WorldWideScience

Sample records for validate clinically important

  1. Clinical importance of electromagnetic fields

    International Nuclear Information System (INIS)

    Ruppe, I.

    1993-01-01

    The clinical importance of most of the electromagnetic fields is not highly. Mostly they only have thermal effects, produced by energy-absorption. About 1 C increase of whole-body-temperature is valid for tolerable limit. For measuring is used the SAR-Value (Specific Absorption Rate) in W/kg body mass. SAR = 0,8W/kg for the whole body is valid to be safety. For the evaluation of possible other effects of electromagnetic fields the scientific knowledges are till now not sufficient to allow a final statement. That could be impacts of electromagnetic fields to conduction or switch processes in the nerves or brains, in the framwork of cellular regulations, in the genetic reactions are occurig is little, but if is necessary to find it out in scinentific investigations. (orig.) [de

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

    Science.gov (United States)

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

    2016-06-01

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

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

    Science.gov (United States)

    Löfmark, Anna; Mårtensson, Gunilla

    2017-03-01

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

  4. The Validity of Attribute-Importance Measurement: A Review

    NARCIS (Netherlands)

    Ittersum, van K.; Pennings, J.M.E.; Wansink, B.; Trijp, van J.C.M.

    2007-01-01

    A critical review of the literature demonstrates a lack of validity among the ten most common methods for measuring the importance of attributes in behavioral sciences. The authors argue that one of the key determinants of this lack of validity is the multi-dimensionality of attribute importance.

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

    Science.gov (United States)

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

    2010-11-01

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

  6. Validating EHR clinical models using ontology patterns.

    Science.gov (United States)

    Martínez-Costa, Catalina; Schulz, Stefan

    2017-12-01

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

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

    Science.gov (United States)

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

    2017-03-01

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

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

    Science.gov (United States)

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

    2017-08-01

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

  9. 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).

  10. 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.

  11. The validity and clinical utility of purging disorder.

    Science.gov (United States)

    Keel, Pamela K; Striegel-Moore, Ruth H

    2009-12-01

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

  12. Circulating tumor cells: clinical validity and utility.

    Science.gov (United States)

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

    2017-06-01

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

  13. Transition questions in clinical practice - validity and reproducibility

    DEFF Research Database (Denmark)

    Lauridsen, Henrik Hein

    2008-01-01

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

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

    Science.gov (United States)

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

    2013-06-01

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

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

    DEFF Research Database (Denmark)

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

    2002-01-01

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

  16. 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.

  17. Clinical validation of the Tempus xO assay

    Science.gov (United States)

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

    2018-01-01

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

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

    Science.gov (United States)

    Zariffa, Jose; Kramer, John L.K.

    2011-01-01

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

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

    OpenAIRE

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

    2013-01-01

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

  20. Responsiveness and minimal clinically important change

    DEFF Research Database (Denmark)

    Christiansen, David Høyrup; Frost, Poul; Falla, Deborah

    2015-01-01

    Study Design A prospective cohort study nested in a randomized controlled trial. Objectives To determine and compare responsiveness and minimal clinically important change of the modified Constant score (CS) and the Oxford Shoulder Score (OSS). Background The OSS and the CS are commonly used...... to assess shoulder outcomes. However, few studies have evaluated the measurement properties of the OSS and CS in terms of responsiveness and minimal clinically important change. Methods The study included 126 patients who reported having difficulty returning to usual activities 8 to 12 weeks after...... were observed for the CS and the OSS. Minimal clinically important change ROC values were 6 points for the OSS and 11 points for the CS, with upper 95% cutoff limits of 12 and 22 points, respectively. Conclusion The CS and the OSS were both suitable for assessing improvement after decompression surgery....

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

    Emery, Joanne L; Bell, John F

    2009-06-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Francisca Fariña

    2013-01-01

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

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

    Science.gov (United States)

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

    2015-04-01

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

  6. 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

  7. 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

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

    Science.gov (United States)

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

    2013-01-01

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

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

    Science.gov (United States)

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

    2016-10-01

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

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

    DEFF Research Database (Denmark)

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

    2014-01-01

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

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

    NARCIS (Netherlands)

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

    2013-01-01

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

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

    Science.gov (United States)

    2018-01-01

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

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

    Science.gov (United States)

    Park, Seong Ho; Kressel, Herbert Y

    2018-05-28

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

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

    Science.gov (United States)

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

    2017-02-01

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

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

    Science.gov (United States)

    2014-01-01

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

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

    Science.gov (United States)

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

    2018-02-01

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

  17. Listeriosis in Mexico: Clinical and epidemiological importance

    Directory of Open Access Journals (Sweden)

    Gloria Castañeda-Ruelas

    2014-11-01

    Full Text Available Listeriosis is caused by Listeria monocytogenes, an important food-borne disease due to its clinical forms, high mortality rate, and the economic impact in both clinical and food production industries. In Mexico, the lack of epidemiological surveillance systems leads to the need of accurate data on the incidence of listeriosis and its association with food-borne disease. In this paper, we present data about the presence of this bacterium in food, reports related to clinical cases of listeriosis, and information of diseases in which L. monocytogenes may be involved. However, in most of these cases the etiology was not established. Given this, there´s a need to inform and warn the appropriate entities, to define strategies for the mandatory search of L. monocytogenes through the whole food production chain and clinical suspects, for the epidemiological importance and control of listeriosis in Mexico.

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

    Science.gov (United States)

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

    2014-10-01

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

  19. PCR-RFLP on β-tubulin gene for rapid identification of the most clinically important species of Aspergillus.

    Science.gov (United States)

    Nasri, Tuba; Hedayati, Mohammad Taghi; Abastabar, Mahdi; Pasqualotto, Alessandro C; Armaki, Mojtaba Taghizadeh; Hoseinnejad, Akbar; Nabili, Mojtaba

    2015-10-01

    Aspergillus species are important agents of life-threatening infections in immunosuppressed patients. Proper speciation in the Aspergilli has been justified based on varied fungal virulence, clinical presentations, and antifungal resistance. Accurate identification of Aspergillus species usually relies on fungal DNA sequencing but this requires expensive equipment that is not available in most clinical laboratories. We developed and validated a discriminative low-cost PCR-based test to discriminate Aspergillus isolates at the species level. The Beta tubulin gene of various reference strains of Aspergillus species was amplified using the universal fungal primers Bt2a and Bt2b. The PCR products were subjected to digestion with a single restriction enzyme AlwI. All Aspergillus isolates were subjected to DNA sequencing for final species characterization. The PCR-RFLP test generated unique patterns for six clinically important Aspergillus species, including Aspergillus flavus, Aspergillus fumigatus, Aspergillus nidulans, Aspergillus terreus, Aspergillus clavatus and Aspergillus nidulans. The one-enzyme PCR-RFLP on Beta tubulin gene designed in this study is a low-cost tool for the reliable and rapid differentiation of the clinically important Aspergillus species. Copyright © 2015 Elsevier B.V. All rights reserved.

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

    Science.gov (United States)

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

    2014-01-01

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

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

    Science.gov (United States)

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

    2002-07-01

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

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

    Science.gov (United States)

    Mueller, Gerhard; Mylonas, Demetrius; Schumacher, Petra

    2018-04-21

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

  3. Model-based clinical dose optimization for phenobarbital in neonates: An illustration of the importance of data sharing and external validation.

    Science.gov (United States)

    Völler, Swantje; Flint, Robert B; Stolk, Leo M; Degraeuwe, Pieter L J; Simons, Sinno H P; Pokorna, Paula; Burger, David M; de Groot, Ronald; Tibboel, Dick; Knibbe, Catherijne A J

    2017-11-15

    Particularly in the pediatric clinical pharmacology field, data-sharing offers the possibility of making the most of all available data. In this study, we utilize previously collected therapeutic drug monitoring (TDM) data of term and preterm newborns to develop a population pharmacokinetic model for phenobarbital. We externally validate the model using prospective phenobarbital data from an ongoing pharmacokinetic study in preterm neonates. TDM data from 53 neonates (gestational age (GA): 37 (24-42) weeks, bodyweight: 2.7 (0.45-4.5) kg; postnatal age (PNA): 4.5 (0-22) days) contained information on dosage histories, concentration and covariate data (including birth weight, actual weight, post-natal age (PNA), postmenstrual age, GA, sex, liver and kidney function, APGAR-score). Model development was carried out using NONMEM ® 7.3. After assessment of model fit, the model was validated using data of 17 neonates included in the DINO (Drug dosage Improvement in NeOnates)-study. Modelling of 229 plasma concentrations, ranging from 3.2 to 75.2mg/L, resulted in a one compartment model for phenobarbital. Clearance (CL) and volume (V d ) for a child with a birthweight of 2.6kg at PNA day 4.5 was 0.0091L/h (9%) and 2.38L (5%), respectively. Birthweight and PNA were the best predictors for CL maturation, increasing CL by 36.7% per kg birthweight and 5.3% per postnatal day of living, respectively. The best predictor for the increase in V d was actual bodyweight (0.31L/kg). External validation showed that the model can adequately predict the pharmacokinetics in a prospective study. Data-sharing can help to successfully develop and validate population pharmacokinetic models in neonates. From the results it seems that both PNA and bodyweight are required to guide dosing of phenobarbital in term and preterm neonates. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  4. 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.

  5. Construct validity of adolescents' self-reported big five personality traits: importance of conceptual breadth and initial validation of a short measure.

    Science.gov (United States)

    Morizot, Julien

    2014-10-01

    While there are a number of short personality trait measures that have been validated for use with adults, few are specifically validated for use with adolescents. To trust such measures, it must be demonstrated that they have adequate construct validity. According to the view of construct validity as a unifying form of validity requiring the integration of different complementary sources of information, this article reports the evaluation of content, factor, convergent, and criterion validities as well as reliability of adolescents' self-reported personality traits. Moreover, this study sought to address an inherent potential limitation of short personality trait measures, namely their limited conceptual breadth. In this study, starting with items from a known measure, after the language-level was adjusted for use with adolescents, items tapping fundamental primary traits were added to determine the impact of added conceptual breadth on the psychometric properties of the scales. The resulting new measure was named the Big Five Personality Trait Short Questionnaire (BFPTSQ). A group of expert judges considered the items to have adequate content validity. Using data from a community sample of early adolescents, the results confirmed the factor validity of the Big Five structure in adolescence as well as its measurement invariance across genders. More important, the added items did improve the convergent and criterion validities of the scales, but did not negatively affect their reliability. This study supports the construct validity of adolescents' self-reported personality traits and points to the importance of conceptual breadth in short personality measures. © The Author(s) 2014.

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

    Science.gov (United States)

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

    2007-04-01

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

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

    Science.gov (United States)

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

    2014-01-01

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

  8. Cost-effective master cell bank validation of multiple clinical-grade human pluripotent stem cell lines from a single donor.

    Science.gov (United States)

    Devito, Liani; Petrova, Anastasia; Miere, Cristian; Codognotto, Stefano; Blakely, Nicola; Lovatt, Archie; Ogilvie, Caroline; Khalaf, Yacoub; Ilic, Dusko

    2014-10-01

    Standardization guidelines for human pluripotent stem cells are still very broadly defined, despite ongoing clinical trials in the U.S., U.K., and Japan. The requirements for validation of human embryonic (hESCs) and induced pluripotent stem cells (iPSCs) in general follow the regulations for other clinically compliant biologics already in place but without addressing key differences between cell types or final products. In order to realize the full potential of stem cell therapy, validation criteria, methodology, and, most importantly, strategy, should address the shortfalls and efficiency of current approaches; without this, hESC- and, especially, iPSC-based therapy will not be able to compete with other technologies in a cost-efficient way. We addressed the protocols for testing cell lines for human viral pathogens and propose a novel strategy that would significantly reduce costs. It is highly unlikely that the multiple cell lines derived in parallel from a tissue sample taken from one donor would have different profiles of endogenous viral pathogens; we therefore argue that samples from the Master Cell Banks of sibling lines could be safely pooled for validation. We illustrate this approach with tiered validation of two sibling clinical-grade hESC lines, KCL033 and KCL034 (stage 1, sterility; stage 2, specific human pathogens; and stage 3, nonspecific human pathogens). The results of all tests were negative. This cost-effective strategy could also be applied for validation of Master Cell Banks of multiple clinical-grade iPSC lines derived from a single donor. ©AlphaMed Press.

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

    Directory of Open Access Journals (Sweden)

    de Vos Barbara

    2010-11-01

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

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

    NARCIS (Netherlands)

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

    2011-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Birtwhistle Richard

    2003-12-01

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

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

    Science.gov (United States)

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

    2015-04-01

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

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

    Science.gov (United States)

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

    2009-01-30

    This study sought to provide further information about the psychometric properties of the Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD), in a large, international, cross-culturally diverse sample. Six hundred and fourteen patients with PD participated in the study. Apart from the CISI-PD, assessments were based on Hoehn & Yahr (HY) staging, the Scales for Outcomes in PD-Motor (SCOPA-M), -Cognition (SCOPA-COG) and -Psychosocial (SCOPA-PS), the Cumulative Illness Rating Scale-Geriatrics, and the Hospital Anxiety and Depression Scale. The total CISI-PD score displayed no floor or ceiling effects. Internal consistency was 0.81, the test-retest intraclass correlation coefficient was 0.84, and item homogeneity was 0.52. Exploratory and confirmatory factor analysis (CFI = 0.99, RMSEA = 0.07) confirmed CISI-PD's unifactorial structure. The CISI-PD showed adequate convergent validity with SCOPA-COG and SCOPA-M (r(S) = 0.46-0.85, respectively) and discriminative validity for HY stages and disease duration (P validation study, thus showing that the CISI-PD is a valid instrument to measure clinical impression of severity in PD. Its simplicity and easy application make it an attractive and useful tool for clinical practice and research.

  14. Adaptive importance sampling for probabilistic validation of advanced driver assistance systems

    NARCIS (Netherlands)

    Gietelink, O.J.; Schutter, B. de; Verhaegen, M.

    2006-01-01

    We present an approach for validation of advanced driver assistance systems, based on randomized algorithms. The new method consists of an iterative randomized simulation using adaptive importance sampling. The randomized algorithm is more efficient than conventional simulation techniques. The

  15. The importance of clinical and management scripts.

    Science.gov (United States)

    Levin, Roger P

    2004-07-01

    Simply having excellent clinical skills is not enough to enable you to achieve practice goals. In the end, people will validate the quality of the practice based on the way you and your team communicate. It is amazing to realize how much impact we have on other individuals, based purely on what we say. A well-groomed dentist and staff possessing very attractive features and beautiful teeth almost invariably will work in the practice's favor. However, these traits, powerful as they may be, are incomplete without the ability to say the right thing at the right time. In the practice, the easiest way to ensure consistently excellent communication is to use clinical and management scripts. Nothing you do in your practice will equal the impact of what you say because it affects patient perceptions of quality and overall customer service experiences. Your goal is to have all routine communications in the practice turned into written scripts within 6 months.

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

    Science.gov (United States)

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

    2017-12-01

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

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

    Science.gov (United States)

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

    2017-08-01

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

  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...... in only 25%. The scales can be applied in ±15 minutes. Clinical Dementia Rating (CDR), Global Deterioration scale (GDS), and Functional Assessment Staging (FAST) have been monitored on reliability and validity, and the CDR currently is the best-evidenced scale, also studied in international perspective...

  19. 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.

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

    Science.gov (United States)

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

    2015-04-08

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

  1. Content Validation of Athletic Therapy Clinical Presentations in Canada

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2012-01-01

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

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

    Science.gov (United States)

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

    2017-10-01

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

  4. 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…

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

    NARCIS (Netherlands)

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

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

  6. 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

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

    NARCIS (Netherlands)

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

    2007-01-01

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

  8. 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.

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

    Science.gov (United States)

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

    2009-02-01

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

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

    Science.gov (United States)

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

    2010-01-01

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

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

    Science.gov (United States)

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

    2016-09-30

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

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

    Science.gov (United States)

    Riley, Richard D.

    2017-01-01

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

  13. Validation of Clinical Testing for Warfarin Sensitivity

    Science.gov (United States)

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

    2009-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Mohammad Al-Amri

    2018-02-01

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

  15. 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…

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

    Science.gov (United States)

    Greher, Michael R; Wodushek, Thomas R

    2017-03-01

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

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

    Science.gov (United States)

    Muhamad, Zailani; Ramli, Ayiesah; Amat, Salleh

    2015-05-01

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

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

    Science.gov (United States)

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

    2016-06-01

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

  19. 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.

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

    DEFF Research Database (Denmark)

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

    2015-01-01

    Anger has high prevalence in clinical and forensic settings, and it is associated with aggressive behavior and ward atmosphere on psychiatric units. Dysregulated anger is a clinical problem in Danish mental health care systems, but no anger assessment instruments have been validated in Danish...... investigated with samples of 477 nonclinical, 250 clinical, 167 male prisoner, and 64 male forensic participants. Anger prevalence and its relationship with other anger measures, anxiety/depression, and aggression were examined. NAS-PI was found to have high reliability, concurrent validity, and discriminant...

  1. Validation of New Cancer Biomarkers

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  2. Pattern of Clinical Medication Seeking for Import Malaria by Migrant Workers

    Directory of Open Access Journals (Sweden)

    Muhammad Mahmudi

    2015-05-01

    Full Text Available Number of malaria cases in Kabupaten Trenggalek in 2014 is 89 cases, and 83 cases are import malaria from migrant workers. Import malaria is transmitted across two areas and affects the clinical medication seeking. This research wants to describe the pattern of clinical medication seeking for import malaria by migrant workers in Puskesmas Pandean working area. This was cross sectional study with descriptive quantitative approach. Research’s sample is 26 import malaria sufferers in 2013–2015 who has chosen purposively with inclusion criteria. Interview had used to get information about characteristics, place felt the symptom, first clinical medication seeking (place and time, clinical diagnosis, medication follow up, and recovery status. The result of the research shows 100% respondent is man and the age about 20-30 years old (53,8 who is working as agricultural laborers outside Java. Mostly of respondent feel the malaria symptoms in their working place (53,8%. The day seeks clinical medication at day three after symptom (34, 6%. Respondents that feel the symptom in Puskesmas Pandean working area chose Puskesmas as clinical medication place (42,3%, and hospital (19,2% for them whose experience the malaria symptom in their working area. Puskesmas is chosen as clinical diagnosis place (69% and only 11,5% respondent got medication follow up. Puskesmas is chosen as intermediate clinical medication place (60% for 19,2% respondent that is not recovered well, although 20% go to Dukun. All of respondent chose the clinical medication as their prime medication. Need to make medication follow up visitation well complete. Keyword: pattern, clinical medication, import malaria, migrant worker

  3. Importance of training on clinical thinking and clinical competence to interventional radiologists

    International Nuclear Information System (INIS)

    Xu Ke; Zhong Hongshan

    2010-01-01

    Although the history of Interventional Radiology is no longer than 50 years, interventional techniques have been dramatically developed. Interventional radiologists have been responsible for much of the medical innovations and development of the minimally invasive procedures that are commonplace today to treat many complicated diseases as physicians. But the education backgrounds of interventional radiologist in China are different. Therefore, we should be aware that the job of an interventional radiologist is totally different from that of a diagnostic radiologist. It is very important to train interventional radiologists for improving their clinical thinking and clinical competence. Herein, we propose our suggestions on how to improve the clinical thinking and clinical competence of interventional radiologists. In this paper we also systemically introduce the accurate and proper treatment procedures which should be strictly followed in clinical work and,meanwhile, the perioperative patients care is emphasized. (authors)

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

    NARCIS (Netherlands)

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

    1999-01-01

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

  5. How valid are commercially available medical simulators?

    Science.gov (United States)

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

    2014-01-01

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

  6. Students' Assessment and Self-assessment of Nursing Clinical Faculty Competencies: Important Feedback in Clinical Education?

    Science.gov (United States)

    Lovrić, Robert; Prlić, Nada; Zec, Davor; Pušeljić, Silvija; Žvanut, Boštjan

    2015-01-01

    The students' assessment of clinical faculty competencies and the faculty members' self-assessment can provide important information about nursing clinical education. The aim of this study was to identify the differences between the students' assessment of the clinical faculty member's competencies and the faculty member's self-assessment. These differences can reveal interesting insights relevant for improving clinical practice.

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

    DEFF Research Database (Denmark)

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

    2011-01-01

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

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

    Science.gov (United States)

    Vreugdenhil, Jettie; Spek, Bea

    2018-03-01

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

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

    Science.gov (United States)

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

    2018-01-01

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

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

    Science.gov (United States)

    Giménez Marín, Ángeles; Rivas-Ruiz, Francisco

    2012-01-01

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

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

    Science.gov (United States)

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

    2016-05-27

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

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2010-12-01

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

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

    NARCIS (Netherlands)

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

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

  15. External validation and clinical utility of a prediction model for 6-month mortality in patients undergoing hemodialysis for end-stage kidney disease.

    Science.gov (United States)

    Forzley, Brian; Er, Lee; Chiu, Helen Hl; Djurdjev, Ognjenka; Martinusen, Dan; Carson, Rachel C; Hargrove, Gaylene; Levin, Adeera; Karim, Mohamud

    2018-02-01

    End-stage kidney disease is associated with poor prognosis. Health care professionals must be prepared to address end-of-life issues and identify those at high risk for dying. A 6-month mortality prediction model for patients on dialysis derived in the United States is used but has not been externally validated. We aimed to assess the external validity and clinical utility in an independent cohort in Canada. We examined the performance of the published 6-month mortality prediction model, using discrimination, calibration, and decision curve analyses. Data were derived from a cohort of 374 prevalent dialysis patients in two regions of British Columbia, Canada, which included serum albumin, age, peripheral vascular disease, dementia, and answers to the "the surprise question" ("Would I be surprised if this patient died within the next year?"). The observed mortality in the validation cohort was 11.5% at 6 months. The prediction model had reasonable discrimination (c-stat = 0.70) but poor calibration (calibration-in-the-large = -0.53 (95% confidence interval: -0.88, -0.18); calibration slope = 0.57 (95% confidence interval: 0.31, 0.83)) in our data. Decision curve analysis showed the model only has added value in guiding clinical decision in a small range of threshold probabilities: 8%-20%. Despite reasonable discrimination, the prediction model has poor calibration in this external study cohort; thus, it may have limited clinical utility in settings outside of where it was derived. Decision curve analysis clarifies limitations in clinical utility not apparent by receiver operating characteristic curve analysis. This study highlights the importance of external validation of prediction models prior to routine use in clinical practice.

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

    Science.gov (United States)

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

    2018-06-04

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

  17. The importance of intuition in the occupational medicine clinical consultation.

    Science.gov (United States)

    Philipp, R; Philipp, E; Thorne, P

    1999-01-01

    Clinical consultation involves unspoken elements which flow between doctor and patient. They are vital ingredients of successful patient management but are not easily measured, objective or evidence-based. These elements include empathy and intuition for what the patient is experiencing and trying to express, or indeed suppressing. Time is needed to explore the instinctive feeling for what is important, particularly in present day society which increasingly recognizes the worth of psychosocial factors. This time should be available in the occupational health consultation. In this paper the importance of intuition and its essential value in the clinical interview are traced through history. Differences between intuition and empathy are explored and the use of intuition as a clinical tool is examined.

  18. Health status measurement in COPD : the minimal clinically important difference of the clinical COPD questionnaire

    NARCIS (Netherlands)

    Kocks, J. W. H.; Tuinenga, M. G.; Uil, S. M.; van den Berg, J. W. K.; Stahl, E.; van der Molen, T.

    2006-01-01

    Background: Patient-reported outcomes ( PRO) questionnaires are being increasingly used in COPD clinical studies. The challenge facing investigators is to determine what change is significant, ie what is the minimal clinically important difference (MCID). This study aimed to identify the MCID for

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

    Directory of Open Access Journals (Sweden)

    Röder Christoph

    2010-09-01

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

  20. How valid are commercially available medical simulators?

    Directory of Open Access Journals (Sweden)

    Stunt JJ

    2014-10-01

    Full Text Available JJ Stunt,1 PH Wulms,2 GM Kerkhoffs,1 J Dankelman,2 CN van Dijk,1 GJM Tuijthof1,2 1Orthopedic Research Center Amsterdam, Department of Orthopedic Surgery, Academic Medical Centre, Amsterdam, the Netherlands; 2Department of Biomechanical Engineering, Faculty of Mechanical, Materials and Maritime Engineering, Delft University of Technology, Delft, the Netherlands Background: Since simulators offer important advantages, they are increasingly used in medical education and medical skills training that require physical actions. A wide variety of simulators have become commercially available. It is of high importance that evidence is provided that training on these simulators can actually improve clinical performance on live patients. Therefore, the aim of this review is to determine the availability of different types of simulators and the evidence of their validation, to offer insight regarding which simulators are suitable to use in the clinical setting as a training modality. Summary: Four hundred and thirty-three commercially available simulators were found, from which 405 (94% were physical models. One hundred and thirty validation studies evaluated 35 (8% commercially available medical simulators for levels of validity ranging from face to predictive validity. Solely simulators that are used for surgical skills training were validated for the highest validity level (predictive validity. Twenty-four (37% simulators that give objective feedback had been validated. Studies that tested more powerful levels of validity (concurrent and predictive validity were methodologically stronger than studies that tested more elementary levels of validity (face, content, and construct validity. Conclusion: Ninety-three point five percent of the commercially available simulators are not known to be tested for validity. Although the importance of (a high level of validation depends on the difficulty level of skills training and possible consequences when skills are

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

    Science.gov (United States)

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

    2014-08-01

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

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

    Science.gov (United States)

    Shin, Sujin; Jung, Dukyoo; Kim, Sungeun

    2015-01-27

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

  3. The German version of the Expanded Prostate Cancer Index Composite (EPIC): translation, validation and minimal important difference estimation.

    Science.gov (United States)

    Umbehr, Martin H; Bachmann, Lucas M; Poyet, Cedric; Hammerer, Peter; Steurer, Johann; Puhan, Milo A; Frei, Anja

    2018-02-20

    No official German translation exists for the 50-item Expanded Prostate Cancer Index Composite (EPIC), and no minimal important difference (MID) has been established yet. The aim of the study was to translate and validate a German version of the EPIC with cultural adaptation to the different German speaking countries and to establish the MID. We translated and culturally adapted the EPIC into German. For validation, we included a consecutive subsample of 92 patients with localized prostate cancer undergoing radical prostatectomy who participated the Prostate Cancer Outcomes Cohort. Baseline and follow-up assessments took place before and six weeks after prostatectomy in 2010 and 2011. We assessed the EPIC, EORTC QLQ-PR25, Feeling Thermometer, SF-36 and a global rating of health state change variable. We calculated the internal consistency, test-retest reliability, construct validity, responsiveness and MID. For most EPIC domains and subscales, our a priori defined criteria for reliability were fulfilled (construct reliability: Cronbach's alpha 0.7-0.9; test-retest reliability: intraclass-correlation coefficient ≥ 0.7). Cross-sectional and longitudinal correlations between EPIC and EORTC QLQ-PR25 domains ranged from 0.14-0.79, and 0.06-0.5 and 0.08-0.72 for Feeling Thermometer and SF-36, respectively. We established MID values of 10, 4, 12, and 6 for the urinary, bowel, sexual and hormonal domain. The German version of the EPIC is reliable, responsive and valid to measure HRQL in prostate cancer patients and is now available in German language. With the suggested MID we provide interpretation to what extent changes in HRQL are clinically relevant for patients. Hence, study results are of interest beyond German speaking countries.

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

    Directory of Open Access Journals (Sweden)

    Marleen E. Jansen

    2017-08-01

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

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

    Science.gov (United States)

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

    2017-12-01

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

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

    Directory of Open Access Journals (Sweden)

    Nahid Sadeghi

    2012-10-01

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

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

    Science.gov (United States)

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

    2008-09-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

  9. 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.…

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

    Science.gov (United States)

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

    2018-01-01

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

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

    Science.gov (United States)

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

    2017-03-16

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

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

    Science.gov (United States)

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

    2015-01-01

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

  13. Giant U waves: an important clinical clue

    Directory of Open Access Journals (Sweden)

    Verma N

    2011-04-01

    Full Text Available Nitin Verma, Vincent M Figueredo, Allan M Greenspan, Gregg S PressmanAlbert Einstein Medical Center, Philadelphia, PA, USAAbstract: Electrocardiographic U waves are a common clinical finding, and yet are poorly understood by many physicians. They can be seen in many clinical conditions, most importantly hypokalemia and ischemic heart disease. Over the years, many theories have been put forth to explain their origin. While still not completely understood, it now appears that mechanoelectrical interactions are responsible for normal U waves. Pathologic U waves may be seen in ischemic heart disease where they sometimes point to acute ischemic events. The large U waves of hypokalemia are most likely not true U waves but rather the terminal deflection in a bifid T wave.Keywords: U waves, hypokalemia, myocardial ischemia, electrocardiogram

  14. 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…

  15. Clinical and diagnostic importance of proteinuria: A review | Oni ...

    African Journals Online (AJOL)

    Clinical and diagnostic importance of proteinuria: A review. ... shown that diabetis mellitus, cardiovascular disease and hypertension could provoke secondary ... Proteinuria is also significant in some non-pathological cases such as pregnancy

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

    Science.gov (United States)

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

    2015-08-01

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

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

    Directory of Open Access Journals (Sweden)

    Shigeyuki Matsui

    2013-01-01

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

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

    Science.gov (United States)

    Poljak, Mario; Oštrbenk, Anja

    2013-01-01

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

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

    NARCIS (Netherlands)

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

    2017-01-01

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

  20. 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.

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Science.gov (United States)

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

    2009-01-01

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

  3. The importance of dialogue in student nurses' clinical education.

    Science.gov (United States)

    Haugan, Grethe; Sørensen, Ann-Hallfrid; Hanssen, Ingrid

    2012-05-01

    Develop in-hospital tutorials where the hospital unit's nurse preceptor, the college teacher and student nurses discuss clinical experiences and together acquire knowledge. Literary research combined with examples from a clinical tutorial/discussion group project with B.A. student nurses, clinical nurses and college teacher. Clinical reflection groups may be an important step towards accomplishing stability in a collaborative effort between hospital and college to help students become knowledgeable, perceptive, reflecting, caring and effective nurses. The teacher's role in clinical practice is changing. The learning method described in this text, however resource-demanding, furthers close collaboration between hospital and college, and success depends on the educator's and clinician's collective competency. Our experience is that all parties concerned found that they gained a more holistic view of nurse education through participating in a forum focused on students' experiences through patient histories. Copyright © 2011 Elsevier Ltd. All rights reserved.

  4. Public health importance of lassa fever epidemiology, clinical ...

    African Journals Online (AJOL)

    The public health importance of Lassa fever can not be over emphasized if one considers the high infectivity and mortality rates associated with the disease. This study dealt extensively on the epidemiology, clinical features and current management of Lassa fever through literature review. The aim of this study is to sensitise ...

  5. 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.

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

    Directory of Open Access Journals (Sweden)

    Flávia Tatiana Pedrolo Hortense

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

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

    Science.gov (United States)

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

    2016-08-05

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

  8. Measuring mental health in the clinical setting: what is important to service users? The Mini-Service user Recovery Evaluation scale (Mini-SeRvE).

    Science.gov (United States)

    Barber, Joanna M; Parsons, Helen; Wilson, Carol A; Cook, Christopher C H

    2017-12-01

    Since 2001, a policy of positive mental health recovery has been promoted in the UK, with service user involvement. This has not been easy to implement in the clinical setting. To develop and validate a brief self-report, service user-designed, outcome measure (Mini-SeRvE), for clinical use, including spiritual and religious issues. From the previously developed Service user Recovery Evaluation scale (SeRvE), 15 questions were selected for Mini-SeRvE which was self-completed by 207 people; 100 service users and, for comparison, 107 staff. Results were analysed using SPSS software (SPSS Inc., Chicago, IL). Mini-SeRvE is reliable, Cronbach's alpha 0.852. Correlation with another recovery scale, Mental Health Recovery Measure, was high, r = 0.819. Three reliable subscales emerged; existential well-being (EWB), mental ill-being (MIB) and religious well-being (RWB). Scores of the EWB and MIB subscales were higher for staff, consistent with higher mental well-being. Religious well-being scores were higher in service users, who also rated religion as more important to them. Mini-SeRvE is a valid measure of service user recovery. The importance of religion/spiritual belief for our users is highlighted, this being reflected in the subject matter of Mini-SeRvE. Mini-SeRvE assessments could show individual priorities, evaluate therapy and aid clinical decision-making.

  9. [The Classification of Headache: Important Aspects of Patient's History and Clinical Diagnostic].

    Science.gov (United States)

    Kamm, Katharina; Ruscheweyh, Ruth; Eren, Ozan; Straube, Andreas

    2017-03-01

    Headache disorders are the most occuring symptoms in human population. Basis for a successful therapy of headaches is a definite diagnosis, which needs in turn valid criteria for the graduation of headaches. Corresponding to the classification of the International Headache Society (IHS) especially relevant questions about patient's history and clinical examination lead to a diagnosis. © Georg Thieme Verlag KG Stuttgart · New York.

