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Sample records for validity clinical validity

  1. Validating EHR clinical models using ontology patterns.

    Science.gov (United States)

    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.

  2. Circulating tumor cells: clinical validity and utility.

    Science.gov (United States)

    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.

  3. Validation of Clinical Testing for Warfarin Sensitivity

    Science.gov (United States)

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

    2009-01-01

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

  4. Clinical validation of the Tempus xO assay

    Science.gov (United States)

    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

  5. The validity and clinical utility of purging disorder.

    Science.gov (United States)

    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.

  6. Comprehensive clinical validation of the nuclear stethoscope

    Energy Technology Data Exchange (ETDEWEB)

    Caruana, M.; Jones, R.; Lahiri, A.; Brigden, G.; Rodrigues, E.; Dore, C.; Raftery, E.B.

    1986-10-01

    Five studies were conducted to examine the degree of variability to be expected during the use of the non-imaging nuclear probe (BIOS Inc.) under a variety of clinical conditions. Comparison of the ejection fraction (EF) readings between the nuclear probe and a gamma camera showed good agreement, with the nuclear probe tending to underestimate lower, and overestimate higher camera EF values. It is concluded that the portable, low cost nuclear probe produces accurate EF measurements when compared with the gamma camera.

  7. Transition questions in clinical practice - validity and reproducibility

    DEFF Research Database (Denmark)

    Lauridsen, Henrik Hein

    2008-01-01

    Transition questions in CLINICAL practice - validity and reproducibility Lauridsen HH1, Manniche C3, Grunnet-Nilsson N1, Hartvigsen J1,2 1   Clinical Locomotion Science, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark. e-mail: hlauridsen......@health.sdu.dk 2   Nordic Institute of Chiropractic and Clinical Biomechanics, Part of Clinical Locomotion Science, Odense, Denmark 3   Backcenter Funen, Part of Clinical Locomotion Science, Ringe, Denmark   Abstract  Understanding a change score is indispensable for interpretation of results from clinical studies...... are reproducible in patients with low back pain and/or leg pain. Despite critique of several biases, our results have reinforced the construct validity of TQ’s as an outcome measure since only 1 hypothesis was rejected. On the basis of our findings we have outlined a proposal for a standardised use of transition...

  8. Completeness and validity in a national clinical thyroid cancer database

    DEFF Research Database (Denmark)

    Londero, Stefano Christian; Mathiesen, Jes Sloth; Krogdahl, Annelise

    2014-01-01

    cancer database: DATHYRCA. STUDY DESIGN AND SETTING: National prospective cohort. Denmark; population 5.5 million. Completeness of case ascertainment was estimated by the independent case ascertainment method using three governmental registries as a reference. The reabstracted record method was used...... to appraise the validity. For validity assessment 100 cases were randomly selected from the DATHYRCA database; medical records were used as a reference. RESULT: The database held 1934 cases of thyroid carcinoma and completeness of case ascertainment was estimated to 90.9%. Completeness of registration......BACKGROUND: Although a prospective national clinical thyroid cancer database (DATHYRCA) has been active in Denmark since January 1, 1996, no assessment of data quality has been performed. The purpose of the study was to evaluate completeness and data validity in the Danish national clinical thyroid...

  9. Validation of a clinical assessment tool for spinal anaesthesia.

    LENUS (Irish Health Repository)

    Breen, D

    2011-07-01

    There is a need for a procedure-specific means of assessment of clinical performance in anaesthesia. The aim of this study was to devise a tool for assessing the performance of spinal anaesthesia, which has both content and construct validity.

  10. Clinical Validation of Point-Source Corneal Topography in Keratoplasty

    NARCIS (Netherlands)

    Vrijling, A C L; Braaf, B.; Snellenburg, J.J.; de Lange, F.; Zaal, M.J.W.; van der Heijde, G.L.; Sicam, V.A.D.P.

    2011-01-01

    Purpose. To validate the clinical performance of point-source corneal topography (PCT) in postpenetrating keratoplasty (PKP) eyes and to compare it with conventional Placido-based topography. Methods. Corneal elevation maps of the anterior corneal surface were obtained from 20 post-PKP corneas using

  11. Content Validation of Athletic Therapy Clinical Presentations in Canada

    Science.gov (United States)

    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:…

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

    Science.gov (United States)

    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.

  13. Validation of a clinical critical thinking skills test in nursing

    Directory of Open Access Journals (Sweden)

    Sujin Shin

    2015-01-01

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

  14. Validation of a clinical critical thinking skills test in nursing.

    Science.gov (United States)

    Shin, Sujin; Jung, Dukyoo; Kim, Sungeun

    2015-01-27

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

  15. Validation of a clinical critical thinking skills test in nursing

    OpenAIRE

    Shin, Sujin; Jung, Dukyoo; Kim, Sungeun

    2015-01-01

    Purpose: The purpose of this study was to develop a revised version of the clinical critical thinking skills test (CCTS) and to subsequently validate its performance. Methods: This study is a secondary analysis of the CCTS. Data were obtained from a convenience sample of 284 college students in June 2011. Thirty items were analyzed using item response theory and test reliability was assessed. Test-retest reliability was measured using the results of 20 nursing college and graduate school stud...

  16. Explicating Validity

    Science.gov (United States)

    Kane, Michael T.

    2016-01-01

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

  17. Clinical validity of prototype personality disorder ratings in adolescents.

    Science.gov (United States)

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

    2015-01-01

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

  18. Validation of Clinical Observations of Mastication in Persons with ALS.

    Science.gov (United States)

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

    2016-06-01

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

  19. Validating relationships among attachment, emotional intelligence and clinical communication.

    Science.gov (United States)

    Cherry, M Gemma; Fletcher, Ian; O'Sullivan, Helen

    2014-10-01

    In a previous study, we found that emotional intelligence (EI) mediates the negative influences of Year 1 medical students' attachment styles on their provider-patient communication (PPC). However, in that study, students were examined on a relatively straightforward PPC skill set and were not assessed on their abilities to elicit relevant clinical information from standardised patients. The influence of these psychological variables in more demanding and realistic clinical scenarios warrants investigation. This study aimed to validate previous research findings by exploring the mediating effect of EI on the relationship between medical students' attachment styles and their PPC across an ecologically valid PPC objective structured clinical examination (OSCE). Year 2 medical students completed measures of attachment (the Experiences in Close Relationships-Short Form [ECR-SF], a 12-item measure which provides attachment avoidance and attachment anxiety dimensional scores) and EI (the Mayer-Salovey-Caruso Emotional Intelligence Test [MSCEIT], a 141-item measure on the perception, use, understanding and management of emotions), prior to their summative PPC OSCE. Provider-patient communication was assessed using OSCE scores. Structural equation modelling (SEM) was used to validate our earlier model of the relationships between attachment style, EI and PPC. A total of 296 of 382 (77.5%) students participated. Attachment avoidance was significantly negatively correlated with total EI scores (r = -0.23, p < 0.01); total EI was significantly positively correlated with OSCE scores (r = 0.32, p < 0.01). Parsimonious SEM confirmed that EI mediated the negative influence of attachment avoidance on OSCE scores. It significantly predicted 14% of the variance in OSCE scores, twice as much as the 7% observed in the previous study. In more demanding and realistic clinical scenarios, EI makes a greater contribution towards effective PPC. Attachment is perceived to be stable

  20. Assessing Discriminative Performance at External Validation of Clinical Prediction Models.

    Directory of Open Access Journals (Sweden)

    Daan Nieboer

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

  1. Patient Experiences with the Preoperative Assessment Clinic (PEPAC): validation of an instrument to measure patient experiences

    NARCIS (Netherlands)

    Edward, G. M.; Lemaire, L. C.; Preckel, B.; Oort, F. J.; Bucx, M. J. L.; Hollmann, M. W.; de Haes, J. C. J. M.

    2007-01-01

    Background. Presently, no comprehensive and validated questionnaire to measure patient experiences of the preoperative assessment clinic (PAC) is available. We developed and validated the Patient Experiences with the Preoperative Assessment Clinic (PEPAC) questionnaire, which can be used for

  2. Construct Validity and Case Validity in Assessment

    Science.gov (United States)

    Teglasi, Hedwig; Nebbergall, Allison Joan; Newman, Daniel

    2012-01-01

    Clinical assessment relies on both "construct validity", which focuses on the accuracy of conclusions about a psychological phenomenon drawn from responses to a measure, and "case validity", which focuses on the synthesis of the full range of psychological phenomena pertaining to the concern or question at hand. Whereas construct validity is…

  3. FACTAR validation

    International Nuclear Information System (INIS)

    Middleton, P.B.; Wadsworth, S.L.; Rock, R.C.; Sills, H.E.; Langman, V.J.

    1995-01-01

    A detailed strategy to validate fuel channel thermal mechanical behaviour codes for use of current power reactor safety analysis is presented. The strategy is derived from a validation process that has been recently adopted industry wide. Focus of the discussion is on the validation plan for a code, FACTAR, for application in assessing fuel channel integrity safety concerns during a large break loss of coolant accident (LOCA). (author)

  4. External validation and comparison of three pediatric clinical dehydration scales.

    Directory of Open Access Journals (Sweden)

    Joshua Jauregui

    Full Text Available OBJECTIVE: To prospectively validate three popular clinical dehydration scales and overall physician gestalt in children with vomiting or diarrhea relative to the criterion standard of percent weight change with rehydration. METHODS: We prospectively enrolled a non-consecutive cohort of children ≤ 18 years of age with an acute episode of diarrhea or vomiting. Patient weight, clinical scale variables and physician clinical impression, or gestalt, were recorded before and after fluid resuscitation in the emergency department and upon hospital discharge. The percent weight change from presentation to discharge was used to calculate the degree of dehydration, with a weight change of ≥ 5% considered significant dehydration. Receiver operating characteristics (ROC curves were constructed for each of the three clinical scales and physician gestalt. Sensitivity and specificity were calculated based on the best cut-points of the ROC curve. RESULTS: We approached 209 patients, and of those, 148 were enrolled and 113 patients had complete data for analysis. Of these, 10.6% had significant dehydration based on our criterion standard. The Clinical Dehydration Scale (CDS and Gorelick scales both had an area under the ROC curve (AUC statistically different from the reference line with AUCs of 0.72 (95% CI 0.60, 0.84 and 0.71 (95% CI 0.57, 0.85 respectively. The World Health Organization (WHO scale and physician gestalt had AUCs of 0.61 (95% CI 0.45, 0.77 and 0.61 (0.44, 0.78 respectively, which were not statistically significant. CONCLUSION: The Gorelick scale and Clinical Dehydration Scale were fair predictors of dehydration in children with diarrhea or vomiting. The World Health Organization scale and physician gestalt were not helpful predictors of dehydration in our cohort.

  5. External validation and comparison of three pediatric clinical dehydration scales.

    Science.gov (United States)

    Jauregui, Joshua; Nelson, Daniel; Choo, Esther; Stearns, Branden; Levine, Adam C; Liebmann, Otto; Shah, Sachita P

    2014-01-01

    To prospectively validate three popular clinical dehydration scales and overall physician gestalt in children with vomiting or diarrhea relative to the criterion standard of percent weight change with rehydration. We prospectively enrolled a non-consecutive cohort of children ≤ 18 years of age with an acute episode of diarrhea or vomiting. Patient weight, clinical scale variables and physician clinical impression, or gestalt, were recorded before and after fluid resuscitation in the emergency department and upon hospital discharge. The percent weight change from presentation to discharge was used to calculate the degree of dehydration, with a weight change of ≥ 5% considered significant dehydration. Receiver operating characteristics (ROC) curves were constructed for each of the three clinical scales and physician gestalt. Sensitivity and specificity were calculated based on the best cut-points of the ROC curve. We approached 209 patients, and of those, 148 were enrolled and 113 patients had complete data for analysis. Of these, 10.6% had significant dehydration based on our criterion standard. The Clinical Dehydration Scale (CDS) and Gorelick scales both had an area under the ROC curve (AUC) statistically different from the reference line with AUCs of 0.72 (95% CI 0.60, 0.84) and 0.71 (95% CI 0.57, 0.85) respectively. The World Health Organization (WHO) scale and physician gestalt had AUCs of 0.61 (95% CI 0.45, 0.77) and 0.61 (0.44, 0.78) respectively, which were not statistically significant. The Gorelick scale and Clinical Dehydration Scale were fair predictors of dehydration in children with diarrhea or vomiting. The World Health Organization scale and physician gestalt were not helpful predictors of dehydration in our cohort.

  6. Clinical and psychometric validation of the psychotic depression assessment scale

    DEFF Research Database (Denmark)

    Østergaard, Søren D; Pedersen, Christina H; Uggerby, Peter

    2015-01-01

    BACKGROUND: Recent studies have indicated that the 11-item Psychotic Depression Assessment Scale (PDAS), consisting of the 6-item melancholia subscale (HAM-D6) of the Hamilton Depression Rating Scale and 5 psychosis items from the Brief Psychiatric Rating Scale (BPRS), is a valid measure for the ...

  7. Validity of Two WPPSI Short Forms in Outpatient Clinic Settings.

    Science.gov (United States)

    Haynes, Jack P.; Atkinson, David

    1983-01-01

    Investigated the validity of subtest short forms for the Wechsler Preschool and Primary Scale of Intelligence in an outpatient population of 116 children. Data showed that the short forms underestimated actual level of intelligence and supported use of a short form only as a brief screening device. (LLL)

  8. Predictive Validity of DSM-IV Oppositional Defiant and Conduct Disorders in Clinically Referred Preschoolers

    Science.gov (United States)

    Keenan, Kate; Boeldt, Debra; Chen, Diane; Coyne, Claire; Donald, Radiah; Duax, Jeanne; Hart, Katherine; Perrott, Jennifer; Strickland, Jennifer; Danis, Barbara; Hill, Carri; Davis, Shante; Kampani, Smita; Humphries, Marisha

    2011-01-01

    Background: Diagnostic validity of oppositional defiant and conduct disorders (ODD and CD) for preschoolers has been questioned based on concerns regarding the ability to differentiate normative, transient disruptive behavior from clinical symptoms. Data on concurrent validity have accumulated, but predictive validity is limited. Predictive…

  9. [Multicenter validation of the clinical dehydration scale for children].

    Science.gov (United States)

    Gravel, J; Manzano, S; Guimont, C; Lacroix, L; Gervaix, A; Bailey, B

    2010-12-01

    Dehydration is an important complication for sick children. The Clinical Dehydration Scale for children (CDS) measures dehydration based on 4 clinical signs: general appearance, eyes, saliva, and tears. To validate the association between the CDS and markers of dehydration in children aged 1 month to 5 years visiting emergency departments (EDs) for vomiting and/or diarrhea. An international prospective cohort study conducted in 3 university-affiliated EDs in 2009. Participants were a convenience sample of children aged 1-60 months presenting to the ED for acute vomiting and/or diarrhea. Following triage, a research nurse obtained informed consent and evaluated dehydration using the CDS. A few days after recovery, another research assistant weighed participants at home. The primary outcome was the percentage of dehydration calculated by the difference in weight at first evaluation and after recovery. Secondary outcomes included proportion of blood test measurements, intravenous use, hospitalization, and inter-rater agreement. During the study period, 264 children were recruited and data regarding weight and dehydration scores were complete for 219 (83%). According to the CDS, 88 had no dehydration, 159 some dehydration, and 15 moderate or severe dehydration. A Chi-square test showed a statistical association between CDS and weight gain, the occurrence of blood tests, intravenous rehydration, hospitalization, and abnormal plasmatic bicarbonate. Good inter-rater correlation was found among participants (linear weighted Kappa score of 0.65; (95% CI, 0.43-0.87). CDS categories correlate with markers of dehydration for young children complaining of vomiting and/or diarrhea in the ED. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

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

    Science.gov (United States)

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

    2007-04-01

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

  11. A Valid and Reliable Tool to Assess Nursing Students` Clinical Performance

    OpenAIRE

    Mehrnoosh Pazargadi; Tahereh Ashktorab; Sharareh Khosravi; Hamid Alavi majd

    2013-01-01

    Background: The necessity of a valid and reliable assessment tool is one of the most repeated issues in nursing students` clinical evaluation. But it is believed that present tools are not mostly valid and can not assess students` performance properly.Objectives: This study was conducted to design a valid and reliable assessment tool for evaluating nursing students` performance in clinical education.Methods: In this methodological study considering nursing students` performance definition; th...

  12. Validation philosophy

    International Nuclear Information System (INIS)

    Vornehm, D.

    1994-01-01

    To determine when a set of calculations falls within an umbrella of an existing validation documentation, it is necessary to generate a quantitative definition of range of applicability (our definition is only qualitative) for two reasons: (1) the current trend in our regulatory environment will soon make it impossible to support the legitimacy of a validation without quantitative guidelines; and (2) in my opinion, the lack of support by DOE for further critical experiment work is directly tied to our inability to draw a quantitative open-quotes line-in-the-sandclose quotes beyond which we will not use computer-generated values

  13. Clinical prediction models for bronchopulmonary dysplasia: a systematic review and external validation study

    NARCIS (Netherlands)

    Onland, Wes; Debray, Thomas P.; Laughon, Matthew M.; Miedema, Martijn; Cools, Filip; Askie, Lisa M.; Asselin, Jeanette M.; Calvert, Sandra A.; Courtney, Sherry E.; Dani, Carlo; Durand, David J.; Marlow, Neil; Peacock, Janet L.; Pillow, J. Jane; Soll, Roger F.; Thome, Ulrich H.; Truffert, Patrick; Schreiber, Michael D.; van Reempts, Patrick; Vendettuoli, Valentina; Vento, Giovanni; van Kaam, Anton H.; Moons, Karel G.; Offringa, Martin

    2013-01-01

    Bronchopulmonary dysplasia (BPD) is a common complication of preterm birth. Very different models using clinical parameters at an early postnatal age to predict BPD have been developed with little extensive quantitative validation. The objective of this study is to review and validate clinical

  14. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus

    DEFF Research Database (Denmark)

    Petri, Michelle; Orbai, Ana-Maria; Alarcón, Graciela S

    2012-01-01

    The Systemic Lupus International Collaborating Clinics (SLICC) group revised and validated the American College of Rheumatology (ACR) systemic lupus erythematosus (SLE) classification criteria in order to improve clinical relevance, meet stringent methodology requirements, and incorporate new...

  15. Validity of randomized clinical trials in gastroenterology from 1964-2000

    DEFF Research Database (Denmark)

    Kjaergard, Lise L; Frederiksen, Sarah L; Gluud, Christian

    2002-01-01

    The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000.......The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000....

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

    Science.gov (United States)

    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…

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

    Science.gov (United States)

    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…

  18. External validation of a clinical scoring system for the risk of gestational diabetes mellitus

    NARCIS (Netherlands)

    van Leeuwen, M.; Opmeer, B. C.; Zweers, E. J. K.; van Ballegooie, E.; ter Brugge, H. G.; de Valk, H. W.; Visser, G. H. A.; Mol, B. W. J.

    Aim: A prediction rule for gestational diabetes mellitus (GDM) could be helpful in early detection and increased efficiency of screening. A prediction rule by means of a clinical scoring system is available, but has never been validated externally. The aim of this study was to validate the scoring

  19. Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity

    Directory of Open Access Journals (Sweden)

    Birtwhistle Richard

    2003-12-01

    Full Text Available Abstract Background Controlled clinical trials of health care interventions are either explanatory or pragmatic. Explanatory trials test whether an intervention is efficacious; that is, whether it can have a beneficial effect in an ideal situation. Pragmatic trials measure effectiveness; they measure the degree of beneficial effect in real clinical practice. In pragmatic trials, a balance between external validity (generalizability of the results and internal validity (reliability or accuracy of the results needs to be achieved. The explanatory trial seeks to maximize the internal validity by assuring rigorous control of all variables other than the intervention. The pragmatic trial seeks to maximize external validity to ensure that the results can be generalized. However the danger of pragmatic trials is that internal validity may be overly compromised in the effort to ensure generalizability. We are conducting two pragmatic randomized controlled trials on interventions in the management of hypertension in primary care. We describe the design of the trials and the steps taken to deal with the competing demands of external and internal validity. Discussion External validity is maximized by having few exclusion criteria and by allowing flexibility in the interpretation of the intervention and in management decisions. Internal validity is maximized by decreasing contamination bias through cluster randomization, and decreasing observer and assessment bias, in these non-blinded trials, through baseline data collection prior to randomization, automating the outcomes assessment with 24 hour ambulatory blood pressure monitors, and blinding the data analysis. Summary Clinical trials conducted in community practices present investigators with difficult methodological choices related to maintaining a balance between internal validity (reliability of the results and external validity (generalizability. The attempt to achieve methodological purity can

  20. Validity, reliability, and feasibility of clinical staging scales in dementia: a systematic review

    DEFF Research Database (Denmark)

    Rikkert, Marcel G M Olde; Tona, Klodiana Daphne; Janssen, Lieneke

    2011-01-01

    New staging systems of dementia require adaptation of disease management programs and adequate staging instruments. Therefore, we systematically reviewed the literature on validity and reliability of clinically applicable, multidomain, and dementia staging instruments. A total of 23 articles...

  1. Clinical reliability and validity of elbow functional assessment in rheumatoid arthritis.

    NARCIS (Netherlands)

    Boer, Y.A. de; Ende, C.H.M. van den; Eygendaal, D.; Jolie, I.M.M.; Hazes, J.M.W.; Rozing, P.M.

    1999-01-01

    OBJECTIVES: (1) To investigate the measurement characteristics of the Hospital for Special Surgery (HSS) and Mayo Clinic elbow assessment instruments, utilizing methodological criteria including feasibility, reliability, validity, and discriminative ability; and (2) to develop an efficient and

  2. Clinical Validity of the Counseling Center Assessment of Psychological Symptoms-62 (CCAPS-62): Further Evaluation and Clinical Applications

    Science.gov (United States)

    McAleavey, Andrew A.; Nordberg, Samuel S.; Hayes, Jeffrey A.; Castonguay, Louis G.; Locke, Benjamin D.; Lockard, Allison J.

    2012-01-01

    Self-report instruments of psychological symptoms are increasingly used in counseling centers but rely on rigorous evaluation of their clinical validity. Three studies reported here (total N = 26,886) investigated the validity of the Counseling Center Assessment of Psychological Symptoms-62 (CCAPS-62; Locke et al., 2011) as an assessment and…

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  5. Validity, reliability, and feasibility of clinical staging scales in dementia: a systematic review

    DEFF Research Database (Denmark)

    Rikkert, Marcel G M Olde; Tona, Klodiana Daphne; Janssen, Lieneke

    2011-01-01

    New staging systems of dementia require adaptation of disease management programs and adequate staging instruments. Therefore, we systematically reviewed the literature on validity and reliability of clinically applicable, multidomain, and dementia staging instruments. A total of 23 articles...... describing 12 staging instruments were identified (N = 6109 participants, age 65-87). Reliability was studied in most (91%) of the articles and was judged moderate to good. Approximately 78% of the articles evaluated concurrent validity, which was good to very good, while discriminant validity was assessed...... in only 25%. The scales can be applied in ±15 minutes. Clinical Dementia Rating (CDR), Global Deterioration scale (GDS), and Functional Assessment Staging (FAST) have been monitored on reliability and validity, and the CDR currently is the best-evidenced scale, also studied in international perspective...

  6. How valid are claims for synergy in published clinical studies?

    Science.gov (United States)

    Ocana, A; Amir, E; Yeung, C; Seruga, B; Tannock, I F

    2012-08-01

    Clinical trials evaluating drug combinations are often stimulated by claims of synergistic interactions in preclinical models. Overuse or misuse of the term synergy could lead to poorly designed clinical studies. We searched PubMed using the terms 'synergy' or 'synergistic' and 'cancer' to select articles published between 2006 and 2010. Eligible studies were those that referred to synergy in preclinical studies to justify a drug combination evaluated in a clinical trial. Eighty-six clinical articles met eligibility criteria and 132 preclinical articles were cited in them. Most of the clinical studies were phase I (43%) or phase II trials (56%). Appropriate methods to evaluate synergy in preclinical studies included isobologram analysis in 18 studies (13.6%) and median effect in 10 studies (7.6%). Only 26 studies using animal models (39%) attempted to evaluate therapeutic index. There was no association between the result of the clinical trial and the use of an appropriate method to evaluate synergy (P=0.25, chi-squared test). Synergy is cited frequently in phase I and phase II studies to justify the evaluation of a specific drug combination. Inappropriate methods for evaluation of synergy and poor assessment of therapeutic index have been used in most preclinical articles.

  7. Clinical validation of a nanodiamond-embedded thermoplastic biomaterial.

    Science.gov (United States)

    Lee, Dong-Keun; Kee, Theodore; Liang, Zhangrui; Hsiou, Desiree; Miya, Darron; Wu, Brian; Osawa, Eiji; Chow, Edward Kai-Hua; Sung, Eric C; Kang, Mo K; Ho, Dean

    2017-11-07

    Detonation nanodiamonds (NDs) are promising drug delivery and imaging agents due to their uniquely faceted surfaces with diverse chemical groups, electrostatic properties, and biocompatibility. Based on the potential to harness ND properties to clinically address a broad range of disease indications, this work reports the in-human administration of NDs through the development of ND-embedded gutta percha (NDGP), a thermoplastic biomaterial that addresses reinfection and bone loss following root canal therapy (RCT). RCT served as the first clinical indication for NDs since the procedure sites involved nearby circulation, localized administration, and image-guided treatment progress monitoring, which are analogous to many clinical indications. This randomized, single-blind interventional treatment study evaluated NDGP equivalence with unmodified GP. This progress report assessed one control-arm and three treatment-arm patients. At 3-mo and 6-mo follow-up appointments, no adverse events were observed, and lesion healing was confirmed in the NDGP-treated patients. Therefore, this study is a foundation for the continued clinical translation of NDs and other nanomaterials for a broad spectrum of applications. Published under the PNAS license.

  8. Clinical validation of synthetic brain MRI in children: initial experience

    International Nuclear Information System (INIS)

    West, Hollie; Leach, James L.; Jones, Blaise V.; Care, Marguerite; Radhakrishnan, Rupa; Merrow, Arnold C.; Alvarado, Enrique; Serai, Suraj D.

    2017-01-01

    The purpose of this study was to determine the diagnostic accuracy of synthetic MR sequences generated through post-acquisition processing of a single sequence measuring inherent R1, R2, and PD tissue properties compared with sequences acquired conventionally as part of a routine clinical pediatric brain MR exam. Thirty-two patients underwent routine clinical brain MRI with conventional and synthetic sequences acquired (22 abnormal). Synthetic axial T1, T2, and T2 fluid attenuation inversion recovery or proton density-weighted sequences were made to match the comparable clinical sequences. Two exams for each patient were de-identified. Four blinded reviewers reviewed eight patients and were asked to generate clinical reports on each exam (synthetic or conventional) at two different time points separated by a mean of 33 days. Exams were rated for overall and specific finding agreement (synthetic/conventional and compared to gold standard consensus review by two senior reviewers with knowledge of clinical report), quality, and diagnostic confidence. Overall agreement between conventional and synthetic exams was 97%. Agreement with consensus readings was 84% (conventional) and 81% (synthetic), p = 0.61. There were no significant differences in sensitivity, specificity, or accuracy for specific imaging findings involving the ventricles, CSF, brain parenchyma, or vasculature between synthetic or conventional exams (p > 0.05). No significant difference in exam quality, diagnostic confidence, or noise/artifacts was noted comparing studies with synthetic or conventional sequences. Diagnostic accuracy and quality of synthetically generated sequences are comparable to conventionally acquired sequences as part of a standard pediatric brain exam. Further confirmation in a larger study is warranted. (orig.)

  9. Clinical validation of synthetic brain MRI in children: initial experience

    Energy Technology Data Exchange (ETDEWEB)

    West, Hollie; Leach, James L.; Jones, Blaise V.; Care, Marguerite; Radhakrishnan, Rupa; Merrow, Arnold C.; Alvarado, Enrique; Serai, Suraj D. [Cincinnati Children' s Hospital Medical Center, Department of Radiology, Cincinnati, OH (United States)

    2017-01-15

    The purpose of this study was to determine the diagnostic accuracy of synthetic MR sequences generated through post-acquisition processing of a single sequence measuring inherent R1, R2, and PD tissue properties compared with sequences acquired conventionally as part of a routine clinical pediatric brain MR exam. Thirty-two patients underwent routine clinical brain MRI with conventional and synthetic sequences acquired (22 abnormal). Synthetic axial T1, T2, and T2 fluid attenuation inversion recovery or proton density-weighted sequences were made to match the comparable clinical sequences. Two exams for each patient were de-identified. Four blinded reviewers reviewed eight patients and were asked to generate clinical reports on each exam (synthetic or conventional) at two different time points separated by a mean of 33 days. Exams were rated for overall and specific finding agreement (synthetic/conventional and compared to gold standard consensus review by two senior reviewers with knowledge of clinical report), quality, and diagnostic confidence. Overall agreement between conventional and synthetic exams was 97%. Agreement with consensus readings was 84% (conventional) and 81% (synthetic), p = 0.61. There were no significant differences in sensitivity, specificity, or accuracy for specific imaging findings involving the ventricles, CSF, brain parenchyma, or vasculature between synthetic or conventional exams (p > 0.05). No significant difference in exam quality, diagnostic confidence, or noise/artifacts was noted comparing studies with synthetic or conventional sequences. Diagnostic accuracy and quality of synthetically generated sequences are comparable to conventionally acquired sequences as part of a standard pediatric brain exam. Further confirmation in a larger study is warranted. (orig.)

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

    DEFF Research Database (Denmark)

    Moeller, Stine Bjerrum; Novaco, Raymond; Heinola-Nielsen, Vivian

    2015-01-01

    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...... 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...

  11. 15N liver function tests - concept, validity, clinical use

    International Nuclear Information System (INIS)

    Faust, H.; Jung, K.; Krumbiegel, P.; Hirschberg, K.; Reinhardt, R.; Junghans, P.

    1987-01-01

    Several liver function tests using the oral application of a nitrogen compound labelled with 15 N and the subsequent determination of 15 N in a certain fraction of urine by emission spectrometry are described. Because of the key position of the liver in the metabolism of nitrogen compounds the results of these tests allow conclusions concerning disturbances of special liver functions. Instructions for the clinical use of the '[ 15 N]Ammonium Test', '[ 15 N]Hippurate Test' the '[ 15 N]Methacetin Test', and the '[ 15 N]Glycine Test' are given. (author)

  12. A comprehensive clinical validation of the nuclear stethoscope

    International Nuclear Information System (INIS)

    Caruana, M.; Jones, R.; Lahiri, A.; Brigden, G.; Rodrigues, E.; Dore, C.; Raftery, E.B.; Medical Research Council, Harrow

    1986-01-01

    Five studies were conducted to examine the degree of variability to be expected during the use of the non-imaging nuclear probe (BIOS Inc.) under a variety of clinical conditions. Comparison of the ejection fraction (EF) readings between the nuclear probe and a gamma camera showed good agreement, with the nuclear probe tending to underestimate lower, and overestimate higher camera EF values. It is concluded that the portable, low cost nuclear probe produces accurate EF measurements when compared with the gamma camera. (author)

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

    Science.gov (United States)

    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.

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

    NARCIS (Netherlands)

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

    2017-01-01

    BACKGROUND & AIMS: Most systems for staging perihilar cholangiocarcinoma (PHC) have been developed for the minority of patients with resectable disease. The recently developed Mayo Clinic system for staging PHC requires only clinical and radiologic variables, but has not yet been validated. We

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

    Science.gov (United States)

    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.…

  16. Validity of a short clinical interview for psychiatric diagnosis : the mini-SCAN

    NARCIS (Netherlands)

    Nienhuis, F. J.; van de Willige, G.; Rijnders, C. A. Th.; de Jonge, P.; Wiersma, D.

    Background To promote clinical application of the Schedules for Clinical Assessment in Neuropsychiatry (SCAN) system a shorter version (the mini-SCAN) was devised. Its psychometric properties were unknown. Aims To establish the validity and practical properties of the mini-SCAN. Method One hundred

  17. Clinical Validation of a Test for the Diagnosis of Vaginitis.

    Science.gov (United States)

    Gaydos, Charlotte A; Beqaj, Sajo; Schwebke, Jane R; Lebed, Joel; Smith, Bonnie; Davis, Thomas E; Fife, Kenneth H; Nyirjesy, Paul; Spurrell, Timothy; Furgerson, Dorothy; Coleman, Jenell; Paradis, Sonia; Cooper, Charles K

    2017-07-01

    Vaginitis may be diagnosed as bacterial vaginosis, vulvovaginal candidiasis, trichomoniasis, or coinfection. A new molecular test assays the vaginal microbiome and organisms that cause three common infections. The objective of the trial was to evaluate the clinical accuracy of the investigational test for vaginal swabs collected by patients (self) or clinicians. The primary and secondary outcomes were to compare the investigational test with reference methods for the three most common causes of vaginitis and compare clinician-collected with self-collected swabs. We conducted a cross-sectional study in which women with symptoms of vaginitis were recruited at ten clinical centers and consented to the investigation between May and September 2015. The woman collected a vaginal swab, sheathed, and then handed it to the clinician. These swabs were to evaluate how self-collected swabs compared with clinician-collected swabs. The clinician collected an investigational test swab and reference test swabs. From 1,740 symptomatic patients, clinician-collected and self-collected vaginal swabs were evaluated by the molecular test and six tests. The reference methods for bacterial vaginosis were Nugent's score and Amsel's criteria for intermediate Nugent results. The reference methods for Candida infection were isolation of any potential Candida microorganisms from inoculation of two culture media: chromogenic and Sabouraud agar and sequencing. The reference methods for trichomoniasis were wet mount and culture. For clinician-collected swabs, by reference methods, bacterial vaginosis was diagnosed in 56.5%, vaginal candidiasis in 32.8%, trichomoniasis in 8%, and none of the three infections in 24% with a coinfection rate of 20%. The investigational test sensitivity was 90.5% (95% confidence interval [CI] 88.3-92.2%) and specificity was 85.8% (95% CI 83.0-88.3%) for bacterial vaginosis. The investigational test sensitivity was 90.9% (95% CI 88.1-93.1%) and specificity was 94

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  20. The Maastricht Clinical Teaching Questionnaire (MCTQ) as a valid and reliable instrument for the evaluation of clinical teachers.

    Science.gov (United States)

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

    2010-11-01

    Clinical teaching's importance in the medical curriculum has led to increased interest in its evaluation. Instruments for evaluating clinical teaching must be theory based, reliable, and valid. The Maastricht Clinical Teaching Questionnaire (MCTQ), based on the theoretical constructs of cognitive apprenticeship, elicits evaluations of individual clinical teachers' performance at the workplace. The authors investigated its construct validity and reliability, and they used the underlying factors to test a causal model representing effective clinical teaching. Between March 2007 and December 2008, the authors asked students who had completed clerkship rotations in different departments of two teaching hospitals to use the MCTQ to evaluate their clinical teachers. To establish construct validity, the authors performed a confirmatory factor analysis of the evaluation data, and they estimated reliability by calculating the generalizability coefficient and standard error measurement. Finally, to test a model of the factors, they fitted a structural linear model to the data. Confirmatory factor analysis yielded a five-factor model which fit the data well. Generalizability studies indicated that 7 to 10 student ratings can produce reliable ratings of individual teachers. The hypothesized structural linear model underlined the central roles played by modeling and coaching (mediated by articulation). The MCTQ is a valid and reliable evaluation instrument, thereby demonstrating the usefulness of the cognitive apprenticeship concept for clinical teaching during clerkships. Furthermore, a valuable model of clinical teaching emerged, highlighting modeling, coaching, and stimulating students' articulation and exploration as crucial to effective teaching at the clinical workplace.

  1. Validation of the presence of comorbidities in a Danish clinical cohort of children with tourette syndrome

    DEFF Research Database (Denmark)

    Debes, N.M.M.M.; Hjalgrim, H.; Skov, L.

    2008-01-01

    attacks, Sleeping disturbances, and depressive Symptoms in a Danish clinical cohort of 314 children with TS using Validated diagnostic instruments. For the assessment of symptoms of seasonal affective disorder and Stuttering, WC Used a nonvalidated systematic interview. In total, only 10...

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

    Science.gov (United States)

    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…

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

    Science.gov (United States)

    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…

  4. FORENSIC-CLINICAL INTERVIEW: RELIABILITY AND VALIDITY FOR THE EVALUATION OF PSYCHOLOGICAL INJURY

    Directory of Open Access Journals (Sweden)

    Francisca Fariña

    2013-01-01

    Full Text Available Forensic evaluation of psychological injury involves the use of a multimethod approximation i.e., a psychometric instrument, normally the MMPI-2, and a clinical interview. In terms of the clinical interview, the traditional clinical interview (e.g., SCID is not valid for forensic settings as it does not fulfil the triple objective of forensic evaluation: diagnosis of psychological injury in terms of Post Traumatic Stress Disorder (PTSD, a differential diagnosis of feigning, and establishing a causal relationship between allegations of intimate partner violence (IPV and psychological injury. To meet this requirement, Arce and Fariña (2001 created the forensic-clinical interview based on two techniques that do not contaminate the contents i.e., reinstating the contexts and free recall, and a methodic categorical system of contents analysis for the diagnosis of psychological injury and a differential diagnosis of feigning. The reliability and validity of the forensic-clinical interview designed for the forensic evaluation of psychological injury was assessed in 51 genuine cases of (IPV and 54 mock victims of IPV who were evaluated using a forensic-clinical interview and the MMPI-2. The result revealed that the forensic-clinical interview was a reliable instrument (α = .85 for diagnostic criteria of psychological injury, and α = .744 for feigning strategies. Moreover, the results corroborated the predictive validity (the diagnosis of PTSD was similar to the expected rate; the convergence validity (the diagnosis of PTSD in the interview strongly correlated with the Pk Scale of the MMPI-2, and discriminant validity (the diagnosis of PTSD in the interview did not correlate with the Pk Scale in feigners. The feigning strategies (differential diagnosis also showed convergent validity (high correlation with the Scales and indices of the MMPI2 for the measure of feigning and discriminant validity (no genuine victim was classified as a feigner

  5. Quality Control Assays for Clinical-Grade Human Mesenchymal Stromal Cells: Validation Strategy.

    Science.gov (United States)

    Radrizzani, Marina; Soncin, Sabrina; Bolis, Sara; Lo Cicero, Viviana; Andriolo, Gabriella; Turchetto, Lucia

    2016-01-01

    The present chapter focuses on the validation of the following analytical methods for the control of mesenchymal stromal cells (MSC) for cell therapy clinical trials: Microbiological control for cellular product Endotoxin assay Mycoplasma assay Cell count and viability Immunophenotype Clonogenic potential (CFU-F assay) In our lab, these methods are in use for product release, process control or control of the biological starting materials. They are described in detail in the accompanying Chapter 19.For each method, validation goals and strategy are presented, and a detailed experimental scheme is proposed.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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 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.

  8. The reliability and validity of the Everyday Feelings Questionnaire in a clinical population.

    Science.gov (United States)

    Mann, Joanna; Henley, William; O'Mahen, Heather; Ford, Tamsin

    2013-06-01

    Depression could be considered to be on a continuum with well-being and some have argued that it is important to measure well-being as well as distress. The Everyday Feelings Questionnaire was designed to measure both these aspects. Its validity has been assessed in a nonclinical population. This project aims to assess the validity and reliability of the EFQ in a clinical population. The EFQ was completed by 105 clients within a mental health clinical setting. The following aspects of the EFQ were explored: its internal structure, concurrent validity, re-test reliability and internal consistency. The EFQ had good internal consistency and correlated highly with other measures of anxiety and depression. The correlation between total EFQ scores on the two occasions was reasonable and there was no effect of time during completion. A Bland-Altman plot showed no obvious pattern between the difference between EFQ scores and the mean score. A one factor model showed a moderate fit to the data. This study does not explore the acceptability or sensitivity to change of the EFQ, and a larger sample size would be needed to extend the analysis conducted. The EFQ is a valid and reliable measure when used in this clinical population. Copyright © 2012 Elsevier B.V. All rights reserved.

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    Flávia Tatiana Pedrolo Hortense

    Full Text Available ABSTRACT Objective: 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. Method: 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. Results: 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. Conclusion: 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.

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

    Science.gov (United States)

    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).

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

    Science.gov (United States)

    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.

  13. The validity and clinical utility of structured diagnoses of antisocial personality disorder with forensic patients.

    Science.gov (United States)

    Marin-Avellan, Luisa E; McGauley, Gillian A; Campbell, Colin D; Fonagy, Peter

    2014-08-01

    Current DSM-based instruments for personality disorders (PDs) limit the investigation of the course and outcome of treatment of these disorders. This study examined the validity of the Shedler-Westen Assessment Procedure-200 (SWAP-200) and the Structured Clinical Interview for DSM-IV Axis II PD (SCID-II) in a sample of forensic PD patients. Results based on 66 participants indicated that the SWAP-200 Q-factors reduced the frequency of diagnostic comorbidity of PD categories by half compared with the SCID-II. Only the SWAP-200's Antisocial PD category showed good convergent and discriminant validity with respect to other instruments describing aspects of PD. The validity of the cutoff score for severe antisocial PD was confirmed, and this category predicted severe incidents in the hospital at 1 year of follow-up. A violence risk scale was constructed, which differentiated violent and nonviolent offenders. The results support the validity of the SWAP-200 and its potential clinical utility with forensic PD patients.

  14. Validating the extract, transform, load process used to populate a large clinical research database.

    Science.gov (United States)

    Denney, Michael J; Long, Dustin M; Armistead, Matthew G; Anderson, Jamie L; Conway, Baqiyyah N

    2016-10-01

    Informaticians at any institution that are developing clinical research support infrastructure are tasked with populating research databases with data extracted and transformed from their institution's operational databases, such as electronic health records (EHRs). These data must be properly extracted from these source systems, transformed into a standard data structure, and then loaded into the data warehouse while maintaining the integrity of these data. We validated the correctness of the extract, load, and transform (ETL) process of the extracted data of West Virginia Clinical and Translational Science Institute's Integrated Data Repository, a clinical data warehouse that includes data extracted from two EHR systems. Four hundred ninety-eight observations were randomly selected from the integrated data repository and compared with the two source EHR systems. Of the 498 observations, there were 479 concordant and 19 discordant observations. The discordant observations fell into three general categories: a) design decision differences between the IDR and source EHRs, b) timing differences, and c) user interface settings. After resolving apparent discordances, our integrated data repository was found to be 100% accurate relative to its source EHR systems. Any institution that uses a clinical data warehouse that is developed based on extraction processes from operational databases, such as EHRs, employs some form of an ETL process. As secondary use of EHR data begins to transform the research landscape, the importance of the basic validation of the extracted EHR data cannot be underestimated and should start with the validation of the extraction process itself. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

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

    Science.gov (United States)

    Emery, Joanne L; Bell, John F

    2009-06-01

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

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

    Science.gov (United States)

    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.

  17. A Multi-Center Prospective Derivation and Validation of a Clinical Prediction Tool for Severe Clostridium difficile Infection.

    LENUS (Irish Health Repository)

    Na, Xi

    2015-04-23

    Prediction of severe clinical outcomes in Clostridium difficile infection (CDI) is important to inform management decisions for optimum patient care. Currently, treatment recommendations for CDI vary based on disease severity but validated methods to predict severe disease are lacking. The aim of the study was to derive and validate a clinical prediction tool for severe outcomes in CDI.

  18. Temporomandibular disorders – validity of clinical diagnostics compared to magnetic resonance imaging

    OpenAIRE

    BADEL, TOMISLAV; MAROTTI, MILJENKO; SAVIĆ PAVIČIN, IVANA; DULČIĆ, NIKŠA; ZADRAVEC, DIJANA; KERN, JOSIPA

    2011-01-01

    Background and Purpose: Orthopedic examination techniques of the musculoskeletal system contribute to the successful diagnostics of temporomandibular disorders (TMD). The purpose of this study is to determine the validity of TMD clinical diagnostics by comparing the findings of manual functional analysis (MFA) and the results of MRI of temporomandibular joint (TMJ). The diagnostic significance of limited mouth opening and pain upon passive mouth opening were taken into consideration. M...

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    Mohammad Al-Amri

    2018-02-01

    Full Text Available 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.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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 measurement instrument can be used for international research on clinical management.

  3. Validity of Quinpirole Sensitization Rat Model of OCD: Linking Evidence from Animal and Clinical Studies.

    Science.gov (United States)

    Stuchlik, Ales; Radostová, Dominika; Hatalova, Hana; Vales, Karel; Nekovarova, Tereza; Koprivova, Jana; Svoboda, Jan; Horacek, Jiri

    2016-01-01

    Obsessive-compulsive disorder (OCD) is a neuropsychiatric disorder with 1-3% prevalence. OCD is characterized by recurrent thoughts (obsessions) and repetitive behaviors (compulsions). The pathophysiology of OCD remains unclear, stressing the importance of pre-clinical studies. The aim of this article is to critically review a proposed animal model of OCD that is characterized by the induction of compulsive checking and behavioral sensitization to the D2/D3 dopamine agonist quinpirole. Changes in this model have been reported at the level of brain structures, neurotransmitter systems and other neurophysiological aspects. In this review, we consider these alterations in relation to the clinical manifestations in OCD, with the aim to discuss and evaluate axes of validity of this model. Our analysis shows that some axes of validity of quinpirole sensitization model (QSM) are strongly supported by clinical findings, such as behavioral phenomenology or roles of brain structures. Evidence on predictive validity is contradictory and ambiguous. It is concluded that this model is useful in the context of searching for the underlying pathophysiological basis of the disorder because of the relatively strong biological similarities with OCD.

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

    Science.gov (United States)

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

    2014-01-01

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

  5. Validity and Reliability of Clinical Dementia Rating Scale among the Elderly in Iran

    Directory of Open Access Journals (Sweden)

    Nahid Sadeghi

    2012-10-01

    Full Text Available Background: The most common cause of dementia among the elderly is Alzheimer’s disease. Given the increasing population of the elderly, achieving a screening tool with high reliability and validity is an essential need for all communities. The main objective of the project was to determine the Persian version of Clinical Dementia Rating Scale (P-CDR1. Materials and Methods: Twenty subjects were randomly selected from among 150, 50-70 year old people, who were illiterate and not mentally retarded, residing in the nursing home; and they were given the Persian version of CDR scale (test. After three months, the group was given the test again. Results: The findings showed that from the specialists’ standpoint CDR scale had acceptable validity, and the test validity was achieved 0.05 at the significant level with Cronbach’s alpha and reliability coefficients 73% and 89%, respectively. Conclusion: CDR scale is a reliable instrument for evaluation of clinical dementia rating among the elderly in Iran. It can be used in screening dementia, Alzheimer, and diagnosis of the severity and stages of Alzheimer.

  6. Development and Initial Validation of the Caregiver Perceptions About Communication With Clinical Team Members (CAPACITY) Measure.

    Science.gov (United States)

    Van Houtven, Courtney Harold; Miller, Katherine E M; O'Brien, Emily C; Wolff, Jennifer L; Lindquist, Jennifer; Kabat, Margaret; Campbell-Kotler, Margaret; Henius, Jennifer; Voils, Corrine I

    2017-12-01

    Despite the important role that family caregivers play managing the care of persons with complex health needs, little is known about how caregivers perceive themselves to be recognized and valued by health care professionals. Our objective was to develop and validate a novel measure, the CAregiver Perceptions About Commun Ication with Clinical Team members (CAPACITY) instrument. Questions focus on perceived quality of communication with the health care team and the extent to which caregivers believe that the health care team considers their capacity and preferences in decision making. A confirmatory factor analysis supported a two-factor solution addressing communication and capacity. Internal consistency reliability was .90 for the communication domain and .93 for the capacity domain. Correlations between these two subscales and individual difference measures provided evidence of convergent and discriminant validity. The CAPACITY instrument may be a useful performance measure that quantifies the extent to which caregivers' experience person- and family-centered health care.

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

    Science.gov (United States)

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

    2018-02-01

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

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

    Science.gov (United States)

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

    2017-05-01

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

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

    Science.gov (United States)

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

    2016-09-30

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

  10. Validity of a new assessment rubric for a short-answer test of clinical reasoning.

    Science.gov (United States)

    Yeung, Euson; Kulasagarem, Kulamakan; Woods, Nicole; Dubrowski, Adam; Hodges, Brian; Carnahan, Heather

    2016-07-26

    The validity of high-stakes decisions derived from assessment results is of primary concern to candidates and certifying institutions in the health professions. In the field of orthopaedic manual physical therapy (OMPT), there is a dearth of documented validity evidence to support the certification process particularly for short-answer tests. To address this need, we examined the internal structure of the Case History Assessment Tool (CHAT); this is a new assessment rubric developed to appraise written responses to a short-answer test of clinical reasoning in post-graduate OMPT certification in Canada. Fourteen physical therapy students (novices) and 16 physical therapists (PT) with minimal and substantial OMPT training respectively completed a mock examination. Four pairs of examiners (n = 8) participated in appraising written responses using the CHAT. We conducted separate generalizability studies (G studies) for all participants and also by level of OMPT training. Internal consistency was calculated for test questions with more than 2 assessment items. Decision studies were also conducted to determine optimal application of the CHAT for OMPT certification. The overall reliability of CHAT scores was found to be moderate; however, reliability estimates for the novice group suggest that the scale was incapable of accommodating for scores of novices. Internal consistency estimates indicate item redundancies for several test questions which will require further investigation. Future validity studies should consider discriminating the clinical reasoning competence of OMPT trainees strictly at the post-graduate level. Although rater variance was low, the large variance attributed to error sources not incorporated in our G studies warrant further investigations into other threats to validity. Future examination of examiner stringency is also warranted.

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

    Science.gov (United States)

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

    2015-04-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

  13. Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project.

    NARCIS (Netherlands)

    Cluzeau, F.A.; Burgers, J.S.; Brouwers, M.M.; Grol, R.P.T.M.; et al.,

    2003-01-01

    BACKGROUND: International interest in clinical practice guidelines has never been greater but many published guidelines do not meet the basic quality requirements. There have been renewed calls for validated criteria to assess the quality of guidelines. OBJECTIVE: To develop and validate an

  14. Construct Validity of Medical Clinical Competence Measures: A Multitrait-Multimethod Matrix Study Using Confirmatory Factor Analysis.

    Science.gov (United States)

    Forsythe, George B.; And Others

    1986-01-01

    Construct validity was investigated for three tests of clinical competence in medicine: National Board of Medical Examiners examination (NBME), California Psychological Inventory (CPI), and Resident Evaluation Form (REF). Scores from 166 residents were analyzed. Results suggested low construct validity for CPI and REF scales, and moderate…

  15. Validity of a short clinical interview for psychiatric diagnosis: the mini-SCAN.

    Science.gov (United States)

    Nienhuis, F J; van de Willige, G; Rijnders, C A Th; de Jonge, P; Wiersma, D

    2010-01-01

    To promote clinical application of the Schedules for Clinical Assessment in Neuropsychiatry (SCAN) system a shorter version (the mini-SCAN) was devised. Its psychometric properties were unknown. To establish the validity and practical properties of the mini-SCAN. One hundred and six participants were interviewed twice, once with the SCAN and once with the mini-SCAN. The level of agreement was established for the categories: no disorder, affective disorders, anxiety disorders, non-affective psychotic disorders, affective psychotic disorders. The mini-SCAN is a valid instrument. Most kappa values were around 0.90. Only for the class of affective psychotic disorders was the agreement moderate. Mean duration of the mini-SCAN interviews was 25 min shorter than the SCAN interviews. Participants and interviewers were generally satisfied with the interview format and questions. The mini-SCAN can be used as a diagnostic instrument for clinical purposes and for clinical studies when the present episode is the focus of attention.

  16. Diagnostic Validity of Clinical Signs Associated with a Large Exophoria at Near

    Directory of Open Access Journals (Sweden)

    Pilar Cacho-Martínez

    2013-01-01

    Full Text Available Purpose. To analyze the diagnostic validity of accommodative and binocular tests in a sample of patients with a large near exophoria with moderate to severe symptoms. Methods. Two groups of patients between 19 and 35 years were recruited from a university clinic: 33 subjects with large exophoria at near vision and moderate or high visual discomfort and 33 patients with normal heterophoria and low visual discomfort. Visual discomfort was defined using the Conlon survey. A refractive exam and an exhaustive evaluation of accommodation and vergence were assessed. Diagnostic validity by means of receiver operator characteristic (ROC curves, sensitivity (S, specificity (Sp, and positive and negative likelihood ratios (LR+, LR− were assessed. This analysis was also carried out considering multiple tests as serial testing strategy. Results. ROC analysis showed the best diagnostic accuracy for receded near point of convergence (NPC recovery (area = 0.929 and binocular accommodative facility (BAF (area = 0.886. Using the cut-offs obtained with ROC analysis, the best diagnostic validity was obtained for the combination of NPC recovery and BAF (S  =  0.77, Sp = 1, LR+ = value tending to infinity, LR− = 0.23 and the combination of NPC break and recovery with BAF (S  =  0.73, Sp = 1, LR+ = tending to infinity, LR− = 0.27. Conclusions. NPC and BAF tests were the tests with the best diagnostic accuracy for subjects with large near exophoria and moderate to severe symptoms.

  17. Validation of a new strength measurement device for amyotrophic lateral sclerosis clinical trials.

    Science.gov (United States)

    Andres, Patricia L; Skerry, Linda M; Munsat, Theodore L; Thornell, Brenda J; Szymonifka, Jackie; Schoenfeld, David A; Cudkowicz, Merit E

    2012-01-01

    Strength measures with reduced variability and higher sensitivity could improve efficiency in clinical trials of amyotrophic lateral sclerosis (ALS). The Accurate Test of Limb Isometric Strength (ATLIS) was developed to precisely and conveniently measure force in 12 muscle groups. In this study we evaluate the reliability and validity of the ATLIS testing protocol. Twenty healthy adults and 10 patients with ALS were tested twice by the same or by different evaluators to determine test-retest and interrater reliability. Twenty healthy adults were examined using ATLIS and a well-validated strength testing protocol (TQNE) to assess criterion-based validity. Mean absolute variation between tests was 8.6%, and intraclass correlation coefficients for each muscle group were high (range 0.82-0.99). The Pearson correlation coefficient of mean ATLIS and TQNE scores was 0.90. A subject survey demonstrated high user acceptance of ATLIS. ATLIS is convenient for patients and evaluators, produces precise strength measurements, and is easily moved between examining rooms. Copyright © 2011 Wiley Periodicals, Inc.

