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Sample records for clinical validation study

  1. Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity

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    Vollmar Horst C

    2006-12-01

    Full Text Available Abstract Background It is often stated that external validity is not sufficiently considered in the assessment of clinical studies. Although tools for its evaluation have been established, there is a lack of awareness of their significance and application. In this article, a comprehensive checklist is presented addressing these relevant criteria. Methods The checklist was developed by listing the most commonly used assessment criteria for clinical studies. Additionally, specific lists for individual applications were included. The categories of biases of internal validity (selection, performance, attrition and detection bias correspond to structural, treatment-related and observational differences between the test and control groups. Analogously, we have extended these categories to address external validity and model validity, regarding similarity between the study population/conditions and the general population/conditions related to structure, treatment and observation. Results A checklist is presented, in which the evaluation criteria concerning external validity and model validity are systemised and transformed into a questionnaire format. Conclusion The checklist presented in this article can be applied to both planning and evaluating of clinical studies. We encourage the prospective user to modify the checklists according to the respective application and research question. The higher expenditure needed for the evaluation of clinical studies in systematic reviews is justified, particularly in the light of the influential nature of their conclusions on therapeutic decisions and the creation of clinical guidelines.

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

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    Baig, Lubna; Violato, Claudio; Crutcher, Rodney

    2010-01-01

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

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

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    Zailani Muhamad

    2015-05-01

    Full Text Available Objectives: The aim of this study was to determine the content validity, internal consistency, testretest reliability and inter-rater reliability of the Clinical Competency Evaluation Instrument (CCEVI in assessing the clinical performance of physiotherapy students. Methods: 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. Results: 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. Conclusion: 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. Validation of the tool assessment of clinical education (AssCE): A study using Delphi method and clinical experts.

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    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.

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

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    Tor, Elina; Steketee, Carole; Mak, Donna

    2016-09-24

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

  6. Reliability and Validity Study of Clinical Ultrasound Imaging on Lateral Curvature of Adolescent Idiopathic Scoliosis.

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    Q Wang

    Full Text Available Non-ionizing radiation imaging assessment has been advocated for the patients with adolescent idiopathic scoliosis (AIS. As one of the radiation-free methods, ultrasound imaging has gained growing attention in scoliosis assessment over the past decade. The center of laminae (COL method has been proposed to measure the spinal curvature in the coronal plane of ultrasound image. However, the reliability and validity of this ultrasound method have not been validated in the clinical setting.To evaluate the reliability and validity of clinical ultrasound imaging on lateral curvature measurements of AIS with their corresponding magnetic resonance imaging (MRI measurements.Thirty curves (ranged 10.2°-68.2° from sixteen patients with AIS were eligible for this study. The ultrasound scan was performed using a 3-D ultrasound unit within the same morning of MRI examination. Two researchers were involved in data collection of these two examinations. The COL method was used to measure the coronal curvature in ultrasound image, compared with the Cobb method in MRI. The intra- and inter-rater reliability of the COL method was evaluated by intra-class correlation coefficient (ICC. The validity of this method was analyzed by paired Student's t-test, Bland-Altman statistics and Pearson correlation coefficient. The level of significance was set as 0.05.The COL method showed high intra- and inter-rater reliabilities (both with ICC (2, K >0.9, p0.9, p<0.05.The ultrasound imaging could provide a reliable and valid measurement of spinal curvature in the coronal plane using the COL method. Further research is needed to validate the proposed ultrasound measurement in larger clinical trial and to optimize the ultrasound scanning and measuring procedure.

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

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    Ales Stuchlik

    2016-10-01

    Full Text Available 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.

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

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    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 (pKorean version of the CUDOS is a very useful measurement for research and for clinical practice. PMID:28138107

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

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

    2016-04-01

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

  10. Diagnostic precision of PET imaging and functional MRI in disorders of consciousness: a clinical validation study.

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    Stender, Johan; Gosseries, Olivia; Bruno, Marie-Aurélie; Charland-Verville, Vanessa; Vanhaudenhuyse, Audrey; Demertzi, Athena; Chatelle, Camille; Thonnard, Marie; Thibaut, Aurore; Heine, Lizette; Soddu, Andrea; Boly, Mélanie; Schnakers, Caroline; Gjedde, Albert; Laureys, Steven

    2014-08-09

    Bedside clinical examinations can have high rates of misdiagnosis of unresponsive wakefulness syndrome (vegetative state) or minimally conscious state. The diagnostic and prognostic usefulness of neuroimaging-based approaches has not been established in a clinical setting. We did a validation study of two neuroimaging-based diagnostic methods: PET imaging and functional MRI (fMRI). For this clinical validation study, we included patients referred to the University Hospital of Liège, Belgium, between January, 2008, and June, 2012, who were diagnosed by our unit with unresponsive wakefulness syndrome, locked-in syndrome, or minimally conscious state with traumatic or non-traumatic causes. We did repeated standardised clinical assessments with the Coma Recovery Scale-Revised (CRS-R), cerebral (18)F-fluorodeoxyglucose (FDG) PET, and fMRI during mental activation tasks. We calculated the diagnostic accuracy of both imaging methods with CRS-R diagnosis as reference. We assessed outcome after 12 months with the Glasgow Outcome Scale-Extended. We included 41 patients with unresponsive wakefulness syndrome, four with locked-in syndrome, and 81 in a minimally conscious state (48=traumatic, 78=non-traumatic; 110=chronic, 16=subacute). (18)F-FDG PET had high sensitivity for identification of patients in a minimally conscious state (93%, 95% CI 85-98) and high congruence (85%, 77-90) with behavioural CRS-R scores. The active fMRI method was less sensitive at diagnosis of a minimally conscious state (45%, 30-61) and had lower overall congruence with behavioural scores (63%, 51-73) than PET imaging. (18)F-FDG PET correctly predicted outcome in 75 of 102 patients (74%, 64-81), and fMRI in 36 of 65 patients (56%, 43-67). 13 of 41 (32%) of the behaviourally unresponsive patients (ie, diagnosed as unresponsive with CRS-R) showed brain activity compatible with (minimal) consciousness (ie, activity associated with consciousness, but diminished compared with fully conscious individuals

  11. Summarising and validating test accuracy results across multiple studies for use in clinical practice.

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    Riley, Richard D; Ahmed, Ikhlaaq; Debray, Thomas P A; Willis, Brian H; Noordzij, J Pieter; Higgins, Julian P T; Deeks, Jonathan J

    2015-06-15

    Following a meta-analysis of test accuracy studies, the translation of summary results into clinical practice is potentially problematic. The sensitivity, specificity and positive (PPV) and negative (NPV) predictive values of a test may differ substantially from the average meta-analysis findings, because of heterogeneity. Clinicians thus need more guidance: given the meta-analysis, is a test likely to be useful in new populations, and if so, how should test results inform the probability of existing disease (for a diagnostic test) or future adverse outcome (for a prognostic test)? We propose ways to address this. Firstly, following a meta-analysis, we suggest deriving prediction intervals and probability statements about the potential accuracy of a test in a new population. Secondly, we suggest strategies on how clinicians should derive post-test probabilities (PPV and NPV) in a new population based on existing meta-analysis results and propose a cross-validation approach for examining and comparing their calibration performance. Application is made to two clinical examples. In the first example, the joint probability that both sensitivity and specificity will be >80% in a new population is just 0.19, because of a low sensitivity. However, the summary PPV of 0.97 is high and calibrates well in new populations, with a probability of 0.78 that the true PPV will be at least 0.95. In the second example, post-test probabilities calibrate better when tailored to the prevalence in the new population, with cross-validation revealing a probability of 0.97 that the observed NPV will be within 10% of the predicted NPV.

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

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    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.

  13. The reuse of subjects in clinical studies: is a bias introduced? Is there a threat to study validity?

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    Pesola, Gene R

    2004-01-01

    The reuse of subjects in clinical studies to answer specific research questions is a common practice. This reuse can take many forms and is at least partly related to study efficiency. It is much easier to reuse known subjects who know the system(s) or are easy to find than to recruit new ones. A hypothetical question is: Are there instances when such practices may not be scientifically valid? This question will be addressed from the perspective of the case-control and experimental study design.

  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

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    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. Validating clinical competence.

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    Chappell, Kathy; Koithan, Mary

    2012-07-01

    Professional registered nurses must be competent to provide care in today's fast-paced, highly technical clinical environment. Competency programs designed to teach and evaluate essential knowledge, skills, and abilities of registered nurses are one method organizations may use to demonstrate nursing proficiency.

  16. Ad aptation of Clinical Decision Making in Nursing Scale to Undergraduate Students of Nursing: The Study of Reliability and Validity

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    Aylin Durmaz Edeer

    2015-09-01

    Full Text Available A clinical decision making skill is essential in the implementation of nursing knowledge and reflecting on patient care. The research was planned to measure the reliability and validity of The Clinical Decision Making in Nursing Scale (CDMNSTr for undergraduate nursing students from Turkey. This study is a methodological design. This study was conducted on 210 undergraduate students of nursing. For validity; Language – Content Validity and Construct Validity (Exploratory and Confirmatory Factor Analysis were examined. For reliability; CDMNS’s Cronbach’s alpha reliability coefficient, item-total score correlation coefficients and stability analysis (test-retest were examined. Item Content Validity Index and Scale Content Validity Index were calculated as .81 and .83 respectively. Confirmatory factor analyses showed that goodness of fit indexes were acceptable. Cronbach alpha value of the scale was .78. Item-to-total score correlation coefficients ranged from .13 to .56. The correlation coefficient for test-retest was .82. The scale can be used as a valid and reliable measurement tool to determine the perceptions of Turkish undergraduate students of nursing regarding to clinical decision making.

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

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    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.

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

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    Mayo, Ann M

    2015-01-01

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

  19. Tissue microarray-based study of hepatocellular carcinoma validating SPIB as potential clinical prognostic marker.

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    Ho, Yi-Jung; Lin, Yueh-Min; Huang, Yen-Chi; Yeh, Kun-Tu; Lin, Liang-In; Lu, Jeng-Wei

    2016-01-01

    Currently, the prognostic significance of SPIB protein overexpression in human hepatocellular carcinoma (HCC) is unclear. The aim of the present study was to investigate the level of SPIB expression in human HCC in order to determine possible correlations between SPIB expression and clinicopathological findings. The expression of SPIB proteins was detected using immunohistochemical staining in commercial multiple-tissue microarrays as a means of examining expression profiles in patients. Using online biomarker validation tool SurvExpress, we focused on the correlation between SPIB overexpression and survival as well as relapse-free survival (RFS). Results show that SPIB protein expression levels were significantly higher in colon, liver, and stomach tumors than in non-tumor tissues (p<0.05). SPIB overexpression in patients with HCC was also significantly higher than that of the normal samples (p<0.001). Among patients with liver disease, SPIB protein expression levels differ significantly according to the stage of liver disease, specifically between stages I, II, and III of HCC (p<0.05). SPIB expression was also shown to be significantly correlated with age (p=0.046) and histological grade (p=0.027). Furthermore, the SurvExpress analysis suggested that high SPIB and KI-67 mRNA expression were significantly associated with the poor survival of patients with HCC (p<0.05). Our results indicate that cross-talk in the expression of SPIB and KI-67 may be associated with poor prognosis and may potentially serve as a clinical prognostic indicator of HCC. This is the first time that such an association has been reported. Copyright © 2015 Elsevier GmbH. All rights reserved.

  20. Development of the clinical learning evaluation questionnaire for undergraduate clinical education: Factor structure, validity, and reliability study

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    A.I. Alhaqwi (Ali I); J. Kuntze (Jeroen); H.T. van der Molen (Henk)

    2014-01-01

    textabstractBackground: Teaching and learning of clinical skills for undergraduate medical students usually takes place during the clinical clerkship. Therefore, it is of vital importance to ensure the effectiveness of the rotations within this clerkship. The aims of this study were to develop an in

  1. Study of the reliability and validity of objective structured clinical examination (OSCE) in the assessment of clinical skills of audiology students.

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    Nickbakht, Mansoureh; Amiri, Marzieh; Latifi, Seyed Mahmoud

    2013-01-31

    Audiology students should possess clinical competence and skills. To achieve this, their clinical skills must be properly assessed. The Objective Structured Clinical Examination (OSCE) is a standard and fair examination of clinical competence. The goal of this study is to devise a checklist of OSCE examination criteria and study their validity and reliability for assessing the clinical competence of Audiology students. Among the various procedures in which audiology students should possess demonstrated competence, 10 specific skills were selected and checklists were prepared. Faculty members of university's Audiology Department were consulted to determine the validity of the checklists. Subsequently, the examination was administered to all 14 fourth-year audiology students in their final semester of study at Ahvaz Jundishapur University of Medical Sciences. The examination consisted of three question stations and seven procedure stations. Each station was managed by two examiners who independently used a checklist to score each student's performance in a given procedure. To determine reliability, the Spearman test was used. The correlation between each examiner's scores of students at question stations was 0.908. The correlation between each examiner's scores at procedure stations was 0.857 (p=0). The site of lesion test had the highest correlation (0.948) and immittance audiometry had the lowest correlation (0.585). The prepared checklists had good validity and reliability and can be used to evaluate the clinical competence of audiology students in their final semester of study.

  2. How to develop, validate, and compare clinical prediction models involving radiological parameters: Study design and statistical methods

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    Han, Kyung Hwa; Choi, Byoung Wook [Dept. of Radiology, and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, Seoul (Korea, Republic of); Song, Ki Jun [Dept. of Biostatistics and Medical Informatics, Yonsei University College of Medicine, Seoul (Korea, Republic of)

    2016-06-15

    Clinical prediction models are developed to calculate estimates of the probability of the presence/occurrence or future course of a particular prognostic or diagnostic outcome from multiple clinical or non-clinical parameters. Radiologic imaging techniques are being developed for accurate detection and early diagnosis of disease, which will eventually affect patient outcomes. Hence, results obtained by radiological means, especially diagnostic imaging, are frequently incorporated into a clinical prediction model as important predictive parameters, and the performance of the prediction model may improve in both diagnostic and prognostic settings. This article explains in a conceptual manner the overall process of developing and validating a clinical prediction model involving radiological parameters in relation to the study design and statistical methods. Collection of a raw dataset; selection of an appropriate statistical model; predictor selection; evaluation of model performance using a calibration plot, Hosmer-Lemeshow test and c-index; internal and external validation; comparison of different models using c-index, net reclassification improvement, and integrated discrimination improvement; and a method to create an easy-to-use prediction score system will be addressed. This article may serve as a practical methodological reference for clinical researchers.

  3. Direct identification of chlamydiae from clinical samples using a DNA microarray assay: a validation study.

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    Borel, Nicole; Kempf, Evelyne; Hotzel, Helmut; Schubert, Evelyn; Torgerson, Paul; Slickers, Peter; Ehricht, Ralf; Tasara, Taurai; Pospischil, Andreas; Sachse, Konrad

    2008-02-01

    While DNA microarrays have become a widely accepted tool for mRNA expression monitoring, their use in rapid diagnosis of bacterial and viral pathogens is only emerging. So far, insufficient sensitivity and high costs have been the major limiting factors preventing more widespread use of microarray platforms in direct testing of clinical samples. In the present study, a total of 339 samples, among them 293 clinical specimens from animals and humans, were examined by the ArrayTube (AT) DNA microarray assay to detect chlamydial DNA and identify the species of Chlamydia and Chlamydophila involved. Samples included nasal and conjunctival swabs, formalin-fixed, paraffin-embedded and fresh organ tissue, milk, feces and cell culture. Notably, the AT test was shown to detect mixed infections in clinical samples. The calculated median sensitivity of 0.81 over the entire panel of clinical samples was comparable to conventional 16S PCR, but slightly lower than real-time PCR and other PCR assays. However, when a panel of long-time stored swab samples was excluded from the calculation, the sensitivity was clearly higher (0.87) and equivalent to that of real-time PCR. Altogether, the data demonstrate the suitability of this DNA microarray assay for routine diagnosis.

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

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    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.

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

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    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…

  6. 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; Han, Changsu; 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

    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.

  7. Validation of a GPU-based Monte Carlo code (gPMC) for proton radiation therapy: clinical cases study

    Science.gov (United States)

    Giantsoudi, Drosoula; Schuemann, Jan; Jia, Xun; Dowdell, Stephen; Jiang, Steve; Paganetti, Harald

    2015-03-01

    Monte Carlo (MC) methods are recognized as the gold-standard for dose calculation, however they have not replaced analytical methods up to now due to their lengthy calculation times. GPU-based applications allow MC dose calculations to be performed on time scales comparable to conventional analytical algorithms. This study focuses on validating our GPU-based MC code for proton dose calculation (gPMC) using an experimentally validated multi-purpose MC code (TOPAS) and compare their performance for clinical patient cases. Clinical cases from five treatment sites were selected covering the full range from very homogeneous patient geometries (liver) to patients with high geometrical complexity (air cavities and density heterogeneities in head-and-neck and lung patients) and from short beam range (breast) to large beam range (prostate). Both gPMC and TOPAS were used to calculate 3D dose distributions for all patients. Comparisons were performed based on target coverage indices (mean dose, V95, D98, D50, D02) and gamma index distributions. Dosimetric indices differed less than 2% between TOPAS and gPMC dose distributions for most cases. Gamma index analysis with 1%/1 mm criterion resulted in a passing rate of more than 94% of all patient voxels receiving more than 10% of the mean target dose, for all patients except for prostate cases. Although clinically insignificant, gPMC resulted in systematic underestimation of target dose for prostate cases by 1-2% compared to TOPAS. Correspondingly the gamma index analysis with 1%/1 mm criterion failed for most beams for this site, while for 2%/1 mm criterion passing rates of more than 94.6% of all patient voxels were observed. For the same initial number of simulated particles, calculation time for a single beam for a typical head and neck patient plan decreased from 4 CPU hours per million particles (2.8-2.9 GHz Intel X5600) for TOPAS to 2.4 s per million particles (NVIDIA TESLA C2075) for gPMC. Excellent agreement was

  8. Usually Available Clinical and Laboratory Data Are Insufficient for a Valid Medication Review: A Crossover Study.

    Science.gov (United States)

    Hurkens, K P G M; Mestres-Gonzalvo, C; de Wit, H A J M; van der Kuy, P H M; Janknegt, R; Verhey, F; Schols, J M G A; Stehouwer, C D A; Winkens, B; Mulder, W

    2016-01-01

    To establish the quality of medication reviews performed by nursing home physicians, general practitioners and pharmacists. 15 Pharmacists, 13 general practitioners and 18 nursing home physicians performed a medication review for three cases (A, B and C), at three evaluation moments. First, they received the medication list. Secondly, they also received laboratory results and reason for admission and finally, we added medical history. Remarks were divided into 6 categories, i.e. indication without medication, medication without indication, contraindications/ interactions, dosage problems, double medication and wrong medication. Remarks were compared to the remarks made by our expert panel and scored according to our grading model as appropriate (0 to +3) or missed or potentially harmful (-1). For each medication error category, the percentage of participants who made this error was computed. After the first evaluation moment, the overall estimated mean percentage score was -1.7% for case A, 3.9% for case B, and 8.7% for case C. After the second review, this score was 15.0% for case A, 19.8% for case B, and 22.2% for case C. This further increased to 30.0% for case A, 36.7% for case B and 44% for case C at the final evaluation. The absence of medication where there was an indication (indication without medication) was frequently missed and did not improve after adding the extra information regarding laboratory results, reason for admission and finally medical history. Increasing clinical information helps physicians and pharmacists to improve their medication reviews, however, additional information was still related with a high margin of error. Detection of certain errors becomes easier with additional information, whereas other errors remain undetected. To achieve a high standard of medication review, we have to change the way medication reviews should be performed.

  9. 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.

  10. 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.

  11. Wireless non-invasive continuous respiratory monitoring with FMCW radar: a clinical validation study.

    Science.gov (United States)

    van Loon, K; Breteler, M J M; van Wolfwinkel, L; Rheineck Leyssius, A T; Kossen, S; Kalkman, C J; van Zaane, B; Peelen, L M

    2016-12-01

    Altered respiratory rate is one of the first symptoms of medical conditions that require timely intervention, e.g., sepsis or opioid-induced respiratory depression. To facilitate continuous respiratory rate monitoring on general hospital wards a contactless, non-invasive, prototype monitor was developed using frequency modulated continuous wave radar. We aimed to study whether radar can reliably measure respiratory rate in postoperative patients. In a diagnostic cross-sectional study patients were monitored with the radar and the reference monitor (pneumotachograph during mechanical ventilation and capnography during spontaneous breathing). Eight patients were included; yielding 796 min of observation time during mechanical ventilation and 521 min during spontaneous breathing. After elimination of movement artifacts the bias and 95 % limits of agreement for mechanical ventilation and spontaneous breathing were -0.12 (-1.76 to 1.51) and -0.59 (-5.82 to 4.63) breaths per minute respectively. The radar was able to accurately measure respiratory rate in mechanically ventilated patients, but the accuracy decreased during spontaneous breathing.

  12. 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...... 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...... 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...

  13. [Validation of a clinical nutritional sucking scale].

    Science.gov (United States)

    Rendón-Macías, Mario Enrique; Villasís-Keever, Miguel Ángel; del Carmen Martínez-García, María

    2016-01-01

    Suck dysfunction in breastfeeding infants has an impact on their appropriate nutrition. The objective was to build and validate one clinical nutritional sucking scale in the components of sucking, swallowing, and respiration. The scale was carried out in two phases: face-validity and psychometric validity. The first was done by expert consensus. For the second phase, 179 infants (153 healthy newborn and 26 infant less than 6 month of age) and 86 infants with high risk for abnormal sucking were evaluated with the new scale. Three observers evaluated all patients during their feeding. With an initial scale of 10 items we calculated the inter-observer concordance and the internal consistence. With an analysis of the mail components and a discrimination index we reduced to pertinent items. Each component of the scale was compared with clinical variables. We reached a 7 items scale, which showed high reliability (Cronbach's alpha of 0.77 and inter-observer concordance of 0.98. The suck component correlated positively with the ingested volume (Ro = 0.61), the swallow component with the peripheral oxygen saturation (Ro = 0.24), and the breath component with the respiratory frequency (Ro = 0.50). With this scale, we can establish different patterns of sucking abnormalities related with history of neurological abnormalities, hemodynamic alteration and immaturity. In this study the clinical nutritional scale showed to be reliable and valid for its use in sucking problems classification. More studies are required to evaluate its application for oral stimulation therapies.

  14. Patient-specific finite-element simulation of the human cornea: a clinical validation study on cataract surgery.

    Science.gov (United States)

    Studer, Harald P; Riedwyl, Hansjörg; Amstutz, Christoph A; Hanson, James V M; Büchler, Philippe

    2013-02-22

    The planning of refractive surgical interventions is a challenging task. Numerical modeling has been proposed as a solution to support surgical intervention and predict the visual acuity, but validation on patient specific intervention is missing. The purpose of this study was to validate the numerical predictions of the post-operative corneal topography induced by the incisions required for cataract surgery. The corneal topography of 13 patients was assessed preoperatively and postoperatively (1-day and 30-day follow-up) with a Pentacam tomography device. The preoperatively acquired geometric corneal topography - anterior, posterior and pachymetry data - was used to build patient-specific finite element models. For each patient, the effects of the cataract incisions were simulated numerically and the resulting corneal surfaces were compared to the clinical postoperative measurements at one day and at 30-days follow up. Results showed that the model was able to reproduce experimental measurements with an error on the surgically induced sphere of 0.38D one day postoperatively and 0.19D 30 days postoperatively. The standard deviation of the surgically induced cylinder was 0.54D at the first postoperative day and 0.38D 30 days postoperatively. The prediction errors in surface elevation and curvature were below the topography measurement device accuracy of ±5μm and ±0.25D after the 30-day follow-up. The results showed that finite element simulations of corneal biomechanics are able to predict post cataract surgery within topography measurement device accuracy. We can conclude that the numerical simulation can become a valuable tool to plan corneal incisions in cataract surgery and other ophthalmosurgical procedures in order to optimize patients' refractive outcome and visual function.

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

    Science.gov (United States)

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

    2017-07-24

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

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

    Science.gov (United States)

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

    2016-10-24

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

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

    Directory of Open Access Journals (Sweden)

    E.L. Andrade

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

  18. Validation studies in nursing: integrative review

    Directory of Open Access Journals (Sweden)

    Maria Andréia silva Ribeiro

    2013-05-01

    Full Text Available The aim of this study was to analyze the methods used for validation studies in nursing research considering the clinical investigation as phenomenon. We carried out literature at BIREME, CINAHL, PUBMED which contain the terms 'validation studies', 'nursing' and 'clinical' and 21 articles were included in the review. The majority of the studies were conducted in 2008; in North America (USA and European Community (62% in the area of adult health. Most of the phenomena investigated were related to nursing care involving physical and emotional aspects. The content validity has been cited in 71.4% of the articles, criterion validity in 28.5% and construct validity in 23.8%. The reliability by means of Cronbach's alpha was used in the majority of the studies. It was found a knowledge gap concerning the validation estudies in the area of public health, child health and the social phenomena related to nursing care.

  19. An ultra-sensitive LC-MS/MS method to determine midazolam levels in human plasma: development, validation and application to a clinical study.

    Science.gov (United States)

    Chen, Mu; Lu, Wenzhe; Lu, Yang; Kang, Lijuan; Zhao, Harry; Lin, Zhongping John; Wang, Weimin; Fraier, Daniela; Ottaviani, Giorgio

    2017-02-01

    Midazolam is a commonly used marker substrate for the in vivo assessment of CYP3A activity. Reliable pharmacokinetic assessment at sub-pharmacological doses of midazolam requires an ultra-sensitive analytical method. A new, ultra-sensitive LC-MS/MS method for the determination of midazolam in human plasma using SPE was developed and fully validated. The lowest limit of quantitation is 0.1 pg/ml with a sample volume of 500 μl. The following parameters were validated: sensitivity, assay accuracy and precision, linearity, selectivity, and stability of midazolam at pertinent analytical and storage conditions. The validated method was utilized successfully for the sample assay during a midazolam microdosing study for the evaluation of CYP3A4 activity of a clinical candidate.

  20. Reliability, validity, and responsiveness of the Japanese version of International Restless Legs Syndrome Study Group rating scale for restless legs syndrome in a clinical trial setting.

    Science.gov (United States)

    Inoue, Yuichi; Oka, Yasunori; Kagimura, Tatsuo; Kuroda, Kenji; Hirata, Koichi

    2013-09-01

    This study was conducted to verify the reliability, validity, and responsiveness of the Japanese version of the International Restless Legs Syndrome Study Group Rating Scale for restless legs syndrome (J-IRLS) as a sub-study of a clinical trial of pramipexole against restless legs syndrome. After evaluating the test-retest reliability, concurrent validity and construct validity were analyzed. The responsiveness of J-IRLS was confirmed by evaluating the correlations between the changes in J-IRLS total score after treatment, Clinical Global Impression Improvement Scale (CGI-I), and Patient Global Impression. Test-retest reliability of J-IRLS was good (intra-class correlation coefficient, 0.877; 95% confidence interval, 0.802-0.925). The correlation coefficient of J-IRLS total score and CGI-S score for the first and second visit was 0.804 and 0.796, respectively (both P restless legs syndrome and for assessing drug efficacy. © 2013 The Authors. Psychiatry and Clinical Neurosciences © 2013 Japanese Society of Psychiatry and Neurology.

  1. Convergent and discriminant validity of psychiatric symptoms reported in The Norwegian Mother and Child Cohort Study at age 3 years with independent clinical assessment in the Longitudinal ADHD Cohort Study

    Directory of Open Access Journals (Sweden)

    Guido Biele

    2014-12-01

    Full Text Available Epidemiological studies often use parent questionnaires to assess children's development and mental health. To date, few studies have investigated the validity of parent questionnaires with standardized clinical assessments as criterion. The current study examines discriminant and convergent validity of parent questionnaires for symptoms of Attention Deficit Hyperactivity Disorder (ADHD, Oppositional Defiance Disorder (ODD, and Conduct Disorder (CD as well as symptoms of Separation Anxiety employed in the Norwegian Mother and Child Cohort Study by using structured clinical interviews performed 5 months later in the Longitudinal ADHD Cohort Study as a criterion. The comparison of confirmatory factor analysis models and examination of factor correlations indicate convergent and discriminant validity of MoBa parent questionnaires for preschool children, especially for the assessment of ADHD and ODD/CD. Future research should attempt to further improve parent questionnaires, examine their validity in representative samples, and explicitly test their utility for screening.

  2. A simulation framework for pre-clinical studies on dose and image quality: concept and first validation

    Science.gov (United States)

    Smans, Kristien; Pauwels, Herman; Rogge, Frank; Struelens, Lara; Dragusin, Octavian; Vanhavere, Filip; Bosmans, Hilde

    2008-03-01

    Purpose: The purposes of the study were to set-up and validate a simulation framework for dose and image quality optimization studies. In a first phase we have evaluated whether CDRAD images as obtained with computed radiography plates could be simulated. Material and Methods: The Monte Carlo method is a numerical method that can be used to simulate radiation transport. It is in diagnostic radiology often used in dosimetry, but in present study it is used to simulate X-ray images. With the Monte Carlo software, MCNPX, the successive steps in the imaging chain were simulated: the X-ray beam, the attenuation and scatter process in a test object and image generation by an ideal detector. Those simulated images were further modified for specific properties of CR imaging systems. The signal-transfer-properties were used to convert the simulated images into the proper grey scale. To account for resolution properties the simulated images were convolved with the point spread function of the CR systems. In a last phase, noise, based on noise power spectrum (NPS) measurements, was added to the image. In this study, we simulated X-ray images of the CDRAD contrast-detail phantom. Those simulated images, modified for the CR-system, were compared with real X-ray images of the CDRAD phantom. All images were scored by computer readings. Results: First results confirm that realistic CDRAD images can be simulated and that reading results of series of simulated and real images have the same tendency. The simulations also show that white noise has a large influence on image quality and CDRAD analyses.

  3. Clinical Studies

    DEFF Research Database (Denmark)

    Pallesen, Ulla

    and repair? Have new materials improved longevity? Are there still clinical and material problems to be solved? And what has the highest impact on longevity of posterior resin restorations – the material, the dentist, the patient or the tooth? These matters will be discussed on the basis of the literature......Within the last 25 years composite resin materials have in many countries successively replaced amalgam as a restorative for posterior teeth. Resin materials and bonding systems are continuously being improved by the manufactures, adhesive procedures are now included in the curriculum of most...... universities and practicing dentists restore millions of teeth throughout the World with composite resin materials. Do we know enough about the clinical performance of these restorations over time? Numerous in vitro studies are being published on resin materials and adhesion, some of them attempting to imitate...

  4. Population-based input function modeling for [(18F]FMPEP-d 2, an inverse agonist radioligand for cannabinoid CB1 receptors: validation in clinical studies.

    Directory of Open Access Journals (Sweden)

    Paolo Zanotti-Fregonara

    Full Text Available BACKGROUND: Population-based input function (PBIF may be a valid alternative to full blood sampling for quantitative PET imaging. PBIF is typically validated by comparing its quantification results with those obtained via arterial sampling. However, for PBIF to be employed in actual clinical research studies, its ability to faithfully capture the whole spectrum of results must be assessed. The present study validated a PBIF for [(18F]FMPEP-d 2, a cannabinoid CB1 receptor radioligand, in healthy volunteers, and also attempted to utilize PBIF to replicate three previously published clinical studies in which the input function was acquired with arterial sampling. METHODS: The PBIF was first created and validated with data from 42 healthy volunteers. This PBIF was used to assess the retest variability of [(18F]FMPEP-d 2, and then to quantify CB1 receptors in alcoholic patients (n = 18 and chronic daily cannabis smokers (n = 29. Both groups were scanned at baseline and after 2-4 weeks of monitored drug abstinence. RESULTS: PBIF yielded accurate results in the 42 healthy subjects (average Logan-distribution volume (V T was 13.3±3.8 mL/cm(3 for full sampling and 13.2±3.8 mL/cm(3 for PBIF; R(2 = 0.8765, p<0.0001 and test-retest results were comparable to those obtained with full sampling (variability: 16%; intraclass correlation coefficient: 0.89. PBIF accurately replicated the alcoholism study, showing a widespread ∼20% reduction of CB1 receptors in alcoholic subjects, without significant change after abstinence. However, a small PBIF-V T bias of -9% was unexpectedly observed in cannabis smokers. This bias led to substantial errors, including a V T decrease in regions that had shown no downregulation in the full input function. Simulated data showed that the original findings could only have been replicated with a PBIF bias between -6% and +4%. CONCLUSIONS: Despite being initially well validated in healthy subjects, PBIF may

  5. A STUDY ON CLINICAL ASSESSMENT OF VARICOSE VEINS BY CLINICAL SCORES AND VALIDATING THE OUTCOME OF TRENDELENBURG PROCEDURE IN VARICOSE VEINS OF LOWER LIMBS

    Directory of Open Access Journals (Sweden)

    Nilavi

    2016-06-01

    Full Text Available cose veins of Lower Limbs. This study was conducted in the Department of General Surgery, ESIC Hospital, over a period of 12 months. METHODS AND MATERIALS This analytical study group consisted of 92 patients between 20 to 80 yrs., inclusive of both males (n=78 and females (n=14. They were assessed for severity of varicose veins by documenting a detailed history, clinical examination findings, imaging studies on a pre-structured case sheet and the result of surgery. It was found that majority of the patients were ≤60 yrs. and the left lower limb was predominantly affected in both sexes. RESULTS Using the VCSS system, 19.57% (n=18 cases had mild disease, 67.39% (n=62 cases had moderate disease and 13.04% (n=12 had severe disease. In the present study as per the VDS system, majority of the patients (n=51 55.43% had grade III disability and 40.22% (n=37 of the patients had moderate grade of venous reflux, i.e. venous reflux duration <1 second. All 92 patients had surgery with majority had uneventful postoperative periods 58.17% (n=52, whereas a few had complications 44.44% (n=40. CONCLUSION A statistically significant result was found for the clinical assessment scores and also for the surgical outcome.

  6. Validity of a self-reported diagnosis of depression among participants in a cohort study using the Structured Clinical Interview for DSM-IV (SCID-I

    Directory of Open Access Journals (Sweden)

    Pla Jorge

    2008-06-01

    Full Text Available Abstract Background Depression assessment in population studies is usually based on depressive symptoms scales. However, the use of scales could lead to the choice of an arbitrary cut-off point depending on the sample characteristics and on the patient diagnosis. Thus, the use of a medical diagnosis of depression could be a more appropriate approach. Objective To validate a self-reported physician diagnosis of depression using the Structured Clinical Interview for DSM-IV (SCID-I as Gold Standard and to assess the factors associated to a valid self-reported diagnosis. Methods The SUN Project is a cohort study based on university graduates followed-up through postal questionnaires. The response to the question included in the questionnaire: Have you ever been diagnosed of depression by a physician? was compared to that obtained through the SCID-I applied by a psychiatrist or a clinical psychologist. The percentages of confirmed depression and non-depression were assessed for the overall sample and according to several characteristics. Logistic regression models were fitted to ascertain the association between different factors and a correct classification regarding depression status. Results The percentage of confirmed depression was 74.2%; 95% confidence interval (95% CI = 63.3–85.1. Out of 42 participants who did not report a depression diagnosis in the questionnaire, 34 were free of the disease (%confirmed non-depression = 81.1%; 95% CI = 69.1–92.9. The probability of being a true positive was higher among ex-smokers and non-smokers and among those overweight or obese but the differences were not statistically significant. Conclusion The validity of a self-reported diagnosis of depression in the SUN cohort is adequate. Thus, this question about depression diagnosis could be used in further investigations regarding this disease in this graduate cohort study.

  7. 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.

  8. Radioimmunoassay of fragment E-related neoantigen: validation studies and clinical application. [Fibrinogen-fibrin degradation products

    Energy Technology Data Exchange (ETDEWEB)

    Chen, J.P.; Hanna, W.T.; Williams, T.K.; Krauss, S. (Tennessee Univ., Knoxville (USA). Memorial Research Center and Hospital)

    1984-05-01

    An E-neoantigen radioimmunoassay (Eneo RIA) is described which can determine normal and pathological plasma levels of E-related fibrinogen-fibrin degradation products (FDP). The assay employs rabbit antiserum produced against fragment E derived from a plasmin digest of fibrinogen and subsequently absorbed with fibrinogen. The absorbed antiserum contains antibodies which are equally reactive with fibrinogen derived E (Fg-E) and fibrin derived E(Fb-E) but not with fibrinogen at 1 mg/ml. The Eneo RIA was validated by assay parallelism and by recovery experiments. Plasma Eneo immunoreactivities in 14 normals were 4-22 ng/ml (mean 12.7 ng/ml). Plasma Eneo levels in 23 of 24 patients with neoplastic and haematological diseases were elevated above normal (range 27-2027 ng/ml). Unusually high Eneo values were observed with three patients whose diseases were complicated by either disseminated intravascular coagulation (DIC) or deep vein thrombosis. After heparin therapy, the Eneo level of a patient with chronic DIC declined. A pathological plasma was eluted from a Sephadex G-200 column and Eneo immunoreactivity was determined on the eluates. The gel filtration pattern of Eneo indicates that E-related FDP is a family of plasmic fragments derived from crosslinked fibrin.

  9. Determination of Clarithromycin in Human Plasma by Liquid Chromatography-Tandem Mass Spectrometry: Validation and Application in Clinical Pharmacokinetic Study

    Institute of Scientific and Technical Information of China (English)

    ZHANGXiang-rong; CHENXiao-yan; LIXiao-yan; ZHONGDa-fang

    2004-01-01

    Aim To develop a liquid chromatographic-tandem mass spectrometric (LC-MS-MS) method to determine clarithromycin in human plasma. Methods The analyte and internal standard roxithromycin were extracted from plasma samples by n-nexane-dichloromethane-isopropanel (300:150:15, V/V/V) and chromatographed on a C18 column. The mobile phase consisted of methanol-water-formic acid (80:20:1, V/V/V). Detection was performed on a triple quadrupole tandem mass spectrometer via electrospray ionization source (ESI) in the positive mode. Results The method had a lower limit of quantification of 10.0 ng·mL-1 when 0.2 mL plasma was used. The linear calibration curves were obtained in the concentration range of 10.0-5000 ng·mL-1. The intra-and inter-rum precisions were lower than 3.3% in terms of relative standard deviation (RSD), and the accuracy ranged±0.7% in terms of relative error (RE). Tmax, Cmax, T1/2 and AUC0-24h values were found to be (3.1±2.7)h, (8 750±4 734)ng·mL-1, (5.3±2.2)h, and (5932±2 449)ng·mL-1, respectively, after a single oral dose of 250 mg clarithromycin tablet to 18 volunteers. Conclusion This validated method was successful in the evaluation of pharmacokinetic profiles of clarithromycin tablets administered to 18 healthy male volubteers.

  10. Clinical measurements of cervical lordosis using flexirule and inclinometer methods in individuals with and without cervical spine dysfunction: A reliability and validity study.

    Science.gov (United States)

    McFarland, Carol; Wang-Price, Sharon; Richard, Shanan

    2015-01-01

    The purposes of this study were to determine the reliability and validity of two clinical measurements of cervical lordosis and to compare these measurements of individuals with cervical spine symptoms to those of asymptomatic individuals. Fifty-seven participants were recruited for the study: 18 following cervical fusion, 20 with neck pain and no surgery, and 19 with no neck pain. Cervical lordosis was measured using a flexible ruler (flexirule) and a modified bubble inclinometer. Intertester and intratester reliability were calculated for both methods. Validity was assessed by correlating measurements taken using both methods to Cobb angles between C2 and C7 on lateral view radiography of the participants in the cervical fusion and the neck pain groups. Intraclass correlation coefficients (ICCs) revealed good intratester reliability for both methods. Intertester reliability was fair for the flexirule method but good for the inclinometer method. Pearson correlations with radiographic angles were poor for both methods. ANOVAs showed no significant difference in cervical lordosis measurements between asymptomatic and symptomatic groups. Although both the flexirule and inclinometer methods are reliable, neither method correlated with the Cobb angle on the radiography, suggesting these methods may measure different aspects of cervical spine alignment.

  11. Bioassays for estrogenic activity: development and validation of estrogen receptor (ERalpha/ERbeta) and breast cancer proliferation bioassays to measure serum estrogenic activity in clinical studies.

    Science.gov (United States)

    Li, J; Lee, L; Gong, Y; Shen, P; Wong, S P; Wise, Stephen D; Yong, E L

    2009-02-01

    Standard estrogenic prodrugs such as estradiol valerate (E2V) and increasingly popular phytoestrogen formulations are commonly prescribed to improve menopausal health. These drugs are metabolized to numerous bioactive compounds, known or unknown, which may exert combinatorial estrogenic effects in vivo. The aim of this study is to develop and validate estrogen receptor (ER) alpha/ERbeta reporter gene and MCF-7 breast cancer cell proliferation bioassays to quantify serum estrogenic activities in a clinical trial setting. We measured changes in serum estrogenicity following ingestion of E2V and compared this to mass spectrometric measurements of its bioactive metabolites, estrone and 17beta-stradiol. ERalpha bioactivity of the 192 serum samples correlated well (R = 79%) with 17beta-estradiol levels, and adding estrone improved R to 0.83 (likelihood ratio test, P estrogenic activity and that these assays suggest that the Epimedium formulation tested is unlikely to exert significant estrogenic effects in humans.

  12. The Korean Clinical Research Center for End-Stage Renal Disease Study Validates the Association of Hemoglobin and Erythropoiesis-Stimulating Agent Dose with Mortality in Hemodialysis Patients.

    Directory of Open Access Journals (Sweden)

    Owen Kwon

    Full Text Available Anemia is an important risk factor for mortality in hemodialysis (HD patients. However, higher hemoglobin (Hb is not necessarily better, as seen in several studies. This study aimed to validate the clinical use of an Hb target of 10-11 g/dL in Korean HD patients.A total of 1,276 HD patients from the Clinical Research Center (CRC for End-Stage Renal Disease (ESRD were investigated in a prospective observational study. Cox proportional hazard analysis was conducted for each category of time-dependent Hb level and erythropoiesis-stimulating agent (ESA dose, with subgroup analysis stratified by age and diabetes status.Using a reference Hb level of 10-11 g/dL, the hazard ratios (HRs of death were 5.12 (95% confidence interval [CI], 2.62-10.02, P <0.05 for Hb level <9.0 g/dL, and 2.03 (CI, 1.16-3.69, P <0.05 for Hb level 9.0-10.0 g/dL, after adjustment for multiple clinical variables. However, an Hb level ≥11 g/dL was not associated with decreased mortality risk. In an adjusted model categorized by Hb and ESA dose, the risk of death at an Hb level <10 g/dL and a higher dose of ESA (≥126 U/kg/week had an HR of 2.25 (CI, 1.03-4.92, P <0.05, as compared to Hb level 10-11 g/dL and a lower dose of ESA. In subgroup analysis, those older than 65 years or who were diabetic had greater risk for mortality only in Hb category <9.0 g/dL. However, there was no significant interaction between age or diabetes status and Hb.Using CRC-ESRD data, we validated the association between Hb and ESA dose and mortality in Korean HD patients. The clinical practice target of an Hb of 10-11 g/dL before the new KDIGO guideline era seems reasonable considering its survival benefit in HD patients.

  13. Validation Study of Tripartite Model of Anxiety and Depression in Children and Adolescents: Clinical Sample in Korea

    OpenAIRE

    Yang, Jae-Won; Hong, Sungdo D.; Joung, Yoo Sook; Kim, Ji-Hae

    2006-01-01

    Although the currently available literature has provided some empirical support for a tripartite model of child and adolescent anxiety and depression, one of the limitations of these studies was that they have been conducted in America, primarily with Caucasians. In order to make this model more applicable to diverse ethnic and cultural groups, this study used a tripartite model for child and adolescent anxiety and depression in Korea, using confirmatory factor analysis with logically selecte...

  14. Validation studies and proficiency testing.

    Science.gov (United States)

    Ankilam, Elke; Heinze, Petra; Kay, Simon; Van den Eede, Guy; Popping, Bert

    2002-01-01

    Genetically modified organisms (GMOs) entered the European food market in 1996. Current legislation demands the labeling of food products if they contain GMO, as assessed for each ingredient of the product. To create confidence in the testing methods and to complement enforcement requirements, there is an urgent need for internationally validated methods, which could serve as reference methods. To date, several methods have been submitted to validation trials at an international level; approaches now exist that can be used in different circumstances and for different food matrixes. Moreover, the requirement for the formal validation of methods is clearly accepted; several national and international bodies are active in organizing studies. Further validation studies, especially on the quantitative polymerase chain reaction methods, need to be performed to cover the rising demand for new extraction methods and other background matrixes, as well as for novel GMO constructs.

  15. Independent Validation and Clinical Utility Study of the Hellenic WISC-III Using a Greek-Cypriot Sample

    Science.gov (United States)

    Souroulla, Andry Vrachimi; Panayiotou, Georgia

    2017-01-01

    The Hellenic WISC-III (Wechsler, 1997) is currently the only standardized and officially published tool for the assessment of the intelligence of children and adolescents in Greece. The test is also used with caution in Cyprus, among Greek speakers, but no specific norms exist for use in this country. The purpose of this study was to provide…

  16. Pre-clinical studies to validate the MITCH PCR Cup: a flexible and anatomically shaped acetabular component with novel bearing characteristics.

    Science.gov (United States)

    Latif, Ahmed M H; Mehats, Aude; Elcocks, Martyn; Rushton, Neil; Field, Richard E; Jones, Eric

    2008-04-01

    A previous clinical study was undertaken to evaluate the safety and efficacy of an anatomically shaped, flexible acetabular cup. Clinical results achieved were satisfactory, although some deficiencies in the model were identified. Design changes to the original model have been implemented to improve both initial stability and long term biological fixation. This was achieved through modifications made to both the anchoring mechanism and by the application of an appropriate backing surface layer promoting bone on-growth. In addition, changes to the articulation couple have also been introduced to improve implant durability and bearing performance, utilising a carbon fibre reinforced polyetheretherketone--alumina couple. Simulated loading, in both models, was performed using Finite Element Analysis. Mechanical and tribological tests were also performed to ensure the robustness of the new optimised design. Bio-compatibility of the articulation couple was demonstrated using an animal model. Implantation of the device has been extensively tested and re-validated in vitro to achieve a favourable polar contact between cup and femoral head and establish a reproducible operative technique. This preliminary work is undertaken prior to commencing a post market surveillance study of the CE marked implant.

  17. Validation study of tripartite model of anxiety and depression in children and adolescents: clinical sample in Korea.

    Science.gov (United States)

    Yang, Jae-Won; Hong, Sungdo D; Joung, Yoo Sook; Kim, Ji-Hae

    2006-12-01

    Although the currently available literature has provided some empirical support for a tripartite model of child and adolescent anxiety and depression, one of the limitations of these studies was that they have been conducted in America, primarily with Caucasians. In order to make this model more applicable to diverse ethnic and cultural groups, this study used a tripartite model for child and adolescent anxiety and depression in Korea, using confirmatory factor analysis with logically selected items from the Revised Children's Manifest Anxiety Scale (RCMAS), as well as the Children's Depression Inventory (CDI). The results indicated that the model fit of a three-factor model was superior to one- and two-factor models. In addition, the findings of discriminant analysis demonstrated that the correct classification rate with three factors of the tripartite model was superior to the classification rate achievable using CDI and RCMAS. In a departure from Clark and Watson's hypothesis, however, the correlations of three factors were significantly higher than had been expected. The results are discussed on the basis of cultural background.

  18. A validation study to find highly correlated parameters with visual assessment for clinical evaluation of cosmetic anti-cellulite products.

    Science.gov (United States)

    Yoo, Mi Ae; Seo, Young Kyoung; Ryu, Ja Hyun; Back, Ji Hwoon; Koh, Jae Sook

    2014-05-01

    There has been growing interest in cellulite on parts of the body; however, no objective assessment has been specifically established. This study aims to demonstrate an optimized method by comparing the existing assessments of cellulite. In Test 1, for subjects of 20 healthy females who have cellulite, we measured volume and roughness of cellulite using fringe projection method, roughness using replica method, dermo-subcutaneous interface length and subcutaneous thickness using ultrasonography and skin temperature using infrared ray, elasticity and blood flow. In Test 2, we applied an anti-cellulite cosmetic to 28 subjects for 6 weeks and observed if they have any changes. In Test 1, the effective parameter that is the most correlated with visual assessment was volume of skin measured using fringe projection method (r = 0.780). Dermo-subcutaneous interface length (r = 0.355) and subcutaneous thickness (r = 0.502) measured using ultrasonography followed in order. In Test 2, after applying a tested product, the correlation coefficient of volume of skin, of dermo-subcutaneous interface length and of subcutaneous thickness are 0.409 (P = 0.000), 0.275 (P = 0.016) and 0.311 (P = 0.012) respectively. We conclude that visual assessment, volume of skin (cavities), dermo-subcutaneous interface length and subcutaneous thickness are optimized methods for assessing an effect of cosmetics on cellulite. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  19. Age and gender effect on alexithymia in large, Japanese community and clinical samples: a cross-validation study of the Toronto Alexithymia Scale (TAS-20

    Directory of Open Access Journals (Sweden)

    Kubo Chiharu

    2007-03-01

    Full Text Available Abstract Background The construct validity of alexithymia and its assessment using the 20-item Toronto Alexithymia Scale (TAS-20 in Japan is unknown. Low reliability has been found for the third factor of the TAS-20 in some cultures, and the factor structure for psychosomatic disorder patients has not been adequately investigated. Although alexithymia most likely has certain developmental aspects, this has infrequently been investigated. Methods The newly-developed Japanese TAS-20 was administered to a normative sample (n = 2,718; 14–84 y.o., along with the NEO Five-Factor Inventory (NEO-FFI for cross validation. Psychosomatic patients (n = 1,924, 12–87 y.o. were tested to evaluate the factor structure in a clinical sample. College students (n = 196 were used for a test-retest study. Internal reliability and consistency were assessed, and the factorial structure was evaluated using confirmatory and exploratory factor analyses for both the normative and the clinical samples. The correlations between the TAS-20 and the NEO-FFI factor scores were evaluated. Age-related and gender differences in the TAS-20 were explored using analysis of variance in the normative sample. Results The original three-factor model of the TAS-20 was confirmed to be valid for these Japanese samples, although a 4-factor solution that included negatively keyed items (NKI as an additional factor was more effective. Significant correlations of the TAS-20 with the NEO-FFI were found, as has been previously reported. Factor analyses of the normative and patient samples showed similar patterns. The TAS-20 total, difficulty in identifying feelings (DIF, and difficulty in describing feelings (DDF scores were high for teenagers, decreased with age, and from 30s did not change significantly. In contrast, externally oriented thinking (EOT scores showed an almost linear positive correlation with age. DIF scores were higher for females, while EOT scores were higher for males

  20. Reliability and validity of the Turkish version of the Structured Clinical Interview for DSM-IV Dissociative Disorders (SCID-D): a preliminary study.

