Min, Ja; Song, Eun Young; Ok, Jung Hui; Lim, Changwon; Kim, Kyunghee; Kim, Ji-Su

2017-01-01

The clinical ladder system categorizes the degree of nursing professionalism and rewards and is an important human resource tool for managing nursing. We developed a model to evaluate nursing professionalism, which determines the clinical ladder system levels, and verified its validity. Data were collected using a clinical competence tool developed in this study, and existing methods such as the nursing professionalism evaluation tool, peer reviews, and face-to-face interviews to evaluate promotions and verify the presented content in a medical institution. Reliability and convergent and discriminant validity of the clinical competence evaluation tool were verified using SmartPLS software. The validity of the model for evaluating overall nursing professionalism was also analyzed. Clinical competence was determined by five dimensions of nursing practice: scientific, technical, ethical, aesthetic, and existential. The structural model explained 66% of the variance. Clinical competence scales, peer reviews, and face-to-face interviews directly determined nursing professionalism levels. The evaluation system can be used for evaluating nurses' professionalism in actual medical institutions from a nursing practice perspective. A conceptual framework for establishing a human resources management system for nurses and a tool for evaluating nursing professionalism at medical institutions is provided.

Development and evaluation of an automated fall risk assessment system.

PubMed

Lee, Ju Young; Jin, Yinji; Piao, Jinshi; Lee, Sun-Mi

2016-04-01

Fall risk assessment is the first step toward prevention, and a risk assessment tool with high validity should be used. This study aimed to develop and validate an automated fall risk assessment system (Auto-FallRAS) to assess fall risks based on electronic medical records (EMRs) without additional data collected or entered by nurses. This study was conducted in a 1335-bed university hospital in Seoul, South Korea. The Auto-FallRAS was developed using 4211 fall-related clinical data extracted from EMRs. Participants included fall patients and non-fall patients (868 and 3472 for the development study; 752 and 3008 for the validation study; and 58 and 232 for validation after clinical application, respectively). The system was evaluated for predictive validity and concurrent validity. The final 10 predictors were included in the logistic regression model for the risk-scoring algorithm. The results of the Auto-FallRAS were shown as high/moderate/low risk on the EMR screen. The predictive validity analyzed after clinical application of the Auto-FallRAS was as follows: sensitivity = 0.95, NPV = 0.97 and Youden index = 0.44. The validity of the Morse Fall Scale assessed by nurses was as follows: sensitivity = 0.68, NPV = 0.88 and Youden index = 0.28. This study found that the Auto-FallRAS results were better than were the nurses' predictions. The advantage of the Auto-FallRAS is that it automatically analyzes information and shows patients' fall risk assessment results without requiring additional time from nurses. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Assessing the impact of growth hormone deficiency and treatment in adults: development of a new disease-specific measure.

PubMed

Brod, Meryl; Højbjerre, Lise; Adalsteinsson, Johan Erpur; Rasmussen, Michael Højby

2014-04-01

Approximately 50 000 adults in the United States are diagnosed with GH deficiency, which has negative impacts on cognitive functioning, psychological well-being, and quality of life. This paper presents development and validation of a patient-reported outcome measure (PRO), the Treatment-Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD). The TRIM-AGHD was developed to measure the impact of GH deficiency and its treatment. The development and validation of the TRIM-AGHD was conducted according to the Food and Drug Administration guidance on the development of PROs. Concept elicitation, conducted in three countries included interviews with patients, clinical experts, and literature review. Qualitative data were analyzed based on grounded theory principles, and draft items were cognitively debriefed. The measure underwent psychometric validation in a US clinic-based population. An a priori statistical analysis plan included assessment of the measurement model, reliability, and validity. Item functioning was reviewed using item response theory analyses. Forty-eight patients and six clinical experts participated in concept elicitation and 169 patients completed the validation study. TRIM-AGHD was measured. Factor analysis resulted in four domains: energy level, physical health, emotional health, and cognitive ability. The item response theory confirmed adequate item fit and placement within their domain. Internal consistency ranged from 0.82 to 0.95 and test-retest ranged from 0.80 to 0.92. All prespecified hypotheses for convergent validity and all but two for discriminant validity were met. The final 26-item TRIM-AGHD can be considered a reliable and valid PRO of the impact of disease and treatment for adult GH deficiency.

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.

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.

Development and psychometric evaluation of the Undergraduate Clinical Education Environment Measure (UCEEM).

PubMed

Strand, Pia; Sjöborg, Karolina; Stalmeijer, Renée; Wichmann-Hansen, Gitte; Jakobsson, Ulf; Edgren, Gudrun

2013-12-01

There is a paucity of instruments designed to evaluate the multiple dimensions of the workplace as an educational environment for undergraduate medical students. The aim was to develop and psychometrically evaluate an instrument to measure how undergraduate medical students perceive the clinical workplace environment, based on workplace learning theories and empirical findings. Development of the instrument relied on established standards including theoretical and empirical grounding, systematic item development and expert review at various stages to ensure content validity. Qualitative and quantitative methods were employed using a series of steps from conceptualization through psychometric analysis of scores in a Swedish medical student population. The final result was a 25-item instrument with two overarching dimensions, experiential learning and social participation, and four subscales that coincided well with theory and empirical findings: Opportunities to learn in and through work & quality of supervision; Preparedness for student entry; Workplace interaction patterns & student inclusion; and Equal treatment. Evidence from various sources supported content validity, construct validity and reliability of the instrument. The Undergraduate Clinical Education Environment Measure represents a valid, reliable and feasible multidimensional instrument for evaluation of the clinical workplace as a learning environment for undergraduate medical students. Further validation in different populations using various psychometric methods is needed.

Development of an instrument to measure the use of behaviors taught in the American Physical Therapy Association Clinical Instructor Education and Credentialing Program (APTA CIECP): a pilot study.

PubMed

Bridges, Patricia H; Carter, Vincent; Rehm, Stephanie; Tintl, Sara Bowers; Halperin, Rebecca; Kniesly, Elizabeth; Pelino, Soni

2013-01-01

Conduct a pilot study to establish the reliability and validity of a survey instrument that directly measures the objectives and content of the APTA CIECP; and measure the self-reported frequency of use of the behaviors taught in the APTA CIECP. Eighteen (18) APTA credentialed CIs. Develop a web-based survey consisting of 58 items representative of the behaviors taught in the APTA CIECP and 8 demographic characteristics. Establish the content validity and reliability of the survey instrument. Conduct a descriptive analysis of the frequency of self-reported use of the behaviors. The APTA Clinical Instructor Education Board (CIEB) reviewed the items and determined that the items matched the objectives and content of the APTA CIECP, thereby establishing content validity. Cronbach's alpha coefficients ranging from 0.79-0.90 confirmed the reliability. The overall mean for all items on a 1-6 scale was 4.81. The content validity and reliability of the survey instrument were established. The outcomes of this pilot study suggest that when measured by a valid and reliable instrument that is representative of the objectives and content of the CIECP, the behaviors taught in the CIECP are being applied in the clinical setting by APTA credentialed clinical instructors.

Validation of the Female Sexual Function Index (FSFI) in Women with Female Orgasmic Disorder and in Women with Hypoactive Sexual Desire Disorder

PubMed Central

Meston, Cindy M.

2010-01-01

The Female Sexual Functioning Index (FSFI; Rosen et al., 2000) is a self-report measure of sexual functioning that has been validated on a clinically diagnosed sample of women with female sexual arousal disorder. The present investigation extended the validation of the FSFI to include women with a primary clinical diagnosis of female orgasmic disorder (FOD; n = 71) or hypoactive sexual desire disorder (HSDD; n = 44). Internal consistency and divergent validity of the FSFI were within the acceptable range for these populations of women. Significant differences between women with FOD and controls and between women with HSDD and controls were noted for each of the FSFI domain and total scores. PMID:12519665

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

PubMed

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

2015-12-18

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

Developing a Workflow Composite Score to Measure Clinical Information Logistics. A Top-down Approach.

PubMed

Liebe, J D; Hübner, U; Straede, M C; Thye, J

2015-01-01

Availability and usage of individual IT applications have been studied intensively in the past years. Recently, IT support of clinical processes is attaining increasing attention. The underlying construct that describes the IT support of clinical workflows is clinical information logistics. This construct needs to be better understood, operationalised and measured. It is therefore the aim of this study to propose and develop a workflow composite score (WCS) for measuring clinical information logistics and to examine its quality based on reliability and validity analyses. We largely followed the procedural model of MacKenzie and colleagues (2011) for defining and conceptualising the construct domain, for developing the measurement instrument, assessing the content validity, pretesting the instrument, specifying the model, capturing the data and computing the WCS and testing the reliability and validity. Clinical information logistics was decomposed into the descriptors data and information, function, integration and distribution, which embraced the framework validated by an analysis of the international literature. This framework was refined selecting representative clinical processes. We chose ward rounds, pre- and post-surgery processes and discharge as sample processes that served as concrete instances for the measurements. They are sufficiently complex, represent core clinical processes and involve different professions, departments and settings. The score was computed on the basis of data from 183 hospitals of different size, ownership, location and teaching status. Testing the reliability and validity yielded encouraging results: the reliability was high with r(split-half) = 0.89, the WCS discriminated between groups; the WCS correlated significantly and moderately with two EHR models and the WCS received good evaluation results by a sample of chief information officers (n = 67). These findings suggest the further utilisation of the WCS. As the WCS does not assume ideal workflows as a gold standard but measures IT support of clinical workflows according to validated descriptors a high portability of the WCS to other hospitals in other countries is very likely. The WCS will contribute to a better understanding of the construct clinical information logistics.

Development and validation of PSPSQ 2.0 measuring patient satisfaction with pharmacist services.

PubMed

Sakharkar, Prashant; Bounthavong, Mark; Hirsch, Jan D; Morello, Candis M; Chen, Timothy C; Law, Anandi V

2015-01-01

The extant literature reveals a lack of psychometrically validated tools measuring patient satisfaction with pharmacist clinical services. The Patient Satisfaction with Pharmacist Services Questionnaire (PSPSQ 2.0) was developed to address this need using a mixed methods approach. To assess the psychometric properties of the PSPSQ 2.0, an instrument developed to measure patient satisfaction with clinical services provided by pharmacists. Validation studies were conducted in two Veterans Affairs (VA)-based and two community-based (diabetes and psychiatric care) disease management/medication therapy management clinics. The PSPSQ 2.0 consisted of 22-items related to three domains identified as quality of care, patient-pharmacist relationship and overall satisfaction using a 4-point, Likert-type scale. It was administered to participants following their session with a pharmacist at the clinics. Collected data were analyzed for descriptive statistics, internal consistency, and validity using exploratory factor analysis. A total of 149 patients completed the survey. Patients from VA clinics were on average 61 years old, mostly white (63%), and predominantly male (95%). Patients from non-VA clinics were on average 47 years old, mostly White (47%) and male (53%). Non-VA patients mostly had Medicaid (42%) and commercial health insurance (31%), whereas VA patients retained benefits with the US Department of Veterans Affairs. Reliability of the scale using internal consistency metrics revealed a Cronbach's alpha of 0.98, 0.98 and 0.95 for VA, diabetes, and psychiatric care clinics, respectively, whereas the Cronbach's alpha for the pooled sample was 0.96. Factor analyses resulted in a three-factor solution accounting for 91% and 69% variance for diabetes and psychiatric care clinics, respectively; however, VA clinics and pooled sample yielded only 2-factor solution with 80% and 66% variance, respectively, with more items loading on patient-pharmacist relationship domain. The results suggest that the PSPSQ 2.0 can serve as a reliable and valid tool for measuring patient satisfaction with pharmacists providing clinical services in VA- and non-VA settings upon further validation. Copyright © 2015 Elsevier Inc. All rights reserved.

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…

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…

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…

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:…

Call for Applications – Clinical Assay Development Program | Office of Cancer Clinical Proteomics Research

Cancer.gov

The NCI Clinical Assay Development Program (CADP) is requesting project applications from investigators seeking clinical assay validation resources.  These resources are designed to assist with the development of assays that may predict therapy response or prognostic behavior of a diagnosed cancer, primarily for use in clinical trials. Approved projects for the NCI CADP will be provided access to the Institute’s assay development and validation resources, including project management support.

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.

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

PubMed

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

2013-01-01

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

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.

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.

A biomarker-based risk score to predict death in patients with atrial fibrillation: the ABC (age, biomarkers, clinical history) death risk score

PubMed Central

Hijazi, Ziad; Oldgren, Jonas; Lindbäck, Johan; Alexander, John H; Connolly, Stuart J; Eikelboom, John W; Ezekowitz, Michael D; Held, Claes; Hylek, Elaine M; Lopes, Renato D; Yusuf, Salim; Granger, Christopher B; Siegbahn, Agneta; Wallentin, Lars

2018-01-01

Abstract Aims In atrial fibrillation (AF), mortality remains high despite effective anticoagulation. A model predicting the risk of death in these patients is currently not available. We developed and validated a risk score for death in anticoagulated patients with AF including both clinical information and biomarkers. Methods and results The new risk score was developed and internally validated in 14 611 patients with AF randomized to apixaban vs. warfarin for a median of 1.9 years. External validation was performed in 8548 patients with AF randomized to dabigatran vs. warfarin for 2.0 years. Biomarker samples were obtained at study entry. Variables significantly contributing to the prediction of all-cause mortality were assessed by Cox-regression. Each variable obtained a weight proportional to the model coefficients. There were 1047 all-cause deaths in the derivation and 594 in the validation cohort. The most important predictors of death were N-terminal pro B-type natriuretic peptide, troponin-T, growth differentiation factor-15, age, and heart failure, and these were included in the ABC (Age, Biomarkers, Clinical history)-death risk score. The score was well-calibrated and yielded higher c-indices than a model based on all clinical variables in both the derivation (0.74 vs. 0.68) and validation cohorts (0.74 vs. 0.67). The reduction in mortality with apixaban was most pronounced in patients with a high ABC-death score. Conclusion A new biomarker-based score for predicting risk of death in anticoagulated AF patients was developed, internally and externally validated, and well-calibrated in two large cohorts. The ABC-death risk score performed well and may contribute to overall risk assessment in AF. ClinicalTrials.gov identifier NCT00412984 and NCT00262600 PMID:29069359

A systematic review of the quality of homeopathic clinical trials

PubMed Central

Jonas, Wayne B; Anderson, Rachel L; Crawford, Cindy C; Lyons, John S

2001-01-01

Background While a number of reviews of homeopathic clinical trials have been done, all have used methods dependent on allopathic diagnostic classifications foreign to homeopathic practice. In addition, no review has used established and validated quality criteria allowing direct comparison of the allopathic and homeopathic literature. Methods In a systematic review, we compared the quality of clinical-trial research in homeopathy to a sample of research on conventional therapies using a validated and system-neutral approach. All clinical trials on homeopathic treatments with parallel treatment groups published between 1945–1995 in English were selected. All were evaluated with an established set of 33 validity criteria previously validated on a broad range of health interventions across differing medical systems. Criteria covered statistical conclusion, internal, construct and external validity. Reliability of criteria application is greater than 0.95. Results 59 studies met the inclusion criteria. Of these, 79% were from peer-reviewed journals, 29% used a placebo control, 51% used random assignment, and 86% failed to consider potentially confounding variables. The main validity problems were in measurement where 96% did not report the proportion of subjects screened, and 64% did not report attrition rate. 17% of subjects dropped out in studies where this was reported. There was practically no replication of or overlap in the conditions studied and most studies were relatively small and done at a single-site. Compared to research on conventional therapies the overall quality of studies in homeopathy was worse and only slightly improved in more recent years. Conclusions Clinical homeopathic research is clearly in its infancy with most studies using poor sampling and measurement techniques, few subjects, single sites and no replication. Many of these problems are correctable even within a "holistic" paradigm given sufficient research expertise, support and methods. PMID:11801202

Is the presence of a validated malnutrition screening tool associated with better nutritional care in hospitalized patients?

PubMed

Eglseer, Doris; Halfens, Ruud J G; Lohrmann, Christa

2017-05-01

The aims of this study were to evaluate the association between the use of clinical guidelines and the use of validated screening tools, evaluate the nutritional screening policy in hospitals, and examine the association between the use of validated screening tools and the prevalence of malnutrition and nutritional interventions in hospitalized patients. This was a cross-sectional, multicenter study. Data were collected using a standardized questionnaire on three levels: institution (presence of a guideline for malnutrition), department (use of a validated screening tool), and patient (e.g., malnutrition prevalence). In all, 53 hospitals with 5255 patients participated. About 45% of the hospitals indicated that they have guidelines for malnutrition. Of the departments surveyed, 38.6% used validated screening tools as part of a standard procedure. The nutritional status of 74.5% of the patients was screened during admission, mostly on the basis of clinical observation and patient weight. A validated screening tool was used for 21.2% of the patients. Significant differences between wards with and without validated screening tools were found with regard to malnutrition prevalence (P = 0.002) and the following interventions: referral to a dietitian (P < 0.001), provision of energy-enriched snacks (P = 0.038), adjustment of consistency (food/drinks; P = 0.004), monitoring of the nutritional intake (P = 0.001), and adjustment of the meal ambiance (P < 0.001). Nutritional screening with validated tools in hospitalized patients remains poor. Generally, the nutritional status of patients is screened with unreliable parameters such as clinical observation and body mass index. The results of the present study suggest that the use of validated malnutrition screening tools is associated with better nutritional care and lower malnutrition prevalence rates in hospitalized patients. Copyright © 2017 Elsevier Inc. All rights reserved.

Non-clinical studies required for new drug development - Part I: early in silico and in vitro studies, new target discovery and validation, proof of principles and robustness of animal studies.

PubMed

Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Freitas, C S; Marcon, R; Schwanke, R C; Siqueira, J M; Calixto, J B

2016-10-24

This review presents a historical overview of drug discovery and the non-clinical stages of the drug development process, from initial target identification and validation, through in silico assays and high throughput screening (HTS), identification of leader molecules and their optimization, the selection of a candidate substance for clinical development, and the use of animal models during the early studies of proof-of-concept (or principle). This report also discusses the relevance of validated and predictive animal models selection, as well as the correct use of animal tests concerning the experimental design, execution and interpretation, which affect the reproducibility, quality and reliability of non-clinical studies necessary to translate to and support clinical studies. Collectively, improving these aspects will certainly contribute to the robustness of both scientific publications and the translation of new substances to clinical development.

Circulating tumor cells: clinical validity and utility.

PubMed

Cabel, Luc; Proudhon, Charlotte; Gortais, Hugo; Loirat, Delphine; Coussy, Florence; Pierga, Jean-Yves; Bidard, François-Clément

2017-06-01

Circulating tumor cells (CTCs) are rare tumor cells and have been investigated as diagnostic, prognostic and predictive biomarkers in many types of cancer. Although CTCs are not currently used in clinical practice, CTC studies have accumulated a high level of clinical validity, especially in breast, lung, prostate and colorectal cancers. In this review, we present an overview of the current clinical validity of CTCs in metastatic and non-metastatic disease, and the main concepts and studies investigating the clinical utility of CTCs. In particular, this review will focus on breast, lung, colorectal and prostate cancer. Three major topics concerning the clinical utility of CTC are discussed-(1) treatment based on CTCs used as liquid biopsy, (2) treatment based on CTC count or CTC variations, and (3) treatment based on CTC biomarker expression. A summary of published or ongoing phase II and III trials is also presented.

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/

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.

ClinicalTrials.gov and Drugs@FDA: A comparison of results reporting for new drug approval trials

PubMed Central

Schwartz, Lisa M.; Woloshin, Steven; Zheng, Eugene; Tse, Tony; Zarin, Deborah A.

2016-01-01

Background Pharmaceutical companies and other trial sponsors must submit certain trial results to ClinicalTrials.gov. The validity of these results is unclear. Purpose To validate results posted on ClinicalTrials.gov against publicly-available FDA reviews on Drugs@FDA. Data sources ClinicalTrials.gov (registry and results database) and Drugs@FDA (medical/statistical reviews). Study selection 100 parallel-group, randomized trials for new drug approvals (1/2013 – 7/2014) with results posted on ClinicalTrials.gov (3/15/2015). Data extraction Two assessors systematically extracted, and another verified, trial design, primary/secondary outcomes, adverse events, and deaths. Results The 100 trials were mostly phase 3 (90%) double-blind (92%), placebo-controlled (73%), representing 32 drugs from 24 companies. Of 137 primary outcomes from ClinicalTrials.gov, 134 (98%) had corresponding data in Drugs@FDA, 130 (95%) had concordant definitions, and 107 (78%) had concordant results; most differences were nominal (i.e. relative difference < 10%). Of 100 trials, primary outcome results in 14 could not be validated . Of 1,927 secondary outcomes from ClinicalTrials.gov, 1,061 (55%) definitions could be validated and 367 (19%) had results. Of 96 trials with ≥ 1 serious adverse event in either source, 14 could be compared and 7 were discordant. Of 62 trials with ≥ 1 death in either source, 25 could be compared and 17 were discordant. Limitations Unknown generalizability to uncontrolled or crossover trial results. Conclusion Primary outcome definitions and results were largely concordant between ClinicalTrials.gov and Drugs@FDA. Half of secondary outcomes could not be validated because Drugs@FDA only includes “key outcomes” for regulatory decision-making; nor could serious adverse events and deaths because Drugs@FDA frequently only includes results aggregated across multiple trials. PMID:27294570

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.

Interviews with children about their mental health problems: The congruence and validity of information that children report.

PubMed

Macleod, Emily; Woolford, June; Hobbs, Linda; Gross, Julien; Hayne, Harlene; Patterson, Tess

2017-04-01

To obtain a child's perspective during a mental health assessment, he or she is usually interviewed. Although researchers and clinicians generally agree that it is beneficial to hear a child's account of his or her presenting issues, there is debate about whether children provide reliable or valid clinical information during these interviews. Here, we examined whether children provide clinically and diagnostically relevant information in a clinical setting. In all, 31 children aged 5-12-years undergoing mental health assessments were asked open-ended questions about their presenting problems during a semi-structured interview. We coded the information that children reported to determine whether it was clinically relevant and could be used to diagnose their problems and to formulate and plan treatment. We also coded children's information to determine whether it was congruent with the children's presenting problems and their eventual clinical diagnoses. Most of the information that children reported was clinically relevant and included information about behaviour, affect, temporal details, thoughts, people, the environment, and the child's physical experiences. The information that children reported was also clinically valid; it was congruent with the problems that were discussed (84%) and also with the eventual diagnosis that the child received after a complete assessment (74%). We conclude that children can contribute relevant, clinically useful, valid information during clinical psychological assessments.

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, Caroline Mead, John Kane, Brian P Marx, Joshua Feast, Thilo Deckersbach, Alex “Sandy” Pentland, Andrew Nierenberg, Ali Azarbayejani. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 16.03.2017.

Clinical staff nurse leadership: Identifying gaps in competency development.

PubMed

Franks-Meeks, Sherron

2018-01-01

To date, there has been no development of a complete, applicable inventory of clinical staff nurse (CSN) leadership role competencies through a valid and reliable methodology. Further, the CSN has not been invited to engage in the identification, definition, or development of their own leadership competencies. Compare existing leadership competencies to identify and highlight gaps in clinical staff nurse leadership role competency development and validation. Literature review. The CSN has not participated in the development of CSN leadership role competencies, nor have the currently identified CSN leadership role competencies been scientifically validated through research. Finally, CSN leadership role competencies are incomplete and do not reflect the CSN perspective. © 2017 Wiley Periodicals, Inc.

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

PubMed Central

2011-01-01

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

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. We also found that cluster analysis using mean method can be used for quality assurance of borderline methods. These findings should be further confirmed by studies in other settings.

The dialysis orders objective structured clinical examination (OSCE): a formative assessment for nephrology fellows.

PubMed

Prince, Lisa K; Campbell, Ruth C; Gao, Sam W; Kendrick, Jessica; Lebrun, Christopher J; Little, Dustin J; Mahoney, David L; Maursetter, Laura A; Nee, Robert; Saddler, Mark; Watson, Maura A; Yuan, Christina M

2018-04-01

Few quantitative nephrology-specific simulations assess fellow competency. We describe the development and initial validation of a formative objective structured clinical examination (OSCE) assessing fellow competence in ordering acute dialysis. The three test scenarios were acute continuous renal replacement therapy, chronic dialysis initiation in moderate uremia and acute dialysis in end-stage renal disease-associated hyperkalemia. The test committee included five academic nephrologists and four clinically practicing nephrologists outside of academia. There were 49 test items (58 points). A passing score was 46/58 points. No item had median relevance less than 'important'. The content validity index was 0.91. Ninety-five percent of positive-point items were easy-medium difficulty. Preliminary validation was by 10 board-certified volunteers, not test committee members, a median of 3.5 years from graduation. The mean score was 49 [95% confidence interval (CI) 46-51], κ = 0.68 (95% CI 0.59-0.77), Cronbach's α = 0.84. We subsequently administered the test to 25 fellows. The mean score was 44 (95% CI 43-45); 36% passed the test. Fellows scored significantly less than validators (P < 0.001). Of evidence-based questions, 72% were answered correctly by validators and 54% by fellows (P = 0.018). Fellows and validators scored least well on the acute hyperkalemia question. In self-assessing proficiency, 71% of fellows surveyed agreed or strongly agreed that the OSCE was useful. The OSCE may be used to formatively assess fellow proficiency in three common areas of acute dialysis practice. Further validation studies are in progress.

A systematic review and comparison of questionnaires in the management of spinal cord injury, multiple sclerosis and the neurogenic bladder.

PubMed

Tsang, B; Stothers, L; Macnab, A; Lazare, D; Nigro, M

2016-03-01

Validated questionnaires are increasingly the preferred method used to obtain historical information. Specialized questionnaires exist validated for patients with neurogenic disease including neurogenic bladder. Those currently available are systematically reviewed and their potential for clinical and research use are described. A systematic search via Medline and PubMed using the key terms questionnaire(s) crossed with Multiple Sclerosis (MS) and Spinal Cord Injury (SCI) for the years 1946 to January 22, 2014 inclusive. Additional articles were selected from review of references in the publications identified. Only peer reviewed articles published in English were included. 18 questionnaires exist validated for patients with neurogenic bladder; 14 related to MS, 3 for SCI, and 1 for neurogenic bladder in general; with 4 cross-validated in both MS and SCI. All 18 are validated for both male and female patients; 59% are available only in English. The domains of psychological impact and physical function are represented in 71% and 76% of questionnaires, respectively. None for the female population included elements to measure symptoms of prolapse. The last decade has seen an expansion of validated questionnaires to document bladder symptoms in neurogenic disease. Disease specific instruments are available for incorporation into the clinical setting for MS and SCI patients with neurogenic bladder. The availability of caregiver and interview options enhances suitability in clinical practice as they can be adapted to various extents of disability. Future developments should include expanded language validation to the top 10 global languages reported by the World Health Organization. © 2015 Wiley Periodicals, Inc.

Observational Assessment of Preschool Disruptive Behavior, Part II: validity of the Disruptive Behavior Diagnostic Observation Schedule (DB-DOS).

PubMed

Wakschlag, Lauren S; Briggs-Gowan, Margaret J; Hill, Carri; Danis, Barbara; Leventhal, Bennett L; Keenan, Kate; Egger, Helen L; Cicchetti, Domenic; Burns, James; Carter, Alice S

2008-06-01

To examine the validity of the Disruptive Behavior Diagnostic Observation Schedule (DB-DOS), a new observational method for assessing preschool disruptive behavior. A total of 327 behaviorally heterogeneous preschoolers from low-income environments comprised the validation sample. Parent and teacher reports were used to identify children with clinically significant disruptive behavior. The DB-DOS assessed observed disruptive behavior in two domains, problems in Behavioral Regulation and Anger Modulation, across three interactional contexts: Examiner Engaged, Examiner Busy, and Parent. Convergent and divergent validity of the DB-DOS were tested in relation to parent and teacher reports and independently observed behavior. Clinical validity was tested in terms of criterion and incremental validity of the DB-DOS for discriminating disruptive behavior status and impairment, concurrently and longitudinally. DB-DOS scores were significantly associated with reported and independently observed behavior in a theoretically meaningful fashion. Scores from both DB-DOS domains and each of the three DB-DOS contexts contributed uniquely to discrimination of disruptive behavior status, concurrently and predictively. Observed behavior on the DB-DOS also contributed incrementally to prediction of impairment over time, beyond variance explained by meeting DSM-IV disruptive behavior disorder symptom criteria based on parent/teacher report. The multidomain, multicontext approach of the DB-DOS is a valid method for direct assessment of preschool disruptive behavior. This approach shows promise for enhancing accurate identification of clinically significant disruptive behavior in young children and for characterizing subtypes in a manner that can directly inform etiological and intervention research.

[Ethic review on clinical experiments of medical devices in medical institutions].

PubMed

Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining

2011-07-01

Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.

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

PubMed

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

2018-04-01

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

Validation of the diagnostic score for acute lower abdominal pain in women of reproductive age.

PubMed

Jearwattanakanok, Kijja; Yamada, Sirikan; Suntornlimsiri, Watcharin; Smuthtai, Waratsuda; Patumanond, Jayanton

2014-01-01

Background. The differential diagnoses of acute appendicitis obstetrics, and gynecological conditions (OB-GYNc) or nonspecific abdominal pain in young adult females with lower abdominal pain are clinically challenging. The present study aimed to validate the recently developed clinical score for the diagnosis of acute lower abdominal pain in female of reproductive age. Method. Medical records of reproductive age women (15-50 years) who were admitted for acute lower abdominal pain were collected. Validation data were obtained from patients admitted during a different period from the development data. Result. There were 302 patients in the validation cohort. For appendicitis, the score had a sensitivity of 91.9%, a specificity of 79.0%, and a positive likelihood ratio of 4.39. The sensitivity, specificity, and positive likelihood ratio in diagnosis of OB-GYNc were 73.0%, 91.6%, and 8.73, respectively. The areas under the receiver operating curves (ROC), the positive likelihood ratios, for appendicitis and OB-GYNc in the validation data were not significantly different from the development data, implying similar performances. Conclusion. The clinical score developed for the diagnosis of acute lower abdominal pain in female of reproductive age may be applied to guide differential diagnoses in these patients.

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.

Manchester Clinical Placement Index (MCPI). Conditions for Medical Students' Learning in Hospital and Community Placements

ERIC Educational Resources Information Center

Dornan, Tim; Muijtjens, Arno; Graham, Jennifer; Scherpbier, Albert; Boshuizen, Henny

2012-01-01

The drive to quality-manage medical education has created a need for valid measurement instruments. Validity evidence includes the theoretical and contextual origin of items, choice of response processes, internal structure, and interrelationship of a measure's variables. This research set out to explore the validity and potential utility of an…

Validation of a Method for Measuring Medical Students' Critical Reflections on Professionalism in Gross Anatomy

ERIC Educational Resources Information Center

Wittich, Christopher M.; Pawlina, Wojciech; Drake, Richard L.; Szostek, Jason H.; Reed, Darcy A.; Lachman, Nirusha; McBride, Jennifer M.; Mandrekar, Jayawant N.; Beckman, Thomas J.

2013-01-01

Improving professional attitudes and behaviors requires critical self reflection. Research on reflection is necessary to understand professionalism among medical students. The aims of this prospective validation study at the Mayo Medical School and Cleveland Clinic Lerner College of Medicine were: (1) to develop and validate a new instrument for…

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...

Evaluating the Complementary Roles of an SJT and Academic Assessment for Entry into Clinical Practice

ERIC Educational Resources Information Center

Cousans, Fran; Patterson, Fiona; Edwards, Helena; Walker, Kim; McLachlan, John C.; Good, David

2017-01-01

Although there is extensive evidence confirming the predictive validity of situational judgement tests (SJTs) in medical education, there remains a shortage of evidence for their predictive validity for performance of postgraduate trainees in their first role in clinical practice. Moreover, to date few researchers have empirically examined the…

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.…

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.

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.

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.

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

Assessment of the Validity of the Research Diagnostic Criteria for Temporomandibular Disorders: Overview and Methodology

PubMed Central

Schiffman, Eric L.; Truelove, Edmond L.; Ohrbach, Richard; Anderson, Gary C.; John, Mike T.; List, Thomas; Look, John O.

2011-01-01

AIMS The purpose of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Validation Project was to assess the diagnostic validity of this examination protocol. An overview is presented, including Axis I and II methodology and descriptive statistics for the study participant sample. This paper details the development of reliable methods to establish the reference standards for assessing criterion validity of the Axis I RDC/TMD diagnoses. Validity testing for the Axis II biobehavioral instruments was based on previously validated reference standards. METHODS The Axis I reference standards were based on the consensus of 2 criterion examiners independently performing a comprehensive history, clinical examination, and evaluation of imaging. Intersite reliability was assessed annually for criterion examiners and radiologists. Criterion exam reliability was also assessed within study sites. RESULTS Study participant demographics were comparable to those of participants in previous studies using the RDC/TMD. Diagnostic agreement of the criterion examiners with each other and with the consensus-based reference standards was excellent with all kappas ≥ 0.81, except for osteoarthrosis (moderate agreement, k = 0.53). Intrasite criterion exam agreement with reference standards was excellent (k ≥ 0.95). Intersite reliability of the radiologists for detecting computed tomography-disclosed osteoarthrosis and magnetic resonance imaging-disclosed disc displacement was good to excellent (k = 0.71 and 0.84, respectively). CONCLUSION The Validation Project study population was appropriate for assessing the reliability and validity of the RDC/TMD Axis I and II. The reference standards used to assess the validity of Axis I TMD were based on reliable and clinically credible methods. PMID:20213028

Psychometric Properties of Korean Version of the Second Victim Experience and Support Tool (K-SVEST).

PubMed

Kim, Eun-Mi; Kim, Sun-Aee; Lee, Ju-Ry; Burlison, Jonathan D; Oh, Eui Geum

2018-02-13

"Second victims" are defined as healthcare professionals whose wellness is influenced by adverse clinical events. The Second Victim Experience and Support Tool (SVEST) was used to measure the second-victim experience and quality of support resources. Although the reliability and validity of the original SVEST have been validated, those for the Korean tool have not been validated. The aim of the study was to evaluate the psychometric properties of the Korean version of the SVEST. The study included 305 clinical nurses as participants. The SVEST was translated into Korean via back translation. Content validity was assessed by seven experts, and test-retest reliability was evaluated by 30 clinicians. Internal consistency and construct validity were assessed via confirmatory factor analysis. The analyses were performed using SPSS 23.0 and STATA 13.0 software. The content validity index value demonstrated validity; item- and scale-level content validity index values were both 0.95. Test-retest reliability and internal consistency reliability were satisfactory: the intraclass consistent coefficient was 0.71, and Cronbach α values ranged from 0.59 to 0.87. The CFA showed a significantly good fit for an eight-factor structure (χ = 578.21, df = 303, comparative fit index = 0.92, Tucker-Lewis index = 0.90, root mean square error of approximation = 0.05). The K-SVEST demonstrated good psychometric properties and adequate validity and reliability. The results showed that the Korean version of SVEST demonstrated the extent of second victimhood and support resources in Korean healthcare workers and could aid in the development of support programs and evaluation of their effectiveness.

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.

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.

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.