  18. Health status in routine clinical practice: validity of the clinical COPD questionnaire at the individual patient level

    Directory of Open Access Journals (Sweden)

    de Vos Barbara

    2010-11-01

    Full Text Available Abstract Background There is a growing interest to use health status or disease control questionnaires in routine clinical practice. However, the validity of most questionnaires is established using techniques developed for group level validation. This study examines a new method, using patient interviews, to validate a short health status questionnaire, the Clinical COPD Questionnaire (CCQ, at the individual patient level. Methods Patients with COPD who visited an outpatient clinic completed the CCQ before the consultation, and the specialist physician completed it after the consultation. After the consultation all patients had a semi-structured in-depth interview. The patients' CCQ scores were compared with those of the treating clinician, and with mean scores from 5 clinicians from a pool of 20 who scored the CCQ after reading the transcript of the in-depth interviews only. Agreement was assessed using Lin's concordance correlation coefficient (CCC, and Blant and Altman plots. Interviews with patients with low agreement were reviewed for possible explanations. Results A total of 44 COPD patients (32 male, mean age 66 years, FEV1 45% of predicted participated. Agreement between the patients' CCQ scores and those of the treating clinicians (CCC = 0.87 and the mean score of the reviewing clinicians (CCC = 0.86 was very high. No systematic error was detected. No explanation for individuals with low agreement was found. Conclusion The validity of the CCQ on the individual patient level, as assessed by these methods, is good. Individual health status assessment with the CCQ is therefore sufficiently accurate to be used in routine clinical practice.

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

    Science.gov (United States)

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

    2018-04-01

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

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

    Science.gov (United States)

    Miguel, Susana; Caldeira, Sílvia; Vieira, Margarida

    2018-04-01

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

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

    Science.gov (United States)

    Giménez Marín, Ángeles; Rivas-Ruiz, Francisco

    2012-01-01

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

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

    Science.gov (United States)

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

    2016-05-27

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

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

    Science.gov (United States)

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

    2017-01-01

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

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

    Science.gov (United States)

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

    2008-09-01

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

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

    Science.gov (United States)

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

    2014-11-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2013-01-01

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

  8. Lesson 6: Signature Validation

    Science.gov (United States)

    Checklist items 13 through 17 are grouped under the Signature Validation Process, and represent CROMERR requirements that the system must satisfy as part of ensuring that electronic signatures it receives are valid.

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

    Science.gov (United States)

    Zariffa, Jose; Kramer, John L.K.

    2011-01-01

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

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

    Science.gov (United States)

    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…

  11. Measurement of glomerular filtration rate by impulse synthesis: Clinical validation and optimization

    International Nuclear Information System (INIS)

    Palagi, B.; Verga, P.; Broggi, A.; Picozzi, R.; Villa, F.; Guzzini, F.; Cozzi, C.; Tomasi, A.

    1988-01-01

    Impulse synthesis is a technique which relies upon the logic of continuous infusion but extracts the clearance value from single-injection data by shifting and adding them until an asymptotic value is attained. This study has been aimed at validating and optimizing clinically the measurement of glomerular filtration rate by impulse synthesis. A single intravenous injection of 51 Cr-EDTA has been made in 32 patients and plasma activity monitored over the next 6 h. Glomerular filtration rate computed by a single-exponential fit method (GFR-SEF) has been shown to be significantly (p [de

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

    Science.gov (United States)

    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 cerebrovascular accident patient's mobility state.

  13. Validation of the walking index for spinal cord injury in a US and European clinical population

    DEFF Research Database (Denmark)

    Ditunno, J.F.; Scivoletto, G.; Patrick, M.

    2008-01-01

    OBJECTIVE: To demonstrate the prospective construct validity of the walking index for spinal cord injury (WISCI) in US/European clinical population. DESIGN: Prospective Cohort in Denmark, Germany, Italy and the USA. PARTICIPANTS/METHOD: Participants with acute complete/incomplete (ASIA Impairment...... Scale (AIS) A, B, C and D) traumatic spinal cord injuries were enrolled from four centers. Lower extremity motor scores (LEMS), WISCI level and Locomotor Functional Independence Measure (LFIM) levels were assessed with change in ambulatory status. WISCI progression was assessed for monotonic direction...

  14. Validity and reliability of the Structured Clinical Interview for Depersonalization–Derealization Spectrum (SCI-DER

    Directory of Open Access Journals (Sweden)

    Marco Mula

    2008-08-01

    Full Text Available Marco Mula, Stefano Pini, Simona Calugi, Matteo Preve, Matteo Masini, Ilaria Giovannini, Ciro Conversano, Paola Rucci, Giovanni B CassanoDepartment of Psychiatry, Neurobiology, Pharmacology and Biotechnologies, University of Pisa, ItalyAbstract: This study evaluates the validity and reliability of a new instrument developed to assess symptoms of depersonalization: the Structured Clinical Interview for the Depersonalization-Derealization Spectrum (SCI-DER. The instrument is based on a spectrum model that emphasizes soft-signs, sub-threshold syndromes as well as clinical and subsyndromal manifestations. Items of the interview include, in addition to DSM-IV criteria for depersonalization, a number of features derived from clinical experience and from a review of phenomenological descriptions. Study participants included 258 consecutive patients with mood and anxiety disorders, 16.7% bipolar I disorder, 18.6% bipolar II disorder, 32.9% major depression, 22.1% panic disorder, 4.7% obsessive compulsive disorder, and 1.5% generalized anxiety disorder; 2.7% patients were also diagnosed with depersonalization disorder. A comparison group of 42 unselected controls was enrolled at the same site. The SCI-DER showed excellent reliability and good concurrent validity with the Dissociative Experiences Scale. It significantly discriminated subjects with any diagnosis of mood and anxiety disorders from controls and subjects with depersonalization disorder from controls. The hypothesized structure of the instrument was confirmed empirically.Keywords: depersonalization, derealization, mood disorders, anxiety disorders

  15. Clinical examinations to validate self-completion questionnaires: dermatitis in the UK printing industry.

    Science.gov (United States)

    Livesley, E J; Rushton, L; English, J S C; Williams, H C

    2002-07-01

    A self-completion questionnaire sent to 2600 Nottinghamshire members of the Graphical Paper and Media Union elicited a 62% response. Forty one per cent of respondents reported suffering a skin complaint at some time and 11% had a current skin problem on the hand. This paper reports the validation stage of the study. Samples of 45 'cases' of self-reported dermatitis and 60 'controls', who reported they had never suffered a skin complaint, were clinically examined. All 45 self-reported cases were clinically confirmed as dermatitis. Occupationally related irritant contact dermatitis (ICD) was diagnosed in 20 (44%); 26 (58%) complaints were thought to be induced or exacerbated by occupation. Of the controls, 21 (35%) were also diagnosed with a skin complaint, the majority being mild, with an occupational association in 17, the majority (15) being ICD. Sixteen ICD cases were patch tested resulting in positive reactions to colophony, neomycin, nickel and potassium dichromate (2 of each). Two cases of basal cell carcinoma on the face were also identified, of which the participants were unaware. Although there was no false positive self-reporting there was a considerable number of false negatives, demonstrating the importance of clinical validation of questionnaires relating to industrial skin disease. This study has highlighted the need for improvement in skin care provision in the printing industry.

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

    Science.gov (United States)

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

    2017-11-01

    Non-invasive hemodynamic monitoring has the potential to be a valuable clinical tool for the screening and management of hypertensive disorders of pregnancy. The objective of this study was to validate the clinical utility of the non-invasive cardiac output monitoring (NICOM) system in pregnant women. Twenty healthy pregnant women with a singleton pregnancy at 22 to 26 weeks' gestation were enrolled in this study. Measures of heart rate, stroke volume, and cardiac output were obtained through NICOM and compared with Doppler echocardiography. NICOM significantly overestimated measures of both stroke volume and cardiac output compared with Doppler echocardiography (95 ± 4 vs. 73 ± 4 mL, P gold standard for the measurement of cardiac output in the setting of pregnancy. However, once normal values have been established, NICOM has the potential to be a useful clinical tool for monitoring maternal hemodynamics in pregnant women. Further investigation regarding the validity of NICOM is required in larger populations of healthy and hypertensive pregnant women to determine whether this device is appropriate for maternal hemodynamic assessment during pregnancy. Copyright © 2017 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2015-10-01

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

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

    NARCIS (Netherlands)

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

    2011-01-01

    Background: Feedback to aid teachers in improving their teaching requires validated evaluation instruments. When implementing an evaluation instrument in a different context, it is important to collect validity evidence from multiple sources. Aim: We examined the validity and reliability of the

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

    Science.gov (United States)

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

    2017-08-01

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

  20. Genomic Biomarkers for Personalized Medicine: Development and Validation in Clinical Studies

    Directory of Open Access Journals (Sweden)

    Shigeyuki Matsui

    2013-01-01

    Full Text Available The establishment of high-throughput technologies has brought substantial advances to our understanding of the biology of many diseases at the molecular level and increasing expectations on the development of innovative molecularly targeted treatments and molecular biomarkers or diagnostic tests in the context of clinical studies. In this review article, we position the two critical statistical analyses of high-dimensional genomic data, gene screening and prediction, in the framework of development and validation of genomic biomarkers or signatures, through taking into consideration the possible different strategies for developing genomic signatures. A wide variety of biomarker-based clinical trial designs to assess clinical utility of a biomarker or a new treatment with a companion biomarker are also discussed.

  1. Reliability, construct and discriminative validity of clinical testing in subjects with and without chronic neck pain

    DEFF Research Database (Denmark)

    Jørgensen, René; Ris Hansen, Inge; Falla, Deborah

    2014-01-01

    -retest reliability in people with and without chronic neck pain. Moreover, construct and between-group discriminative validity of the tests were examined. METHODS: Twenty-one participants with chronic neck pain and 21 asymptomatic participants were included. Intra- and inter-reliability were evaluated for the Cranio-Cervical...... Flexion Test (CCFT), Range of Movement (ROM), Joint Position Error (JPE), Gaze Stability (GS), Smooth Pursuit Neck Torsion Test (SPNTT), and neuromuscular control of the Deep Cervical Extensors (DCE). Test-retest reliability was assessed for Postural Control (SWAY) and Pressure Pain Threshold (PPT) over......BACKGROUND: The reliability of clinical tests for the cervical spine has not been adequately evaluated. Six cervical clinical tests, which are low cost and easy to perform in clinical settings, were tested for intra- and inter-examiner reliability, and two performance tests were assessed for test...

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

    International Nuclear Information System (INIS)

    Ceberg, S.

    2016-01-01

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

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

    International Nuclear Information System (INIS)

    Juang, T.

    2016-01-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

    Juang, T. [Stanford Cancer Center (United States)

    2016-06-15

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

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

    Energy Technology Data Exchange (ETDEWEB)

    Ceberg, S. [Lund University (Sweden)

    2016-06-15

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

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

    Science.gov (United States)

    2014-01-01

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

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

    Science.gov (United States)

    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.

  8. The Reliability and Validity of the Outcome Rating Scale: A Replication Study of a Brief Clinical Measure

    National Research Council Canada - National Science Library

    Bringhurst, David L; Watson, Curtis W; Miller, Scott D; Duncan, Barry L

    2004-01-01

    ... (Miller, Duncan, Brown, Sparks, AND Claud, 2003). This article reports the findings of an independent replication study evaluating the reliability and concurrent validity of the ORS as studied in a non-clinical sample...

  9. The Air Force Mobile Forward Surgical Team (MFST): Using the Estimating Supplies Program to Validate Clinical Requirement

    National Research Council Canada - National Science Library

    Nix, Ralph E; Onofrio, Kathleen; Konoske, Paula J; Galarneau, Mike R; Hill, Martin

    2004-01-01

    .... The primary objective of the study was to provide the Air Force with the ability to validate clinical requirements of the MFST assemblage, with the goal of using NHRC's Estimating Supplies Program (ESP...

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

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

    2017-05-01

    The aim was to evaluate the cross-cultural validity of the Lupus Impact Tracker (LIT) in five European countries and to assess its acceptability and feasibility from the patient and physician perspectives. A prospective, observational, cross-sectional and multicentre validation study was conducted in clinical settings. Before the visit, patients completed LIT, Short Form 36 (SF-36) and care satisfaction questionnaires. During the visit, physicians assessed disease activity [Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI], organ damage [SLICC/ACR damage index (SDI)] and flare occurrence. Cross-cultural validity was assessed using the Differential Item Functioning method. Five hundred and sixty-nine SLE patients were included by 25 specialists; 91.7% were outpatients and 89.9% female, with mean age 43.5 (13.0) years. Disease profile was as follows: 18.3% experienced flares; mean SELENA-SLEDAI score 3.4 (4.5); mean SDI score 0.8 (1.4); and SF-36 mean physical and mental component summary scores: physical component summary 42.8 (10.8) and mental component summary 43.0 (12.3). Mean LIT score was 34.2 (22.3) (median: 32.5), indicating that lupus moderately impacted patients' daily life. A cultural Differential Item Functioning of negligible magnitude was detected across countries (pseudo- R 2 difference of 0.01-0.04). Differences were observed between LIT scores and Physician Global Assessment, SELENA-SLEDAI, SDI scores = 0 (P cultural invariability across countries. They suggest that LIT can be used in routine clinical practice to evaluate and follow patient-reported outcomes in order to improve patient-physician interaction. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

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

    Science.gov (United States)

    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 (pscales (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.

  13. Principles of Proper Validation

    DEFF Research Database (Denmark)

    Esbensen, Kim; Geladi, Paul

    2010-01-01

    to suffer from the same deficiencies. The PPV are universal and can be applied to all situations in which the assessment of performance is desired: prediction-, classification-, time series forecasting-, modeling validation. The key element of PPV is the Theory of Sampling (TOS), which allow insight......) is critically necessary for the inclusion of the sampling errors incurred in all 'future' situations in which the validated model must perform. Logically, therefore, all one data set re-sampling approaches for validation, especially cross-validation and leverage-corrected validation, should be terminated...

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

    Science.gov (United States)

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

    2018-01-01

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

  15. Measurement-based Treatment of Residual Symptoms Using Clinically Useful Depression Outcome Scale: Korean Validation Study

    Science.gov (United States)

    Jeon, Sang Won; Han, Changsu; Ko, Young-Hoon; Yoon, Seo Young; Pae, Chi-Un; Choi, Joonho; Park, Yong Chon; Kim, Jong-Woo; Yoon, Ho-Kyoung; Ko, Seung-Duk; Patkar, Ashwin A.; Zimmerman, Mark

    2017-01-01

    Objective This study was aimed at evaluating the diagnostic validity of the Korean version of the Clinically Useful Depression Outcome Scale (CUDOS) with varying follow-up in a typical clinical setting in multiple centers. Methods In total, 891 psychiatric outpatients were enrolled at the time of their intake appointment. Current diagnostic characteristics were examined using the Structured Clinical Interview for DSM-IV (41% major depressive disorder). The CUDOS was measured and compared with three clinician rating scales and four self-report scales. Results The CUDOS showed excellent results for internal consistency (Cronbach’s α, 0.91), test-retest reliability (patients at intake, r=0.81; depressed patients in ongoing treatment, r=0.89), and convergent and discriminant validity (measures of depression, r=0.80; measures of anxiety and somatization, r=0.42). The CUDOS had a high ability to discriminate between different levels of depression severity based on the rating of Clinical Global Impression for depression severity and the diagnostic classification of major depression, minor depression, and non-depression. The ability of the CUDOS to identify patients with major depression was high (area under the receiver operating characteristic curve=0.867). A score of 20 as the optimal cutoff point was suggested when screening for major depression using the CUDOS (sensitivity=89.9%, specificity=69.5%). The CUDOS was sensitive to change after antidepressant treatment: patients with greater improvement showed a greater decrease in CUDOS scores (p<0.001). Conclusion The results of this multi-site outpatient study found that the Korean version of the CUDOS is a very useful measurement for research and for clinical practice. PMID:28138107

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

    Science.gov (United States)

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

    2013-01-01

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

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

    Science.gov (United States)

    Riley, W T; McCranie, E W

    1990-01-01

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

  18. Clinical validation of a quality of life questionnaire in angina pectoris patients.

    Science.gov (United States)

    Marquis, P; Fayol, C; Joire, J E

    1995-11-01

    Angina pectoris impairs patients' quality of life. In order to assess its impact on quality of life, a questionnaire was developed using a literature review and interviews with patients and clinicians. It consisted of a general profile (SF-36) which measured functional status, well-being, perceived health, and a specific index, the Angina Pectoris Quality of Life Questionnaire, supplemented by new items. The acceptability, internal consistency reliability and clinical validity of this 70-item questionnaire were analysed in a cross-sectional study. Of 197 coronary patients approached, 93% (n = 184) agreed to participate and 86% (n = 170) returned the mailed questionnaire. Mean age of patients was 67 years (+/- 10); 79% were male and 70% were retired. Sixty patients were asymptomatic and 110 reported anginal crises (Canadian Cardiovascular Society Classification: class I: 48; II: 37; III: 13; IV: 0; V: 12). Globally, angina pectoris was found to affect each quality of life concept measured: physical functioning, well-being, and perceived health. Quality of life profiles worsened in accordance with increasing severity of the condition, as stratified by angina pectoris class. Asymptomatic patients reported better general and specific profiles. These results support the feasibility and usefulness of evaluating quality of life using the questionnaire. The validation of the data is very encouraging and enables the questionnaire to be used in clinical trials.

  19. Validation of the Prague C&M classification of Barrett's esophagus in clinical practice

    NARCIS (Netherlands)

    Alvarez Herrero, Lorenza; Curvers, Wouter L.; van Vilsteren, Frederike G. I.; Wolfsen, Herbert; Ragunath, Krish; Wong Kee Song, Louis-Michel; Mallant-Hent, Rosalie C.; van Oijen, Arnoud; Scholten, Pieter; Schoon, Erik J.; Schenk, Ed B. E.; Weusten, Bas L. A. M.; Bergman, Jacques G. H. M.

    2013-01-01

    Background and study aims: The Prague C&M classification for Barrett's esophagus has found widespread acceptance but has only been validated by Barrett's experts scoring video sequences. To date, validation has been lacking for its application in routine practice during real-time endoscopy. The aim

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

    Science.gov (United States)

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

    2009-02-01

    Measuring patient-centered outcomes is becoming increasingly important in patients with peripheral arterial disease (PAD), both as a means of determining the benefits of treatment and as an aid for disease management. In order to monitor health status in a reliable and sensitive way, the disease-specific measure Peripheral Artery Questionnaire (PAQ) was developed. However, to date, its correlation with traditional clinical indices is unknown. The primary aim of this study was to better establish the clinical validity of the PAQ by examining its association with functional indices related to PAD. Furthermore, we hypothesized that the clinical validity of this disease-specific measure is better as compared with the EuroQol-5-dimensional (EQ-5D), a standardized generic instrument. Data on 711 consecutive PAD patients undergoing surgery were collected from 11 Dutch hospitals in 2004. At 3-year follow-up, questionnaires including the PAQ, EQ-5D, and EuroQol-Visual Analogue Scale (EQ VAS) were completed in 84% of survivors. The PAQ was analyzed according to three domains, as established by a factor analyses in the Dutch population, and the summary score. Baseline clinical indices included the presence and severity of claudication intermittent (CI) and the Lee Cardiac Risk Index. All three PAQ domains (Physical Function, Perceived Disability, and Treatment Satisfaction) were significantly associated with CI symptoms (P values PAQ summary scores as compared with asymptomatic patients (58.6 +/- 27.8 vs 68.6 +/- 27.8, P = PAQ summary score and the subscale scores for Physical Functioning and Perceived Disability demonstrated a clear dose-response relation for walking distance and the Lee Risk Index (P values PAQ proved to be good as the PAQ subscales discriminated well between patients with or without symptomatic PAD and its severity as defined by walking distance. Furthermore, the PAQ subscales were directly proportional to the presence and number of risk factors relevant

  1. Validation of the Rowland Universal Dementia Assessment Scale for multicultural screening in Danish memory clinics.

    Science.gov (United States)

    Nielsen, T Rune; Andersen, Birgitte Bo; Gottrup, Hanne; Lützhøft, Jan H; Høgh, Peter; Waldemar, Gunhild

    2013-01-01

    The Rowland Universal Dementia Assessment Scale (RUDAS) is a brief cognitive screening test that was developed to detect dementia in multicultural populations. The RUDAS has not previously been validated in multicultural populations outside of Australia. The aim of this study was to evaluate the diagnostic accuracy of the RUDAS in a multicultural sample of patients referred to Danish memory clinics. Data were collected from 137 consecutive patients (34 with an immigrant background) in three Danish memory clinics. All patients were given the RUDAS as a supplement to the standard diagnostic workup. Diagnostic accuracy for the RUDAS [area under the curve (AUC) = 0.838] was similar to that of the Mini-Mental State Examination (MMSE; AUC = 0.840). The cutoff score with the best balance of sensitivity, specificity and accuracy was multicultural patient populations. © 2013 S. Karger AG, Basel.

  2. Validation and Assessment of a Technology Familiarity Score in Patients Attending a Symptomatic Breast Clinic.

    Science.gov (United States)

    O'Brien, C; Kelly, J; Lehane, E A; Livingstone, V; Cotter, B; Butt, A; Kelly, L; Corrigan, M A

    2015-10-01

    New media technologies (computers, mobile phones and the internet) have the potential to transform the healthcare information needs of patients with breast disease (Ferlay et al. in Eur J Cancer 49:1374-1403, 2013). However, patients' current level of use and their willingness to accept new media for education and communication remain unknown. This was a single-centre clinic-based prospective cross-sectional study. A previously developed instrument was modified, validated and tested on patients attending a symptomatic breast clinic. The instrument was evaluated on 200 symptomatic breast patients. The commonest outlets for education were staff (95 %), leaflets (69 %) and websites (59 %). Websites are more likely to be consulted by younger patients (higher education were more likely to favour apps, websites and email (p technology use among breast patients is expanding as expected along generational trends. As such its' further integration into healthcare systems can potentially ameliorate patient education and communication.

  3. Next-generation negative symptom assessment for clinical trials: validation of the Brief Negative Symptom Scale.

    Science.gov (United States)

    Strauss, Gregory P; Keller, William R; Buchanan, Robert W; Gold, James M; Fischer, Bernard A; McMahon, Robert P; Catalano, Lauren T; Culbreth, Adam J; Carpenter, William T; Kirkpatrick, Brian

    2012-12-01

    The current study examined the psychometric properties of the Brief Negative Symptom Scale (BNSS), a next-generation rating instrument developed in response to the NIMH sponsored consensus development conference on negative symptoms. Participants included 100 individuals with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who completed a clinical interview designed to assess negative, positive, disorganized, and general psychiatric symptoms, as well as functional outcome. A battery of anhedonia questionnaires and neuropsychological tests were also administered. Results indicated that the BNSS has excellent internal consistency and temporal stability, as well as good convergent and discriminant validity in its relationships with other symptom rating scales, functional outcome, self-reported anhedonia, and neuropsychological test scores. Given its brevity (13-items, 15-minute interview) and good psychometric characteristics, the BNSS can be considered a promising new instrument for use in clinical trials. Copyright © 2012 Elsevier B.V. All rights reserved.

  4. Identification and Validation of Clinically Relevant Clusters of Severe Fatigue in Rheumatoid Arthritis.

    Science.gov (United States)

    Basu, Neil; Jones, Gareth T; Macfarlane, Gary J; Druce, Katie L

    The considerable heterogeneity of rheumatoid arthritis (RA)-related fatigue is the greatest challenge to determining pathogenesis. The identification of homogenous subtypes of severe fatigue would inform the design and analysis of experiments seeking to characterize the likely numerous causal pathways that underpin the symptom. This study aimed to identify and validate such fatigue subtypes in patients with RA. Data were obtained from patients recruited to the British Society for Rheumatology Biologics register for RA, as either receiving traditional disease-modifying antirheumatic drugs (DMARD cohort, n = 522) or commencing anti-tumor necrosis factor therapy (anti-TNF cohort, n = 3909). In those reporting severe fatigue (Short-Form 36 vitality ≤ 12.5), this cross-sectional analysis applied hierarchical clustering with weighted-average linkage identified clusters of pain, fatigue, mental health (all Short-Form 36), disability (Health Assessment Questionnaire), and inflammation (erythrocyte sedimentation rate) in the DMARD cohort. K-means clustering sought to validate the solution in the anti-TNF cohort. Clusters were characterized using a priori generated symptom definitions and between-cluster comparisons. Four severe fatigue clusters, labeled as basic (46%), affective (40%), inflammatory (4.5%), and global (8.9%) were identified in the DMARD cohort. All clusters had severe levels of pain and disability and were distinguished by the presence/absence of poor mental health and high inflammation. The same symptom clusters were present in the anti-TNF cohort, although the proportion of participants in each cluster differed (basic = 28.7%; affective = 30.2%; global = 24.1%; inflammatory = 16.9%). Among RA patients with severe fatigue, recruited to two diverse RA cohorts, clinically relevant clusters were identified and validated. These may provide the basis for future mechanistic studies and ultimately support a stratified approach to fatigue management.

  5. A newer and broader definition of burnout: validation of the "Burnout Clinical Subtype Questionnaire (BCSQ-36)".

    Science.gov (United States)

    Montero-Marín, Jesús; García-Campayo, Javier

    2010-06-02

    Burnout syndrome has been clinically characterised by a series of three subtypes: frenetic, underchallenged, and worn-out, with reference to coping strategies for stress and frustration at work with different degrees of dedication. The aims of the study are to present an operating definition of these subtypes in order to assess their reliability and convergent validity with respect to a standard burnout criterion and to examine differences with regard to sex and the temporary nature of work contracts. An exploratory factor analysis was performed by the main component method on a range of items devised by experts. The sample was composed of 409 employees of the University of Zaragoza, Spain. The reliability of the scales was assessed with Cronbach's alpha, convergent validity in relation to the Maslach Burnout Inventory with Pearson's r, and differences with Student's t-test and the Mann-Whitney U test. The factorial validity and reliability of the scales were good. The subtypes presented relations of differing degrees with the criterion dimensions, which were greater when dedication to work was lower. The frenetic profile presented fewer relations with the criterion dimensions while the worn-out profile presented relations of the greatest magnitude. Sex was not influential in establishing differences. However, the temporary nature of work contracts was found to have an effect: temporary employees exhibited higher scores in the frenetic profile (p < 0.001), while permanent employees did so in the underchallenged (p = 0.018) and worn-out (p < 0.001) profiles. The classical Maslach description of burnout does not include the frenetic profile; therefore, these patients are not recognised. The developed questionnaire may be a useful tool for the design and appraisal of specific preventive and treatment approaches based on the type of burnout experienced.

  6. A newer and broader definition of burnout: Validation of the "Burnout Clinical Subtype Questionnaire (BCSQ-36"

    Directory of Open Access Journals (Sweden)

    García-Campayo Javier

    2010-06-01

    Full Text Available Abstract Background Burnout syndrome has been clinically characterised by a series of three subtypes: frenetic, underchallenged and worn-out, with reference to coping strategies for stress and frustration at work with different degrees of dedication. The aims of the study are to present an operating definition of these subtypes in order to assess their reliability and convergent validity with respect to a standard burnout criterion and to examine differences with regard to sex and the temporary nature of work contracts. Method An exploratory factor analysis was performed by the main component method on a range of items devised by experts. The sample was composed of 409 employees of the University of Zaragoza, Spain. The reliability of the scales was assessed with Cronbach's α, convergent validity in relation to the Maslach Burnout Inventory with Pearson's r, and differences with Student's t-test and the Mann-Whitney U test. Results The factorial validity and reliability of the scales were good. The subtypes presented relations of differing degrees with the criterion dimensions, which were greater when dedication to work was lower. The frenetic profile presented fewer relations with the criterion dimensions while the worn-out profile presented relations of the greatest magnitude. Sex was not influential in establishing differences. However, the temporary nature of work contracts was found to have an effect: temporary employees exhibited higher scores in the frenetic profile (p p = 0.018 and worn-out (p Conclusions The classical Maslach description of burnout does not include the frenetic profile; therefore, these patients are not recognised. The developed questionnaire may be a useful tool for the design and appraisal of specific preventive and treatment approaches based on the type of burnout experienced.

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

    Science.gov (United States)

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

    2017-03-01

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

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

    NARCIS (Netherlands)

    Vreugdenhil, Jettie; Spek, Bea

    2017-01-01

    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

  9. Validity of the WISC-IV Spanish for a clinically referred sample of Hispanic children.

    Science.gov (United States)

    San Miguel Montes, Liza E; Allen, Daniel N; Puente, Antonio E; Neblina, Cris

    2010-06-01

    The Wechsler Intelligence Scale for Children (WISC) is the most commonly used intelligence test for children. Five years ago, a Spanish version of the WISC-IV was published (WISC-IV Spanish; Wechsler, 2005), but a limited amount of published information is available regarding its utility when assessing clinical samples. The current study included 107 children who were Spanish speaking and of Puerto Rican descent that had been administered the WISC-IV Spanish. They were subdivided into a clinical sample of 35 children with diagnoses of various forms of brain dysfunction (primarily learning disability, attention-deficit/hyperactivity disorder, and epilepsy) and a comparison group made up of 72 normal children who were part of the WISC-IV Spanish version standardization sample. Comparisons between these groups and the standardization sample were performed for the WISC-IV Spanish index and subtest scores. Results indicated that the clinical sample performed worse than the comparison samples on the Working Memory and Processing Speed Indexes, although findings varied to some extent depending on whether the clinical group was compared with the normal comparison group or the standardization sample. These findings provide support for the criterion validity of the WISC-IV Spanish when it is used to assess a clinically referred sample with brain dysfunction.

  10. Empirical Derivation and Validation of a Clinical Case Definition for Neuropsychological Impairment in Children and Adolescents.

    Science.gov (United States)

    Beauchamp, Miriam H; Brooks, Brian L; Barrowman, Nick; Aglipay, Mary; Keightley, Michelle; Anderson, Peter; Yeates, Keith O; Osmond, Martin H; Zemek, Roger

    2015-09-01

    Neuropsychological assessment aims to identify individual performance profiles in multiple domains of cognitive functioning; however, substantial variation exists in how deficits are defined and what cutoffs are used, and there is no universally accepted definition of neuropsychological impairment. The aim of this study was to derive and validate a clinical case definition rule to identify neuropsychological impairment in children and adolescents. An existing normative pediatric sample was used to calculate base rates of abnormal functioning on eight measures covering six domains of neuropsychological functioning. The dataset was analyzed by varying the range of cutoff levels [1, 1.5, and 2 standard deviations (SDs) below the mean] and number of indicators of impairment. The derived rule was evaluated by bootstrap, internal and external clinical validation (orthopedic and traumatic brain injury). Our neuropsychological impairment (NPI) rule was defined as "two or more test scores that fall 1.5 SDs below the mean." The rule identifies 5.1% of the total sample as impaired in the assessment battery and consistently targets between 3 and 7% of the population as impaired even when age, domains, and number of tests are varied. The NPI rate increases in groups known to exhibit cognitive deficits. The NPI rule provides a psychometrically derived method for interpreting performance across multiple tests and may be used in children 6-18 years. The rule may be useful to clinicians and scientists who wish to establish whether specific individuals or clinical populations present within expected norms versus impaired function across a battery of neuropsychological tests.

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

    Science.gov (United States)

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

    2001-01-01

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

  12. Virtual Reality for Enhanced Ecological Validity and Experimental Control in the Clinical, Affective and Social Neurosciences

    Science.gov (United States)

    Parsons, Thomas D.

    2015-01-01

    An essential tension can be found between researchers interested in ecological validity and those concerned with maintaining experimental control. Research in the human neurosciences often involves the use of simple and static stimuli lacking many of the potentially important aspects of real world activities and interactions. While this research is valuable, there is a growing interest in the human neurosciences to use cues about target states in the real world via multimodal scenarios that involve visual, semantic, and prosodic information. These scenarios should include dynamic stimuli presented concurrently or serially in a manner that allows researchers to assess the integrative processes carried out by perceivers over time. Furthermore, there is growing interest in contextually embedded stimuli that can constrain participant interpretations of cues about a target’s internal states. Virtual reality environments proffer assessment paradigms that combine the experimental control of laboratory measures with emotionally engaging background narratives to enhance affective experience and social interactions. The present review highlights the potential of virtual reality environments for enhanced ecological validity in the clinical, affective, and social neurosciences. PMID:26696869

  13. Validation of the Danish Addenbrooke's Cognitive Examination as a screening test in a memory clinic.

    Science.gov (United States)

    Stokholm, Jette; Vogel, Asmus; Johannsen, Peter; Waldemar, Gunhild

    2009-01-01

    Addenbrooke's Cognitive Examination (ACE) is a cognitive screening test developed to detect dementia. It has been validated in several countries. Validation studies have predominantly included patients with various degrees of dementia and healthy controls. The aim of this study was to evaluate the Danish version of ACE as a screening test for early dementia in an outpatient memory clinic. Further, we wanted to investigate the ability of the ACE to discriminate patients with early Alzheimer's disease (AD) from patients with depression. 78 patients with mild AD (MMSE >or=20), 30 non-demented patients diagnosed with depression (originally referred for evaluation of cognitive symptoms), and 63 healthy volunteers, all between 60 and 85 years of age, were included. All patients were given the ACE as a supplement to the standard diagnostic work-up. The cut-off points for optimal trade-off between sensitivity and specificity for ACE were 85/86 (sensitivity 0.99, specificity 0.94). When these cut-off points were applied to the group of depressive patients, the specificity dropped to 0.64, indicating a great overlap in individual test scores for demented and depressed patients. The optimal cut-off points for ACE found in this Danish study were close to what is reported in most other European studies. The great overlap in ACE scores for demented and depressed patients emphasize that test scores must be interpreted with great caution when used in diagnostic work-up.

  14. Validation of the Balance Board for Clinical Evaluation of Balance During Serious Gaming Rehabilitation Exercises.

    Science.gov (United States)

    Bonnechère, Bruno; Jansen, Bart; Omelina, Lubos; Sholukha, Victor; Van Sint Jan, Serge

    2016-09-01

    Balance and posture can be affected in various conditions or become decreased with aging. A diminution of balance control induces an increase of fall's risk. The Nintendo Wii Balance Board™ (WBB) is used in rehabilitation to perform balance exercises (using commercial video games). The WBB has also been validated to assess balance and posture in static conditions. However, there is currently no study investigating the use of WBB to assess balance during the realization of balance exercises using this device. The aim of this study was to validate the use of WBB, coupled with specially developed serious games, to assess dynamic balance during rehabilitation exercises. Thirty five subjects participated in this study. Subjects were asked to play two specially developed serious games. Center of pressure (CP) displacements were simultaneously recorded with a WBB and a gold standard force plate (FP). Nine parameters were derived from CP displacement. Bland and Altman plots, paired-sample t tests, intraclass correlation coefficient's, and Pearson's coefficient correlations were computed. Excellent correlation between both devices was found for each parameter for the two games (R = 0.95 and 0.96). Unlike previous work on the WBB, these excellent results were obtained without using any calibration procedure. Despite this, results were highly correlated between the WBB and the FP. The WBB could be used in clinics to assess balance during rehabilitation exercises and, thus, allows a more regular patient follow-up.

  15. Clinical validation of a non-heteronormative version of the Social Interaction Anxiety Scale (SIAS).

    Science.gov (United States)

    Lindner, Philip; Martell, Christopher; Bergström, Jan; Andersson, Gerhard; Carlbring, Per

    2013-12-19

    Despite welcomed changes in societal attitudes and practices towards sexual minorities, instances of heteronormativity can still be found within healthcare and research. The Social Interaction Anxiety Scale (SIAS) is a valid and reliable self-rating scale of social anxiety, which includes one item (number 14) with an explicit heteronormative assumption about the respondent's sexual orientation. This heteronormative phrasing may confuse, insult or alienate sexual minority respondents. A clinically validated version of the SIAS featuring a non-heteronormative phrasing of item 14 is thus needed. 129 participants with diagnosed social anxiety disorder, enrolled in an Internet-based intervention trial, were randomly assigned to responding to the SIAS featuring either the original or a novel non-heteronormative phrasing of item 14, and then answered the other item version. Within-subject, correlation between item versions was calculated and the two scores were statistically compared. The two items' correlations with the other SIAS items and other psychiatric rating scales were also statistically compared. Item versions were highly correlated and scores did not differ statistically. The two items' correlations with other measures did not differ statistically either. The SIAS can be revised with a non-heteronormative formulation of item 14 with psychometric equivalence on item and scale level. Implications for other psychiatric instruments with heteronormative phrasings are discussed.

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

    Science.gov (United States)

    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.

  17. Reliability and Validity of Objective Structured Clinical Examination for Residents of Obstetrics and Gynecology at Kermanshah University of Medical Sciences

    Directory of Open Access Journals (Sweden)

    Nasrin Jalilian

    2012-11-01

    Full Text Available Introduction: Objective structured clinical examination (OSCE is used for the evaluation of the clinical competence in medicine for which it is essential to measure validity and reliability. This study aimed to investigate the validity and reliability of OSCE for residents of obstetrics and gynecology at Kermanshah University of Medical Sciences in 2011.Methods: A descriptive-correlation study was designed and the data of OSCE for obstetrics and gynecology were collected via learning behavior checklists in method stations and multiple choice questions in question stations. The data were analyzed through Pearson correlation coefficient and Cronbach's alpha, using SPSS software (version 16. To determine the criterion validity, correlation of OSCE scores with scores of resident promotion test, direct observation of procedural skills, and theoretical knowledge was determined; for reliability, however, Cronbach's alpha was used. Total sample consisted of 25 participants taking part in 14 stations. P value of less than 0.05 was considered as significant.Results: The mean OSCE scores was 22.66 (±6.85. Criterion validity of the stations with resident promotion theoretical test, first theoretical knowledge test, second theoretical knowledge, and direct observation of procedural skills (DOPS was 0.97, 0.74, 0.49, and 0.79, respectively. In question stations, criterion validity was 0.15, and total validity of OSCE was 0.77.Conclusion: Findings of the present study indicated acceptable validity and reliability of OSCE for residents of obstetrics and gynecology.

  18. External validation of a biomarker and clinical prediction model for hospital mortality in acute respiratory distress syndrome.

    Science.gov (United States)

    Zhao, Zhiguo; Wickersham, Nancy; Kangelaris, Kirsten N; May, Addison K; Bernard, Gordon R; Matthay, Michael A; Calfee, Carolyn S; Koyama, Tatsuki; Ware, Lorraine B

    2017-08-01

    Mortality prediction in ARDS is important for prognostication and risk stratification. However, no prediction models have been independently validated. A combination of two biomarkers with age and APACHE III was superior in predicting mortality in the NHLBI ARDSNet ALVEOLI trial. We validated this prediction tool in two clinical trials and an observational cohort. The validation cohorts included 849 patients from the NHLBI ARDSNet Fluid and Catheter Treatment Trial (FACTT), 144 patients from a clinical trial of sivelestat for ARDS (STRIVE), and 545 ARDS patients from the VALID observational cohort study. To evaluate the performance of the prediction model, the area under the receiver operating characteristic curve (AUC), model discrimination, and calibration were assessed, and recalibration methods were applied. The biomarker/clinical prediction model performed well in all cohorts. Performance was better in the clinical trials with an AUC of 0.74 (95% CI 0.70-0.79) in FACTT, compared to 0.72 (95% CI 0.67-0.77) in VALID, a more heterogeneous observational cohort. The AUC was 0.73 (95% CI 0.70-0.76) when FACTT and VALID were combined. We validated a mortality prediction model for ARDS that includes age, APACHE III, surfactant protein D, and interleukin-8 in a variety of clinical settings. Although the model performance as measured by AUC was lower than in the original model derivation cohort, the biomarker/clinical model still performed well and may be useful for risk assessment for clinical trial enrollment, an issue of increasing importance as ARDS mortality declines, and better methods are needed for selection of the most severely ill patients for inclusion.

  19. Validity in Qualitative Evaluation

    OpenAIRE

    Vasco Lub

    2015-01-01

    This article provides a discussion on the question of validity in qualitative evaluation. Although validity in qualitative inquiry has been widely reflected upon in the methodological literature (and is still often subject of debate), the link with evaluation research is underexplored. Elaborating on epistemological and theoretical conceptualizations by Guba and Lincoln and Creswell and Miller, the article explores aspects of validity of qualitative research with the explicit objective of con...

  20. The improved Clinical Global Impression Scale (iCGI: development and validation in depression

    Directory of Open Access Journals (Sweden)

    Kadouri Alane

    2007-02-01

    Full Text Available Abstract Background The Clinical Global Impression scale (CGI is frequently used in medical care and clinical research because of its face validity and practicability. This study proposes to improve the reliability of the Clinical Global Impression (CGI scale in depressive disorders by the use of a semi-standardized interview, a new response format, and a Delphi procedure. Methods Thirty patients hospitalised for a major depressive episode were filmed at T1 (first week in hospital and at T2 (2 weeks later during a 5' specific interview. The Hamilton Depressive Rating Scale and the Symptom Check List were also rated. Eleven psychiatrists rated these videos using either the usual CGI response format or an improved response format, with or without a Delphi procedure. Results The new response format slightly improved (but not significantly the interrater agreement, the Delphi procedure did not. The best results were obtained when ratings by 4 independent raters were averaged. In this situation, intraclass correlation coefficients were about 0.9. Conclusion The Clinical Global Impression is a useful approach in psychiatry since it apprehends patients in their entirety. This study shows that it is possible to quantify such impressions with a high level of interrater agreement.

  1. The Berlin Inventory of Gambling behavior - Screening (BIG-S): Validation using a clinical sample.

    Science.gov (United States)

    Wejbera, Martin; Müller, Kai W; Becker, Jan; Beutel, Manfred E

    2017-05-18

    Published diagnostic questionnaires for gambling disorder in German are either based on DSM-III criteria or focus on aspects other than life time prevalence. This study was designed to assess the usability of the DSM-IV criteria based Berlin Inventory of Gambling Behavior Screening tool in a clinical sample and adapt it to DSM-5 criteria. In a sample of 432 patients presenting for behavioral addiction assessment at the University Medical Center Mainz, we checked the screening tool's results against clinical diagnosis and compared a subsample of n=300 clinically diagnosed gambling disorder patients with a comparison group of n=132. The BIG-S produced a sensitivity of 99.7% and a specificity of 96.2%. The instrument's unidimensionality and the diagnostic improvements of DSM-5 criteria were verified by exploratory and confirmatory factor analysis as well as receiver operating characteristic analysis. The BIG-S is a reliable and valid screening tool for gambling disorder and demonstrated its concise and comprehensible operationalization of current DSM-5 criteria in a clinical setting.

  2. Clinical validity of a population database definition of remission in patients with major depression.

    Science.gov (United States)

    Sicras-Mainar, Antoni; Blanca-Tamayo, Milagrosa; Gutiérrez-Nicuesa, Laura; Salvatella-Pasant, Jordi; Navarro-Artieda, Ruth

    2010-02-11

    Major depression (MD) is one of the most frequent diagnoses in Primary Care. It is a disabling illness that increases the use of health resources. To describe the concordance between remission according to clinical assessment and remission obtained from the computerized prescription databases of patients with MD in a Spanish population. multicenter cross-sectional. The population under study was comprised of people from six primary care facilities, who had a MD episode between January 2003 and March 2007. A specialist in psychiatry assessed a random sample of patient histories and determined whether a certain patient was in remission according to clinical criteria (ICPC-2). Regarding the databases, patients were considered in remission when they did not need further prescriptions of AD for at least 6 months after completing treatment for a new episode. Validity indicators (sensitivity [S], specificity [Sp]) and clinical utility (positive and negative probability ratio [PPR] and [NPR]) were calculated. The concordance index was established using Cohen's kappa coefficient. Significance level was p Reliability analysis: Cronbach's alpha: 90.6% (CI was 95%: 85.6 - 95.6%). Results show an acceptable level of concordance between remission obtained from the computerized databases and clinical criteria. The major discrepancies were found in diagnostic accuracy.

  3. Validated Measures of Insomnia, Function, Sleepiness, and Nasal Obstruction in a CPAP Alternatives Clinic Population.

    Science.gov (United States)

    Lam, Austin S; Collop, Nancy A; Bliwise, Donald L; Dedhia, Raj C

    2017-08-15

    Although efficacious in the treatment of obstructive sleep apnea (OSA), continuous positive airway pressure (CPAP) can be difficult to tolerate, with long-term adherence rates approaching 50%. CPAP alternatives clinics specialize in the evaluation and treatment of CPAP-intolerant patients; yet this population has not been studied in the literature. To better understand these patients, we sought to assess insomnia, sleep-related functional status, sleepiness, and nasal obstruction, utilizing data from validated instruments. After approval from the Emory University Institutional Review Board, a retrospective chart review was performed from September 2015 to September 2016 of new patient visits at the Emory CPAP alternatives clinic. Patient demographics and responses were recorded from the Insomnia Severity Index, Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10), Epworth Sleepiness Scale, and Nasal Obstruction Symptom Evaluation questionnaires. A total of 172 patients were included, with 81% having moderate-severe OSA. Most of the patients demonstrated moderate-severe clinical insomnia and at least moderate nasal obstruction. FOSQ-10 scores indicated sleep-related functional impairment in 88%. However, most patients did not demonstrate excessive daytime sleepiness. This patient population demonstrates significant symptomatology and functional impairment. Because of the severity of their OSA, they are at increased risk of complications. In order to mitigate the detrimental effects of OSA, these significantly impacted patients should be identified and encouraged to seek CPAP alternatives clinics that specialize in the treatment of this population. © 2017 American Academy of Sleep Medicine

  4. The dutch social interaction anxiety scale and the social phobia scale: reliability, validity, and clinical utility.

    Science.gov (United States)

    de Beurs, Edwin; Tielen, Deirdre; Wollmann, Lisa

    2014-01-01

    The social interaction anxiety scale (SIAS) and the social phobia scale (SPS) assess anxiety in social interactions and fear of scrutiny by others. This study examines the psychometric properties of the Dutch versions of the SIAS and SPS using data from a large group of patients with social phobia and a community-based sample. Confirmatory factor analysis revealed that the SIAS is unidimensional, whereas the SPS is comprised of three subscales. The internal consistency of the scales and subscales was good. The concurrent and discriminant validity was supported and the scales were well able to discriminate between patients and community-based respondents. Cut-off values with excellent sensitivity and specificity are presented. Of all self-report measures included, the SPS was the most sensitive for treatment effects. Normative data are provided which can be used to assess whether clinically significant change has occurred in individual patients.

  5. The Dutch Social Interaction Anxiety Scale and the Social Phobia Scale: Reliability, Validity, and Clinical Utility

    Directory of Open Access Journals (Sweden)

    Edwin de Beurs

    2014-01-01

    Full Text Available The social interaction anxiety scale (SIAS and the social phobia scale (SPS assess anxiety in social interactions and fear of scrutiny by others. This study examines the psychometric properties of the Dutch versions of the SIAS and SPS using data from a large group of patients with social phobia and a community-based sample. Confirmatory factor analysis revealed that the SIAS is unidimensional, whereas the SPS is comprised of three subscales. The internal consistency of the scales and subscales was good. The concurrent and discriminant validity was supported and the scales were well able to discriminate between patients and community-based respondents. Cut-off values with excellent sensitivity and specificity are presented. Of all self-report measures included, the SPS was the most sensitive for treatment effects. Normative data are provided which can be used to assess whether clinically significant change has occurred in individual patients.

  6. Validity of Newborn Clinical Assessment to Determine Gestational Age in Bangladesh.

    Science.gov (United States)

    Lee, Anne Cc; Mullany, Luke C; Ladhani, Karima; Uddin, Jamal; Mitra, Dipak; Ahmed, Parvez; Christian, Parul; Labrique, Alain; DasGupta, Sushil K; Lokken, R Peter; Quaiyum, Mohammed; Baqui, Abdullah H

    2016-07-01

    Gestational age (GA) is frequently unknown or inaccurate in pregnancies in low-income countries. Early identification of preterm infants may help link them to potentially life-saving interventions. We conducted a validation study in a community-based birth cohort in rural Bangladesh. GA was determined by pregnancy ultrasound (distribution, agreement, and diagnostic accuracy of different clinical methods of GA assessment were determined compared with early ultrasound dating. In the live-born cohort (n = 1066), the mean ultrasound GA was 39.1 weeks (SD 2.0) and prevalence of preterm birth (births (community health worker prematurity scorecard [sensitivity/specificity: 70%/27%]; Capurro [5%/96%]; Eregie [75%/58%]; Bhagwat [18%/87%], foot length birth weight rates of fetal growth restriction. Copyright © 2016 by the American Academy of Pediatrics.

  7. Validation of HEDR models

    International Nuclear Information System (INIS)

    Napier, B.A.; Simpson, J.C.; Eslinger, P.W.; Ramsdell, J.V. Jr.; Thiede, M.E.; Walters, W.H.

    1994-05-01

    The Hanford Environmental Dose Reconstruction (HEDR) Project has developed a set of computer models for estimating the possible radiation doses that individuals may have received from past Hanford Site operations. This document describes the validation of these models. In the HEDR Project, the model validation exercise consisted of comparing computational model estimates with limited historical field measurements and experimental measurements that are independent of those used to develop the models. The results of any one test do not mean that a model is valid. Rather, the collection of tests together provide a level of confidence that the HEDR models are valid

  8. Symptomatic peripheral arterial disease: the value of a validated questionnaire and a clinical decision rule

    NARCIS (Netherlands)

    Bendermacher, Bianca L. W.; Teijink, Joep A. W.; Willigendael, Edith M.; Bartelink, Marie-Louise; Büller, Harry R.; Peters, Ron J. G.; Boiten, Jelis; Langenberg, Machteld; Prins, Martin H.

    2006-01-01

    BACKGROUND: If a validated questionnaire, when applied to patients reporting with symptoms of intermittent claudication, could adequately discriminate between those with and without peripheral arterial disease, GPs could avoid the diagnostic measurement of the ankle brachial index. AIM: To

  9. Design and validation of standardized clinical and functional remission criteria in schizophrenia

    Science.gov (United States)

    Mosolov, Sergey N; Potapov, Andrey V; Ushakov, Uriy V; Shafarenko, Aleksey A; Kostyukova, Anastasiya B

    2014-01-01

    Background International Remission Criteria (IRC) for schizophrenia were developed recently by a group of internationally known experts. The IRC detect only 10%–30% of cases and do not cover the diversity of forms and social functioning. Our aim was to design a more applicable tool and validate its use – the Standardized Clinical and Functional Remission Criteria (SCFRC). Methods We used a 6-month follow-up study of 203 outpatients from two Moscow centers and another further sample of stable patients from a 1-year controlled trial of atypical versus typical medication. Diagnosis was confirmed by International Classification of Diseases Version 10 (ICD10) criteria and the Mini-International Neuropsychiatric Interview (MINI). Patients were assessed by the Positive and Negative Syndrome Scale, including intensity threshold, and further classified using the Russian domestic remission criteria and the level of social and personal functioning, according to the Personal and Social Performance Scale (PSP). The SCFRC were formulated and were validated by a data reanalysis on the first population sample and on a second independent sample (104 patients) and in an open-label prospective randomized 12-month comparative study of risperidone long-acting injectable (RLAI) versus olanzapine. Results Only 64 of the 203 outpatients (31.5%) initially met the IRC, and 53 patients (26.1%) met the IRC after 6 months, without a change in treatment. Patients who were in remission had episodic and progressive deficit (39.6%), or remittent (15%) paranoid schizophrenia, or schizoaffective disorder (17%). In addition, 105 patients of 139 (51.7%), who did not meet symptomatic IRC, remained stable within the period. Reanalysis of data revealed that 65.5% of the patients met the SCFRC. In the controlled trial, 70% of patients in the RLAI group met the SCFRC and only 19% the IRC. In the routine treatment group, 55.9% met the SCFRC and only 5.7% the IRC. Results of the further independent

  10. Central Pressure Appraisal: Clinical Validation of a Subject-Specific Mathematical Model.

    Directory of Open Access Journals (Sweden)

    Francesco Tosello

    Full Text Available Current evidence suggests that aortic blood pressure has a superior prognostic value with respect to brachial pressure for cardiovascular events, but direct measurement is not feasible in daily clinical practice.The aim of the present study is the clinical validation of a multiscale mathematical model for non-invasive appraisal of central blood pressure from subject-specific characteristics.A total of 51 young male were selected for the present study. Aortic systolic and diastolic pressure were estimated with a mathematical model and were compared to the most-used non-invasive validated technique (SphygmoCor device, AtCor Medical, Australia. SphygmoCor was calibrated through diastolic and systolic brachial pressure obtained with a sphygmomanometer, while model inputs consist of brachial pressure, height, weight, age, left-ventricular end-systolic and end-diastolic volumes, and data from a pulse wave velocity study.Model-estimated systolic and diastolic central blood pressures resulted to be significantly related to SphygmoCor-assessed central systolic (r = 0.65 p <0.0001 and diastolic (r = 0.84 p<0.0001 blood pressures. The model showed a significant overestimation of systolic pressure (+7.8 (-2.2;14 mmHg, p = 0.0003 and a significant underestimation of diastolic values (-3.2 (-7.5;1.6, p = 0.004, which imply a significant overestimation of central pulse pressure. Interestingly, model prediction errors mirror the mean errors reported in large meta-analysis characterizing the use of the SphygmoCor when non-invasive calibration is performed.In conclusion, multi-scale mathematical model predictions result to be significantly related to SphygmoCor ones. Model-predicted systolic and diastolic aortic pressure resulted in difference of less than 10 mmHg in the 51% and 84% of the subjects, respectively, when compared with SphygmoCor-obtained pressures.