    Science.gov (United States)

    Kundakçi, Turgut; Sar, Vedat; Kiziltan, Emre; Yargiç, Ilhan L; Tutkun, Hamdi

    2014-01-01

    A total of 34 consecutive patients with dissociative identity disorder or dissociative disorder not otherwise specified were evaluated using the Turkish version of the Structured Clinical Interview for DSM-IV Dissociative Disorders (SCID-D). They were compared with a matched control group composed of 34 patients who had a nondissociative psychiatric disorder. Interrater reliability was evaluated by 3 clinicians who assessed videotaped interviews conducted with 5 dissociative and 5 nondissociative patients. All subjects who were previously diagnosed by clinicians as having a dissociative disorder were identified as positive, and all subjects who were previously diagnosed as not having a dissociative disorder were identified as negative. The scores of the main symptom clusters and the total score of the SCID-D differentiated dissociative patients from the nondissociative group. There were strong correlations between the SCID-D and the Dissociative Experiences Scale total and subscale scores. These results are promising for the validity and reliability of the Turkish version of the SCID-D. However, as the present study was conducted on a predominantly female sample with very severe dissociation, these findings should not be generalized to male patients, to dissociative disorders other than dissociative identity disorder, or to broader clinical or nonclinical populations.

  1. The Clinical Validity of the Process for Assessment of Effective Student Functioning.

    Science.gov (United States)

    Lambert, Nadine M.

    1981-01-01

    Reports the clinical validity of the Process for Assessment of Effective Student Functioning. A clinical team studied 300 representative second and fifth graders. Found the Process was valid for predicting independent clinical judgments of the status of these children, and located potentially handicapped children better than teacher referral.…

  2. A predeployment trauma team training course creates confidence in teamwork and clinical skills: a post-Afghanistan deployment validation study of Canadian Forces healthcare personnel.

    Science.gov (United States)

    McLaughlin, Thomas; Hennecke, Peter; Garraway, Naisan Robert; Evans, David C; Hameed, Morad; Simons, Richard K; Doucet, Jay; Hansen, Daniel; Annand, Siobhan; Bell, Nathaniel; Brown, D Ross

    2011-11-01

    The 10-day Intensive Trauma Team Training Course (ITTTC) was developed by the Canadian Forces (CFs) to teach teamwork and clinical trauma skills to military healthcare personnel before deploying to Afghanistan. This article attempts to validate the impact of the ITTTC by surveying participants postdeployment. A survey consisting of Likert-type multiple-choice questions was created and sent to all previous ITTTC participants. The survey asked respondents to rate their confidence in applying teamwork skills and clinical skills learned in the ITTTC. It explored the relevancy of objectives and participants' prior familiarity with the objectives. The impact of different training modalities was also surveyed. The survey showed that on average 84.29% of participants were "confident" or "very confident" in applying teamwork skills to their subsequent clinical experience and 52.10% were "confident" or "very confident" in applying clinical knowledge and skills. On average 43.74% of participants were "familiar" or "very familiar" with the clinical topics before the course, indicating the importance of training these skills. Participants found that clinical shadowing was significantly less valuable in training clinical skills than either animal laboratory experience or experience in human patient simulators; 68.57% respondents thought that ITTTC was "important" or "very important" in their training. The ITTTC created lasting self-reported confidence in CFs healthcare personnel surveyed upon return from Afghanistan. This validates the importance of the course for the training of CFs healthcare personnel and supports the value of team training in other areas of trauma and medicine.

  3. ESSENCE-Q – a first clinical validation study of a new screening questionnaire for young children with suspected neurodevelopmental problems in south Japan

    Directory of Open Access Journals (Sweden)

    Hatakenaka Y

    2016-07-01

    2 or maybe/a little ≥3 on the ESSENCE-Q (0.87 (95% CI: [0.79, 0.92] sensitivity and 0.77 (95% CI: [0.50, 0.93] specificity.Conclusion and implication: The ESSENCE-Q can be a good instrument for use as a screening tool for aiding in the process of early identification of neurodevelopmental disorders in clinical settings. To establish the broader validity and reliability of the ESSENCE-Q, case–control studies and general population studies of children in different age groups are needed. Keywords: ESSENCE, ESSENCE-Q, cutoff levels, receiver operating characteristic analysis

  4. ESSENCE-Q – a first clinical validation study of a new screening questionnaire for young children with suspected neurodevelopmental problems in south Japan

    Science.gov (United States)

    Hatakenaka, Yuhei; Fernell, Elisabeth; Sakaguchi, Masahiko; Ninomiya, Hitoshi; Fukunaga, Ichiro; Gillberg, Christopher

    2016-01-01

    Background Early identification of autism spectrum disorder, intellectual developmental disorder, attention-deficit/hyperactivity disorder, and other neurodevelopmental disorders/problems is crucial, yet diagnosis is often delayed for years under the often misguided “wait-and-see” paradigm. The early symptomatic syndromes eliciting neurodevelopmental clinical examinations-questionnaire (ESSENCE-Q) is a brief (12-item) screening questionnaire developed specifically for the purpose of speeding up the identification process of a wide variety of neurodevelopmental problems. The aims were to 1) estimate the reliability of the ESSENCE-Q, 2) evaluate the clinical cutoff levels suggested by the author of the ESSENCE-Q, and 3) propose optimal cutoff levels based on receiver operating characteristic analysis. Methods The ESSENCE-Q was used for 1 year by a psychiatrist in Kochi, Japan, assessing children under the age of 6 years referred for developmental problems. The children were also clinically assessed with regard to whether or not they met criteria for a developmental disorder (diagnosis positive and diagnosis negative groups). We contrasted the results of the ESSENCE-Q and those of clinical diagnostic assessments in 130 cases. Results Cronbach’s alpha was 0.82, sensitivity was 0.94 (95% confidence interval [CI]: [0.88, 0.98]), and specificity 0.53 (95% CI: [0.28, 0.77]), which are reasonable psychometrics for a first-step screening tool. Based on receiver operating characteristic analysis, we recommended an optimal cutoff level of yes ≥2 or maybe/a little ≥3 on the ESSENCE-Q (0.87 (95% CI: [0.79, 0.92]) sensitivity and 0.77 (95% CI: [0.50, 0.93]) specificity). Conclusion and implication The ESSENCE-Q can be a good instrument for use as a screening tool for aiding in the process of early identification of neurodevelopmental disorders in clinical settings. To establish the broader validity and reliability of the ESSENCE-Q, case–control studies and general

  5. Evaluation of the reliability and validity of the Medical Outcomes Study sleep scale in patients with painful diabetic peripheral neuropathy during an international clinical trial

    Directory of Open Access Journals (Sweden)

    Hays Ron D

    2008-12-01

    Full Text Available Abstract Background Sleep is an important element of functioning and well-being. The Medical Outcomes Study Sleep Scale (MOS-Sleep includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. A sleep problems index, grouping items from each of the former domains, is also available. This study evaluates the psychometric properties of MOS-Sleep Scale in a painful diabetic peripheral neuropathic population based on a clinical trial conducted in six countries. Methods Clinical data and health-related quality of life data were collected at baseline and after 12 weeks of follow-up. Overall, 396 patients were included in the analysis. Psychometric properties of the MOS-Sleep were assessed in the overall population and per country when the sample size was sufficient. Internal consistency reliability was assessed by Cronbach's alpha; the structure of the instrument was assessed by verifying item convergent and discriminant criteria; construct validity was evaluated by examining the relationships between MOS-Sleep scores and sleep interference and pain scores, and SF-36 scores; effect-sizes were used to assess the MOS-Sleep responsiveness. The study was conducted in compliance with United States Food and Drug Administration regulations for informed consent and protection of patient rights. Results Cronbach's alpha ranged from 0.71 to 0.81 for the multi-item dimensions and the sleep problems index. Item convergent and discriminant criteria were satisfied with item-scale correlations for hypothesized dimensions higher than 0.40 and tending to exceed the correlations of items with other dimensions, respectively. Taken individually, German, Polish and English language versions had good internal consistency reliability and dimension structure. Construct validity was supported with lower sleep adequacy score and greater sleep problems index scores associated with

  6. 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.

  7. VMAT-SBRT planning based on an average intensity projection for lung tumors located in close proximity to the diaphragm: a phantom and clinical validity study.

    Science.gov (United States)

    Ohira, Shingo; Ueda, Yoshihiro; Hashimoto, Misaki; Miyazaki, Masayoshi; Isono, Masaru; Kamikaseda, Hiroshi; Masaoka, Akira; Takashina, Masaaki; Koizumi, Masahiko; Teshima, Teruki

    2016-01-01

    The aim of the this study was to validate the use of an average intensity projection (AIP) for volumetric-modulated arc therapy for stereotactic body radiation therapy (VMAT-SBRT) planning for a moving lung tumor located near the diaphragm. VMAT-SBRT plans were created using AIPs reconstructed from 10 phases of 4DCT images that were acquired with a target phantom moving with amplitudes of 5, 10, 20 and 30 mm. To generate a 4D dose distribution, the static dose for each phase was recalculated and the doses were accumulated by using the phantom position known for each phase. For 10 patients with lung tumors, a deformable registration was used to generate 4D dose distributions. Doses to the target volume obtained from the AIP plan and the 4D plan were compared, as were the doses obtained from each plan to the organs at risk (OARs). In both phantom and clinical study, dose discrepancies for all parameters of the dose volume (D(min), D(99), D(max), D(1) and D(mean)) to the target were planning CT image for predicting 4D dose, but doses to the OARs with large respiratory motion were underestimated with the AIP approach.

  8. 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 developed using targeted educational interventions. The validation of this theoretical model of PPC in Year 2 medical students strengthens the potential educational implications of EI. © 2014 John Wiley & Sons Ltd.

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

    Science.gov (United States)

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

    2006-01-01

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

  10. Funding, disease area, and internal validity of hepatobiliary randomized clinical trials

    DEFF Research Database (Denmark)

    Kjaergard, Lise Lotte; Gluud, Christian

    2002-01-01

    The aim of this study was to assess whether funding and the disease area are related to the internal validity of hepatobiliary randomized clinical trials.......The aim of this study was to assess whether funding and the disease area are related to the internal validity of hepatobiliary randomized clinical trials....

  11. CTF Void Drift Validation Study

    Energy Technology Data Exchange (ETDEWEB)

    Salko, Robert K. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Gosdin, Chris [Pennsylvania State Univ., University Park, PA (United States); Avramova, Maria N. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Gergar, Marcus [Pennsylvania State Univ., University Park, PA (United States)

    2015-10-26

    This milestone report is a summary of work performed in support of expansion of the validation and verification (V&V) matrix for the thermal-hydraulic subchannel code, CTF. The focus of this study is on validating the void drift modeling capabilities of CTF and verifying the supporting models that impact the void drift phenomenon. CTF uses a simple turbulent-diffusion approximation to model lateral cross-flow due to turbulent mixing and void drift. The void drift component of the model is based on the Lahey and Moody model. The models are a function of two-phase mass, momentum, and energy distribution in the system; therefore, it is necessary to correctly model the ow distribution in rod bundle geometry as a first step to correctly calculating the void distribution due to void drift.

  12. Cell Line Derived Multi-Gene Predictor of Pathologic Response to Neoadjuvant Chemotherapy in Breast Cancer: A Validation Study on US Oncology 02-103 Clinical Trial

    Directory of Open Access Journals (Sweden)

    Shen Kui

    2012-11-01

    Full Text Available Abstract Background The purpose of this study is to assess the predictive accuracy of a multi-gene predictor of response to docetaxel, 5-fluorouracil, epirubicin and cyclophosphamide combination chemotherapy on gene expression data from patients who received these drugs as neoadjuvant treatment. Methods Tumor samples were obtained from patients with stage II-III breast cancer before starting neoadjuvant chemotherapy with four cycles of 5-fluorouracil/epirubicin/cyclophosphamide (FEC followed by four cycles of docetaxel/capecitabine (TX on US Oncology clinical trial 02-103. Most patients with HER-2-positive cancer also received trastuzumab (H. The chemotherapy predictor (TFEC-MGP was developed from publicly available gene expression data of 42 breast cancer cell-lines with corresponding in vitro chemotherapy sensitivity results for the four chemotherapy drugs. No predictor was developed for treatment with trastuzumab. The predictive performance of TFEC-MGP in distinguishing cases with pathologic complete response from those with residual disease was evaluated for the FEC/TX and FEC/TX plus H group separately. The area under the receiver-operating characteristic curve (AU-ROC was used as the metric of predictive performance. Genomic predictions were performed blinded to clinical outcome. Results The AU-ROC was 0.70 (95% CI: 0.57-0.82 for the FEC/TX group (n=66 and 0.43 (95% CI: 0.20-0.66 for the FEC/TX plus H group (n=25. Among the patients treated with FEC/TX, the AU-ROC was 0.69 (95% CI: 0.52-0.86 for estrogen receptor (ER-negative (n=28 and it was 0.59 (95% CI: 0.36-0.82 for ER-positive cancers (n=37. ER status was not reported for one patient. Conclusions Our results indicate that the cell line derived 291-probeset genomic predictor of response to FEC/TX combination chemotherapy shows good performance in a blinded validation study, particularly in ER-negative patients.

  13. Rapid and Accurate Detection of Mycobacterium tuberculosis in Sputum Samples by Cepheid Xpert MTB/RIF Assay—A Clinical Validation Study

    Science.gov (United States)

    Rachow, Andrea; Zumla, Alimuddin; Heinrich, Norbert; Rojas-Ponce, Gabriel; Mtafya, Bariki; Reither, Klaus; Ntinginya, Elias N.; O'Grady, Justin; Huggett, Jim; Dheda, Keertan; Boehme, Catharina; Perkins, Mark; Saathoff, Elmar; Hoelscher, Michael

    2011-01-01

    Background A crucial impediment to global tuberculosis control is the lack of an accurate, rapid diagnostic test for detection of patients with active TB. A new, rapid diagnostic method, (Cepheid) Xpert MTB/RIF Assay, is an automated sample preparation and real-time PCR instrument, which was shown to have good potential as an alternative to current reference standard sputum microscopy and culture. Methods We performed a clinical validation study on diagnostic accuracy of the Xpert MTB/RIF Assay in a TB and HIV endemic setting. Sputum samples from 292 consecutively enrolled adults from Mbeya, Tanzania, with suspected TB were subject to analysis by the Xpert MTB/RIF Assay. The diagnostic performance of Xpert MTB/RIF Assay was compared to standard sputum smear microscopy and culture. Confirmed Mycobacterium tuberculosis in a positive culture was used as a reference standard for TB diagnosis. Results Xpert MTB/RIF Assay achieved 88.4% (95%CI = 78.4% to 94.9%) sensitivity among patients with a positive culture and 99% (95%CI = 94.7% to 100.0%) specificity in patients who had no TB. HIV status did not affect test performance in 172 HIV-infected patients (58.9% of all participants). Seven additional cases (9.1% of 77) were detected by Xpert MTB/RIF Assay among the group of patients with clinical TB who were culture negative. Within 45 sputum samples which grew non-tuberculous mycobacteria the assay's specificity was 97.8% (95%CI = 88.2% to 99.9%). Conclusions The Xpert MTB/RIF Assay is a highly sensitive, specific and rapid method for diagnosing TB which has potential to complement the current reference standard of TB diagnostics and increase its overall sensitivity. Its usefulness in detecting sputum smear and culture negative patients needs further study. Further evaluation in high burden TB and HIV areas under programmatic health care settings to ascertain applicability, cost-effectiveness, robustness and local acceptance are required. PMID:21738575

  14. Rapid and accurate detection of Mycobacterium tuberculosis in sputum samples by Cepheid Xpert MTB/RIF assay--a clinical validation study.

    Directory of Open Access Journals (Sweden)

    Andrea Rachow

    Full Text Available BACKGROUND: A crucial impediment to global tuberculosis control is the lack of an accurate, rapid diagnostic test for detection of patients with active TB. A new, rapid diagnostic method, (Cepheid Xpert MTB/RIF Assay, is an automated sample preparation and real-time PCR instrument, which was shown to have good potential as an alternative to current reference standard sputum microscopy and culture. METHODS: We performed a clinical validation study on diagnostic accuracy of the Xpert MTB/RIF Assay in a TB and HIV endemic setting. Sputum samples from 292 consecutively enrolled adults from Mbeya, Tanzania, with suspected TB were subject to analysis by the Xpert MTB/RIF Assay. The diagnostic performance of Xpert MTB/RIF Assay was compared to standard sputum smear microscopy and culture. Confirmed Mycobacterium tuberculosis in a positive culture was used as a reference standard for TB diagnosis. RESULTS: Xpert MTB/RIF Assay achieved 88.4% (95%CI = 78.4% to 94.9% sensitivity among patients with a positive culture and 99% (95%CI = 94.7% to 100.0% specificity in patients who had no TB. HIV status did not affect test performance in 172 HIV-infected patients (58.9% of all participants. Seven additional cases (9.1% of 77 were detected by Xpert MTB/RIF Assay among the group of patients with clinical TB who were culture negative. Within 45 sputum samples which grew non-tuberculous mycobacteria the assay's specificity was 97.8% (95%CI = 88.2% to 99.9%. CONCLUSIONS: The Xpert MTB/RIF Assay is a highly sensitive, specific and rapid method for diagnosing TB which has potential to complement the current reference standard of TB diagnostics and increase its overall sensitivity. Its usefulness in detecting sputum smear and culture negative patients needs further study. Further evaluation in high burden TB and HIV areas under programmatic health care settings to ascertain applicability, cost-effectiveness, robustness and local acceptance are required.

  15. National validation of the NACNS clinical nurse specialist core competencies.

    Science.gov (United States)

    Baldwin, Kathleen M; Clark, Angela P; Fulton, Janet; Mayo, Ann

    2009-01-01

    To validate the 75 core National Association of Clinical Nurse Specialists' (NACNS) clinical nurse specialist (CNS) competencies among practicing CNSs. Specific aims were to (a) determine the extent to which 75 core CNS competencies were used in current CNS practice, (b) determine the importance of those competencies to practicing CNSs, and (c) identify gaps between CNS core competencies and role expectations in current practice. A survey design was used with both paper-and-pencil and online instruments. The survey included 150 items and three open-ended questions. A convenience sampling method was used, which targeted practicing CNSs. Respondents (N=505) were practicing CNSs who entered the field as RNs between 1956 and 2006. The survey had a high degree of internal consistency reliability (0.967%) between the subscales. The 75 NACNS core competencies were found to be useful and important for CNSs. A few gaps were identified between CNS core competencies and CNS role expectations in current practice. No one method for validating competencies will be satisfactory for all situations; however, the processes and methods used in this study were well suited to accomplish the goal of validating CNS core competencies. The process described here may be instructive to leaders of other national and international professional organizations interested in developing and evaluating competencies. Core competencies are useful and important to currently practicing CNSs. The CNS role is growing internationally. Core CNS competencies can be a framework for CNS role development, education, and practice. As described here, a competency validation survey is one way to assure that CNSs are meeting healthcare needs.

  16. The validation of a computer-adaptive test (CAT) for assessing health-related quality of life in children and adolescents in a clinical sample: study design, methods and first results of the Kids-CAT study.

    Science.gov (United States)

    Barthel, D; Otto, C; Nolte, S; Meyrose, A-K; Fischer, F; Devine, J; Walter, O; Mierke, A; Fischer, K I; Thyen, U; Klein, M; Ankermann, T; Rose, M; Ravens-Sieberer, U

    2017-05-01

    Recently, we developed a computer-adaptive test (CAT) for assessing health-related quality of life (HRQoL) in children and adolescents: the Kids-CAT. It measures five generic HRQoL dimensions. The aims of this article were (1) to present the study design and (2) to investigate its psychometric properties in a clinical setting. The Kids-CAT study is a longitudinal prospective study with eight measurements over one year at two University Medical Centers in Germany. For validating the Kids-CAT, 270 consecutive 7- to 17-year-old patients with asthma (n = 52), diabetes (n = 182) or juvenile arthritis (n = 36) answered well-established HRQoL instruments (Pediatric Quality of Life Inventory™ (PedsQL), KIDSCREEN-27) and scales measuring related constructs (e.g., social support, self-efficacy). Measurement precision, test-retest reliability, convergent and discriminant validity were investigated. The mean standard error of measurement ranged between .38 and .49 for the five dimensions, which equals a reliability between .86 and .76, respectively. The Kids-CAT measured most reliably in the lower HRQoL range. Convergent validity was supported by moderate to high correlations of the Kids-CAT dimensions with corresponding PedsQL dimensions ranging between .52 and .72. A lower correlation was found between the social dimensions of both instruments. Discriminant validity was confirmed by lower correlations with non-corresponding subscales of the PedsQL. The Kids-CAT measures pediatric HRQoL reliably, particularly in lower areas of HRQoL. Its test-retest reliability should be re-investigated in future studies. The validity of the instrument was demonstrated. Overall, results suggest that the Kids-CAT is a promising candidate for detecting psychosocial needs in chronically ill children.

  17. Performance of InterVA for assigning causes of death to verbal autopsies: multisite validation study using clinical diagnostic gold standards

    Directory of Open Access Journals (Sweden)

    Flaxman Abraham D

    2011-08-01

    Full Text Available Abstract Background InterVA is a widely disseminated tool for cause of death attribution using information from verbal autopsies. Several studies have attempted to validate the concordance and accuracy of the tool, but the main limitation of these studies is that they compare cause of death as ascertained through hospital record review or hospital discharge diagnosis with the results of InterVA. This study provides a unique opportunity to assess the performance of InterVA compared to physician-certified verbal autopsies (PCVA and alternative automated methods for analysis. Methods Using clinical diagnostic gold standards to select 12,542 verbal autopsy cases, we assessed the performance of InterVA on both an individual and population level and compared the results to PCVA, conducting analyses separately for adults, children, and neonates. Following the recommendation of Murray et al., we randomly varied the cause composition over 500 test datasets to understand the performance of the tool in different settings. We also contrasted InterVA with an alternative Bayesian method, Simplified Symptom Pattern (SSP, to understand the strengths and weaknesses of the tool. Results Across all age groups, InterVA performs worse than PCVA, both on an individual and population level. On an individual level, InterVA achieved a chance-corrected concordance of 24.2% for adults, 24.9% for children, and 6.3% for neonates (excluding free text, considering one cause selection. On a population level, InterVA achieved a cause-specific mortality fraction accuracy of 0.546 for adults, 0.504 for children, and 0.404 for neonates. The comparison to SSP revealed four specific characteristics that lead to superior performance of SSP. Increases in chance-corrected concordance are attained by developing cause-by-cause models (2%, using all items as opposed to only the ones that mapped to InterVA items (7%, assigning probabilities to clusters of symptoms (6%, and using empirical

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

    Science.gov (United States)

    Hickey, Graeme L; Blackstone, Eugene H

    2016-08-01

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

  19. The clinical conscientiousness index: a valid tool for exploring professionalism in the clinical undergraduate setting.

    Science.gov (United States)

    Kelly, Martina; O'Flynn, Siun; McLachlan, John; Sawdon, Marina A

    2012-09-01

    The need to develop effective tools to measure professionalism continues to challenge medical educators; thus, as a follow-up to a recent examination of the "Conscientiousness Index" (CI, a novel measure of one facet of professionalism) in one setting with preclinical medical students, the authors aimed to investigate the validity of the CI as a proxy measure of professionalism in a different context and in the clinical phase of undergraduate medical education. In academic year 2009-2010, the authors collected data similar to those collected for the original preclinical study. In an effort to create a Clinical Conscientiousness Index (CCI) score, they collected the following information on 124 third-year medical students completing their clinical rotations: attendance, timeliness of assessment submissions, and completion of rotation evaluations. Then, they compared the resultant CCI scores with faculty views on professionalism and with formal assessments of students' professionalism (i.e., their portfolios and objective structured clinical examinations [OSCEs]). The authors demonstrate significant correlations between CCI scores and faculty views on professionalism (rS = 0.3; P = .001), and between CCI scores and OSCE score (rS = 0.237; P = .008), but not between CCI scores and portfolio assessment (rS = 0.084; P = .354). The authors also present relationships between CCI scores and demographics. The CCI is a practical, valid proxy measure of professionalism, achieving good correlation with faculty views on professionalism and clinical competency examinations, but not portfolio assessment, in one clinical undergraduate setting.

  20. VALIDITY AND RELIABILITY OF CLINICAL TESTS FOR THE SACROILIAC JOINT

    OpenAIRE

    2002-01-01

    Background: The sacroiliac joint (SIJ) can be a source of low back pain. The complexity of the system involving the SIJ and the varied SIJ pain referral pattern makes it difficult to clinically assess SIJ dysfunction. Despite the emergence of detail of the SIJ complex, the basis of the clinical tests has not been thoroughly investigated. Objective: To review the literature from the last decade dealing with the validity and reliability of clinical tests for SIJ dysfunction in order to determin...

  1. Verification and validation of diagnostic laboratory tests in clinical virology.

    Science.gov (United States)

    Rabenau, Holger F; Kessler, Harald H; Kortenbusch, Marhild; Steinhorst, Andreas; Raggam, Reinhard B; Berger, Annemarie

    2007-10-01

    This review summarizes major issues of verification and validation procedures and describes minimum requirements for verification and validation of diagnostic assays in clinical virology including instructions for CE/IVD-labeled as well as for self-developed ("home-brewed") tests or test systems. It covers techniques useful for detection of virus specific antibodies, for detection of viral antigens, for detection of viral nucleic acids, and for isolation of viruses on cell cultures in the routine virology laboratory.

  2. Low-dose single acquisition rest {sup 99m}Tc/stress {sup 201}Tl myocardial perfusion SPECT protocol: phantom studies and clinical validation

    Energy Technology Data Exchange (ETDEWEB)

    Dey, Thomas [RWTH Aachen University, Institute of Imaging and Computer Vision, Aachen (Germany); Backus, Barbra E.; Romijn, R.Leo [St. Antonius Hospital, Department of Nuclear Medicine, Nieuwegein (Netherlands); Wieczorek, Herfried [Philips Research, Eindhoven (Netherlands); Verzijlbergen, J.F. [St. Antonius Hospital, Department of Nuclear Medicine, Nieuwegein (Netherlands); Erasmus Medical Center, Department of Nuclear Medicine, Rotterdam (Netherlands)

    2014-03-15

    We developed and tested a single acquisition rest {sup 99m}Tc-sestamibi/stress {sup 201}Tl dual isotope protocol (SDI) with the intention of improving the clinical workflow and patient comfort of myocardial perfusion single photon emission computed tomography (SPECT). The technical feasibility of SDI was evaluated by a series of anthropomorphic phantom studies on a standard SPECT camera. The attenuation map was created by a moving transmission line source. Iterative reconstruction including attenuation correction, resolution recovery and Monte Carlo simulation of scatter was used for simultaneous reconstruction of dual tracer distribution. For clinical evaluation, patient studies were compared to stress {sup 99m}Tc and rest {sup 99m}Tc reference images acquired in a 2-day protocol. Clinical follow-up examinations like coronary angiography (CAG) and fractional flow reserve (FFR) were included in the assessment if available. Phantom studies demonstrated the technical feasibility of SDI. Artificial lesions inserted in the phantom mimicking ischaemia could be clearly identified. In 51/53 patients, the image quality was adequate for clinical evaluation. For the remaining two obese patients with body mass index > 32 the injected {sup 201}Tl dose of 74 MBq was insufficient for clinical assessment. In answer to this the {sup 201}Tl dose was adapted for obese patients in the rest of the study. In 31 patients, SDI and {sup 99m}Tc reference images resulted in equivalent clinical assessment. Significant differences were found in 20 patients. In 18 of these 20 patients additional examinations were available. In 15 patients the diagnosis based on the SDI images was confirmed by the results of CAG or FFR. In these patients the SDI images were more accurate than the {sup 99m}Tc reference study. In three patients minor ischaemic lesions were detected by SDI but were not confirmed by CAG. In one of these cases this was probably caused by pronounced apical thinning. For two patients

  3. Transition questions in clinical practice - validity and reproducibility

    DEFF Research Database (Denmark)

    Lauridsen, Henrik Hein

    2008-01-01

    of construct validity and reproducibility of a TQ and make proposals for standardised use. One-hundred-and-ninety-one patients with low back pain and/or leg pain were followed over an 8-week period receiving 3 disability and 2 pain questionnaires together with a 7-point TQ. Reproducibility was determined using...... 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......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...

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

    Science.gov (United States)

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

    2017-01-31

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

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

    OpenAIRE

    2014-01-01

    Objective 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. Design 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-cou...

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

    Science.gov (United States)

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

    2006-01-01

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

  7. Validity of PROMIS® Physical Function Measures in Diverse Clinical Samples

    Science.gov (United States)

    Schalet, Benjamin D.; Hays, Ron D.; Jensen, Sally E.; Beaumont, Jennifer L.; Fries, James F.; Cella, David

    2016-01-01

    Objective To evaluate the validity of the PROMIS® Physical Function measures using longitudinal data collected in six chronic health conditions. Study Design and Setting Individuals with rheumatoid arthritis (RA), major depressive disorder (MDD), back pain, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF), and cancer completed the PROMIS Physical Function computerized adaptive test (CAT) or fixed-length short form (SF) at baseline and at the end of clinically-relevant follow-up intervals. Anchor items were also administered to assess change in physical function and general health. Linear mixed effects models and standardized response means were estimated at baseline and follow-up. Results 1415 individuals participated (COPD n = 121; CHF n = 57; back pain n = 218; MDD n = 196, RA n = 521; cancer n = 302). The PROMIS Physical Function scores improved significantly for treatment of CHF and back pain patients, but not for patients with MDD or COPD. Most of the patient subsamples that reported improvement or worsening on the anchors showed a corresponding positive or negative change in PROMIS Physical Function. Conclusion This study provides evidence that the PROMIS Physical Function measures are sensitive to change in intervention studies where physical function is expected to change and able to distinguish among different clinical samples. The results inform the estimation of meaningful change, enabling comparative effectiveness research. PMID:26970039

  8. 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…

  9. 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…

  10. 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.

    2009-01-01

    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 s

  11. Reliability and validation of a behavioral model of clinical behavioral formulation

    Directory of Open Access Journals (Sweden)

    Amanda M Muñoz-Martínez

    2011-05-01

    Full Text Available The aim of this study was to determine the reliability and content and predictive validity of a clinical case formulation, developed from a behavioral perspective. A mixed design integrating levels of descriptive analysis and A-B case study with follow-up was used. The study established the reliability of the following descriptive and explanatory categories: (a problem description, (b predisposing factors, (c precipitating factors, (d acquisition and (e inferred mechanism (maintenance. The analysis was performed on cases from 2005 to 2008 formulated with the model derived from the current study. With regards to validity, expert judges considered that the model had content validity. The predictive validity was established across application of model to three case studies. Discussion shows the importance of extending the investigation with the model in other populations and to establish the clinical and concurrent validity of the model.

  12. Experimental design and reporting standards for improving the internal validity of pre-clinical studies in the field of pain: Consensus of the IMI-Europain consortium

    DEFF Research Database (Denmark)

    Knopp, K.L.; Stenfors, C.; Baastrup, Cathrine Søndergaard

    2015-01-01

    , and significantly impacts the interpretation of failed attempts to replicate published findings. Evidence suggests that systematic biases in experimental design and conduct and insufficiencies in reporting play significant roles in poor reproducibility across pre-clinical studies. It then follows...... is focused on two aspects: experimental design and conduct, and study reporting. Results Minimum requirements for experimental design and conduct were agreed upon across the dimensions of animal characteristics, sample size calculations, inclusion and exclusion criteria, random allocation to groups......, allocation concealment, and blinded assessment of outcome. Building upon the Animals in Research: Reporting in vivo Experiments (ARRIVE) guidelines, reporting standards were developed for pre-clinical studies of pain. These include specific recommendations for reporting on ethical issues, experimental design...

  13. VALIDATION OF TWO CLINICAL MEASURES OF CORE STABILITY.

    Science.gov (United States)

    Butowicz, Courtney M; Ebaugh, D David; Noehren, Brian; Silfies, Sheri P

    2016-02-01

    Emerging evidence suggests poor core stability is a risk factor for low back and lower extremity injuries in athletes. Recently the trunk stability test (TST) and unilateral hip bridge endurance test (UHBE) were developed to clinically assess core stability. Although these and other clinical tests of core stability exist, how well they assess core stability when compared to biomechanical measures of isolated core stability has not been thoroughly evaluated. The purposes of this study were to 1) determine concurrent validity of two novel clinical core stability assessments (TST and UHBE), and 2) assess relationships between these assessments and the trunk endurance and Y-Balance tests. The authors' hypothesized that the TST and UHBE would be highly correlated to the lab-based biomechanical measure of isolated core stability. Also, the TST and UHBE would be moderately correlated with each other, but not with the trunk extensor endurance and Y-Balance. Cross-Sectional design. Twenty healthy active individuals completed the TST (recorded number of errors), UHBE (s), trunk extensor endurance (s), Y-Balance (% leg length) test (YBT), and biomechanical test of core stability. Correlational analyses revealed a small, non-significant association between TST and biomechanical measures (rs = 0.2 - 0.22), while a moderate, significant relationship existed between UHBE and biomechanical measures (rs = -0.49 to -0.56, p core stability. The poor relationship between the TST and biomechanical measures, combined with observation of most control faults occurring in the lower extremity (LE) suggest the TST may not be an appropriate clinical test of core stability. Level 3.

  14. Prognostic Validity of Clinical and Psychometric Variables in Psychogeriatric Inpatients.

    Science.gov (United States)

    Appell, Julian; Kazarian, Shahe S.

    1990-01-01

    Evaluated prognostic validity of clinical and psychometric variables in psychogeriatric inpatients. Divided elderly patients into three outcome groups: nondischarged (n=29), discharged-readmitted (n=38), and discharged-nonreadmitted (n=67). Discriminant analysis of data yielded two predictive functions, which appeared to represent physical status…

  15. Validation of Malingered Amnesia Measures with a Large Clinical Sample.

    Science.gov (United States)

    Greiffenstein, Manfred F.; And Others

    1994-01-01

    A sample of chronic postconcussive patients with and without overt malingering signs was compared with objectively brain-injured patients (total sample=106) on common episodic memory and malingered amnesia measures. Findings validate commonly cited malingering measures and new methods of classifying malingering in real-world clinical samples. (SLD)

  16. Self-reported adherence with the use of a device in a clinical trial as validated by electronic monitors: the VIBES study

    Directory of Open Access Journals (Sweden)

    Jeffrey Brianne A

    2012-11-01

    Full Text Available Abstract Background Adherences to treatments that require a behavioral action often rely on self-reported recall, yet it is vital to determine whether real time self reporting of adherence using a simple logbook accurately captures adherence. The purpose of this study was to determine whether real time self-reported adherence is an accurate measurement of device usage during a clinical trial by comparing it to electronic recording. Methods Using data collected from older adult men and women (N=135, mean age 82.3 yrs; range 66 to 98 yrs participating in a clinical trial evaluating a vibrating platform for the treatment of osteoporosis, daily adherence to platform treatment was monitored using both self-reported written logs and electronically recorded radio-frequency identification card usage, enabling a direct comparison of the two methods over one year. Agreement between methods was also evaluated after stratification by age, gender, time in study, and cognition status. Results The two methods were in high agreement (overall intraclass correlation coefficient = 0.96. The agreement between the two methods did not differ between age groups, sex, time in study and cognitive function. Conclusions Using a log book to report adherence to a daily intervention requiring a behavioral action in older adults is an accurate and simple approach to use in clinical trials, as evidenced by the high degree of concordance with an electronic monitor. Trial registration Clinicaltrials.gov NCT00396994

  17. Validity and Reliability of pre-internship Objective Structured Clinical Examination in Shiraz Medical School

    Directory of Open Access Journals (Sweden)

    NARGES VASEGHI

    2013-07-01

    Full Text Available Introduction: Objective Structured Clinical Examination (OSCE is one of the most appropriate methods for assessment of clinical skills.Validity and reliability assurance is a mandatory factor for any assessment tool. In Shiraz University of Medical Sciences, medical students’ clinical competences are evaluated by a pre-internship OSCE. This study is designed to examine the validity and reliability of this exam. Validity is the extent to which the test measures what it intends to measure. Reliability refers to the accuracy of measurement and the consistency of test results. Methods: Content validity was evaluated by expert opinion about blueprinting and station checklists. To determine the construct validity, station scores correlation with the total OSCE score and inter station correlations were calculated. The inter examiner reliability was assessed by coefficient of correlation. Results: Content validity was established by alignment between the curriculum and the blueprint using expert opinion. Correlation of the station scores with the total OSCE score were positive and statistically significant in all stations except the 16th station (suturing. Inter examiner reliability coefficients of correlations ranged 0.33 – 0.99, with an average of 0.83. Conclusions: Our findings support the assumption that the pre-internship OSCE is valid, reliable and suitable to assess students’ clinical competence. Validity and reliability studies should be performed for all new assessment tools, particularly in high-stakes assessments.

  18. Clinical validation and calibration of in vitro peroxide tooth whitening.

    Science.gov (United States)

    Putt, Mark S; Moore, Michael H; Milleman, Jeffery L; Milleman, Kimberly R; Thong, Stephen H; Vorwerk, Linda M; Charig, Andrew J; Nelson, Bruce J; Winston, Anthony E

    2009-01-01

    The purpose of this study was to validate and calibrate an in vitro test method for screening the performance of peroxide-containing toothpastes against actual clinical whitening performance. An additional objective was to estimate the whitening performance of a new peroxide-additive gel using the in vitro methodology. A one-month longitudinal clinical study was performed to provide a benchmark for the in vivo intrinsic whitening performance of a peroxide-containing fluoride toothpaste. An in vitro study was then conducted, using freshly prepared slurries of the same peroxide-containing toothpaste in artificial saliva, to repeatedly treat extracted human teeth with natural intrinsic stain. The effect of cumulative treatment time on whiteness was determined using objective chromometer whiteness measurements (L*, a*, and b*), and more subjective Vita Shade guide (Vitapan) comparisons, and the results were correlated. A non-peroxide fluoride toothpaste was used as a negative control. The peroxide gel additive, combined in a 1:1 ratio with each of two non-peroxide toothpastes and diluted in artificial saliva, was evaluated using the same instrumental and subjective measures for in vitro whitening efficacy. The previously evaluated peroxide toothpaste and one of the non-peroxide toothpastes were used as positive and negative controls, respectively. In the clinical study, the peroxide-containing toothpaste produced a linear increase in tooth whiteness with time, achieving an approximately two Vita Shade guide improvement in whiteness at the end of four weeks. The same peroxide toothpaste in vitro produced a curvilinear increase in tooth whiteness versus cumulative treatment time, with a two-shade increase being achieved in 116 minutes. The non-peroxide control toothpaste produced less than half a shade guide increase in whiteness within the first 30 minutes, and none thereafter. Both the clinical and in vitro studies indicated that further whitening can be obtained with

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

    Science.gov (United States)

    Skúladóttir, Hafdís; Svavarsdóttir, Margrét Hrönn

    2016-09-01

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

  20. Clinical validation of simultaneous dual-isotope myocardial scintigraphy

    Energy Technology Data Exchange (ETDEWEB)

    Weinmann, Pierre; Moretti, Jean Luc [Department of Nuclear Medicine, Avicenne Hospital, Paris XIII University, 125, Rue de Stalingrad, 93 009 Bobigny Cedex (France); Faraggi, Marc [Department of Nuclear Medicine, Bichat Hospital, Paris VII University (France); Hannequin, Pascal [Centre d' Imagerie Nucleaire, Annecy (France)

    2003-01-01

    Simultaneous dual-isotope (rest thallium-201/stress technetium-99m sestamibi) myocardial single-photon emission tomography (SPET) would be an ideal procedure; however, {sup 99m}Tc cross-talk on the {sup 201}Tl window hampers its routine use. Photon energy recovery (PER) is a spectral deconvolution technique validated for scatter and cross-talk removal in phantom studies and a limited series of patients. In this study we aimed to validate the technique in 295 patients within a context of clinical routine practice. Conventional separate rest {sup 201}Tl myocardial SPET data sets were visually compared with simultaneous dual-isotope data sets corrected by PER. Conventional separate rest {sup 201}Tl data sets were identical to dual PER-corrected {sup 201}Tl data sets in 173 (58.6%) patients. As dual PER {sup 201}Tl data sets are corrected for {sup 99m}Tc cross-talk but also for {sup 201}Tl scatter, they were compared with separate rest {sup 201}Tl data sets corrected by PER in the 122 discordant patients. No difference was found in 77 (26.1%) patients. In 26 (8.8%) patients, the difference consisted in the presence of a defect on dual PER {sup 201}Tl data sets only, mirroring an ischaemic defect on {sup 99m}Tc-sestamibi data sets. This difference can be attributed to the influence of stress on the kinetics of {sup 201}Tl injected at rest. In the remaining 19 (6.4%) patients, the difference between separate and simultaneous PER-corrected data sets was scored as mild in 11 and moderate in eight patients and seemed to be related to multiple methodological factors. It is concluded that PER correctly removes {sup 99m}Tc cross-talk. With the addition of an appropriate attenuation correction, the PER technique may allow the routine use of simultaneous dual-isotope myocardial scintigraphy in the near future. (orig.)

  1. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... Children & Clinical Studies NHLBI Trials Clinical Trial Websites Children and Clinical Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to ...

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

    Directory of Open Access Journals (Sweden)

    David A Springate

    Full Text Available 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.

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

    Science.gov (United States)

    Graham, Roseanna

    2010-01-01

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

  4. 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.…

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

    NARCIS (Netherlands)

    Plochg, T.; Arah, O.A.; Botje, D.; Thompson, C.A.; Klazinga, N.S.; Wagner, C.; Mannion, R.; Lombarts, K.

    2014-01-01

    Objective: 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. Design: T

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

    Science.gov (United States)

    Fernandes, Helder Miguel; Vasconcelos-Raposo, Jose

    2013-01-01

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

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

    Science.gov (United States)

    Fernandes, Helder Miguel; Vasconcelos-Raposo, Jose

    2013-01-01

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

  8. Thinking and Creative Styles: A Validity Study

    Science.gov (United States)

    Wechsler, Solange Muglia; Vendramini, Claudette Maria Medeiros; Oakland, Thomas

    2012-01-01

    The validity evidences of thinking and creative styles were analyzed. Two studies are reported, one analyzing the dimensionality of creative styles and the other verifying their external validity. Participants were Brazilians, 1,752 in the first study (55% women) and 128 in the second study (53% women), among whom 45% had demonstrated creative…

  9. Big Data Clinical Research: Validity, Ethics, and Regulation.

    Science.gov (United States)

    Balas, E Andrew; Vernon, Marlo; Magrabi, Farah; Gordon, Lynne Thomas; Sexton, Joanne

    2015-01-01

    Electronic Health Records (EHR) promise improvement for patient care and also offer great value for biomedical research including clinical, public health, and health services research. Unfortunately, the full potential of EHR big data research has remained largely unrealized. The purpose of this study was to identify rate limiting factors, and develop recommendations to better balance unrestricted extramural EHR access with legitimate safeguarding of EHR data in retrospective research. By exploring primary, secondary, and tertiary sources, this review identifies external constraints and provides a comparative analysis of social influencers in retrospective EHR-based research. Results indicate that EHRs have the advantage of reflecting the reality of patient care but also show a frequency of between 4.3-86% of incomplete and inaccurate data in various fields. The rapid spread of alternative analytics for health data challenges traditional interpretations of confidentiality protections. A confusing multiplicity of controls creates barriers to big data EHR research. More research on the use of EHR big data is likely to improve accuracy and validity. Information governance and research approval processes should be simplified. Comprehensive regulatory policies that do not exclusively cover health care entities, are needed. Finally, new computing safeguards are needed to address public concerns, like research access only to aggregate data and not to individually identifiable information.

  10. Near-infrared fluorescence-guided surgery : pre-clinical validation and clinical translation

    NARCIS (Netherlands)

    Vorst, Joost Renier van der

    2014-01-01

    This thesis focus on preclinical validation of novel fluorescent contrast agents for solid tumor imaging (Part I), the clinical introduction of NIR fluorescence sentinel lymph node imaging in several cancer types using indocyanine green (Part II) and the clinical translation of NIR fluorescence imag

  11. Development and validation of evaluation tools of nursing students’ clinical pharmacology unit

    Science.gov (United States)

    Navabi, Nasrin; Ghaffari, Fatemeh; Shamsalinia, Abbas; Faghani, Safieh

    2016-01-01

    Introduction The need for valid, reliable, and objective tools has always been emphasized in studies related to the clinical assessment of nursing students. The aims of this study were to develop and assess the validity and reliability of the tools used to evaluate the clinical pharmacology unit. Methods This study was a methodological one, conducted in 2016. An item pool was developed based on the literature review and personal interviews with faculty members. The tool’s validity was determined through assessment of face validity, content validity, and construct validity, using exploratory factor analysis on the data provided by 264 second- and third-semester nursing students of the Islamic Azad University of Babol University of Medical Sciences. Reliability was determined through internal and external consistency, using a Cronbach’s coefficient of the correlation between classes. Results Based on the exploratory factor analysis, all items with a special value of >1 were grouped into six factors: 1) professional behavior; 2) effective communication; 3) recognition of medical terminology; 4) nursing actions before administering medicine; 5) nursing actions while administering medicine; and 6) nursing actions after administering medicine. These factors explained 77% of the total variance of the concept of assessment of the clinical pharmacology unit. In this study, reliability was demonstrated by a Cronbach’s alpha coefficient of 0.96; the correlation coefficient between floors for the total tool was 0.91, ranging from 0.64 to 0.89 in its dimensions. Conclusion The evaluation tool of the clinical pharmacology unit has an acceptable construct validity and satisfactory reliability and validity. Therefore, it can be used to evaluate the clinical pharmacology unit in the nursing education system in Iran. PMID:28008285

  12. A Comparison of Second- and Fourth-Year Medical Students on a Standardized-Patient Examination of Clinical Competence: A Construct Validity Study.

    Science.gov (United States)

    Barnhart, Amber J.; And Others

    The construct validity of the standardized-patient (SP) examination used at Southern Illinois University (Springfield) School of Medicine was assessed by comparing 66 second-year and 70 fourth-year medical students on 5 SP cases. The results show sizable differences between the groups. The usefulness of passing rates the effect-size measures as a…

  13. The validity of DSM-IV-TR criteria B and C of hair-pulling disorder (trichotillomania): evidence from a clinical study.

    Science.gov (United States)

    Lochner, Christine; Stein, Dan J; Woods, Douglas; Pauls, David L; Franklin, Martin E; Loerke, Elizabeth H; Keuthen, Nancy J

    2011-09-30

    In both DSM-IV-TR and the ICD-10, hair-pulling disorder (trichotillomania, or TTM) is described as hair-pulling, with a rising urge or tension prior to pulling or when attempting to resist, and pleasure, relief or gratification during or after pulling. However, it has been questioned whether all patients with hair-pulling experience these other phenomena, and whether they occur with all pulling episodes. The objective of this study was to examine the DSM-IV-TR requirement of criteria B and C for a diagnosis of TTM in a sample of people with hair-pulling. A multi-site sample of adults with hair-pulling who met both DSM-IV-TR diagnostic criteria B and C (n=82, 89.13%) were compared to those who failed to satisfy both B and C (n=10, 10.87%) on a number of clinical variables. There were no differences in hair-pulling severity, levels of comorbid depressive and anxiety symptoms, number of comorbid body-focused repetitive behaviors, or impairment between those patients who did and did not meet criteria B and C. Our study does not provide convincing support for the inclusion of the current diagnostic criteria B and C for TTM in DSM-5.

  14. Study of clinical nurses scientific research integrity awareness scale reliability and validity%临床护士科研诚信意识量表信度和效度的研究

    Institute of Scientific and Technical Information of China (English)

    刘美满; 周霞; 郑亚光

    2013-01-01

      目的编制临床护士科研诚信意识量表,并对其进行信度和效度的评价。方法参阅大量文献,收集资料,并通过与对科研诚信方面研究较深的护理专家进行深度访谈,完成量表编制。用临床护士科研诚信意识量表对286名临床护士进行调查,对测定结果进行信效度分析。结果量表的内容效度指数为0.885,同质性信度系数为0.883,重测信度为0.878。结论临床护士科研诚信意识量表具有较好的信效度,可用于测评临床护士科研诚信意识状况。%Objective To design the scale of scientific research integrity awareness among clinical nurses and study its reliability and validity.Methods The scale were completed by reviewing literature,collecting data and interviewing nursing specialists.A total of 286 clinical nurses were investigated by the scale for the research in its reliability and validity.Results The index of content validity was 0.885,and the reliability was 0.883 and the test-retest reliability was 0.878.Conclusion The scale is reliable and valid when used for assessing the integrity awareness of nurses.

  15. Determination of body composition from skinfold thickness: a validation study.

    OpenAIRE

    Reilly, J J; Wilson, J.; Durnin, J V

    1995-01-01

    Measurement of body composition is proving increasingly important in clinical nutrition and research. Skinfold thickness is a simple means of estimating body composition which is widely used in children, but there is little information on its validity. There has been a proliferation of equations for estimation of body composition from skinfolds, but some doubt as to their general applicability. The aim of the present study was to validate five currently used equations for this purpose in a sa...

  16. The diagnosis of urinary tract infections in young children (DUTY: protocol for a diagnostic and prospective observational study to derive and validate a clinical algorithm for the diagnosis of UTI in children presenting to primary care with an acute illness

    Directory of Open Access Journals (Sweden)

    Downing Harriet

    2012-07-01

    Full Text Available Abstract Background Urinary tract infection (UTI is common in children, and may cause serious illness and recurrent symptoms. However, obtaining a urine sample from young children in primary care is challenging and not feasible for large numbers. Evidence regarding the predictive value of symptoms, signs and urinalysis for UTI in young children is urgently needed to help primary care clinicians better identify children who should be investigated for UTI. This paper describes the protocol for the Diagnosis of Urinary Tract infection in Young children (DUTY study. The overall study aim is to derive and validate a cost-effective clinical algorithm for the diagnosis of UTI in children presenting to primary care acutely unwell. Methods/design DUTY is a multicentre, diagnostic and prospective observational study aiming to recruit at least 7,000 children aged before their fifth birthday, being assessed in primary care for any acute, non-traumatic, illness of ≤ 28 days duration. Urine samples will be obtained from eligible consented children, and data collected on medical history and presenting symptoms and signs. Urine samples will be dipstick tested in general practice and sent for microbiological analysis. All children with culture positive urines and a random sample of children with urine culture results in other, non-positive categories will be followed up to record symptom duration and healthcare resource use. A diagnostic algorithm will be constructed and validated and an economic evaluation conducted. The primary outcome will be a validated diagnostic algorithm using a reference standard of a pure/predominant growth of at least >103, but usually >105 CFU/mL of one, but no more than two uropathogens. We will use logistic regression to identify the clinical predictors (i.e. demographic, medical history, presenting signs and symptoms and urine dipstick analysis results most strongly associated with a positive urine culture result. We will

  17. Nursing outcomes content validation according to Nursing Outcomes Classification (NOC) for clinical, surgical and critical patients.