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

PubMed

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

2017-12-01

The international ICALIC initiative aims at developing a new indirect calorimeter according to the needs of the clinicians and researchers in the field of clinical nutrition and metabolism. The project initially focuses on validating the calorimeter for use in mechanically ventilated acutely ill adult patient. However, standard methods to validate the accuracy of calorimeters have not yet been established. This paper describes the procedures for the in-vitro tests to validate the accuracy of the new indirect calorimeter, and defines the ranges for the parameters to be evaluated in each test to optimize the validation for clinical and research calorimetry measurements. Two in-vitro tests have been defined to validate the accuracy of the gas analyzers and the overall function of the new calorimeter. 1) Gas composition analysis allows validating the accuracy of O 2 and CO 2 analyzers. Reference gas of known O 2 (or CO 2 ) concentration is diluted by pure nitrogen gas to achieve predefined O 2 (or CO 2 ) concentration, to be measured by the indirect calorimeter. O 2 and CO 2 concentrations to be tested were determined according to their expected ranges of concentrations during calorimetry measurements. 2) Gas exchange simulator analysis validates O 2 consumption (VO 2 ) and CO 2 production (VCO 2 ) measurements. CO 2 gas injection into artificial breath gas provided by the mechanical ventilator simulates VCO 2 . Resulting dilution of O 2 concentration in the expiratory air is analyzed by the calorimeter as VO 2 . CO 2 gas of identical concentration to the fraction of inspired O 2 (FiO 2 ) is used to simulate identical VO 2 and VCO 2 . Indirect calorimetry results from publications were analyzed to determine the VO 2 and VCO 2 values to be tested for the validation. O 2 concentration in respiratory air is highest at inspiration, and can decrease to 15% during expiration. CO 2 concentration can be as high as 5% in expired air. To validate analyzers for measurements of FiO 2 up to 70%, ranges of O 2 and CO 2 concentrations to be tested were defined as 15-70% and 0.5-5.0%, respectively. The mean VO 2 in 426 adult mechanically ventilated patients was 270 ml/min, with 2 standard deviation (SD) ranges of 150-391 ml/min. Thus, VO 2 and VCO 2 to be simulated for the validation were defined as 150, 250, and 400 ml/min. The procedures for the in-vitro tests of the new indirect calorimeter and the ranges for the parameters to be evaluated in each test have been defined to optimize the validation of accuracy for clinical and research indirect calorimetry measurements. The combined methods will be used to validate the accuracy of the new indirect calorimeter developed by the ICALIC initiative, and should become the standard method to validate the accuracy of any future indirect calorimeters. Copyright © 2017 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

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

PubMed

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

2013-01-01

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

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

NASA Technical Reports Server (NTRS)

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

2001-01-01

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

The validity of the Health-Relevant Personality Inventory (HP5i) and the Junior Temperament and Character Inventory (JTCI) among adolescents referred for a substance misuse problem.

PubMed

Hemphälä, Malin; Gustavsson, J Petter; Tengström, Anders

2013-01-01

The aim was to study the validity of 2 personality instruments, the Health-Relevant Personality Inventory (HP5i) and the Junior Temperament and Character Inventory (JTCI), among adolescents with a substance use problem. Clinical interviews were completed with 180 adolescents and followed up after 12 months. Discriminant validity was demonstrated in the lack of correlation to intelligence in both instruments' scales. Two findings were in support of convergent validity: Negative affectivity (HP5i) and harm avoidance (JTCI) were correlated to internalizing symptoms, and impulsivity (HP5i) and novelty seeking (JTCI) were correlated to externalizing symptoms. The predictive validity of JTCI was partly supported. When psychiatric symptoms at baseline were controlled for, cooperativeness predicted conduct disorder after 12 months. Summarizing, both instruments can be used in adolescent clinical samples to tailor treatment efforts, although some scales need further investigation. It is important to include personality assessment when evaluating psychiatric problems in adolescents.

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.

Criterion validity and clinical usefulness of Attention Deficit Hyperactivity Disorder Rating Scale IV in attention deficit hyperactivity disorder (ADHD) as a function of method and age.

PubMed

López-Villalobos, José A; Andrés-De Llano, Jesús; López-Sánchez, María V; Rodríguez-Molinero, Luis; Garrido-Redondo, Mercedes; Sacristán-Martín, Ana M; Martínez-Rivera, María T; Alberola-López, Susana

2017-02-01

The aim of this research is to analyze Attention Deficit Hyperactivity Disorder Rating Scales IV (ADHD RS-IV) criteria validity and its clinical usefulness for the assessment of Attention Deficit Hyperactivity Disorder (ADHD) as a function of assessment method and age. A sample was obtained from an epidemiological study (n = 1095, 6-16 years). Clinical cases of ADHD  (ADHD-CL) were selected by dimensional ADHD RS-IV and later by clinical interview (DSM-IV). ADHD-CL cases were compared with four categorical results of ADHD RS-IV provided by parents (CATPA), teachers (CATPR), either parents or teachers (CATPAOPR) and both parents and teachers (CATPA&PR). Criterion validity and clinical usefulness of the answer modalities to ADHD RS-IV were studied. ADHD-CL rate was 6.9% in childhood, 6.2% in preadolescence and 6.9% in adolescence. Alternative methods to the clinical interview led to increased numbers of ADHD cases in all age groups analyzed, in the following sequence: CATPAOPR> CATPRO> CATPA> CATPA&PR> ADHD-CL. CATPA&PR was the procedure with the greatest validity, specificity and clinical usefulness in all three age groups, particularly in the childhood. Isolated use of ADHD RS-IV leads to an increase in ADHD cases compared to clinical interview, and varies depending on the procedure used.

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

Reliability and Validity of the KIPPPI: An Early Detection Tool for Psychosocial Problems in Toddlers

PubMed Central

Kruizinga, Ingrid; Jansen, Wilma; de Haan, Carolien L.; Raat, Hein

2012-01-01

Background The KIPPPI (Brief Instrument Psychological and Pedagogical Problem Inventory) is a Dutch questionnaire that measures psychosocial and pedagogical problems in 2-year olds and consists of a KIPPPI Total score, Wellbeing scale, Competence scale, and Autonomy scale. This study examined the reliability, validity, screening accuracy and clinical application of the KIPPPI. Methods Parents of 5959 2-year-old children in the Rotterdam area, the Netherlands, were invited to participate in the study. Parents of 3164 children (53.1% of all invited parents) completed the questionnaire. The internal consistency was evaluated and in subsamples the test-retest reliability and concurrent validity with regard to the Child Behavioral Checklist (CBCL). Discriminative validity was evaluated by comparing scores of parents who worried about their child’s upbringing and parent’s that did not. Screening accuracy of the KIPPPI was evaluated against the CBCL by calculating the Receiver Operating Characteristic (ROC) curves. The clinical application was evaluated by the relation between KIPPPI scores and the clinical decision made by the child health professionals. Results Psychometric properties of the KIPPPI Total score, Wellbeing scale, Competence scale and Autonomy scale were respectively: Cronbach’s alphas: 0.88, 0.86, 0.83, 0.58. Test-retest correlations: 0.80, 0.76, 0.73, 0.60. Concurrent validity was as hypothesised. The KIPPPI was able to discriminate between parents that worried about their child and parents that did not. Screening accuracy was high (>0.90) for the KIPPPI Total score and for the Wellbeing scale. The KIPPPI scale scores and clinical decision of the child health professional were related (p<0.05), indicating a good clinical application. Conclusion The results in this large-scale study of a diverse general population sample support the reliability, validity and clinical application of the KIPPPI Total score, Wellbeing scale and Competence scale. Also, the screening accuracy of the KIPPPI Total score and Wellbeing scale were supported. The Autonomy scale needs further study. PMID:23185388

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

PubMed

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

2013-01-01

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

[An instrument in Spanish to evaluate the performance of clinical teachers by students].

PubMed

Bitran, Marcela; Mena, Beltrán; Riquelme, Arnoldo; Padilla, Oslando; Sánchez, Ignacio; Moreno, Rodrigo

2010-06-01

The modernization of clinical teaching has called for the creation of faculty development programs, and the design of suitable instruments to evaluate clinical teachers' performance. To report the development and validation of an instrument in Spanish designed to measure the students' perceptions of their clinical teachers' performance and to provide them with feedback to improve their teaching practices. In a process that included the active participation of authorities, professors in charge of courses and internships, clinical teachers, students and medical education experts, we developed a 30-item questionnaire called MEDUC30 to evaluate the performance of clinical teachers by their students. The internal validity was assessed by factor analysis of 5214 evaluations of 265 teachers, gathered from 2004 to 2007. The reliability was measured with the Cronbach's alpha coefficient and the generalizability coefficient (g). MEDUC30 had good content and construct validity. Its internal structure was compatible with four factors: patient-centered teaching, teaching skills, assessment skills and learning climate, and it proved to be consistent with the structure anticipated by the theory. The scores were highly reliable (Cronbach's alpha: 0.97); five evaluations per teacher were sufficient to reach a reliability coefficient (g) of 0.8. MEDUC30 is a valid, reliable and useful instrument to evaluate the performance of clinical teachers. To our knowledge, this is the first instrument in Spanish for which solid validity and reliability evidences have been reported. We hope that MEDUC30 will be used to improve medical education in Spanish-speaking medical schools, providing teachers a specific feedback upon which to improve their pedagogical practice, and authorities with valuable information for the assessment of their faculty.

Developing an instrument to measure effective factors on Clinical Learning

PubMed Central

DADGARAN, IDEH; SHIRAZI, MANDANA; MOHAMMADI, AEEN; RAVARI, ALI

2016-01-01

Introduction Although nursing students spend a large part of their learning period in the clinical environment, clinical learning has not been perceived by its nature yet. To develop an instrument to measure effective factors on clinical learning in nursing students. Methods This is a mixed methods study performed in 2 steps. First, the researchers defined “clinical learning” in nursing students through qualitative content analysis and designed items of the questionnaire based on semi-structured individual interviews with nursing students. Then, as the second step, psychometric properties of the questionnaire were evaluated using the face validity, content validity, construct validity, and internal consistency evaluated on 227 students from fourth or higher semesters. All the interviews were recorded and transcribed, and then, they were analyzed using Max Qualitative Data Analysis and all of qualitative data were analyzed using SPSS 14. Results To do the study, we constructed the preliminary questionnaire containing 102 expressions. After determination of face and content validities by qualitative and quantitative approaches, the expressions of the questionnaire were reduced to 45. To determine the construct validity, exploratory factor analysis was applied. The results indicated that the maximum variance percentage (40.55%) was defined by the first 3 factors while the rest of the total variance percentage (59.45%) was determined by the other 42 factors. Results of exploratory factor analysis of this questionnaire indicated the presence of 3 instructor-staff, students, and educational related factors. Finally, 41 expressions were kept in 3 factor groups. The α-Cronbach coefficient (0.93) confirmed the high internal consistency of the questionnaire. Conclusion Results indicated that the prepared questionnaire was an efficient instrument in the study of the effective factors on clinical learning as viewed by nursing students since it involves 41 expressions and properties such as instrument design based on perception and experiences of the nursing students about effective factors on clinical learning, definition of facilitator and preventive factors of the clinical learning, simple scoring, suitable validity and reliability, and applicability in different occasions. PMID:27382579

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.

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.

Psychometric Testing of the Greek Version of the Clinical Learning Environment-Teacher (CLES+T).

PubMed

Papastavrou, Evridiki; Dimitriadou, Maria; Tsangari, Haritini

2015-09-01

Clinical practice is an important part of nursing education, and robust instruments are required to evaluate the effectiveness of the hospital setting as a learning environment. The study aim is the psychometric test of the Clinical Learning Environment+Teacher (CLES+T) scale-Greek version. 463 students practicing in acute care hospitals participated in the study. The reliability of the instrument was estimated with Cronbach's alpha coefficients. The construct validity was evaluated using exploratory factor analysis (EFA) with Varimax rotation. Convergent validity was examined by measuring the bivariate correlations between the scale/subscales. Content, validity and semantic equivalence were examined through reviews by a panel of experts. The total scale showed high internal consistency (α=0.95). EFA was identical to the original scale, had eigen values larger than one and explained a total of 67.4% of the variance. The factor with the highest eigen value and the largest percentage of variance explained was "supervisory relationship", with an original eigenvalue of 13.1 (6.8 after Varimax rotation) and an explanation of around 38% of the variance (or 20% after rotation). Convergent validity was examined by measuring the bivariate correlations between the scale and a question that measured the general satisfaction. The Greek version of the CLES+T is a valid and reliable instrument that can be used to examine students' perceptions of the clinical learning environment.

Validation of the Japanese version of the Pediatric Quality of Life Inventory (PedsQL) Cancer Module.

PubMed

Tsuji, Naoko; Kakee, Naoko; Ishida, Yasushi; Asami, Keiko; Tabuchi, Ken; Nakadate, Hisaya; Iwai, Tsuyako; Maeda, Miho; Okamura, Jun; Kazama, Takuro; Terao, Yoko; Ohyama, Wataru; Yuza, Yuki; Kaneko, Takashi; Manabe, Atsushi; Kobayashi, Kyoko; Kamibeppu, Kiyoko; Matsushima, Eisuke

2011-04-10

The PedsQL 3.0 Cancer Module is a widely used instrument to measure pediatric cancer specific health-related quality of life (HRQOL) for children aged 2 to 18 years. We developed the Japanese version of the PedsQL Cancer Module and investigated its reliability and validity among Japanese children and their parents. Participants were 212 children with cancer and 253 of their parents. Reliability was determined by internal consistency using Cronbach's coefficient alpha and test-retest reliability using intra-class correlation coefficient (ICC). Validity was assessed through factor validity, convergent and discriminant validity, concurrent validity, and clinical validity. Factor validity was examined by exploratory factor analysis. Convergent and discriminant validity were examined by multitrait scaling analysis. Concurrent validity was assessed using Spearman's correlation coefficients between the Cancer Module and Generic Core Scales, and the comparison of the scores of child self-reports with those of other self-rating depression scales for children. Clinical validity was assessed by comparing the on- and off- treatment scores using Kruskal-Wallis and Mann-Whitney U tests. Cronbach's coefficient alpha was over 0.70 for the total scale and over 0.60 for each subscale by age except for the 'pain and hurt' subscale for children aged 5 to 7 years. For test-retest reliability, the ICC exceeded 0.70 for the total scale for each age. Exploratory factor analysis demonstrated sufficient factorial validity. Multitrait scaling analysis showed high success rates. Strong correlations were found between the reports by children and their parents, and the scores of the Cancer Module and the Generic Core Scales except for 'treatment anxiety' subscales for child reports. The Depression Self-Rating Scale for Children (DSRS-C) scores were significantly correlated with emotional domains and the total score of the cancer module. Children who had been off treatment over 12 months demonstrated significantly higher scores than those on treatment. The results demonstrate the reliability and validity of the Japanese version of the PedsQL Cancer Module among Japanese children.

Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: Recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Group†

PubMed Central

Schiffman, Eric; Ohrbach, Richard; Truelove, Edmond; Look, John; Anderson, Gary; Goulet, Jean-Paul; List, Thomas; Svensson, Peter; Gonzalez, Yoly; Lobbezoo, Frank; Michelotti, Ambra; Brooks, Sharon L.; Ceusters, Werner; Drangsholt, Mark; Ettlin, Dominik; Gaul, Charly; Goldberg, Louis J.; Haythornthwaite, Jennifer A.; Hollender, Lars; Jensen, Rigmor; John, Mike T.; De Laat, Antoon; de Leeuw, Reny; Maixner, William; van der Meulen, Marylee; Murray, Greg M.; Nixdorf, Donald R.; Palla, Sandro; Petersson, Arne; Pionchon, Paul; Smith, Barry; Visscher, Corine M.; Zakrzewska, Joanna; Dworkin, Samuel F.

2015-01-01

Aims The original Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I diagnostic algorithms have been demonstrated to be reliable. However, the Validation Project determined that the RDC/TMD Axis I validity was below the target sensitivity of ≥ 0.70 and specificity of ≥ 0.95. Consequently, these empirical results supported the development of revised RDC/TMD Axis I diagnostic algorithms that were subsequently demonstrated to be valid for the most common pain-related TMD and for one temporomandibular joint (TMJ) intra-articular disorder. The original RDC/TMD Axis II instruments were shown to be both reliable and valid. Working from these findings and revisions, two international consensus workshops were convened, from which recommendations were obtained for the finalization of new Axis I diagnostic algorithms and new Axis II instruments. Methods Through a series of workshops and symposia, a panel of clinical and basic science pain experts modified the revised RDC/TMD Axis I algorithms by using comprehensive searches of published TMD diagnostic literature followed by review and consensus via a formal structured process. The panel's recommendations for further revision of the Axis I diagnostic algorithms were assessed for validity by using the Validation Project's data set, and for reliability by using newly collected data from the ongoing TMJ Impact Project—the follow-up study to the Validation Project. New Axis II instruments were identified through a comprehensive search of the literature providing valid instruments that, relative to the RDC/TMD, are shorter in length, are available in the public domain, and currently are being used in medical settings. Results The newly recommended Diagnostic Criteria for TMD (DC/TMD) Axis I protocol includes both a valid screener for detecting any pain-related TMD as well as valid diagnostic criteria for differentiating the most common pain-related TMD (sensitivity ≥ 0.86, specificity ≥ 0.98) and for one intra-articular disorder (sensitivity of 0.80 and specificity of 0.97). Diagnostic criteria for other common intra-articular disorders lack adequate validity for clinical diagnoses but can be used for screening purposes. Inter-examiner reliability for the clinical assessment associated with the validated DC/TMD criteria for pain-related TMD is excellent (kappa ≥ 0.85). Finally, a comprehensive classification system that includes both the common and less common TMD is also presented. The Axis II protocol retains selected original RDC/TMD screening instruments augmented with new instruments to assess jaw function as well as behavioral and additional psychosocial factors. The Axis II protocol is divided into screening and comprehensive self-report instrument sets. The screening instruments’ 41 questions assess pain intensity, pain-related disability, psychological distress, jaw functional limitations, and parafunctional behaviors, and a pain drawing is used to assess locations of pain. The comprehensive instruments, composed of 81 questions, assess in further detail jaw functional limitations and psychological distress as well as additional constructs of anxiety and presence of comorbid pain conditions. Conclusion The recommended evidence-based new DC/TMD protocol is appropriate for use in both clinical and research settings. More comprehensive instruments augment short and simple screening instruments for Axis I and Axis II. These validated instruments allow for identification of patients with a range of simple to complex TMD presentations. PMID:24482784

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 validation of a multidimensional sum-scaling questionnaire to measure patient-reported outcomes in acute respiratory tract infections in primary care: the acute respiratory tract infection questionnaire.

PubMed

Aabenhus, Rune; Thorsen, Hanne; Siersma, Volkert; Brodersen, John

2013-01-01

Patient-reported outcomes are seldom validated measures in clinical trials of acute respiratory tract infections (ARTIs) in primary care. We developed and validated a patient-reported outcome sum-scaling measure to assess the severity and functional impacts of ARTIs. Qualitative interviews and field testing among adults with an ARTI were conducted to ascertain a high degree of face and content validity of the questionnaire. Subsequently, a draft version of the Acute Respiratory Tract Infection Questionnaire (ARTIQ) was statistically validated by using the partial credit Rasch model to test dimensionality, objectivity, and reliability of items. Test of known groups' validity was conducted by comparing participants with and without an ARTI. The final version of the ARTIQ consisted of 38 items covering five dimensions (Physical-upper, Physical-lower, Psychological, Sleep, and Medicine) and five single items. All final dimensions were confirmed to fit the Rasch model, thus enabling sum-scaling of responses. The ARTIQ scores in participants with an ARTI were significantly higher than in those without ARTI (known groups' validity). A self-administered, multidimensional, sum-scaling questionnaire with high face and content validity and adequate psychometric properties for assessing severity and functional impacts from ARTIs in adults is available to clinical trials and audits in primary care. Copyright © 2013, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.

[The Basel Screening Instrument for Psychosis (BSIP): development, structure, reliability and validity].

PubMed

Riecher-Rössler, A; Aston, J; Ventura, J; Merlo, M; Borgwardt, S; Gschwandtner, U; Stieglitz, R-D

2008-04-01

Early detection of psychosis is of growing clinical importance. So far there is, however, no screening instrument for detecting individuals with beginning psychosis in the atypical early stages of the disease with sufficient validity. We have therefore developed the Basel Screening Instrument for Psychosis (BSIP) and tested its feasibility, interrater-reliability and validity. Aim of this paper is to describe the development and structure of the instrument, as well as to report the results of the studies on reliability and validity. The instrument was developed based on a comprehensive search of literature on the most important risk factors and early signs of schizophrenic psychoses. The interraterreliability study was conducted on 24 psychiatric cases. Validity was tested based on 206 individuals referred to our early detection clinic from 3/1/2000 until 2/28/2003. We identified seven categories of relevance for early detection of psychosis and used them to construct a semistructured interview. Interrater-reliability for high risk individuals was high (Kappa .87). Predictive validity was comparable to other, more comprehensive instruments: 16 (32 %) of 50 individuals classified as being at risk for psychosis by the BSIP have in fact developed frank psychosis within an follow-up period of two to five years. The BSIP is the first screening instrument for the early detection of psychosis which has been validated based on transition to psychosis. The BSIP is easy to use by experienced psychiatrists and has a very good interrater-reliability and predictive validity.

Cross-cultural adaptation and psychometric evaluation of oral health impact profile among school teacher community

PubMed Central

Vyas, Shaleen; Nagarajappa, Sandesh; Dasar, Pralhad L.; Mishra, Prashant

2018-01-01

AIM: To translate OHIP-14 into Hindi and test its psychometric properties among school teacher community. METHODS: The OHIP-14 was translated to OHIP-14-H using WHO recommended translation protocol. During pre-testing, an expert panel assessed content validity of the questionnaire. Face validity was assessed on a sample of 10 individuals. The OHIP-14-H was administered on a random sample of 170 primary school teachers. Internal consistency and test-retest reliability were assessed using Cronbach's alpha and Intra-class correlation coefficient (ICC) respectively, with 2 weeks interval. Predictive validity was tested by comparing OHIP-14-H scores with clinical parameters. The concurrent validity was assessed using self-reported oral health and discriminant validity was ascertained through negative association with sociodemographic variables. RESULTS: The mean OHIP-14-H score was 9.57 (S.D = 4.58). ICC and Cronbach's alpha for OHIP-14-H was 0.96 and 0.92 respectively. Concurrent validity using binomial regression model indicated that good (OR = 0.56, 95% CI = 0.55 – 4.47) and moderate (OR = 0.25, 95% CI = 0.17 – 1.87) OHIP-14-H scores were negative but significant risk indicators of poor self reported oral health (P < 0.009). Significant predictive validity was observed between OHIP-14-H scores and clinical parameters (P < 0.000). CONCLUSION: Translated and culturally adapted OHIP-14-H indicates good reliability and validity among primary school teachers. PMID:29417064

The reliability and validity of ultrasound to quantify muscles in older adults: a systematic review

PubMed Central

Scafoglieri, Aldo; Jager‐Wittenaar, Harriët; Hobbelen, Johannes S.M.; van der Schans, Cees P.

2017-01-01

Abstract This review evaluates the reliability and validity of ultrasound to quantify muscles in older adults. The databases PubMed, Cochrane, and Cumulative Index to Nursing and Allied Health Literature were systematically searched for studies. In 17 studies, the reliability (n = 13) and validity (n = 8) of ultrasound to quantify muscles in community‐dwelling older adults (≥60 years) or a clinical population were evaluated. Four out of 13 reliability studies investigated both intra‐rater and inter‐rater reliability. Intraclass correlation coefficient (ICC) scores for reliability ranged from −0.26 to 1.00. The highest ICC scores were found for the vastus lateralis, rectus femoris, upper arm anterior, and the trunk (ICC = 0.72 to 1.000). All included validity studies found ICC scores ranging from 0.92 to 0.999. Two studies describing the validity of ultrasound to predict lean body mass showed good validity as compared with dual‐energy X‐ray absorptiometry (r 2 = 0.92 to 0.96). This systematic review shows that ultrasound is a reliable and valid tool for the assessment of muscle size in older adults. More high‐quality research is required to confirm these findings in both clinical and healthy populations. Furthermore, ultrasound assessment of small muscles needs further evaluation. Ultrasound to predict lean body mass is feasible; however, future research is required to validate prediction equations in older adults with varying function and health. PMID:28703496

Number of organ dysfunctions predicts mortality in emergency department patients with suspected infection: a multicenter validation study.

PubMed

Jessen, Marie K; Skibsted, Simon; Shapiro, Nathan I

2017-06-01

The aim of this study was to validate the association between number of organ dysfunctions and mortality in emergency department (ED) patients with suspected infection. This study was conducted at two medical care center EDs. The internal validation set was a prospective cohort study conducted in Boston, USA. The external validation set was a retrospective case-control study conducted in Aarhus, Denmark. The study included adult patients (>18 years) with clinically suspected infection. Laboratory results and clinical data were used to assess organ dysfunctions. Inhospital mortality was the outcome measure. Multivariate logistic regression was used to determine the independent mortality odds for number and types of organ dysfunctions. We enrolled 4952 (internal) and 483 (external) patients. The mortality rate significantly increased with increasing number of organ dysfunctions: internal validation: 0 organ dysfunctions: 0.5% mortality, 1: 3.6%, 2: 9.5%, 3: 17%, and 4 or more: 37%; external validation: 2.2, 6.7, 17, 41, and 57% mortality (both P<0.001 for trend). Age-adjusted and comorbidity-adjusted number of organ dysfunctions remained an independent predictor. The effect of specific types of organ dysfunction on mortality was most pronounced for hematologic [odds ratio (OR) 3.3 (95% confidence interval (CI) 2.0-5.4)], metabolic [OR 3.3 (95% CI 2.4-4.6); internal validation], and cardiovascular dysfunctions [OR 14 (95% CI 3.7-50); external validation]. The number of organ dysfunctions predicts sepsis mortality.

Reliability and validity of a novel Kinect-based software program for measuring posture, balance and side-bending.

PubMed

Grooten, Wilhelmus Johannes Andreas; Sandberg, Lisa; Ressman, John; Diamantoglou, Nicolas; Johansson, Elin; Rasmussen-Barr, Eva

2018-01-08

Clinical examinations are subjective and often show a low validity and reliability. Objective and highly reliable quantitative assessments are available in laboratory settings using 3D motion analysis, but these systems are too expensive to use for simple clinical examinations. Qinematic™ is an interactive movement analyses system based on the Kinect camera and is an easy-to-use clinical measurement system for assessing posture, balance and side-bending. The aim of the study was to test the test-retest the reliability and construct validity of Qinematic™ in a healthy population, and to calculate the minimal clinical differences for the variables of interest. A further aim was to identify the discriminative validity of Qinematic™ in people with low-back pain (LBP). We performed a test-retest reliability study (n = 37) with around 1 week between the occasions, a construct validity study (n = 30) in which Qinematic™ was tested against a 3D motion capture system, and a discriminative validity study, in which a group of people with LBP (n = 20) was compared to healthy controls (n = 17). We tested a large range of psychometric properties of 18 variables in three sections: posture (head and pelvic position, weight distribution), balance (sway area and velocity in single- and double-leg stance), and side-bending. The majority of the variables in the posture and balance sections, showed poor/fair reliability (ICC < 0.4) and poor/fair validity (Spearman <0.4), with significant differences between occasions, between Qinematic™ and the 3D-motion capture system. In the clinical study, Qinematic™ did not differ between people with LPB and healthy for these variables. For one variable, side-bending to the left, there was excellent reliability (ICC =0.898), excellent validity (r = 0.943), and Qinematic™ could differentiate between LPB and healthy individuals (p = 0.012). This paper shows that a novel software program (Qinematic™) based on the Kinect camera for measuring balance, posture and side-bending has poor psychometric properties, indicating that the variables on balance and posture should not be used for monitoring individual changes over time or in research. Future research on the dynamic tasks of Qinematic™ is warranted.

Development and Validation of Criterion-Referenced Clinically Relevant Fitness Standards for Maintaining Physical Independence in Later Years

ERIC Educational Resources Information Center

Rikli, Roberta E.; Jones, C. Jessie

2013-01-01

Purpose: To develop and validate criterion-referenced fitness standards for older adults that predict the level of capacity needed for maintaining physical independence into later life. The proposed standards were developed for use with a previously validated test battery for older adults--the Senior Fitness Test (Rikli, R. E., & Jones, C. J.…

Examination of the Structural, Convergent, and Incremental Validity of the Reynolds Intellectual Assessment Scales (RIAS) with a Clinical Sample

ERIC Educational Resources Information Center

Nelson, Jason M.; Canivez, Gary L.

2012-01-01

Empirical examination of the Reynolds Intellectual Assessment Scales (RIAS; C. R. Reynolds & R. W. Kamphaus, 2003a) has produced mixed results regarding its internal structure and convergent validity. Various aspects of validity of RIAS scores with a sample (N = 521) of adolescents and adults seeking psychological evaluations at a university-based…

Evaluating the accuracy of the Wechsler Memory Scale-Fourth Edition (WMS-IV) logical memory embedded validity index for detecting invalid test performance.

PubMed

Soble, Jason R; Bain, Kathleen M; Bailey, K Chase; Kirton, Joshua W; Marceaux, Janice C; Critchfield, Edan A; McCoy, Karin J M; O'Rourke, Justin J F

2018-01-08

Embedded performance validity tests (PVTs) allow for continuous assessment of invalid performance throughout neuropsychological test batteries. This study evaluated the utility of the Wechsler Memory Scale-Fourth Edition (WMS-IV) Logical Memory (LM) Recognition score as an embedded PVT using the Advanced Clinical Solutions (ACS) for WAIS-IV/WMS-IV Effort System. This mixed clinical sample was comprised of 97 total participants, 71 of whom were classified as valid and 26 as invalid based on three well-validated, freestanding criterion PVTs. Overall, the LM embedded PVT demonstrated poor concordance with the criterion PVTs and unacceptable psychometric properties using ACS validity base rates (42% sensitivity/79% specificity). Moreover, 15-39% of participants obtained an invalid ACS base rate despite having a normatively-intact age-corrected LM Recognition total score. Receiving operating characteristic curve analysis revealed a Recognition total score cutoff of < 61% correct improved specificity (92%) while sensitivity remained weak (31%). Thus, results indicated the LM Recognition embedded PVT is not appropriate for use from an evidence-based perspective, and that clinicians may be faced with reconciling how a normatively intact cognitive performance on the Recognition subtest could simultaneously reflect invalid performance validity.

Predictive validity of the Braden Scale, Norton Scale, and Waterlow Scale in the Czech Republic.

PubMed

Šateková, Lenka; Žiaková, Katarína; Zeleníková, Renáta

2017-02-01

The aim of this study was to determine the predictive validity of the Braden, Norton, and Waterlow scales in 2 long-term care departments in the Czech Republic. Assessing the risk for developing pressure ulcers is the first step in their prevention. At present, many scales are used in clinical practice, but most of them have not been properly validated yet (for example, the Modified Norton Scale in the Czech Republic). In the Czech Republic, only the Braden Scale has been validated so far. This is a prospective comparative instrument testing study. A random sample of 123 patients was recruited. The predictive validity of the pressure ulcer risk assessment scales was evaluated based on sensitivity, specificity, positive and negative predictive values, and the area under the receiver operating characteristic curve. The data were collected from April to August 2014. In the present study, the best predictive validity values were observed for the Norton Scale, followed by the Braden Scale and the Waterlow Scale, in that order. We recommended that the above 3 pressure ulcer risk assessment scales continue to be evaluated in the Czech clinical setting. © 2016 John Wiley & Sons Australia, Ltd.

Evaluating the validity and reliability of the V-scale instrument (Turkish version) used to determine nurses' attitudes towards vital sign monitoring.

PubMed

Ertuğ, Nurcan

2018-06-01

The aim of this study was to determine the validity and reliability of the Turkish version of the V-scale, which measures nurses' attitudes towards vital signs monitoring in the detection of clinical deterioration. This validity and reliability study was conducted at a tertiary hospital in Ankara, Turkey, in 2016. A total of 169 ward nurses participated in the study. Exploratory factor analysis, Cronbach's alpha coefficient, and the intraclass correlation coefficient were used to determine the validity and reliability of the scale. A 5-factor, 16-item scale explained 60.823% of the total variance according to the validity analysis. Our version matched the original scale in terms of the number of items and factor structure. Cronbach's alpha coefficient of the Turkish version of the V-scale was 0.764. The test-retest reliability results were 0.855 for the overall intraclass correlation coefficient, and the t-test result was P > 0.05. The V-scale is a reliable and valid instrument to measure Turkish nurses' attitudes towards vital signs monitoring in the detection of clinical deterioration. © 2018 John Wiley & Sons Australia, Ltd.

The city of hope-quality of life-ostomy questionnaire: persian translation and validation.

PubMed

Anaraki, F; Vafaie, M; Behboo, R; Esmaeilpour, S; Maghsoodi, N; Safaee, A; Grant, M

2014-07-01

Since there is no disease-specific instrument for measuring quality-of-life (QOL) in Ostomy patients in Persian language. This study was designed to translate and evaluate the validity and reliability of City of Hope-quality of life-Ostomy questionnaire (COH-QOL-Ostomy questionnaire). This study was designed as cross-sectional study. Reliability of the subscales and the summary scores were demonstrated by intra-class correlation coefficients. Pearson's correlations of an item with its own scale and other scales were calculated to evaluated convergent and discriminant validity. Clinical validity was also evaluated by known-group comparisons. Cronbach's alpha coefficient for all subscales was about 0.70 or higher. Results of interscale correlation were satisfactory and each subscale only measured a single and specified trait. All subscales met the standards of convergent and discriminant validity. Known group comparison analysis showed significant differences in social and spiritual well-being. The findings confirmed the reliability and validity of Persian version of COH-QOL-Ostomy questionnaire. The instrument was also well received by the Iranian patients. It can be considered as a valuable instrument to assess the different aspects of health related quality-of-life in Ostomy patients and used in clinical research in the future.

Reliability and criterion-related validity testing (construct) of the Endotracheal Suction Assessment Tool (ESAT©).

PubMed

Davies, Kylie; Bulsara, Max K; Ramelet, Anne-Sylvie; Monterosso, Leanne

2018-05-01

To establish criterion-related construct validity and test-retest reliability for the Endotracheal Suction Assessment Tool© (ESAT©). Endotracheal tube suction performed in children can significantly affect clinical stability. Previously identified clinical indicators for endotracheal tube suction were used as criteria when designing the ESAT©. Content validity was reported previously. The final stages of psychometric testing are presented. Observational testing was used to measure construct validity and determine whether the ESAT© could guide "inexperienced" paediatric intensive care nurses' decision-making regarding endotracheal tube suction. Test-retest reliability of the ESAT© was performed at two time points. The researchers and paediatric intensive care nurse "experts" developed 10 hypothetical clinical scenarios with predetermined endotracheal tube suction outcomes. "Experienced" (n = 12) and "inexperienced" (n = 14) paediatric intensive care nurses were presented with the scenarios and the ESAT© guiding decision-making about whether to perform endotracheal tube suction for each scenario. Outcomes were compared with those predetermined by the "experts" (n = 9). Test-retest reliability of the ESAT© was measured at two consecutive time points (4 weeks apart) with "experienced" and "inexperienced" paediatric intensive care nurses using the same scenarios and tool to guide decision-making. No differences were observed between endotracheal tube suction decisions made by "experts" (n = 9), "inexperienced" (n = 14) and "experienced" (n = 12) nurses confirming the tool's construct validity. No differences were observed between groups for endotracheal tube suction decisions at T1 and T2. Criterion-related construct validity and test-retest reliability of the ESAT© were demonstrated. Further testing is recommended to confirm reliability in the clinical setting with the "inexperienced" nurse to guide decision-making related to endotracheal tube suction. The ESAT© is the first validated tool to systematically guide endotracheal nursing practice for the "inexperienced" nurse. © 2018 John Wiley & Sons Ltd.