  11. Validation of a clinical assessment of spectral-ripple resolution for cochlear implant users.

    Science.gov (United States)

    Drennan, Ward R; Anderson, Elizabeth S; Won, Jong Ho; Rubinstein, Jay T

    2014-01-01

    Nonspeech psychophysical tests of spectral resolution, such as the spectral-ripple discrimination task, have been shown to correlate with speech-recognition performance in cochlear implant (CI) users. However, these tests are best suited for use in the research laboratory setting and are impractical for clinical use. A test of spectral resolution that is quicker and could more easily be implemented in the clinical setting has been developed. The objectives of this study were (1) To determine whether this new clinical ripple test would yield individual results equivalent to the longer, adaptive version of the ripple-discrimination test; (2) To evaluate test-retest reliability for the clinical ripple measure; and (3) To examine the relationship between clinical ripple performance and monosyllabic word recognition in quiet for a group of CI listeners. Twenty-eight CI recipients participated in the study. Each subject was tested on both the adaptive and the clinical versions of spectral ripple discrimination, as well as consonant-nucleus-consonant word recognition in quiet. The adaptive version of spectral ripple used a two-up, one-down procedure for determining spectral ripple discrimination threshold. The clinical ripple test used a method of constant stimuli, with trials for each of 12 fixed ripple densities occurring six times in random order. Results from the clinical ripple test (proportion correct) were then compared with ripple-discrimination thresholds (in ripples per octave) from the adaptive test. The clinical ripple test showed strong concurrent validity, evidenced by a good correlation between clinical ripple and adaptive ripple results (r = 0.79), as well as a correlation with word recognition (r = 0.7). Excellent test-retest reliability was also demonstrated with a high test-retest correlation (r = 0.9). The clinical ripple test is a reliable nonlinguistic measure of spectral resolution, optimized for use with CI users in a clinical setting. The test

  12. VALIDATION OF A CLINICAL ASSESSMENT OF SPECTRAL RIPPLE RESOLUTION FOR COCHLEAR-IMPLANT USERS

    Science.gov (United States)

    Drennan, Ward. R.; Anderson, Elizabeth S.; Won, Jong Ho; Rubinstein, Jay T.

    2013-01-01

    Objectives Non-speech psychophysical tests of spectral resolution, such as the spectral-ripple discrimination task, have been shown to correlate with speech recognition performance in cochlear implant (CI) users (Henry et al., 2005; Won et al. 2007, 2011; Drennan et al. 2008; Anderson et al. 2011). However, these tests are best suited for use in the research laboratory setting and are impractical for clinical use. A test of spectral resolution that is quicker and could more easily be implemented in the clinical setting has been developed. The objectives of this study were 1) To determine if this new clinical ripple test would yield individual results equivalent to the longer, adaptive version of the ripple discrimination test; 2) To evaluate test-retest reliability for the clinical ripple measure; and 3) To examine the relationship between clinical ripple performance and monosyllabic word recognition in quiet for a group of CI listeners. Design Twenty-eight CI recipients participated in the study. Each subject was tested on both the adaptive and the clinical versions of spectral ripple discrimination, as well as CNC word recognition in quiet. The adaptive version of spectral ripple employed a 2-up, 1-down procedure for determining spectral ripple discrimination threshold. The clinical ripple test used a method of constant stimuli, with trials for each of 12 fixed ripple densities occurring six times in random order. Results from the clinical ripple test (proportion correct) were then compared to ripple discrimination thresholds (in ripples per octave) from the adaptive test. Results The clinical ripple test showed strong concurrent validity, evidenced by a good correlation between clinical ripple and adaptive ripple results (r=0.79), as well as a correlation with word recognition (r = 0.7). Excellent test-retest reliability was also demonstrated with a high test-retest correlation (r = 0.9). Conclusions The clinical ripple test is a reliable non-linguistic measure

  13. Predictive validity of measurements of clinical competence using the team objective structured bedside assessment (TOSBA): assessing the clinical competence of final year medical students.

    LENUS (Irish Health Repository)

    Meagher, Frances M

    2009-11-01

    The importance of valid and reliable assessment of student competence and performance is gaining increased recognition. Provision of valid patient-based formative assessment is an increasing challenge for clinical teachers in a busy hospital setting. A formative assessment tool that reliably predicts performance in the summative setting would be of value to both students and teachers.

  14. Clinical validation of immunoglobulin A nephropathy diagnosis in Swedish biopsy registers

    Directory of Open Access Journals (Sweden)

    Jarrick S

    2017-01-01

    Full Text Available Simon Jarrick,1,2 Sigrid Lundberg,3,4 Adina Welander,5,6 C Michael Fored,6 Jonas F Ludvigsson2,7,8 1Department of Pediatrics, Faculty of Health and Medicine, Örebro University, 2Department of Pediatrics, Örebro University Hospital, Örebro, 3Department of Nephrology, Karolinska University Hospital, 4Department of Clinical Science, Intervention and Technology, Karolinska Institutet, 5Boston Consulting Group, 6Clinical Epidemiology Unit, Department of Medicine, 7Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden; 8Division of Epidemiology and Public Health, School of Medicine, University of Nottingham, Nottingham, UK Aims: The aims of this study were to validate the diagnosis of IgA nephropathy (IgAN in Swedish biopsy registers against patient charts and to describe the clinical characteristics of patients with a biopsy indicating IgAN. Methods: This is a population-based cohort study. Out of 4,069 individuals with a renal biopsy consistent with IgAN (biopsies performed in 1974–2011, this study reviewed patient charts of a random subset of 127 individuals. Clinical and biopsy characteristics at the time of biopsy were evaluated, and positive predictive values (PPV were calculated with 95% confidence intervals (CI. Results: Out of 127 individuals with a renal biopsy consistent with IgAN, 121 had a likely or confirmed clinical diagnosis of IgAN, primary or secondary to Henoch–Schönlein purpura, yielding a PPV of 95% (95% CI =92%–99%. The median age at biopsy was 39 years (range: 4–79 years; seven patients (6% were <16 years. The male to female ratio was 2.8:1. The most common causes for consultation were macroscopic hematuria (n=37; 29%, screening (n=33; 26%, and purpura (n=14, 11%. In patients with available data, the median creatinine level was 104 µmol/L (range 26–986 µmol/L, n=110 and glomerular filtration rate 75 mL/min/1.73m² (range 5–173 mL/min/1.73m², n=114. Hypertension was

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

    Science.gov (United States)

    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.

  16. Estimation of skull table thickness with clinical CT and validation with microCT.

    Science.gov (United States)

    Lillie, Elizabeth M; Urban, Jillian E; Weaver, Ashley A; Powers, Alexander K; Stitzel, Joel D

    2015-01-01

    Brain injuries resulting from motor vehicle crashes (MVC) are extremely common yet the details of the mechanism of injury remain to be well characterized. Skull deformation is believed to be a contributing factor to some types of traumatic brain injury (TBI). Understanding biomechanical contributors to skull deformation would provide further insight into the mechanism of head injury resulting from blunt trauma. In particular, skull thickness is thought be a very important factor governing deformation of the skull and its propensity for fracture. Current computed tomography (CT) technology is limited in its ability to accurately measure cortical thickness using standard techniques. A method to evaluate cortical thickness using cortical density measured from CT data has been developed previously. This effort validates this technique for measurement of skull table thickness in clinical head CT scans using two postmortem human specimens. Bone samples were harvested from the skulls of two cadavers and scanned with microCT to evaluate the accuracy of the estimated cortical thickness measured from clinical CT. Clinical scans were collected at 0.488 and 0.625 mm in plane resolution with 0.625 mm thickness. The overall cortical thickness error was determined to be 0.078 ± 0.58 mm for cortical samples thinner than 4 mm. It was determined that 91.3% of these differences fell within the scanner resolution. Color maps of clinical CT thickness estimations are comparable to color maps of microCT thickness measurements, indicating good quantitative agreement. These data confirm that the cortical density algorithm successfully estimates skull table thickness from clinical CT scans. The application of this technique to clinical CT scans enables evaluation of cortical thickness in population-based studies. © 2014 Anatomical Society.

  17. Validation of clinical case definition of acute intussusception in infants in Viet Nam and Australia.

    Science.gov (United States)

    Bines, Julie E; Liem, Nguyen Thanh; Justice, Frances; Son, Tran Ngoc; Carlin, John B; de Campo, Margaret; Jamsen, Kris; Mulholland, Kim; Barnett, Peter; Barnes, Graeme L

    2006-07-01

    To test the sensitivity and specificity of a clinical case definition of acute intussusception in infants to assist health-care workers in settings where diagnostic facilities are not available. Prospective studies were conducted at a major paediatric hospital in Viet Nam (the National Hospital of Pediatrics, Hanoi) from November 2002 to December 2003 and in Australia (the Royal Children's Hospital, Melbourne) from March 2002 to March 2004 using a clinical case definition of intussusception. Diagnosis of intussusception was confirmed by air enema or surgery and validated in a subset of participants by an independent clinician who was blinded to the participant's status. Sensitivity of the definition was evaluated in 584 infants agedclinical features consistent with intussusception but for whom another diagnosis was established (234 infants in Hanoi; 404 in Melbourne). In both locations the definition used was sensitive (96% sensitivity in Hanoi; 98% in Melbourne) and specific (95% specificity in Hanoi; 87% in Melbourne) for intussusception among infants with sufficient data to allow classification (449/533 in Hanoi; 50/51 in Melbourne). Reanalysis of patients with missing data suggests that modifying minor criteria would increase the applicability of the definition while maintaining good sensitivity (96-97%) and specificity (83-89%). The clinical case definition was sensitive and specific for the diagnosis of acute intussusception in infants in both a developing country and a developed country but minor modifications would enable it to be used more widely.

  18. Mock Pages Are a Valid Construct for Assessment of Clinical Decision Making and Interprofessional Communication.

    Science.gov (United States)

    Boehler, Margaret L; Schwind, Cathy J; Markwell, Stephen J; Minter, Rebecca M

    2017-01-01

    Answering pages from nurses about patients in need of immediate attention is one of the most difficult challenges a resident faces during their first days as a physician. A Mock Page program has been developed and adopted into a national surgical resident preparatory curriculum to prepare senior medical students for this important skill. The purpose of this study is to assess standardized mock page cases as a valid construct to assess clinical decision making and interprofessional communication skills. Mock page cases (n = 16) were administered to 213 senior medical students from 12 medical schools participating in a national surgical resident preparatory curriculum in 2013 and 2014. Clinical decision making and interprofessional communication were measured by case-specific assessments evaluating these skills which have undergone rigorous standard-setting to determine pass/fail cut points. Students' performance improved in general for both communication and clinical decision making over the 4-week course. Cases have been identified that seem to be best suited for differentiating high- from low-performing students. Chest pain, pulmonary embolus, and mental status change cases posed the greatest difficulty for student learners. Simulated mock pages demonstrate an innovative technique for training students in both effective interprofessional communication and management of common postoperative conditions they will encounter as new surgical interns.

  19. Reflective THz and MR imaging of burn wounds: a potential clinical validation of THz contrast mechanisms

    Science.gov (United States)

    Bajwa, Neha; Nowroozi, Bryan; Sung, Shijun; Garritano, James; Maccabi, Ashkan; Tewari, Priyamvada; Culjat, Martin; Singh, Rahul; Alger, Jeffry; Grundfest, Warren; Taylor, Zachary

    2012-10-01

    Terahertz (THz) imaging is an expanding area of research in the field of medical imaging due to its high sensitivity to changes in tissue water content. Previously reported in vivo rat studies demonstrate that spatially resolved hydration mapping with THz illumination can be used to rapidly and accurately detect fluid shifts following induction of burns and provide highly resolved spatial and temporal characterization of edematous tissue. THz imagery of partial and full thickness burn wounds acquired by our group correlate well with burn severity and suggest that hydration gradients are responsible for the observed contrast. This research aims to confirm the dominant contrast mechanism of THz burn imaging using a clinically accepted diagnostic method that relies on tissue water content for contrast generation to support the translation of this technology to clinical application. The hydration contrast sensing capabilities of magnetic resonance imaging (MRI), specifically T2 relaxation times and proton density values N(H), are well established and provide measures of mobile water content, lending MRI as a suitable method to validate hydration states of skin burns. This paper presents correlational studies performed with MR imaging of ex vivo porcine skin that confirm tissue hydration as the principal sensing mechanism in THz burn imaging. Insights from this preliminary research will be used to lay the groundwork for future, parallel MRI and THz imaging of in vivo rat models to further substantiate the clinical efficacy of reflective THz imaging in burn wound care.

  20. Adaptation and validation of the instrument Clinical Learning Environment and Supervision for medical students in primary health care

    Directory of Open Access Journals (Sweden)

    Eva Öhman

    2016-12-01

    Full Text Available Abstract Background Clinical learning takes place in complex socio-cultural environments that are workplaces for the staff and learning places for the students. In the clinical context, the students learn by active participation and in interaction with the rest of the community at the workplace. Clinical learning occurs outside the university, therefore is it important for both the university and the student that the student is given opportunities to evaluate the clinical placements with an instrument that allows evaluation from many perspectives. The instrument Clinical Learning Environment and Supervision (CLES was originally developed for evaluation of nursing students’ clinical learning environment. The aim of this study was to adapt and validate the CLES instrument to measure medical students’ perceptions of their learning environment in primary health care. Methods In the adaptation process the face validity was tested by an expert panel of primary care physicians, who were also active clinical supervisors. The adapted CLES instrument with 25 items and six background questions was sent electronically to 1,256 medical students from one university. Answers from 394 students were eligible for inclusion. Exploratory factor analysis based on principal component methods followed by oblique rotation was used to confirm the adequate number of factors in the data. Construct validity was assessed by factor analysis. Confirmatory factor analysis was used to confirm the dimensions of CLES instrument. Results The construct validity showed a clearly indicated four-factor model. The cumulative variance explanation was 0.65, and the overall Cronbach’s alpha was 0.95. All items loaded similarly with the dimensions in the non-adapted CLES except for one item that loaded to another dimension. The CLES instrument in its adapted form had high construct validity and high reliability and internal consistency. Conclusion CLES, in its adapted form, appears

  1. Validation of autism spectrum disorder diagnoses recorded in the Clinical Practice Research Datalink, 1990–2014

    Directory of Open Access Journals (Sweden)

    Hagberg KW

    2017-09-01

    Full Text Available Katrina Wilcox Hagberg, Susan S Jick Boston Collaborative Drug Surveillance Program, Boston University School of Public Health, Lexington, MA, USA Background: Prior studies have reported that the validity of autism spectrum disorder (ASD diagnoses recorded in the Clinical Practice Research Datalink (CPRD was high; however, diagnostic criteria and screening practices have changed since the last study was published in 2004.Objectives: 1 To calculate the positive predictive value (PPV of ASD diagnoses recorded in the CPRD compared to original medical records and 2 to describe characteristics of cases and use of clinical codes that support the ASD diagnosis as recorded in the electronic data by general practitioners over time.Methods: We identified children with a code for ASD (autism spectrum disorder, autism, Asperger’s, or pervasive developmental disorder in the CPRD from 1990 to 2014. We evaluated presence of codes in the electronic medical record indicating the presence of developmental delay, speech delay, behavioral problems, and other supporting clinical codes (e.g., therapy, referrals, etc.. We also evaluated changes in recording of these clinical codes over time. We compared the information present in the electronic medical record to original medical records for a sample of cases and calculated PPVs of ASD diagnoses recorded in the CPRD.Results: We identified 2154 children with a code for ASD. The mean age at diagnosis was 5.8 years, and 84% of cases were male. The majority (78.4% had 1 ASD diagnosis code in their electronic medical record. Approximately half of the cases had a code indicating behavioral problem, developmental delay, or speech delay, and 24.7% had a code indicating specialist referral or visit. After review of original medical records, the PPV of ASD diagnoses recorded in the CPRD was 91.9%. Conclusion: The results of this study suggest that ASD diagnoses recorded in the CPRD are reliable and can be used with confidence

  2. Prediction of higher cost of antiretroviral therapy (ART) according to clinical complexity. A validated clinical index.

    Science.gov (United States)

    Velasco, Cesar; Pérez, Inaki; Podzamczer, Daniel; Llibre, Josep Maria; Domingo, Pere; González-García, Juan; Puig, Inma; Ayala, Pilar; Martín, Mayte; Trilla, Antoni; Lázaro, Pablo; Gatell, Josep Maria

    2016-03-01

    The financing of antiretroviral therapy (ART) is generally determined by the cost incurred in the previous year, the number of patients on treatment, and the evidence-based recommendations, but not the clinical characteristics of the population. To establish a score relating the cost of ART and patient clinical complexity in order to understand the costing differences between hospitals in the region that could be explained by the clinical complexity of their population. Retrospective analysis of patients receiving ART in a tertiary hospital between 2009 and 2011. Factors potentially associated with a higher cost of ART were assessed by bivariate and multivariate analysis. Two predictive models of "high-cost" were developed. The normalized estimated (adjusted for the complexity scores) costs were calculated and compared with the normalized real costs. In the Hospital Index, 631 (16.8%) of the 3758 patients receiving ART were responsible for a "high-cost" subgroup, defined as the highest 25% of spending on ART. Baseline variables that were significant predictors of high cost in the Clinic-B model in the multivariate analysis were: route of transmission of HIV, AIDS criteria, Spanish nationality, year of initiation of ART, CD4+ lymphocyte count nadir, and number of hospital admissions. The Clinic-B score ranged from 0 to 13, and the mean value (5.97) was lower than the overall mean value of the four hospitals (6.16). The clinical complexity of the HIV patient influences the cost of ART. The Clinic-B and Clinic-BF scores predicted patients with high cost of ART and could be used to compare and allocate costs corrected for the patient clinical complexity. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  3. RELIABILITY AND VALIDITY OF CLINICAL AND ULTRASOUND EXAMINATIONS OF DEVELOPMENTAL HIP DYSPLASIA

    Directory of Open Access Journals (Sweden)

    Predrag Grubor

    2011-03-01

    Full Text Available Developmental dysplasia of the hip (DDH is the most common congenital deformation of the musculoskeletal system and its successful treatment is closely related to early diagnosis. The study is aimed at examining the incidence of developmental dysplasia of the hip (DDH and at analysing the validity of clinical examination, which is used for the early detection of DDH in the neonatal period, compared to ultrasound examination.The study involved 400 neonates born in the Banja Luka Region. A new questionnaire was open during the first regular ultrasound and clinical examination of the neonates’ hips and anamnestic and clinical data were recorded in it: the asymmetry of the gluteal, inguinal and femoral folds (Bade sign, the result of abduction testseparately for each hip, the Ortolani sign of luxation and the Palmen sign of reposition, then hip sonography. A Toshiba ultrasound machine with a 7.5 MHz linear probe was used. The method employed was Professor Reinhard Graf’s. Out of the total number of the children with a positive sonographic finding for DDH, 63.16% of them have one of the clinical signs of DDH. The ability of a clinical finding to identify those patients who do not have DDH and have a negative sonographic finding is 79.8%. Out of the total number of the examined children with a positive clinical finding, only 15.58% of them also have a positive sonographic finding for DDH. This research has showed that clinical examination of the hips is of low sensitivity, specificity and reliability, and that not all types of DDH can be detected. Clinical examination must remain an integral part of every infant’s examination, but it constitutes a complementary diagnostic procedure to ultrasound examination. The ultrasound examination of DDH has created new possibilities and has filled the void that existed due to the deficiency of clinical tests, and at the same time it has reduced the number of X-ray examinations of the hips. This research has

  4. Validation of simulation models

    DEFF Research Database (Denmark)

    Rehman, Muniza; Pedersen, Stig Andur

    2012-01-01

    In philosophy of science, the interest for computational models and simulations has increased heavily during the past decades. Different positions regarding the validity of models have emerged but the views have not succeeded in capturing the diversity of validation methods. The wide variety...

  5. Development, validation and clinical assessment of a short questionnaire to assess disease-related knowledge in inflammatory bowel disease patients.

    LENUS (Irish Health Repository)

    Keegan, Denise

    2013-02-01

    Only two inflammatory bowel disease (IBD) knowledge scales are available, both primarily aimed at evaluating the effectiveness of clinical education programs. The aim of this study was to develop and validate a short knowledge questionnaire for clinical and academic research purposes.

  6. A validated risk score to estimate mortality risk in patients with dementia and pneumonia: barriers to clinical impact

    NARCIS (Netherlands)

    van der Steen, J.T.; Albers, G.; Strunk, E.; Muller, M.T.; Ribbe, M.W.

    2011-01-01

    Background: The clinical impact of risk score use in end-of-life settings is unknown, with reports limited to technical properties. Methods: We conducted a mixed-methods study to evaluate clinical impact of a validated mortality risk score aimed at informing prognosis and supporting clinicians in

  7. Defining surgical criteria for empty nose syndrome: Validation of the office-based cotton test and clinical interpretability of the validated Empty Nose Syndrome 6-Item Questionnaire.

    Science.gov (United States)

    Thamboo, Andrew; Velasquez, Nathalia; Habib, Al-Rahim R; Zarabanda, David; Paknezhad, Hassan; Nayak, Jayakar V

    2017-08-01

    The validated Empty Nose Syndrome 6-Item Questionnaire (ENS6Q) identifies empty nose syndrome (ENS) patients. The unvalidated cotton test assesses improvement in ENS-related symptoms. By first validating the cotton test using the ENS6Q, we define the minimal clinically important difference (MCID) score for the ENS6Q. Individual case-control study. Fifteen patients diagnosed with ENS and 18 controls with non-ENS sinonasal conditions underwent office cotton placement. Both groups completed ENS6Q testing in three conditions-precotton, cotton in situ, and postcotton-to measure the reproducibility of ENS6Q scoring. Participants also completed a five-item transition scale ranging from "much better" to "much worse" to rate subjective changes in nasal breathing with and without cotton placement. Mean changes for each transition point, and the ENS6Q MCID, were then calculated. In the precotton condition, significant differences (P < .001) in all ENS6Q questions between ENS and controls were noted. With cotton in situ, nearly all prior ENS6Q differences normalized between ENS and control patients. For ENS patients, the changes in the mean differences between the precotton and cotton in situ conditions compared to postcotton versus cotton in situ conditions were insignificant among individuals. Including all 33 participants, the mean change in the ENS6Q between the parameters "a little better" and "about the same" was 4.25 (standard deviation [SD] = 5.79) and -2.00 (SD = 3.70), giving an MCID of 6.25. Cotton testing is a validated office test to assess for ENS patients. Cotton testing also helped to determine the MCID of the ENS6Q, which is a 7-point change from the baseline ENS6Q score. 3b. Laryngoscope, 127:1746-1752, 2017. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

  8. Development and validation of a clinically applicable score to classify cachexia stages in advanced cancer patients

    Science.gov (United States)

    Zhou, Ting; Wang, Bangyan; Liu, Huiquan; Yang, Kaixiang; Thapa, Sudip; Zhang, Haowen; Li, Lu

    2018-01-01

    Abstract Background Cachexia is a multifactorial syndrome that is highly prevalent in advanced cancer patients and leads to progressive functional impairments. The classification of cachexia stages is essential for diagnosing and treating cachexia. However, there is a lack of simple tools with good discrimination for classifying cachexia stages. Therefore, our study aimed to develop a clinically applicable cachexia staging score (CSS) and validate its discrimination of clinical outcomes for different cachexia stages. Methods Advanced cancer patients were enrolled in our study. A CSS comprising the following five components was developed: weight loss, a simple questionnaire of sarcopenia (SARC‐F), Eastern Cooperative Oncology Group, appetite loss, and abnormal biochemistry. According to the CSS, patients were classified into non‐cachexia, pre‐cachexia, cachexia, and refractory cachexia stages, and clinical outcomes were compared among the four groups. Results Of the 297 participating patients, data from 259 patients were ultimately included. Based on the CSS, patients were classified into non‐cachexia (n = 69), pre‐cachexia (n = 68), cachexia (n = 103), and refractory cachexia (n = 19) stages. Patients with more severe cachexia stages had lower skeletal muscle indexes (P = 0.002 and P = 0.004 in male and female patients, respectively), higher prevalence of sarcopenia (P = 0.017 and P = 0.027 in male and female patients, respectively), more severe symptom burden (P cachexia stages. This score is extremely useful for the clinical treatment and prognosis of cachexia and for designing clinical trials. PMID:29372594

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

    Science.gov (United States)

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

    2015-04-01

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

  10. The Metacognitive Anger Processing (MAP) Scale - Validation in a Mixed Clinical and a Forensic In-Patient Sample

    DEFF Research Database (Denmark)

    Moeller, Stine Bjerrum; Bech, Per

    2018-01-01

    BACKGROUND: The metacognitive approach by Wells and colleagues has gained empirical support with a broad range of symptoms. The Metacognitive Anger Processing (MAP) scale was developed to provide a metacognitive measure on anger (Moeller, 2016). In the preliminary validation, three components were...... identified (positive beliefs, negative beliefs and rumination) to be positively correlated with the anger. AIMS: To validate the MAP in a sample of mixed clinical patients (n = 88) and a sample of male forensic patients (n = 54). METHOD: The MAP was administered together with measures of metacognition, anger......, rumination, anxiety and depressive symptoms. RESULTS: The MAP showed acceptable scalability and excellent reliability. Convergent validity was evidenced using the general metacognitive measure (MCQ-30), and concurrent validity was supported using two different anger measures (STAXI-2 and NAS). CONCLUSIONS...

  11. Development and Validation of a Clinically Based Risk Calculator for the Transdiagnostic Prediction of Psychosis

    Science.gov (United States)

    Rutigliano, Grazia; Stahl, Daniel; Davies, Cathy; Bonoldi, Ilaria; Reilly, Thomas; McGuire, Philip

    2017-01-01

    Importance The overall effect of At Risk Mental State (ARMS) services for the detection of individuals who will develop psychosis in secondary mental health care is undetermined. Objective To measure the proportion of individuals with a first episode of psychosis detected by ARMS services in secondary mental health services, and to develop and externally validate a practical web-based individualized risk calculator tool for the transdiagnostic prediction of psychosis in secondary mental health care. Design, Setting, and Participants Clinical register-based cohort study. Patients were drawn from electronic, real-world, real-time clinical records relating to 2008 to 2015 routine secondary mental health care in the South London and the Maudsley National Health Service Foundation Trust. The study included all patients receiving a first index diagnosis of nonorganic and nonpsychotic mental disorder within the South London and the Maudsley National Health Service Foundation Trust in the period between January 1, 2008, and December 31, 2015. Data analysis began on September 1, 2016. Main Outcomes and Measures Risk of development of nonorganic International Statistical Classification of Diseases and Related Health Problems, Tenth Revision psychotic disorders. Results A total of 91 199 patients receiving a first index diagnosis of nonorganic and nonpsychotic mental disorder within South London and the Maudsley National Health Service Foundation Trust were included in the derivation (n = 33 820) or external validation (n = 54 716) data sets. The mean age was 32.97 years, 50.88% were men, and 61.05% were white race/ethnicity. The mean follow-up was 1588 days. The overall 6-year risk of psychosis in secondary mental health care was 3.02 (95% CI, 2.88-3.15), which is higher than the 6-year risk in the local general population (0.62). Compared with the ARMS designation, all of the International Statistical Classification of Diseases and Related Health Problems

  12. Model-based PSF and MTF estimation and validation from skeletal clinical CT images.

    Science.gov (United States)

    Pakdel, Amirreza; Mainprize, James G; Robert, Normand; Fialkov, Jeffery; Whyne, Cari M

    2014-01-01

    A method was developed to correct for systematic errors in estimating the thickness of thin bones due to image blurring in CT images using bone interfaces to estimate the point-spread-function (PSF). This study validates the accuracy of the PSFs estimated using said method from various clinical CT images featuring cortical bones. Gaussian PSFs, characterized by a different extent in the z (scan) direction than in the x and y directions were obtained using our method from 11 clinical CT scans of a cadaveric craniofacial skeleton. These PSFs were estimated for multiple combinations of scanning parameters and reconstruction methods. The actual PSF for each scan setting was measured using the slanted-slit technique within the image slice plane and the longitudinal axis. The Gaussian PSF and the corresponding modulation transfer function (MTF) are compared against the actual PSF and MTF for validation. The differences (errors) between the actual and estimated full-width half-max (FWHM) of the PSFs were 0.09 ± 0.05 and 0.14 ± 0.11 mm for the xy and z axes, respectively. The overall errors in the predicted frequencies measured at 75%, 50%, 25%, 10%, and 5% MTF levels were 0.06 ± 0.07 and 0.06 ± 0.04 cycles/mm for the xy and z axes, respectively. The accuracy of the estimates was dependent on whether they were reconstructed with a standard kernel (Toshiba's FC68, mean error of 0.06 ± 0.05 mm, MTF mean error 0.02 ± 0.02 cycles/mm) or a high resolution bone kernel (Toshiba's FC81, PSF FWHM error 0.12 ± 0.03 mm, MTF mean error 0.09 ± 0.08 cycles/mm). The method is accurate in 3D for an image reconstructed using a standard reconstruction kernel, which conforms to the Gaussian PSF assumption but less accurate when using a high resolution bone kernel. The method is a practical and self-contained means of estimating the PSF in clinical CT images featuring cortical bones, without the need phantoms or any prior knowledge about the scanner-specific parameters.

  13. Model-based PSF and MTF estimation and validation from skeletal clinical CT images

    International Nuclear Information System (INIS)

    Pakdel, Amirreza; Mainprize, James G.; Robert, Normand; Fialkov, Jeffery; Whyne, Cari M.

    2014-01-01

    Purpose: A method was developed to correct for systematic errors in estimating the thickness of thin bones due to image blurring in CT images using bone interfaces to estimate the point-spread-function (PSF). This study validates the accuracy of the PSFs estimated using said method from various clinical CT images featuring cortical bones. Methods: Gaussian PSFs, characterized by a different extent in the z (scan) direction than in the x and y directions were obtained using our method from 11 clinical CT scans of a cadaveric craniofacial skeleton. These PSFs were estimated for multiple combinations of scanning parameters and reconstruction methods. The actual PSF for each scan setting was measured using the slanted-slit technique within the image slice plane and the longitudinal axis. The Gaussian PSF and the corresponding modulation transfer function (MTF) are compared against the actual PSF and MTF for validation. Results: The differences (errors) between the actual and estimated full-width half-max (FWHM) of the PSFs were 0.09 ± 0.05 and 0.14 ± 0.11 mm for the xy and z axes, respectively. The overall errors in the predicted frequencies measured at 75%, 50%, 25%, 10%, and 5% MTF levels were 0.06 ± 0.07 and 0.06 ± 0.04 cycles/mm for the xy and z axes, respectively. The accuracy of the estimates was dependent on whether they were reconstructed with a standard kernel (Toshiba's FC68, mean error of 0.06 ± 0.05 mm, MTF mean error 0.02 ± 0.02 cycles/mm) or a high resolution bone kernel (Toshiba's FC81, PSF FWHM error 0.12 ± 0.03 mm, MTF mean error 0.09 ± 0.08 cycles/mm). Conclusions: The method is accurate in 3D for an image reconstructed using a standard reconstruction kernel, which conforms to the Gaussian PSF assumption but less accurate when using a high resolution bone kernel. The method is a practical and self-contained means of estimating the PSF in clinical CT images featuring cortical bones, without the need phantoms or any prior knowledge about the

  14. Model-based PSF and MTF estimation and validation from skeletal clinical CT images

    Energy Technology Data Exchange (ETDEWEB)

    Pakdel, Amirreza [Sunnybrook Research Institute, Toronto, Ontario M4N 3M5, Canada and Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, Ontario M5S 3M2 (Canada); Mainprize, James G.; Robert, Normand [Sunnybrook Research Institute, Toronto, Ontario M4N 3M5 (Canada); Fialkov, Jeffery [Division of Plastic Surgery, Sunnybrook Health Sciences Center, Toronto, Ontario M4N 3M5, Canada and Department of Surgery, University of Toronto, Toronto, Ontario M5S 3M2 (Canada); Whyne, Cari M., E-mail: cari.whyne@sunnybrook.ca [Sunnybrook Research Institute, Toronto, Ontario M4N 3M5, Canada and Department of Surgery, Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, Ontario M5S 3M2 (Canada)

    2014-01-15

    Purpose: A method was developed to correct for systematic errors in estimating the thickness of thin bones due to image blurring in CT images using bone interfaces to estimate the point-spread-function (PSF). This study validates the accuracy of the PSFs estimated using said method from various clinical CT images featuring cortical bones. Methods: Gaussian PSFs, characterized by a different extent in the z (scan) direction than in the x and y directions were obtained using our method from 11 clinical CT scans of a cadaveric craniofacial skeleton. These PSFs were estimated for multiple combinations of scanning parameters and reconstruction methods. The actual PSF for each scan setting was measured using the slanted-slit technique within the image slice plane and the longitudinal axis. The Gaussian PSF and the corresponding modulation transfer function (MTF) are compared against the actual PSF and MTF for validation. Results: The differences (errors) between the actual and estimated full-width half-max (FWHM) of the PSFs were 0.09 ± 0.05 and 0.14 ± 0.11 mm for the xy and z axes, respectively. The overall errors in the predicted frequencies measured at 75%, 50%, 25%, 10%, and 5% MTF levels were 0.06 ± 0.07 and 0.06 ± 0.04 cycles/mm for the xy and z axes, respectively. The accuracy of the estimates was dependent on whether they were reconstructed with a standard kernel (Toshiba's FC68, mean error of 0.06 ± 0.05 mm, MTF mean error 0.02 ± 0.02 cycles/mm) or a high resolution bone kernel (Toshiba's FC81, PSF FWHM error 0.12 ± 0.03 mm, MTF mean error 0.09 ± 0.08 cycles/mm). Conclusions: The method is accurate in 3D for an image reconstructed using a standard reconstruction kernel, which conforms to the Gaussian PSF assumption but less accurate when using a high resolution bone kernel. The method is a practical and self-contained means of estimating the PSF in clinical CT images featuring cortical bones, without the need phantoms or any prior knowledge

  15. Pressure pain thresholds, clinical assessment, and differential diagnosis: reliability and validity in patients with myogenic pain.

    Science.gov (United States)

    Ohrbach, R; Gale, E N

    1989-11-01

    Four studies are presented testing the validity and reliability of pressure pain thresholds (PPTs) and of examination parameters believed to be important in the clinical assessment of sites commonly used for such measures in patient samples. Forty-five patients with a myogenous temporomandibular disorder were examined clinically prior to PPT measures. Criteria for history and examination included functional aspects of the pain, tissue quality of the pain site, and the type of pain elicited from palpation. Control sites within the same muscle and in the contralateral muscle were also examined. PPTs were measured as an index of tenderness using a strain gauge algometer at these sites. The data from the 5 male subjects were excluded from subsequent analyses due to the higher PPT in the males and to their unequal distribution among the various factorial conditions. The first study demonstrated strong validity in PPT measures between patients (using pain sites replicating the patients' pain) and matched controls (n = 11). The PPT was not significantly different between the primary pain site (referred pain and non-referred pain collapsed) and the no-pain control site in the same muscle (n = 16). The PPT was significantly lower at the pain site compared to the no-pain control site in the contralateral muscle (n = 13). The second study indicated adequate reliability in patient samples of the PPT measures. In the third study, the PPT was significantly lower at sites producing referred pain on palpation compared to sites producing localized pain on palpation. The PPT findings from the control sites were inconsistent on this factor. The fourth study presented preliminary evidence that palpable bands and nodular areas in muscle were most commonly associated with muscle regions that produce pain; such muscle findings were not specific, however, for regions that produce pain. Further, the intraexaminer reliability in reassessing these pain sites qualitatively was only fair

  16. Is Doubling of Serum Creatinine a Valid Clinical 'Hard' Endpoint in Clinical Nephrology Trials?

    NARCIS (Netherlands)

    Lambers Heerspink, H. J.; Perkovic, V.; de Zeeuw, D.

    2011-01-01

    The composite of end stage renal disease (ESRD), doubling of serum creatinine and (renal) death, is a frequently used endpoint in randomized clinical trials in nephrology. Doubling of serum creatinine is a well-accepted part of this endpoint because a doubling of serum creatinine reflects a large

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

    Science.gov (United States)

    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.

  18. Proposal and validation of a clinical trunk control test in individuals with spinal cord injury.

    Science.gov (United States)

    Quinzaños, J; Villa, A R; Flores, A A; Pérez, R

    2014-06-01

    One of the problems that arise in spinal cord injury (SCI) is alteration in trunk control. Despite the need for standardized scales, these do not exist for evaluating trunk control in SCI. To propose and validate a trunk control test in individuals with SCI. National Institute of Rehabilitation, Mexico. The test was developed and later evaluated for reliability and criteria, content, and construct validity. We carried out 531 tests on 177 patients and found high inter- and intra-rater reliability. In terms of criterion validity, analysis of variance demonstrated a statistically significant difference in the test score of patients with adequate or inadequate trunk control according to the assessment of a group of experts. A receiver operating characteristic curve was plotted for optimizing the instrument's cutoff point, which was determined at 13 points, with a sensitivity of 98% and a specificity of 92.2%. With regard to construct validity, the correlation between the proposed test and the spinal cord independence measure (SCIM) was 0.873 (P=0.001) and that with the evolution time was 0.437 (P=0.001). For testing the hypothesis with qualitative variables, the Kruskal-Wallis test was performed, which resulted in a statistically significant difference between the scores in the proposed scale of each group defined by these variables. It was proven experimentally that the proposed trunk control test is valid and reliable. Furthermore, the test can be used for all patients with SCI despite the type and level of injury.

  19. The Arabic Mood and Feelings Questionnaire: psychometrics and validity in a clinical sample.

    Science.gov (United States)

    Tavitian, Lucy; Atwi, Mia; Bawab, Soha; Hariz, Nayla; Zeinoun, Pia; Khani, Munir; Maalouf, Fadi T

    2014-06-01

    The purpose of this study was to provide clinicians in the Arab World with a child and adolescent depression screening tool. Child and parent versions of the Mood and Feelings Questionnaire (CMFQ and PMFQ respectively) were translated to Arabic and administered along with the Strengths and Difficulties Questionnaire (SDQ) to 30 children and adolescents and with mood disorders and 76 children and adolescents with other psychiatric disorders seeking treatment at a child and adolescent psychiatry clinic. DSM-IV diagnoses were generated through clinical interviews by a psychiatrist blinded to self-reports. Internal consistency for both versions was excellent with moderate inter-informant agreement and good convergent validity with the SDQ emotional symptoms subscales on the child and parent forms. The CMFQ and PMFQ significantly differentiated between currently depressed participants and those with other psychiatric disorders. CMFQ scores were a stronger predictor of categorization into depressed and non-depressed groups than the PMFQ. Two modes of cutoffs were calculated with one favoring sensitivity (a score of 26 for the CMFQ and 22 for the PMFQ) and another favoring specificity (a score of 31 for the CMFQ and 28 for the PMFQ).

  20. [Validation of a clinical prediction rule to distinguish bacterial from aseptic meningitis].

    Science.gov (United States)

    Agüero, Gonzalo; Davenport, María C; Del Valle, María de la P; Gallegos, Paulina; Kannemann, Ana L; Bokser, Vivian; Ferrero, Fernando

    2010-02-01

    Despite most meningitis are not bacterial, antibiotics are usually administered on admission because bacterial meningitis is difficult to be rule-out. Distinguishing bacterial from aseptic meningitis on admission could avoid inappropriate antibiotic use and hospitalization. We aimed to validate a clinical prediction rule to distinguish bacterial from aseptic meningitis in children, on arriving to the emergency room. This prospective study included patients aged or = 1000 cells/mm(3), CSF protein > or = 80 mg/dl, peripheral blood absolute neutrophil count > or = 10.000/mm(3), seizure = 1 point each. Sensitivity (S), specificity (E), positive and negative predictive values (PPV and NPV), positive and negative likelihood ratios (PLR and NLR) of the BMS to predict bacterial meningitis were calculated. Seventy patients with meningitis were included (14 bacterial meningitis). When BMS was calculated, 25 patients showed a BMS= 0 points, 11 BMS= 1 point, and 34 BMS > or = 2 points. A BMS = 0 showed S: 100%, E: 44%, VPP: 31%, VPN: 100%, RVP: 1,81 RVN: 0. A BMS > or = 2 predicted bacterial meningitis with S: 100%, E: 64%, VPP: 41%, VPN: 100%, PLR: 2.8, NLR:0. Using BMS was simple, and allowed identifying children with very low risk of bacterial meningitis. It could be a useful tool to assist clinical decision making.

  1. HPLC determination of plasma dimethylarginines: method validation and preliminary clinical application.

    Science.gov (United States)

    Ivanova, Mariela; Artusi, Carlo; Boffa, Giovanni Maria; Zaninotto, Martina; Plebani, Mario

    2010-11-11

    Asymmetric dimethylarginine (ADMA) has been suggested as a possible marker of endothelial dysfunction, and interest in its use in clinical practice is increasing. However, the potential role of symmetric dimethylarginine (SDMA) as an endogenous marker of renal function, has been less widely investigated. The aims of the present study were therefore to determine reference values for dimethylarginines in plasma after method validation, and to ascertain ADMA plasma concentrations in patients with disorders characterized by endothelial dysfunction; a further end-point was to investigate the relationship between SDMA plasma concentrations and estimated GFR (eGFR) as well as plasmatic creatinine in patients with chronic kidney disease (CKD). HPLC with fluorescence detection was used for the determination of plasma dimethylarginines. To verify the clinical usefulness of ADMA and SDMA, values from 4 groups of patients at a high risk of cardiovascular complications as well renal dysfunction (chronic heart failure n=126; type II diabetes n=43; pulmonary arterial hypertension n=17; chronic kidney disease n=42) were evaluated, and compared with the reference values, obtained from 225 blood donors. The intra- and inter-assay CVs (peadiatric populations, for which the use of eGFR is not recommended. 2010 Elsevier B.V. All rights reserved.

  2. Clinical validation of targeted next-generation sequencing for inherited disorders.

    Science.gov (United States)

    Yohe, Sophia; Hauge, Adam; Bunjer, Kari; Kemmer, Teresa; Bower, Matthew; Schomaker, Matthew; Onsongo, Getiria; Wilson, Jon; Erdmann, Jesse; Zhou, Yi; Deshpande, Archana; Spears, Michael D; Beckman, Kenneth; Silverstein, Kevin A T; Thyagarajan, Bharat

    2015-02-01

    Although next-generation sequencing (NGS) can revolutionize molecular diagnostics, several hurdles remain in the implementation of this technology in clinical laboratories. To validate and implement an NGS panel for genetic diagnosis of more than 100 inherited diseases, such as neurologic conditions, congenital hearing loss and eye disorders, developmental disorders, nonmalignant diseases treated by hematopoietic cell transplantation, familial cancers, connective tissue disorders, metabolic disorders, disorders of sexual development, and cardiac disorders. The diagnostic gene panels ranged from 1 to 54 genes with most of panels containing 10 genes or fewer. We used a liquid hybridization-based, target-enrichment strategy to enrich 10 067 exons in 568 genes, followed by NGS with a HiSeq 2000 sequencing system (Illumina, San Diego, California). We successfully sequenced 97.6% (9825 of 10 067) of the targeted exons to obtain a minimum coverage of 20× at all bases. We demonstrated 100% concordance in detecting 19 pathogenic single-nucleotide variations and 11 pathogenic insertion-deletion mutations ranging in size from 1 to 18 base pairs across 18 samples that were previously characterized by Sanger sequencing. Using 4 pairs of blinded, duplicate samples, we demonstrated a high degree of concordance (>99%) among the blinded, duplicate pairs. We have successfully demonstrated the feasibility of using the NGS platform to multiplex genetic tests for several rare diseases and the use of cloud computing for bioinformatics analysis as a relatively low-cost solution for implementing NGS in clinical laboratories.

  3. Clinical validation of the planar radionuclide ventriculography in patients with right ventricular dysfunction.

    Science.gov (United States)

    Bontemps, L; Merabet, Y; Chevalier, P; Itti, R

    2013-01-01

    Gated radionuclide ventriculography (RNV) may be used for the evaluation of the right ventricular function. However, the accuracy of the method should be clinically validated in patients suffering from diseases with specific pathology of the right ventricle (RV) and with possible left ventricular (LV) interaction. Three groups of 15 patients each, diagnosed with arrhythmogenic right ventricular dysplasia (ARVD), pulmonary artery hypertension (PAH) or atrial septal defect (ASD) were compared to a group of normal subjects. The parameters for both ventricles were evaluated separately (ejection fractions: LVEF and RVEF, and intraventricular synchronism quantified as phase standard deviation: LVPSD and RVPSD) as well as the relation or interdependence of the right to left ventricle (RV/LV volume ratio, LV/RV ejection fraction and stroke volume ratios, and interventricular synchronism). All the variables as a whole were analyzed to identify groups of patients according to their functional behaviour. Significant differences were found between the patients and control group for the RV function while the LV function remained mostly within normal limits. When the RV function was considered, the control group and ASD patient group showed differences regarding the ARVD and PAH patients. On evaluating the RV/LV ratios, differences were found between the control group and the ASD group. In the PAH patients, LV function showed differences in relation to the rest of the groups. RNV is a reliable clinical tool to evaluate RV function in patients with RV abnormality. Copyright © 2013 Elsevier España, S.L. and SEMNIM. All rights reserved.

  4. Clinical validity of a population database definition of remission in patients with major depression

    Directory of Open Access Journals (Sweden)

    Salvatella-Pasant Jordi

    2010-02-01

    Full Text Available Abstract Background Major depression (MD is one of the most frequent diagnoses in Primary Care. It is a disabling illness that increases the use of health resources. Aim: To describe the concordance between remission according to clinical assessment and remission obtained from the computerized prescription databases of patients with MD in a Spanish population. Methods Design: multicenter cross-sectional. The population under study was comprised of people from six primary care facilities, who had a MD episode between January 2003 and March 2007. A specialist in psychiatry assessed a random sample of patient histories and determined whether a certain patient was in remission according to clinical criteria (ICPC-2. Regarding the databases, patients were considered in remission when they did not need further prescriptions of AD for at least 6 months after completing treatment for a new episode. Validity indicators (sensitivity [S], specificity [Sp] and clinical utility (positive and negative probability ratio [PPR] and [NPR] were calculated. The concordance index was established using Cohen's kappa coefficient. Significance level was p Results 133 patient histories were reviewed. The kappa coefficient was 82.8% (confidence intervals [CI] were 95%: 73.1 - 92.6, PPR 9.8% and NPR 0.1%. Allocation discrepancies between both criteria were found in 11 patients. S was 92.5% (CI was 95%: 88.0 - 96.9% and Sp was 90.6% (CI was 95%: 85.6 - 95.6%, p Conclusions Results show an acceptable level of concordance between remission obtained from the computerized databases and clinical criteria. The major discrepancies were found in diagnostic accuracy.

  5. Construct Validity: Advances in Theory and Methodology

    OpenAIRE

    Strauss, Milton E.; Smith, Gregory T.

    2009-01-01

    Measures of psychological constructs are validated by testing whether they relate to measures of other constructs as specified by theory. Each test of relations between measures reflects on the validity of both the measures and the theory driving the test. Construct validation concerns the simultaneous process of measure and theory validation. In this chapter, we review the recent history of validation efforts in clinical psychological science that has led to this perspective, and we review f...

  6. Direct Observation of Clinical Skills Feedback Scale: Development and Validity Evidence.

    Science.gov (United States)

    Halman, Samantha; Dudek, Nancy; Wood, Timothy; Pugh, Debra; Touchie, Claire; McAleer, Sean; Humphrey-Murto, Susan

    2016-01-01

    Construct: This article describes the development and validity evidence behind a new rating scale to assess feedback quality in the clinical workplace. Competency-based medical education has mandated a shift to learner-centeredness, authentic observation, and frequent formative assessments with a focus on the delivery of effective feedback. Because feedback has been shown to be of variable quality and effectiveness, an assessment of feedback quality in the workplace is important to ensure we are providing trainees with optimal learning opportunities. The purposes of this project were to develop a rating scale for the quality of verbal feedback in the workplace (the Direct Observation of Clinical Skills Feedback Scale [DOCS-FBS]) and to gather validity evidence for its use. Two panels of experts (local and national) took part in a nominal group technique to identify features of high-quality feedback. Through multiple iterations and review, 9 features were developed into the DOCS-FBS. Four rater types (residents n = 21, medical students n = 8, faculty n = 12, and educators n = 12) used the DOCS-FBS to rate videotaped feedback encounters of variable quality. The psychometric properties of the scale were determined using a generalizability analysis. Participants also completed a survey to gather data on a 5-point Likert scale to inform the ease of use, clarity, knowledge acquisition, and acceptability of the scale. Mean video ratings ranged from 1.38 to 2.96 out of 3 and followed the intended pattern suggesting that the tool allowed raters to distinguish between examples of higher and lower quality feedback. There were no significant differences between rater type (range = 2.36-2.49), suggesting that all groups of raters used the tool in the same way. The generalizability coefficients for the scale ranged from 0.97 to 0.99. Item-total correlations were all above 0.80, suggesting some redundancy in items. Participants found the scale easy to use (M = 4.31/5) and clear

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

    Science.gov (United States)

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

    2010-06-01

    The objective was to validate the clinical dehydration scale (CDS) for children with gastroenteritis in a different pediatric emergency department (ED) from where it was initially derived and validated. A prospective cohort study was performed in a tertiary care pediatric ED over a 1-year period. A sample of triage nurses were trained in applying the CDS. The CDS consists of four clinical characteristics (general appearance, eyes, mucous membranes, and tears), each of which are scored 0, 1, or 2 for a total score of 0 to 8, with 0 representing no dehydration; 1 to 4, some dehydration; and 5 to 8, moderate/severe dehydration. Children 1 month to 5 years of age with vomiting and/or diarrhea who had the CDS documented at triage and a final diagnosis of gastroenteritis, gastritis, or enteritis were enrolled. Exclusion criteria included a chronic disease, treatment with intravenous (IV) rehydration within the previous 24 hours, visit to the ED for the same illness in the 7 days prior to arrival, and diarrhea of more than 10 days' duration. The primary outcome was the length of stay (LOS) in the ED from the time of seeing a physician to discharge, analyzed with a Kruskal-Wallis test. From April 2008 to March 2009, 150 patients with a mean (+/-SD) age of 22 (+/-14) months (range = 4 months to 4 years) were enrolled. Fifty-six patients had no dehydration, 74 had some dehydration, and 20 had moderate/severe dehydration. The median LOS in the ED after being seen by a physician was significantly longer as children appeared more dehydrated according to the CDS: 54 minutes (interquartile range [IQR] = 26-175 minutes), 128 minutes (IQR = 25-334 minutes), and 425 minutes (IQR = 218-673 minutes) for the no, some, and moderate/severe dehydration groups, respectively (p children with gastroenteritis in a different pediatric center than the original one where it was developed. It is a good predictor of LOS in the ED after being seen by a physician. (c) 2010 by the Society for

  8. Validation of the Danish Addenbrooke's Cognitive Examination as a screening test in a memory clinic

    DEFF Research Database (Denmark)

    Stokholm, Jette; Vogel, Asmus; Johannsen, Peter

    2009-01-01

    BACKGROUND: Addenbrooke's Cognitive Examination (ACE) is a cognitive screening test developed to detect dementia. It has been validated in several countries. Validation studies have predominantly included patients with various degrees of dementia and healthy controls. OBJECTIVE: The aim...... (MMSE >or=20), 30 non-demented patients diagnosed with depression (originally referred for evaluation of cognitive symptoms), and 63 healthy volunteers, all between 60 and 85 years of age, were included. All patients were given the ACE as a supplement to the standard diagnostic work-up. RESULTS: The cut...

  9. Model Validation Status Review

    International Nuclear Information System (INIS)

    E.L. Hardin

    2001-01-01

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

  10. Model Validation Status Review

    Energy Technology Data Exchange (ETDEWEB)

    E.L. Hardin

    2001-11-28

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

  11. Validation Study of the Korean Version of the Brief Clinical Form of the Neuropsychiatric Inventory

    Directory of Open Access Journals (Sweden)

    Hee-Jin Kim

    2016-06-01

    Full Text Available Aim: This study aims to provide a brief questionnaire form of the Neuropsychiatric Inventory (NPI-Q in Korean translated from the original NPI-Q that is intended for the evaluation of behavioral and psychological symptoms of dementia in routine clinical practice. Patients and Methods: We developed a Korean version of the NPI-Q (KNPI-Q and compared subitems with those of the Korean version of the NPI (KNPI in 63 dementia patients; 47 patients had been diagnosed with Alzheimer's disease with dementia, 8 with vascular dementia, and 8 with dementia with Lewy body disease. The diagnosis was based on the National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association criteria for possible and probable Alzheimer's disease and the International Statistical Classification of Diseases and Related Health Problems, 10th revision, criteria for vascular dementia and other dementing diseases. All patients received the Korean version of the Mini-Mental State Examination and the Clinical Dementia Rating within 1 month of the KNPI-Q. Results: Test-retest reliability of the KNPI-Q using a Pearson correlation index was r = 0.89 for the total symptom scale and r = 0.90 for the distress scale. The prevalence of analogous symptom ratings differed by less than 6.7%. Convergent validity between the KNPI-Q and the NPI using a Pearson correlation index was r = 0.879 for the total symptom scale and r = 0.92 for the distress scale. Conclusions: The KNPI-Q is a reliable and brief instrument that can be employed for screening in the evaluation of neuropsychiatric symptoms of dementia and associated caregiver distress. It may be suitable for use in general clinical practice and could be administered as a brief neuropsychiatric interview.

  12. Design and validation of standardized clinical and functional remission criteria in schizophrenia

    Directory of Open Access Journals (Sweden)

    Mosolov SN

    2014-01-01

    Full Text Available Sergey N Mosolov,1 Andrey V Potapov,1 Uriy V Ushakov,2 Aleksey A Shafarenko,1 Anastasiya B Kostyukova11Department of Mental Disorders Therapy, Moscow Research Institute of Psychiatry, Moscow, Russia; 2Moscow Psychiatric Outpatient Services #21, Moscow, RussiaBackground: International Remission Criteria (IRC for schizophrenia were developed recently by a group of internationally known experts. The IRC detect only 10%–30% of cases and do not cover the diversity of forms and social functioning. Our aim was to design a more applicable tool and validate its use – the Standardized Clinical and Functional Remission Criteria (SCFRC.Methods: We used a 6-month follow-up study of 203 outpatients from two Moscow centers and another further sample of stable patients from a 1-year controlled trial of atypical versus typical medication. Diagnosis was confirmed by International Classification of Diseases Version 10 (ICD10 criteria and the Mini-International Neuropsychiatric Interview (MINI. Patients were assessed by the Positive and Negative Syndrome Scale, including intensity threshold, and further classified using the Russian domestic remission criteria and the level of social and personal functioning, according to the Personal and Social Performance Scale (PSP. The SCFRC were formulated and were validated by a data reanalysis on the first population sample and on a second independent sample (104 patients and in an open-label prospective randomized 12-month comparative study of risperidone long-acting injectable (RLAI versus olanzapine.Results: Only 64 of the 203 outpatients (31.5% initially met the IRC, and 53 patients (26.1% met the IRC after 6 months, without a change in treatment. Patients who were in remission had episodic and progressive deficit (39.6%, or remittent (15% paranoid schizophrenia, or schizoaffective disorder (17%. In addition, 105 patients of 139 (51.7%, who did not meet symptomatic IRC, remained stable within the period. Reanalysis of

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

    Science.gov (United States)

    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.