    Science.gov (United States)

    Seganfredo, Deborah Hein; Almeida, Miriam de Abreu

    2011-01-01

    The objective of this study was to validate the Nursing Outcomes (NO) from the Nursing Outcomes Classification (NOC) for the two Nursing Diagnoses (ND) most frequent in hospitalized surgical, clinical and critical patients. The content validation of the REs was performed adapting the Fehring Model. The sample consisted of 12 expert nurses. The instrument for data collection consisted of the NOs proposed by NOC for the two NDs in the study, its definition and a five-point Likert scale. The data were analyzed using descriptive statistics. The NOs that obtained averages of 0.80 or higher were validated. The ND Risk for Infection was the most frequent, being validated eight (38.1%) of 21 NOs proposed by the NOC. The ND Self-Care Deficit: Bathing/Hygiene was the second most frequent and five (14.28%) out of 35 NOs were validated.

  18. 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.

  19. Reliability and Validity of the Objective Structured Clinical Examination in the Evaluation of Clinical Skills of Midwifery Students (Kashan, 2014

    Directory of Open Access Journals (Sweden)

    Saeideh Nasiri

    2015-09-01

    Full Text Available This study was conducted to determine the validity and reliability of OSCE in evaluating the clinical skills of midwifery students at Kashan University of Medical Sciences in 2014. This descriptive-correlational study was carried out on 23 senior midwifery students. The OSCE scores were calculated according to the structured objective checklists. Content and criterion validity and reliability were also assessed. The obtained data were analyzed by SPSS-16 using ANOVA and Spearman correlation coefficients. There was a significant relationship between the clinical scores and the OSCE score (P=0.03. The reliability results of the evaluation of stations by two observers showed that the lowest and highest correlation coefficients between observers were 0.58 and 1.00, respectively. Owing to good reliability and validity of this test in the first period of its implementation in Kashan, it can be recommended for subsequent periods as part of the final exam for midwifery students.

  20. Objective Structured Clinical Examinations Provide Valid Clinical Skills Assessment in Emergency Medicine Education

    Directory of Open Access Journals (Sweden)

    Wallenstein, Joshua

    2014-12-01

    Full Text Available Introduction: Evaluation of emergency medicine (EM learners based on observed performance in the emergency department (ED is limited by factors such as reproducibility and patient safety. EM educators depend on standardized and reproducible assessments such as the objective structured clinical examination (OSCE. The validity of the OSCE as an evaluation tool in EM education has not been previously studied. The objective was to assess the validity of a novel management-focused OSCE as an evaluation instrument in EM education through demonstration of performance correlation with established assessment methods and case item analysis. Methods: We conducted a prospective cohort study of fourth-year medical students enrolled in a required EM clerkship. Students enrolled in the clerkship completed a five-station EM OSCE. We used Pearson’s coefficient to correlate OSCE performance with performance in the ED based on completed faculty evaluations. Indices of difficulty and discrimination were computed for each scoring item. Results: We found a moderate and statistically-significant correlation between OSCE score and ED performance score [r(239 =0.40, p<0.001]. Of the 34 OSCE testing items the mean index of difficulty was 63.0 (SD =23.0 and the mean index of discrimination was 0.52 (SD =0.21. Conclusion: Student performance on the OSCE correlated with their observed performance in the ED, and indices of difficulty and differentiation demonstrated alignment with published best-practice testing standards. This evidence, along with other attributes of the OSCE, attest to its validity. Our OSCE can be further improved by modifying testing items that performed poorly and by examining and maximizing the inter-rater reliability of our evaluation instrument. [West J Emerg Med. 2015;16(1:121–126.

  1. 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 desc......, and is available in 14 languages. Taking into account the increasing differentiation of Alzheimer's disease in preclinical and predementia stages, there is an urgent need for global rating scales to be refined as well.......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...

  2. The Possible Clinical Predictors of Fatigue in Parkinson’s Disease: A Study of 135 Patients as Part of International Nonmotor Scale Validation Project

    Directory of Open Access Journals (Sweden)

    Vinod Metta

    2011-01-01

    Full Text Available Fatigue is a common yet poorly understood and underresearched nonmotor symptom in Parkinson’s disease. Although fatigue is recognized to significantly affect health-related quality of life, it remains underrecognised and empirically treated. In this paper, the prevalence of fatigue as measured by a validated visual analogue scale and the Parkinson’s disease nonmotor symptoms scale (PDNMSS was correlated with other motor and nonmotor comorbidities. In a cohort of patients from a range of disease stages, occurrence of fatigue correlated closely with more advanced Parkinson’s disease, as well as with depression, anxiety, and sleep disorders, hinting at a common underlying basis.

  3. The reliability, validity, and usefulness of the Objective Structured Clinical Examination (OSCE) in dental education

    Science.gov (United States)

    Graham, Roseanna

    This study evaluated the reliability, validity, and educational usefulness of a comprehensive, multidisciplinary Objective Structured Clinical Examination (OSCE) in dental education. The OSCE was administered to dental students at the Columbia University College of Dental Medicine (CDM) before they entered clinical training. Participants in this study included CDM's class of 2010 which consisted of 78 students. The overall reliability of the examination was measured via calculation of Cronbach's alpha. Content validity was examined through evaluation of the OSCE by three experienced clinical faculty members. Predictive validity was evaluated by correlating student grades on the OSCE to future clinical performance as measured by number of clinical points achieved during the third year of training. Student perceptions regarding the educational usefulness of the examination were evaluated through a 12-question Liken-type survey and focus group interviews analyzed using a phenomenological approach. Findings of the study indicated the OSCE was a highly reliable examination (alpha=0.86) with high content validity and a moderately high correlation to future clinical performance (r=.614, p<.0001). Overall, student perceptions of the educational usefulness of the OSCE were positive as based on their responses to a 5-point Likert scale (1=strongly disagree and 5=strongly agree). They reported that the exam required the ability to think critically and problem-solve (4.0 +/- 0.85), assessed clinically relevant skills (4.59 +/- 0.69), helped identify clinical weaknesses (4.16 +/- 0.90), and was a learning experience (4.58 +/- 0.84). Findings from the qualitative portion of the study identified four main themes including the student perception that the OSCE is a unique assessment experience that required integration and application of knowledge. Recommendations for the use of the OSCE to improve clinical teaching and the implications of this study relating to the expanded use of

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

    DEFF Research Database (Denmark)

    Østergaard, Søren Dinesen; 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 ...

  5. Objective Assessment of Hypernasality in Patients with Cleft Lip and Palate with the NasalView System: A Clinical Validation Study.

    Science.gov (United States)

    Wermker, Kai; Jung, Susanne; Joos, Ulrich; Kleinheinz, Johannes

    2012-01-01

    Introduction. The objective of this investigation was to evaluate the reliability and validity of the NasalView system as a screening tool for hypernasality within the scope of a routine diagnostic procedure in cleft lip and palate patients. Material and Methods. In a collective of 95 patients with cleft and lip palate ranging from 4 to 25 years of age, hypernasality was exploited perceptually, patients were classified in four degrees, and nasalance was measured objectively with the NasalView system. Speech stimuli existed in one nasal and one nonnasal sentence; nasalance ratio and distance were calculated. Results. The test-retest error was within a range of 2%. Sensitivity ranged from 83.3% to 91.1% for the nonnasal sentence, from 70% to 78.4% for nasalance ratio and from 68.1% to 81.1% for nasalance distance. Specifity ranged from 87% to 93.1% for the nonnasal sentence, from 69.6% to 97.5% for nasalance ratio, and from 70.7% to 73.9% for nasalance distance. Conclusions. With a quick and gentle screening procedure, it is easily possible to identify hypernasal patients by an objective diagnostic tool of hypernasality, the NasalView system, with good reliability and validity.

  6. Extension and validation of an analytical model for in vivo PET verification of proton therapy--a phantom and clinical study

    NARCIS (Netherlands)

    Attanasi, F; Knopf, A; Parodi, K.; Paganetti, Harald; Bortfeld, Thomas; Rosso, V; Del Guerra, Alberto

    2011-01-01

    The interest in positron emission tomography (PET) as a tool for treatment verification in proton therapy has become widespread in recent years, and several research groups worldwide are currently investigating the clinical implementation. After the first off-line investigation with a PET/CT scanner

  7. Data from clinical database on septic shock are valid

    DEFF Research Database (Denmark)

    Grønlykke, Lars; Brandstrup, Sofie Louise Rygaard; Perner, Anders

    2012-01-01

    Clinical databases have become important tools in intensive care. Disease severity and organ dysfunction scoring systems are registered in the databases, including the Simplified Acute Physiology Score II (SAPS II) and the Sequential Organ Failure Assessment (SOFA) score. The purpose of this study...... was to evaluate the reliability and accuracy of a clinical database on intensive care unit (ICU) patients....

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

    OpenAIRE

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

    2006-01-01

    Use of instruments or questionnaires in different cultural settings without proper validation can result in inaccurate results. Issues like reliability, validity, feasibility and acceptability should be considered in the use of an instrument. The study aims to determine the usefulness of the CIS-R Malay version in detecting common mental health problems specifically to establish the validity. The CIS-R instrument (PROQSY* format) was translated through the back translation process into Malay....

  9. Prolactinomas : clinical studies

    NARCIS (Netherlands)

    Kars, Marleen

    2008-01-01

    Prolactinoma are treated with dopamine agonists, which are effective in reducing prolactin and tumor size. Studies reporting clinical and radiological outcome are scarce. The study described in chapter 2, assesses long-term outcome in patients treated with dopamine agonists for macroprolactinoma. An

  10. Prolactinomas : clinical studies

    NARCIS (Netherlands)

    Kars, Marleen

    2008-01-01

    Prolactinoma are treated with dopamine agonists, which are effective in reducing prolactin and tumor size. Studies reporting clinical and radiological outcome are scarce. The study described in chapter 2, assesses long-term outcome in patients treated with dopamine agonists for macroprolactinoma. An

  11. 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…

  12. 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…

  13. Data-mining to build a knowledge representation store for clinical decision support. Studies on curation and validation based on machine performance in multiple choice medical licensing examinations.

    Science.gov (United States)

    Robson, Barry; Boray, Srinidhi

    2016-06-01

    Extracting medical knowledge by structured data mining of many medical records and from unstructured data mining of natural language source text on the Internet will become increasingly important for clinical decision support. Output from these sources can be transformed into large numbers of elements of knowledge in a Knowledge Representation Store (KRS), here using the notation and to some extent the algebraic principles of the Q-UEL Web-based universal exchange and inference language described previously, rooted in Dirac notation from quantum mechanics and linguistic theory. In a KRS, semantic structures or statements about the world of interest to medicine are analogous to natural language sentences seen as formed from noun phrases separated by verbs, prepositions and other descriptions of relationships. A convenient method of testing and better curating these elements of knowledge is by having the computer use them to take the test of a multiple choice medical licensing examination. It is a venture which perhaps tells us almost as much about the reasoning of students and examiners as it does about the requirements for Artificial Intelligence as employed in clinical decision making. It emphasizes the role of context and of contextual probabilities as opposed to the more familiar intrinsic probabilities, and of a preliminary form of logic that we call presyllogistic reasoning. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural Research Research Resources Research Meeting Summaries Technology Transfer Clinical Trials What Are Clinical Trials? Children & Clinical Studies NHLBI Trials Clinical Trial Websites News & ...

  15. Design and validation of a qPCR assay for accurate detection and initial serogrouping of Legionella pneumophila in clinical specimens by the ESCMID Study Group for Legionella Infections (ESGLI).

    Science.gov (United States)

    Mentasti, M; Kese, D; Echahidi, F; Uldum, S A; Afshar, B; David, S; Mrazek, J; De Mendonça, R; Harrison, T G; Chalker, V J

    2015-07-01

    Prompt detection of Legionella pneumophila is essential for rapid investigation of legionellosis. Furthermore, as the majority of L. pneumophila infections are caused by serogroup 1 (sg1) strains, rapid identification of such strains can be critical in both routine and outbreak scenarios. The ESCMID Study Group for Legionella Infections (ESGLI) was established in 2012 and immediately identified as a priority the validation of a reliable, easy to perform and interpret, cost-effective qPCR assay to standardise the detection of L. pneumophila DNA amongst members. A novel L. pneumophila assay targeting the mip gene was designed and combined with previously published methodologies amplifying the sg1 marker (wzm) and the green fluorescent protein gene (gfp) internal process control. The resulting triplex assay was validated internationally on the three qPCR platforms used by the majority of European Legionella reference laboratories: ABI 7500 (Life Technologies), LightCycler 480 Instrument II (Roche) and Rotor-Gene Q (Qiagen). Clinical and EQA specimens were tested together with a large panel of strains (251 in total) to validate the assay. The assay proved to be 100% specific for L. pneumophila and sg1 DNA both in silico and in vitro. Efficiency values for mip and wzm assays ranged between 91.97 and 97.69%. Limit of detection values estimated with 95% confidence were adopted for mip and wzm assays on all three qPCR platforms. Inhibition was not observed. This study describes a robust assay that could be widely implemented to standardise the molecular detection of L. pneumophila among ESGLI laboratories and beyond.

  16. Sample Preparation and Extraction in Small Sample Volumes Suitable for Pediatric Clinical Studies: Challenges, Advances, and Experiences of a Bioanalytical HPLC-MS/MS Method Validation Using Enalapril and Enalaprilat

    Directory of Open Access Journals (Sweden)

    Bjoern B. Burckhardt

    2015-01-01

    Full Text Available In USA and Europe, medicines agencies force the development of child-appropriate medications and intend to increase the availability of information on the pediatric use. This asks for bioanalytical methods which are able to deal with small sample volumes as the trial-related blood lost is very restricted in children. Broadly used HPLC-MS/MS, being able to cope with small volumes, is susceptible to matrix effects. The latter restrains the precise drug quantification through, for example, causing signal suppression. Sophisticated sample preparation and purification utilizing solid-phase extraction was applied to reduce and control matrix effects. A scale-up from vacuum manifold to positive pressure manifold was conducted to meet the demands of high-throughput within a clinical setting. Faced challenges, advances, and experiences in solid-phase extraction are exemplarily presented on the basis of the bioanalytical method development and validation of low-volume samples (50 μL serum. Enalapril, enalaprilat, and benazepril served as sample drugs. The applied sample preparation and extraction successfully reduced the absolute and relative matrix effect to comply with international guidelines. Recoveries ranged from 77 to 104% for enalapril and from 93 to 118% for enalaprilat. The bioanalytical method comprising sample extraction by solid-phase extraction was fully validated according to FDA and EMA bioanalytical guidelines and was used in a Phase I study in 24 volunteers.

  17. Towards validating use of self reported health (SRH) for community-based studies: Impact of environmental chemicals, sociodemographic variables, depression, and clinical indicators of health and nutrition

    Science.gov (United States)

    Environmental health impact assessment (HIA) studies, should consider social, behavioral, nutritional, dietary, environmental exposure and health risk factors at both the individual and community levels. Chemicals measured in blood or urine are often evaluated in relation to one ...

  18. Revealing Latent Value of Clinically Acquired CTs of Traumatic Brain Injury Through Multi-Atlas Segmentation in a Retrospective Study of 1,003 with External Cross-Validation.

    Science.gov (United States)

    Plassard, Andrew J; Kelly, Patrick D; Asman, Andrew J; Kang, Hakmook; Patel, Mayur B; Landman, Bennett A

    2015-03-20

    Medical imaging plays a key role in guiding treatment of traumatic brain injury (TBI) and for diagnosing intracranial hemorrhage; most commonly rapid computed tomography (CT) imaging is performed. Outcomes for patients with TBI are variable and difficult to predict upon hospital admission. Quantitative outcome scales (e.g., the Marshall classification) have been proposed to grade TBI severity on CT, but such measures have had relatively low value in staging patients by prognosis. Herein, we examine a cohort of 1,003 subjects admitted for TBI and imaged clinically to identify potential prognostic metrics using a "big data" paradigm. For all patients, a brain scan was segmented with multi-atlas labeling, and intensity/volume/texture features were computed in a localized manner. In a 10-fold cross-validation approach, the explanatory value of the image-derived features is assessed for length of hospital stay (days), discharge disposition (five point scale from death to return home), and the Rancho Los Amigos functional outcome score (Rancho Score). Image-derived features increased the predictive R(2) to 0.38 (from 0.18) for length of stay, to 0.51 (from 0.4) for discharge disposition, and to 0.31 (from 0.16) for Rancho Score (over models consisting only of non-imaging admission metrics, but including positive/negative radiological CT findings). This study demonstrates that high volume retrospective analysis of clinical imaging data can reveal imaging signatures with prognostic value. These targets are suited for follow-up validation and represent targets for future feature selection efforts. Moreover, the increase in prognostic value would improve staging for intervention assessment and provide more reliable guidance for patients.

  19. The Portuguese version of the Clinical Global Impression - Schizophrenia Scale: validation study Versão em português da Impressão Clínica Global - Escala de Esquizofrenia: estudo de validação

    Directory of Open Access Journals (Sweden)

    Maurício Silva de Lima

    2007-09-01

    Full Text Available OBJECTIVES: The Clinical Global Impression - Schizophrenia Scale was designed to assess severity and treatment response in subjects with schizophrenia involved in naturalistic studies and daily clinical practice. The objective of this study is to validate the Portuguese version of the Clinical Global Impression - Schizophrenia Scale in Brazil by assessing its psychometric properties. METHOD: Cross-sectional validation study of the Portuguese version of the Clinical Global Impression - Schizophrenia Scale, tested in outpatients and inpatients with schizophrenia (DSM-IV, ICD-10 from 6 centers in Brazil. Concurrent validity and sensitivity to change were assessed by comparison with the Positive and Negative Syndrome Scale, which is considered the gold standard tool to evaluate patients with schizophrenia. Interrater reliability was evaluated by intraclass correlation coefficients (ICC calculated based on the scoring of two concomitant raters. RESULTS: 70 inpatients and 70 outpatients were evaluated. Total Clinical Global Impression - Schizophrenia Scale and Positive and Negative Syndrome Scale scores were highly correlated (r = 0.79; p OBJETIVOS: A Escala de Impressão Clínica Global - Esquizofrenia é um instrumento de aplicação simples e rápido, utilizado para avaliar a severidade de sintomas em pacientes com esquizofrenia. Pode ser aplicado em estudos naturalísticos e na prática clínica. O objetivo deste trabalho é estudar as propriedades psicométricas e validar a versão Brasileira da Escala de Impressão Clínica Global - Esquizofrenia em nosso meio. MÉTODO: Estudo transversal de validação da Escala de Impressão Clínica Global - Esquizofrenia, na versão em Português, em pacientes com esquizofrenia, hospitalizados e em tratamento ambulatorial (DSM-IV, ICD-10, selecionados em seis centros no Brasil. Validade concorrente e sensibilidade à mudança foram determinadas em comparação com a escala Positive and Negative Syndrome

  20. Reliability and validation of a behavioral model of clinical behavioral formulation

    OpenAIRE

    2011-01-01

    The aim of this study was to determine the reliability and content and predictive validity of a clinical case formulation, developed from a behavioral perspective. A mixed design integrating levels of descriptive analysis and A-B case study with follow-up was used. The study established the reliability of the following descriptive and explanatory categories: (a) problem description, (b) predisposing factors, (c) precipitating factors, (d) acquisition and (e) inferred mechanism (maintenance). ...

  1. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to accept ... treatments based on what is known to work in adults. To improve clinical care of children, more ...

  2. The Diagnosis of Urinary Tract infection in Young children (DUTY): a diagnostic prospective observational study to derive and validate a clinical algorithm for the diagnosis of urinary tract infection in children presenting to primary care with an acute illness.

    Science.gov (United States)

    Hay, Alastair D; Birnie, Kate; Busby, John; Delaney, Brendan; Downing, Harriet; Dudley, Jan; Durbaba, Stevo; Fletcher, Margaret; Harman, Kim; Hollingworth, William; Hood, Kerenza; Howe, Robin; Lawton, Michael; Lisles, Catherine; Little, Paul; MacGowan, Alasdair; O'Brien, Kathryn; Pickles, Timothy; Rumsby, Kate; Sterne, Jonathan Ac; Thomas-Jones, Emma; van der Voort, Judith; Waldron, Cherry-Ann; Whiting, Penny; Wootton, Mandy; Butler, Christopher C

    2016-01-01

    BACKGROUND It is not clear which young children presenting acutely unwell to primary care should be investigated for urinary tract infection (UTI) and whether or not dipstick testing should be used to inform antibiotic treatment. OBJECTIVES To develop algorithms to accurately identify pre-school children in whom urine should be obtained; assess whether or not dipstick urinalysis provides additional diagnostic information; and model algorithm cost-effectiveness. DESIGN Multicentre, prospective diagnostic cohort study. SETTING AND PARTICIPANTS Children < 5 years old presenting to primary care with an acute illness and/or new urinary symptoms. METHODS One hundred and seven clinical characteristics (index tests) were recorded from the child's past medical history, symptoms, physical examination signs and urine dipstick test. Prior to dipstick results clinician opinion of UTI likelihood ('clinical diagnosis') and urine sampling and treatment intentions ('clinical judgement') were recorded. All index tests were measured blind to the reference standard, defined as a pure or predominant uropathogen cultured at ≥ 10(5) colony-forming units (CFU)/ml in a single research laboratory. Urine was collected by clean catch (preferred) or nappy pad. Index tests were sequentially evaluated in two groups, stratified by urine collection method: parent-reported symptoms with clinician-reported signs, and urine dipstick results. Diagnostic accuracy was quantified using area under receiver operating characteristic curve (AUROC) with 95% confidence interval (CI) and bootstrap-validated AUROC, and compared with the 'clinician diagnosis' AUROC. Decision-analytic models were used to identify optimal urine sampling strategy compared with 'clinical judgement'. RESULTS A total of 7163 children were recruited, of whom 50% were female and 49% were < 2 years old. Culture results were available for 5017 (70%); 2740 children provided clean-catch samples, 94% of whom were ≥ 2 years old

  3. Venous Thrombosis Risk after Cast Immobilization of the Lower Extremity: Derivation and Validation of a Clinical Prediction Score, L-TRiP(cast, in Three Population-Based Case-Control Studies.

    Directory of Open Access Journals (Sweden)

    Banne Nemeth

    2015-11-01

    Full Text Available Guidelines and clinical practice vary considerably with respect to thrombosis prophylaxis during plaster cast immobilization of the lower extremity. Identifying patients at high risk for the development of venous thromboembolism (VTE would provide a basis for considering individual thromboprophylaxis use and planning treatment studies. The aims of this study were (1 to investigate the predictive value of genetic and environmental risk factors, levels of coagulation factors, and other biomarkers for the occurrence of VTE after cast immobilization of the lower extremity and (2 to develop a clinical prediction tool for the prediction of VTE in plaster cast patients.We used data from a large population-based case-control study (MEGA study, 4,446 cases with VTE, 6,118 controls without designed to identify risk factors for a first VTE. Cases were recruited from six anticoagulation clinics in the Netherlands between 1999 and 2004; controls were their partners or individuals identified via random digit dialing. Identification of predictor variables to be included in the model was based on reported associations in the literature or on a relative risk (odds ratio > 1.2 and p ≤ 0.25 in the univariate analysis of all participants. Using multivariate logistic regression, a full prediction model was created. In addition to the full model (all variables, a restricted model (minimum number of predictors with a maximum predictive value and a clinical model (environmental risk factors only, no blood draw or assays required were created. To determine the discriminatory power in patients with cast immobilization (n = 230, the area under the curve (AUC was calculated by means of a receiver operating characteristic. Validation was performed in two other case-control studies of the etiology of VTE: (1 the THE-VTE study, a two-center, population-based case-control study (conducted in Leiden, the Netherlands, and Cambridge, United Kingdom with 784 cases and 523

  4. Venous Thrombosis Risk after Cast Immobilization of the Lower Extremity: Derivation and Validation of a Clinical Prediction Score, L-TRiP(cast), in Three Population-Based Case–Control Studies

    Science.gov (United States)

    Nemeth, Banne; van Adrichem, Raymond A.; van Hylckama Vlieg, Astrid; Bucciarelli, Paolo; Martinelli, Ida; Baglin, Trevor; Rosendaal, Frits R.; le Cessie, Saskia; Cannegieter, Suzanne C.

    2015-01-01

    Background Guidelines and clinical practice vary considerably with respect to thrombosis prophylaxis during plaster cast immobilization of the lower extremity. Identifying patients at high risk for the development of venous thromboembolism (VTE) would provide a basis for considering individual thromboprophylaxis use and planning treatment studies. The aims of this study were (1) to investigate the predictive value of genetic and environmental risk factors, levels of coagulation factors, and other biomarkers for the occurrence of VTE after cast immobilization of the lower extremity and (2) to develop a clinical prediction tool for the prediction of VTE in plaster cast patients. Methods and Findings We used data from a large population-based case–control study (MEGA study, 4,446 cases with VTE, 6,118 controls without) designed to identify risk factors for a first VTE. Cases were recruited from six anticoagulation clinics in the Netherlands between 1999 and 2004; controls were their partners or individuals identified via random digit dialing. Identification of predictor variables to be included in the model was based on reported associations in the literature or on a relative risk (odds ratio) > 1.2 and p ≤ 0.25 in the univariate analysis of all participants. Using multivariate logistic regression, a full prediction model was created. In addition to the full model (all variables), a restricted model (minimum number of predictors with a maximum predictive value) and a clinical model (environmental risk factors only, no blood draw or assays required) were created. To determine the discriminatory power in patients with cast immobilization (n = 230), the area under the curve (AUC) was calculated by means of a receiver operating characteristic. Validation was performed in two other case–control studies of the etiology of VTE: (1) the THE-VTE study, a two-center, population-based case–control study (conducted in Leiden, the Netherlands, and Cambridge, United Kingdom

  5. Instruments for the assessment of social anxiety disorder: Validation studies.

    Science.gov (United States)

    Osório, Flávia de Lima; Crippa, José Alexandre de Souza; Loureiro, Sonia Regina

    2012-10-22

    Great progress has been observed in the literature over the last decade regarding the validation of instruments for the assessment of Social Anxiety Disorder in the Brazilian context. Particularly outstanding in this respect is the production of a group of Brazilian investigators regarding the psychometric study of the following instruments: Liebowitz Social Anxiety Scale, Social Phobia Inventory, Brief Social Phobia Scale, Disability Profile, Liebowitz Self-Rated Disability Scale, Social Phobia Safety Behaviors Scale and Self-Statements During Public Speaking Scale, which have proved to be appropriate and valid for use in the adult Brazilian population, representing resources for the assessment of social anxiety in clinical and experimental situations.

  6. Clinical Validation of Computer-Assisted Navigation in Total Hip Arthroplasty

    Directory of Open Access Journals (Sweden)

    Eric Beaumont

    2011-01-01

    Full Text Available A CT-based navigation system is helpful to evaluate the reamer shaft and the impactor position/orientation during unilateral total hip arthroplasty (THA. The main objective of this study is to determine the accuracy of the Navitrack system by measuring the implant's true anteversion and inclination, based on pre- and postoperative CT scans (n=9 patients. The secondary objective is to evaluate the clinical validity of measurements based on postop anteroposterior (AP radiographs for determining the cup orientation. Postop CT-scan reconstructions and postop planar radiographs showed no significant differences in orientation compared to peroperative angles, suggesting a clinical validity of the system. Postoperative AP radiographs normally used in clinic are acceptable to determine the cup orientation, and small angular errors may originate from the patient position on the table.

  7. Development, Validation, and Field-Testing of an Instrument for Clinical Assessment of HIV-Associated Neuropathy and Neuropathic Pain in Resource-Restricted and Large Population Study Settings

    Science.gov (United States)

    Kamerman, Peter R.; Veliotes, Demetri G. A.; Phillips, Tudor J.; Asboe, David; Boffito, Marta; Rice, Andrew S. C.

    2016-01-01

    HIV-associated sensory peripheral neuropathy (HIV-SN) afflicts approximately 50% of patients on antiretroviral therapy, and is associated with significant neuropathic pain. Simple accurate diagnostic instruments are required for clinical research and daily practice in both high- and low-resource setting. A 4-item clinical tool (CHANT: Clinical HIV-associated Neuropathy Tool) assessing symptoms (pain and numbness) and signs (ankle reflexes and vibration sense) was developed by selecting and combining the most accurate measurands from a deep phenotyping study of HIV positive people (Pain In Neuropathy Study–HIV-PINS). CHANT was alpha-tested in silico against the HIV-PINS dataset and then clinically validated and field-tested in HIV-positive cohorts in London, UK and Johannesburg, South Africa. The Utah Early Neuropathy Score (UENS) was used as the reference standard in both settings. In a second step, neuropathic pain in the presence of HIV-SN was assessed using the Douleur Neuropathique en 4 Questions (DN4)-interview and a body map. CHANT achieved high accuracy on alpha-testing with sensitivity and specificity of 82% and 90%, respectively. In 30 patients in London, CHANT diagnosed 43.3% (13/30) HIV-SN (66.7% with neuropathic pain); sensitivity = 100%, specificity = 85%, and likelihood ratio = 6.7 versus UENS, internal consistency = 0.88 (Cronbach alpha), average item-total correlation = 0.73 (Spearman’s Rho), and inter-tester concordance > 0.93 (Spearman’s Rho). In 50 patients in Johannesburg, CHANT diagnosed 66% (33/50) HIV-SN (78.8% neuropathic pain); sensitivity = 74.4%, specificity = 85.7%, and likelihood ratio = 5.29 versus UENS. A positive CHANT score markedly increased of pre- to post-test clinical certainty of HIV-SN from 43% to 83% in London, and from 66% to 92% in Johannesburg. In conclusion, a combination of four easily and quickly assessed clinical items can be used to accurately diagnose HIV-SN. DN4-interview used in the context of bilateral feet

  8. 脑卒中患者临床神经功能缺损程度评分的信度与效度%Study on reliability and validity of the clinical neurologic deficit scale in patients with stroke

    Institute of Scientific and Technical Information of China (English)

    巫嘉陵; 王纪佐; 王世民; 安中平

    2009-01-01

    目的 评价脑卒中患者临床神经功能缺损程度评分的信度和效度.方法 222例急性脑卒中患者,分别由不同评定者于入院当天、入院第14天、发病后第90天对同一例脑卒中患者进行临床神经功能缺损程度评分.重测信度与评定者间信度用Kappa值表示,分半信度、内部一致性信度用Croubach α值表示.同时效度、预测效度采用Spearman相关分析.结构效度采用因子分析的方法,其中脑梗死患者根据英国牛津郡社区脑卒中项目(OCSP)分型评定3种不同梗死类型的临床神经功能缺损程度评分的结构效度.结果 所有条目重测信度均>0.6,评定者间信度中条目"步行能力"为0.542,分半信度0.911,Cronbach α值为0.886,不同评定方式间信度显示"上肢肌力"、"手肌力"的信度分别为0.393、0.386.其与NIHSS评定结果呈正相关(均P=0.000),不同OCSP分型患者神经功能缺损程度评分与NIHSS评分结果均相关,且与发病后90 d的Barthel指数和改良Rankin评分均相关.结论 临床神经功能缺损程度评分内部一致性信度较高,其与NIHSS有同时效度,对脑卒中预后有预测效度;对部分前循环梗死患者的结构效度最好,可以用来评定椎-基底动脉系统的脑卒中,但并不敏感.%Objective To study the reliability and validity of the clinical neurologic deficit scale in evaluating stroke patients. Methods A total of 222 inpatients with acute stroke onset were included in the study. They were assessed when admitted, at the 14th and 90th day of hospitalization by different physicians using the clinical neurologic deficit scale. Intrarater and interrater reliability were determined using Kappa correlation. The split-half rehability and internal consistency were evaluated using Cranbach's a coefficient. Concurrent validity and the predictive validity were determined by spearman rank correlation coefficients. Construct validity was assessed by the factor analysis and the

  9. Cross-cultural adaptation and clinical validation of the Neonatal Skin Condition Score to Brazilian Portuguese

    Directory of Open Access Journals (Sweden)

    Juliana Machado Schardosim

    2014-10-01

    Full Text Available OBJECTIVE: to describe the process of cross-cultural adaptation and clinical validation of the Neonatal Skin Condition Score.METHODS: this methodological cross-cultural adaptation study included five steps: initial translation, synthesis of the initial translation, back translation, review by an Committee of Specialists and testing of the pre-final version, and an observational cross-sectional study with analysis of the psychometric properties using the Adjusted Kappa, Intraclass Correlation Coefficient, and Bland-Altman Method statistical tests. A total of 38 professionals were randomly recruited to review the clarity of the adapted instrument, and 47 newborns hospitalized in the Neonatology Unit of the Clinical Hospital of Porto Alegre were selected by convenience for the clinical validation of the instrument.RESULTS: the adapted scale showed approximately 85% clarity. The statistical tests showed moderate to strong intra and interobserver item to item reliability and from strong to very strong in the total score, with a variation of less than 2 points among the scores assigned by the nurses to the patients.CONCLUSIONS: the scale was adapted and validated to Brazilian Portuguese. The psychometric properties of the Brazilian version of the Neonatal Skin Condition Score instrument were similar to the validation results of the original scale.

  10. Clinical Validation of a New Tinnitus Assessment Technology

    Science.gov (United States)

    Hébert, Sylvie; Fournier, Philippe

    2017-01-01

    Current clinical assessment of tinnitus relies mainly on self-report. Psychoacoustic assessment of tinnitus pitch and loudness are recommended but methods yield variable results. Herein, we investigated the proposition that a previously validated fixed laboratory-based method (Touchscreen) and a newly developed clinically relevant portable prototype (Stand-alone) yield comparable results in the assessment of psychoacoustic tinnitus pitch and loudness. Participants with tinnitus [N = 15, 7 with normal hearing and 8 with hearing loss (HL)] and participants simulating tinnitus (simulators, N = 15) were instructed to rate the likeness of pure tones (250—16 kHz) to their tinnitus pitch and match their loudness using both methods presented in a counterbalanced order. Results indicate that simulators rated their “tinnitus” at lower frequencies and at louder levels (~10 dB) compared to tinnitus participants. Tinnitus subgroups (with vs. without HL) differed in their predominant tinnitus pitch (i.e., lower in the tinnitus with HL subgroups), but not in their loudness matching in decibel SL. Loudness at the predominant pitch was identified as a factor yielding significant sensitivity and specificity in discriminating between the two groups of participants. Importantly, despite differences in the devices’ physical presentations, likeness and loudness ratings were globally consistent between the two methods and, moreover, highly reproducible from one method to the other in both groups. All in all, both methods yielded robust tinnitus data in less than 12 min, with the Stand-alone having the advantage of not being dependent of learning effects, being user-friendly, and being adapted to the audiogram of each patient to further reduce testing time. PMID:28270792

  11. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... of Intramural Research Research Resources Research Meeting Summaries Technology Transfer Clinical Trials What Are Clinical Trials? Children & ... Clinical Studies Children have often had to accept medicines and treatments based on what is known to ...

  12. 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.)

  13. 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.

  14. Meaningful prevention of breast cancer metastasis: candidate therapeutics, preclinical validation, and clinical trial concerns.

    Science.gov (United States)

    Zimmer, Alexandra S; Steeg, Patricia S

    2015-01-01

    The development of drugs to treat breast and other cancers proceeds through phase I dose finding, phase II efficacy, and phase III comparative studies in the metastatic setting, only then asking if metastasis can be prevented in adjuvant trials. Compounds without overt cytotoxic activity, such as those developed to inhibit metastatic colonization, will likely fail to shrink established lesions in the metastatic setting and never be tested in a metastasis prevention scenario where they were preclinically validated. We and others have proposed phase II primary and secondary metastasis prevention studies to address this need. Herein, we have asked whether preclinical metastasis prevention data agrees with the positive adjuvant setting trials. The data are limited but complimentary. We also review fundamental pathways involved in metastasis, including Src, integrins, focal adhesion kinase (FAK), and fibrosis, for their clinical progress to date and potential for metastasis prevention. Issues of inadequate preclinical validation and clinical toxicity profiles are discussed.

  15. 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).

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

    OpenAIRE

    García-Campayo Javier; Montero-Marín Jesús

    2010-01-01

    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 tempora...

  17. Sexualization and lifestyle impulsivity: clinically valid discriminators in sexual offenders.

    Science.gov (United States)

    Eher, Reinhard; Neuwirth, Wolfgang; Fruehwald, Stefan; Frottier, Patrick

    2003-08-01

    Following clinical observations in this study a comparison was undertaken between nonsexualized rapists, sexualized rapists, and pedophilic child molesters in terms of psychometric measures, criminological data, and DSM-IV diagnoses following the authors' hypotheses that nonsexualized and sexualized rapists differ in respect of psychiatric comorbidity and criminal history and sexualized rapists and pedophilic child molesters are more similar as regards to psychiatric comorbidity (anxiety, depression, and aggression) and criminal history variables than nonsexualized and sexualized rapists are. Preliminary findings confirmed the hypotheses: the authors found significant differences between paraphilic and sexualized sex offenders on one hand--regardless whether they had offended against minors or adults--and a group of sex offenders exhibiting a history of high lifestyle impulsivity on the other hand. From a psychiatric clinical point of view, paraphilic or sexualized rapists could be shown to resemble more the pedophilic child molesters. Therapeutic approaches should take these findings into account.

  18. 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......, and is available in 14 languages. Taking into account the increasing differentiation of Alzheimer's disease in preclinical and predementia stages, there is an urgent need for global rating scales to be refined as well....

  19. The feasibility and validity of care mapping in the clinical neurosciences.

    Science.gov (United States)

    O'Hanlon, Katie; Leigh, Andrew; Sheldrick, Russell; Surr, Claire; Hare, Dougal Julian

    2015-01-01

    Dementia Care Mapping (DCM) is an observational tool and process that is widely used in dementia care in measuring and improving person-centred care (PCC). DCM was previously piloted on a neurorehabilitation ward, where it was found to be feasible and acceptable in this setting. Following this, a new modified tool and accompanying manual were developed: Care Mapping - Neurorehabilitation (DCM-NR). The current study aimed to assess the feasibility and validity of DCM-NR by piloting its use in a range of clinical neuroscience settings. A mixed-methods design was used employing both quantitative and qualitative techniques. The new DCM-NR was found to be feasible for use both in terms of the suitability of its coding system and the implementation process. DCM-NR was shown to have a moderate level of concurrent validity with participants' self-report of PCC. Participants' subjective reports on their experiences of care provided validation for the areas of psychological need observed in DCM-NR. The results of this study indicate that DCM-NR is feasible and valid for use in a range of clinical neuroscience settings. Further longitudinal research is required to evaluate the impact of DCM-NR on PCC practices over time.

  20. 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 kno...

  1. 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; Klazinga, NS; Kringos, DS; Lombarts, MJMH; Plochg, T; Lopez, MA; Secanell, M; Sunol, R; Vallejo, P; Bartels, P; Kristensen, S; Michel, P; Saillour-Glenisson, F; Vlcek, F; Car, M; Jones, S; Klaus, E; Bottaro, S; Garel, P; Saluvan, M; Bruneau, C; Depaigne-Loth, A; Shaw, C; Hammer, A; Ommen, O; Pfaff, H; Groene, O; Botje, D; Wagner, C; Kutaj-Wasikowska, H; Kutryba, B; Escoval, A; Lívio, A; Eiras, M; Franca, M; Leite, I; Almeman, F; Kus, H; Ozturk, K; Mannion, R; Arah, OA; DerSarkissian, M; Thompson, CA; Wang, A; Thompson, A

    2014-01-01

    Objective 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. Design 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). Setting and Participants A sample of 3386 leading physicians and nurses working in 188 hospitals located in Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey. Main Outcome Measures Validity and reliability of professional involvement scales and subscales. Results Psychometric analysis yielded four subscales for leading physicians: (i) Administration and budgeting, (ii) Managing medical practice, (iii) Strategic management and (iv) Managing nursing practice. Only the first three factors applied well to the nurses. Cronbach's alpha for internal consistency ranged from 0.74 to 0.86 for the physicians, and from 0.61 to 0.81 for the nurses. Except for the 0.74 correlation between ‘Administration and budgeting’ and ‘Managing medical practice’ among physicians, all inter-scale correlations were <0.70 (range 0.43–0.61). Under testing for construct validity, the subscales were positively correlated with ‘formal management roles’ of physicians and nurses. Conclusions The professional involvement scales appear to yield reliable and valid data in European hospital settings, but the scale ‘Managing medical practice’ for nurses needs further exploration. The measurement instrument can be used for international research on clinical management. PMID:24615595

  2. 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....

  3. 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…

  4. 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.

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

    Science.gov (United States)

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

    2010-01-01

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

  6. Valuing structured professional judgment: predictive validity, decision-making, and the clinical-actuarial conflict.

    Science.gov (United States)

    Falzer, Paul R

    2013-01-01

    Structured professional judgment (SPJ) has received considerable attention as an alternative to unstructured clinical judgment and actuarial assessment, and as a means of resolving their ongoing conflict. However, predictive validity studies have typically relied on receiver operating characteristic (ROC) analysis, the same technique commonly used to validate actuarial assessment tools. This paper presents SPJ as distinct from both unstructured clinical judgment and actuarial assessment. A key distinguishing feature of SPJ is the contribution of modifiable factors, either dynamic or protective, to summary risk ratings. With modifiable factors, the summary rating scheme serves as a prognostic model rather than a classification procedure. However, prognostic models require more extensive and thorough predictive validity testing than can be provided by ROC analysis. It is proposed that validation should include calibration and reclassification techniques, as well as additional measures of discrimination. Several techniques and measures are described and illustrated. The paper concludes by tracing the limitations of ROC analysis to its philosophical foundation and its origin as a statistical theory of decision-making. This foundation inhibits the performance of crucial tasks, such as determining the sufficiency of a risk assessment and examining the evidentiary value of statistical findings. The paper closes by noting a current effort to establish a viable and complementary relationship between SPJ and decision-making theory.

  7. Cultural adaptation and validation of the Portuguese version of the Nursing Clinical Facilitators Questionnaire

    Science.gov (United States)

    Frederico-Ferreira, Maria Manuela; Camarneiro, Ana Paula Forte; Loureiro, Cândida Rosalinda Exposto da Costa; Ventura, Maria Clara Amado Apóstolo

    2016-01-01

    ABSTRACT Objective: to perform the cultural adaptation to Portuguese of the Nursing Clinical Facilitators Questionnaire (NCFQ), which was designed by the Centre for Learning and Teaching at the University of Technology of Sydney, and to validate this instrument. Methods: this methodological study involved the cultural adaptation of the questionnaire by using translation, back-translation, semantic comparison, idiomatic and conceptual equivalence, and validation through validity and reliability analyses and used a sample of 767 students in their second year of the Nursing Program. Results: construct validity had a two-factor solution according to the varimax rotation method. In addition, there was a high overall internal consistency for the questionnaire (Cronbach's alpha of 0.977) and for the factors found (0.966 and 0.952, respectively). Conclusion: the Portuguese version has good psychometric characteristics; therefore, it is adequate to obtain reliable information on the perception of nursing students concerning the type of supervision that is provided in clinical practice, and this version is adequate to improve teaching practices. PMID:27533275

  8. The feasibility, reliability, and validity of a post-encounter form for evaluating clinical reasoning.

    NARCIS (Netherlands)

    Durning, S.J.; Artino, A.; Boulet, J.; Rochelle, J. La; Vleuten, C.P.M. van der; Arze, B.; Schuwirth, L.

    2012-01-01

    BACKGROUND: Developing feasible, reliable and valid methods for the evaluation of clinical reasoning is challenging. AIM: To explore feasibility, reliability, and validity evidence for a post-encounter form assessing clinical reasoning. METHOD: A free-text, post-encounter form was used in an Objecti

  9. CLINICAL STUDY ON ACUTE PANCREATITIS

    Directory of Open Access Journals (Sweden)

    Suhaib Rehaman

    2015-07-01

    Full Text Available INTRODUCTION : Early diagnosis and severity evaluation on patients with acute pancreatitis are very important due to its potential morbidity and mortality. Given the wide spectrum of disease seen, the care of patients with pancreatitis must be highly individualized. Sev eral clinical, laboratory and radiologic factors and many scoring systems have been proposed for outcome prediction. AIMS AND OBJECTIVES: To study the symptomatology, clinical presentation and management in pancreatitis . To study the severity of acute panc reatitis according to Glasgow Scale . METHODS: Present study includes consecutive 38 patients hospitalized in CSI Holdsworth Memorial Hospital over the period of 2 years. All patients were thoroughly investigated and were stratified according to the Glasgow criteria. Data was collected on complications, investigations and interventions undertaken, outcome, duration of stay in hospital and ICU. STATISTICAL ANALYSIS USED: Descriptive, Chi square tests, Crosstabs (Contingency coefficient analysis . RESULTS : Mean age of presentation in our study was 43.1 years. There was a male predominance accounting for 68.4% compared to 31.6% females. Alcohol was the main etiological factor in about 50% of the patients. Sensitivity to S. amylase was about 100%. Accuracy of USG abdomen in diagnosing pancreatitis was about 88.5%. Ascitis was the commonest complication seen in 13.2%. Mean duration of hospital stay was 6.2 days. The patient were stratified according to Glasgow scoring system into mild (0 - 3 and severe (>3 panc reatitis. In our study 32 people were graded with mild pancreatitis, all improved and in 6 people who were graded with severe pancreatitis, 83.3 % improved and 2.6% expired because of complications. Test statistics showed Contingency coefficient 0.355 and P 0.019 (NS. CONCLUSION : Glasgow scoring system remains a valid predicting system for the outcome in patients with acute pancreatitis. It is simple easy to apply with

  10. Predictive validity of the MMPI-2 clinical, PSY-5, and RC scales for therapy disruptive behavior.

    Science.gov (United States)

    Scholte, Wubbo; Tiemens, Bea G; Verheul, Roel; Meerman, Anke; Egger, Jos; Hutschemaekers, Giel

    2012-11-01

    Impulsive acts, parasuicidal behavior, and other therapy disruptive incidents occur frequently in the treatment of patients with personality disorders and increase the risk that patients will drop out of treatment. This study examined the predictive validity of the Minnesota Multiphasic Personality Inventory (MMPI)-2 Restructured Clinical (RC) and Psychopathology Five (PSY-5) Scales for therapy disruptive behavior and compared them with the original clinical scales. Using an inventory, the treatment staff recorded the therapy disruptive behavior of 104 patients with personality disorders who were receiving inpatient psychotherapy. Both the RC and the PSY-5 scales predicted several categories of therapy disruptive behavior, and both scales predicted more categories of therapy disruptive behavior than the original clinical scales. Anger outbursts were predicted especially well by a combination of two of the RC scales. The information about the MMPI-2 obtained in this study may be helpful in case formulation when initiating inpatient treatment for patients with personality disorders.

  11. Validation study of Polar V800 accelerometer.

    Science.gov (United States)

    Hernández-Vicente, Adrián; Santos-Lozano, Alejandro; De Cocker, Katrien; Garatachea, Nuria

    2016-08-01

    The correct quantification of physical activity (PA) and energy expenditure (EE) in daily life is an important target for researchers and professionals. The objective of this paper is to study the validity of the Polar V800 for the quantification of PA and the estimation of EE against the ActiGraph (ActiTrainer) in healthy young adults. Eighteen Caucasian active people (50% women) aged between 19-23 years wore an ActiTrainer on the right hip and a Polar V800 on the preferred wrist during 7 days. Paired samples t-tests were used to analyze differences in outcomes between devices, and Pearson's correlation coefficients to examine the correlation between outcomes. The agreement was studied using the Bland-Altman method. Also, the association between the difference and the magnitude of the measurement (heteroscedasticity) was examined. Sensitivity, specificity and area under the receiver operating characteristic curve (ROC-AUC value) were calculated to evaluate the ability of the devices to accurately define a person who fulfills the recommendation of 10,000 daily steps. The devices significantly differed from each other on all outcomes (Pvalue was fair (0.781±0.048) and the sensitivity and specificity was 98% and 58%, respectively. The Polar V800 accelerometer has a comparable validity to the accelerometer in free-living conditions, regarding "1 hour sedentary bouts" and "V800's walking time vs. ActiTrainer's lifestyle time" in young adults.

  12. Discriminant validity study of Achilles enthesis ultrasound.

    Science.gov (United States)

    Expósito Molinero, María Rosa; de Miguel Mendieta, Eugenio

    2016-01-01

    We want to know if the ultrasound examination of the Achilles tendon in spondyloarthritis is different compared to other rheumatic diseases. We studied 97 patients divided into five groups: rheumatoid arthritis, spondyloarthritis, gout, chondrocalcinosis and osteoarthritis, exploring six elementary lesions in 194 Achilles entheses examined. In our study the total index ultrasonographic Achilles is higher in spondyloarthritis with significant differences. The worst elementary spondyloarthritis lesions for discriminations against other pathologies were calcification. This study aims to demonstrate the discriminant validity of Achilles enthesitis observed by ultrasound in spondyloarthritis compared with other rheumatic diseases that may also have ultrasound abnormalities such enthesis level. Copyright © 2015 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

  13. Clinical studies involving probiotics

    OpenAIRE

    Degnan, Fred H

    2012-01-01

    Researchers from a diverse array of scientific disciplines have focused and continue to focus on opportunities and areas for responsible clinical research involving the possible beneficial health effects of “probiotics.” Investigators and researchers should be aware that not all clinical research involving probiotics reasonably falls within the requirements of the “investigational new drug” (IND) rubric administered and enforced by the US Food and Drug Administration. In determining whether a...

  14. Clinical Nursing Records Study

    Science.gov (United States)

    1991-08-01

    for Sam Houston, Texas MAJ Joanne Burton , AN, Clinical Head Nurse, Psychiatry MAJ Shelby Christian, AN, Clinical Head Nurse, OB/GYN MAJ Melissa Opio...Specify Level) Parenting, Potential Alteration In Decubitus Ulcer Self-Care Deficit, Total (Specify Level) Social Isolation Fluid Volume Deficit. Potential...METABOLIC PATTERN Self-Care Dieficit. Total (Specify Level) SiX alizaticni Alterations ifl Decubitus ulcer S-If-Batingrla.v~qene Oeticit 601?Cif Levet

  15. Simple clinical variables predict liver histology in hepatitis C: prospective validation of a clinical prediction model.

    Science.gov (United States)

    Romagnuolo, Joseph; Andrews, Christopher N; Bain, Vincent G; Bonacini, Maurizio; Cotler, Scott J; Ma, Mang; Sherman, Morris

    2005-11-01

    A recent single-center multivariate analysis of hepatitis C (HCV) patients showed that having any two criteria: 1) ferritin > or =200 microg/l and 2) spider nevi and/or albumin clinical prediction model using an independent multicenter sample. Eighty-one patients with previously untreated active chronic HCV underwent physical examination, laboratory investigation, and liver biopsy. Biopsies were read, in blinded fashion, by a single pathologist, using a modified Hytiroglou (1995) scale. The clinical scoring system was correlated with histology; likelihood ratios (LRs), Fisher's exact p-values, and receiver operating characteristics (ROCs) were calculated. Data recording was complete in 77 and 38 patients regarding fibrotic stage and inflammatory grade, respectively. For fibrosis, 3/3 patients with any three criteria (LR 17, positive predictive value (PPV) 100%), 4/5 patients with any two criteria (LR 5.1), and 15/47 with no criteria (LR 0.6, negative predictive value (NPV) 68%) had stage 2 or greater fibrosis on biopsy (p=0.01). For inflammation, 5/5 patients with both criteria (LR 15, PPV 100%), and 8/19 patients with no criteria (LR 0.5, NPV 58%) had moderate-severe inflammation on liver biopsy (p=0.036). When missing variables were assumed to be normal, recalculated LRs were almost identical. An alanine aminotransferase (ALAT) level data set has validated our published model which uses simple clinical variables accurately and significantly to predict hepatic fibrosis and inflammation in HCV patients.