Validity and reliability of the iPhone to measure rib hump in scoliosis.

PubMed

Balg, Frederic; Juteau, Mathieu; Theoret, Chantal; Svotelis, Amy; Grenier, Guillaume

2014-12-01

This was a prospective blinded validity and reliability analysis. The aim of this study was validation and reliability evaluation of the Scoligauge iPhone app. The scoliometer is used to clinically measure the rib hump in scoliosis as a means to evaluate the axial trunk rotation. The increasing availability of smartphone with built-in accelerometer led to the development of a vast number of applications to measure angles. Of these, the Scoligauge mimics a scoliometer. The aim of this study was to compare the validity of the Scoligauge iPhone application without an associated adapter with the traditional scoliometer and to test the reliability of the application in a clinical setting. Two observers measured the rib hump deformity on 34 consecutive patients with idiopathic scoliosis with an average Cobb angle of 24.2 ± 13.5 degrees (range, 4 to 65 degrees). Measurements were made with an iPhone without the adapter and with a scoliometer. The validity as well as the interobserver and intraobserver reliability were calculated using the intraclass coefficient (ICC) and the Bland-Altman test. The mean difference between the scoliometer and the Scoligauge application was 0.4 degrees [95% confidence interval (CI) of ± 3.1 degrees] with an ICC of 0.947 (P < 0.001). The intraobserver and interobserver ICC were 0.961 (P < 0.001) and 0.901 (P < 0.001), respectively. The mean intraobserver difference was 0.0 degrees (95% CI of ± 2.7 degrees) and the mean interobserver difference was 0.1 degrees (95% CI of ± 4.4 degrees). The intraobserver and interobserver reliability of the Scoligauge iPhone app, as well as its validity compared with the scoliometer, are excellent. The mean differences between measurements are small and clinically not significant. Thus, the Scoligauge application is valid for clinical evaluation even without special adapter. Level I (Diagnostic Study).

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.

Classification Accuracy of MMPI-2 Validity Scales in the Detection of Pain-Related Malingering: A Known-Groups Study

ERIC Educational Resources Information Center

Bianchini, Kevin J.; Etherton, Joseph L.; Greve, Kevin W.; Heinly, Matthew T.; Meyers, John E.

2008-01-01

The purpose of this study was to determine the accuracy of "Minnesota Multiphasic Personality Inventory" 2nd edition (MMPI-2; Butcher, Dahlstrom, Graham, Tellegen, & Kaemmer, 1989) validity indicators in the detection of malingering in clinical patients with chronic pain using a hybrid clinical-known groups/simulator design. The…

Psychometric Properties of the Beck Depression Inventory-II in a Clinically-Identified Sample of Mexican American Adolescents

ERIC Educational Resources Information Center

VanVoorhis, Carmen R. Wilson; Blumentritt, Tracie L.

2007-01-01

We examined the internal consistency reliability, convergent and divergent validity, and factor structure of the Beck Depression Inventory-II (BDI-II) in a sample of 131 Mexican American youth. The BDI-II demonstrated excellent internal consistency reliability (alpha = 0.90) and solid convergent and divergent validity with various clinical scales…

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.…

Combined Use of Tissue Morphology, Neural Network Analysis of Chromatin Texture and Clinical Variables to Predict Prostate Cancer Agressiveness from Biopsy Water

DTIC Science & Technology

2000-10-01

Purpose: To combine clinical, serum, pathologic and computer derived information into an artificial neural network to develop/validate a model to...Development of an artificial neural network (year 02). Prospective validation of this model (projected year 03). All models will be tested and

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).

Paediatric Automatic Phonological Analysis Tools (APAT).

PubMed

Saraiva, Daniela; Lousada, Marisa; Hall, Andreia; Jesus, Luis M T

2017-12-01

To develop the pediatric Automatic Phonological Analysis Tools (APAT) and to estimate inter and intrajudge reliability, content validity, and concurrent validity. The APAT were constructed using Excel spreadsheets with formulas. The tools were presented to an expert panel for content validation. The corpus used in the Portuguese standardized test Teste Fonético-Fonológico - ALPE produced by 24 children with phonological delay or phonological disorder was recorded, transcribed, and then inserted into the APAT. Reliability and validity of APAT were analyzed. The APAT present strong inter- and intrajudge reliability (>97%). The content validity was also analyzed (ICC = 0.71), and concurrent validity revealed strong correlations between computerized and manual (traditional) methods. The development of these tools contributes to fill existing gaps in clinical practice and research, since previously there were no valid and reliable tools/instruments for automatic phonological analysis, which allowed the analysis of different corpora.

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.

Use of Latent Class Analysis to define groups based on validity, cognition, and emotional functioning.

PubMed

Morin, Ruth T; Axelrod, Bradley N

Latent Class Analysis (LCA) was used to classify a heterogeneous sample of neuropsychology data. In particular, we used measures of performance validity, symptom validity, cognition, and emotional functioning to assess and describe latent groups of functioning in these areas. A data-set of 680 neuropsychological evaluation protocols was analyzed using a LCA. Data were collected from evaluations performed for clinical purposes at an urban medical center. A four-class model emerged as the best fitting model of latent classes. The resulting classes were distinct based on measures of performance validity and symptom validity. Class A performed poorly on both performance and symptom validity measures. Class B had intact performance validity and heightened symptom reporting. The remaining two Classes performed adequately on both performance and symptom validity measures, differing only in cognitive and emotional functioning. In general, performance invalidity was associated with worse cognitive performance, while symptom invalidity was associated with elevated emotional distress. LCA appears useful in identifying groups within a heterogeneous sample with distinct performance patterns. Further, the orthogonal nature of performance and symptom validities is supported.

Development of a Research Participants’ Perception Survey to Improve Clinical Research

PubMed Central

Yessis, Jennifer L.; Kost, Rhonda G.; Lee, Laura M.; Coller, Barry S.; Henderson, David K.

2012-01-01

Abstract Introduction: Clinical research participants’ perceptions regarding their experiences during research protocols provide outcome‐based insights into the effectiveness of efforts to protect rights and safety, and opportunities to enhance participants’ clinical research experiences. Use of validated surveys measuring patient‐centered outcomes is standard in hospitals, yet no instruments exist to assess outcomes of clinical research processes. Methods: We derived survey questions from data obtained from focus groups comprised of research participants and professionals. We assessed the survey for face/content validity, and privacy/confidentiality protections and fielded it to research participants at 15 centers. We conducted analyses of response rates, sample characteristics, and psychometrics, including survey and item completion and analysis, internal consistency, item internal consistency, criterion‐related validity, and item usefulness. Responses were tested for fit into existing patient‐centered dimensions of care and new clinical research dimensions using Cronbach's alpha coefficient. Results: Surveys were mailed to 18,890 individuals; 4,961 were returned (29%). Survey completion was 89% overall; completion rates exceeded 90% for 88 of 93 evaluable items. Questions fit into three dimensions of patient‐centered care and two novel clinical research dimensions (Cronbach's alpha for dimensions: 0.69–0.85). Conclusions: The validated survey offers a new method for assessing and improving outcomes of clinical research processes. Clin Trans Sci 2012; Volume 5: 452–460 PMID:23253666

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

PubMed

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

2018-05-01

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

Spanish translation, cross-cultural adaptation, and validation of the Questionnaire for Diabetes-Related Foot Disease (Q-DFD)

PubMed Central

Castillo-Tandazo, Wilson; Flores-Fortty, Adolfo; Feraud, Lourdes; Tettamanti, Daniel

2013-01-01

Purpose To translate, cross-culturally adapt, and validate the Questionnaire for Diabetes-Related Foot Disease (Q-DFD), originally created and validated in Australia, for its use in Spanish-speaking patients with diabetes mellitus. Patients and methods The translation and cross-cultural adaptation were based on international guidelines. The Spanish version of the survey was applied to a community-based (sample A) and a hospital clinic-based sample (samples B and C). Samples A and B were used to determine criterion and construct validity comparing the survey findings with clinical evaluation and medical records, respectively; while sample C was used to determine intra- and inter-rater reliability. Results After completing the rigorous translation process, only four items were considered problematic and required a new translation. In total, 127 patients were included in the validation study: 76 to determine criterion and construct validity and 41 to establish intra- and inter-rater reliability. For an overall diagnosis of diabetes-related foot disease, a substantial level of agreement was obtained when we compared the Q-DFD with the clinical assessment (kappa 0.77, sensitivity 80.4%, specificity 91.5%, positive likelihood ratio [LR+] 9.46, negative likelihood ratio [LR−] 0.21); while an almost perfect level of agreement was obtained when it was compared with medical records (kappa 0.88, sensitivity 87%, specificity 97%, LR+ 29.0, LR− 0.13). Survey reliability showed substantial levels of agreement, with kappa scores of 0.63 and 0.73 for intra- and inter-rater reliability, respectively. Conclusion The translated and cross-culturally adapted Q-DFD showed good psychometric properties (validity, reproducibility, and reliability) that allow its use in Spanish-speaking diabetic populations. PMID:24039434

Development, validation and psychometric properties of a diagnostic/prognostic tool for breakthrough pain in mixed chronic-pain patients.

PubMed

Samolsky Dekel, Boaz Gedaliahu; Remondini, Francesca; Gori, Alberto; Vasarri, Alessio; Di Nino, GianFranco; Melotti, Rita Maria

2016-02-01

Breakthrough pain (BTP) shows variable prevalence in different clinical contexts of cancer and non-cancer patients. BTP diagnostic tools with demonstrated reliability, validation and prognostic capability are lacking. We report the development, psychometric and validation properties of a diagnostic/prognostic tool, the IQ-BTP, for BTP recognition, its likelihood and clinical features among chronic-pain (CP) patients. n=120 consecutive mixed cancer/non-cancer CP in/outpatients. Development, psychometric analyses and formal validation included: Face/Content validity (by 'experts' opinion and assessing the relationship between the IQ-BTP classes and criteria derived from BTP operational-case-definition); Construct validity, by Principle Component Analysis (PCA); and the strength of Spearman correlation between IQ-BTP classes and the Brief Pain Inventory (BPI) items; Reliability, by Cronbach's alpha statistics. Associations with clinical/demographic moderators were assessed applying χ(2) analysis. Potential-BTP was found in 36.7% of patients (38.4% of non-cancer and 32.4% of cancer patients). Among these the likelihood for BTP diagnosis was 'high' in 25%, 'intermediate' in 41% and, 'low' 34% of patients. Analyses showed significant differences between IQ-BTP classes and between the latter BPI pain-item scores. Correlation between IQ-BTP classes and BPI items was moderate. PCA and scree test identified 3 components accounting for 62.3% of the variance. Cronbach's alpha was 0.71. The IQ-BTP showed satisfactory psychometric and validation properties. With adequate feasibility it enabled the allocating of cancer/non-cancer CP patients in three prognostic classes. Results are sufficient to warrant a subsequent impact study of the IQ-BTP as prognostic model and screening tool for BTP in both CP populations. Copyright © 2016 Elsevier B.V. All rights reserved.

The dialysis orders objective structured clinical examination (OSCE): a formative assessment for nephrology fellows

PubMed Central

Prince, Lisa K; Campbell, Ruth C; Gao, Sam W; Kendrick, Jessica; Lebrun, Christopher J; Little, Dustin J; Mahoney, David L; Maursetter, Laura A; Nee, Robert; Saddler, Mark; Watson, Maura A

2018-01-01

Abstract Background Few quantitative nephrology-specific simulations assess fellow competency. We describe the development and initial validation of a formative objective structured clinical examination (OSCE) assessing fellow competence in ordering acute dialysis. Methods The three test scenarios were acute continuous renal replacement therapy, chronic dialysis initiation in moderate uremia and acute dialysis in end-stage renal disease-associated hyperkalemia. The test committee included five academic nephrologists and four clinically practicing nephrologists outside of academia. There were 49 test items (58 points). A passing score was 46/58 points. No item had median relevance less than ‘important’. The content validity index was 0.91. Ninety-five percent of positive-point items were easy–medium difficulty. Preliminary validation was by 10 board-certified volunteers, not test committee members, a median of 3.5 years from graduation. The mean score was 49 [95% confidence interval (CI) 46–51], κ = 0.68 (95% CI 0.59–0.77), Cronbach’s α = 0.84. Results We subsequently administered the test to 25 fellows. The mean score was 44 (95% CI 43–45); 36% passed the test. Fellows scored significantly less than validators (P < 0.001). Of evidence-based questions, 72% were answered correctly by validators and 54% by fellows (P = 0.018). Fellows and validators scored least well on the acute hyperkalemia question. In self-assessing proficiency, 71% of fellows surveyed agreed or strongly agreed that the OSCE was useful. Conclusions The OSCE may be used to formatively assess fellow proficiency in three common areas of acute dialysis practice. Further validation studies are in progress. PMID:29644053

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.

Validation of a single summary score for the Prolapse/Incontinence Sexual Questionnaire-IUGA revised (PISQ-IR).

PubMed

Constantine, Melissa L; Pauls, Rachel N; Rogers, Rebecca R; Rockwood, Todd H

2017-12-01

The Prolapse/Incontinence Sexual Questionnaire-International Urogynecology Association (IUGA) Revised (PISQ-IR) measures sexual function in women with pelvic floor disorders (PFDs) yet is unwieldy, with six individual subscale scores for sexually active women and four for women who are not. We hypothesized that a valid and responsive summary score could be created for the PISQ-IR. Item response data from participating women who completed a revised version of the PISQ-IR at three clinical sites were used to generate item weights using a magnitude estimation (ME) and Q-sort (Q) approaches. Item weights were applied to data from the original PISQ-IR validation to generate summary scores. Correlation and factor analysis methods were used to evaluate validity and responsiveness of summary scores. Weighted and nonweighted summary scores for the sexually active PISQ-IR demonstrated good criterion validity with condition-specific measures: Incontinence Severity Index = 0.12, 0.11, 0.11; Pelvic Floor Distress Inventory-20 = 0.39, 0.39, 0.12; Epidemiology of Prolapse and Incontinence Questionnaire-Q35 = 0.26 0,.25, 0.40); Female Sexual Functioning Index subscale total score = 0.72, 0.75, 0.72 for nonweighted, ME, and Q summary scores, respectively. Responsiveness evaluation showed weighted and nonweighted summary scores detected moderate effect sizes (Cohen's d > 0.5). Weighted items for those NSA demonstrated significant floor effects and did not meet criterion validity. A PISQ-IR summary score for use with sexually active women, nonweighted or calculated with ME or Q item weights, is a valid and reliable measure for clinical use. The summary scores provide value for assesing clinical treatment of pelvic floor disorders.

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

Multiple reaction monitoring (MRM) of plasma proteins in cardiovascular proteomics.

PubMed

Dardé, Verónica M; Barderas, Maria G; Vivanco, Fernando

2013-01-01

Different methodologies have been used through years to discover new potential biomarkers related with cardiovascular risk. The conventional proteomic strategy involves a discovery phase that requires the use of mass spectrometry (MS) and a validation phase, usually on an alternative platform such as immunoassays that can be further implemented in clinical practice. This approach is suitable for a single biomarker, but when large panels of biomarkers must be validated, the process becomes inefficient and costly. Therefore, it is essential to find an alternative methodology to perform the biomarker discovery, validation, and -quantification. The skills provided by quantitative MS turn it into an extremely attractive alternative to antibody-based technologies. Although it has been traditionally used for quantification of small molecules in clinical chemistry, MRM is now emerging as an alternative to traditional immunoassays for candidate protein biomarker validation.

Assessment of performance validity in the Stroop Color and Word Test in mild traumatic brain injury patients: a criterion-groups validation design.

PubMed

Guise, Brian J; Thompson, Matthew D; Greve, Kevin W; Bianchini, Kevin J; West, Laura

2014-03-01

The current study assessed performance validity on the Stroop Color and Word Test (Stroop) in mild traumatic brain injury (TBI) using criterion-groups validation. The sample consisted of 77 patients with a reported history of mild TBI. Data from 42 moderate-severe TBI and 75 non-head-injured patients with other clinical diagnoses were also examined. TBI patients were categorized on the basis of Slick, Sherman, and Iverson (1999) criteria for malingered neurocognitive dysfunction (MND). Classification accuracy is reported for three indicators (Word, Color, and Color-Word residual raw scores) from the Stroop across a range of injury severities. With false-positive rates set at approximately 5%, sensitivity was as high as 29%. The clinical implications of these findings are discussed. © 2012 The British Psychological Society.

Validation of a 4-item Negative Symptom Assessment (NSA-4): a short, practical clinical tool for the assessment of negative symptoms in schizophrenia.

PubMed

Alphs, Larry; Morlock, Robert; Coon, Cheryl; Cazorla, Pilar; Szegedi, Armin; Panagides, John

2011-06-01

The 16-item Negative Symptom Assessment (NSA-16) scale is a validated tool for evaluating negative symptoms of schizophrenia. The psychometric properties and predictive power of a four-item version (NSA-4) were compared with the NSA-16. Baseline data from 561 patients with predominant negative symptoms of schizophrenia who participated in two identically designed clinical trials were evaluated. Ordered logistic regression analysis of ratings using NSA-4 and NSA-16 were compared with ratings using several other standard tools to determine predictive validity and construct validity. Internal consistency and test--retest reliability were also analyzed. NSA-16 and NSA-4 scores were both predictive of scores on the NSA global rating (odds ratio = 0.83-0.86) and the Clinical Global Impressions--Severity scale (odds ratio = 0.91-0.93). NSA-16 and NSA-4 showed high correlation with each other (Pearson r = 0.85), similar high correlation with other measures of negative symptoms (demonstrating convergent validity), and lesser correlations with measures of other forms of psychopathology (demonstrating divergent validity). NSA-16 and NSA-4 both showed acceptable internal consistency (Cronbach α, 0.85 and 0.64, respectively) and test--retest reliability (intraclass correlation coefficient, 0.87 and 0.82). This study demonstrates that NSA-4 offers accuracy comparable to the NSA-16 in rating negative symptoms in patients with schizophrenia. Copyright © 2011 John Wiley & Sons, Ltd.

The key-features approach to assess clinical decisions: validity evidence to date.

PubMed

Bordage, G; Page, G

2018-05-17

The key-features (KFs) approach to assessment was initially proposed during the First Cambridge Conference on Medical Education in 1984 as a more efficient and effective means of assessing clinical decision-making skills. Over three decades later, we conducted a comprehensive, systematic review of the validity evidence gathered since then. The evidence was compiled according to the Standards for Educational and Psychological Testing's five sources of validity evidence, namely, Content, Response process, Internal structure, Relations to other variables, and Consequences, to which we added two other types related to Cost-feasibility and Acceptability. Of the 457 publications that referred to the KFs approach between 1984 and October 2017, 164 are cited here; the remaining 293 were either redundant or the authors simply mentioned the KFs concept in relation to their work. While one set of articles reported meeting the validity standards, another set examined KFs test development choices and score interpretation. The accumulated validity evidence for the KFs approach since its inception supports the decision-making construct measured and its use to assess clinical decision-making skills at all levels of training and practice and with various types of exam formats. Recognizing that gathering validity evidence is an ongoing process, areas with limited evidence, such as item factor analyses or consequences of testing, are identified as well as new topics needing further clarification, such as the use of the KFs approach for formative assessment and its place within a program of assessment.

The use of the FACT-H&N (v4) in clinical settings within a developing country: a mixed method study.

PubMed

Bilal, Sobia; Doss, Jennifer Geraldine; Rogers, Simon N

2014-12-01

In the last decade there has been an increasing awareness about 'quality of life' (QOL) of cancer survivors in developing countries. The study aimed to cross-culturally adapt and validate the FACT-H&N (v4) in Urdu language for Pakistani head and neck cancer patients. In this study the 'same language adaptation method' was used. Cognitive debriefing through in-depth interviews of 25 patients to assess semantic, operational and conceptual equivalence was done. The validation phase included 50 patients to evaluate the psychometric properties. The translated FACT-H&N was easily comprehended (100%). Cronbach's alpha for FACT-G subscales ranged from 0.726 - 0.969. The head and neck subscale and Pakistani questions subscale showed low internal consistency (0.426 and 0.541 respectively). Instrument demonstrated known-group validity in differentiating patients of different clinical stages, treatment status and tumor sites (p < 0.05). Most FACT summary scales correlated strongly with each other (r > 0.75) and showed convergent validity (r > 0.90), with little discriminant validity. Factor analysis revealed 6 factors explaining 85.1% of the total variance with very good (>0.8) Kaiser-Meyer-Olkin and highly significant Bartlett's Test of Sphericity (p < 0.001). The cross-culturally adapted FACT-H&N into Urdu language showed adequate reliability and validity to be incorporated in Pakistani clinical settings for head and neck cancer patients. Copyright © 2014 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

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.

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.

WHO Study on the reliability and validity of the alcohol and drug use disorder instruments: overview of methods and results.

PubMed

Ustün, B; Compton, W; Mager, D; Babor, T; Baiyewu, O; Chatterji, S; Cottler, L; Göğüş, A; Mavreas, V; Peters, L; Pull, C; Saunders, J; Smeets, R; Stipec, M R; Vrasti, R; Hasin, D; Room, R; Van den Brink, W; Regier, D; Blaine, J; Grant, B F; Sartorius, N

1997-09-25

The WHO Study on the reliability and validity of the alcohol and drug use disorder instruments in an international study which has taken place in centres in ten countries, aiming to test the reliability and validity of three diagnostic instruments for alcohol and drug use disorders: the Composite International Diagnostic Interview (CIDI), the Schedules for Clinical Assessment in Neuropsychiatry (SCAN) and a special version of the Alcohol Use Disorder and Associated Disabilities Interview schedule-alcohol/drug-revised (AUDADIS-ADR). The purpose of the reliability and validity (R&V) study is to further develop the alcohol and drug sections of these instruments so that a range of substance-related diagnoses can be made in a systematic, consistent, and reliable way. The study focuses on new criteria proposed in the tenth revision of the International Classification of Diseases (ICD-10) and the fourth revision of the diagnostic and statistical manual of mental disorders (DSM-IV) for dependence, harmful use and abuse categories for alcohol and psychoactive substance use disorders. A systematic study including a scientifically rigorous measure of reliability (i.e. 1 week test-retest reliability) and validity (i.e. comparison between clinical and non-clinical measures) has been undertaken. Results have yielded useful information on reliability and validity of these instruments at diagnosis, criteria and question level. Overall the diagnostic concordance coefficients (kappa, kappa) were very good for dependence disorders (0.7-0.9), but were somewhat lower for the abuse and harmful use categories. The comparisons among instruments and independent clinical evaluations and debriefing interviews gave important information about possible sources of unreliability, and provided useful clues on the applicability and consistency of nosological concepts across cultures.

Can we have an overall osteoarthritis severity score for the patellofemoral joint using magnetic resonance imaging? Reliability and validity.

PubMed

Kobayashi, Sarah; Peduto, Anthony; Simic, Milena; Fransen, Marlene; Refshauge, Kathryn; Mah, Jean; Pappas, Evangelos

2018-04-01

This work aimed to assess inter-rater reliability and agreement of a magnetic resonance imaging (MRI)-based Kellgren and Lawrence (K&L) grading for patellofemoral joint osteoarthritis (OA) and to validate it against the MRI Osteoarthritis Knee Score (MOAKS). MRI scans from people aged 45 to 75 years with chronic knee pain participating in a randomised clinical trial evaluating dietary supplements were utilised. Fifty participants were randomly selected and scored using the MRI-based K&L grading using axial and sagittal MRI scans. Raters conducted inter-rater reliability, blinded to clinical information, radiology reports and other rater results. Intra- and inter-rater reliability and agreement were evaluated using the intra-class correlation coefficient (ICC) and Cohen's weighted kappa. There was a 2-week interval between the first and second readings for intra-rater reliability. Validity was assessed using the MOAKS and evaluated using Spearman's correlation coefficient. Intra-rater reliability of the K&L system was excellent: ICC 0.91 (95% CI 0.82-0.95); weighted kappa (ĸ = 0.69). Inter-rater reliability was high (ICC 0.88; 95% CI 0.79-0.93), while agreement between raters was moderate (ĸ = 0.49-0.57). Validity analysis demonstrated a strong correlation between the total MOAKS features score and the K&L grading system (ρ = 0.62-0.67) but weak correlations when compared with individual MOAKS features (ρ = 0.19-0.61). The high reliability and good agreement show consistency in grading the severity of patellofemoral OA with the MRI-based K&L score. Our validity results suggest that the scale may be useful, particularly in the clinical environment. Future research should validate this method against clinical findings.

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.

Parameter Selection Methods in Inverse Problem Formulation

DTIC Science & Technology

2010-11-03

clinical data and used for prediction and a model for the reaction of the cardiovascular system to an ergometric workload. Key Words: Parameter selection...model for HIV dynamics which has been successfully validated with clinical data and used for prediction and a model for the reaction of the...recently developed in-host model for HIV dynamics which has been successfully validated with clinical data and used for prediction [4, 8]; b) a global

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

Validation of the Economic and Health Outcomes Model of Type 2 Diabetes Mellitus (ECHO-T2DM).

PubMed

Willis, Michael; Johansen, Pierre; Nilsson, Andreas; Asseburg, Christian

2017-03-01

The Economic and Health Outcomes Model of Type 2 Diabetes Mellitus (ECHO-T2DM) was developed to address study questions pertaining to the cost-effectiveness of treatment alternatives in the care of patients with type 2 diabetes mellitus (T2DM). Naturally, the usefulness of a model is determined by the accuracy of its predictions. A previous version of ECHO-T2DM was validated against actual trial outcomes and the model predictions were generally accurate. However, there have been recent upgrades to the model, which modify model predictions and necessitate an update of the validation exercises. The objectives of this study were to extend the methods available for evaluating model validity, to conduct a formal model validation of ECHO-T2DM (version 2.3.0) in accordance with the principles espoused by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Society for Medical Decision Making (SMDM), and secondarily to evaluate the relative accuracy of four sets of macrovascular risk equations included in ECHO-T2DM. We followed the ISPOR/SMDM guidelines on model validation, evaluating face validity, verification, cross-validation, and external validation. Model verification involved 297 'stress tests', in which specific model inputs were modified systematically to ascertain correct model implementation. Cross-validation consisted of a comparison between ECHO-T2DM predictions and those of the seminal National Institutes of Health model. In external validation, study characteristics were entered into ECHO-T2DM to replicate the clinical results of 12 studies (including 17 patient populations), and model predictions were compared to observed values using established statistical techniques as well as measures of average prediction error, separately for the four sets of macrovascular risk equations supported in ECHO-T2DM. Sub-group analyses were conducted for dependent vs. independent outcomes and for microvascular vs. macrovascular vs. mortality endpoints. All stress tests were passed. ECHO-T2DM replicated the National Institutes of Health cost-effectiveness application with numerically similar results. In external validation of ECHO-T2DM, model predictions agreed well with observed clinical outcomes. For all sets of macrovascular risk equations, the results were close to the intercept and slope coefficients corresponding to a perfect match, resulting in high R 2 and failure to reject concordance using an F test. The results were similar for sub-groups of dependent and independent validation, with some degree of under-prediction of macrovascular events. ECHO-T2DM continues to match health outcomes in clinical trials in T2DM, with prediction accuracy similar to other leading models of T2DM.

Clinical utility of the mBIAS and NSI validity-10 to detect symptom over-reporting following mild TBI: A multicenter investigation with military service members.

PubMed

Armistead-Jehle, Patrick; Cooper, Douglas B; Grills, Chad E; Cole, Wesley R; Lippa, Sara M; Stegman, Robert L; Lange, Rael T

2018-04-01

Self-report measures are commonly relied upon in military healthcare environments to assess service members following a mild traumatic brain injury (mTBI). However, such instruments are susceptible to over-reporting and rarely include validity scales. This study evaluated the utility of the mild Brain Injury Atypical Symptoms scale (mBIAS) and the Neurobehavioral Symptom Inventory Validity-10 scale to detect symptom over-reporting. A total of 359 service members with a reported history of mTBI were separated into two symptom reporting groups based on MMPI-2-RF validity scales (i.e., non-over-reporting versus symptom over-reporting). The clinical utility of the mBIAS and Validity-10 as diagnostic indicators and screens of symptom over-reporting were evaluated by calculating sensitivity, specificity, positive test rate, positive predictive power (PPP), and negative predictive power (NPP) values. An mBIAS cut score of ≥10 was optimal as a diagnostic indicator, which resulted in high specificity and PPP; however, sensitivity was low. The utility of the mBIAS as a screening instrument was limited. A Validity-10 cut score of ≥33 was optimal as a diagnostic indicator. This resulted in very high specificity and PPP, but low sensitivity. A Validity-10 cut score of ≥7 was considered optimal as a screener, which resulted in moderate sensitivity, specificity, NPP, but relatively low PPP. Owing to low sensitivity, the current data suggests that both the mBIAS and Validity-10 are insufficient as stand-alone measures of symptom over-reporting. However, Validity-10 scores above the identified cut-off of ≥7should be taken as an indication that further evaluation to rule out symptom over-reporting is necessary.

Modeling complex treatment strategies: construction and validation of a discrete event simulation model for glaucoma.

PubMed

van Gestel, Aukje; Severens, Johan L; Webers, Carroll A B; Beckers, Henny J M; Jansonius, Nomdo M; Schouten, Jan S A G

2010-01-01

Discrete event simulation (DES) modeling has several advantages over simpler modeling techniques in health economics, such as increased flexibility and the ability to model complex systems. Nevertheless, these benefits may come at the cost of reduced transparency, which may compromise the model's face validity and credibility. We aimed to produce a transparent report on the construction and validation of a DES model using a recently developed model of ocular hypertension and glaucoma. Current evidence of associations between prognostic factors and disease progression in ocular hypertension and glaucoma was translated into DES model elements. The model was extended to simulate treatment decisions and effects. Utility and costs were linked to disease status and treatment, and clinical and health economic outcomes were defined. The model was validated at several levels. The soundness of design and the plausibility of input estimates were evaluated in interdisciplinary meetings (face validity). Individual patients were traced throughout the simulation under a multitude of model settings to debug the model, and the model was run with a variety of extreme scenarios to compare the outcomes with prior expectations (internal validity). Finally, several intermediate (clinical) outcomes of the model were compared with those observed in experimental or observational studies (external validity) and the feasibility of evaluating hypothetical treatment strategies was tested. The model performed well in all validity tests. Analyses of hypothetical treatment strategies took about 30 minutes per cohort and lead to plausible health-economic outcomes. There is added value of DES models in complex treatment strategies such as glaucoma. Achieving transparency in model structure and outcomes may require some effort in reporting and validating the model, but it is feasible.

The Minnesota Multiphasic Personality Inventory-2-RF in Treatment-Seeking Veterans with History of Mild Traumatic Brain Injury.

PubMed

Jurick, S M; Crocker, L D; Keller, A V; Hoffman, S N; Bomyea, J; Jacobson, M W; Jak, A J

2018-05-30

This study examined the Minnesota Multiphasic Personality Inventory-Second Edition-Restructured Form (MMPI-2-RF) to better understand symptom presentation in a sample of treatment-seeking Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans with self-reported history of mild traumatic brain injury (mTBI). Participants underwent a comprehensive clinical neuropsychological battery including performance and symptom validity measures and self-report measures of depressive, posttraumatic, and post-concussive symptomatology. Those with possible symptom exaggeration (SE+) on the MMPI-2-RF were compared with those without (SE-) with regard to injury, psychiatric, validity, and cognitive variables. Between 50% and 87% of participants demonstrated possible symptom exaggeration on one or more MMPI-2-RF validity scales, and a large majority were elevated on content scales related to cognitive, somatic, and emotional complaints. The SE+ group reported higher depressive, posttraumatic, and post-concussive symptomatology, had higher scores on symptom validity measures, and performed more poorly on neuropsychological measures compared with the SE- group. There were no group differences with regard to injury variables or performance validity measures. Participants were more likely to exhibit possible symptom exaggeration on cognitive/somatic compared with traditional psychopathological validity scales. A sizable portion of treatment-seeking OEF/OIF Veterans demonstrated possible symptom exaggeration on MMPI-2-RF validity scales, which was associated with elevated scores on self-report measures and poorer cognitive performance, but not higher rates of performance validity failure, suggesting symptom and performance validity are distinct concepts. These findings have implications for the interpretation of clinical data in the context of possible symptom exaggeration and treatment in Veterans with persistent post-concussive symptoms.

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.

Development of a clinical feeding assessment scale for very young infants in South Africa

PubMed Central

2016-01-01

Background There is a need for validated neonatal feeding assessment instruments in South Africa. A locally developed instrument may contribute to standardised evaluation procedures of high-risk neonates and address needs in resource constrained developing settings. Objective The aim of the study was to develop and validate the content of a clinical feeding assessment scale to diagnose oropharyngeal dysphagia (OPD) in neonates. Method The Neonatal Feeding Assessment Scale (NFAS) was developed using the Delphi method. Five international and South African speech-language therapists (SLTs) formed the expert panel, participating in two rounds of electronic questionnaires to develop and validate the content of the NFAS. Results All participants agreed on the need for the development of a valid clinical feeding assessment instrument to use with the neonatal population. The initial NFAS consisted of 240 items across 8 sections, and after the Delphi process was implemented, the final format was reduced to 211 items across 6 sections. The final format of the NFAS is scored using a binary scoring system guiding the clinician to diagnose the presence or absence of OPD. All members agreed on the format, the scoring system and the feeding constructs addressed in the revised final format of the NFAS. Conclusion The Delphi method and the diverse clinical and research experience of participants could be integrated to develop the NFAS which may be used in clinical practice in South Africa or similar developing contexts. Because of demographically different work settings marked by developed versus developing contexts, participants did not have the same expectations of a clinical dysphagia assessment. The international participants contributed to evidence-based content development. Local participants considered the contextual challenges of South African SLTs entering the field with basic competencies in neonatal dysphagia management, thereby justifying a comprehensive clinical instrument. The NFAS is aimed at clinicians working in Neonatal Intensive Care Units where they manage large caseloads of high-risk neonates. Further validation of the NFAS is recommended to determine its criterion validity in comparison with a widely accepted standard such as the modified barium swallow study. PMID:27796101

The development and psychometric testing of a theory-based instrument to evaluate nurses' perception of clinical reasoning competence.