  14. 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

    Directory of Open Access Journals (Sweden)

    Marleen E. Jansen

    2017-08-01

    Full Text Available 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.

  15. Validity in Qualitative Evaluation

    Directory of Open Access Journals (Sweden)

    Vasco Lub

    2015-12-01

    Full Text Available This article provides a discussion on the question of validity in qualitative evaluation. Although validity in qualitative inquiry has been widely reflected upon in the methodological literature (and is still often subject of debate, the link with evaluation research is underexplored. Elaborating on epistemological and theoretical conceptualizations by Guba and Lincoln and Creswell and Miller, the article explores aspects of validity of qualitative research with the explicit objective of connecting them with aspects of evaluation in social policy. It argues that different purposes of qualitative evaluations can be linked with different scientific paradigms and perspectives, thus transcending unproductive paradigmatic divisions as well as providing a flexible yet rigorous validity framework for researchers and reviewers of qualitative evaluations.

  16. Non-clinical models: validation, study design and statistical consideration in safety pharmacology.

    Science.gov (United States)

    Pugsley, M K; Towart, R; Authier, S; Gallacher, D J; Curtis, M J

    2010-01-01

    The current issue of the Journal of Pharmacological and Toxicological Methods (JPTM) focuses exclusively on safety pharmacology methods. This is the 7th year the Journal has published on this topic. Methods and models that specifically relate to methods relating to the assessment of the safety profile of a new chemical entity (NCE) prior to first in human (FIH) studies are described. Since the Journal started publishing on this topic there has been a major effort by safety pharmacologists, toxicologists and regulatory scientists within Industry (both large and small Pharma as well as Biotechnology companies) and also from Contract Research Organizations (CRO) to publish the surgical details of the non-clinical methods utilized but also provide important details related to standard and non-standard (or integrated) study models and designs. These details from core battery and secondary (or ancillary) drug safety assessment methods used in drug development programs have been the focus of these special issues and have been an attempt to provide validation of methods. Similarly, the safety pharmacology issues of the Journal provide the most relevant forum for scientists to present novel and modified methods with direct applicability to determination of drug safety-directly to the safety pharmacology scientific community. The content of the manuscripts in this issue includes the introduction of additional important surgical methods, novel data capture and data analysis methods, improved study design and effects of positive control compounds with known activity in the model. Copyright 2010 Elsevier Inc. All rights reserved.

  17. Mining, Validation, and Clinical Significance of Colorectal Cancer (CRC)-Associated lncRNAs.

    Science.gov (United States)

    Sun, Xiangwei; Hu, Yingying; Zhang, Liang; Hu, Changyuan; Guo, Gangqiang; Mao, Chenchen; Xu, Jianfeng; Ye, Sisi; Huang, Guanli; Xue, Xiangyang; Guo, Aizhen; Shen, Xian

    2016-01-01

    Colorectal cancer (CRC) is one of the deadliest tumours, but its pathogenesis remains unclear. The involvement of differentially expressed long non-coding RNAs (lncRNAs) in CRC tumorigenesis makes them suitable tumour biomarkers. Here, we screened 150 cases of CRC and 85 cases of paracancerous tissues in the GEO database for differentially expressed lncRNAs. The levels of lncRNA candidates in 84 CRC and paracancerous tissue samples were validated by qRT-PCR and their clinical significance was analyzed. We identified 15 lncRNAs with differential expression in CRC tumours; among them, AK098081 was significantly up-regulated, whereas AK025209, BC040303, BC037331, AK026659, and CR749831 were down-regulated in CRC. In a receiver operating characteristic curve analysis, the area under the curve for the six lncRNAs was 0.914. High expression of AK098081 and low expression of BC040303, CR749831, and BC037331 indicated poor CRC differentiation. CRC patients with lymph node metastasis had lower expression of BC037331. In addition, the group with high AK098081 expression presented significantly lower overall survival and disease-free survival rates than the low-expression group, confirming AK098081 as an independent risk factor for CRC patients. In conclusion, we have identified multiple CRC-associated lncRNAs from microarray expression profiles that can serve as novel biomarkers for the diagnosis and prognosis of CRC.

  18. Flexible ex vivo phantoms for validation of diffusion tensor tractography on a clinical scanner.

    Science.gov (United States)

    Watanabe, Makoto; Aoki, Shigeki; Masutani, Yoshitaka; Abe, Osamu; Hayashi, Naoto; Masumoto, Tomohiko; Mori, Harushi; Kabasawa, Hiroyuki; Ohtomo, Kuni

    2006-11-01

    The aim of this study was to develop ex vivo diffusion tensor (DT) flexible phantoms. Materials were bundles of textile threads of cotton, monofilament nylon, rayon, and polyester bunched with spiral wrapping bands and immersed in water. DT images were acquired on a 1.5-Tesla clinical magnetic resonance scanner using echo planar imaging sequences with 15 motion probing gradient directions. DT tractography with seeding and a line-tracking method was carried out by software originally developed on a PC-based workstation. We observed relatively high fractional anisotropy on the polyester phantom and were able to reconstruct tractography. Straight tracts along the bundle were displayed when it was arranged linearly. It was easy to bend arcuately or bifurcate at one end; and tracts followed the course of the bundle, whether it was curved or branched and had good agreement with direct visual observation. Tractography with the other fibers was unsuccessful. The polyester phantom revealed a diffusion anisotropic structure according to its shape and would be utilizable repeatedly under the same conditions, differently from living central neuronal system. It would be useful to validate DT sequences and to optimize an algorithm or parameters of DT tractography software. Additionally, the flexibility of the phantom would enable us to model human axonal projections.

  19. Flexible ex vivo phantoms for validation of diffusion tensor tractography on a clinical scanner

    International Nuclear Information System (INIS)

    Watanabe, Makoto; Aoki, Shigeki; Masutani, Yoshitaka; Abe, Osamu; Hayashi, Naoto; Masumoto, Tomohiko; Mori, Harushi; Kabasawa, Hiroyuki; Ohtomo, Kuni

    2006-01-01

    The aim of this study was to develop ex vivo diffusion tensor (DT) flexible phantoms. Materials were bundles of textile threads of cotton, monofilament nylon, rayon, and polyester bunched with spiral wrapping bands and immersed in water. DT images were acquired on a 1.5-Tesla clinical magnetic resonance scanner using echo planar imaging sequences with 15 motion probing gradient directions. DT tractography with seeding and a line-tracking method was carried out by software originally developed on a PC-based workstation. We observed relatively high fractional anisotropy on the polyester phantom and were able to reconstruct tractography. Straight tracts along the bundle were displayed when it was arranged linearly. It was easy to bend arcuately or bifurcate at one end; and tracts followed the course of the bundle, whether it was curved or branched and had good agreement with direct visual observation. Tractography with the other fibers was unsuccessful. The polyester phantom revealed a diffusion anisotropic structure according to its shape and would be utilizable repeatedly under the same conditions, differently from living central neuronal system. It would be useful to validate DT sequences and to optimize an algorithm or parameters of DT tractography software. Additionally, the flexibility of the phantom would enable us to model human axonal projections. (author)

  20. Reexamining the validity and reliability of the clinical version of the Iowa gambling task: Evidence from a normal subject group

    Directory of Open Access Journals (Sweden)

    Ching-Hung eLin

    2013-05-01

    Full Text Available Over past decade, the Iowa gambling task (IGT has been utilized to test various decision deficits induced by neurological damage or psychiatric disorders. The IGT has recently been standardized for identifying 13 different neuropsychological disorders. Neuropsychological patients choose bad decks frequently, and normal subjects prefer good EV decks. However, the IGT has several validity and reliability problems. Some research groups have pointed out that the validity of IGT is influenced by the personality and emotional state of subjects. Additionally, several other studies have proposed that the prominent deck B phenomenon (PDB phenomenon – that is, normal subjects preferring bad deck B – may be the most serious problem confronting IGT validity. Specifically, deck B offers a high frequency of gains but negative EV. In the standard IGT administration, choice behavior can be understood with reference to gain-loss frequency (GLF rather than inferred future consequences (EV, the basic assumption of IGT. Furthermore, using two different criteria (basic assumption vs. professional norm results in significantly different classification results. Therefore, we recruited 72 normal subjects to test the validity and reliability of IGT. Each subject performed three runs of the computer-based clinical IGT version. The PDB phenomenon has been observed to a significant degree in the first and second stages of the clinical IGT version. Obviously, validity, reliability and the practice effect were unstable between two given stages. The present form of the clinical IGT version has only one stage, so its use should be reconsidered for examining normal decision makers; results from patient groups must also be interpreted with great care. GLF could be the main factor to be considered in establishing the constructional validity and reliability of the clinical IGT version.

  1. Preliminary Validation of a New Clinical Tool for Identifying Problem Video Game Playing

    Science.gov (United States)

    King, Daniel Luke; Delfabbro, Paul H.; Zajac, Ian T.

    2011-01-01

    Research has estimated that between 6 to 13% of individuals who play video games do so excessively. However, the methods and definitions used to identify "problem" video game players often vary considerably. This research presents preliminary validation data for a new measure of problematic video game play called the Problem Video Game…

  2. Validation of the Rowland Universal Dementia Assessment Scale for Multicultural Screening in Danish Memory Clinics

    DEFF Research Database (Denmark)

    Nielsen, Thomas Rune; Andersen, Birgitte Bo; Gottrup, Hanne

    2013-01-01

    Background/Aims: The Rowland Universal Dementia Assessment Scale (RUDAS) is a brief cognitive screening test that was developed to detect dementia in multicultural populations. The RUDAS has not previously been validated in multicultural populations outside of Australia. The aim of this study...

  3. Examining the Validity of ADHD as a Diagnosis for Adolescents with Intellectual Disabilities: Clinical Presentation

    Science.gov (United States)

    Neece, Cameron L.; Baker, Bruce L.; Crnic, Keith; Blacher, Jan

    2013-01-01

    Children with intellectual and developmental disabilities are at heightened risk for mental disorders. Using current diagnostic criteria, disruptive behavior disorders, specifically Attention-Deficit/Hyperactivity Disorder (ADHD), appear to be the most prevalent co-occurring disorders. However, the validity of ADHD as a diagnosis for children and…

  4. On the clinical validity of the Maslach Burnout Inventory and the Burnout Measure

    NARCIS (Netherlands)

    Schaufeli, WB; Bakker, A B; Hoogduin, K; Schaap, C; Kladler, A

    2001-01-01

    Current knowledge about burnout suffers from a healthy worker bias since only working - and thus relatively healthy - employees have been investigated. The main objective of this study is to examine - for the first time among employees who sought psychological treatment - the validity of the two

  5. Validating Models of Clinical Word Recognition Tests for Spanish/English Bilinguals

    Science.gov (United States)

    Shi, Lu-Feng

    2014-01-01

    Purpose: Shi and Sánchez (2010) developed models to predict the optimal test language for evaluating Spanish/English (S/E) bilinguals' word recognition. The current study intended to validate their conclusions in a separate bilingual listener sample. Method: Seventy normal-hearing S/E bilinguals varying in language profile were included.…

  6. Translation of the Manchester Clinical Supervision Scale (MCSS) into Danish and a preliminary psychometric validation

    DEFF Research Database (Denmark)

    Buus, Niels; Gonge, Henrik

    2013-01-01

    for the translation of the MCSS from English into Danish and to present a preliminary psychometric validation of the Danish version of the scale. Methods included a formal translation/back-translation procedure and statistical analyses. The sample consisted of MCSS scores from 139 Danish mental health nursing staff...

  7. Reliability and Validity of the Spanish Adaptation of EOSS, Comparing Normal and Clinical Samples

    Science.gov (United States)

    Valero-Aguayo, Luis; Ferro-Garcia, Rafael; Lopez-Bermudez, Miguel Angel; de Huralde, Ma. Angeles Selva-Lopez

    2012-01-01

    The Experiencing of Self Scale (EOSS) was created for the evaluation of Functional Analytic Psychotherapy (Kohlenberg & Tsai, 1991, 2001, 2008) in relation to the concept of the experience of personal self as socially and verbally constructed. This paper presents a reliability and validity study of the EOSS with a Spanish sample (582…

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

    Science.gov (United States)

    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

  9. Cross validation in LULOO

    DEFF Research Database (Denmark)

    Sørensen, Paul Haase; Nørgård, Peter Magnus; Hansen, Lars Kai

    1996-01-01

    The leave-one-out cross-validation scheme for generalization assessment of neural network models is computationally expensive due to replicated training sessions. Linear unlearning of examples has recently been suggested as an approach to approximative cross-validation. Here we briefly review...... the linear unlearning scheme, dubbed LULOO, and we illustrate it on a systemidentification example. Further, we address the possibility of extracting confidence information (error bars) from the LULOO ensemble....

  10. Verification and validation benchmarks.

    Energy Technology Data Exchange (ETDEWEB)

    Oberkampf, William Louis; Trucano, Timothy Guy

    2007-02-01

    Verification and validation (V&V) are the primary means to assess the accuracy and reliability of computational simulations. V&V methods and procedures have fundamentally improved the credibility of simulations in several high-consequence fields, such as nuclear reactor safety, underground nuclear waste storage, and nuclear weapon safety. Although the terminology is not uniform across engineering disciplines, code verification deals with assessing the reliability of the software coding, and solution verification deals with assessing the numerical accuracy of the solution to a computational model. Validation addresses the physics modeling accuracy of a computational simulation by comparing the computational results with experimental data. Code verification benchmarks and validation benchmarks have been constructed for a number of years in every field of computational simulation. However, no comprehensive guidelines have been proposed for the construction and use of V&V benchmarks. For example, the field of nuclear reactor safety has not focused on code verification benchmarks, but it has placed great emphasis on developing validation benchmarks. Many of these validation benchmarks are closely related to the operations of actual reactors at near-safety-critical conditions, as opposed to being more fundamental-physics benchmarks. This paper presents recommendations for the effective design and use of code verification benchmarks based on manufactured solutions, classical analytical solutions, and highly accurate numerical solutions. In addition, this paper presents recommendations for the design and use of validation benchmarks, highlighting the careful design of building-block experiments, the estimation of experimental measurement uncertainty for both inputs and outputs to the code, validation metrics, and the role of model calibration in validation. It is argued that the understanding of predictive capability of a computational model is built on the level of

  11. Transient FDTD simulation validation

    OpenAIRE

    Jauregui Tellería, Ricardo; Riu Costa, Pere Joan; Silva Martínez, Fernando

    2010-01-01

    In computational electromagnetic simulations, most validation methods have been developed until now to be used in the frequency domain. However, the EMC analysis of the systems in the frequency domain many times is not enough to evaluate the immunity of current communication devices. Based on several studies, in this paper we propose an alternative method of validation of the transients in time domain allowing a rapid and objective quantification of the simulations results.

  12. HEDR model validation plan

    International Nuclear Information System (INIS)

    Napier, B.A.; Gilbert, R.O.; Simpson, J.C.; Ramsdell, J.V. Jr.; Thiede, M.E.; Walters, W.H.

    1993-06-01

    The Hanford Environmental Dose Reconstruction (HEDR) Project has developed a set of computational ''tools'' for estimating the possible radiation dose that individuals may have received from past Hanford Site operations. This document describes the planned activities to ''validate'' these tools. In the sense of the HEDR Project, ''validation'' is a process carried out by comparing computational model predictions with field observations and experimental measurements that are independent of those used to develop the model

  13. Verification and validation benchmarks

    International Nuclear Information System (INIS)

    Oberkampf, William Louis; Trucano, Timothy Guy

    2007-01-01

    Verification and validation (V and V) are the primary means to assess the accuracy and reliability of computational simulations. V and V methods and procedures have fundamentally improved the credibility of simulations in several high-consequence fields, such as nuclear reactor safety, underground nuclear waste storage, and nuclear weapon safety. Although the terminology is not uniform across engineering disciplines, code verification deals with assessing the reliability of the software coding, and solution verification deals with assessing the numerical accuracy of the solution to a computational model. Validation addresses the physics modeling accuracy of a computational simulation by comparing the computational results with experimental data. Code verification benchmarks and validation benchmarks have been constructed for a number of years in every field of computational simulation. However, no comprehensive guidelines have been proposed for the construction and use of V and V benchmarks. For example, the field of nuclear reactor safety has not focused on code verification benchmarks, but it has placed great emphasis on developing validation benchmarks. Many of these validation benchmarks are closely related to the operations of actual reactors at near-safety-critical conditions, as opposed to being more fundamental-physics benchmarks. This paper presents recommendations for the effective design and use of code verification benchmarks based on manufactured solutions, classical analytical solutions, and highly accurate numerical solutions. In addition, this paper presents recommendations for the design and use of validation benchmarks, highlighting the careful design of building-block experiments, the estimation of experimental measurement uncertainty for both inputs and outputs to the code, validation metrics, and the role of model calibration in validation. It is argued that the understanding of predictive capability of a computational model is built on the

  14. Verification and validation benchmarks

    International Nuclear Information System (INIS)

    Oberkampf, William L.; Trucano, Timothy G.

    2008-01-01

    Verification and validation (V and V) are the primary means to assess the accuracy and reliability of computational simulations. V and V methods and procedures have fundamentally improved the credibility of simulations in several high-consequence fields, such as nuclear reactor safety, underground nuclear waste storage, and nuclear weapon safety. Although the terminology is not uniform across engineering disciplines, code verification deals with assessing the reliability of the software coding, and solution verification deals with assessing the numerical accuracy of the solution to a computational model. Validation addresses the physics modeling accuracy of a computational simulation by comparing the computational results with experimental data. Code verification benchmarks and validation benchmarks have been constructed for a number of years in every field of computational simulation. However, no comprehensive guidelines have been proposed for the construction and use of V and V benchmarks. For example, the field of nuclear reactor safety has not focused on code verification benchmarks, but it has placed great emphasis on developing validation benchmarks. Many of these validation benchmarks are closely related to the operations of actual reactors at near-safety-critical conditions, as opposed to being more fundamental-physics benchmarks. This paper presents recommendations for the effective design and use of code verification benchmarks based on manufactured solutions, classical analytical solutions, and highly accurate numerical solutions. In addition, this paper presents recommendations for the design and use of validation benchmarks, highlighting the careful design of building-block experiments, the estimation of experimental measurement uncertainty for both inputs and outputs to the code, validation metrics, and the role of model calibration in validation. It is argued that the understanding of predictive capability of a computational model is built on the

  15. Validation suite for MCNP

    International Nuclear Information System (INIS)

    Mosteller, Russell D.

    2002-01-01

    Two validation suites, one for criticality and another for radiation shielding, have been defined and tested for the MCNP Monte Carlo code. All of the cases in the validation suites are based on experiments so that calculated and measured results can be compared in a meaningful way. The cases in the validation suites are described, and results from those cases are discussed. For several years, the distribution package for the MCNP Monte Carlo code1 has included an installation test suite to verify that MCNP has been installed correctly. However, the cases in that suite have been constructed primarily to test options within the code and to execute quickly. Consequently, they do not produce well-converged answers, and many of them are physically unrealistic. To remedy these deficiencies, sets of validation suites are being defined and tested for specific types of applications. All of the cases in the validation suites are based on benchmark experiments. Consequently, the results from the measurements are reliable and quantifiable, and calculated results can be compared with them in a meaningful way. Currently, validation suites exist for criticality and radiation-shielding applications.

  16. Severity score system for progressive myelopathy: development and validation of a new clinical scale

    Directory of Open Access Journals (Sweden)

    R.M. Castilhos

    2012-07-01

    Full Text Available Progressive myelopathies can be secondary to inborn errors of metabolism (IEM such as mucopolysaccharidosis, mucolipidosis, and adrenomyeloneuropathy. The available scale, Japanese Orthopaedic Association (JOA score, was validated only for degenerative vertebral diseases. Our objective is to propose and validate a new scale addressing progressive myelopathies and to present validating data for JOA in these diseases. A new scale, Severity Score System for Progressive Myelopathy (SSPROM, covering motor disability, sphincter dysfunction, spasticity, and sensory losses. Inter- and intra-rater reliabilities were measured. External validation was tested by applying JOA, the Expanded Disability Status Scale (EDSS, the Barthel index, and the Osame Motor Disability Score. Thirty-eight patients, 17 with adrenomyeloneuropathy, 3 with mucopolysaccharidosis I, 3 with mucopolysaccharidosis IV, 2 with mucopolysaccharidosis VI, 2 with mucolipidosis, and 11 with human T-cell lymphotropic virus type-1 (HTLV-1-associated myelopathy participated in the study. The mean ± SD SSPROM and JOA scores were 74.6 ± 11.4 and 12.4 ± 2.3, respectively. Construct validity for SSPROM (JOA: r = 0.84, P < 0.0001; EDSS: r = -0.83, P < 0.0001; Barthel: r = 0.56, P < 0.002; Osame: r = -0.94, P < 0.0001 and reliability (intra-rater: r = 0.83, P < 0.0001; inter-rater: r = 0.94, P < 0.0001 were demonstrated. The metric properties of JOA were similar to those found in SSPROM. Several clinimetric requirements were met for both SSPROM and JOA scales. Since SSPROM has a wider range, it should be useful for follow-up studies on IEM myelopathies.

  17. Validation of administrative and clinical case definitions for gestational diabetes mellitus against laboratory results.

    Science.gov (United States)

    Bowker, S L; Savu, A; Donovan, L E; Johnson, J A; Kaul, P

    2017-06-01

    To examine the validity of International Classification of Disease, version 10 (ICD-10) codes for gestational diabetes mellitus in administrative databases (outpatient and inpatient), and in a clinical perinatal database (Alberta Perinatal Health Program), using laboratory data as the 'gold standard'. Women aged 12-54 years with in-hospital, singleton deliveries between 1 October 2008 and 31 March 2010 in Alberta, Canada were included in the study. A gestational diabetes diagnosis was defined in the laboratory data as ≥2 abnormal values on a 75-g oral glucose tolerance test or a 50-g glucose screen ≥10.3 mmol/l. Of 58 338 pregnancies, 2085 (3.6%) met gestational diabetes criteria based on laboratory data. The gestational diabetes rates in outpatient only, inpatient only, outpatient or inpatient combined, and Alberta Perinatal Health Program databases were 5.2% (3051), 4.8% (2791), 5.8% (3367) and 4.8% (2825), respectively. Although the outpatient or inpatient combined data achieved the highest sensitivity (92%) and specificity (97%), it was associated with a positive predictive value of only 57%. The majority of the false-positives (78%), however, had one abnormal value on oral glucose tolerance test, corresponding to a diagnosis of impaired glucose tolerance in pregnancy. The ICD-10 codes for gestational diabetes in administrative databases, especially when outpatient and inpatient databases are combined, can be used to reliably estimate the burden of the disease at the population level. Because impaired glucose tolerance in pregnancy and gestational diabetes may be managed similarly in clinical practice, impaired glucose tolerance in pregnancy is often coded as gestational diabetes. © 2016 Diabetes UK.

  18. Clinical validation of cutoff target ranges in newborn screening of metabolic disorders by tandem mass spectrometry : A worldwide collaborative project

    NARCIS (Netherlands)

    McHugh, David M. S.; Cameron, Cynthia A.; Abdenur, Jose E.; Abdulrahman, Mahera; Adair, Ona; Al Nuaimi, Shahira Ahmed; Ahlman, Henrik; Allen, Jennifer J.; Antonozzi, Italo; Archer, Shaina; Au, Sylvia; Auray-Blais, Christiane; Baker, Mei; Bamforth, Fiona; Beckmann, Kinga; Pino, Gessi Bentz; Berberich, Stanton L.; Binard, Robert; Boemer, Francois; Bonham, Jim; Breen, Nancy N.; Bryant, Sandra C.; Caggana, Michele; Caldwell, S. Graham; Camilot, Marta; Campbell, Carlene; Carducci, Claudia; Cariappa, Rohit; Carlisle, Clover; Caruso, Ubaldo; Cassanello, Michela; Miren Castilla, Ane; Castineiras Ramos, Daisy E.; Chakraborty, Pranesh; Chandrasekar, Ram; Ramos, Alfredo Chardon; Cheillan, David; Chien, Yin-Hsiu; Childs, Thomas A.; Chrastina, Petr; Sica, Yuri Cleverthon; Cocho de Juan, Jose Angel; Elena Colandre, Maria; Cornejo Espinoza, Veronica; Corso, Gaetano; Currier, Robert; Cyr, Denis; Czuczy, Noemi; D'Apolito, Oceania; Davis, Tim; de Sain-Van der Velden, Monique G.; Delgado Pecellin, Carmen; Di Gangi, Iole Maria; Di Stefano, Cristina Maria; Dotsikas, Yannis; Downing, Melanie; Downs, Stephen M.; Dy, Bonifacio; Dymerski, Mark; Rueda, Inmaculada; Elvers, Bert; Eaton, Roger; Eckerd, Barbara M.; El Mougy, Fatma; Eroh, Sarah; Espada, Mercedes; Evans, Catherine; Fawbush, Sandy; Fijolek, Kristel F.; Fisher, Lawrence; Franzson, Leifur; Frazier, Dianne M.; Garcia, Luciana R. C.; Garcia-Valdecasas Bermejo, Maria Sierra; Gavrilov, Dimitar; Gerace, Rosemarie; Giordano, Giuseppe; Irazabal, Yolanda Gonzalez; Greed, Lawrence C.; Grier, Robert; Grycki, Elyse; Gu, Xuefan; Gulamali-Majid, Fizza; Hagar, Arthur F.; Han, Lianshu; Hannon, W. Harry; Haslip, Christa; Hassan, Fayza Abdelhamid; He, Miao; Hietala, Amy; Himstedt, Leslie; Hoffman, Gary L.; Hoffman, William; Hoggatt, Philis; Hopkins, Patrick V.; Hougaard, David M.; Hughes, Kerie; Hunt, Patricia R.; Hwu, Wuh-Liang; Hynes, June; Ibarra-Gonzalez, Isabel; Ingham, Cindy A.; Ivanova, Maria; Jacox, Ward B.; John, Catharine; Johnson, John P.; Jonsson, Jon J.; Karg, Eszter; Kasper, David; Klopper, Brenda; Katakouzinos, Dimitris; Khneisser, Issam; Knoll, Detlef; Kobayashi, Hirinori; Koneski, Ronald; Kozich, Viktor; Kouapei, Rasoul; Kohlmueller, Dirk; Kremensky, Ivo; la Marca, Giancarlo; Lavochkin, Marcia; Lee, Soo-Youn; Lehotay, Denis C.; Lemes, Aida; Lepage, Joyce; Lesko, Barbara; Lewis, Barry; Lim, Carol; Linard, Sharon; Lindner, Martin; Lloyd-Puryear, Michele A.; Lorey, Fred; Loukas, Yannis L.; Luedtke, Julie; Maffitt, Neil; Magee, J. Fergall; Manning, Adrienne; Manos, Shawn; Marie, Sandrine; Hadachi, Sonia Marchezi; Marquardt, Gregg; Martin, Stephen J.; Matern, Dietrich; Gibson, Stephanie K. Mayfield; Mayne, Philip; McCallister, Tonya D.; McCann, Mark; McClure, Julie; McGill, James J.; McKeever, Christine D.; McNeilly, Barbara; Morrissey, Mark A.; Moutsatsou, Paraskevi; Mulcahy, Eleanor A.; Nikoloudis, Dimitris; Norgaard-Pedersen, Bent; Oglesbee, Devin; Oltarzewski, Mariusz; Ombrone, Daniela; Ojodu, Jelili; Papakonstantinou, Vagelis; Reoyo, Sherly Pardo; Park, Hyung-Doo; Pasquali, Marzia; Pasquini, Elisabetta; Patel, Pallavi; Pass, Kenneth A.; Peterson, Colleen; Pettersen, Rolf D.; Pitt, James J.; Poh, Sherry; Pollak, Arnold; Porter, Cory; Poston, Philip A.; Price, Ricky W.; Queijo, Cecilia; Quesada, Jonessy; Randell, Edward; Ranieri, Enzo; Raymond, Kimiyo; Reddic, John E.; Reuben, Alejandra; Ricciardi, Charla; Rinaldo, Piero; Rivera, Jeff D.; Roberts, Alicia; Rocha, Hugo; Roche, Geraldine; Greenberg, Cheryl Rochman; Egea Mellado, Jose Maria; Jess Juan-Fita, Maria; Ruiz, Consuelo; Ruoppolo, Margherita; Rutledge, S. Lane; Ryu, Euijung; Saban, Christine; Sahai, Inderneel; Salazar Garcia-Blanco, Maria Isabel; Santiago-Borrero, Pedro; Schenone, Andrea; Schoos, Roland; Schweitzer, Barb; Scott, Patricia; Seashore, Margretta R.; Seeterlin, Mary A.; Sesser, David E.; Sevier, Darrin W.; Shone, Scott M.; Sinclair, Graham; Skrinska, Victor A.; Stanley, Eleanor L.; Strovel, Erin T.; Jones, April L. Studinski; Sunny, Sherlykutty; Takats, Zoltan; Tanyalcin, Tijen; Teofoli, Francesca; Thompson, J. Robert; Tomashitis, Kathy; Domingos, Mouseline Torquado; Torres, Jasmin; Torres, Rosario; Tortorelli, Silvia; Turi, Sandor; Turner, Kimberley; Tzanakos, Nick; Valiente, Alf G.; Vallance, Hillary; Vela-Amieva, Marcela; Vilarinho, Laura; von Doebeln, Ulrika; Vincent, Marie-Francoise; Vorster, B. Chris; Watson, Michael S.; Webster, Dianne; Weiss, Sheila; Wilcken, Bridget; Wiley, Veronica; Williams, Sharon K.; Willis, Sharon A.; Woontner, Michael; Wright, Katherine; Yahyaoui, Raquel; Yamaguchi, Seiji; Yssel, Melissa; Zakowicz, Wendy M.

    Purpose: To achieve clinical validation of cutoff values for newborn screening by tandem mass spectrometry through a worldwide collaborative effort. Methods: Cumulative percentiles of amino acids and acylcarnitines in dried blood spots of approximately 25-30 million normal newborns and 10,742

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

    Science.gov (United States)

    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...

  20. Incremental Criterion Validity of the WJ-III COG Clinical Clusters: Marginal Predictive Effects beyond the General Factor

    Science.gov (United States)

    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…

  1. Clinical validation of a body-fixed 3D accelerometer and algorithm for activity monitoring in orthopaedic patients

    Directory of Open Access Journals (Sweden)

    Matthijs Lipperts

    2017-10-01

    Conclusion: Activity monitoring of orthopaedic patients by counting and timing a large set of relevant daily life events is feasible in a user- and patient-friendly way and at high clinical validity using a generic three-dimensional accelerometer and algorithms based on empirical and physical methods. The algorithms performed well for healthy individuals as well as patients recovering after total joint replacement in a challenging validation set-up. With such a simple and transparent method real-life activity parameters can be collected in orthopaedic practice for diagnostics, treatments, outcome assessment, or biofeedback.

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

    Science.gov (United States)

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

    2017-06-01

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

  3. Containment Code Validation Matrix

    International Nuclear Information System (INIS)

    Chin, Yu-Shan; Mathew, P.M.; Glowa, Glenn; Dickson, Ray; Liang, Zhe; Leitch, Brian; Barber, Duncan; Vasic, Aleks; Bentaib, Ahmed; Journeau, Christophe; Malet, Jeanne; Studer, Etienne; Meynet, Nicolas; Piluso, Pascal; Gelain, Thomas; Michielsen, Nathalie; Peillon, Samuel; Porcheron, Emmanuel; Albiol, Thierry; Clement, Bernard; Sonnenkalb, Martin; Klein-Hessling, Walter; Arndt, Siegfried; Weber, Gunter; Yanez, Jorge; Kotchourko, Alexei; Kuznetsov, Mike; Sangiorgi, Marco; Fontanet, Joan; Herranz, Luis; Garcia De La Rua, Carmen; Santiago, Aleza Enciso; Andreani, Michele; Paladino, Domenico; Dreier, Joerg; Lee, Richard; Amri, Abdallah

    2014-01-01

    The Committee on the Safety of Nuclear Installations (CSNI) formed the CCVM (Containment Code Validation Matrix) task group in 2002. The objective of this group was to define a basic set of available experiments for code validation, covering the range of containment (ex-vessel) phenomena expected in the course of light and heavy water reactor design basis accidents and beyond design basis accidents/severe accidents. It was to consider phenomena relevant to pressurised heavy water reactor (PHWR), pressurised water reactor (PWR) and boiling water reactor (BWR) designs of Western origin as well as of Eastern European VVER types. This work would complement the two existing CSNI validation matrices for thermal hydraulic code validation (NEA/CSNI/R(1993)14) and In-vessel core degradation (NEA/CSNI/R(2001)21). The report initially provides a brief overview of the main features of a PWR, BWR, CANDU and VVER reactors. It also provides an overview of the ex-vessel corium retention (core catcher). It then provides a general overview of the accident progression for light water and heavy water reactors. The main focus is to capture most of the phenomena and safety systems employed in these reactor types and to highlight the differences. This CCVM contains a description of 127 phenomena, broken down into 6 categories: - Containment Thermal-hydraulics Phenomena; - Hydrogen Behaviour (Combustion, Mitigation and Generation) Phenomena; - Aerosol and Fission Product Behaviour Phenomena; - Iodine Chemistry Phenomena; - Core Melt Distribution and Behaviour in Containment Phenomena; - Systems Phenomena. A synopsis is provided for each phenomenon, including a description, references for further information, significance for DBA and SA/BDBA and a list of experiments that may be used for code validation. The report identified 213 experiments, broken down into the same six categories (as done for the phenomena). An experiment synopsis is provided for each test. Along with a test description

  4. Groundwater Model Validation

    Energy Technology Data Exchange (ETDEWEB)

    Ahmed E. Hassan

    2006-01-24

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

  5. Validation of co-registration of clinical lung ventilation and perfusion SPECT

    International Nuclear Information System (INIS)

    Marsh, S.H.; O'Keeffe, D.S.; Barnden, L.R.

    2010-01-01

    Full text: This talk will present results from a recent validation study of coregistration of computed tomography ventilation and perfusion (SPECT V/Q) images. The coregistration algorithm was incorporated in Qonsub, a program to coregister, normalise and subtract the SPECT (V/Q) images. Ventilation and perfusion image data were acquired from 23 patients undergoing a routine clinical SPECT V/Q study. The only change to normal patient management was the placement of three Tc 9 9 m filled fiducial markers adhered to the skin on the patient's torso. To quantify coregistration accuracy, image data were modified (within software) to remove the markers and Qonsub determined a parameter set of six values fully describing the six degree rigid transformation. The accuracy with which the six parameters coregister the images was then quantified by applying the same transformation parameters to the ventilation markers and determining how well they locate to the perfusion marker positions. Results show that for 65% of patients surveyed co-registration accuracy was to within I pixel, 30% were co-registered with an accuracy between 1 and 2 pixels and 5% were co-registered with an accuracy of between 2 and 3 pixels. Because patient placement between scans resulted in a misregistration of at most five pixels, a more rigorous test of the algorithm was required. Ethics approval had not been sought to intentionally misregister patient images, so the algorithm had to be further tested by synthetically misregistering the images. For these images Qonsub generally co-registered with the same accuracy as the original image. (author)

  6. The validation and clinical implementation of BRCAplus: a comprehensive high-risk breast cancer diagnostic assay.

    Directory of Open Access Journals (Sweden)

    Hansook Kim Chong

    Full Text Available Breast cancer is the most commonly diagnosed cancer in women, with 10% of disease attributed to hereditary factors. Although BRCA1 and BRCA2 account for a high percentage of hereditary cases, there are more than 25 susceptibility genes that differentially impact the risk for breast cancer. Traditionally, germline testing for breast cancer was performed by Sanger dideoxy terminator sequencing in a reflexive manner, beginning with BRCA1 and BRCA2. The introduction of next-generation sequencing (NGS has enabled the simultaneous testing of all genes implicated in breast cancer resulting in diagnostic labs offering large, comprehensive gene panels. However, some physicians prefer to only test for those genes in which established surveillance and treatment protocol exists. The NGS based BRCAplus test utilizes a custom tiled PCR based target enrichment design and bioinformatics pipeline coupled with array comparative genomic hybridization (aCGH to identify mutations in the six high-risk genes: BRCA1, BRCA2, PTEN, TP53, CDH1, and STK11. Validation of the assay with 250 previously characterized samples resulted in 100% detection of 3,025 known variants and analytical specificity of 99.99%. Analysis of the clinical performance of the first 3,000 BRCAplus samples referred for testing revealed an average coverage greater than 9,000X per target base pair resulting in excellent specificity and the sensitivity to detect low level mosaicism and allele-drop out. The unique design of the assay enabled the detection of pathogenic mutations missed by previous testing. With the abundance of NGS diagnostic tests being released, it is essential that clinicians understand the advantages and limitations of different test designs.

  7. Validation of the Six Sigma Z-score for the quality assessment of clinical laboratory timeliness.

    Science.gov (United States)

    Ialongo, Cristiano; Bernardini, Sergio

    2018-03-28

    The International Federation of Clinical Chemistry and Laboratory Medicine has introduced in recent times the turnaround time (TAT) as mandatory quality indicator for the postanalytical phase. Classic TAT indicators, namely, average, median, 90th percentile and proportion of acceptable test (PAT), are in use since almost 40 years and to date represent the mainstay for gauging the laboratory timeliness. In this study, we investigated the performance of the Six Sigma Z-score, which was previously introduced as a device for the quantitative assessment of timeliness. A numerical simulation was obtained modeling the actual TAT data set using the log-logistic probability density function. Five thousand replicates for each size of the artificial TAT random sample (n=20, 50, 250 and 1000) were generated, and different laboratory conditions were simulated manipulating the PDF in order to generate more or less variable data. The Z-score and the classic TAT indicators were assessed for precision (%CV), robustness toward right-tailing (precision at different sample variability), sensitivity and specificity. Z-score showed sensitivity and specificity comparable to PAT (≈80% with n≥250), but superior precision that ranged within 20% by moderately small sized samples (n≥50); furthermore, Z-score was less affected by the value of the cutoff used for setting the acceptable TAT, as well as by the sample variability that reflected into the magnitude of right-tailing. The Z-score was a valid indicator of laboratory timeliness and a suitable device to improve as well as to maintain the achieved quality level.

  8. Anatomical masking of pressure footprints based on the Oxford Foot Model: validation and clinical relevance.

    Science.gov (United States)

    Giacomozzi, Claudia; Stebbins, Julie A

    2017-03-01

    Plantar pressure analysis is widely used in the assessment of foot function. In order to assess regional loading, a mask is applied to the footprint to sub-divide it into regions of interest (ROIs). The most common masking method is based on geometric features of the footprint (GM). Footprint masking based on anatomical landmarks of the foot has been implemented more recently, and involves the integration of a 3D motion capture system, plantar pressure measurement device, and a multi-segment foot model. However, thorough validation of anatomical masking (AM) using pathological footprints has not yet been presented. In the present study, an AM method based on the Oxford Foot Model (OFM) was compared to an equivalent GM. Pressure footprints from 20 young healthy subjects (HG) and 20 patients with clubfoot (CF) were anatomically divided into 5 ROIs using a subset of the OFM markers. The same foot regions were also identified by using a standard GM method. Comparisons of intra-subject coefficient of variation (CV) showed that the OFM-based AM was at least as reliable as the GM for all investigated pressure parameters in all foot regions. Clinical relevance of AM was investigated by comparing footprints from HG and CF groups. Contact time, maximum force, force-time integral and contact area proved to be sensitive parameters that were able to distinguish HG and CF groups, using both AM and GM methods However, the AM method revealed statistically significant differences between groups in 75% of measured variables, compared to 62% using a standard GM method, indicating that the AM method is more sensitive for revealing differences between groups. Copyright © 2017 Elsevier B.V. All rights reserved.

  9. European Randomized Study of Screening for Prostate Cancer Risk Calculator: External Validation, Variability, and Clinical Significance.

    Science.gov (United States)

    Gómez-Gómez, Enrique; Carrasco-Valiente, Julia; Blanca-Pedregosa, Ana; Barco-Sánchez, Beatriz; Fernandez-Rueda, Jose Luis; Molina-Abril, Helena; Valero-Rosa, Jose; Font-Ugalde, Pilar; Requena-Tapia, Maria José

    2017-04-01

    To externally validate the European Randomized Study of Screening for Prostate Cancer (ERSPC) risk calculator (RC) and to evaluate its variability between 2 consecutive prostate-specific antigen (PSA) values. We prospectively catalogued 1021 consecutive patients before prostate biopsy for suspicion of prostate cancer (PCa). The risk of PCa and significant PCa (Gleason score ≥7) from 749 patients was calculated according to ERSPC-RC (digital rectal examination-based version 3 of 4) for 2 consecutive PSA tests per patient. The calculators' predictions were analyzed using calibration plots and the area under the receiver operating characteristic curve (area under the curve). Cohen kappa coefficient was used to compare the ability and variability. Of 749 patients, PCa was detected in 251 (33.5%) and significant PCa was detected in 133 (17.8%). Calibration plots showed an acceptable parallelism and similar discrimination ability for both PSA levels with an area under the curve of 0.69 for PCa and 0.74 for significant PCa. The ERSPC showed 226 (30.2%) unnecessary biopsies with the loss of 10 significant PCa. The variability of the RC was 16% for PCa and 20% for significant PCa, and a higher variability was associated with a reduced risk of significant PCa. We can conclude that the performance of the ERSPC-RC in the present cohort shows a high similitude between the 2 PSA levels; however, the RC variability value is associated with a decreased risk of significant PCa. The use of the ERSPC in our cohort detects a high number of unnecessary biopsies. Thus, the incorporation of ERSPC-RC could help the clinical decision to carry out a prostate biopsy. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. Validation of an arterial tortuosity measure with application to hypertension collection of clinical hypertensive patients.

    Science.gov (United States)

    Diedrich, Karl T; Roberts, John A; Schmidt, Richard H; Kang, Chang-Ki; Cho, Zang-Hee; Parker, Dennis L

    2011-10-18

    Hypertension may increase tortuosity or twistedness of arteries. We applied a centerline extraction algorithm and tortuosity metric to magnetic resonance angiography (MRA) brain images to quantitatively measure the tortuosity of arterial vessel centerlines. The most commonly used arterial tortuosity measure is the distance factor metric (DFM). This study tested a DFM based measurement's ability to detect increases in arterial tortuosity of hypertensives using existing images. Existing images presented challenges such as different resolutions which may affect the tortuosity measurement, different depths of the area imaged, and different artifacts of imaging that require filtering. The stability and accuracy of alternative centerline algorithms was validated in numerically generated models and test brain MRA data. Existing images were gathered from previous studies and clinical medical systems by manually reading electronic medical records to identify hypertensives and negatives. Images of different resolutions were interpolated to similar resolutions. Arterial tortuosity in MRA images was measured from a DFM curve and tested on numerically generated models as well as MRA images from two hypertensive and three negative control populations. Comparisons were made between different resolutions, different filters, hypertensives versus negatives, and different negative controls. In tests using numerical models of a simple helix, the measured tortuosity increased as expected with more tightly coiled helices. Interpolation reduced resolution-dependent differences in measured tortuosity. The Korean hypertensive population had significantly higher arterial tortuosity than its corresponding negative control population across multiple arteries. In addition one negative control population of different ethnicity had significantly less arterial tortuosity than the other two. Tortuosity can be compared between images of different resolutions by interpolating from lower to higher

  11. Validation of Serious Games

    Directory of Open Access Journals (Sweden)

    Katinka van der Kooij

    2015-09-01

    Full Text Available The application of games for behavioral change has seen a surge in popularity but evidence on the efficacy of these games is contradictory. Anecdotal findings seem to confirm their motivational value whereas most quantitative findings from randomized controlled trials (RCT are negative or difficult to interpret. One cause for the contradictory evidence could be that the standard RCT validation methods are not sensitive to serious games’ effects. To be able to adapt validation methods to the properties of serious games we need a framework that can connect properties of serious game design to the factors that influence the quality of quantitative research outcomes. The Persuasive Game Design model [1] is particularly suitable for this aim as it encompasses the full circle from game design to behavioral change effects on the user. We therefore use this model to connect game design features, such as the gamification method and the intended transfer effect, to factors that determine the conclusion validity of an RCT. In this paper we will apply this model to develop guidelines for setting up validation methods for serious games. This way, we offer game designers and researchers handles on how to develop tailor-made validation methods.

  12. Development and validation of an instrument to assess and improve clinical consultation skills

    OpenAIRE

    Lefroy, JE; Gay, SP; Gibson, S; Williams, S; McKinley, RK

    2011-01-01

    Context: Development of medical students’ consultation skills with patients is at the core of the UK General Medical Council’s 'Tomorrow’s Doctors' guide (2009). Teaching and assessment of these skills must therefore be a core component of the medical undergraduate curriculum. The Calgary Cambridge guide to the medical interview and the Leicester Assessment Package (LAP) provide a foundation for teaching and assessment, but both have different strengths. Objective: To develop and validate a c...

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

    Science.gov (United States)

    2015-10-01

    biomarkers; prediction models; PCA3; TMPRSS2: ERG ; kallikreins; 4KScore; OncotypeDX; 5 3. ACCOMPLISHMENTS What were the major goals and...urine, alone or in combination with TMPRSS2: ERG mRNA. (Lead site: FHCRC) Milestone 10. Urine specimens identified for analysis. Due 12/30/2014...COMPLETED Milestone 11. PCA3 and TMPRSS2: ERG validation complete in PASS cohort. Due 12/30/2015 Milestone 12. Manuscript submission of PCA3 and TMPRSS2: ERG

  14. Clinical validation of a non-heteronormative version of the Social Interaction Anxiety Scale (SIAS)

    OpenAIRE

    Lindner, Philip; Martell, Christopher; Bergström, Jan; Andersson, Gerhard; Carlbring, Per

    2013-01-01

    Introduction: Despite welcomed changes in societal attitudes and practices towards sexual minorities, instances of heteronormativity can still be found within healthcare and research. The Social Interaction Anxiety Scale (SIAS) is a valid and reliable self-rating scale of social anxiety, which includes one item (number 14) with an explicit heteronormative assumption about the respondents sexual orientation. This heteronormative phrasing may confuse, insult or alienate sexual minority responde...

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

    Science.gov (United States)

    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.

  16. Patient-reported outcome measures for systemic lupus erythematosus clinical trials: a review of content validity, face validity and psychometric performance.

    Science.gov (United States)

    Holloway, Laura; Humphrey, Louise; Heron, Louise; Pilling, Claire; Kitchen, Helen; Højbjerre, Lise; Strandberg-Larsen, Martin; Hansen, Brian Bekker

    2014-07-22

    Despite overall progress in treatment of autoimmune diseases, patients with systemic lupus erythematosus (SLE) experience many inflammatory symptoms representing an unmet medical need. This study aimed to create a conceptual model of the humanistic and economic burden of SLE, and review the patient-reported outcomes (PROs) used to measure such concepts in SLE clinical trials. A conceptual model for SLE was developed from structured review of published articles from 2007 to August 2013 identified from literature databases (MEDLINE, EMBASE, PsycINFO, EconLit) plus other sources (PROLabels, FDA/EMA websites, Clinicaltrials.gov). PROs targeting key symptoms/impacts were identified from the literature. They were reviewed in the context of available guidance and assessed for face and content validity and psychometric properties to determine appropriateness for use in SLE trials. The conceptual model identified fatigue, pain, cognition, daily activities, emotional well-being, physical/social functioning and work productivity as key SLE concepts. Of the 68 articles reviewed, 38 reported PRO data. From these and the other sources, 15 PROs were selected for review, including SLE-specific health-related quality of life (HRQoL) measures (n = 5), work productivity (n = 1), and generic measures of fatigue (n = 3), pain (n = 2), depression (n = 2) and HRQoL (n = 2). The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue), Brief Pain Inventory (BPI-SF) and LupusQoL demonstrated the strongest face validity, conceptual coverage and psychometric properties measuring key concepts in the conceptual model. All PROs reviewed, except for three Lupus-specific measures, lacked qualitative SLE patient involvement during development. The Hospital Anxiety and Depression Scale (HADS), Short Form [36 item] Health Survey version 2 (SF-36v2), EuroQoL 5-dimensions (EQ-5D-3L and EQ-5D-5L) and Work Productivity and Activity Impairment Questionnaire: Lupus (WPAI

  17. Patient-reported outcome measures for systemic lupus erythematosus clinical trials: a review of content validity, face validity and psychometric performance

    Science.gov (United States)

    2014-01-01

    Background Despite overall progress in treatment of autoimmune diseases, patients with systemic lupus erythematosus (SLE) experience many inflammatory symptoms representing an unmet medical need. This study aimed to create a conceptual model of the humanistic and economic burden of SLE, and review the patient-reported outcomes (PROs) used to measure such concepts in SLE clinical trials. Methods A conceptual model for SLE was developed from structured review of published articles from 2007 to August 2013 identified from literature databases (MEDLINE, EMBASE, PsycINFO, EconLit) plus other sources (PROLabels, FDA/EMA websites, Clinicaltrials.gov). PROs targeting key symptoms/impacts were identified from the literature. They were reviewed in the context of available guidance and assessed for face and content validity and psychometric properties to determine appropriateness for use in SLE trials. Results The conceptual model identified fatigue, pain, cognition, daily activities, emotional well-being, physical/social functioning and work productivity as key SLE concepts. Of the 68 articles reviewed, 38 reported PRO data. From these and the other sources, 15 PROs were selected for review, including SLE-specific health-related quality of life (HRQoL) measures (n = 5), work productivity (n = 1), and generic measures of fatigue (n = 3), pain (n = 2), depression (n = 2) and HRQoL (n = 2). The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue), Brief Pain Inventory (BPI-SF) and LupusQoL demonstrated the strongest face validity, conceptual coverage and psychometric properties measuring key concepts in the conceptual model. All PROs reviewed, except for three Lupus-specific measures, lacked qualitative SLE patient involvement during development. The Hospital Anxiety and Depression Scale (HADS), Short Form [36 item] Health Survey version 2 (SF-36v2), EuroQoL 5-dimensions (EQ-5D-3L and EQ-5D-5L) and Work Productivity and

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

    Science.gov (United States)

    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

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

    Directory of Open Access Journals (Sweden)

    Dimitrov BD

    2015-04-01

    Full Text Available Borislav D Dimitrov,1,2 Nicola Motterlini,2,† Tom Fahey2 1Academic Unit of Primary Care and Population Sciences, University of Southampton, Southampton, United Kingdom; 2HRB Centre for Primary Care Research, Department of General Medicine, Division of Population Health Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland †Nicola Motterlini passed away on November 11, 2012 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

  20. Automated characterization of perceptual quality of clinical chest radiographs: Validation and calibration to observer preference

    International Nuclear Information System (INIS)

    Samei, Ehsan; Lin, Yuan; Choudhury, Kingshuk R.; Page McAdams, H.

    2014-01-01

    Purpose: The authors previously proposed an image-based technique [Y. Lin et al. Med. Phys. 39, 7019–7031 (2012)] to assess the perceptual quality of clinical chest radiographs. In this study, an observer study was designed and conducted to validate the output of the program against rankings by expert radiologists and to establish the ranges of the output values that reflect the acceptable image appearance so the program output can be used for image quality optimization and tracking. Methods: Using an IRB-approved protocol, 2500 clinical chest radiographs (PA/AP) were collected from our clinical operation. The images were processed through our perceptual quality assessment program to measure their appearance in terms of ten metrics of perceptual image quality: lung gray level, lung detail, lung noise, rib–lung contrast, rib sharpness, mediastinum detail, mediastinum noise, mediastinum alignment, subdiaphragm–lung contrast, and subdiaphragm area. From the results, for each targeted appearance attribute/metric, 18 images were selected such that the images presented a relatively constant appearance with respect to all metrics except the targeted one. The images were then incorporated into a graphical user interface, which displayed them into three panels of six in a random order. Using a DICOM calibrated diagnostic display workstation and under low ambient lighting conditions, each of five participating attending chest radiologists was tasked to spatially order the images based only on the targeted appearance attribute regardless of the other qualities. Once ordered, the observer also indicated the range of image appearances that he/she considered clinically acceptable. The observer data were analyzed in terms of the correlations between the observer and algorithmic rankings and interobserver variability. An observer-averaged acceptable image appearance was also statistically derived for each quality attribute based on the collected individual acceptable ranges

  1. Automated characterization of perceptual quality of clinical chest radiographs: Validation and calibration to observer preference

    Energy Technology Data Exchange (ETDEWEB)

    Samei, Ehsan, E-mail: samei@duke.edu [Carl E. Ravin Advanced Imaging Laboratories, Departments of Radiology, Physics, Biomedical Engineering, Electrical and Computer Engineering, Medical Physics Graduate Program, Duke Clinical Imaging Physics Group, Duke University, Durham, North Carolina 27710 (United States); Lin, Yuan [Carl E. Ravin Advanced Imaging Laboratories, Departments of Radiology and Physics, Duke University, Durham, North Carolina 27710 (United States); Choudhury, Kingshuk R. [Carl E. Ravin Advanced Imaging Laboratories, Department of Radiology and Biostatistics and Bioinformatics, Duke University, Durham, North Carolina 27710 (United States); Page McAdams, H. [Carl E. Ravin Advanced Imaging Laboratories, Department of Radiology, Duke University, Durham, North Carolina 27710 (United States)

    2014-11-01

    Purpose: The authors previously proposed an image-based technique [Y. Lin et al. Med. Phys. 39, 7019–7031 (2012)] to assess the perceptual quality of clinical chest radiographs. In this study, an observer study was designed and conducted to validate the output of the program against rankings by expert radiologists and to establish the ranges of the output values that reflect the acceptable image appearance so the program output can be used for image quality optimization and tracking. Methods: Using an IRB-approved protocol, 2500 clinical chest radiographs (PA/AP) were collected from our clinical operation. The images were processed through our perceptual quality assessment program to measure their appearance in terms of ten metrics of perceptual image quality: lung gray level, lung detail, lung noise, rib–lung contrast, rib sharpness, mediastinum detail, mediastinum noise, mediastinum alignment, subdiaphragm–lung contrast, and subdiaphragm area. From the results, for each targeted appearance attribute/metric, 18 images were selected such that the images presented a relatively constant appearance with respect to all metrics except the targeted one. The images were then incorporated into a graphical user interface, which displayed them into three panels of six in a random order. Using a DICOM calibrated diagnostic display workstation and under low ambient lighting conditions, each of five participating attending chest radiologists was tasked to spatially order the images based only on the targeted appearance attribute regardless of the other qualities. Once ordered, the observer also indicated the range of image appearances that he/she considered clinically acceptable. The observer data were analyzed in terms of the correlations between the observer and algorithmic rankings and interobserver variability. An observer-averaged acceptable image appearance was also statistically derived for each quality attribute based on the collected individual acceptable ranges

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

    International Nuclear Information System (INIS)

    Melchior, M; Salinas Aranda, F; Sciutto, S; Dodat, D; Larragueta, N

    2014-01-01

    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 scanning 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

  3. Validation of New Cancer Biomarkers

    DEFF Research Database (Denmark)

    Duffy, Michael J; Sturgeon, Catherine M; Söletormos, Georg

    2015-01-01

    BACKGROUND: Biomarkers are playing increasingly important roles in the detection and management of patients with cancer. Despite an enormous number of publications on cancer biomarkers, few of these biomarkers are in widespread clinical use. CONTENT: In this review, we discuss the key steps...... in advancing a newly discovered cancer candidate biomarker from pilot studies to clinical application. Four main steps are necessary for a biomarker to reach the clinic: analytical validation of the biomarker assay, clinical validation of the biomarker test, demonstration of clinical value from performance...... of the biomarker test, and regulatory approval. In addition to these 4 steps, all biomarker studies should be reported in a detailed and transparent manner, using previously published checklists and guidelines. Finally, all biomarker studies relating to demonstration of clinical value should be registered before...