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

    Science.gov (United States)

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

    2016-10-30

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

  17. Experimental validation and clinical comparison of quantitative coronary analysis systems

    NARCIS (Netherlands)

    J. Haase (Jürgen)

    1993-01-01

    textabstractThe kernel topic of this thesis is the validation of QCA systems by a new experimental approach involving the percutaneous insertion of coronary stenosis phantoms in swine coronary arteries. The reliability of digital as well as cinefilm-based QCA systems has been compared on the basis

  18. Biostatistics: a toolkit for exploration, validation, and interpretation of clinical data.

    Science.gov (United States)

    Mandrekar, Jayawant N; Mandrekar, Sumithra J

    2009-12-01

    Biostatistics plays a key role in all phases of clinical research starting from the design to the monitoring, data collection, data analysis, and interpretation of the results. A clear understanding of the statistical framework as it relates to the study hypothesis, reported results, and interpretation is vital for the scientific integrity of the study and its acceptance in the general medical community. In this brief report, we will put in perspective the general analytical framework for exploring and validating prognostic factors using data from large databases.

  19. Reliability, Validity, and Clinical Utility of the Dominic Interactive for Adolescents–Revised

    Science.gov (United States)

    Smolla, Nicole; Berthiaume, Claude; Renaud, Johanne; Breton, Jean-Jacques; St.-Georges, Marie; Morin, Pauline; Zavaglia, Elissa; Labelle, Réal

    2016-01-01

    Objectives: The Dominic Interactive for Adolescents–Revised (DIA-R) is a multimedia self-report screen for 9 mental disorders, borderline personality traits, and suicidality defined by the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). This study aimed to examine the reliability and the validity of this instrument. Methods: French- and English-speaking adolescents aged 12 to 15 years (N = 447) were recruited from schools and clinical settings in Montreal and were evaluated twice. The internal consistency was estimated by Cronbach alpha coefficients and the test-retest reliability by intraclass correlation coefficients. Cutoff points on the DIA-R scales were determined by using clinically relevant measures for defining external validation criteria: the Schedule for Affective Disorders and Schizophrenia for School-Aged Children, the Beck Hopelessness Scale, and the Abbreviated-Diagnostic Interview for Borderlines. Receiver operating characteristic (ROC) analyses provided accuracy estimates (area under the ROC curve, sensitivity, specificity, likelihood ratio) to evaluate the ability of the DIA-R scales to predict external criteria. Results: For most of the DIA-R scales, reliability coefficients were excellent or moderate. High or moderate accuracy estimates from ROC analyses demonstrated the ability of the DIA-R thresholds to predict psychopathological conditions. These thresholds were generally capable to discriminate between clinical and school subsamples. However, the validity of the obsessions/compulsions scale was too low. Conclusions: Findings clearly support the reliability and the validity of the DIA-R. This instrument may be useful to assess a wide range of adolescents’ mental health problems in the continuum of services. This conclusion applies to all scales, except the obsessions/compulsions one. PMID:27638424

  20. Validation Studies for the Diet History Questionnaire II

    Science.gov (United States)

    Data show that the DHQ I instrument provides reasonable nutrient estimates, and three studies were conducted to assess its validity/calibration. There have been no such validation studies with the DHQ II.

  1. Validation of secondary data sources to identify Parkinson disease against clinical diagnostic criteria.

    Science.gov (United States)

    Jain, Samay; Himali, Jayandra; Beiser, Alexa; Ton, Thanh G N; Kelly-Hayes, Margaret; Biggs, Mary Lou; Delaney, Joseph A C; Rosano, Caterina; Seshadri, Sudha; Frank, Samuel A

    2015-02-01

    Parkinson disease (PD) is the second most common neurodegenerative disorder. Its diagnosis relies solely on a clinical examination and is not straightforward because no diagnostic test exists. Large, population-based, prospective cohort studies designed to examine other outcomes that are more common than PD might provide cost-efficient alternatives for studying the disease. However, most cohort studies have not implemented rigorous systematic screening for PD. A majority of epidemiologic studies that utilize population-based prospective designs rely on secondary data sources to identify PD cases. Direct validation of these secondary sources against clinical diagnostic criteria is lacking. The Framingham Heart Study has prospectively screened and evaluated participants for PD based on clinical diagnostic criteria. We assessed the predictive value of secondary sources for PD identification relative to clinical diagnostic criteria in the Framingham Heart Study (2001-2012). We found positive predictive values of 1.0 (95% confidence interval: 0.868, 1.0), 1.0 (95% confidence interval: 0.839, 1.0), and 0.50 (95% confidence interval: 0.307, 0.694) for PD identified from self-report, use of antiparkinsonian medications, and Medicare claims, respectively. The negative predictive values were all higher than 0.99. Our results highlight the limitations of using only Medicare claims data and suggest that population-based cohorts may be utilized for the study of PD determined via self-report or medication inventories while preserving a high degree of confidence in the validity of PD case identification.

  2. 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

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

    Science.gov (United States)

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

    2014-12-01

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

  4. [The ICD-10 Symptom Rating (ISR): validation of the depression scale in a clinical sample].

    Science.gov (United States)

    Brandt, Wolfram Alexis; Loew, Thomas; von Heymann, Friedrich; Stadtmüller, Godehard; Georgi, Alexander; Tischinger, Michael; Strom, Frederik; Mutschler, Friederike; Tritt, Karin

    2015-06-01

    The ICD-10 Symptom Rating (ISR) 1 measures the severity of psychiatric disorders with 29 items on 5 subscales as comprehensively as possible. The following syndromes are measured: Depressive syndrome, anxiety syndrome, obsessive-compulsive syndrome, Somatoform syndrome, eating disorder syndrome as well as additional items that cover various mental syndromes, and an overall score. The study reports findings on the validity and sensitivity to change of the depression subscale (ISR-D). In a clinical sample of N=949 inpatients with depression spectrum disorders the convergent validity was determined by correlation with the Beck Depression Inventory (BDI) 3 and the subscale "depression" of the Symptom-Checklist-90-R (SCL-90-R) 4. The high correlation between the different instruments confirms the validity of the ISR-Depression Scale. The sensitivity to change of the ISR seems higher than that of the BDI and the SCL-90. Because of its economy and the good psychometric properties the ISR is recommended for use in clinical samples.

  5. Validity of clinical information from a maternity survey.

    Science.gov (United States)

    Meng, Y Y; Jatulis, D E; Elashoff, R M; Liu, E; Leung, K M; Legorreta, A P

    1997-01-01

    This research was designed to validate data collected through a survey--an inexpensive way to provide information for quality measurement. The survey was sent to health maintenance organization (HMO) enrollees who had given birth(s) between October 1, 1994, and May 31, 1995. The responses were compared with the medical records. A sample of 407 women was randomly selected from the completed surveys. Medical records were reviewed for 89.9% (362/407) of the sample based on medical record availability. Over 98% of responses agreed with the medical record information regarding whether there were cesarean sections for previous deliveries (kappa = 1.0), cesarean section for recent delivery (kappa = 0.95), and vaginal birth after cesarean section (kappa = 0.96). Over 99% of the mothers agreed with the information regarding whether the newborn birth weight was under 2500 g (kappa = 0.91). The findings strongly support the validation of this instrument. Using this validated instrument enables health plans to cost-effectively obtain crucial information.

  6. 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.

  7. 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

  8. Validation of undergraduate clinical data by electronic capture (barcode).

    Science.gov (United States)

    Chadwick, Barbara L; Oliver, Richard G; Gyton, Jane

    2002-03-01

    Assessment of clinical activity is common in dental schools. An audit project to confirm that dental undergraduate clinical activity recorded by electronic data capture is an accurate representation of the clinical case entry is reported. A printout of clinical activity for a period of a week was generated retrospectively and used to identify case notes. Activity recorded in the case notes was compared with the computer printout. All discrepancies were noted. A total of 125 patient files with 270 barcoded items of treatment were retrieved; 29 of 78 (37.1%) paediatric and 23 of 47 (48.9%) orthodontic cases had discrepancies between the case notes and the computer entry. However, some items recorded in the notes do not require barcoding and vice versa. When these were accounted for, only 19 items of treatment appeared in the notes that should have been barcoded, a 7% shortfall in recording of clinical activity. The barcode system is an accurate and reliable way of recording undergraduate clinical activity.

  9. The birth satisfaction scale: Turkish adaptation, validation and reliability study.

    Science.gov (United States)

    Cetin, Fatma Cosar; Sezer, Ayse; Merih, Yeliz Dogan

    2015-01-01

    The objective of this study is to investigate the validity and the reliability of Birth Satisfaction Scale (BSS) and to adapt it into the Turkish language. This scale is used for measuring maternal satisfaction with birth in order to evaluate women's birth perceptions. In this study there were 150 women who attended to inpatient postpartum clinic. The participants filled in an information form and the BSS questionnaire forms. The properties of the scale were tested by conducting reliability and validation analyses. BSS entails 30 Likert-type questions. It was developed by Hollins Martin and Fleming. Total scale scores ranged between 30-150 points. Higher scores from the scale mean increases in birth satisfaction. Three overarching themes were identified in Scale: service provision (home assessment, birth environment, support, relationships with health care professionals); personal attributes (ability to cope during labour, feeling in control, childbirth preparation, relationship with baby); and stress experienced during labour (distress, obstetric injuries, receiving sufficient medical care, obstetric intervention, pain, prolonged labour and baby's health). Cronbach's alfa coefficient was 0.62. According to the present study, BSS entails 30 Likert-type questions and evaluates women's birth perceptions. The Turkish version of BSS has been proven to be a valid and a reliable scale.

  10. The birth satisfaction scale: Turkish adaptation, validation and reliability study

    Science.gov (United States)

    Cetin, Fatma Cosar; Sezer, Ayse; Merih, Yeliz Dogan

    2015-01-01

    OBJECTIVE: The objective of this study is to investigate the validity and the reliability of Birth Satisfaction Scale (BSS) and to adapt it into the Turkish language. This scale is used for measuring maternal satisfaction with birth in order to evaluate women’s birth perceptions. METHODS: In this study there were 150 women who attended to inpatient postpartum clinic. The participants filled in an information form and the BSS questionnaire forms. The properties of the scale were tested by conducting reliability and validation analyses. RESULTS: BSS entails 30 Likert-type questions. It was developed by Hollins Martin and Fleming. Total scale scores ranged between 30–150 points. Higher scores from the scale mean increases in birth satisfaction. Three overarching themes were identified in Scale: service provision (home assessment, birth environment, support, relationships with health care professionals); personal attributes (ability to cope during labour, feeling in control, childbirth preparation, relationship with baby); and stress experienced during labour (distress, obstetric injuries, receiving sufficient medical care, obstetric intervention, pain, prolonged labour and baby’s health). Cronbach’s alfa coefficient was 0.62. CONCLUSION: According to the present study, BSS entails 30 Likert-type questions and evaluates women’s birth perceptions. The Turkish version of BSS has been proven to be a valid and a reliable scale. PMID:28058355

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

    Science.gov (United States)

    Öhman, Eva; Alinaghizadeh, Hassan; Kaila, Päivi; Hult, Håkan; Nilsson, Gunnar H; Salminen, Helena

    2016-12-01

    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. 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. 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. CLES, in its adapted form, appears to be a valid instrument to evaluate medical students' perceptions of

  12. 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

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

    Science.gov (United States)

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

    2004-01-01

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

  14. Development and validation of a high-performance liquid chromatography-tandem mass spectrometry method for the simultaneous determination of irinotecan and its main metabolites in human plasma and its application in a clinical pharmacokinetic study.

    Directory of Open Access Journals (Sweden)

    Elena Marangon

    Full Text Available Irinotecan is currently used in several cancer regimens mainly in colorectal cancer (CRC. This drug has a narrow therapeutic range and treatment can lead to side effects, mainly neutropenia and diarrhea, frequently requiring discontinuing or lowering the drug dose. A wide inter-individual variability in irinotecan pharmacokinetic parameters and pharmacodynamics has been reported and associated to patients' genetic background. In particular, a polymorphism in the UGT1A1 gene (UGT1A1*28 has been linked to an impaired detoxification of SN-38 (irinotecan active metabolite to SN-38 glucuronide (SN-38G leading to increased toxicities. Therefore, therapeutic drug monitoring of irinotecan, SN-38 and SN-38G is recommended to personalize therapy. In order to quantify simultaneously irinotecan and its main metabolites in patients' plasma, we developed and validated a new, sensitive and specific HPLC-MS/MS method applicable to all irinotecan dosages used in clinic. This method required a small plasma volume, addition of camptothecin as internal standard and simple protein precipitation. Chromatographic separation was done on a Gemini C18 column (3 μM, 100 mm x 2.0 mm using 0.1% acetic acid/bidistilled water and 0.1% acetic acid/acetonitrile as mobile phases. The mass spectrometer worked with electrospray ionization in positive ion mode and selected reaction monitoring. The standard curves were linear (R2 ≥0.9962 over the concentration ranges (10-10000 ng/mL for irinotecan, 1-500 ng/mL for SN-38 and SN-38G and 1-5000 ng/mL for APC and had good back-calculated accuracy and precision. The intra- and inter-day precision and accuracy, determined on three quality control levels for all the analytes, were always <12.3% and between 89.4% and 113.0%, respectively. Moreover, we evaluated this bioanalytical method by re-analysis of incurred samples as an additional measure of assay reproducibility. This method was successfully applied to a pharmacokinetic study in

  15. 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.

  16. FETAX interlaboratory validation study: Phase 2 testing

    Energy Technology Data Exchange (ETDEWEB)

    Bantle, J.A. (Oklahoma State Univ., Stillwater, OK (United States). Dept. of Zoology); Burton, D.T. (WYE Research and Educational Center, Queenstown, MD (United States)); Dawson, D.A. (Ashland Univ., OH (United States). Dept. of Biology and Toxicology) (and others)

    1994-10-01

    The Frog Embryo Teratogenesis Assay-Xenopus (FETAX) is a 96-h whole embryo developmental toxicity screening assay that can be used in ecotoxicology and in detecting mammalian developmental toxicants when an in vitro metabolic activation system is employed. A standardized American Society for Testing and Materials (ASTM) guide for the conduct of FETAX has been published along with a companion atlas that helps in embryo staging and identifying malformations. As part of the ASTM process, an interlaboratory validation study was undertaken to evaluate the repeatability and reliability of FETAX. Six different laboratories participated in the study. Each laboratory utilized one technician with the exception of one laboratory, which utilized two independent technicians. In Phase 1, FETAX proved to be more repeatable and reliable than many other bioassays. However, some excessive variation was observed in a few laboratories. Some of this variation may have been due to an initial lack of experience with the assay by some technicians. Phase 2, which is reported here, showed far less intralaboratory and interlaboratory variability than did Phase 1. Nonteratogens such as saccharin and sodium cyclamate showed the most consistent results, whereas more variability was observed for the teratogens caffeine and 5-fluorouracil. Interlaboratory coefficient of variation values for all FETAX end points ranged from 7.3 to 54.7%. The minimum concentration to inhibit growth proved to be the most variable end point for three of the four test chemicals, whereas the LC50 and EC50 (malformation) proved to be less variable.

  17. International Adaptations of the Millon Clinical Multiaxial Inventory: Construct Validity and Clinical Applications.

    Science.gov (United States)

    Rossi, Gina; Derksen, Jan

    2015-01-01

    This article examines the influence of the Millon Clinical Multiaxial Inventory (MCMI) as a clinical and research instrument beyond the borders of the United States. The MCMI's theoretical and empirical grounding, its alignment with the Diagnostic and Statistical Manual of Mental Disorders (DSM), and scales that can be interpreted both categorically and dimensionally, are the primary features that make the test attractive. We begin with studies that evaluated the construct equivalence of the different language adaptations. Data from the most widely researched non English-language forms (Danish, Dutch, and Spanish) show excellent comparability with Millon's original. Nevertheless, significant problems were noted in efforts to create clinical groups that would allow for equivalence of diagnostic accuracy when using the cutoff scores. Although dimensional aspects of the scale scores were not affected by this, the adapted measures might show attenuated diagnostic accuracy compared with Millon's original. Next, we present MCMI studies conducted in clinical settings to document where the adapted tests have made their greatest impact in the international literature. A wide variety of clinical applications demonstrated broad utility, and given the high number of issues addressed, we think Millon's influence will certainly stand the test of time in different domains and settings.

  18. 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...

  19. A new clinical rating scale for work absence and productivity: validation in patients with major depressive disorder

    Directory of Open Access Journals (Sweden)

    Yatham Lakshmi N

    2009-12-01

    Full Text Available Abstract Background The prevalence of major depressive disorder (MDD is highest in working age people and depression causes significant impairment in occupational functioning. Work productivity and work absence should be incorporated into clinical assessments but currently available scales may not be optimized for clinical use. This study seeks to validate the Lam Employment Absence and Productivity Scale (LEAPS, a 10-item self-report questionnaire that takes 3-5 minutes to complete. Methods The study sample consisted of consecutive patients attending a Mood Disorders outpatient clinic who were in full- or part-time paid work. All patients met DSM-IV criteria for MDD and completed during their intake assessment the LEAPS, the self-rated version of the Quick Inventory for Depressive Symptomatology (QIDS-SR, the Sheehan Disability Scale (SDS and the Health and Work Performance Questionnaire (HPQ. Standard psychometric analyses for validation were conducted. Results A total of 234 patients with MDD completed the assessments. The LEAPS displayed excellent internal consistency as assessed by Cronbach's alpha of 0.89. External validity was assessed by comparing the LEAPS to the other clinical and work functioning scales. The LEAPS total score was significantly correlated with the SDS work disability score (r = 0.63, p Conclusion The LEAPS displays good internal and external validity in a population of patients with MDD attending an outpatient clinic, which suggests that it may be a clinically useful tool to assess and monitor work functioning and productivity in depressed patients.

  20. Recurrent miscarriage is a useful and valid clinical concept

    DEFF Research Database (Denmark)

    Christiansen, Ole B

    2014-01-01

    Although epidemiological, clinical and biochemical risk factors are known for recurrent miscarriage (RM), the etiology is mainly unknown. Two main hypotheses dominate: that RM is mainly caused by aneuploid conceptions and other conception errors and that the recurrence rate is explained by the co......Although epidemiological, clinical and biochemical risk factors are known for recurrent miscarriage (RM), the etiology is mainly unknown. Two main hypotheses dominate: that RM is mainly caused by aneuploid conceptions and other conception errors and that the recurrence rate is explained...

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

    NARCIS (Netherlands)

    Olde Rikkert, M.G.M.; Tona, K.D.; Janssen, L.; Burns, A.; Lobo, A.; Robert, P.; Sartorius, N.; Stoppe, G.; Waldemar, G.

    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 describ

  2. [MISSCARE Survey - Italian Version: findings from an Italian validation study].

    Science.gov (United States)

    Sist, Luisa; Contini, Carla; Bandini, Anna; Bandini, Stefania; Massa, Licia; Zanin, Roberta; Maricchio, Rita; Gianesini, Gloria; Bassi, Erika; Tartaglini, Daniela; Palese, Alvisa; Ferraresi, Annamaria

    2017-01-01

    The Missed Nursing Care (MNC) refers to nursing interventions that are not completed, partially completed, or postponed. Despite the relevance of MNC, no assessment tools are available in the Italian context, and no data regarding the occurrence of this phenomenon has been documented on a large scale to date. The study aims were: (1) to validate the Italian version of the MISSCARE Survey tool; (2) to measure the prevalence of missed interventions and reasons for missed care as perceived by clinical nurses working in Italian health care settings. After having conducted the forward and backward translation, pre-pilot and pilot phases were developed to ensure face and content validity as well as semantic and conceptual equivalence of the Italian version with the original version. The MISSCARE survey questionnaire was then distributed to 1,233 clinical nurses of whom 1,003 completed the questionnaire. Overall, 979 questionnaires were analysed. The questionnaires were completed from January to March 2012, by nurses working in medical and surgical hospital departments in the Emilia Romagna region of Italy. Construct validity and internal consistency of the instrument were assessed. The face and content validity were ascertained by a group of experts. The instrument acceptability was good given that 79.4% of respondents replied to all items. Construct validity was investigated by an Exploratory Factor Analysis. Four factors explaining 64.18% of variance emerged: communication, lack of facilities/supplies, lack of staff, and unexpected events. Internal consistency, evaluated with Cronbach a, was 0.94. The nursing interventions omitted with greater frequency were, in order: ambulation (74.8%), passive mobilization (69.6%) and oral care (51.3%). The three main reasons for missed interventions were: an unexpected increase in the number of patients (90.5%), increased instability of the clinical condition (86.1%) and insufficient human resources (85.5%). The Italian version of

  3. External validation of two tools for the clinical diagnosis of acute diverticulitis without imaging

    NARCIS (Netherlands)

    Kiewiet, J.J.S.; Andeweg, C.S.; Laurell, H.; Daniels, L.; Laméris, W.; Reitsma, J.B.; Hendriks, J.C.; Bleichrodt, R.; van Goor, H.; Boermeester, M.A.

    2014-01-01

    Aim External validation and comparison of the diagnostic accuracy of two predictive tools, the emergency department triad and the clinical scoring tool in diagnosing acute diverticulitis. Methods Two derivation datasets were used crosswise for external validation. In addition, both tools were valida

  4. Translating and validating the Finnish version of the Manchester Clinical Supervision Scale.

    Science.gov (United States)

    Hyrkäs, Kristiina; Appelqvist-Schmidlechner, Kaija; Paunonen-Ilmonen, Marita

    2003-12-01

    Evaluation research provides new perspectives for clinical supervision (CS), and international collaboration offers advantages to develop valid instruments for this purpose. Besides translation, an instrument developed and tested in another culture requires systematic validation. The study focuses on the translation process of the Manchester Clinical Supervision Scale for testing in Finland carried out collaboratively between the Universities of Tampere and Manchester. The instrument is a 45-item questionnaire with a Likert-type (1-5) scale comprising seven sub-scales: trust and rapport, supervisor advice and support, improved care and skills, importance and value of CS, finding time, personal issues and reflection and total score. At first, a licensed translator translated the instrument into Finnish. A native British language teacher at the University language centre performed the blind back-translation into English. The translations were compared by both collaborative parties and by three experienced Finnish supervisors. A pilot sample (n = 182) was collected to test the translated instrument. In this sample Cronbach's alpha value for the total score was 0.9227 and in the sub-scales 0.6393-0.8838. The mean values in the sub-scales were 14.2-29.3, SDs 3.02-3.88 and modes 14.0-30.0. The British test sample had almost similar values. Translating an instrument into another language not only requires expertise in language, but also in practice. The cultural validation is the most important phase in the process that can be accomplished with pilot testing and statistical methods. However, further expert evaluation is required for the validity of the instrument.

  5. Performance validity testing in a clinical sample of adults with sickle cell disease.

    Science.gov (United States)

    Dorociak, Katherine E; Schulze, Evan T; Piper, Lauren E; Molokie, Robert E; Janecek, Julie K

    2017-06-15

    Neuropsychologists utilize performance validity tests (PVTs) as objective means for drawing inferences about performance validity. The Test of Memory Malingering (TOMM) is a well-validated, stand-alone PVT and the Reliable Digit Span (RDS) and Reliable Digit Span-Revised (RDS-R) from the Digit Span subtest of the WAIS-IV are commonly employed, embedded PVTs. While research has demonstrated the utility of these PVTs with various clinical samples, no research has investigated their use in adults with sickle cell disease (SCD), a condition associated with multiple neurological, physical, and psychiatric symptoms. Thus, the purpose of this study was to explore PVT performance in adults with SCD. Fifty-four adults with SCD (Mage = 40.61, SD = 12.35) were consecutively referred by their hematologist for a routine clinical outpatient neuropsychological evaluation. During the evaluation, participants were administered the TOMM (Trials 1 and 2), neuropsychological measures including the WAIS-IV Digit Span subtest, and mood and behavioral questionnaires. The average score on the TOMM was 47.70 (SD = 3.47, range = 34-50) for Trial 1 and 49.69 (SD = 1.66, range = 38-50) for Trial 2. Only one participant failed Trial 2 of the TOMM, yielding a 98.1% pass rate for the sample. Pass rates at various RDS and RDS-R values were calculated with TOMM Trial 2 performance as an external criterion. Results support the use of the TOMM as a measure of performance validity for individuals with SCD, while RDS and RDS-R should be interpreted with caution in this population.

  6. Reliable and Valid Assessment of Clinical Bronchoscopy Performance

    DEFF Research Database (Denmark)

    Konge, Lars; Larsen, Klaus Richter; Clementsen, Paul

    2012-01-01

    aimed for the use in a clinical setting. Methods: Five junior residents, 5 senior residents and 9 consultants performed 3 bronchoscopies each. All 57 bronchoscopies were video-recorded and assessed blindly and independently by two bronchoscopy experts using the new assessment tool. Results...

  7. Clinical and research validity of hadrontherapy with ion beams.

    Science.gov (United States)

    Orecchia, Roberto; Krengli, Marco; Jereczek-Fossa, Barbara A; Franzetti, Silvia; Gerard, Jean Pierre

    2004-08-01

    Clinical results obtained with hadrontherapy have been extremely positive for various tumours, with percentages of local control and survival higher than those ascribed to conventional radiotherapy. Most clinical data obtained with charged particles are related to protontherapy but the implementation of carbon ion therapy has demonstrated to be of great interest in the last decade. These results, accompanied by the new performances in accelerator technology and calculation systems of the delivered doses, have determined over the past years an increased interest for the development of hadrontherapy, with the construction of new centres provided with equipment entirely dedicated to clinical activity (LLUMC, Loma Linda and NPTC, Boston in USA, HIMAC-NIRS, Chiba, PROBEAT, Tsukuba, and Hyogo Beam Medical Centres in Japan). A revision of the clinical indications specifically focused on ion therapy is presented as well as the results obtained in the different centres. With hadrontherapy, it is finally possible to increase the spectrum of treatments allowing preserving the organ and its functionality, with positive impacts from a social and economic point of view.

  8. Data from clinical database on septic shock are valid

    DEFF Research Database (Denmark)

    Grønlykke, Lars; Brandstrup, Sofie Louise Rygaard; Perner, Anders

    2012-01-01

    Clinical databases have become important tools in intensive care. Disease severity and organ dysfunction scoring systems are registered in the databases, including the Simplified Acute Physiology Score II (SAPS II) and the Sequential Organ Failure Assessment (SOFA) score. The purpose of this stud...

  9. External Validation of the HERNIAscore: An Observational Study.

    Science.gov (United States)

    Cherla, Deepa V; Moses, Maya L; Mueck, Krislynn M; Hannon, Craig; Ko, Tien C; Kao, Lillian S; Liang, Mike K

    2017-09-01

    The HERNIAscore is a ventral incisional hernia (VIH) risk assessment tool that uses only preoperative variables and predictable intraoperative variables. The aim of this study was to validate and modify, if needed, the HERNIAscore in an external dataset. This was a retrospective observational study of all patients undergoing resection for gastrointestinal malignancy from 2011 through 2015 at a safety-net hospital. The primary end point was clinical postoperative VIH. Patients were stratified into low-risk, medium-risk, and high-risk groups based on HERNIAscore. A revised HERNIAscore was calculated with the addition of earlier abdominal operation as a categorical variable. Cox regression of incisional hernia with stratification by risk class was performed. Incidence rates of clinical VIH formation within each risk class were also calculated. Two hundred and forty-seven patents were enrolled. On Cox regression, in addition to the 3 variables of the HERNIAscore (BMI, COPD, and incision length), earlier abdominal operation was also predictive of VIH. The revised HERNIAscore demonstrated improved predictive accuracy for clinical VIH. Although the original HERNIAscore effectively stratified the risk of an incisional radiographic VIH developing, the revised HERNIAscore provided a statistically significant stratification for both clinical and radiographic VIHs in this patient cohort. We have externally validated and improved the HERNIAscore. The revised HERNIAscore uses BMI, incision length, COPD, and earlier abdominal operation to predict risk of postoperative incisional hernia. Future research should assess methods to prevent incisional hernias in moderate-to-high risk patients. Copyright © 2017 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  10. Clinical validity of outcome pain measures in naturally occurring canine osteoarthritis

    Directory of Open Access Journals (Sweden)

    Rialland Pascale

    2012-09-01

    Full Text Available Abstract Background The conceptual validity of kinetic gait analysis and disability outcome assessment methods has guided their use in the assessment of pain caused by osteoarthritis (OA. No consensus on the best clinical methods for pain evaluation in canine OA exists, particularly, when evaluating treatments where a smaller treatment effect is anticipated than with pharmacological pain killers. This study thus aimed at determining the technical validity of some clinical endpoints on OA pain in dogs using the green-lipped mussel (GLM-enriched diet. Twenty-three adult dogs with clinical OA completed the prospective controlled study. All the dogs were fed a balanced diet over a 30-day control period followed by a GLM-enriched diet over a 60-day period. The kinetic gait analysis parameter (PVFBW, peak vertical force adjusted for body weight change, electrodermal activity (EDA, and a standardized multifactorial pain questionnaire (MFQ were performed on day (D 0 (inclusion, D30 (start and D90 (end. The owners completed a client-specific outcome measures (CSOM instrument twice a week. Motor activity (MA was continuously recorded in seven dogs using telemetered accelerometric counts. We hypothesized that these methods would produce convergent results related to diet changes. A Type I error of 0.05 was adjusted to correct for the multiplicity of the primary clinical endpoints. Results Neither the EDA nor the MFQ were found reliable or could be validated. Changes in the PVFBW (Padj = 0.0004, the CSOM (Padj = 0.006 and the MA intensity (Padj = 0.02 from D0 to D90 suggested an effect of diet(s. Only the PVFBW clearly increased after the GLM-diet (Padj = 0.003. The CSOM exhibited a negative relationship with the PVFBW (P = 0.02 and MA duration (P = 0.02. Conclusions The PVFBW exhibited the best technical validity for the characterization of the beneficial effect of a GLM-enriched diet. The CSOM and MA appeared less responsive

  11. Rotating-crystal Malaria Diagnosis: Pre-clinical validation

    CERN Document Server

    Orban, Agnes; Prohle, Zsofia; Fulop, Gergely; Zelles, Tivadar; Forsyth, Wasan; Hill, Danika; Schofield, Louis; Mueller, Ivo; Karl, Stephan; Kezsmarki, Istvan

    2013-01-01

    Improving the efficiency of malaria diagnosis is one of the main goals of current malaria research. We have recently developed a magneto-optical (MO) method which allows high-sensitivity detection of malaria pigment (hemozoin) crystals via their magnetically induced rotation in blood. Here, we validate this technique on laboratory derived blood samples infected with \\textit{Plasmodium falciparum}. Using two parasite cultures, the first containing mostly ring stages and the second corresponding to the end of the parasite life cycle, we demonstrate that our novel method can detect parasite densities as low as $\\sim$40 and $\\sim$10\\,parasites per microliter of blood for ring and schizont stage parasites, respectively. This detection limit exceeds the performance of rapid diagnostic tests and competes with the threshold achievable by light microscopic observation of blood smears. Our method can be performed with as little as 50\\,microliter of capillary blood and is sensitive to the presence of hemozoin micro-crys...

  12. Analysis of polyethylene wear of reverse shoulder components: A validated technique and initial clinical results.

    Science.gov (United States)

    Lewicki, Kathleen A; Bell, John-Erik; Van Citters, Douglas W

    2016-06-27

    One of the most prevalent phenomena associated with reverse total shoulder arthroplasty (rTSA) is scapular notching. Current methods examine only the damage to the scapula and no methods are available for quantifying the total wear volume of the polyethylene humeral bearing. Quantifying the polyethylene material loss may provide insight into the mechanism for scapular notching and into the particle dose delivered to the patient. A coordinate measurement machine (CMM) and custom computer algorithms were employed to quantify the volumetric wear of polyethylene humeral bearings. This technique was validated using two never-implanted polyethylene humeral liners with a controlled amount of wear in clinically relevant locations. The technique was determined to be accurate to within 10% of the known value and within 5 mm(3) of the gravimetrically determined values. Following validation, ten retrieved polyethylene humeral liners were analyzed to determine a baseline for future clinical tests. Four of the ten polyethylene humeral liners showed visible and measureable wear volumes ranging from 40 mm(3) to 90 mm(3) total with a maximum wear rate as high as 470 mm(3) /year in one short duration and significantly damaged humeral liner. This validated technique has the potential to relate patient outcomes such as scapular notching grades to polyethylene release into the body. While the total wear volumes are less than reported in literature for cases of osteolysis in knee and hip patients, dosages are well within the osteolytic thresholds that have been suggested, indicating that osteolysis may be a clinical concern in the shoulder. This work provides the basis for future studies that relate volumetric wear to patient outcomes. This article is protected by copyright. All rights reserved.

  13. 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.

  14. The Portuguese version of the RhinoQOL Questionnaire: validation and clinical application,

    Directory of Open Access Journals (Sweden)

    Rui Cerejeira

    2015-12-01

    Full Text Available ABSTRACT INTRODUCTION: Rhinosinusitis constitutes an important health problem, with significant interference in personal, professional, and social functioning. This study presents the validation process of the Portuguese version of the RhinoQOL, to be used as a routine procedure in the assessment of patients with chronic rhinosinusitis. OBJECTIVE: To demonstrate that the Portuguese version of the RhinoQOL is as valid as the English version to measure symptoms and health-related quality of life in chronic rhinosinusitis. METHODS: The Portuguese version of the RhinoQOL was administered consecutively to 58 patients with chronic rhinosinusitis with and without nasal polyps, assessed for endoscopic sinus surgery. A follow-up survey was completed three months after surgery. Statistical analysis was performed to determine its psychometric properties. RESULTS: Face and content validity were confirmed by similar internal consistency as the original questionnaire for each sub-scale, and strong correlation between individual items and total score. The questionnaire was easy and quick to administer (5.5 min. At three months, there was a significant decrease from baseline for all sub-scale scores, indicating clinical improvement, with an effect size considered as large. CONCLUSION: This study provides a questionnaire that is equivalent to the original English version, with good responsiveness to change, which can be especially valuable to measure the outcome of surgery.

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

    Energy Technology Data Exchange (ETDEWEB)

    Brennan, Douglas [University of Colorado School of Medicine, Aurora, Colorado (United States); Schubert, Leah; Diot, Quentin [Department of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado (United States); Castillo, Richard [Department of Radiation Oncology, The University of Texas Medical Branch, Galveston, Texas (United States); Castillo, Edward; Guerrero, Thomas [Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, Michigan (United States); Martel, Mary K. [Department of Radiation Physics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Linderman, Derek; Gaspar, Laurie E.; Miften, Moyed; Kavanagh, Brian D. [Department of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado (United States); Vinogradskiy, Yevgeniy, E-mail: yevgeniy.vinogradskiy@ucdenver.edu [Department of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado (United States)

    2015-06-01

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

  16. 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....... Because the Novaco Anger Scale and Provocation Inventory (NAS-PI) has been extensively validated with different clinical populations and lends itself to clinical case formulation, it was selected for translation and evaluation in the present multistudy project. Psychometric properties of the NAS-PI were...... investigated with samples of 477 nonclinical, 250 clinical, 167 male prisoner, and 64 male forensic participants. Anger prevalence and its relationship with other anger measures, anxiety/depression, and aggression were examined. NAS-PI was found to have high reliability, concurrent validity, and discriminant...

  17. Learn about Clinical Studies

    Science.gov (United States)

    ... is to make sure that the study is ethical and that the rights and welfare of participants ... trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. ...

  18. 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.

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

    Science.gov (United States)

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

    2017-01-01

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

  20. Exploring the clinical validity of predicted TRE in navigation

    Science.gov (United States)

    Bickel, M.; Güler, Ö.; Kral, F.; Schwarm, F.; Freysinger, W.

    2010-02-01

    In a detailed laboratory investigation we performed a series of experiments in order to assess the validity of the widely used TRE concept to predict the application accuracy. On base of 1mm CT scan a plastic skull, a cadaver head and a volunteer were registered to an in house navigation system. We stored the position data of an optical camera (NDI Polaris) for registration with pre-defined CT coordinates. For every specimen we choose 3, 5, 7 and 9 registration and 10 evaluation points, respectively, performing 10 registrations. The data were evaluated both with the Arun and the Horn approaches. The vectorial difference between actual and predefined position in the CT data set was stored and evaluated for FRE and TRE. Evaluation and visualization was implemented in Matlab. The data were analyzed, specifically for normal distribution, with MS Excel and SPSS Version 15.0. For the plastic skull and the anatomic specimen submillimetric application accuracy was found experimentally and confirmed by the calculated TRE. Since for the volunteer no Titanium screws were implanted anatomic landmarks had to be used for registration and evaluation; an application accuracy in the low millimeter regime was found in all approaches. However, the detailed statistical analysis of the data revealed that the model predictions and the actual measurements do not exhibit a strong statistical correlation (p < 0.05). These data suggest that the TRE predictions are too optimistic and should be used with caution intraoperatively.

  1. A validated enantioselective LC-MS/MS assay for quantification of a major chiral metabolite of an achiral 11-β-hydroxysteroid-dehydrogenase 1 inhibitor in human plasma: Application to a clinical pharmacokinetic study.

    Science.gov (United States)

    Furlong, Michael T; Ji, Qin C; Iacono, Lisa; Dang, Oanh; Noren, Marzena; Bruce, John; Aubry, Anne-Françoise; Arnold, Mark E

    2016-06-01

    BMS-823778 is a potent 11-β-hydroxysteroid-dehydrogenase 1 (11βHSD-1) inhibitor and a potential therapeutic agent for type 2 diabetes mellitus (T2DM). A high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay was developed and validated to enable reliable separation and quantification of both enantiomers of a chiral hydroxy metabolite (BMT-094817) in human plasma. Following liquid-liquid extraction in a 96-well plate format, chromatographic separation of the metabolite enantiomers was achieved by isocratic elution on a Chiralpak IA-3 column. Chromatographic conditions were optimized to ensure separation of both metabolite enantiomers. Metabolite enantiomers and stable isotope-labeled (SIL) internal standards were detected by positive ion electrospray tandem mass spectrometry. The LC-MS/MS assay was validated over a concentration range of 0.200-200ng/mL. Intra- and inter-assay precision values for replicate quality control samples were less than 9.9% for both enantiomers during the assay validation. Mean quality control accuracy values were within ±7.3%. Assay recoveries were high (>75%) and consistent across the assay range. The metabolite enantiomers were stable in human blood for 2h on ice. The analytes were also stable in human plasma for 25h at room temperature, 34days at -20°C and -70°C, and following five freeze-thaw cycles. No interconversion of the metabolite enantiomers was detected under any bioanalytical stress conditions, from blood collection/processing through extracted sample storage. The validated assay was successfully applied to the quantification of both metabolite enantiomers in human plasma in support of a human pharmacokinetic study.

  2. Japanese Orthopaedic Association Back Pain Evaluation Questionnaire. Part 3. Validity study and establishment of the measurement scale : Subcommittee on Low Back Pain and Cervical Myelopathy Evaluation of the Clinical Outcome Committee of the Japanese Orthopaedic Association, Japan.

    Science.gov (United States)

    Fukui, Mitsuru; Chiba, Kazuhiro; Kawakami, Mamoru; Kikuchi, Shin-ichi; Konno, Shin-ichi; Miyamoto, Masabumi; Seichi, Atsushi; Shimamura, Tadashi; Shirado, Osamu; Taguchi, Toshihiko; Takahashi, Kazuhisa; Takeshita, Katsushi; Tani, Toshikazu; Toyama, Yoshiaki; Wada, Eiji; Yonenobu, Kazuo; Tanaka, Takashi; Hirota, Yoshio

    2008-05-01

    The Japanese Orthopaedic Association decided to revise the JOA score for low back pain and to develop a new outcome measure. In February 2002, the first survey was performed with a preliminary questionnaire consisting of 60 evaluation items. Based on findings of that survey, 25 items were selected for a draft of the JOA Back Pain Evaluation Questionnaire (JOABPEQ). The second survey was performed to confirm the reliability of the draft questionnaire. This article further evaluates the validity of this questionnaire and establishes a measurement scale. The subjects of this study consisted of 355 patients with low back disorders of any type (201 men, 154 women; mean age 50.7 years). Each patient was asked to fill in a self-administered questionnaire. Superficial validity was checked in terms of the completion rate for filling out the entire questionnaire. Factor analysis was then performed to evaluate the validity of the questionnaire and establish a measurement scale. As a result of the factor analysis, 25 items were categorized into five factors. The factors were named based on the commonality of the items: social function, mental health, lumbar function, walking ability, and low back pain. To establish a measurement scale for each factor, we determined the coefficient for each item so the difference between the maximum factor scores and minimum factor scores was approximately 100. We adjusted the formula so the maximum for each factor score was 100 and the minimum was 0. We confirmed the validity of the JOA Back Pain Evaluation Questionnaire and established a measurement scale.

  3. Clinical validation of the analysis of fluconazole in oral fluid in hospitalized children.

    Science.gov (United States)

    van der Elst, Kim C M; van Alst, Manouche; Lub-de Hooge, Marjolijn N; van Hateren, Kai; Kosterink, Jos G W; Alffenaar, Jan-Willem C; Schölvinck, Elisabeth H

    2014-11-01

    Fluconazole is a first-line antifungal agent for the treatment and prophylaxis of invasive candidiasis in pediatric patients. Pediatric patients are at risk of suboptimal drug exposure, due to developmental changes in gastrointestinal and renal function, metabolic capacity, and volume of distribution. Therapeutic drug monitoring (TDM) can therefore be useful to prevent underexposure of fluconazole in children and infants. Children, however, often fear needles and can have difficult vascular access. The purpose of this study was to develop and clinically validate a method of analysis to determine fluconazole in oral fluid in pediatric patients. Twenty-one paired serum and oral fluid samples were obtained from 19 patients and were analyzed using a validated liquid chromatography-tandem mass spectrometry (LC-MS-MS) method after cross-validation between serum and oral fluid. The results were within accepted ranges for accuracy and precision, and samples were stable at room temperature for at least 17 days. A Pearson correlation test for the fluconazole concentrations in serum and oral fluid showed a correlation coefficient of 0.960 (P fluconazole in pediatric patients and can be a noninvasive, painless alternative to perform TDM of fluconazole when blood sampling is not possible or desirable. When patients receive prolonged courses of antifungal treatment and use fluconazole at home, this method of analysis can extend the possibilities of TDM for patients at home.

  4. Further validation of the visual analogue scale for irritable bowel syndrome after use in clinical practice.

    Science.gov (United States)

    Bengtsson, Mariette; Persson, Jesper; Sjölund, Kristina; Ohlsson, Bodil

    2013-01-01

    The Visual Analogue Scale for Irritable Bowel Syndrome (VAS-IBS), a self-rating questionnaire, was designed to measure symptoms and the effect of treatment in patients suffering from irritable bowel syndrome. The aim of this descriptive correlational study was to conduct further psychometric validation after the VAS-IBS had been used in clinical practice, translate it into English, and compare the results with controls. Forty-nine patients with irritable bowel syndrome (median age = 38 years old [range, 18-69 years]) were compared with 90 healthy persons (median age = 44 years old [range, 21-77 years]) who served as controls. The patients with irritable bowel syndrome completed 3 questionnaires: the VAS-IBS, the Gastrointestinal Symptom Rating Scale, and the Perception of Change of Symptoms. Controls completed only the VAS-IBS. Results showed that the VAS-IBS is a valid questionnaire that measures the degree of change of symptoms and discriminates between patients who have irritable bowel syndrome from those who do not. It is important to compare the VAS-IBS among different cultural populations so we suggest that the English version of the VAS-IBS should now be used in English-speaking countries and be further tested for validity and reliability with English-speaking patients.

  5. 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…

  6. Angle-independent myocardial elastography: theoretical analysis and clinical validation

    Science.gov (United States)

    Konofagou, Elisa E.; Lee, Wei-Ning; Fung-kee-Fung, Simon D.

    2007-03-01

    Several methods have been introduced in the past few years to quantify left-ventricular strain in order to detect myocardial ischemia and infarction. Myocardial Elastography is one of these methods, which is based on ultrasound Radio-Frequency (RF) signal processing at high frame rates for the highest precision and resolution of strain estimation. Myocardial elastography estimates displacement and strain during the natural contraction of the myocardium using cross-correlation techniques. We have previously shown that imaging of the myocardial strain at high precision allows the correct assessment of the contractility of the cardiac muscle and thus measurement of the extent of ischemia or infarct. In this paper, for the first time in echocardiography, we show how angle-independent techniques can be used to estimate and image the mechanics of normal and pathological myocardia, both in simulations and in vivo. First, the fundamental limits of 2D normal and principal strain component estimation are determined using an ultrasound image formation model and a 2D short-axis view of a 3D left-ventricular, finite-element model, in normal and ischemic configurations. Two-dimensional (i.e., lateral and axial) cumulative displacement and strain components were iteratively estimated and imaged using 1D cross-correlation and recorrelation techniques in a 2D search. Validation of these elastographic findings in one normal human subject was performed. Principal strains were also imaged for the characterization of normal myocardium. In conclusion, the feasibility of angle-independent, 2D myocardial elastography technique was shown through the calculation of the in-plane principal strains, which was proven essential in the reliable depiction of strains independent of the beam-tissue angle or the type of sonographic view used.

  7. College of the Canyons Predictive Validity Studies.

    Science.gov (United States)

    College of the Canyons, Valencia, CA. Office of Institutional Development.

    Matriculation regulations in California require that community colleges which adopt standardized placement tests demonstrate that the tests are valid predictors of future course success. A positive correlation of at least .35 between test score and subsequent student performance in a particular course is needed to demonstrate the predictive…

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

    Science.gov (United States)

    Karabekiroglu, Koray; Aman, Michael G.

    2009-01-01

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

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

    Science.gov (United States)

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

    2004-01-01

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

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

    Science.gov (United States)

    Kelly, William E.; Lutz, Daniel

    2014-01-01

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

  11. 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.

    2010-01-01

    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 a

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

    NARCIS (Netherlands)

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

    2010-01-01

    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 hundre

  13. 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

  14. Validation of new psychosocial factors questionnaires: a Colombian national study.

    Science.gov (United States)

    Villalobos, Gloria H; Vargas, Angélica M; Rondón, Martin A; Felknor, Sarah A

    2013-01-01

    The study of workers' health problems possibly associated with stressful conditions requires valid and reliable tools for monitoring risk factors. The present study validates two questionnaires to assess psychosocial risk factors for stress-related illnesses within a sample of Colombian workers. The validation process was based on a representative sample survey of 2,360 Colombian employees, aged 18-70 years. Worker response rate was 90%; 46% of the responders were women. Internal consistency was calculated, construct validity was tested with factor analysis and concurrent validity was tested with Spearman correlations. The questionnaires demonstrated adequate reliability (0.88-0.95). Factor analysis confirmed the dimensions proposed in the measurement model. Concurrent validity resulted in significant correlations with stress and health symptoms. "Work and Non-work Psychosocial Factors Questionnaires" were found to be valid and reliable for the assessment of workers' psychosocial factors, and they provide information for research and intervention. Copyright © 2012 Wiley Periodicals, Inc.

  15. Validation of computerized diagnostic information in a clinical database from a national equine clinic network

    Directory of Open Access Journals (Sweden)

    Egenvall Agneta

    2009-12-01

    Full Text Available Abstract Background Computerized diagnostic information offers potential for epidemiological research; however data accuracy must be addressed. The principal aim of this study was to evaluate the completeness and correctness of diagnostic information in a computerized equine clinical database compared to corresponding hand written veterinary clinical records, used as gold standard, and to assess factors related to correctness. Further, the aim was to investigate completeness (epidemiologic sensitivity, correctness (positive predictive value, specificity and prevalence for diagnoses for four body systems and correctness for affected limb information for four joint diseases. Methods A random sample of 450 visits over the year 2002 (nvisits = 49,591 was taken from 18 nation wide clinics headed under one company. Computerized information for the visits selected and copies of the corresponding veterinary clinical records were retrieved. Completeness and correctness were determined using semi-subjective criteria. Logistic regression was used to examine factors associated with correctness for diagnosis. Results Three hundred and ninety six visits had veterinary clinical notes that were retrievable. The overall completeness and correctness were 91% and 92%, respectively; both values considered high. Descriptive analyses showed significantly higher degree of correctness for first visits compared to follow up visits and for cases with a diagnostic code recorded in the veterinary records compared to those with no code noted. The correctness was similar regardless of usage category (leisure/sport horse, racing trotter and racing thoroughbred or gender. For the four body systems selected (joints, skin and hooves, respiratory, skeletal the completeness varied between 71% (respiration and 91% (joints and the correctness ranged from 87% (skin and hooves to 96% (respiration, whereas the specificity was >95% for all systems. Logistic regression showed that

  16. 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

  17. "Absolute" quantification in magnetic resonance spectroscopy: validation of a clinical protocol in multiple sclerosis.

    Science.gov (United States)

    Bagory, Matthieu; Durand-Dubief, Françoise; Ibarrola, Danielle; Confavreux, Christian; Sappey-Marinier, Dominique

    2007-01-01

    MRS allows to measure cerebral metabolites, thus helping to characterize brain disease diagnosis and followup. Metabolite concentration quantification is usually based on metabolite ratio referring to creatine. If this metabolite concentration is supposed to be constant, it may vary in pathological processes. Therefore, "absolute" concentration methodology is needed. The aim of this study is to validate a clinical "absolute" quantification protocol through the development of an external metabolic phantom, calibration and correction, and the investigation of reproducibility issues. When phantom stability was investigated by a short-term and a long-term reproducibility study, both Standard Deviations (SD) were in agreement with literature values. This "absolute" quantification method was applied to patients with Multiple Sclerosis (MS). The results show a significant decrease in both N-Acetyl Aspartate (NAA) and choline concentrations.