PubMed

Liou, Shwu-Ru; Liu, Hsiu-Chen; Tsai, Hsiu-Min; Tsai, Ying-Huang; Lin, Yu-Ching; Chang, Chia-Hao; Cheng, Ching-Yu

2016-03-01

The purpose of the study was to develop and psychometrically test the Nurses Clinical Reasoning Scale. Clinical reasoning is an essential skill for providing safe and quality patient care. Identifying pre-graduates' and nurses' needs and designing training courses to improve their clinical reasoning competence becomes a critical task. However, there is no instrument focusing on clinical reasoning in the nursing profession. Cross-sectional design was used. This study included the development of the scale, a pilot study that preliminary tested the readability and reliability of the developed scale and a main study that implemented and tested the psychometric properties of the developed scale. The Nurses Clinical Reasoning Scale was developed based on the Clinical Reasoning Model. The scale includes 15 items using a Likert five-point scale. Data were collected from 2013-2014. Two hundred and fifty-one participants comprising clinical nurses and nursing pre-graduates completed and returned the questionnaires in the main study. The instrument was tested for internal consistency and test-retest reliability. Its validity was tested with content, construct and known-groups validity. One factor emerged from the factor analysis. The known-groups validity was confirmed. The Cronbach's alpha for the entire instrument was 0·9. The reliability and validity of the Nurses Clinical Reasoning Scale were supported. The scale is a useful tool and can be easily administered for the self-assessment of clinical reasoning competence of clinical nurses and future baccalaureate nursing graduates. Study limitations and further recommendations are discussed. © 2015 John Wiley & Sons Ltd.

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.

Validity, Responsiveness, Minimal Detectable Change, and Minimal Clinically Important Change of the Pediatric Motor Activity Log in Children with Cerebral Palsy

ERIC Educational Resources Information Center

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…

Rater reliability and construct validity of a mobile application for posture analysis

PubMed Central

Szucs, Kimberly A.; Brown, Elena V. Donoso

2018-01-01

[Purpose] Measurement of posture is important for those with a clinical diagnosis as well as researchers aiming to understand the impact of faulty postures on the development of musculoskeletal disorders. A reliable, cost-effective and low tech posture measure may be beneficial for research and clinical applications. The purpose of this study was to determine rater reliability and construct validity of a posture screening mobile application in healthy young adults. [Subjects and Methods] Pictures of subjects were taken in three standing positions. Two raters independently digitized the static standing posture image twice. The app calculated posture variables, including sagittal and coronal plane translations and angulations. Intra- and inter-rater reliability were calculated using the appropriate ICC models for complete agreement. Construct validity was determined through comparison of known groups using repeated measures ANOVA. [Results] Intra-rater reliability ranged from 0.71 to 0.99. Inter-rater reliability was good to excellent for all translations. ICCs were stronger for translations versus angulations. The construct validity analysis found that the app was able to detect the change in the four variables selected. [Conclusion] The posture mobile application has demonstrated strong rater reliability and preliminary evidence of construct validity. This application may have utility in clinical and research settings. PMID:29410561

Modified Moral Distress Scale (MDS-11): Validation Study Among Italian Nurses.

PubMed

Badolamenti, Sondra; Fida, Roberto; Biagioli, Valentina; Caruso, Rosario; Zaghini, Francesco; Sili, Alessandro; Rea, Teresa

2017-01-01

Moral distress (MD) has significant implications on individual and organizational health. However there is a lack of an instrument to assess it among Italian nurses. The main aim of this study was to validate a brief instrument to assess MD, developed from the Corley's Moral Distress Scale (MDS). The modified MDS scale was subjected to content and cultural validity. The scale was administered to 347 nurses. Psychometric analysis were performed to assess construct validity. The scale consists of 11 items, investigating MD in nursing practice in different clinical settings. The dimensionality of the scale was investigated through exploratory factor analysis (EFA), which showed a two-dimensional structure labeled futility and potential damage. The futility refers to feelings of powerlessness and ineffectiveness in some clinical situations; the potential damage dimension captures feelings of powerlessness when nurses are forced to tolerate or perform perceived abusive clinical proceedings. Nurses who experienced higher MD, were more lilely to experience burnout. The modified MDS showed good psychometric properties, and it is valid and reliable for assessing moral distress among Italian nurses. Hence, the modified MDS allows to monitor the distress experienced by nurses and it is an important contribution to the scientific community and all those dealing with well-being of health workers.

Development and Psychometric Evaluation of the Hypoglycemia Perspectives Questionnaire in Patients with Type 2 Diabetes Mellitus.

PubMed

Kawata, Ariane K; Wilson, Hilary; Ong, Siew Hwa; Kulich, Karoly; Coyne, Karin

2016-10-01

The aim of this study was to evaluate the factor structure and psychometric characteristics of the Hypoglycemia Perspectives Questionnaire (HPQ) assessing experience and perceptions of hypoglycemia in patients with type 2 diabetes mellitus (T2DM). HPQ was administered to adults with T2DM in a clinical sample from Cyprus (HYPO-Cyprus, n = 500) and a community sample in the United States (US, n = 1257) from the 2011 US National Health and Wellness Survey. Demographic and clinical data were collected. Analysis of HPQ data from two convenience samples examined item performance, factor structure, and HPQ measurement properties (reliability, convergent validity, known-groups validity). Analyses supported three HPQ domains: symptom concern (six items), compensatory behavior (five items), and worry (five items). Internal consistency was high for all three domains (all ≥0.75), supporting reliability. Convergent validity was supported by moderate Spearman correlations between HPQ domain scores and the Audit of Diabetes-Dependent Quality of Life (ADDQoL-19) total score. Patients with recent hypoglycemia events had significantly higher HPQ scores, supporting known-group validity. HPQ may be a valid and reliable measure capturing the experience and impact of hypoglycemia and useful in clinical trials and community-based settings.

Rater reliability and construct validity of a mobile application for posture analysis.

PubMed

Szucs, Kimberly A; Brown, Elena V Donoso

2018-01-01

[Purpose] Measurement of posture is important for those with a clinical diagnosis as well as researchers aiming to understand the impact of faulty postures on the development of musculoskeletal disorders. A reliable, cost-effective and low tech posture measure may be beneficial for research and clinical applications. The purpose of this study was to determine rater reliability and construct validity of a posture screening mobile application in healthy young adults. [Subjects and Methods] Pictures of subjects were taken in three standing positions. Two raters independently digitized the static standing posture image twice. The app calculated posture variables, including sagittal and coronal plane translations and angulations. Intra- and inter-rater reliability were calculated using the appropriate ICC models for complete agreement. Construct validity was determined through comparison of known groups using repeated measures ANOVA. [Results] Intra-rater reliability ranged from 0.71 to 0.99. Inter-rater reliability was good to excellent for all translations. ICCs were stronger for translations versus angulations. The construct validity analysis found that the app was able to detect the change in the four variables selected. [Conclusion] The posture mobile application has demonstrated strong rater reliability and preliminary evidence of construct validity. This application may have utility in clinical and research settings.

Development and Psychometric Evaluation of the HPV Clinical Trial Survey for Parents (CTSP-HPV) Using Traditional Survey Development Methods and Community Engagement Principles.

PubMed

Cunningham, Jennifer; Wallston, Kenneth A; Wilkins, Consuelo H; Hull, Pamela C; Miller, Stephania T

2015-12-01

This study describes the development and psychometric evaluation of HPV Clinical Trial Survey for Parents with Children Aged 9 to 15 (CTSP-HPV) using traditional instrument development methods and community engagement principles. An expert panel and parental input informed survey content and parents recommended study design changes (e.g., flyer wording). A convenience sample of 256 parents completed the final survey measuring parental willingness to consent to HPV clinical trial (CT) participation and other factors hypothesized to influence willingness (e.g., HPV vaccine benefits). Cronbach's a, Spearman correlations, and multiple linear regression were used to estimate internal consistency, convergent and discriminant validity, and predictively validity, respectively. Internal reliability was confirmed for all scales (a ≥ 0.70.). Parental willingness was positively associated (p < 0.05) with trust in medical researchers, adolescent CT knowledge, HPV vaccine benefits, advantages of adolescent CTs (r range 0.33-0.42), supporting convergent validity. Moderate discriminant construct validity was also demonstrated. Regression results indicate reasonable predictive validity with the six scales accounting for 31% of the variance in parents' willingness. This instrument can inform interventions based on factors that influence parental willingness, which may lead to the eventual increase in trial participation. Further psychometric testing is warranted. © 2015 Wiley Periodicals, Inc.

"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 and usefulness.

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.

2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria.

PubMed

Wolfe, Frederick; Clauw, Daniel J; Fitzcharles, Mary-Ann; Goldenberg, Don L; Häuser, Winfried; Katz, Robert L; Mease, Philip J; Russell, Anthony S; Russell, Irwin Jon; Walitt, Brian

2016-12-01

The provisional criteria of the American College of Rheumatology (ACR) 2010 and the 2011 self-report modification for survey and clinical research are widely used for fibromyalgia diagnosis. To determine the validity, usefulness, potential problems, and modifications required for the criteria, we assessed multiple research reports published in 2010-2016 in order to provide a 2016 update to the criteria. We reviewed 14 validation studies that compared 2010/2011 criteria with ACR 1990 classification and clinical criteria, as well as epidemiology, clinical, and databank studies that addressed important criteria-level variables. Based on definitional differences between 1990 and 2010/2011 criteria, we interpreted 85% sensitivity and 90% specificity as excellent agreement. Against 1990 and clinical criteria, the median sensitivity and specificity of the 2010/2011 criteria were 86% and 90%, respectively. The 2010/2011 criteria led to misclassification when applied to regional pain syndromes, but when a modified widespread pain criterion (the "generalized pain criterion") was added misclassification was eliminated. Based on the above data and clinic usage data, we developed a (2016) revision to the 2010/2011 fibromyalgia criteria. Fibromyalgia may now be diagnosed in adults when all of the following criteria are met: CONCLUSIONS: The fibromyalgia criteria have good sensitivity and specificity. This revision combines physician and questionnaire criteria, minimizes misclassification of regional pain disorders, and eliminates the previously confusing recommendation regarding diagnostic exclusions. The physician-based criteria are valid for individual patient diagnosis. The self-report version of the criteria is not valid for clinical diagnosis in individual patients but is valid for research studies. These changes allow the criteria to function as diagnostic criteria, while still being useful for classification. Copyright © 2016 Elsevier Inc. All rights reserved.

Manufacturing validation of biologically functional T cells targeted to CD19 antigen for autologous adoptive cell therapy

PubMed Central

Hollyman, Daniel; Stefanski, Jolanta; Przybylowski, Mark; Bartido, Shirley; Borquez-Ojeda, Oriana; Taylor, Clare; Yeh, Raymond; Capacio, Vanessa; Olszewska, Malgorzata; Hosey, James; Sadelain, Michel; Brentjens, Renier J.; Rivière, Isabelle

2009-01-01

Summary Based on promising pre-clinical data demonstrating the eradication of systemic B cell malignancies by CD19-targeted T lymphocytes in vivo in SCID beige mouse models, we are launching Phase 1 clinical trials in patients with chronic lymphocytic leukemia (CLL) and acute lymphoblastic leukemia (ALL). We present here the validation of the bioprocess we developed for the production and expansion of clinical grade autologous T cells derived from patients with CLL. We demonstrate that T cells genetically modified with a replication-defective gammaretroviral vector derived from the Moloney murine leukemia virus encoding a chimeric antigen receptor (CAR) targeted to CD19 (1928z) can be expanded with Dynabeads® CD3/CD28. This bioprocess allows us to generate clinical doses of 1928z+ T cells in approximately 2 to 3 weeks in a large-scale semi-closed culture system using the Wave bioreactor. These 1928z+ T cells remain biologically functional not only in vitro but also in SCID beige mice bearing disseminated tumors. The validation requirements in terms of T cell expansion, T cell transduction with the 1928z CAR, biological activity, quality control testing and release criteria were met for all four validation runs using apheresis products from patients with CLL. Additionally, following expansion of the T cells, the diversity of the skewed Vβ T cell receptor repertoire was significantly restored. This validated process will be used in phase I clinical trials in patients with chemo-refractory CLL and in patients with relapsed ALL. It can also be adapted for other clinical trials involving the expansion and transduction of patient or donor T cells using any chimeric antigen receptor or T cell receptor. PMID:19238016

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.

Psychometric validation of the Italian Rehabilitation Complexity Scale-Extended version 13

PubMed Central

Agosti, Maurizio; Merlo, Andrea; Maini, Maurizio; Lombardi, Francesco; Tedeschi, Claudio; Benedetti, Maria Grazia; Basaglia, Nino; Contini, Mara; Nicolotti, Domenico; Brianti, Rodolfo

2017-01-01

In Italy, at present, a well-known problem is inhomogeneous provision of rehabilitative services, as stressed by MoH, requiring appropriate criteria and parameters to plan rehabilitation actions. According to the Italian National Rehabilitation Plan, Comorbidity, Disability and Clinical Complexity should be assessed to define the patient’s real needs. However, to date, clinical complexity is still difficult to measure with shared and validated tools. The study aims to psychometrically validate the Italian Rehabilitation Complexity Scale-Extended v13 (RCS-E v13), in order to meet the guidelines requirements. An observational multicentre prospective cohort study, involving 8 intensive rehabilitation facilities of the Emilia-Romagna Region and 1712 in-patients, [823 male (48%) and 889 female (52%), mean age 68.34 years (95% CI 67.69–69.00 years)] showing neurological, orthopaedic and cardiological problems, was carried out. The construct and concurrent validity of the RCS-E v13 was confirmed through its correlation to Barthel Index (disability) and Cumulative Illness Rating Scale (comorbidity) and appropriate admission criteria (not yet published), respectively. Furthermore, the factor analysis indicated two different components (“Basic Care or Risk—Equipment” and “Medical—Nursing Needs and Therapy Disciplines”) of the RCS-E v13. In conclusion, the Italian RCS-E v13 appears to be a useful tool to assess clinical complexity in the Italian rehab scenario case-mix and its psychometric validation may have an important clinical rehabilitation impact allowing the assessment of the rehabilitation needs considering all three dimensions (disability, comorbidity and clinical complexity) as required by the Guidelines and the inhomogeneity could be reduced. PMID:29045409

Design and internal validation of an obstetric early warning score: secondary analysis of the Intensive Care National Audit and Research Centre Case Mix Programme database.

PubMed

Carle, C; Alexander, P; Columb, M; Johal, J

2013-04-01

We designed and internally validated an aggregate weighted early warning scoring system specific to the obstetric population that has the potential for use in the ward environment. Direct obstetric admissions from the Intensive Care National Audit and Research Centre's Case Mix Programme Database were randomly allocated to model development (n = 2240) or validation (n = 2200) sets. Physiological variables collected during the first 24 h of critical care admission were analysed. Logistic regression analysis for mortality in the model development set was initially used to create a statistically based early warning score. The statistical score was then modified to create a clinically acceptable early warning score. Important features of this clinical obstetric early warning score are that the variables are weighted according to their statistical importance, a surrogate for the FI O2 /Pa O2 relationship is included, conscious level is assessed using a simplified alert/not alert variable, and the score, trigger thresholds and response are consistent with the new non-obstetric National Early Warning Score system. The statistical and clinical early warning scores were internally validated using the validation set. The area under the receiver operating characteristic curve was 0.995 (95% CI 0.992-0.998) for the statistical score and 0.957 (95% CI 0.923-0.991) for the clinical score. Pre-existing empirically designed early warning scores were also validated in the same way for comparison. The area under the receiver operating characteristic curve was 0.955 (95% CI 0.922-0.988) for Swanton et al.'s Modified Early Obstetric Warning System, 0.937 (95% CI 0.884-0.991) for the obstetric early warning score suggested in the 2003-2005 Report on Confidential Enquiries into Maternal Deaths in the UK, and 0.973 (95% CI 0.957-0.989) for the non-obstetric National Early Warning Score. This highlights that the new clinical obstetric early warning score has an excellent ability to discriminate survivors from non-survivors in this critical care data set. Further work is needed to validate our new clinical early warning score externally in the obstetric ward environment. Anaesthesia © 2013 The Association of Anaesthetists of Great Britain and Ireland.

Examining the Factor Structure and Psychometric Properties of a Guilt Management Scale (GMS).

PubMed

McIvor, Katy; Degnan, Amy; Pugh, Lauren; Bettney, Laura; Emsley, Richard; Berry, Katherine

2018-06-19

Guilt is commonly associated with distress and psychopathology. However, there is a lack of validated measures that assess how people cope with this aversive emotional and cognitive experience. We therefore developed and validated a self-report measure that assesses how people manage their guilt: the Guilt Management Scale (GMS). The GMS was administered to a non-clinical (n = 339) and clinical (n = 67) sample, alongside other validated measures of guilt severity, coping, thought control and psychological distress. Results from a principal component analysis (PCA) and assessments of test-retest reliability and internal consistency are presented. The PCA yielded a six subscale solution (Self-Punishment, Reparation, People-Focused, Spirituality, Avoidance and Metacognition), accounting for 56.14% of variance. Test-retest reliability and internal consistency was found to be good-excellent for the majority of subscales. Across samples, Self-Punishment was related to higher levels of guilt and distress whilst Metacognition and Reparation were related to less guilt and distress in the non-clinical sample only. This paper provides preliminary evidence for the psychometric properties of the GMS in a non-clinical sample. With development and validation in clinical samples, the GMS could be used to inform psychological formulations of guilt and assess therapy outcomes.

The application and value of information sources in clinical practice: an examination of the perspective of naturopaths.

PubMed

Steel, Amie; Adams, Jon

2011-06-01

The approach of evidence-based medicine (EBM), providing a paradigm to validate information sources and a process for critiquing their value, is an important platform for guiding practice. Researchers have explored the application and value of information sources in clinical practice with regard to a range of health professions; however, naturopathic practice has been overlooked. An exploratory study of naturopaths' perspectives of the application and value of information sources has been undertaken. Semi-structured interviews with 12 naturopaths in current clinical practice, concerning the information sources used in clinical practice and their perceptions of these sources. Thematic analysis identified differences in the application of the variety of information sources used, depending upon the perceived validity. Internet databases were viewed as highly valid. Textbooks, formal education and interpersonal interactions were judged based upon a variety of factors, whilst validation of general internet sites and manufacturers information was required prior to use. The findings of this study will provide preliminary aid to those responsible for supporting naturopaths' information use and access. In particular, it may assist publishers, medical librarians and professional associations in developing strategies to expand the clinically useful information sources available to naturopaths. © 2011 The authors. Health Information and Libraries Journal © 2011 Health Libraries Group.

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.

Drug designs fulfilling the requirements of clinical trials aiming at personalizing medicine

PubMed Central

Mandrekar, Sumithra J.; Sargent, Daniel J.

2014-01-01

In the current era of stratified medicine and biomarker-driven therapies, the focus has shifted from predictions based on the traditional anatomic staging systems to guide the choice of treatment for an individual patient to an integrated approach using the genetic makeup of the tumor and the genotype of the patient. The clinical trial designs utilized in the developmental pathway for biomarkers and biomarker-directed therapies from discovery to clinical practice are rapidly evolving. While several issues need careful consideration, two critical issues that surround the validation of biomarkers are the choice of the clinical trial design (which is based on the strength of the preliminary evidence and marker prevalence), and biomarker assay related issues surrounding the marker assessment methods such as the reliability and reproducibility of the assay. In this review, we focus on trial designs aiming at personalized medicine in the context of early phase trials for initial marker validation, as well as in the context of larger definitive trials. Designs for biomarker validation are broadly classified as retrospective (i.e., using data from previously well-conducted randomized controlled trials (RCTs) versus prospective (enrichment, all-comers, hybrid or adaptive). We believe that the systematic evaluation and implementation of these design strategies are essential to accelerate the clinical validation of biomarker guided therapy. PMID:25414851

[Prescribing monitoring in clinical practice: from enlightened empiricism to rational strategies].

PubMed

Buclin, Thierry; Herzig, Lilli

2013-05-15

Monitoring of a medical condition is the periodic measurement of one or several physiological or biological variables to detect a signal regarding its clinical progression or its response to treatment. We distinguish different medical situations between diagnostic, clinical and therapeutic process to apply monitoring. Many clinical, variables can be used for monitoring, once their intrinsic properties (normal range, critical difference, kinetics, reactivity) and external validity (pathophysiological importance, predictive power for clinical outcomes) are established. A formal conceptualization of monitoring is being developed and should support the rational development of monitoring strategies and their validation through appropriate clinical trials.

Examining the Impact of Unscorable Item Responses on the Validity and Interpretability of MMPI-2/MMPI-2-RF Restructured Clinical (RC) Scale Scores

ERIC Educational Resources Information Center

Dragon, Wendy R.; Ben-Porath, Yossef S.; Handel, Richard W.

2012-01-01

This article examined the impact of unscorable item responses on the psychometric validity and practical interpretability of scores on the Restructured Clinical (RC) Scales of the Minnesota Multiphasic Personality Inventory-2/Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2/MMPI-2-RF). In analyses conducted with five…

Six Years of Comprehensive, Clinical, Performance-Based Assessment Using Standardized Patients at the Southern Illinois University School of Medicine.

ERIC Educational Resources Information Center

Vu, Nu Viet; And Others

1992-01-01

The use of a performance-based assessment of senior medical students' clinical skills utilizing standardized patients was evaluated, with 6,804 student-patient encounters involving 405 students over 6 years. Results provide evidence for test security, content validity, construct validity, reliability, and test ability to discriminate a wide range…

Reliability and Validity of a Measure of Sexual and Physical Abuse Histories among Women with Serious Mental Illness.

ERIC Educational Resources Information Center

Meyer, Ilan H.; And Others

1996-01-01

Structured clinical interviews concerning childhood histories of physical and sexual abuse with 70 mentally ill women at 2 times found test-retest reliability of .63 for physical abuse and .82 for sexual abuse. Validity, assessed as consistency with an independent clinical assessment, showed 75% agreement for physical abuse and 93% agreement for…

NCI Awards 18 Grants to Continue the Early Detection Research Network (EDRN) Biomarkers Effort | Division of Cancer Prevention

Cancer.gov

The NCI has awarded 18 grants to continue the Early Detection Research Network (EDRN), a national infrastructure that supports the integrated development, validation, and clinical application of biomarkers for the early detection of cancer. The awards fund 7 Biomarker Developmental Laboratories, 8 Clinical Validation Centers, 2 Biomarker Reference Laboratories, and a Data

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…

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.

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.

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.

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

PubMed

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

2018-05-01

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

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 clinical use was reduced to a few hours.« less

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; Choi M; McClain DB; Celaya A; Quan SF. Spanish translation and cross-language validation of a Sleep Habits Questionnaire for use in clinical and research settings. J Clin Sleep Med 2012;8(2):137-146. PMID:22505858

The validity and reliability of the sixth-year internal medical examination administered at the King Abdulaziz University Medical College.

PubMed

Fallatah, Hind I; Tekian, Ara; Park, Yoon Soo; Al Shawa, Lana

2015-02-01

Exams are essential components of medical students' knowledge and skill assessment during their clinical years of study. The paper provides a retrospective analysis of validity evidence for the internal medicine component of the written and clinical exams administered in 2012 and 2013 at King Abdulaziz University's Faculty of Medicine. Students' scores for the clinical and written exams were obtained. Four faculty members (two senior members and two junior members) were asked to rate the exam questions, including MCQs and OSCEs, for evidence of content validity using a rating scale of 1-5 for each item. Cronbach's alpha was used to measure the internal consistency reliability. Correlations were used to examine the associations between different forms of assessment and groups of students. A total of 824 students completed the internal medicine course and took the exam. The numbers of rated questions were 320 and 46 for the MCQ and OSCE, respectively. Significant correlations were found between the MCQ section, the OSCE section, and the continuous assessment marks, which include 20 long-case presentations during the course; participation in daily rounds, clinical sessions and tutorials; the performance of simple procedures, such as IV cannulation and ABG extraction; and the student log book. Although the OSCE exam was reliable for the two groups that had taken the final clinical OSCE, the clinical long- and short-case exams were not reliable across the two groups that had taken the oral clinical exams. The correlation analysis showed a significant linear association between the raters with respect to evidence of content validity for both the MCQ and OSCE, r = .219 P < .001 and r = .678 P < .001, respectively, and r = .241 P < .001 and r = .368 P = .023 for the internal structure validity, respectively. Reliability measured using Cronbach's alpha was greater for assessments administered in 2013. The pattern of relationships between the MCQ and OSCE scores provides evidence of the validity of these measures for use in the evaluation of knowledge and clinical skills in internal medicine. The OSCE exam is more reliable than the short- and long-case clinical exams and requires less effort on the part of examiners and patients.

Risk score to predict gastrointestinal bleeding after acute ischemic stroke.

PubMed

Ji, Ruijun; Shen, Haipeng; Pan, Yuesong; Wang, Penglian; Liu, Gaifen; Wang, Yilong; Li, Hao; Singhal, Aneesh B; Wang, Yongjun

2014-07-25

Gastrointestinal bleeding (GIB) is a common and often serious complication after stroke. Although several risk factors for post-stroke GIB have been identified, no reliable or validated scoring system is currently available to predict GIB after acute stroke in routine clinical practice or clinical trials. In the present study, we aimed to develop and validate a risk model (acute ischemic stroke associated gastrointestinal bleeding score, the AIS-GIB score) to predict in-hospital GIB after acute ischemic stroke. The AIS-GIB score was developed from data in the China National Stroke Registry (CNSR). Eligible patients in the CNSR were randomly divided into derivation (60%) and internal validation (40%) cohorts. External validation was performed using data from the prospective Chinese Intracranial Atherosclerosis Study (CICAS). Independent predictors of in-hospital GIB were obtained using multivariable logistic regression in the derivation cohort, and β-coefficients were used to generate point scoring system for the AIS-GIB. The area under the receiver operating characteristic curve (AUROC) and the Hosmer-Lemeshow goodness-of-fit test were used to assess model discrimination and calibration, respectively. A total of 8,820, 5,882, and 2,938 patients were enrolled in the derivation, internal validation and external validation cohorts. The overall in-hospital GIB after AIS was 2.6%, 2.3%, and 1.5% in the derivation, internal, and external validation cohort, respectively. An 18-point AIS-GIB score was developed from the set of independent predictors of GIB including age, gender, history of hypertension, hepatic cirrhosis, peptic ulcer or previous GIB, pre-stroke dependence, admission National Institutes of Health stroke scale score, Glasgow Coma Scale score and stroke subtype (Oxfordshire). The AIS-GIB score showed good discrimination in the derivation (0.79; 95% CI, 0.764-0.825), internal (0.78; 95% CI, 0.74-0.82) and external (0.76; 95% CI, 0.71-0.82) validation cohorts. The AIS-GIB score was well calibrated in the derivation (P = 0.42), internal (P = 0.45) and external (P = 0.86) validation cohorts. The AIS-GIB score is a valid clinical grading scale to predict in-hospital GIB after AIS. Further studies on the effect of the AIS-GIB score on reducing GIB and improving outcome after AIS are warranted.

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.

Resilience in a reborn nation: Validation of the Lithuanian Resilience Scale for Adults (RSA).

PubMed

Hilbig, Jan; Viliūnienė, Rima; Friborg, Oddgeir; Pakalniškienė, Vilmantė; Danilevičiūtė, Vita

2015-07-01

Resilience, as an ability to withstand or rebound from crisis or adversity, is becoming an increasingly significant concept in health promotion and well-being. Individuals exhibiting resilience use skills or resources flexibly to solve situational demands. The Resilience Scale for Adults (RSA) may be used to assess protective resources, and the aim of the present study was to validate the Lithuanian translation. The translated RSA was administered to a clinical (n=125) and a non clinical sample (n=499) to examine the discriminant validity of the RSA items with a confirmatory factor analysis, the internal consistency as well as construct validity by correlating it with the Quick Psycho-Affective Symptoms Scan (QPASS). The internal consistency, the test-retest stability and the factor structure were replicated as adequate, thus indicating good psychometric properties and support of discriminant validity. Females reported more resilience resources for the domains of social competence, family cohesion and social resources compared to men. The RSA subscales correlated negatively with the QPASS scores, and patients reported significantly less resilience resources than non-patients, thus indicating construct validity. Valid psychometric tools for research purposes and routine every-day use are urgently needed in Lithuania, a young nation still under numerous challenges due to social, economic and political transitions. The RSA represents a reliable and valid tool for assessing protective factors. Assessing resilience factors may extend the understanding of factors relevant for mental health problems as well as treatment prognosis beyond the capabilities of mere symptom oriented approaches. Copyright © 2015 Elsevier Inc. All rights reserved.

Single-joint outcome measures: preliminary validation of patient-reported outcomes and physical examination.

PubMed

Heald, Alison E; Fudman, Edward J; Anklesaria, Pervin; Mease, Philip J

2010-05-01

To assess the validity, responsiveness, and reliability of single-joint outcome measures for determining target joint (TJ) response in patients with inflammatory arthritis. Patient-reported outcomes (PRO), consisting of responses to single questions about TJ global status on a 100-mm visual analog scale (VAS; TJ global score), function on a 100-mm VAS (TJ function score), and pain on a 5-point Likert scale (TJ pain score) were piloted in 66 inflammatory arthritis subjects in a phase 1/2 clinical study of an intraarticular gene transfer agent and compared to physical examination measures (TJ swelling, TJ tenderness) and validated function questionnaires (Disabilities of the Arm, Shoulder and Hand scale, Rheumatoid Arthritis Outcome Score, and the Health Assessment Questionnaire). Construct validity was assessed by evaluating the correlation between the single-joint outcome measures and validated function questionnaires using Spearman's rank correlation. Responsiveness or sensitivity to change was assessed through calculating effect size and standardized response means (SRM). Reliability of physical examination measures was assessed by determining interobserver agreement. The single-joint PRO were highly correlated with each other and correlated well with validated functional measures. The TJ global score exhibited modest effect size and modest SRM that correlated well with the patient's assessment of response on a 100-mm VAS. Physical examination measures exhibited high interrater reliability, but correlated less well with validated functional measures and the patient's assessment of response. Single-joint PRO, particularly the TJ global score, are simple to administer and demonstrate construct validity and responsiveness in patients with inflammatory arthritis. (ClinicalTrials.gov identifier NCT00126724).

Psychometric evaluation of the HIV symptom distress scale

PubMed Central

Marc, Linda G.; Wang, Ming-Mei; Testa, Marcia A.

2012-01-01

The objective of this paper is to psychometrically validate the HIV Symptom Distress Scale (SDS), an instrument that can be used to measure overall HIV symptom distress or clinically relevant groups of HIV symptoms. A secondary data analysis was conducted using the Collaborations in HIV Outcomes Research U.S. Cohort (CHORUS). Inclusion criteria required study participants (N=5,521) to have a valid baseline measure of the AIDS Clinical Trial Group Symptom Distress Module, with an SF-12 or SF-36 completed on the same day. Psychometric testing assessed unidimensionality, internal consistency and factor structure using exploratory and confirmatory factor analysis, and structural equation modeling (SEM). Construct validity examined whether the new measure discriminates across clinical significance (CD4 and HIV viral load). Findings show that the SDS has high reliability (α=0.92), and SEM supports a correlated second-order factor model (physical and mental distress) with acceptable fit (GFI=0.88, AGFI=0.85, NFI=0.99, NNFI=0.99; RMSEA=0.06, [90% CI 0.06 – 0.06]; Satorra Bentler Scaled, C2 =3274.20; p=0.0). Construct validity shows significant differences across categories for HIV-1 viral load (p< 0.001) and CD4 (p< 0.001). Differences in mean SDS scores exist across gender (p< 0.001), race/ethnicity (p< 0.05) and educational attainment (p < 0.001). Hence, the HIV Symptom Distress Scale is a reliable and valid instrument, which measures overall HIV symptoms or clinically relevant groups of symptoms. PMID:22409246

Development and validation of a measure of pediatric oral health-related quality of life: the POQL

PubMed Central

Huntington, Noelle L; Spetter, Dante; Jones, Judith A.; Rich, Sharon E.; Garcia, Raul I.; Spiro, Avron

2011-01-01

Objective To develop a brief measure of oral health-related quality of life in children and demonstrate its reliability and validity in a diverse population. Methods We administered the initial 20-item POQL to children (Child Self-Report) and parents (Parent Report on Child) from diverse populations in both school-based and clinic-based settings. Clinical oral health status was measured on a subset of children. We used factor analysis to determine the underlying scales and then reduced the measure to 10 items based on several considerations. Multitrait analysis on the resulting 10-item POQL was used to reaffirm the discrimination of scales and assess the measure’s internal consistency and interscale correlations. We established discriminant and convergent validity with clinical status, perceived oral health and responses on the PedsQL and determined sensitivity to change with children undergoing ECC surgical repair. Results Factor analysis returned a four-scale solution for the initial items – Physical Functioning, Role Functioning, Social Functioning and Emotional Functioning. The reduced items represented the same four scales – two each on Physical and Role and three each on Social and Emotional. Good reliability and validity were shown for the POQL as a whole and for each of the scales. Conclusions The POQL is a valid and reliable measure of oral health-related quality of life for use in pre-school and school-aged children, with high utility for both clinical assessments and large-scale population studies. PMID:21972458

Assessing young children's intention-reading in authentic communicative contexts: preliminary evidence and clinical utility.

PubMed

Greenslade, Kathryn J; Coggins, Truman E

2014-01-01

Identifying what a communication partner is looking at (referential intention) and why (social intention) is essential to successful social communication, and may be challenging for children with social communication deficits. This study explores a clinical task that assesses these intention-reading abilities within an authentic context. To gather evidence of the task's reliability and validity, and to discuss its clinical utility. The intention-reading task was administered to twenty 4-7-year-olds with typical development (TD) and ten with autism spectrum disorder (ASD). Task items were embedded in an authentic activity, and they targeted the child's ability to identify the examiner's referential and social intentions, which were communicated through joint attention behaviours. Reliability and construct validity evidence were addressed using established psychometric methods. Reliability and validity evidence supported the use of task scores for identifying children whose intention-reading warranted concern. Evidence supported the reliability of task administration and coding, and item-level codes were highly consistent with overall task performance. Supporting task validity, group differences aligned with predictions, with children with ASD exhibiting poorer and more variable task scores than children with TD. Also, as predicted, task scores correlated significantly with verbal mental age and ratings of parental concerns regarding social communication abilities. The evidence provides preliminary support for the reliability and validity of the clinical task's scores in assessing young children's real-time intention-reading abilities, which are essential for successful interactions in school and beyond. © 2014 Royal College of Speech and Language Therapists.

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.

Development and validation of a measure of pediatric oral health-related quality of life: the POQL.

PubMed

Huntington, Noelle L; Spetter, Dante; Jones, Judith A; Rich, Sharron E; Garcia, Raul I; Spiro, Avron

2011-01-01

To develop a brief measure of oral health-related quality of life (OHQL) in children and demonstrate its reliability and validity in a diverse population. We administered the initial 20-item Pediatric Oral Health-Related Quality of Life (POQL) to children (Child Self-Report) and parents (Parent Report on Child) from diverse populations in both school-based and clinic-based settings. Clinical oral health status was measured on a subset of children. We used factor analysis to determine the underlying scales and then reduced the measure to 10 items based on several considerations. Multitrait analysis on the resulting 10-item POQL was used to reaffirm the discrimination of scales and assess the measure's internal consistency and interscale correlations. We established discriminant and convergent validity with clinical status, perceived oral health and responses on the PedsQL, and determined sensitivity to change with children undergoing ECC surgical repair. Factor analysis returned a four-scale solution for the initial items--Physical Functioning, Role Functioning, Social Functioning, and Emotional Functioning. The reduced items represented the same four scales--two each on Physical and Role and three each on Social and Emotional. Good reliability and validity were shown for the POQL as a whole and for each of the scales. The POQL is a valid and reliable measure of OHQL for use in preschool and school-aged children, with high utility for both clinical assessments and large-scale population studies.