  4. Checklists for external validity

    DEFF Research Database (Denmark)

    Dyrvig, Anne-Kirstine; Kidholm, Kristian; Gerke, Oke

    2014-01-01

    to an implementation setting. In this paper, currently available checklists on external validity are identified, assessed and used as a basis for proposing a new improved instrument. METHOD: A systematic literature review was carried out in Pubmed, Embase and Cinahl on English-language papers without time restrictions....... The retrieved checklist items were assessed for (i) the methodology used in primary literature, justifying inclusion of each item; and (ii) the number of times each item appeared in checklists. RESULTS: Fifteen papers were identified, presenting a total of 21 checklists for external validity, yielding a total...... of 38 checklist items. Empirical support was considered the most valid methodology for item inclusion. Assessment of methodological justification showed that none of the items were supported empirically. Other kinds of literature justified the inclusion of 22 of the items, and 17 items were included...

  5. Shift Verification and Validation

    Energy Technology Data Exchange (ETDEWEB)

    Pandya, Tara M. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Evans, Thomas M. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Davidson, Gregory G [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Johnson, Seth R. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Godfrey, Andrew T. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

    2016-09-07

    This documentation outlines the verification and validation of Shift for the Consortium for Advanced Simulation of Light Water Reactors (CASL). Five main types of problems were used for validation: small criticality benchmark problems; full-core reactor benchmarks for light water reactors; fixed-source coupled neutron-photon dosimetry benchmarks; depletion/burnup benchmarks; and full-core reactor performance benchmarks. We compared Shift results to measured data and other simulated Monte Carlo radiation transport code results, and found very good agreement in a variety of comparison measures. These include prediction of critical eigenvalue, radial and axial pin power distributions, rod worth, leakage spectra, and nuclide inventories over a burn cycle. Based on this validation of Shift, we are confident in Shift to provide reference results for CASL benchmarking.

  6. Phase-II Clinical Validation of a Powered Exoskeleton for the Treatment of Elbow Spasticity.

    Science.gov (United States)

    Crea, Simona; Cempini, Marco; Mazzoleni, Stefano; Carrozza, Maria Chiara; Posteraro, Federico; Vitiello, Nicola

    2017-01-01

    Introduction: Spasticity is a typical motor disorder in patients affected by stroke. Typically post-stroke rehabilitation consists of repetition of mobilization exercises on impaired limbs, aimed to reduce muscle hypertonia and mitigate spastic reflexes. It is currently strongly debated if the treatment's effectiveness improves with the timeliness of its adoption; in particular, starting intensive rehabilitation as close as possible to the stroke event may counteract the growth and postpone the onset of spasticity. In this paper we present a phase-II clinical validation of a robotic exoskeleton in treating subacute post-stroke patients. Methods: Seventeen post-stroke patients participated in 10 daily rehabilitation sessions using the NEUROExos Elbow Module exoskeleton, each one lasting 45 min: the exercises consisted of isokinetic passive mobilization of the elbow, with torque threshold to detect excessive user's resistance to the movement. We investigated the safety by reporting possible adverse events, such as mechanical, electrical or software failures of the device or injuries or pain experienced by the patient. As regards the efficacy , the Modified Ashworth Scale, was identified as primary outcome measure and the NEEM metrics describing elbow joint resistance to passive extension (i.e., maximum extension torque and zero-torque angle) as secondary outcomes. Results: During the entire duration of the treatments no failures or adverse events for the patients were reported. No statistically significant differences were found in the Modified Ashworth Scale scores, between pre-treatment and post-treatment and between post-treatment and follow-up sessions, indicating the absence of spasticity increase throughout (14 days) and after (3-4 months follow-up) the treatment. Exoskeleton metrics confirmed the absence of significant difference in between pre- and post-treatment data, whereas intra-session data highlighted significant differences in the secondary outcomes

  7. Phase-II Clinical Validation of a Powered Exoskeleton for the Treatment of Elbow Spasticity

    Directory of Open Access Journals (Sweden)

    Simona Crea

    2017-05-01

    Full Text Available Introduction: Spasticity is a typical motor disorder in patients affected by stroke. Typically post-stroke rehabilitation consists of repetition of mobilization exercises on impaired limbs, aimed to reduce muscle hypertonia and mitigate spastic reflexes. It is currently strongly debated if the treatment's effectiveness improves with the timeliness of its adoption; in particular, starting intensive rehabilitation as close as possible to the stroke event may counteract the growth and postpone the onset of spasticity. In this paper we present a phase-II clinical validation of a robotic exoskeleton in treating subacute post-stroke patients.Methods: Seventeen post-stroke patients participated in 10 daily rehabilitation sessions using the NEUROExos Elbow Module exoskeleton, each one lasting 45 min: the exercises consisted of isokinetic passive mobilization of the elbow, with torque threshold to detect excessive user's resistance to the movement. We investigated the safety by reporting possible adverse events, such as mechanical, electrical or software failures of the device or injuries or pain experienced by the patient. As regards the efficacy, the Modified Ashworth Scale, was identified as primary outcome measure and the NEEM metrics describing elbow joint resistance to passive extension (i.e., maximum extension torque and zero-torque angle as secondary outcomes.Results: During the entire duration of the treatments no failures or adverse events for the patients were reported. No statistically significant differences were found in the Modified Ashworth Scale scores, between pre-treatment and post-treatment and between post-treatment and follow-up sessions, indicating the absence of spasticity increase throughout (14 days and after (3–4 months follow-up the treatment. Exoskeleton metrics confirmed the absence of significant difference in between pre- and post-treatment data, whereas intra-session data highlighted significant differences in the

  8. Validity and clinical feasibility of the ADHD rating scale (ADHD-RS) A Danish Nationwide Multicenter Study

    DEFF Research Database (Denmark)

    Szomlaiski, N; Dyrborg, J; Rasmussen, H

    2008-01-01

    Aim: To establish the validity of a Danish version of the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS), secondly to present national norm scores compared to that of United States and other European data and thirdly to evaluate ADHD-RS when used for monitoring treatment...... effectiveness. Methods: A Danish translation of the ADHD-RS was used on a normative sample of 837 children. Two clinical samples, 138 hyperkinetic disorder (HKD) cases and 110 clinical controls were recruited from eleven Danish Child and Adolescent Mental Health (CAMH) centres and assessed according to usual...... clinical standards. The HKD children were rated by parents and teachers at baseline and at follow-up 3 months later. Results: Internal validity of ADHD-RS was high and the factor structure supported the diagnostic classification system ICD-10. The questionnaire discriminated HKD patients in a mixed...

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

    Science.gov (United States)

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

    2015-07-01

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

  10. Six-minute stepper test: a valid clinical exercise tolerance test for COPD patients

    Directory of Open Access Journals (Sweden)

    Grosbois JM

    2016-03-01

    .005. Performances on the 6MST and 6MWT were significantly improved after PR (570 vs 488 steps, P=0.001 and 448 vs 406 m, respectively; P<0.0001. Improvements of the 6MST and 6MWT after PR were significantly correlated (r=0.34; P=0.03.Conclusion: The results of this study show that the 6MST is a valid test to evaluate exercise tolerance in COPD patients. The use of this test in clinical practice appears to be particularly relevant for the assessment of patients managed by home PR. Keywords: 6-minute stepper test, 6-minute walk test, exercise tolerance, pulmonary rehabilitation, cardiopulmonary exercise testing, validity

  11. Validating Animal Models

    Directory of Open Access Journals (Sweden)

    Nina Atanasova

    2015-06-01

    Full Text Available In this paper, I respond to the challenge raised against contemporary experimental neurobiology according to which the field is in a state of crisis because of the multiple experimental protocols employed in different laboratories and strengthening their reliability that presumably preclude the validity of neurobiological knowledge. I provide an alternative account of experimentation in neurobiology which makes sense of its experimental practices. I argue that maintaining a multiplicity of experimental protocols and strengthening their reliability are well justified and they foster rather than preclude the validity of neurobiological knowledge. Thus, their presence indicates thriving rather than crisis of experimental neurobiology.

  12. Validation Process Methods

    Energy Technology Data Exchange (ETDEWEB)

    Lewis, John E. [National Renewable Energy Lab. (NREL), Golden, CO (United States); English, Christine M. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Gesick, Joshua C. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Mukkamala, Saikrishna [National Renewable Energy Lab. (NREL), Golden, CO (United States)

    2018-01-04

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

  13. Validation and clinical application of a nested PCR for paracoccidioidomycosis diagnosis in clinical samples from Colombian patients.

    Science.gov (United States)

    Gaviria, Marcela; Rivera, Vanessa; Muñoz-Cadavid, Cesar; Cano, Luz Elena; Naranjo, Tonny Williams

    2015-01-01

    Paracoccidioidomycosis is a systemic and endemic mycosis, restricted to tropical and subtropical areas of Latin America. The infection is caused by the thermal dimorphic fungus Paracoccidioides brasiliensis and Paracoccidioides lutzii. The diagnosis of paracoccidioidomycosis is usually performed by microscopic examination, culture and immunodiagnostic tests to respiratory specimens, body fluids and/or biopsies; however these methods require laboratory personnel with experience and several days to produce a result. In the present study, we have validated and evaluated a nested PCR assay targeting the gene encoding the Paracoccidioides gp43 membrane protein in 191 clinical samples: 115 samples from patients with proven infections other than paracoccidioidomycosis, 51 samples as negative controls, and 25 samples from patients diagnosed with paracoccidioidomycosis. Additionally, the specificity of the nested PCR assay was also evaluated using purified DNA isolated from cultures of different microorganisms (n=35) previously identified by culture and/or sequencing. The results showed that in our hands, this nested PCR assay for gp43 protein showed specificity and sensitivity rates of 100%. The optimized nested PCR conditions in our laboratory allowed detection down to 1fg of P. brasiliensis DNA. Copyright © 2015 Elsevier Editora Ltda. All rights reserved.

  14. Are screening instruments valid for psychotic-like experiences? A validation study of screening questions for psychotic-like experiences using in-depth clinical interview.

    LENUS (Irish Health Repository)

    Kelleher, Ian

    2011-03-01

    Individuals who report psychotic-like experiences are at increased risk of future clinical psychotic disorder. They constitute a unique "high-risk" group for studying the developmental trajectory to schizophrenia and related illnesses. Previous research has used screening instruments to identify this high-risk group, but the validity of these instruments has not yet been established. We administered a screening questionnaire with 7 items designed to assess psychotic-like experiences to 334 adolescents aged 11-13 years. Detailed clinical interviews were subsequently carried out with a sample of these adolescents. We calculated sensitivity and specificity and positive predictive value (PPV) and negative predictive value (NPV) for each screening question for the specific symptom it enquired about and also in relation to any psychotic-like experience. The predictive power varied substantially between items, with the question on auditory hallucinations ("Have you ever heard voices or sounds that no one else can hear?") providing the best predictive power. For interview-verified auditory hallucinations specifically, this question had a PPV of 71.4% and an NPV of 90.4%. When assessed for its predictive power for any psychotic-like experience (including, but not limited to, auditory hallucinations), it provided a PPV of 100% and an NPV of 88.4%. Two further questions-relating to visual hallucinations and paranoid thoughts-also demonstrated good predictive power for psychotic-like experiences. Our results suggest that it may be possible to screen the general adolescent population for psychotic-like experiences with a high degree of accuracy using a short self-report questionnaire.

  15. Are screening instruments valid for psychotic-like experiences? A validation study of screening questions for psychotic-like experiences using in-depth clinical interview.

    LENUS (Irish Health Repository)

    Kelleher, Ian

    2012-02-01

    Individuals who report psychotic-like experiences are at increased risk of future clinical psychotic disorder. They constitute a unique "high-risk" group for studying the developmental trajectory to schizophrenia and related illnesses. Previous research has used screening instruments to identify this high-risk group, but the validity of these instruments has not yet been established. We administered a screening questionnaire with 7 items designed to assess psychotic-like experiences to 334 adolescents aged 11-13 years. Detailed clinical interviews were subsequently carried out with a sample of these adolescents. We calculated sensitivity and specificity and positive predictive value (PPV) and negative predictive value (NPV) for each screening question for the specific symptom it enquired about and also in relation to any psychotic-like experience. The predictive power varied substantially between items, with the question on auditory hallucinations ("Have you ever heard voices or sounds that no one else can hear?") providing the best predictive power. For interview-verified auditory hallucinations specifically, this question had a PPV of 71.4% and an NPV of 90.4%. When assessed for its predictive power for any psychotic-like experience (including, but not limited to, auditory hallucinations), it provided a PPV of 100% and an NPV of 88.4%. Two further questions-relating to visual hallucinations and paranoid thoughts-also demonstrated good predictive power for psychotic-like experiences. Our results suggest that it may be possible to screen the general adolescent population for psychotic-like experiences with a high degree of accuracy using a short self-report questionnaire.

  16. Validity and clinical utility of the simplified Wells rule for assessing clinical probability for the exclusion of pulmonary embolism

    NARCIS (Netherlands)

    Douma, Renée A.; Gibson, Nadine S.; Gerdes, Victor E. A.; Büller, Harry R.; Wells, Philip S.; Perrier, Arnaud; Le Gal, Grégoire

    2009-01-01

    The recently introduced simplified Wells rule for the exclusion of pulmonary embolism (PE) assigns only one point to the seven variables of the original Wells rule. This study was performed to independently validate the simplified Wells rule for the exclusion of PE. We retrospectively calculated the

  17. Validity, responsiveness, and minimal clinically important difference of EQ-5D-5L in stroke patients undergoing rehabilitation.

    Science.gov (United States)

    Chen, Poyu; Lin, Keh-Chung; Liing, Rong-Jiuan; Wu, Ching-Yi; Chen, Chia-Ling; Chang, Ku-Chou

    2016-06-01

    To examine the criterion validity, responsiveness, and minimal clinically important difference (MCID) of the EuroQoL 5-Dimensions Questionnaire (EQ-5D-5L) and visual analog scale (EQ-VAS) in people receiving rehabilitation after stroke. The EQ-5D-5L, along with four criterion measures-the Medical Research Council scales for muscle strength, the Fugl-Meyer assessment, the functional independence measure, and the Stroke Impact Scale-was administered to 65 patients with stroke before and after 3- to 4-week therapy. Criterion validity was estimated using the Spearman correlation coefficient. Responsiveness was analyzed by the effect size, standardized response mean (SRM), and criterion responsiveness. The MCID was determined by anchor-based and distribution-based approaches. The percentage of patients exceeding the MCID was also reported. Concurrent validity of the EQ-Index was better compared with the EQ-VAS. The EQ-Index has better power for predicting the rehabilitation outcome in the activities of daily living than other motor-related outcome measures. The EQ-Index was moderately responsive to change (SRM = 0.63), whereas the EQ-VAS was only mildly responsive to change. The MCID estimation of the EQ-Index (the percentage of patients exceeding the MCID) was 0.10 (33.8 %) and 0.10 (33.8 %) based on the anchor-based and distribution-based approaches, respectively, and the estimation of EQ-VAS was 8.61 (41.5 %) and 10.82 (32.3 %). The EQ-Index has shown reasonable concurrent validity, limited predictive validity, and acceptable responsiveness for detecting the health-related quality of life in stroke patients undergoing rehabilitation, but not for EQ-VAS. Future research considering different recovery stages after stroke is warranted to validate these estimations.

  18. The dialogic validation

    DEFF Research Database (Denmark)

    Musaeus, Peter

    2005-01-01

    This paper is inspired by dialogism and the title is a paraphrase on Bakhtin's (1981) "The Dialogic Imagination". The paper investigates how dialogism can inform the process of validating inquiry-based qualitative research. The paper stems from a case study on the role of recognition...

  19. A valid licence

    NARCIS (Netherlands)

    Spoolder, H.A.M.; Ingenbleek, P.T.M.

    2010-01-01

    A valid licence Tuesday, April 20, 2010 Dr Hans Spoolder and Dr Paul Ingenbleek, of Wageningen University and Research Centres, share their thoughts on improving farm animal welfare in Europe At the presentation of the European Strategy 2020 on 3rd March, President Barroso emphasised the need for

  20. The Chimera of Validity

    Science.gov (United States)

    Baker, Eva L.

    2013-01-01

    Background/Context: Education policy over the past 40 years has focused on the importance of accountability in school improvement. Although much of the scholarly discourse around testing and assessment is technical and statistical, understanding of validity by a non-specialist audience is essential as long as test results drive our educational…

  1. Validating year 2000 compliance

    NARCIS (Netherlands)

    A. van Deursen (Arie); P. Klint (Paul); M.P.A. Sellink

    1997-01-01

    textabstractValidating year 2000 compliance involves the assessment of the correctness and quality of a year 2000 conversion. This entails inspecting both the quality of the conversion emph{process followed, and of the emph{result obtained, i.e., the converted system. This document provides an

  2. Validation and test report

    DEFF Research Database (Denmark)

    Pedersen, Jens Meldgaard; Andersen, T. Bull

    2012-01-01

    . As a consequence of extensive movement artefacts seen during dynamic contractions, the following validation and test report consists of a report that investigates the physiological responses to a static contraction in a standing and a supine position. Eight subjects performed static contractions of the ankle...

  3. Statistical Analysis and validation

    NARCIS (Netherlands)

    Hoefsloot, H.C.J.; Horvatovich, P.; Bischoff, R.

    2013-01-01

    In this chapter guidelines are given for the selection of a few biomarker candidates from a large number of compounds with a relative low number of samples. The main concepts concerning the statistical validation of the search for biomarkers are discussed. These complicated methods and concepts are

  4. Validity and Fairness

    Science.gov (United States)

    Kane, Michael

    2010-01-01

    This paper presents the author's critique on Xiaoming Xi's article, "How do we go about investigating test fairness?," which lays out a broad framework for studying fairness as comparable validity across groups within the population of interest. Xi proposes to develop a fairness argument that would identify and evaluate potential fairness-based…

  5. Infant bone age estimation based on fibular shaft length: model development and clinical validation

    International Nuclear Information System (INIS)

    Tsai, Andy; Stamoulis, Catherine; Bixby, Sarah D.; Breen, Micheal A.; Connolly, Susan A.; Kleinman, Paul K.

    2016-01-01

    Bone age in infants (<1 year old) is generally estimated using hand/wrist or knee radiographs, or by counting ossification centers. The accuracy and reproducibility of these techniques are largely unknown. To develop and validate an infant bone age estimation technique using fibular shaft length and compare it to conventional methods. We retrospectively reviewed negative skeletal surveys of 247 term-born low-risk-of-abuse infants (no persistent child protection team concerns) from July 2005 to February 2013, and randomized them into two datasets: (1) model development (n = 123) and (2) model testing (n = 124). Three pediatric radiologists measured all fibular shaft lengths. An ordinary linear regression model was fitted to dataset 1, and the model was evaluated using dataset 2. Readers also estimated infant bone ages in dataset 2 using (1) the hemiskeleton method of Sontag, (2) the hemiskeleton method of Elgenmark, (3) the hand/wrist atlas of Greulich and Pyle, and (4) the knee atlas of Pyle and Hoerr. For validation, we selected lower-extremity radiographs of 114 normal infants with no suspicion of abuse. Readers measured the fibulas and also estimated bone ages using the knee atlas. Bone age estimates from the proposed method were compared to the other methods. The proposed method outperformed all other methods in accuracy and reproducibility. Its accuracy was similar for the testing and validating datasets, with root-mean-square error of 36 days and 37 days; mean absolute error of 28 days and 31 days; and error variability of 22 days and 20 days, respectively. This study provides strong support for an infant bone age estimation technique based on fibular shaft length as a more accurate alternative to conventional methods. (orig.)

  6. Design, construction and validation of a Plasmodium vivax microarray for the transcriptome profiling of clinical isolates

    KAUST Repository

    Boopathi, Pon Arunachalam

    2016-10-09

    High density oligonucleotide microarrays have been used on Plasmodium vivax field isolates to estimate whole genome expression. However, no microarray platform has been experimentally optimized for studying the transcriptome of field isolates. In the present study, we adopted both bioinformatics and experimental testing approaches to select best optimized probes suitable for detecting parasite transcripts from field samples and included them in designing a custom 15K P. vivax microarray. This microarray has long oligonucleotide probes (60 mer) that were in-situ synthesized onto glass slides using Agilent SurePrint technology and has been developed into an 8X15K format (8 identical arrays on a single slide). Probes in this array were experimentally validated and represents 4180 P. vivax genes in sense orientation, of which 1219 genes have also probes in antisense orientation. Validation of the 15K array by using field samples (n =14) has shown 99% of parasite transcript detection from any of the samples. Correlation analysis between duplicate probes (n = 85) present in the arrays showed perfect correlation (r(2) = 0.98) indicating the reproducibility. Multiple probes representing the same gene exhibited similar kind of expression pattern across the samples (positive correlation, r >= 0.6). Comparison of hybridization data with the previous studies and quantitative real-time PCR experiments were performed to highlight the microarray validation procedure. This array is unique in its design, and results indicate that the array is sensitive and reproducible. Hence, this microarray could be a valuable functional genomics tool to generate reliable expression data from P. vivax field isolates. (C) 2016 Published by Elsevier B.V.

  7. Infant bone age estimation based on fibular shaft length: model development and clinical validation

    Energy Technology Data Exchange (ETDEWEB)

    Tsai, Andy; Stamoulis, Catherine; Bixby, Sarah D.; Breen, Micheal A.; Connolly, Susan A.; Kleinman, Paul K. [Boston Children' s Hospital, Harvard Medical School, Department of Radiology, Boston, MA (United States)

    2016-03-15

    Bone age in infants (<1 year old) is generally estimated using hand/wrist or knee radiographs, or by counting ossification centers. The accuracy and reproducibility of these techniques are largely unknown. To develop and validate an infant bone age estimation technique using fibular shaft length and compare it to conventional methods. We retrospectively reviewed negative skeletal surveys of 247 term-born low-risk-of-abuse infants (no persistent child protection team concerns) from July 2005 to February 2013, and randomized them into two datasets: (1) model development (n = 123) and (2) model testing (n = 124). Three pediatric radiologists measured all fibular shaft lengths. An ordinary linear regression model was fitted to dataset 1, and the model was evaluated using dataset 2. Readers also estimated infant bone ages in dataset 2 using (1) the hemiskeleton method of Sontag, (2) the hemiskeleton method of Elgenmark, (3) the hand/wrist atlas of Greulich and Pyle, and (4) the knee atlas of Pyle and Hoerr. For validation, we selected lower-extremity radiographs of 114 normal infants with no suspicion of abuse. Readers measured the fibulas and also estimated bone ages using the knee atlas. Bone age estimates from the proposed method were compared to the other methods. The proposed method outperformed all other methods in accuracy and reproducibility. Its accuracy was similar for the testing and validating datasets, with root-mean-square error of 36 days and 37 days; mean absolute error of 28 days and 31 days; and error variability of 22 days and 20 days, respectively. This study provides strong support for an infant bone age estimation technique based on fibular shaft length as a more accurate alternative to conventional methods. (orig.)

  8. Design, construction and validation of a Plasmodium vivax microarray for the transcriptome profiling of clinical isolates

    KAUST Repository

    Boopathi, Pon Arunachalam; Subudhi, Amit; Middha, Sheetal; Acharya, Jyoti; Mugasimangalam, Raja Chinnadurai; Kochar, Sanjay Kumar; Kochar, Dhanpat Kumar; Das, Ashis

    2016-01-01

    High density oligonucleotide microarrays have been used on Plasmodium vivax field isolates to estimate whole genome expression. However, no microarray platform has been experimentally optimized for studying the transcriptome of field isolates. In the present study, we adopted both bioinformatics and experimental testing approaches to select best optimized probes suitable for detecting parasite transcripts from field samples and included them in designing a custom 15K P. vivax microarray. This microarray has long oligonucleotide probes (60 mer) that were in-situ synthesized onto glass slides using Agilent SurePrint technology and has been developed into an 8X15K format (8 identical arrays on a single slide). Probes in this array were experimentally validated and represents 4180 P. vivax genes in sense orientation, of which 1219 genes have also probes in antisense orientation. Validation of the 15K array by using field samples (n =14) has shown 99% of parasite transcript detection from any of the samples. Correlation analysis between duplicate probes (n = 85) present in the arrays showed perfect correlation (r(2) = 0.98) indicating the reproducibility. Multiple probes representing the same gene exhibited similar kind of expression pattern across the samples (positive correlation, r >= 0.6). Comparison of hybridization data with the previous studies and quantitative real-time PCR experiments were performed to highlight the microarray validation procedure. This array is unique in its design, and results indicate that the array is sensitive and reproducible. Hence, this microarray could be a valuable functional genomics tool to generate reliable expression data from P. vivax field isolates. (C) 2016 Published by Elsevier B.V.

  9. Clinical validation of a dose reduction study in paediatric abdomen MSCT scanning

    International Nuclear Information System (INIS)

    Ciccarone, A.; Fonda, C.; Zatelli, Giovanna; Mazzocchi, S.

    2008-01-01

    Full text: In our previous work an individual dose adaptation in abdomen of paediatric patients has been showed at the Meyer children hospital of Florence. For each kV really feasible in our MSCT scanner, a table of mAs versus abdomen thickness and width ratio has been developed only on the basis of water cylinder phantoms. The choice of the water arise by the fact that in pediatric patient the quantity of water inside the body is major than that of adult. In this way a reduction dose has showed with respect to the ordinary paediatric scanning protocol in use before and the same image quality has been preserved in the case of an optimized CT scanning technique of a standard adult patient of height 175 cm and weight 70 kg. However these results were only theoretical because relied on water phantoms. Now this work concerns the clinical validation of our dose reduction study on phantoms. So 50 examinations were acquired with the dose reduction scanning technique and scored randomly, without knowing weight and height of patient by three radiologists. These scores were compared with that of other 50 abdomen examination before dose reduction study. The scores refers to the noise perceived by radiologist and to the diagnostic quality of radiograph. As last, a score on the low contrast tissue separation between muscle and fat and a score on visibility of structure therein have been asked to the radiologists. The same work has concerned the abdomen examinations with iodine contrast medium. In this study the score of each radiographs has been catalogued in four range of age, 0 - 1; 1 - 3; 3 - 8; 8 - 13 years. Aligned rank and Wilcoxon's signed rank tests were used for statistical analyses. The table of modulating mAs with respect to the size of patient obtained with only water phantom study has been revised so that none reduced detection in low-visibility structures like fat or muscle or liver was evident. Nevertheless a reduction in CTDI of 30 % has been reached in our new

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

    Science.gov (United States)

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

    2017-06-01

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

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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

  13. EOS Terra Validation Program

    Science.gov (United States)

    Starr, David

    2000-01-01

    The EOS Terra mission will be launched in July 1999. This mission has great relevance to the atmospheric radiation community and global change issues. Terra instruments include Advanced Spaceborne Thermal Emission and Reflection Radiometer (ASTER), Clouds and Earth's Radiant Energy System (CERES), Multi-Angle Imaging Spectroradiometer (MISR), Moderate Resolution Imaging Spectroradiometer (MODIS) and Measurements of Pollution in the Troposphere (MOPITT). In addition to the fundamental radiance data sets, numerous global science data products will be generated, including various Earth radiation budget, cloud and aerosol parameters, as well as land surface, terrestrial ecology, ocean color, and atmospheric chemistry parameters. Significant investments have been made in on-board calibration to ensure the quality of the radiance observations. A key component of the Terra mission is the validation of the science data products. This is essential for a mission focused on global change issues and the underlying processes. The Terra algorithms have been subject to extensive pre-launch testing with field data whenever possible. Intensive efforts will be made to validate the Terra data products after launch. These include validation of instrument calibration (vicarious calibration) experiments, instrument and cross-platform comparisons, routine collection of high quality correlative data from ground-based networks, such as AERONET, and intensive sites, such as the SGP ARM site, as well as a variety field experiments, cruises, etc. Airborne simulator instruments have been developed for the field experiment and underflight activities including the MODIS Airborne Simulator (MAS) AirMISR, MASTER (MODIS-ASTER), and MOPITT-A. All are integrated on the NASA ER-2 though low altitude platforms are more typically used for MASTER. MATR is an additional sensor used for MOPITT algorithm development and validation. The intensive validation activities planned for the first year of the Terra

  14. [Autism Spectrum Disorder in DSM-5 - concept, validity, and reliability, impact on clinical care and future research].

    Science.gov (United States)

    Freitag, Christine M

    2014-05-01

    Autism Spectrum Disorder (ASD) in DSM-5 comprises the former DSM-IV-TR diagnoses of Autistic Disorder, Asperger's Disorder and PDD-nos. The criteria for ASD in DSM-5 were considerably revised from those of ICD-10 and DSM-IV-TR. The present article compares the diagnostic criteria, presents studies on the validity and reliability of ASD, and discusses open questions. It ends with a clinical and research perspective.

  15. Validation of a Predictive Model for Survival in Metastatic Cancer Patients Attending an Outpatient Palliative Radiotherapy Clinic

    International Nuclear Information System (INIS)

    Chow, Edward; Abdolell, Mohamed; Panzarella, Tony; Harris, Kristin; Bezjak, Andrea; Warde, Padraig; Tannock, Ian

    2009-01-01

    Purpose: To validate a predictive model for survival of patients attending a palliative radiotherapy clinic. Methods and Materials: We described previously a model that had good predictive value for survival of patients referred during 1999 (1). The six prognostic factors (primary cancer site, site of metastases, Karnofsky performance score, and the fatigue, appetite and shortness-of-breath items from the Edmonton Symptom Assessment Scale) identified in this training set were extracted from the prospective database for the year 2000. We generated a partial score whereby each prognostic factor was assigned a value proportional to its prognostic weight. The sum of the partial scores for each patient was used to construct a survival prediction score (SPS). Patients were also grouped according to the number of these risk factors (NRF) that they possessed. The probability of survival at 3, 6, and 12 months was generated. The models were evaluated for their ability to predict survival in this validation set with appropriate statistical tests. Results: The median survival and survival probabilities of the training and validation sets were similar when separated into three groups using both SPS and NRF methods. There was no statistical difference in the performance of the SPS and NRF methods in survival prediction. Conclusion: Both the SPS and NRF models for predicting survival in patients referred for palliative radiotherapy have been validated. The NRF model is preferred because it is simpler and avoids the need to remember the weightings among the prognostic factors

  16. Reliability and validity of teacher-rated symptoms of oppositional defiant disorder and conduct disorder in a clinical sample.

    Science.gov (United States)

    Ise, Elena; Görtz-Dorten, Anja; Döpfner, Manfred

    2014-01-01

    It is recommended to use information from multiple informants when making diagnostic decisions concerning oppositional defiant disorder (ODD) and conduct disorder (CD). The purpose of this study was to investigate the reliability and validity of teacher-rated symptoms of ODD and CD in a clinical sample. The sample comprised 421 children (84% boys; 6-17 years) diagnosed with ODD, CD, and/or attention deficit hyperactivity disorder (ADHD). Teachers completed a standardized ODD/CD symptom rating scale and the Teacher Report Form (TRF). The reliability (internal consistency) of the symptom rating scale was high (α = 0.90). Convergent and divergent validity were demonstrated by substantial correlations with similar TRF syndrome scales and low-to-moderate correlations with dissimilar TRF scales. Discriminant validity was shown by the ability of the symptom rating scale to differentiate between children with ODD/CD and those with ADHD. Factorial validity was demonstrated by principal component analysis, which produced a two-factor solution that is largely consistent with the two-dimensional model of ODD and CD proposed by the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV-TR, although some CD symptoms representing aggressive behavior loaded on the ODD dimension. These findings suggest that DSM-IV-TR-based teacher rating scales are useful instruments for assessing disruptive behavior problems in children and adolescents.

  17. Clinical Functional Capacity Testing in Patients With Facioscapulohumeral Muscular Dystrophy: Construct Validity and Interrater Reliability of Antigravity Tests.

    Science.gov (United States)

    Rijken, Noortje H; van Engelen, Baziel G; Weerdesteyn, Vivian; Geurts, Alexander C

    2015-12-01

    To evaluate the construct validity and interrater reliability of 4 simple antigravity tests in a small group of patients with facioscapulohumeral muscular dystrophy (FSHD). Case-control study. University medical center. Patients with various severity levels of FSHD (n=9) and healthy control subjects (n=10) were included (N=19). Not applicable. A 4-point ordinal scale was designed to grade performance on the following 4 antigravity tests: sit to stance, stance to sit, step up, and step down. In addition, the 6-minute walk test, 10-m walking test, Berg Balance Scale, and timed Up and Go test were administered as conventional tests. Construct validity was determined by linear regression analysis using the Clinical Severity Score (CSS) as the dependent variable. Interrater agreement was tested using a κ analysis. Patients with FSHD performed worse on all 4 antigravity tests compared with the controls. Stronger correlations were found within than between test categories (antigravity vs conventional). The antigravity tests revealed the highest explained variance with regard to the CSS (R(2)=.86, P=.014). Interrater agreement was generally good. The results of this exploratory study support the construct validity and interrater reliability of the proposed antigravity tests for the assessment of functional capacity in patients with FSHD taking into account the use of compensatory strategies. Future research should further validate these results in a larger sample of patients with FSHD. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  18. Proteomic signatures of infertile men with clinical varicocele and their validation studies reveal mitochondrial dysfunction leading to infertility

    Directory of Open Access Journals (Sweden)

    Ashok Agarwal

    2016-01-01

    Full Text Available To study the major differences in the distribution of spermatozoa proteins in infertile men with varicocele by comparative proteomics and validation of their level of expression. The study-specific estimates for each varicocele outcome were combined to identify the proteins involved in varicocele-associated infertility in men irrespective of stage and laterality of their clinical varicocele. Expression levels of 5 key proteins (PKAR1A, AK7, CCT6B, HSPA2, and ODF2 involved in stress response and sperm function including molecular chaperones were validated by Western blotting. Ninety-nine proteins were differentially expressed in the varicocele group. Over 87% of the DEP involved in major energy metabolism and key sperm functions were underexpressed in the varicocele group. Key protein functions affected in the varicocele group were spermatogenesis, sperm motility, and mitochondrial dysfunction, which were further validated by Western blotting, corroborating the proteomics analysis. Varicocele is essentially a state of energy deprivation, hypoxia, and hyperthermia due to impaired blood supply, which is corroborated by down-regulation of lipid metabolism, mitochondrial electron transport chain, and Krebs cycle enzymes. To corroborate the proteomic analysis, expression of the 5 identified proteins of interest was validated by Western blotting. This study contributes toward establishing a biomarker "fingerprint" to assess sperm quality on the basis of molecular parameters.

  19. Commentary: moving toward cost-effectiveness in using psychophysiological measures in clinical assessment: validity, decision making, and adding value.

    Science.gov (United States)

    Youngstrom, Eric A; De Los Reyes, Andres

    2015-01-01

    Psychophysiological measures offer a variety of potential advantages, including more direct assessment of certain processes, as well as provision of information that may contrast with other sources. The role of psychophysiological measures in clinical practice will be best defined when researchers (a) switch to research designs and statistical models that better approximate how clinicians administer assessments and make clinical decisions in practice, (b) systematically compare the validity of psychophysiological measures to incumbent methods for assessing similar criteria, (c) test whether psychophysiological measures show either greater validity or clinically meaningful incremental validity, and (d) factor in fiscal costs as well as the utilities that the client attaches to different assessment outcomes. The statistical methods are now readily available, along with the interpretive models for integrating assessment results into client-centered decision making. These, combined with technology reducing the cost of psychophysiological measurement and improving ease of interpretation, poise the field for a rapid transformation of assessment practice, but only if we let go of old habits of research.

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

    Science.gov (United States)

    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.

  1. Hospitalization for community-acquired febrile urinary tract infection: validation and impact assessment of a clinical prediction rule.

    Science.gov (United States)

    Stalenhoef, Janneke E; van der Starre, Willize E; Vollaard, Albert M; Steyerberg, Ewout W; Delfos, Nathalie M; Leyten, Eliane M S; Koster, Ted; Ablij, Hans C; Van't Wout, Jan W; van Dissel, Jaap T; van Nieuwkoop, Cees

    2017-06-06

    There is a lack of severity assessment tools to identify adults presenting with febrile urinary tract infection (FUTI) at risk for complicated outcome and guide admission policy. We aimed to validate the Prediction Rule for Admission policy in Complicated urinary Tract InfeCtion LEiden (PRACTICE), a modified form of the pneumonia severity index, and to subsequentially assess its use in clinical practice. A prospective observational multicenter study for model validation (2004-2009), followed by a multicenter controlled clinical trial with stepped wedge cluster-randomization for impact assessment (2010-2014), with a follow up of 3 months. Paricipants were 1157 consecutive patients with a presumptive diagnosis of acute febrile UTI (787 in validation cohort and 370 in the randomized trial), enrolled at emergency departments of 7 hospitals and 35 primary care centers in the Netherlands. The clinical prediction rule contained 12 predictors of complicated course. In the randomized trial the PRACTICE included guidance on hospitalization for high risk (>100 points) and home discharge for low risk patients (urinary tract infection, futher improvement is necessary to reduce the occurrence of secondary hospital admissions. NTR4480 http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4480 , registered retrospectively 25 mrt 2014 (during enrollment of subjects).

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

    Science.gov (United States)

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

    2017-08-18

    Stroke is a leading cause of adult disability and death worldwide. The neurological impairments associated with stroke prevent patients from performing basic daily activities and have enormous impact on families and caregivers. Practical and accurate tools to assist in predicting outcome after stroke at patient level can provide significant aid for patient management. Furthermore, prediction models of this kind can be useful for clinical research, health economics, policymaking and clinical decision support. 2869 patients with first-ever stroke from South London Stroke Register (SLSR) (1995-2004) will be included in the development cohort. We will use information captured after baseline to construct multilevel models and a Cox proportional hazard model to predict cognitive impairment, functional outcome and mortality up to 5 years after stroke. Repeated random subsampling validation (Monte Carlo cross-validation) will be evaluated in model development. Data from participants recruited to the stroke register (2005-2014) will be used for temporal validation of the models. Data from participants recruited to the Dijon Stroke Register (1985-2015) will be used for external validation. Discrimination, calibration and clinical utility of the models will be presented. Patients, or for patients who cannot consent their relatives, gave written informed consent to participate in stroke-related studies within the SLSR. The SLSR design was approved by the ethics committees of Guy's and St Thomas' NHS Foundation Trust, Kings College Hospital, Queens Square and Westminster Hospitals (London). The Dijon Stroke Registry was approved by the Comité National des Registres and the InVS and has authorisation of the Commission Nationale de l'Informatique et des Libertés. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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

    Science.gov (United States)

    Winzer, Eva; Luger, Maria; Schindler, Karin

    2018-06-01

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

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    Hall, Emily A; Docherty, Carrie L

    2017-07-01

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

  6. Flight code validation simulator

    Science.gov (United States)

    Sims, Brent A.

    1996-05-01

    An End-To-End Simulation capability for software development and validation of missile flight software on the actual embedded computer has been developed utilizing a 486 PC, i860 DSP coprocessor, embedded flight computer and custom dual port memory interface hardware. This system allows real-time interrupt driven embedded flight software development and checkout. The flight software runs in a Sandia Digital Airborne Computer and reads and writes actual hardware sensor locations in which Inertial Measurement Unit data resides. The simulator provides six degree of freedom real-time dynamic simulation, accurate real-time discrete sensor data and acts on commands and discretes from the flight computer. This system was utilized in the development and validation of the successful premier flight of the Digital Miniature Attitude Reference System in January of 1995 at the White Sands Missile Range on a two stage attitude controlled sounding rocket.

  7. Software Validation in ATLAS

    International Nuclear Information System (INIS)

    Hodgkinson, Mark; Seuster, Rolf; Simmons, Brinick; Sherwood, Peter; Rousseau, David

    2012-01-01

    The ATLAS collaboration operates an extensive set of protocols to validate the quality of the offline software in a timely manner. This is essential in order to process the large amounts of data being collected by the ATLAS detector in 2011 without complications on the offline software side. We will discuss a number of different strategies used to validate the ATLAS offline software; running the ATLAS framework software, Athena, in a variety of configurations daily on each nightly build via the ATLAS Nightly System (ATN) and Run Time Tester (RTT) systems; the monitoring of these tests and checking the compilation of the software via distributed teams of rotating shifters; monitoring of and follow up on bug reports by the shifter teams and periodic software cleaning weeks to improve the quality of the offline software further.

  8. CIPS Validation Data Plan

    Energy Technology Data Exchange (ETDEWEB)

    Nam Dinh

    2012-03-01

    This report documents analysis, findings and recommendations resulted from a task 'CIPS Validation Data Plan (VDP)' formulated as an POR4 activity in the CASL VUQ Focus Area (FA), to develop a Validation Data Plan (VDP) for Crud-Induced Power Shift (CIPS) challenge problem, and provide guidance for the CIPS VDP implementation. The main reason and motivation for this task to be carried at this time in the VUQ FA is to bring together (i) knowledge of modern view and capability in VUQ, (ii) knowledge of physical processes that govern the CIPS, and (iii) knowledge of codes, models, and data available, used, potentially accessible, and/or being developed in CASL for CIPS prediction, to devise a practical VDP that effectively supports the CASL's mission in CIPS applications.

  9. CIPS Validation Data Plan

    International Nuclear Information System (INIS)

    Dinh, Nam

    2012-01-01

    This report documents analysis, findings and recommendations resulted from a task 'CIPS Validation Data Plan (VDP)' formulated as an POR4 activity in the CASL VUQ Focus Area (FA), to develop a Validation Data Plan (VDP) for Crud-Induced Power Shift (CIPS) challenge problem, and provide guidance for the CIPS VDP implementation. The main reason and motivation for this task to be carried at this time in the VUQ FA is to bring together (i) knowledge of modern view and capability in VUQ, (ii) knowledge of physical processes that govern the CIPS, and (iii) knowledge of codes, models, and data available, used, potentially accessible, and/or being developed in CASL for CIPS prediction, to devise a practical VDP that effectively supports the CASL's mission in CIPS applications.

  10. Validating MEDIQUAL Constructs

    Science.gov (United States)

    Lee, Sang-Gun; Min, Jae H.

    In this paper, we validate MEDIQUAL constructs through the different media users in help desk service. In previous research, only two end-users' constructs were used: assurance and responsiveness. In this paper, we extend MEDIQUAL constructs to include reliability, empathy, assurance, tangibles, and responsiveness, which are based on the SERVQUAL theory. The results suggest that: 1) five MEDIQUAL constructs are validated through the factor analysis. That is, importance of the constructs have relatively high correlations between measures of the same construct using different methods and low correlations between measures of the constructs that are expected to differ; and 2) five MEDIQUAL constructs are statistically significant on media users' satisfaction in help desk service by regression analysis.

  11. DDML Schema Validation

    Science.gov (United States)

    2016-02-08

    XML schema govern DDML instance documents. For information about XML, refer to RCC 125-15, XML Style Guide.2 Figure 4 provides an XML snippet of a...we have documented three main types of information .  User Stories: A user story describes a specific requirement of the schema in the terms of a...instance document is a schema -valid XML file that completely describes the information in the test case in a manner that satisfies the user story

  12. What is validation

    International Nuclear Information System (INIS)

    Clark, H.K.

    1985-01-01

    Criteria for establishing the validity of a computational method to be used in assessing nuclear criticality safety, as set forth in ''American Standard for Nuclear Criticality Safety in Operations with Fissionable Materials Outside Reactors,'' ANSI/ANS-8.1-1983, are examined and discussed. Application of the criteria is illustrated by describing the procedures followed in deriving subcritical limits that have been incorporated in the Standard

  13. Clinical validity of a normal pulmonary angiogram in patients with suspected pulmonary embolism - A critical review

    International Nuclear Information System (INIS)

    Beek, Edwin J.R. van; Brouwers, Elise M.J.; Song Bin; Stein, Paul D.; Oudkerk, Matthijs

    2001-01-01

    AIM: To determine the validity of a normal pulmonary angiogram in the exclusion of pulmonary embolism (PE), based on the safety of withholding anticoagulant therapy in patients with a normal pulmonary angiogram. MATERIALS AND METHODS: A review of English reports published between 1965 and April 1999 was carried out. Eligible articles described prospective studies in patients with suspected PE and a normal pulmonary angiogram, who remained untreated and were followed-up for a minimum of 3 months. Articles were evaluated by two authors, using pre-defined criteria for strength of design. End points consisted of fatal and non-fatal recurrent thromboembolic events. A sensitivity analysis was performed, by removing one study at a time from the overall results and by comparing pre- and post-1990 publications. RESULTS: Among 1050 patients in eight articles included in the analysis, recurrent thromboembolic events were described in 18 patients (1.7% 95% CI: 1.0-2.7%). These were fatal in three patients (0.3% 95% CI: 0.02-0.7%). The recurrence rate of PE decreased from 2.9% (95% CI: 1.4-6.8%) before 1990 to 1.1% (95% CI: 0.5-2.2%) after 1990. CONCLUSION: It would appear that the ability to exclude PE by angiography has improved over the years, as indicated by recurrence rate of PE. The low recurrence rate of PE supports the validity of a normal pulmonary angiogram for the exclusion of PE. Beek, E.J.R. van et al. (2001)

  14. Clinical validation of an epigenetic assay to predict negative histopathological results in repeat prostate biopsies.

    Science.gov (United States)

    Partin, Alan W; Van Neste, Leander; Klein, Eric A; Marks, Leonard S; Gee, Jason R; Troyer, Dean A; Rieger-Christ, Kimberly; Jones, J Stephen; Magi-Galluzzi, Cristina; Mangold, Leslie A; Trock, Bruce J; Lance, Raymond S; Bigley, Joseph W; Van Criekinge, Wim; Epstein, Jonathan I

    2014-10-01

    The DOCUMENT multicenter trial in the United States validated the performance of an epigenetic test as an independent predictor of prostate cancer risk to guide decision making for repeat biopsy. Confirming an increased negative predictive value could help avoid unnecessary repeat biopsies. We evaluated the archived, cancer negative prostate biopsy core tissue samples of 350 subjects from a total of 5 urological centers in the United States. All subjects underwent repeat biopsy within 24 months with a negative (controls) or positive (cases) histopathological result. Centralized blinded pathology evaluation of the 2 biopsy series was performed in all available subjects from each site. Biopsies were epigenetically profiled for GSTP1, APC and RASSF1 relative to the ACTB reference gene using quantitative methylation specific polymerase chain reaction. Predetermined analytical marker cutoffs were used to determine assay performance. Multivariate logistic regression was used to evaluate all risk factors. The epigenetic assay resulted in a negative predictive value of 88% (95% CI 85-91). In multivariate models correcting for age, prostate specific antigen, digital rectal examination, first biopsy histopathological characteristics and race the test proved to be the most significant independent predictor of patient outcome (OR 2.69, 95% CI 1.60-4.51). The DOCUMENT study validated that the epigenetic assay was a significant, independent predictor of prostate cancer detection in a repeat biopsy collected an average of 13 months after an initial negative result. Due to its 88% negative predictive value adding this epigenetic assay to other known risk factors may help decrease unnecessary repeat prostate biopsies. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  15. Validation and clinical utility of a bowel habit questionnaire in school-age children.

    Science.gov (United States)

    Wald, Ellen R; Jagodzinski, Tanya D; Moyer, Stacey C L; Wald, Arnold; Eickhoff, Jens C; Edmonson, M Bruce

    2011-11-01

    The aim of the study was to validate a brief Bowel Habit Questionnaire (BHQ) with prospectively obtained data from a 14-day diary and to determine whether the BHQ predicts the development of medically significant constipation (MSC) during the following year. The BHQ was distributed to parents of children ages 5 to 8 years during health supervision visits. Both the BHQ and subsequent diary were scored to indicate constipation if at least 2 of the following were reported: infrequent bowel movements, stool accidents, straining, avoidance, discomfort with defecation, or passing large stools >25% of the time. One year later, the BHQ was repeated to assess for MSC, defined as medical encounters about constipation or use of enemas, suppositories, laxatives, or stool softeners. MSC was reported for 57 (13.7%) of 416 children on the first BHQ. Paired BHQ and diary data were obtained for 269 children; 54 (20.1%) had diary scores indicating constipation. BHQ had a sensitivity of 59.6% (95% confidence interval [CI] 46.7%-71.4%) and a specificity of 82.6% (95% CI 77.0%-87.1%). One year later, 11 children (5.2%) had developed new-onset MSC; 7 (63.6%) of these children had initial BHQ scores of at least 2. Positive and negative predictive values for MSC were 19.4% (95% CI 9.8%-35.0%) and 97.7% (94.2%-99.1%), respectively. Parents often do not recognize constipation in young school-age children and most constipated children remain untreated. A brief screening questionnaire in this population proved to be valid but only moderately sensitive; efforts to improve sensitivity are needed before recommending it for routine use.

  16. Anti-signal recognition particle autoantibody ELISA validation and clinical associations.

    Science.gov (United States)

    Aggarwal, Rohit; Oddis, Chester V; Goudeau, Danielle; Fertig, Noreen; Metes, Ilinca; Stephens, Chad; Qi, Zengbiao; Koontz, Diane; Levesque, Marc C

    2015-07-01

    The aim of this study was to develop and validate a quantitative anti-signal recognition particle (SRP) autoantibody serum ELISA in patients with myositis and longitudinal association with myositis disease activity. We developed a serum ELISA using recombinant purified full-length human SRP coated on ELISA plates and a secondary antibody that bound human IgG to detect anti-SRP binding. Protein immunoprecipitation was used as the gold standard for the presence of anti-SRP. Serum samples from three groups were analysed: SRP(+) myositis subjects by immunoprecipitation, SRP(-) myositis subjects by immunoprecipitation and non-myositis controls. The ELISA's sensitivity, specificity, positive predictive value and negative predictive value were evaluated. Percentage agreement and test-retest reliability were assessed. Serial samples from seven SRP immunoprecipitation-positive subjects were also tested, along with serum muscle enzymes and manual muscle testing. Using immunoprecipitation, we identified 26 SRP(+) myositis patients and 77 SRP(-) controls (including 38 patients with necrotizing myopathy). Non-myositis control patients included SLE (n = 4) and SSc (n = 7) patients. Anti-SRP positivity by ELISA showed strong agreement (97.1%) with immunoprecipitation (κ = 0.94). The sensitivity, specificity, positive predictive value, and negative predictive value of the anti-SRP ELISA were 88, 100, 100 and 96, respectively. The area under the curve was 0.94, and test-retest reliability was strong (r = 0.91, P < 0.001). Serial samples showed that anti-SRP levels paralleled changes in muscle enzymes and manual muscle testing. We developed a quantitative ELISA for detecting serum anti-SRP autoantibodies and validated the assay in myositis. Longitudinal assessment of SRP levels by ELISA may be a useful biomarker for disease activity. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions

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

    Science.gov (United States)

    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.

  18. Psychometric Properties and Validation of the Positive and Negative Suicide Ideation (PANSI) Inventory in an Outpatient Clinical Population in Malaysia.

    Science.gov (United States)

    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.

  19. PSYCHOMETRIC PROPERTIES AND VALIDATION OF THE POSITIVE AND NEGATIVE SUICIDE IDEATION (PANSI INVENTORY IN AN OUTPATIENT CLINICAL POPULATION IN MALAYSIA

    Directory of Open Access Journals (Sweden)

    Aishvarya eSinniah

    2015-12-01

    Full Text Available 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.

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

    Science.gov (United States)

    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

  1. Development and validation of a self-efficacy questionnaire (SE-12) measuring the clinical communication skills of health care professionals

    DEFF Research Database (Denmark)

    Axboe, Mette K; Christensen, Kaj S; Kofoed, Poul-Erik

    2016-01-01

    of the theoretical approach applied in the communication course, statements from former course participants, teachers, and experts in the field. The questionnaire was initially validated through face-to-face interviews with 9 staff members following a test-retest including 195 participants. Results After minor......Background The outcome of communication training is widely measured by self-efficacy ratings, and different questionnaires have been used. Nevertheless, none of these questionnaires have been formally validated through systematic measurement of assessment properties. Consequently, we decided....... We consider the questionnaire useful for self-evaluation of clinical communication skills; the SE-12 is user-friendly and can be administered as an electronic questionnaire. However, future research should explore potential needs for adjustments to reduce the identified ceiling effect. Keyword...