  10. 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...

  11. 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...

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

    OpenAIRE

    Shin, Sujin; Jung, Dukyoo; Kim, Sungeun

    2015-01-01

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

  13. External validation of a clinical prediction rule to predict full recovery and ongoing moderate/severe disability following acute whiplash injury.

    Science.gov (United States)

    Ritchie, Carrie; Hendrikz, Joan; Jull, Gwendolen; Elliott, James; Sterling, Michele

    2015-04-01

    Retrospective secondary analysis of data. To investigate the external validity of the whiplash clinical prediction rule (CPR). We recently derived a whiplash CPR to consolidate previously established prognostic factors for poor recovery from a whiplash injury and predicted 2 recovery pathways. Prognostic factors for full recovery were being less than 35 years of age and having an initial Neck Disability Index (NDI) score of 32% or less. Prognostic factors for ongoing moderate/severe pain and disability were being 35 years of age or older, having an initial NDI score of 40% or more, and the presence of hyperarousal symptoms. Validation is required to confirm the reproducibility and accuracy of this CPR. Clinician feedback on the usefulness of the CPR is also important to gauge acceptability. A secondary analysis of data from 101 individuals with acute whiplash-associated disorder who had previously participated in either a randomized controlled clinical trial or prospective cohort study was performed using accuracy statistics. Full recovery was defined as NDI score at 6 months of 10% or less, and ongoing moderate/severe pain and disability were defined as an NDI score at 6 months of 30% or greater. In addition, a small sample of physical therapists completed an anonymous survey on the clinical acceptability and usability of the tool. Results The positive predictive value of ongoing moderate/severe pain and disability was 90.9% in the validation cohort, and the positive predictive value of full recovery was 80.0%. Surveyed physical therapists reported that the whiplash CPR was simple, understandable, would be easy to use, and was an acceptable prognostic tool. External validation of the whiplash CPR confirmed the reproducibility and accuracy of this dual-pathway tool for individuals with acute whiplash-associated disorder. Further research is needed to assess prospective validation, the impact of inclusion on practice, and to examine the efficacy of linking treatment

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

    Science.gov (United States)

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

    2017-11-01

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

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

    Science.gov (United States)

    Forsythe, George B.; And Others

    1986-01-01

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

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

    Science.gov (United States)

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

    2017-05-01

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

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

    Science.gov (United States)

    Dellson, P; Nilbert, M; Bendahl, P-O; Malmström, P; Carlsson, C

    2011-07-01

    Clinical trials are crucial to improve cancer treatment but recruitment is difficult. Optimised patient information has been recognised as a key issue. In line with the increasing focus on patients' perspectives in health care, we aimed to study patients' opinions about the written information used in three clinical trials for breast cancer. Primary data collection was done in focus group interviews with breast cancer patient advocates. Content analysis identified three major themes: comprehensibility, emotions and associations, and decision making. Based on the advocates' suggestions for improvements, 21 key issues were defined and validated through a questionnaire in an independent group of breast cancer patient advocates. Clear messages, emotionally neutral expressions, careful descriptions of side effects, clear comparisons between different treatment alternatives and information about the possibility to discontinue treatment were perceived as the most important issues. Patients' views of the information in clinical trials provide new insights and identify key issues to consider in optimising future written information and may improve recruitment to clinical cancer trials. © 2010 Blackwell Publishing Ltd.

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

    Science.gov (United States)

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

    2015-10-01

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

  19. Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials

    Directory of Open Access Journals (Sweden)

    Schmitz Heinz

    2010-11-01

    Full Text Available Abstract Background When comparing active treatments, a non-inferiority (or one-sided equivalence study design is often used. This design requires the definition of a non-inferiority margin, the threshold value of clinical relevance. In recent studies, a non-inferiority margin of 15 mm has been used for the change in endometriosis-associated pelvic pain (EAPP on a visual analog scale (VAS. However, this value was derived from other chronic painful conditions and its validation in EAPP was lacking. Methods Data were analyzed from two placebo-controlled studies of active treatments in endometriosis, including 281 patients with laparoscopically-confirmed endometriosis and moderate-to-severe EAPP. Patients recorded EAPP on a VAS at baseline and the end of treatment. Patients also assessed their satisfaction with treatment on a modified Clinical Global Impression scale. Changes in VAS score were compared with patients' self-assessments to derive an empirically validated non-inferiority margin. This anchor-based value was compared to a non-inferiority margin derived using the conventional half standard deviation rule for minimal clinically important difference (MCID in patient-reported outcomes. Results Anchor-based and distribution-based MCIDs were-7.8 mm and-8.6 mm, respectively. Conclusions An empirically validated non-inferiority margin of 10 mm for EAPP measured on a VAS is appropriate to compare treatments in endometriosis.

  20. The Nursing Diagnosis of risk for pressure ulcer: content validation

    Directory of Open Access Journals (Sweden)

    Cássia Teixeira dos Santos

    2016-01-01

    Full Text Available Abstract Objective: to validate the content of the new nursing diagnosis, termed risk for pressure ulcer. Method: the content validation with a sample made up of 24 nurses who were specialists in skin care from six different hospitals in the South and Southeast of Brazil. Data collection took place electronically, through an instrument constructed using the SurveyMonkey program, containing a title, definition, and 19 risk factors for the nursing diagnosis. The data were analyzed using Fehring's method and descriptive statistics. The project was approved by a Research Ethics Committee. Results: title, definition and seven risk factors were validated as "very important": physical immobilization, pressure, surface friction, shearing forces, skin moisture, alteration in sensation and malnutrition. Among the other risk factors, 11 were validated as "important": dehydration, obesity, anemia, decrease in serum albumin level, prematurity, aging, smoking, edema, impaired circulation, and decrease in oxygenation and in tissue perfusion. The risk factor of hyperthermia was discarded. Conclusion: the content validation of these components of the nursing diagnosis corroborated the importance of the same, being able to facilitate the nurse's clinical reasoning and guiding clinical practice in the preventive care for pressure ulcers.

  1. 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

  2. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations

    DEFF Research Database (Denmark)

    Dworkin, R.H.; Turk, D.C.; Wyrwich, K.W.

    2008-01-01

    of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT...

  3. Individual Importance Weighting of Domain Satisfaction Ratings does Not Increase Validity

    Science.gov (United States)

    Rohrer, Julia M.; Schmukle, Stefan C.

    2018-01-01

    Bottom-up models of life satisfaction are based on the assumption that individuals judge the overall quality of their lives by aggregating information across various life domains, such as health, family, and income. This aggregation supposedly involves a weighting procedure because individuals care about different parts of their lives to varying degrees. Thus, composite measures of well-being should be more accurate if domain satisfaction scores are weighted by the importance that respondents assign to the respective domains. Previous studies have arrived at mixed conclusions about whether such a procedure actually works. In the present study, importance weighting was investigated in the Panel Study of Income Dynamics (PSID; N = 5,049). Both weighted composite scores and moderated regression analyses converged in producing the conclusion that individual importance weights did not result in higher correlations with the outcome variable, a global measure of life satisfaction. By contrast, using weights that vary normatively across domains (e.g., assigning a larger weight to family satisfaction than to housing satisfaction for all respondents) significantly increased the correlation with global life satisfaction (although incremental validity was rather humble). These results converge with findings from other fields such as self-concept research, where evidence for individual importance weighting seems elusive as best. PMID:29652406

  4. Individual Importance Weighting of Domain Satisfaction Ratings does Not Increase Validity.

    Science.gov (United States)

    Rohrer, Julia M; Schmukle, Stefan C

    2018-01-01

    Bottom-up models of life satisfaction are based on the assumption that individuals judge the overall quality of their lives by aggregating information across various life domains, such as health, family, and income. This aggregation supposedly involves a weighting procedure because individuals care about different parts of their lives to varying degrees. Thus, composite measures of well-being should be more accurate if domain satisfaction scores are weighted by the importance that respondents assign to the respective domains. Previous studies have arrived at mixed conclusions about whether such a procedure actually works. In the present study, importance weighting was investigated in the Panel Study of Income Dynamics (PSID; N = 5,049). Both weighted composite scores and moderated regression analyses converged in producing the conclusion that individual importance weights did not result in higher correlations with the outcome variable, a global measure of life satisfaction. By contrast, using weights that vary normatively across domains (e.g., assigning a larger weight to family satisfaction than to housing satisfaction for all respondents) significantly increased the correlation with global life satisfaction (although incremental validity was rather humble). These results converge with findings from other fields such as self-concept research, where evidence for individual importance weighting seems elusive as best.

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

    Science.gov (United States)

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

    2017-03-23

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

  6. What constitutes a clinically important pain reduction in patients after third molar surgery?

    NARCIS (Netherlands)

    Martin, W.J.J.M.; Ashton-James, C.E.; Skorpil, N.E.; Heymans, M.W.; Forouzanfar, T.

    2013-01-01

    BACKGROUND: For patients with surgical third molar removal, it is unknown what constitutes a clinically important change in patients’ visual analogue scale (VAS) reports of pain intensity. OBJECTIVES: To determine what constitutes a clinically important change in pain intensity on a VAS following

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2016-06-15

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

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

    International Nuclear Information System (INIS)

    Juang, T.

    2016-01-01

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

  9. Health status in patients with coexistent COPD and heart failure: a validation and comparison between the Clinical COPD Questionnaire and the Minnesota Living with Heart Failure Questionnaire.

    Science.gov (United States)

    Berkhof, Farida F; Metzemaekers, Leola; Uil, Steven M; Kerstjens, Huib A M; van den Berg, Jan W K

    2014-01-01

    Chronic obstructive pulmonary disease (COPD) and heart failure (HF) are both common diseases that coexist frequently. Patients with both diseases have worse stable state health status when compared with patients with one of these diseases. In many outpatient clinics, health status is monitored routinely in COPD patients using the Clinical COPD Questionnaire (CCQ) and in HF patients with the Minnesota Living with Heart Failure Questionnaire (MLHF-Q). This study validated and compared which questionnaire, ie, the CCQ or the MLHF-Q, is suited best for patients with coexistent COPD and HF. Patients with both COPD and HF and aged ≥40 years were included. Construct validity, internal consistency, test-retest reliability, and agreement were determined. The Short-Form 36 was used as the external criterion. All questionnaires were completed at baseline. The CCQ and MLHF-Q were repeated after 2 weeks, together with a global rating of change. Fifty-eight patients were included, of whom 50 completed the study. Construct validity was acceptable. Internal consistency was adequate for CCQ and MLHF-Q total and domain scores, with a Cronbach's alpha ≥0.70. Reliability was adequate for MLHF-Q and CCQ total and domain scores, and intraclass correlation coefficients were 0.70-0.90, except for the CCQ symptom score (intraclass correlation coefficient 0.42). The standard error of measurement on the group level was smaller than the minimal clinical important difference for both questionnaires. However, the standard error of measurement on the individual level was larger than the minimal clinical important difference. Agreement was acceptable on the group level and limited on the individual level. CCQ and MLHF-Q were both valid and reliable questionnaires for assessment of health status in patients with coexistent COPD and HF on the group level, and hence for research. However, in clinical practice, on the individual level, the characteristics of both questionnaires were not as good

  10. Approaches for estimating minimal clinically important differences in systemic lupus erythematosus.

    Science.gov (United States)

    Rai, Sharan K; Yazdany, Jinoos; Fortin, Paul R; Aviña-Zubieta, J Antonio

    2015-06-03

    A minimal clinically important difference (MCID) is an important concept used to determine whether a medical intervention improves perceived outcomes in patients. Prior to the introduction of the concept in 1989, studies focused primarily on statistical significance. As most recent clinical trials in systemic lupus erythematosus (SLE) have failed to show significant effects, determining a clinically relevant threshold for outcome scores (that is, the MCID) of existing instruments may be critical for conducting and interpreting meaningful clinical trials as well as for facilitating the establishment of treatment recommendations for patients. To that effect, methods to determine the MCID can be divided into two well-defined categories: distribution-based and anchor-based approaches. Distribution-based approaches are based on statistical characteristics of the obtained samples. There are various methods within the distribution-based approach, including the standard error of measurement, the standard deviation, the effect size, the minimal detectable change, the reliable change index, and the standardized response mean. Anchor-based approaches compare the change in a patient-reported outcome to a second, external measure of change (that is, one that is more clearly understood, such as a global assessment), which serves as the anchor. Finally, the Delphi technique can be applied as an adjunct to defining a clinically important difference. Despite an abundance of methods reported in the literature, little work in MCID estimation has been done in the context of SLE. As the MCID can help determine the effect of a given therapy on a patient and add meaning to statistical inferences made in clinical research, we believe there ought to be renewed focus on this area. Here, we provide an update on the use of MCIDs in clinical research, review some of the work done in this area in SLE, and propose an agenda for future research.

  11. Standardized Ki67 Diagnostics Using Automated Scoring--Clinical Validation in the GeparTrio Breast Cancer Study.

    Science.gov (United States)

    Klauschen, Frederick; Wienert, Stephan; Schmitt, Wolfgang D; Loibl, Sibylle; Gerber, Bernd; Blohmer, Jens-Uwe; Huober, Jens; Rüdiger, Thomas; Erbstößer, Erhard; Mehta, Keyur; Lederer, Bianca; Dietel, Manfred; Denkert, Carsten; von Minckwitz, Gunter

    2015-08-15

    Scoring proliferation through Ki67 immunohistochemistry is an important component in predicting therapy response to chemotherapy in patients with breast cancer. However, recent studies have cast doubt on the reliability of "visual" Ki67 scoring in the multicenter setting, particularly in the lower, yet clinically important, proliferation range. Therefore, an accurate and standardized Ki67 scoring is pivotal both in routine diagnostics and larger multicenter studies. We validated a novel fully automated Ki67 scoring approach that relies on only minimal a priori knowledge on cell properties and requires no training data for calibration. We applied our approach to 1,082 breast cancer samples from the neoadjuvant GeparTrio trial and compared the performance of automated and manual Ki67 scoring. The three groups of autoKi67 as defined by low (≤ 15%), medium (15.1%-35%), and high (>35%) automated scores showed pCR rates of 5.8%, 16.9%, and 29.5%, respectively. AutoKi67 was significantly linked to prognosis with overall and progression-free survival P values P(OS) cancer that correlated with clinical endpoints and is deployable in routine diagnostics. It may thus help to solve recently reported reliability concerns in Ki67 diagnostics. ©2014 American Association for Cancer Research.

  12. 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.

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

    DEFF Research Database (Denmark)

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

    2018-01-01

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

  14. Importance of Pharmaceutical Training and Clinical Research at Medical Facilities.

    Science.gov (United States)

    Myotoku, Michiaki

    2017-01-01

    To respond to advancements in medical techniques, and to address the separation of medical and dispensary practices, clinical professors are required to educate human resource staff to become highly-skilled pharmacists. For this purpose, it is extremely important for these professors to learn about cutting-edge practical skills and knowledge, as well as to advance their expertise. In addition, they need to conduct clinical research in cooperation with relevant facilities. As our university does not have its own hospital or pharmacy, it is important to provide training for clinical professors in clinical facilities. Such training mainly involves medical teams' in-hospital rounds and participation in conferences (nutrition support team; NST), operation of the pharmacy department, and intervention targeting improvement in the department's duties. We have conducted collaborative studies, provided research instructions, implemented studies aimed at improving the department's work (pharmacists appointed on wards at all times to ensure medical safety) as well as studies regarding team medical care (nutritional evaluation during outpatient chemotherapy), and resolved issues regarding this work (drug solution mixability in a hand-held constant infusion pump, and a safe pump-filling methods). Thus, it has become possible to keep track of the current state of a pharmacists' work within team medical care, to access information about novel drugs, to view clinical and prescription-claim data, to cooperate with other professionals (e.g., doctors and nurses), to promote pharmacists' self-awareness of their roles in cooperative medical practice, and to effectively maintain the hospital's clinical settings.

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

    Science.gov (United States)

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

    2018-01-01

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

  16. Greek pre-service physical education teachers’ beliefs about curricular orientations: Instrument validation and examination of four important goals

    Directory of Open Access Journals (Sweden)

    Manolis Adamakis

    2013-12-01

    Full Text Available BACKGROUND: The way people interpret reality is influenced by their mental constructions, their cognitive abilities and their beliefs. Physical Education (PE students have a wide range of formed beliefs concerning the purposes of PE, which cannot be easily modified, even during undergraduate studies. OBJECTIVE: This study validated the scores from a previously constructed questionnaire and investigated the Physical Education students’ belief systems toward the Greek curricular outcome goals. METHODS: Students (N = 483; males = 259, females = 224 from a Greek Faculty of Physical Education and Sport Science shared their beliefs about curricular outcomes. They completed the Greek version of the four factor instrument “Attitudes/beliefs toward curriculum in physical education”. A confirmatory factor analysis was conducted for the validation of the instrument and MANOVAs followed in order to control for group differences. Finally, a profile analysis was run in order to determine if PE students considered each goal to be equally important. RESULTS: The validation of the instrument confirmed the proposed four factors dependant model. Both internal consistency and the confirmatory factor analysis fit indices produced valid and reliable scores. The profile analysis was significant, indicating that students did not view the outcome goals as equally important. The leading goal was physical activity and fitness, followed by self-actualization, social development and motor skill development. MANOVA results for comparisons between sub-groups revealed significant differences only between genders. CONCLUSIONS: Between groups similarities and differences are discussed, focusing on the classification of the four important outcome goals. Currently, Greek Physical Education students consider physical activity and fitness outcome goal as the most important, while motor skill development is considered the least important one.

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

    Science.gov (United States)

    Shirasaki, Osamu; Asou, Yosuke; Takahashi, Yukio

    2007-12-01

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

  18. 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.

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

    International Nuclear Information System (INIS)

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

    2014-01-01

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

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

    NARCIS (Netherlands)

    Vreugdenhil, Jettie; Spek, Bea

    2017-01-01

    Clinical reasoning in patient care is a skill that cannot be observed directly. So far, no reliable, valid instrument exists for the assessment of nursing students' clinical reasoning skills in hospital practice. Lasater's clinical judgment rubric (LCJR), based on Tanner's model "Thinking like a

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

    DEFF Research Database (Denmark)

    Szomlaiski, N; Dyrborg, J; Rasmussen, H

    2008-01-01

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

  2. The Minimal Clinically Important Difference for the Mayo-Portland Adaptability Inventory.

    Science.gov (United States)

    Malec, James F; Kean, Jacob; Monahan, Patrick O

    To determine the Minimal Clinically Important Difference (MCID) and Robust Clinically Important Difference (RCID) of the Mayo-Portland Adaptability Inventory-4 (MPAI-4) as measures of response to intervention. Retrospective analysis of existing data. Both distribution- and anchor-based methods were used to triangulate on the MCID and to identify a moderate, that is, more robust, level of change (RCID) for the MPAI-4. These were further evaluated with respect to clinical provider ratings. Data for individuals with acquired brain injury in rehabilitation programs throughout the United States in the OutcomeInfo Database (n = 3087) with 2 MPAI-4 ratings. MPAI-4, Supervision Rating Scale, Clinician Rating of Global Clinical Improvement. Initial analyses suggested 5 T-score points (5T) as the MCID and 9T as the RCID. Eighty-one percent to 87% of clinical raters considered a 5T change and 99% considered a 9T change to indicate meaningful improvement. 5T represents the MCID for the MPAI-4 and 9T, the RCID. Both values are notably less than the Reliable Change Index (RCI). While the RCI indicates change with a high level of statistical confidence, it may be insensitive to change that is considered meaningful by providers and participants as indicated by the MCID.

  3. MARTIN–GRUBER ANASTOMOSIS AND ITS CLINICAL IMPORTANCE

    Directory of Open Access Journals (Sweden)

    I. G. Mikhaylyuk

    2015-01-01

    Full Text Available The communication between the median and ulnar nerves on the forearm, known as the Martin–Gruber anastomosis, is widespread in the general population. Despite the fact that this connection is described by anatomists in XVIII century, its importance has only recently been appreciated because of the widespread of the electrophysiological techniques in clinical practies. However, in the Russian literature aspects of its practical value described so far is not enough. This article deals with the prevalence of the anastomosis, its anatomical and electrophysiological classification, options innervation of muscles of the hand, is carried out through him, described electrophysiological methods and criteria for its diagnosis, including the collision technique, in healthy subjects and patients with lesions of the median and ulnar nerves, given its practical value. Such a course of nerve fibers through this anastomosis can have a significant impact on the clinical manifestations in patients with lesions of the median and ulnar nerves, as well as the results of an electrophysiological study. Martin–Gruber anastomosis provides variability innervation muscles of the hand, which can make it difficult topic diagnostic damage to the median and ulnar nerves, in addition, because of the connection between the nerves of the clinical presentation may not reflect the extent of their defeat: the hand muscles function can be preserved with full nerve damage or, conversely, significantly disrupted with minimal nerve lesions. Moreover, different electrophysiological findings on patients with pathology of the median or ulnar nerves in the conditions of functioning anastomosis may also complicate the interpretation of the clinical data. Thus, knowledge of the anatomy and physiology of the Martin–Gruber communication as necessary for the electrophysiologist for correct interpretation of the finding and the clinician to accurately diagnose the pathology of the median

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

    Science.gov (United States)

    Youngstrom, Eric A; De Los Reyes, Andres

    2015-01-01

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

  5. CT and MR imaging of the liver. Clinical importance of nutritional status

    International Nuclear Information System (INIS)

    Leander, P.; Sjoeberg, S.; Hoeglund, P.

    2000-01-01

    Purpose: In an experimental study in rats a correlation between nutritional status and hepatic attenuation in CT and signal intensities in MR imaging was shown. Is physiological nutritional status of importance in clinical CT and MR imaging? Material and methods: In a cross-over study including 12 healthy volunteers (6 women and 6 men, mean age 34 years), CT and MR imaging of the liver were performed with nutritional status at three different levels, i.e., normal, fasting and after glycogen-rich meals. CT and MR were performed on clinical imaging systems and hepatic attenuation and signal intensity, respectively, were assessed. In MR, T1-weighted, proton density-weighted and T2-weighted pulse-sequences were used. Results: In CT there were significantly (p<0.01) higher liver attenuations in normal nutritional status and after glycogen rich-meals compared to the fasting condition. The difference between fasting and glycogen-rich meals were 10.5 HU for men, 7.4 for women and mean 8.8 HU for all 12 volunteers. In MR imaging the differences were small and non-significant. The results of this study are in accordance with an earlier experimental study in rats. Conclusion: In CT it may be of importance not to have patients in a fasting condition as it lowers the attenuation in normal liver tissue. The findings are important for planning of clinical studies where hepatic attenuation will be assessed and may be of some importance in clinical CT. In MR imaging the results indicate that the nutritional status is of less importance

  6. Construct Validity and Case Validity in Assessment

    Science.gov (United States)

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

    2012-01-01

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

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

    Science.gov (United States)

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

    2014-04-01

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

  8. Optimizer convergence and local minima errors and their clinical importance

    International Nuclear Information System (INIS)

    Jeraj, Robert; Wu, Chuan; Mackie, Thomas R

    2003-01-01

    Two of the errors common in the inverse treatment planning optimization have been investigated. The first error is the optimizer convergence error, which appears because of non-perfect convergence to the global or local solution, usually caused by a non-zero stopping criterion. The second error is the local minima error, which occurs when the objective function is not convex and/or the feasible solution space is not convex. The magnitude of the errors, their relative importance in comparison to other errors as well as their clinical significance in terms of tumour control probability (TCP) and normal tissue complication probability (NTCP) were investigated. Two inherently different optimizers, a stochastic simulated annealing and deterministic gradient method were compared on a clinical example. It was found that for typical optimization the optimizer convergence errors are rather small, especially compared to other convergence errors, e.g., convergence errors due to inaccuracy of the current dose calculation algorithms. This indicates that stopping criteria could often be relaxed leading into optimization speed-ups. The local minima errors were also found to be relatively small and typically in the range of the dose calculation convergence errors. Even for the cases where significantly higher objective function scores were obtained the local minima errors were not significantly higher. Clinical evaluation of the optimizer convergence error showed good correlation between the convergence of the clinical TCP or NTCP measures and convergence of the physical dose distribution. On the other hand, the local minima errors resulted in significantly different TCP or NTCP values (up to a factor of 2) indicating clinical importance of the local minima produced by physical optimization

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

    Science.gov (United States)

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

    2014-01-01

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

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

    OpenAIRE

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

    2011-01-01

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

  11. Development and Validation of the Sleep Inertia Questionnaire (SIQ) and Assessment of Sleep Inertia in Analogue and Clinical Depression.

    Science.gov (United States)

    Kanady, Jennifer C; Harvey, Allison G

    2015-10-01

    Sleep inertia is the transitional state from sleep to wake. Research on sleep inertia is important in depression because many people with depression report having difficulty getting out of bed, which contributes to impairment and can impede the implementation of interventions. The first aim was to develop and validate the first self-report measure of sleep inertia, the Sleep Inertia Questionnaire (SIQ). The second aim was to compare reports of sleep inertia across three groups: (1) No-to-Mild-Depression, (2) Analogue-Depression, and (3) Syndromal-Depression. The SIQ demonstrates strong psychometric properties; it has good to excellent internal consistency, strong construct validity, and SIQ severity is associated with less prior sleep duration. Sleep inertia is more severe in the Analogue-Depression and Syndromal-Depression groups compared to the No-to-Mild-Depression group. In conclusion, the SIQ is a reliable measure of sleep inertia and has potential for improving the assessment of sleep inertia in clinical and research settings.

  12. Graduate admissions in clinical neuropsychology: the importance of undergraduate training.

    Science.gov (United States)

    Karazsia, Bryan T; Stavnezer, Amy Jo; Reeves, Jonathan W

    2013-11-01

    Discussions of and recommendations for the training of clinical neuropsychologists exist at the doctoral, internship, and post-doctoral level. With few exceptions, the literature on undergraduate preparations in clinical neuropsychology is sparse and lacks empirical evidence. In the present study, graduate-level faculty and current trainees completed surveys about graduate school preparations. Faculty expectations of minimum and ideal undergraduate training were highest for research methods, statistics, and assessment. Preferences for "goodness of fit" also emerged as important admissions factors. These results offer evidence for desirable undergraduate preparations for advanced study in clinical neuropsychology. Although undergraduate training in psychology is intentionally broad, results from this study suggest that students who desire advanced study in clinical neuropsychology need to tailor their experiences to be competitive in the application process. The findings have implications for prospective graduate students, faculty who train and mentor undergraduates, and faculty who serve on admissions committees.

  13. Is statistical significance clinically important?--A guide to judge the clinical relevance of study findings

    NARCIS (Netherlands)

    Sierevelt, Inger N.; van Oldenrijk, Jakob; Poolman, Rudolf W.

    2007-01-01

    In this paper we describe several issues that influence the reporting of statistical significance in relation to clinical importance, since misinterpretation of p values is a common issue in orthopaedic literature. Orthopaedic research is tormented by the risks of false-positive (type I error) and

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

    Science.gov (United States)

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

    2018-02-01

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

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

    Science.gov (United States)

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

    2016-03-01

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

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

    Science.gov (United States)

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

    2010-01-01

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

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

    Science.gov (United States)

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

    2016-12-15

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

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

    Science.gov (United States)

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

    2013-01-01

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

  19. 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.

  20. Validation and clinical significance of the Childhood Myositis Assessment Scale for assessment of muscle function in the juvenile idiopathic inflammatory myopathies.

    Science.gov (United States)

    Huber, Adam M; Feldman, Brian M; Rennebohm, Robert M; Hicks, Jeanne E; Lindsley, Carol B; Perez, Maria D; Zemel, Lawrence S; Wallace, Carol A; Ballinger, Susan H; Passo, Murray H; Reed, Ann M; Summers, Ronald M; White, Patience H; Katona, Ildy M; Miller, Frederick W; Lachenbruch, Peter A; Rider, Lisa G

    2004-05-01

    To examine the measurement characteristics of the Childhood Myositis Assessment Scale (CMAS) in children with juvenile idiopathic inflammatory myopathy (juvenile IIM), and to obtain preliminary data on the clinical significance of CMAS scores. One hundred eight children with juvenile IIM were evaluated on 2 occasions, 7-9 months apart, using various measures of physical function, strength, and disease activity. Interrater reliability, construct validity, and responsiveness of the CMAS were examined. The minimum clinically important difference (MID) and CMAS scores corresponding to various degrees of physical disability were estimated. The intraclass correlation coefficient for 26 patients assessed by 2 examiners was 0.89, indicating very good interrater reliability. The CMAS score correlated highly with the Childhood Health Assessment Questionnaire (C-HAQ) score and with findings on manual muscle testing (MMT) (r(s) = -0.73 and 0.73, respectively) and moderately with physician-assessed global disease activity and skin activity, parent-assessed global disease severity, and muscle magnetic resonance imaging (r(s) = -0.44 to -0.61), thereby demonstrating good construct validity. The standardized response mean was 0.81 (95% confidence interval 0.53, 1.09) in patients with at least 0.8 cm improvement on a 10-cm visual analog scale for physician-assessed global disease activity, indicating strong responsiveness. In bivariate regression models predicting physician-assessed global disease activity, MMT remained significant in models containing the CMAS (P = 0.03) while the C-HAQ did not (P = 0.4). Estimates of the MID ranged from 1.5 to 3.0 points on a 0-52-point scale. CMAS scores corresponding to no, mild, mild-to-moderate, and moderate physical disability, respectively, were 48, 45, 39, and 30. The CMAS exhibits good reliability, construct validity, and responsiveness, and is therefore a valid instrument for the assessment of physical function, muscle strength, and

  1. Determining Minimal Clinically Important Differences in Japanese Cedar/Cypress Pollinosis Patients

    OpenAIRE

    Takaya Higaki; Mitsuhiro Okano; Shin Kariya; Tazuko Fujiwara; Takenori Haruna; Haruka Hirai; Aya Murai; Minoru Gotoh; Kimihiro Okubo; Shuji Yonekura; Yoshitaka Okamoto; Kazunori Nishizaki

    2013-01-01

    Background: Statistically significant results of medical intervention trials are not always clinically meaningful. We sought to estimate the minimal clinically important difference (MCID) (the smallest change in a given endpoint that is meaningful to a patient) during seasonal alteration of Japanese cedar/cypress pollinosis (JCCP). Methods: Results of a double-blinded, placebo-controlled trial of JCCP patients conducted between 2008 and 2010 were analyzed using an anchor-based method in wh...

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

    Science.gov (United States)

    2003-02-01

    International interest in clinical practice guidelines has never been greater but many published guidelines do not meet the basic quality requirements. There have been renewed calls for validated criteria to assess the quality of guidelines. To develop and validate an international instrument for assessing the quality of the process and reporting of clinical practice guideline development. The instrument was developed through a multi-staged process of item generation, selection and scaling, field testing, and refinement procedures. 100 guidelines selected from 11 participating countries were evaluated independently by 194 appraisers with the instrument. Following refinement the instrument was further field tested on three guidelines per country by a new set of 70 appraisers. The final version of the instrument contained 23 items grouped into six quality domains with a 4 point Likert scale to score each item (scope and purpose, stakeholder involvement, rigour of development, clarity and presentation, applicability, editorial independence). 95% of appraisers found the instrument useful for assessing guidelines. Reliability was acceptable for most domains (Cronbach's alpha 0.64-0.88). Guidelines produced as part of an established guideline programme had significantly higher scores on editorial independence and, after the publication of a national policy, had significantly higher quality scores on rigour of development (pinternationally. The instrument is sensitive to differences in important aspects of guidelines and can be used consistently and easily by a wide range of professionals from different backgrounds. The adoption of common standards should improve the consistency and quality of the reporting of guideline development worldwide and provide a framework to encourage international comparison of clinical practice guidelines.

  3. 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.