Reliability, validity, and utility of the Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF) in assessments of bariatric surgery candidates.

PubMed

Tarescavage, Anthony M; Wygant, Dustin B; Boutacoff, Lana I; Ben-Porath, Yossef S

2013-12-01

In the current study, we examined the reliability, validity, and clinical utility of Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF; Ben-Porath & Tellegen, 2011) scores in a sample of 759 bariatric surgery candidates. We provide descriptives for all scales, internal consistency and standard error of measurement estimates for all substantive scales, external correlates of substantive scales using chart review and self-report criteria, and relative risk ratios to assess the clinical utility of the instrument. Results generally support the reliability, validity, and clinical utility of MMPI-2-RF scale scores in the psychological evaluation of bariatric surgery candidates. Limitations, future directions, and practical application of these results are discussed. (c) 2013 APA, all rights reserved.

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.

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.

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.

Validation and Diagnostic Efficiency of the Mini-SPIN in Spanish-Speaking Adolescents

PubMed Central

Garcia-Lopez, LuisJoaquín; Moore, Harry T. A.

2015-01-01

Objectives Social Anxiety Disorder (SAD) is one of the most common mental disorders in adolescence. Many validated psychometric tools are available to diagnose individuals with SAD efficaciously. However, there is a demand for shortened self-report instruments that identify adolescents at risk of developing SAD. We validate the Mini-SPIN and its diagnostic efficiency in overcoming this problem in Spanish-speaking adolescents in Spain. Methods The psychometric properties of the 3-item Mini-SPIN scale for adolescents were assessed in a community (study 1) and clinical sample (study 2). Results Study 1 consisted of 573 adolescents, and found the Mini-SPIN to have appropriate internal consistency and high construct validity. Study 2 consisted of 354 adolescents (147 participants diagnosed with SAD and 207 healthy controls). Data revealed that the Mini-SPIN has good internal consistency, high construct validity and adequate diagnostic efficiency. Conclusions Our findings suggest that the Mini-SPIN has good psychometric properties on clinical and healthy control adolescents and general population, which indicates that it can be used as a screening tool in Spanish-speaking adolescents. Cut-off scores are provided. PMID:26317695

Validation of Metagenomic Next-Generation Sequencing Tests for Universal Pathogen Detection.

PubMed

Schlaberg, Robert; Chiu, Charles Y; Miller, Steve; Procop, Gary W; Weinstock, George

2017-06-01

- Metagenomic sequencing can be used for detection of any pathogens using unbiased, shotgun next-generation sequencing (NGS), without the need for sequence-specific amplification. Proof-of-concept has been demonstrated in infectious disease outbreaks of unknown causes and in patients with suspected infections but negative results for conventional tests. Metagenomic NGS tests hold great promise to improve infectious disease diagnostics, especially in immunocompromised and critically ill patients. - To discuss challenges and provide example solutions for validating metagenomic pathogen detection tests in clinical laboratories. A summary of current regulatory requirements, largely based on prior guidance for NGS testing in constitutional genetics and oncology, is provided. - Examples from 2 separate validation studies are provided for steps from assay design, and validation of wet bench and bioinformatics protocols, to quality control and assurance. - Although laboratory and data analysis workflows are still complex, metagenomic NGS tests for infectious diseases are increasingly being validated in clinical laboratories. Many parallels exist to NGS tests in other fields. Nevertheless, specimen preparation, rapidly evolving data analysis algorithms, and incomplete reference sequence databases are idiosyncratic to the field of microbiology and often overlooked.

Spanish adaptation of the Gambling Motives Questionnaire (GMQ): Validation in adult pathological gamblers and relationship with anxious-depressive symptomatology and perceived stress.

PubMed

Jauregui, Paula; Estevez, Ana; Onaindia, Jaione

2018-10-01

Gambling has been found to be related to different motives, such as enhancement, social, and behavioral and emotional coping. The most used instrument in this field is the Gambling Motives Questionnaire (GMQ; Stewart & Zack, 2008), which has not been validated in clinical samples. This study aimed to validate a Spanish version of the GMQ in a sample of adult pathological gamblers and to analyze its relationship with pathological gambling, anxiety, depression, and perceived stress. A sample of 164 gamblers was recruited from centers for the treatment of pathological gambling. The three-factor structure (enhancement, social, and coping motives) of the GMQ was validated through exploratory and confirmatory factorial analyses, and its convergent validity was proven. Gambling motives correlated with pathological gambling, anxiety, depression, and perceived stress. Enhancement motives predicted pathological gambling, while controlling for the effect of anxiety, depression, and perceived stress. These results are relevant for clinical evaluation and intervention with adult pathological gamblers. Copyright © 2018 Elsevier Ltd. All rights reserved.

External validation of the Cairns Prediction Model (CPM) to predict conversion from laparoscopic to open cholecystectomy.

PubMed

Hu, Alan Shiun Yew; Donohue, Peter O'; Gunnarsson, Ronny K; de Costa, Alan

2018-03-14

Valid and user-friendly prediction models for conversion to open cholecystectomy allow for proper planning prior to surgery. The Cairns Prediction Model (CPM) has been in use clinically in the original study site for the past three years, but has not been tested at other sites. A retrospective, single-centred study collected ultrasonic measurements and clinical variables alongside with conversion status from consecutive patients who underwent laparoscopic cholecystectomy from 2013 to 2016 in The Townsville Hospital, North Queensland, Australia. An area under the curve (AUC) was calculated to externally validate of the CPM. Conversion was necessary in 43 (4.2%) out of 1035 patients. External validation showed an area under the curve of 0.87 (95% CI 0.82-0.93, p = 1.1 × 10 -14 ). In comparison with most previously published models, which have an AUC of approximately 0.80 or less, the CPM has the highest AUC of all published prediction models both for internal and external validation. Crown Copyright © 2018. Published by Elsevier Inc. All rights reserved.

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.

Validation and Diagnostic Efficiency of the Mini-SPIN in Spanish-Speaking Adolescents.

PubMed

Garcia-Lopez, LuisJoaquín; Moore, Harry T A

2015-01-01

Social Anxiety Disorder (SAD) is one of the most common mental disorders in adolescence. Many validated psychometric tools are available to diagnose individuals with SAD efficaciously. However, there is a demand for shortened self-report instruments that identify adolescents at risk of developing SAD. We validate the Mini-SPIN and its diagnostic efficiency in overcoming this problem in Spanish-speaking adolescents in Spain. The psychometric properties of the 3-item Mini-SPIN scale for adolescents were assessed in a community (study 1) and clinical sample (study 2). Study 1 consisted of 573 adolescents, and found the Mini-SPIN to have appropriate internal consistency and high construct validity. Study 2 consisted of 354 adolescents (147 participants diagnosed with SAD and 207 healthy controls). Data revealed that the Mini-SPIN has good internal consistency, high construct validity and adequate diagnostic efficiency. Our findings suggest that the Mini-SPIN has good psychometric properties on clinical and healthy control adolescents and general population, which indicates that it can be used as a screening tool in Spanish-speaking adolescents. Cut-off scores are provided.

Open source posturography.

PubMed

Rey-Martinez, Jorge; Pérez-Fernández, Nicolás

2016-12-01

The proposed validation goal of 0.9 in intra-class correlation coefficient was reached with the results of this study. With the obtained results we consider that the developed software (RombergLab) is a validated balance assessment software. The reliability of this software is dependent of the used force platform technical specifications. Develop and validate a posturography software and share its source code in open source terms. Prospective non-randomized validation study: 20 consecutive adults underwent two balance assessment tests, six condition posturography was performed using a clinical approved software and force platform and the same conditions were measured using the new developed open source software using a low cost force platform. Intra-class correlation index of the sway area obtained from the center of pressure variations in both devices for the six conditions was the main variable used for validation. Excellent concordance between RombergLab and clinical approved force platform was obtained (intra-class correlation coefficient =0.94). A Bland and Altman graphic concordance plot was also obtained. The source code used to develop RombergLab was published in open source terms.

Standard Specimen Reference Set: Colon — EDRN Public Portal

Cancer.gov

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

Incremental validity of the Minnesota Multiphasic Personality Inventory-2 and symptom checklist-90-revised with mental health inpatients.

PubMed

Simonds, Elise C; Handel, Richard W; Archer, Robert P

2008-03-01

This study evaluated the incremental validity of scores from the Minnesota Multiphasic Personality Inventory-2 (MMPI-2) and the Symptom Checklist-90-Revised (SCL-90-R) in a sample of mental health inpatients originally published by Archer, Griffin, and Aiduk (1995). The incremental validity of scores from the SCL-90-R primary symptom dimensions and MMPI-2 Clinical, Content, and Restructured Clinical scales was assessed in a sample of 544 mental health inpatients using conceptually related items from the Brief Psychiatric Rating Scale (BPRS) as criteria. A series of hierarchical multiple regressions indicated that scores from the SCL-90-R primary symptom dimensions exhibited limited incremental validity (Mdn DeltaR(2) = .01, range = 0-.01), whereas scores from MMPI-2 scales contributed additional information in the prediction of ratings on all but one BPRS item (Mdn DeltaR( 2) = .08, range = .04-.12).

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.

Development and validation of a UPLC-MS/MS method for simultaneous determination of fotagliptin and its two major metabolites in human plasma and urine.

PubMed

Wang, Zhenlei; Jiang, Ji; Hu, Pei; Zhao, Qian

2017-02-01

Fotagliptin is a novel dipeptidyl peptidase IV inhibitor under clinical development for the treatment of Type II diabetes mellitus. The objective of this study was to develop and validate a specific and sensitive ultra-performance liquid chromatography (UPLC)-MS/MS method for simultaneous determination of fotagliptin and its two major metabolites in human plasma and urine. Methodology & results: After being pretreated using an automatized procedure, the plasma and urine samples were separated and detected using a UPLC-ESI-MS/MS method, which was validated following the international guidelines. A selective and sensitive UPLC-MS/MS method was first developed and validated for quantifying fotagliptin and its metabolite in human plasma and urine. The method was successfully applied to support the clinical study of fotagliptin in Chinese healthy subjects.

[Modeling in value-based medicine].

PubMed

Neubauer, A S; Hirneiss, C; Kampik, A

2010-03-01

Modeling plays an important role in value-based medicine (VBM). It allows decision support by predicting potential clinical and economic consequences, frequently combining different sources of evidence. Based on relevant publications and examples focusing on ophthalmology the key economic modeling methods are explained and definitions are given. The most frequently applied model types are decision trees, Markov models, and discrete event simulation (DES) models. Model validation includes besides verifying internal validity comparison with other models (external validity) and ideally validation of its predictive properties. The existing uncertainty with any modeling should be clearly stated. This is true for economic modeling in VBM as well as when using disease risk models to support clinical decisions. In economic modeling uni- and multivariate sensitivity analyses are usually applied; the key concepts here are tornado plots and cost-effectiveness acceptability curves. Given the existing uncertainty, modeling helps to make better informed decisions than without this additional information.

The quest for fragile X biomarkers.

PubMed

Westmark, Cara J

2014-12-01

Fragile X is the most common form of inherited intellectual disability and the leading known genetic cause of autism. There is currently no cure or approved medication for fragile X although various drugs target specific disease symptoms and a large number of therapeutics are in various stages of clinical development. Multiple recent clinical trials have failed on their primary endpoints indicating that there is a compelling need for validated biomarkers and outcome measures in fragile X. There are currently no validated blood-based biomarkers to assess disease severity or to monitor drug efficacy in fragile X syndrome. Herein, we review candidate blood protein biomarkers including extracellular-regulated kinase, phosphoinositide 3-kinase, matrix metalloproteinase 9, amyloid-beta and amyloid-beta protein precursor. Bench-to-bedside plans for fragile X syndrome are severely limited by the lack of validated outcome measures. The reviewed candidate biomarkers are at early stages of validation and deserve further investigation.

aMAP is a validated pipeline for registration and segmentation of high-resolution mouse brain data

PubMed Central

Niedworok, Christian J.; Brown, Alexander P. Y.; Jorge Cardoso, M.; Osten, Pavel; Ourselin, Sebastien; Modat, Marc; Margrie, Troy W.

2016-01-01

The validation of automated image registration and segmentation is crucial for accurate and reliable mapping of brain connectivity and function in three-dimensional (3D) data sets. While validation standards are necessarily high and routinely met in the clinical arena, they have to date been lacking for high-resolution microscopy data sets obtained from the rodent brain. Here we present a tool for optimized automated mouse atlas propagation (aMAP) based on clinical registration software (NiftyReg) for anatomical segmentation of high-resolution 3D fluorescence images of the adult mouse brain. We empirically evaluate aMAP as a method for registration and subsequent segmentation by validating it against the performance of expert human raters. This study therefore establishes a benchmark standard for mapping the molecular function and cellular connectivity of the rodent brain. PMID:27384127

Validation of Procedures for Monitoring Crewmember Immune Function - Short Duration Biological Investigation

NASA Technical Reports Server (NTRS)

Sams, Clarence; Crucian, Brian; Stowe, Raymond; Pierson, Duane; Mehta, Satish; Morukov, Boris; Uchakin, Peter; Nehlsen-Cannarella, Sandra

2008-01-01

Validation of Procedures for Monitoring Crew Member Immune Function - Short Duration Biological Investigation (Integrated Immune-SDBI) will assess the clinical risks resulting from the adverse effects of space flight on the human immune system and will validate a flightcompatible immune monitoring strategy. Immune system changes will be monitored by collecting and analyzing blood, urine and saliva samples from crewmembers before, during and after space flight.

The City of Hope-Quality of Life-Ostomy Questionnaire: Persian Translation and Validation

PubMed Central

Anaraki, F; Vafaie, M; Behboo, R; Esmaeilpour, S; Maghsoodi, N; Safaee, A; Grant, M

2014-01-01

Background: Since there is no disease-specific instrument for measuring quality-of-life (QOL) in Ostomy patients in Persian language. Aim: This study was designed to translate and evaluate the validity and reliability of City of Hope-quality of life-Ostomy questionnaire (COH-QOL-Ostomy questionnaire). Subjects and Methods: This study was designed as cross-sectional study. Reliability of the subscales and the summary scores were demonstrated by intra-class correlation coefficients. Pearson's correlations of an item with its own scale and other scales were calculated to evaluated convergent and discriminant validity. Clinical validity was also evaluated by known-group comparisons. Results: Cronbach's alpha coefficient for all subscales was about 0.70 or higher. Results of interscale correlation were satisfactory and each subscale only measured a single and specified trait. All subscales met the standards of convergent and discriminant validity. Known group comparison analysis showed significant differences in social and spiritual well-being. Conclusion: The findings confirmed the reliability and validity of Persian version of COH-QOL-Ostomy questionnaire. The instrument was also well received by the Iranian patients. It can be considered as a valuable instrument to assess the different aspects of health related quality-of-life in Ostomy patients and used in clinical research in the future. PMID:25221719

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.

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

Knowledge and skills of cancer clinical trials nurses in Australia.

PubMed

Scott, Kathleen; White, Kate; Johnson, Catherine; Roydhouse, Jessica K

2012-05-01

  This paper is a report of the development and testing of a questionnaire measuring knowledge and skills of cancer clinical trials nurse in Australia.   The role of cancer clinical trials nurse, widely acknowledged as an integral member of the clinical research team, has evolved in recent years. Elements of the clinical trials nurse role in cancer have previously been described. To evaluate specific cancer clinical trials nurse educational and training needs, the development of a valid and reliable tool is required.   In 2009, a study was conducted in three stages. Stage I: questionnaire development and pilot testing; stage II: focus group; stage III: national survey. Internal consistency reliability testing and multi-trait analysis of item convergent/divergent validity were employed. Regression analysis was used to identify predictors of clinical trials nurse knowledge and skills.   The national survey was a 48-item questionnaire, measuring six clinical trial knowledge and seven skills sub-scales. Of 61 respondents, 90% were women, with mean age 43 years, 19 years as a Registered Nurse and 5 years as a cancer clinical trials nurse. Self-reported knowledge and skills were satisfactory to good. Internal consistency reliability was high (Cronbach's alpha: knowledge = 0·98; skills = 0·90). Criteria for item convergent/divergent validity were met. Number of years as cancer clinical trials nurse was positively related to self-reported knowledge and skills.   Preliminary data suggest that the national survey is reliable and valid. Data have contributed to better understanding the knowledge and skills of cancer clinical trials nurse in Australia and development of a postgraduate course in clinical trials. © 2011 Blackwell Publishing Ltd.

Development and psychometric evaluation of a clinical global impression for schizoaffective disorder scale.

PubMed

Allen, Michael H; Daniel, David G; Revicki, Dennis A; Canuso, Carla M; Turkoz, Ibrahim; Fu, Dong-Jing; Alphs, Larry; Ishak, K Jack; Bartko, John J; Lindenmayer, Jean-Pierre

2012-01-01

The Clinical Global Impression for Schizoaffective Disorder scale is a new rating scale adapted from the Clinical Global Impression scale for use in patients with schizoaffective disorder. The psychometric characteristics of the Clinical Global Impression for Schizoaffective Disorder are described. Content validity was assessed using an investigator questionnaire. Inter-rater reliability was determined with 12 sets of videotaped interviews rated independently by two trained individuals. Test-retest reliability was assessed using 30 randomly selected raters from clinical trials who evaluated the same videos on separate occasions two weeks apart. Convergent and divergent validity and effect size were evaluated by comparing scores between the Clinical Global Impression for Schizoaffective Disorder and the Positive and Negative Syndrome Scale, 21-item Hamilton Rating Scale for Depression, and Young Mania Rating Scale scales using pooled patient data from two clinical trials. Clinical Global Impression for Schizoaffective Disorder scores were then linked to corresponding Positive and Negative Syndrome Scale scores. Content validity was strong. Inter-rater agreement was good to excellent for most scales and subscales (intra-class correlation coefficient ≥ 0.50). Test-retest showed good reproducibility, with intraclass correlation coefficients ranging from 0.444 to 0.898. Spearman correlations between Clinical Global Impression for Schizoaffective Disorder domains and corresponding symptom scales were 0.60 or greater, and effect sizes for Clinical Global Impression for Schizoaffective Disorder overall and domain scores were similar to Positive and Negative Syndrome Scale Young Mania Rating Scale, and 21-item Hamilton Rating Scale for Depression scores. Raters anticipated that the scale might be less effective in distinguishing negative from depressive symptoms, and, in fact, the results here may reflect that clinical reality. Multiple lines of evidence support the reliability and validity of the Clinical Global Impression for Schizoaffective Disorder for studies in schizoaffective disorder.

The Importance of Considering Clinical Utility in the Construction of a Diagnostic Manual.

PubMed

Mullins-Sweatt, Stephanie N; Lengel, Gregory J; DeShong, Hilary L

2016-01-01

The development of major diagnostic manuals primarily has been guided by construct validity rather than clinical utility. The purpose of this article is to summarize recent research and theory examining the importance of clinical utility when constructing and evaluating a diagnostic manual. We suggest that construct validity is a necessary but not sufficient criterion for diagnostic constructs. This article discusses components of clinical utility and how these have applied to the current and forthcoming diagnostic manuals. Implications and suggestions for future research are provided.

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.

Adaptation of clinical prediction models for application in local settings.

PubMed

Kappen, Teus H; Vergouwe, Yvonne; van Klei, Wilton A; van Wolfswinkel, Leo; Kalkman, Cor J; Moons, Karel G M

2012-01-01

When planning to use a validated prediction model in new patients, adequate performance is not guaranteed. For example, changes in clinical practice over time or a different case mix than the original validation population may result in inaccurate risk predictions. To demonstrate how clinical information can direct updating a prediction model and development of a strategy for handling missing predictor values in clinical practice. A previously derived and validated prediction model for postoperative nausea and vomiting was updated using a data set of 1847 patients. The update consisted of 1) changing the definition of an existing predictor, 2) reestimating the regression coefficient of a predictor, and 3) adding a new predictor to the model. The updated model was then validated in a new series of 3822 patients. Furthermore, several imputation models were considered to handle real-time missing values, so that possible missing predictor values could be anticipated during actual model use. Differences in clinical practice between our local population and the original derivation population guided the update strategy of the prediction model. The predictive accuracy of the updated model was better (c statistic, 0.68; calibration slope, 1.0) than the original model (c statistic, 0.62; calibration slope, 0.57). Inclusion of logistical variables in the imputation models, besides observed patient characteristics, contributed to a strategy to deal with missing predictor values at the time of risk calculation. Extensive knowledge of local, clinical processes provides crucial information to guide the process of adapting a prediction model to new clinical practices.

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.

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

PubMed

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

2018-02-01

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

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

PubMed

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

2010-05-01

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

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

Are United States Medical Licensing Exam Step 1 and 2 scores valid measures for postgraduate medical residency selection decisions?

PubMed

McGaghie, William C; Cohen, Elaine R; Wayne, Diane B

2011-01-01

United States Medical Licensing Examination (USMLE) scores are frequently used by residency program directors when evaluating applicants. The objectives of this report are to study the chain of reasoning and evidence that underlies the use of USMLE Step 1 and 2 scores for postgraduate medical resident selection decisions and to evaluate the validity argument about the utility of USMLE scores for this purpose. This is a research synthesis using the critical review approach. The study first describes the chain of reasoning that underlies a validity argument about using test scores for a specific purpose. It continues by summarizing correlations of USMLE Step 1 and 2 scores and reliable measures of clinical skill acquisition drawn from nine studies involving 393 medical learners from 2005 to 2010. The integrity of the validity argument about using USMLE Step 1 and 2 scores for postgraduate residency selection decisions is tested. The research synthesis shows that USMLE Step 1 and 2 scores are not correlated with reliable measures of medical students', residents', and fellows' clinical skill acquisition. The validity argument about using USMLE Step 1 and 2 scores for postgraduate residency selection decisions is neither structured, coherent, nor evidence based. The USMLE score validity argument breaks down on grounds of extrapolation and decision/interpretation because the scores are not associated with measures of clinical skill acquisition among advanced medical students, residents, and subspecialty fellows. Continued use of USMLE Step 1 and 2 scores for postgraduate medical residency selection decisions is discouraged.

Validation of the Older Adult Social Evaluative Scale (OASES) as a measure of social anxiety.

PubMed

Kok, Brian C; Ma, Vanessa K; Gould, Christine E

2018-03-21

Social anxiety disorder (SAD) (formerly called social phobia) is among the most common mental health diagnoses among older adults; however, the research on late-life social anxiety is scarce. A limited number of studies have examined the assessment and diagnosis of social anxiety disorder in this population, and there are few social anxiety measures that are validated for use with older adults. One such measure, the Older Adult Social Evaluative Scale (OASES), was designed for use with this population, but until now has lacked validation against a gold-standard diagnostic interview. Using a sample of 47 community-dwelling older adults (aged 60 years and over) with anxiety, the present study compared OASES performance to that of the Structured Clinical Interview for DSM-5 Disorders (SCID-5), as well as other measures of anxiety and depression. The OASES demonstrated convergent validity with other measures of anxiety, and demonstrated discriminant validity on other measures (e.g. depression, somatic symptoms). Receiver operating characteristic (ROC) analysis revealed that a cut-point of ≥76 optimized sensitivity and specificity compared to SCID-5 derived diagnoses of social anxiety disorder. This study is the first study to provide psychometric validation for the OASES and one of the first to administer the SCID-5 to an older adult sample. In addition to establishing a clinically significant cut-off, this study also describes the clinical utility of the OASES, which can be used to identify distressing situations, track anxiety severity, and monitor behavioral avoidance across a variety of social situations.

Development and psychometric characteristics of a new domain of the stanford faculty development program instrument.

PubMed

Owolabi, Mayowa O

2014-01-01

Teacher's attitude domain, a pivotal aspect of clinical teaching, is missing in the Stanford Faculty Development Program Questionnaire (SFDPQ), the most widely used student-based assessment method of clinical teaching skills. This study was conducted to develop and validate the teacher's attitude domain and evaluate the validity and internal consistency reliability of the augmented SFDPQ. Items generated for the new domain included teacher's enthusiasm, sobriety, humility, thoroughness, empathy, and accessibility. The study involved 20 resident doctors assessed once by 64 medical students using the augmented SFDPQ. Construct validity was explored using correlation among the different domains and a global rating scale. Factor analysis was performed. The response rate was 94%. The new domain had a Cronbach's alpha of 0.89, with 1-factor solution explaining 57.1% of its variance. It showed the strongest correlation to the global rating scale (rho = 0.71). The augmented SFDPQ, which had a Cronbach's alpha of 0.93, correlated better (rho = 0.72, p < 0.00001) to the global rating scale than the original SFDPQ (rho = 0.67, p < 0.00001). The new teacher's attitude domain exhibited good internal consistency and construct and factorial validity. It enhanced the content and construct validity of the SFDPQ. The validated construct of the augmented SFDPQ is recommended for design and evaluation of basic and continuing clinical teaching programs. © 2014 The Alliance for Continuing Education in the Health Professions, the Society for Academic Continuing Medical Education, and the Council on Continuing Medical Education, Association for Hospital Medical Education.

Validity of a novel computerized screening test system for mild cognitive impairment.

PubMed

Park, Jin-Hyuck; Jung, Minye; Kim, Jongbae; Park, Hae Yean; Kim, Jung-Ran; Park, Ji-Hyuk

2018-06-20

ABSTRACTBackground:The mobile screening test system for screening mild cognitive impairment (mSTS-MCI) was developed for clinical use. However, the clinical usefulness of mSTS-MCI to detect elderly with MCI from those who are cognitively healthy has yet to be validated. Moreover, the comparability between this system and traditional screening tests for MCI has not been evaluated. The purpose of this study was to examine the validity and reliability of the mSTS-MCI and confirm the cut-off scores to detect MCI. The data were collected from 107 healthy elderly people and 74 elderly people with MCI. Concurrent validity was examined using the Korean version of Montreal Cognitive Assessment (MoCA-K) as a gold standard test, and test-retest reliability was investigated using 30 of the study participants at four-week intervals. The sensitivity, specificity, positive predictive value, and negative predictive value (NPV) were confirmed through Receiver Operating Characteristic (ROC) analysis, and the cut-off scores for elderly people with MCI were identified. Concurrent validity showed statistically significant correlations between the mSTS-MCI and MoCA-K and test-rests reliability indicated high correlation. As a result of screening predictability, the mSTS-MCI had a higher NPV than the MoCA-K. The mSTS-MCI was identified as a system with a high degree of validity and reliability. In addition, the mSTS-MCI showed high screening predictability, indicating it can be used in the clinical field as a screening test system for mild cognitive impairment.

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.…

Validity of the Children's Social Behavior Questionnaire (CSBQ) in Children with Intellectual Disability: Comparing the CSBQ with ADI-R, ADOS, and Clinical DSM-IV-TR Classification

ERIC Educational Resources Information Center

de Bildt, Annelies; Mulder, Erik J.; Hoekstra, Pieter J.; van Lang, Natasja D. J.; Minderaa, Ruud B.; Hartman, Catharina A.

2009-01-01

The Children's Social Behavior Questionnaire (CSBQ) was compared with the Autism Diagnostic Interview-Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS), and clinical classification in children with mild and moderate intellectual disability (ID), to investigate its criterion related validity. The contribution of the CSBQ to a…

The Investigation of ADHD Prevalence in Kindergarten Children in Northeast Iran and a Determination of the Criterion Validity of Conners' Questionnaire via Clinical Interview

ERIC Educational Resources Information Center

Abdekhodaie, Zahra; Tabatabaei, Seyed Mahmood; Gholizadeh, Mortaza

2012-01-01

In this study, the prevalence of attention-deficit hyperactivity disorder (ADHD) in kindergarten children in northeast Iran was investigated, and the criterion validity of Conners' parent-teacher questionnaire was evaluated through the use of clinical interviews. This study was a cross-sectional descriptive research project with children in…

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…

Establishing the Validity of the Affirmative Training Inventory: Assessing the Relationship between Lesbian, Gay, and Bisexual Affirmative Training and Students' Clinical Competence

ERIC Educational Resources Information Center

Carlson, Thomas Stone; McGeorge, Christi R.; Toomey, Russell B.

2013-01-01

This study established the validity and factor structure of the Affirmative Training Inventory (ATI; T. S. Carlson, C. R. McGeorge & M. Rock, unpublished) as a measure of lesbian, gay, and bisexual (LGB) affirmative clinical training. Additionally, this study examined the latent associations among the subscales of the ATI and the Sexual…

Clinical Risk Score for Persistent Postconcussion Symptoms Among Children With Acute Concussion in the ED.

PubMed

Zemek, Roger; Barrowman, Nick; Freedman, Stephen B; Gravel, Jocelyn; Gagnon, Isabelle; McGahern, Candice; Aglipay, Mary; Sangha, Gurinder; Boutis, Kathy; Beer, Darcy; Craig, William; Burns, Emma; Farion, Ken J; Mikrogianakis, Angelo; Barlow, Karen; Dubrovsky, Alexander S; Meeuwisse, Willem; Gioia, Gerard; Meehan, William P; Beauchamp, Miriam H; Kamil, Yael; Grool, Anne M; Hoshizaki, Blaine; Anderson, Peter; Brooks, Brian L; Yeates, Keith Owen; Vassilyadi, Michael; Klassen, Terry; Keightley, Michelle; Richer, Lawrence; DeMatteo, Carol; Osmond, Martin H

2016-03-08

Approximately one-third of children experiencing acute concussion experience ongoing somatic, cognitive, and psychological or behavioral symptoms, referred to as persistent postconcussion symptoms (PPCS). However, validated and pragmatic tools enabling clinicians to identify patients at risk for PPCS do not exist. To derive and validate a clinical risk score for PPCS among children presenting to the emergency department. Prospective, multicenter cohort study (Predicting and Preventing Postconcussive Problems in Pediatrics [5P]) enrolled young patients (aged 5-<18 years) who presented within 48 hours of an acute head injury at 1 of 9 pediatric emergency departments within the Pediatric Emergency Research Canada (PERC) network from August 2013 through September 2014 (derivation cohort) and from October 2014 through June 2015 (validation cohort). Participants completed follow-up 28 days after the injury. All eligible patients had concussions consistent with the Zurich consensus diagnostic criteria. The primary outcome was PPCS risk score at 28 days, which was defined as 3 or more new or worsening symptoms using the patient-reported Postconcussion Symptom Inventory compared with recalled state of being prior to the injury. In total, 3063 patients (median age, 12.0 years [interquartile range, 9.2-14.6 years]; 1205 [39.3%] girls) were enrolled (n = 2006 in the derivation cohort; n = 1057 in the validation cohort) and 2584 of whom (n = 1701 [85%] in the derivation cohort; n = 883 [84%] in the validation cohort) completed follow-up at 28 days after the injury. Persistent postconcussion symptoms were present in 801 patients (31.0%) (n = 510 [30.0%] in the derivation cohort and n = 291 [33.0%] in the validation cohort). The 12-point PPCS risk score model for the derivation cohort included the variables of female sex, age of 13 years or older, physician-diagnosed migraine history, prior concussion with symptoms lasting longer than 1 week, headache, sensitivity to noise, fatigue, answering questions slowly, and 4 or more errors on the Balance Error Scoring System tandem stance. The area under the curve was 0.71 (95% CI, 0.69-0.74) for the derivation cohort and 0.68 (95% CI, 0.65-0.72) for the validation cohort. A clinical risk score developed among children presenting to the emergency department with concussion and head injury within the previous 48 hours had modest discrimination to stratify PPCS risk at 28 days. Before this score is adopted in clinical practice, further research is needed for external validation, assessment of accuracy in an office setting, and determination of clinical utility.

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

Community-Based Validation of the Social Phobia Screener (SOPHS).

PubMed

Batterham, Philip J; Mackinnon, Andrew J; Christensen, Helen

2017-10-01

There is a need for brief, accurate screening scales for social anxiety disorder to enable better identification of the disorder in research and clinical settings. A five-item social anxiety screener, the Social Phobia Screener (SOPHS), was developed to address this need. The screener was validated in two samples: (a) 12,292 Australian young adults screened for a clinical trial, including 1,687 participants who completed a phone-based clinical interview and (b) 4,214 population-based Australian adults recruited online. The SOPHS (78% sensitivity, 72% specificity) was found to have comparable screening performance to the Social Phobia Inventory (77% sensitivity, 71% specificity) and Mini-Social Phobia Inventory (74% sensitivity, 73% specificity) relative to clinical criteria in the trial sample. In the population-based sample, the SOPHS was also accurate (95% sensitivity, 73% specificity) in identifying Diagnostic and Statistical Manual of Mental Disorders-Fifth edition social anxiety disorder. The SOPHS is a valid and reliable screener for social anxiety that is freely available for use in research and clinical settings.

The Research Diagnostic Criteria for Temporomandibular Disorders. I: overview and methodology for assessment of validity.

PubMed

Schiffman, Eric L; Truelove, Edmond L; Ohrbach, Richard; Anderson, Gary C; John, Mike T; List, Thomas; Look, John O

2010-01-01

The purpose of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Validation Project was to assess the diagnostic validity of this examination protocol. The aim of this article is to provide an overview of the project's methodology, descriptive statistics, and data for the study participant sample. This article also details the development of reliable methods to establish the reference standards for assessing criterion validity of the Axis I RDC/TMD diagnoses. The Axis I reference standards were based on the consensus of two criterion examiners independently performing a comprehensive history, clinical examination, and evaluation of imaging. Intersite reliability was assessed annually for criterion examiners and radiologists. Criterion examination reliability was also assessed within study sites. Study participant demographics were comparable to those of participants in previous studies using the RDC/TMD. Diagnostic agreement of the criterion examiners with each other and with the consensus-based reference standards was excellent with all kappas > or = 0.81, except for osteoarthrosis (moderate agreement, k = 0.53). Intrasite criterion examiner agreement with reference standards was excellent (k > or = 0.95). Intersite reliability of the radiologists for detecting computed tomography-disclosed osteoarthrosis and magnetic resonance imaging-disclosed disc displacement was good to excellent (k = 0.71 and 0.84, respectively). The Validation Project study population was appropriate for assessing the reliability and validity of the RDC/TMD Axis I and II. The reference standards used to assess the validity of Axis I TMD were based on reliable and clinically credible methods.

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

PubMed

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

2006-06-30

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

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.

Development and validation of a visual grading scale for assessing image quality of AP pelvis radiographic images.