  2. Structural and incremental validity of the Wechsler Adult Intelligence Scale-Fourth Edition with a clinical sample.

    Science.gov (United States)

    Nelson, Jason M; Canivez, Gary L; Watkins, Marley W

    2013-06-01

    Structural and incremental validity of the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV; Wechsler, 2008a) was examined with a sample of 300 individuals referred for evaluation at a university-based clinic. Confirmatory factor analysis indicated that the WAIS-IV structure was best represented by 4 first-order factors as well as a general intelligence factor in a direct hierarchical model. The general intelligence factor accounted for the most common and total variance among the subtests. Incremental validity analyses indicated that the Full Scale IQ (FSIQ) generally accounted for medium to large portions of academic achievement variance. For all measures of academic achievement, the first-order factors combined accounted for significant achievement variance beyond that accounted for by the FSIQ, but individual factor index scores contributed trivial amounts of achievement variance. Implications for interpreting WAIS-IV results are discussed. (PsycINFO Database Record (c) 2013 APA, all rights reserved).

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

    Science.gov (United States)

    Dutta, Dipankar

    2016-02-09

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

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

    Directory of Open Access Journals (Sweden)

    Meer van der Jos

    2009-04-01

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

  5. Development and validation of Burkholderia pseudomallei-specific real-time PCR assays for clinical, environmental or forensic detection applications.

    Directory of Open Access Journals (Sweden)

    Erin P Price

    Full Text Available The bacterium Burkholderia pseudomallei causes melioidosis, a rare but serious illness that can be fatal if untreated or misdiagnosed. Species-specific PCR assays provide a technically simple method for differentiating B. pseudomallei from near-neighbor species. However, substantial genetic diversity and high levels of recombination within this species reduce the likelihood that molecular signatures will differentiate all B. pseudomallei from other Burkholderiaceae. Currently available molecular assays for B. pseudomallei detection lack rigorous validation across large in silico datasets and isolate collections to test for specificity, and none have been subjected to stringent quality control criteria (accuracy, precision, selectivity, limit of quantitation (LoQ, limit of detection (LoD, linearity, ruggedness and robustness to determine their suitability for environmental, clinical or forensic investigations. In this study, we developed two novel B. pseudomallei specific assays, 122018 and 266152, using a dual-probe approach to differentiate B. pseudomallei from B. thailandensis, B. oklahomensis and B. thailandensis-like species; other species failed to amplify. Species specificity was validated across a large DNA panel (>2,300 samples comprising Burkholderia spp. and non-Burkholderia bacterial and fungal species of clinical and environmental relevance. Comparison of assay specificity to two previously published B. pseudomallei-specific assays, BurkDiff and TTS1, demonstrated comparable performance of all assays, providing between 99.7 and 100% specificity against our isolate panel. Last, we subjected 122018 and 266152 to rigorous quality control analyses, thus providing quantitative limits of assay performance. Using B. pseudomallei as a model, our study provides a framework for comprehensive quantitative validation of molecular assays and provides additional, highly validated B. pseudomallei assays for the scientific research community.

  6. How valid are commercially available medical simulators?

    Science.gov (United States)

    Stunt, JJ; Wulms, PH; Kerkhoffs, GM; Dankelman, J; van Dijk, CN; Tuijthof, GJM

    2014-01-01

    Background Since simulators offer important advantages, they are increasingly used in medical education and medical skills training that require physical actions. A wide variety of simulators have become commercially available. It is of high importance that evidence is provided that training on these simulators can actually improve clinical performance on live patients. Therefore, the aim of this review is to determine the availability of different types of simulators and the evidence of their validation, to offer insight regarding which simulators are suitable to use in the clinical setting as a training modality. Summary Four hundred and thirty-three commercially available simulators were found, from which 405 (94%) were physical models. One hundred and thirty validation studies evaluated 35 (8%) commercially available medical simulators for levels of validity ranging from face to predictive validity. Solely simulators that are used for surgical skills training were validated for the highest validity level (predictive validity). Twenty-four (37%) simulators that give objective feedback had been validated. Studies that tested more powerful levels of validity (concurrent and predictive validity) were methodologically stronger than studies that tested more elementary levels of validity (face, content, and construct validity). Conclusion Ninety-three point five percent of the commercially available simulators are not known to be tested for validity. Although the importance of (a high level of) validation depends on the difficulty level of skills training and possible consequences when skills are insufficient, it is advisable for medical professionals, trainees, medical educators, and companies who manufacture medical simulators to critically judge the available medical simulators for proper validation. This way adequate, safe, and affordable medical psychomotor skills training can be achieved. PMID:25342926

  7. Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis.

    Science.gov (United States)

    Banks, Jamie L; Marotta, Charles A

    2007-03-01

    The modified Rankin scale (mRS), a clinician-reported measure of global disability, is widely applied for evaluating stroke patient outcomes and as an end point in randomized clinical trials. Extensive evidence on the validity of the mRS exists across a large but fragmented literature. As new treatments for acute ischemic stroke are submitted for agency approval, an appreciation of the mRS's attributes, specifically its relationship to other stroke evaluation scales, would be valuable for decision-makers to properly assess the impact of a new drug on treatment paradigms. The purpose of this report is to assemble and systematically assess the properties of the mRS to provide decision-makers with pertinent evaluative information. A Medline search was conducted to identify reports in the peer-reviewed medical literature (1957-2006) that provide information on the structure, validation, scoring, and psychometric properties of the mRS and its use in clinical trials. The selection of articles was based on defined criteria that included relevance, study design and use of appropriate statistical methods. Of 224 articles identified by the literature search, 50 were selected for detailed assessment. Inter-rater reliability with the mRS is moderate and improves with structured interviews (kappa 0.56 versus 0.78); strong test-re-test reliability (kappa=0.81 to 0.95) has been reported. Numerous studies demonstrate the construct validity of the mRS by its relationships to physiological indicators such as stroke type, lesion size, perfusion and neurological impairment. Convergent validity between the mRS and other disability scales is well documented. Patient comorbidities and socioeconomic factors should be considered in properly applying and interpreting the mRS. Recent analyses suggest that randomized clinical trials of acute stroke treatments may require a smaller sample size if the mRS is used as a primary end point rather than the Barthel Index. Multiple types of evidence

  8. Content validity and its estimation

    Directory of Open Access Journals (Sweden)

    Yaghmale F

    2003-04-01

    Full Text Available Background: Measuring content validity of instruments are important. This type of validity can help to ensure construct validity and give confidence to the readers and researchers about instruments. content validity refers to the degree that the instrument covers the content that it is supposed to measure. For content validity two judgments are necessary: the measurable extent of each item for defining the traits and the set of items that represents all aspects of the traits. Purpose: To develop a content valid scale for assessing experience with computer usage. Methods: First a review of 2 volumes of International Journal of Nursing Studies, was conducted with onlyI article out of 13 which documented content validity did so by a 4-point content validity index (CV! and the judgment of 3 experts. Then a scale with 38 items was developed. The experts were asked to rate each item based on relevance, clarity, simplicity and ambiguity on the four-point scale. Content Validity Index (CVI for each item was determined. Result: Of 38 items, those with CVIover 0.75 remained and the rest were discarded reSulting to 25-item scale. Conclusion: Although documenting content validity of an instrument may seem expensive in terms of time and human resources, its importance warrants greater attention when a valid assessment instrument is to be developed. Keywords: Content Validity, Measuring Content Validity

  9. Validating and Determining the Weight of Items Used for Evaluating Clinical Governance Implementation Based on Analytic Hierarchy Process Model

    Directory of Open Access Journals (Sweden)

    Elaheh Hooshmand

    2015-10-01

    Full Text Available Background The purpose of implementing a system such as Clinical Governance (CG is to integrate, establish and globalize distinct policies in order to improve quality through increasing professional knowledge and the accountability of healthcare professional toward providing clinical excellence. Since CG is related to change, and change requires money and time, CG implementation has to be focused on priority areas that are in more dire need of change. The purpose of the present study was to validate and determine the significance of items used for evaluating CG implementation. Methods The present study was descriptive-quantitative in method and design. Items used for evaluating CG implementation were first validated by the Delphi method and then compared with one another and ranked based on the Analytical Hierarchy Process (AHP model. Results The items that were validated for evaluating CG implementation in Iran include performance evaluation, training and development, personnel motivation, clinical audit, clinical effectiveness, risk management, resource allocation, policies and strategies, external audit, information system management, research and development, CG structure, implementation prerequisites, the management of patients’ non-medical needs, complaints and patients’ participation in the treatment process. The most important items based on their degree of significance were training and development, performance evaluation, and risk management. The least important items included the management of patients’ non-medical needs, patients’ participation in the treatment process and research and development. Conclusion The fundamental requirements of CG implementation included having an effective policy at national level, avoiding perfectionism, using the expertise and potentials of the entire country and the coordination of this model with other models of quality improvement such as accreditation and patient safety.

  10. Validating and determining the weight of items used for evaluating clinical governance implementation based on analytic hierarchy process model.

    Science.gov (United States)

    Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Vafaee Najar, Ali; Meraji, Marziye; Ebrahimipour, Hossein

    2015-04-08

    The purpose of implementing a system such as Clinical Governance (CG) is to integrate, establish and globalize distinct policies in order to improve quality through increasing professional knowledge and the accountability of healthcare professional toward providing clinical excellence. Since CG is related to change, and change requires money and time, CG implementation has to be focused on priority areas that are in more dire need of change. The purpose of the present study was to validate and determine the significance of items used for evaluating CG implementation. The present study was descriptive-quantitative in method and design. Items used for evaluating CG implementation were first validated by the Delphi method and then compared with one another and ranked based on the Analytical Hierarchy Process (AHP) model. The items that were validated for evaluating CG implementation in Iran include performance evaluation, training and development, personnel motivation, clinical audit, clinical effectiveness, risk management, resource allocation, policies and strategies, external audit, information system management, research and development, CG structure, implementation prerequisites, the management of patients' non-medical needs, complaints and patients' participation in the treatment process. The most important items based on their degree of significance were training and development, performance evaluation, and risk management. The least important items included the management of patients' non-medical needs, patients' participation in the treatment process and research and development. The fundamental requirements of CG implementation included having an effective policy at national level, avoiding perfectionism, using the expertise and potentials of the entire country and the coordination of this model with other models of quality improvement such as accreditation and patient safety. © 2015 by Kerman University of Medical Sciences.

  11. Development, external validation and clinical usefulness of a practical prediction model for radiation-induced dysphagia in lung cancer patients

    International Nuclear Information System (INIS)

    Dehing-Oberije, Cary; De Ruysscher, Dirk; Petit, Steven; Van Meerbeeck, Jan; Vandecasteele, Katrien; De Neve, Wilfried; Dingemans, Anne Marie C.; El Naqa, Issam; Deasy, Joseph; Bradley, Jeff; Huang, Ellen; Lambin, Philippe

    2010-01-01

    Introduction: Acute dysphagia is a distressing dose-limiting toxicity occurring frequently during concurrent chemo-radiation or high-dose radiotherapy for lung cancer. It can lead to treatment interruptions and thus jeopardize survival. Although a number of predictive factors have been identified, it is still not clear how these could offer assistance for treatment decision making in daily clinical practice. Therefore, we have developed and validated a nomogram to predict this side-effect. In addition, clinical usefulness was assessed by comparing model predictions to physicians' predictions. Materials and methods: Clinical data from 469 inoperable lung cancer patients, treated with curative intent, were collected prospectively. A prediction model for acute radiation-induced dysphagia was developed. Model performance was evaluated by the c-statistic and assessed using bootstrapping as well as two external datasets. In addition, a prospective study was conducted comparing model to physicians' predictions in 138 patients. Results: The final multivariate model consisted of age, gender, WHO performance status, mean esophageal dose (MED), maximum esophageal dose (MAXED) and overall treatment time (OTT). The c-statistic, assessed by bootstrapping, was 0.77. External validation yielded an AUC of 0.94 on the Ghent data and 0.77 on the Washington University St. Louis data for dysphagia ≥ grade 3. Comparing model predictions to the physicians' predictions resulted in an AUC of 0.75 versus 0.53, respectively. Conclusions: The proposed model performed well was successfully validated and demonstrated the ability to predict acute severe dysphagia remarkably better than the physicians. Therefore, this model could be used in clinical practice to identify patients at high or low risk.

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

    Science.gov (United States)

    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.

  13. Validering av Evolution 220

    OpenAIRE

    Krakeli, Tor-Arne

    2013-01-01

    - Det har blitt kjøpt inn et nytt spektrofotometer (Evolution 220, Thermo Scientific) til BioLab Nofima. I den forbindelsen har det blitt utført en validering som involverer kalibreringsstandarder fra produsenten og en test på normal distribusjon (t-test) på to metoder (Total fosfor, Tryptofan). Denne valideringen fant Evolution 220 til å være et akseptabelt alternativ til det allerede benyttede spektrofotometeret (Helios Beta). På bakgrunn av noen instrumentbegrensninger må de aktuelle an...

  14. Is there a genetic cause for cancer cachexia? – a clinical validation study in 1797 patients

    Science.gov (United States)

    Solheim, T S; Fayers, P M; Fladvad, T; Tan, B; Skorpen, F; Fearon, K; Baracos, V E; Klepstad, P; Strasser, F; Kaasa, S

    2011-01-01

    Background: Cachexia has major impact on cancer patients' morbidity and mortality. Future development of cachexia treatment needs methods for early identification of patients at risk. The aim of the study was to validate nine single-nucleotide polymorphisms (SNPs) previously associated with cachexia, and to explore 182 other candidate SNPs with the potential to be involved in the pathophysiology. Method: A total of 1797 cancer patients, classified as either having severe cachexia, mild cachexia or no cachexia, were genotyped. Results: After allowing for multiple testing, there was no statistically significant association between any of the SNPs analysed and the cachexia groups. However, consistent with prior reports, two SNPs from the acylpeptide hydrolase (APEH) gene showed suggestive statistical significance (P=0.02; OR, 0.78). Conclusion: This study failed to detect any significant association between any of the SNPs analysed and cachexia; although two SNPs from the APEH gene had a trend towards significance. The APEH gene encodes the enzyme APEH, postulated to be important in the endpoint of the ubiquitin system and thus the breakdown of proteins into free amino acids. In cachexia, there is an extensive breakdown of muscle proteins and an increase in the production of acute phase proteins in the liver. PMID:21934689

  15. Speech chronemics--a hidden dimension of speech. Theoretical background, measurement and clinical validity.

    Science.gov (United States)

    Krüger, H P

    1989-02-01

    The term "speech chronemics" is introduced to characterize a research strategy which extracts from the physical qualities of the speech signal only the pattern of ons ("speaking") and offs ("pausing"). The research in this field can be structured into the methodological dimension "unit of time", "number of speakers", and "quality of the prosodic measures". It is shown that a researcher's actual decision for one method largely determines the outcome of his study. Then, with the Logoport a new portable measurement device is presented. It enables the researcher to study speaking behavior over long periods of time (up to 24 hours) in the normal environment of his subjects. Two experiments are reported. The first shows the validity of articulation pauses for variations in the physiological state of the organism. The second study proves a new betablocking agent to have sociotropic effects: in a long-term trial socially high-strung subjects showed an improved interaction behavior (compared to placebo and socially easy-going persons) in their everyday life. Finally, the need for a comprehensive theoretical foundation and for standardization of measurement situations and methods is emphasized.

  16. Initial development and preliminary validation of a new negative symptom measure: the Clinical Assessment Interview for Negative Symptoms (CAINS).

    Science.gov (United States)

    Forbes, Courtney; Blanchard, Jack J; Bennett, Melanie; Horan, William P; Kring, Ann; Gur, Raquel

    2010-12-01

    As part of an ongoing scale development process, this study provides an initial examination of the psychometric properties and validity of a new interview-based negative symptom instrument, the Clinical Assessment Interview for Negative Symptoms (CAINS), in outpatients with schizophrenia or schizoaffective disorder (N = 37). The scale was designed to address limitations of existing measures and to comprehensively assess five consensus-based negative symptoms: asociality, avolition, anhedonia (consummatory and anticipatory), affective flattening, and alogia. Results indicated satisfactory internal consistency reliability for the total CAINS scale score and promising inter-rater agreement, with clear areas identified in need of improvement. Convergent validity was evident in general agreement between the CAINS and alternative negative symptom measures. Further, CAINS subscales significantly correlated with relevant self-report emotional experience measures as well as with social functioning. Discriminant validity of the CAINS was strongly supported by its small, non-significant relations with positive symptoms, general psychiatric symptoms, and depression. These preliminary data on an early beta-version of the CAINS provide initial support for this new assessment approach to negative symptoms and suggest directions for further scale development. Copyright © 2010 Elsevier B.V. All rights reserved.

  17. Simulation Validation for Societal Systems

    National Research Council Canada - National Science Library

    Yahja, Alex

    2006-01-01

    .... There are however, substantial obstacles to validation. The nature of modeling means that there are implicit model assumptions, a complex model space and interactions, emergent behaviors, and uncodified and inoperable simulation and validation knowledge...

  18. Validation of the "United Registries for Clinical Assessment and Research" (UR-CARE), a European online registry for clinical care and research in Inflammatory Bowel Disease

    DEFF Research Database (Denmark)

    Burisch, Johan; Gisbert, Javier P; Siegmund, Britta

    2018-01-01

    Background: The "United Registries for Clinical Assessment and Research" (UR-CARE) database is an initiative of the European Crohn's and Colitis Organisation (ECCO) to facilitate daily patient care and research studies in inflammatory bowel disease (IBD). Herein, we sought to validate the database......-99%); Case 5: 91% (87-93%)]. These numbers did not differ significantly from those found 6 weeks later (NcNemar's test p>0.05). Conclusion: The UR-CARE database appears to be feasible, valid and reliable as a tool and easy to use regardless of prior user experience and level of clinical IBD experience. UR......-CARE has the potential to enhance future European collaborations regarding clinical research in IBD....

  19. Development and validation of a self-efficacy questionnaire (SE-12) measuring the clinical communication skills of health care professionals.

    Science.gov (United States)

    Axboe, Mette K; Christensen, Kaj S; Kofoed, Poul-Erik; Ammentorp, Jette

    2016-10-18

    The outcome of communication training is widely measured by self-efficacy ratings, and different questionnaires have been used. Nevertheless, none of these questionnaires have been formally validated through systematic measurement of assessment properties. Consequently, we decided to further develop a self-efficacy questionnaire which has been used in previous studies. This study aims to examine the content, internal structure, and relations with other variables of the new version of the self-efficacy questionnaire (SE-12). The questionnaire was developed on the basis of the theoretical approach applied in the communication course, statements from former course participants, teachers, and experts in the field. The questionnaire was initially validated through face-to-face interviews with 9 staff members following a test-retest including 195 participants. After minor adjustments, the SE-12 questionnaire demonstrated evidence of content validity. An explorative factor analysis indicated unidimensionality with highly correlated items. A Cronbach's α of 0.95 and a Loevinger's H coefficient of 0.71 provided evidence of statistical reliability and scalability. The test-retest reliability had a value of 0.71 when evaluated using intra-class correlation. Expected relations with other variables were partially confirmed in two of three hypotheses, but a ceiling effect was present in 9 of 12 items. The SE-12 scale should be regarded a reliable and partially valid instrument. We consider the questionnaire useful for self-evaluation of clinical communication skills; the SE-12 is user-friendly and can be administered as an electronic questionnaire. However, future research should explore potential needs for adjustments to reduce the identified ceiling effect.

  20. Sleep quality, the neglected outcome variable in clinical studies focusing on locomotor system; a construct validation study

    Directory of Open Access Journals (Sweden)

    Röder Christoph

    2010-09-01

    Full Text Available Abstract Background In addition to general health and pain, sleep is highly relevant to judging the well-being of an individual. Of these three important outcome variables, however, sleep is neglected in most outcome studies. Sleep is a very important resource for recovery from daily stresses and strains, and any alteration of sleep will likely affect mental and physical health, especially during disease. Sleep assessment therefore should be standard in all population-based or clinical studies focusing on the locomotor system. Yet current sleep assessment tools are either too long or too specific for general use. Methods Based on a literature review and subsequent patient-based rating of items, an expert panel designed a four-item questionnaire about sleep. Construct validation of the questionnaire in a random sample of the German-speaking Swiss population was performed in 2003. Reliability, correlation, and tests for internal consistency and validity were analyzed. Results Overall, 16,634 (70% out of 23,763 eligible individuals participated in the study. Test-retest reliability coefficients ranged from 0.72 to 0.87, and a Cronbach's alpha of 0.83 indicates good internal consistency. Results show a moderate to good correlation between sleep disturbances and health perception, and between sleep disturbances and overall pain. Conclusions The Sleep Standard Evaluation Questionnaire (SEQ-Sleep is a reliable and short tool with confirmed construct validity for sleep assessment in population-based observational studies. It is easy to administer and therefore suitable for postal surveys of the general population. Criterion validity remains to be determined.

  1. Audit Validation Using Ontologies

    Directory of Open Access Journals (Sweden)

    Ion IVAN

    2015-01-01

    Full Text Available Requirements to increase quality audit processes in enterprises are defined. It substantiates the need for assessment and management audit processes using ontologies. Sets of rules, ways to assess the consistency of rules and behavior within the organization are defined. Using ontologies are obtained qualifications that assess the organization's audit. Elaboration of the audit reports is a perfect algorithm-based activity characterized by generality, determinism, reproducibility, accuracy and a well-established. The auditors obtain effective levels. Through ontologies obtain the audit calculated level. Because the audit report is qualitative structure of information and knowledge it is very hard to analyze and interpret by different groups of users (shareholders, managers or stakeholders. Developing ontology for audit reports validation will be a useful instrument for both auditors and report users. In this paper we propose an instrument for validation of audit reports contain a lot of keywords that calculates indicators, a lot of indicators for each key word there is an indicator, qualitative levels; interpreter who builds a table of indicators, levels of actual and calculated levels.

  2. Reliability and validity in a nutshell.

    Science.gov (United States)

    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.

  3. Interactive adaptation of a volumetric imaging radiotherapy treatment: development and validation of tools for its implementation in clinical routine

    International Nuclear Information System (INIS)

    Huger, Sandrine

    2013-01-01

    Changing anatomy during radiotherapy can lead to significant dosimetric consequences for organs at risk (OARs) and/or target volumes. Adaptive radiotherapy can compensate for these variations however its deployment for clinical work is hampered by the increased workload for the medical staff and there is still no commercialized software available for clinical use. We developed a simple in vivo dosimetric alert tool allowing rapid identification of patients who might benefit from an adaptive radiotherapy. Dosimetric evaluation of delivered treatment has been conducted onto 3D on board imaging (CBCT) whose dose calculation accuracy has been evaluated. The tool does not require a new volume of interest delineation. Tool alert is based on objectives and quantifiable criteria defined by the exceeding volumes of interest dose thresholds. Tool precision and detectability have been validated and applied in a retrospective study on 10 head and neck patients. The tool allows detecting patients where an adaptive treatment could have been considered. In its clinical implementation, adaptive radiotherapy process requires deformable matching algorithms to follow patient local's deformations occurring during treatment. Nevertheless, their use has not been validated. We conducted an evaluation of the Block Matching deformable algorithm, suitable for multimodality imaging (CT/CBCT), in comparison to rigid algorithm. A study has been conducted for 10 head and neck patients based on volume of interest contours comparison for 76 CBCT. Similarity parameters used consisted on Dice Similarity Index, Robust Hausdorff Distance (in mm) and the absolute volume difference (in cc). (author)

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

    Science.gov (United States)

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

    2015-01-01

    Degenerative joint disease and associated pain are common in cats, particularly in older cats. There is a need for treatment options, however evaluation of putative therapies is limited by a lack of suitable, validated outcome measures that can be used in the target population of client owned cats. The objectives of this study were to evaluate low-dose daily meloxicam for the treatment of pain associated with degenerative joint disease in cats, and further validate two clinical metrology instruments, the Feline Musculoskeletal Pain Index (FMPI) and the Client Specific Outcome Measures (CSOM). Sixty-six client owned cats with degenerative joint disease and owner-reported impairments in mobility were screened and enrolled into a double-masked, placebo-controlled, randomized clinical trial. Following a run-in baseline period, cats were given either placebo or meloxicam for 21 days, then in a masked washout, cats were all given placebo for 21 days. Subsequently, cats were given the opposite treatment, placebo or meloxicam, for 21 days. Cats wore activity monitors throughout the study, owners completed clinical metrology instruments following each period. Activity counts were increased in cats during treatment with daily meloxicam (pdegenerative joint disease.

  5. Validation of the Oral Hygiene Habits Scale: Relationships with sociodemographic variables in the general and clinical population of Monterrey, Mexico.

    Directory of Open Access Journals (Sweden)

    Norma Rodríguez

    2016-12-01

    Full Text Available Several socioeconomic factors are associated with poor oral hygiene habits. A version of the Oral Hygiene Habits Scale (OHHS was developed in Mexico to measure these factors; however, its relationship with sociodemographic variables has not been studied. The verification of these relationships could contribute to the validation of the scale. Objective: To evaluate the relationship between oral hygiene habits and sociodemographic variables of sex, age, schooling, self-defined socioeconomic stratum, occupation and marital status in the general and clinical population of Monterrey, Mexico. Materials and Methods: A general population sample (GPS of 256 participants and a clinical sample (CPS of 240 participants were studied. The OHHS consisted of an eight-item Likert scale of 4 points ranging from 0 to 4. A descriptive correlational study was performed with a cross-sectional design. Data were analyzed using the Mann-Whitney U test, Kruskal-Wallis test, Spearman correlation coefficient, Cramer's V coefficient, and multivariate aligned rank test. Results: In GPS and CPS groups, OHHS was related to sex, schooling, socioeconomic stratum, occupation and marital status, but not to age. There were no significant interactions between the samples (GPS and CPS and sociodemographic variables. Conclusion: There is a statistically significant relationship between oral hygiene habits and some sociodemographic variables in the general and clinical population. This relationship supports the validity of the OHHS.

  6. Towards optimised information about clinical trials; identification and validation of key issues in collaboration with cancer patient advocates

    DEFF Research Database (Denmark)

    Dellson, P; Nilbert, M; Bendahl, P-O

    2011-01-01

    for improvements, 21 key issues were defined and validated through a questionnaire in an independent group of breast cancer patient advocates. Clear messages, emotionally neutral expressions, careful descriptions of side effects, clear comparisons between different treatment alternatives and information about......Clinical trials are crucial to improve cancer treatment but recruitment is difficult. Optimised patient information has been recognised as a key issue. In line with the increasing focus on patients' perspectives in health care, we aimed to study patients' opinions about the written information used...... the possibility to discontinue treatment were perceived as the most important issues. Patients' views of the information in clinical trials provide new insights and identify key issues to consider in optimising future written information and may improve recruitment to clinical cancer trials....

  7. A validated clinical MRI injury scoring system in neonatal hypoxic-ischemic encephalopathy

    Energy Technology Data Exchange (ETDEWEB)

    Trivedi, Shamik B.; Vesoulis, Zachary A.; Rao, Rakesh; Liao, Steve M.; Mathur, Amit M. [Washington University School of Medicine, Division of Newborn Medicine, Edward Mallinckrodt Department of Pediatrics, St. Louis, MO (United States); Shimony, Joshua S.; McKinstry, Robert C. [Washington University School of Medicine, Mallinckrodt Institute of Radiology, St. Louis, MO (United States)

    2017-10-15

    Deep nuclear gray matter injury in neonatal hypoxic-ischemic encephalopathy (HIE) is associated with worse neurodevelopmental outcomes. We previously published a qualitative MRI injury scoring system utilizing serial T1-weighted, T2-weighted and diffusion-weighted imaging (DWI), weighted for deep nuclear gray matter injury. To establish the validity of the MRI scoring system with neurodevelopmental outcome at 18-24 months. MRI scans from neonates with moderate to severe HIE treated with therapeutic hypothermia were evaluated. Signal abnormality was scored on T1-weighted, T2-weighted and DWI sequences and assessed using an established system in five regions: (a) subcortical: caudate nucleus, globus pallidus and putamen, thalamus and the posterior limb of the internal capsule; (b) white matter; (c) cortex, (d) cerebellum and (e) brainstem. MRI injury was graded as none, mild, moderate or severe. Inter-rater reliability was tested on a subset of scans by two independent and blinded neuroradiologists. Surviving infants underwent the Bayley Scales of Infant and Toddler Development-III (Bayley-III) at 18-24 months. Data were analyzed using univariate and multivariate linear and logistic regression. Fifty-seven eligible neonates underwent at least one MRI scan in the first 2 weeks of life. Mean postnatal age at scan 1 was 4±2 days in 50/57 (88%) neonates and 48/54 (89%) surviving infants underwent scan 2 at 10±2 days. In 54/57 (95%) survivors, higher MRI injury grades were significantly associated with worse outcomes in the cognitive, motor and language domains of the Bayley-III. A qualitative MRI injury scoring system weighted for deep nuclear gray matter injury is a significant predictor of neurodevelopmental outcome at 18-24 months in neonates with HIE. (orig.)

  8. A validated clinical MRI injury scoring system in neonatal hypoxic-ischemic encephalopathy

    International Nuclear Information System (INIS)

    Trivedi, Shamik B.; Vesoulis, Zachary A.; Rao, Rakesh; Liao, Steve M.; Mathur, Amit M.; Shimony, Joshua S.; McKinstry, Robert C.

    2017-01-01

    Deep nuclear gray matter injury in neonatal hypoxic-ischemic encephalopathy (HIE) is associated with worse neurodevelopmental outcomes. We previously published a qualitative MRI injury scoring system utilizing serial T1-weighted, T2-weighted and diffusion-weighted imaging (DWI), weighted for deep nuclear gray matter injury. To establish the validity of the MRI scoring system with neurodevelopmental outcome at 18-24 months. MRI scans from neonates with moderate to severe HIE treated with therapeutic hypothermia were evaluated. Signal abnormality was scored on T1-weighted, T2-weighted and DWI sequences and assessed using an established system in five regions: (a) subcortical: caudate nucleus, globus pallidus and putamen, thalamus and the posterior limb of the internal capsule; (b) white matter; (c) cortex, (d) cerebellum and (e) brainstem. MRI injury was graded as none, mild, moderate or severe. Inter-rater reliability was tested on a subset of scans by two independent and blinded neuroradiologists. Surviving infants underwent the Bayley Scales of Infant and Toddler Development-III (Bayley-III) at 18-24 months. Data were analyzed using univariate and multivariate linear and logistic regression. Fifty-seven eligible neonates underwent at least one MRI scan in the first 2 weeks of life. Mean postnatal age at scan 1 was 4±2 days in 50/57 (88%) neonates and 48/54 (89%) surviving infants underwent scan 2 at 10±2 days. In 54/57 (95%) survivors, higher MRI injury grades were significantly associated with worse outcomes in the cognitive, motor and language domains of the Bayley-III. A qualitative MRI injury scoring system weighted for deep nuclear gray matter injury is a significant predictor of neurodevelopmental outcome at 18-24 months in neonates with HIE. (orig.)

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

    Science.gov (United States)

    Mueller, Gerhard; Mylonas, Demetrius; Schumacher, Petra

    2018-04-21

    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.

  10. Multi-institutional Quantitative Evaluation and Clinical Validation of Smart Probabilistic Image Contouring Engine (SPICE) Autosegmentation of Target Structures and Normal Tissues on Computer Tomography Images in the Head and Neck, Thorax, Liver, and Male Pelvis Areas

    DEFF Research Database (Denmark)

    Zhu, Mingyao; Bzdusek, Karl; Brink, Carsten

    2013-01-01

    Clinical validation and quantitative evaluation of computed tomography (CT) image autosegmentation using Smart Probabilistic Image Contouring Engine (SPICE).......Clinical validation and quantitative evaluation of computed tomography (CT) image autosegmentation using Smart Probabilistic Image Contouring Engine (SPICE)....

  11. Validation of thermalhydraulic codes

    International Nuclear Information System (INIS)

    Wilkie, D.

    1992-01-01

    Thermalhydraulic codes require to be validated against experimental data collected over a wide range of situations if they are to be relied upon. A good example is provided by the nuclear industry where codes are used for safety studies and for determining operating conditions. Errors in the codes could lead to financial penalties, to the incorrect estimation of the consequences of accidents and even to the accidents themselves. Comparison between prediction and experiment is often described qualitatively or in approximate terms, e.g. ''agreement is within 10%''. A quantitative method is preferable, especially when several competing codes are available. The codes can then be ranked in order of merit. Such a method is described. (Author)

  12. Identification and content validation of wound therapy clinical endpoints relevant to clinical practice and patient values for FDA approval. Part 1. Survey of the wound care community.

    Science.gov (United States)

    Driver, Vickie R; Gould, Lisa J; Dotson, Peggy; Gibbons, Gary W; Li, William W; Ennis, William J; Kirsner, Robert S; Eaglstein, William H; Bolton, Laura L; Carter, Marissa J

    2017-05-01

    Wounds that exhibit delayed healing add extraordinary clinical, economic, and personal burdens to patients, as well as to increasing financial costs to health systems. New interventions designed to ease such burdens for patients with cancer, renal, or ophthalmologic conditions are often cleared for approval by the U.S. Food and Drug Administration (FDA) using multiple endpoints but the requirement of complete healing as a primary endpoint for wound products impedes FDA clearance of interventions that can provide other clinical or patient-centered benefits for persons with wounds. A multidisciplinary group of wound experts undertook an initiative, in collaboration with the FDA, to identify and content validate supporting FDA criteria for qualifying wound endpoints relevant to clinical practice (CP) and patient-centered outcomes (PCO) as primary outcomes in clinical trials. As part of the initiative, a research study was conducted involving 628 multidisciplinary expert wound clinicians and researchers from 4 different groups: the interdisciplinary core advisory team; attendees of the Spring 2015 Symposium on Advanced Wound Care (SAWC); clinicians employed by a national network of specialty clinics focused on comprehensive wound care; and Association for the Advancement of Wound Care (AAWC) and Wound Healing Society (WHS) members who had not previously completed the survey. The online survey assessed 28 literature-based wound care endpoints for their relevance and importance to clinical practice and clinical research. Fifteen of the endpoints were evaluated for their relevance to improving quality of life. Twenty-two endpoints had content validity indexes (CVI) ≥ 0.75, and 15 were selected as meriting potential inclusion as additional endpoints for FDA approval of future wound care interventions. This study represents an important first step in identifying and validating new measurable wound care endpoints for clinical research and practice and for regulatory

  13. Do clinical and translational science graduate students understand linear regression? Development and early validation of the REGRESS quiz.

    Science.gov (United States)

    Enders, Felicity

    2013-12-01

    Although regression is widely used for reading and publishing in the medical literature, no instruments were previously available to assess students' understanding. The goal of this study was to design and assess such an instrument for graduate students in Clinical and Translational Science and Public Health. A 27-item REsearch on Global Regression Expectations in StatisticS (REGRESS) quiz was developed through an iterative process. Consenting students taking a course on linear regression in a Clinical and Translational Science program completed the quiz pre- and postcourse. Student results were compared to practicing statisticians with a master's or doctoral degree in statistics or a closely related field. Fifty-two students responded precourse, 59 postcourse , and 22 practicing statisticians completed the quiz. The mean (SD) score was 9.3 (4.3) for students precourse and 19.0 (3.5) postcourse (P REGRESS quiz was internally reliable (Cronbach's alpha 0.89). The initial validation is quite promising with statistically significant and meaningful differences across time and study populations. Further work is needed to validate the quiz across multiple institutions. © 2013 Wiley Periodicals, Inc.

  14. Reliability and Validity of the Clinical Dementia Rating for Community-Living Elderly Subjects without an Informant

    Directory of Open Access Journals (Sweden)

    Ma Shwe Zin Nyunt

    2013-10-01

    Full Text Available Background: The Clinical Dementia Rating (CDR scale is widely used to assess cognitive impairment in Alzheimer's disease. It requires collateral information from a reliable informant who is not available in many instances. We adapted the original CDR scale for use with elderly subjects without an informant (CDR-NI and evaluated its reliability and validity for assessing mild cognitive impairment (MCI and dementia among community-dwelling elderly subjects. Method: At two consecutive visits 1 week apart, nurses trained in CDR assessment interviewed, observed and rated cognitive and functional performance according to a protocol in 90 elderly subjects with suboptimal cognitive performance [Mini-Mental State Examination (MMSE Results: The CDR-NI scores (0, 0.5, 1 showed good internal consistency (Crohnbach's a 0.83-0.84, inter-rater reliability (κ 0.77-1.00 for six domains and 0.95 for global rating and test-retest reliability (κ 0.75-1.00 for six domains and 0.80 for global rating, good agreement (κ 0.79 with the clinical assessment status of MCI (n = 37 and dementia (n = 4 and significant differences in the mean scores for MMSE, MOCA and Instrumental Activities of Daily Living (ANOVA global p Conclusion: Owing to the protocol of the interviews, assessments and structured observations gathered during the two visits, CDR-NI provides valid and reliable assessment of MCI and dementia in community-living elderly subjects without an informant.

  15. Validity of colour doppler ultrasonography with d-dimers in clinically suspected deep venous thrombosis of the lower limb

    International Nuclear Information System (INIS)

    Babar, T.H.; Nafees, M.N.; Sarwar, S.; Ashraf, N.

    2010-01-01

    Objective: This study was designed to evaluate the validity of colour Doppler ultrasonography with D-dimers in clinically suspected deep venous thrombosis of the lower limb. Study Design: Validation study Place and Duration of study: Radiology Department CMH/MH Rawalpindi Six months from 15 June 2006 to 31 December 2006. Subjects and Methods: Thirty cases of clinically suspected deep venous thrombosis of the lower limb were included in the study selected on non probability convenience sampling technique. Colour Doppler ultrasonography examination of the affected lower limb was carried out and results compared with D-dimers assays results. Results: Among 30 patients who underwent colour Doppler ultrasonography examination of the affected limb for diagnosis of deep venous thrombosis, 27 (90%) were diagnosed to have deep venous thrombosis, 3 (10%) were diagnosed not to have deep venous thrombosis. Amongst them 2 patients had raised D-dimers levels and repeat Doppler ultrasound advised. On revised ultrasound deep venous thrombosis in these patients was confirmed. This showed that colour Doppler ultrasonography examination has sensitivity of 93.1%, specificity 100%, positive predictive value 100%, negative predictive value 33.33% and overall accuracy of 93.33 %. Conclusion: Colour Doppler ultrasonography has a high diagnostic yield in cases of deep venous thrombosis of lower limb when used in conjunction with D-dimers assays. (author)

  16. The development and validation of a five-factor model of Sources of Self-Efficacy in clinical nursing education

    NARCIS (Netherlands)

    Gloudemans, H.; Reynaert, W.; Schalk, R.; Braeken, J.

    2013-01-01

    Background: The aim of this study is to validate a newly developed nurses' self-efficacy sources inventory. We test the validity of a five-dimensional model of sources of self-efficacy, which we contrast with the traditional four-dimensional model based on Bandura’s theoretical

  17. The development and validation of a five factor model of sources of self-efficacy in clinical nursing education

    NARCIS (Netherlands)

    Prof. Dr. Rene Schalk; dr. Wouter Reynaert; Dr. Johan Braeken; Drs. Henk Gloudemans

    2012-01-01

    Background: The aim of this study is to validate a newly developed nurses' self-efficacy sources inventory. We test the validity of a five-dimensional model of sources of self-efficacy, which we contrast with the traditional four-dimensional model based on Bandura's theoretical concepts. Methods:

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

    Science.gov (United States)

    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…

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

    NARCIS (Netherlands)

    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

  20. The development and validation of a five-factor model of sources of self-efficacy in clinical nursing education

    NARCIS (Netherlands)

    Gloudemans, H.; Schalk, R.; Reynaert, W.M.; Braeken, J.

    2013-01-01

    Background: The aim of this study is to validate a newly developed nurses' self-efficacy sources inventory. We test the validity of a five-dimensional model of sources of self-efficacy, which we contrast with the traditional four-dimensional model based on Bandura’s theoretical concepts. Methods:

  1. Symptom severity scale of the DSM5 for schizophrenia, and other psychotic disorders: diagnostic validity and clinical feasibility.

    Science.gov (United States)

    Ritsner, Michael S; Mar, Maria; Arbitman, Marina; Grinshpoon, Alexander

    2013-06-30

    Innovations in DSM5 include dimensional diagnosis of schizophrenia (SZ) and other psychotic (OP) disorders using the symptom severity scale (SS-DSM5). We evaluated the psychometric properties and diagnostic validity of the SS-DSM5 scale using a cross-sectional design and an unselected convenience unselected sample of 314 inpatients and outpatients with SZ/OP and mood disorders who received standard care in routine clinical practice. The SS-DSM5 scale, the Clinical Global Impression-Severity scale (CGI-S), the Positive and Negative Syndrome Scale (PANSS), and the Bech-Rafaelsen Mania Scale (BRMS) were administered. Factor structure, reliability, internal consistency, convergent and diagnostic ability of the DSM5-SS were evaluated. Factor analysis indicated two latent factors underlying the SS-DSM5 (Psychotic and Deficit sub-scales). Cronbach's alpha was >0.70. Convergent validity of the SS-DSM5 was highly significant. Patients with SZ/PO disorders were correctly diagnosed (77.9%) using the SS-DSM5 scale (72% using PANSS). The agreement of the diagnostic decisions between the SS-DSM5 and PANSS was substantial for SZ/PO disorders (Kappa=0.75). Classifying participants with SZ/PO versus mood disorders using SS-DSM5 provided a sensitivity of 95%, and specificity of 34%. Thus, this study suggests that the SS-DSM5 has acceptable psychometric properties and that its use in clinical practice and research is feasible in clinical settings. The dimensional option for the diagnosis of schizophrenia and related disorders using SS-DSM5 is discussed. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  2. Clinical Validation of Simultaneous Analysis of Tacrolimus, Cyclosporine A, and Creatinine in Dried Blood Spots in Kidney Transplant Patients.

    Science.gov (United States)

    Veenhof, Herman; Koster, Remco A; Alffenaar, Jan-Willem C; Berger, Stefan P; Bakker, Stephan J L; Touw, Daan J

    2017-07-01

    Monitoring of creatinine and immunosuppressive drug concentrations, such as tacrolimus (TaC) and cyclosporin A (CsA), is important in the outpatient follow-up of kidney transplant recipients. Monitoring by dried blood spot (DBS) provides patients the opportunity to sample a drop of blood from a fingerprick at home, which can be sent to the laboratory by mail. We performed a clinical validation in which we compared measurements from whole-blood samples obtained by venapuncture with measurements from DBS samples simultaneously obtained by fingerprick. After exclusion of 10 DBS for poor quality, and 2 for other reasons, 199, 104, and 58 samples from a total of 172 patients were available for validation of creatinine, TaC and CsA, respectively. Validation was performed by means of Passing & Bablok regression, and bias was assessed by Bland-Altman analysis. For creatinine, we found y = 0.73x - 1.55 (95% confidence interval [95% CI] slope, 0.71-0.76), giving the conversion formula: (creatinine plasma concentration in μmol/L) = (creatinine concentration in DBS in μmol/L)/0.73, with a nonclinically relevant bias of -2.1 μmol/L (95% CI, -3.7 to -0.5 μmol/L). For TaC, we found y = 1.00x - 0.23 (95% CI slope, 0.91-1.08), with a nonclinically relevant bias of -0.28 μg/L (95% CI, -0.45 to -0.12 μg/L). For CsA, we found y = 0.99x - 1.86 (95% CI slope, 0.91-1.08) and no significant bias. Therefore, for neither TaC nor CsA, a conversion formula is required. DBS sampling for the simultaneous analysis of immunosuppressants and creatinine can replace conventional venous sampling in daily routine.

  3. The "DOC" screen: Feasible and valid screening for depression, Obstructive Sleep Apnea (OSA) and cognitive impairment in stroke prevention clinics.

    Science.gov (United States)

    Swartz, Richard H; Cayley, Megan L; Lanctôt, Krista L; Murray, Brian J; Cohen, Ashley; Thorpe, Kevin E; Sicard, Michelle N; Lien, Karen; Sahlas, Demetrios J; Herrmann, Nathan

    2017-01-01

    Post-stroke Depression, Obstructive sleep apnea (OSA) and Cognitive impairment ("DOC") are associated with greater mortality, worse recovery and poorer quality of life. Best practice recommendations endorse routine screening for each condition; yet, all are under-assessed, diagnosed and treated. We seek to determine the feasibility and validity of an integrated tool ("DOC" screen) to identify stroke clinic patients at high-risk of depression, OSA, and cognitive impairment. All consecutive new referrals to a regional Stroke Prevention Clinic who were English-speaking and non-aphasic were eligible to be screened. Time for screen completion was logged. DOC screen results were compared to the neuropsychological battery and polysomnogram assessments using a modified receiver operator characteristic and area under the curve analysis. Data is reported to conform to STARD guidelines. 1503 people were screened over 2 years. 89% of eligible patients completed the screen in 5 minutes or less (mean 4.2 minutes), less than half the time it takes to complete the Montreal Cognitive Assessment (MoCA). 437 people consented to detailed testing. Of those, 421 completed the Structured Clinical Interview for Depression within 3 months of screening, 387 completed detailed neuropsychological testing within 3 months, and 88 had overnight polysomnograms. Screening scores combined with demographic variables (age, sex, education, body mass index), had excellent validity compared to gold standard diagnoses: DOC-Mood AUC 0.90; DOC-Apnea AUC 0.80; DOC-Cog AUC 0.81. DOC screen scores can reliably categorize patients in to low-, intermediate- or high-risk groups for further action and can do so with comparable accuracy to more time-consuming screens. Systematic screening of depression, obstructive sleep apnea, and cognitive impairment in 5 minutes or less is feasible and valid in a high volume stroke clinic using the DOC screen. The DOC screen may facilitate improved identification and treatment

  4. Design for validation: An approach to systems validation

    Science.gov (United States)

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

    1989-01-01

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

  5. Development and Validation of Simulated Virtual Patients to Impart Early Clinical Exposure in Endocrine Physiology

    Science.gov (United States)

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

    2018-01-01

    In the country presently, preclinical medical students are not routinely exposed to real patients. Thus, when they start clinical postings, they are found to have poor clinical reasoning skills. Simulated virtual patients (SVPs) can improve clinical skills without endangering real patients. This pilot study describes the development of two SVPs in…

  6. How valid are commercially available medical simulators?

    Directory of Open Access Journals (Sweden)

    Stunt JJ

    2014-10-01

    Full Text Available JJ Stunt,1 PH Wulms,2 GM Kerkhoffs,1 J Dankelman,2 CN van Dijk,1 GJM Tuijthof1,2 1Orthopedic Research Center Amsterdam, Department of Orthopedic Surgery, Academic Medical Centre, Amsterdam, the Netherlands; 2Department of Biomechanical Engineering, Faculty of Mechanical, Materials and Maritime Engineering, Delft University of Technology, Delft, the Netherlands Background: Since simulators offer important advantages, they are increasingly used in medical education and medical skills training that require physical actions. A wide variety of simulators have become commercially available. It is of high importance that evidence is provided that training on these simulators can actually improve clinical performance on live patients. Therefore, the aim of this review is to determine the availability of different types of simulators and the evidence of their validation, to offer insight regarding which simulators are suitable to use in the clinical setting as a training modality. Summary: Four hundred and thirty-three commercially available simulators were found, from which 405 (94% were physical models. One hundred and thirty validation studies evaluated 35 (8% commercially available medical simulators for levels of validity ranging from face to predictive validity. Solely simulators that are used for surgical skills training were validated for the highest validity level (predictive validity. Twenty-four (37% simulators that give objective feedback had been validated. Studies that tested more powerful levels of validity (concurrent and predictive validity were methodologically stronger than studies that tested more elementary levels of validity (face, content, and construct validity. Conclusion: Ninety-three point five percent of the commercially available simulators are not known to be tested for validity. Although the importance of (a high level of validation depends on the difficulty level of skills training and possible consequences when skills are

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

    Science.gov (United States)

    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

  8. A leprosy clinical severity scale for erythema nodosum leprosum: An international, multicentre validation study of the ENLIST ENL Severity Scale.

    Science.gov (United States)

    Walker, Stephen L; Sales, Anna M; Butlin, C Ruth; Shah, Mahesh; Maghanoy, Armi; Lambert, Saba M; Darlong, Joydeepa; Rozario, Benjamin Jewel; Pai, Vivek V; Balagon, Marivic; Doni, Shimelis N; Hagge, Deanna A; Nery, José A C; Neupane, Kapil D; Baral, Suwash; Sangma, Biliom A; Alembo, Digafe T; Yetaye, Abeba M; Hassan, Belaynesh A; Shelemo, Mohammed B; Nicholls, Peter G; Lockwood, Diana N J

    2017-07-01

    We wished to validate our recently devised 16-item ENLIST ENL Severity Scale, a clinical tool for measuring the severity of the serious leprosy associated complication of erythema nodosum leprosum (ENL). We also wished to assess the responsiveness of the ENLIST ENL Severity Scale in detecting clinical change in patients with ENL. Participants, recruited from seven centres in six leprosy endemic countries, were assessed using the ENLIST ENL Severity Scale by two researchers, one of whom categorised the severity of ENL. At a subsequent visit a further assessment using the scale was made and both participant and physician rated the change in ENL using the subjective categories of "Much better", "somewhat better", "somewhat worse" and "much worse" compared with "No change" or "about the same". 447 participants were assessed with the ENLIST ENL Severity Scale. The Cronbach alpha of the scale and each item was calculated to determine the internal consistency of the scale. The ENLIST ENL Severity Scale had good internal consistency and this improved following removal of six items to give a Cronbach's alpha of 0.77. The cut off between mild ENL and more severe disease was 9 determined using ROC curves. The minimal important difference of the scale was determined to be 5 using both participant and physician ratings of change. The 10-item ENLIST ENL Severity Scale is the first valid, reliable and responsive measure of ENL severity and improves our ability to assess and compare patients and their treatments in this severe and difficult to manage complication of leprosy. The ENLIST ENL Severity Scale will assist physicians in the monitoring and treatment of patients with ENL. The ENLIST ENL Severity Scale is easy to apply and will be useful as an outcome measure in treatment studies and enable the standardisation of other clinical and laboratory ENL research.

  9. Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project.

    Science.gov (United States)

    2003-02-01

    International interest in clinical practice guidelines has never been greater but many published guidelines do not meet the basic quality requirements. There have been renewed calls for validated criteria to assess the quality of guidelines. To develop and validate an international instrument for assessing the quality of the process and reporting of clinical practice guideline development. The instrument was developed through a multi-staged process of item generation, selection and scaling, field testing, and refinement procedures. 100 guidelines selected from 11 participating countries were evaluated independently by 194 appraisers with the instrument. Following refinement the instrument was further field tested on three guidelines per country by a new set of 70 appraisers. The final version of the instrument contained 23 items grouped into six quality domains with a 4 point Likert scale to score each item (scope and purpose, stakeholder involvement, rigour of development, clarity and presentation, applicability, editorial independence). 95% of appraisers found the instrument useful for assessing guidelines. Reliability was acceptable for most domains (Cronbach's alpha 0.64-0.88). Guidelines produced as part of an established guideline programme had significantly higher scores on editorial independence and, after the publication of a national policy, had significantly higher quality scores on rigour of development (pinternationally. The instrument is sensitive to differences in important aspects of guidelines and can be used consistently and easily by a wide range of professionals from different backgrounds. The adoption of common standards should improve the consistency and quality of the reporting of guideline development worldwide and provide a framework to encourage international comparison of clinical practice guidelines.

  10. The script concordance test in radiation oncology: validation study of a new tool to assess clinical reasoning

    International Nuclear Information System (INIS)

    Lambert, Carole; Gagnon, Robert; Nguyen, David; Charlin, Bernard

    2009-01-01

    The Script Concordance test (SCT) is a reliable and valid tool to evaluate clinical reasoning in complex situations where experts' opinions may be divided. Scores reflect the degree of concordance between the performance of examinees and that of a reference panel of experienced physicians. The purpose of this study is to demonstrate SCT's usefulness in radiation oncology. A 90 items radiation oncology SCT was administered to 155 participants. Three levels of experience were tested: medical students (n = 70), radiation oncology residents (n = 38) and radiation oncologists (n = 47). Statistical tests were performed to assess reliability and to document validity. After item optimization, the test comprised 30 cases and 70 questions. Cronbach alpha was 0.90. Mean scores were 51.62 (± 8.19) for students, 71.20 (± 9.45) for residents and 76.67 (± 6.14) for radiation oncologists. The difference between the three groups was statistically significant when compared by the Kruskall-Wallis test (p < 0.001). The SCT is reliable and useful to discriminate among participants according to their level of experience in radiation oncology. It appears as a useful tool to document the progression of reasoning during residency training

  11. Validation of the Brazilian version of the Clinical Gait and Balance Scale and comparison with the Berg Balance Scale

    Directory of Open Access Journals (Sweden)

    Jussara Almeida Oliveira Baggio

    2013-09-01

    Full Text Available Objective To validate the Clinical Gait and Balance Scale (GABS for a Brazilian population of patients with Parkinson's disease (PD and to compare it to the Berg Balance Scale (BBS. Methods One hundred and seven PD patients were evaluated by shortened UPDRS motor scale (sUPDRSm, Hoehn and Yahr (HY, Schwab and England scale (SE, Falls Efficacy Scale International (FES-I, Freezing of Gait Questionnaire (FOG-Q, BBS and GABS. Results The internal consistency of the GABS was 0.94, the intra-rater and inter-rater reliability were 0.94 and 0.98 respectively. The area under the receiver operating characteristic (ROC curve was 0.72, with a sensitivity of 0.75 and specificity of 0.6, to discriminate patients with a history of falls in the last twelve months, for a cut-off score of 13 points. Conclusions Our study shows that the Brazilian version of the GABS is a reliable and valid instrument to assess gait and balance in PD.

  12. Development and Validation of the Sleep Inertia Questionnaire (SIQ) and Assessment of Sleep Inertia in Analogue and Clinical Depression.