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

    Science.gov (United States)

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

    2012-01-01

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

  5. Minimal clinically important difference on the Motor Examination part of MDS-UPDRS.

    Science.gov (United States)

    Horváth, Krisztina; Aschermann, Zsuzsanna; Ács, Péter; Deli, Gabriella; Janszky, József; Komoly, Sámuel; Balázs, Éva; Takács, Katalin; Karádi, Kázmér; Kovács, Norbert

    2015-12-01

    Recent studies increasingly utilize the Movement Disorders Society Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS). However, the minimal clinically important difference (MCID) has not been fully established for MDS-UPDRS yet. To assess the MCID thresholds for MDS-UPDRS Motor Examination (Part III). 728 paired investigations of 260 patients were included. At each visit both MDS-UPDRS and Clinician-reported Global Impression-Improvement (CGI-I) scales were assessed. MDS-UPDRS Motor Examination (ME) score changes associated with CGI-I score 4 (no change) were compared with MDS-UPDRS ME score changes associated with CGI-I score 3 (minimal improvement) and CGI-I score 5 (minimal worsening). Both anchor- and distribution-based techniques were utilized to determine the magnitude of MCID. The MCID estimates for MDS-UPDRS ME were asymmetric: -3.25 points for detecting minimal, but clinically pertinent, improvement and 4.63 points for observing minimal, but clinically pertinent, worsening. MCID is the smallest change of scores that are clinically meaningful to patients. These MCID estimates may allow the judgement of a numeric change in MDS-UPDRS ME on its clinical importance. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

    Ohrbach, R; Gale, E N

    1989-11-01

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

  7. Effort-Based Decision-Making Paradigms for Clinical Trials in Schizophrenia: Part 2—External Validity and Correlates.

    Science.gov (United States)

    Horan, William P; Reddy, L Felice; Barch, Deanna M; Buchanan, Robert W; Dunayevich, Eduardo; Gold, James M; Marder, Steven R; Wynn, Jonathan K; Young, Jared W; Green, Michael F

    2015-09-01

    Effort-based decision making has strong conceptual links to the motivational disturbances that define a key subdomain of negative symptoms. However, the extent to which effort-based decision-making performance relates to negative symptoms, and other clinical and functionally important variables has yet to be systematically investigated. In 94 clinically stable outpatients with schizophrenia, we examined the external validity of 5 effort-based paradigms, including the Effort Expenditure for Rewards, Balloon Effort, Grip Strength Effort, Deck Choice Effort, and Perceptual Effort tasks. These tasks covered 3 types of effort: physical, cognitive, and perceptual. Correlations between effort related performance and 6 classes of variables were examined, including: (1) negative symptoms, (2) clinically rated motivation and community role functioning, (3) self-reported motivational traits, (4) neurocognition, (5) other psychiatric symptoms and clinical/demographic characteristics, and (6) subjective valuation of monetary rewards. Effort paradigms showed small to medium relationships to clinical ratings of negative symptoms, motivation, and functioning, with the pattern more consistent for some measures than others. They also showed small to medium relations with neurocognitive functioning, but were generally unrelated to other psychiatric symptoms, self-reported traits, antipsychotic medications, side effects, and subjective valuation of money. There were relatively strong interrelationships among the effort measures. In conjunction with findings from a companion psychometric article, all the paradigms warrant further consideration and development, and 2 show the strongest potential for clinical trial use at this juncture. © The Author 2015. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  8. 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.

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

    Directory of Open Access Journals (Sweden)

    Joshua Jauregui

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

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

    NARCIS (Netherlands)

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

    2003-01-01

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

  11. Validating archetypes for the Multiple Sclerosis Functional Composite.

    Science.gov (United States)

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

    2014-08-03

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

  12. Clinical Utility and "DSM-V"

    Science.gov (United States)

    Mullins-Sweatt, Stephanie N.; Widiger, Thomas A.

    2009-01-01

    The construction of the American Psychiatric Association's diagnostic manual has been guided primarily by concerns of construct validity rather than of clinical utility, despite claims by its authors that the highest priority has in fact been clinical utility. The purpose of this article was to further articulate the concept and importance of…

  13. Minimal clinically important difference in the fibromyalgia impact questionnaire.

    Science.gov (United States)

    Bennett, Robert M; Bushmakin, Andrew G; Cappelleri, Joseph C; Zlateva, Gergana; Sadosky, Alesia B

    2009-06-01

    The Fibromyalgia Impact Questionnaire (FIQ) is a disease-specific composite instrument that measures the effect of problems experienced by patients with fibromyalgia (FM). Utilization of the FIQ in measuring changes due to interventions in FM requires derivation of a clinically meaningful change for that instrument. Analyses were conducted to estimate the minimal clinically important difference (MCID), and to propose FIQ severity categories. Data from 3 similarly designed, 3-month placebo-controlled, clinical treatment trials of pregabalin 300, 450, and 600 mg/day in patients with FM were modeled to estimate the change in the mean FIQ total and stiffness items corresponding to each category on the Patient Global Impression of Change. FIQ severity categories were modeled and determined using established pain severity cutpoints as an anchor. A total of 2228 patients, mean age 49 years, 93% women, with a mean baseline FIQ total score of 62 were treated in the 3 studies. Estimated MCID on a given measure were similar across the studies. In a pooled analysis the estimated MCID (95% confidence interval) was 14% (13; 15) and for FIQ stiffness it was 13% (12; 14). In the severity analysis a FIQ total score from 0 to or= 39 to or=59 to 100 a severe effect. The analysis indicates that a 14% change in the FIQ total score is clinically relevant, and results of these analyses should enhance the clinical utility of the FIQ in research and practice.

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

    Science.gov (United States)

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

    2016-07-26

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

  15. 77 FR 66848 - Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and...

    Science.gov (United States)

    2012-11-07

    ...] Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation... Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation.'' FDA is co... (MCID) for patient-reported outcome (PRO) instruments used in orthopaedic extremity device-related...

  16. 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).

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

    Energy Technology Data Exchange (ETDEWEB)

    Ceberg, S. [Lund University (Sweden)

    2016-06-15

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

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

    International Nuclear Information System (INIS)

    Ceberg, S.

    2016-01-01

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

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

    NARCIS (Netherlands)

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

    2011-01-01

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

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

    Science.gov (United States)

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

    2017-03-01

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

  1. The Physician Recommendation Coding System (PhyReCS): A Reliable and Valid Method to Quantify the Strength of Physician Recommendations During Clinical Encounters.

    Science.gov (United States)

    Scherr, Karen A; Fagerlin, Angela; Williamson, Lillie D; Davis, J Kelly; Fridman, Ilona; Atyeo, Natalie; Ubel, Peter A

    2017-01-01

    Physicians' recommendations affect patients' treatment choices. However, most research relies on physicians' or patients' retrospective reports of recommendations, which offer a limited perspective and have limitations such as recall bias. To develop a reliable and valid method to measure the strength of physician recommendations using direct observation of clinical encounters. Clinical encounters (n = 257) were recorded as part of a larger study of prostate cancer decision making. We used an iterative process to create the 5-point Physician Recommendation Coding System (PhyReCS). To determine reliability, research assistants double-coded 50 transcripts. To establish content validity, we used 1-way analyses of variance to determine whether relative treatment recommendation scores differed as a function of which treatment patients received. To establish concurrent validity, we examined whether patients' perceived treatment recommendations matched our coded recommendations. The PhyReCS was highly reliable (Krippendorf's alpha = 0.89, 95% CI [0.86, 0.91]). The average relative treatment recommendation score for each treatment was higher for individuals who received that particular treatment. For example, the average relative surgery recommendation score was higher for individuals who received surgery versus radiation (mean difference = 0.98, SE = 0.18, P recommendations matched coded recommendations 81% of the time. The PhyReCS is a reliable and valid way to capture the strength of physician recommendations. We believe that the PhyReCS would be helpful for other researchers who wish to study physician recommendations, an important part of patient decision making. © The Author(s) 2016.

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

    Science.gov (United States)

    Riley, W T; McCranie, E W

    1990-01-01

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

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

    Science.gov (United States)

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

    1995-11-01

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

  4. 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.

  5. The importance of clinical case reports in research

    Directory of Open Access Journals (Sweden)

    Ricardo Pineda-Leguízamo

    2018-04-01

    Full Text Available Clinical case reports correspond to articles that have the lowest level of evidence within different research trials. However, not only are they common and significant in the medical field, but they have often been the basis the generation of research. The purpose of their publication can be scientific or educational. In general terms, the discovery of new diseases, the presentation of rare diseases, unusual forms of common diseases, the complications of a common treatment, or the effect (beneficial or adverse of a treatment, among other things, are narrated in these documents. Clinical case reports continue to be one of the most important sources of knowledge. The advent of a standardized guideline for the creation of this type of reports allows homogenizing the form and content of the cases intended to be described in the near future and, furthermore, will enable authors to have a reference when preparing this type of publications. Case reports are valuable resources of new and unusual information that can encourage and serve to conduct future research studies with a higher level of evidence.

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

    Science.gov (United States)

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

    2013-01-01

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

  7. Reversible left ventricular dysfunction - important clinical problem of contemporary cardiology

    International Nuclear Information System (INIS)

    Witkowski, A.

    1994-01-01

    An important clinical issue there is determination whether left ventricular damages are reversible or not single photon emission computed tomography and positron computed tomography techniques are shown to provide valuable data in this problem. Article describes basic syndromes connected with left ventricular dysfunction, namely: hibernating myocardium, stunned myocardium and ischemic myocardium preconditioning. (author). 18 refs

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2017-01-01

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

  10. 77 FR 75670 - Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services,Inc.

    Science.gov (United States)

    2012-12-21

    ... Registration; Fisher Clinical Services,Inc. By Notice dated September 20, 2012, and published in the Federal Register on October 2, 2012, 77 FR 60143, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown... that the registration of Fisher Clinical Services, Inc., to import the basic class of controlled...

  11. 78 FR 23958 - Importer of Controlled Substances: Notice of Registration; Fisher Clinical Services, Inc.

    Science.gov (United States)

    2013-04-23

    ... Registration; Fisher Clinical Services, Inc. By Notice dated November 27, 2012, and published in the Federal Register on December 5, 2012, 77 FR 72409, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown... the registration of Fisher Clinical Services, Inc., to import the basic class of controlled substance...

  12. 78 FR 5497 - Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services, Inc.

    Science.gov (United States)

    2013-01-25

    ... Registration; Fisher Clinical Services, Inc. By Notice dated November 1, 2012, and published in the Federal Register on November 9, 2012, 77 FR 67396, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown... the registration of Fisher Clinical Services, Inc., to import the basic class of controlled substance...

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

    Science.gov (United States)

    Abbas, Ismail; Rovira, Joan; Casanovas, Josep

    2006-12-01

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

  14. 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.

  15. 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

  16. Validity evidence and reliability of a simulated patient feedback instrument.

    Science.gov (United States)

    Schlegel, Claudia; Woermann, Ulrich; Rethans, Jan-Joost; van der Vleuten, Cees

    2012-01-27

    In the training of healthcare professionals, one of the advantages of communication training with simulated patients (SPs) is the SP's ability to provide direct feedback to students after a simulated clinical encounter. The quality of SP feedback must be monitored, especially because it is well known that feedback can have a profound effect on student performance. Due to the current lack of valid and reliable instruments to assess the quality of SP feedback, our study examined the validity and reliability of one potential instrument, the 'modified Quality of Simulated Patient Feedback Form' (mQSF). Content validity of the mQSF was assessed by inviting experts in the area of simulated clinical encounters to rate the importance of the mQSF items. Moreover, generalizability theory was used to examine the reliability of the mQSF. Our data came from videotapes of clinical encounters between six simulated patients and six students and the ensuing feedback from the SPs to the students. Ten faculty members judged the SP feedback according to the items on the mQSF. Three weeks later, this procedure was repeated with the same faculty members and recordings. All but two items of the mQSF received importance ratings of > 2.5 on a four-point rating scale. A generalizability coefficient of 0.77 was established with two judges observing one encounter. The findings for content validity and reliability with two judges suggest that the mQSF is a valid and reliable instrument to assess the quality of feedback provided by simulated patients.

  17. Clinical skill center: a review of present situation and importance in medical education curriculum

    Directory of Open Access Journals (Sweden)

    Haleh Talaei

    2002-07-01

    Full Text Available Clinical skill centers were designed in 1960, offers innovative, more effective clinical health care and treatment curriculum. Clinical skill center (CSC can provide a special facility for clinical and communication skills practice in a setting outside hospital wards in order to train students with enough confidence of confronting real patients. Learning clinical skills in these centers are not patient-dependent and by practicing on manikins and simulated models errors in real patients can be prevented. Moreover, possible feedback of this method can be used for evaluation and can improve quality and quantity of the education. This review intends to determine the purpose, undertaking, and structure of CSC. The study emphasizes the importance of integrating the clinical skill centers into the teaching curriculum of medical universities. Apparently, organizing clinical skill centers can play an important role for improving the quality and quantity of the educational system and consequently post-graduate performance. The authors recommend this program can be a solution for having both the knowledge and skill of diagnosis and treatment seasonal and rare diseases. Key words clinical skill center, medical education, curriculum

  18. The attitudes of medical students in Europe toward the clinical importance of histology.

    Science.gov (United States)

    Moxham, Bernard John; Emmanouil-Nikoloussi, Elpida; Brenner, Erich; Plaisant, Odile; Brichova, Hana; Kucera, Tomas; Pais, Diogo; Stabile, Isobel; Borg, Jordy; Scholz, Michael; Paulsen, Friedrich; Luis Bueno-López, José; Alfonso Arraez Aybar, Luis; De Caro, Raffaele; Arsic, Stojanka; Lignier, Baptiste; Chirculescu, Andy

    2017-07-01

    Many studies have been undertaken to assess the attitudes of medical students to the clinical importance of gross anatomy. However, much less is known about their attitudes toward the clinical importance of histology. Using Thurstone and Chave methods to assess attitudes, over 2,000 early stage medical students across Europe provided responses to a survey that tested the hypothesis that the students have a high regard for histology's clinical relevance. Regardless of the university and country surveyed, and of the teaching methods employed for histology, our findings were not consistent with our hypotheses, students providing a more moderate assessment of histology's importance compared to gross anatomy but more positive than their attitudes toward embryology. Histology should play a significant role in medical education in terms of appreciating not just normal structure and function but also pathology. We conclude that teachers of histology should pay special attention to informing newly-recruited medical students of the significant role played by histology in attaining clinical competence and in underpinning their status as being learned members of a healthcare profession. This work was conducted under the auspices of the Trans-European Pedagogic Research Group (TEPARG). Clin. Anat. 30:635-643, 2017. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

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

    Science.gov (United States)

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

    2018-04-01

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

  20. [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.

  1. 78 FR 46371 - Importer of Controlled Substances; Notice of Registration; Almac Clinical Services, Inc.

    Science.gov (United States)

    2013-07-31

    ... Register on April 19, 2013, 78 FR 23594, Almac Clinical Services, Inc., (ACSI), 25 Fretz Road, Souderton... registration of Almac Clinical Services, Inc., (ACSI) to import the basic classes of controlled substances is..., conventions, or protocols in effect on May 1, 1971. DEA has investigated Almac Clinical Services, Inc., (ACSI...

  2. 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...

  3. 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

  4. A putative biomarker signature for clinically effective AKT inhibition: correlation of in vitro, in vivo and clinical data identifies the importance of modulation of the mTORC1 pathway.

    Science.gov (United States)

    Cheraghchi-Bashi, Azadeh; Parker, Christine A; Curry, Ed; Salazar, Jean-Frederic; Gungor, Hatice; Saleem, Azeem; Cunnea, Paula; Rama, Nona; Salinas, Cristian; Mills, Gordon B; Morris, Shannon R; Kumar, Rakesh; Gabra, Hani; Stronach, Euan A

    2015-12-08

    Our identification of dysregulation of the AKT pathway in ovarian cancer as a platinum resistance specific event led to a comprehensive analysis of in vitro, in vivo and clinical behaviour of the AKT inhibitor GSK2141795. Proteomic biomarker signatures correlating with effects of GSK2141795 were developed using in vitro and in vivo models, well characterised for related molecular, phenotypic and imaging endpoints. Signatures were validated in temporally paired biopsies from patients treated with GSK2141795 in a clinical study. GSK2141795 caused growth-arrest as single agent in vitro, enhanced cisplatin-induced apoptosis in vitro and reduced tumour volume in combination with platinum in vivo. GSK2141795 treatment in vitro and in vivo resulted in ~50-90% decrease in phospho-PRAS40 and 20-80% decrease in fluoro-deoxyglucose (FDG) uptake. Proteomic analysis of GSK2141795 in vitro and in vivo identified a signature of pathway inhibition including changes in AKT and p38 phosphorylation and total Bim, IGF1R, AR and YB1 levels. In patient biopsies, prior to treatment with GSK2141795 in a phase 1 clinical trial, this signature was predictive of post-treatment changes in the response marker CA125. Development of this signature represents an opportunity to demonstrate the clinical importance of AKT inhibition for re-sensitisation of platinum resistant ovarian cancer to platinum.

  5. CARVEDILOL POPULATION PHARMACOKINETIC ANALYSIS – APPLIED VALIDATION PROCEDURE

    Directory of Open Access Journals (Sweden)

    Aleksandra Catić-Đorđević

    2013-09-01

    Full Text Available Carvedilol is a nonselective beta blocker/alpha-1 blocker, which is used for treatment of essential hypertension, chronic stable angina, unstable angina and ischemic left ventricular dysfunction. The aim of this study was to describe carvedilol population pharmacokinetic (PK analysis as well as the validation of analytical procedure, which is an important step regarding this approach. In contemporary clinical practice, population PK analysis is often more important than standard PK approach in setting a mathematical model that describes the PK parameters. Also, it includes the variables that have particular importance in the drugs pharmacokinetics such as sex, body mass, dosage, pharmaceutical form, pathophysiological state, disease associated with the organism or the presence of a specific polymorphism in the isoenzyme important for biotransformation of the drug. One of the most frequently used approach in population PK analysis is the Nonlinear Modeling of Mixed Effects - NONMEM modeling. Analytical methods used in the data collection period is of great importance for the implementation of a population PK analysis of carvedilol in order to obtain reliable data that can be useful in clinical practice. High performance liquid chromatography (HPLC analysis of carvedilol is used to confirm the identity of a drug and provide quantitative results and also to monitor the efficacy of the therapy. Analytical procedures used in other studies could not be fully implemented in our research as it was necessary to perform certain modification and validation of the method with the aim of using the obtained results for the purpose of a population pharmacokinetic analysis. Validation process is a logical terminal phase of analytical procedure development that provides applicability of the procedure itself. The goal of validation is to ensure consistency of the method and accuracy of results or to confirm the selection of analytical method for a given sample

  6. Clinically important drug interactions with zopiclone, zolpidem and zaleplon.

    Science.gov (United States)

    Hesse, Leah M; von Moltke, Lisa L; Greenblatt, David J

    2003-01-01

    Insomnia, an inability to initiate or maintain sleep, affects approximately one-third of the American population. Conventional benzodiazepines, such as triazolam and midazolam, were the treatment of choice for short-term insomnia for many years but are associated with adverse effects such as rebound insomnia, withdrawal and dependency. The newer hypnosedatives include zolpidem, zaleplon and zopiclone. These agents may be preferred over conventional benzodiazepines to treat short-term insomnia because they may be less likely to cause significant rebound insomnia or tolerance and are as efficacious as the conventional benzodiazepines. This review aims to summarise the published clinical drug interaction studies involving zolpidem, zaleplon and zopiclone. The pharmacokinetic and pharmacodynamic interactions that may be clinically important are highlighted. Clinical trials have studied potential interactions of zaleplon, zolpidem and zopiclone with the following types of drugs: cytochrome P450 (CYP) inducers (rifampicin), CYP inhibitors (azoles, ritonavir and erythromycin), histamine H(2) receptor antagonists (cimetidine and ranitidine), antidepressants, antipsychotics, antagonists of benzodiazepines and drugs causing sedation. Rifampicin significantly induced the metabolism of the newer hypnosedatives and decreased their sedative effects, indicating that a dose increase of these agents may be necessary when they are administered with rifampicin. Ketoconazole, erythromycin and cimetidine inhibited the metabolism of the newer hypnosedatives and enhanced their sedative effects, suggesting that a dose reduction may be required. Addition of ethanol to treatment with the newer hypnosedatives resulted in additive sedative effects without altering the pharmacokinetic parameters of the drugs. Compared with some of the conventional benzodiazepines, fewer clinically important interactions appear to have been reported in the literature with zaleplon, zolpidem and zopiclone. The

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

    National Research Council Canada - National Science Library

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

    2004-01-01

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

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

    National Research Council Canada - National Science Library

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

    2004-01-01

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

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

    Science.gov (United States)

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

    2016-03-01

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

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

    Science.gov (United States)

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

    2017-06-01

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

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

    DEFF Research Database (Denmark)

    Moeller, Stine Bjerrum; Bech, Per

    2018-01-01

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

  12. Burden to importance ratio as a quantitative measure to validate the RISC-3 SSC in OPTION-2

    International Nuclear Information System (INIS)

    Ha, J. S.; Sung, P. H.

    2004-01-01

    A Risk-Informed Safety Significance Categorization (RISSC) is to categorize structures, systems, or components (SSCs) of a Nuclear Power Plant (NPP) into two or more groups, according to their safety significance using both probabilistic and deterministic insights. Recently, OPTION-2 (which is an emerging risk-informed paradigm) recommends that SSCs should be categorized into four groups according to whether they are safety-related or not as well as their safety significance. With the change of 10 CFR 50, safety-related components which categorized into low safety significant SSC (RISC-3 SSC) can be exempted from the existing conservative requirements. Consequently, as OPTION-2 paradigm is applied, a validation process focused on the RISC-3 SSC is needed to assure the categorization results, because most of existing RISSC methods focused on the categorization of the whole SSCs of NPPs based on importance measures obtained from probabilistic and deterministic insights. In this work, Burden to Importance Ratio (BIR) is utilized as a measure for the validation of RISC-3 SSC in OPTION-2. To demonstrate the usefulness of the proposed approach, the approach is applied to 22 components selected from 512 In-Service Test (IST) components of Ulchin unit 3. The results of the application show that the proposed approach is useful for the validation of RISC-3 SSC in OPTION-2

  13. Individualism: a valid and important dimension of cultural differences between nations.

    Science.gov (United States)

    Schimmack, Ulrich; Oishi, Shigehiro; Diener, Ed

    2005-01-01

    Oyserman, Coon, and Kemmelmeier's (2002) meta-analysis suggested problems in the measurement of individualism and collectivism. Studies using Hofstede's individualism scores show little convergent validity with more recent measures of individualism and collectivism. We propose that the lack of convergent validity is due to national differences in response styles. Whereas Hofstede statistically controlled for response styles, Oyserman et al.'s meta-analysis relied on uncorrected ratings. Data from an international student survey demonstrated convergent validity between Hofstede's individualism dimension and horizontal individualism when response styles were statistically controlled, whereas uncorrected scores correlated highly with the individualism scores in Oyserman et al.'s meta-analysis. Uncorrected horizontal individualism scores and meta-analytic individualism scores did not correlate significantly with nations' development, whereas corrected horizontal individualism scores and Hofstede's individualism dimension were significantly correlated with development. This pattern of results suggests that individualism is a valid construct for cross-cultural comparisons, but that the measurement of this construct needs improvement.

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

    Science.gov (United States)

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

    2017-01-01

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

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

    International Nuclear Information System (INIS)

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

    1988-01-01

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

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

    Science.gov (United States)

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

    2014-11-01

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

  17. The importance of Clinical Research

    Directory of Open Access Journals (Sweden)

    Frank Lizaraso Caparó

    2016-01-01

    Full Text Available Objetives: to describe the clinical and epidemiological characteristics, evolution and to identify mortality factors associated in patients with snp.Material and methods: descriptive study of a serie of cases of the intensive care unit (icu of a general hospital. medical records of patients which received medical attention and who meet the selection criteria were reviewed. Results: forty-one clinical records were evaluated. the average age was 69 old, predominantly male (68,3%. snp was the reason of admission in 60.9% and 95.1% required mechanical ventilation. hospital stay prior to diagnosis was 10 days, 65% of patients had some risk factor for multi resistence organisms, cpis of entry was 9.3, cultures were positive in 39% of the cases and of these, 48.8% received proper antibiotic according to culture results. the days of stay in icu were 20.6 days and 20 of the 41 medical records were for death patients. the clinical and epidemiological characteristics were similar between death and alive patients. an analysis of factors that could be associated with mortality snp was made and it was found that for an age ≥ 70 years, the presence of any risk factor for multidrug resistence organism and control cpis ≥ 6 were associated with higher mortality; while acquisition of the icu was associated to lower mortality. Conclusions: the clinical, epidemiological characteristics and evolution of patients with snp in our icu were similar to those describe in the literature. three factors associated with mortality in the icu were identified.

  18. Emerging souvenirs-clinical presentation of the returning traveller with imported arbovirus infections in Europe.

    Science.gov (United States)

    Eckerle, I; Briciu, V T; Ergönül, Ö; Lupşe, M; Papa, A; Radulescu, A; Tsiodras, S; Tsitou, C; Drosten, C; Nussenblatt, V R; Reusken, C B; Sigfrid, L A; Beeching, N J

    2018-03-01

    Arboviruses are an emerging group of viruses that are causing increasing health concerns globally, including in Europe. Clinical presentation usually consists of a nonspecific febrile illness that may be accompanied by rash, arthralgia and arthritis, with or without neurological or haemorrhagic syndromes. The range of differential diagnoses of other infectious and noninfectious aetiologies is broad, presenting a challenge for physicians. While knowledge of the geographical distribution of pathogens and the current epidemiological situation, incubation periods, exposure risk factors and vaccination history can help guide the diagnostic approach, the nonspecific and variable clinical presentation can delay final diagnosis. This narrative review aims to summarize the main clinical and laboratory-based findings of the three most common imported arboviruses in Europe. Evidence is extracted from published literature and clinical expertise of European arbovirus experts. We present three cases that highlight similarities and differences between some of the most common travel-related arboviruses imported to Europe. These include a patient with chikungunya virus infection presenting in Greece, a case of dengue fever in Turkey and a travel-related case of Zika virus infection in Romania. Early diagnosis of travel-imported cases is important to reduce the risk of localized outbreaks of tropical arboviruses such as dengue and chikungunya and the risk of local transmission from body fluids or vertical transmission. Given the global relevance of arboviruses and the continuous risk of (re)emerging arbovirus events, clinicians should be aware of the clinical syndromes of arbovirus fevers and the potential pitfalls in diagnosis. Copyright © 2018. Published by Elsevier Ltd.

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

    Science.gov (United States)

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

    2012-04-15

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

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

    Science.gov (United States)

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

    2018-01-01

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

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

    Science.gov (United States)

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

    2017-05-01

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

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

    Science.gov (United States)

    Winzer, Eva; Luger, Maria; Schindler, Karin

    2018-06-01

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

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

    Science.gov (United States)

    Hall, Emily A; Docherty, Carrie L

    2017-07-01

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

  4. [Clinical analysis of two cases of imported children Zika virus infection in China].

    Science.gov (United States)

    Zheng, C G; Xu, Y; Jiang, H Q; Yin, Y X; Zhang, J H; Zhu, W J; Liang, X J; Chen, M X; Ye, J W; Tan, L M; Luo, D; Gong, S T

    2016-05-01

    To analyze the clinical characteristics, outcome and diagnosis of two cases of imported children Zika virus infection in China. A retrospective analysis was performed on clinical characteristics, treatment and outcome of two cases of imported children with Zika virus infection in February 2016 in Enping People's Hospital of Guangdong. Two cases of children with imported Zika virus infection resided in an affected area of Venezuela, 8-year-old girl and her 6 year-old brother. The main findings on physical examination included the following manifestations: fever, rash, and conjunctivitis. The rash was first limited to the abdomen, but extended to the torso, neck and face, and faded after 3-4 d. The total number of white blood cells was not high and liver function was normal. The diagnosis of two cases of Zika virus infection was confirmed by the expert group of Guangdong Provincial Center for Disease Control and Prevention, according to the epidemiological history, clinical manifestations and Zika virus nucleic acid detection results.Treatment of Zika virus infection involves supportive care. Two Zika virus infection children had a relatively benign outcome. At present, Zika virus infection in children is an imported disease in China. No specific therapy is available for this disease. Information on long-term outcomes among infants and children with Zika virus disease is limited, routine pediatric care is advised for these infants and children.

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

    Science.gov (United States)

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

    2015-07-01

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

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

    Science.gov (United States)

    Dutta, Dipankar

    2016-02-09

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

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

    Science.gov (United States)

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

    2012-01-01

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

  8. Borderline personality disorder subscale (Chinese version) of the structured clinical interview for DSM-IV axis II personality disorders: a validation study in Cantonese-speaking Hong Kong Chinese.

    Science.gov (United States)

    Wong, H M; Chow, L Y

    2011-06-01

    Borderline personality disorder is an important but under-recognised clinical entity, for which there are only a few available diagnostic instruments in the Chinese language. None has been tested for its psychometric properties in the Cantonese-speaking population in Hong Kong. The present study aimed to assess the validity of the Chinese version of the Borderline Personality Disorder subscale of the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders Axis II Personality Disorders (SCID-II) in Cantonese-speaking Hong Kong Chinese. A convenience sampling method was used. The subjects were seen by a multidisciplinary clinical team, who arrived at a best-estimate diagnosis and then by application of the SCID-II rater using the Chinese version of the Borderline Personality Disorder subscale. The study was carried out at the psychiatric clinic of the Prince of Wales Hospital in Hong Kong. A total of 87 patients of Chinese ethnicity aged 18 to 64 years who attended the clinic in April 2007 were recruited. The aforementioned patient parameters were used to examine the internal consistency, best-estimate clinical diagnosis-SCID diagnosis agreement, sensitivity, and specificity of the Chinese version of the subscale. The Borderline Personality Disorder subscale (Chinese version) of SCID-II had an internal consistency of 0.82 (Cronbach's alpha coefficient), best-estimate clinical diagnosis-SCID diagnosis agreement of 0.82 (kappa), sensitivity of 0.92, and specificity of 0.94. The Borderline Personality Disorder subscale (Chinese version) of the SCID-II rater had reasonable validity when applied to Cantonese-speaking Chinese subjects in Hong Kong.

  9. Determination of minimal clinically important change in early and advanced Parkinson's disease.

    Science.gov (United States)

    Hauser, Robert A; Auinger, Peggy

    2011-04-01

    Two common primary efficacy outcome measures in Parkinson's disease (PD) are change in Unified Parkinson's Disease Rating Scale (UPDRS) scores in early PD and change in "off" time in patients with motor fluctuations. Defining the minimal clinically important change (MCIC) in these outcome measures is important to interpret the clinical relevance of changes observed in clinical trials and other situations. We analyzed data from 2 multicenter, placebo-controlled, randomized clinical trials of rasagiline; TEMPO studied 404 early PD subjects, and PRESTO studied 472 levodopa-treated subjects with motor fluctuations. An anchor-based approach using clinical global impression of improvement (CGI-I) was used to determine MCIC for UPDRS scores and daily "off" time. MCIC was defined as mean change in actively treated subjects rated minimally improved on CGI-I. Receiver operating characteristic (ROC) curves defined optimal cutoffs discriminating between changed and unchanged subjects. MCIC for improvement in total UPDRS score (parts I-III) in early PD was determined to be -3.5 points based on mean scores and -3.0 points based on ROC curves. In addition, we found an MCIC for reduction in "off" time of 1.0 hours as defined by mean reduction in "off" time in active treated subjects self-rated as minimally improved on CGI-I minus mean reduction in "off" time in placebo-treated subjects self-rated as unchanged (1.9-0.9 hours). We hypothesize that many methodological factors can influence determination of the MCIC, and a range of values is likely to emerge from multiple studies. Copyright © 2011 Movement Disorder Society.

  10. Important considerations for designing and reporting epidemiologic and clinical studies in dental traumatology

    DEFF Research Database (Denmark)

    Andersson, Lars; Andreasen, Jens O

    2011-01-01

    The purpose of this article is to suggest important considerations for epidemiologic and clinical studies in the field of dental traumatology. The article is based on the authors' experiences from research in this field and editorial board work for the scientific journal Dental Traumatology....... Examples are given of issues where development is important. The importance of planning ahead of the study and consulting with experts in other fields is emphasized....

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

    Directory of Open Access Journals (Sweden)

    Francesco Tosello

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

  12. 77 FR 67396 - Importer of Controlled Substances; Notice of Application, Fisher Clinical Services, Inc.

    Science.gov (United States)

    2012-11-09

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application, Fisher Clinical Services, Inc. Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on August 20, 2012, Fisher Clinical Services, Inc., 7554 Schantz Road, [[Page 67397...

  13. 77 FR 60143 - Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc.

    Science.gov (United States)

    2012-10-02

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc. Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on July 18, 2012, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown...

  14. 77 FR 72409 - Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc.

    Science.gov (United States)

    2012-12-05

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc. Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this is notice that on October 16, 2012, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown...

  15. 78 FR 59064 - Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc.

    Science.gov (United States)

    2013-09-25

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc. Pursuant to Title 21 Code of Federal Regulations (CFR) 1301.34 (a), this is notice that on June 21, 2013, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown...

  16. 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.

  17. Development and initial validity of the in-hand manipulation assessment.

    Science.gov (United States)

    Klymenko, Gabrielle; Liu, Karen P Y; Bissett, Michelle; Fong, Kenneth N K; Welage, Nandana; Wong, Rebecca S M

    2018-04-01

    A review of the literature related to in-hand manipulation (IHM) revealed that there is no assessment which specifically measures this construct in the adult population. This study reports the face and content validity of an IHM assessment for adults with impaired hand function based on expert opinion. The definition of IHM skills, assessment tasks and scoring methods identified from literature was discussed in a focus group (n = 4) to establish face validity. An expert panel (n = 16) reviewed the content validity of the proposed assessment; evaluating the representativeness and relevance of encompassing the IHM skills in the proposed assessment tasks, the clarity and importance to daily life of the task and the clarity and applicability to clinical environment of the scoring method. The content validity was calculated using the content validity index for both the individual task and all tasks together (I-CVI and S-CVI). Feedback was incorporated to create the assessment. The focus group members agreed to include 10 assessment tasks that covered all IHM skills. In the expert panel review, all tasks received an I-CVI above 0.78 and S-CVI above 0.80 in representativeness and relevance ratings, representing good content validity. With the comments from the expert panel, tasks were modified to improve the clarity and importance to daily life. A four-point Likert scale was identified for assessing both the completion of the assessment tasks and the quality of IHM skills within the task performance. Face and content validity were established in this new IHM assessment. Further studies to examine psychometric properties and use within clinical practice are recommended. © 2018 Occupational Therapy Australia.