  18. Validation of radiocarpal joint contact models based on images from a clinical MRI scanner.

    Science.gov (United States)

    Johnson, Joshua E; McIff, Terence E; Lee, Phil; Toby, E Bruce; Fischer, Kenneth J

    2014-01-01

    This study was undertaken to assess magnetic resonance imaging (MRI)-based radiocarpal surface contact models of functional loading in a clinical MRI scanner for future in vivo studies, by comparison with experimental measures from three cadaver forearm specimens. Experimental data were acquired using a Tekscan sensor during simulated light grasp. Magnetic resonance (MR) images were used to obtain model geometry and kinematics (image registration). Peak contact pressures (PPs) and average contact pressures (APs), contact forces and contact areas were determined in the radiolunate and radioscaphoid joints. Contact area was also measured directly from MR images acquired with load and compared with model data. Based on the validation criteria (within 25% of experimental data), out of the six articulations (three specimens with two articulations each), two met the criterion for AP (0%, 14%); one for peak pressure (20%); one for contact force (5%); four for contact area with respect to experiment (8%, 13%, 19% and 23%), and three contact areas met the criterion with respect to direct measurements (14%, 21% and 21%). Absolute differences between model and experimental PPs were reasonably low (within 2.5 MPa). Overall, the results indicate that MRI-based models generated from 3T clinical MR scanner appear sufficient to obtain clinically relevant data.

  19. Toddler Autism Screening Questionnaire: Development and Potential Clinical Validity

    Science.gov (United States)

    Tsai, Wen-Che; Soong, Wei-Tsuen; Shyu, Yea-Ing Lotus

    2012-01-01

    No feasible screening instrument is available for early detection of children with autism in Taiwan. The existing instruments may not be appropriate for use in Taiwan due to different health care systems and child-rearing cultures. The purpose of this study was to develop and test a screening questionnaire for generic autism. The initial 18-item…

  20. 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.

  1. Clinical Validation of Adjusted Corneal Power in Patients with Previous Myopic Lasik Surgery

    Directory of Open Access Journals (Sweden)

    Vicente J. Camps

    2015-01-01

    Full Text Available Purpose. To validate clinically a new method for estimating the corneal power (Pc using a variable keratometric index (nkadj in eyes with previous laser refractive surgery. Setting. University of Alicante and Medimar International Hospital (Oftalmar, Alicante, (Spain. Design. Retrospective case series. Methods. This retrospective study comprised 62 eyes of 62 patients that had undergone myopic LASIK surgery. An algorithm for the calculation of nkadj was used for the estimation of the adjusted keratometric corneal power (Pkadj. This value was compared with the classical keratometric corneal power (Pk, the True Net Power (TNP, and the Gaussian corneal power (PcGauss. Likewise, Pkadj was compared with other previously described methods. Results. Differences between PcGauss and Pc values obtained with all methods evaluated were statistically significant (p<0.01. Differences between Pkadj and PcGauss were in the limit of clinical significance (p<0.01, loA [−0.33,0.60] D. Differences between Pkadj and TNP were not statistically and clinically significant (p=0.319, loA [−0.50,0.44] D. Differences between Pkadj and previously described methods were statistically significant (p<0.01, except with PcHaigisL (p=0.09, loA [−0.37,0.29] D. Conclusion. The use of the adjusted keratometric index (nkadj is a valid method to estimate the central corneal power in corneas with previous myopic laser refractive surgery, providing results comparable to PcHaigisL.

  2. Digital Learning Literacies – A Validation Study

    Directory of Open Access Journals (Sweden)

    Gila Kurtz

    2016-05-01

    As can be concluded from the findings, most of the participants evaluate themselves as digitally literate with regard to the basic information research and retrieval skills, validation and information management. But when it comes to PSs that require complex decision making or higher order thinking strategies, it seems that a large number of participants lack these skills. Also, social responsibility and digital integrity domains are perceived as known by the participants but not very well taken in terms of pro-active action to enforce appropriate digital behavior, or avoiding illegally obtained music or movies.

  3. Development and validation of a sensitive liquid chromatographic-tandem mass spectrometric method for the simultaneous analysis of granisetron and 7-hydroxy granisetron in human plasma and urine samples: application in a clinical pharmacokinetic study in pregnant subject.

    Science.gov (United States)

    Zhao, Yang; Chen, Hui-Jun; Caritis, Steve; Venkataramanan, Raman

    2016-02-01

    A liquid chromatography-tandem mass spectrometric method for the quantification of granisetron and its major metabolite, 7-hydroxy granisetron in human plasma and urine samples was developed and validated. Respective stable isotopically labeled granisetron and 7-hydroxy granisetron were used as internal standards (IS). Chromatography was performed using an Xselect HSS T3 analytical column with a mobile phase of 20% acetonitrile in water (containing 0.2 mM ammonium formate and 0.14% formic acid, pH 4) delivered in an isocratic mode. Tandem mass spectrometry operating in positive electrospray ionization mode with multiple reaction monitoring was used for quantification. The standard curves were linear in the concentration ranges of 0.5-100 ng/mL for granisetron and 0.1-100 ng/mL for 7-hydroxy granisetron in human plasma samples, and 2-2000 ng/mL for granisetron and 2-1000 ng/mL for 7-hydroxy granisetron in human urine samples, respectively. The accuracies were >85% and the precision as determined by the coefficient of variations was validated method was successfully applied to a pharmacokinetic study after intravenous administration of 1 mg granisetron to a pregnant subject.

  4. Development and validation of a tool to measure incivility in clinical nursing education.

    Science.gov (United States)

    Anthony, Maureen; Yastik, Joanne; MacDonald, Douglas A; Marshall, Katherine A

    2014-01-01

    Although the literature suggests that incivility on the part of staff nurses toward student nurses in the clinical setting exists, no instrument was found that addressed this phenomenon. This article describes the development and validation of the uncivil behavior in clinical nursing education (UBCNE) tool to measure nursing students' experiences with incivility in the clinical learning environment. The 20-item UBCNE was administered to 118 nursing students at a midwestern school of nursing. Analyses included evaluation of interitem response consistency, internal structure via principal components analysis using both orthogonal and oblique rotation, and assessment of the association to demographic variables and stress while on placement as a criterion measure. Six items were dropped due to high loading on more than 1 component. This resulted in a 12-item test with 2 modified subscales-hostile/mean/dismissive and exclusionary behavior. The revised subscales and total test demonstrate good reliability, and both subscales are clearly represented in the separate components. The UBCNE is an easily administered tool with good internal consistency. Future studies with a larger sample and in different settings need to be conducted. Copyright © 2014. Published by Elsevier Inc.

  5. 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.

  6. Determination of body composition from skinfold thickness: a validation study.

    Science.gov (United States)

    Reilly, J J; Wilson, J; Durnin, J V

    1995-01-01

    Measurement of body composition is proving increasingly important in clinical nutrition and research. Skinfold thickness is a simple means of estimating body composition which is widely used in children, but there is little information on its validity. There has been a proliferation of equations for estimation of body composition from skinfolds, but some doubt as to their general applicability. The aim of the present study was to validate five currently used equations for this purpose in a sample of 98 healthy prepubertal children (64 boys, 34 girls), mean (SD) age 9.1 (1.7) years by comparison of estimates from each equation with measurements of fatness derived from hydrodensitometry. Differences between methods were determined by calculation of biases and limits of agreement. Limits of agreement between predicted and measured fatness were wide, particularly in the girls, and some distinct biases were apparent. Choice of prediction equation therefore has a substantial influence on the estimate of fatness obtained when using skinfolds in children. The existing published equations are associated with large random errors or significant systematic errors. For the time being skinfolds might best be regarded as indices (rather than measures) of body fatness in individuals, or means of estimating body fatness of groups. Estimating the total body fatness of individual prepubertal children using skinfolds, on the basis of this evidence, is not advisable at present. PMID:7492193

  7. 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.

  8. Validation study on avermectine residues in foodstuffs.

    Science.gov (United States)

    Giannetti, L; Giorgi, A; Necci, F; Ferretti, G; Buiarelli, F; Neri, B

    2011-08-26

    Avermectines are antiparasitic agents widely used as veterinary drugs for food producing animals. The European Community, due to their side effects, limited the use of these molecules establishing maximum residue limits (MRLs) in some foods. A validated qualitative and quantitative high performance liquid chromatography method with fluorescence detection (HPLC-FL) is presented for the simultaneous determination of ivermectin (IVM), abemectin (ABA), moxidectin (MOX), eprinomectin (EPR), doramectin (DOR) and emamectin (EMA) in foodstuffs (muscle, eggs and milk). Samples were extracted with acetonitrile, purified with liquid-liquid extraction (LLE), and analysed by HLPC-FL previous derivatization with trifluoroacetic anhydride (TFAA) in presence of 1-methyl-imidazole (MI) and acetic acid. To date, the presented method is the first validated for the matrix eggs, and in accordance with the requirements set by Commission Decision 2002/657/EC. Recoveries of the methods, calculated spiking the samples in the range 5.0-100.0 μg kg(-1), were 64-83% for muscle, 65-89% for milk and 63-84% for eggs. The precision (CV) ranged between 9.2 and 17.1% for muscle, 9.9 and 16.6% for milk and from 9.4 to 17.4% for eggs. Linearity for the six analytes was calculated from 5.0 to 200.0 μg kg(-1). The main advantages of the presented method are its rapidity, the specificity, the good precision and recovery that make it very suitable to the detection and determination of avermectines.

  9. Clinical usefulness and validity of robotic measures of reaching movement in hemiparetic stroke patients.

    Science.gov (United States)

    Otaka, Eri; Otaka, Yohei; Kasuga, Shoko; Nishimoto, Atsuko; Yamazaki, Kotaro; Kawakami, Michiyuki; Ushiba, Junichi; Liu, Meigen

    2015-08-12

    Various robotic technologies have been developed recently for objective and quantitative assessment of movement. Among them, robotic measures derived from a reaching task in the KINARM Exoskeleton device are characterized by their potential to reveal underlying motor control in reaching movements. The aim of this study was to examine the clinical usefulness and validity of these robot-derived measures in hemiparetic stroke patients. Fifty-six participants with a hemiparetic arm due to chronic stroke were enrolled. The robotic assessment was performed using the Visually Guided Reaching (VGR) task in the KINARM Exoskeleton, which allows free arm movements in the horizontal plane. Twelve parameters were derived based on motor control theory. The following clinical assessments were also administered: the proximal upper limb section in the Fugl-Meyer Assessment (FMA-UE(A)), the proximal upper limb part in the Stroke Impairment Assessment Set (SIAS-KM), the Modified Ashworth Scale for the affected elbow flexor muscles (MAS elbow), and seven proximal upper limb tasks in the Wolf Motor Function Test (WMFT). To explore which robotic measures represent deficits of motor control in the affected arm, the VGR parameters in the paretic arm were compared with those in the non-paretic arm using the Wilcoxon signed rank test. Then, to explore which VGR parameters were related to overall motor control regardless of the paresis, correlations between the paretic and non-paretic arms were examined. Finally, to investigate the relationships between the robotic measures and the clinical scales, correlations between the VGR parameters and clinical scales were investigated. Spearman's rank correlation coefficients were used for all correlational analyses. Eleven VGR parameters on the paretic side were significantly different from those on the non-paretic side with large effect sizes (|effect size| = 0.76-0.87). Ten VGR parameters correlated significantly with FMA-UE(A) (|r| = 0

  10. 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.

  11. [French validation study of the levels of emotional awareness scale].

    Science.gov (United States)

    Bydlowski, S; Corcos, M; Paterniti, S; Guilbaud, O; Jeammet, P; Consoli, S M

    2002-01-01

    According to a thesis based on the idea of an influence of cognitions in the structuring of internal reality, emotional awareness, ie the capacity of representing your own emotional experience and that of others, is a cognitive process that goes into maturation. Defining this concept, Lane and Schwartz present a cognitivo-developmental model in five stages of the processes of symbolization, accounting for the differences in levels of emotional awareness observed in individuals. The organization of these cognitive processes would thus be structured in well differentiated stages, in which the development of the emotions would be inseparable from the development of ego and of the relation to others. These authors focus on the capacity of representing in a conscious way the emotional experience and consider that verbal representations used to describe the contents of what is experience constitute a good reflection of the organization structural of the emotional awareness. Therefore, they worked out an instrument of evaluation: the Levels of Emotional Awareness Scale (LEAS), which measures the capacity to describe your own emotional experience and the one you allow to others, in an emotional situation. The system of quotation of this scale is based on the analysis of the verbal contents of the provided answers, in direct reference to the authors' theory of the levels of differentiation and integration of the emotional experience. It is therefore an empirical measurement which is centered specifically on the structural organization of the emotional experience. The various studies of validation of this instrument show that it presents solid metrological properties. This work presents the validation of the French version of Lane and Schwartz's LEAS. Validity and fidelity were studied in a group of 121 healthy subjects. This setting is part of a larger clinical evaluation, also including a collection of socio-demographic and clinical data, and other instruments of self

  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. Validating the effectiveness of Clinically Oriented Physiology Teaching (COPT in undergraduate physiology curriculum

    Directory of Open Access Journals (Sweden)

    Ramnarayan Komattil

    2008-07-01

    Full Text Available Abstract Background It has been proved that basic science knowledge learned in the context of a clinical case is actually better comprehended and more easily applied by medical students than basic science knowledge learned in isolation. The present study intended to validate the effectiveness of Clinically Oriented Physiology Teaching (COPT in undergraduate medical curriculum at Melaka Manipal Medical College (Manipal Campus, Manipal, India. Methods COPT was a teaching strategy wherein, students were taught physiology using cases and critical thinking questions. Three batches of undergraduate medical students (n = 434 served as the experimental groups to whom COPT was incorporated in the third block (teaching unit of Physiology curriculum and one batch (n = 149 served as the control group to whom COPT was not incorporated. The experimental group of students were trained to answer clinically oriented questions whereas the control group of students were not trained. Both the group of students undertook a block exam which consisted of clinically oriented questions and recall questions, at the end of each block. Results Comparison of pre-COPT and post-COPT essay exam scores of experimental group of students revealed that the post-COPT scores were significantly higher compared to the pre-COPT scores. Comparison of post-COPT essay exam scores of the experimental group and control group of students revealed that the experimental group of students performed better compared to the control group. Feedback from the students indicated that they preferred COPT to didactic lectures. Conclusion The study supports the fact that assessment and teaching patterns should fall in line with each other as proved by the better performance of the experimental group of students compared to the control group. COPT was also found to be a useful adjunct to didactic lectures in teaching physiology.

  14. Validating the effectiveness of Clinically Oriented Physiology Teaching (COPT) in undergraduate physiology curriculum.

    Science.gov (United States)

    Abraham, Reem; Ramnarayan, Komattil; Kamath, Asha

    2008-07-24

    It has been proved that basic science knowledge learned in the context of a clinical case is actually better comprehended and more easily applied by medical students than basic science knowledge learned in isolation. The present study intended to validate the effectiveness of Clinically Oriented Physiology Teaching (COPT) in undergraduate medical curriculum at Melaka Manipal Medical College (Manipal Campus), Manipal, India. COPT was a teaching strategy wherein, students were taught physiology using cases and critical thinking questions. Three batches of undergraduate medical students (n = 434) served as the experimental groups to whom COPT was incorporated in the third block (teaching unit) of Physiology curriculum and one batch (n = 149) served as the control group to whom COPT was not incorporated. The experimental group of students were trained to answer clinically oriented questions whereas the control group of students were not trained. Both the group of students undertook a block exam which consisted of clinically oriented questions and recall questions, at the end of each block. Comparison of pre-COPT and post-COPT essay exam scores of experimental group of students revealed that the post-COPT scores were significantly higher compared to the pre-COPT scores. Comparison of post-COPT essay exam scores of the experimental group and control group of students revealed that the experimental group of students performed better compared to the control group. Feedback from the students indicated that they preferred COPT to didactic lectures. The study supports the fact that assessment and teaching patterns should fall in line with each other as proved by the better performance of the experimental group of students compared to the control group. COPT was also found to be a useful adjunct to didactic lectures in teaching physiology.

  15. Are chronic fatigue and chronic fatigue syndrome valid clinical entities across countries and health-care settings?

    NARCIS (Netherlands)

    Hickie, I.; Davenport, T.; Vernon, S.D.; Nisenbaum, R.; Reeves, W.C.; Hadzi-Pavlovic, D.; Lloyd, A.; Bleijenberg, G.; Werf, S.P. van der; Prins, J.B.; Blenkiron, P.M.; Buchwald, D.; Smith, W.R.; Edwards, R.; Lynch, S.; Kirmayer, L.J.; Taillefer, S.S.; Lee, S.; Martin, N.G.; Gillespie, N.E.; McIlvenny, S.; Sartorius, N.; Ustun, T.B.; Skapinakis, P.; Wessely, S.; Chalder, T.; Hotopf, M.; Nimnuan, C.; Candy, B.; Darbishire, L.; Ridsdale, L.; White, P.D.; Thomas, J.M.; Wilhelm, K.; Wilson, A.

    2009-01-01

    OBJECTIVE: The validity of the diagnosis of chronic fatigue syndrome and related chronic fatigue states remains controversial, particularly in psychiatry. This project utilized international epidemiological and clinical research data to test construct validity across diagnostic categories, health-ca

  16. Development and validation of a selective and robust LC-MS/MS method for high-throughput quantifying rizatriptan in small plasma samples: application to a clinical pharmacokinetic study.

    Science.gov (United States)

    Chen, Yi; Miao, Haijun; Lin, Mei; Fan, Guorong; Hong, Zhanying; Wu, Huiling; Wu, Yutian

    2006-12-05

    An analytical method based on liquid chromatography with positive ion electrospray ionization (ESI) coupled to tandem mass spectrometry detection (LC-MS/MS) was developed for the determination of a potent 5-HT(1B/1D) receptor agonist, rizatriptan in human plasma using granisetron as the internal standard. The analyte and internal standard were isolated from 100 microL plasma samples by liquid-liquid extraction (LLE) and chromatographed on a Lichrospher C18 column (4.6mm x 50mm, 5 microm) with a mobile phase consisting of acetonitrile-10mM aqueous ammonium acetate-acetic acid (50:50:0.5, v/v/v) pumped at 1.0 mL/min. The method had a chromatographic total run time of 2 min. A Varian 1200 L electrospray tandem mass spectrometer equipped with an electrospray ionization source was operated in selected reaction monitoring (SRM) mode with the precursor-to-product ion transitions m/z 270-->201 (rizatriptan) and 313.4-->138 (granisetron) used for quantitation. The assay was validated over the concentration range of 0.05-50 ng/mL and was found to have acceptable accuracy, precision, linearity, and selectivity. The mean extraction recovery from spiked plasma samples was above 98%. The intra-day accuracy of the assay was within 12% of nominal and intra-day precision was better than 13% C.V. Following a 10mg dose of the compound administered to human subjects, mean concentrations of rizatriptan ranged from 0.2 to 70.6 ng/mL in plasma samples collected up to 24h after dosing. Inter-day accuracy and precision results for quality control samples run over a 5-day period alongside clinical samples showed mean accuracies of within 12% of nominal and precision better than 9.5% C.V.

  17. Failure to Validate a Multivariable Clinical Prediction Model to Identify Pediatric Intensive Care Unit Patients at High Risk for Candidemia.

    Science.gov (United States)

    Fisher, Brian T; Ross, Rachael K; Roilides, Emmanuel; Palazzi, Debra L; Abzug, Mark J; Hoffman, Jill A; Berman, David M; Prasad, Priya A; Localio, A Russell; Steinbach, William J; Vogiatzi, Lambrini; Dutta, Ankhi; Zaoutis, Theoklis E

    2016-12-01

    We attempted to validate a previously derived clinical prediction rule for candidemia in the pediatric intensive care unit. This multicenter case control study did not identify significant association of candidemia with most of the previously identified predictors. Additional study in larger cohorts with other predictor variables is needed. © The Author 2015. Published by Oxford University Press on behalf of the Pediatric Infectious Diseases Society. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  18. The feasibility and validity of the comprehensive ICF core set for stroke in Chinese clinical settings.

    Science.gov (United States)

    Wang, Pu; Li, Huagang; Guo, Yi; Xie, Yuxiao; Ge, Ruidong; Qiu, Zhuoying

    2014-02-01

    To inspect the feasibility and content validity of the comprehensive International Classification of Functioning, Disability and Health (ICF) core set for stroke by describing relevant aspects of functioning, disability and environmental factors affected in Chinese patients post stroke. Multicentre, cross-sectional study. Department of rehabilitation medicine. The content validity was evaluated using frequency and percentage of 208 patients with a mean age of 60 years post stroke in China. Aspects of body function and structure, activity and participation, and environmental factors in the comprehensive ICF core set for stroke. Six ICF categories of body function were identified as a problem in over 90% (n = 187) of the patients (functions of the cardiovascular system and neuromusculoskeletal and movement-related functions). Impairments of brain, upper and lower extremity were identified as a problem in over 50% (n = 104) of the patients. Four ICF categories of activities and participation were documented as a problem in 100% (n = 208) of the patients (domestic and civic life). In environmental factors, nine ICF categories were documented as barriers by more than 10% (n = 20) and fewer than 50% (n = 104) of the patients (products and technology, physical geography, societal attitudes, services, systems and polices). Six ICF categories were identified as facilitators in over 90% (n = 187) of the patients (support and relationships and attitudes). The findings suggest that it is feasible to apply the comprehensive ICF core set for stroke in the Chinese clinical setting, after the appropriate reduction of some categories according to Chinese patients' characteristics and culture.

  19. 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.

  20. 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.

  1. A patient with a large pulmonary saddle embolus eluding both clinical gestalt and validated decision rules.

    Science.gov (United States)

    Hennessey, Adam; Setyono, Devy A; Lau, Wayne Bond; Fields, Jason Matthew

    2012-06-01

    We report a patient with chest pain who was classified as having low risk for pulmonary embolism with clinical gestalt and accepted clinical decision rules. An inadvertently ordered D-dimer and abnormal result, however, led to the identification of a large saddle embolus. This case illustrates the fallibility of even well-validated decision aids and that an embolism missed by these tools is not necessarily low risk or indicative of a low clot burden. Copyright © 2011. Published by Mosby, Inc.

  2. Identification and prospective validation of clinically relevant chronic obstructive pulmonary disease (COPD) subtypes.

    OpenAIRE

    García Aymerich, Judith; Gomez, F. P.; Benet Mora, Marta; Farrero, E.; Basagaña, Xavier; Gayete, A.; Pare i Bardera, J. Carles; Freixa, X.; Ferrer, J.; Ferrer Monreal, Antonio; Roca Elias, Josep; Galdiz, J. P.; Sauleda, J. E.; Monso, E; Gea Guiral, Joaquim

    2010-01-01

    Background Chronic obstructive pulmonary disease (COPD) is increasingly considered a heterogeneous condition. It was hypothesised that COPD, as currently defined, includes different clinically relevant subtypes. Methods To identify and validate COPD subtypes, 342 subjects hospitalised for the first time because of a COPD exacerbation were recruited. Three months after discharge, when clinically stable, symptoms and quality of life, lung function, exercise capacity, nutritional status, biomark...

  3. Measuring Long-Distance Romantic Relationships: A Validity Study

    Science.gov (United States)

    Pistole, M. Carole; Roberts, Amber

    2011-01-01

    This study investigated aspects of construct validity for the scores of a new long-distance romantic relationship measure. A single-factor structure of the long-distance romantic relationship index emerged, with convergent and discriminant evidence of external validity, high internal consistency reliability, and applied utility of the scores.…

  4. A Validity Study of the Pain Apperception Test

    Science.gov (United States)

    Haase, Richard F.; And Others

    1975-01-01

    This study assessed the validity of the Pain Apperception Test (PAT) against an accepted and validated predictive measure of pain tolerance, a Kinesthetic After Effects Task (KAE). As well, it replicated an earlier finding by Petrovich that suggested that scores derived from the PAT are related significantly to neuroticism. (Author/RK)

  5. The Self-Consciousness Scale: A Discriminant Validity Study

    Science.gov (United States)

    Carver, Charles S.; Glass, David C.

    1976-01-01

    A validity study is conducted of the Self-Consciousness Scale components with male undergraduates. The components, Private and Public Self Consciousness and Social Anxiety did not correlate with any other measures used to establish their validity and thus seem to be independent of other measures tested. (Author/DEP)

  6. 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...

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

    Science.gov (United States)

    Marshall, Margarita B.; Bagby, R. Michael

    2006-01-01

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

  8. [Validity of schintigraphy in the study of neurogenic dysphagia].

    Science.gov (United States)

    Galli, J; Valenza, V; D'Alatri, L; Gajate Samanes, A M; Reale, F; La Mura, F

    2000-08-01

    The purpose of the present study was to verify the validity and potential application of oropharyngealesophageal scintigraphy in the analysis of neurogenic dysphagia. Scintigraphy was used on 36 patients divided into 2 groups: Group 1 (control) comprised 17 healthy volunteers; Group 2 included 19 patients suffering from various neurological and neuromuscular pathologies (myasthenia gravis, Parkinson's disease, polymyositis, stroke, paralysis of the last cranial nerves). In group 1 scintigraphy provided normal results both for mode of swallowing and transit, and for the values of the various parameters studied. On the other hand, scintigraphy showed that in group 2 all oral, pharyngeal and esophageal phases of swallowing were altered vs the controls with a statistically significant increase in the average values for the oral transit time (OTT) (1.45 sec., p = 0.0005), pharyngeal transit time (OTT) (3.23 sec., p = 0.044), esophageal transit time (ETT) e19.87 sec., p = 0.005) as well as in the corresponding bolus retention indexes ORU (12.95%, p = 0.0003), FIR (15.05%, p = 0.0003) and ERI (28.63%, p = 0.002). Moreover, the quality and means of swallowing also proved altered while tracheobronchial aspiration was only seen in 6 of the 19 patients (maximum value: 90%, average value; 7.66%) with a marked prevalence in the stroke subgroup (4/8). In light of these results and considering the low dose of radiation (0.00043 Gy), the lack of invasiveness and excellent tolerability, scintigraphy has confirmed its clinical validity in the functional, objective and quali-quantitative study of deglutition, even in patients suffering from neurogenic dysphagia.

  9. International adaptations of the Millon Clinical Multiaxial Inventory: Construct validity and clinical applications

    NARCIS (Netherlands)

    Rossi, G.M.P.; Derksen, J.J.L.

    2015-01-01

    This article examines the influence of the Millon Clinical Multiaxial Inventory (MCMI) as a clinical and research instrument beyond the borders of the United States. The MCMI's theoretical and empirical grounding, its alignment with the Diagnostic and Statistical Manual of Mental Disorders (DSM), an

  10. Improving clinical reality in chronic obstructive pulmonary disease economic modelling : development and validation of a micro-simulation approach.

    Science.gov (United States)

    Asukai, Yumi; Baldwin, Michael; Fonseca, Tiago; Gray, Alastair; Mungapen, Laura; Price, David

    2013-02-01

    Chronic obstructive pulmonary disease (COPD) is a progressive and irreversible disease responsible for the deaths of 3 million people worldwide in 2005, and predicted to be the third leading cause of death worldwide by 2030. Many COPD models developed to date have followed a Markov structure, in which patients or populations can move between defined health states over successive time periods or cycles. In COPD, health states are typically based on disease severity defined solely by lung function, as described by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines. These current modelling methods may restrict the ability to reflect the disease progression/clinical pathway or clinical practice. Given these limitations in previous COPD models, the authors aimed to develop a more flexible model that could improve on the description of the clinical disease pathway. The overall objective of this model was to inform the development of policies, guidelines or cost-effectiveness analyses. A second objective was to validate the model in relation to existing epidemiology studies of COPD. A patient simulation model was developed in Microsoft Excel™. The predictability of the model was tested by populating it with data from natural history of disease studies as well as with clinical trial data. Each patient moves through the model with demographic characteristics randomly generated from a set distribution. These characteristics determine the risk of clinical events occurring in the model. The validation with these studies found the model to have generally good predictive ability, yielding in this way a good degree of external validity. The micro-simulation model is a flexible approach for modelling COPD that allows consideration of complex COPD treatment pathways. The model was found to be generally robust in terms of predicting clinical outcomes of published studies when tested against other studies. It has significant potential as a tool for

  11. Clinical and psychometric validation of the quality of life assessment system for advanced gastric cancer based on traditional Chinese medicine.

    Science.gov (United States)

    Quan, Peng; Zheng, Pei-Yong; You, Sheng-Fu; Hua, Yong-Qiang; Song, Yi; Liu, Tao; Wan, Chong-Hua; Lu, Jin-Gen

    2016-08-01

    To establish questionnaire scaling and reliability and examine the clinical and psychometric validity of the quality of life assessment based on Traditional Chinese Medicine for advanced gastric cancer (QLASTCM-Ga). The QLASTCM-Ga was developed based on programmed decision procedures with multiple nominal and focus group discussions, in-depth interview, pretesting and quantitative statistical procedures. The questionnaire was administered to 240 patients diagnosed with advanced gastric cancer before and after treatment. Structured group methods were employed to establish a general and a specifific module respectively. The psychometric properties of the scale were evaluated with respect to validity, reliability and responsiveness. The three identified scales of the QLASTCM-Ga and the total score demonstrated good psychometric properties. Test-retest reliability of the total scale and all domains ranged from 0.90 to 0.94, and internal consistency ranged from 0.86 to 0.93. Correlation and factor analysis demonstrated good construct validity. Signifificant difference in the subscales and the total score were found among groups differing in traditional Chinese medicine syndrome, supporting the clinical sensitivity of the QLASTCM-Ga. Statistically signifificant changes were found for each scale and the total score. Responsiveness was also good. The QLASTCM-Ga demonstrates good psychometric and clinical validity to assess quality of life in patients with advanced gastric cancer undergoing traditional Chinese medicine therapy. This study is an important fifirst step for future research in this area.

  12. Embedded Measures of Performance Validity in the Rey Complex Figure Test in a Clinical Sample of Veterans.

    Science.gov (United States)

    Sugarman, Michael A; Holcomb, Erin M; Axelrod, Bradley N; Meyers, John E; Liethen, Philip C

    2016-01-01

    The purpose of this study was to determine how well scores from the Rey Complex Figure Test (RCFT) could serve as embedded measures of performance validity in a large, heterogeneous clinical sample at an urban-based Veterans' Affairs hospital. Participants were divided into credible performance (n = 244) and noncredible performance (n = 87) groups based on common performance validity tests during their respective clinical evaluations. We evaluated how well preselected RCFT scores could discriminate between the 2 groups using cut scores from single indexes as well as multivariate logistic regression prediction models. Additionally, we evaluated how well memory error patterns (MEPs) could discriminate between the 2 groups. Optimal discrimination occurred when indexes from the Copy and Recognition trials were simultaneous predictors in logistic regression models, with 91% specificity and at least 53% sensitivity. Logistic regression yielded superior discrimination compared with individual indexes and compared with the use of MEPs. Specific scores on the RCFT, including the Copy and Recognition trials, can serve as adequate indexes of performance validity, when using both cut scores and logistic regression prediction models. We provide logistic regression equations that can be applied in similar clinical settings to assist in determining performance validity.

  13. 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

  14. [Clinical studies on pramipexol retard].

    Science.gov (United States)

    Klivényi, Péter; Vécsei, László

    2010-05-30

    Pramipexol retard is the newest drug for the treatment of Parkinson's disease. The prolonged release of the agent in this preparation allows a more continuous dopaminergic stimulation than previous preparations, without reducing the agent's already known and proven clinical efficiency. In addition, it has a more favourable adverse effect profile than previous preparations, and patient compliance can also be better as it needs to be taken only once daily. These benefits have been proven in recent clinical studies, of which the most important ones are reviewed here.

  15. 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.

  16. Nursing interventions classification in systematized nomenclature of medicine clinical terms: a cross-mapping validation.

    Science.gov (United States)

    Park, Hyun-Tae; Lu, Der-Fa; Konicek, Debra; Delaney, Connie

    2007-01-01

    The Systemized Nomenclature of Medical Clinical Terms, or SNOMED-CT, was developed to create a comprehensive clinical healthcare reference terminology. Standardized nursing language concepts and terminologies recognized by the American Nurses Association have been added to SNOMED-CT and include the NANDA's Taxonomy II, NIC, NOC, the Omaha System, and CCC. The relationship link between terminologies and SNOMED-CT is provided in a mapping table, which identifies the source terminology. The purpose of this study is to examine the validity of the cross-mapping between the source system (NIC) and the target system (SNOMED-CT) using the methodology developed by Lu and colleagues to detect misassigned concepts. Knowledge representation concepts in the NIC and SNOMED-CT systems were compared using expert human judgment. Of 514 NIC concepts, 14 (2.7%) were identified as misassigned in SNOMED-CT. Two inappropriate representations of concepts were discovered in NIC. Results and recommendations were given to NIC and to SNOMED-CT.

  17. [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.

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

    Directory of Open Access Journals (Sweden)

    Margaret E Gruen

    Full Text Available 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 (p<0.0001 compared to baseline. The FMPI results and activity count data offer concurrent validation for the FMPI, though the relationship between baseline activity counts and FMPI scores at baseline was poor (R2=0.034. The CSOM did not show responsiveness for improvement in this study, and the relationship between baseline activity counts and CSOM scores at baseline was similarly poor (R2=0.042.Refinements to the FMPI, including abbreviation of the instrument and scoring as percent of possible score are recommended. This study offered further validation of the FMPI as a clinical metrology instrument for use in detecting therapeutic efficacy in cats with degenerative joint disease.

  19. 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.

  20. Rorschach scores in applied clinical practice: a survey of perceived validity by experienced clinicians.

    Science.gov (United States)

    Meyer, Gregory J; Hsiao, Wei-Cheng; Viglione, Donald J; Mihura, Joni L; Abraham, Leah M

    2013-01-01

    We surveyed practicing clinicians who regularly used the Rorschach about the perceived clinical validity of specific Rorschach scores from many coding systems. The survey included quantitative feedback on the validity of specific variables as well as qualitative input in several areas, including the validity of specific variables, the potentially unique information that can be obtained from them, coding challenges associated with Comprehensive System (CS) codes, and recommendations for CS developments. Participants were recruited by applying a snowball sampling strategy. Based on responses from 246 experienced clinicians from 26 countries, composite judgments on rated variables were quite reliable (e.g., M α = .95 across 88 CS variables), despite limited agreement among any 2 judges. The aggregated judgments clearly differentiated among scores that were considered more and less clinically valid and the overall results aligned with recently obtained meta-analytic conclusions from the traditional validity literature (Mihura, Meyer, Dumitrascu, & Bombel, 2012). The judges also provided guidance concerning revisions and enhancements that would facilitate Rorschach-based assessment in the future. We discuss the implication of the quantitative and qualitative findings and provide suggestions for future directions based on the results.

  1. Simulation Based Studies in Software Engineering: A Matter of Validity

    Directory of Open Access Journals (Sweden)

    Breno Bernard Nicolau de França

    2015-04-01

    Full Text Available Despite the possible lack of validity when compared with other science areas, Simulation-Based Studies (SBS in Software Engineering (SE have supported the achievement of some results in the field. However, as it happens with any other sort of experimental study, it is important to identify and deal with threats to validity aiming at increasing their strength and reinforcing results confidence. OBJECTIVE: To identify potential threats to SBS validity in SE and suggest ways to mitigate them. METHOD: To apply qualitative analysis in a dataset resulted from the aggregation of data from a quasi-systematic literature review combined with ad-hoc surveyed information regarding other science areas. RESULTS: The analysis of data extracted from 15 technical papers allowed the identification and classification of 28 different threats to validity concerned with SBS in SE according Cook and Campbell’s categories. Besides, 12 verification and validation procedures applicable to SBS were also analyzed and organized due to their ability to detect these threats to validity. These results were used to make available an improved set of guidelines regarding the planning and reporting of SBS in SE. CONCLUSIONS: Simulation based studies add different threats to validity when compared with traditional studies. They are not well observed and therefore, it is not easy to identify and mitigate all of them without explicit guidance, as the one depicted in this paper.

  2. Validation of the Korean-Version of the Clinical Assessment Interview for Negative Symptoms of Schizophrenia (CAINS).

    Science.gov (United States)

    Jung, Sung Il; Woo, Jungmin; Kim, Yang-Tae; Kwak, Sang Gyu

    2016-07-01

    The Clinical Assessment Interview for Negative Symptoms (CAINS) was developed to overcome the limitations of existing instruments and reflect the current view of negative symptoms. The aim of the present study was to evaluate the reliability and validity of the Korean version of the Clinical Assessment Interview for Negative Symptoms (K-CAINS). Inpatients (n = 49) and outpatients (n = 70) with schizophrenia were recruited from three institutions. The confirmative factor analysis, test-retest reliability, inter-rater reliability, convergent validity, and discriminant validity were assessed. The study group consisted of 71 males (59.7%) and 48 females (40.3%). Their mean age was 42.15 years (SD = 12.2). The K-CAINS was confirmed to be divided into two subscales of 9 items related to "motivation/pleasure" and 4 items related to "expression" in concordance with the original version of the CAINS. The results showed that the K-CAINS had a good inter-rater reliability (ICC = 0.84-0.94), test-retest reliability (r = 0.90, P Korean version of the Beck depression inventory (BDI), the Korean version of the Calgary depression scale for schizophrenia (K-CDSS), and the Modified Simpson Angus scale (MSAS). The K-CAINS could be a reliable and valid tool to assess the negative symptoms of Korean schizophrenia patients.

  3. The Dutch version of the Child Posttraumatic Cognitions Inventory: validation in a clinical sample and a school sample

    Directory of Open Access Journals (Sweden)

    Julia Diehle

    2015-02-01

    Full Text Available 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 validating the Dutch version of the Child Posttraumatic Cognitions Inventory (CPTCI. Method: We included children aged 8–19 years in our study and assessed the factor structure, reliability and validity of the CPTCI in a clinical sample (n=184 and a school sample (n=318. Results: Our results supported the two-factor structure of the CPTCI and showed good internal consistency for the total scale and the two subscales. We found significant positive correlations between the CPTCI and measures of PTSD, depression, and anxiety disorder. The CPTCI correlated negatively with a measure of quality of life. Furthermore, we found significantly higher scores in the clinical sample than in the school sample. For children who received treatment, we found that a decrease in CPTCI scores was accompanied by a decrease in posttraumatic stress symptoms and comorbid problems indicating that the CPTCI is able to detect treatment effects. Conclusion: Overall, our results suggest that the Dutch CPTCI is a reliable and valid instrument.

  4. VALIDITY OF TWO CLINICAL KNEE STRENGTH ASSESSMENTS COMPARED TO THE REFERENCE STANDARD

    Directory of Open Access Journals (Sweden)

    Philipp Weng

    2015-12-01

    Full Text Available Objectives: Patello femoral Pain (PFP is the most common lower limb condition encountered in clinical practice. It recently emerged as the third highest ranked topic out of 185 in the Chartered Society of Physiotherapy Musculoskeletal Research Priority Project. For a valid assessment of knee strength during rehabilitation, the isometric test using the isokinetic dynamometer (Cybex and the hand-held dynamometer (HHD is not well received with clinical practice. An alternative way is through functional hop tests which clinicians have used to assess their patients' lower extremity muscular strength. This study investigates the validity of knee strength assessments conducted with the HHD and the hoptest compared to the isokinetic dynamometer and also explores differences between genders of the three assessments. Design: Each assessment included one submaximal and three recorded maximal efforts of the dominant leg. Quadriceps muscle strength was displayed in normalized torques. Correlation coefficients and box-and-whisker plots was used to analyze the data. Setting: Movement analysis laboratory Participants: Sixteen males (age 23.5 ± 4.23 years, height 1.79 ± 0.08 m and body mass 76.21 ± 10.58 kg, BMI 23.82 ± 2.38 kg/m² and 16 females (age 25.38 ± 5.49 years, height 1.67 ± 0.08 m and body mass 71.99 ± 16.05 kg, BMI 25.83 ± 4.74 kg/m² between 18 and 40 years old without any musculoskeletal injuries participated. Main outcome measures: Knee moments normalized for bodyweight (Nm/kg for dynamometers and distance jumped for single legged hoptest. Results: The strongest significant correlation was found for the comparison between the HHD and Cybex (r=0.71, r²=0.504, p=0.001. Correlation between the HHD and hoptest (r=0.4, r²=0.19, p=0.013, and Cybex and hoptest (r=0.53, r²=0.295, p=0.001 were poor. Comparing genders, the normalized knee extension moment on the Cybex was 28.8% lower and with the HHD 22.3% lower for females. Conclusions: Single

  5. Urinary orosomucoid: validation of an automated immune turbidimetric test and its possible clinical use.

    Science.gov (United States)

    Kustán, Péter; Szirmay, Balázs; Horváth-Szalai, Zoltán; Ludány, Andrea; Lakatos, Ágnes; Mühl, Diána; Christensen, Per Hjort; Miseta, Attila; Kovács, Gábor L; Kőszegi, Tamás

    2016-10-15

    Besides routine serum markers of inflammatory diseases, the diagnostic potential of selected urinary proteins has not been fully exploited yet. Former studies revealed that urinary orosomucoid (u-ORM) might have complementary information in inflammatory disorders. Our aim was to develop and validate a fully automated method for u-ORM measurements and to evaluate its potential clinical impact on systemic inflammatory diseases. A particle-enhanced immune turbidimetric assay was validated for a Cobas 8000/c502 analyzer to determine u-ORM levels. Spot urine samples from 72 healthy individuals, 28 patients with Crohn's disease and 30 septic patients were studied. Our assay time was 10 minutes and the detection limit of u-ORM was 0.02 mg/L. The intra- and inter-assay imprecision expressed as CV was less than 5%, and the recovery ranged between 95-103%. Within 10 to 60 years of age, a preliminary reference range for urinary orosomucoid/creatinine ratio (u-ORM/u-CREAT) was found to be 0.08 (0.01-0.24) mg/mmol [median (2.5-97.5 percentiles)]. Compared to controls, a five-fold increase of u-ORM/u-CREAT values in Crohn's disease and approximately a 240-fold increase in sepsis were observed. We set up a fast, sensitive and precise turbidimetric approach for automated u-ORM determination. Our highly sensitive assay is ideal for routine u-ORM measurements and might be a potential novel laboratory test in the management of systemic inflammatory processes.

  6. Urinary orosomucoid: validation of an automated immune turbidimetric test and its possible clinical use

    Science.gov (United States)

    Kustán, Péter; Szirmay, Balázs; Horváth-Szalai, Zoltán; Ludány, Andrea; Lakatos, Ágnes; Mühl, Diána; Christensen, Per Hjort; Miseta, Attila; Kovács, Gábor L.; Kőszegi, Tamás

    2016-01-01

    Introduction Besides routine serum markers of inflammatory diseases, the diagnostic potential of selected urinary proteins has not been fully exploited yet. Former studies revealed that urinary orosomucoid (u-ORM) might have complementary information in inflammatory disorders. Our aim was to develop and validate a fully automated method for u-ORM measurements and to evaluate its potential clinical impact on systemic inflammatory diseases. Materials and methods A particle-enhanced immune turbidimetric assay was validated for a Cobas 8000/c502 analyzer to determine u-ORM levels. Spot urine samples from 72 healthy individuals, 28 patients with Crohn’s disease and 30 septic patients were studied. Results Our assay time was 10 minutes and the detection limit of u-ORM was 0.02 mg/L. The intra- and inter-assay imprecision expressed as CV was less than 5%, and the recovery ranged between 95–103%. Within 10 to 60 years of age, a preliminary reference range for urinary orosomucoid/creatinine ratio (u-ORM/u-CREAT) was found to be 0.08 (0.01–0.24) mg/mmol [median (2.5–97.5 percentiles)]. Compared to controls, a five-fold increase of u-ORM/u-CREAT values in Crohn’s disease and approximately a 240-fold increase in sepsis were observed. Conclusions We set up a fast, sensitive and precise turbidimetric approach for automated u-ORM determination. Our highly sensitive assay is ideal for routine u-ORM measurements and might be a potential novel laboratory test in the management of systemic inflammatory processes. PMID:27812309

  7. 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.

  8. The diagnostic validity of clinical airway assessments for predicting difficult laryngoscopy using a grey zone approach.

    Science.gov (United States)

    Min, Jeong Jin; Kim, Gahyun; Kim, Eunhee; Lee, Jong-Hwan

    2016-08-01

    The diagnostic validity of clinical airway assessment tests for predicting difficult laryngoscopy in patients requiring endotracheal intubation were evaluated using receiver operating characteristic (ROC) curve analysis and a grey zone approach. In this prospective observational study, patients were evaluated during a pre-anaesthetic visit. Predictive airway assessment tests (i.e. Modified Mallampati [MMT] classification; upper lip bite test [ULBT]; mouth opening; sternomental distance; thyromental distance [TMD]; neck circumference; neck mobility; height to thyromental distance [HT/TMD]; neck circumference-to-thyromental distance [NC/TMD]) were performed on each patient and LEMON, Naguib, and MACOCHA scores were also calculated. In addition, laryngeal images were acquired and assessed for percentage of glottic opening (POGO) scores. A POGO score of zero was categorized as difficult laryngoscopy. The incidence of difficult laryngoscopy was 14.4% (35/243). Although seven predictive airway assessments (i.e. MMT classification, ULBT, mouth opening, HT/TMD, NC/TMD, and the LEMON and Naguib models) predicted difficult laryngoscopy by ROC analyses, a grey zone approach showed that the parameters were inconclusive in approximately 70% of patients. From all the tests, the HT/TMD ratio showed the highest sensitivity (80.0%) and ULBT had the highest specificity (95.2%). Using the grey zone approach, all predictive airway assessment tests showed large inconclusive zones which may explain previous inconsistent results in the prediction of difficult laryngoscopy. Our results suggest that the usefulness of clinical airway evaluation tests for predicting difficult laryngoscopy remains controversial. ClinicalTrials.gov (NCT01719848). © The Author(s) 2016.

  9. Measuring teamwork performance: Validity testing of the Team Emergency Assessment Measure (TEAM) with clinical resuscitation teams.

    Science.gov (United States)

    Cooper, Simon; Cant, Robyn; Connell, Cliff; Sims, Lyndall; Porter, Joanne E; Symmons, Mark; Nestel, Debra; Liaw, Sok Ying

    2016-04-01

    To test the resuscitation non-technical Team Emergency Assessment Measure (TEAM) for feasibility, validity and reliability, in two Australian Emergency Departments (ED). Non-technical (teamwork) skills have been identified as inadequate and as such have a significant impact on patient safety. Valid and reliable teamwork assessment tools are an important element of performance assessment and debriefing processes. A quasi experimental design based on observational ratings of resuscitation non-technical skills in two metropolitan ED. Senior nursing staff rated 106 adult resuscitation team events over a ten month period where three or more resuscitation team members attended. Resuscitation events, team performance and validity and reliability data was collected for the TEAM. Most rated events were for full cardiac resuscitation (43%) with 3-15 team members present for an average of 45 min. The TEAM was found to be feasible and quickly completed with minimal or no training. Discriminant validity was good as was internal consistency with a Cronbach alpha of 0.94. Uni-dimensional and concurrent validity also reached acceptable standards, 0.94 and >0.63 (p=performance indicating a need for leadership training. The TEAM is a feasible, valid and reliable non-technical assessment measure in simulated and real clinical settings. Emergency teams need to develop leadership skills through training and reflective debriefing. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  10. The Clinical Interview Schedule--Sinhala version: validation in a community setting in Sri Lanka.

    Science.gov (United States)

    Wickramasinghe, Shiranee Champika; Rajapakse, Lalini; Abeysinghe, Ranil; Prince, Martin

    2002-01-01

    The Clinical Interview Schedule Revised (CIS-R) was validated in a clinic setting for adolescents 15-19 years of age in Sri Lanka. The interview schedule was translated into Sinhala and modified to include sections introducing each symptom group. One-hundred-and-thirty-one adolescents attending a psychiatric clinic for the first time were interviewed by a lay interviewer using CIS-R (Translated). They had previously been examined and rated by a psychiatrist using local (emic) diagnostic procedures. All the filtering questions showed a high level of sensitivity (80%-96%). None of the questions in the sleep problems and phobias sections were effective at discriminating between those who did and did not show significant symptoms in these areas according to the psychiatrist. The internal consistency of the sections of the interview schedule (when these two sections were excluded) varied between 0.60 and 0.82. Linear regression showed that, when both sections were excluded, 97% of the variation of total score could be explained. Therefore, it was decided to exclude the sleep problems and phobias sections from the modified interview schedule. As the population samples are likely to be different from clinic samples it is necessary to test the validity again in a community sample before confirming the validity of the modified interview schedule.

  11. Standardization, Clinical Validation, and Typicality Norms of a New Test Assessing Semantic Verbal Fluency.

    Science.gov (United States)

    Quaranta, Davide; Caprara, Alessia; Piccininni, Chiara; Vita, Maria G; Gainotti, Guido; Marra, Camillo

    2016-08-01

    Semantic verbal fluency (SVF) tests are widely used in clinical neuropsychology. We propose the standardization and clinical validation of a new SVF test based on the production of names of birds and articles of furniture (Birds and Articles of Furniture test-BAF). A sample of 268 subjects aged 40 years or more underwent the test. The clinical validation was conducted on subjects affected by amnesic Mild Cognitive Impairment (aMCI; N = 106), mild (N = 178), and moderate (N = 114) Alzheimer's disease (AD). The BAF total score was influenced by both age and education, whereas the single scores obtained on BAF were also influenced by gender. The percentage of subjects with pathological score on BAF increased from aMCI (19%) to mild (45.5%) and moderate (71.1%) AD, and receiver operating characteristic curves analysis showed that the BAF may be highly reliable in distinguishing aMCI and AD patients from healthy subjects. We also provide typicality norms for birds and articles of furniture that could be useful in the assessment of qualitative features of words produced in semantic fluency tests. The BAF test could be a valid and reliable tool in both clinical practice and research on subjects affected by cognitive impairment. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  12. Derivation and Validation of Systemic Lupus International Collaborating Clinics Classification Criteria for Systemic Lupus Erythematosus

    Science.gov (United States)

    Petri, Michelle; Orbai, Ana-Maria; Alarcón, Graciela S.; Gordon, Caroline; Merrill, Joan T.; Fortin, Paul R.; Bruce, Ian N.; Isenberg, David; Wallace, Daniel J.; Nived, Ola; Sturfelt, Gunnar; Ramsey-Goldman, Rosalind; Bae, Sang-Cheol; Hanly, John G.; Sanchez-Guerrero, Jorge; Clarke, Ann; Aranow, Cynthia; Manzi, Susan; Urowitz, Murray; Gladman, Dafna; Kalunian, Kenneth; Costner, Melissa; Werth, Victoria P.; Zoma, Asad; Bernatsky, Sasha; Ruiz-Irastorza, Guillermo; Khamashta, Munther A.; Jacobsen, Soren; Buyon, Jill P.; Maddison, Peter; Dooley, Mary Anne; van Vollenhoven, Ronald F.; Ginzler, Ellen; Stoll, Thomas; Peschken, Christine; Jorizzo, Joseph L.; Callen, Jeffrey P.; Lim, S. Sam; Fessler, Barri J.; Inanc, Murat; Kamen, Diane L.; Rahman, Anisur; Steinsson, Kristjan; Franks, Andrew G.; Sigler, Lisa; Hameed, Suhail; Fang, Hong; Pham, Ngoc; Brey, Robin; Weisman, Michael H.; McGwin, Gerald; Magder, Laurence S.