    Science.gov (United States)

    Kanady, Jennifer C; Harvey, Allison G

    2015-10-01

    Sleep inertia is the transitional state from sleep to wake. Research on sleep inertia is important in depression because many people with depression report having difficulty getting out of bed, which contributes to impairment and can impede the implementation of interventions. The first aim was to develop and validate the first self-report measure of sleep inertia, the Sleep Inertia Questionnaire (SIQ). The second aim was to compare reports of sleep inertia across three groups: (1) No-to-Mild-Depression, (2) Analogue-Depression, and (3) Syndromal-Depression. The SIQ demonstrates strong psychometric properties; it has good to excellent internal consistency, strong construct validity, and SIQ severity is associated with less prior sleep duration. Sleep inertia is more severe in the Analogue-Depression and Syndromal-Depression groups compared to the No-to-Mild-Depression group. In conclusion, the SIQ is a reliable measure of sleep inertia and has potential for improving the assessment of sleep inertia in clinical and research settings.

  13. Site characterization and validation

    International Nuclear Information System (INIS)

    Olsson, O.; Eriksson, J.; Falk, L.; Sandberg, E.

    1988-04-01

    The borehole radar investigation program of the SCV-site (Site Characterization and Validation) has comprised single hole reflection measurements with centre frequencies of 22, 45, and 60 MHz. The radar range obtained in the single hole reflection measurements was approximately 100 m for the lower frequency (22 MHz) and about 60 m for the centre frequency 45 MHz. In the crosshole measurements transmitter-receiver separations from 60 to 200 m have been used. The radar investigations have given a three dimensional description of the structure at the SCV-site. A generalized model of the site has been produced which includes three major zones, four minor zones and a circular feature. These features are considered to be the most significant at the site. Smaller features than the ones included in the generalized model certainly exist but no additional features comparable to the three major zones are thought to exist. The results indicate that the zones are not homogeneous but rather that they are highly irregular containing parts of considerably increased fracturing and parts where their contrast to the background rock is quite small. The zones appear to be approximately planar at least at the scale of the site. At a smaller scale the zones can appear quite irregular. (authors)

  14. Spare Items validation

    International Nuclear Information System (INIS)

    Fernandez Carratala, L.

    1998-01-01

    There is an increasing difficulty for purchasing safety related spare items, with certifications by manufacturers for maintaining the original qualifications of the equipment of destination. The main reasons are, on the top of the logical evolution of technology, applied to the new manufactured components, the quitting of nuclear specific production lines and the evolution of manufacturers quality systems, originally based on nuclear codes and standards, to conventional industry standards. To face this problem, for many years different Dedication processes have been implemented to verify whether a commercial grade element is acceptable to be used in safety related applications. In the same way, due to our particular position regarding the spare part supplies, mainly from markets others than the american, C.N. Trillo has developed a methodology called Spare Items Validation. This methodology, which is originally based on dedication processes, is not a single process but a group of coordinated processes involving engineering, quality and management activities. These are to be performed on the spare item itself, its design control, its fabrication and its supply for allowing its use in destinations with specific requirements. The scope of application is not only focussed on safety related items, but also to complex design, high cost or plant reliability related components. The implementation in C.N. Trillo has been mainly curried out by merging, modifying and making the most of processes and activities which were already being performed in the company. (Author)

  15. Short-Term Memory and Auditory Processing Disorders: Concurrent Validity and Clinical Diagnostic Markers

    Science.gov (United States)

    Maerlender, Arthur

    2010-01-01

    Auditory processing disorders (APDs) are of interest to educators and clinicians, as they impact school functioning. Little work has been completed to demonstrate how children with APDs perform on clinical tests. In a series of studies, standard clinical (psychometric) tests from the Wechsler Intelligence Scale for Children, Fourth Edition…

  16. SHIELD verification and validation report

    International Nuclear Information System (INIS)

    Boman, C.

    1992-02-01

    This document outlines the verification and validation effort for the SHIELD, SHLDED, GEDIT, GENPRT, FIPROD, FPCALC, and PROCES modules of the SHIELD system code. Along with its predecessors, SHIELD has been in use at the Savannah River Site (SRS) for more than ten years. During this time the code has been extensively tested and a variety of validation documents have been issued. The primary function of this report is to specify the features and capabilities for which SHIELD is to be considered validated, and to reference the documents that establish the validation

  17. The metabolic syndrome: validity and utility of clinical definitions for cardiovascular disease and diabetes risk prediction.

    Science.gov (United States)

    Cameron, Adrian

    2010-02-01

    The purpose of clinical definitions of the metabolic syndrome is frequently misunderstood. While the metabolic syndrome as a physiological process describes a clustering of numerous age-related metabolic abnormalities that together increase the risk for cardiovascular disease and type 2 diabetes, clinical definitions include obesity which is thought to be a cause rather than a consequence of metabolic disturbance, and several elements that are routinely measured in clinical practice, including high blood pressure, high blood glucose and dyslipidaemia. Obesity is frequently a central player in the development of the metabolic syndrome and should be considered a key component of clinical definitions. Previous clinical definitions have differed in the priority given to obesity. Perhaps more importantly than its role in a clinical definition, however, is obesity in isolation before the hallmarks of metabolic dysfunction that typify the syndrome have developed. This should be treated seriously as an opportunity to prevent the consequences of the global diabetes epidemic now apparent. Clinical definitions were designed to identify a population at high lifetime CVD and type 2 diabetes risk, but in the absence of several major risk factors for each condition, are not optimal risk prediction devices for either. Despite this, the metabolic syndrome has several properties that make it a useful construct, in conjunction with short-term risk prediction algorithms and sound clinical judgement, for the identification of those at high lifetime risk of CVD and diabetes. A recently published consensus definition provides some much needed clarity about what a clinical definition entails. Even this, however, remains a work in progress until more evidence becomes available, particularly in the area of ethnicity-specific waist cut-points. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

  18. CBF-measurement of Xe-133 inhalation. Validity and clinical applications in psychiatry

    International Nuclear Information System (INIS)

    Risberg, J.

    1980-01-01

    Some methodological questions are dealt with, especially elimination of influence from non-cerebral sources of radiation. Experience from clinical applications of the method in psychiatry are briefly reviewed. (Auth.)

  19. TU-G-BRB-03: IROC Houston’s Proton Beam Validation for Clinical Trials

    International Nuclear Information System (INIS)

    Taylor, P.

    2015-01-01

    Proton therapy, in particular, and ion therapy, just beginning, are becoming an increasing focus of attention in clinical radiation oncology and medical physics. Both modalities have been criticized of lacking convincing evidence from randomized trials proving their efficacy, justifying the higher costs involved in these therapies. This session will provide an overview of the current status of clinical trials in proton therapy, including recent developments in ion therapy. As alluded to in the introductory talk by Dr. Schulte, opinions are diverging widely as to the usefulness and need for clinical trials in particle therapy and the challenge of equipoise. The lectures will highlight some of the challenges that surround clinical trials in particle therapy. One, presented by Dr. Choy from UT Southwestern, is that new technology and even different types of particles such as helium and carbon ions are introduced into this environment, increasing the phase space of clinical variables. The other is the issue of medical physics quality assurance with physical phantoms, presented by Mrs. Taylor from IROC Houston, which is more challenging because 3D and 4D image guidance and active delivery techniques are in relatively early stages of development. The role of digital phantoms in developing clinical treatment planning protocols and as a QA tool will also be highlighted by Dr. Lee from NCI. The symposium will be rounded off by a panel discussion among the Symposium speakers, arguing pro or con the need and readiness for clinical trials in proton and ion therapy. Learning Objectives: To get an update on the current status of clinical trials allowing or mandating proton therapy. Learn about the status of planned clinical trials in the U.S. and worldwide involving ion therapy. Discuss the challenges in the design and QA of clinical trials in particle therapy. Learn about existing and future physical and computational anthropomorphic phantoms for charged particle clinical trial

  20. Validation of clinical case definition of acute intussusception in infants in Viet Nam and Australia.

    OpenAIRE

    Bines, JE; Liem, NT; Justice, F; Son, TN; Carlin, JB; de Campo, M; Jamsen, K; Mulholland, K; Barnett, P; Barnes, GL

    2006-01-01

    OBJECTIVE: To test the sensitivity and specificity of a clinical case definition of acute intussusception in infants to assist health-care workers in settings where diagnostic facilities are not available. METHODS: Prospective studies were conducted at a major paediatric hospital in Viet Nam (the National Hospital of Pediatrics, Hanoi) from November 2002 to December 2003 and in Australia (the Royal Children's Hospital, Melbourne) from March 2002 to March 2004 using a clinical case definition ...

  1. Development and Validation of a Tool to Evaluate the Evolution of Clinical Reasoning in Trauma Using Virtual Patients.

    Science.gov (United States)

    Fleiszer, David; Hoover, Michael L; Posel, Nancy; Razek, Tarek; Bergman, Simon

    Undergraduate medical students at a large academic trauma center are required to manage a series of online virtual trauma patients as a mandatory exercise during their surgical rotation. Clinical reasoning during undergraduate medical education can be difficult to assess. The purpose of the study was to determine whether we could use components of the students' virtual patient management to measure changes in their clinical reasoning over the course of the clerkship year. In order to accomplish this, we decided to determine if the use of scoring rubrics could change the traditional subjective assessment to a more objective evaluation. Two groups of students, one at the beginning of clerkship (Juniors) and one at the end of clerkship (Seniors), were chosen. Each group was given the same virtual patient case, a clinical scenario based on the Advanced Trauma Life Support (ATLS) Primary Trauma Survey, which had to be completed during their trauma rotation. The learner was required to make several key patient management choices based on their clinical reasoning, which would take them along different routes through the case. At the end of the case they had to create a summary report akin to sign-off. These summaries were graded independently by two domain "Experts" using a traditional subjective surgical approach to assessment and by two "Non-Experts" using two internally validated scoring rubrics. One rubric assessed procedural or domain knowledge (Procedural Rubric), while the other rubric highlighted semantic qualifiers (Semantic Rubric). Each of the rubrics was designed to reflect established components of clinical reasoning. Student's t-tests were used to compare the rubric scores for the two groups and Cohen's d was used to determine effect size. Kendall's τ was used to compare the difference between the two groups based on the "Expert's" subjective assessment. Inter-rater reliability (IRR) was determined using Cronbach's alpha. The Seniors did better than the

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

    Science.gov (United States)

    Perez-Martinez, Pablo; Alcala-Diaz, Juan F; Kabagambe, Edmon K; Garcia-Rios, Antonio; Tsai, Michael Y; Delgado-Lista, Javier; Kolovou, Genovefa; Straka, Robert J; Gomez-Delgado, Francisco; Hopkins, Paul N; Marin, Carmen; Borecki, Ingrid; Yubero-Serrano, Elena M; Hixson, James E; Camargo, Antonio; Province, Michael A; Lopez-Moreno, Javier; Rodriguez-Cantalejo, Fernando; Tinahones, Francisco J; Mikhailidis, Dimitri P; Perez-Jimenez, Francisco; Arnett, Donna K; Ordovas, Jose M; Lopez-Miranda, Jose

    2016-01-01

    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. To determine the postprandial TG response in 2 independent studies and validate who should benefit diagnostically from an oral-fat tolerance test (OFTT) in clinical practice. A population of 1002 patients with coronary heart disease (CHD) from the CORDIOPREV clinical trial and 1115 white US subjects from the GOLDN study underwent OFTTs. Subjects were classified into 3 groups according to fasting cut points of TGs to predict the usefulness of OFTT: (1) TG  180 mg/dl (>2 mmol/l). Postprandial TG concentration at any point > 220 mg/dl (>2.5 mmol/l) has been pre-established as an undesirable postprandial response. Of the total, 49% patients with CHD and 42% from the general population showed an undesirable response after the OFTT. The prevalence of undesirable postprandial TG in the CORDIOPREV clinical trial was 12.8, 50.3, and 89.7%, in group 1, 2, and 3, respectively (P 2 mmol/l, >180 mg/dl). Copyright © 2016 National Lipid Association. Published by Elsevier Inc. All rights reserved.

  3. Towards optimised information about clinical trials; identification and validation of key issues in collaboration with cancer patient advocates.

    Science.gov (United States)

    Dellson, P; Nilbert, M; Bendahl, P-O; Malmström, P; Carlsson, C

    2011-07-01

    Clinical trials are crucial to improve cancer treatment but recruitment is difficult. Optimised patient information has been recognised as a key issue. In line with the increasing focus on patients' perspectives in health care, we aimed to study patients' opinions about the written information used in three clinical trials for breast cancer. Primary data collection was done in focus group interviews with breast cancer patient advocates. Content analysis identified three major themes: comprehensibility, emotions and associations, and decision making. Based on the advocates' suggestions for improvements, 21 key issues were defined and validated through a questionnaire in an independent group of breast cancer patient advocates. Clear messages, emotionally neutral expressions, careful descriptions of side effects, clear comparisons between different treatment alternatives and information about the possibility to discontinue treatment were perceived as the most important issues. Patients' views of the information in clinical trials provide new insights and identify key issues to consider in optimising future written information and may improve recruitment to clinical cancer trials. © 2010 Blackwell Publishing Ltd.

  4. Initial validation of 4D-model for a clinical PET scanner using the Monte Carlo code gate

    International Nuclear Information System (INIS)

    Vieira, Igor F.; Lima, Fernando R.A.; Gomes, Marcelo S.; Vieira, Jose W.; Pacheco, Ludimila M.; Chaves, Rosa M.

    2011-01-01

    Building exposure computational models (ECM) of emission tomography (PET and SPECT) currently has several dedicated computing tools based on Monte Carlo techniques (SimSET, SORTEO, SIMIND, GATE). This paper is divided into two steps: (1) using the dedicated code GATE (Geant4 Application for Tomographic Emission) to build a 4D model (where the fourth dimension is the time) of a clinical PET scanner from General Electric, GE ADVANCE, simulating the geometric and electronic structures suitable for this scanner, as well as some phenomena 4D, for example, rotating gantry; (2) the next step is to evaluate the performance of the model built here in the reproduction of test noise equivalent count rate (NEC) based on the NEMA Standards Publication NU protocols 2-2007 for this tomography. The results for steps (1) and (2) will be compared with experimental and theoretical values of the literature showing actual state of art of validation. (author)

  5. Validation of the Marijuana Effect Expectancies Questionnaire (MEEQ in a Non-Clinical French-Speaking Adolescent Sample

    Directory of Open Access Journals (Sweden)

    Emilie Schmits

    2016-02-01

    Full Text Available Teenagers commonly use cannabis. Expectancies related to the effects of cannabis play an important role in its consumption and are frequently measured with the Marijuana Effect Expectancies Questionnaire (MEEQ. This study aims to assess the psychometric properties (factor structure, internal consistency reliability, criterion validity of the French MEEQ. A sample of 1,343 non-clinical teenagers (14–18 years were recruited to answer a self-report questionnaire; 877 of them responded twice (one-year interval. A four-factor structure was obtained: Cognitive Impairment and Negative, Relaxation and Social Facilitation, Perceptual Enhancement and Craving and Negative Behavioral Effect Expectancies. It is concluded that the French MEEQ constitutes an appropriate tool to measure cannabis effect expectancies among adolescents.

  6. Initial validation of 4D-model for a clinical PET scanner using the Monte Carlo code gate

    Energy Technology Data Exchange (ETDEWEB)

    Vieira, Igor F.; Lima, Fernando R.A.; Gomes, Marcelo S., E-mail: falima@cnen.gov.b [Centro Regional de Ciencias Nucleares do Nordeste (CRCN-NE/CNEN-PE), Recife, PE (Brazil); Vieira, Jose W.; Pacheco, Ludimila M. [Instituto Federal de Educacao, Ciencia e Tecnologia (IFPE), Recife, PE (Brazil); Chaves, Rosa M. [Instituto de Radium e Supervoltagem Ivo Roesler, Recife, PE (Brazil)

    2011-07-01

    Building exposure computational models (ECM) of emission tomography (PET and SPECT) currently has several dedicated computing tools based on Monte Carlo techniques (SimSET, SORTEO, SIMIND, GATE). This paper is divided into two steps: (1) using the dedicated code GATE (Geant4 Application for Tomographic Emission) to build a 4D model (where the fourth dimension is the time) of a clinical PET scanner from General Electric, GE ADVANCE, simulating the geometric and electronic structures suitable for this scanner, as well as some phenomena 4D, for example, rotating gantry; (2) the next step is to evaluate the performance of the model built here in the reproduction of test noise equivalent count rate (NEC) based on the NEMA Standards Publication NU protocols 2-2007 for this tomography. The results for steps (1) and (2) will be compared with experimental and theoretical values of the literature showing actual state of art of validation. (author)

  7. Experimental validation of UTDefect

    Energy Technology Data Exchange (ETDEWEB)

    Eriksson, A.S. [ABB Tekniska Roentgencentralen AB, Taeby (Sweden); Bostroem, A.; Wirdelius, H. [Chalmers Univ. of Technology, Goeteborg (Sweden). Div. of Mechanics

    1997-01-01

    This study reports on conducted experiments and computer simulations of ultrasonic nondestructive testing (NDT). Experiments and simulations are compared with the purpose of validating the simulation program UTDefect. UTDefect simulates ultrasonic NDT of cracks and some other defects in isotropic and homogeneous materials. Simulations for the detection of surface breaking cracks are compared with experiments in pulse-echo mode on surface breaking cracks in carbon steel plates. The echo dynamics are plotted and compared with the simulations. The experiments are performed on a plate with thickness 36 mm and the crack depths are 7.2 mm and 18 mm. L- and T-probes with frequency 1, 2 and 4 MHz and angels 45, 60 and 70 deg are used. In most cases the probe and the crack is on opposite sides of the plate, but in some cases they are on the same side. Several cracks are scanned from two directions. In total 53 experiments are reported for 33 different combinations. Generally the simulations agree well with the experiments and UTDefect is shown to be able to, within certain limits, perform simulations that are close to experiments. It may be concluded that: For corner echoes the eight 45 deg cases and the eight 60 deg cases show good agreement between experiments and UTDefect, especially for the 7.2 mm crack. The amplitudes differ more for some cases where the defect is close to the probe and for the corner of the 18 mm crack. For the two 70 deg cases there are too few experimental values to compare the curve shapes, but the amplitudes do not differ too much. The tip diffraction echoes also agree well in general. For some cases, where the defect is close to the probe, the amplitudes differ more than 10-15 dB, but for all but two cases the difference in amplitude is less than 7 dB. 6 refs.

  8. From clinical to tissue-based dual TIA: Validation and refinement of ABCD3-I score.

    Science.gov (United States)

    Dai, Qiliang; Sun, Wen; Xiong, Yunyun; Hankey, Graeme J; Xiao, Lulu; Zhu, Wusheng; Ma, Minmin; Liu, Wenhua; Liu, Dezhi; Cai, Qiankun; Han, Yunfei; Duan, Lihui; Chen, Xiangliang; Xu, Gelin; Liu, Xinfeng

    2015-04-07

    To investigate whether dual tissue-defined ischemic attacks, defined as multiple diffusion-weighted imaging lesions of different age and/or arterial territory (dual DWI), are an independent and stronger predictor of 90-day stroke than dual clinical TIAs (dual TIA). Consecutive patients with clinically defined TIA were enrolled and assessed clinically and by MRI within 3 days. The predictive ability of the ABCD clinical factors, dual TIA, and dual DWI was evaluated by means of multivariate logistic regression. Among 658 patients who were included in the study and completed 90 days of follow-up, a total of 70 patients (10.6%) experienced subsequent stroke by 90 days. Multivariate logistic regression indicated that dual DWI was an independent predictor for subsequent stroke (odds ratio 4.64, 95% confidence interval 2.15-10.01), while dual TIA was not (odds ratio 1.18, 95% confidence interval 0.69-2.01). C statistics was higher when the item of dual TIA in ABCD3-I score was replaced by dual DWI (0.759 vs 0.729, p = 0.035). The net reclassification value for 90-day stroke risk was also improved (continuous net reclassification improvement 0.301, p = 0.017). Dual DWI independently predicted future stroke in patients with TIA. A new ABCD3-I score with dual DWI instead of dual clinical TIA may improve risk stratification for early stroke risk after TIA. © 2015 American Academy of Neurology.

  9. 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.

    Science.gov (United States)

    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.

  10. Continuing Development and Initial Validation of a Questionnaire to Measure Sonographer Skill-Teaching Perceptions in Clinical Practice

    Directory of Open Access Journals (Sweden)

    Delwyn Nicholls

    2017-06-01

    Conclusion: Results indicate that the SonoSTePs instrument items and factors are underpinned by theories and principles related to teaching a complex psychomotor skill. The initial data suggest that the tool is both reliable and valid.

  11. Noncredible cognitive performance at clinical evaluation of adult ADHD : An embedded validity indicator in a visuospatial working memory test

    NARCIS (Netherlands)

    Fuermaier, Anselm B M; Tucha, Oliver; Koerts, Janneke; Lange, Klaus W; Weisbrod, Matthias; Aschenbrenner, Steffen; Tucha, Lara

    2017-01-01

    The assessment of performance validity is an essential part of the neuropsychological evaluation of adults with attention-deficit/hyperactivity disorder (ADHD). Most available tools, however, are inaccurate regarding the identification of noncredible performance. This study describes the development

  12. Clinical Functional Capacity Testing in Patients With Facioscapulohumeral Muscular Dystrophy: Construct Validity and Interrater Reliability of Antigravity Tests

    NARCIS (Netherlands)

    Rijken, N.H.M.; Engelen, B.G.M. van; Weerdesteyn, V.G.M.; Geurts, A.C.H.

    2015-01-01

    OBJECTIVE: To evaluate the construct validity and interrater reliability of 4 simple antigravity tests in a small group of patients with facioscapulohumeral muscular dystrophy (FSHD). DESIGN: Case-control study. SETTING: University medical center. PARTICIPANTS: Patients with various severity levels

  13. Dengue score as a diagnostic predictor for pleural effusion and/or ascites: external validation and clinical application.

    Science.gov (United States)

    Suwarto, Suhendro; Hidayat, Mohammad Jauharsyah; Widjaya, Bing

    2018-02-23

    The Dengue Score is a model for predicting pleural effusion and/or ascites and uses the hematocrit (Hct), albumin concentration, platelet count and aspartate aminotransferase (AST) ratio as independent variables. As this metric has not been validated, we conducted a study to validate the Dengue Score and assess its clinical application. A retrospective study was performed at a private hospital in Jakarta, Indonesia. Patients with dengue infection hospitalized from January 2011 through March 2016 were included. The Dengue Score was calculated using four parameters: Hct increase≥15.1%, serum albumin≤3.49 mg/dL, platelet count≤49,500/μL and AST ratio ≥ 2.51. Each parameter was scored as 1 if present and 0 if absent. To validate the Dengue Score, goodness-of-fit was used to assess calibration, and the area under the receiver operating characteristic curve (AROC) was used to assess discrimination. Associations between clinical parameters and Dengue Score groups were determined by bivariate analysis. A total of 207 patients were included in this study. The calibration of the Dengue Score was acceptable (Hosmer-Lemeshow test, p = 0.11), and the score's discriminative ability was good (AROC = 0.88 (95% CI: 0.83-0.92)). At a cutoff of ≥2, the Dengue Score had a positive predictive value (PPV) of 79.03% and a negative predictive value (NPV) of 90.36% for the diagnostic prediction of pleural effusion and/or ascites. Compared with the Dengue Score ≤ 1 group, the Dengue Score = 2 group was significantly associated with hemoconcentration> 20% (p = 0.029), severe thrombocytopenia (p = 0.029), and increased length of hospital stay (p = 0.003). Compared with the Dengue Score = 2 group, the Dengue Score ≥ 3 group was significantly associated with hemoconcentration> 20% (p = 0.001), severe thrombocytopenia (p = 0.024), severe dengue (p = 0.039), and increased length of hospital stay (p = 0.011). The Dengue Score performed well and can

  14. What is a biomarker? Research investments and lack of clinical integration necessitate a review of biomarker terminology and validation schema.

    Science.gov (United States)

    Ptolemy, Adam S; Rifai, Nader

    2010-01-01

    A continual trend of annual growth can be seen within research devoted to the discovery and validation of disease biomarkers within both the natural and clinical sciences. This expansion of intellectual endeavours was quantified through database searches of (a) research grant awards provided by the various branches of the National Institutes of Health (NIH) and (b) academic publications. A search of awards presented between 1986 and 2009 revealed a total of 28,856 grants awarded by the NIH containing the term "biomarker". The total funds for these awards in 2008 and 2009 alone were over $2.5 billion. During the same respective time frames, searches of "biomarker" and either "discovery", "genomics", "proteomics" or "metabolomics" yielded a total of 4,928 NIH grants whose combined funding exceeded $1.2 billion. The derived trend in NIH awards paralleled the annual expansion in "biomarker" literature. A PubMed search for the term, between 1990 and 2009, revealed a total of 441,510 published articles, with 38,457 published in 2008. These enormous investments and academic outputs however have not translated into the expected integration of new biomarkers for patient care. For example no proteomics derived biomarkers are currently being utilized in routine clinical management. This translational chasm necessitates a review of the previously proposed biomarker definitions and evaluation schema. A subsequent discussion of both the analytical and pre-analytical considerations for such research is also presented within. This required knowledge should aid scientists in their pursuit and validation of new biological markers of disease.

  15. Utility, reliability, sensitivity and validity of an online test system designed to monitor changes in cognitive function in clinical trials.

    Science.gov (United States)

    Wesnes, Keith A; Brooker, Helen; Ballard, Clive; McCambridge, Laura; Stenton, Robert; Corbett, Anne

    2017-12-01

    The advent of long-term remotely conducted clinical trials requires assessments which can be administered online. This paper considers the utility, reliability, sensitivity and validity of an internet-based system for measuring changes in cognitive function which is being used in one such trial. The Platform for Research Online to investigate Genetics and Cognition in Ageing is a 10-year longitudinal and entirely remote study launched in November 2015. The CogTrack TM System is being used to monitor changes in important aspects of cognitive function using tests of attention, information processing and episodic memory. On study entry, the participants performed CogTrack TM up to three times over seven days, and these data are evaluated in this paper. During the first six months of the study, 14 531 individuals aged 50 to 94 years enrolled and performed the CogTrack TM System, 8627 of whom completed three test sessions. On the first administration, 99.4% of the study tasks were successfully completed. Repeated testing showed training/familiarisation effects on four of the ten measures which had largely stabilised by the third test session. The factor structure of the various measures was found to be robust. Evaluation of the influence of age identified clinically relevant declines over the age range of the population on one or more measures from all tasks. The results of these analyses identify CogTrack TM to be a practical and valid method to reliably, sensitively, remotely and repeatedly collect cognitive data from large samples of individuals aged 50 and over. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  16. A Korean validation study of the Clinically Useful Anxiety Outcome Scale: Comorbidity and differentiation of anxiety and depressive disorders

    Science.gov (United States)

    Jeon, Sang Won; Ko, Young-Hoon; Yoon, Seoyoung; Pae, Chi-Un; Choi, Joonho; Kim, Jae-Min; Yoon, Ho-Kyoung; Lee, Hoseon; Patkar, Ashwin A.; Zimmerman, Mark

    2017-01-01

    Background This study aimed to evaluate the psychometric properties of the Korean version of the Clinically Useful Anxiety Outcome Scale (CUXOS) and to examine the current diagnostic comorbidity and differential severity of anxiety symptoms between major depressive disorder (MDD) and anxiety disorders. Methodology In total, 838 psychiatric outpatients were analyzed at their intake appointment. Diagnostic characteristics were examined using the structured clinical interview from the DSM-IV because the DSM5 was not available at the start of the study. The CUXOS score was measured and compared with that of 3 clinician rating scales and 4 self-report scales. Principal findings The CUXOS showed excellent results for internal consistency (Cronbach’s α = 0.90), test–retest reliability (r = 0.74), and discriminant and convergent validity. The CUXOS significantly discriminated between different levels of anxiety severity, and the measure was sensitive to change after treatment. Approximately 45% of patients with MDD were additionally diagnosed with anxiety disorders while 55% of patients with anxiety disorders additionally reported an MDD. There was a significant difference in CUXOS scores between diagnostic categories (MDD only, anxiety only, both disorders, and no MDD or anxiety disorder). The CUXOS scores differed significantly between all categories of depression (major, minor, and non-depression) except for the comparison between minor depression and non-depression groups. Conclusions The Korean version of the CUXOS is a reliable and valid measure of the severity of anxiety symptoms. The use of the CUXOS could broaden the understanding of coexisting and differentiating characteristics of anxiety and depression. PMID:28604808

  17. A Korean validation study of the Clinically Useful Anxiety Outcome Scale: Comorbidity and differentiation of anxiety and depressive disorders.

    Directory of Open Access Journals (Sweden)

    Sang Won Jeon

    Full Text Available This study aimed to evaluate the psychometric properties of the Korean version of the Clinically Useful Anxiety Outcome Scale (CUXOS and to examine the current diagnostic comorbidity and differential severity of anxiety symptoms between major depressive disorder (MDD and anxiety disorders.In total, 838 psychiatric outpatients were analyzed at their intake appointment. Diagnostic characteristics were examined using the structured clinical interview from the DSM-IV because the DSM5 was not available at the start of the study. The CUXOS score was measured and compared with that of 3 clinician rating scales and 4 self-report scales.The CUXOS showed excellent results for internal consistency (Cronbach's α = 0.90, test-retest reliability (r = 0.74, and discriminant and convergent validity. The CUXOS significantly discriminated between different levels of anxiety severity, and the measure was sensitive to change after treatment. Approximately 45% of patients with MDD were additionally diagnosed with anxiety disorders while 55% of patients with anxiety disorders additionally reported an MDD. There was a significant difference in CUXOS scores between diagnostic categories (MDD only, anxiety only, both disorders, and no MDD or anxiety disorder. The CUXOS scores differed significantly between all categories of depression (major, minor, and non-depression except for the comparison between minor depression and non-depression groups.The Korean version of the CUXOS is a reliable and valid measure of the severity of anxiety symptoms. The use of the CUXOS could broaden the understanding of coexisting and differentiating characteristics of anxiety and depression.

  18. The International Certification of Addiction Medicine: Validating Clinical Knowledge across Borders

    Science.gov (United States)

    el-Guebaly, Nady; Violato, Claudio

    2011-01-01

    The experience of the International Society of Addiction Medicine in setting up the first international certification of clinical knowledge is reported. The steps followed and the results of a psychometric analysis of the tests from the first 65 candidates are reported. Lessons learned in the first 5 years and challenges for the future are…

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

    DEFF Research Database (Denmark)

    Lescai, Francesco; Marasco, Elena; Bacchelli, Chiara

    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 G...

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

    Science.gov (United States)

    2016-10-01

    aim 2: Evaluate a panel of four-kallikrein plasma-based markers to determine the presence of or progression to clinically relevant prostate cancer...and sent to Genomic Health, Inc. for processing. Task 3: Analysis of scientific Aim 2: Evaluate a panel of four-kallikrein plasma-based markers to...site: FHCRC) PCA3 and the TMPRSS2:ERG fusion are prostate cancer-specific biomarkers that hold promise for stratifying risk in the setting of AS

  1. Effort-Based Decision-Making Paradigms for Clinical Trials in Schizophrenia: Part 2—External Validity and Correlates.

    Science.gov (United States)

    Horan, William P; Reddy, L Felice; Barch, Deanna M; Buchanan, Robert W; Dunayevich, Eduardo; Gold, James M; Marder, Steven R; Wynn, Jonathan K; Young, Jared W; Green, Michael F

    2015-09-01

    Effort-based decision making has strong conceptual links to the motivational disturbances that define a key subdomain of negative symptoms. However, the extent to which effort-based decision-making performance relates to negative symptoms, and other clinical and functionally important variables has yet to be systematically investigated. In 94 clinically stable outpatients with schizophrenia, we examined the external validity of 5 effort-based paradigms, including the Effort Expenditure for Rewards, Balloon Effort, Grip Strength Effort, Deck Choice Effort, and Perceptual Effort tasks. These tasks covered 3 types of effort: physical, cognitive, and perceptual. Correlations between effort related performance and 6 classes of variables were examined, including: (1) negative symptoms, (2) clinically rated motivation and community role functioning, (3) self-reported motivational traits, (4) neurocognition, (5) other psychiatric symptoms and clinical/demographic characteristics, and (6) subjective valuation of monetary rewards. Effort paradigms showed small to medium relationships to clinical ratings of negative symptoms, motivation, and functioning, with the pattern more consistent for some measures than others. They also showed small to medium relations with neurocognitive functioning, but were generally unrelated to other psychiatric symptoms, self-reported traits, antipsychotic medications, side effects, and subjective valuation of money. There were relatively strong interrelationships among the effort measures. In conjunction with findings from a companion psychometric article, all the paradigms warrant further consideration and development, and 2 show the strongest potential for clinical trial use at this juncture. © The Author 2015. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  2. Cleaning Validation of Fermentation Tanks

    DEFF Research Database (Denmark)

    Salo, Satu; Friis, Alan; Wirtanen, Gun

    2008-01-01

    Reliable test methods for checking cleanliness are needed to evaluate and validate the cleaning process of fermentation tanks. Pilot scale tanks were used to test the applicability of various methods for this purpose. The methods found to be suitable for validation of the clenlinees were visula...

  3. The validation of language tests

    African Journals Online (AJOL)

    KATEVG

    Stellenbosch Papers in Linguistics, Vol. ... validation is necessary because of the major impact which test results can have on the many ... Messick (1989: 20) introduces his much-quoted progressive matrix (cf. table 1), which ... argue that current accounts of validity only superficially address theories of measurement.

  4. Validity in SSM: neglected areas

    NARCIS (Netherlands)

    Pala, O.; Vennix, J.A.M.; Mullekom, T.L. van

    2003-01-01

    Contrary to the prevailing notion in hard OR, in soft system methodology (SSM), validity seems to play a minor role. The primary reason for this is that SSM models are of a different type, they are not would-be descriptions of real-world situations. Therefore, establishing their validity, that is

  5. The Consequences of Consequential Validity.

    Science.gov (United States)

    Mehrens, William A.

    1997-01-01

    There is no agreement at present about the importance or meaning of the term "consequential validity." It is important that the authors of revisions to the "Standards for Educational and Psychological Testing" recognize the debate and relegate discussion of consequences to a context separate from the discussion of validity.…

  6. Current Concerns in Validity Theory.

    Science.gov (United States)

    Kane, Michael

    Validity is concerned with the clarification and justification of the intended interpretations and uses of observed scores. It has not been easy to formulate a general methodology set of principles for validation, but progress has been made, especially as the field has moved from relatively limited criterion-related models to sophisticated…

  7. Examining the validity of the unitary theory of clinical relationships: comparison of observed and experienced parent-doctor interaction.

    Science.gov (United States)

    Young, Bridget; Ward, Jo; Forsey, Mary; Gravenhorst, Katja; Salmon, Peter

    2011-10-01

    We explored parent-doctor relationships in the care of children with leukaemia from three perspectives simultaneously: parents', doctors' and observers'. Our aim was to investigate convergence and divergence between these perspectives and thereby examine the validity of unitary theory of emotionality and authority in clinical relationships. 33 audiorecorded parent-doctor consultations and separate interviews with parents and doctors, which we analysed qualitatively and from which we selected three prototype cases. Across the whole sample doctors' sense of relationship generally converged with our observations of consultation, but parents' sense of relationship diverged strongly from each. Contrary to current assumptions, parents' sense of emotional connection with doctors did not depend on doctors' emotional behaviour, and parents did not feel disempowered by doctors' authority. Moreover, authority and emotionality were not conceptually distinct for parents, who gained emotional support from doctors' exercise of authority. The relationships looked very different from the three perspectives. These divergences indicate weaknesses in current ideas of emotionality and authority in clinical relationships and the necessity of multisource datasets to develop these ideas in a way that characterises clinical relationships from all perspectives. Methodological development will be needed to address the challenges posed by multisource datasets. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  8. Empirical support for DSM-IV schizoaffective disorder: clinical and cognitive validators from a large patient sample.

    Science.gov (United States)

    DeRosse, Pamela; Burdick, Katherine E; Lencz, Todd; Siris, Samuel G; Malhotra, Anil K

    2013-01-01

    The diagnosis of schizoaffective disorder has long maintained an uncertain status in psychiatric nosology. Studies comparing clinical and biological features of patients with schizoaffective disorder to patients with related disorders [e.g., schizophrenia and bipolar disorder] can provide an evidence base for judging the validity of the diagnostic category. However, because most prior studies of schizoaffective disorder have only evaluated differences between groups at a static timepoint, it is unclear how these disorders may be related when the entire illness course is taken into consideration. We ascertained a large cohort [N = 993] of psychiatric patients with a range of psychotic diagnoses including schizophrenia with no history of major affective episodes [SZ-; N = 371], schizophrenia with a superimposed mood syndrome [SZ+; N = 224], schizoaffective disorder [SAD; N = 129] and bipolar I disorder with psychotic features [BPD+; N = 269]. Using cross-sectional data we designed key clinical and neurocognitive dependent measures that allowed us to test longitudinal hypotheses about the differences between these diagnostic entities. Large differences between diagnostic groups on several demographic and clinical variables were observed. Most notably, groups differed on a putative measure of cognitive decline. Specifically, the SAD group demonstrated significantly greater post-onset cognitive decline compared to the BP+ group, with the SZ- and SZ+ group both exhibiting levels of decline intermediate to BPD+ and SAD. These results suggest that schizoaffective disorder may possess distinct features. Contrary to earlier formulations, schizoaffective disorder may be a more severe form of illness.

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

    Science.gov (United States)

    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.

  10. Validity of Commonly Used Clinical Tests to Diagnose and Screen for Spinal Pain in Adolescents

    DEFF Research Database (Denmark)

    Aartun, Ellen; Hartvigsen, Jan; Hestbaek, Lise

    2016-01-01

    , the area under the receiver operating characteristic curve ranged from 0.60 to 0.65. None of the selected tests could predict incidence cases of neck pain, mid back pain, or low back pain. CONCLUSION: Clinical tests commonly used in spinal screening in adolescents could not detect present spinal pain...... under the receiver operating characteristic curve was calculated for evaluation of all tests combined. RESULTS: The sensitivity was low, and specificity was high for all tests at both baseline (age, 11-13 years) and follow-up (age, 13-15 years). When all tests were evaluated collectively in 1 model...

  11. Validation of the 'United Registries for Clinical Assessment and Research' [UR-CARE], a European Online Registry for Clinical Care and Research in Inflammatory Bowel Disease.

    Science.gov (United States)

    Burisch, Johan; Gisbert, Javier P; Siegmund, Britta; Bettenworth, Dominik; Thomsen, Sandra Bohn; Cleynen, Isabelle; Cremer, Anneline; Ding, Nik John Sheng; Furfaro, Federica; Galanopoulos, Michail; Grunert, Philip Christian; Hanzel, Jurij; Ivanovski, Tamara Knezevic; Krustins, Eduards; Noor, Nurulamin; O'Morain, Neil; Rodríguez-Lago, Iago; Scharl, Michael; Tua, Julia; Uzzan, Mathieu; Ali Yassin, Nuha; Baert, Filip; Langholz, Ebbe

    2018-04-27

    The 'United Registries for Clinical Assessment and Research' [UR-CARE] database is an initiative of the European Crohn's and Colitis Organisation [ECCO] to facilitate daily patient care and research studies in inflammatory bowel disease [IBD]. Herein, we sought to validate the database by using fictional case histories of patients with IBD that were to be entered by observers of varying experience in IBD. Nineteen observers entered five patient case histories into the database. After 6 weeks, all observers entered the same case histories again. For each case history, 20 key variables were selected to calculate the accuracy for each observer. We assumed that the database was such that ≥ 90% of the entered data would be correct. The overall proportion of correctly entered data was calculated using a beta-binomial regression model to account for inter-observer variation and compared to the expected level of validity. Re-test reliability was assessed using McNemar's test. For all case histories, the overall proportion of correctly entered items and their confidence intervals included the target of 90% (Case 1: 92% [88-94%]; Case 2: 87% [83-91%]; Case 3: 93% [90-95%]; Case 4: 97% [94-99%]; Case 5: 91% [87-93%]). These numbers did not differ significantly from those found 6 weeks later [NcNemar's test p > 0.05]. The UR-CARE database appears to be feasible, valid and reliable as a tool and easy to use regardless of prior user experience and level of clinical IBD experience. UR-CARE has the potential to enhance future European collaborations regarding clinical research in IBD.

  12. Modeling and validating Bayesian accrual models on clinical data and simulations using adaptive priors.

    Science.gov (United States)

    Jiang, Yu; Simon, Steve; Mayo, Matthew S; Gajewski, Byron J

    2015-02-20

    Slow recruitment in clinical trials leads to increased costs and resource utilization, which includes both the clinic staff and patient volunteers. Careful planning and monitoring of the accrual process can prevent the unnecessary loss of these resources. We propose two hierarchical extensions to the existing Bayesian constant accrual model: the accelerated prior and the hedging prior. The new proposed priors are able to adaptively utilize the researcher's previous experience and current accrual data to produce the estimation of trial completion time. The performance of these models, including prediction precision, coverage probability, and correct decision-making ability, is evaluated using actual studies from our cancer center and simulation. The results showed that a constant accrual model with strongly informative priors is very accurate when accrual is on target or slightly off, producing smaller mean squared error, high percentage of coverage, and a high number of correct decisions as to whether or not continue the trial, but it is strongly biased when off target. Flat or weakly informative priors provide protection against an off target prior but are less efficient when the accrual is on target. The accelerated prior performs similar to a strong prior. The hedging prior performs much like the weak priors when the accrual is extremely off target but closer to the strong priors when the accrual is on target or only slightly off target. We suggest improvements in these models and propose new models for future research. Copyright © 2014 John Wiley & Sons, Ltd.

  13. Non-Clinical Models for Neurodegenerative Diseases: Therapeutic Approach and Drug Validation in Animal Models

    Directory of Open Access Journals (Sweden)

    Caridad Ivette Fernandez

    2017-12-01

    Full Text Available In 2016, 19.8% of the Cuban population was aged 60 or over. As a result, age-associated degenerative diseases and other diseases have become priority targets from a prophylactic, diagnostic and therapeutic perspective. As a result, the Cuban biomedical scientific community has addressed its basic, preclinical and epidemiological research in order to rise up to the challenge. A firm step in this direction has been the international congress “State of the art in non-clinical models for neurodegenerative diseases” which has brought together preclinical and clinical researchers, technicians and regulatory staff members from different countries to review the state of the art in neurodegenerations, find unifying ideas, objectives and collaborations or partnership. The objective is to expose the perspectives of new biotechnological products from Cuba and other countries from the diagnostic, therapeutic and neuroprotective point of view. It is crucial, therefore, that the irreplaceable role of laboratory animals in achieving these objectives is understood but they must be used in rational, adequate and ethical manner. We expose the current development trends in this field, being of common interest to the work directed to the search for potential drugs, diagnostic tools and the promotion of changes in lifestyle as a preventive projection.

  14. The magazine picture collage: its clinical use and validity as an assessment device.

    Science.gov (United States)

    Lerner, C J

    1979-08-01

    To contribute to an understanding of the magazine picture collage as a clinical assessment device, experienced psychiatric staff from various disciplines were asked to distinguish the collages of hospitalized psychiatric patients from those of paired controls, to note whatever descriptive and dynamic features about the individual that could be inferred from the collage, and to document what specific aspects of the collage were used in drawing the inferences. The raters, on the basis of the collage, were not able to distinguish the patients from the controls but were able to derive highly accurate inferences. The results were taken to indicate that, while the collage is best used as a means of assessing psychological processes as contrasted with assigning a diagnosis or predicting behavior, more rigorous research is needed to relate collage factors to personality factors.

  15. Design and validation of a clinical-scale bioreactor for long-term isolated lung culture.

    Science.gov (United States)

    Charest, Jonathan M; Okamoto, Tatsuya; Kitano, Kentaro; Yasuda, Atsushi; Gilpin, Sarah E; Mathisen, Douglas J; Ott, Harald C

    2015-06-01

    The primary treatment for end-stage lung disease is lung transplantation. However, donor organ shortage remains a major barrier for many patients. In recent years, techniques for maintaining lungs ex vivo for evaluation and short-term (advance to more complex interventions for lung repair and regeneration, the need for a long-term organ culture system becomes apparent. Herein we describe a novel clinical scale bioreactor capable of maintaining functional porcine and human lungs for at least 72 h in isolated lung culture (ILC). The fully automated, computer controlled, sterile, closed circuit system enables physiologic pulsatile perfusion and negative pressure ventilation, while gas exchange function, and metabolism can be evaluated. Creation of this stable, biomimetic long-term culture environment will enable advanced interventions in both donor lungs and engineered grafts of human scale. Copyright © 2015 Elsevier Ltd. All rights reserved.

  16. Validity of Forced Eyelid Closure Test: A Novel Clinical Screening Test for Ocular Myasthenia Gravis.

    Science.gov (United States)

    Apinyawasisuk, Supanut; Zhou, Xinkai; Tian, Jack J; Garcia, Giancarlo A; Karanjia, Rustum; Sadun, Alfredo A

    2017-09-01

    Forced eyelid closure test (FECT) is a clinical screening test developed from the original Cogan lid twitch (CLT) sign to assist in the diagnosis of ocular myasthenia gravis (OMG), We evaluated the sensitivity and specificity of FECT compared with CLT and benchmarked to standard diagnostic tests. This study was a retrospective chart review of 48 patients using electronic medical records of those that presented with ptosis and/or diplopia at Doheny Eye Institute, University of California, Los Angeles between February 2015 and April 2016. Patients without FECT testing were excluded. FECT and CLT results, and final diagnosis were recorded. To perform FECT, the patient was asked to squeeze his or her eyelids shut for 5-10 seconds then open quickly and fixate in primary position. The excessive upward overshoot of eyelids movement indicated a positive FECT. The test was performed by a neuro-ophthalmologist before establishing the diagnosis. Patients who had equivocal test results and/or inconclusive final diagnosis were excluded. Of the 48 patients studied, 18 patients (37.5%) had positive FECT; 15 of whom had a final diagnosis of OMG (83.3%). Of the 30 patients with negative FECT, 1 had OMG (3.3%). Of the 48 patients, 35 patients also had a documented CLT result (72.9%). CLT was positive in 11 of these 35 patients (31.4%), and 9 of these 11 had OMG (81.8%). Of the 24 patients with negative CLT, 2 of them had OMG (8.3%). Sensitivity and specificity of FECT were 94% and 91% (joint 95% confidence region: sensitivity × specificity = [0.70, 1] × [0.75, 1]). The relative true-positive fraction (rTPF) between FECT and CLT was 1.15; the relative false-positive fraction was 1.31. FECT is a simple clinical screening test with good sensitivity and specificity for OMG.

  17. How to Identify High-Risk APS Patients: Clinical Utility and Predictive Values of Validated Scores.

    Science.gov (United States)

    Oku, Kenji; Amengual, Olga; Yasuda, Shinsuke; Atsumi, Tatsuya

    2017-08-01

    Antiphospholipid syndrome (APS) is a clinical disorder characterised by thrombosis and/or pregnancy morbidity in the persistence of antiphospholipid (aPL) antibodies that are pathogenic and have pro-coagulant activities. Thrombosis in APS tends to recur and require prophylaxis; however, the stereotypical treatment for APS patients is inadequate and stratification of the thrombotic risks is important as aPL are prevalently observed in various diseases or elderly population. It is previously known that the multiple positive aPL or high titre aPL correlate to thrombotic events. To progress the stratification of thrombotic risks in APS patients and to quantitatively analyse those risks, antiphospholipid score (aPL-S) and the Global Anti-phospholipid Syndrome Score (GAPSS) were defined. These scores were raised from the large patient cohort data and either aPL profile classified in detail (aPL-S) or simplified aPL profile with classical thrombotic risk factors (GAPSS) was put into a scoring system. Both the aPL-S and GAPSS have shown a degree of accuracy in identifying high-risk APS patients, especially those at a high risk of thrombosis. However, there are several areas requiring improvement, or at least that clinicians should be aware of, before these instruments are applied in clinical practice. One such issue is standardisation of the aPL tests, including general testing of phosphatidylserine-dependent antiprothrombin antibodies (aPS/PT). Additionally, clinicians may need to be aware of the patient's medical history, particularly with respect to the incidence of SLE, which influences the cutoff value for identifying high-risk patients.

  18. The measurement of instrumental ADL: content validity and construct validity

    DEFF Research Database (Denmark)

    Avlund, K; Schultz-Larsen, K; Kreiner, S

    1993-01-01

    do not depend on help. It is also possible to add the items in a valid way. However, to obtain valid IADL-scales, we omitted items that were highly relevant to especially elderly women, such as house-work items. We conclude that the criteria employed for this IADL-measure are somewhat contradictory....... showed that 14 items could be combined into two qualitatively different additive scales. The IADL-measure complies with demands for content validity, distinguishes between what the elderly actually do, and what they are capable of doing, and is a good discriminator among the group of elderly persons who...

  19. Validation of asthma recording in the Clinical Practice Research Datalink (CPRD).

    Science.gov (United States)

    Nissen, Francis; Morales, Daniel R; Mullerova, Hana; Smeeth, Liam; Douglas, Ian J; Quint, Jennifer K

    2017-08-11

    The optimal method of identifying people with asthma from electronic health records in primary care is not known. The aim of this study is to determine the positive predictive value (PPV) of different algorithms using clinical codes and prescription data to identify people with asthma in the United Kingdom Clinical Practice Research Datalink (CPRD). 684 participants registered with a general practitioner (GP) practice contributing to CPRD between 1 December 2013 and 30 November 2015 were selected according to one of eight predefined potential asthma identification algorithms. A questionnaire was sent to the GPs to confirm asthma status and provide additional information to support an asthma diagnosis. Two study physicians independently reviewed and adjudicated the questionnaires and additional information to form a gold standard for asthma diagnosis. The PPV was calculated for each algorithm. 684 questionnaires were sent, of which 494 (72%) were returned and 475 (69%) were complete and analysed. All five algorithms including a specific Read code indicating asthma or non-specific Read code accompanied by additional conditions performed well. The PPV for asthma diagnosis using only a specific asthma code was 86.4% (95% CI 77.4% to 95.4%). Extra information on asthma medication prescription (PPV 83.3%), evidence of reversibility testing (PPV 86.0%) or a combination of all three selection criteria (PPV 86.4%) did not result in a higher PPV. The algorithm using non-specific asthma codes, information on reversibility testing and respiratory medication use scored highest (PPV 90.7%, 95% CI (82.8% to 98.7%), but had a much lower identifiable population. Algorithms based on asthma symptom codes had low PPVs (43.1% to 57.8%)%). People with asthma can be accurately identified from UK primary care records using specific Read codes. The inclusion of spirometry or asthma medications in the algorithm did not clearly improve accuracy. The protocol for this research was approved

  20. Validity and limitations of the Nidek NT-4000 non-contact tonometer: a clinical study.

    Science.gov (United States)

    Regine, Federico; Scuderi, Gian Luca; Cesareo, Massimo; Ricci, Federico; Cedrone, Claudio; Nucci, Carlo

    2006-01-01

    Using Goldmann applanation tonometry (GAT) as a gold standard, we evaluated the accuracy of Nidek NT-4000 pneumotonometry (NPT) in adults without corneal disease. Bland and Altman analysis of serial intra-ocular pressures (IOPs) measured with NPT and GAT in 10 healthy subjects revealed that the repeatability coefficients for the two methods were similar. NPT, GAT and ultrasonic pachymetry were then performed in 100 patients. Bland and Altman analysis showed that NPT yielded significantly higher readings than GAT [mean biases for right and left eye measurements were 1.37 mmHg (95% limits of agreement: -3.02-5.76) and 1.17 mmHg (95% limits of agreement: -2.76-5.11) respectively] and was more affected by corneal thickness variations. For detection of IOPs > or =21 mmHg, NPT displayed very high sensitivity (0.90) and good specificity (0.95). NPT may be useful in screening and clinical settings but borderline-high IOP readings should be confirmed with GAT.

  1. Dentists' use of validated child dental anxiety measures in clinical practice: a mixed methods study.

    Science.gov (United States)

    Alshammasi, Hussain; Buchanan, Heather; Ashley, Paul

    2018-01-01

    Assessing anxiety is an important part of the assessment of a child presenting for dental treatment; however, the use of dental anxiety scales in practice is not well-documented. To introduce child dental anxiety scales, and to monitor the extent to which dentists used them; to explore the experience and views of dentists regarding anxiety assessment. A mixed-methods design was employed. A protocol for child anxiety assessment was introduced to paediatric dentists in Eastman Dental Hospital. After 6 months, 100 patient files were audited to examine compliance with the protocol. Fourteen dentists were interviewed to explore their experience and views regarding anxiety assessment. Only five patients were assessed using the scales. Thematic analysis of the dentist interviews revealed three themes: 'Clinical observations and experience: The gold standard'; 'Scales as an estimate or adjunct'; and 'Shortcomings and barriers to using scales'. The dentists in our study did not use anxiety scales, instead they rely on their own experience/judgement. Therefore, scales should be recommended as an adjunct to judgement. Brief scales are recommended as clinicians lack time and expertise in administering anxiety questionnaires. Advantages of using scales and hands-on experience could be incorporated more in undergraduate training. © 2017 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  2. Clinical validation of nuclear factor kappa B expression in invasive breast cancer.

    Science.gov (United States)

    Agrawal, Anil Kumar; Pielka, Ewa; Lipinski, Artur; Jelen, Michal; Kielan, Wojciech; Agrawal, Siddarth

    2018-01-01

    Breast cancer is the most commonly diagnosed cancer in Polish women. The expression of transcription nuclear factor kappa B, a key inducer of inflammatory response promoting carcinogenesis and cancer progression in breast cancer, is not well-established. We assessed the nuclear factor kappa B expression in a total of 119 invasive breast carcinomas and 25 healthy control samples and correlated this expression pattern with several clinical and pathologic parameters including histologic type and grade, tumor size, lymph node status, estrogen receptor status, and progesterone receptor status. The data used for the analysis were derived from medical records. An immunohistochemical analysis of nuclear factor kappa B, estrogen receptor, and progesterone receptor was carried out and evaluation of stainings was performed. The expression of nuclear factor kappa B was significantly higher than that in the corresponding healthy control samples. No statistical difference was demonstrated in nuclear factor kappa B expression in relation to age, menopausal status, lymph node status, tumor size and location, grade and histologic type of tumor, and hormonal status (estrogen receptor and progesterone receptor). Nuclear factor kappa B is significantly overexpressed in invasive breast cancer tissues. Although nuclear factor kappa B status does not correlate with clinicopathological findings, it might provide important additional information on prognosis and become a promising object for targeted therapy.