  18. Treatment Fidelity: Its Importance and Reported Frequency in Aphasia Treatment Studies

    Science.gov (United States)

    Hinckley, Jacqueline J.; Douglas, Natalie F.

    2013-01-01

    Purpose: Treatment fidelity is a measure of the reliability of the administration of an intervention in a treatment study. It is an important aspect of the validity of a research study, and it has implications for the ultimate implementation of evidence-supported interventions in typical clinical settings. Method: Aphasia treatment studies…

  19. Importance of Computer Model Validation in Pyroprocessing Technology Development

    Energy Technology Data Exchange (ETDEWEB)

    Jung, Y. E.; Li, Hui; Yim, M. S. [Korea Advanced Institute of Science and Technology, Daejeon (Korea, Republic of)

    2014-05-15

    In this research, we developed a plan for experimental validation of one of the computer models developed for ER process modeling, i. e., the ERAD code. Several candidate surrogate materials are selected for the experiment considering the chemical and physical properties. Molten salt-based pyroprocessing technology is being examined internationally as an alternative to treat spent nuclear fuel over aqueous technology. The central process in pyroprocessing is electrorefining(ER) which separates uranium from transuranic elements and fission products present in spent nuclear fuel. ER is a widely used process in the minerals industry to purify impure metals. Studies of ER by using actual spent nuclear fuel materials are problematic for both technical and political reasons. Therefore, the initial effort for ER process optimization is made by using computer models. A number of models have been developed for this purpose. But as validation of these models is incomplete and often times problematic, the simulation results from these models are inherently uncertain.

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

    Science.gov (United States)

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

    2017-08-01

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

  1. Validation of the 'United Registries for Clinical Assessment and Research' [UR-CARE], a European Online Registry for Clinical Care and Research in Inflammatory Bowel Disease.

    Science.gov (United States)

    Burisch, Johan; Gisbert, Javier P; Siegmund, Britta; Bettenworth, Dominik; Thomsen, Sandra Bohn; Cleynen, Isabelle; Cremer, Anneline; Ding, Nik John Sheng; Furfaro, Federica; Galanopoulos, Michail; Grunert, Philip Christian; Hanzel, Jurij; Ivanovski, Tamara Knezevic; Krustins, Eduards; Noor, Nurulamin; O'Morain, Neil; Rodríguez-Lago, Iago; Scharl, Michael; Tua, Julia; Uzzan, Mathieu; Ali Yassin, Nuha; Baert, Filip; Langholz, Ebbe

    2018-04-27

    The 'United Registries for Clinical Assessment and Research' [UR-CARE] database is an initiative of the European Crohn's and Colitis Organisation [ECCO] to facilitate daily patient care and research studies in inflammatory bowel disease [IBD]. Herein, we sought to validate the database by using fictional case histories of patients with IBD that were to be entered by observers of varying experience in IBD. Nineteen observers entered five patient case histories into the database. After 6 weeks, all observers entered the same case histories again. For each case history, 20 key variables were selected to calculate the accuracy for each observer. We assumed that the database was such that ≥ 90% of the entered data would be correct. The overall proportion of correctly entered data was calculated using a beta-binomial regression model to account for inter-observer variation and compared to the expected level of validity. Re-test reliability was assessed using McNemar's test. For all case histories, the overall proportion of correctly entered items and their confidence intervals included the target of 90% (Case 1: 92% [88-94%]; Case 2: 87% [83-91%]; Case 3: 93% [90-95%]; Case 4: 97% [94-99%]; Case 5: 91% [87-93%]). These numbers did not differ significantly from those found 6 weeks later [NcNemar's test p > 0.05]. The UR-CARE database appears to be feasible, valid and reliable as a tool and easy to use regardless of prior user experience and level of clinical IBD experience. UR-CARE has the potential to enhance future European collaborations regarding clinical research in IBD.

  2. Incidental extracerebral findings on brain nonenhanced magnetic resonance imaging: frequency, nondetection rate, and clinical importance

    Energy Technology Data Exchange (ETDEWEB)

    Wang, Ming-Liang; Wei, Xiao-Er [School of Medicine, Department of Radiology, Shanghai Jiao Tong University Affiliated Sixth People' s Hospital, Shanghai (China); Lu, Li-Yan [Nanjing Medical University, Department of Radiology, Nanjing First Hospital, Nanjing (China); Li, Wen-Bin [School of Medicine, Department of Radiology, Shanghai Jiao Tong University Affiliated Sixth People' s Hospital, Shanghai (China); Kashgar Prefecture Second People' s Hospital, Imaging Center, Kashgar (China)

    2017-03-15

    This study aims to elucidate the frequency, nondetection rate, and clinical importance of incidental extracerebral findings (IECFs) on brain nonenhanced magnetic resonance imaging (MRI). A total of 8284 brain MRIs performed between January 1, 2015 and December 31, 2015 were evaluated for the presence of IECFs and the distribution of IECFs was analyzed. IECFs were categorized as E1 (clinically unimportant, e.g., sinus mucosal thickening); E2 (likely unimportant, e.g., pharyngeal mucosal symmetrical thickening); and E3 (potentially important, e.g., pharyngeal mucosal asymmetrical thickening). The nondetection rate was determined by comparing the results of the structured approach with the initial MRI reports. The medical records were examined for patients with E3 IECFs to assess clinical importance and outcome of these lesions. A total of 5992 IECFs were found in 4469 of the 8284 patients (54.0%). E1 findings constituted 82.2% (4924/5992) of all IECFs; E2 constituted 16.6% (995/5992) and E3 constituted 1.2% (73/5992). Overall IECFs and E1 findings were significantly more common in male patients (P < 0.05). Statistically significant difference was also seen between the different age groups (P < 0.001). The nondetection rate was 56.9% (3409/5992) for overall IECFs and 32.9% (24/73) for E3 IECFs. Of the 73 patients with E3 IECFs, 34 (46.6%) received final diagnosis and appropriate treatment during the study period. IECFs are prevalent in clinical patients on brain MR images with a nondetection rate of 32.9% for potentially important (E3) findings. The reporting of IECFs according to clinical importance is helpful for patients' management. (orig.)

  3. 77 FR 50162 - Importer of Controlled Substances; Notice of Registration; Almac Clinical Services, Inc.

    Science.gov (United States)

    2012-08-20

    ... Register on April 26, 2012, 77 FR 24985, Almac Clinical Services, Inc., (ACSI), 25 Fretz Road, Souderton... that the registration of Almac Clinical Services, Inc. (ACSI) to import the basic classes of controlled..., Inc. (ACSI) to ensure that the company's registration is consistent with the public interest. The...

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

    Science.gov (United States)

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

    2017-05-18

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

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

    Directory of Open Access Journals (Sweden)

    Matthijs Lipperts

    2017-10-01

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

  6. A leprosy clinical severity scale for erythema nodosum leprosum: An international, multicentre validation study of the ENLIST ENL Severity Scale.

    Science.gov (United States)

    Walker, Stephen L; Sales, Anna M; Butlin, C Ruth; Shah, Mahesh; Maghanoy, Armi; Lambert, Saba M; Darlong, Joydeepa; Rozario, Benjamin Jewel; Pai, Vivek V; Balagon, Marivic; Doni, Shimelis N; Hagge, Deanna A; Nery, José A C; Neupane, Kapil D; Baral, Suwash; Sangma, Biliom A; Alembo, Digafe T; Yetaye, Abeba M; Hassan, Belaynesh A; Shelemo, Mohammed B; Nicholls, Peter G; Lockwood, Diana N J

    2017-07-01

    We wished to validate our recently devised 16-item ENLIST ENL Severity Scale, a clinical tool for measuring the severity of the serious leprosy associated complication of erythema nodosum leprosum (ENL). We also wished to assess the responsiveness of the ENLIST ENL Severity Scale in detecting clinical change in patients with ENL. Participants, recruited from seven centres in six leprosy endemic countries, were assessed using the ENLIST ENL Severity Scale by two researchers, one of whom categorised the severity of ENL. At a subsequent visit a further assessment using the scale was made and both participant and physician rated the change in ENL using the subjective categories of "Much better", "somewhat better", "somewhat worse" and "much worse" compared with "No change" or "about the same". 447 participants were assessed with the ENLIST ENL Severity Scale. The Cronbach alpha of the scale and each item was calculated to determine the internal consistency of the scale. The ENLIST ENL Severity Scale had good internal consistency and this improved following removal of six items to give a Cronbach's alpha of 0.77. The cut off between mild ENL and more severe disease was 9 determined using ROC curves. The minimal important difference of the scale was determined to be 5 using both participant and physician ratings of change. The 10-item ENLIST ENL Severity Scale is the first valid, reliable and responsive measure of ENL severity and improves our ability to assess and compare patients and their treatments in this severe and difficult to manage complication of leprosy. The ENLIST ENL Severity Scale will assist physicians in the monitoring and treatment of patients with ENL. The ENLIST ENL Severity Scale is easy to apply and will be useful as an outcome measure in treatment studies and enable the standardisation of other clinical and laboratory ENL research.

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Pilar Cacho-Martínez

    2013-01-01

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

  9. Important considerations for designing and reporting epidemiologic and clinical studies in dental traumatology.

    Science.gov (United States)

    Andersson, Lars; Andreasen, Jens O

    2011-08-01

    The purpose of this article is to suggest important considerations for epidemiologic and clinical studies in the field of dental traumatology. The article is based on the authors' experiences from research in this field and editorial board work for the scientific journal Dental Traumatology. Examples are given of issues where development is important. The importance of planning ahead of the study and consulting with experts in other fields is emphasized. © 2011 John Wiley & Sons A/S.

  10. Minimal clinically important difference and the effect of clinical variables on the ankle osteoarthritis scale in surgically treated end-stage ankle arthritis.

    Science.gov (United States)

    Coe, Marcus P; Sutherland, Jason M; Penner, Murray J; Younger, Alastair; Wing, Kevin J

    2015-05-20

    There is much debate regarding the best outcome tool for use in foot and ankle surgery, specifically in patients with ankle arthritis. The Ankle Osteoarthritis Scale (AOS) is a validated, disease-specific score. The goals of this study were to investigate the clinical performance of the AOS and to determine a minimal clinically important difference (MCID) for it, using a large cohort of 238 patients undergoing surgery for end-stage ankle arthritis. Patients treated with total ankle arthroplasty or ankle arthrodesis were prospectively followed for a minimum of two years at a single site. Data on demographics, comorbidities, AOS score, Short Form-36 results, and the relationship between expectations and satisfaction were collected at baseline (preoperatively), at six and twelve months, and then yearly thereafter. A linear regression analysis examined the variables affecting the change in AOS scores between baseline and the two-year follow-up. An MCID in the AOS change score was then determined by employing an anchor question, which asked patients to rate their relief from symptoms after surgery. Surgical treatment of end-stage ankle arthritis resulted in a mean improvement (and standard deviation) of 31.2 ± 22.7 points in the AOS score two years after surgery. The MCID of the AOS change score was a mean of 28.0 ± 17.9 points. The change in AOS score was significantly affected by the preoperative AOS score, smoking, back pain, and age. Patients undergoing arthroplasty or arthrodesis for end-stage ankle arthritis experienced a mean improvement in AOS score that was greater than the estimated MCID (31.2 versus 28.0 points). Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.

  11. 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...

  12. What Constitutes a Clinically Important Pain Reduction in Patients after Third Molar Surgery?

    Directory of Open Access Journals (Sweden)

    Wilhelmus JJM Martin

    2013-01-01

    Full Text Available BACKGROUND: For patients with surgical third molar removal, it is unknown what constitutes a clinically important change in patients’ visual analogue scale (VAS reports of pain intensity.

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

    Science.gov (United States)

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

    2014-01-01

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

  14. Predictors, Prognosis, and Management of New Clinically Important Atrial Fibrillation After Noncardiac Surgery: A Prospective Cohort Study.

    Science.gov (United States)

    Alonso-Coello, Pablo; Cook, Deborah; Xu, Shou Chun; Sigamani, Alben; Berwanger, Otavio; Sivakumaran, Soori; Yang, Homer; Xavier, Denis; Martinez, Luz Ximena; Ibarra, Pedro; Rao-Melacini, Purnima; Pogue, Janice; Zarnke, Kelly; Paniagua, Pilar; Ostrander, Jack; Yusuf, Salim; Devereaux, P J

    2017-07-01

    Despite the frequency of new clinically important atrial fibrillation (AF) after noncardiac surgery and its increased association with the risk of stroke at 30 days, there are limited data informing their prediction, association with outcomes, and management. We used the data from the PeriOperative ISchemic Evaluation trial to determine, in patients undergoing noncardiac surgery, the association of new clinically important AF with 30-day outcomes, and to assess management of these patients. We also aimed to derive a clinical prediction rule for new clinically important AF in this population. We defined new clinically important AF as new AF that resulted in symptoms or required treatment. We recorded an electrocardiogram 6 to 12 hours postoperatively and on the 1st, 2nd, and 30th days after surgery. A total of 211 (2.5% [8351 patients]; 95% confidence interval, 2.2%-2.9%) patients developed new clinically important AF within 30 days of randomization (8140 did not develop new AF). AF was independently associated with an increased length of hospital stay by 6.0 days (95% confidence interval, 3.5-8.5 days) and vascular complications (eg, stroke or congestive heart failure). The usage of an oral anticoagulant at the time of hospital discharge among patients with new AF and a CHADS2 score of 0, 1, 2, 3, and ≥4 was 6.9%, 10.2%, 23.0%, 9.4%, and 33.3%, respectively. Two independent predictors of patients developing new clinically important AF were identified (ie, age and surgery). The prediction rule included the following factors and assigned weights: age ≥85 years (4 points), age 75 to 84 years (3 points), age 65 to 74 years (2 points), intrathoracic surgery (3 points), major vascular surgery (2 points), and intra-abdominal surgery (1 point). The incidence of new AF based on scores of 0 to 1, 2, 3 to 4, and 5 to 6 was 0.5%, 1.0%, 3.1%, and 5.3%, respectively. Age and surgery are independent predictors of new clinically important AF in the perioperative setting. A

  15. Opioid detoxification : from controlled clinical trial to clinical practice

    NARCIS (Netherlands)

    Dijkstra, Boukje A G; De Jong, Cor A J; Wensing, Michel; Krabbe, Paul F M; van der Staak, Cees P F

    2010-01-01

    Controlled clinical trials have high internal validity but suffer from difficulties in external validity. This study evaluates the generalizability of the results of a controlled clinical trial on rapid detoxification in the everyday clinical practice of two addiction treatment centers. The results

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

    Science.gov (United States)

    Miguel, Susana; Caldeira, Sílvia; Vieira, Margarida

    2018-04-01

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

  17. 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.

  18. Clinical global impression of cognition in schizophrenia (CGI-CogS): reliability and validity of a co-primary measure of cognition.

    Science.gov (United States)

    Ventura, Joseph; Cienfuegos, Angel; Boxer, Oren; Bilder, Robert

    2008-11-01

    Cognitive deficits are core features of schizophrenia that have been associated reliably with functional outcomes and now are a focus of treatment research. New rating scales are needed to complement current psychometric testing procedures, both to enable wider clinical use, and to serve as endpoints in clinical trials. Subjects were 35 schizophrenia patient-and-caregiver pairs recruited from the UCLA and West Los Angeles VA Outpatient Psychiatry Departments. Participants were assessed with the Clinical Global Impression of Cognition in Schizophrenia (CGI-CogS), an interview-based rating scale of cognitive functioning, on 3 occasions (baseline, 1 month, and 3 months). A computerized neurocognitive battery (Cogtest), an assessment of functioning, and symptom measures were administered at two occasions (baseline and one month). The CGI-CogS ratings generally showed a high level of internal consistency (Cronbach's alpha=.69 to .96), adequate levels of inter-rater reliability (ICC's=.71 to .80), and high test-retest stability (ICC's=.92 to .95). Correlations of caregiver and rater global (but not "patient only rating") CGI-CogS ratings with neurocognitive performance were in the moderate range (r's=-.27 to -.48), while most of the correlations with functional outcome were moderate to high (r's=-.41 to -.72). In fact, the CGI-CogS ratings were significantly more correlated with Social Functioning than were objective neurocognitive test scores (p=.02) and showed a trend in the same direction for predicting Instrumental Functioning (p=.06). We found moderate correlations between CGI-CogS global ratings and PANSS positive (r's=.36 to .49) and SANS negative symptoms (r=.41 to .61), but not with BPRS depression (r's=.11 to .13). An interview-based measure of cognition demonstrated high internal consistency, good inter-rater reliability, and high test-retest reliability. Caregiver ratings appear to add important clinical information over patient-only ratings. The CGI

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

    Science.gov (United States)

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

    2016-07-01

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

  20. Vitamin D binding protein: a multifunctional protein of clinical importance.

    Science.gov (United States)

    Speeckaert, Marijn M; Speeckaert, Reinhart; van Geel, Nanja; Delanghe, Joris R

    2014-01-01

    Since the discovery of group-specific component and its polymorphism by Hirschfeld in 1959, research has put spotlight on this multifunctional transport protein (vitamin D binding protein, DBP). Besides the transport of vitamin D metabolites, DBP is a plasma glycoprotein with many important functions, including sequestration of actin, modulation of immune and inflammatory responses, binding of fatty acids, and control of bone development. A considerable DBP polymorphism has been described with a specific allele distribution in different geographic area. Multiple studies have shed light on the interesting relationship between polymorphisms of the DBP gene and the susceptibility to diseases. In this review, we give an overview of the multifunctional character of DBP and describe the clinical importance of DBP and its polymorphisms. Finally, we discuss the possibilities to use DBP as a novel therapeutic agent.

  1. Descriptive analysis of the verbal behavior of a therapist: a known-group validity analysis of the putative behavioral functions involved in clinical interaction.

    Science.gov (United States)

    Virues-Ortega, Javier; Montaño-Fidalgo, Montserrat; Froján-Parga, María Xesús; Calero-Elvira, Ana

    2011-12-01

    This study analyzes the interobserver agreement and hypothesis-based known-group validity of the Therapist's Verbal Behavior Category System (SISC-INTER). The SISC-INTER is a behavioral observation protocol comprised of a set of verbal categories representing putative behavioral functions of the in-session verbal behavior of a therapist (e.g., discriminative, reinforcing, punishing, and motivational operations). The complete therapeutic process of a clinical case of an individual with marital problems was recorded (10 sessions, 8 hours), and data were arranged in a temporal sequence using 10-min periods. Hypotheses based on the expected performance of the putative behavioral functions portrayed by the SISC-INTER codes across prevalent clinical activities (i.e., assessing, explaining, Socratic method, providing clinical guidance) were tested using autoregressive integrated moving average (ARIMA) models. Known-group validity analyses provided support to all hypotheses. The SISC-INTER may be a useful tool to describe therapist-client interaction in operant terms. The utility of reliable and valid protocols for the descriptive analysis of clinical practice in terms of verbal behavior is discussed. Copyright © 2011. Published by Elsevier Ltd.

  2. Methodology and tools for independent verification and validation of computerized I and C systems important to safety

    International Nuclear Information System (INIS)

    Lindner, A.; Miedl, H.

    1998-01-01

    Modular software based I and C systems are state-of-the-art in industrial automation. For I and C systems important to safety in nuclear power plants, software based systems are also more and more applied. According to existing national and international guidelines and standards, the assessment of these systems calls for appropriate test methods and tools. By use of tools quality of the assessment process should be improved and expense should be limited. The paper outlines the structure of the independent verification and validation (V and V) process of the Teleperm XS system and the lessons learnt from this process. Furthermore, tools are discussed used for V and V of the Teleperm XS software. The recently developed tool VALIDATOR, dedicated to V and V of the plant specific I and C functions is described in more detail. We consider V and V of the basic software components and the system software to be required only once, but the C source codes of the plant specific functional diagrams have to be checked for each application separately. The VALIDATOR is designed to perform this task. It gives evidence of compliance of the automatically generated C source codes with the graphical design of the functional diagrams in reasonable time and with acceptable costs. The working method, performance and results of the VALIDATOR are shown by means of an actual example. (author)

  3. What is clinical leadership and why might it be important in dentistry?

    Science.gov (United States)

    Brocklehurst, P; Ferguson, J; Taylor, N; Tickle, M

    2013-03-01

    The concept of leadership means different things to different people. At present there is no single definition of leadership nor an established theoretical approach. Despite this, leadership in the clinical environment is becoming increasingly cited as an important component in the transition of the National Health Service (NHS) and in the development of clinician led services. In medicine, clinical commissioning groups (CCGs) will soon be operational and the Department of Health (DH) seeks to establish a similar approach in dentistry, where local clinicians drive forward a quality agenda with a focus on patient outcomes. To facilitate this, the NHS Commissioning Board (NHSCB) are in the process of developing Local Professional Networks (LPNs) for dentistry. Given this shift towards localism and clinician led services it would appear that leadership will have a significant role in both medicine and dentistry. This paper explores what leadership is, before determining why it might be important in providing a clinician-led, patient-based and outcomes-focused service.

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

    Science.gov (United States)

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

    2016-08-01

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

  5. Translation and cultural validation of clinical observational scales - the Fugl-Meyer assessment for post stroke sensorimotor function in Colombian Spanish.

    Science.gov (United States)

    Barbosa, Nubia E; Forero, Sandra M; Galeano, Claudia P; Hernández, Edgar D; Landinez, Nancy S; Sunnerhagen, Katharina S; Alt Murphy, Margit

    2018-04-24

    Fugl-Meyer Assessment (FMA) is the most widely used and recommended clinical scale for evaluation of sensorimotor impairment post stroke, but an official Spanish version is not available today. This study aimed to establish methodological structure for translation and cultural adaptation process and perform a transcultural validation of the upper and lower extremity FMA to Colombian Spanish. Procedures included forward and backward translation, step-wise reviewing by bilingual and professional experts to ensure conceptual and semantic equivalence. Validation included a pilot evaluation of item-level agreement on 10 individuals with stroke at the Central Military Hospital of Colombia. Comprehensive step-wise procedure for transcultural validation was established. Low agreement (less than 70%) was detected for items assessing arm movements within synergies and for coordination/speed subscale. All points of disagreement were systematically reviewed and agreed upon when drafting the final version of the Spanish FMA. Use of FMA will allow unified description of stroke severity and motor recovery in Spanish speaking countries. This will open up possibility to compare stroke and rehabilitation outcomes with other countries and regions world-wide. Comprehensive methodological procedures provided can facilitate introduction of well-established clinical scales in other languages. Implications for Rehabilitation The Fugl-Meyer Assessment (FMA) of upper and lower extremity is the most used and recommended clinical scale for evaluation of sensorimotor impairment after stroke. The Spanish version of FMA, validated in this study, is now first time available for use in research and clinical practice. Use of FMA will allow unified description of stroke severity and motor recovery in Spanish speaking countries, which in turn opens up possibility to compare stroke and rehabilitation outcomes with other countries and regions world-wide.

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

    Science.gov (United States)

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

    2010-06-01

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

  7. Initial clinical validation of Health Heritage, a patient-facing tool for personal and family history collection and cancer risk assessment.

    Science.gov (United States)

    Baumgart, Leigh A; Postula, Kristen J Vogel; Knaus, William A

    2016-04-01

    Personal and family health histories remain important independent risk factors for cancer; however they are currently not being well collected or used effectively. Health Heritage was designed to address this need. The purpose of this study was to validate the ability of Health Heritage to identify patients appropriate for further genetic evaluation and to accurately stratify cancer risk. A retrospective chart review was conducted on 100 random patients seen at an adult genetics clinic presenting with concern for an inherited predisposition to cancer. Relevant personal and family history obtained from the patients' medical records was entered into Health Heritage. Recommendations by Health Heritage were compared to national guidelines of eligibility for genetic evaluation. Agreement between Health Heritage referral for genetic evaluation and guideline eligibility for genetic evaluation was 97% (sensitivity 98% and specificity 88%). Risk stratification for cancer was also compared between Health Heritage and those documented by a geneticist. For patients at increased risk for breast, ovarian, or colorectal cancer as determined by the geneticist, risk stratification by Health Heritage agreed 90, 93, and 75%, respectively. Discordances in risk stratification were attributed to both complex situations better handled by the geneticist and Health Heritage's adherence to incorporating all information into its algorithms. Health Heritage is a clinically valid tool to identify patients appropriate for further genetic evaluation and to encourage them to confirm the assessment and management recommendations with cancer genetic experts. Health Heritage also provides an estimate of cancer risk that is complementary to a genetics team.

  8. Clinical importance of voluntary and induced Bennett movement.

    Science.gov (United States)

    Tupac, R G

    1978-07-01

    A total of 136 dentulous patients were divided into three groups for purposes of quantitative pantographic comparison of voluntary and induced Bennett movement. The effects of patient age and operator experience on recording the Bennett movement were also studied. The results indicates that for patients studied with Bennett movement iduced in the manner described: 1. Experienced operators can obtain more induced Bennett movement that inexperienced operators. 2. Inducing Bennett movement has a greater effect on the immediate side shift component than it has on the progressive side shift component. 3. For older individuals the amount and direction of induced immediate side shift is greater than for younger patients, statistically highly significant, and therefore clinically important. In conclusion, if the objective of a pantographic survey is to record the complete capacity of the joint to move, *lateral jaw movements must be induced.

  9. Reconceptualising the external validity of discrete choice experiments.

    Science.gov (United States)

    Lancsar, Emily; Swait, Joffre

    2014-10-01

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

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

    DEFF Research Database (Denmark)

    Lescai, Francesco; Marasco, Elena; Bacchelli, Chiara

    2014-01-01

    The choice of an appropriate variant calling pipeline for exome sequencing data is becoming increasingly more important in translational medicine projects and clinical contexts. Within GOSgene, which facilitates genetic analysis as part of a joint effort of the University College London and the G...

  11. Health status measurement in COPD: the minimal clinically important difference of the clinical COPD questionnaire

    Directory of Open Access Journals (Sweden)

    van den Berg JWK

    2006-04-01

    Full Text Available Abstract Background Patient-reported outcomes (PRO questionnaires are being increasingly used in COPD clinical studies. The challenge facing investigators is to determine what change is significant, ie what is the minimal clinically important difference (MCID. This study aimed to identify the MCID for the clinical COPD questionnaire (CCQ in terms of patient referencing, criterion referencing, and by the standard error of measurement (SEM. Methods Patients were ≥40 years of age, diagnosed with COPD, had a smoking history of >10 pack-years, and were participating in a randomized, controlled clinical trial comparing intravenous and oral prednisolone in patients admitted with an acute exacerbation of COPD. The CCQ was completed on Days 1–7 and 42. A Global Rating of Change (GRC assessment was taken to establish the MCID by patient referencing. For criterion referencing, health events during a period of 1 year after Day 42 were included in this analysis. Results 210 patients were recruited, 168 completed the CCQ questionnaire on Day42. The MCID of the CCQ total score, as indicated by patient referencing in terms of the GRC, was 0.44. The MCID of the CCQ in terms of criterion referencing for the major outcomes was 0.39, and calculation of the SEM resulted in a value of 0.21. Conclusion This investigation, which is the first to determine the MCID of a PRO questionnaire via more than one approach, indicates that the MCID of the CCQ total score is 0.4.

  12. Clinical utility of measures of breathlessness.

    Science.gov (United States)

    Cullen, Deborah L; Rodak, Bernadette

    2002-09-01

    The clinical utility of measures of dyspnea has been debated in the health care community. Although breathlessness can be evaluated with various instruments, the most effective dyspnea measurement tool for patients with chronic lung disease or for measuring treatment effectiveness remains uncertain. Understanding the evidence for the validity and reliability of these instruments may provide a basis for appropriate clinical application. Evaluate instruments designed to measure breathlessness, either as single-symptom or multidimensional instruments, based on psychometrics foundations such as validity, reliability, and discriminative and evaluative properties. Classification of each dyspnea measurement instrument will recommend clinical application in terms of exercise, benchmarking patients, activities of daily living, patient outcomes, clinical trials, and responsiveness to treatment. Eleven dyspnea measurement instruments were selected. Each instrument was assessed as discriminative or evaluative and then analyzed as to its psychometric properties and purpose of design. Descriptive data from all studies were described according to their primary patient application (ie, chronic obstructive pulmonary disease, asthma, or other patient populations). The Borg Scale and the Visual Analogue Scale are applicable to exertion and thus can be applied to any cardiopulmonary patient to determine dyspnea. All other measures were determined appropriate for chronic obstructive pulmonary disease, whereas the Shortness of Breath Questionnaire can be applied to cystic fibrosis and lung transplant patients. The most appropriate utility for all instruments was measuring the effects on activities of daily living and for benchmarking patient progress. Instruments that quantify function and health-related quality of life have great utility for documenting outcomes but may be limited as to documenting treatment responsiveness in terms of clinically important changes. The dyspnea

  13. eCOMPAGT integrates mtDNA: import, validation and export of mitochondrial DNA profiles for population genetics, tumour dynamics and genotype-phenotype association studies

    Directory of Open Access Journals (Sweden)

    Specht Günther

    2010-03-01

    Full Text Available Abstract Background Mitochondrial DNA (mtDNA is widely being used for population genetics, forensic DNA fingerprinting and clinical disease association studies. The recent past has uncovered severe problems with mtDNA genotyping, not only due to the genotyping method itself, but mainly to the post-lab transcription, storage and report of mtDNA genotypes. Description eCOMPAGT, a system to store, administer and connect phenotype data to all kinds of genotype data is now enhanced by the possibility of storing mtDNA profiles and allowing their validation, linking to phenotypes and export as numerous formats. mtDNA profiles can be imported from different sequence evaluation programs, compared between evaluations and their haplogroup affiliations stored. Furthermore, eCOMPAGT has been improved in its sophisticated transparency (support of MySQL and Oracle, security aspects (by using database technology and the option to import, manage and store genotypes derived from various genotyping methods (SNPlex, TaqMan, and STRs. It is a software solution designed for project management, laboratory work and the evaluation process all-in-one. Conclusions The extended mtDNA version of eCOMPAGT was designed to enable error-free post-laboratory data handling of human mtDNA profiles. This software is suited for small to medium-sized human genetic, forensic and clinical genetic laboratories. The direct support of MySQL and the improved database security options render eCOMPAGT a powerful tool to build an automated workflow architecture for several genotyping methods. eCOMPAGT is freely available at http://dbis-informatik.uibk.ac.at/ecompagt.

  14. eCOMPAGT integrates mtDNA: import, validation and export of mitochondrial DNA profiles for population genetics, tumour dynamics and genotype-phenotype association studies.

    Science.gov (United States)

    Weissensteiner, Hansi; Schönherr, Sebastian; Specht, Günther; Kronenberg, Florian; Brandstätter, Anita

    2010-03-09

    Mitochondrial DNA (mtDNA) is widely being used for population genetics, forensic DNA fingerprinting and clinical disease association studies. The recent past has uncovered severe problems with mtDNA genotyping, not only due to the genotyping method itself, but mainly to the post-lab transcription, storage and report of mtDNA genotypes. eCOMPAGT, a system to store, administer and connect phenotype data to all kinds of genotype data is now enhanced by the possibility of storing mtDNA profiles and allowing their validation, linking to phenotypes and export as numerous formats. mtDNA profiles can be imported from different sequence evaluation programs, compared between evaluations and their haplogroup affiliations stored. Furthermore, eCOMPAGT has been improved in its sophisticated transparency (support of MySQL and Oracle), security aspects (by using database technology) and the option to import, manage and store genotypes derived from various genotyping methods (SNPlex, TaqMan, and STRs). It is a software solution designed for project management, laboratory work and the evaluation process all-in-one. The extended mtDNA version of eCOMPAGT was designed to enable error-free post-laboratory data handling of human mtDNA profiles. This software is suited for small to medium-sized human genetic, forensic and clinical genetic laboratories. The direct support of MySQL and the improved database security options render eCOMPAGT a powerful tool to build an automated workflow architecture for several genotyping methods. eCOMPAGT is freely available at http://dbis-informatik.uibk.ac.at/ecompagt.