    2012-01-01

    Objective The Systemic Lupus Collaborating Clinics (SLICC) revised and validated the American College of Rheumatology (ACR) SLE classification criteria in order to improve clinical relevance, meet stringent methodology requirements and incorporate new knowledge in SLE immunology. Methods The classification criteria were derived from a set of 702 expert-rated patient scenarios. Recursive partitioning was used to derive an initial rule that was simplified and refined based on SLICC physician consensus. SLICC validated the classification criteria in a new validation sample of 690 SLE patients and controls. Results Seventeen criteria were identified. The SLICC criteria for SLE classification requires: 1) Fulfillment of at least four criteria, with at least one clinical criterion AND one immunologic criterion OR 2) Lupus nephritis as the sole clinical criterion in the presence of ANA or anti-dsDNA antibodies. In the derivation set, the SLICC classification criteria resulted in fewer misclassifications than the current ACR classification criteria (49 versus 70, p=0.0082), had greater sensitivity (94% versus 86%, p<0.0001) and equal specificity (92% versus 93%, p=0.39). In the validation set, the SLICC Classification criteria resulted in fewer misclassifications (62 versus 74, p=0.24), had greater sensitivity (97% versus 83%, p<0.0001) but less specificity (84% versus 96%, p<0.0001). Conclusions The new SLICC classification criteria performed well on a large set of patient scenarios rated by experts. They require that at least one clinical criterion and one immunologic criterion be present for a classification of SLE. Biopsy confirmed nephritis compatible with lupus (in the presence of SLE autoantibodies) is sufficient for classification. PMID:22553077

  13. 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 su

  14. Hepatocellular carcinoma associated microRNA expression signature: integrated bioinformatics analysis, experimental validation and clinical significance.

    Science.gov (United States)

    Shi, Ke-Qing; Lin, Zhuo; Chen, Xiang-Jian; Song, Mei; Wang, Yu-Qun; Cai, Yi-Jing; Yang, Nai-Bing; Zheng, Ming-Hua; Dong, Jin-Zhong; Zhang, Lei; Chen, Yong-Ping

    2015-09-22

    microRNA (miRNA) expression profiles varied greatly among current studies due to different technological platforms and small sample size. Systematic and integrative analysis of published datesets that compared the miRNA expression profiles between hepatocellular carcinoma (HCC) tissue and paired adjacent noncancerous liver tissue was performed to determine candidate HCC associated miRNAs. Moreover, we further validated the confirmed miRNAs in a clinical setting using qRT-PCR and Tumor Cancer Genome Atlas (TCGA) dataset. A miRNA integrated-signature of 5 upregulated and 8 downregulated miRNAs was identified from 26 published datesets in HCC using robust rank aggregation method. qRT-PCR demonstrated that miR-93-5p, miR-224-5p, miR-221-3p and miR-21-5p was increased, whereas the expression of miR-214-3p, miR-199a-3p, miR-195-5p, miR-150-5p and miR-145-5p was decreased in the HCC tissues, which was also validated on TCGA dataset. A miRNA based score using LASSO regression model provided a high accuracy for identifying HCC tissue (AUC = 0.982): HCC risk score = 0.180E_miR-221 + 0.0262E_miR-21 - 0.007E_miR-223 - 0.185E_miR-130a. E_miR-n = Log 2 (expression of microRNA n). Furthermore, expression of 5 miRNAs (miR-222, miR-221, miR-21 miR-214 and miR-130a) correlated with pathological tumor grade. Cox regression analysis showed that miR-21 was related with 3-year survival (hazard ratio [HR]: 1.509, 95%CI: 1.079-2.112, P = 0.016) and 5-year survival (HR: 1.416, 95%CI: 1.057-1.897, P = 0.020). However, none of the deregulated miRNAs was related with microscopic vascular invasion. This study provides a basis for further clinical application of miRNAs in HCC.

  15. Clinical validation of NGS technology for HLA: An early adopter's perspective.

    Science.gov (United States)

    Weimer, Eric T

    2016-10-01

    Clinical validation of NGS for HLA typing has been a topic of interest with many laboratories investigating the merits. NGS has proven effective at reducing ambiguities and costs while providing more detailed information on HLA genes not previously sequenced. The ability of NGS to multiplex many patients within a single run presents unique challenges and sequencing new regions of HLA genes requires application of our knowledge of genetics to accurately determine HLA typing. This review represents my laboratory's experience in validation of NGS for HLA typing. It describes the obstacles faced with validation of NGS and is broken down into pre-analytic, analytic, and post-analytic challenges. Each section includes solutions to address them.

  16. CLINICAL STUDY OF ACUTE POISONING

    Directory of Open Access Journals (Sweden)

    Panduranga

    2014-09-01

    Full Text Available BACKGROUND AND OBJECTIVE: Acute poisoning is an important medical emergency. Studies of this nature will be useful tool in planning, early diagnosis and management of acute poisoning cases. The objective of the study are to study the clinical features, diagnosis and management, morbidity and mortality of various acute poisoning. METHODOLOGY: This study comprises of 350 patients of acute poisoning admitted to Chigateri General Hospital and Bapuji Hospital attached to J. J. M. Medical College, Davangere, between 1st March 2011 to 31st October 2011. REUSLTS: Out of 350 cases of acute poisoning studied, there were 268 males and 82 females. Males comprised 76.57%and females 23.42% of the total, in this series, Organophosphorous compounds were the commonest (30%, majority of the patients hailed from rural area 70%. Mortality is 10.57%.

  17. The Subaxial Cervical Spine Injury Classification System: an external agreement validation study

    NARCIS (Netherlands)

    Middendorp, J.J. van; Audige, L.; Bartels, R.H.M.A.; Bolger, C.; Deverall, H.; Dhoke, P.; Diekerhof, C.H.; Govaert, G.A.; Guimera, V.; Koller, H.; Morris, S.A.; Setiobudi, T.; Hosman, A.J.F.

    2013-01-01

    BACKGROUND CONTEXT: In 2007, the Subaxial Cervical Spine Injury Classification (SLIC) system was introduced demonstrating moderate reliability in an internal validation study. PURPOSE: To assess the agreement on the SLIC system using clinical data from a spinal trauma population and whether the SLIC

  18. Measuring disabilities in stroke patients with apraxia : A validation study of an observational method

    NARCIS (Netherlands)

    van Heugten, CM; Dekker, J; Deelman, BG; van Dijk, AJ; Stehmann-Saris, FC; Kinebanian, A

    2000-01-01

    The objective of the present study was to determine the clinical and construct validity of the assessment of disabilities in stroke patients with apraxia. Disabilities were assessed by means of observation of activities of daily living (ADL), such as washing the face and upper body and putting on a

  19. Measuring disabilities in stroke patients with apraxia: a validation study of an observational method.

    NARCIS (Netherlands)

    Heugten, C.M. van; Dekker, J.; Deelman, B.G.; Dijk, A.J. van; Stehmann-Saris, F.C.; Kinebanian, A.

    2000-01-01

    The objective of the present study was to determine the clinical and construct validity of the assessment of disabilities in stroke patients with apraxia. Disabilities were assessed by means of observation of activities of daily living (ADL), such as washing the face and upper body and putting on a

  20. The Subaxial Cervical Spine Injury Classification System: an external agreement validation study

    NARCIS (Netherlands)

    Middendorp, J.J. van; Audige, L.; Bartels, R.H.M.A.; Bolger, C.; Deverall, H.; Dhoke, P.; Diekerhof, C.H.; Govaert, G.A.; Guimera, V.; Koller, H.; Morris, S.A.; Setiobudi, T.; Hosman, A.J.F.

    2013-01-01

    BACKGROUND CONTEXT: In 2007, the Subaxial Cervical Spine Injury Classification (SLIC) system was introduced demonstrating moderate reliability in an internal validation study. PURPOSE: To assess the agreement on the SLIC system using clinical data from a spinal trauma population and whether the SLIC

  1. The Subaxial Cervical Spine Injury Classification System : an external agreement validation study

    NARCIS (Netherlands)

    van Middendorp, Joost J.; Audige, Laurent; Bartels, Ronald H.; Bolger, Ciaran; Deverall, Hamish; Dhoke, Priyesh; Diekerhof, Carel H.; Govaert, Geertje A. M.; Guimera, Vicente; Koller, Heiko; Morris, Stephen A. C.; Setiobudi, Tony; Hosman, Allard J. F.

    BACKGROUND CONTEXT: In 2007, the Subaxial Cervical Spine Injury Classification (SLIC) system was introduced demonstrating moderate reliability in an internal validation study. PURPOSE: To assess the agreement on the SLIC system using clinical data from a spinal trauma population and whether the SLIC

  2. The Subaxial Cervical Spine Injury Classification System : an external agreement validation study

    NARCIS (Netherlands)

    van Middendorp, Joost J.; Audige, Laurent; Bartels, Ronald H.; Bolger, Ciaran; Deverall, Hamish; Dhoke, Priyesh; Diekerhof, Carel H.; Govaert, Geertje A. M.; Guimera, Vicente; Koller, Heiko; Morris, Stephen A. C.; Setiobudi, Tony; Hosman, Allard J. F.

    2013-01-01

    BACKGROUND CONTEXT: In 2007, the Subaxial Cervical Spine Injury Classification (SLIC) system was introduced demonstrating moderate reliability in an internal validation study. PURPOSE: To assess the agreement on the SLIC system using clinical data from a spinal trauma population and whether the SLIC

  3. Measuring disabilities in stroke patients with apraxia : A validation study of an observational method

    NARCIS (Netherlands)

    van Heugten, CM; Dekker, J; Deelman, BG; van Dijk, AJ; Stehmann-Saris, FC; Kinebanian, A

    The objective of the present study was to determine the clinical and construct validity of the assessment of disabilities in stroke patients with apraxia. Disabilities were assessed by means of observation of activities of daily living (ADL), such as washing the face and upper body and putting on a

  4. Human Rights Attitude Scale: A Validity and Reliability Study

    Science.gov (United States)

    Ercan, Recep; Yaman, Tugba; Demir, Selcuk Besir

    2015-01-01

    The objective of this study is to develop a valid and reliable attitude scale having quality psychometric features that can measure secondary school students' attitudes towards human rights. The study group of the research is comprised by 710 6th, 7th and 8th grade students who study at 4 secondary schools in the centre of Sivas. The study group…

  5. Lumbar segmental instability: a criterion-related validity study of manual therapy assessment

    Directory of Open Access Journals (Sweden)

    Chapple Cathy

    2005-11-01

    Full Text Available Abstract Background Musculoskeletal physiotherapists routinely assess lumbar segmental motion during the clinical examination of a patient with low back pain. The validity of manual assessment of segmental motion has not, however, been adequately investigated. Methods In this prospective, multi-centre, pragmatic, diagnostic validity study, 138 consecutive patients with recurrent or chronic low back pain (R/CLBP were recruited. Physiotherapists with post-graduate training in manual therapy performed passive accessory intervertebral motion tests (PAIVMs and passive physiological intervertebral motion tests (PPIVMs. Consenting patients were referred for flexion-extension radiographs. Sagittal angular rotation and sagittal translation of each lumbar spinal motion segment was measured from these radiographs, and compared to a reference range derived from a study of 30 asymptomatic volunteers. Motion beyond two standard deviations from the reference mean was considered diagnostic of rotational lumbar segmental instability (LSI and translational LSI. Accuracy and validity of the clinical assessments were expressed using sensitivity, specificity, and likelihood ratio statistics with 95% confidence intervals (CI. Results Only translation LSI was found to be significantly associated with R/CLBP (p Conclusion This study provides the first evidence reporting the concurrent validity of manual tests for the detection of abnormal sagittal planar motion. PAIVMs and PPIVMs are highly specific, but not sensitive, for the detection of translation LSI. Likelihood ratios resulting from positive test results were only moderate. This research indicates that manual clinical examination procedures have moderate validity for detecting segmental motion abnormality.

  6. Validation of an asthma symptom diary for interventional studies

    OpenAIRE

    Santanello, N.; Davies, G.(Imperial College, London, UK); Galant, S.; Pedinoff, A.; Sveum, R.; Seltzer, J.; Seidenberg, B.; Knorr, B.

    1999-01-01

    OBJECTIVE—The Pediatric Asthma Diary was developed and validated to assess efficacy of interventions in children with asthma.
DESIGN, PATIENTS, AND SETTING—Diary validation was performed in a three week, prospective study of 106 children aged 6-14 years with asthma. Children were classified at baseline as either stable (requiring no additional asthma treatment) or new onset/worse (requiring either addition of or increase in anti-inflammatory treatment).
RESULTS—A dayti...

  7. Validity and reliability of patient reported outcomes used in Psoriasis: results from two randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Koo John

    2003-10-01

    Full Text Available Abstract Background Two Phase III randomized controlled clinical trials were conducted to assess the efficacy, safety, and tolerability of weekly subcutaneous administration of efalizumab for the treatment of psoriasis. Patient reported measures of psoriasis-related functionality and health-related quality of life and of psoriasis-related symptom assessments were included as part of the trials. Objective To assess the reliability, validity, and responsiveness of the patient reported outcome measures that were used in the trials – the Dermatology Life Quality Index (DLQI, the Psoriasis Symptom Assessment (PSA Scale, and two itch measures, a Visual Analog Scale (VAS and the National Psoriasis Foundation (NPF itch measure. Methods Subjects aged 18 to 70 years with moderate to severe psoriasis for at least 6 months were recruited into the two clinical trials (n = 1095. Internal consistency reliability was evaluated for all patient reported outcomes at baseline and at 12 weeks. Construct validity was evaluated by relations among the different patient reported outcomes and between the patient reported outcomes and the clinical assessments (Psoriasis Area and Severity Index; Overall Lesion Severity Scale; Physician's Global Assessment of Change assessed at baseline and at 12 weeks, as was the change over the course of the 12 week portion of the trial. Results Internal consistency reliability ranged from 0.86 to 0.95 for the patient reported outcome measures. The patient reported outcome measures were all shown to have significant construct validity with respect to each other and with respect to the clinical assessments. The four measures also demonstrated significant responsiveness to change in underlying clinical status of the patients over the course of the trial, as measured by the independently assessed clinical outcomes. Conclusions The DLQI, the PSA, VAS, and the NPF are considered useful tools for the measurement of dermatology

  8. Semantic validation of the use of SNOMED CT in HL7 clinical documents

    Directory of Open Access Journals (Sweden)

    Heymans Stijn

    2011-07-01

    Full Text Available Abstract Background The HL7 Clinical Document Architecture (CDA constrains the HL7 Reference Information model (RIM to specify the format of HL7-compliant clinical documents, dubbed CDA documents. The use of clinical terminologies such as SNOMED CT® further improves interoperability as they provide a shared understanding of concepts used in clinical documents. However, despite the use of the RIM and of shared terminologies such as SNOMED CT®, gaps remain as to how to use both the RIM and SNOMED CT® in HL7 clinical documents. The HL7 implementation guide on Using SNOMED CT in HL7 Version 3 is an effort to close this gap. It is, however, a human-readable document that is not suited for automatic processing. As such, health care professionals designing clinical documents need to ensure validity of documents manually. Results We represent the CDA using the Ontology Web Language OWL and further use the OWL version of SNOMED CT® to enable the translation of CDA documents to so-called OWL ontologies. We formalize a subset of the constraints in the implementation guide on Using SNOMED CT in HL7 Version 3 as OWL Integrity Constraints and show that we can automatically validate CDA documents using OWL reasoners such as Pellet. Finally, we evaluate our approach via a prototype implementation that plugs in the Open Health Workbench. Conclusions We present a methodology to automatically check the validity of CDA documents which make reference to SNOMED CT® terminology. The methodology relies on semantic technologies such as OWL. As such it removes the burden from IT health care professionals of having to manually implement such guidelines in systems that use HL7 Version 3 documents.

  9. EFLM WG-Preanalytical phase opinion paper: local validation of blood collection tubes in clinical laboratories.

    Science.gov (United States)

    Lippi, Giuseppe; Cornes, Michael P; Grankvist, Kjell; Nybo, Mads; Simundic, Ana-Maria

    2016-05-01

    The selection or procurement of blood collection devices in healthcare facilities is often an underestimated issue. This is probably due to different factors including the lack of knowledge of policymakers, hospital administrators and even laboratory managers about the importance of preanalytical quality and phlebotomy process, as well as to the absence of reliable guidelines or recommendations on how to precisely assess the quality of blood collection devices around the globe. With the awareness that a gap remains between manufacturers' and local validation of blood collection devices, the Working Group for Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has drafted a consensus document aimed to provide a set of essential requisites, technical criteria (e.g. presence of physical defects, malfunctioning, safety problems) and clinical issues for supporting laboratory professionals in organization blood collection tubes tenders and validating new devices before local routine implementation. The laboratory professionals should also make sure that the tenders accurately and strictly define the responsibilities for validation experiments and the potential consequences in the case the validation outcome shows that tubes due not fulfill the expectations.

  10. Validation of the Millon Clinical Multiaxial Inventory for Axis II disorders: does it meet the Daubert standard?

    Science.gov (United States)

    Rogers, R; Salekin, R T; Sewell, K W

    1999-08-01

    Relevant to forensic practice, the Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, Inc. (1993) established the boundaries for the admissibility of scientific evidence that take into account its trustworthiness as assessed via evidentiary reliability. In conducting forensic evaluations, psychologists and other mental health professionals must be able to offer valid diagnoses, including Axis II disorders. The most widely available measure of personality disorders is the Million Clinical Multiaxial Inventory (MCMI) and its subsequent revisions (MCMI-II and MCMI-III). We address the critical question, "Do the MCMI-II and MCMI-III meet the requirements of Daubert?" Fundamental problems in the scientific validity and error rates for MCMI-III appear to preclude its admissibility under Daubert for the assessment of Axis II disorders. We address the construct validity for the MCMI and MCMI-II via a meta-analysis of 33 studies. The resulting multitrait-multimethod approach allowed us to address their convergent and discriminant validity through method effects (Marsh, 1990). With reference to Daubert, the results suggest a circumscribed use for the MCMI-II with good evidence of construct validity for Avoidant, Schizotypal, and Borderline personality disorders.

  11. Validation of the Chinese Version of the Revised Clinical Interview Schedule: Findings from Hong Kong Mental Morbidity Survey.

    Science.gov (United States)

    Chan, W C; Wong, C Sm; Chen, E Yh; Ng, R Mk; Hung, S F; Cheung, E Fc; Sham, P C; Chiu, H Fk; Lam, M; Chang, W C; Lee, E Hm; Chiang, T P; Lau, J Tf; van Os, J; Lewis, G; Bebbington, P; Lam, L Cw

    2017-03-01

    This study aimed to assess the psychometric properties of the Chinese version of the Revised Clinical Interview Schedule (C-CIS-R), and explore its applicability as a diagnostic instrument for common mental disorders (CMDs) in Hong Kong. Its psychometric properties were evaluated among 140 patients and 161 healthy controls. In comparison to the diagnoses made by the Structured Clinical Interview for the DSM-IV, the C-CIS-R showed good criterion validity in diagnosing CMDs. The correlation of the total score of C-CIS-R with the 12-item General Health Questionnaire and Hospital Anxiety and Depression Scale was satisfactory, indicating favourable convergent validity as well. The inter-rater and test-retest reliability were also satisfactory. Receiver operating characteristic analyses suggested an optimal cut-off point of 11/12 for detecting diagnosable CMDs (sensitivity: 0.69; specificity: 0.93) and 17/18 for identifying a need for treatment (sensitivity: 0.70; specificity: 0.95). In conclusion, C-CIS-R is a valid diagnostic instrument for CMDs in a Chinese community. Its cut-off points for clinically significant symptoms and treatment needs among Chinese are identical to those adopted in the original English version.

  12. 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).

  13. 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 55.9% for INDELs. We confirm that GATK/Queue is a reliable pipeline in translational medicine and clinical context. We conclude that in our working environment, UnifiedGenotyper is the caller of choice, being an accurate method, with a high validation rate of error-prone calls like LoF variants. We...

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

    Science.gov (United States)

    2015-10-01

    biomarkers to determine the presence of or progression to aggressive disease. ( Lead site: FHCRC) Milestone 2. Execute collaboration agreement with...panel of four-kallikrein plasma-based markers to determine the presence of or progression to clinically relevant prostate cancer. ( Lead site: FHCRC... Lead site: FHCRC) Milestone 10. Urine specimens identified for analysis. Due 12/30/2014 COMPLETED Milestone 11. PCA3 and TMPRSS2:ERG validation

  15. Validity and reliability of patient reported outcomes used in Psoriasis: results from two randomized clinical trials

    OpenAIRE

    Koo John; Thompson Christine; Stone Stephen P; Bresnahan Brian W; Shikiar Richard; Revicki Dennis A

    2003-01-01

    Abstract Background Two Phase III randomized controlled clinical trials were conducted to assess the efficacy, safety, and tolerability of weekly subcutaneous administration of efalizumab for the treatment of psoriasis. Patient reported measures of psoriasis-related functionality and health-related quality of life and of psoriasis-related symptom assessments were included as part of the trials. Objective To assess the reliability, validity, and responsiveness of the patient reported outcome m...

  16. Use of a validated screening tool for psoriatic arthritis in dermatology clinics

    OpenAIRE

    Ganatra, Bella; Manoharan, Dishan; Akhras, Victoria

    2015-01-01

    Dermatology clinics represent a key opportunity to screen patients with psoriasis for psoriatic arthritis (PA) which often remains unrecognised. A significant proportion of adults with psoriasis develop arthropathy [5] with around two-thirds having progressive arthritis.[6] NICE has recognised this by the annual use of a validated screening tool such as psoriasis epidemiological screening tool (PEST) on all psoriasis patients without PA. We introduced the PEST into our dermatology department ...

  17. Certification of Electronic Health Record systems and the importance of the validation of clinical archetypes.

    Science.gov (United States)

    De Moor, Georges; Kalra, Dipak; Devlies, Jos

    2008-01-01

    If Electronic Health Record (EHR) systems are to provide an effective contribution to healthcare across Europe, a set of benchmarks need to be set to ensure the quality of such systems. This article describes the results of the EU funded QRec- project and emphasizes the need for validation of clinical archetypes to support the semantic interoperability between EHR systems and other interacting eHealth applications.

  18. Discriminant validity of constructs derived from the self-regulative model for evaluation anxiety for predicting clinical manifestations of test anxiety.

    Science.gov (United States)

    Herzer, Frank; Wendt, Julia; Hamm, Alfons O

    2015-10-01

    Test anxiety is a highly prevalent and impairing syndrome. However, research on clinically relevant manifestations of test anxiety and especially on effective treatment components is still very sparse. In the present study we examined the predictive validity of constructs derived from the self-regulative model for evaluation anxiety proposed by Zeidner and Matthews (2007) for discriminating clinical and non-clinical levels of test anxiety. We compared self-report data from 47 clinically test anxious patients with those from 41 healthy university students. Results showed that learning goals, self-concept of abilities, self-incrimination, elaboration and perfectionism were the constructs that independently separated clinical from non-clinical levels of test anxiety, thus providing the strongest discriminant validity even when controlling for an effect of the global severity of mental health problems. These constructs spread across all three domains proposed in the model, thus providing important implications for possible targets of interventions to reduce clinical levels of test anxiety.

  19. Validity of conducting clinical dysphagia assessments for patients with normal to mild cognitive impairment via telerehabilitation.

    Science.gov (United States)

    Ward, Elizabeth C; Sharma, Shobha; Burns, Clare; Theodoros, Deborah; Russell, Trevor

    2012-12-01

    To assess the validity of conducting clinical dysphagia assessments via telerehabilitation, 40 individuals with dysphagia from various etiologies were assessed simultaneously by a face-to-face speech-language pathologist (FTF-SLP) and a telerehabilitation SLP (T-SLP) via an Internet-based videoconferencing telerehabilitation system. Dysphagia status was assessed using a Clinical Swallowing Examination (CSE) protocol, delivered via a specialized telerehabilitation videoconferencing system and involving the use of an assistant at the patient's end of the consultation to facilitate the assessment. Levels of agreement between the FTF-SLP and T-SLP revealed that the majority of parameters reached set levels of clinically acceptable levels of agreement. Specifically, agreement between the T-SLP and FTF-SLP ratings for the oral, oromotor, and laryngeal function tasks revealed levels of exact agreement ranging from 75 to 100% (kappa = 0.36-1.0), while the parameters relating to food and fluid trials ranged in exact agreement from 79 to 100% (kappa = 0.61-1.0). Across the parameters related to aspiration risk and clinical management, exact agreement ranged between 79 and 100% (kappa = 0.49-1.0). The data show that a CSE conducted via telerehabilitation can provide valid and reliable outcomes comparable to clinical decisions made in the FTF environment.

  20. 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.

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

    Science.gov (United States)

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

    2010-09-01

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

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

    Science.gov (United States)

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

    2015-10-01

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

  3. CLINICAL STUDY OF ECTOPIC PREGNANCY

    Directory of Open Access Journals (Sweden)

    Swami

    2015-10-01

    Full Text Available An ectopic pregnancy is one in which fertilized ovum is implanted at the site other than normal uterine cavity.[1] Incidence of ectopic pregnancy is 1:160 deliveries.[2] Clinical presentation is variable from acute to chronic type. Due to its varied clinical presentation ectopic pregnancy poses great diagnostic difficulty both to obstetrician, physician and surgeons.[3] OBJECTIVE: To find out incidence in our study population and to evaluate symptomatically and clinical presentation in these patients. MATERIALS AND METHODS: Retrospective study of 34 ectopic pregnancies admitted and treated in Medical College hospital, Ujjain from 2010 to 2015 are included in the study. RESULTS: The incidence of ectopic pregnancy is more between the age group of 21-30years (73.52% and in Multigravida 64.71%. Infertility and previous tubal surgery are the high risk factors for tubal pregnancy. Pain in abdomen was present in all 34 cases, amenorrhea in 97.05% and bleeding per vagina in 76.47% cases. Syncopal attacks, vomiting were detected in 14.70% cases. Acute ectopic pregnancy was detected in 14.71% and chronic in 85.29% cases. 82.35% cases presented with adnexal mass, 79.41% with cervical motion tenderness, 50% with pallor, 32.35% with abdominal lump and tenderness and 11.76% with fullness in POD. CONCLUSION: Ectopic pregnancy is leading cause of maternal mortality in first trimester. In spite of advanced diagnostic techniques. It poses great diagnostic difficulties due to varied signs and symptoms. Previous tubal surgery pelvic inflammatory disease and infertility are the risk factors of tubal pregnancy.

  4. Emphatic Tendency Scale for Student Teachers: Validity and Reliability Studies

    Science.gov (United States)

    Kocak, Canan; Onen, Aysem Seda

    2013-01-01

    The purpose of this study was to analyze the validity and reliability of the Empathic Tendency Scale, which was developed in order to identify student teachers' empathic tendencies. The sampling of the study consisted of 730 student teachers studying at Hacettepe University Faculty of Education. To determine the factor pattern of Empathic…

  5. The Portuguese version of the RhinoQOL Questionnaire: validation and clinical application,

    OpenAIRE

    Rui Cerejeira; Rafaela Veloso-Teles; Nuno Lousan; Carla Pinto Moura

    2015-01-01

    ABSTRACT INTRODUCTION: Rhinosinusitis constitutes an important health problem, with significant interference in personal, professional, and social functioning. This study presents the validation process of the Portuguese version of the RhinoQOL, to be used as a routine procedure in the assessment of patients with chronic rhinosinusitis. OBJECTIVE: To demonstrate that the Portuguese version of the RhinoQOL is as valid as the English version to measure symptoms and health-related quality of...

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1988-08-01

    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 /sup 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<0.001) overestimated when compared with the glomerular filtration rate obtained by the impulse synthesis technique (GFR-IS) in spite of an excellent (r=0.989) linear correlation between the two sets of data. On the other hand, the comparison between GFR-IS and 24-h creatinine clearance has not shown any significant difference. Moreover, we have found that in patients with severe renal failure GFR-IS is overestimated when the sampling time span is shortened to 3 h. On the other hand, GFR-IS is slightly underestimated in patients with severe renal failure when the convolution time interval is increased over a few minutes.

  7. 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

  8. The Anti-Clot Treatment Scale (ACTS in clinical trials: cross-cultural validation in venous thromboembolism patients

    Directory of Open Access Journals (Sweden)

    Cano Stefan J

    2012-09-01

    Full Text Available Abstract Background The Anti-Clot Treatment Scale (ACTS is a 15-item patient-reported instrument of satisfaction with anticoagulant treatment. It includes a 12-item ACTS Burdens scale and a 3-item ACTS Benefits scale. Its role in clinical trials and other settings should be supported by evidence that it is both clinically meaningful and scientifically sound. The aim of the study was to evaluate the measurement performance of the ACTS (Dutch, Italian, French, German and English language versions in patients with venous thromboembolism based on traditional psychometric methods. Methods ACTS Burdens and Benefits scale data from a large clinical trial (EINSTEIN DVT involving 1336 people with venous thromboembolism were analysed at both the scale and item level. Five key psychometric properties were examined using traditional psychometric methods: acceptability, scaling assumptions, reliability (including internal consistency reliability, test-retest reproducibility; validity (including known groups and discriminant validity; and responsiveness. These methods of examination underpin the US Food and Drug Administration recommendations for patient-reported outcome instrument evaluation. Results Overall, the 12-item ACTS Burdens scale and 3-item ACTS Benefits scale met the psychometric criteria evaluated at both item and scale levels, with the exception of some relatively minor issues in the Dutch language version, which were just below reliability criteria (i.e. alpha = 0.72, test-retest intraclass correlation = 0.79. A consistent finding from item-level evaluations of aggregate endorsement frequencies and skewness suggested that response scales may be improved by reducing the number of response options from five to four. Conclusions Both the ACTS Burdens and ACTS Benefits scales consistently satisfied traditional reliability and validity criteria across multiple language datasets, supporting it as a clinically useful patient

  9. Daily physical activity in ankylosing spondylitis: validity and reliability of the IPAQ and SQUASH and the relation with clinical assessments

    Science.gov (United States)

    2013-01-01

    Introduction The aim of this study was to investigate the construct validity and test-retest reliability of the International Physical Activity Questionnaire (IPAQ; long form) and the Short QUestionnaire to Assess Health-enhancing physical activity (SQUASH) and to investigate the relation between daily physical activity and clinical assessments in patients with ankylosing spondylitis (AS). Methods For validity, the self-report questionnaires IPAQ and SQUASH were compared with daily physical activity assessed with the ActiGraph accelerometer during 7 consecutive days in 63 AS outpatients. For reliability, the IPAQ and SQUASH were administered twice approximately 1 week apart in 52 AS outpatients. In all 115 patients, clinical assessments were performed at the outpatient clinic. Results IPAQ and SQUASH total scores correlated significantly with accelerometer outcome: ρ = 0.38 and r = 0.35, respectively. Intraclass correlation coefficients between first and second assessments of the IPAQ and SQUASH were 0.83 and 0.89, respectively. Bland-Altman analyses showed no systemic bias, but in particular for the IPAQ the 95% limits of agreement were wide. Daily physical activity assessed by accelerometer, IPAQ, and SQUASH correlated significantly with disease activity, physical activity, and quality of life. A relation with spinal mobility was found only for the accelerometer and SQUASH. The direction of these correlations indicates that higher daily physical activity is related to lower disease activity and better physical function, spinal mobility and quality of life. Conclusions Both physical activity questionnaires showed modest construct validity. The SQUASH showed good test-retest reliability, superior to the IPAQ. These results indicate that the SQUASH is more suitable than the IPAQ to assess daily physical activity in AS population studies. However, it is desirable to add questions on AS-specific physical activity. Further studies are needed to investigate the

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

    NARCIS (Netherlands)

    Douma, R.A.; Gibson, N.S.; Gerdes, V.E.A.; Buller, H.R.; Wells, P.S.; Perrier, A.; Le Gal, G.

    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

  11. Reliability and validity of a simple and clinically applicable pain stimulus

    DEFF Research Database (Denmark)

    O'Neill, Søren; Graven-Nielsen, Thomas; Manniche, Claus;

    2014-01-01

    , but it is not commonly assessed in clinical practice. Whereas a range of tools and procedures for the quantitative sensory testing of pain sensitivity is available for laboratory pain research, most experimental pain stimuli are not well suited for clinical practice. In the current study, a simple and inexpensive......-clamp seems a potentially useful instrument for quantitative sensory testing in a clinical setting....

  12. 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

    2016-05-01

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

  13. Experimental Validation of Depth Cameras for the Parameterization of Functional Balance of Patients in Clinical Tests

    Science.gov (United States)

    Moreno, Francisco-Ángel; Merchán-Baeza, José Antonio; González-Sánchez, Manuel; González-Jiménez, Javier; Cuesta-Vargas, Antonio I.

    2017-01-01

    In clinical practice, patients’ balance can be assessed using standard scales. Two of the most validated clinical tests for measuring balance are the Timed Up and Go (TUG) test and the MultiDirectional Reach Test (MDRT). Nowadays, inertial sensors (IS) are employed for kinematic analysis of functional tests in the clinical setting, and have become an alternative to expensive, 3D optical motion capture systems. In daily clinical practice, however, IS-based setups are yet cumbersome and inconvenient to apply. Current depth cameras have the potential for such application, presenting many advantages as, for instance, being portable, low-cost and minimally-invasive. This paper aims at experimentally validating to what extent this technology can substitute IS for the parameterization and kinematic analysis of the TUG and the MDRT tests. Twenty healthy young adults were recruited as participants to perform five different balance tests while kinematic data from their movements were measured by both a depth camera and an inertial sensor placed on their trunk. The reliability of the camera’s measurements is examined through the Interclass Correlation Coefficient (ICC), whilst the Pearson Correlation Coefficient (r) is computed to evaluate the correlation between both sensor’s measurements, revealing excellent reliability and strong correlations in most cases. PMID:28241455

  14. Psychometric validation of the O'leary-Sant interstitial cystitis symptom index in a clinical trial of pentosan polysulfate sodium.

    Science.gov (United States)

    Lubeck, D P; Whitmore, K; Sant, G R; Alvarez-Horine, S; Lai, C

    2001-06-01

    The O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) has been proposed as a treatment outcome measure in interstitial cystitis (IC). The psychometric properties of the ICSI were assessed for reliability and validity in a randomized, double-blind clinical study of 300, 600, and 900 mg daily dose of pentosan polysulfate sodium (PPS) in patients with IC. The ICSI contains 4 items that measure urgency and frequency of urination, nighttime urination, and pain or burning. The ICSI index score is the sum of the item scores (range: 0-20). ICSI scores were obtained at baseline, 4, 8, 12, 16, 24, and 32 weeks of treatment. Patients' overall ratings of improvement of symptoms (PORIS) scores evaluating improvements in pain, urgency, and overall IC symptoms were also collected except at baseline. A total of 376 patients were included in the analysis. Psychometric properties evaluated included variability (range), test-retest reliability (intraclass correlation coefficient [ICC]), internal consistency (the Cronbach alpha), construct validity (convergent, discriminant), responsiveness, and clinically meaningful change. The ICSI items and index score had good variability and test-retest reliability. The ICSI demonstrated internal consistency reliability and was responsive to change. Participants indicating a 75% improvement in PORIS had a 48% mean reduction in the ICSI score, while participants reporting 100% improvement in PORIS had a 77% mean reduction in the ICSI score. The ICSI is a valid, reliable, and responsive measure of change in IC symptoms. This outcome measure should be utilized in future treatment outcomes studies in IC.

  15. Empyema thoracis: A clinical study

    Directory of Open Access Journals (Sweden)

    Acharya Preetam

    2007-01-01

    Full Text Available Background: Empyema thoracis is a disease that, despite centuries of study, still causes significant morbidity and mortality. Aim: The present study was undertaken to study the age-sex profile, symptomatology, microbiologic findings, etiology and the management and treatment outcome in a tertiary care hospital. Settings and Design: A prospective study of empyema thoracis was conducted on 40 consecutive patients with empyema thoracis admitted to the tuberculosis and chest diseases ward of a teaching hospital. Materials and Methods: The demographic data, clinical presentation, microbiological findings, etiology, the clinical course and management were recorded as per a planned pro forma and analyzed. Results: The peak age was in the range of 21-40 years, the male-to-female ratio was 3.4:1.0 and the left pleura was more commonly affected than the right pleura. Risk factors include pulmonary tuberculosis, chronic obstructive pulmonary diseases, smoking, diabetes mellitus and pneumonia. Etiology of empyema was tubercular in 65% cases and nontubercular in 35% cases. Gram-negative organisms were cultured in 11 cases (27.5%. Two patients received antibiotics with repeated thoracentesis only, intercostal chest tube drainage was required in 38 cases (95% and more aggressive surgery was performed on 2 patients. The average duration for which the chest tube was kept in the complete expansion cases was 22.3 days. Conclusion: It was concluded that all cases of simple empyema with thin pus and only those cases of simple empyema with thick pus where size of empyema is small should be managed by aspiration/s. Cases failed by the above method, all cases of simple empyema with thick pus and with moderate to large size of empyema and all cases of empyema with bronchopleural fistula should be managed by intercostal drainage tube connected to water seal. It was also observed that all cases of empyema complicated by bronchopleural fistula were difficult to manage and

  16. Imagery Measures of Ego, Id, Superego, and Identity: Validity Studies.

    Science.gov (United States)

    Cartwright, D.; DeBruin, J.

    1988-01-01

    Five validity studies of the id, ego, superego, and identity scales of the Study of Imagery are reported, using undergraduate students. Multistage Bonferroni procedures are used to evaluate the significance of results. The scales are related to each other and to toughmindedness, self-control, and behavioral conflict. (TJH)

  17. The Jackson Career Explorer: Two Further Validity Studies

    Science.gov (United States)

    Schermer, Julie Aitken

    2012-01-01

    The present report consists of two further validity studies using the Jackson Career Explorer (JCE), a short form and continuous version of the Jackson Vocational Interest Survey, measuring 34 interests. The first study examined the relationships between the JCE and five personality factors, from a sample of 528 individuals. The correlations found…

  18. 29 CFR 1607.5 - General standards for validity studies.

    Science.gov (United States)

    2010-07-01

    ..., such as those described in the Standards for Educational and Psychological Tests prepared by a joint... studies. A. Acceptable types of validity studies. For the purposes of satisfying these guidelines, users... they become accepted by the psychological profession. B. Criterion-related, content, and construct...

  19. A Re-analysis of Published Differential Validity Studies.

    Science.gov (United States)

    Ruch, William W.

    A survey of recent literature was undertaken to locate validity studies of paper-and-pencil tests which met the following criteria: (1) Studies were conducted in a business or industrial (i.e. non-education, non-military) setting; (2) Separate statistics were available for blacks and whites; (3) Race was not confounded with some outside variable…

  20. California Diploma Project Technical Report III: Validity Study--Validity Study of the Health Sciences and Medical Technology Standards

    Science.gov (United States)

    McGaughy, Charis; Bryck, Rick; de Gonzalez, Alicia

    2012-01-01

    This study is a validity study of the recently revised version of the Health Science Standards. The purpose of this study is to understand how the Health Science Standards relate to college and career readiness, as represented by survey ratings submitted by entry-level college instructors of health science courses and industry representatives. For…

  1. Two preclinical tests to evaluate anticancer activity and to help validate drug candidates for clinical trials

    Science.gov (United States)

    López-Lázaro, Miguel

    2015-01-01

    Current approaches to assessing preclinical anticancer activity do not reliably predict drug efficacy in cancer patients. Most of the compounds that show remarkable anticancer effects in preclinical models actually fail when tested in clinical trials. We blame these failures on the complexity of the disease and on the limitations of the preclinical tools we require for our research. This manuscript argues that this lack of clinical response may also be caused by poor in vitro and in vivo preclinical designs, in which cancer patients' needs are not fully considered. Then, it proposes two patient-oriented tests to assess in vitro and in vivo anticancer activity and to help validate drug candidates for clinical evaluation. PMID:25859551

  2. 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.

  3. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... Health Information Center Health Professionals Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education Researchers Funding Training & Career Development ...

  4. 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.

  5. CLINICAL STUDY OF ANORECTAL MALFORMATIONS

    Directory of Open Access Journals (Sweden)

    Umesh

    2015-01-01

    Full Text Available BACKGROUND: A norectal malformations are relatively encountered anomalies. Presentations may vary from mild to severe and bowel control is t he main concern. AIM: To study the modes of presentation , types of anomalies , associated anomalies , reliability of clinical signs and radiological investigations in the diagnosis and the prognosis and continence in the post - operative in relation to type of anomaly and associated anomaly (s. MATERIAL AND METHODS: 50 cases of anorectal malformations admit ted to Department of Paediatric Surgery , in Medical Coll ege and Research Institute , were included in the study. Data related to the objectives of the study were collected. RESULTS: Commonest mode of presentation was failure to pass meconium 50%. 59% of mal es had high anomalies , while 53% females had intermediate anomalies. The diagnosis of low anomaly was made clinically , while high and intermediate anomalies needed further investigations. Associated anomalies were noted in 46.6% of the cases. 71.42% of the se patients had either a high or intermediate ARM. All patients with high anomalies underwent a 3 stage procedure , while low anomalies underwent a single stage procedure followed by anal dilatations. Rectal mucosal prolapse (2 cases , wound infection (4 ca ses , stenosis (3 cases , retraction of neo anus (1 case was seen. All the patients with low anomalies had a good functional result post operatively , while 57% and 28% of patients with intermediate and high anomalies had good results. CONCLUSION : Anorectal malformations are common congenital anomalies. Males are more commonly affected (1.3:1. Low anomalies are the commonest lesions noted in both the sexes (36.67%. High anomalies are more frequent in males. Invertogram offer an accurate diagnosis for planning management in patients with anorectal malformations. Low anomalies have a better outcome following surgery. For intermediate and high anomalies a staged repair offers better results

  6. Cultural adaptation and validation of the Portuguese version of the Nursing Clinical Facilitators Questionnaire.

    Science.gov (United States)

    Frederico-Ferreira, Maria Manuela; Camarneiro, Ana Paula Forte; Loureiro, Cândida Rosalinda Exposto da Costa; Ventura, Maria Clara Amado Apóstolo

    2016-08-15

    to perform the cultural adaptation to Portuguese of the Nursing Clinical Facilitators Questionnaire (NCFQ), which was designed by the Centre for Learning and Teaching at the University of Technology of Sydney, and to validate this instrument. this methodological study involved the cultural adaptation of the questionnaire by using translation, back-translation, semantic comparison, idiomatic and conceptual equivalence, and validation through validity and reliability analyses and used a sample of 767 students in their second year of the Nursing Program. construct validity had a two-factor solution according to the varimax rotation method. In addition, there was a high overall internal consistency for the questionnaire (Cronbach's alpha of 0.977) and for the factors found (0.966 and 0.952, respectively). the Portuguese version has good psychometric characteristics; therefore, it is adequate to obtain reliable information on the perception of nursing students concerning the type of supervision that is provided in clinical practice, and this version is adequate to improve teaching practices. realizar a adaptação cultural para a língua portuguesa do Nursing Clinical Facilitators Questionnaire (NCFQ) concebido pelo Centre for Learning and Teaching, University of Technology de Sydney e proceder à validação do instrumento. estudo metodológico de adaptação cultural do questionário através de tradução, retroversão, comparação semântica, idiomática e equivalência conceitual, seguido de validação em uma amostra de 767 estudantes do 2º ano do Curso de Licenciatura em Enfermagem, por meio de análise da validade e confiabilidade. a validade de constructo apresenta uma solução bifatorial após rotação varimax. A consistência interna global do questionário é elevada (alfa de Cronbach 0,977), assim como dos fatores encontrados (respectivamente, 0,966 e 0,952). a versão portuguesa apresenta boas características psicométricas, sendo um instrumento v

  7. A clinical study of vitiligo

    Directory of Open Access Journals (Sweden)

    Martis Jacintha

    2002-01-01

    Full Text Available A clinical study of one hundred patients having vitiligo revealed the incidence among new patients to be 1.84%. The male/female ratio was 1:1.22. Family history of vitiligo was available in 8% of our patients. The different morphological pattern consisted of vitiligo vulgaris (39 cases, focal vitiligo (27 cases, acrofacial vitiligo (18 cases, lip - tip vitiligo (7 cases, lip vitiligo (5 cases, segmental vitiligo (3 cases and universal vitiligo (1 case. Associated diseases include atopic dermatitis (2 cases, Hansen s disease (2 cases, alopecia areata (1 case, halo naevus (1 case, chronic urticaria (1 case, lichen planus (1 case, diabetes mellitus (9 cases, hypertension (4 cases, hypothyroidism (2 cases, epilepsy (1 case and IHD (1 case.

  8. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... of Intramural Research Research Resources Research Meeting Summaries Technology Transfer Clinical Trials What Are Clinical Trials? Children & ... the general public. Last Updated: August 3, 2015 Resources Educational Website - English / Spanish ... FEAR ACT OIG CONTACT US National Institutes of Health Department of Health and Human Services USA.gov

  9. Validity and reliability of the Structured Clinical Interview for the Trauma and Loss Spectrum (SCI-TALS

    Directory of Open Access Journals (Sweden)

    Conversano Ciro

    2008-01-01

    Full Text Available Abstract Background DSM-IV identifies three stress response disorders (acute stress Disorder (ASD, post-traumatic stress Disorder (PTSD and adjustment disorders (AD that derive from specific life events. An additional condition of complicated grief (CG, well described in the literature, is triggered by bereavement. This paper reports on the reliability and validity of the Structured Clinical Interview for Trauma and Loss Spectrum (SCI-TALS developed to assess the spectrum of stress response. The instrument is based on a spectrum model that emphasizes soft signs, low-grade symptoms, subthreshold syndromes, as well as temperamental and personality traits comprising clinical and subsyndromal manifestations. Methods Study participants, enrolled at 6 Italian Departments of Psychiatry located at six sites, included consecutive patients with PTSD, 44 with CG and a comparative group of 48 unselected controls. Results We showed good reliability and validity of the SCI-TALS. Domain scores were significantly higher in participants with PTSD or CG compared to controls. There were high correlations between specific SCI-TALS domains and corresponding scores on established measures of similar constructs. Participants endorsing grief and loss events reported similar scores on all instruments, except those with CG who scored significantly higher on the domain of grief reactions. Conclusion These findings provide strong support for the internal consistency, the discriminant validity and the reliability of the SCI-TALS. These results also support the existence of a specific grief-related condition and the proposal that different forms of stress response have similar manifestations.

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

    NARCIS (Netherlands)

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

    2013-01-01

    Background: The modern standard of evaluating treatment results includes the use of rating systems. Elbow-specific rating systems are frequently used in studies aiming at elbow-specific pathology. However, proper validation studies seem to be relatively sparse. In addition, these scoring systems mig

  11. 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

    Introduction Degenerative joint disease and associated pain are common in cats, particularly in older cats. There is a need for treatment options, however evaluation of putative therapies is limited by a lack of suitable, validated outcome measures that can be used in the target population of client owned cats. The objectives of this study were to evaluate low-dose daily meloxicam for the treatment of pain associated with degenerative joint disease in cats, and further validate two clinical metrology instruments, the Feline Musculoskeletal Pain Index (FMPI) and the Client Specific Outcome Measures (CSOM). Methods Sixty-six client owned cats with degenerative joint disease and owner-reported impairments in mobility were screened and enrolled into a double-masked, placebo-controlled, randomized clinical trial. Following a run-in baseline period, cats were given either placebo or meloxicam for 21 days, then in a masked washout, cats were all given placebo for 21 days. Subsequently, cats were given the opposite treatment, placebo or meloxicam, for 21 days. Cats wore activity monitors throughout the study, owners completed clinical metrology instruments following each period. Results Activity counts were increased in cats during treatment with daily meloxicam (pcats with degenerative joint disease. PMID:26162101

  12. Evaluation of bone remodeling around single dental implants of different lengths: a mechanobiological numerical simulation and validation using clinical data.

    Science.gov (United States)

    Sotto-Maior, Bruno Salles; Mercuri, Emílio Graciliano Ferreira; Senna, Plinio Mendes; Assis, Neuza Maria Souza Picorelli; Francischone, Carlos Eduardo; Del Bel Cury, Altair Antoninha

    2016-01-01

    Algorithmic models have been proposed to explain adaptive behavior of bone to loading; however, these models have not been applied to explain the biomechanics of short dental implants. Purpose of present study was to simulate bone remodeling around single implants of different lengths using mechanoregulatory tissue differentiation model derived from the Stanford theory, using finite elements analysis (FEA) and to validate the theoretical prediction with the clinical findings of crestal bone loss. Loading cycles were applied on 7-, 10-, or 13-mm-long dental implants to simulate daily mastication and bone remodeling was assessed by changes in the strain energy density of bone after a 3, 6, and 12 months of function. Moreover, clinical findings of marginal bone loss in 45 patients rehabilitated with same implant designs used in the simulation (n = 15) were computed to validate the theoretical results. FEA analysis showed that although the bone density values reduced over time in the cortical bone for all groups, bone remodeling was independent of implant length. Clinical data showed a similar pattern of bone resorption compared with the data generated from mathematical analyses, independent of implant length. The results of this study showed that the mechanoregulatory tissue model could be employed in monitoring the morphological changes in bone that is subjected to biomechanical loads. In addition, the implant length did not influence the bone remodeling around single dental implants during the first year of loading.

  13. Gene Expression-Based Survival Prediction in Lung Adenocarcinoma: A Multi-Site, Blinded Validation Study

    Science.gov (United States)

    Shedden, Kerby; Taylor, Jeremy M.G.; Enkemann, Steve A.; Tsao, Ming S.; Yeatman, Timothy J.; Gerald, William L.; Eschrich, Steve; Jurisica, Igor; Venkatraman, Seshan E.; Meyerson, Matthew; Kuick, Rork; Dobbin, Kevin K.; Lively, Tracy; Jacobson, James W.; Beer, David G.; Giordano, Thomas J.; Misek, David E.; Chang, Andrew C.; Zhu, Chang Qi; Strumpf, Dan; Hanash, Samir; Shepherd, Francis A.; Ding, Kuyue; Seymour, Lesley; Naoki, Katsuhiko; Pennell, Nathan; Weir, Barbara; Verhaak, Roel; Ladd-Acosta, Christine; Golub, Todd; Gruidl, Mike; Szoke, Janos; Zakowski, Maureen; Rusch, Valerie; Kris, Mark; Viale, Agnes; Motoi, Noriko; Travis, William; Sharma, Anupama

    2009-01-01

    Although prognostic gene expression signatures for survival in early stage lung cancer have been proposed, for clinical application it is critical to establish their performance across different subject populations and in different laboratories. Here we report a large, training-testing, multi-site blinded validation study to characterize the performance of several prognostic models based on gene expression for 442 lung adenocarcinomas. The hypotheses proposed examined whether microarray measurements of gene expression either alone or combined with basic clinical covariates (stage, age, sex) can be used to predict overall survival in lung cancer subjects. Several models examined produced risk scores that substantially correlated with actual subject outcome. Most methods performed better with clinical data, supporting the combined use of clinical and molecular information when building prognostic models for early stage lung cancer. This study also provides the largest available set of microarray data with extensive pathological and clinical annotation for lung adenocarcinomas. PMID:18641660

  14. 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 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.