PubMed

Mraity, Hussien A A B; England, Andrew; Cassidy, Simon; Eachus, Peter; Dominguez, Alejandro; Hogg, Peter

2016-01-01

The aim of this article was to apply psychometric theory to develop and validate a visual grading scale for assessing the visual perception of digital image quality anteroposterior (AP) pelvis. Psychometric theory was used to guide scale development. Seven phantom and seven cadaver images of visually and objectively predetermined quality were used to help assess scale reliability and validity. 151 volunteers scored phantom images, and 184 volunteers scored cadaver images. Factor analysis and Cronbach's alpha were used to assess scale validity and reliability. A 24-item scale was produced. Aggregated mean volunteer scores for each image correlated with the rank order of the visually and objectively predetermined image qualities. Scale items had good interitem correlation (≥0.2) and high factor loadings (≥0.3). Cronbach's alpha (reliability) revealed that the scale has acceptable levels of internal reliability for both phantom and cadaver images (α = 0.8 and 0.9, respectively). Factor analysis suggested that the scale is multidimensional (assessing multiple quality themes). This study represents the first full development and validation of a visual image quality scale using psychometric theory. It is likely that this scale will have clinical, training and research applications. This article presents data to create and validate visual grading scales for radiographic examinations. The visual grading scale, for AP pelvis examinations, can act as a validated tool for future research, teaching and clinical evaluations of image quality.

Linguistic and clinical validation of the Arabic-translated Aberdeen Menorrhagia Severity Scale as an indicator of quality of life for women with abnormal uterine bleeding.

PubMed

Abu-Rafea, Basim F; Vilos, George A; Al Jasser, Rakia S; Al Anazy, Reem M; Javaid, Khalida; Al-Mandeel, Hazem M

2012-08-01

To develop a conceptually and semantically valid Arabic version of a validated disease-specific instrument of quality of life (QoL) for women with abnormal uterine bleeding (AUB). This is a prospective cohort study conducted at the Department of Obstetrics & Gynecology, King Saud University, Riyadh, Kingdom of Saudi Arabia between December 2010 and December 2011 following ethics approval. Forward translation of the Aberdeen Menorrhagia Severity Scale (AMSS) from English into Arabic was followed by backward translation of the consensus target (Arabic) version into the source (English) language. Subsequently, a final target (Arabic) language version was created. Sixty-one Arabic-speaking women of reproductive age participated in the study. The final Arabic questionnaire was administered to 41 women with self-perceived normal menses (Group 1) on 2 occasions 2 weeks apart. Agreement in the answers deems the questionnaire reliable. The final Arabic version was administered to 20 women with self-perceived AUB (Group 2), and their scores were compared with the first response of Group 1. A significant difference between the groups deems the questionnaire valid. For linguistic validation; intra-class correlation coefficient (ICC) of 0.87 and Kappa statistics of 0.56 to 0.87 indicated good to excellent agreement. For clinical validation, there was a significant difference between Group 1 and 2 (p=0.001). The translated Arabic AMSS is a reliable and valid indicator of QoL in Saudi women with AUB.

Development and validation of a visual grading scale for assessing image quality of AP pelvis radiographic images

PubMed Central

England, Andrew; Cassidy, Simon; Eachus, Peter; Dominguez, Alejandro; Hogg, Peter

2016-01-01

Objective: The aim of this article was to apply psychometric theory to develop and validate a visual grading scale for assessing the visual perception of digital image quality anteroposterior (AP) pelvis. Methods: Psychometric theory was used to guide scale development. Seven phantom and seven cadaver images of visually and objectively predetermined quality were used to help assess scale reliability and validity. 151 volunteers scored phantom images, and 184 volunteers scored cadaver images. Factor analysis and Cronbach's alpha were used to assess scale validity and reliability. Results: A 24-item scale was produced. Aggregated mean volunteer scores for each image correlated with the rank order of the visually and objectively predetermined image qualities. Scale items had good interitem correlation (≥0.2) and high factor loadings (≥0.3). Cronbach's alpha (reliability) revealed that the scale has acceptable levels of internal reliability for both phantom and cadaver images (α = 0.8 and 0.9, respectively). Factor analysis suggested that the scale is multidimensional (assessing multiple quality themes). Conclusion: This study represents the first full development and validation of a visual image quality scale using psychometric theory. It is likely that this scale will have clinical, training and research applications. Advances in knowledge: This article presents data to create and validate visual grading scales for radiographic examinations. The visual grading scale, for AP pelvis examinations, can act as a validated tool for future research, teaching and clinical evaluations of image quality. PMID:26943836

Reliability and Validity of the Korean Version of the Cancer Stigma Scale.

PubMed

So, Hyang Sook; Chae, Myeong Jeong; Kim, Hye Young

2017-02-01

In this study the reliability and validity of the Korean version of the Cancer Stigma Scale (KCSS) was evaluated. The KCSS was formed through translation and modification of Cataldo Lung Cancer Stigma Scale. The KCSS, Psychological Symptom Inventory (PSI), and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) were administered to 247 men and women diagnosed with one of the five major cancers. Construct validity, item convergent and discriminant validity, concurrent validity, known-group validity, and internal consistency reliability of the KCSS were evaluated. Exploratory factor analysis supported the construct validity with a six-factor solution; that explained 65.7% of the total variance. The six-factor model was validated by confirmatory factor analysis (Q (χ²/df)= 2.28, GFI=.84, AGFI=.81, NFI=.80, TLI=.86, RMR=.03, and RMSEA=.07). Concurrent validity was demonstrated with the QLQ-C30 (global: r=-.44; functional: r=-.19; symptom: r=.42). The KCSS had known-group validity. Cronbach's alpha coefficient for the 24 items was .89. The results of this study suggest that the 24-item KCSS has relatively acceptable reliability and validity and can be used in clinical research to assess cancer stigma and its impacts on health-related quality of life in Korean cancer patients. © 2017 Korean Society of Nursing Science

Analysis of model development strategies: predicting ventral hernia recurrence.

PubMed

Holihan, Julie L; Li, Linda T; Askenasy, Erik P; Greenberg, Jacob A; Keith, Jerrod N; Martindale, Robert G; Roth, J Scott; Liang, Mike K

2016-11-01

There have been many attempts to identify variables associated with ventral hernia recurrence; however, it is unclear which statistical modeling approach results in models with greatest internal and external validity. We aim to assess the predictive accuracy of models developed using five common variable selection strategies to determine variables associated with hernia recurrence. Two multicenter ventral hernia databases were used. Database 1 was randomly split into "development" and "internal validation" cohorts. Database 2 was designated "external validation". The dependent variable for model development was hernia recurrence. Five variable selection strategies were used: (1) "clinical"-variables considered clinically relevant, (2) "selective stepwise"-all variables with a P value <0.20 were assessed in a step-backward model, (3) "liberal stepwise"-all variables were included and step-backward regression was performed, (4) "restrictive internal resampling," and (5) "liberal internal resampling." Variables were included with P < 0.05 for the Restrictive model and P < 0.10 for the Liberal model. A time-to-event analysis using Cox regression was performed using these strategies. The predictive accuracy of the developed models was tested on the internal and external validation cohorts using Harrell's C-statistic where C > 0.70 was considered "reasonable". The recurrence rate was 32.9% (n = 173/526; median/range follow-up, 20/1-58 mo) for the development cohort, 36.0% (n = 95/264, median/range follow-up 20/1-61 mo) for the internal validation cohort, and 12.7% (n = 155/1224, median/range follow-up 9/1-50 mo) for the external validation cohort. Internal validation demonstrated reasonable predictive accuracy (C-statistics = 0.772, 0.760, 0.767, 0.757, 0.763), while on external validation, predictive accuracy dipped precipitously (C-statistic = 0.561, 0.557, 0.562, 0.553, 0.560). Predictive accuracy was equally adequate on internal validation among models; however, on external validation, all five models failed to demonstrate utility. Future studies should report multiple variable selection techniques and demonstrate predictive accuracy on external data sets for model validation. Copyright © 2016 Elsevier Inc. All rights reserved.

Exploring the measurement properties of the osteopathy clinical teaching questionnaire using Rasch analysis.

PubMed

Vaughan, Brett

2018-01-01

Clinical teaching evaluations are common in health profession education programs to ensure students are receiving a quality clinical education experience. Questionnaires students use to evaluate their clinical teachers have been developed in professions such as medicine and nursing. The development of a questionnaire that is specifically for the osteopathy on-campus, student-led clinic environment is warranted. Previous work developed the 30-item Osteopathy Clinical Teaching Questionnaire. The current study utilised Rasch analysis to investigate the construct validity of the Osteopathy Clinical Teaching Questionnaire and provide evidence for the validity argument through fit to the Rasch model. Senior osteopathy students at four institutions in Australia, New Zealand and the United Kingdom rated their clinical teachers using the Osteopathy Clinical Teaching Questionnaire. Three hundred and ninety-nine valid responses were received and the data were evaluated for fit to the Rasch model. Reliability estimations (Cronbach's alpha and McDonald's omega) were also evaluated for the final model. The initial analysis demonstrated the data did not fit the Rasch model. Accordingly, modifications to the questionnaire were made including removing items, removing person responses, and rescoring one item. The final model contained 12 items and fit to the Rasch model was adequate. Support for unidimensionality was demonstrated through both the Principal Components Analysis/t-test, and the Cronbach's alpha and McDonald's omega reliability estimates. Analysis of the questionnaire using McDonald's omega hierarchical supported a general factor (quality of clinical teaching in osteopathy). The evidence for unidimensionality and the presence of a general factor support the calculation of a total score for the questionnaire as a sufficient statistic. Further work is now required to investigate the reliability of the 12-item Osteopathy Clinical Teaching Questionnaire to provide evidence for the validity argument.

Evaluating the predictive accuracy and the clinical benefit of a nomogram aimed to predict survival in node-positive prostate cancer patients: External validation on a multi-institutional database.

PubMed

Bianchi, Lorenzo; Schiavina, Riccardo; Borghesi, Marco; Bianchi, Federico Mineo; Briganti, Alberto; Carini, Marco; Terrone, Carlo; Mottrie, Alex; Gacci, Mauro; Gontero, Paolo; Imbimbo, Ciro; Marchioro, Giansilvio; Milanese, Giulio; Mirone, Vincenzo; Montorsi, Francesco; Morgia, Giuseppe; Novara, Giacomo; Porreca, Angelo; Volpe, Alessandro; Brunocilla, Eugenio

2018-04-06

To assess the predictive accuracy and the clinical value of a recent nomogram predicting cancer-specific mortality-free survival after surgery in pN1 prostate cancer patients through an external validation. We evaluated 518 prostate cancer patients treated with radical prostatectomy and pelvic lymph node dissection with evidence of nodal metastases at final pathology, at 10 tertiary centers. External validation was carried out using regression coefficients of the previously published nomogram. The performance characteristics of the model were assessed by quantifying predictive accuracy, according to the area under the curve in the receiver operating characteristic curve and model calibration. Furthermore, we systematically analyzed the specificity, sensitivity, positive predictive value and negative predictive value for each nomogram-derived probability cut-off. Finally, we implemented decision curve analysis, in order to quantify the nomogram's clinical value in routine practice. External validation showed inferior predictive accuracy as referred to in the internal validation (65.8% vs 83.3%, respectively). The discrimination (area under the curve) of the multivariable model was 66.7% (95% CI 60.1-73.0%) by testing with receiver operating characteristic curve analysis. The calibration plot showed an overestimation throughout the range of predicted cancer-specific mortality-free survival rates probabilities. However, in decision curve analysis, the nomogram's use showed a net benefit when compared with the scenarios of treating all patients or none. In an external setting, the nomogram showed inferior predictive accuracy and suboptimal calibration characteristics as compared to that reported in the original population. However, decision curve analysis showed a clinical net benefit, suggesting a clinical implication to correctly manage pN1 prostate cancer patients after surgery. © 2018 The Japanese Urological Association.

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.

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

Interpreting SF-12 mental component score: an investigation of its convergent validity with CESD-10.

PubMed

Yu, Doris S F; Yan, Elsie C W; Chow, Choi Kai

2015-09-01

To examine the convergent validity of Mental Component Scale of the Short-Form 12 (SF-12 MCS) with the Center for Epidemiologic Studies Depression Scale (CESD-10). The CESD-10 is a screening tool for probably clinically significant depression in the Chinese population. Data were obtained from a household survey carried out in Hong Kong. A two-stage stratified sampling method successfully interviewed 1795 adult subjects from 1239 households. Data on SF-12 MCS and the CESD-10 were extracted. Receiver operating characteristics (ROC) analyses were performed to examine the convergent validity of SF-12 MCS against the CESD-10 threshold for probably clinically significant depression for the younger to middle-aged, late middle-aged and older population cohorts. ROC analysis indicated the excellent convergent validity of SF-12 MCS with the CESD-10 threshold for identifying probably clinically significant depression, with the area under curve ranged from 0.81 to 0.85. The optimal cutoff scores for depression among the younger to middle age group, late middle age group and older age group were 48.1, 50.2 and 50.2, respectively, with sensitivities ranged from 77 to 83 % and specificities ranged from 73 to 78 %. Bootstrapping estimates of the mean difference indicated no significant difference in the optimal cutoff scores between these age cohorts. SF-12 is a widely adopted measure to capture the health profile of Chinese population. The study findings indicated the satisfactory performance of the SF-12 MCS in identifying probably clinical depression. Future study is warrant to examine the diagnostic validity of the SF-12 MCS by using gold standard to assess clinical depression.

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.

Manufacturing validation of biologically functional T cells targeted to CD19 antigen for autologous adoptive cell therapy.

PubMed

Hollyman, Daniel; Stefanski, Jolanta; Przybylowski, Mark; Bartido, Shirley; Borquez-Ojeda, Oriana; Taylor, Clare; Yeh, Raymond; Capacio, Vanessa; Olszewska, Malgorzata; Hosey, James; Sadelain, Michel; Brentjens, Renier J; Rivière, Isabelle

2009-01-01

On the basis of promising preclinical data demonstrating the eradication of systemic B-cell malignancies by CD19-targeted T lymphocytes in vivo in severe combined immunodeficient-beige mouse models, we are launching phase I clinical trials in patients with chronic lymphocytic leukemia (CLL) and acute lymphoblastic leukemia. We present here the validation of the bioprocess which we developed for the production and expansion of clinical grade autologous T cells derived from patients with CLL. We demonstrate that T cells genetically modified with a replication-defective gammaretroviral vector derived from the Moloney murine leukemia virus encoding a chimeric antigen receptor (CAR) targeted to CD19 (1928z) can be expanded with Dynabeads CD3/CD28. This bioprocess allows us to generate clinical doses of 1928z+ T cells in approximately 2 to 3 weeks in a large-scale semiclosed culture system using the Wave Bioreactor. These 1928z+ T cells remain biologically functional not only in vitro but also in severe combined immunodeficient-beige mice bearing disseminated tumors. The validation requirements in terms of T-cell expansion, T-cell transduction with the 1928z CAR, biologic activity, quality control testing, and release criteria were met for all 4 validation runs using apheresis products from patients with CLL. Additionally, after expansion of the T cells, the diversity of the skewed Vbeta T-cell receptor repertoire was significantly restored. This validated process will be used in phase I clinical trials in patients with chemorefractory CLL and in patients with relapsed acute lymphoblastic leukemia. It can also be adapted for other clinical trials involving the expansion and transduction of patient or donor T cells using any CAR or T-cell receptor.

The MG Composite

PubMed Central

Burns, Ted M.; Conaway, Mark; Sanders, Donald B.

2010-01-01

Objective: To study the concurrent and construct validity and test-retest reliability in the practice setting of an outcome measure for myasthenia gravis (MG). Methods: Eleven centers participated in the validation study of the Myasthenia Gravis Composite (MGC) scale. Patients with MG were evaluated at 2 consecutive visits. Concurrent and construct validities of the MGC were assessed by evaluating MGC scores in the context of other MG-specific outcome measures. We used numerous potential indicators of clinical improvement to assess the sensitivity and specificity of the MGC for detecting clinical improvement. Test-retest reliability was performed on patients at the University of Virginia. Results: A total of 175 patients with MG were enrolled at 11 sites from July 1, 2008, to January 31, 2009. A total of 151 patients were seen in follow-up. Total MGC scores showed excellent concurrent validity with other MG-specific scales. Analyses of sensitivities and specificities of the MGC revealed that a 3-point improvement in total MGC score was optimal for signifying clinical improvement. A 3-point improvement in the MGC also appears to represent a meaningful improvement to most patients, as indicated by improved 15-item myasthenia gravis quality of life scale (MG-QOL15) scores. The psychometric properties were no better for an individualized subscore made up of the 2 functional domains that the patient identified as most important to treat. The test-retest reliability coefficient of the MGC was 98%, with a lower 95% confidence interval of 97%, indicating excellent test-retest reliability. Conclusions: The Myasthenia Gravis Composite is a reliable and valid instrument for measuring clinical status of patients with myasthenia gravis in the practice setting and in clinical trials. PMID:20439845

Computational Biomarker Pipeline from Discovery to Clinical Implementation: Plasma Proteomic Biomarkers for Cardiac Transplantation

PubMed Central

Cohen Freue, Gabriela V.; Meredith, Anna; Smith, Derek; Bergman, Axel; Sasaki, Mayu; Lam, Karen K. Y.; Hollander, Zsuzsanna; Opushneva, Nina; Takhar, Mandeep; Lin, David; Wilson-McManus, Janet; Balshaw, Robert; Keown, Paul A.; Borchers, Christoph H.; McManus, Bruce; Ng, Raymond T.; McMaster, W. Robert

2013-01-01

Recent technical advances in the field of quantitative proteomics have stimulated a large number of biomarker discovery studies of various diseases, providing avenues for new treatments and diagnostics. However, inherent challenges have limited the successful translation of candidate biomarkers into clinical use, thus highlighting the need for a robust analytical methodology to transition from biomarker discovery to clinical implementation. We have developed an end-to-end computational proteomic pipeline for biomarkers studies. At the discovery stage, the pipeline emphasizes different aspects of experimental design, appropriate statistical methodologies, and quality assessment of results. At the validation stage, the pipeline focuses on the migration of the results to a platform appropriate for external validation, and the development of a classifier score based on corroborated protein biomarkers. At the last stage towards clinical implementation, the main aims are to develop and validate an assay suitable for clinical deployment, and to calibrate the biomarker classifier using the developed assay. The proposed pipeline was applied to a biomarker study in cardiac transplantation aimed at developing a minimally invasive clinical test to monitor acute rejection. Starting with an untargeted screening of the human plasma proteome, five candidate biomarker proteins were identified. Rejection-regulated proteins reflect cellular and humoral immune responses, acute phase inflammatory pathways, and lipid metabolism biological processes. A multiplex multiple reaction monitoring mass-spectrometry (MRM-MS) assay was developed for the five candidate biomarkers and validated by enzyme-linked immune-sorbent (ELISA) and immunonephelometric assays (INA). A classifier score based on corroborated proteins demonstrated that the developed MRM-MS assay provides an appropriate methodology for an external validation, which is still in progress. Plasma proteomic biomarkers of acute cardiac rejection may offer a relevant post-transplant monitoring tool to effectively guide clinical care. The proposed computational pipeline is highly applicable to a wide range of biomarker proteomic studies. PMID:23592955

Identification of men with low-risk biopsy-confirmed prostate cancer as candidates for active surveillance.

PubMed

Lin, Daniel W; Crawford, E David; Keane, Thomas; Evans, Brent; Reid, Julia; Rajamani, Saradha; Brown, Krystal; Gutin, Alexander; Tward, Jonathan; Scardino, Peter; Brawer, Michael; Stone, Steven; Cuzick, Jack

2018-06-01

A combined clinical cell-cycle risk (CCR) score that incorporates prognostic molecular and clinical information has been recently developed and validated to improve prostate cancer mortality (PCM) risk stratification over clinical features alone. As clinical features are currently used to select men for active surveillance (AS), we developed and validated a CCR score threshold to improve the identification of men with low-risk disease who are appropriate for AS. The score threshold was selected based on the 90th percentile of CCR scores among men who might typically be considered for AS based on NCCN low/favorable-intermediate risk criteria (CCR = 0.8). The threshold was validated using 10-year PCM in an unselected, conservatively managed cohort and in the subset of the same cohort after excluding men with high-risk features. The clinical effect was evaluated in a contemporary clinical cohort. In the unselected validation cohort, men with CCR scores below the threshold had a predicted mean 10-year PCM of 2.7%, and the threshold significantly dichotomized low- and high-risk disease (P = 1.2 × 10 -5 ). After excluding high-risk men from the validation cohort, men with CCR scores below the threshold had a predicted mean 10-year PCM of 2.3%, and the threshold significantly dichotomized low- and high-risk disease (P = 0.020). There were no prostate cancer-specific deaths in men with CCR scores below the threshold in either analysis. The proportion of men in the clinical testing cohort identified as candidates for AS was substantially higher using the threshold (68.8%) compared to clinicopathologic features alone (42.6%), while mean 10-year predicted PCM risks remained essentially identical (1.9% vs. 2.0%, respectively). The CCR score threshold appropriately dichotomized patients into low- and high-risk groups for 10-year PCM, and may enable more appropriate selection of patients for AS. Copyright © 2018 Elsevier Inc. All rights reserved.

Current status of clinical education in paramedic programs: a descriptive research project.

PubMed

Grubbs, K C

1997-01-01

Development of competence in exercising therapeutic judgment skills represents the goal of clinical education. Time (clock hours) is not a valid predictor of attainment of competence in paramedic clinical education. Quantity of patient contact experiences facilitates development of judgment skills, and offers a valid measure of progress toward competence. This project uses national survey data from accredited programs to describe the availability and accessibility of patient contact experiences within paramedic clinical education. Data from this local program supplements the national survey results. The components of clinical judgment are enumerated, and strategies to teach and evaluate clinical judgment skills are discussed.

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.

Prediction of Primary Care Depression Outcomes at Six Months: Validation of DOC-6 ©.

PubMed

Angstman, Kurt B; Garrison, Gregory M; Gonzalez, Cesar A; Cozine, Daniel W; Cozine, Elizabeth W; Katzelnick, David J

2017-01-01

The goal of this study was to develop and validate an assessment tool for adult primary care patients diagnosed with depression to determine predictive probability of clinical outcomes at 6 months. We retrospectively reviewed 3096 adult patients enrolled in collaborative care management (CCM) for depression. Patients enrolled on or before December 31, 2013, served as the training set (n = 2525), whereas those enrolled after that date served as the preliminary validation set (n = 571). Six variables (2 demographic and 4 clinical) were statistically significant in determining clinical outcomes. Using the validation data set, the remission classifier produced the receiver operating characteristics (ROC) curve with a c-statistic or area under the curve (AUC) of 0.62 with predicted probabilities than ranged from 14.5% to 79.1%, with a median of 50.6%. The persistent depressive symptoms (PDS) classifier produced an ROC curve with a c-statistic or AUC of 0.67 and predicted probabilities that ranged from 5.5% to 73.1%, with a median of 23.5%. We were able to identify readily available variables and then validated these in the prediction of depression remission and PDS at 6 months. The DOC-6 tool may be used to predict which patients may be at risk for worse outcomes. © Copyright 2017 by the American Board of Family Medicine.

Development and Psychometric Evaluation of the HPV Clinical Trial Survey for Parents (CTSP‐HPV) Using Traditional Survey Development Methods and Community Engagement Principles

PubMed Central

Wallston, Kenneth A.; Wilkins, Consuelo H.; Hull, Pamela C.; Miller, Stephania T.

2015-01-01

Abstract Objective This study describes the development and psychometric evaluation of HPV Clinical Trial Survey for Parents with Children Aged 9 to 15 (CTSP‐HPV) using traditional instrument development methods and community engagement principles. Methods An expert panel and parental input informed survey content and parents recommended study design changes (e.g., flyer wording). A convenience sample of 256 parents completed the final survey measuring parental willingness to consent to HPV clinical trial (CT) participation and other factors hypothesized to influence willingness (e.g., HPV vaccine benefits). Cronbach's a, Spearman correlations, and multiple linear regression were used to estimate internal consistency, convergent and discriminant validity, and predictively validity, respectively. Results Internal reliability was confirmed for all scales (a ≥ 0.70.). Parental willingness was positively associated (p < 0.05) with trust in medical researchers, adolescent CT knowledge, HPV vaccine benefits, advantages of adolescent CTs (r range 0.33–0.42), supporting convergent validity. Moderate discriminant construct validity was also demonstrated. Regression results indicate reasonable predictive validity with the six scales accounting for 31% of the variance in parents’ willingness. Conclusions This instrument can inform interventions based on factors that influence parental willingness, which may lead to the eventual increase in trial participation. Further psychometric testing is warranted. PMID:26530324

SurvExpress: an online biomarker validation tool and database for cancer gene expression data using survival analysis.

PubMed

Aguirre-Gamboa, Raul; Gomez-Rueda, Hugo; Martínez-Ledesma, Emmanuel; Martínez-Torteya, Antonio; Chacolla-Huaringa, Rafael; Rodriguez-Barrientos, Alberto; Tamez-Peña, José G; Treviño, Victor

2013-01-01

Validation of multi-gene biomarkers for clinical outcomes is one of the most important issues for cancer prognosis. An important source of information for virtual validation is the high number of available cancer datasets. Nevertheless, assessing the prognostic performance of a gene expression signature along datasets is a difficult task for Biologists and Physicians and also time-consuming for Statisticians and Bioinformaticians. Therefore, to facilitate performance comparisons and validations of survival biomarkers for cancer outcomes, we developed SurvExpress, a cancer-wide gene expression database with clinical outcomes and a web-based tool that provides survival analysis and risk assessment of cancer datasets. The main input of SurvExpress is only the biomarker gene list. We generated a cancer database collecting more than 20,000 samples and 130 datasets with censored clinical information covering tumors over 20 tissues. We implemented a web interface to perform biomarker validation and comparisons in this database, where a multivariate survival analysis can be accomplished in about one minute. We show the utility and simplicity of SurvExpress in two biomarker applications for breast and lung cancer. Compared to other tools, SurvExpress is the largest, most versatile, and quickest free tool available. SurvExpress web can be accessed in http://bioinformatica.mty.itesm.mx/SurvExpress (a tutorial is included). The website was implemented in JSP, JavaScript, MySQL, and R.

SurvExpress: An Online Biomarker Validation Tool and Database for Cancer Gene Expression Data Using Survival Analysis

PubMed Central

Aguirre-Gamboa, Raul; Gomez-Rueda, Hugo; Martínez-Ledesma, Emmanuel; Martínez-Torteya, Antonio; Chacolla-Huaringa, Rafael; Rodriguez-Barrientos, Alberto; Tamez-Peña, José G.; Treviño, Victor

2013-01-01

Validation of multi-gene biomarkers for clinical outcomes is one of the most important issues for cancer prognosis. An important source of information for virtual validation is the high number of available cancer datasets. Nevertheless, assessing the prognostic performance of a gene expression signature along datasets is a difficult task for Biologists and Physicians and also time-consuming for Statisticians and Bioinformaticians. Therefore, to facilitate performance comparisons and validations of survival biomarkers for cancer outcomes, we developed SurvExpress, a cancer-wide gene expression database with clinical outcomes and a web-based tool that provides survival analysis and risk assessment of cancer datasets. The main input of SurvExpress is only the biomarker gene list. We generated a cancer database collecting more than 20,000 samples and 130 datasets with censored clinical information covering tumors over 20 tissues. We implemented a web interface to perform biomarker validation and comparisons in this database, where a multivariate survival analysis can be accomplished in about one minute. We show the utility and simplicity of SurvExpress in two biomarker applications for breast and lung cancer. Compared to other tools, SurvExpress is the largest, most versatile, and quickest free tool available. SurvExpress web can be accessed in http://bioinformatica.mty.itesm.mx/SurvExpress (a tutorial is included). The website was implemented in JSP, JavaScript, MySQL, and R. PMID:24066126

The Serbian version of the Juvenile Arthritis Multidimensional Assessment Report (JAMAR).

PubMed

Susic, Gordana; Vojinovic, Jelena; Vijatov-Djuric, Gordana; Stevanovic, Dejan; Lazarevic, Dragana; Djurovic, Nada; Novakovic, Dusica; Consolaro, Alessandro; Bovis, Francesca; Ruperto, Nicolino

2018-04-01

The Juvenile Arthritis Multidimensional Assessment Report (JAMAR) is a new parent/patient-reported outcome measure that enables a thorough assessment of the disease status in children with juvenile idiopathic arthritis (JIA). We report the results of the cross-cultural adaptation and validation of the parent and patient versions of the JAMAR in the Serbian language. The reading comprehension of the questionnaire was tested in 10 JIA parents and patients. Each participating centre was asked to collect demographic, clinical data and the JAMAR in 100 consecutive JIA patients or all consecutive patients seen in a 6-month period and to administer the JAMAR to 100 healthy children and their parents. The statistical validation phase explored descriptive statistics and the psychometric issues of the JAMAR: the three Likert assumptions, floor/ceiling effects, internal consistency, Cronbach's alpha, interscale correlations, test-retest reliability, and construct validity (convergent and discriminant validity). A total of 248 JIA patients (5.2% systemic, 44.3% oligoarticular, 23.8% RF-negative polyarthritis, 26.7% other categories) and 100 healthy children were enrolled in three centres. The JAMAR components discriminated healthy subjects from JIA patients. All JAMAR components revealed good psychometric performances. In conclusion, the Serbian version of the JAMAR is a valid tool for the assessment of children with JIA and is suitable for use both in routine clinical practice and clinical research.

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.

The German version of the Juvenile Arthritis Multidimensional Assessment Report (JAMAR).

PubMed

Holzinger, Dirk; Foell, Dirk; Horneff, Gerd; Foeldvari, Ivan; Tzaribachev, Nikolay; Tzaribachev, Catrin; Minden, Kirsten; Kallinich, Tilmann; Ganser, Gerd; Clara, Lucia; Haas, Johannes-Peter; Hügle, Boris; Huppertz, Hans-Iko; Weller, Frank; Consolaro, Alessandro; Bovis, Francesca; Ruperto, Nicolino

2018-04-01

The Juvenile Arthritis Multidimensional Assessment Report (JAMAR) is a new parent/patient reported outcome measure that enables a thorough assessment of the disease status in children with juvenile idiopathic arthritis (JIA). We report the results of the cross-cultural adaptation and validation of the parent and patient versions of the JAMAR in the German language. The reading comprehension of the questionnaire was tested in 10 JIA parents and patients. The participating centres were asked to collect demographic and clinical data along the JAMAR questionnaire in 100 consecutive JIA patients or all consecutive patients seen in a 6-month period and to administer the JAMAR to 100 healthy children and their parents. The statistical validation phase explored descriptive statistics and the psychometric issues of the JAMAR: the three Likert assumptions, floor/ceiling effects, internal consistency, Cronbach's alpha, interscale correlations, test-retest reliability, and construct validity (convergent and discriminant validity). A total of 319 JIA patients (2.8% systemic, 36.7% oligoarticular, 23.5% RF negative polyarthritis, and 37% other categories) and 100 healthy children were enrolled in eight centres. The JAMAR components discriminated well healthy subjects from JIA patients. All JAMAR components revealed good psychometric performances. In conclusion, the German version of the JAMAR is a valid tool for the assessment of children with JIA and is suitable for use both in routine clinical practice and in clinical research.

Validation of the Physician-Pharmacist Collaborative Index for physicians in Malaysia.

PubMed

Sellappans, Renukha; Ng, Chirk Jenn; Lai, Pauline Siew Mei

2015-12-01

Establishing a collaborative working relationship between doctors and pharmacists is essential for the effective provision of pharmaceutical care. The Physician-Pharmacist Collaborative Index (PPCI) was developed to assess the professional exchanges between doctors and pharmacists. Two versions of the PPCI was developed: one for physicians and one for pharmacists. However, these instruments have not been validated in Malaysia. To determine the validity and reliability of the PPCI for physicians in Malaysia. An urban tertiary hospital in Malaysia. This prospective study was conducted from June to August 2014. Doctors were grouped as either a "collaborator" or a "non-collaborator". Collaborators were doctors who regularly worked with one particular clinical pharmacist in their ward, while non-collaborators were doctors who interacted with any random pharmacist who answered the general pharmacy telephone line whenever they required assistance on medication-related enquiries, as they did not have a clinical pharmacist in their ward. Collaborators were firstly identified by the clinical pharmacist he/she worked with, then invited to participate in this study through email, as it was difficult to locate and approach them personally. Non-collaborators were sampled conveniently by approaching them in person as these doctors could be easily sampled from any wards without a clinical pharmacist. The PPCI for physicians was administered at baseline and 2 weeks later. Validity (face validity, factor analysis and discriminative validity) and reliability (internal consistency and test-retest) of the PPCI for physicians. A total of 116 doctors (18 collaborators and 98 non-collaborators) were recruited. Confirmatory factor analysis confirmed that the PPCI for physicians was a 3-factor model. The correlation of the mean domain scores ranged from 0.711 to 0.787. "Collaborators" had significantly higher scores compared to "non-collaborators" (81.4 ± 10.1 vs. 69.3 ± 12.1, p < 0.001). The Cronbach alpha for the overall PPCI for physicians was 0.949, while the Cronbach alpha values for the individual domains ranged from 0.877 to 0.926. Kappa values at test-retest ranged from 0.553 to 0.752. The PPCI for physicians was a valid and reliable measure in determining doctors' views about collaborative working relationship with pharmacists, in Malaysia.

Impact of hormone therapy on quality of life after menopause.

PubMed

Utian, Wulf H; Woods, Nancy Fugate

2013-10-01

Given the complexity of the literature on quality of life (QOL) and hormone therapy (HT) among women in the menopausal transition and postmenopause, the purposes of this integrative review were to (1) define QOL as a multidimensional construct; (2) review validated instruments for measurement of QOL; (3) review results of HT and QOL clinical trials that have used validated instruments; and (4) assess the effectiveness of HT on QOL, including health-related QOL (HRQOL), menopause-specific QOL (MSQOL), and global QOL (GQOL). The literature on HT and QOL was searched for definitions of QOL and validated instruments for measuring QOL, and the results were summarized. The purposes of this integrative review were to evaluate the effects of HT on HRQOL, differentiating the effects of HT on GQOL, HRQOL, and MSQOL. As a basis for this review, we searched for published controlled clinical trials in which the effects of HT on QOL were studied using validated QOL instruments, in particular menopause-specific validated instruments. Clear definitions are elucidated. Validated instruments for the measurements of HRQOL, GQOL, and MSQOL are summarized, and the necessity of their incorporation into future research and clinical practice is emphasized. The published effects on QOL of estrogens and progestogens administered to symptomatic and nonsymptomatic women in the menopausal transition and beyond are reviewed. The impact of various health state-related symptoms on HRQOL and GQOL is now an integral component of contemporary health care. Effects of HT include GQOL and HRQOL and should be menopause-specific. There is clearly a need for further studies on menopause and menopause-related therapies using appropriate and validated instruments. Literature review shows that HT provides a significant benefit for MSQOL in midlife women, mainly through relief of symptoms, but treatment also may result in a global increase in sense of well-being (GQOL). HRQOL benefits are contingent on symptom status, as are MSQOL outcomes. Women who are severely symptomatic experience a significant improvement in HRQOL and MSQOL, although this improvement is not significant among women without severe symptoms at baseline measures in clinical trials.

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 medical content. ALICE is a nonprofit simulator, easy to use, and showed high students' acceptance; thus it potentially provides an additional tool for supporting student teaching in the daily clinical curriculum. Copyright © 2015 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Factor Structure and Initial Validation of a Multidimensional Measure of Difficulties in the Regulation of Positive Emotions: The DERS-Positive

PubMed Central

Weiss, Nicole H.; Gratz, Kim L.; Lavender, Jason M.