  15. The comparative importance of books: clinical psychology in the health sciences library.

    Science.gov (United States)

    Wehmeyer, J M; Wehmeyer, S

    1999-01-01

    Clinical psychology has received little attention as a subject in health sciences library collections. This study seeks to demonstrate the relative importance of the monographic literature to clinical psychology through the examination of citations in graduate student theses and dissertations at the Fordham Health Sciences Library, Wright State University. Dissertations and theses were sampled randomly; citations were classified by format, counted, and subjected to statistical analysis. Books and book chapters together account for 35% of the citations in clinical psychology dissertations, 25% in nursing theses, and 8% in biomedical sciences theses and dissertations. Analysis of variance indicates that the citations in dissertations and theses in the three areas differ significantly (F = 162.2 with 2 and 253 degrees of freedom, P = 0.0001). Dissertations and theses in biomedical sciences and nursing theses both cite significantly more journals per book than the dissertations in clinical psychology. These results support the hypothesis that users of clinical psychology literature rely more heavily on books than many other users of a health sciences library. Problems with using citation analyses in a single subject to determine a serials to monographs ratio for a health sciences library are pointed out. PMID:10219478

  16. 77 FR 24985 - Importer of Controlled Substances; Notice of Application; Almac Clinical Services, Inc., (ACSI)

    Science.gov (United States)

    2012-04-26

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Almac Clinical Services, Inc., (ACSI) Pursuant to 21 U.S.C. 958(i), the Attorney General shall... on March 5, 2012, Almac Clinical Services, Inc., (ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964...

  17. The mollusks in zootherapy: traditional medicine and clinical-pharmacological importance

    Directory of Open Access Journals (Sweden)

    Eraldo Medeiros Costa Neto

    2006-09-01

    Full Text Available The use of animals as sources of medicines is a cross-cultural phenomenon that is historically ancient and geographically widespread. This article reviews the use of mollusks in traditional medicine and discusses the clinical and pharmacological importance of these invertebrates. The roles that mollusks play in folk practices related to the healing and/or prevention of illnesses have been recorded in different social-cultural contexts worldwide. The clinical and therapeutic use of compounds coming from different species of mollusks is recorded in the literature. The chemistry of natural products provided by oysters, mussels, clams, sluggards, and snails has been substantially investigated, but the majority of these studies have focused on the subclasses Opistobranchia and Prosobranchia. Research into the knowledge and practices of folk medicine makes possible a better understanding of the interaction between human beings and the environment, in addition to allowing the elaboration of suitable strategies for the conservation of natural resources.

  18. Automated realtime data import for the i2b2 clinical data warehouse: introducing the HL7 ETL cell.

    Science.gov (United States)

    Majeed, Raphael W; Röhrig, Rainer

    2012-01-01

    Clinical data warehouses are used to consolidate all available clinical data from one or multiple organizations. They represent an important source for clinical research, quality management and controlling. Since its introduction, the data warehouse i2b2 gathered a large user base in the research community. Yet, little work has been done on the process of importing clinical data into data warehouses using existing standards. In this article, we present a novel approach of utilizing the clinical integration server as data source, commonly available in most hospitals. As information is transmitted through the integration server, the standardized HL7 message is immediately parsed and inserted into the data warehouse. Evaluation of import speeds suggest feasibility of the provided solution for real-time processing of HL7 messages. By using the presented approach of standardized data import, i2b2 can be used as a plug and play data warehouse, without the hurdle of customized import for every clinical information system or electronic medical record. The provided solution is available for download at http://sourceforge.net/projects/histream/.

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

    Directory of Open Access Journals (Sweden)

    Dimitrov BD

    2015-04-01

    Full Text Available Borislav D Dimitrov,1,2 Nicola Motterlini,2,† Tom Fahey2 1Academic Unit of Primary Care and Population Sciences, University of Southampton, Southampton, United Kingdom; 2HRB Centre for Primary Care Research, Department of General Medicine, Division of Population Health Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland †Nicola Motterlini passed away on November 11, 2012 Objective: Estimating calibration performance of clinical prediction rules (CPRs in systematic reviews of validation studies is not possible when predicted values are neither published nor accessible or sufficient or no individual participant or patient data are available. Our aims were to describe a simplified approach for outcomes prediction and calibration assessment and evaluate its functionality and validity. Study design and methods: Methodological study of systematic reviews of validation studies of CPRs: a ABCD2 rule for prediction of 7 day stroke; and b CRB-65 rule for prediction of 30 day mortality. Predicted outcomes in a sample validation study were computed by CPR distribution patterns (“derivation model”. As confirmation, a logistic regression model (with derivation study coefficients was applied to CPR-based dummy variables in the validation study. Meta-analysis of validation studies provided pooled estimates of “predicted:observed” risk ratios (RRs, 95% confidence intervals (CIs, and indexes of heterogeneity (I2 on forest plots (fixed and random effects models, with and without adjustment of intercepts. The above approach was also applied to the CRB-65 rule. Results: Our simplified method, applied to ABCD2 rule in three risk strata (low, 0–3; intermediate, 4–5; high, 6–7 points, indicated that predictions are identical to those computed by univariate, CPR-based logistic regression model. Discrimination was good (c-statistics =0.61–0.82, however, calibration in some studies was low. In such cases with miscalibration, the under

  20. 78 FR 23594 - Importer of Controlled Substances, Notice of Application, Almac Clinical Services, Inc., (ACSI)

    Science.gov (United States)

    2013-04-19

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances, Notice of Application, Almac Clinical Services, Inc., (ACSI) Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on March 5, 2013, Almac Clinical Services, Inc., (ACSI), 25 Fretz Road, Souderton...

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

    Directory of Open Access Journals (Sweden)

    Daan Nieboer

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

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

    Science.gov (United States)

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

    2017-01-01

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

  3. NCI-FDA Interagency Oncology Task Force Workshop Provides Guidance for Analytical Validation of Protein-based Multiplex Assays | Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    An NCI-FDA Interagency Oncology Task Force (IOTF) Molecular Diagnostics Workshop was held on October 30, 2008 in Cambridge, MA, to discuss requirements for analytical validation of protein-based multiplex technologies in the context of its intended use. This workshop developed through NCI's Clinical Proteomic Technologies for Cancer initiative and the FDA focused on technology-specific analytical validation processes to be addressed prior to use in clinical settings. In making this workshop unique, a case study approach was used to discuss issues related to

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

    Science.gov (United States)

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

    2013-01-01

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

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

    International Nuclear Information System (INIS)

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

    2010-01-01

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

  6. Validation of survey information on smoking and alcohol consumption against import statistics, Greenland 1993-2010.

    Science.gov (United States)

    Bjerregaard, Peter; Becker, Ulrik

    2013-01-01

    Questionnaires are widely used to obtain information on health-related behaviour, and they are more often than not the only method that can be used to assess the distribution of behaviour in subgroups of the population. No validation studies of reported consumption of tobacco or alcohol have been published from circumpolar indigenous communities. The purpose of the study is to compare information on the consumption of tobacco and alcohol obtained from 3 population surveys in Greenland with import statistics. Estimates of consumption of cigarettes and alcohol using several different survey instruments in cross-sectional population studies from 1993-1994, 1999-2001 and 2005-2010 were compared with import statistics from the same years. For cigarettes, survey results accounted for virtually the total import. Alcohol consumption was significantly under-reported with reporting completeness ranging from 40% to 51% for different estimates of habitual weekly consumption in the 3 study periods. Including an estimate of binge drinking increased the estimated total consumption to 78% of the import. Compared with import statistics, questionnaire-based population surveys capture the consumption of cigarettes well in Greenland. Consumption of alcohol is under-reported, but asking about binge episodes in addition to the usual intake considerably increased the reported intake in this population and made it more in agreement with import statistics. It is unknown to what extent these findings at the population level can be inferred to population subgroups.

  7. 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…

  8. 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

  9. Videoconference-based mini mental state examination: a validation study.

    Science.gov (United States)

    Timpano, Francesca; Pirrotta, Fabio; Bonanno, Lilla; Marino, Silvia; Marra, Angela; Bramanti, Placido; Lanzafame, Pietro

    2013-12-01

    Neuropsychological testing is a prime criterion of good practice to document cognitive deficits in a rapidly aging population. Telecommunication technologies may overcome limitations related to test administration. We compared performance of the Italian videoconference-based version of the Mini Mental State Examination (VMMSE) with performance of the standard MMSE administered face-to-face (F2F), to validate the Italian version of the 28-item VMMSE. To validate the Italian version of the VMMSE, we compared its performance with standard F2F. The sample (n=342) was administered three VMMSEs within 6 weeks after F2F testing. We identified the optimal cutoff through the receiver operating characteristic curve, as well as the VMMSE consistency through inter- and intrarater reliability (Inter/RR and Intra/RR) analysis. We found high levels of sensitivity and specificity for the optimal VMMSE cutoff identification and an accuracy of 0.96 (95% confidence interval 0.94-0.98). Intra/RR and inter/RR were highly significant. This study demonstrates that VMMSE is a valid instrument in clinical and research screening and monitoring of subjects affected by cognitive disorders. This study shows a significant correlation between videoconference assessment and the F2F one, providing an important impetus to expand studies and the knowledge about the usefulness of tele-assistance services. Our findings have important implications for both longitudinal assistance and clinical care of demented patients.

  10. Hearing aids in children: the importance of the verification and validation processes.

    Science.gov (United States)

    Rissatto, Mara Renata; Novaes, Beatriz Cavalcanti de Albuquerque Caiuby

    2009-01-01

    during the fitting of hearing aids in children it is important, besides using a verification protocol, to have a validation process. to describe and discuss the use of a protocol for the fitting and the verification of hearing aids in children, as well as the impact of the adjustment of the acoustic characteristics in speech perception tasks. ten children aging from three to eleven years were enrolled in this study. All children presented bilateral sensorineural hearing impairment, were users of hearing aids and were followed at a public hearing health care service in Bahia. The children were submitted to the following procedures: pure tone air and bone conduction thresholds; real-ear coupler difference (RECD); verification with real-ear measurement equipment: coupler gain/output and insertion gain and to speech perception tasks: 'The Six-Sound Test' (Ling, 2006) and the 'Word Associations for Syllable Perception' (WASP - Koch, 1999). The programmed electro acoustic characteristics of the hearing aids were compared to the electro acoustic characteristics prescribed by the DSL [i/o] v4.1 software. The speech perception tasks were reapplied on three occasions: straight after the modification of the electro acoustic characteristics, after 30 days and 60 days. for more than 50% of the tested children, the programmed electro acoustic characteristics of the hearing aids did not correspond to that suggested by the DSL [i/o] software. Adequate prescription was verified in 70% of the investigated sample; this was also confirmed by the results in the speech perception tasks (p=0.000). This data confirmed that the mean percentage of correct answers increased after the modification of the electro acoustic characteristics. the use of a protocol that verifies and validates the fitting of hearing aids in children is necessary.

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

    Science.gov (United States)

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

    2017-08-18

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

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

    Science.gov (United States)

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

    2001-01-01

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

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

    Science.gov (United States)

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

    2010-11-11

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

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

    Science.gov (United States)

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

    2016-01-01

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

  15. Validity and reliability of the attention deficit hyperactivity disorder self-report scale (ASRS-v1.1) in a clinical sample with eating disorders.

    Science.gov (United States)

    Carlucci, Samantha; Ivanova, Iryna; Bissada, Hany; Tasca, Giorgio A

    2017-08-01

    Individuals with eating disorders (EDs) commonly experience comorbid attention deficit hyperactivity disorder (ADHD). The shared features of EDs and ADHD, such as inattention, impulsivity and hyperactivity, may exacerbate ED symptomatology and pose challenges to treatment. It is important to screen patients with EDs for symptoms of ADHD to optimize their treatment outcomes. However, the psychometrics of common measures of ADHD have not yet been examined within an ED population. An example of such a measure is the ADHD self-report scale (ASRS-v1.1) symptom checklist, which identifies the presence of ADHD symptoms. This study reports a psychometric study of the ASRS-v1.1 in a clinical sample of 500 adults with an ED. A confirmatory factor analysis indicated the ASRS-v1.1 maintained its two-factor structure of inattention and impulsivity/hyperactivity. The item loadings demonstrated path invariance across ED diagnostic groups indicating construct validity. Further, the subscales exhibited good internal consistency and they were significantly correlated with other measures of impulsivity indicating convergent validity. The ED sample had significantly higher mean scores than published nonclinical norms indicating predictive validity, but the ASRS-v1.1 scores were not significantly different among ED diagnostic groups. Results suggest the ASRS-v1.1 is a valid and reliable screening tool for identifying symptoms of ADHD among adults seeking treatment for ED. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Science.gov (United States)

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

    2015-02-01

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

  18. Comparison of 4-Dimensional Computed Tomography Ventilation With Nuclear Medicine Ventilation-Perfusion Imaging: A Clinical Validation Study

    International Nuclear Information System (INIS)

    Vinogradskiy, Yevgeniy; Koo, Phillip J.; Castillo, Richard; Castillo, Edward; Guerrero, Thomas; Gaspar, Laurie E.; Miften, Moyed; Kavanagh, Brian D.

    2014-01-01

    Purpose: Four-dimensional computed tomography (4DCT) ventilation imaging provides lung function information for lung cancer patients undergoing radiation therapy. Before 4DCT-ventilation can be implemented clinically it needs to be validated against an established imaging modality. The purpose of this work was to compare 4DCT-ventilation to nuclear medicine ventilation, using clinically relevant global metrics and radiologist observations. Methods and Materials: Fifteen lung cancer patients with 16 sets of 4DCT and nuclear medicine ventilation-perfusion (VQ) images were used for the study. The VQ-ventilation images were acquired in planar mode using Tc-99m-labeled diethylenetriamine-pentaacetic acid aerosol inhalation. 4DCT data, spatial registration, and a density-change-based model were used to compute a 4DCT-based ventilation map for each patient. The percent ventilation was calculated in each lung and each lung third for both the 4DCT and VQ-ventilation scans. A nuclear medicine radiologist assessed the VQ and 4DCT scans for the presence of ventilation defects. The VQ and 4DCT-based images were compared using regional percent ventilation and radiologist clinical observations. Results: Individual patient examples demonstrate good qualitative agreement between the 4DCT and VQ-ventilation scans. The correlation coefficients were 0.68 and 0.45, using the percent ventilation in each individual lung and lung third, respectively. Using radiologist-noted presence of ventilation defects and receiver operating characteristic analysis, the sensitivity, specificity, and accuracy of the 4DCT-ventilation were 90%, 64%, and 81%, respectively. Conclusions: The current work compared 4DCT with VQ-based ventilation using clinically relevant global metrics and radiologist observations. We found good agreement between the radiologist's assessment of the 4DCT and VQ-ventilation images as well as the percent ventilation in each lung. The agreement lessened when the data were

  19. Coronary artery anomalies and clinically important anatomy in patients with congenital heart disease: multislice CT findings

    International Nuclear Information System (INIS)

    Goo, Hyun Woo; Seo, Dong-Man; Yun, Tae-Jin; Park, Jeong-Jun; Park, In-Sook; Ko, Jae Kon; Kim, Young Hwee

    2009-01-01

    In patients with congenital heart disease, coronary artery anomalies are common and have different clinical importance from individuals with structurally normal hearts. Visibility of the coronary arteries by CT has markedly improved due to high temporal resolution and ECG-synchronized data acquisition. In this article we describe current multislice CT techniques for coronary artery imaging and illustrate coronary artery anomalies and clinically important coronary artery anatomy from the point of view of congenital heart disease. (orig.)

  20. Coronary artery anomalies and clinically important anatomy in patients with congenital heart disease: multislice CT findings

    Energy Technology Data Exchange (ETDEWEB)

    Goo, Hyun Woo [University of Ulsan College of Medicine, Department of Radiology and Research Institute of Radiology, Asan Medical Center, Seoul (Korea); Seo, Dong-Man; Yun, Tae-Jin; Park, Jeong-Jun [University of Ulsan College of Medicine, Department of Pediatric Cardiac Surgery, Asan Medical Center, Seoul (Korea); Park, In-Sook; Ko, Jae Kon; Kim, Young Hwee [University of Ulsan College of Medicine, Department of Pediatric Cardiology, Asan Medical Center, Seoul (Korea)

    2009-03-15

    In patients with congenital heart disease, coronary artery anomalies are common and have different clinical importance from individuals with structurally normal hearts. Visibility of the coronary arteries by CT has markedly improved due to high temporal resolution and ECG-synchronized data acquisition. In this article we describe current multislice CT techniques for coronary artery imaging and illustrate coronary artery anomalies and clinically important coronary artery anatomy from the point of view of congenital heart disease. (orig.)

  1. Validity and Reliability of Clinical Examination in the Diagnosis of Myofascial Pain Syndrome and Myofascial Trigger Points in Upper Quarter Muscles.

    Science.gov (United States)

    Mayoral Del Moral, Orlando; Torres Lacomba, María; Russell, I Jon; Sánchez Méndez, Óscar; Sánchez Sánchez, Beatriz

    2017-12-15

    To determine whether two independent examiners can agree on a diagnosis of myofascial pain syndrome (MPS). To evaluate interexaminer reliability in identifying myofascial trigger points in upper quarter muscles. To evaluate the reliability of clinical diagnostic criteria for the diagnosis of MPS. To evaluate the validity of clinical diagnostic criteria for the diagnosis of MPS. Validity and reliability study. Provincial Hospital. Toledo, Spain. Twenty myofascial pain syndrome patients and 20 healthy, normal control subjects, enrolled by a trained and experienced examiner. Ten bilateral muscles from the upper quarter were evaluated by two experienced examiners. The second examiner was blinded to the diagnosis group. The MPS diagnosis required at least one muscle to have an active myofascial trigger point. Three to four days separated the two examinations. The primary outcome measure was the frequency with which the two examiners agreed on the classification of the subjects as patients or as healthy controls. The kappa statistic (K) was used to determine the level of agreement between both examinations, interpreted as very good (0.81-1.00), good (0.61-0.80), moderate (0.41-0.60), fair (0.21-0.40), or poor (≤0.20). Interexaminer reliability for identifying subjects with MPS was very good (K = 1.0). Interexaminer reliability for identifying muscles leading to a diagnosis of MPS was also very good (K = 0.81). Sensitivity and specificity showed high values for most examination tests in all muscles, which confirms the validity of clinical diagnostic criteria in the diagnosis of MPS. Interrater reliability between two expert examiners identifying subjects with MPS involving upper quarter muscles exhibited substantial agreement. These results suggest that clinical criteria can be valid and reliable in the diagnosis of this condition. © 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

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

    Science.gov (United States)

    Sinniah, Aishvarya; Oei, Tian P S; Chinna, Karuthan; Shah, Shamsul A; Maniam, T; Subramaniam, Ponnusamy

    2015-01-01

    The PANSI is a measure designed to assess the risk and protective factors related to suicidal behaviors. The present study evaluated the psychometric properties and factor structure of the Positive and Negative Suicide Ideation (PANSI) Inventory in a sample of clinical outpatients at a major hospital in Malaysia. In this study, 283 psychiatric patients and 200 medical (non-psychiatric) patients participated. All the patients completed the PANSI and seven other self-report instruments. Confirmative factor analysis supported the 2-factor oblique model. The internal consistency of the two subscales of PANSI-Negative and the PANSI-Positive were 0.93 and 0.84, respectively. In testing construct validity, PANSI showed sizable correlation with the other seven scales. Criterion validity was supported by scores on PANSI which differentiated psychiatric patients from medical patients. Logistic regression analyses showed PANSI can be used to classify the patients into suicidal or non-suicidal. The PANSI is a reliable and valid instrument to measure the severity of suicidal ideation among clinical outpatients in Malaysia.

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

    Directory of Open Access Journals (Sweden)

    Aishvarya eSinniah

    2015-12-01

    Full Text Available The PANSI is a measure designed to assess the risk and protective factors related to suicidal behaviors. The present study evaluated the psychometric properties and factor structure of the Positive and Negative Suicide Ideation (PANSI Inventory in a sample of clinical outpatients at a major hospital in Malaysia. In this study, 283 psychiatric patients and 200 medical (non- psychiatric patients participated. All the patients completed the PANSI and seven other self-report instruments. Confirmative factor analysis supported the 2-factor oblique model. The internal consistency of the two subscales of PANSI-Negative and the PANSI-Positive were 0.93 and 0.84, respectively. In testing construct validity, PANSI showed sizable correlation with the other seven scales. Criterion validity was supported by scores on PANSI which differentiated psychiatric patients from medical patients. Logistic regression analyses showed PANSI can be used to classify the patients into suicidal or non-suicidal. The PANSI is a reliable and valid instrument to measure the severity of suicidal ideation among clinical outpatients in Malaysia.

  4. The Childbirth Experience Questionnaire (CEQ) - validation of its use in a Danish population

    DEFF Research Database (Denmark)

    Boie, Sidsel; Glavind, Julie; Uldbjerg, Niels

    experience is lacking. The Childbirth Experience Questionnaire (CEQ) was developed in Sweden in 2010 and validated in Swedish women, but never validated in a Danish setting, and population. The purpose of our study was to validate the CEQ as a reliable tool for measuring the childbirth experience in Danish......Title The Childbirth Experience Questionnaire (CEQ) - validation the use in a Danish population Introduction Childbirth experience is arguably as important as measuring birth outcomes such as mode of delivery or perinatal morbidity. A robust, validated, Danish tool for evaluating childbirth...... index of agreement between the two scores. Case description (mandatory for Clinical Report) Results (mandatory for Original Research) Face validity: All respondents stated that it was easy to understand and complete the questionnaire. Construct validity: Statistically significant higher CEQ scores were...

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

    Science.gov (United States)

    Park, Dae-Sung; Lee, GyuChang

    2014-06-10

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

  6. [Questionnaire to evaluate the importance of the family in nursing care. Validation of the Spanish version (FINC-NA)].

    Science.gov (United States)

    Pascual Fernández, M C; Ignacio Cerro, M C; Cervantes Estévez, L; Jiménez Carrascosa, M A; Medina Torres, M; García Pozo, A M

    2015-01-01

    The nursing profession is focused on patient care, without forgetting that patients are part of a social group, the family. The aim of this study was the adaptation of the "Families' Importance in Nursing Care-Nurses' Attitudes" (FINC-NA) scale to the Spanish language and its validation. A descriptive cross-sectional study was carried out, using the bidirectional translation method for linguistic-cultural adaptation. It was applied to the nursing staff in the Paediatric Department of a University Hospital in Madrid. To evaluate the psychometric properties of the Spanish version, reliability, internal consistence and construct validity were calculated. The sample consisted of 274 professionals. Cronbach´s Alpha coefficient for the total scale was 0.864, oscillating between 0.888 and 0.769 in the subscales. The principal components factor analysis identified 4 factors, which explained 54.22% of total variance. The new instrument makes it possible to determine the importance nurses give to participation by family members and their attitude to involving the latter in patient care, and the possibility of involving them in planning. It has been adapted to the Spanish population with good psychometrics results and enough evidence for its use in this context.

  7. Psychological and interactional characteristics of patients with somatoform disorders: Validation of the Somatic Symptoms Experiences Questionnaire (SSEQ) in a clinical psychosomatic population.

    Science.gov (United States)

    Herzog, Annabel; Voigt, Katharina; Meyer, Björn; Wollburg, Eileen; Weinmann, Nina; Langs, Gernot; Löwe, Bernd

    2015-06-01

    The new DSM-5 Somatic Symptom Disorder (SSD) emphasizes the importance of psychological processes related to somatic symptoms in patients with somatoform disorders. To address this, the Somatic Symptoms Experiences Questionnaire (SSEQ), the first self-report scale that assesses a broad range of psychological and interactional characteristics relevant to patients with a somatoform disorder or SSD, was developed. This prospective study was conducted to validate the SSEQ. The 15-item SSEQ was administered along with a battery of self-report questionnaires to psychosomatic inpatients. Patients were assessed with the Structured Clinical Interview for DSM-IV to confirm a somatoform, depressive, or anxiety disorder. Confirmatory factor analyses, tests of internal consistency and tests of validity were performed. Patients (n=262) with a mean age of 43.4 years, 60.3% women, were included in the analyses. The previously observed four-factor model was replicated and internal consistency was good (Cronbach's α=.90). Patients with a somatoform disorder had significantly higher scores on the SSEQ (t=4.24, pquality of life. Sensitivity to change was shown by significantly higher effect sizes of the SSEQ change scores for improved patients than for patients without improvement. The SSEQ appears to be a reliable, valid, and efficient instrument to assess a broad range of psychological and interactional features related to the experience of somatic symptoms. Copyright © 2015 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2015-07-01

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

  9. Validation of dengue infection severity score

    Directory of Open Access Journals (Sweden)

    Pongpan S

    2014-03-01

    Full Text Available Surangrat Pongpan,1,2 Jayanton Patumanond,3 Apichart Wisitwong,4 Chamaiporn Tawichasri,5 Sirianong Namwongprom1,6 1Clinical Epidemiology Program, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; 2Department of Occupational Medicine, Phrae Hospital, Phrae, Thailand; 3Clinical Epidemiology Program, Faculty of Medicine, Thammasat University, Bangkok, Thailand; 4Department of Social Medicine, Sawanpracharak Hospital, Nakorn Sawan, Thailand; 5Clinical Epidemiology Society at Chiang Mai, Chiang Mai, Thailand; 6Department of Radiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand Objective: To validate a simple scoring system to classify dengue viral infection severity to patients in different settings. Methods: The developed scoring system derived from 777 patients from three tertiary-care hospitals was applied to 400 patients in the validation data obtained from another three tertiary-care hospitals. Percentage of correct classification, underestimation, and overestimation was compared. The score discriminative performance in the two datasets was compared by analysis of areas under the receiver operating characteristic curves. Results: Patients in the validation data were different from those in the development data in some aspects. In the validation data, classifying patients into three severity levels (dengue fever, dengue hemorrhagic fever, and dengue shock syndrome yielded 50.8% correct prediction (versus 60.7% in the development data, with clinically acceptable underestimation (18.6% versus 25.7% and overestimation (30.8% versus 13.5%. Despite the difference in predictive performances between the validation and the development data, the overall prediction of the scoring system is considered high. Conclusion: The developed severity score may be applied to classify patients with dengue viral infection into three severity levels with clinically acceptable under- or overestimation. Its impact when used in routine

  10. Utility, reliability, sensitivity and validity of an online test system designed to monitor changes in cognitive function in clinical trials.

    Science.gov (United States)

    Wesnes, Keith A; Brooker, Helen; Ballard, Clive; McCambridge, Laura; Stenton, Robert; Corbett, Anne

    2017-12-01

    The advent of long-term remotely conducted clinical trials requires assessments which can be administered online. This paper considers the utility, reliability, sensitivity and validity of an internet-based system for measuring changes in cognitive function which is being used in one such trial. The Platform for Research Online to investigate Genetics and Cognition in Ageing is a 10-year longitudinal and entirely remote study launched in November 2015. The CogTrack TM System is being used to monitor changes in important aspects of cognitive function using tests of attention, information processing and episodic memory. On study entry, the participants performed CogTrack TM up to three times over seven days, and these data are evaluated in this paper. During the first six months of the study, 14 531 individuals aged 50 to 94 years enrolled and performed the CogTrack TM System, 8627 of whom completed three test sessions. On the first administration, 99.4% of the study tasks were successfully completed. Repeated testing showed training/familiarisation effects on four of the ten measures which had largely stabilised by the third test session. The factor structure of the various measures was found to be robust. Evaluation of the influence of age identified clinically relevant declines over the age range of the population on one or more measures from all tasks. The results of these analyses identify CogTrack TM to be a practical and valid method to reliably, sensitively, remotely and repeatedly collect cognitive data from large samples of individuals aged 50 and over. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

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

    Science.gov (United States)

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

    2010-02-11

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

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

    Science.gov (United States)

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

    2017-10-01

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

  13. [Validation of interaction databases in psychopharmacotherapy].

    Science.gov (United States)

    Hahn, M; Roll, S C

    2018-03-01

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

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

    DEFF Research Database (Denmark)

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

    2014-01-01

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

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

    Science.gov (United States)

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

    2017-02-01

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

  16. Validity of the modified child psychopathy scale for juvenile justice center residents

    NARCIS (Netherlands)

    Verschuere, B.; Candel, I.; van Reenen, L.; Korebrits, A.

    2012-01-01

    Adult psychopathy has proven to be an important clinical and forensic construct, but much less is known about juvenile psychopathy. In the present study, we examined the construct validity of the self report modified Child Psychopathy Scale mCPS; Lynam (Psychological Bulletin 120:(2), 209-234, 1997)

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

    Science.gov (United States)

    Szucs, Kimberly A; Brown, Elena V Donoso

    2018-01-01

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

  18. The Structured Interview & Scoring Tool-Massachusetts Alzheimer's Disease Research Center (SIST-M): development, reliability, and cross-sectional validation of a brief structured clinical dementia rating interview.

    Science.gov (United States)

    Okereke, Olivia I; Copeland, Maura; Hyman, Bradley T; Wanggaard, Taylor; Albert, Marilyn S; Blacker, Deborah

    2011-03-01

    The Clinical Dementia Rating (CDR) and CDR Sum-of-Boxes can be used to grade mild but clinically important cognitive symptoms of Alzheimer disease. However, sensitive clinical interview formats are lengthy. To develop a brief instrument for obtaining CDR scores and to assess its reliability and cross-sectional validity. Using legacy data from expanded interviews conducted among 347 community-dwelling older adults in a longitudinal study, we identified 60 questions (from a possible 131) about cognitive functioning in daily life using clinical judgment, inter-item correlations, and principal components analysis. Items were selected in 1 cohort (n=147), and a computer algorithm for generating CDR scores was developed in this same cohort and re-run in a replication cohort (n=200) to evaluate how well the 60 items retained information from the original 131 items. Short interviews based on the 60 items were then administered to 50 consecutively recruited older individuals, with no symptoms or mild cognitive symptoms, at an Alzheimer's Disease Research Center. Clinical Dementia Rating scores based on short interviews were compared with those from independent long interviews. In the replication cohort, agreement between short and long CDR interviews ranged from κ=0.65 to 0.79, with κ=0.76 for Memory, κ=0.77 for global CDR, and intraclass correlation coefficient for CDR Sum-of-Boxes=0.89. In the cross-sectional validation, short interview scores were slightly lower than those from long interviews, but good agreement was observed for global CDR and Memory (κ≥0.70) as well as for CDR Sum-of-Boxes (intraclass correlation coefficient=0.73). The Structured Interview & Scoring Tool-Massachusetts Alzheimer's Disease Research Center is a brief, reliable, and sensitive instrument for obtaining CDR scores in persons with symptoms along the spectrum of mild cognitive change.

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

    Science.gov (United States)

    Banks, Jamie L; Marotta, Charles A

    2007-03-01

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

  20. Association between clinically important depressive symptoms and academic achivement among students in Cartagena, Colombia

    Directory of Open Access Journals (Sweden)

    Zuleima Cogollo

    2007-06-01

    Full Text Available Background: Some studies show a strongassociation between depressive symptoms andacademic achievement in the adolescent population.However, there are few Colombian publicationsabout this topic.Objective: To establish the association betweenclinically important depressive symptoms and academic achievement among low socioeconomicstatus adolescent students.Method: A group of 13 to 17 year-aged adolescentswas studied. Meaningful clinically depressivesymptoms were measured with Zung’self-rating depression scale (40/80. Academicachievement was evaluated according to Colombianqualitative model.Results: A total of 43.5% of students reportedclinically important depressive symptoms and30.7% accomplished a poor academic achievement,according to teacher report. The academicachievement was independent of meaningfulclinically depressive symptoms, after controllingother variables.Conclusion: Meaningful clinically depressivesymptoms are frequent in low socioeconomic statusadolescent students. But, meaningful clinicallydepressive symptoms are not associatedwith academic performance. Further investigationsare needed.

  1. Development and Validation of the Eating Loss of Control Scale

    Science.gov (United States)

    Blomquist, Kerstin K.; Roberto, Christina A.; Barnes, Rachel D.; White, Marney A.; Masheb, Robin M.; Grilo, Carlos M.

    2014-01-01

    Recurrent objective bulimic episodes (OBE) are a defining diagnostic characteristic of binge eating disorder (BED) and bulimia nervosa (BN). OBEs are characterized by experiencing loss of control (LOC) while eating an unusually large quantity of food. Despite nosological importance and complex heterogeneity across patients, measurement of LOC has been assessed dichotomously (present/absent). This study describes the development and initial validation of the Eating Loss of Control Scale (ELOCS), a self-report questionnaire that examines the complexity of the LOC construct. Participants were 168 obese treatment-seeking individuals with BED who completed the Eating Disorder Examination interview and self-report measures. Participants rated their LOC-related feelings or behaviors on continuous Likert-type scales and reported the number of LOC episodes in the past 28 days. Principal component analysis identified a single-factor, 18-item scale, which demonstrated good internal reliability (α=0.90). Frequency of LOC episodes was significantly correlated with frequency of OBEs and subjective bulimic episodes. The ELOCS demonstrated good convergent validity and was significantly correlated with greater eating pathology, greater emotion dysregulation, greater depression, and lower self-control, but not with BMI. The findings suggest that the ELOCS is a valid self-report questionnaire that may provide important clinical information regarding experiences of LOC in obese persons with BED. Future research should examine the ELOCS in other eating disorders and non-clinical samples. PMID:24219700

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

    Science.gov (United States)

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

    2015-09-01

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

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

    Science.gov (United States)

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

    2017-01-01

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

  4. Antibacterial effect of bioactive glasses on clinically important anaerobic bacteria in vitro.

    Science.gov (United States)

    Leppäranta, Outi; Vaahtio, Minna; Peltola, Timo; Zhang, Di; Hupa, Leena; Hupa, Mikko; Ylänen, Heimo; Salonen, Jukka I; Viljanen, Matti K; Eerola, Erkki

    2008-02-01

    Bioactive glasses (BAGs) of different compositions have been studied for decades for clinical use and they have found many dental and orthopaedic applications. Particulate BAGs have also been shown to have antibacterial properties. This large-scale study shows that two bioactive glass powders (S53P4 and 13-93) and a sol-gel derived material (CaPSiO II) have an antibacterial effect on 17 clinically important anaerobic bacterial species. All the materials tested demonstrated growth inhibition, although the concentration and time needed for the effect varied depending on the BAG. Glass S53P4 had a strong growth-inhibitory effect on all pathogens tested. Glass 13-93 and sol-gel derived material CaPSiO II showed moderate antibacterial properties.