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

    Science.gov (United States)

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

    2017-08-08

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

  16. Model validation studies of solar systems, Phase III. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Lantz, L.J.; Winn, C.B.

    1978-12-01

    Results obtained from a validation study of the TRNSYS, SIMSHAC, and SOLCOST solar system simulation and design are presented. Also included are comparisons between the FCHART and SOLCOST solar system design programs and some changes that were made to the SOLCOST program. Finally, results obtained from the analysis of several solar radiation models are presented. Separate abstracts were prepared for ten papers.

  17. Teachers' Engagement at Work: An International Validation Study

    Science.gov (United States)

    Klassen, Robert M.; Aldhafri, Said; Mansfield, Caroline F.; Purwanto, Edy; Siu, Angela F. Y.; Wong, Marina W.; Woods-McConney, Amanda

    2012-01-01

    This study explored the validity of the Utrecht Work Engagement Scale in a sample of 853 practicing teachers from Australia, Canada, China (Hong Kong), Indonesia, and Oman. The authors used multigroup confirmatory factor analysis to test the factor structure and measurement invariance across settings, after which they examined the relationships…

  18. A Validation Study of the Student Oral Proficiency Assessment (SOPA).

    Science.gov (United States)

    Thompson, Lynn E.; Kenyon, Dorry M.; Rhodes, Nancy C.

    This study validated the Student Oral Proficiency Assessment (SOPA), an oral proficiency instrument designed for students in elementary foreign language programs. Elementary students who were tested with the SOPA were also administered other instruments designed to measure proficiency. These instruments included the Stanford Foreign Language Oral…

  19. A Validity Study of the Self-Esteem Inventory.

    Science.gov (United States)

    Landis, H. John

    Results of this validation study of a slightly modified version of the Coppersmith Self-Esteem Inventory substantiate its use with seventh graders to assess Goal I (concerning self-understanding and appreciation of self-worth) of the Educational Quality Assessment Program in Pennsylvania. Appendixes include the definition and rationale for Goal I,…

  20. A validation study of the Brief Irrational Thoughts Inventory

    NARCIS (Netherlands)

    L.M. Hoogsteder; I.B. Wissink; G.J.J.M. Stams; J.E. van Horn; J. Hendriks

    2014-01-01

    This study examines the reliability and validity of the "Brief Irrational Thoughts Inventory" (BITI) in a sample of 256 justice-involved youths. The BITI is a questionnaire used to determine the nature and severity of irrational thoughts related to aggressive (externalizing), sub-assertive (internal

  1. Rap-Music Attitude and Perception Scale: A Validation Study

    Science.gov (United States)

    Tyson, Edgar H.

    2006-01-01

    Objective: This study tests the validity of the Rap-music Attitude and Perception (RAP) Scale, a 1-page, 24-item measure of a person's thoughts and feelings surrounding the effects and content of rap music. The RAP was designed as a rapid assessment instrument for youth programs and practitioners using rap music and hip hop culture in their work…

  2. A Validation Study of Maslow's Hierarchy of Needs Theory.

    Science.gov (United States)

    Clay, Rex J.

    A study was conducted to expand the body of research that tests the validity of Abraham Maslow's hierarchy of needs theory in a work context where it often serves as a guide for the supervisor's relationships with his subordinates. Data was gathered by questionnaire which tested for a hierarchy of needs among instructors at four community colleges…

  3. A Validation Study of Maslow's Hierarchy of Needs Theory.

    Science.gov (United States)

    Clay, Rex J.

    A study was conducted to expand the body of research that tests the validity of Abraham Maslow's hierarchy of needs theory in a work context where it often serves as a guide for the supervisor's relationships with his subordinates. Data was gathered by questionnaire which tested for a hierarchy of needs among instructors at four community colleges…

  4. Understanding Foreign Language Learning Strategies: A Validation Study

    Science.gov (United States)

    Tragant, Elsa; Thompson, Marilyn S.; Victori, Mia

    2013-01-01

    The present work aims to contribute to our understanding of the underlying dimensions of language learning strategies in foreign language contexts. The study analyzes alternative factor structures underlying a recently developed instrument (Tragant and Victori, 2012) and it includes the age factor in the examination of its construct validity. The…

  5. A Validation Study of the Existential Anxiety Scale.

    Science.gov (United States)

    Hullett, Michael A.

    Logotherapy is a meaning-centered psychotherapy which focuses on both the meaning of human existence and the personal search for meaning. If the will to search for meaning is frustrated, "existential frustration" may result. This study validates the Existential Anxiety Scale (EAS) developed by Good and Good (1974). Basic principles of…

  6. Understanding Foreign Language Learning Strategies: A Validation Study

    Science.gov (United States)

    Tragant, Elsa; Thompson, Marilyn S.; Victori, Mia

    2013-01-01

    The present work aims to contribute to our understanding of the underlying dimensions of language learning strategies in foreign language contexts. The study analyzes alternative factor structures underlying a recently developed instrument (Tragant and Victori, 2012) and it includes the age factor in the examination of its construct validity. The…

  7. 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.

  8. 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

    2016-11-17

    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.

  9. [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.

  10. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... NHLBI Entire Site Health Topics News & Resources Intramural Research Public Health Topics Education & Awareness Resources Contact The ... Researchers Funding Training & Career Development Division of Intramural Research Research Resources Research Meeting Summaries Technology Transfer Clinical ...

  11. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Topics News & Resources Intramural Research Public Health Topics Education & Awareness Resources Contact The Health Information Center Health ... Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural ...

  12. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... Topics News & Resources Intramural Research Public Health Topics Education & Awareness Resources Contact The Health Information Center Health ... Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural ...

  13. Clinical study of ectopic pregnancy.

    Science.gov (United States)

    Chhabra, S; Aher, K; Jaiswal, M

    1992-01-01

    Ectopic pregnancy remains a leading cause of maternal mortality and accounts for a sizeable proportion of infertility and ectopic recurrence. The possibility that a woman is experiencing an ectopic pregnancy must be considered when evaluating a woman, especially a sterilized woman, who has a possible pregnancy, amenorrhea, abdominal pain, or abnormal bleeding; studies have found that one in six pregnancies occurring after tubal sterilization are ectopic. The authors present a clinical study of 82 cases of ectopic pregnancy admitted to the department of Obstetrics and Gynecology of Mahatma Gandhi Institute of Medical Sciences, Sevagram. Cases of ectopic pregnancy represent 0.99% of total obstetric admissions, of whom 69.51% were diagnosed as such on admission. 40.24% of the women were older than 30 years, while 34.14% were elderly beyond third parity. 70.73% of the women presented before missing their second period. Patients presented with multiple complaints, but the most common was abdominal pain reported by 61.70%. 78.04% were admitted with an acute abdomen, but shock was present in only 7.14% of cases. The main surgical treatment modality was salpingectomy among 59.75%. There was no maternal mortality through postoperative morbidity in the form of paralytic ileus, although fever did occur in some women.

  14. 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...

  15. 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.

  16. Development and validation study of the Smartphone Overuse Screening Questionnaire.

    Science.gov (United States)

    Lee, Han-Kyeong; Kim, Ji-Hae; Fava, Maurizio; Mischoulon, David; Park, Jae-Hyun; Shim, Eun-Jung; Lee, Eun-Ho; Lee, Ji Hyeon; Jeon, Hong Jin

    2017-08-02

    The aim of this study was to develop a screening questionnaire that could distinguish individuals at high risk of smartphone overuse from casual users. The reliability, validity, and diagnostic ability of the Smartphone Overuse Screening Questionnaire (SOS-Q) were evaluated. Preliminary items were assessed by 50 addiction experts on-line, and 28 questions were selected. A total of 158 subjects recruited from six community centers for internet addiction participated in this study. The SOS-Q, Young's internet addiction scale, Korean scale for internet addiction, and Smartphone Scale for Smartphone Addiction (S-Scale) were used to assess the concurrent validity. Construct validity was supported by a six-factor model using an exploratory factor analysis. The internal consistency and the item-total correlations were favorable (α = 0.95, r = 0.35-0.81). The test-retest reliability was moderate (r = 0.70). The SOS-Q showed superior concurrent validity with the highest correlation between the S-Scale (r = 0.76). Receiver operating characteristic curve analysis revealed an area under the curve of 0.877. A cut-off point of 49 effectively categorized addiction high-risk group with a sensitivity of 0.81 and specificity of 0.86. Overall, the current study supports the use of SOS-Q as both a primary and supplementary measurement tool in a variety of settings. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

  17. 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.

  18. Use of a validated screening tool for psoriatic arthritis in dermatology clinics

    Science.gov (United States)

    Ganatra, Bella; Manoharan, Dishan; Akhras, Victoria

    2015-01-01

    Dermatology clinics represent a key opportunity to screen patients with psoriasis for psoriatic arthritis (PA) which often remains unrecognised. A significant proportion of adults with psoriasis develop arthropathy [5] with around two-thirds having progressive arthritis.[6] NICE has recognised this by the annual use of a validated screening tool such as psoriasis epidemiological screening tool (PEST) on all psoriasis patients without PA. We introduced the PEST into our dermatology department since there was no established system of screening for PA. Twenty-one percent of patients that were identified through PEST as requiring a referral at baseline were not referred to rheumatology through the current system without PEST. This represented a significantly missed proportion of patients with possible PA. Using the PDSA cycle method, we introduced the PEST into cycle 1 and educated key staff about the tool. All eligible patients were referred appropriately. Through doctor and patient feedback, changes were adopted for cycle 2 and informative emails to all key staff about PEST were sent. We noted a drop in the number of PEST uptake in this cycle possibly due to lack of awareness on the purpose and use of PEST among staff, across the department. An educational teaching session was delivered to a wider audience and posters were placed in strategic areas of the department prior to the final cycle. This resulted in 100% PEST uptake and 100% of those with a score of >3 being referred. A total of 51 patients were studied, comprising of 30 eligible patients for PEST. Of these, 27 patients were actually screened (90%) and five with a PEST score of ≥ 3 were identified and referred appropriately (18.5%). We felt this represented a successful outcome in increasing PEST uptake within the department and in capturing a significant proportion of patients at risk of PA. PMID:26734320

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

    Science.gov (United States)

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

    2013-01-01

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

  20. Methodological Aspects in Studies Based on Clinical Routine Data.

    Science.gov (United States)

    Kennes, Lieven Nils

    2017-09-12

    Randomized controlled clinical trials are regarded as the gold standard for comparing different clinical interventions, but generally their conduct is operationally cumbersome, time-consuming, and expensive. Studies and investigations based on clinical routine data on the contrary utilize existing data acquired under real-life conditions and are increasingly popular among practitioners. In this paper, methodological aspects of studies based on clinical routine data are discussed. Important limitations and considerations as well as unique strengths of these types of studies are indicated and exemplarily demonstrated in a recent real-case study based on clinical routine data. In addition two simulation studies reveal the impact of bias in studies based on clinical routine data on the type I error rate and false decision rate in favor of the inferior intervention. It is concluded that correctly analyzing clinical routine data yields a valuable addition to clinical research; however, as a result of a lack of statistical foundation, internal validity, and comparability, generalizing results and inferring properties derived from clinical routine data to all patients of interest has to be considered with extreme caution. Grünenthal GmbH.

  1. German version of ItchyQoL: validation and initial clinical findings.

    Science.gov (United States)

    Krause, Karoline; Kessler, Birgit; Weller, Karsten; Veidt, Jennifer; Chen, Suephy C; Martus, Peter; Church, Martin K; Metz, Martin; Maurer, Marcus

    2013-09-04

    Pruritus is a major symptom of numerous skin and systemic diseases and causes a substantial burden on patients' quality of life (QoL). We report here the validation of the German version (GerItchyQoL) of the first pruritus-specific QoL instrument ItchyQoL. GerItchyQoL was created from the original version following standard protocols. It was completed by 308 patients with chronic pruritus of different origin and tested for validity, reliability and responsiveness. Factor analysis of Ger-ItchyQoL revealed the 4 domains symptoms, functioning, feelings, and self-perception. Reliability was demonstrated by good internal consistency of all domains. We confirmed convergent validity by comparing the instrument with itch severity, as measured with a visual analogue scale (VAS 0-10), and with the Short-Form-12 (SF-12), a widely used generic health-related QoL instrument. Concurrent validity was shown by the ability to discriminate between patient groups of different itch severity. Changes in GerItchyQoL scores correlated with changes in itch severity (VAS), suggesting responsiveness of the German tool. This study provides preliminary evidence of validity, reliability and responsiveness of GerItchyQoL and also shows a high impact of chronic pruritus on QoL. Further translations of ItchyQoL into additional languages will enable large-scale international, multilingual trials.

  2. Clinical prediction model to aid emergency doctors managing febrile children at risk of serious bacterial infections: Diagnostic study

    NARCIS (Netherlands)

    R.G. Nijman (Ruud); Y. Vergouwe (Yvonne); M.J. Thompson (Matthew); M.V. Veen (Mirjam Van); A.H.J. van Meurs (Alfred); J. van der Lei (Johan); E.W. Steyerberg (Ewout); H.A. Moll (Henriëtte); R. Oostenbrink (Rianne)

    2013-01-01

    textabstractObjective: To derive, cross validate, and externally validate a clinical prediction model that assesses the risks of different serious bacterial infections in children with fever at the emergency department. Design: Prospective observational diagnostic study. Setting: Three paediatric em

  3. Validation of a computer based objective structured clinical examination in the assessment of undergraduate dermatology courses

    Directory of Open Access Journals (Sweden)

    Feroze Kaliyadan

    2014-01-01

    Full Text Available Many teaching centers have now adopted objective structured clinical examination (OSCE as an assessment method for undergraduate dermatology courses. A modification of the standard OSCE in dermatology is computer based or electronic OSCE (eOSCE. We attempted to validate the use of a computer-based OSCE in dermatology in a group of fifth year medical students. The scores of the students in the computer-based OSCE showed a strong positive correlation with the scores on the clinical presentation (Pearson′s co-efficient - 0.923, P value <0.000, significant at the 0.01 level and a good correlation with overall scores of the student (Pearson′s co-efficient - 0.728, P value <0.000, significant at the 0.01 level, indicating that this is a reliable method for assessment in dermatology. Generally, the students′ feedback regarding the methods was positive.

  4. Digit Symbol-Incidental Learning in the WAIS-III: construct validity and clinical significance.

    Science.gov (United States)

    Joy, Stephen; Kaplan, Edith; Fein, Deborah

    2003-05-01

    We analyzed WAIS-III/WMS-III standardization data for evidence of the construct validity and clinical utility of the Digit Symbol-Incidental Learning procedures (Pairing and Free Recall). Scores on both tests correlated moderately with WMS-III memory index scores (mean r=.38 for Pairing and .36 for Free Recall). Cutoff scores can be used to identify younger and older adults likely to suffer from memory impairment. In the standardization sample (which excludes neurological patients), these have moderate positive predictive power (averaging .56 if either test yields a positive finding), moderate negative predictive power (.76), and high specificity (.88), but low sensitivity (.35). In a clinical sample, the same cutoff scores were much more sensitive, correctly identifying 88% of a group of patients with Alzheimer's Disease. Examinees who obtain these low scores should receive follow-up memory testing. Very high scores are associated with a reduced risk of memory impairment.

  5. Predictive Validity of the MMPI-2 Clinical, PSY-5, and RC Scales for Therapy Disruptive Behavior

    NARCIS (Netherlands)

    Scholte, W.; Tiemens, B.G.; Verheul, R.; Meerman, A.; Egger, J.; Hutschemaekers, G.

    2012-01-01

    Background. Impulsive acts, parasuicidal behavior, and other therapy disruptive incidents occur frequently in the treatment of patients with personality disorders and increase the risk that patients will drop out of treatment. Objective. This study examined the predictive validity of the Minnesota M

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

    NARCIS (Netherlands)

    Schaufeli, WB; Bakker, AB; 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 mos

  7. 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

  8. Validation of antibiotic susceptibility testing guidelines in a routine clinical microbiology laboratory exemplifies general key challenges in setting clinical breakpoints.

    Science.gov (United States)

    Hombach, Michael; Courvalin, Patrice; Böttger, Erik C

    2014-07-01

    This study critically evaluated the new European Committee for Antimicrobial Susceptibility Testing (EUCAST) antibiotic susceptibility testing guidelines on the basis of a large set of disk diffusion diameters determined for clinical isolates. We report several paradigmatic problems that illustrate key issues in the selection of clinical susceptibility breakpoints, which are of general importance not only for EUCAST but for all guidelines systems, i.e., (i) the need for species-specific determinations of clinical breakpoints/epidemiological cutoffs (ECOFFs), (ii) problems arising from pooling data from various sources, and (iii) the importance of the antibiotic disk content for separating non-wild-type and wild-type populations.

  9. A clinical study of retinoblastoma

    Directory of Open Access Journals (Sweden)

    L Subha

    2015-01-01

    Full Text Available Aim: The aim was to analyze general incidence, age incidence, laterality, common mode of presentation, staging of the tumor, radiological evidence, histopathological confirmation, management and follow-up of cases, which were diagnosed as retinoblastoma. Design: Interventional case series study from April 1997 to March 2000. Materials and Methods: Detailed history regarding the symptoms such as white reflex, watering, pain, redness, protrusion of eyeball, squint, hyphema, and defective vision were obtained. Family history regarding consanguinity between parents, health of the siblings and other relatives were recorded. Ocular examination included vision, pupillary reaction, detailed fundus examination, ocular tension, and corneal diameter. Investigations included X-ray orbit and skull, computed tomography scan orbit and brain, B-scan orbit, serum and aqueous lactate dehydrogenase; enucleated eyes were subjected to holoprosencephaly (HPE. Enucleation, radiotherapy, cryotherapy and chemotherapy were modalities of treatment. The empty socket and the other apparently normal eye were examined carefully at each visit. Results: The incidence of retinoblastoma is less when compared to other diseases of the eye. There was no sex predilection. Most of the cases diagnosed were sporadic and unilateral. Age of onset is earlier for bilateral cases than unilateral cases. Consanguinity bears close relationship with bilateral involvement. Predominant clinical sign is white reflex in the pupillary area. Majority of cases presented in the second stage of the disease. Enucleation plays a greater role in the management of retinoblastoma. HPE should include several sections of the optic nerve to find out skip lesions.

  10. 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.

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

    Science.gov (United States)

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

    2008-01-01

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

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

    Science.gov (United States)

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

    2008-01-01

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

  13. Millon Clinical Multiaxial Inventory (MCMI-III): the inability of the validity conditions to detect random responders.

    Science.gov (United States)

    Charter, Richard A; Lopez, Michael N

    2002-12-01

    The effectiveness of the MCMI-III Validity scale, Scale X, and the Clinical Personality Pattern scales to detect random responding is put to the test. The binomial expansion and Monte Carlo techniques were used. If the examiner is willing to interpret tests of questionable validity, then 50% of the random responders will not be detected. Scale X and the Clinical Personality Pattern scales were useless in detecting random responders.

  14. A validated gene expression profile for detecting clinical outcome in breast cancer using artificial neural networks.

    Science.gov (United States)

    Lancashire, L J; Powe, D G; Reis-Filho, J S; Rakha, E; Lemetre, C; Weigelt, B; Abdel-Fatah, T M; Green, A R; Mukta, R; Blamey, R; Paish, E C; Rees, R C; Ellis, I O; Ball, G R

    2010-02-01

    Gene expression microarrays allow for the high throughput analysis of huge numbers of gene transcripts and this technology has been widely applied to the molecular and biological classification of cancer patients and in predicting clinical outcome. A potential handicap of such data intensive molecular technologies is the translation to clinical application in routine practice. In using an artificial neural network bioinformatic approach, we have reduced a 70 gene signature to just 9 genes capable of accurately predicting distant metastases in the original dataset. Upon validation in a follow-up cohort, this signature was an independent predictor of metastases free and overall survival in the presence of the 70 gene signature and other factors. Interestingly, the ANN signature and CA9 expression also split the groups defined by the 70 gene signature into prognostically distinct groups. Subsequently, the presence of protein for the principal prognosticator gene was categorically assessed in breast cancer tissue of an experimental and independent validation patient cohort, using immunohistochemistry. Importantly our principal prognosticator, CA9, showed that it is capable of selecting an aggressive subgroup of patients who are known to have poor prognosis.

  15. Computational fluid dynamics modelling of perfusion measurements in dynamic contrast-enhanced computed tomography: development, validation and clinical applications

    Science.gov (United States)

    Peladeau-Pigeon, M.; Coolens, C.

    2013-09-01

    Dynamic contrast-enhanced computed tomography (DCE-CT) is an imaging tool that aids in evaluating functional characteristics of tissue at different stages of disease management: diagnostic, radiation treatment planning, treatment effectiveness, and monitoring. Clinical validation of DCE-derived perfusion parameters remains an outstanding problem to address prior to perfusion imaging becoming a widespread standard as a non-invasive quantitative measurement tool. One approach to this validation process has been the development of quality assurance phantoms in order to facilitate controlled perfusion ex vivo. However, most of these systems fail to establish and accurately replicate physiologically relevant capillary permeability and exchange performance. The current work presents the first step in the development of a prospective suite of physics-based perfusion simulations based on coupled fluid flow and particle transport phenomena with the goal of enhancing the understanding of clinical contrast agent kinetics. Existing knowledge about a controllable, two-compartmental fluid exchange phantom was used to validate the computational fluid dynamics (CFD) simulation model presented herein. The sensitivity of CFD-derived contrast uptake curves to contrast injection parameters, including injection duration and flow rate, were quantified and found to be within 10% accuracy. The CFD model was employed to evaluate two commonly used clinical kinetic algorithms used to derive perfusion parameters: Fick's principle and the modified Tofts model. Neither kinetic model was able to capture the true transport phenomena it aimed to represent but if the overall contrast concentration after injection remained identical, then successive DCE-CT evaluations could be compared and could indeed reflect differences in regional tissue flow. This study sets the groundwork for future explorations in phantom development and pharmaco-kinetic modelling, as well as the development of novel contrast

  16. WISC-IV and Clinical Validation of the Four- and Five-Factor Interpretative Approaches

    Science.gov (United States)

    Weiss, Lawrence G.; Keith, Timothy Z.; Zhu, Jianjun; Chen, Hsinyi

    2013-01-01

    The purpose of this study was to determine the constructs measured by the WISC-IV and the consistency of measurement across large normative and clinical samples. Competing higher order four- and five-factor models were analyzed using the WISC-IV normative sample and clinical subjects. The four-factor solution is the model published with the test…

  17. Construct validity of clinical spinal mobility tests in ankylosing spondylitis: a systematic review and meta-analysis.

    Science.gov (United States)

    Castro, Marcelo P; Stebbings, Simon M; Milosavljevic, Stephan; Bussey, Melanie D

    2016-07-01

    The study aimed to determine, using systematic review and meta-analysis, the level of evidence supporting the construct validity of spinal mobility tests for assessing patients with ankylosing spondylitis. Following the guidelines proposed in the Preferred Reporting Items for Systematic reviews and Meta-Analyses, three sets of keywords were used for data searching: (i) ankylosing spondylitis, spondyloarthritis, spondyloarthropathy, spondylarthritis; (ii) accuracy, association, construct, correlation, Outcome Measures in Rheumatoid Arthritis Clinical Trials, OMERACT, truth, validity; (iii) mobility, Bath Ankylosing Spondylitis Metrology Index-BASMI, radiography, spinal measures, cervical rotation, Schober (a further 19 keywords were used). Initially, 2558 records were identified, and from these, 21 studies were retained. Fourteen of these studies were considered high level of evidence. Compound indexes of spinal mobility showed mostly substantial to excellent levels of agreement with global structural damage. Individual mobility tests for the cervico-thoracic spine showed only moderate agreements with cervical structural damage, and considering structural damage at the lumbar spine, the original Schober was the only test that presented consistently substantial levels of agreement. Three studies assessed the construct validity of mobility measures for inflammation and low to fair levels of agreement were observed. Two meta-analyses were conducted, with assessment of agreement between BASMI and two radiological indexes of global structural damage. The spinal mobility indexes and the original Schober test show acceptable construct validity for inferring the extent of structural damage when assessing patients with ankylosing spondylitis. Spinal mobility measures do not reflect levels of inflammation at either the sacroiliac joints and/or the spine.

  18. Facilitating case studies in massage therapy clinical education.

    Science.gov (United States)

    Baskwill, Amanda

    2013-01-01

    The integration of evidence into reflective health care practice has been on the rise in recent years and is a phenomenon that has affected all health care professions, including massage therapy. Clinical case studies are a research design that follows one patient or subject, making the studies ideal for use in clinical practice. They are valuable for communicating information from clinical practice to the broader community. Case studies have face validity that may be more valuable to individual practitioners than homogeneous randomized controlled trials, as the practitioner may recognize a complex patient in the case report. At Humber College, Student Massage Therapists (SMTs) create, conduct, and communicate results of a clinical case study prior to graduation. This article describes the process and experience.

  19. Greek version of the Internet Addiction Test: a validation study.

    Science.gov (United States)

    Tsimtsiou, Zoi; Haidich, Anna-Bettina; Kokkali, Stamatia; Dardavesis, Theodoros; Young, Kimberly S; Arvanitidou, Malamatenia

    2014-06-01

    The aim of this project was to translate, culturally adapt and validate the Internet Addiction Test (IAT) in Greek adults. Twenty-one post-graduate medical students participated in the cultural adaptation procedure and 151 both post- and under-graduate medical students in the validation process. The internal consistency shown by a Cronbach's alpha was 0.91. Two-week test-retest reliability was rtt = 0.84, p students. In terms of convergent validity, the hours of daily internet use were positively correlated with IAT score (rho = 0.48, p students that reported use of online gambling (40.5 vs 29.2, p = 0.004), pornographic sites (36.5 vs 28.0, p = 0.003) and online games (35.6 vs 28.2, p = 0.009). Exploratory factor analysis revealed three interpretable factors for the IAT, "Psychological/Emotional Conflict", "Time Management" and "Neglect Work", that showed good internal consistency and concurrent validity, explaining 55.3 % of the variance. The Greek version of IAT has shown good psychometric properties, comparable with the original IAT and the previously published translated versions, and can be a useful tool in future studies on internet addiction.

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

    Science.gov (United States)

    Bowen, Raffick A R; Adcock, Dorothy M

    2016-12-01

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

  1. 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

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

    Science.gov (United States)

    Badran, Hani; Pluye, Pierre; Grad, Roland

    2017-03-14

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

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

    Science.gov (United States)

    2017-01-01

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

  4. 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.

  5. Development and validation of a tool to measure self-confidence and anxiety in nursing students during clinical decision making.

    Science.gov (United States)

    White, Krista A

    2014-01-01

    Clinical decision making (CDM) is a cornerstone skill for nurses. Self-confidence and anxiety affect the learning and adeptness of CDM. This study aimed to develop and test a quantitative tool to assess undergraduate nursing students' self-confidence and anxiety during CDM. The 27-item Nursing Anxiety and Self-Confidence with Clinical Decision Making (NASC-CDM) scale is a 6-point, Likert-type tool with two subscales. Two samples of prelicensure associate and baccalaureate nursing students participated in the pilot (n = 303) and main testing (n = 242) phases of the study. Construct validity assessment, using exploratory factor analysis, produced a stable three-dimensional scale. Convergent validity assessment produced positive, moderate, and statistically significant correlations of the tool sub-scales with two existing instruments. Internal consistency reliability was assessed for each subscale (self-confidence, α = .97; anxiety, α = .96). The NASC-CDM scale may be a useful assessment tool for nurse educators to help novice clinicians improve CDM skills.

  6. THE SPORT IMAGERY QUESTIONNAIRE: A STUDY OF VALIDITY AND RELIABILITY

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    Muhammed Emin KAFKAS

    2011-08-01

    Full Text Available The aim of this research is to adapt The Sport Imagery Questionnaire (Hall, Munroe-Chandler, Fishburne ve Hall, 2009 into Turkish and to examine its psychometric properties. The research was conducted on 208 female (38.2% and 337 male (61.8% volunteering students aged mostly between 12-16 studying at 1st and 2nd stage of primary schools affiliated to central district of Malatya province, Turkey. First the linguistic equivalence of the scale was tested, which is then followed by validity and reliability studies. Internal consistency coefficients varied between .66-.87 and test-retest reliability coefficients varied between .60-.86. Corrected item-total correlations ranged from .60 to .85. Based on these results the Sport Imagery Questionnaire can be used as a valid and reliable instrument.

  7. Translation and validation of the clinical learning environment, supervision and nurse teacher scale (CLES + T) in Croatian language.

    Science.gov (United States)

    Lovrić, Robert; Piškorjanac, Silvija; Pekić, Vlasta; Vujanić, Jasenka; Ratković, Karolina Kramarić; Luketić, Suzana; Plužarić, Jadranka; Matijašić-Bodalec, Dubravka; Barać, Ivana; Žvanut, Boštjan

    2016-07-01

    Clinical practice is essential to nursing education as it provides experience with patients and work environments that prepare students for future work as nurses. The aim of this study was to translate the "Clinical Learning Environment, Supervision and Nurse Teacher" questionnaire in Croatian language and test its validity and reliability in practice. The study was performed at the Faculty of medicine, Josip Juraj Strossmayer University of Osijek, Croatia in April 2014. The translated questionnaire was submitted to 136 nursing students: 20 males and 116 females. Our results reflected a slightly different factor structure, consisting of four factors. All translated items of the original constructs "Supervisory relationship", "Role of nurse teacher" and "Leadership style of the ward manager" loaded on factor 1. Items of "Pedagogical atmosphere on the ward" are distributed on two factors (3 and 4). The items of "Premises of nursing on the ward" loaded on factor 2. Three items were identified as problematic and iteratively removed from the analysis. The translated version of the aforementioned questionnaire has properties suitable for the evaluation of clinical practice for nursing students within a Croatian context and reflects the specifics of the nursing clinical education in this country.

  8. Predictive validity of the Biomedical Admissions Test: an evaluation and case study.

    Science.gov (United States)

    McManus, I C; Ferguson, Eamonn; Wakeford, Richard; Powis, David; James, David

    2011-01-01

    There has been an increase in the use of pre-admission selection tests for medicine. Such tests need to show good psychometric properties. Here, we use a paper by Emery and Bell [2009. The predictive validity of the Biomedical Admissions Test for pre-clinical examination performance. Med Educ 43:557-564] as a case study to evaluate and comment on the reporting of psychometric data in the field of medical student selection (and the comments apply to many papers in the field). We highlight pitfalls when reliability data are not presented, how simple zero-order associations can lead to inaccurate conclusions about the predictive validity of a test, and how biases need to be explored and reported. We show with BMAT that it is the knowledge part of the test which does all the predictive work. We show that without evidence of incremental validity it is difficult to assess the value of any selection tests for medicine.

  9. 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.

    2016-01-01

    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 mo

  10. Development and validation of a clinical prediction rule for chest wall syndrome in primary care

    Directory of Open Access Journals (Sweden)

    Ronga Alexandre

    2012-08-01

    Full Text Available Abstract Background Chest wall syndrome (CWS, the main cause of chest pain in primary care practice, is most often an exclusion diagnosis. We developed and evaluated a clinical prediction rule for CWS. Methods Data from a multicenter clinical cohort of consecutive primary care patients with chest pain were used (59 general practitioners, 672 patients. A final diagnosis was determined after 12 months of follow-up. We used the literature and bivariate analyses to identify candidate predictors, and multivariate logistic regression was used to develop a clinical prediction rule for CWS. We used data from a German cohort (n = 1212 for external validation. Results From bivariate analyses, we identified six variables characterizing CWS: thoracic pain (neither retrosternal nor oppressive, stabbing, well localized pain, no history of coronary heart disease, absence of general practitioner’s concern, and pain reproducible by palpation. This last variable accounted for 2 points in the clinical prediction rule, the others for 1 point each; the total score ranged from 0 to 7 points. The area under the receiver operating characteristic (ROC curve was 0.80 (95% confidence interval 0.76-0.83 in the derivation cohort (specificity: 89%; sensitivity: 45%; cut-off set at 6 points. Among all patients presenting CWS (n = 284, 71% (n = 201 had a pain reproducible by palpation and 45% (n = 127 were correctly diagnosed. For a subset (n = 43 of these correctly classified CWS patients, 65 additional investigations (30 electrocardiograms, 16 thoracic radiographies, 10 laboratory tests, eight specialist referrals, one thoracic computed tomography had been performed to achieve diagnosis. False positives (n = 41 included three patients with stable angina (1.8% of all positives. External validation revealed the ROC curve to be 0.76 (95% confidence interval 0.73-0.79 with a sensitivity of 22% and a specificity of 93%. Conclusions This CWS score offers

  11. Validation of a [Al(18)F]PSMA-11 preparation for clinical applications.

    Science.gov (United States)

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

    2017-09-06

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

  12. Nottingham Prognostic Index Plus: Validation of a clinical decision making tool in breast cancer in an independent series.

    Science.gov (United States)

    Green, Andrew R; Soria, Daniele; Stephen, Jacqueline; Powe, Desmond G; Nolan, Christopher C; Kunkler, Ian; Thomas, Jeremy; Kerr, Gillian R; Jack, Wilma; Cameron, David; Piper, Tammy; Ball, Graham R; Garibaldi, Jonathan M; Rakha, Emad A; Bartlett, John Ms; Ellis, Ian O

    2016-01-01

    The Nottingham Prognostic Index Plus (NPI+) is a clinical decision making tool in breast cancer (BC) that aims to provide improved patient outcome stratification superior to the traditional NPI. This study aimed to validate the NPI+ in an independent series of BC. Eight hundred and eighty five primary early stage BC cases from Edinburgh were semi-quantitatively assessed for 10 biomarkers [Estrogen Receptor (ER), Progesterone Receptor (PgR), cytokeratin (CK) 5/6, CK7/8, epidermal growth factor receptor (EGFR), HER2, HER3, HER4, p53, and Mucin 1] using immunohistochemistry and classified into biological classes by fuzzy logic-derived algorithms previously developed in the Nottingham series. Subsequently, NPI+ Prognostic Groups (PGs) were assigned for each class using bespoke NPI-like formulae, previously developed in each NPI+ biological class of the Nottingham series, utilising clinicopathological parameters: number of positive nodes, pathological tumour size, stage, tubule formation, nuclear pleomorphism and mitotic counts. Biological classes and PGs were compared between the Edinburgh and Nottingham series using Cramer's V and their role in patient outcome prediction using Kaplan-Meier curves and tested using Log Rank. The NPI+ biomarker panel classified the Edinburgh series into seven biological classes similar to the Nottingham series (p > 0.01). The biological classes were significantly associated with patient outcome (p  0.01). The good PGs were similarly validated in Luminal B, Basal p53 normal, HER2+/ER- tumours and the poor PG in the Luminal N class (p > 0.01). Due to small patient numbers assigned to the remaining PGs, Luminal N, Luminal B, Basal p53 normal and HER2+/ER- classes could not be validated. This study demonstrates the reproducibility of NPI+ and confirmed its prognostic value in an independent cohort of primary BC. Further validation in large randomised controlled trial material is warranted.

  13. 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.

  14. Validation of the post sleep questionnaire for assessing subjects with restless legs syndrome: results from two double-blind, multicenter, placebo-controlled clinical trials

    Directory of Open Access Journals (Sweden)

    Bharmal Murtuza

    2011-04-01

    Full Text Available Abstract Background Because of the subjective nature of Restless Legs Syndrome (RLS symptoms and the impact of these symptoms on sleep, patient-reported outcomes (PROs play a prominent role as study endpoints in clinical trials investigating RLS treatments. The objective of this study was to validate a new measure, the Post Sleep Questionnaire (PSQ, to assess sleep dysfunction in subjects with moderate-to-severe RLS symptoms. Methods Pooled data were analyzed from two 12-week, randomized, placebo-controlled trials of gabapentin enacarbil (N = 540. At baseline and Week 12, subjects completed the PSQ and other validated health surveys: IRLS Rating Scale, Clinical Global Impression of Improvement (CGI-I, Profile of Mood States (POMS, Medical Outcomes Study Scale-Sleep (MOS-Sleep, and RLS-Quality of Life (RLSQoL. Pooled data were used post hoc to examine the convergent, divergent, known-group validity and the responsiveness of the PSQ. Results Convergent validity was demonstrated by significant correlations between baseline PSQ items and total scores of IRLS, POMS, RLSQoL, and the MOS-Sleep Scale (p ≤ 0.007 each. Divergent validity was demonstrated through the lack of significant correlations between PSQ items and demographic characteristics. Correlations (p Conclusions Although these analyses were potentially limited by the use of clinical trial data and not prospective data from a study conducted solely for validation purposes, the PSQ demonstrated robust psychometric properties and is a valid instrument for assessing sleep and sleep improvements in subjects with moderate-to-severe RLS symptoms. Trial Registration This study analyzed data from two registered trials, NCT00298623 and NCT00365352.

  15. The Dutch Marital Satisfaction and Communication Questionnaire: A Validation study

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    Ann Van den Troost

    2005-09-01

    Full Text Available The purpose of this study is to validate the Dutch Marital Satisfaction and Communication Questionnaire (DMSCQ, a 16-item measure that disentangles marital satisfaction, negative communication and open communication. In three subsequent studies empirical evidence for the construct and criterion validity is presented using (confirmatory factor analyses, and correlational analyses with criterion variables. Results indicate that the 16 items represent a solid three-factor structure, which was replicated across time and in independent samples. High agreement in factor structure between men and women was demonstrated by high levels of Tucker's coefficient of congruence. The internal consistencies of the marital satisfaction and negative communication scales are good; for the open communication scale it is somewhat lower but still acceptable. Consistent evidence was obtained for a negative relationship between the three marital outcomes and parental depression and conflictual family climate whereas the three former are positively related to life satisfaction and well-being. Spouses who feel restricted by their parental role or experience parenting stress tend to be less satisfied with their partnership and perceive the marital communication as more negative. Our results demonstrate that the DMSCQ provides a brief, valid and reliable measure of marital satisfaction, negative and open communication.

  16. Validation and implementation of a liquid chromatography/tandem mass spectrometry assay to quantitate dimethyl benzoylphenylurea (BPU) and its five metabolites in human plasma and urine for clinical pharmacology studies.

    Science.gov (United States)

    Rudek, Michelle A; Zhao, Ming; He, Ping; Zabelina, Yelena; Jin, Runyan; Messersmith, Wells A; Wolff, Antonio C; Baker, Sharyn D

    2005-12-15

    A method has been developed for the quantitation of N-[4-(5-bromo-2-pyrimidinyloxy)-3-methylphenyl]-N'-(2-dimethylamino-benzoyl)urea (BPU) and its metabolites in human plasma and urine. BPU and metabolites were separated on a C18 column with acetonitrile-water mobile phase containing 0.1% formic acid using isocratic flow for 5 min. The analytes were monitored by tandem mass spectrometry. Calibration curves were generated over the range of 2.5-500 ng/mL for BPU, mmBPU, and aminoBPU in plasma; and 0.1-20, 0.1-20, 0.5-100, 10-2000, 1-200, and 3-600 ng/mL for BPU, mmBPU, aminoBPU, G280, G308, and G322 in urine, respectively. The method has been successfully applied to study the pharmacokinetics of BPU.

  17. Reliability and Criterion Validity of a Novel Clinical Test of Simple and Complex Reaction Time in Athletes1

    Science.gov (United States)

    Eckner, James T.; Richardson, James K.; Kim, Hogene; Joshi, Monica S.; Oh, Youkeun K.; Ashton-Miller, James A.

    2015-01-01

    Summary Slowed reaction time (RT) represents both a risk factor for and a consequence of sport concussion. The purpose of this study was to determine the reliability and criterion validity of a novel clinical test of simple and complex RT, called RTclin, in contact sport athletes. Both tasks were adapted from the well-known ruler drop test of RT and involve manually grasping a falling vertical shaft upon its release, with the complex task employing a go/no-go paradigm based on a slight cue. In 46 healthy contact sport athletes (24 males; M = 16.3 yr., SD = 5.0; 22 women: M age= 15.0 yr., SD = 4.0) whose sports included soccer, ice hockey, American football, martial arts, wrestling, and lacrosse, the latency and accuracy of simple and complex RTclin had acceptable test-retest and inter-rater reliabilities and correlated with a computerized criterion standard, the Axon Computerized Cognitive Assessment Tool. Medium to large effect sizes were found. The novel RTclin tests have acceptable reliability and criterion validity for clinical use and hold promise as concussion assessment tools. PMID:26106803

  18. A study on construction, validation and determination of normalization of adolescents depression scale

    Directory of Open Access Journals (Sweden)

    Khadijeh Babakhani

    2014-01-01

    Full Text Available This paper presents an empirical investigation to construct, to validate and to determine normalization factors associated with adolescents depression scale. The study is performed among 750 randomly selected guided and high school students, 364 male and 386 female, who live in city of Zanjan, Iran. Validity of Beck Depression Inventory (BDI, Validity of Simpson-Angus Scale (SAS and divergence validity of the Coopersmith self- esteem coefficients are 0.72, 0.37 and -0.71, respectively. Result suggests that adolescents’ depression test is a reliable and valid tool for assessing depression, with utility in both research and clinical settings, counseling centers. In addition, the results of correlation test indicate there are some meaningful differences between depression levels of female and male students. In fact, our survey indicates that female students have more depression than male students do (F-value = 33.06, Sig. = 0.000. In addition, there are some meaningful differences between depression levels in various educational levels (F-value = 8.59, Sig. = 0.000. However, the study does not find sufficient evidence to believe there is any meaningful correlation between educational backgrounds and gender.

  19. Validation of the clinical diagnostic criteria for temporomandibular disorders for the diagnostic subgroup of degenerative joint disease.

    Science.gov (United States)

    Brandlmaier, I; Grüner, S; Rudisch, A; Bertram, S; Emshoff, R

    2003-04-01

    Research is needed to assess the validity of the Clinical Diagnostic Criteria for Temporomandibular Disorders (CDC/TMD). The purpose of this study was to test the reliability of the clinical diagnosis of temporomandibular joint (TMJ) degenerative joint disease (DJD) as compared with the magnetic resonance imaging (MRI) 'gold standard'. The TMJ DJD group comprised 48 joints in 24 consecutive patients who were assigned a clinical bilateral diagnosis of TMJ DJD. The TMJ non-DJD group consisted of 82 joints in 41 consecutive patients without a TMJ-related diagnosis of TMD. Bilateral sagittal and coronal MR images were obtained subsequently to establish the corresponding diagnosis of degenerative joint changes. An MRI diagnosis of osteoarthrosis (OA) was defined by the presence of flattening, subchondral sclerosis, surface irregularities, and erosion of the condyle or presence of condylar deformities associated with flattening, subchondral sclerosis, surface irregularities, erosion and osteophyte. For the CDC/TMD interpretations, the positive predictive of DJD for OA was 67%, and for the presence of degenerative joint changes 88%. The overall diagnostic agreement for DJD was 44.6% with a corresponding K-value of 0.01. Most of the disagreement was due to false-negative interpretations of asymptomatic joints. The results suggest CDC/TMD to be predictive for degenerative joint changes but insufficient for determination of OA. Patients assigned a clinical TMJ-related diagnosis of DJD may need to be supplemented by evidence from MRI to determine the presence or absence of OA.

  20. Validation and clinical implementation of commercial secondary check software with heterogeneity corrections.

    Science.gov (United States)

    Kuppusamy, Vijayalakshmi; Nagarajan, Vivekanandan; Murugan, Lavanya

    2016-01-01

    To validate and implement PTW diamond secondary check software (SCS) in a routine clinical use. The secondary independent monitor unit or dose calculation verifications have led to a significant increase in the workflow associated with QA treatments. Modelling, validation and commissioning are necessary steps thereby making it a useful tool for QA. PTW Diamond SCS is capable of calculating VMAT fields, based on modified Clarkson integration, accounting for multi-leaf collimators (MLC) transmission and measured collimator scatter factors. Validation for heterogeneity corrections is made using circular phantom with inserts of various density materials. 150 VMAT plans were compared using (i) plans calculated in homogeneous cylindrical phantom and (ii) VMAT plans calculated with heterogeneity corrections using electron density values for each organ. Diamond SCS calculated dose for homogeneous cylindrical phantom resulted in average deviation of (0.1 ± 2.14%) with Eclipse TPS calculated dose and (-2.0 ± 1.66%) with absolute measured dose. PTW's OCTAVIUS-4D phantom with 729 ion chamber detector array measurements agreed well with Eclipse TPS calculated dose showing an average deviation of (-1.69 ± 1.56%). Diamond SCS dose calculations were performed with heterogeneity corrections for 124 VMAT plans with isocentre at a region above -350 HU. The overall MU variations between Diamond SCS and TPS Acuros-XB algorithms were within ±5%. Hence, the Diamond SCS can be used as an additional tool along with phantom measurements for patient specific quality assurance of VMAT plans with heterogeneity corrections having isocentre at a region above -350 HU.

  1. ESPEN diagnostic criteria for malnutrition - A validation study in hospitalized patients.

    Science.gov (United States)

    Guerra, Rita S; Fonseca, Isabel; Sousa, Ana S; Jesus, Alison; Pichel, Fernando; Amaral, Teresa F

    2017-10-01

    The European Society for Clinical Nutrition and Metabolism (ESPEN) released a consensus statement for undernutrition diagnosis: ESPEN diagnostic criteria for malnutrition (EDC). The EDC lacks validation and therefore, the present study aims to assess the concurrent and predictive validity of this tool in a cohort of inpatients. A prospective observational study took place in a university hospital. Concurrent validity of EDC was evaluated using the Patient Generated Subjective Global Assessment (PG-SGA) nutrition status classification as the reference method. Sensitivity, specificity, positive and negative predictive values were determined. The EDC predictive validity was assessed by its independent association with length of hospital stay (LOS), applying Cox proportional hazards ratio method. Of the 632 included patients, 455 participants (72%) were nutritionally-at-risk (Nutritional Risk Screening initial screening). For those that had screened positive, 260 (57.1%) and 55 participants (12.1%) were undernourished according to PG-SGA and to EDC, respectively. Compared to PG-SGA, the EDC revealed a sensitivity of 17.1% and a specificity of 98.3%. Positive and negative predictive values were respectively 89.1% and 58.9%. Undernutrition evaluated by EDC was independently associated with lower hazard ratio for being discharged home over time, 0.695 (95% confidence interval: 0.509; 0.950). The EDC could be used in clinical settings to confirm undernutrition suggested by other methods. The independent association of undernutrition by EDC with LOS shows this method is of clinical relevance. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  2. Formal Logic and Flowchart for Diagnosis Validity Verification and Inclusion in Clinical Decision Support Systems

    Science.gov (United States)

    Sosa, M.; Grundel, L.; Simini, F.

    2016-04-01

    Logical reasoning is part of medical practice since its origins. Modern Medicine has included information-intensive tools to refine diagnostics and treatment protocols. We are introducing formal logic teaching in Medical School prior to Clinical Internship, to foster medical practice. Two simple examples (Acute Myocardial Infarction and Diabetes Mellitus) are given in terms of formal logic expression and truth tables. Flowcharts of both diagnostic processes help understand the procedures and to validate them logically. The particularity of medical information is that it is often accompanied by “missing data” which suggests to adapt formal logic to a “three state” logic in the future. Medical Education must include formal logic to understand complex protocols and best practices, prone to mutual interactions.

  3. Biomarker validation in the emergency department. General criteria and clinical implications

    Directory of Open Access Journals (Sweden)

    Giuseppe Lippi

    2014-03-01

    Full Text Available The routine use of biomarkers, which is also rapidly expanding in the emergency department, carries some potential drawbacks such as the risk of producing false positive results and also places a substantial economical burden on the healthcare system, especially when the use of laboratory resources is poorly discretionary or even inappropriate. The aim of this article is to provide an overview about some general criteria for biomarker validation in the emergency department, and discuss some relevant clinical implications. The leading aspects include analysis of data distribution and diagnostic performance, along with economical and organizational issues. We also brought a pragmatic example, comparing creatine kinase MB, a contemporary-sensitive troponin I and a high-sensitivity troponin I immunoassays for evaluation of patients with suspected acute myocardial infarction at emergency department admission.

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

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    Thomas D Parsons

    2015-12-01

    Full Text Available 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.

  5. 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.

  6. 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

  7. 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 Maas

  8. Validation of Clinical Tools for Vaginal and Vulvar Symptom Assessment in Cancer Patients and Survivors.

    Science.gov (United States)

    Eaton, Anne A; Baser, Raymond E; Seidel, Barbara; Stabile, Cara; Canty, Jocelyn P; Goldfrank, Deborah J; Carter, Jeanne

    2017-01-01

    Health care professionals can play a pivotal role in promoting vulvovaginal health through assessment and appropriate intervention. To develop and validate brief clinical measurements to facilitate the identification of vulvovaginal symptoms in patients with and survivors of cancer. One hundred seventy-five women survivors of cancer attending a Female Sexual Medicine and Women's Health Program from September 26, 2012 through October 31, 2014 completed the Vaginal Assessment Scale (VAS) and the Vulvar Assessment Scale (VuAS)-a modified version of the VAS that targets vulvar symptoms. Pelvic examination results were recorded using a clinical examination checklist. Internal consistency of the two scales was assessed using Cronbach α, and the correlation between scales and other outcomes was reported. The internal consistency measurements of the VAS and VuAS at the first visit were 0.70 and 0.68, which decreased to 0.53 and 0.66 at the last visit. The VAS composite and VuAS composite scores were moderately correlated with each other (0.42 and 0.45 at first and last visits, respectively). A strong correlation was observed between VAS pain with intercourse and Female Sexual Function Index (FSFI) pain with intercourse (-0.63 and -0.71 at the first and last visits, respectively). Worse pain with examination, worse functioning on the FSFI pain, lubrication, and total scores, and worse vulvar irritation were correlated with more severe symptoms on the VAS and VuAS. The VAS and VuAS are simple tools that can be used by clinicians to assess health concerns in women diagnosed with and treated for cancer. Validation is needed across diverse settings and groups of women. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

  9. Improving the external validity of clinical trials: the case of multiple chronic conditions

    Directory of Open Access Journals (Sweden)

    Martin Fortin

    2013-12-01

    Full Text Available The U.S. Department of Health and Human Services vision and strategic framework on multiple chronic conditions (MCCs incorporates recommendations designed to facilitate research that will improve our knowledge about interventions and systems that will benefit individuals with MCCs (or multimorbidity. The evidence base supporting the management of patients with MCCs will be built both through intervention trials specifically designed to address multimorbidity and identification of MCCs in participants across the clinical trial range. This article specifically focuses on issues relating to external validity with specific reference to trials involving patients with MCCs. The exclusion of such patients from clinical trials has been well documented. Randomized control trials (RCTs are considered the “gold standard” of evidence, but may have drawbacks in relation to external validity, particularly in relation to multimorbidity. It may, therefore, be necessary to consider a broader range of research methods that can provide converging evidence on intervention effects to address MCCs. Approaches can also be taken to increase the usefulness of RCTs in general for providing evidence to inform multimorbidity management. Additional improvements to RCTs would include better reporting of inclusion and exclusion criteria and participant characteristics in relation to MCCs. New trials should be considered in terms of how they will add to the existing evidence base and should inform how interventions may work in different settings and patient groups. Research on treatments and interventions for patients with MCCs is badly needed. It is important that this research includes patient-centered measures and that generalizability issues be explicitly addressed.