2015-01-01

Emotion regulation difficulties are a transdiagnostic construct relevant to numerous clinical difficulties. Although the Difficulties in Emotion Regulation Scale (Gratz & Roemer, 2004) is a multidimensional measure of maladaptive ways of responding to emotions, it focuses on difficulties with the regulation of negative emotions and does not assess emotion dysregulation in the form of problematic responding to positive emotions. The aim of this study was to develop and validate a measure of clinically-relevant difficulties in the regulation of positive emotions (DERS-Positive). Findings revealed a 3-factor structure and supported the internal consistency and construct validity of the total and subscale scores. PMID:25576185

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.

Factor Structure and Initial Validation of a Multidimensional Measure of Difficulties in the Regulation of Positive Emotions: The DERS-Positive.

PubMed

Weiss, Nicole H; Gratz, Kim L; Lavender, Jason M

2015-05-01

Emotion regulation difficulties are a transdiagnostic construct relevant to numerous clinical difficulties. Although the Difficulties in Emotion Regulation Scale (DERS) is a multidimensional measure of maladaptive ways of responding to emotions, it focuses on difficulties with the regulation of negative emotions and does not assess emotion dysregulation in the form of problematic responding to positive emotions. The aim of this study was to develop and validate a measure of clinically relevant difficulties in the regulation of positive emotions (DERS-Positive). Findings revealed a three-factor structure and supported the internal consistency and construct validity of the total and subscale scores. © The Author(s) 2015.

Validation and properties of the verbal numeric scale in children with acute pain.

PubMed

Bailey, Benoit; Daoust, Raoul; Doyon-Trottier, Evelyne; Dauphin-Pierre, Sabine; Gravel, Jocelyn

2010-05-01

Although the verbal numeric scale (VNS) is used frequently at patients' bedsides, it has never been formally validated in children with acute pain. In order to validate this scale, a prospective cohort study was performed in children between 8 and 17years presenting to a pediatric emergency department (ED) with acute pain. Pain was graded using the VNS, the visual analogue scale (VAS), and the verbal rating scale (VRS). A second assessment was done before discharge. We determined a priori that in order to be valid, the VNS would need to: correlate with the VAS (concurrent validity); decrease after intervention to reduce pain (construct validity); and be associated with the VRS categories (content validity). The VNS interchangeability with the VAS, its minimal clinically significant difference, and test-retest reliability were also determined. A total of 202 patients (mean age: 12.2+/-2.6years) were enrolled. The VNS correlated with the VAS: r(ic)=0.93, p<0.001. There were differences in the VNS before versus after interventions (p<0.001), and between VRS categories (mild versus moderate, p<0.001; moderate versus severe, p<0.001). The 95% limits of agreement (interchangeability) between VNS/VAS were outside the a priori set limit of +/-2.0: -1.8, 2.5. The VNS minimal clinically significant difference was 1. The VNS had good test-retest reliability with 95% limits of agreement of -0.9 and 1.2. In conclusion, the VNS provides a valid and reliable scale to evaluate acute pain in children aged 8-17years but is not interchangeable with the VAS. Copyright 2009 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Cross-cultural Adaptation and Validation of the Medication Regimen Complexity Index Adapted to Spanish.

PubMed

Saez de la Fuente, Javier; Such Diaz, Ana; Cañamares-Orbis, Irene; Ramila, Estela; Izquierdo-Garcia, Elsa; Esteban, Concepcion; Escobar-Rodríguez, Ismael

2016-11-01

The most widely used validated instrument to assess the complexity of medication regimens is the Medication Regimen Complexity Index (MRCI). This study aimed to translate, adapt, and validate a reliable version of the MRCI adapted to Spanish (MRCI-E). The cross-cultural adaptation process consisted of an independent translation by 3 clinical pharmacists and a backtranslation by 2 native English speakers. A reliability analysis was conducted on 20 elderly randomly selected patients. Two clinical pharmacists calculated the MRCI-E from discharge treatments and 2 months later. For the validity analysis, the sample was augmented to 60 patients. Convergent validity was assessed by analyzing the correlation between the number of medications; discriminant validity was stratified by gender; and predictive validity was determined by analyzing the ability to predict readmission and mortality at 3 and 6 months. The MRCI-E retained the original structure of 3 sections. The reliability analysis demonstrated an excellent internal consistency (Cronbach's α=0.83), and the intraclass correlation coefficient exceeded 0.9 in all cases. The correlation coefficient with the number of medications was 0.883 ( P<0.001). No significant differences were found when stratified by gender (3.6; 95%CI=-2.9 to 10.2; P=0.27). Patients who were readmitted at 3 months had a higher MRCI-E score (10.7; 95%CI=4.4 to 17.2; P=0.001). The differences remained significant in patients readmitted at 6 months, but differences in mortality were not detected. The MRCI-E retains the reliability and validity of the original index and provides a suitable tool to assess the complexity of medication regimens in Spanish.

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.

Assessment of the External Validity of the National Comprehensive Cancer Network and European Society for Medical Oncology Guidelines for Non-Small-Cell Lung Cancer in a Population of Patients Aged 80 Years and Older.

PubMed

Battisti, Nicolò Matteo Luca; Sehovic, Marina; Extermann, Martine

2017-09-01

Non-small-cell lung cancer (NSCLC) is a disease of the elderly, who are under-represented in clinical trials. This challenges the external validity of the evidence base for its management and of current guidelines, that we evaluated in a population of older patients. We retrieved randomized clinical trials (RCTs) supporting the guidelines and identified 18 relevant topics. We matched a cohort of NSCLC patients aged older than 80 years from the Moffitt Cancer Center database with the studies' eligibility criteria to check their qualification for at least 2 studies. Eligibility > 60% was rated full validity, 30% to 60% partial validity, and < 30% limited validity. We obtained data from 760 elderly patients in stage-adjusted groups and collected 244 RCTs from the National Comprehensive Cancer Network (NCCN) and 148 from the European Society for Medical Oncology (ESMO) guidelines. External validity was deemed insufficient for neoadjuvant chemotherapy in stage III disease (27.37% and 25.26% of patients eligible for NCCN and ESMO guidelines, respectively) and use of bevacizumab (13.86% and 16.27% of patients eligible). For ESMO guidelines, it was inadequate regarding double-agent chemotherapy (25.90% of patients eligible), its duration (24.10%) and therapy for Eastern Cooperative Oncology Group performance status 2 patients (17.74%). For NCCN guidelines external validity was lacking for neoadjuvant chemoradiotherapy in stage IIIA disease (25.86% of patients eligible). Our analysis highlighted the effect of RCT eligibility criteria on guidelines' external validity in elderly patients. Eligibility criteria should be carefully considered in trial design and more studies that do not exclude elderly patients should be included in guidelines. Copyright © 2017 Elsevier Inc. All rights reserved.

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

Evaluation of the aspartate aminotransferase/platelet ratio index and enhanced liver fibrosis tests to detect significant fibrosis due to chronic hepatitis C.

PubMed

Petersen, John R; Stevenson, Heather L; Kasturi, Krishna S; Naniwadekar, Ashutosh; Parkes, Julie; Cross, Richard; Rosenberg, William M; Xiao, Shu-Yuan; Snyder, Ned

2014-04-01

The assessment of liver fibrosis in chronic hepatitis C patients is important for prognosis and making decisions regarding antiviral treatment. Although liver biopsy is considered the reference standard for assessing hepatic fibrosis in patients with chronic hepatitis C, it is invasive and associated with sampling and interobserver variability. Serum fibrosis markers have been utilized as surrogates for a liver biopsy. We completed a prospective study of 191 patients in which blood draws and liver biopsies were performed on the same visit. Using liver biopsies the sensitivity, specificity, and negative and positive predictive values for both aspartate aminotransferase/platelet ratio index (APRI) and enhanced liver fibrosis (ELF) were determined. The patients were divided into training and validation patient sets to develop and validate a clinically useful algorithm for differentiating mild and significant fibrosis. The area under the ROC curve for the APRI and ELF tests for the training set was 0.865 and 0.880, respectively. The clinical sensitivity in separating mild (F0-F1) from significant fibrosis (F2-F4) was 80% and 86.0% with a clinical specificity of 86.7% and 77.8%, respectively. For the validation sets the area under the ROC curve for the APRI and ELF tests was, 0.855 and 0.780, respectively. The clinical sensitivity of the APRI and ELF tests in separating mild (F0-F1) from significant (F2-F4) fibrosis for the validation set was 90.0% and 70.0% with a clinical specificity of 73.3% and 86.7%, respectively. There were no differences between the APRI and ELF tests in distinguishing mild from significant fibrosis for either the training or validation sets (P=0.61 and 0.20, respectively). Using APRI as the primary test followed by ELF for patients in the intermediate zone, would have decreased the number of liver biopsies needed by 40% for the validation set. Overall, use of our algorithm would have decreased the number of patients who needed a liver biopsy from 95 to 24-a 74.7% reduction. This study has shown that the APRI and ELF tests are equally accurate in distinguishing mild from significant liver fibrosis, and combining them into a validated algorithm improves their performance in distinguishing mild from significant fibrosis.

Validity and reliability of a novel immunosuppressive adverse effects scoring system in renal transplant recipients.

PubMed

Meaney, Calvin J; Arabi, Ziad; Venuto, Rocco C; Consiglio, Joseph D; Wilding, Gregory E; Tornatore, Kathleen M

2014-06-12

After renal transplantation, many patients experience adverse effects from maintenance immunosuppressive drugs. When these adverse effects occur, patient adherence with immunosuppression may be reduced and impact allograft survival. If these adverse effects could be prospectively monitored in an objective manner and possibly prevented, adherence to immunosuppressive regimens could be optimized and allograft survival improved. Prospective, standardized clinical approaches to assess immunosuppressive adverse effects by health care providers are limited. Therefore, we developed and evaluated the application, reliability and validity of a novel adverse effects scoring system in renal transplant recipients receiving calcineurin inhibitor (cyclosporine or tacrolimus) and mycophenolic acid based immunosuppressive therapy. The scoring system included 18 non-renal adverse effects organized into gastrointestinal, central nervous system and aesthetic domains developed by a multidisciplinary physician group. Nephrologists employed this standardized adverse effect evaluation in stable renal transplant patients using physical exam, review of systems, recent laboratory results, and medication adherence assessment during a clinic visit. Stable renal transplant recipients in two clinical studies were evaluated and received immunosuppressive regimens comprised of either cyclosporine or tacrolimus with mycophenolic acid. Face, content, and construct validity were assessed to document these adverse effect evaluations. Inter-rater reliability was determined using the Kappa statistic and intra-class correlation. A total of 58 renal transplant recipients were assessed using the adverse effects scoring system confirming face validity. Nephrologists (subject matter experts) rated the 18 adverse effects as: 3.1 ± 0.75 out of 4 (maximum) regarding clinical importance to verify content validity. The adverse effects scoring system distinguished 1.75-fold increased gastrointestinal adverse effects (p=0.008) in renal transplant recipients receiving tacrolimus and mycophenolic acid compared to the cyclosporine regimen. This finding demonstrated construct validity. Intra-class correlation was 0.81 (95% confidence interval: 0.65-0.90) and Kappa statistic of 0.68 ± 0.25 for all 18 adverse effects and verified substantial inter-rater reliability. This immunosuppressive adverse effects scoring system in stable renal transplant recipients was evaluated and substantiated face, content and construct validity with inter-rater reliability. The scoring system may facilitate prospective, standardized clinical monitoring of immunosuppressive adverse drug effects in stable renal transplant recipients and improve medication adherence.

Validity of clinical color vision tests for air traffic control specialists.

DOT National Transportation Integrated Search

1992-10-01

An experiment on the relationship between aeromedical color vision screening test performance and performance on color-dependent tasks of Air Traffic Control Specialists was replicated to expand the data base supporting the job-related validity of th...

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.

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.

[An instrument for assessing clinical aptitude in cervicovaginitis in the family medicine practice].

PubMed

Arrieta-Pérez, Raúl Tomás; Lona-Calixto, Beatriz

2011-01-01

the cervicovaginitis is one of the first twelve causes on demand at primary care medicine thus the family physician must be able to identify and treat it. The objective was to validate a constructed instrument for measuring the clinical aptitude on cervicovaginitis. cross-sectional, descriptive, prolective study was carried out. An instrument with five clinical cases was done. It has seven indicators, whose answers were true, false and I do not know. The validity content was done by three family physicians and a Gynecologist, with experience in education. The trustworthiness was determined by means of the test of Kuder-Richardson formula 20 with the results obtained in a pilot test in 50 family medicine residents. the instrument was constituted by five clinical cases with 140 Items distributed in seven indicators with 20 items for each indicator and a total of 70 true answers and 70 false answers; seven categories for the degree of clinical aptitude settled down. The trustworthiness of the instrument was 0.81. the instrument is valid and reliable to identify the clinical aptitude of the family physician on cervicovaginitis.

Biomarkers for Early Detection of Clinically Relvant Prostate Cancer: A Multi-Institutional Validation Trial - Genomic Health, Inc. — EDRN Public Portal

Cancer.gov

Validate a panel of tissue-based biomarkers to determine the presence of or progression to clinically relevant prostate cancer at the time of diagnosis. Utilize a novel, biopsy based multi-gene quantitative RT-PCR assay developed by Genomic Health, Oncotype DX Prostate Cancer Assay, which discriminates aggressive from indolent cancer on multivariate modeling of PCa patients.

Reliability, factor structure, and validity of the German version of the Trauma Symptom Checklist for Children in a sample of adolescents

PubMed Central

Matulis, Simone; Loos, Laura; Langguth, Nadine; Schreiber, Franziska; Gutermann, Jana; Gawrilow, Caterina; Steil, Regina

2015-01-01

Background The Trauma Symptom Checklist for Children (TSC-C) is the most widely used self-report scale to assess trauma-related symptoms in children and adolescents on six clinical scales. The purpose of the present study was to develop a German version of the TSC-C and to investigate its psychometric properties, such as factor structure, reliability, and validity, in a sample of German adolescents. Method A normative sample of N=583 and a clinical sample of N=41 adolescents with a history of physical or sexual abuse aged between 13 and 21 years participated in the study. Results The Confirmatory Factor Analysis on the six-factor model (anger, anxiety, depression, dissociation, posttraumatic stress, and sexual concerns with the subdimensions preoccupation and distress) revealed acceptable to good fit statistics in the normative sample. One item had to be excluded from the German version of the TSC-C because the factor loading was too low. All clinical scales presented acceptable to good reliability, with Cronbach's α's ranging from .80 to .86 in the normative sample and from .72 to .87 in the clinical sample. Concurrent validity was also demonstrated by the high correlations between the TSC-C scales and instruments measuring similar psychopathology. TSC-C scores reliably differentiated between adolescents with trauma history and those without trauma history, indicating discriminative validity. Conclusions In conclusion, the German version of the TSC-C is a reliable and valid instrument for assessing trauma-related symptoms on six different scales in adolescents aged between 13 and 21 years. PMID:26498182

Reliability, factor structure, and validity of the German version of the Trauma Symptom Checklist for Children in a sample of adolescents.

PubMed

Matulis, Simone; Loos, Laura; Langguth, Nadine; Schreiber, Franziska; Gutermann, Jana; Gawrilow, Caterina; Steil, Regina

2015-01-01

The Trauma Symptom Checklist for Children (TSC-C) is the most widely used self-report scale to assess trauma-related symptoms in children and adolescents on six clinical scales. The purpose of the present study was to develop a German version of the TSC-C and to investigate its psychometric properties, such as factor structure, reliability, and validity, in a sample of German adolescents. A normative sample of N=583 and a clinical sample of N=41 adolescents with a history of physical or sexual abuse aged between 13 and 21 years participated in the study. The Confirmatory Factor Analysis on the six-factor model (anger, anxiety, depression, dissociation, posttraumatic stress, and sexual concerns with the subdimensions preoccupation and distress) revealed acceptable to good fit statistics in the normative sample. One item had to be excluded from the German version of the TSC-C because the factor loading was too low. All clinical scales presented acceptable to good reliability, with Cronbach's α's ranging from .80 to .86 in the normative sample and from .72 to .87 in the clinical sample. Concurrent validity was also demonstrated by the high correlations between the TSC-C scales and instruments measuring similar psychopathology. TSC-C scores reliably differentiated between adolescents with trauma history and those without trauma history, indicating discriminative validity. In conclusion, the German version of the TSC-C is a reliable and valid instrument for assessing trauma-related symptoms on six different scales in adolescents aged between 13 and 21 years.

A method and knowledge base for automated inference of patient problems from structured data in an electronic medical record.

PubMed

Wright, Adam; Pang, Justine; Feblowitz, Joshua C; Maloney, Francine L; Wilcox, Allison R; Ramelson, Harley Z; Schneider, Louise I; Bates, David W

2011-01-01

Accurate knowledge of a patient's medical problems is critical for clinical decision making, quality measurement, research, billing and clinical decision support. Common structured sources of problem information include the patient problem list and billing data; however, these sources are often inaccurate or incomplete. To develop and validate methods of automatically inferring patient problems from clinical and billing data, and to provide a knowledge base for inferring problems. We identified 17 target conditions and designed and validated a set of rules for identifying patient problems based on medications, laboratory results, billing codes, and vital signs. A panel of physicians provided input on a preliminary set of rules. Based on this input, we tested candidate rules on a sample of 100,000 patient records to assess their performance compared to gold standard manual chart review. The physician panel selected a final rule for each condition, which was validated on an independent sample of 100,000 records to assess its accuracy. Seventeen rules were developed for inferring patient problems. Analysis using a validation set of 100,000 randomly selected patients showed high sensitivity (range: 62.8-100.0%) and positive predictive value (range: 79.8-99.6%) for most rules. Overall, the inference rules performed better than using either the problem list or billing data alone. We developed and validated a set of rules for inferring patient problems. These rules have a variety of applications, including clinical decision support, care improvement, augmentation of the problem list, and identification of patients for research cohorts.

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.

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

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.

Leveraging biospecimen resources for discovery or validation of markers for early cancer detection.

PubMed

Schully, Sheri D; Carrick, Danielle M; Mechanic, Leah E; Srivastava, Sudhir; Anderson, Garnet L; Baron, John A; Berg, Christine D; Cullen, Jennifer; Diamandis, Eleftherios P; Doria-Rose, V Paul; Goddard, Katrina A B; Hankinson, Susan E; Kushi, Lawrence H; Larson, Eric B; McShane, Lisa M; Schilsky, Richard L; Shak, Steven; Skates, Steven J; Urban, Nicole; Kramer, Barnett S; Khoury, Muin J; Ransohoff, David F

2015-04-01

Validation of early detection cancer biomarkers has proven to be disappointing when initial promising claims have often not been reproducible in diagnostic samples or did not extend to prediagnostic samples. The previously reported lack of rigorous internal validity (systematic differences between compared groups) and external validity (lack of generalizability beyond compared groups) may be effectively addressed by utilizing blood specimens and data collected within well-conducted cohort studies. Cohort studies with prediagnostic specimens (eg, blood specimens collected prior to development of clinical symptoms) and clinical data have recently been used to assess the validity of some early detection biomarkers. With this background, the Division of Cancer Control and Population Sciences (DCCPS) and the Division of Cancer Prevention (DCP) of the National Cancer Institute (NCI) held a joint workshop in August 2013. The goal was to advance early detection cancer research by considering how the infrastructure of cohort studies that already exist or are being developed might be leveraged to include appropriate blood specimens, including prediagnostic specimens, ideally collected at periodic intervals, along with clinical data about symptom status and cancer diagnosis. Three overarching recommendations emerged from the discussions: 1) facilitate sharing of existing specimens and data, 2) encourage collaboration among scientists developing biomarkers and those conducting observational cohort studies or managing healthcare systems with cohorts followed over time, and 3) conduct pilot projects that identify and address key logistic and feasibility issues regarding how appropriate specimens and clinical data might be collected at reasonable effort and cost within existing or future cohorts. © Published by Oxford University Press 2015.

Leveraging Biospecimen Resources for Discovery or Validation of Markers for Early Cancer Detection

PubMed Central

Carrick, Danielle M.; Mechanic, Leah E.; Srivastava, Sudhir; Anderson, Garnet L.; Baron, John A.; Berg, Christine D.; Cullen, Jennifer; Diamandis, Eleftherios P.; Doria-Rose, V. Paul; Goddard, Katrina A. B.; Hankinson, Susan E.; Kushi, Lawrence H.; Larson, Eric B.; McShane, Lisa M.; Schilsky, Richard L.; Shak, Steven; Skates, Steven J.; Urban, Nicole; Kramer, Barnett S.; Khoury, Muin J.; Ransohoff, David F.

2015-01-01

Validation of early detection cancer biomarkers has proven to be disappointing when initial promising claims have often not been reproducible in diagnostic samples or did not extend to prediagnostic samples. The previously reported lack of rigorous internal validity (systematic differences between compared groups) and external validity (lack of generalizability beyond compared groups) may be effectively addressed by utilizing blood specimens and data collected within well-conducted cohort studies. Cohort studies with prediagnostic specimens (eg, blood specimens collected prior to development of clinical symptoms) and clinical data have recently been used to assess the validity of some early detection biomarkers. With this background, the Division of Cancer Control and Population Sciences (DCCPS) and the Division of Cancer Prevention (DCP) of the National Cancer Institute (NCI) held a joint workshop in August 2013. The goal was to advance early detection cancer research by considering how the infrastructure of cohort studies that already exist or are being developed might be leveraged to include appropriate blood specimens, including prediagnostic specimens, ideally collected at periodic intervals, along with clinical data about symptom status and cancer diagnosis. Three overarching recommendations emerged from the discussions: 1) facilitate sharing of existing specimens and data, 2) encourage collaboration among scientists developing biomarkers and those conducting observational cohort studies or managing healthcare systems with cohorts followed over time, and 3) conduct pilot projects that identify and address key logistic and feasibility issues regarding how appropriate specimens and clinical data might be collected at reasonable effort and cost within existing or future cohorts. PMID:25688116

Functional Recovery Measures for Spinal Cord Injury: An Evidence-Based Review for Clinical Practice and Research

PubMed Central

Anderson, Kim; Aito, Sergio; Atkins, Michal; Biering-Sørensen, Fin; Charlifue, Susan; Curt, Armin; Ditunno, John; Glass, Clive; Marino, Ralph; Marshall, Ruth; Mulcahey, Mary Jane; Post, Marcel; Savic, Gordana; Scivoletto, Giorgio; Catz, Amiram

2008-01-01

Background/Objective: The end goal of clinical care and clinical research involving spinal cord injury (SCI) is to improve the overall ability of persons living with SCI to function on a daily basis. Neurologic recovery does not always translate into functional recovery. Thus, sensitive outcome measures designed to assess functional status relevant to SCI are important to develop. Method: Evaluation of currently available SCI functional outcome measures by a multinational work group. Results: The 4 measures that fit the prespecified inclusion criteria were the Modified Barthel Index (MBI), the Functional Independence Measure (FIM), the Quadriplegia Index of Function (QIF), and the Spinal Cord Independence Measure (SCIM). The MBI and the QIF were found to have minimal evidence for validity, whereas the FIM and the SCIM were found to be reliable and valid. The MBI has little clinical utility for use in the SCI population. Likewise, the FIM applies mainly when measuring burden of care, which is not necessarily a reflection of functional recovery. The QIF is useful for measuring functional recovery but only in a subpopulation of people with SCI, and substantial validity data are still required. The SCIM is the only functional recovery outcome measure designed specifically for SCI. Conclusions: The multinational work group recommends that the latest version of the SCIM (SCIM III) continue to be refined and validated and subsequently implemented worldwide as the primary functional recovery outcome measure for SCI. The QIF may continue to be developed and validated for use as a supplemental tool for the nonambulatory tetraplegic population. PMID:18581660

Validity of the Kinect for Gait Assessment: A Focused Review

PubMed Central

Springer, Shmuel; Yogev Seligmann, Galit

2016-01-01

Gait analysis may enhance clinical practice. However, its use is limited due to the need for expensive equipment which is not always available in clinical settings. Recent evidence suggests that Microsoft Kinect may provide a low cost gait analysis method. The purpose of this report is to critically evaluate the literature describing the concurrent validity of using the Kinect as a gait analysis instrument. An online search of PubMed, CINAHL, and ProQuest databases was performed. Included were studies in which walking was assessed with the Kinect and another gold standard device, and consisted of at least one numerical finding of spatiotemporal or kinematic measures. Our search identified 366 papers, from which 12 relevant studies were retrieved. The results demonstrate that the Kinect is valid only for some spatiotemporal gait parameters. Although the kinematic parameters measured by the Kinect followed the trend of the joint trajectories, they showed poor validity and large errors. In conclusion, the Kinect may have the potential to be used as a tool for measuring spatiotemporal aspects of gait, yet standardized methods should be established, and future examinations with both healthy subjects and clinical participants are required in order to integrate the Kinect as a clinical gait analysis tool. PMID:26861323

The development of an instrument to match individuals with disabilities and service animals.

PubMed

Zapf, S A; Rough, R B

There has been an increase in the use of service animals assisting persons with disabilities in the past decade. However many of the service dog agencies do not utilize an assessment that is designed to match the person to the animal in the rehabilitation and psycho-social domains. The purpose of this study was to develop the Service Animal Adaptive Intervention Assessment (SAAIA) and to measure the content validity, inter-rater reliability and clinical utility of the assessment. Two subject groups were used. Subject group one had 43 subjects who measured the content validity and clinical utility of the SAAIA Survey. Subject group two had 12 subjects who measured the inter-rater reliability by completing the SAAIA using information obtained through a video-taped client case scenario. Content validity results indicated a good to high percentage of agreement and a fair percentage of agreement for clinical utility. Inter-rater reliability results indicate good to high agreement on six of the eight variables of the SAAIA. However, the Kappa score indicates low inter-rater reliability. Results indicate the SAAIA has good content validity and inter-rater reliability and fair clinical utility based on percent agreement. However, further research is needed on the reliability of the SAAIA.

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

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 implication in situations when predicted outcomes in CPR validation studies are lacking or deficient by describing how such predictions can be obtained by everyone using the derivation study alone, without any need for highly specialized knowledge or sophisticated statistics. PMID:25931829

Reliability and validity of simplified Chinese version of Swiss Spinal Stenosis Questionnaire for patients with degenerative lumbar spinal stenosis.

PubMed

Yi, Honglei; Wei, Xianzhao; Zhang, Wei; Chen, Ziqiang; Wang, Xinhui; Ji, Xinran; Zhu, Xiaodong; Wang, Fei; Xu, Ximing; Li, Zhikun; Fan, Jianping; Wang, Chuanfeng; Chen, Kai; Zhang, Guoyou; Zhao, Yinchuan; Li, Ming

2014-05-01

This was a prospective clinical validation study. To evaluate the reliability and validity of the adapted simplified Chinese version of Swiss Spinal Stenosis (SC-SSS) Questionnaire. The SSS Questionnaire is a reliable and valid instrument to assess the perception of function and pain for patients with degenerative lumbar spinal stenosis. However, there is no culturally adapted SSS Questionnaire for use in mainland China. This was a prospective clinical validation study. The adaption was conducted according to International Quality of Life Assessment Project guidelines. To examine the psychometric properties of the adapted SC-SSS Questionnaire, a sample of 105 patients with lumbar spinal stenosis were included. Thirty-two patients were randomly selected to evaluate the test-retest reliability. Reliability assessment of the SC-SSS Questionnaire was determined by calculating Cronbach α and intraclass coefficient values. Concurrent validity was assessed by correlating SC-SSS Questionnaire scores with relevant domains of the 36-Item Short Form Health Survey. Cronbach α of the symptom severity scale, physical function scale, patients, and satisfaction scale of SC-SSS Questionnaire are 0.89, 0.86, 0.91, respectively, which revealed very good internal consistency. The test-retest reproducibility was found to be excellent with the intraclass correlation coefficient of 0.93, 0.91, and 0.95. In terms of concurrent validity, SC-SSS Questionnaire had good correlation with physical functioning and bodily pain of 36-Item Short Form Health Survey (r = 0.663, 0.653) and low correlation with mental health (r = 0.289). The physical function scale had good correlation with physical functioning of 36-Item Short Form Health Survey (r = 0.637), whereas the rest had moderate correlation. The satisfaction scale score was highly correlated with the change in the symptom severity (r = 0.71) and physical function (r = 0.68) scale score. The SC-SSS Questionnaire showed satisfactory reliability and validity in the evaluation of functionality in patients with lumbar spinal stenosis who are experiencing neurogenic claudication. It is simple and easy to use and can be recommended in clinical and research practice in mainland China. 3.

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.

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

PubMed Central

2017-01-01

Background The Information Assessment Method (IAM) allows clinicians to report the cognitive impact, clinical relevance, intention to use, and expected patient health benefits associated with clinical information received by email. More than 15,000 Canadian physicians and pharmacists use the IAM in continuing education programs. In addition, information providers can use IAM ratings and feedback comments from clinicians to improve their products. Objective Our general objective was to validate the IAM questionnaire for the delivery of educational material (ecological and logical content validity). Our specific objectives were to measure the relevance and evaluate the representativeness of IAM items for assessing information received by email. Methods A 3-part mixed methods study was conducted (convergent design). In part 1 (quantitative longitudinal study), the relevance of IAM items was measured. Participants were 5596 physician members of the Canadian Medical Association who used the IAM. A total of 234,196 ratings were collected in 2012. The relevance of IAM items with respect to their main construct was calculated using descriptive statistics (relevance ratio R). In part 2 (qualitative descriptive study), the representativeness of IAM items was evaluated. A total of 15 family physicians completed semistructured face-to-face interviews. For each construct, we evaluated the representativeness of IAM items using a deductive-inductive thematic qualitative data analysis. In part 3 (mixing quantitative and qualitative parts), results from quantitative and qualitative analyses were reviewed, juxtaposed in a table, discussed with experts, and integrated. Thus, our final results are derived from the views of users (ecological content validation) and experts (logical content validation). Results Of the 23 IAM items, 21 were validated for content, while 2 were removed. In part 1 (quantitative results), 21 items were deemed relevant, while 2 items were deemed not relevant (R=4.86% [N=234,196] and R=3.04% [n=45,394], respectively). In part 2 (qualitative results), 22 items were deemed representative, while 1 item was not representative. In part 3 (mixing quantitative and qualitative results), the content validity of 21 items was confirmed, and the 2 nonrelevant items were excluded. A fully validated version was generated (IAM-v2014). Conclusions This study produced a content validated IAM questionnaire that is used by clinicians and information providers to assess the clinical information delivered in continuing education programs. PMID:28292738

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 testing and validation of the FORGE AHEAD CRCT demonstrated that the tool is acceptable, valid and reliable. The CRCT has been successfully used to support the implementation of the FORGE AHEAD Program and the health services changes that partnering First Nations communities have designed and undertaken to improve diabetes care. Current ClinicalTrial.gov protocol ID NCT02234973 . Date of Registration: July 30, 2014.

The clinical effectiveness and cost-effectiveness of testing for cytochrome P450 polymorphisms in patients with schizophrenia treated with antipsychotics: a systematic review and economic evaluation.

PubMed

Fleeman, N; McLeod, C; Bagust, A; Beale, S; Boland, A; Dundar, Y; Jorgensen, A; Payne, K; Pirmohamed, M; Pushpakom, S; Walley, T; de Warren-Penny, P; Dickson, R

2010-01-01

To determine whether testing for cytochrome P450 (CYP) polymorphisms in adults entering antipsychotic treatment for schizophrenia leads to improvement in outcomes, is useful in medical, personal or public health decision-making, and is a cost-effective use of health-care resources. The following electronic databases were searched for relevant published literature: Cochrane Controlled Trials Register, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness, EMBASE, Health Technology Assessment database, ISI Web of Knowledge, MEDLINE, PsycINFO, NHS Economic Evaluation Database, Health Economic Evaluation Database, Cost-effectiveness Analysis (CEA) Registry and the Centre for Health Economics website. In addition, publicly available information on various genotyping tests was sought from the internet and advisory panel members. A systematic review of analytical validity, clinical validity and clinical utility of CYP testing was undertaken. Data were extracted into structured tables and narratively discussed, and meta-analysis was undertaken when possible. A review of economic evaluations of CYP testing in psychiatry and a review of economic models related to schizophrenia were also carried out. For analytical validity, 46 studies of a range of different genotyping tests for 11 different CYP polymorphisms (most commonly CYP2D6) were included. Sensitivity and specificity were high (99-100%). For clinical validity, 51 studies were found. In patients tested for CYP2D6, an association between genotype and tardive dyskinesia (including Abnormal Involuntary Movement Scale scores) was found. The only other significant finding linked the CYP2D6 genotype to parkinsonism. One small unpublished study met the inclusion criteria for clinical utility. One economic evaluation assessing the costs and benefits of CYP testing for prescribing antidepressants and 28 economic models of schizophrenia were identified; none was suitable for developing a model to examine the cost-effectiveness of CYP testing. Tests for determining genotypes appear to be accurate although not all aspects of analytical validity were reported. Given the absence of convincing evidence from clinical validity studies, the lack of clinical utility and economic studies, and the unsuitability of published schizophrenia models, no model was developed; instead key features and data requirements for economic modelling are presented. Recommendations for future research cover both aspects of research quality and data that will be required to inform the development of future economic models.

Multisite external validation of a risk prediction model for the diagnosis of blood stream infections in febrile pediatric oncology patients without severe neutropenia.

PubMed

Esbenshade, Adam J; Zhao, Zhiguo; Aftandilian, Catherine; Saab, Raya; Wattier, Rachel L; Beauchemin, Melissa; Miller, Tamara P; Wilkes, Jennifer J; Kelly, Michael J; Fernbach, Alison; Jeng, Michael; Schwartz, Cindy L; Dvorak, Christopher C; Shyr, Yu; Moons, Karl G M; Sulis, Maria-Luisa; Friedman, Debra L

2017-10-01

Pediatric oncology patients are at an increased risk of invasive bacterial infection due to immunosuppression. The risk of such infection in the absence of severe neutropenia (absolute neutrophil count ≥ 500/μL) is not well established and a validated prediction model for blood stream infection (BSI) risk offers clinical usefulness. A 6-site retrospective external validation was conducted using a previously published risk prediction model for BSI in febrile pediatric oncology patients without severe neutropenia: the Esbenshade/Vanderbilt (EsVan) model. A reduced model (EsVan2) excluding 2 less clinically reliable variables also was created using the initial EsVan model derivative cohort, and was validated using all 5 external validation cohorts. One data set was used only in sensitivity analyses due to missing some variables. From the 5 primary data sets, there were a total of 1197 febrile episodes and 76 episodes of bacteremia. The overall C statistic for predicting bacteremia was 0.695, with a calibration slope of 0.50 for the original model and a calibration slope of 1.0 when recalibration was applied to the model. The model performed better in predicting high-risk bacteremia (gram-negative or Staphylococcus aureus infection) versus BSI alone, with a C statistic of 0.801 and a calibration slope of 0.65. The EsVan2 model outperformed the EsVan model across data sets with a C statistic of 0.733 for predicting BSI and a C statistic of 0.841 for high-risk BSI. The results of this external validation demonstrated that the EsVan and EsVan2 models are able to predict BSI across multiple performance sites and, once validated and implemented prospectively, could assist in decision making in clinical practice. Cancer 2017;123:3781-3790. © 2017 American Cancer Society. © 2017 American Cancer Society.