  5. A Measure of Perceived Chronic Social Adversity: Development and Validation

    Directory of Open Access Journals (Sweden)

    Jingqiu Zhang

    2017-12-01

    Full Text Available The goal of this study was to develop a measure that assesses negative daily social encounters. Specifically, we examined the concept of perceived chronic social adversity and its assessment, the Perceived Chronic Social Adversity Questionnaire (PCSAQ. The PCSAQ focused on the subjective processing of daily social experiences. Psychometric properties were examined within two non-clinical samples (N = 331 and N = 390 and one clinical sample (N = 86. Exploratory and confirmatory factor analyses supported a three-factor model of the PCSAQ, which corresponds to three types of daily social stressors. The final 28-item PCSAQ was shown to be internally consistent, and to have good construct validity in terms of factor structure and group differences. It was also shown to have good concurrent validity in terms of association with outcome variables (sense of control, happiness, and mood and anxiety symptoms. Perceived chronic social adversity was also shown to be correlated with PTSD severity. Taken together, these findings suggest that the PCSAQ is a reliable, valid, and useful measure that can be used to assess negative social and clinical aspects of personal experiences. This study is an important exploratory step in improving our understanding of the relationship between the cumulative effect of negative social encounters and psychological difficulty.

  6. 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.

  7. Validity and clinical utility of the DSM-5 severity specifier for bulimia nervosa: results from a multisite sample of patients who received evidence-based treatment.

    Science.gov (United States)

    Dakanalis, Antonios; Bartoli, Francesco; Caslini, Manuela; Crocamo, Cristina; Zanetti, Maria Assunta; Riva, Giuseppe; Clerici, Massimo; Carrà, Giuseppe

    2017-12-01

    A new "severity specifier" for bulimia nervosa (BN), based on the frequency of inappropriate weight compensatory behaviours (IWCBs), was added to the DSM-5 as a means of documenting heterogeneity and variability in the severity of the disorder. Yet, evidence for its validity in clinical populations, including prognostic significance for treatment outcome, is currently lacking. Existing data from 281 treatment-seeking patients with DSM-5 BN, who received the best available treatment for their disorder (manual-based cognitive behavioural therapy; CBT) in an outpatient setting, were re-analysed to examine whether these patients subgrouped based on the DSM-5 severity levels would show meaningful and consistent differences on (a) a range of clinical variables assessed at pre-treatment and (b) post-treatment abstinence from IWCBs. Results highlight that the mild, moderate, severe, and extreme severity groups were statistically distinguishable on 22 variables assessed at pre-treatment regarding eating disorder pathological features, maintenance factors of BN, associated (current) and lifetime psychopathology, social maladjustment and illness-specific functional impairment, and abstinence outcome. Mood intolerance, a maintenance factor of BN but external to eating disorder pathological features (typically addressed within CBT), emerged as the primary clinical variable distinguishing the severity groups showing a differential treatment response. Overall, the findings speak to the concurrent and predictive validity of the new DSM-5 severity criterion for BN and are important because a common benchmark informing patients, clinicians, and researchers about severity of the disorder and allowing severity fluctuation and patient's progress to be tracked does not exist so far. Implications for future research are outlined.

  8. Evaluation and feedback for effective clinical teaching in postgraduate medical education: validation of an assessment instrument incorporating the CanMEDS roles.

    Science.gov (United States)

    Fluit, Cornelia; Bolhuis, Sanneke; Grol, Richard; Ham, Marieke; Feskens, Remco; Laan, Roland; Wensing, Michel

    2012-01-01

    Providing clinical teachers in postgraduate medical education with feedback about their teaching skills is a powerful tool to improve clinical teaching. A systematic review showed that available instruments do not comprehensively cover all domains of clinical teaching. We developed and empirically test a comprehensive instrument for assessing clinical teachers in the setting of workplace learning and linked to the CanMEDS roles. In a Delphi study, the content validity of a preliminary instrument with 88 items was studied, leading to the construction of the EFFECT (evaluation and feedback for effective clinical teaching) instrument. The response process was explored in a pilot test and focus group research with 18 residents of 6 different disciplines. A confirmatory factor analyses (CFA) and reliability analyses were performed on 407 evaluations of 117 supervisors, collected in 3 medical disciplines (paediatrics, pulmonary diseases and surgery) of 6 departments in 4 different hospitals. CFA yielded an 11 factor model with a good to excellent fit and internal consistencies ranged from 0.740 to 0.940 per domain; 7 items could be deleted. The model of workplace learning showed to be a useful framework for developing EFFECT, which incorporates the CanMEDS competencies and proved to be valid and reliable.

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

    Science.gov (United States)

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

    2010-06-01

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

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

    Science.gov (United States)

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

    2014-01-01

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

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

    International Nuclear Information System (INIS)

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

    2014-01-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2014-01-15

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

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

    Science.gov (United States)

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

    2014-01-01

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

  14. Bactericidal effects of bioactive glasses on clinically important aerobic bacteria.

    Science.gov (United States)

    Munukka, Eveliina; Leppäranta, Outi; Korkeamäki, Mika; Vaahtio, Minna; Peltola, Timo; Zhang, Di; Hupa, Leena; Ylänen, Heimo; Salonen, Jukka I; Viljanen, Matti K; Eerola, Erkki

    2008-01-01

    Bioactive glasses (BAGs) have been studied for decades for clinical use, and they have found many dental and orthopedic applications. BAGs have also been shown to have an antibacterial effect e.g., on some oral microorganisms. In this extensive work we show that six powdered BAGs and two sol-gel derived materials have a clear antibacterial effect on 29 clinically important bacterial species. We also incorporated a rapid and accurate flow cytometric (FCM) method to calculate and standardize the numbers of viable bacteria inoculated in the suspensions used in the tests for antibacterial activity. In all materials tested growth inhibition could be demonstrated, although the concentration and time needed for the effect varied depending on the BAG. The most effective glass was S53P4, which had a clear growth-inhibitory effect on all pathogens tested. The sol-gel derived materials CaPSiO and CaPSiO II also showed a strong antibacterial effect. In summary, BAGs were found to clearly inhibit the growth of a wide selection of bacterial species causing e.g., infections on the surfaces of prostheses in the body after implantation.

  15. Validation of survey information on smoking and alcohol consumption against import statistics, Greenland 1993–2010

    Directory of Open Access Journals (Sweden)

    Peter Bjerregaard

    2013-03-01

    Full Text Available Background. Questionnaires are widely used to obtain information on health-related behaviour, and they are more often than not the only method that can be used to assess the distribution of behaviour in subgroups of the population. No validation studies of reported consumption of tobacco or alcohol have been published from circumpolar indigenous communities. Objective. The purpose of the study is to compare information on the consumption of tobacco and alcohol obtained from 3 population surveys in Greenland with import statistics. Design. Estimates of consumption of cigarettes and alcohol using several different survey instruments in cross-sectional population studies from 1993–1994, 1999–2001 and 2005–2010 were compared with import statistics from the same years. Results. For cigarettes, survey results accounted for virtually the total import. Alcohol consumption was significantly under-reported with reporting completeness ranging from 40% to 51% for different estimates of habitual weekly consumption in the 3 study periods. Including an estimate of binge drinking increased the estimated total consumption to 78% of the import. Conclusion. Compared with import statistics, questionnaire-based population surveys capture the consumption of cigarettes well in Greenland. Consumption of alcohol is under-reported, but asking about binge episodes in addition to the usual intake considerably increased the reported intake in this population and made it more in agreement with import statistics. It is unknown to what extent these findings at the population level can be inferred to population subgroups.

  16. Evaluation of construct and criterion validity for the 'Liverpool Osteoarthritis in Dogs' (LOAD clinical metrology instrument and comparison to two other instruments.

    Directory of Open Access Journals (Sweden)

    Myles Benjamin Walton

    Full Text Available To test the 'Liverpool Osteoarthritis in Dogs' (LOAD questionnaire for construct and criterion validity, and to similarly test the Helsinki Chronic Pain Index (HCPI and the Canine Brief Pain Inventory (CBPI.Prospective Study.222 dogs with osteoarthritis.Osteoarthritis was diagnosed in a cohort of dogs on the basis of clinical history and orthopedic examination. Force-platform analysis was performed and a "symmetry index" for peak vertical force (PVF was calculated. Owners completed LOAD, CBPI and HCPI instruments. As a test of construct validity, inter-instrument correlations were calculated. As a test of criterion validity, the correlations between instrument scores and PVF symmetry scores were calculated. Additionally, internal consistency of all instruments was calculated and compared to those previously reported. Factor analysis is reported for the first time for LOAD, and is compared to that previously reported for CBPI and HCPI.Significant moderate correlations were found between all instruments, implying construct validity for all instruments. Significant weak correlations were found between LOAD scores and PVF symmetry index, and between CBPI scores and PVF symmetry index.LOAD is an owner-completed clinical metrology instrument that can be recommended for the measurement of canine osteoarthritis. It is convenient to use, validated and, as demonstrated here for the first time, has a correlation with force-platform data.

  17. Minnesota Impulse Disorders Interview (MIDI): Validation of a structured diagnostic clinical interview for impulse control disorders in an enriched community sample.

    Science.gov (United States)

    Chamberlain, Samuel R; Grant, Jon E

    2018-05-08

    Disorders of impulsivity are common, functionally impairing, and highly relevant across different clinical and research settings. Few structured clinical interviews for the identification and diagnosis of impulse control disorders exist, and none have been validated in a community sample in terms of psychometric properties. The Minnesota Impulse control disorders Interview (MIDI v2.0) was administered to an enriched sample of 293 non-treatment seeking adults aged 18-35 years, recruited using media advertisements in two large US cities. In addition to the MIDI, participants undertook extended clinical interview for other mental disorders, the Barratt impulsiveness questionnaire, and the Padua obsessive-compulsive inventory. The psychometric properties of the MIDI were characterized. In logistic regression, the MIDI showed good concurrent validity against the reference measures (versus gambling disorder interview, p  0.05). Test re-test reliability was excellent (0.95). The MIDI has good psychometric properties and thus may be a valuable interview tool for clinical and research studies involving impulse control disorders. Further research is needed to better understanding the optimal diagnostic classification and neurobiology of these neglected disorders. Crown Copyright © 2018. Published by Elsevier B.V. All rights reserved.

  18. 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.

  19. Validation of computerized sniffer for monitoring perioperative normothermia.

    Science.gov (United States)

    Giri, Jyothsna; Li, Man; Pickering, Brian; Subramanian, Arun; Kor, Daryl J; Herasevich, Vitaly

    2013-01-01

    The World Health Organization sets a standard to maintain patient core temperature greater than 36°C throughout the perioperative period. Normothermia (defined as >36°C) in the Operating Room (OR) is an important factor to preventing complications in patients (MI, infection, coagulopathy). Randomized studies suggests that maintaining at higher temperatures may further reduce complications in surgery (less complications for group at 36.4°C than the control group at 36.0°C) [1,2]. Perioperative normothermia is an important but often unrecognized element during anesthesia. Early recognition of hypothermia would allow for appropriate interventions and prevent complications. Manual validation of the diagnostic performance a clinical tool (alert) that would automatically measure changes in core temperature to identify patients who fail to be in range of normothermia during surgery. The clinical tool (alert) was found to be 97 % sensitive.

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

    Science.gov (United States)

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

    2017-06-01

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

  1. Clinical validation of the C-VAT 2.0 assessment tool for gaming disorder: a sensitivity analysis of the proposed DSM-5 criteria and the clinical characteristics of young patients with ‘video game addiction’.

    NARCIS (Netherlands)

    Rooij, A.J. van; Schoenmakers, T.M.; Mheen, D. van de

    2017-01-01

    Aims: Clinicians struggle with the identification of video gaming problems. To address this issue, a clinical assessment tool (C-VAT 2.0) was developed and tested in a clinical setting. The instrument allows exploration of the validity of the DSM-5 proposal for ‘internet gaming disorder’. Method:

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

    Science.gov (United States)

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

    2013-01-01

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

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

    Science.gov (United States)

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

    2013-06-30

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

  4. Importância clínica e laboratorial do volume plaquetário médio The clinical and laboratory importance of mean platelet volume

    Directory of Open Access Journals (Sweden)

    Mariela Granero Farias

    2010-08-01

    the main methodologies and the interfering factors in determining platelet count and MPV, highlighting the importance of the clinical laboratory analyses to validate this parameter, allowing its use in the diagnosis of hematological disorders and other pathologies.

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

    Science.gov (United States)

    Veenhof, Herman; Koster, Remco A; Alffenaar, Jan-Willem C; Berger, Stefan P; Bakker, Stephan J L; Touw, Daan J

    2017-07-01

    Monitoring of creatinine and immunosuppressive drug concentrations, such as tacrolimus (TaC) and cyclosporin A (CsA), is important in the outpatient follow-up of kidney transplant recipients. Monitoring by dried blood spot (DBS) provides patients the opportunity to sample a drop of blood from a fingerprick at home, which can be sent to the laboratory by mail. We performed a clinical validation in which we compared measurements from whole-blood samples obtained by venapuncture with measurements from DBS samples simultaneously obtained by fingerprick. After exclusion of 10 DBS for poor quality, and 2 for other reasons, 199, 104, and 58 samples from a total of 172 patients were available for validation of creatinine, TaC and CsA, respectively. Validation was performed by means of Passing & Bablok regression, and bias was assessed by Bland-Altman analysis. For creatinine, we found y = 0.73x - 1.55 (95% confidence interval [95% CI] slope, 0.71-0.76), giving the conversion formula: (creatinine plasma concentration in μmol/L) = (creatinine concentration in DBS in μmol/L)/0.73, with a nonclinically relevant bias of -2.1 μmol/L (95% CI, -3.7 to -0.5 μmol/L). For TaC, we found y = 1.00x - 0.23 (95% CI slope, 0.91-1.08), with a nonclinically relevant bias of -0.28 μg/L (95% CI, -0.45 to -0.12 μg/L). For CsA, we found y = 0.99x - 1.86 (95% CI slope, 0.91-1.08) and no significant bias. Therefore, for neither TaC nor CsA, a conversion formula is required. DBS sampling for the simultaneous analysis of immunosuppressants and creatinine can replace conventional venous sampling in daily routine.

  6. Reliability and validity in a nutshell.

    Science.gov (United States)

    Bannigan, Katrina; Watson, Roger

    2009-12-01

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

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

    Science.gov (United States)

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

    2010-02-01

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

  8. A practical approach for the validation and clinical implementation of a high-sensitivity cardiac troponin I assay across a North American city

    Directory of Open Access Journals (Sweden)

    Peter A. Kavsak

    2015-04-01

    Full Text Available Objectives: Despite several publications on the analytical performance of high-sensitivity cardiac troponin (hs-cTn assays, there has been little information on how laboratories should validate and implement these assays into clinical service. Our study provides a practical approach for the validation and implementation of a hs-cTn assay across a large North American City. Design and methods: Validation for the Abbott ARCHITECT hs-cTnI assay (across 5 analyzers consisted of verification of limit of blank (LoB, precision (i.e., coefficient of variation; CV testing at the reported limit of detection (LoD and within and outside the 99th percentile, linearity testing, cTnI versus hs-cTnI patient comparison within and between analyzers (Passing and Bablok and non-parametric analyses. Education, clinical communications, and memorandums were issued in advance to inform all staff across the city as well as a selected reminder the day before live-date to important users. All hospitals switched to the hs-cTnI assay concurrently (the contemporary cTnI assay removed with laboratory staff instructed to repeat samples previously measured with the contemporary cTnI assay with the hs-cTnI assay only by physician request. Results: Across the 5 analyzers and 6 reagent packs the overall LoB was 0.6 ng/L (n=60 with a CV of 33% at an overall mean of 1.2 ng/L (n=60; reported LoD=1.0 ng/L, with linearity demonstrated from 45,005 ng/L to 1.1 ng/L. Precision testing with a normal patient-pool QC material (mean range across 5 analyzers was 3.9–4.4 ng/L yielded a range of CVs from 7% to 10% (within-run and CVs from 7% to 18% (between-run with the high patient-pool QC material (mean range across 5 analyzers was 29.6–36.3 ng/L yielding a range of CVs from 2% to 5% (within-run and CVs from 4% to 8% (between-run. There was agreement between hs-cTnI versus cTnI with the patient samples (slope ranges: 0.89–1.03; intercept ranges: 1.9–3

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

    NARCIS (Netherlands)

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

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

  10. Model-based clinical dose optimization for phenobarbital in neonates: An illustration of the importance of data sharing and external validation

    NARCIS (Netherlands)

    Völler, S. (Swantje); R. Flint (Robert); L. Stolk (Lisette); Degraeuwe, P.L.J. (Pieter L.J.); S.H. Simons (Sinno); P. Pokorna (Pavla); D.M. Burger (David); de Groot, R. (Ronald); D. Tibboel (Dick); C.A.J. Knibbe (Catherijne)

    2017-01-01

    textabstractBackground: Particularly in the pediatric clinical pharmacology field, data-sharing offers the possibility of making the most of all available data. In this study, we utilize previously collected therapeutic drug monitoring (TDM) data of term and preterm newborns to develop a population

  11. [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.

  12. Identification and validation of multiple cell surface markers of clinical-grade adipose-derived mesenchymal stromal cells as novel release criteria for good manufacturing practice-compliant production.

    Science.gov (United States)

    Camilleri, Emily T; Gustafson, Michael P; Dudakovic, Amel; Riester, Scott M; Garces, Catalina Galeano; Paradise, Christopher R; Takai, Hideki; Karperien, Marcel; Cool, Simon; Sampen, Hee-Jeong Im; Larson, A Noelle; Qu, Wenchun; Smith, Jay; Dietz, Allan B; van Wijnen, Andre J

    2016-08-11

    Clinical translation of mesenchymal stromal cells (MSCs) necessitates basic characterization of the cell product since variability in biological source and processing of MSCs may impact therapeutic outcomes. Although expression of classical cell surface markers (e.g., CD90, CD73, CD105, and CD44) is used to define MSCs, identification of functionally relevant cell surface markers would provide more robust release criteria and options for quality control. In addition, cell surface expression may distinguish between MSCs from different sources, including bone marrow-derived MSCs and clinical-grade adipose-derived MSCs (AMSCs) grown in human platelet lysate (hPL). In this work we utilized quantitative PCR, flow cytometry, and RNA-sequencing to characterize AMSCs grown in hPL and validated non-classical markers in 15 clinical-grade donors. We characterized the surface marker transcriptome of AMSCs, validated the expression of classical markers, and identified nine non-classical markers (i.e., CD36, CD163, CD271, CD200, CD273, CD274, CD146, CD248, and CD140B) that may potentially discriminate AMSCs from other cell types. More importantly, these markers exhibit variability in cell surface expression among different cell isolates from a diverse cohort of donors, including freshly prepared, previously frozen, or proliferative state AMSCs and may be informative when manufacturing cells. Our study establishes that clinical-grade AMSCs expanded in hPL represent a homogeneous cell culture population according to classical markers,. Additionally, we validated new biomarkers for further AMSC characterization that may provide novel information guiding the development of new release criteria. Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis (BMAC): Clinicaltrials.gov NCT01931007 . Registered August 26, 2013. MSC for Occlusive Disease of the Kidney: Clinicaltrials.gov NCT01840540 . Registered April 23, 2013. Mesenchymal Stem Cell Therapy in Multiple

  13. Design for validation: An approach to systems validation

    Science.gov (United States)

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

    1989-01-01

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

  14. Swallowing sparing intensity modulated radiotherapy (SW-IMRT) in head and neck cancer : Clinical validation according to the model-based approach

    NARCIS (Netherlands)

    Christianen, Miranda E. M. C.; van der Schaaf, Arjen; van der Laan, Hans Paul; Verdonck-de Leeuw, Irma M.; Doornaert, Patricia; Chouvalova, Olga; Steenbakkers, Roel J. H. M.; Leemans, Charles Rene; Oosting, Sjoukje F.; van der Laan, Bernard F. A. M.; Roodenburg, Jan L. N.; Slotman, Ben J.; Bijl, Hendrik P.; Langendijk, Johannes A.

    Purpose: The aim of this study was to clinically validate a multivariable normal tissue complication probability (NTCP) model for grade 2-4 swallowing dysfunction at 6 months after radiotherapy or chemoradiation (SWAL(M6)) in head and neck cancer patients treated with swallowing sparing intensity

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

    Directory of Open Access Journals (Sweden)

    Hagberg KW

    2017-09-01

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

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

    Science.gov (United States)

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

    2013-06-01

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

  17. Enhancing importance-performance analysis

    DEFF Research Database (Denmark)

    Eskildsen, Jacob Kjær; Kristensen, Kai

    2006-01-01

    Purpose: The interpretation of the importance/performance map is based on an assumption of independence between importance and performance but many studies question the validity of this assumption. The aim of this research is to develop a new typology for job satisfaction attributes as well...... as a new importance/performance map that can be an aid for organizations when they prioritize their improvement actions based on a job satisfaction study. Design/methodology/approach: A typology for possible relationships between importance and performance in job satisfaction studies is developed based...... on theoretical considerations. This typology is then applied and validated on approximately 10,000 responses from the European Employee Index 2002. Ultimately a new importance/performance map for priority setting in job satisfaction studies is developed based on the new typology for possible relationships...

  18. Combining clinical practice and academic work in nursing: A qualitative study about perceived importance, facilitators and barriers regarding clinical academic careers for nurses in university hospitals.

    Science.gov (United States)

    van Oostveen, Catharina J; Goedhart, Nicole S; Francke, Anneke L; Vermeulen, Hester

    2017-12-01

    To obtain in-depth insight into the perceptions of nurse academics and other stakeholders regarding the importance, facilitators and barriers for nurses combining clinical and academic work in university hospitals. Combining clinical practice and academic work facilitates the use of research findings for high-quality patient care. However, nurse academics move away from the bedside because clinical academic careers for nurses have not yet been established in the Netherlands. This qualitative study was conducted in two Dutch university hospitals and their affiliated medical faculties and universities of applied sciences. Data were collected between May 2015 and August 2016. We used purposive sampling for 24 interviews. We asked 14 participants in two focus groups for their perceptions of importance, facilitators and barriers in nurses' combined clinical and academic work in education and research. We audiotaped, transcribed and thematically analysed the interviews and focus groups. Three themes related to perceived importance, facilitators and barriers: culture, leadership and infrastructure. These themes represent deficiencies in facilitating clinical academic careers for nurses. The current nursing culture emphasises direct patient care, which is perceived as an academic misfit. Leadership is lacking at all levels, resulting in the underuse of nurse academics and the absence of supporting structures for nurses who combine clinical and academic work. The present nursing culture appears to be the root cause of the dearth of academic positions and established clinical academic posts. A culture change would require a show of leadership that would promote and enable combined research, teaching and clinical practice and that would introduce clinical academic career pathways for nurses. Meanwhile, nurse academics should collaborate with established medical academics for whom combined roles are mainstream, and they should take advantage of their established infrastructure

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

    Science.gov (United States)

    Sabour, Siamak

    2018-03-08

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

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

    Science.gov (United States)

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

    2015-10-01

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

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

    Science.gov (United States)

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

    2012-12-01

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

  2. Validating spatiotemporal predictions of an important pest of small grains.

    Science.gov (United States)

    Merrill, Scott C; Holtzer, Thomas O; Peairs, Frank B; Lester, Philip J

    2015-01-01

    Arthropod pests are typically managed using tactics applied uniformly to the whole field. Precision pest management applies tactics under the assumption that within-field pest pressure differences exist. This approach allows for more precise and judicious use of scouting resources and management tactics. For example, a portion of a field delineated as attractive to pests may be selected to receive extra monitoring attention. Likely because of the high variability in pest dynamics, little attention has been given to developing precision pest prediction models. Here, multimodel synthesis was used to develop a spatiotemporal model predicting the density of a key pest of wheat, the Russian wheat aphid, Diuraphis noxia (Kurdjumov). Spatially implicit and spatially explicit models were synthesized to generate spatiotemporal pest pressure predictions. Cross-validation and field validation were used to confirm model efficacy. A strong within-field signal depicting aphid density was confirmed with low prediction errors. Results show that the within-field model predictions will provide higher-quality information than would be provided by traditional field scouting. With improvements to the broad-scale model component, the model synthesis approach and resulting tool could improve pest management strategy and provide a template for the development of spatially explicit pest pressure models. © 2014 Society of Chemical Industry.

  3. FACE Analysis as a Fast and Reliable Methodology to Monitor the Sulfation and Total Amount of Chondroitin Sulfate in Biological Samples of Clinical Importance

    Directory of Open Access Journals (Sweden)

    Evgenia Karousou

    2014-06-01

    Full Text Available Glycosaminoglycans (GAGs due to their hydrophilic character and high anionic charge densities play important roles in various (pathophysiological processes. The identification and quantification of GAGs in biological samples and tissues could be useful prognostic and diagnostic tools in pathological conditions. Despite the noteworthy progress in the development of sensitive and accurate methodologies for the determination of GAGs, there is a significant lack in methodologies regarding sample preparation and reliable fast analysis methods enabling the simultaneous analysis of several biological samples. In this report, developed protocols for the isolation of GAGs in biological samples were applied to analyze various sulfated chondroitin sulfate- and hyaluronan-derived disaccharides using fluorophore-assisted carbohydrate electrophoresis (FACE. Applications to biologic samples of clinical importance include blood serum, lens capsule tissue and urine. The sample preparation protocol followed by FACE analysis allows quantification with an optimal linearity over the concentration range 1.0–220.0 µg/mL, affording a limit of quantitation of 50 ng of disaccharides. Validation of FACE results was performed by capillary electrophoresis and high performance liquid chromatography techniques.

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

    Science.gov (United States)

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

    2014-06-01

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

  5. Understanding latent structures of clinical information logistics: A bottom-up approach for model building and validating the workflow composite score.

    Science.gov (United States)

    Esdar, Moritz; Hübner, Ursula; Liebe, Jan-David; Hüsers, Jens; Thye, Johannes

    2017-01-01

    Clinical information logistics is a construct that aims to describe and explain various phenomena of information provision to drive clinical processes. It can be measured by the workflow composite score, an aggregated indicator of the degree of IT support in clinical processes. This study primarily aimed to investigate the yet unknown empirical patterns constituting this construct. The second goal was to derive a data-driven weighting scheme for the constituents of the workflow composite score and to contrast this scheme with a literature based, top-down procedure. This approach should finally test the validity and robustness of the workflow composite score. Based on secondary data from 183 German hospitals, a tiered factor analytic approach (confirmatory and subsequent exploratory factor analysis) was pursued. A weighting scheme, which was based on factor loadings obtained in the analyses, was put into practice. We were able to identify five statistically significant factors of clinical information logistics that accounted for 63% of the overall variance. These factors were "flow of data and information", "mobility", "clinical decision support and patient safety", "electronic patient record" and "integration and distribution". The system of weights derived from the factor loadings resulted in values for the workflow composite score that differed only slightly from the score values that had been previously published based on a top-down approach. Our findings give insight into the internal composition of clinical information logistics both in terms of factors and weights. They also allowed us to propose a coherent model of clinical information logistics from a technical perspective that joins empirical findings with theoretical knowledge. Despite the new scheme of weights applied to the calculation of the workflow composite score, the score behaved robustly, which is yet another hint of its validity and therefore its usefulness. Copyright © 2016 Elsevier Ireland

  6. Which factors are important for the successful development and implementation of clinical pathways? A qualitative study.

    Science.gov (United States)

    De Allegri, Manuela; Schwarzbach, Matthias; Loerbroks, Adrian; Ronellenfitsch, Ulrich

    2011-03-01

    Clinical pathways (CPs) are detailed longitudinal care plans delineating measures to be conducted during a patient's treatment. Although positive effects on resource consumption and quality of care have been shown, CPs are still underutilised in many clinical settings because their development and implementation are difficult. Evidence underpinning successful development and implementation is sparse. The authors conducted semistructured face-to-face interviews with key staff members involved in the design and implementation of CPs in a large surgery department. Interviewees were asked to provide opinions on various issues, which were previously identified as potentially important in CP development and implementation. The transcribed text was read and coded independently by two researchers. Respondents highlighted the importance of a multidisciplinary participatory approach for CP design and implementation. There was a strong initial fear of losing individual freedom of treatment, which subsided after people worked with CPs in clinical everyday life. It was appreciated that the project originated from people at different levels of the department's hierarchy. Likewise, it was felt that CP implementation granted more autonomy to lower-level staff. The structured qualitative approach of this study provides information on what issues are considered important by staff members for CP design and implementation. Whereas some concepts such as the importance of a multidisciplinary approach or continuous feedback of results are known from theories, others such as strengthening the authority especially of lower-level health professionals through CPs have not been described so far. Many of the findings point towards strong interactions between factors important for CP implementation and a department's organisational structure.

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

    Science.gov (United States)

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

    2015-01-01

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

  8. Clinical importance of caffeine dependence and abuse.

    Science.gov (United States)

    Ogawa, Naoshi; Ueki, Hirofumi

    2007-06-01

    Caffeine is the most widely consumed psychoactive substance and is a legal stimulant that is readily available to children. Caffeine has occasionally been considered a drug of abuse and the potential for dependence on caffeine has been debated. Presently, due to a paucity of clinical evidence on caffeine dependence or abuse, no such diagnosis is included in the Diagnostic and Statistical Manual of Mental Disorder-fourth edition. The authors present two cases of abuse or dependence on the caffeine contained in 'eutrophic' (energy/nutritional) beverages or caffeine preparations, followed by a review of clinical studies demonstrating evidence that some people can manifest a clinical syndrome of caffeine dependence or abuse. The cases suggest that caffeine can produce a clinical dependence syndrome similar to those produced by other psychoactive substances and has a potential for abuse. In a recent study using a structured interview and the Diagnostic and Statistical Manual of Mental Disorder-fourth edition criteria for substance dependence and abuse, a subset of the general population was found to demonstrate caffeine dependence or caffeine abuse. Therefore, the authors propose that companies or businesses manufacturing or marketing caffeine or products containing caffeine must meet the following guidelines: (i) clearly indicate the caffeine content of products containing comparatively higher quantities of caffeine; (ii) warn that such products should be avoided by infants and children wherever possible, and inform adult consumers about the precise quantity of caffeine that is considered safe for consumption; and (iii) clearly state that consuming large quantities of caffeine and the long-term use of caffeine carry health risks.

  9. Clinical indicators to monitor patients with risk for ineffective cerebral tissue perfusion

    Directory of Open Access Journals (Sweden)

    Miriam de Abreu Almeida

    2015-04-01

    Full Text Available Objective. Select and validate the clinical indicators to monitor patients on risk for ineffective cerebral tissue perfusion, according to the Nursing Outcomes Classification (NOC. Methodology. Validation study carried out between November 2012 and August 2013, in a Brazilian hospital. Seventeen judges nurses evaluated the clinical indicators of Nursing Outcomes, according to NOC for patients on risk for ineffective cerebral tissue perfusion. In the first stage, were selected the nursing results for the assessment of the studied diagnosis and, in the second nurses assessment the importance of the indicators of the validated results in the previous step through a five points Likert scale (1 = not important to 5 = extremely important. Were used the content validity index (CVI that corresponds to the calculation of weighted averages of them marks awarded for each indicator, as it considered the following weights: 1=0.00, 2=0.25, 3=0.50; 4=0.75; 5=1.00. For categorization, the CVI considered as critical = ≥0.80; supplementary =≥0.50 to 0.79 and were disposed results <0.50. Results. Of the 9 nursing results, only the cerebral tissue perfusion obtained a 100% consensus. The CVI of the 18 indicators of this result showed that five were validated as critical (impaired neurological reflexes, systolic blood pressure, diastolic blood pressure, reduced level of consciousness and mean arterial pressure, 12 were validated as supplementary (Agitation, Impaired cognition, Intracranial pressure, Syncope, Vomiting, Findings of cerebral angiography, Headache, Restlessness, Fever, Unexplained anxiety, listlessness and Hiccughs and one was disposed (carotid bruit. Conclusions. The validation of information about the conditions of risk may allow early intervention to minimize the consequences of ineffective cerebral tissue perfusion.