  10. Validity and reliability of a novel written examination to assess knowledge and clinical decision making skills of medical students on the surgery clerkship.

    Science.gov (United States)

    Reinert, Anna; Berlin, Ana; Swan-Sein, Aubrie; Nowygrod, Roman; Fingeret, Abbey

    2014-02-01

    The Surgery Clerkship Clinical Skills Examination (CSE) is a novel written examination developed to assess the surgical knowledge, clinical decision making, communication skills, and professionalism of medical students on the surgery clerkship. This study was undertaken to determine its validity. Data were prospectively collected from July 2011 through February 2013. Multivariate linear and logistic regression analyses were used to assess score trend; convergent validity with National Board of Medical Examiners surgery and medicine subject scores, United States Medical Licensing Examination Step 1 and Step 2 Clinical Knowledge scores, and evaluation of clinical reasoning and fund of knowledge; and the effect of clerkship order. Exam reliability was assessed using a modified Cronbach's α statistic. During the study period, 262 students completed the CSE, with a normal distribution of performance. United States Medical Licensing Examination Step 2 Clinical Knowledge score and end-of-clerkship evaluations of fund of knowledge and clinical reasoning predicted CSE score. Performance on the CSE was independent of clerkship order or prior clerkships. The modified Cronbach's α value for the exam was .67. The CSE is an objective, valid, reliable instrument for assessing students on the surgery clerkship, independent of clerkship order. Copyright © 2014 Elsevier Inc. All rights reserved.

  11. Conceptualizing and Validating Marital Quality in Beijing: A Pilot Study.

    Science.gov (United States)

    Zhang, Huiping; Xu, Xiaohe; Tsang, Sandra K M

    2013-08-01

    Since the inception of the economic reform, marital relationship in urban China has undergone dramatic transformations. Though the burgeoning body of scholarly research has demonstrated that marital quality has increasingly become an important aspect of family life among married persons in urban China, both the conceptualization and measurement of marital quality remain underdeveloped. The purpose of this pilot study is to develop and validate a comprehensive and culturally appropriate marital quality scale, namely the Chinese Marital Quality Scale (CMQS). Results from the confirmatory factor analysis (CFA) conducted on a sample of 387 married persons from Beijing indicate that the CMQS can be conceptualized as a two-factorial and multidimensional construct, encompassing marital happiness, marital interaction, marital disagreement, marital problem, and marital instability. Additional statistical analyses also indicate that the CMQS has exhibited satisfactory reliability and concurrent validity. It is thus concluded that the CMQS is a reliable and valid instrument to measure marital quality in contemporary Beijing and possibly in other Chinese cities.

  12. Rivaroxaban real-world evidence: Validating safety and effectiveness in clinical practice.

    Science.gov (United States)

    Beyer-Westendorf, Jan; Camm, A John; Coleman, Craig I; Tamayo, Sally

    2016-09-28

    Randomised controlled trials (RCTs) are considered the gold standard of clinical research as they use rigorous methodologies, detailed protocols, pre-specified statistical analyses and well-defined patient cohorts. However, RCTs do not take into account the complexity of real-world clinical decision-making. To tackle this, real-world data are being increasingly used to evaluate the long-term safety and effectiveness of a given therapy in routine clinical practice and in patients who may not be represented in RCTs, addressing key clinical questions that may remain. Real-world evidence plays a substantial role in supporting the use of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) in clinical practice. By providing data on patient profiles and the use of anticoagulation therapies in routine clinical practice, real-world evidence expands the current awareness of NOACs, helping to ensure that clinicians are well-informed on their use to implement patient-tailored clinical decisions. There are various issues with current anticoagulation strategies, including under- or overtreatment and frequent monitoring with VKAs. Real-world studies have demonstrated that NOAC use is increasing (Dresden NOAC registry and Global Anticoagulant Registry in the FIELD-AF [GARFIELD-AF]), as well as reaffirming the safety and effectiveness of rivaroxaban previously observed in RCTs (XArelto on preveNtion of sTroke and non-central nervoUS system systemic embolism in patients with non-valvular atrial fibrillation [XANTUS] and IMS Disease Analyzer). This article will describe the latest updates in real-world evidence across a variety of methodologies, such as non-interventional studies (NIS), registries and database analyses studies. It is anticipated that these studies will provide valuable clinical insights into the management of thromboembolism, and enhance the current knowledge on anticoagulant use and outcomes for patients.

  13. Metaanalysis of Validity Studies Published Between 1964 and 1982 and the Investigation of Study Characteristics.

    Science.gov (United States)

    Schmitt, Neal; And Others

    1984-01-01

    Reviewed published validation studies for the years 1964-1982 of the Journal of Applied Psychology and Personnel Psychology. Results indicated minimal differences across study designs in the average validity coefficient and found selection ratios, standard deviations, reliabilities, predictor and criterion intercorrelations to be rarely and…

  14. A validation study of a new nasogastric polyfunctional catheter.

    Science.gov (United States)

    Chiumello, D; Gallazzi, E; Marino, A; Berto, V; Mietto, C; Cesana, B; Gattinoni, L

    2011-05-01

    Pleural and abdominal pressure are clinically estimated by measuring the esophageal and bladder or intragastric pressure (IGP), respectively. A new nasogastric polyfunctional catheter is now commercially available, equipped with two balloons in the lower and distal part; this catheter allows simultaneous esophageal pressure (Pes) and IGP measurements and can be also used to feed the patient. We compared the Pes and IGP measured using this new device with those obtained with a standard balloon catheter taken as gold standard. Twenty-four intubated patients requiring ventilator support (mean age 64.3 ± 16.8 years, body mass index 25.3 ± 3.0 kg/m(2), and PaO(2)/FiO(2) 280.8 ± 123.4 mmHg) were enrolled. Esophageal pressure and IGP were measured with the new nasogastric polyfunctional catheter (Nutrivent, Sidam, Italy) and with a standard balloon catheter (Smart Cath Viasys, USA). The Smart Cath was first inserted in the stomach and then retracted to the esophagus to measure IGP and Pes, respectively. In each patient two paired measurements were averaged. In the Bland-Altman analysis, the bias and agreement bands for Pes, ΔPes (computed as the difference of esophageal pressure between end-inspiration and expiration), and IGP were -0.25 (-2.65 to +2.15), 0.0 (-0.9 to +0.9), and -0.45 (-2.85 to + 1.95) cmH(2)O, respectively. No side effects or complications were recorded. The new polyfunctional catheter showed a clinically acceptable validity in recording esophageal and intragastric pressure. This device should help physicians to better individualize the clinical patient management.

  15. Histological Validity and Clinical Evidence for Use of Fractional Lasers for Acne Scars

    Science.gov (United States)

    Sardana, Kabir; Garg, Vijay K; Arora, Pooja; Khurana, Nita

    2012-01-01

    Though fractional lasers are widely used for acne scars, very little clinical or histological data based on the objective clinical assessment or the depth of penetration of lasers on in vivo facial tissue are available. The depth probably is the most important aspect that predicts the improvement in acne scars but the studies on histology have little uniformity in terms of substrate (tissue) used, processing and stains used. The variability of the laser setting (dose, pulses and density) makes comparison of the studies difficult. It is easier to compare the end results, histological depth and clinical results. We analysed all the published clinical and histological studies on fractional lasers in acne scars and analysed the data, both clinical and histological, by statistical software to decipher their significance. On statistical analysis, the depth was found to be variable with the 1550-nm lasers achieving a depth of 679 μm versus 10,600 nm (895 μm) and 2940 nm (837 μm) lasers. The mean depth of penetration (in μm) in relation to the energy used, in millijoules (mj), varies depending on the laser studied. This was statistically found to be 12.9–28.5 for Er:glass, 3–54.38 for Er:YAG and 6.28–53.66 for CO2. The subjective clinical improvement was a modest 46%. The lack of objective evaluation of clinical improvement and scar-specific assessment with the lack of appropriate in vivo studies is a case for combining conventional modalities like subcision, punch excision and needling with fractional lasers to achieve optimal results. PMID:23060702

  16. Histological validity and clinical evidence for use of fractional lasers for acne scars

    Directory of Open Access Journals (Sweden)

    Kabir Sardana

    2012-01-01

    Full Text Available Though fractional lasers are widely used for acne scars, very little clinical or histological data based on the objective clinical assessment or the depth of penetration of lasers on in vivo facial tissue are available. The depth probably is the most important aspect that predicts the improvement in acne scars but the studies on histology have little uniformity in terms of substrate (tissue used, processing and stains used. The variability of the laser setting (dose, pulses and density makes comparison of the studies difficult. It is easier to compare the end results, histological depth and clinical results. We analysed all the published clinical and histological studies on fractional lasers in acne scars and analysed the data, both clinical and histological, by statistical software to decipher their significance. On statistical analysis, the depth was found to be variable with the 1550-nm lasers achieving a depth of 679 μm versus 10,600 nm (895 μm and 2940 nm (837 μm lasers. The mean depth of penetration (in μm in relation to the energy used, in millijoules (mj, varies depending on the laser studied. This was statistically found to be 12.9-28.5 for Er:glass, 3-54.38 for Er:YAG and 6.28-53.66 for CO 2 . The subjective clinical improvement was a modest 46%. The lack of objective evaluation of clinical improvement and scar-specific assessment with the lack of appropriate in vivo studies is a case for combining conventional modalities like subcision, punch excision and needling with fractional lasers to achieve optimal results.

  17. A Big Five facet analysis of a psychopath: The validity of the HDS mischievous scale of sub-clinical psychopathy.

    Science.gov (United States)

    Furnham, Adrian; Crump, John

    2016-04-01

    Around 5,700 British adults completed the NEO-PI-R, which measures the Big Five Personality factors at the Domain and the Facet level, as well as the Hogan Development Survey (HDS); measure of Anti-Social Personality Disorder called Mischievous. Previous work in this field has used clinical measures of psychopathy and either student or patient samples. This sought to validate this measure by comparing NEO facet correlational results with other studies. The Mischievous score from the HDS was the criterion variable in the correlations and multiple regressions. Mischievous people were Disagreeable, Stable, Extraverts, lacking in Conscientiousness. Facet analysis showed them high on Excitement-seeking but low of Straightforwardness, Anxiety and Deliberation. Limitations are of the study are discussed.

  18. Validation and reproducibility assessment of modality independent elastography in a pre-clinical model of breast cancer

    Science.gov (United States)

    Weis, Jared A.; Kim, Dong K.; Yankeelov, Thomas E.; Miga, Michael I.

    2014-03-01

    Clinical observations have long suggested that cancer progression is accompanied by extracellular matrix remodeling and concomitant increases in mechanical stiffness. Due to the strong association of mechanics and tumor progression, there has been considerable interest in incorporating methodologies to diagnose cancer through the use of mechanical stiffness imaging biomarkers, resulting in commercially available US and MR elastography products. Extension of this approach towards monitoring longitudinal changes in mechanical properties along a course of cancer therapy may provide means for assessing early response to therapy; therefore a systematic study of the elasticity biomarker in characterizing cancer for therapeutic monitoring is needed. The elastography method we employ, modality independent elastography (MIE), can be described as a model-based inverse image-analysis method that reconstructs elasticity images using two acquired image volumes in a pre/post state of compression. In this work, we present preliminary data towards validation and reproducibility assessment of our elasticity biomarker in a pre-clinical model of breast cancer. The goal of this study is to determine the accuracy and reproducibility of MIE and therefore the magnitude of changes required to determine statistical differences during therapy. Our preliminary results suggest that the MIE method can accurately and robustly assess mechanical properties in a pre-clinical system and provide considerable enthusiasm for the extension of this technique towards monitoring therapy-induced changes to breast cancer tissue architecture.

  19. Shortened questionnaires to assess anxiety and depression during in-hospital rehabilitation: clinical validation and cutoff scores

    Directory of Open Access Journals (Sweden)

    Bertolotti G

    2016-10-01

    Full Text Available Giorgio Bertolotti,1 Loretta Moroni,1 Roberto Burro,2 Antonio Spanevello,3 Roberto FE Pedretti,4 Giandomenico Giorgetti5 1Psychology Unit, Salvatore Maugeri Foundation, IRCCS, Scientific Institute, Tradate, 2Department of Human Sciences – University of Verona, Verona, 3Department of Cardiology, 4Division of Pulmonary Disease, 5Department of Neuromotor Rehabilitation, Salvatore Maugeri Foundation, IRCCS, Scientific Institute of Tradate, Italy Background: A postacute phase needs reliable routine screening instruments in order to identify the patients to be referred for a clinical interview with a psychologist. The aim of this study was to estimate the clinical cutoff scores of the anxiety and depression questionnaires and their clinical validity using a gold standard. Methods: The study involved 177 patients with pulmonary, cardiac, or neurological disease undergoing in-hospital rehabilitation. Receiver operating characteristic curves were used to determine the best concordance between questionnaire’s scores and the gold standards. Results: There was a significant difference (P<0.001 between clinically anxious and depressed patients and nonclinical subjects. The receiver operating characteristic curve for anxiety indicated that the best area under the curve for State Anxiety Inventory is obtained with a cutoff point of 21 for males and 25 for females; for depression scores, the highest area under the curve for Depression Questionnaire-Reduced Form is obtained with a cutoff point of six for males and eight for females. Conclusion: Using appropriate cutoff values, the State Anxiety Inventory and Depression Questionnaire-Reduced Form allow psychologists to optimize early clinical intervention strategies selecting patients with significant needs. Keywords: anxiety, depression, questionnaire, sensitivity and specificity, rehabilitation

  20. 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.

  1. 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 OBJECTIVE: 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. DESIGN: Prospective Study. ANIMALS: 222 dogs with osteoarthritis. PROCEDURE: 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. RESULTS: 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. CONCLUSION AND CLINICAL RELEVANCE: 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.

  2. Annotations on Mexico's WISC-IV: a validity study.

    Science.gov (United States)

    Fina, Anthony D; Sánchez-Escobedo, Pedro; Hollingworth, Liz

    2012-01-01

    This project seeks to provide evidence on the internal structure of the Escala Wechsler de Inteligencia para Niños-IV (EWIN-IV; Wechsler, 2007a ) through a confirmatory factor analysis and intercorrelational study. Also provided is information on the adaptation process and other sources of validity evidence in support of the EWIN-IV norms. The standardization data for the EWIN-IV were used for all analyses. The factor loadings and correlational patterns found on the EWIN-IV are comparable to those seen in the American versions of the test. The proposed factor and scoring structure of the EWIN-IV was supported.

  3. Poor replication validity of biomedical association studies reported by newspapers

    Science.gov (United States)

    Smith, Andy; Boraud, Thomas; Gonon, François

    2017-01-01

    Objective To investigate the replication validity of biomedical association studies covered by newspapers. Methods We used a database of 4723 primary studies included in 306 meta-analysis articles. These studies associated a risk factor with a disease in three biomedical domains, psychiatry, neurology and four somatic diseases. They were classified into a lifestyle category (e.g. smoking) and a non-lifestyle category (e.g. genetic risk). Using the database Dow Jones Factiva, we investigated the newspaper coverage of each study. Their replication validity was assessed using a comparison with their corresponding meta-analyses. Results Among the 5029 articles of our database, 156 primary studies (of which 63 were lifestyle studies) and 5 meta-analysis articles were reported in 1561 newspaper articles. The percentage of covered studies and the number of newspaper articles per study strongly increased with the impact factor of the journal that published each scientific study. Newspapers almost equally covered initial (5/39 12.8%) and subsequent (58/600 9.7%) lifestyle studies. In contrast, initial non-lifestyle studies were covered more often (48/366 13.1%) than subsequent ones (45/3718 1.2%). Newspapers never covered initial studies reporting null findings and rarely reported subsequent null observations. Only 48.7% of the 156 studies reported by newspapers were confirmed by the corresponding meta-analyses. Initial non-lifestyle studies were less often confirmed (16/48) than subsequent ones (29/45) and than lifestyle studies (31/63). Psychiatric studies covered by newspapers were less often confirmed (10/38) than the neurological (26/41) or somatic (40/77) ones. This is correlated to an even larger coverage of initial studies in psychiatry. Whereas 234 newspaper articles covered the 35 initial studies that were later disconfirmed, only four press articles covered a subsequent null finding and mentioned the refutation of an initial claim. Conclusion Journalists

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

    Science.gov (United States)

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

    2016-12-01

    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 (60mer) 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.

  5. Clinical Validation of a Smartphone-Based Adapter for Optic Disc Imaging in Kenya.

    Science.gov (United States)

    Bastawrous, Andrew; Giardini, Mario Ettore; Bolster, Nigel M; Peto, Tunde; Shah, Nisha; Livingstone, Iain A T; Weiss, Helen A; Hu, Sen; Rono, Hillary; Kuper, Hannah; Burton, Matthew

    2016-02-01

    Visualization and interpretation of the optic nerve and retina are essential parts of most physical examinations. To design and validate a smartphone-based retinal adapter enabling image capture and remote grading of the retina. This validation study compared the grading of optic nerves from smartphone images with those of a digital retinal camera. Both image sets were independently graded at Moorfields Eye Hospital Reading Centre. Nested within the 6-year follow-up (January 7, 2013, to March 12, 2014) of the Nakuru Eye Disease Cohort in Kenya, 1460 adults (2920 eyes) 55 years and older were recruited consecutively from the study. A subset of 100 optic disc images from both methods were further used to validate a grading app for the optic nerves. Data analysis was performed April 7 to April 12, 2015. Vertical cup-disc ratio for each test was compared in terms of agreement (Bland-Altman and weighted κ) and test-retest variability. A total of 2152 optic nerve images were available from both methods (also 371 from the reference camera but not the smartphone, 170 from the smartphone but not the reference camera, and 227 from neither the reference camera nor the smartphone). Bland-Altman analysis revealed a mean difference of 0.02 (95% CI, -0.21 to 0.17) and a weighted κ coefficient of 0.69 (excellent agreement). The grades of an experienced retinal photographer were compared with those of a lay photographer (no health care experience before the study), and no observable difference in image acquisition quality was found. Nonclinical photographers using the low-cost smartphone adapter were able to acquire optic nerve images at a standard that enabled independent remote grading of the images comparable to those acquired using a desktop retinal camera operated by an ophthalmic assistant. The potential for task shifting and the detection of avoidable causes of blindness in the most at-risk communities makes this an attractive public health intervention.

  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. Geographic literacy perception scale (GLPS validity and reliability study

    Directory of Open Access Journals (Sweden)

    Yurdal Dikmenli

    2014-04-01

    Full Text Available Geographic literacy could be defined as the competence of turning understanding and comprehension of geographical knowledge into a skill because literacy consists of solving problems, reasoning, critical and creative thinking processes. Today, in order to impart literacy skills to individuals, teachers should first have these skills. It is important that teacher candidates should attain these skills before graduation. When these conditions are established, it will be easier for teacher candidates to be aware of their geographic literacy skills, bring these competences to a conscious level and contribute to students’ geographic literacy skills and processes in their professional lives. The main purpose of this study is to develop an attitude scale in order to specify teacher candidates’ geographic literacy perception levels. The study group of the research consisted of 473 teacher candidates. In order to detect the validity of the scale, exploratory factor analyses, item factor total correlations and item discriminations were conducted. In order to assess the reliability of the scale, the level of internal consistency and stability levels were calculated. The analyses provided evidence that the Geographic Literacy Perception Scale (GLPS is a valid and reliable scale that can be used in order to determine geographic literacy levels

  8. Use of wearable technology for performance assessment: a validation study.

    Science.gov (United States)

    Papi, Enrica; Osei-Kuffour, Denise; Chen, Yen-Ming A; McGregor, Alison H

    2015-07-01

    The prevalence of osteoarthritis is increasing globally but current compliance with rehabilitation remains poor. This study explores whether wearable sensors can be used to provide objective measures of performance with a view to using them as motivators to aid compliance to osteoarthritis rehabilitation. More specifically, the use of a novel attachable wearable sensor integrated into clothing and inertial measurement units located in two different positions, at the waist and thigh pocket, was investigated. Fourteen healthy volunteers were asked to complete exercises adapted from a knee osteoarthritis rehabilitation programme whilst wearing the three sensors including five times sit-to-stand test, treadmill walking at slow, preferred and fast speeds. The performances of the three sensors were validated against a motion capture system and an instrumented treadmill. The systems showed a high correlation (r(2) > 0.7) and agreement (mean difference range: -0.02-0.03 m, 0.005-0.68 s) with gold standards. The novel attachable wearable sensor was able to monitor exercise tasks as well as the inertial measurement units (ICC > 0.95). Results also suggested that a functional placement (e.g., situated in a pocket) is a valid position for performance monitoring. This study shows the potential use of wearable technologies for assessing subject performance during exercise and suggests functional solutions to enhance acceptance.

  9. Assessing interpersonal aspects of schizoid personality disorder: preliminary validation studies.

    Science.gov (United States)

    Kosson, David S; Blackburn, Ronald; Byrnes, Katherine A; Park, Sohee; Logan, Caroline; Donnelly, John P

    2008-03-01

    In 2 studies, we examined the reliability and validity of an interpersonal measure of schizoid personality disorder (SZPD) based on nonverbal behaviors and interpersonal interactions occurring during interviews. A total of 556 male jail inmates in the United States participated in Study 1; 175 mentally disordered offenders in maximum security hospitals in the United Kingdom participated in Study 2. Across both samples, scores on the Interpersonal Measure of Schizoid Personality Disorder (IM-SZ) exhibited adequate reliability and patterns of correlations with other measures consistent with expectations. The scale displayed patterns of relatively specific correlations with interview and self-report measures of SZPD. In addition, the IM-SZ correlated in an expected manner with features of psychopathy and antisocial personality and with independent ratings of interpersonal behavior. We address implications for assessment of personality disorder.

  10. Characterization of artificial spherical particles for DEM validation studies

    Institute of Scientific and Technical Information of China (English)

    Ignazio Cavarretta; Catherine O'Sullivan; Erdin Ibraim; Martin Lings; Simon Hamlin; David Muir Wood

    2012-01-01

    This paper describes a study in which advanced particle-scale characterization was carried out on spherical particles that can be used in experimental tests to validate discrete element method (DEM) simulations,Two types of particle,alkaline and borosilicate glass heads,made from two different materials,were considered.The particle shape,stiffness,contact friction properties and surface roughness were measured.The influences of hardness and roughness on the mechanical response of the particles were carefully considered.Compared to the alkaline beads,the borosilicate beads were more spherical and more uniform in size,and they exhibited mechanical characteristics closer to natural quartz sand.While only two material types were studied,the work has the broader implication as a methodology for selecting particles suitable for use in DEM studies and the key parameters that should be considered in the selection process are highlighted.

  11. Monte Carlo model of the Studsvik BNCT clinical beam: description and validation.

    Science.gov (United States)

    Giusti, Valerio; Munck af Rosenschöld, Per M; Sköld, Kurt; Montagnini, Bruno; Capala, Jacek

    2003-12-01

    The neutron beam at the Studsvik facility for boron neutron capture therapy (BNCT) and the validation of the related computational model developed for the MCNP-4B Monte Carlo code are presented. Several measurements performed at the epithermal neutron port used for clinical trials have been made in order to validate the Monte Carlo computational model. The good general agreement between the MCNP calculations and the experimental results has provided an adequate check of the calculation procedure. In particular, at the nominal reactor power of 1 MW, the calculated in-air epithermal neutron flux in the energy interval between 0.4 eV-10 keV is 3.24 x 10(9) n cm(-2) s(-1) (+/- 1.2% 1 std. dev.) while the measured value is 3.30 x 10(9) n cm(-20 s(-1) (+/- 5.0% 1 std. dev.). Furthermore, the calculated in-phantom thermal neutron flux, equal to 6.43 x 10(9) n cm(-2) s(-1) (+/- 1.0% 1 std. dev.), and the corresponding measured value of 6.33 X 10(9) n cm(-2) s(-1) (+/- 5.3% 1 std. dev.) agree within their respective uncertainties. The only statistically significant disagreement is a discrepancy of 39% between the MCNP calculations of the in-air photon kerma and the corresponding experimental value. Despite this, a quite acceptable overall in-phantom beam performance was obtained, with a maximum value of the therapeutic ratio (the ratio between the local tumor dose and the maximum healthy tissue dose) equal to 6.7. The described MCNP model of the Studsvik facility has been deemed adequate to evaluate further improvements in the beam design as well as to plan experimental work.

  12. 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.

  13. 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.

  14. [Validation study of the implicit theories of intelligence scale].

    Science.gov (United States)

    Da Fonseca, D; Schiano-Lomoriello, S; Cury, F; Poinso, F; Rufo, M; Therme, P

    2007-09-01

    According to several authors, it seems that beliefs about the nature of intelligence have a very powerful impact on behavior in learning situations. These implicit theories of intelligence create a meaning system or conceptual framework that influences the individuals interpretation of school situations. Thus, an entity theory of intelligence is the belief that intelligence is a fixed trait, a personal quality that cannot be changed. Students who subscribe to this theory believe that although people can learn new things, their underlying intelligence remains the same. In contrast, an incremental theory of intelligence is the belief that intelligence is a malleable quality that can increase through efforts. This paper presents the development and the validation of the Implicit Theories Of Intelligence scale (TIDI) for French teenagers. Most of the studies attest the validity of the scales measuring the implicit theories of the intelligence. The instrument used by the authors include 3 items assessing the entity theory. Recently, theoretical debates suggested to measure within a single questionnaire both theories at the same time. Moreover, there is no instrument in French language which measures the implicit theories of the intelligence. Two studies have been conducted. The purpose of the first study was to test the factorial validity and the internal consistency of the scale. The goal of the second study was to test the temporal stability of the instrument. STUDY 1: This study describes the procedures used to create the TIDI, the internal consistency and the factorial validity. This instrument was composed of two subscales of three items assessing incremental theory of the intelligence and entity theory of the intelligence. French teenagers (n=453) aged 11 to 16 years completed the questionnaire during a lecture. Cronbach's alpha was 0.81 for the scale assessing incremental theory and 0.78 for the scale assessing entity theory. Confirmatory factor analysis was

  15. 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.

  16. The modified patient enablement instrument: a Portuguese cross-cultural adaptation, validity and reliability study.

    Science.gov (United States)

    Remelhe, Mafalda; Teixeira, Pedro M; Lopes, Irene; Silva, Luís; Correia de Sousa, Jaime

    2017-01-12

    Enabling patients with asthma to obtain the knowledge, confidence and skills they need in order to assume a major role in the management of their disease is cost effective. It should be an integral part of any plan for long-term control of asthma. The modified Patient Enablement Instrument (mPEI) is an easily administered questionnaire that was adapted in the United Kingdom to measure patient enablement in asthma, but its applicability in Portugal is not known. Validity and reliability of questionnaires should be tested before use in settings different from those of the original version. The purpose of this study was to test the applicability of the mPEI to Portuguese asthma patients after translation and cross-cultural adaptation, and to verify the structural validity, internal consistency and reproducibility of the instrument. The mPEI was translated to Portuguese and back translated to English. Its content validity was assessed by a debriefing interview with 10 asthma patients. The translated instrument was then administered to a random sample of 142 patients with persistent asthma. Structural validity and internal consistency were assessed. For reproducibility analysis, 86 patients completed the instrument again 7 days later. Item-scale correlations and exploratory factor analysis were used to assess structural validity. Cronbach's alpha was used to test internal consistency, and the intra-class correlation coefficient was used for the analysis of reproducibility. All items of the Portuguese version of the mPEI were found to be equivalent to the original English version. There were strong item-scale correlations that confirmed construct validity, with a one component structure and good internal consistency (Cronbach's alpha >0.8) as well as high test-retest reliability (ICC=0.85). The mPEI showed sound psychometric properties for the evaluation of enablement in patients with asthma making it a reliable instrument for use in research and clinical practice in

  17. Obtaining valid laboratory data in clinical trials conducted in resource diverse settings: lessons learned from a microbicide phase III clinical trial.

    Directory of Open Access Journals (Sweden)

    Tania Crucitti

    Full Text Available BACKGROUND: Over the last decade several phase III microbicides trials have been conducted in developing countries. However, laboratories in resource constrained settings do not always have the experience, infrastructure, and the capacity to deliver laboratory data meeting the high standards of clinical trials. This paper describes the design and outcomes of a laboratory quality assurance program which was implemented during a phase III clinical trial evaluating the efficacy of the candidate microbicide Cellulose Sulfate 6% (CS [1]. METHODOLOGY: In order to assess the effectiveness of CS for HIV and STI prevention, a phase III clinical trial was conducted in 5 sites: 3 in Africa and 2 in India. The trial sponsor identified an International Central Reference Laboratory (ICRL, responsible for the design and management of a quality assurance program, which would guarantee the reliability of laboratory data. The ICRL provided advice on the tests, assessed local laboratories, organized trainings, conducted supervision visits, performed re-tests, and prepared control panels. Local laboratories were provided with control panels for HIV rapid tests and Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG amplification technique. Aliquots from respective control panels were tested by local laboratories and were compared with results obtained at the ICRL. RESULTS: Overall, good results were observed. However, discordances between the ICRL and site laboratories were identified for HIV and CT/NG results. One particular site experienced difficulties with HIV rapid testing shortly after study initiation. At all sites, DNA contamination was identified as a cause of invalid CT/NG results. Both problems were timely detected and solved. Through immediate feedback, guidance and repeated training of laboratory staff, additional inaccuracies were prevented. CONCLUSIONS: Quality control guidelines when applied in field laboratories ensured the reliability and validity

  18. 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

    2010-01-01

    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…

  19. 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

    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. METHOD: 78 patients with mild AD...

  20. Clinical Validation of the Trait and State Versions of the Food Craving Questionnaire

    Science.gov (United States)

    Moreno, Silvia; Rodriguez, Sonia; Fernandez, Mari Carmen; Tamez, Jeannine; Cepeda-Benito, Antonio

    2008-01-01

    This is the first study to evaluate the psychometric properties of the Food Craving Questionnaire-Trait (FCQ-T), and Food Craving Questionnaire-State (FCQ-S) measures using a clinically heterogeneous sample of eating disorder patients (N = 177) recruited from seven different outpatient eating disorder treatment centers in Spain. Confirmatory…

  1. Evaluation of the PharmGKB knowledge base as a resource for efficiently assessing the clinical validity and utility of pharmacogenetic assays.

    Science.gov (United States)

    Kawamoto, Kensaku; Orlando, Lori A; Voora, Deepak; Lobach, David F; Joy, Scott; Cho, Alex; Ginsburg, Geoffrey S

    2009-11-14

    Prior to clinical use, pharmacogenetic tests should be systematically evaluated for their clinical validity and utility. Here, we evaluated whether the publicly available, online Pharmacogenomics Knowledge Base (PharmGKB) could facilitate such assessments by efficiently identifying relevant peer-reviewed manuscripts. The search targets were 55 manuscripts regarding clinical validity and utility included in systematic reviews of warfarin, antidepressant, and irinotecan pharmacogenetics. When direct inclusion in PharmGKB was the search criterion, recall was 33% and precision was 16%. However, recall increased to 78% when citation within a PharmGKB-identified manuscript was added as a search criterion. These recalled manuscripts accounted for 87% of the study subjects, and domain experts determined that the omission of the remaining manuscripts was unlikely to have changed the conclusions of the reviews. Thus, we conclude that PharmGKB can facilitate the systematic assessment of pharmacogenetic assays through the efficient identification of relevant peer-reviewed manuscripts.

  2. Lamb wave Shearwave dispersion ultrasound Vibrometry (SDUV) validation study.

    Science.gov (United States)

    Nenadic, Ivan; Urban, Matthew W; Mitchell, Scott A; Greenleaf, James F

    2010-01-01

    Our group has been investigating the use of Shearwave Dispersion Ultrasound Vibrometry (SDUV) for quantifying viscoelasticity of the myocardium. The primary aim of this study is the design and testing of viscoelastic materials suitable for validation of the Lamb wave model in the heart. The Lamb wave SDUV method was used to measure shear wave velocity dispersion of gelatin and urethane rubber plates in the range 40-500 Hz and estimate the material properties. A finite element model (FEM) of a viscoelastic plate submerged in water was used to study the appropriateness of the Lamb wave dispersion equations. An embedded sphere method was used as an independent measurement of viscoelasticity. The FEM wave velocity dispersion data were in excellent agreement with the theoretical predictions. Elasticity and viscosity of urethane and gelatin obtained using the Lamb wave SDUV and embedded sphere methods agree within one standard deviation.

  3. Development, validation and stability study of pediatric atenolol syrup.

    Science.gov (United States)

    Foppa, T; Murakami, F S; Silva, M A S

    2007-07-01

    Atenolol [4-(2-hydroxy-isopropylaminopropoxy)-phenylacetamide], is a cardioselective beta1-adrenergic receptor blocking agent prescribed for treatment of hypertension, angina pectoris and cardiac arrhythmias. However, most of these medicines are not formulated for easy or accurate administration to children. Atenolol is unstable in solutions and therefore the development of a liquid dosage form is a significant challenge. Studies showed that the degradation rate of atenolol is dependent on the temperature, indicating higher stability at 4 degrees C. Atenolol syrup is stable for 9 days, with acceptable apearance. A second order model adequately described atenolol decomposition when stored as syrup. A stability-indicating method was developed and validated in order to evaluate these studies.

  4. SPORT FAN MOTIVATION QUESTIONNAIRE: A STUDY OF VALIDITY AND RELIABILITY

    Directory of Open Access Journals (Sweden)

    Muhammed Emin KAFKAS

    2012-04-01

    Full Text Available The purpose of this research, Yousof Al-Thibiti (2004 Fan Motivational scale was developed by Turkish adapts and scales to analyze the validity and reliability. The study group was composed that Inonu University studying at different faculty of education between the age of 17-31 494’ü (%54 women and 421’i (%46 male students. Firstly of linguistic equivalence of the scale were examined. Secondly after linguistic equivalence was performed reliability analysis. The total scale internal consistency coefficients for sizes .85 and subscale range of .70-.78, the re-test reliability coefficients were between .79-.89. at the same time, exploratory factor analysis and confirmatory factor analysis is carried out with the scale and found to comply with the data. As a result of scale to measure the status of individuals to participate in sporting activities was found to have an appropriate structure.

  5. The Fast Scattering Code (FSC): Validation Studies and Program Guidelines

    Science.gov (United States)

    Tinetti, Ana F.; Dunn, Mark H.

    2011-01-01

    The Fast Scattering Code (FSC) is a frequency domain noise prediction program developed at the NASA Langley Research Center (LaRC) to simulate the acoustic field produced by the interaction of known, time harmonic incident sound with bodies of arbitrary shape and surface impedance immersed in a potential flow. The code uses the equivalent source method (ESM) to solve an exterior 3-D Helmholtz boundary value problem (BVP) by expanding the scattered acoustic pressure field into a series of point sources distributed on a fictitious surface placed inside the actual scatterer. This work provides additional code validation studies and illustrates the range of code parameters that produce accurate results with minimal computational costs. Systematic noise prediction studies are presented in which monopole generated incident sound is scattered by simple geometric shapes - spheres (acoustically hard and soft surfaces), oblate spheroids, flat disk, and flat plates with various edge topologies. Comparisons between FSC simulations and analytical results and experimental data are presented.

  6. Validation of the Brazilian version of the Clinical Gait and Balance Scale and comparison with the Berg Balance Scale

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    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.

  7. The Development and Validation of a Smartphone Visual Acuity Test (Peek Acuity) for Clinical Practice and Community-Based Fieldwork

    Science.gov (United States)

    Bastawrous, Andrew; Rono, Hillary; Livingstone, Iain AT; Weiss, Helen A.; Jordan, Stewart; Kuper, Hannah; Burton, Matthew

    2017-01-01

    Importance Visual acuity is the most frequently performed measure of visual function in clinical practice and the majority of people worldwide living with visual impairment are living in low and middle-income countries Objective To design and validate a smartphone-based visual acuity test that is not dependent on familiarity with symbols or letters commonly used in the English language. Design Validation study comparing results from smartphone Peek Acuity to Snellen Acuity (clinical normal) and the Early Treatment Diabetic Retinopathy Study (ETDRS) LogMAR chart (reference standard). Setting This study was nested within the six-year follow-up of the Nakuru Eye Disease Cohort in central Kenya. Participants Three hundred adults aged 55 years and above, recruited consecutively from the Nakuru Eye Disease Cohort Study.. Main Outcome(s) and Measure(s) Outcome measures were monocular logarithm of the minimum angle of resolution (LogMAR) visual acuity scores for each test: ETDRS LogMAR, Snellen and Peek. Peek was compared, in terms of test-retest variability (TRV) and measurement time, with that of the Snellen and ETDRS LogMAR chart in participants’ homes and temporary clinic settings in rural Kenya in 2013/2014. Results The 95% confidence limits for TRV of smartphone acuity data were +/-0.033 LogMAR. The mean difference between smartphone and ETDRS and smartphone and Snellen acuity data was 0.07 (95%CI: 0.05-0.09) and 0.08 (95%CI: 0.06-0.10) LogMAR respectively indicating that smartphone acuities agreed well with those of the ETDRS chart and Snellen. The agreement of Peek and ETDRS was greater than Snellen with ETDRS, p=0.08 (95%CI 0.05 to 0.10). The local Kenyan community health care workers readily accepted the Peek Acuity smartphone test; it required minimal training and took no longer than Snellen; 77s vs. 82s (95%CI: 71 – 84s vs. 73 – 91s, p=0.13). Conclusions The study demonstrated that the Peek Acuity smartphone test is capable of accurate and repeatable

  8. Prominent medical journals often provide insufficient information to assess the validity of studies with negative results

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    Dittus Robert S

    2002-09-01

    Full Text Available Abstract Background Physicians reading the medical literature attempt to determine whether research studies are valid. However, articles with negative results may not provide sufficient information to allow physicians to properly assess validity. Methods We analyzed all original research articles with negative results published in 1997 in the weekly journals BMJ, JAMA, Lancet, and New England Journal of Medicine as well as those published in the 1997 and 1998 issues of the bimonthly Annals of Internal Medicine (N = 234. Our primary objective was to quantify the proportion of studies with negative results that comment on power and present confidence intervals. Secondary outcomes were to quantify the proportion of these studies with a specified effect size and a defined primary outcome. Stratified analyses by study design were also performed. Results Only 30% of the articles with negative results comment on power. The reporting of power (range: 15%-52% and confidence intervals (range: 55–81% varied significantly among journals. Observational studies of etiology/risk factors addressed power less frequently (15%, 95% CI, 8–21% than did clinical trials (56%, 95% CI, 46–67%, p Conclusion Prominent medical journals often provide insufficient information to assess the validity of studies with negative results.

  9. 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.)

  10. [Psychometric approach of metacognition: Pilot study in clinical population].

    Science.gov (United States)

    Visinet, A; Soumet-Leman, C; Baptista, A; Bungener, C; Jouvent, R

    2017-04-01

    Metacognition describes the process of thinking about one's own thought processes. This concept was introduced by Flavell in 1979 and has since been widely developed in the cognitive approach to mood and anxiety disorders. As it happens, many recent studies have underlined the links between metacognition and anxio-depressive symptoms, pointing out the interest of assessing its various dimensions. The short form of the Metacognitions Questionnaire is a brief multidimensional measure of a range of metacognitive processes and metacognitive beliefs about worry and cognition relevant to the vulnerability to and the maintenance of emotional disorders. The aim of this study was twofold: firstly to adapt and validate a French version of the short form of the Metacognitions Questionnaire (MCQ-30) and to assess its psychometric properties in a clinical sample, and secondly to investigate metacognitive predictors of anxiety and depression in this sample. The sample included 55 clinical participants (24 men, 31 women, mean age=51.33±14.62) with DSM-IV-TR psychiatric disorders (major depression, bipolar disorder and obsessive-compulsive disorder). Instrument reliability (internal consistency), construct validity (confirmatory factor analysis), and convergent validity were measured. The total score and the five subscale scores were also compared with previous results in non-clinical samples. Reliability analyses indicated that the French version of the MCQ-30 possessed satisfactory internal consistency (Cronbach α=0.84), and confirmatory factor analysis supported the MCQ's original five-factor structure. Correlation with measurements of depression, anxiety and pathological worry demonstrated convergent validity (r=0.62, Pmetacognition, in relation to the anxio-depressive symptomatology and the subsequent management of patients. Copyright © 2016 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

  11. A validation study of a stochastic model of human interaction

    Science.gov (United States)

    Burchfield, Mitchel Talmadge

    The purpose of this dissertation is to validate a stochastic model of human interactions which is part of a developmentalism paradigm. Incorporating elements of ancient and contemporary philosophy and science, developmentalism defines human development as a progression of increasing competence and utilizes compatible theories of developmental psychology, cognitive psychology, educational psychology, social psychology, curriculum development, neurology, psychophysics, and physics. To validate a stochastic model of human interactions, the study addressed four research questions: (a) Does attitude vary over time? (b) What are the distributional assumptions underlying attitudes? (c) Does the stochastic model, {-}N{intlimitssbsp{-infty}{infty}}varphi(chi,tau)\\ Psi(tau)dtau, have utility for the study of attitudinal distributions and dynamics? (d) Are the Maxwell-Boltzmann, Fermi-Dirac, and Bose-Einstein theories applicable to human groups? Approximately 25,000 attitude observations were made using the Semantic Differential Scale. Positions of individuals varied over time and the logistic model predicted observed distributions with correlations between 0.98 and 1.0, with estimated standard errors significantly less than the magnitudes of the parameters. The results bring into question the applicability of Fisherian research designs (Fisher, 1922, 1928, 1938) for behavioral research based on the apparent failure of two fundamental assumptions-the noninteractive nature of the objects being studied and normal distribution of attributes. The findings indicate that individual belief structures are representable in terms of a psychological space which has the same or similar properties as physical space. The psychological space not only has dimension, but individuals interact by force equations similar to those described in theoretical physics models. Nonlinear regression techniques were used to estimate Fermi-Dirac parameters from the data. The model explained a high degree

  12. Cortisol and cortisone ratio in urine: LC-MS/MS method validation and preliminary clinical application.

    Science.gov (United States)

    Antonelli, Giorgia; Artusi, Carlo; Marinova, Mariela; Brugnolo, Laura; Zaninotto, Martina; Scaroni, Carla; Gatti, Rosalba; Mantero, Franco; Plebani, Mario

    2014-02-01

    The determination of urinary cortisol/cortisone ratio is of clinical utility in cases of Cushing's syndrome, apparent mineralocorticoid excess, and also provides information on 11β-hydroxysteroid dehydrogenase (11β-HSD) type 2 activity. It is therefore of utmost importance to ensure accurate cortisol and cortisone measurement and establish appropriate reference ranges. After the isotopic dilution of urine, sample cleanups were obtained with on-line solid-phase extraction and cortisol and cortisone, separated using a Zorbax Eclipse XDB-C18 HPLC analytical column, were analyzed by tandem mass spectrometry with an electrospray ionization source in positive ion mode operation. The method was linear, with concentrations of up to 625 and 1125 nmol/L and lower limit of quantitation (LLOQ) of 5 and 6 nmol/L, for cortisol and cortisone, respectively. Within-run and between-run coefficients of variation were cortisone, respectively. No ion suppression was observed. The non-parametric reference range for the cortisol/cortisone ratio was 0.14-1.09. A simple and sensitive liquid chromatography tandem mass spectrometry method was developed and validated for the measurement of cortisol and cortisone in urine. Our findings indicate that the proposed analytical method is suitable for routine purposes and useful in many pathological conditions.

  13. CLINICAL STUDY OF DUODENAL PERFORATION

    Directory of Open Access Journals (Sweden)

    Sambasiva Rao

    2016-04-01

    Full Text Available BACKGROUND The duodenal injury can pose a formidable challenge to the surgeon and failure to manage it properly may have devastating results. Over the centuries, there was little to offer the patient of acute abdomen beyond cupping, purgation and enemas, all of which did more harm than good. It was not until 1884 that Mikulicz made an attempt to repair a perforation. Recent statistics indicate roughly 10% of population develop gastric or duodenal ulcer in life time. Roughly 1-3% of population above the age of 20 years have some degree of peptic ulcer activity during any annual period. A detailed history with regards to the signs and symptoms of the patient, a meticulous examination, radiological and biochemical investigations help to arrive at a correct preoperative diagnosis. In this study, a sincere effort has been put to understand the demographic patterns, to understand the underlying aetiology and to understand the effectiveness of the standard methods of investigation and treatment in use today. METHODS This is a 24 months prospective study i.e., from September 2011 to September 2013 carried out at Dr. Pinnamaneni Siddhartha Institute of Medical Sciences & Research Foundation. The study included the patients presenting to Dr. Pinnamaneni Siddhartha Institute of Medical Sciences & Research Foundation to emergency ward with signs and symptoms of hollow viscus perforation. The sample size included 30 cases of duodenal perforation. RESULTS Duodenal ulcer perforation commonly occurs in the age group of 30-60 years, but it can occur in any age group. Majority of the patients were male. Smoking and alcohol consumption were risk factors in most cases (53.3% for the causation of duodenal ulcer perforation. Sudden onset of abdominal pain, situated at epigastrium and right hypochondrium was a constant symptom (100%. Vomiting, constipation and fever were not so common. CONCLUSION The emergency surgical management for perforated duodenal ulcer is by

  14. [Adaptive clinical study methodologies in drug development].

    Science.gov (United States)

    Antal, János

    2015-11-29

    The evolution of drug development in human, clinical phase studies triggers the overview of those technologies and procedures which are labelled as adaptive clinical trials. The most relevant procedural and operational aspects will be discussed in this overview from points of view of clinico-methodological aspect.

  15. Clinical validation of three short forms of the Dutch Wechsler Memory Scale – Fourth Edition (WMS-IV-NL) in a mixed clinical sample

    NARCIS (Netherlands)

    Bouman, Z.; Hendriks, M.P.H.; Veld, W.M. van der; Aldenkamp, A.P.; Kessels, R.P.C.

    2016-01-01

    The reliability and validity of three short forms of the Dutch version of the Wechsler Memory Scale–Fourth Edition (WMS-IV-NL) were evaluated in a mixed clinical sample of 235 patients. The short forms were based on the WMS-IV Flexible Approach, that is, a 3-subtest combination (Older Adult Battery

  16. The Structured Clinical Interview for DSM-5 Internet Gaming Disorder: Development and Validation for Diagnosing IGD in Adolescents

    Science.gov (United States)

    Koo, Hoon Jung; Han, Doug Hyun; Park, Sung-Yong

    2017-01-01

    Objective This study aimed to develop and validate a Structured Clinical Interview for Internet Gaming Disorder (SCI-IGD) in adolescents. Methods First, we generated preliminary items of the SCI-IGD based on the information from the DSM-5 literature reviews and expert consultations. Next, a total of 236 adolescents, from both community and clinical settings, were recruited to evaluate the psychometric properties of the SCI-IGD. Results First, the SCI-IGD was found to be consistent over the time period of about one month. Second, diagnostic concordances between the SCI-IGD and clinician's diagnostic impression were good to excellent. The Likelihood Ratio Positive and the Likelihood Ratio Negative estimates for the diagnosis of SCI-IGD were 10.93 and 0.35, respectively, indicating that SCI-IGD was ‘very useful test’ for identifying the presence of IGD and ‘useful test’ for identifying the absence of IGD. Third, SCI-IGD could identify disordered gamers from non-disordered gamers. Conclusion The implications and limitations of the study are also discussed. PMID:28096871

  17. The Structured Clinical Interview for DSM-5 Internet Gaming Disorder: Development and Validation for Diagnosing IGD in Adolescents.

    Science.gov (United States)

    Koo, Hoon Jung; Han, Doug Hyun; Park, Sung-Yong; Kwon, Jung-Hye

    2017-01-01

    This study aimed to develop and validate a Structured Clinical Interview for Internet Gaming Disorder (SCI-IGD) in adolescents. First, we generated preliminary items of the SCI-IGD based on the information from the DSM-5 literature reviews and expert consultations. Next, a total of 236 adolescents, from both community and clinical settings, were recruited to evaluate the psychometric properties of the SCI-IGD. First, the SCI-IGD was found to be consistent over the time period of about one month. Second, diagnostic concordances between the SCI-IGD and clinician's diagnostic impression were good to excellent. The Likelihood Ratio Positive and the Likelihood Ratio Negative estimates for the diagnosis of SCI-IGD were 10.93 and 0.35, respectively, indicating that SCI-IGD was 'very useful test' for identifying the presence of IGD and 'useful test' for identifying the absence of IGD. Third, SCI-IGD could identify disordered gamers from non-disordered gamers. The implications and limitations of the study are also discussed.

  18. on the clinical validity of the maslach burnout inventory and the burnout measure.

    Science.gov (United States)

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

    2001-09-01

    Abstract 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 most widely used burnout instruments; the Maslach Burnout Inventory (MBI) and the Burnout Measure (BM). Two groups were distinguished: a "burned out" group (n = 71) that suffers from work-related neurasthenia (according to ICD-10 criteria), and a "non-burned out" group (n = 68). Results show that: (1) the validity of the three-factor structure of the MBI and the BM is confirmed; (2) burnout can partly be differentiated from other mental syndromes (e.g., anxiety and depression); and (3) two MBI-scales (Emotional Exhaustion and Depersonalization) and one BM-scale (Exhaustion) are able to discriminate between burned out and non-burned out employees. The practical implications of these results are discussed.

  19. Validation of the PHQ-9 as a screening instrument for depression in diabetes patients in specialized outpatient clinics

    Directory of Open Access Journals (Sweden)

    van Steenbergen-Weijenburg Kirsten M

    2010-08-01

    Full Text Available Abstract Background For the treatment of depression in diabetes patients, it is important that depression is recognized at an early stage. A screening method for depression is the patient health questionnaire (PHQ-9. The aim of this study is to validate the 9-item Patient Health Questionnaire (PHQ-9 as a screening instrument for depression in diabetes patients in outpatient clinics. Methods 197 diabetes patients from outpatient clinics in the Netherlands filled in the PHQ-9. Within 2 weeks they were approached for an interview with the Mini Neuropsychiatric Interview. DSM-IV diagnoses of Major Depressive Disorder (MDD were the criterion for which the sensitivity, specificity, positive- and negative predictive values and Receiver Operator Curves (ROC for the PHQ-9 were calculated. Results The cut-off point of a summed score of 12 on the PHQ-9 resulted in a sensitivity of 75.7% and a specificity of 80.0%. Predictive values for negative and positive test results were respectively 93.4% and 46.7%. The ROC showed an area under the curve of 0.77. Conclusions The PHQ-9 proved to be an efficient and well-received screening instrument for MDD in this sample of diabetes patients in a specialized outpatient clinic. The higher cut-off point of 12 that was needed and somewhat lower sensitivity than had been reported elsewhere may be due to the fact that the patients from a specialized diabetes clinic have more severe pathology and more complications, which could be recognized by the PHQ-9 as depression symptoms, while instead being diabetes symptoms.

  20. 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.

    2011-01-01

    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 deiden

  1. 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

    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

  2. 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; Gre