The EQ-5D-5L is a valid approach to measure health related quality of life in patients undergoing bariatric surgery.

PubMed

Fermont, Jilles M; Blazeby, Jane M; Rogers, Chris A; Wordsworth, Sarah

2017-01-01

Bariatric surgery is considered an effective treatment for individuals with severe and complex obesity. Besides reducing weight and improving obesity related comorbidities such as diabetes, bariatric surgery could improve patients' health-related quality of life. However, the frequently used instrument to measure quality of life, the EQ-5D has not been validated for use in bariatric surgery, which is a major limitation to its use in this clinical context. Our study undertook a psychometric validation of the 5 level EQ-5D (EQ-5D-5L) using clinical trial data to measure health-related quality of life in patients with severe and complex obesity undergoing bariatric surgery. Health-related quality of life was assessed at baseline (before randomisation) and six months later in 189 patients in a randomised controlled trial of bariatric surgery. Patients completed two generic health-related quality of life instruments, the EQ-5D-5L and SF-12, which were used together for the validation using data from all patients in the trial as the trial is ongoing. Psychometric analyses included construct and criterion validity and responsiveness to change. Of the 189 validation patients, 141 (75%) were female, the median age was 49 years old (range 23-70 years) and body mass index ranged from 33-70 kg/m2. For construct validity, there were significant improvements in the distribution of responses in all EQ-5D dimensions between baseline and 6 months after randomisation. For criterion validity, the highest degree of correlation was between the EQ-5D pain/discomfort and SF-12 bodily pain domain. For responsiveness the EQ-5D and SF-12 showed statistically significant improvements in health-related quality of life between baseline and 6 months after randomisation. The EQ-5D-5L is a valid generic measure for measuring health-related quality of life in bariatric surgery patients.

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 Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

A design of experiments approach to validation sampling for logistic regression modeling with error-prone medical records.

PubMed

Ouyang, Liwen; Apley, Daniel W; Mehrotra, Sanjay

2016-04-01

Electronic medical record (EMR) databases offer significant potential for developing clinical hypotheses and identifying disease risk associations by fitting statistical models that capture the relationship between a binary response variable and a set of predictor variables that represent clinical, phenotypical, and demographic data for the patient. However, EMR response data may be error prone for a variety of reasons. Performing a manual chart review to validate data accuracy is time consuming, which limits the number of chart reviews in a large database. The authors' objective is to develop a new design-of-experiments-based systematic chart validation and review (DSCVR) approach that is more powerful than the random validation sampling used in existing approaches. The DSCVR approach judiciously and efficiently selects the cases to validate (i.e., validate whether the response values are correct for those cases) for maximum information content, based only on their predictor variable values. The final predictive model will be fit using only the validation sample, ignoring the remainder of the unvalidated and unreliable error-prone data. A Fisher information based D-optimality criterion is used, and an algorithm for optimizing it is developed. The authors' method is tested in a simulation comparison that is based on a sudden cardiac arrest case study with 23 041 patients' records. This DSCVR approach, using the Fisher information based D-optimality criterion, results in a fitted model with much better predictive performance, as measured by the receiver operating characteristic curve and the accuracy in predicting whether a patient will experience the event, than a model fitted using a random validation sample. The simulation comparisons demonstrate that this DSCVR approach can produce predictive models that are significantly better than those produced from random validation sampling, especially when the event rate is low. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Derivation and external validation of a case mix model for the standardized reporting of 30-day stroke mortality rates.

PubMed

Bray, Benjamin D; Campbell, James; Cloud, Geoffrey C; Hoffman, Alex; James, Martin; Tyrrell, Pippa J; Wolfe, Charles D A; Rudd, Anthony G

2014-11-01

Case mix adjustment is required to allow valid comparison of outcomes across care providers. However, there is a lack of externally validated models suitable for use in unselected stroke admissions. We therefore aimed to develop and externally validate prediction models to enable comparison of 30-day post-stroke mortality outcomes using routine clinical data. Models were derived (n=9000 patients) and internally validated (n=18 169 patients) using data from the Sentinel Stroke National Audit Program, the national register of acute stroke in England and Wales. External validation (n=1470 patients) was performed in the South London Stroke Register, a population-based longitudinal study. Models were fitted using general estimating equations. Discrimination and calibration were assessed using receiver operating characteristic curve analysis and correlation plots. Two final models were derived. Model A included age (<60, 60-69, 70-79, 80-89, and ≥90 years), National Institutes of Health Stroke Severity Score (NIHSS) on admission, presence of atrial fibrillation on admission, and stroke type (ischemic versus primary intracerebral hemorrhage). Model B was similar but included only the consciousness component of the NIHSS in place of the full NIHSS. Both models showed excellent discrimination and calibration in internal and external validation. The c-statistics in external validation were 0.87 (95% confidence interval, 0.84-0.89) and 0.86 (95% confidence interval, 0.83-0.89) for models A and B, respectively. We have derived and externally validated 2 models to predict mortality in unselected patients with acute stroke using commonly collected clinical variables. In settings where the ability to record the full NIHSS on admission is limited, the level of consciousness component of the NIHSS provides a good approximation of the full NIHSS for mortality prediction. © 2014 American Heart Association, Inc.

Psychometric Properties of the Physical Activity Questionnaire for Older Children in Italy: Testing the Validity among a General and Clinical Pediatric Population.

PubMed

Gobbi, Erica; Elliot, Catherine; Varnier, Maurizio; Carraro, Attilio

2016-01-01

The purpose of this research was to assess an Italian version of the Physical Activity Questionnaire for Older Children (PAQ-C-It). Three separate studies were conducted, whereby testing general psychometric properties, construct validity, concurrent validity and the factor structure of the PAQ-C-It among general and clinical pediatric population. Study 1 (n = 1170) examined the psychometric properties, internal consistency, factor structure (exploratory factor analysis, EFA) and construct validity with enjoyment perception during physical activity. Study 2 (n = 59) reported on reliability, construct validity with enjoyment and BMI, and on cross-sectional concurrent validity with objectively measured MVPA (tri-axial accelerometry) over the span of seven consecutive days. Study 3 (n = 58) examined the PAQ-C-It reliability, construct validity with BMI and VO2max as the objective measurement among a population of children with congenital heart defects (CHD). In study 2 and 3, the factor structure of the PAQ-C-It was then re-examined with an EFA. The PAQ-C-It showed acceptable to good reliability (alpha .70 to .83). Results on construct validity showed moderate but significant association with enjoyment perception (r = .30 and .36), with BMI (r = -.30 and -.79 for CHD simple form), and with the VO2max (r = .55 for CHD simple form). Significant concurrent validity with the objectively measured MVPA was reported (rho = .30, p < .05). Findings of the EFA suggested a two-factor structure for the PAQ-C-It, with items 2, 3, and 4 contributing little to the total score. This study supports the PAQ-C-It as an appropriate instrument to assess the MVPA levels of Italian children, including children with simple forms of CHD. Support is given to the possible instrument effectiveness on a large international perspective in order to level out data gathering across the globe.

Psychometric Properties of the Physical Activity Questionnaire for Older Children in Italy: Testing the Validity among a General and Clinical Pediatric Population

PubMed Central

Gobbi, Erica; Elliot, Catherine; Varnier, Maurizio; Carraro, Attilio

2016-01-01

The purpose of this research was to assess an Italian version of the Physical Activity Questionnaire for Older Children (PAQ-C-It). Three separate studies were conducted, whereby testing general psychometric properties, construct validity, concurrent validity and the factor structure of the PAQ-C-It among general and clinical pediatric population. Study 1 (n = 1170) examined the psychometric properties, internal consistency, factor structure (exploratory factor analysis, EFA) and construct validity with enjoyment perception during physical activity. Study 2 (n = 59) reported on reliability, construct validity with enjoyment and BMI, and on cross-sectional concurrent validity with objectively measured MVPA (tri-axial accelerometry) over the span of seven consecutive days. Study 3 (n = 58) examined the PAQ-C-It reliability, construct validity with BMI and VO2max as the objective measurement among a population of children with congenital heart defects (CHD). In study 2 and 3, the factor structure of the PAQ-C-It was then re-examined with an EFA. The PAQ-C-It showed acceptable to good reliability (alpha .70 to .83). Results on construct validity showed moderate but significant association with enjoyment perception (r = .30 and .36), with BMI (r = -.30 and -.79 for CHD simple form), and with the VO2max (r = .55 for CHD simple form). Significant concurrent validity with the objectively measured MVPA was reported (rho = .30, p < .05). Findings of the EFA suggested a two-factor structure for the PAQ-C-It, with items 2, 3, and 4 contributing little to the total score. This study supports the PAQ-C-It as an appropriate instrument to assess the MVPA levels of Italian children, including children with simple forms of CHD. Support is given to the possible instrument effectiveness on a large international perspective in order to level out data gathering across the globe. PMID:27228050

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.

Development and validation of self-reported line drawings of the modified Beighton score for the assessment of generalised joint hypermobility.

PubMed

Cooper, Dale J; Scammell, Brigitte E; Batt, Mark E; Palmer, Debbie

2018-01-17

The impracticalities and comparative expense of carrying out a clinical assessment is an obstacle in many large epidemiological studies. The purpose of this study was to develop and validate a series of electronic self-reported line drawing instruments based on the modified Beighton scoring system for the assessment of self-reported generalised joint hypermobility. Five sets of line drawings were created to depict the 9-point Beighton score criteria. Each instrument consisted of an explanatory question whereby participants were asked to select the line drawing which best represented their joints. Fifty participants completed the self-report online instrument on two occasions, before attending a clinical assessment. A blinded expert clinical observer then assessed participants' on two occasions, using a standardised goniometry measurement protocol. Validity of the instrument was assessed by participant-observer agreement and reliability by participant repeatability and observer repeatability using unweighted Cohen's kappa (k). Validity and reliability were assessed for each item in the self-reported instrument separately, and for the sum of the total scores. An aggregate score for generalised joint hypermobility was determined based on a Beighton score of 4 or more out of 9. Observer-repeatability between the two clinical assessments demonstrated perfect agreement (k 1.00; 95% CI 1.00, 1.00). Self-reported participant-repeatability was lower but it was still excellent (k 0.91; 95% CI 0.74, 1.00). The participant-observer agreement was excellent (k 0.96; 95% CI 0.87, 1.00). Validity was excellent for the self-report instrument, with a good sensitivity of 0.87 (95% CI 0.81, 0.91) and excellent specificity of 0.99 (95% CI 0.98, 1.00). The self-reported instrument provides a valid and reliable assessment of the presence of generalised joint hypermobility and may have practical use in epidemiological studies.

Prediction of serious complications in patients with seemingly stable febrile neutropenia: validation of the Clinical Index of Stable Febrile Neutropenia in a prospective cohort of patients from the FINITE study.

PubMed

Carmona-Bayonas, Alberto; Jiménez-Fonseca, Paula; Virizuela Echaburu, Juan; Antonio, Maite; Font, Carme; Biosca, Mercè; Ramchandani, Avinash; Martínez, Jerónimo; Hernando Cubero, Jorge; Espinosa, Javier; Martínez de Castro, Eva; Ghanem, Ismael; Beato, Carmen; Blasco, Ana; Garrido, Marcelo; Bonilla, Yaiza; Mondéjar, Rebeca; Arcusa Lanza, María Ángeles; Aragón Manrique, Isabel; Manzano, Aránzazu; Sevillano, Elena; Castañón, Eduardo; Cardona, Mercé; Gallardo Martín, Elena; Pérez Armillas, Quionia; Sánchez Lasheras, Fernando; Ayala de la Peña, Francisco

2015-02-10

To validate a prognostic score predicting major complications in patients with solid tumors and seemingly stable episodes of febrile neutropenia (FN). The definition of clinical stability implies the absence of organ dysfunction, abnormalities in vital signs, and major infections. We developed the Clinical Index of Stable Febrile Neutropenia (CISNE), with six explanatory variables associated with serious complications: Eastern Cooperative Oncology Group performance status ≥ 2 (2 points), chronic obstructive pulmonary disease (1 point), chronic cardiovascular disease (1 point), mucositis of grade ≥ 2 (National Cancer Institute Common Toxicity Criteria; 1 point), monocytes < 200 per μL (1 point), and stress-induced hyperglycemia (2 points). We integrated these factors into a score ranging from 0 to 8, which classifies patients into three prognostic classes: low (0 points), intermediate (1 to 2 points), and high risk (≥ 3 points). We present a multicenter validation of CISNE. We prospectively recruited 1,133 patients with seemingly stable FN from 25 hospitals. Complication rates in the training and validation subsets, respectively, were 1.1% and 1.1% in low-, 6.1% and 6.2% in intermediate-, and 32.5% and 36% in high-risk patients; mortality rates within each class were 0% in low-, 1.6% and 0% in intermediate-, and 4.3% and 3.1% in high-risk patients. Areas under the receiver operating characteristic curves in the validation subset were 0.652 (95% CI, 0.598 to 0.703) for Talcott, 0.721 (95% CI, 0.669 to 0.768) for Multinational Association for Supportive Care in Cancer (MASCC), and 0.868 (95% CI, 0.827 to 0.903) for CISNE (P = .002 for comparison between CISNE and MASCC). CISNE is a valid model for accurately classifying patients with cancer with seemingly stable FN episodes. © 2015 by American Society of Clinical Oncology.

Assessing the Culture of Residency Using the C - Change Resident Survey: Validity Evidence in 34 U.S. Residency Programs.

PubMed

Pololi, Linda H; Evans, Arthur T; Civian, Janet T; Shea, Sandy; Brennan, Robert T

2017-07-01

A practical instrument is needed to reliably measure the clinical learning environment and professionalism for residents. To develop and present evidence of validity of an instrument to assess the culture of residency programs and the clinical learning environment. During 2014-2015, we surveyed residents using the C - Change Resident Survey to assess residents' perceptions of the culture in their programs. Residents in all years of training in 34 programs in internal medicine, pediatrics, and general surgery in 14 geographically diverse public and private academic health systems. The C - Change Resident Survey assessed residents' perceptions of 13 dimensions of the culture: Vitality, Self-Efficacy, Institutional Support, Relationships/Inclusion, Values Alignment, Ethical/Moral Distress, Respect, Mentoring, Work-Life Integration, Gender Equity, Racial/Ethnic Minority Equity, and self-assessed Competencies. We measured the internal reliability of each of the 13 dimensions and evaluated response process, content validity, and construct-related evidence validity by assessing relationships predicted by our conceptual model and prior research. We also assessed whether the measurements were sensitive to differences in specialty and across institutions. A total of 1708 residents completed the survey [internal medicine: n = 956, pediatrics: n = 411, general surgery: n = 311 (51% women; 16% underrepresented in medicine minority)], with a response rate of 70% (range across programs, 51-87%). Internal consistency of each dimension was high (Cronbach α: 0.73-0.90). The instrument was able to detect significant differences in the learning environment across programs and sites. Evidence of validity was supported by a good response process and the demonstration of several relationships predicted by our conceptual model. The C - Change Resident Survey assesses the clinical learning environment for residents, and we encourage further study of validity in different contexts. Results could be used to facilitate and monitor improvements in the clinical learning environment and resident well-being.

Note on concurrent validation of the personality assessment inventory in law enforcement.

PubMed

Hays, J R

1997-08-01

This study compared the Personality Assessment Inventory and MMPI-168 profiles of 9 law enforcement applicants with published MMPI profiles to provide concurrent validation for the use of the Personality Assessment Inventory to assess personality pathology of peace officer applicants. The sample showed subclinical elevations of the Positive Impression and Treatment Rejection scales on the Personality Assessment Inventory and subclinical elevations on the MMPI validity scales of Lie and Correction and the clinical scales of Psychopathic Deviate and Hypomania. The applicants' mean MMPI profile provided concurrent validation for the use of the Personality Assessment Inventory in this decision on fitness to serve.

Adaptation of the Tinnitus Handicap Inventory into Polish and its testing on a clinical population of tinnitus sufferers.

PubMed

Skarzynski, Piotr H; Raj-Koziak, Danuta; J Rajchel, Joanna; Pilka, Adam; Wlodarczyk, Andrzej W; Skarzynski, Henryk

2017-10-01

To describe how the Tinnitus Handicap Inventory (THI) was translated into Polish (THI-POL) and to present psychometric data on how well it performed in a clinical population of tinnitus sufferers. The original version of THI was adapted into Polish. The reliability of THI-POL was investigated using test-retest, Cronbach's alpha, endorsement rate and item-total correlation. Construct validity and convergent validity were also assessed based on confirmatory factor analysis, inter-item correlation and Pearson product-moment correlations using subscale A (Tinnitus) of the Tinnitus and Hearing Survey (THS-POL); divergent validity was checked using subscale B (Hearing) of THS-POL. A group of 167 adults filled in THI-POL twice over their three-day hospitalisation period. Test-retest reliability for the total THI-POL scores was strong (r = 0.91). Cronbach's alpha coefficient for the total score was high (r = 0.95), confirming the questionnaire's stability. Confirmatory factor analysis (CFA) and inter-item correlation did not confirm the three-factor model. Convergent validity from the Tinnitus subscale of THS showed a positive strong (r = 0.75) correlation. Divergent validity showed only a moderate correlation. All analyses were statistically significant (p <  0.01). THI-POL is a valid and reliable self-administered tool, which allows the overall tinnitus handicap of Polish-speaking patients to be effectively assessed.

Reliability and Validity of the Korean Version of the Symptom Checklist-Post-Traumatic Stress Disorder Scale

PubMed Central

2016-01-01

The Symptom Checklist - Post-Traumatic Stress Disorder Scale (SCL-PTSD), also known as Crime-Related PTSD Scale has been validated in survivors of interpersonal trauma in the general population. However, the psychometric properties have not been investigated in a clinical setting for patients with PTSD from diverse traumatic events. This study investigates the reliability and validity of the Korean version of the SCL-PTSD among 104 psychiatric outpatients with PTSD, caused by interpersonal (n = 50) or non-interpersonal trauma (n = 54). Self-report data of the SCL-PTSD, Beck Depression Inventory (BDI), State-Trait Anxiety Inventory (STAI), and Impact of Events Scale-Revised (IES-R) were gathered. The Korean version of the SCL-PTSD showed excellent internal consistency and moderate-to-good four-week temporal stability in both the interpersonal and non-interpersonal trauma groups. In comparison with other diagnostic groups, the scores of the SCL-PTSD were significantly higher compared to those of adjustment disorder, depression, other anxiety disorders, and schizophrenia, demonstrating its criteria-related validity. Convergent validity was confirmed because the scores of the SCL-PTSD were significantly correlated with BDI, SAI and TAI scores. Concurrent validity was demonstrated by significant correlation with the IES-R score. This study demonstrated the favorable psychometric prosperities of the Korean version of the SCL-PTSD, supporting its use in clinical research and practice. PMID:27134501

Validation of the Italian Version of the Dizziness Handicap Inventory, the Situational Vertigo Questionnaire, and the Activity-Specific Balance Confidence Scale for Peripheral and Central Vestibular Symptoms.

PubMed

Colnaghi, Silvia; Rezzani, Cristiana; Gnesi, Marco; Manfrin, Marco; Quaglieri, Silvia; Nuti, Daniele; Mandalà, Marco; Monti, Maria Cristina; Versino, Maurizio

2017-01-01

Neurophysiological measurements of the vestibular function for diagnosis and follow-up evaluations provide an objective assessment, which, unfortunately, does not necessarily correlate with the patients' self-feeling. The literature provides many questionnaires to assess the outcome of rehabilitation programs for disequilibrium, but only for the Dizziness Handicap Inventory (DHI) is an Italian translation available, validated on a small group of patients suffering from a peripheral acute vertigo. We translated and validated the reliability and validity of the DHI, the Situational Vertigo Questionnaire (SVQ), and the Activities-Specific Balance Confidence Scale (ABC) in 316 Italian patients complaining of dizziness due either to a peripheral or to a central vestibular deficit, or in whom vestibular signs were undetectable by means of instrumental testing or clinical evaluation. Cronbach's coefficient alpha, the homogeneity index, and test-retest reproducibility, confirmed reliability of the Italian version of the three questionnaires. Validity was confirmed by correlation test between questionnaire scores. Correlations with clinical variables suggested that they can be used as a complementary tool for the assessment of vestibular symptoms. In conclusion, the Italian versions of DHI, SVQ, and ABC are reliable and valid questionnaires for assessing the impact of dizziness on the quality of life of Italian patients with peripheral or central vestibular deficit.

Validation of the Italian Version of the Dizziness Handicap Inventory, the Situational Vertigo Questionnaire, and the Activity-Specific Balance Confidence Scale for Peripheral and Central Vestibular Symptoms

PubMed Central

Colnaghi, Silvia; Rezzani, Cristiana; Gnesi, Marco; Manfrin, Marco; Quaglieri, Silvia; Nuti, Daniele; Mandalà, Marco; Monti, Maria Cristina; Versino, Maurizio

2017-01-01

Neurophysiological measurements of the vestibular function for diagnosis and follow-up evaluations provide an objective assessment, which, unfortunately, does not necessarily correlate with the patients’ self-feeling. The literature provides many questionnaires to assess the outcome of rehabilitation programs for disequilibrium, but only for the Dizziness Handicap Inventory (DHI) is an Italian translation available, validated on a small group of patients suffering from a peripheral acute vertigo. We translated and validated the reliability and validity of the DHI, the Situational Vertigo Questionnaire (SVQ), and the Activities-Specific Balance Confidence Scale (ABC) in 316 Italian patients complaining of dizziness due either to a peripheral or to a central vestibular deficit, or in whom vestibular signs were undetectable by means of instrumental testing or clinical evaluation. Cronbach’s coefficient alpha, the homogeneity index, and test–retest reproducibility, confirmed reliability of the Italian version of the three questionnaires. Validity was confirmed by correlation test between questionnaire scores. Correlations with clinical variables suggested that they can be used as a complementary tool for the assessment of vestibular symptoms. In conclusion, the Italian versions of DHI, SVQ, and ABC are reliable and valid questionnaires for assessing the impact of dizziness on the quality of life of Italian patients with peripheral or central vestibular deficit. PMID:29066999

Turkish Version of the Student Nurse Stress Index: Validity and Reliability.

PubMed

Sarikoc, Gamze; Bayram Demiralp, Meral; Oksuz, Emine; Pazar, Berrin

2017-06-01

This study aimed to adapt the Student Nurse Stress Index (SNSI) for the Turkish nursing students and investigate its psychometric properties. Research was conducted with 152 volunteer female students who attended a university college in Ankara, Turkey. Test-retest reliability was investigated for the scale internal consistency (Cronbach α) and stability. Also, content validity and construct validity of the SNSI were assessed. In order to determine the construct validity of SNSI, Uygulamalı Çok Değişkenli İstatistiksel Yöntemler and confirmatory factor analysis was conducted. The Turkish version of SNSI with 15 items comprised four factors (academic load, clinical concerns, personal problems, interface worries). The content validity index (CVI) score was .97. Factor loadings of Turkish version of SNSI varied between .532 and .868. The "personal problems" subscale explained 19.01% of the variance; "clinical concerns" explained 18.51%; "interface worries" explained 15.32%; "academic load" explained 14.14%. The total variance explained was 66.99%. CFA results (χ 2 /SD, GFI, CFI, TLI, IFI, RMSEA and SRMR) were acceptable and in good agreement. The internal consistency coefficient of the SNSI was .86. Results showed that the SNSI had a satisfactory level of reliability and validity in nursing students in Turkey. Multicenter studies including nursing students from different nursing schools are recommended for the SNSI to be generalized. Copyright © 2017. Published by Elsevier B.V.

The Scientific Status of Projective Techniques.

PubMed

Lilienfeld, S O; Wood, J M; Garb, H N

2000-11-01

Although projective techniques continue to be widely used in clinical and forensic settings, their scientific status remains highly controversial. In this monograph, we review the current state of the literature concerning the psychometric properties (norms, reliability, validity, incremental validity, treatment utility) of three major projective instruments: Rorschach Inkblot Test, Thematic Apperception Test (TAT), and human figure drawings. We conclude that there is empirical support for the validity of a small number of indexes derived from the Rorschach and TAT. However, the substantial majority of Rorschach and TAT indexes are not empirically supported. The validity evidence for human figure drawings is even more limited. With a few exceptions, projective indexes have not consistently demonstrated incremental validity above and beyond other psychometric data. In addition, we summarize the results of a new meta-analysis intended to examine the capacity of these three instruments to detect child sexual abuse. Although some projective instruments were better than chance at detecting child sexual abuse, there were virtually no replicated findings across independent investigative teams. This meta-analysis also provides the first clear evidence of substantial file drawer effects in the projectives literature, as the effect sizes from published studies markedly exceeded those from unpublished studies. We conclude with recommendations regarding the (a) construction of projective techniques with adequate validity, (b) forensic and clinical use of projective techniques, and (c) education and training of future psychologists regarding projective techniques. © 2000 Association for Psychological Science.

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.

Predictive Validity of the HKT-R Risk Assessment Tool: Two and 5-Year Violent Recidivism in a Nationwide Sample of Dutch Forensic Psychiatric Patients.

PubMed

Bogaerts, Stefan; Spreen, Marinus; Ter Horst, Paul; Gerlsma, Coby

2018-06-01

This study has examined the predictive validity of the Historical Clinical Future [ Historisch Klinisch Toekomst] Revised risk assessment scheme in a cohort of 347 forensic psychiatric patients, which were discharged between 2004 and 2008 from any of 12 highly secure forensic centers in the Netherlands. Predictive validity was measured 2 and 5 years after release. Official reconviction data obtained from the Dutch Ministry of Security and Justice were used as outcome measures. Violent reoffending within 2 and 5 years after discharge was assessed. With regard to violent reoffending, results indicated that the predictive validity of the Historical domain was modest for 2 (area under the curve [AUC] = .75) and 5 (AUC = .74) years. The predictive validity of the Clinical domain was marginal for 2 (admission: AUC = .62; discharge: AUC = .63) and 5 (admission: AUC = .69; discharge: AUC = .62) years after release. The predictive validity of the Future domain was modest (AUC = .71) for 2 years and low for 5 (AUC = .58) years. The total score of the instrument was modest for 2 years (AUC = .78) and marginal for 5 (AUC = .68) years. Finally, the Final Risk Judgment was modest for 2 years (AUC = .78) and marginal for 5 (AUC = .63) years time at risk. It is concluded that this risk assessment instrument appears to be a satisfactory instrument for risk assessment.

Validation of the Italian version of the Apathy Evaluation Scale (AES-I) in institutionalized geriatric patients.

PubMed

Borgi, Marta; Caccamo, Floriana; Giuliani, Alessandro; Piergentili, Alessandro; Sessa, Sonia; Reda, Emilia; Alleva, Enrico; Cirulli, Francesca; Miraglia, Fabio

2016-01-01

Apathy is a very common symptom in the institutionalized elderly and represents a condition of both clinical and public health importance. The Apathy Evaluation Scale (AES) has been shown to be a valid and reliable tool for characterizing, quantifying and differentiating apathy in various health conditions. The aims of this study were to establish the validity and reliability of the Italian version of the AES, and to assess the severity of apathy in a sample of Italian institutionalized geriatric patients. Data were collected from clinical interviews using the AES informant version (AES-I). Associations between measures of apathy and depression, cognitive functioning and perceived quality of life were evaluated, as well as the effects of the living environment on apathetic symptoms. Multiple forms of reliability and validity (i.e. test-retest, internal consistency, discriminability of apathy rating from a standard measure of depression) were satisfied. Our results also show that the characteristics of the care setting may affect the severity of apathetic symptoms. The AES-I Italian version is a reliable and valid instrument for measuring apathy in Italian patients, also allowing a direct comparison with data gathered in other countries.

[Reliability and validity of the Turkish version of the internalized stigma of mental illness scale].

PubMed

Ersoy, Mehmet Akif; Varan, Azmi

2007-01-01

The aim of this study was to evaluate the reliability and validity of the Turkish version of the Internalized Stigma of Mental Illness Scale (ISMI) in patients with psychiatric disorders. The study included 203 patients diagnosed with various psychiatric disorders in a psychiatry outpatient clinic of a university hospital. The reliability of the scale was assessed by investigation of its internal consistency and split-half reliability. The convergent validity of the scale was demonstrated by the relationship between the Turkish form of the ISMI and various criteria scales. Cronbach's alpha value was 0.93 for the entire scale and ranged between 0.63 and 0.87 for the 5 subscales of the ISMI. In terms of convergent validity, the total score of the Turkish ISMI significantly correlated with the Beck Depression Inventory, Rosenberg Self-Esteem Scale, Sociotropy-Autonomy Scale, Brief Symptom Inventory, Multidimensional Scale of Perceived Social Support, Clinical Global Impression Scale, and Global Assessment of Functioning Scale scores. All values were in the expected direction. In the light of the findings, it was concluded that the Turkish version of ISMI could be used as a reliable and valid tool in assessing internalized stigma of the Turkish psychiatric patients.

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.

On the Value of Homogeneous Constructs for Construct Validation, Theory Testing, and the Description of Psychopathology

PubMed Central

Smith, Gregory T.; McCarthy, Denis M.; Zapolski, Tamika C. B.

2010-01-01

The authors argue for a significant shift in how clinical psychology researchers conduct construct validation and theory validation tests. They argue that sound theory and validation tests can best be conducted on measures of unidimensional or homogeneous constructs. Hierarchical organizations of such constructs are useful descriptively and theoretically, but higher order composites do not refer to definable psychological processes. Application of this perspective to the approach of the Diagnostic and Statistical Manual of Mental Disorders to describing psychopathology calls into doubt the traditional use of the syndromal approach, in which single scores reflect the presence of multidimensional disorders. For many forms of psychological dysfunction, this approach does not appear optimal and may need to be discarded. The authors note that their perspective represents a straightforward application of existing psychometric theory, they demonstrate the practical value of adopting this perspective, and they provide evidence that this shift is already under way among clinical researchers. Description in terms of homogeneous dimensions provides improved validity, utility, and parsimony. In contrast, the use of composite diagnoses can retard scientific progress and hamper clinicians' efforts to understand and treat dysfunction. PMID:19719340

Statistical considerations on prognostic models for glioma

PubMed Central

Molinaro, Annette M.; Wrensch, Margaret R.; Jenkins, Robert B.; Eckel-Passow, Jeanette E.

2016-01-01

Given the lack of beneficial treatments in glioma, there is a need for prognostic models for therapeutic decision making and life planning. Recently several studies defining subtypes of glioma have been published. Here, we review the statistical considerations of how to build and validate prognostic models, explain the models presented in the current glioma literature, and discuss advantages and disadvantages of each model. The 3 statistical considerations to establishing clinically useful prognostic models are: study design, model building, and validation. Careful study design helps to ensure that the model is unbiased and generalizable to the population of interest. During model building, a discovery cohort of patients can be used to choose variables, construct models, and estimate prediction performance via internal validation. Via external validation, an independent dataset can assess how well the model performs. It is imperative that published models properly detail the study design and methods for both model building and validation. This provides readers the information necessary to assess the bias in a study, compare other published models, and determine the model's clinical usefulness. As editors, reviewers, and readers of the relevant literature, we should be cognizant of the needed statistical considerations and insist on their use. PMID:26657835

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.

The Arabic version of the Mayo-Portland Adaptability Inventory 4: a validation study.

PubMed

Hamed, Razan; Tariah, Hashem Abu; Malkawi, Somaya; Holm, Margo B

2012-09-01

The Mayo-Portland Adaptability Inventory 4 (MPAI-4) is a valid and reliable assessment tool to detect clinical impairments in patients with acquired brain injury. The tool is widely used by rehabilitation therapists worldwide, given its good psychometric properties and its availability in several languages. The purpose of this study was to translate the tool into Arabic and to examine its validity and reliability with multiple sclerosis and stroke patients. A total of 128 participants were enrolled in this study: 49 with multiple sclerosis, 17 with stroke, and 62 healthy adults. The psychometric properties of discriminative and convergent construct validity as well as test-retest reliability were tested. The translated tool, the Arabic-MPAI-4 (A-MPAI-4), significantly discriminated among the three subgroups (F=50.93, P<0.001), correlated moderately but significantly with the Arabic version of the Performance Assessment of Self-Care Skills Self-Report as a measure of functional independence in daily activities (r=-0.35, P<0.001), and showed good stability over time (r=0.73, P<0.001). The A-MPAI-4 is a valid and reliable tool for clinical use with multiple sclerosis and stroke patients who speak Arabic.

[German Validation of the "King's Brief Interstitial Lung Disease (K-Bild) Health Status Questionnaire"].

PubMed

Kreuter, M; Birring, S S; Wijsenbeek, M; Wapenaar, M; Oltmanns, U; Costabel, U; Bonella, F

2016-11-01

Background: Health status and quality of life are impaired in patients with interstitial lung disease (ILD). To assess these parameters in ILD patients no valid and reliable questionnaire exists in German language so far. The K-BILD questionnaire is a brief and valid tool to evaluate health status in ILD patients, with no validated German version. Method: The linguistic validation of K-BILD was carried out in a multistage process in collaboration with the developer of the questionnaire and bilingual, professional translators. Review by the developers and back translations as well as clinical assessment by ILD patients ensured that the translated questionnaire reflected the intention of the original K-BILD. Results: A German version of K-BILD with 15 questions concerning the health status was composed. The questions cover the three domains breathlessness and activities, psychological aspects and chest symptoms. Problems in understanding or difficulties in replying to the questions were not stated by the ILD patients. Conclusion: The German version of the K-BILD questionnaire allows the clinical and scientific use to measure reliable health quality in ILD patients. © Georg Thieme Verlag KG Stuttgart · New York.

What tests should you use to assess small intestinal bacterial overgrowth in systemic sclerosis?

PubMed

Braun-Moscovici, Yolanda; Braun, Marius; Khanna, Dinesh; Balbir-Gurman, Alexandra; Furst, Daniel E

2015-01-01

Small intestinal bacterial overgrowth (SIBO) plays a major role in the pathogenesis of malabsorption in SSc patients and is a source of great morbidity and even mortality, in those patients. This manuscript reviews which tests are valid and should be used in SSc when evaluating SIBO. We performed systematic literature searches in PubMed, Embase and the Cochrane library from 1966 up to November 2014 for English language, published articles examining bacterial overgrowth in SSc (e.g. malabsorption tests, breath tests, xylose test, etc). Articles obtained from these searches were reviewed for additional references. The validity of the tests was evaluated according to the OMERACT principles of truth, discrimination and feasibility. From a total of 65 titles, 22 articles were reviewed and 20 were ultimately extracted to examine the validity of tests for GI morphology, bacterial overgrowth and malabsorption in SSc. Only 1 test (hydrogen and methane breath tests) is fully validated. Four tests are partially validated, including jejunal cultures, xylose, lactulose tests, and 72 hours fecal fat test. Only 1 of a total of 5 GI tests of bacterial overgrowth (see above) is fully validated in SSc. For clinical trials, fully validated tests are preferred, although some investigators use partially validated tests (4 tests). Further validation of GI tests in SSc is needed.