  3. Hypsarrhythmia assessment exhibits poor interrater reliability: a threat to clinical trial validity.

    Science.gov (United States)

    Hussain, Shaun A; Kwong, Grace; Millichap, John J; Mytinger, John R; Ryan, Nicole; Matsumoto, Joyce H; Wu, Joyce Y; Lerner, Jason T; Sankar, Raman

    2015-01-01

    Hypsarrhythmia is the classic interictal electroencephalographic pattern associated with infantile spasms, and characterized by high voltage, disorganization, and multifocal independent epileptiform discharges. Given this seemingly simple definition, one might expect excellent interrater reliability (IRR) in the identification of this pattern. Alternatively, it may be argued that assessments of voltage and disorganization are fairly subjective, and thus quite challenging in borderline cases. We sought to test the IRR of hypsarrhythmia assessment in a systematic fashion. Six blinded pediatric electroencephalographers from four centers reviewed 22 electroencephalography (EEG) samples from patients with infantile spasms. Each sample was 5 min in duration and included only wakefulness. Raters determined if each EEG was abnormal and if hypsarrhythmia was present/absent, and characterized relevant features: voltage, organization, epileptiform discharges, slowing, interictal attenuations, symmetry, and synchrony. In addition, raters indicated their level of confidence for each assessment. Multirater kappa statistics (κ) were calculated for the assessment of hypsarrhythmia and each feature. Although IRR was favorable in determining whether a study was normal or abnormal (κ=0.89), reliability was unfavorable for assessment of hypsarrhythmia (κ=0.40), modified hypsarrhythmia (κ=0.47), high voltage (κ=0.37), disorganization (κ=0.22), multifocal epileptiform discharges (κ=0.68), interictal voltage attenuations (κ=0.21), slowing (κ=0.20), asymmetry (κ=0.26), and asynchrony (κ=0.08). Despite generally unsatisfactory interrater agreement, raters consistently reported high confidence in assessments. This study contradicts the view that hypsarrhythmia assessment is straightforward. Even small variability in the identification of hypsarrhythmia has potentially deleterious consequences for clinical care, as its presence or absence impacts decisions to pursue high-risk and

  4. Validation and clinical application of a method to quantify nevirapine in dried blood spots and dried breast-milk spots.

    Science.gov (United States)

    Olagunju, Adeniyi; Amara, Alieu; Waitt, Catriona; Else, Laura; Penchala, Sujan D; Bolaji, Oluseye; Soyinka, Julius; Siccardi, Marco; Back, David; Owen, Andrew; Khoo, Saye

    2015-10-01

    The validation and clinical application of an LC-MS/MS method for the quantification of nevirapine in dried blood spots (DBS) and dried breast-milk spots (DBMS) are presented. DBS and DBMS were prepared from 50 and 30 μL of nevirapine-spiked whole blood and human breast milk, respectively. Chromatographic separation was achieved on a reverse-phase C18 column with 0.1% formic acid in water/acetonitrile using a solvent gradient programme at a flow rate of 400 μL/min, and detection was by a TSQ Quantum Access triple quadrupole mass spectrometer. The clinical application was evaluated in HIV-positive nursing mothers and their breastfed infants. The assay was validated over the concentration range 50-10,000 ng/mL. Accuracy ranged from 93.3% to 113.4% and precision ranged from 1.9% to 12.0%. The mean (percentage coefficient of variation) recovery of nevirapine from DBS and DBMS was ≥ 70.7% (≤ 8.2) and the matrix effect was ≤ 1.04 (≤ 6.1). Nevirapine was stable in DBS and DBMS for ≥ 15 months at room temperature and -80°C. Mean (SD) AUC0-12, Cmax and Cmin in maternal plasma versus breast milk were 57,808 ng · h/mL (24,315) versus 55,817 ng · h/mL (22,368), 6140 ng/mL (2605) versus 5231 ng/mL (2215) and 4334 ng/mL (1880) versus 4342 ng/mL (2245), respectively. The milk-to-plasma concentration ratio over the dosing interval was 0.94 (0.15). Infant plasma concentrations 2 and 8 h after maternal dosing were 580.6 ng/mL (464.7-1607) and 584.1 ng/mL (381.5-1570), respectively. These methods further extend opportunities for conducting clinical pharmacokinetic studies in nursing mother-infant pairs, especially in resource-limited settings. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  5. Initial validation of a proxy indicator of functioning as a potential tool for establishing a clinically meaningful cocaine use outcome.

    Science.gov (United States)

    Kiluk, Brian D; Babuscio, Theresa A; Nich, Charla; Carroll, Kathleen M

    2017-10-01

    Establishing a non-abstinence cocaine use outcome as clinically meaningful has been elusive, in part due to the lack of association between cocaine use outcomes and meaningful indicators of long-term functioning. Using data pooled across 7 clinical trials evaluating treatments for cocaine (N=718), a dichotomous indicator of functioning was created to represent a meaningful outcome ('problem-free functioning' - PFF), defined as the absence of problems across non-substance-related domains on the Addiction Severity Index. Its validity was evaluated at multiple time points (baseline, end-of-treatment, terminal follow-up) and used to explore associations with cocaine use. The percentage of participants meeting PFF criteria increased over time (baseline=18%; end-of-treatment=32%; terminal follow-up=37%). At each time point, ANOVAs indicated those who met PFF criteria reported significantly less distress on the Brief Symptom Inventory and less perceived stress on the Perceived Stress Scale. Generalized linear models indicated categorical indices of self-reported cocaine use at the end of treatment were predictive of the probability of meeting PFF criteria during follow-up (β=-0.01, pcocaine use in the final month of treatment was associated with PFF during follow-up, with strongest associations between PFF and abstinence or 'occasional' use. Copyright © 2017 Elsevier B.V. All rights reserved.

  6. Standardized Ki67 Diagnostics Using Automated Scoring--Clinical Validation in the GeparTrio Breast Cancer Study.

    Science.gov (United States)

    Klauschen, Frederick; Wienert, Stephan; Schmitt, Wolfgang D; Loibl, Sibylle; Gerber, Bernd; Blohmer, Jens-Uwe; Huober, Jens; Rüdiger, Thomas; Erbstößer, Erhard; Mehta, Keyur; Lederer, Bianca; Dietel, Manfred; Denkert, Carsten; von Minckwitz, Gunter

    2015-08-15

    Scoring proliferation through Ki67 immunohistochemistry is an important component in predicting therapy response to chemotherapy in patients with breast cancer. However, recent studies have cast doubt on the reliability of "visual" Ki67 scoring in the multicenter setting, particularly in the lower, yet clinically important, proliferation range. Therefore, an accurate and standardized Ki67 scoring is pivotal both in routine diagnostics and larger multicenter studies. We validated a novel fully automated Ki67 scoring approach that relies on only minimal a priori knowledge on cell properties and requires no training data for calibration. We applied our approach to 1,082 breast cancer samples from the neoadjuvant GeparTrio trial and compared the performance of automated and manual Ki67 scoring. The three groups of autoKi67 as defined by low (≤ 15%), medium (15.1%-35%), and high (>35%) automated scores showed pCR rates of 5.8%, 16.9%, and 29.5%, respectively. AutoKi67 was significantly linked to prognosis with overall and progression-free survival P values P(OS) cancer that correlated with clinical endpoints and is deployable in routine diagnostics. It may thus help to solve recently reported reliability concerns in Ki67 diagnostics. ©2014 American Association for Cancer Research.

  7. Reliability and Validity of the Clinical Dementia Rating for Community-Living Elderly Subjects without an Informant.

    Science.gov (United States)

    Nyunt, Ma Shwe Zin; Chong, Mei Sian; Lim, Wee Shiong; Lee, Tih Shih; Yap, Philip; Ng, Tze Pin

    2013-01-01

    The Clinical Dementia Rating (CDR) scale is widely used to assess cognitive impairment in Alzheimer's disease. It requires collateral information from a reliable informant who is not available in many instances. We adapted the original CDR scale for use with elderly subjects without an informant (CDR-NI) and evaluated its reliability and validity for assessing mild cognitive impairment (MCI) and dementia among community-dwelling elderly subjects. At two consecutive visits 1 week apart, nurses trained in CDR assessment interviewed, observed and rated cognitive and functional performance according to a protocol in 90 elderly subjects with suboptimal cognitive performance [Mini-Mental State Examination (MMSE) reliability (κ 0.77-1.00 for six domains and 0.95 for global rating) and test-retest reliability (κ 0.75-1.00 for six domains and 0.80 for global rating), good agreement (κ 0.79) with the clinical assessment status of MCI (n = 37) and dementia (n = 4) and significant differences in the mean scores for MMSE, MOCA and Instrumental Activities of Daily Living (ANOVA global p reliable assessment of MCI and dementia in community-living elderly subjects without an informant.

  8. Microbiological/clinical characteristics and validation of topical therapy with kanamycin in aerobic vaginitis: a pilot study.

    Science.gov (United States)

    Tempera, G; Bonfiglio, G; Cammarata, E; Corsello, S; Cianci, A

    2004-07-01

    The term 'aerobic vaginitis' defines a 'new' vaginal pathology that is neither classifiable as specific vaginitis nor as bacterial vaginosis. We studied a sample of 30 women with a clinical and microbiological diagnosis of aerobic vaginitis and compared the efficacy and tolerability of kanamycin and meclocycline, two products commercially available in Italy in the form of vaginal pessaries. In chronological order of enrollment, the patients were alternately treated with kanamycin or meclocycline; the dose of administration in both groups was of one pessary per day for 6 days. The evaluation of the therapeutic efficacy was carried out both at the first check-up (7th-8th day) and at a second check-up (13th-16th day). At the first follow-up carried out immediately at the end of therapy, the percentage of normalisation of clinical signs and symptoms was increased independently of the type of treatment in the case of moderate grade aerobic vaginitis, while kanamycin was produced a better effect in the group with severe aerobic vaginitis. Furthermore, at the second follow-up, a direct correlation with recovery of vaginal homeostasis was demonstrated by the normalisation of the vaginal pH and by the presence of lactobacilli, only in kanamycin treated group. In conclusion, our results showed the validity of the treatment with kanamycin intravaginally in this recently recognised disease.

  9. Convergent validity test, construct validity test and external validity test of the David Liberman algorithm

    Directory of Open Access Journals (Sweden)

    David Maldavsky

    2013-08-01

    Full Text Available The author first exposes a complement of a previous test about convergent validity, then a construct validity test and finally an external validity test of the David Liberman algorithm.  The first part of the paper focused on a complementary aspect, the differential sensitivity of the DLA 1 in an external comparison (to other methods, and 2 in an internal comparison (between two ways of using the same method, the DLA.  The construct validity test exposes the concepts underlined to DLA, their operationalization and some corrections emerging from several empirical studies we carried out.  The external validity test examines the possibility of using the investigation of a single case and its relation with the investigation of a more extended sample.

  10. Using the web for recruitment, screen, tracking, data management, and quality control in a dietary assessment clinical validation trial.

    Science.gov (United States)

    Arab, Lenore; Hahn, Harry; Henry, Judith; Chacko, Sara; Winter, Ashley; Cambou, Mary C

    2010-03-01

    Screening and tracking subjects and data management in clinical trials require significant investments in manpower that can be reduced through the use of web-based systems. To support a validation trial of various dietary assessment tools that required multiple clinic visits and eight repeats of online assessments, we developed an interactive web-based system to automate all levels of management of a biomarker-based clinical trial. The "Energetics System" was developed to support 1) the work of the study coordinator in recruiting, screening and tracking subject flow, 2) the need of the principal investigator to review study progress, and 3) continuous data analysis. The system was designed to automate web-based self-screening into the trial. It supported scheduling tasks and triggered tailored messaging for late and non-responders. For the investigators, it provided real-time status overviews on all subjects, created electronic case reports, supported data queries and prepared analytic data files. Encryption and multi-level password protection were used to insure data privacy. The system was programmed iteratively and required six months of a web programmer's time along with active team engagement. In this study the enhancement in speed and efficiency of recruitment and quality of data collection as a result of this system outweighed the initial investment. Web-based systems have the potential to streamline the process of recruitment and day-to-day management of clinical trials in addition to improving efficiency and quality. Because of their added value they should be considered for trials of moderate size or complexity. Copyright 2009 Elsevier Inc. All rights reserved.

  11. The Telehealth Satisfaction Scale (TeSS): Reliability, validity, and satisfaction with telehealth in a rural memory clinic population

    Science.gov (United States)

    Morgan, Debra G; Kosteniuk, Julie; Stewart, Norma; O’Connell, Megan E; Karunanyake, Chandima; Beever, Rob

    2015-01-01

    Introduction Patient satisfaction is a key aspect of quality of care and can inform continuous quality improvement. Of the few studies that have reported on patient satisfaction with telehealth in programs aimed at individuals with memory problems, none has reported on the psychometric properties of the user satisfaction scales employed. Methods We evaluated the construct validity and internal consistency reliability of the Telehealth Satisfaction Scale (TeSS), a 10-item scale adapted for use in a Rural and Remote Memory Clinic (RRMC). The RRMC is a one-stop interprofessional clinic for rural and remote seniors with suspected dementia, located in a tertiary care hospital. Telehealth videoconferencing is used for pre-clinic assessment and for follow-up. Patients and caregivers completed the TeSS after each telehealth appointment. With data from 223 patients, exploratory factor analysis was conducted using the principal components analysis extraction method. Results The eigenvalue for the first factor (5.2) was greater than 1 and much larger than the second eigenvalue (.92), supporting a one-factor solution that was confirmed by the scree plot. The total variance explained by factor 1 was 52.1%. Factor loadings (range 0.54 – 0.84) were above recommended cutoffs. The TeSS items demonstrated high internal consistency reliability (Cronbach’s alpha = 0.90). Satisfaction scores on the TeSS items ranged from 3.43 to 3.72 on a 4-point Likert scale, indicating high satisfaction with telehealth. Conclusions The study findings demonstrate high user satisfaction with telehealth in a rural memory clinic, and sound psychometric properties of the TeSS in this population. PMID:25272141

  12. Reliable prediction of clinical outcome in patients with chronic HCV infection and compensated advanced hepatic fibrosis: a validated model using objective and readily available clinical parameters.

    Science.gov (United States)

    van der Meer, Adriaan J; Hansen, Bettina E; Fattovich, Giovanna; Feld, Jordan J; Wedemeyer, Heiner; Dufour, Jean-François; Lammert, Frank; Duarte-Rojo, Andres; Manns, Michael P; Ieluzzi, Donatella; Zeuzem, Stefan; Hofmann, W Peter; de Knegt, Robert J; Veldt, Bart J; Janssen, Harry L A

    2015-02-01

    Reliable tools to predict long-term outcome among patients with well compensated advanced liver disease due to chronic HCV infection are lacking. Risk scores for mortality and for cirrhosis-related complications were constructed with Cox regression analysis in a derivation cohort and evaluated in a validation cohort, both including patients with chronic HCV infection and advanced fibrosis. In the derivation cohort, 100/405 patients died during a median 8.1 (IQR 5.7-11.1) years of follow-up. Multivariate Cox analyses showed age (HR=1.06, 95% CI 1.04 to 1.09, pstatistic=0.78, 95% CI 0.72 to 0.83). In the validation cohort, 58/296 patients with cirrhosis died during a median of 6.6 (IQR 4.4-9.0) years. Among patients with estimated 5-year mortality risks 10%, the observed 5-year mortality rates in the derivation cohort and validation cohort were 0.9% (95% CI 0.0 to 2.7) and 2.6% (95% CI 0.0 to 6.1), 8.1% (95% CI 1.8 to 14.4) and 8.0% (95% CI 1.3 to 14.7), 21.8% (95% CI 13.2 to 30.4) and 20.9% (95% CI 13.6 to 28.1), respectively (C statistic in validation cohort = 0.76, 95% CI 0.69 to 0.83). The risk score for cirrhosis-related complications also incorporated HCV genotype (C statistic = 0.80, 95% CI 0.76 to 0.83 in the derivation cohort; and 0.74, 95% CI 0.68 to 0.79 in the validation cohort). Prognosis of patients with chronic HCV infection and compensated advanced liver disease can be accurately assessed with risk scores including readily available objective clinical parameters. 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.

  13. Spanish validation of the adult Attention Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS): relevance of clinical subtypes.

    Science.gov (United States)

    Richarte, Vanesa; Corrales, Montserrat; Pozuelo, Marian; Serra-Pla, Juanfran; Ibáñez, Pol; Calvo, Eva; Corominas, Margarida; Bosch, Rosa; Casas, Miquel; Ramos-Quiroga, Josep Antoni

    Adult attention deficit hyperactivity disorder (ADHD) has a prevalence between 2.5% and 4% of the general adult population. Over the past few decades, self-report measures have been developed for the current evaluation of adult ADHD. The ADHD-RS is a 18-items scale self-report version for assessing symptoms for ADHD DSM-IV. A validation of Spanish version of the ADHD-RS was performed. The sample consisted of 304 adult with ADHD and 94 controls. A case control study was carried out (adult ADHD vs. non ADHD). The diagnosis of ADHD was evaluated with the Structured Clinical Interview for DSM-IV (SCID-I) and the Conners Adult ADHD Diagnostic Interview for DSM-IV (CAADID-II). To determinate the internal validity of the two dimensions structure of ADHD-RS an exploratory factor analysis was performed. The α-coefficients were taken as a measure of the internal consistency of the dimensions considered. A logistic regression study was carried out to evaluate the model in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive values (NPV). Average age was 33.29 (SD=10.50) and 66% of subjects were men (there were no significant differences between the two groups). Factor analysis was done with a principal component analysis followed by a normalized varimax rotation. The Kaiser-Meyer-Olkin measure of sampling adequacy tests was .868 (remarkable) and the Bartlett's test of sphericity was 2 (153)=1,835.76, P<.0005, indicating the appropriateness of the factor analysis. This two-factor model accounted for 37.81% of the explained variance. The α-coefficient of the two factors was .84 and .82. The original strategy proposed 24 point for cut-off: sensitivity (81.9%), specificity (74.7%), PPV (50.0%), NPV (93.0%), kappa coefficient .78 and area under the curve (AUC) .89. The new score strategy proposed by our group suggests different cut-off for different clinical presentations. The 24 point is the best cut-off for ADHD combined presentation

  14. Validation of EAF-2005 data

    International Nuclear Information System (INIS)

    Kopecky, J.

    2005-01-01

    Full text: Validation procedures applied on EAF-2003 starter file, which lead to the production of EAF-2005 library, are described. The results in terms of reactions with assigned quality scores in EAF-20005 are given. Further the extensive validation against the recent integral data is discussed together with the status of the final report 'Validation of EASY-2005 using integral measurements'. Finally, the novel 'cross section trend analysis' is presented with some examples of its use. This action will lead to the release of improved library EAF-2005.1 at the end of 2005, which shall be used as the starter file for EAF-2007. (author)

  15. Validity and validation of expert (Q)SAR systems.

    Science.gov (United States)

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

    2005-08-01

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

  16. NCI-FDA Interagency Oncology Task Force Workshop Provides Guidance for Analytical Validation of Protein-based Multiplex Assays | Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    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

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  19. The Malaysian Medication Adherence Scale (MALMAS: Concurrent Validity Using a Clinical Measure among People with Type 2 Diabetes in Malaysia.

    Directory of Open Access Journals (Sweden)

    Wen Wei Chung

    Full Text Available Medication non-adherence is a prevalent problem worldwide but up to today, no gold standard is available to assess such behavior. This study was to evaluate the psychometric properties, particularly the concurrent validity of the English version of the Malaysian Medication Adherence Scale (MALMAS among people with type 2 diabetes in Malaysia. Individuals with type 2 diabetes, aged 21 years and above, using at least one anti-diabetes agent and could communicate in English were recruited. The MALMAS was compared with the 8-item Morisky Medication Adherence Scale (MMAS-8 to assess its convergent validity while concurrent validity was evaluated based on the levels of glycated hemoglobin (HbA1C. Participants answered the MALMAS twice: at baseline and 4 weeks later. The study involved 136 participants. The MALMAS achieved acceptable internal consistency (Cronbach's alpha=0.565 and stable reliability as the test-retest scores showed fair correlation (Spearman's rho=0.412. The MALMAS has good correlation with the MMAS-8 (Spearman's rho=0.715. Participants who were adherent to their anti-diabetes medications had significantly lower median HbA1C values than those who were non-adherence (7.90 versus 8.55%, p=0.032. The odds of participants who were adherent to their medications achieving good glycemic control was 3.36 times (95% confidence interval: 1.09-10.37 of those who were non-adherence. This confirms the concurrent validity of the MALMAS. The sensitivity of the MALMAS was 88.9% while its specificity was 29.6%. The findings of this study further substantiates the reliability and validity of the MALMAS, in particular its concurrent validity and sensitivity for assessing medication adherence of people with type 2 diabetes in Malaysia.

  20. Noncredible cognitive performance at clinical evaluation of adult ADHD: An embedded validity indicator in a visuospatial working memory test.

    Science.gov (United States)

    Fuermaier, Anselm B M; Tucha, Oliver; Koerts, Janneke; Lange, Klaus W; Weisbrod, Matthias; Aschenbrenner, Steffen; Tucha, Lara

    2017-12-01

    The assessment of performance validity is an essential part of the neuropsychological evaluation of adults with attention-deficit/hyperactivity disorder (ADHD). Most available tools, however, are inaccurate regarding the identification of noncredible performance. This study describes the development of a visuospatial working memory test, including a validity indicator for noncredible cognitive performance of adults with ADHD. Visuospatial working memory of adults with ADHD (n = 48) was first compared to the test performance of healthy individuals (n = 48). Furthermore, a simulation design was performed including 252 individuals who were randomly assigned to either a control group (n = 48) or to 1 of 3 simulation groups who were requested to feign ADHD (n = 204). Additional samples of 27 adults with ADHD and 69 instructed simulators were included to cross-validate findings from the first samples. Adults with ADHD showed impaired visuospatial working memory performance of medium size as compared to healthy individuals. Simulation groups committed significantly more errors and had shorter response times as compared to patients with ADHD. Moreover, binary logistic regression analysis was carried out to derive a validity index that optimally differentiates between true and feigned ADHD. ROC analysis demonstrated high classification rates of the validity index, as shown in excellent specificity (95.8%) and adequate sensitivity (60.3%). The visuospatial working memory test as presented in this study therefore appears sensitive in indicating cognitive impairment of adults with ADHD. Furthermore, the embedded validity index revealed promising results concerning the detection of noncredible cognitive performance of adults with ADHD. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  1. Design and validation of realistic breast models for use in multiple alternative forced choice virtual clinical trials.

    Science.gov (United States)

    Elangovan, Premkumar; Mackenzie, Alistair; Dance, David R; Young, Kenneth C; Cooke, Victoria; Wilkinson, Louise; Given-Wilson, Rosalind M; Wallis, Matthew G; Wells, Kevin

    2017-04-07

    A novel method has been developed for generating quasi-realistic voxel phantoms which simulate the compressed breast in mammography and digital breast tomosynthesis (DBT). The models are suitable for use in virtual clinical trials requiring realistic anatomy which use the multiple alternative forced choice (AFC) paradigm and patches from the complete breast image. The breast models are produced by extracting features of breast tissue components from DBT clinical images including skin, adipose and fibro-glandular tissue, blood vessels and Cooper's ligaments. A range of different breast models can then be generated by combining these components. Visual realism was validated using a receiver operating characteristic (ROC) study of patches from simulated images calculated using the breast models and from real patient images. Quantitative analysis was undertaken using fractal dimension and power spectrum analysis. The average areas under the ROC curves for 2D and DBT images were 0.51  ±  0.06 and 0.54  ±  0.09 demonstrating that simulated and real images were statistically indistinguishable by expert breast readers (7 observers); errors represented as one standard error of the mean. The average fractal dimensions (2D, DBT) for real and simulated images were (2.72  ±  0.01, 2.75  ±  0.01) and (2.77  ±  0.03, 2.82  ±  0.04) respectively; errors represented as one standard error of the mean. Excellent agreement was found between power spectrum curves of real and simulated images, with average β values (2D, DBT) of (3.10  ±  0.17, 3.21  ±  0.11) and (3.01  ±  0.32, 3.19  ±  0.07) respectively; errors represented as one standard error of the mean. These results demonstrate that radiological images of these breast models realistically represent the complexity of real breast structures and can be used to simulate patches from mammograms and DBT images that are indistinguishable from

  2. The reliability and validity of video analysis for the assessment of the clinical signs of concussion in Australian football.

    Science.gov (United States)

    Makdissi, Michael; Davis, Gavin

    2016-10-01

    The objective of this study was to determine the reliability and validity of identifying clinical signs of concussion using video analysis in Australian football. Prospective cohort study. All impacts and collisions potentially resulting in a concussion were identified during 2012 and 2013 Australian Football League seasons. Consensus definitions were developed for clinical signs associated with concussion. For intra- and inter-rater reliability analysis, two experienced clinicians independently assessed 102 randomly selected videos on two occasions. Sensitivity, specificity, positive and negative predictive values were calculated based on the diagnosis provided by team medical staff. 212 incidents resulting in possible concussion were identified in 414 Australian Football League games. The intra-rater reliability of the video-based identification of signs associated with concussion was good to excellent. Inter-rater reliability was good to excellent for impact seizure, slow to get up, motor incoordination, ragdoll appearance (2 of 4 analyses), clutching at head and facial injury. Inter-rater reliability for loss of responsiveness and blank and vacant look was only fair and did not reach statistical significance. The feature with the highest sensitivity was slow to get up (87%), but this sign had a low specificity (19%). Other video signs had a high specificity but low sensitivity. Blank and vacant look (100%) and motor incoordination (81%) had the highest positive predictive value. Video analysis may be a useful adjunct to the side-line assessment of a possible concussion. Video analysis however should not replace the need for a thorough multimodal clinical assessment. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  3. Regional cerebral blood flow (RCBF) measurements by SPECT analysis of Xenon-133 transit: Validation of technique and clinical correlation

    International Nuclear Information System (INIS)

    Rezai, K.; Kirchner, P.; Armstrong, C.; Ehrhardt, J.; Damasio, H.; Adams, H.; Damasio, A.

    1984-01-01

    The SPECT system (Tomomatic-64) developed by a previous study for rCBF measurements with Xe-133 was validated with phantom simulations and clinical studies. A bi-compartmental flow phantom was developed consisting of a Xenon-133 pump connected in series to head and lung compartments. Flow rates between 0.2 and 1.4 brain volumes/min (20-140 cc/100ml/min) were tested against Tomomatic measurements by linear regression. Correlation was excellent (r=1.0) in the range of 0.2-1.2 (20-120 cc/100ml/min), representing flow rates which are most likely to be encountered in clinical studies. Flow rates above 1.2 (120 cc/100 ml/min) were significantly underestimated. 32 studies on 20 volunteers gave a mean normal flow of 72 (SD=12) cc/ 100g/min. Mean regional flow ranged from 62 in frontal lobes to 75 in central gray matter. Right-to-left variation was less than 5%. The lowest regional flow in a normal subject was 45 cc/100g/min. 68 studies were performed on 30 stroke patients. In 27 rCBF was less than 45 in affected brain areas for a sensitivity of 90% which improved to 97% when comparisons with contralateral brain were included. Initial CT scans were normal or non-diagnostic in 10, but showed CVA's in regions of reduced rCBF in 17 patients. rCBF abnormalities involved greater portions of brain than CT changes, often (8/17) including distant regions, unpredicted by CT or clinical studies but known to be strongly interconnected to the area of structural damage. SPECT estimates of rCBF appear to be a sensitive research and diagnostic tool and complement the structural information provided by CT

  4. Empirical support for DSM-IV schizoaffective disorder: clinical and cognitive validators from a large patient sample.

    Directory of Open Access Journals (Sweden)

    Pamela DeRosse

    Full Text Available The diagnosis of schizoaffective disorder has long maintained an uncertain status in psychiatric nosology. Studies comparing clinical and biological features of patients with schizoaffective disorder to patients with related disorders [e.g., schizophrenia and bipolar disorder] can provide an evidence base for judging the validity of the diagnostic category. However, because most prior studies of schizoaffective disorder have only evaluated differences between groups at a static timepoint, it is unclear how these disorders may be related when the entire illness course is taken into consideration.We ascertained a large cohort [N = 993] of psychiatric patients with a range of psychotic diagnoses including schizophrenia with no history of major affective episodes [SZ-; N = 371], schizophrenia with a superimposed mood syndrome [SZ+; N = 224], schizoaffective disorder [SAD; N = 129] and bipolar I disorder with psychotic features [BPD+; N = 269]. Using cross-sectional data we designed key clinical and neurocognitive dependent measures that allowed us to test longitudinal hypotheses about the differences between these diagnostic entities.Large differences between diagnostic groups on several demographic and clinical variables were observed. Most notably, groups differed on a putative measure of cognitive decline. Specifically, the SAD group demonstrated significantly greater post-onset cognitive decline compared to the BP+ group, with the SZ- and SZ+ group both exhibiting levels of decline intermediate to BPD+ and SAD.These results suggest that schizoaffective disorder may possess distinct features. Contrary to earlier formulations, schizoaffective disorder may be a more severe form of illness.

  5. Validation of Autonomous Space Systems

    Data.gov (United States)

    National Aeronautics and Space Administration — System validation addresses the question "Will the system do the right thing?" When system capability includes autonomy, the question becomes more pointed. As NASA...

  6. Magnetic Signature Analysis & Validation System

    National Research Council Canada - National Science Library

    Vliet, Scott

    2001-01-01

    The Magnetic Signature Analysis and Validation (MAGSAV) System is a mobile platform that is used to measure, record, and analyze the perturbations to the earth's ambient magnetic field caused by object such as armored vehicles...

  7. Mercury and Cyanide Data Validation

    Science.gov (United States)

    Document designed to offer data reviewers guidance in determining the validity ofanalytical data generated through the USEPA Contract Laboratory Program (CLP) Statement ofWork (SOW) ISM01.X Inorganic Superfund Methods (Multi-Media, Multi-Concentration)

  8. ICP-MS Data Validation

    Science.gov (United States)

    Document designed to offer data reviewers guidance in determining the validity ofanalytical data generated through the USEPA Contract Laboratory Program Statement ofWork (SOW) ISM01.X Inorganic Superfund Methods (Multi-Media, Multi-Concentration)

  9. Contextual Validity in Hybrid Logic

    DEFF Research Database (Denmark)

    Blackburn, Patrick Rowan; Jørgensen, Klaus Frovin

    2013-01-01

    interpretations. Moreover, such indexicals give rise to a special kind of validity—contextual validity—that interacts with ordinary logi- cal validity in interesting and often unexpected ways. In this paper we model these interactions by combining standard techniques from hybrid logic with insights from the work...... of Hans Kamp and David Kaplan. We introduce a simple proof rule, which we call the Kamp Rule, and first we show that it is all we need to take us from logical validities involving now to contextual validities involving now too. We then go on to show that this deductive bridge is strong enough to carry us...... to contextual validities involving yesterday, today and tomorrow as well....

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

    Directory of Open Access Journals (Sweden)

    Erica Gobbi

    Full Text Available 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.

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

    Science.gov (United States)

    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 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.

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

    Science.gov (United States)

    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.

  13. MARS Validation Plan and Status

    International Nuclear Information System (INIS)

    Ahn, Seung-hoon; Cho, Yong-jin

    2008-01-01

    The KINS Reactor Thermal-hydraulic Analysis System (KINS-RETAS) under development is directed toward a realistic analysis approach of best-estimate (BE) codes and realistic assumptions. In this system, MARS is pivoted to provide the BE Thermal-Hydraulic (T-H) response in core and reactor coolant system to various operational transients and accidental conditions. As required for other BE codes, the qualification is essential to ensure reliable and reasonable accuracy for a targeted MARS application. Validation is a key element of the code qualification, and determines the capability of a computer code in predicting the major phenomena expected to occur. The MARS validation was made by its developer KAERI, on basic premise that its backbone code RELAP5/MOD3.2 is well qualified against analytical solutions, test or operational data. A screening was made to select the test data for MARS validation; some models transplanted from RELAP5, if already validated and found to be acceptable, were screened out from assessment. It seems to be reasonable, but does not demonstrate whether code adequacy complies with the software QA guidelines. Especially there may be much difficulty in validating the life-cycle products such as code updates or modifications. This paper presents the plan for MARS validation, and the current implementation status

  14. Validation: an overview of definitions

    International Nuclear Information System (INIS)

    Pescatore, C.

    1995-01-01

    The term validation is featured prominently in the literature on radioactive high-level waste disposal and is generally understood to be related to model testing using experiments. In a first class, validation is linked to the goal of predicting the physical world as faithfully as possible but is unattainable and unsuitable for setting goals for the safety analyses. In a second class, validation is associated to split-sampling or to blind-tests predictions. In the third class of definition, validation focuses on the quality of the decision-making process. Most prominent in the present review is the observed lack of use of the term validation in the field of low-level radioactive waste disposal. The continued informal use of the term validation in the field of high level wastes disposals can become cause for misperceptions and endless speculations. The paper proposes either abandoning the use of this term or agreeing to a definition which would be common to all. (J.S.). 29 refs

  15. A novel enterovirus and parechovirus multiplex one-step real-time PCR-validation and clinical experience.

    Science.gov (United States)

    Nielsen, Alex Christian Yde; Böttiger, Blenda; Midgley, Sofie Elisabeth; Nielsen, Lars Peter

    2013-11-01

    As the number of new enteroviruses and human parechoviruses seems ever growing, the necessity for updated diagnostics is relevant. We have updated an enterovirus assay and combined it with a previously published assay for human parechovirus resulting in a multiplex one-step RT-PCR assay. The multiplex assay was validated by analysing the sensitivity and specificity of the assay compared to the respective monoplex assays, and a good concordance was found. Furthermore, the enterovirus assay was able to detect 42 reference strains from all 4 species, and an additional 9 genotypes during panel testing and routine usage. During 15 months of routine use, from October 2008 to December 2009, we received and analysed 2187 samples (stool samples, cerebrospinal fluids, blood samples, respiratory samples and autopsy samples) were tested, from 1546 patients and detected enteroviruses and parechoviruses in 171 (8%) and 66 (3%) of the samples, respectively. 180 of the positive samples could be genotyped by PCR and sequencing and the most common genotypes found were human parechovirus type 3, echovirus 9, enterovirus 71, Coxsackievirus A16, and echovirus 25. During 2009 in Denmark, both enterovirus and human parechovirus type 3 had a similar seasonal pattern with a peak during the summer and autumn. Human parechovirus type 3 was almost invariably found in children less than 4 months of age. In conclusion, a multiplex assay was developed allowing simultaneous detection of 2 viruses, which can cause similar clinical symptoms. Copyright © 2013 Elsevier B.V. All rights reserved.

  16. Clinical validation and applicability of different tipranavir/ritonavir genotypic scores in HIV-1 protease inhibitor-experienced patients.

    Science.gov (United States)

    Saracino, Annalisa; Monno, Laura; Tartaglia, Alessandra; Tinelli, Carmine; Seminari, Elena; Maggiolo, Franco; Bonora, Stefano; Rusconi, Stefano; Micheli, Valeria; Lo Caputo, Sergio; Lazzaroni, Laura; Ferrara, Sergio; Ladisa, Nicoletta; Nasta, Paola; Parruti, Giustino; Bellagamba, Rita; Forbici, Federica; Angarano, Gioacchino

    2009-07-01

    Tipranavir, a non-peptidic protease inhibitor which shows in vitro efficacy against some HIV-1-resistant strains, can be used in salvage therapies for multi-experienced HIV patients due to its peculiar resistance profile including 21 mutations at 16 protease positions according to International AIDS Society (IAS). Other genotypic scores, however, which attribute a different weight to single amino-acid substitutions, have been recently proposed. To validate the clinical utility of four different genotypic scores for selecting tipranavir responders, the baseline resistance pattern of 176 HIV heavily experienced patients was correlated with virological success (HIV-RNA42.5% of patients. With univariate analysis, genotypic scores were all associated with outcome but showed a low accuracy with ROC analysis, with the weighted score (WS) by Scherer et al. demonstrating the best performance with an AUC of 68%. Only 52% of patients classified as susceptible (WSIAS mutations: L33F, I54AMV, Q58E, and non-IAS mutation: N37DES. On the contrary, the use of T20 in T20-naïve patients and the V82AFSI and F53LY non-IAS mutations were associated with virological success. The study suggests that even if the "weighted" scores are able to interpret correctly the antiretroviral resistance profile of multi-experienced patients, it is difficult to individuate a cut-off which can be easily applied to this population for discriminating responders.

  17. The internal consistency and concurrent validity of the Hopelessness, Helplessness, and Haplessness Scale in a Turkish clinical sample.

    Science.gov (United States)

    Vatan, Sevginar; Lester, David

    2008-12-01

    The aim of this study was to estimate the concurrent validity of the Hopelessness, Helplessness, and Haplessness Scale developed by Lester (1998). Data were obtained from 75 psychiatric patients. Cronbach alphas ranged from .67 to .90. Scores on the scales were associated with Beck, Weissman, Lester, and Trexler's measure of hopelessness, with the correlation strongest for the new hopelessness scale.

  18. The Dutch version of the Child Posttraumatic Cognitions Inventory: validation in a clinical sample and a school sample

    NARCIS (Netherlands)

    Diehle, Julia; de Roos, Carlijn; Meiser-Stedman, Richard; Boer, Frits; Lindauer, Ramón J. L.

    2015-01-01

    Background: With the inclusion of trauma-related cognitions in the DSM-5 criteria for posttraumatic stress disorder (PTSD), the assessment of these cognitions has become essential. Therefore, valid tools for the assessment of these cognitions are warranted. Objective: The current study aimed at

  19. A Validated Clinical Risk Prediction Model for Lung Cancer in Smokers of All Ages and Exposure Types

    DEFF Research Database (Denmark)

    Markaki, Maria; Tsamardinos, Ioannis; Langhammer, Arnulf

    2018-01-01

    Lung cancer causes >1·6 million deaths annually, with early diagnosis being paramount to effective treatment. Here we present a validated risk assessment model for lung cancer screening. The prospective HUNT2 population study in Norway examined 65,237 people aged >20years in 1995-97. After a median...

  20. Telepsychiatry clinical decision support system used by non-psychiatrists in remote areas: Validity & reliabilityof diagnostic module

    Directory of Open Access Journals (Sweden)

    Savita Malhotra

    2017-01-01

    Interpretation & conclusions: Diagnostic tool showed acceptable to good validity and reliability when used by non-specialists at remote sites. Our findings show that diagnostic tool of the telepsychiatry application has potential to empower non-psychiatrist doctors and paramedics to diagnose psychiatric disorders accurately and reliably in remote sites.

  1. Comparison of 4-Dimensional Computed Tomography Ventilation With Nuclear Medicine Ventilation-Perfusion Imaging: A Clinical Validation Study

    International Nuclear Information System (INIS)

    Vinogradskiy, Yevgeniy; Koo, Phillip J.; Castillo, Richard; Castillo, Edward; Guerrero, Thomas; Gaspar, Laurie E.; Miften, Moyed; Kavanagh, Brian D.

    2014-01-01

    Purpose: Four-dimensional computed tomography (4DCT) ventilation imaging provides lung function information for lung cancer patients undergoing radiation therapy. Before 4DCT-ventilation can be implemented clinically it needs to be validated against an established imaging modality. The purpose of this work was to compare 4DCT-ventilation to nuclear medicine ventilation, using clinically relevant global metrics and radiologist observations. Methods and Materials: Fifteen lung cancer patients with 16 sets of 4DCT and nuclear medicine ventilation-perfusion (VQ) images were used for the study. The VQ-ventilation images were acquired in planar mode using Tc-99m-labeled diethylenetriamine-pentaacetic acid aerosol inhalation. 4DCT data, spatial registration, and a density-change-based model were used to compute a 4DCT-based ventilation map for each patient. The percent ventilation was calculated in each lung and each lung third for both the 4DCT and VQ-ventilation scans. A nuclear medicine radiologist assessed the VQ and 4DCT scans for the presence of ventilation defects. The VQ and 4DCT-based images were compared using regional percent ventilation and radiologist clinical observations. Results: Individual patient examples demonstrate good qualitative agreement between the 4DCT and VQ-ventilation scans. The correlation coefficients were 0.68 and 0.45, using the percent ventilation in each individual lung and lung third, respectively. Using radiologist-noted presence of ventilation defects and receiver operating characteristic analysis, the sensitivity, specificity, and accuracy of the 4DCT-ventilation were 90%, 64%, and 81%, respectively. Conclusions: The current work compared 4DCT with VQ-based ventilation using clinically relevant global metrics and radiologist observations. We found good agreement between the radiologist's assessment of the 4DCT and VQ-ventilation images as well as the percent ventilation in each lung. The agreement lessened when the data were

  2. Evaluation of construct and criterion validity for the 'Liverpool Osteoarthritis in Dogs' (LOAD clinical metrology instrument and comparison to two other instruments.

    Directory of Open Access Journals (Sweden)

    Myles Benjamin Walton

    Full Text Available To test the 'Liverpool Osteoarthritis in Dogs' (LOAD questionnaire for construct and criterion validity, and to similarly test the Helsinki Chronic Pain Index (HCPI and the Canine Brief Pain Inventory (CBPI.Prospective Study.222 dogs with osteoarthritis.Osteoarthritis was diagnosed in a cohort of dogs on the basis of clinical history and orthopedic examination. Force-platform analysis was performed and a "symmetry index" for peak vertical force (PVF was calculated. Owners completed LOAD, CBPI and HCPI instruments. As a test of construct validity, inter-instrument correlations were calculated. As a test of criterion validity, the correlations between instrument scores and PVF symmetry scores were calculated. Additionally, internal consistency of all instruments was calculated and compared to those previously reported. Factor analysis is reported for the first time for LOAD, and is compared to that previously reported for CBPI and HCPI.Significant moderate correlations were found between all instruments, implying construct validity for all instruments. Significant weak correlations were found between LOAD scores and PVF symmetry index, and between CBPI scores and PVF symmetry index.LOAD is an owner-completed clinical metrology instrument that can be recommended for the measurement of canine osteoarthritis. It is convenient to use, validated and, as demonstrated here for the first time, has a correlation with force-platform data.

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

    Science.gov (United States)

    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.

  4. Site characterization and validation - validation drift fracture data, stage 4

    International Nuclear Information System (INIS)

    Bursey, G.; Gale, J.; MacLeod, R.; Straahle, A.; Tiren, S.

    1991-08-01

    This report describes the mapping procedures and the data collected during fracture mapping in the validation drift. Fracture characteristics examined include orientation, trace length, termination mode, and fracture minerals. These data have been compared and analysed together with fracture data from the D-boreholes to determine the adequacy of the borehole mapping procedures and to assess the nature and degree of orientation bias in the borehole data. The analysis of the validation drift data also includes a series of corrections to account for orientation, truncation, and censoring biases. This analysis has identified at least 4 geologically significant fracture sets in the rock mass defined by the validation drift. An analysis of the fracture orientations in both the good rock and the H-zone has defined groups of 7 clusters and 4 clusters, respectively. Subsequent analysis of the fracture patterns in five consecutive sections along the validation drift further identified heterogeneity through the rock mass, with respect to fracture orientations. These results are in stark contrast to the results form the D-borehole analysis, where a strong orientation bias resulted in a consistent pattern of measured fracture orientations through the rock. In the validation drift, fractures in the good rock also display a greater mean variance in length than those in the H-zone. These results provide strong support for a distinction being made between fractures in the good rock and the H-zone, and possibly between different areas of the good rock itself, for discrete modelling purposes. (au) (20 refs.)

  5. Measuring the reliability and validity of the Greek edition of the Diabetes Quality of Life Brief Clinical Inventory.

    Science.gov (United States)

    Rekleiti, Maria; Souliotis, Kyriakos; Sarafis, Pavlos; Kyriazis, Ioannis; Tsironi, Maria

    2018-06-01

    The present study focuses on studying the validity and reliability of the Greek edition of DQOL-BCI. DQOL-BCI includes 15 questions-elements that are evaluated on a 5-grade scale like Likert and two general form-shapes. The translation process was conducted in conformity with the guidelines of EuroQol group. A non-random sample of 65 people-patients diagnosed with diabetes I and II was selected. The questionnaire that was used to collect the data was the translated version of DQOL-BCI, and included the demographic characteristics of the interviewees. The content validity of DQOL-BCI was re-examined from a team of five experts (expert panel) for qualitative and quantitative performance. The completion of the questionnaire was done via a personal interview. The sample consisted of 58 people (35 men and 23 women, 59.9 ± 10.9 years). The translation of the questionnaire was found appropriate in accordance to the peculiarities of the Greek language and culture. The largest deviation of values is observed in QOL1 (1.71) in comparison to QOL6 (2.98). The difference between the standard deviations is close to 0.6. The statistics results of the tests showed satisfactory content validity and high construct validity, while the high values for Cronbach alpha index (0.95) reveal high reliability and internal consistency. The Greek version of DQOL-BCI has acceptable psychometric properties and appears to demonstrate high internal reliability and satisfactory construct validity, which allows its use as an important tool in evaluating the quality of life of diabetic patients in relation to their health. Copyright © 2018. Published by Elsevier B.V.

  6. Clinical validation of an ultra high-throughput spiral microfluidics for the detection and enrichment of viable circulating tumor cells.

    Directory of Open Access Journals (Sweden)

    Bee Luan Khoo

    Full Text Available Circulating tumor cells (CTCs are cancer cells that can be isolated via liquid biopsy from blood and can be phenotypically and genetically characterized to provide critical information for guiding cancer treatment. Current analysis of CTCs is hindered by the throughput, selectivity and specificity of devices or assays used in CTC detection and isolation.Here, we enriched and characterized putative CTCs from blood samples of patients with both advanced stage metastatic breast and lung cancers using a novel multiplexed spiral microfluidic chip. This system detected putative CTCs under high sensitivity (100%, n = 56 (Breast cancer samples: 12-1275 CTCs/ml; Lung cancer samples: 10-1535 CTCs/ml rapidly from clinically relevant blood volumes (7.5 ml under 5 min. Blood samples were completely separated into plasma, CTCs and PBMCs components and each fraction were characterized with immunophenotyping (Pan-cytokeratin/CD45, CD44/CD24, EpCAM, fluorescence in-situ hybridization (FISH (EML4-ALK or targeted somatic mutation analysis. We used an ultra-sensitive mass spectrometry based system to highlight the presence of an EGFR-activating mutation in both isolated CTCs and plasma cell-free DNA (cf-DNA, and demonstrate concordance with the original tumor-biopsy samples.We have clinically validated our multiplexed microfluidic chip for the ultra high-throughput, low-cost and label-free enrichment of CTCs. Retrieved cells were unlabeled and viable, enabling potential propagation and real-time downstream analysis using next generation sequencing (NGS or proteomic analysis.

  7. Face validity of a pre-clinical model of operant binge drinking: just a question of speed.

    Science.gov (United States)

    Jeanblanc, Jérôme; Sauton, Pierre; Jeanblanc, Virginie; Legastelois, Rémi; Echeverry-Alzate, Victor; Lebourgeois, Sophie; Gonzalez-Marin, Maria Del Carmen; Naassila, Mickaël

    2018-06-04

    Binge drinking (BD) is often defined as a large amount of alcohol consumed in a 'short' period of time or 'per occasion'. In clinical research, few researchers have included the notion of 'speed of drinking' in the definition of BD. Here, we aimed to describe a novel pre-clinical model based on voluntary operant BD, which included both the quantity of alcohol and the rapidity of consumption. In adult Long-Evans male rats, we induced BD by regularly decreasing the duration of ethanol self-administration from 1-hour to 15-minute sessions. We compared the behavioral consequences of BD with the behaviors of rats subjected to moderate drinking or heavy drinking (HD). We found that, despite high ethanol consumption levels (1.2 g/kg/15 minutes), the total amounts consumed were insufficient to differentiate HD from BD. However, consumption speed could distinguish between these groups. The motivation to consume was higher in BD than in HD rats. After BD, we observed alterations in locomotor coordination in rats that consumed greater than 0.8 g/kg, which was rarely observed in HD rats. Finally, chronic BD led to worse performance in a decision-making task, and as expected, we observed a lower stimulated dopaminergic release within nucleus accumbens slices in poor decision makers. Our BD model exhibited good face validity and can now provide animals voluntarily consuming very rapidly enough alcohol to achieve intoxication levels and thus allowing the study of the complex interaction between individual and environmental factors underlying BD behavior. © 2018 Society for the Study of Addiction.

  8. Validation of dengue infection severity score

    Directory of Open Access Journals (Sweden)

    Pongpan S

    2014-03-01

    Full Text Available Surangrat Pongpan,1,2 Jayanton Patumanond,3 Apichart Wisitwong,4 Chamaiporn Tawichasri,5 Sirianong Namwongprom1,6 1Clinical Epidemiology Program, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; 2Department of Occupational Medicine, Phrae Hospital, Phrae, Thailand; 3Clinical Epidemiology Program, Faculty of Medicine, Thammasat University, Bangkok, Thailand; 4Department of Social Medicine, Sawanpracharak Hospital, Nakorn Sawan, Thailand; 5Clinical Epidemiology Society at Chiang Mai, Chiang Mai, Thailand; 6Department of Radiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand Objective: To validate a simple scoring system to classify dengue viral infection severity to patients in different settings. Methods: The developed scoring system derived from 777 patients from three tertiary-care hospitals was applied to 400 patients in the validation data obtained from another three tertiary-care hospitals. Percentage of correct classification, underestimation, and overestimation was compared. The score discriminative performance in the two datasets was compared by analysis of areas under the receiver operating characteristic curves. Results: Patients in the validation data were different from those in the development data in some aspects. In the validation data, classifying patients into three severity levels (dengue fever, dengue hemorrhagic fever, and dengue shock syndrome yielded 50.8% correct prediction (versus 60.7% in the development data, with clinically acceptable underestimation (18.6% versus 25.7% and overestimation (30.8% versus 13.5%. Despite the difference in predictive performances between the validation and the development data, the overall prediction of the scoring system is considered high. Conclusion: The developed severity score may be applied to classify patients with dengue viral infection into three severity levels with clinically acceptable under- or overestimation. Its impact when used in routine

  9. Assessment of validity with polytrauma Veteran populations.

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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…

  11. Swallowing sparing intensity modulated radiotherapy (SW-IMRT) in head and neck cancer : Clinical validation according to the model-based approach

    NARCIS (Netherlands)

    Christianen, Miranda E. M. C.; van der Schaaf, Arjen; van der Laan, Hans Paul; Verdonck-de Leeuw, Irma M.; Doornaert, Patricia; Chouvalova, Olga; Steenbakkers, Roel J. H. M.; Leemans, Charles Rene; Oosting, Sjoukje F.; van der Laan, Bernard F. A. M.; Roodenburg, Jan L. N.; Slotman, Ben J.; Bijl, Hendrik P.; Langendijk, Johannes A.

    Purpose: The aim of this study was to clinically validate a multivariable normal tissue complication probability (NTCP) model for grade 2-4 swallowing dysfunction at 6 months after radiotherapy or chemoradiation (SWAL(M6)) in head and neck cancer patients treated with swallowing sparing intensity

  12. Neurophysiological localisation of ulnar neuropathy at the elbow: validation of diagnostic criteria developed by a taskforce of the Danish Society of Clinical Neurophysiology

    DEFF Research Database (Denmark)

    Pugdahl, Kirsten; Beniczky, Sándor; Wanscher, Benedikte

    2017-01-01

    OBJECTIVE: This study validates consensus criteria for localisation of ulnar neuropathy at elbow (UNE) developed by a taskforce of the Danish Society of Clinical Neurophysiology and compares them to the existing criteria from the American Association of Neuromuscular and Electrodiagnostic Medicine...

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

    Science.gov (United States)

    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.

  14. Quality data validation: Comprehensive approach to environmental data validation

    International Nuclear Information System (INIS)

    Matejka, L.A. Jr.

    1993-01-01

    Environmental data validation consists of an assessment of three major areas: analytical method validation; field procedures and documentation review; evaluation of the level of achievement of data quality objectives based in part on PARCC parameters analysis and expected applications of data. A program utilizing matrix association of required levels of validation effort and analytical levels versus applications of this environmental data was developed in conjunction with DOE-ID guidance documents to implement actions under the Federal Facilities Agreement and Consent Order in effect at the Idaho National Engineering Laboratory. This was an effort to bring consistent quality to the INEL-wide Environmental Restoration Program and database in an efficient and cost-effective manner. This program, documenting all phases of the review process, is described here

  15. In-vivo dosimetry in external radiotherapy with amorphous silicon Portal Imaging Devices: from method to clinical validation

    International Nuclear Information System (INIS)

    Boissard, Philippe

    2012-01-01

    In vivo dose verification is used to prevent major deviations between the prescribed dose and the dose really delivered to the patient. This quality control was, nationally and internationally, widely recommended by scientific organizations. In France, its implementation and its use are now regulated. To do this, small detectors are fixed on the patient skin at the beginning of the treatment. However, the treatment delay is increased and not all treatment techniques could be assessed, such as IMRT plans (Intensity Modulated Radiation Therapy). In this context, Transit dosimetry performed with Electronic Portal Imaging Devices (EPIDs) appears as an interesting alternative for in vivo dose verification. During the treatment session, a transit dose is measured with the EPID, in two dimensions, and the dose in the patient is estimated from back projection of the portal dose. This work presents a quick and simple alternative method for verification of dose delivered to the patient using photon beams. Verifications in cases of complexes patient shapes and Intensity Modulated Radiation Therapy (IMRT) have been improved by using a Clarkson-Cunningham's integration method. 46 phantom test cases were designed to assess the accuracy of the method for 4, 6, 10 and 20 MV photon beams. For some points of interest the dose reconstructed by the method is compared to the dose measured with an ionization chamber. An additional in vivo uncertainty due to day to day deviations is defined and investigated. In the same time, a clinical study was driven during three years. In vivo dosimetry was performed for 494 patients treated for various tumors sites. Most of the patients were treated for a pr