  10. Validation of liquid biopsy: plasma cell-free DNA testing in clinical management of advanced non-small cell lung cancer

    Directory of Open Access Journals (Sweden)

    Veldore VH

    2018-01-01

    Full Text Available Vidya H Veldore,1,* Anuradha Choughule,2,* Tejaswi Routhu,1 Nitin Mandloi,1 Vanita Noronha,2 Amit Joshi,2 Amit Dutt,3 Ravi Gupta,1 Ramprasad Vedam,1 Kumar Prabhash2 1MedGenome Labs Private Ltd,, Bangalore, India; 2Tata Memorial Centre, Parel, Mumbai, India; 3The Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Center, Kharghar, Navi Mumbai, Maharashtra, India *These authors contributed equally to this work Abstract: Plasma cell-free tumor DNA, or circulating tumor DNA (ctDNA, from liquid biopsy is a potential source of tumor genetic material, in the absence of tissue biopsy, for EGFR testing. Our validation study reiterates the clinical utility of ctDNA next generation sequencing (NGS for EGFR mutation testing in non-small cell lung cancer (NSCLC. A total of 163 NSCLC cases were included in the validation, of which 132 patients had paired tissue biopsy and ctDNA. We chose to validate ctDNA using deep sequencing with custom designed bioinformatics methods that could detect somatic mutations at allele frequencies as low as 0.01%. Benchmarking allele specific real time PCR as one of the standard methods for tissue-based EGFR mutation testing, the ctDNA NGS test was validated on all the plasma derived cell-free DNA samples. We observed a high concordance (96.96% between tissue biopsy and ctDNA for oncogenic driver mutations in Exon 19 and Exon 21 of the EGFR gene. The sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of the assay were 91.1%, 100% 100%, 95.6%, and 97%, respectively. A false negative rate of 3% was observed. A subset of mutations was also verified on droplet digital PCR. Sixteen percent EGFR mutation positivity was observed in patients where only liquid biopsy was available, thus creating options for targeted therapy. This is the first and largest study from India, demonstrating successful validation of circulating cell-free DNA as a clinically

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

    Science.gov (United States)

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

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

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

    Science.gov (United States)

    Zander, Eric; Sturm, Harald; Bölte, Sven

    2015-01-01

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

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

    DEFF Research Database (Denmark)

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

    2008-01-01

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

  14. The importance of content and face validity in instrument development: lessons learnt from service users when developing the Recovering Quality of Life measure (ReQoL).

    Science.gov (United States)

    Connell, Janice; Carlton, Jill; Grundy, Andrew; Taylor Buck, Elizabeth; Keetharuth, Anju Devianee; Ricketts, Thomas; Barkham, Michael; Robotham, Dan; Rose, Diana; Brazier, John

    2018-07-01

    Service user involvement in instrument development is increasingly recognised as important, but is often not done and seldom reported. This has adverse implications for the content validity of a measure. The aim of this paper is to identify the types of items that service users felt were important to be included or excluded from a new Recovering Quality of Life measure for people with mental health difficulties. Potential items were presented to service users in face-to-face structured individual interviews and focus groups. The items were primarily taken or adapted from current measures and covered themes identified from earlier qualitative work as being important to quality of life. Content and thematic analysis was undertaken to identify the types of items which were either important or unacceptable to service users. We identified five key themes of the types of items that service users found acceptable or unacceptable; the items should be relevant and meaningful, unambiguous, easy to answer particularly when distressed, do not cause further upset, and be non-judgemental. Importantly, this was from the perspective of the service user. This research has underlined the importance of service users' views on the acceptability and validity of items for use in developing a new measure. Whether or not service users favoured an item was associated with their ability or intention to respond accurately and honestly to the item which will impact on the validity and sensitivity of the measure.

  15. Combining clinical practice and academic work in nursing: a qualitative study about perceived importance, facilitators and barriers regarding clinical academic careers for nurses in university hospitals.

    NARCIS (Netherlands)

    Oostveen, C.J. van; Goedhart, N.S.; Francke, A.L.; Vermeulen, H.

    2017-01-01

    Aims and objectives: To obtain in-depth insight into the perceptions of nurse aca- demics and other stakeholders regarding the importance, facilitators and barriers for nurses combining clinical and academic work in university hospitals. Background: Combining clinical practice and academic work

  16. Clinical importance of cross-reactivity in food allergy

    NARCIS (Netherlands)

    van Ree, Ronald

    2004-01-01

    PURPOSE OF REVIEW: Review of recent developments in the field of cross-reactivity in food allergy and the clinical relevance of these developments. RECENT FINDINGS: New foods have been added to the list of Bet v 1 and profilin-related food allergies. Clinical relevance of cross-reactions based on

  17. A cross-cultural convergent parallel mixed methods study of what makes a cancer-related symptom or functional health problem clinically important.

    Science.gov (United States)

    Giesinger, Johannes M; Aaronson, Neil K; Arraras, Juan I; Efficace, Fabio; Groenvold, Mogens; Kieffer, Jacobien M; Loth, Fanny L; Petersen, Morten Aa; Ramage, John; Tomaszewski, Krzysztof A; Young, Teresa; Holzner, Bernhard

    2018-02-01

    In this study, we investigated what makes a symptom or functional impairment clinically important, that is, relevant for a patient to discuss with a health care professional (HCP). This is the first part of a European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group project focusing on the development of thresholds for clinical importance for the EORTC QLQ-C30 questionnaire and its corresponding computer-adaptive version. We conducted interviews with cancer patients and HCPs in 6 European countries. Participants were asked to name aspects of a symptom or problem that make it clinically important and to provide importance ratings for a predefined set of aspects (eg, need for help and limitations of daily functioning). We conducted interviews with 83 cancer patients (mean age, 60.3 y; 50.6% men) and 67 HCPs. Participants related clinical importance to limitations of everyday life (patients, 65.1%; HCPs, 77.6%), the emotional impact of a symptom/problem (patients, 53.0%; HCPs, 64.2%), and duration/frequency (patients, 51.8%; HCPs, 49.3%). In the patient sample, importance ratings were highest for worries by partner or family, limitations in everyday life, and need for help from the medical staff. Health care professionals rated limitations in everyday life and need for help from the medical staff to be most important. Limitations in everyday life, need for (medical) help, and emotional impact on the patient or family/partner were found to be relevant aspects of clinical importance. Based on these findings, we will define anchor items for the development of thresholds for clinical importance for the EORTC measures in a Europe-wide field study. Copyright © 2017 John Wiley & Sons, Ltd.

  18. Assessing the stroke-specific quality of life for outcome measurement in stroke rehabilitation: minimal detectable change and clinically important difference.

    Science.gov (United States)

    Lin, Keh-chung; Fu, Tiffany; Wu, Ching-yi; Hsieh, Ching-ju

    2011-01-19

    This study was conducted to establish the minimal detectable change (MDC) and clinically important differences (CIDs) of the physical category of the Stroke-Specific Quality of Life Scale in patients with stroke. MDC and CIDs scores were calculated from the data of 74 participants enrolled in randomized controlled trials investigating the effects of two rehabilitation programs in patients with stroke. These participants received treatments for 3 weeks and underwent clinical assessment before and after treatment. To obtain test-retest reliability for calculating MDC, another 25 patients with chronic stroke were recruited. The MDC was calculated from the standard error of measurement (SEM) to indicate a real change with 95% confidence for individual patients (MDC95). Distribution-based and anchor-based methods were adopted to triangulate the ranges of minimal CIDs. The percentage of scale width was calculated by dividing the MDC and CIDs by the total score range of each physical category. The percentage of patients exceeding MDC95 and minimal CIDs was also reported. The MDC95 of the mobility, self-care, and upper extremity (UE) function subscales were 5.9, 4.0, and 5.3 respectively. The minimal CID ranges for these 3 subscales were 1.5 to 2.4, 1.2 to 1.9, and 1.2 to 1.8. The percentage of patients exceeding MDC95 and minimal CIDs of the mobility, self-care, and UE function subscales were 9.5% to 28.4%, 6.8% to 28.4%, and 12.2% to 33.8%, respectively. The change score of an individual patient has to reach 5.9, 4.0, and 5.3 on the 3 subscales to indicate a true change. The mean change scores of a group of patients with stroke on these subscales should reach the lower bound of CID ranges of 1.5 (6.3% scale width), 1.2 (6.0% scale width), and 1.2 (6.0% scale width) to be regarded as clinically important change. This information may facilitate interpretations of patient-reported outcomes after stroke rehabilitation. Future research is warranted to validate these findings.

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

    Directory of Open Access Journals (Sweden)

    Salvatella-Pasant Jordi

    2010-02-01

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

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

    Directory of Open Access Journals (Sweden)

    Ma Shwe Zin Nyunt

    2013-10-01

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

  1. Determining the Minimal Clinically Important Difference for Six-Minute Walk Distance in Fibromyalgia

    Science.gov (United States)

    Kaleth, Anthony S.; Slaven, James E.; Ang, Dennis C.

    2016-01-01

    Objective To estimate the minimal clinically important difference (MCID) for 6-minute walk distance (6MWD) in patients with fibromyalgia (FM). Design Data from a recently completed trial that included 187 patients who completed the 6-minute walk test, Fibromyalgia Impact Questionnaire (FIQ), and Short-Form 36 (SF36) at 12 and 36 weeks were used to examine longitudinal changes in 6MWD. An anchor-based approach that used linear regression analyses was used to determine the MCID for 6MWD, using the total FIQ score (FIQ-Total) and SF36-physical function domain (SF36-PF) as clinical anchors. Results The mean (SD) change in 6MWD from baseline to week 36 was 34.4 (65.2) m (pFIQ and SF36-PF, respectively. These MCID’s correspond with clinically meaningful improvements in FIQ (14% reduction) and SF36-PF (10 point increase). Conclusion The MCID for 6MWD in patients with FM was 156 to 167 m. These findings provide the first evidence of the change in 6MWD that is perceived by patients to be clinically meaningful. Further research using other MCID calculation methods is needed to refine estimates of the MCID for 6MWD in patients with FM. PMID:27003201

  2. Determining the Minimal Clinically Important Difference for 6-Minute Walk Distance in Fibromyalgia.

    Science.gov (United States)

    Kaleth, Anthony S; Slaven, James E; Ang, Dennis C

    2016-10-01

    The aim of this study was to estimate the minimal clinically important difference (MCID) for 6-min walk distance (6MWD) in patients with fibromyalgia. Data from a recently completed trial that included 187 patients who completed the 6-min walk test, Fibromyalgia Impact Questionnaire (FIQ), and Short-Form 36 (SF36) at 12 and 36 wks were used to examine longitudinal changes in 6MWD. An anchor-based approach that used linear regression analyses was used to determine the MCID for 6MWD, using the total FIQ score (FIQ-Total) and SF36-physical function domain as clinical anchors. The mean (SD) change in 6MWD from baseline to week 36 was 34.4 (65.2) m (P FIQ and SF36-physical function domain, respectively. These MCIDs correspond with clinically meaningful improvements in FIQ (14% reduction) and SF36-physical function domain (10-point increase). The MCID for 6MWD in patients with fibromyalgia was 156 to 167 m. These findings provide the first evidence of the change in 6MWD that is perceived by patients to be clinically meaningful. Further research using other MCID calculation methods is needed to refine estimates of the MCID for 6MWD in patients with fibromyalgia.

  3. The development and validation of the Body-Image Ideals Questionnaire.

    Science.gov (United States)

    Cash, T F; Szymanski, M L

    1995-06-01

    The Body-Image Ideals Questionnaire (BIQ) was developed as a unique attitudinal body-image assessment that considers one's perceived discrepancy from and degree of investment in personal ideals on multiple physical attributes. Reliability and validity of the 20-item instrument were examined for a sample of 284 college women. The results indicated that the BIQ consists of two relatively distinct and internally consistent Discrepancy and Importance subscales, as well as their multiplicative composite. The subscales' respective convergent validities vis-à-vis extant body-image measures and specific facets of personality (i.e., public self-consciousness and perfectionism) and psychosocial adjustment (i.e., social anxiety, depression, and eating disturbance) were confirmed. Evidence also supported the incremental validity of multiple self-ideal discrepancies. Effects due to socially desirable responding were inconsequential. Directions for needed basic and clinical research were identified.

  4. Validation of the partner version of the multidimensional vaginal penetration disorder questionnaire: A tool for clinical assessment of lifelong vaginismus in a sample of Iranian population.

    Science.gov (United States)

    Molaeinezhad, Mitra; Khoei, Effat Merghati; Salehi, Mehrdad; Yousfy, Alireza; Roudsari, Robab Latifnejad

    2014-01-01

    The role of spousal response in woman's experience of pain during the vaginal penetration attempts believed to be an important factor; however, studies are rather limited in this area. The aim of this study was to develop and investigate the psychometric indexes of the partner version of a multidimensional vaginal penetration disorder questionnaire (PV-MVPDQ); hence, the clinical assessment of spousal psychosexual reactions to vaginismus by specialists will be easier. A mixed-methods sequential exploratory design was used, through that, the findings from a thematic qualitative research with 20 unconsummated couples, which followed by an extensive literature review used for development of PV-MVPDQ. A consecutive sample of 214 men who their wives' suffered from lifelong vaginismus (LLV) based on Diagnostic and Statistical Manual of Mental Disorders 4(th) version (DSM)-IVTR criteria during a cross-sectional design, completed the questionnaire and additional questions regarding their demographic and sexual history. Validation measures and reliability were conducted by exploratory factor analysis (EFA) and Cronbach's alpha coefficient through SPSS version 16 manufactured by SPSS Inc. (IBM corporation, Armonk, USA). After conducting EFA PV-MVPDQ emerged as having 40 items and 7 dimensions: Helplessness, sexual information, vicious cycle of penetration, hypervigilance and solicitous, catastrophic cognitions, sexual and marital adjustment and optimism. Subscales of PV-MVPDQ showed a significant reliability (0.71-0.85) and results of test-retest were satisfactory. The present study shows PV-MVPDQ is a multi-dimensional valid and reliable self-report questionnaire for assessment of cognitions, sexual and marital relations related to vaginal penetrations in spouses of women with LLV. It may assist specialists to base on which clinical judgment and appropriate planning for clinical management.

  5. The "DOC" screen: Feasible and valid screening for depression, Obstructive Sleep Apnea (OSA) and cognitive impairment in stroke prevention clinics.

    Science.gov (United States)

    Swartz, Richard H; Cayley, Megan L; Lanctôt, Krista L; Murray, Brian J; Cohen, Ashley; Thorpe, Kevin E; Sicard, Michelle N; Lien, Karen; Sahlas, Demetrios J; Herrmann, Nathan

    2017-01-01

    Post-stroke Depression, Obstructive sleep apnea (OSA) and Cognitive impairment ("DOC") are associated with greater mortality, worse recovery and poorer quality of life. Best practice recommendations endorse routine screening for each condition; yet, all are under-assessed, diagnosed and treated. We seek to determine the feasibility and validity of an integrated tool ("DOC" screen) to identify stroke clinic patients at high-risk of depression, OSA, and cognitive impairment. All consecutive new referrals to a regional Stroke Prevention Clinic who were English-speaking and non-aphasic were eligible to be screened. Time for screen completion was logged. DOC screen results were compared to the neuropsychological battery and polysomnogram assessments using a modified receiver operator characteristic and area under the curve analysis. Data is reported to conform to STARD guidelines. 1503 people were screened over 2 years. 89% of eligible patients completed the screen in 5 minutes or less (mean 4.2 minutes), less than half the time it takes to complete the Montreal Cognitive Assessment (MoCA). 437 people consented to detailed testing. Of those, 421 completed the Structured Clinical Interview for Depression within 3 months of screening, 387 completed detailed neuropsychological testing within 3 months, and 88 had overnight polysomnograms. Screening scores combined with demographic variables (age, sex, education, body mass index), had excellent validity compared to gold standard diagnoses: DOC-Mood AUC 0.90; DOC-Apnea AUC 0.80; DOC-Cog AUC 0.81. DOC screen scores can reliably categorize patients in to low-, intermediate- or high-risk groups for further action and can do so with comparable accuracy to more time-consuming screens. Systematic screening of depression, obstructive sleep apnea, and cognitive impairment in 5 minutes or less is feasible and valid in a high volume stroke clinic using the DOC screen. The DOC screen may facilitate improved identification and treatment

  6. The criterion validity of the web-based Major Depression Inventory when used on clinical suspicion of depression in primary care

    DEFF Research Database (Denmark)

    Nielsen, Marie Germund; Ørnbøl, Eva; Bech, Per

    2017-01-01

    the web-based MDI in a primary care setting. The validation was based on the Munich-Composite International Diagnostic Interview (M-CIDI) by phone. GPs in the 22 practices in our study included 132 persons suspected of depression. Depression was rated as yes/no according to the MDI and M-CIDI. Sensitivity......BACKGROUND: The Major Depression Inventory (MDI) is widely used in Danish general practice as a screening tool to assess depression in symptomatic patients. Nevertheless, no validation studies of the MDI have been performed. The aim of this study was to validate the web-based version of the MDI...... against a fully structured telephone interview in a population selected on clinical suspicion of depression (ie, presence of two or three core symptoms of depression) in general practice. MATERIALS AND METHODS: General practitioners (GPs) invited consecutive persons suspected of depression to complete...

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

    Science.gov (United States)

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

    2011-06-01

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

  8. Variations in Transverse Foramina of Cervical Vertebrae: Morphology & Clinical Importance

    Directory of Open Access Journals (Sweden)

    Vaishakhi Gonsai

    2015-12-01

    Full Text Available Background: The purpose of this study is to investigate variations in transverse foramina in the cervical vertebrae and its morphological and clinical importance. Materials and Method : The variations in the number and size of transverse foramina was studied in total 200 human dried cervical vertebrae, which were taken from the Department of Anatomy, B.J.Medical College, Ahmedabad. All the vertebrae were observed for variation in number and size of transverse foramina. Results: Out of 200 cervical vertebrae, complete double transverse foramina were observed in 40 vertebrae (20%, among them unilateral double foramina were found in 31 vertebrae (15.5% and the bilateral double foramina were found in 9 vertebrae (4.5%. Incomplete double transverse foramina were observed in 22 vertebrae (11%, among them unilateral double foramina were found in 16 vertebrae (8% and bilateral double foramina were observed in 6 vertebrae (3%. Conclusion: Complete unilateral double transverse foramina of cervical vertebrae were more common than bilateral. Also unilateral small size transverse foramina of cervical vertebrae were also common. This variation is important for the neurosurgeon during cervical surgery. Under such condition the course of the vertebral artery may be distorted. It is also useful for Radiologist during CT and MRI scan.

  9. The ENDOCARE questionnaire guides European endometriosis clinics to improve the patient-centeredness of their care.

    Science.gov (United States)

    Dancet, E A F; Apers, S; Kluivers, K B; Kremer, J A M; Sermeus, W; Devriendt, C; Nelen, W L D M; D'Hooghe, T M

    2012-11-01

    How patient-centered are two included specialized endometriosis clinics relative to each other and how can they improve the patient-centeredness of their care? The validated ENDOCARE questionnaire (ECQ) reliably concluded that the adjusted overall patient-centeredness did not differ between the clinics, that each clinic was significantly more patient-centered for 2 out of 10 dimensions of patient-centered endometriosis care and that clinics 1 and 2 had to improve 8 and 13 specific care aspects, respectively. Patient-centered endometriosis care is essential to high-quality care and is defined by 10 dimensions. The ECQ was developed, validated and proved to be reliable in a European setting of self-reported endometriosis patients but had not yet been used at a clinic level for quality management. A cross-sectional survey was disseminated in 2011 to all 514 women diagnosed with endometriosis during a laparoscopy indicated for pain and/or infertility during a retrospective 2-year period (2009-2010) in two university clinics from two different European countries. In total 337 patients completed the ECQ (216 and 121 per clinic). Respondents had a mean age of 34.3 years. Three in four reported a surgical diagnosis of moderate or severe endometriosis and the majority reported surgical treatment by a multidisciplinary team. The ECQ assessed the 10 dimensions of patient-centeredness, more specifically whether the health-care performance, as perceived by patients, measured up to what is important to patients in general. The ECQ was completed by 337 respondents (response rate = 65.6%). Reliability and validity of the ECQ for use on clinic level were confirmed. Clinics did not differ in overall mean importance scores; importance rankings of the ECQ dimensions were almost identical. The overall patient-centeredness scores (PCS), adjusted for education level, did not discriminate between the clinics. However, the adjusted PCS for the dimensions 'clinic staff' and 'technical

  10. 3D molecular descriptors important for clinical success.

    Science.gov (United States)

    Kombo, David C; Tallapragada, Kartik; Jain, Rachit; Chewning, Joseph; Mazurov, Anatoly A; Speake, Jason D; Hauser, Terry A; Toler, Steve

    2013-02-25

    The pharmacokinetic and safety profiles of clinical drug candidates are greatly influenced by their requisite physicochemical properties. In particular, it has been shown that 2D molecular descriptors such as fraction of Sp3 carbon atoms (Fsp3) and number of stereo centers correlate with clinical success. Using the proteomic off-target hit rate of nicotinic ligands, we found that shape-based 3D descriptors such as the radius of gyration and shadow indices discriminate off-target promiscuity better than do Fsp3 and the number of stereo centers. We have deduced the relevant descriptor values required for a ligand to be nonpromiscuous. Investigating the MDL Drug Data Report (MDDR) database as compounds move from the preclinical stage toward the market, we have found that these shape-based 3D descriptors predict clinical success of compounds at preclinical and phase1 stages vs compounds withdrawn from the market better than do Fsp3 and LogD. Further, these computed 3D molecular descriptors correlate well with experimentally observed solubility, which is among well-known physicochemical properties that drive clinical success. We also found that about 84% of launched drugs satisfy either Shadow index or Fsp3 criteria, whereas withdrawn and discontinued compounds fail to meet the same criteria. Our studies suggest that spherical compounds (rather than their elongated counterparts) with a minimal number of aromatic rings may exhibit a high propensity to advance from clinical trials to market.

  11. The Neuropsychiatric Inventory--NPI. Validation of the Danish version

    DEFF Research Database (Denmark)

    Korner, A.; Lauritzen, Lotte; Lolk, A.

    2008-01-01

    NPI and NPI-VAS were high; only two domains had coefficients below 0.60: depression and agitation/aggression. NPI-total scores increase with increasing severity of dementia. The NPI did not fulfil the scalability assessed by the Mokken and Loevinger coefficients. The NPI Danish version is valid......Assessment of neuropsychiatric symptoms in dementia has great clinical importance. The aim of the study was validation of the Danish version of the NPI, using assessments of 72 demented and 29 non-demented of age 65+ years and their caregivers at three visits. The NPI was administered by the same...... and reliable in assessing neuropsychiatric symptoms in dementia but not fully scalable. The use of single item scores and not total sum score is recommended Udgivelsesdato: 2008...

  12. Decision analysis. Clinical art or Clinical Science

    Science.gov (United States)

    1977-05-01

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

  13. Content validity and nursing sensitivity of community-level outcomes from the Nursing Outcomes Classification (NOC).

    Science.gov (United States)

    Head, Barbara J; Aquilino, Mary Lober; Johnson, Marion; Reed, David; Maas, Meridean; Moorhead, Sue

    2004-01-01

    To evaluate the content validity and nursing sensitivity of six community-level outcomes from the Nursing Outcomes Classification (NOC; Johnson, Maas, & Moorhead, 2000). A survey research design was used. Questionnaires were mailed to 300 public health nursing experts; 102 nurses responded. Experts evaluated between 11 and 30 indicators for each of the six outcomes for: (a) importance of the indicators for measuring the outcome, and (b) influence of nursing on the indicators. Content validity and nursing sensitivity of the outcomes were estimated with a modified Fehring technique. All outcomes were deemed important; only Community Competence had an outcome content validity score < .80. The outcome sensitivity score for Community Health: Immunity was .80; other outcome scores ranged from .62-.70. Indicator ratios for all 102 indicators met the study criterion for importance, with 87% designated as critical and 13% as supplemental. Sensitivity ratios reflected judgments that 45% of the indicators were sensitive to nursing intervention. The study provided evidence of outcome content validity and nursing sensitivity of the study outcomes; further validation research is recommended, followed by testing of the study outcomes in clinical practice. Community-level nursing-sensitive outcomes will potentially enable study of the efficacy and effectiveness of public health interventions focused on improving health of populations and communities.

  14. What the clinical cardiologist requires from cardiovascular nuclear medicine

    International Nuclear Information System (INIS)

    Dahl, J. vom

    2004-01-01

    Nuclear cardiology in Germany is right now at an important step for its future development. It is necessary to increase the publicity to the clinical community with regard to the well known and appreciated strengths of nuclear cardiology. Diagnosis of coronary artery disease (CAD), assessment of prognosis in patients with CAD with or without a history of myocardial infarction, imaging of myocardial viability as well as economic aspects of diagnostic and therapeutic strategies have been validated in numerous studies involving thousands of patients. Clinical ''marketing'' of these important aspects has to be significantly improved in the near future. The ''service'' to the clinical partners, such as general practitioners, internists or cardiologists, needs further improvement as well as interdisciplinary communication to avoid that nuclear cardiology will be replaced by other techniques such as MRI oder MSCT and to assure that nuclear cardiology will play an important role within the clinical work-up of patients with CAD as it has in countries like the US. (orig.)

  15. A simple, rapid and validated high-performance liquid chromatography method suitable for clinical measurements of human mercaptalbumin and non-mercaptalbumin.

    Science.gov (United States)

    Yasukawa, Keiko; Shimosawa, Tatsuo; Okubo, Shigeo; Yatomi, Yutaka

    2018-01-01

    Background Human mercaptalbumin and human non-mercaptalbumin have been reported as markers for various pathological conditions, such as kidney and liver diseases. These markers play important roles in redox regulations throughout the body. Despite the recognition of these markers in various pathophysiologic conditions, the measurements of human mercaptalbumin and non-mercaptalbumin have not been popular because of the technical complexity and long measurement time of conventional methods. Methods Based on previous reports, we explored the optimal analytical conditions for a high-performance liquid chromatography method using an anion-exchange column packed with a hydrophilic polyvinyl alcohol gel. The method was then validated using performance tests as well as measurements of various patients' serum samples. Results We successfully established a reliable high-performance liquid chromatography method with an analytical time of only 12 min per test. The repeatability (within-day variability) and reproducibility (day-to-day variability) were 0.30% and 0.27% (CV), respectively. A very good correlation was obtained with the results of the conventional method. Conclusions A practical method for the clinical measurement of human mercaptalbumin and non-mercaptalbumin was established. This high-performance liquid chromatography method is expected to be a powerful tool enabling the expansion of clinical usefulness and ensuring the elucidation of the roles of albumin in redox reactions throughout the human body.

  16. Validation of a prediction model that allows direct comparison of the Oxford Knee Score and American Knee Society clinical rating system.

    Science.gov (United States)

    Maempel, J F; Clement, N D; Brenkel, I J; Walmsley, P J

    2015-04-01

    This study demonstrates a significant correlation between the American Knee Society (AKS) Clinical Rating System and the Oxford Knee Score (OKS) and provides a validated prediction tool to estimate score conversion. A total of 1022 patients were prospectively clinically assessed five years after TKR and completed AKS assessments and an OKS questionnaire. Multivariate regression analysis demonstrated significant correlations between OKS and the AKS knee and function scores but a stronger correlation (r = 0.68, p Society of Bone & Joint Surgery.

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

    Science.gov (United States)

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

    2013-12-19

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

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

    International Nuclear Information System (INIS)

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

    2009-01-01

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

  19. 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

  20. PET: the importance of physicists for the clinical arena

    CERN Multimedia

    2005-01-01

    David Townsend giving a seminar at CERN on 9 February. The past few years have seen significant advances in the development of instrumentation for Positron Emission Tomography (PET). The recent appearance of combined PET and Computed Tomography (CT) scanners that can simultaneously image both anatomy and function is of particular importance. This was the main subject of "Advances in PET imaging: from physics to physician", a seminar presented at CERN by David Townsend on Wednesday 9 February  and organized by the TT and PH groups. David Townsend, who started his career at CERN in the 1970s, is now Professor at the Department of Medicine, University of Tennessee Medical Center (Knoxville, TN). Recipient of the 2004 Clinical Scientist of the Year Award, he is an internationally renowned researcher and PET physicist, with over 25 years of experience in the field. His 1999 image of the year, an award from the Society of Nuclear Medicine in the US, was produced using a combined state-of-the art PET and a true d...

  1. Italian version of Nursing Students’ Perception of Instructor Caring (I-NSPIC: assessment of reliability and validity

    Directory of Open Access Journals (Sweden)

    C. Arrigoni

    2017-11-01

    Full Text Available Abstract Background Clinical experience is an essential component of nursing education since it provides students with the opportunity to construct and develop clinical competencies. Instructor caring is a pivotal facilitator at the forefront of clinical education, playing a key and complex educating role in clinical sectors. For these reasons the aims of this study was to assess the validity and reliability of the Italian version of NSPIC (I-NSPIC. Methods A validation multicentre study was conducted in three different Italian universities. A total of 333 nursing students were enrolled in the 2014/2015 academic year. Exploratory factor analysis (EFA with oblique rotation was performed to test the construct validity of I-NSPIC. The Cronbach’s alpha coefficient and test retest via Intraclass Correlation Coefficient (ICC analyses were done to assess the internal consistency and stability of the scale. A Spearman’s correlation with another scale (CLES-T was used to examine the concurrent validities. Results Four factors (control versus flexibility, supportive learning climate, confidence through caring, appreciation of life meaning and respectful sharing were identified in EFA. The Cronbach’s alpha value showed that I-NSPIC was a reliable instrument (α = 0.94 and the ICC coefficient was satisfactory. Conclusion The I-NSPIC is a valid instrument for assessing the perception of instructor caring in Italian nursing students. It may also prove helpful in promoting the caring ability of nursing students and in increasing the caring interactions in the relationship between instructor and nursing students. The knowledge emerged from this study provide important insight in developing effective training strategies in the clinical training of undergraduate nursing students.

  2. Self-assessed health-related quality of life (HRQOL) in men who completed radiotherapy for prostate cancer: Instrument validation and its relation to patient-assessed importance of symptoms

    International Nuclear Information System (INIS)

    Wang, Herbert; Huang, Edward; Dale, William; Ignacio, Lani; Ray, Paul; Kopnick, Mitchell; Vijayakumar, Srinivasan

    1997-01-01

    Purpose: The focus of this study is on the development of a questionnaire designed to assess the disease-specific dimensions of health related quality of life (HRQOL) in the urinary function (UF), bowel function (BF), and sexual function (SF) domains in prostate cancer (PC) patients treated with radiation therapy. The scales created were tested for reliability and validity. In addition, we assessed the relationship between these dimensions and the degree to which a decreased HRQOL increases the degrees to which patients feel bothered about their symptoms. A similar study was conducted for patients during radiotherapy for PC, and similar validation was performed. Materials and Methods: Patients were given a six-page questionnaire during their follow-up visits after completing radiotherapy for PC. Questionnaire design is based on clinical experience and a literature review for assessment of three HRQOL dimensions. Likert-type questions were employed related to BF (12 items), UR (11 items), and SF (9 items), as well as a single question for each asking how bothersome the reported symptoms are to the patient. Items in each section were analyzed with principal components factor analysis for identifying factors from which were formed scales. Items found to have high factor loadings were grouped together to form 6 scales, two for each dimension, and the reliability and validity of the created scales were assessed. The scale scores were used for assessment whether increased symptoms resulted in increases in the perceived importance of the symptoms to patients. Results: For 93 cases, 2 scales were identified within each dimension from the factor analysis. For BF, the 2 scales were an Urgency scale (4 items) and a Daily Living scale (3 items). For UF, the 2 scales were an Urgency scale (5 items) and a Weakness of (Urinary) Stream scale (3 items). For SF, the 2 scales were an Interest/Satisfaction scale (5 items) and an Impotence scale (3 items). Internal

  3. The Importance of Conditional Probability in Diagnostic Reasoning and Clinical Decision Making: A Primer for the Eye Care Practitioner.

    Science.gov (United States)

    Sanfilippo, Paul G; Hewitt, Alex W; Mackey, David A

    2017-04-01

    To outline and detail the importance of conditional probability in clinical decision making and discuss the various diagnostic measures eye care practitioners should be aware of in order to improve the scope of their clinical practice. We conducted a review of the importance of conditional probability in diagnostic testing for the eye care practitioner. Eye care practitioners use diagnostic tests on a daily basis to assist in clinical decision making and optimizing patient care and management. These tests provide probabilistic information that can enable the clinician to increase (or decrease) their level of certainty about the presence of a particular condition. While an understanding of the characteristics of diagnostic tests are essential to facilitate proper interpretation of test results and disease risk, many practitioners either confuse or misinterpret these measures. In the interests of their patients, practitioners should be aware of the basic concepts associated with diagnostic testing and the simple mathematical rule that underpins them. Importantly, the practitioner needs to recognize that the prevalence of a disease in the population greatly determines the clinical value of a diagnostic test.

  4. Feasibility, reliability, and clinical validity of the Test of Attentional Performance for Children (KiTAP in Fragile X syndrome (FXS

    Directory of Open Access Journals (Sweden)

    Knox Andrew

    2012-02-01

    Full Text Available Abstract Background Attention and inhibition are core executive-function deficits in FRagile X syndrome (FXS. This pilot study evaluated the feasibility, reproducibility, and clinical relevance of the KiTAP, a computer-based pictorial measure of attention and inhibition with an enchanted-castle theme, in an FXS cohort. Methods The 8-subtest KiTAP battery (as many subtests as each could perform was given to 36 subjects with FXS, of variable age and cognitive/behavioral functioning, and 29 were retested, with an interval of 2 to 4 weeks between sessions. Subjects were rated by parents on the Aberrant Behavior Checklist-Community Edition (ABC-C and Behavior Assessment System for Children, Second Edition (BASC-2. Feasibility, ceiling and basal effects, and data range and distribution analyses were used to eliminate outliers and invalid data points. Reproducibility of scores was analyzed using intraclass correlation coefficients (ICCs and validity/clinical relevance was assessed by correlating KiTAP scores with ABC-C and BASC-2 scores. Results Most of the participants with FXS were able to complete the Alertness, Distractibility, Flexibility, and Go/NoGo subtests.About 50 to 60% completed the Visual Scanning and Vigilance subtests, and 20 to 25% completed the Sustained Attention and Divided Attention subtests. A panel of seven scores from four subtests were identified as feasible for most subjects, lacked excessive ceiling, basal, or learning effects, exhibited an acceptable range and distribution of scores, had good reproducibility (ICC > 0.7, and correlated with behavioral ratings for hyperactivity or attention (P Conclusions The KiTAP can be administered to cohorts with FXS over a wide range of function with valid reproducible scores. With additional validation, it could represent a useful outcome measure for assessment of attention/executive-function abilities in clinical trials targeted to these core deficits in FXS.

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

    Science.gov (United States)

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

    2017-08-15

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

  6. Assessment of the Clinical Trainer as a Role Model: A Role Model Apperception Tool (RoMAT)

    NARCIS (Netherlands)

    Jochemsen-van der Leeuw, H. G. A. Ria; van Dijk, Nynke; Wieringa-de Waard, Margreet

    2014-01-01

    Purpose Positive role modeling by clinical trainers is important for helping trainees learn professional and competent behavior. The authors developed and validated an instrument to assess clinical trainers as role models: the Role Model Apperception Tool (RoMAT). Method On the basis of a 2011

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

    International Nuclear Information System (INIS)

    Huger, Sandrine

    2013-01-01

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

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

    Science.gov (United States)

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

    2014-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Ashok Agarwal

    2016-01-01

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

  10. The preanalytic phase in veterinary clinical pathology.

    Science.gov (United States)

    Braun, Jean-Pierre; Bourgès-Abella, Nathalie; Geffré, Anne; Concordet, Didier; Trumel, Cathy

    2015-03-01

    This article presents the general causes of preanalytic variability with a few examples showing specialists and practitioners that special and improved care should be given to this too often neglected phase. The preanalytic phase of clinical pathology includes all the steps from specimen collection to analysis. It is the phase where most laboratory errors occur in human, and probably also in veterinary clinical pathology. Numerous causes may affect the validity of the results, including technical factors, such as the choice of anticoagulant, the blood vessel sampled, and the duration and conditions of specimen handling. While the latter factors can be defined, influence of biologic and physiologic factors such as feeding and fasting, stress, and biologic and endocrine rhythms can often not be controlled. Nevertheless, as many factors as possible should at least be documented. The importance of the preanalytic phase is often not given the necessary attention, although the validity of the results and consequent clinical decision making and medical management of animal patients would likely be improved if the quality of specimens submitted to the laboratory was optimized. © 2014 American Society for Veterinary Clinical Pathology.

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

    DEFF Research Database (Denmark)

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

    2016-01-01

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

  12. Balance of trade: export-import in family medicine.

    Science.gov (United States)

    Pust, Ronald E

    2007-01-01

    North American family physicians leaving for less-developed countries (LDCs) may not be aware of internationally validated diagnostic and treatment technologies originating in LDCs. Thus they may bring with them inappropriate models and methods of medical care. More useful "exports" are based in sharing our collaborative vocational perspective with dedicated indigenous generalist clinicians who serve their communities. More specifically, Western doctors abroad can promote local reanalyses of international evidence-based medicine (EBM) studies, efficient deployment of scarce clinical resources, and a family medicine/generalist career ladder, ultimately reversing the "brain drain" from LDCs. Balancing these exports, we should import the growing number of EBM best practices originated in World Health Organization and other LDCs research that are applicable in developed nations. Many generalist colleagues, expatriate and indigenous, with long-term LDC experience stand ready to help us import these practices and perspectives.

  13. Evaluation of the stability and validity of participant samples recruited over the Internet.

    Science.gov (United States)

    Lieberman, Daniel Z

    2008-12-01

    Research conducted via the Internet has the potential to reach important clinical populations of participants who would not participate in traditional studies. Concerns exist, however, about the validity of samples recruited in this manner, especially when participants are anonymous and never have contact with study staff. This study evaluated two anonymous samples that were recruited over the Internet to test an online program designed to help problem drinkers. The two studies were conducted 3 years apart, and different recruitment strategies were utilized. Despite these differences, the two samples were highly similar in demographic and clinical features. Correlations that have been found between variables in traditional non-anonymous studies were also found in both online samples, supporting the validity of the data that was collected. Appropriate skepticism is required when critically evaluating Internet studies. Nevertheless, the results of this study indicate that it is possible to obtain stable, valid data from anonymous participants over the Internet, even when there are significant differences in the way the participants are obtained.

  14. 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.

  15. Construct Validity: Advances in Theory and Methodology

    OpenAIRE

    Strauss, Milton E.; Smith, Gregory T.

    2009-01-01

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

  16. [Imported malaria and HIV infection in Madrid. Clinical and epidemiological features].

    Science.gov (United States)

    Ramírez-Olivencia, G; Herrero, M D; Subirats, M; de Juanes, J R; Peña, J M; Puente, S

    2012-01-01

    Few data are available in Spain data on human immunodeficiency virus (HIV) patients coinfected with malaria. This study has aimed to determine the epidemiological and clinical characteristics of imported malaria in patients coinfected with HIV. A case-series retrospective study was performed using the patient's medical records. The study population consisted on patients diagnosed with malaria attended in our center from january 1, 2002 to december 31, 2007. A total of 484 episodes of malaria, 398 of which were included in this study, were identified. Co-infection with HIV was described in 32 cases. All of them occurred in individuals presumably with some degree of semi-immunity. In the coinfected group, there were 13 cases (40.6%) asymptomatic, whereas this event occurred in 99 cases of patients not coinfected (37.2%) (P=0.707). The greater presence of anemia in co-infected patients (62.5% vs 32.3% in non-coinfected [P=0.001]) stands out. In present study, the clinical presentation forms were similar, regardless of the presence or absence of HIV infection. Although the study population does not reflect all possible scenarios of malaria and HIV coinfection, our results indicate the reality of patients attended in the Autonomous Community of Madrid. Copyright © 2011 Elsevier España, S.L. All rights reserved.

  17. The Consequences of Consequential Validity.

    Science.gov (United States)

    Mehrens, William A.

    1997-01-01

    There is no agreement at present about the importance or meaning of the term "consequential validity." It is important that the authors of revisions to the "Standards for Educational and Psychological Testing" recognize the debate and relegate discussion of consequences to a context separate from the discussion of validity.…

  18. Clinical importance of pharmacogenetics in the treatment of hepatitis C virus infection.

    Science.gov (United States)

    Kamal, Adina Maria; MitruŢ, Paul; Kamal, Kamal Constantin; Tica, Oana Sorina; Niculescu, Mihaela; Alexandru, Dragoş Ovidiu; Tica, Andrei Adrian

    2016-01-01

    Globally, over 4% of the world population is affected by hepatitis C virus (HCV) infection. The current standard of care for hepatitis C infection is combination therapy with pegylated interferon and ribavirin for 48 weeks, which yield a sustained virological response in only a little over half of the patients with genotype 1 HCV. We investigated the clinical importance of pharmacogenetics in treatment efficacy and prediction of hematotoxicity. A total of 148 patients infected with HCV were enrolled. All patients were treated for a period of 48 weeks or less with pegylated interferon and ribavirin. Four genotypes were investigated: inosine triphosphatase (ITPA) rs1127354, C20orf194 rs6051702, interferon lambda (IFNL)3 rs8099917, IFNL3÷4 rs12979860 in the population from southwestern Romania. Genetic variants for rs129798660 and rs6051702 proved once more to represent an indisputable clinical tool for predicting sustained virological response (SVR) (69.23%, chi-square p=0.007846, ppharmacogenetics should play a constant role in treatment decisions for patients infected with hepatitis C virus.

  19. Content validity and its estimation

    Directory of Open Access Journals (Sweden)

    Yaghmale F

    2003-04-01

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

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

    DEFF Research Database (Denmark)

    Zhu, Mingyao; Bzdusek, Karl; Brink, Carsten

    2013-01-01

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

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

    Science.gov (United States)

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

    2014-07-22

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

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

    Science.gov (United States)

    2014-01-01

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

  3. Specific determination of clinical and toxicological important substances in biological samples by LC-MS

    International Nuclear Information System (INIS)

    Mitulovic, G.

    2001-02-01

    This thesis of this dissertation is the specific determination of clinical and toxicological important substances in biological samples by LC-MS. Nicotine was determined in serum after application of nicotine plaster and nicotine nasal spray with HPLC-ESI-MS. Cotinine was determined direct in urine with HPLC-ESI-MS. Short time anesthetics were determined in blood and cytostatics were determined in liquor with HPLC-ESI-MS. (botek)

  4. A Slovenian version of the "clinical learning environment, supervision and nurse teacher scale (Cles+T)" and its comparison with the Croatian version.

    Science.gov (United States)

    Žvanut, Boštjan; Lovrić, Robert; Kolnik, Tamara Štemberger; Šavle, Majda; Pucer, Patrik

    2018-02-26

    Nursing clinical learning environments are particularly important for the achievement of good practice in clinical training of student nurses, and thus, for the nursing competence development. Hence, it is important to have an instrument consisting of reliable and valid criteria for assessing the clinical learning environment, applicable in different contexts, and translated in the respondents mother tongue. The goal of the present research was to test the reliability and validity of the Slovenian version of the "Clinical Learning Environment, Supervision and Nurse Teacher evaluation scale", and to compare it with the Croatian version. The data was collected between 10 March and 10 June 2015 at four Slovenian institutions, where nursing BSc study programmes are performed. The final sample consisted of 232 students (response rate 68.8%): 81.9% were females and 18.1% males, average age was 23. The translated instrument in Slovenian language resulted as reliable and valid, it reflects the expected five factors of the original version despite some minor problems in the factor structure and in test-retest. The most important difference between the Slovenian and Croatian version is in the factor structure regarding the implementation of roles in clinical learning environment. Copyright © 2018 Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

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

    2015-01-01

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

  6. Can preventable adverse events be predicted among hospitalized older patients? The development and validation of a predictive model.

    NARCIS (Netherlands)

    Steeg, L. van de; Langelaan, M.; Wagner, C.

    2014-01-01

    Objective: To develop and validate a predictive model for preventable adverse events (AEs) in hospitalized older patients, using clinically important risk factors that are readily available on admission. Design: Data from two retrospective patient record review studies on AEs were used. Risk factors

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

    Science.gov (United States)

    Perez-Martinez, Pablo; Alcala-Diaz, Juan F; Kabagambe, Edmon K; Garcia-Rios, Antonio; Tsai, Michael Y; Delgado-Lista, Javier; Kolovou, Genovefa; Straka, Robert J; Gomez-Delgado, Francisco; Hopkins, Paul N; Marin, Carmen; Borecki, Ingrid; Yubero-Serrano, Elena M; Hixson, James E; Camargo, Antonio; Province, Michael A; Lopez-Moreno, Javier; Rodriguez-Cantalejo, Fernando; Tinahones, Francisco J; Mikhailidis, Dimitri P; Perez-Jimenez, Francisco; Arnett, Donna K; Ordovas, Jose M; Lopez-Miranda, Jose

    2016-01-01

    Previous studies have suggested that for clinical purposes, subjects with fasting triglycerides (TGs) between 89-180 mg/dl (1-2 mmol/l) would benefit from postprandial TGs testing. To determine the postprandial TG response in 2 independent studies and validate who should benefit diagnostically from an oral-fat tolerance test (OFTT) in clinical practice. A population of 1002 patients with coronary heart disease (CHD) from the CORDIOPREV clinical trial and 1115 white US subjects from the GOLDN study underwent OFTTs. Subjects were classified into 3 groups according to fasting cut points of TGs to predict the usefulness of OFTT: (1) TG  180 mg/dl (>2 mmol/l). Postprandial TG concentration at any point > 220 mg/dl (>2.5 mmol/l) has been pre-established as an undesirable postprandial response. Of the total, 49% patients with CHD and 42% from the general population showed an undesirable response after the OFTT. The prevalence of undesirable postprandial TG in the CORDIOPREV clinical trial was 12.8, 50.3, and 89.7%, in group 1, 2, and 3, respectively (P 2 mmol/l, >180 mg/dl). Copyright © 2016 National Lipid Association. Published by Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2018-01-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

  10. Neurophysiological localisation of ulnar neuropathy at the elbow: validation of diagnostic criteria developed by a taskforce of the Danish Society of Clinical Neurophysiology

    DEFF Research Database (Denmark)

    Pugdahl, Kirsten; Beniczky, Sándor; Wanscher, Benedikte

    2017-01-01

    OBJECTIVE: This study validates consensus criteria for localisation of ulnar neuropathy at elbow (UNE) developed by a taskforce of the Danish Society of Clinical Neurophysiology and compares them to the existing criteria from the American Association of Neuromuscular and Electrodiagnostic Medicine...

  11. Importance of placebo effect in cough clinical trials.

    Science.gov (United States)

    Eccles, Ron

    2010-01-01

    Cough is a unique symptom because, unlike sneeze and other symptoms, it can be under voluntary control and this complicates clinical trials on cough medicines. All over-the-counter cough medicines (OTC) are very effective treatments because of their placebo effect. The placebo effect is enhanced by expectancy related to advertising, brand, packaging, and formulation. This placebo effect creates a problem for the conduct of clinical trials on OTC cough medicines that attempt to demonstrate the efficacy of a pharmacological agent above that of any placebo effect. Up to 85% of the efficacy of some cough medicines can be attributed to a placebo effect. The placebo effect apparent in clinical trials consists of several components: natural recovery, regression of cough response toward mean, demulcent effect, effect of sweetness, voluntary control, and effects related to expectancy and meaning of the treatment. The placebo effect has been studied most in the pain model, and placebo analgesia is reported to depend on the activation of endogenous opioid systems in the brain; this model may be applicable to cough. A balanced placebo design may help to control for the placebo effect, but this trial design may not be acceptable due to deception of patients. The placebo effect in clinical trials may be controlled by use of a crossover design, where feasible, and the changes in the magnitude of the placebo effect in this study design are discussed.

  12. Clinical and angiographic predictors of haemodynamically significant angiographic lesions: development and validation of a risk score to predict positive fractional flow reserve.

    Science.gov (United States)

    Sareen, Nishtha; Baber, Usman; Kezbor, Safwan; Sayseng, Sonny; Aquino, Melissa; Mehran, Roxana; Sweeny, Joseph; Barman, Nitin; Kini, Annapoorna; Sharma, Samin K

    2017-04-07

    Coronary revascularisation based upon physiological evaluation of lesions improves clinical outcomes. Angiographic or visual stenosis assessment alone is insufficient in predicting haemodynamic stenosis severity by fractional flow reserve (FFR) and therefore cannot be used to guide revascularisation, particularly in the lesion subset system formulated. Of 1,023 consecutive lesions (883 patients), 314 (31%) were haemodynamically significant. Characteristics associated with FFR ≤0.8 include male gender, higher SYNTAX score, lesions ≥20 mm, stenosis >50%, bifurcation, calcification, absence of tortuosity and smaller reference diameter. A user-friendly integer score was developed with the five variables demonstrating the strongest association. On prospective validation (in 279 distinct lesions), the increasing value of the score correlated well with increasing haemodynamic significance (C-statistic 0.85). We identified several clinical and angiographic characteristics and formulated a scoring system to guide the approach to intermediate lesions. This may translate into cost savings. Larger studies with prospective validation are required to confirm our results.

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

    International Nuclear Information System (INIS)

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

    2010-01-01

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

  14. Pragmatic characteristics of patient-reported outcome measures are important for use in clinical practice.

    Science.gov (United States)

    Kroenke, Kurt; Monahan, Patrick O; Kean, Jacob

    2015-09-01

    Measures for assessing patient-reported outcomes (PROs) that may have initially been developed for research are increasingly being recommended for use in clinical practice as well. Although psychometric rigor is essential, this article focuses on pragmatic characteristics of PROs that may enhance uptake into clinical practice. Three sources were drawn on in identifying pragmatic criteria for PROs: (1) selected literature review including recommendations by other expert groups; (2) key features of several model public domain PROs; and (3) the authors' experience in developing practical PROs. Eight characteristics of a practical PRO include: (1) actionability (i.e., scores guide diagnostic or therapeutic actions/decision making); (2) appropriateness for the relevant clinical setting; (3) universality (i.e., for screening, severity assessment, and monitoring across multiple conditions); (4) self-administration; (5) item features (number of items and bundling issues); (6) response options (option number and dimensions, uniform vs. varying options, time frame, intervals between options); (7) scoring (simplicity and interpretability); and (8) accessibility (nonproprietary, downloadable, available in different languages and for vulnerable groups, and incorporated into electronic health records). Balancing psychometric and pragmatic factors in the development of PROs is important for accelerating the incorporation of PROs into clinical practice. Published by Elsevier Inc.

  15. Validation of self-reported erythema

    DEFF Research Database (Denmark)

    Petersen, B; Thieden, E; Lerche, C M

    2013-01-01

    Most epidemiological data of sunburn related to skin cancer have come from self-reporting in diaries and questionnaires. We thought it important to validate the reliability of such data.......Most epidemiological data of sunburn related to skin cancer have come from self-reporting in diaries and questionnaires. We thought it important to validate the reliability of such data....

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

    Science.gov (United States)

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

    2015-12-01

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

  17. The Validity of the Different Versions of the Hamilton Depression Scale in Separating Remission Rates of Placebo and Antidepressants in Clinical Trials of Major Depression

    DEFF Research Database (Denmark)

    Kyle, Phillip Raphael; Lemming, Ole Michael; Timmerby, Nina

    2016-01-01

    . The traditional HAM-D17 version was compared with the shorter HAM-D6 and the longer HAM-D21 or HAM-D24 in a fixed-dose placebo-controlled vortioxetine study. Clinical Global Impression of Severity scores were used to establish standardized cutoff scores for remission across each scale. Using these cutoff scores......Our objective was to validate the different versions of the Hamilton Depression Scale (HAM-D) both psychometrically (scalability) and clinically in discriminating antidepressants from placebo in terms of remission rates in an 8-week clinical trial in the acute treatment of major depression...... in the longer HAM-D versions indicated smaller discriminating validity over placebo. The HAM-D6 indicated a dose effect on remission for vortioxetine in both moderate and severe major depression. The brief HAM-D6 was thus found superior to HAM-D17, HAM-D21, and HAM-D24 both in terms of scalability...

  18. Avoiding misdiagnosis of imported malaria: screening of emergency department samples with thrombocytopenia detects clinically unsuspected cases

    NARCIS (Netherlands)

    Hänscheid, Thomas; Melo-Cristino, José; Grobusch, Martin P.; Pinto, Bernardino G.

    2003-01-01

    BACKGROUND: Misdiagnosis of imported malaria is not uncommon and even abnormal routine laboratory tests may not trigger malaria smears. However, blind screening of all thrombocytopenic samples might be a possible way to detect clinically unsuspected malaria cases in the accident and emergency

  19. Validity and reliability of the NAB Naming Test.

    Science.gov (United States)

    Sachs, Bonnie C; Rush, Beth K; Pedraza, Otto

    2016-05-01

    Confrontation naming is commonly assessed in neuropsychological practice, but few standardized measures of naming exist and those that do are susceptible to the effects of education and culture. The Neuropsychological Assessment Battery (NAB) Naming Test is a 31-item measure used to assess confrontation naming. Despite adequate psychometric information provided by the test publisher, there has been limited independent validation of the test. In this study, we investigated the convergent and discriminant validity, internal consistency, and alternate forms reliability of the NAB Naming Test in a sample of adults (Form 1: n = 247, Form 2: n = 151) clinically referred for neuropsychological evaluation. Results indicate adequate-to-good internal consistency and alternate forms reliability. We also found strong convergent validity as demonstrated by relationships with other neurocognitive measures. We found preliminary evidence that the NAB Naming Test demonstrates a more pronounced ceiling effect than other commonly used measures of naming. To our knowledge, this represents the largest published independent validation study of the NAB Naming Test in a clinical sample. Our findings suggest that the NAB Naming Test demonstrates adequate validity and reliability and merits consideration in the test arsenal of clinical neuropsychologists.

  20. 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

    that recommendations on how to improve these factors are warranted. Methods Members of Europain, a pain research consortium funded by the European Innovative Medicines Initiative (IMI), developed internal recommendations on how to improve the reliability of pre-clinical studies between laboratories. This guidance...... and conduct, and data analysis and interpretation. Key principles such as sample size calculation, a priori definition of a primary efficacy measure, randomization, allocation concealments, and blinding are discussed. In addition, considerations of how stress and normal rodent physiology impact outcome...... development in order to estimate possible publication bias is discussed. Conclusions More systematic research is needed to analyze how inadequate internal validity and/or experimental bias may impact reproducibility across pre-clinical pain studies. Addressing the potential threats to internal validity...

  1. Novel System for Real-Time Integration of 3-D Echocardiography and Fluoroscopy for Image-Guided Cardiac Interventions: Preclinical Validation and Clinical Feasibility Evaluation

    Science.gov (United States)

    Housden, R. James; Ma, Yingliang; Rajani, Ronak; Gao, Gang; Nijhof, Niels; Cathier, Pascal; Bullens, Roland; Gijsbers, Geert; Parish, Victoria; Kapetanakis, Stamatis; Hancock, Jane; Rinaldi, C. Aldo; Cooklin, Michael; Gill, Jaswinder; Thomas, Martyn; O'neill, Mark D.; Razavi, Reza; Rhode, Kawal S.

    2014-01-01

    Real-time imaging is required to guide minimally invasive catheter-based cardiac interventions. While transesophageal echocardiography allows for high-quality visualization of cardiac anatomy, X-ray fluoroscopy provides excellent visualization of devices. We have developed a novel image fusion system that allows real-time integration of 3-D echocardiography and the X-ray fluoroscopy. The system was validated in the following two stages: 1) preclinical to determine function and validate accuracy; and 2) in the clinical setting to assess clinical workflow feasibility and determine overall system accuracy. In the preclinical phase, the system was assessed using both phantom and porcine experimental studies. Median 2-D projection errors of 4.5 and 3.3 mm were found for the phantom and porcine studies, respectively. The clinical phase focused on extending the use of the system to interventions in patients undergoing either atrial fibrillation catheter ablation (CA) or transcatheter aortic valve implantation (TAVI). Eleven patients were studied with nine in the CA group and two in the TAVI group. Successful real-time view synchronization was achieved in all cases with a calculated median distance error of 2.2 mm in the CA group and 3.4 mm in the TAVI group. A standard clinical workflow was established using the image fusion system. These pilot data confirm the technical feasibility of accurate real-time echo-fluoroscopic image overlay in clinical practice, which may be a useful adjunct for real-time guidance during interventional cardiac procedures. PMID:27170872

  2. Systematic evaluation of the teaching qualities of Obstetrics and Gynecology faculty: reliability and validity of the SETQ tools

    NARCIS (Netherlands)

    van der Leeuw, Renée; Lombarts, Kiki; Heineman, Maas Jan; Arah, Onyebuchi

    2011-01-01

    The importance of effective clinical teaching for the quality of future patient care is globally understood. Due to recent changes in graduate medical education, new tools are needed to provide faculty with reliable and individualized feedback on their teaching qualities. This study validates two

  3. Validity and reliability of haemoglobin colour scale and its comparison with clinical signs in diagnosing anaemia in pregnancy in Ahmedabad, India.

    Science.gov (United States)

    Bala, D V; Vyas, S; Shukla, A; Tiwari, H; Bhatt, G; Gupta, K

    2012-07-01

    This study compared the validity of the haemoglobin colour scale (HCS) and clinical signs in diagnosing anaemia against Sahli's haemoglobinometer method as the gold standard, and assessed the reliability of HCS. The sample comprised 129 pregnant women recruited from 6 urban health centres in Ahmedabad. The prevalence of anaemia was 69.8% by Sahli's method, 78.3% by HCS and 89.9% by clinical signs; there was no statistically significant difference between Sahli's method and HCS whereas there was between Sahlis method and clinical signs. The mean haemoglobin level by Sahli's method and HCS differed significantly. The sensitivity, specificity, positive predictive value and negative predictive value of HCS was 83.3%, 33.3%, 74.3% and 46.4% respectively and that of clinical signs was 91.1%, 12.8%, 70.7% and 38.5% respectively. Interobserver agreement for HCS was moderate (K = 0.43). Clinical signs are better than HCS for diagnosing anaemia. HCS can be used in the field provided assessors are adequately trained.

  4. Validation of a clinical practice-based algorithm for the diagnosis of autosomal recessive cerebellar ataxias based on NGS identified cases.

    Science.gov (United States)

    Mallaret, Martial; Renaud, Mathilde; Redin, Claire; Drouot, Nathalie; Muller, Jean; Severac, Francois; Mandel, Jean Louis; Hamza, Wahiba; Benhassine, Traki; Ali-Pacha, Lamia; Tazir, Meriem; Durr, Alexandra; Monin, Marie-Lorraine; Mignot, Cyril; Charles, Perrine; Van Maldergem, Lionel; Chamard, Ludivine; Thauvin-Robinet, Christel; Laugel, Vincent; Burglen, Lydie; Calvas, Patrick; Fleury, Marie-Céline; Tranchant, Christine; Anheim, Mathieu; Koenig, Michel

    2016-07-01

    Establishing a molecular diagnosis of autosomal recessive cerebellar ataxias (ARCA) is challenging due to phenotype and genotype heterogeneity. We report the validation of a previously published clinical practice-based algorithm to diagnose ARCA. Two assessors performed a blind analysis to determine the most probable mutated gene based on comprehensive clinical and paraclinical data, without knowing the molecular diagnosis of 23 patients diagnosed by targeted capture of 57 ataxia genes and high-throughput sequencing coming from a 145 patients series. The correct gene was predicted in 61 and 78 % of the cases by the two assessors, respectively. There was a high inter-rater agreement [K = 0.85 (0.55-0.98) p < 0.001] confirming the algorithm's reproducibility. Phenotyping patients with proper clinical examination, imaging, biochemical investigations and nerve conduction studies remain crucial for the guidance of molecular analysis and to interpret next generation sequencing results. The proposed algorithm should be helpful for diagnosing ARCA in clinical practice.

  5. Secondary Hemophagocytic Syndrome: The Importance of Clinical Suspicion

    Directory of Open Access Journals (Sweden)

    Cristina Oliveira

    2014-01-01

    Full Text Available Hemophagocytic syndrome is a rare and potentially fatal disorder characterized by pathological immune activation associated with a primary familial disorder, genetic mutations, or occurring as a sporadic condition. The latter can be secondary to infections, malignancies, or autoimmune diseases. Clinically, patients present signs of severe inflammation, with unremitting fever, cytopenias, spleen enlargement, phagocytosis of bone marrow elements, hypertriglyceridemia, and hypofibrinogenemia. Increased suspicion is determinant to timely initiate treatment in an attempt to alter the natural history. The authors present three clinical cases of this syndrome, with a brief review of the diagnostic criteria and treatment.

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

    Science.gov (United States)

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

    2017-12-01

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

  7. Some considerations for validation of repository performance assessment models

    International Nuclear Information System (INIS)

    Eisenberg, N.

    1991-01-01

    Validation is an important aspect of the regulatory uses of performance assessment. A substantial body of literature exists indicating the manner in which validation of models is usually pursued. Because performance models for a nuclear waste repository cannot be tested over the long time periods for which the model must make predictions, the usual avenue for model validation is precluded. Further impediments to model validation include a lack of fundamental scientific theory to describe important aspects of repository performance and an inability to easily deduce the complex, intricate structures characteristic of a natural system. A successful strategy for validation must attempt to resolve these difficulties in a direct fashion. Although some procedural aspects will be important, the main reliance of validation should be on scientific substance and logical rigor. The level of validation needed will be mandated, in part, by the uses to which these models are put, rather than by the ideal of validation of a scientific theory. Because of the importance of the validation of performance assessment models, the NRC staff has engaged in a program of research and international cooperation to seek progress in this important area. 2 figs., 16 refs

  8. Clinical protein science developments for patient monitoring in hospital central laboratories.

    Science.gov (United States)

    Malm, Johan; Marko-Varga, György

    2016-12-01

    Patient care relies heavily on standardized tests performed in hospital laboratories, typically including clinical chemistry, pathology and microbiology. With the introduction of personalized medicine tremendous efforts have been made to identify new biomarkers of disease with various omics technologies, often including mass spectrometry. In order to validate new biomarkers and perform clinical studies high quality biobank samples are of key importance. In this editorial different aspects of mass spectrometry in future personalized medicine are discussed.

  9. Statistical significance versus clinical importance: trials on exercise therapy for chronic low back pain as example.

    NARCIS (Netherlands)

    van Tulder, M.W.; Malmivaara, A.; Hayden, J.; Koes, B.

    2007-01-01

    STUDY DESIGN. Critical appraisal of the literature. OBJECIVES. The objective of this study was to assess if results of back pain trials are statistically significant and clinically important. SUMMARY OF BACKGROUND DATA. There seems to be a discrepancy between conclusions reported by authors and

  10. The SPAI-18, a brief version of the social phobia and anxiety inventory: reliability and validity in clinically referred and non-referred samples.

    Science.gov (United States)

    de Vente, Wieke; Majdandžić, Mirjana; Voncken, Marisol J; Beidel, Deborah C; Bögels, Susan M

    2014-03-01

    We developed a new version of the Social Phobia and Anxiety Inventory (SPAI) in order to have a brief instrument for measuring social anxiety and social anxiety disorder (SAD) with a strong conceptual foundation. In the construction phase, a set of items representing 5 core aspects of social anxiety was selected by a panel of social anxiety experts. The selected item pool was validated using factor analysis, reliability analysis, and diagnostic analysis in a sample of healthy participants (N = 188) and a sample of clinically referred participants diagnosed with SAD (N = 98). This procedure resulted in an abbreviated version of the Social Phobia Subscale of the SPAI consisting of 18 items (i.e. the SPAI-18), which correlated strongly with the Social Phobia Subscale of the original SPAI (both groups r = .98). Internal consistency and diagnostic characteristics using a clinical cut-off score > 48 were good to excellent (Cronbach's alpha healthy group = .93; patient group = .91; sensitivity: .94; specificity: .88). The SPAI-18 was further validated in a community sample of parents-to-be without SAD (N = 237) and with SAD (N = 65). Internal consistency was again excellent (both groups Cronbach's alpha = .93) and a screening cut-off of > 36 proved to result in good sensitivity and specificity. The SPAI-18 also correlated strongly with other social anxiety instruments, supporting convergent validity. In sum, the SPAI-18 is a psychometrically sound instrument with good screening capacity for social anxiety disorder in clinical as well as community samples. Copyright © 2013 Elsevier Ltd. All rights reserved.

  11. A clinical decision rule for the use of plain radiography in children after acute wrist injury: development and external validation of the Amsterdam Pediatric Wrist Rules

    International Nuclear Information System (INIS)

    Slaar, Annelie; Maas, Mario; Rijn, Rick R. van; Walenkamp, Monique M.J.; Bentohami, Abdelali; Goslings, J.C.; Steyerberg, Ewout W.; Jager, L.C.; Sosef, Nico L.; Velde, Romuald van; Ultee, Jan M.; Schep, Niels W.L.

    2016-01-01

    In most hospitals, children with acute wrist trauma are routinely referred for radiography. To develop and validate a clinical decision rule to decide whether radiography in children with wrist trauma is required. We prospectively developed and validated a clinical decision rule in two study populations. All children who presented in the emergency department of four hospitals with pain following wrist trauma were included and evaluated for 18 clinical variables. The outcome was a wrist fracture diagnosed by plain radiography. Included in the study were 787 children. The prediction model consisted of six variables: age, swelling of the distal radius, visible deformation, distal radius tender to palpation, anatomical snuffbox tender to palpation, and painful or abnormal supination. The model showed an area under the receiver operator characteristics curve of 0.79 (95% CI: 0.76-0.83). The sensitivity and specificity were 95.9% and 37.3%, respectively. The use of this model would have resulted in a 22% absolute reduction of radiographic examinations. In a validation study, 7/170 fractures (4.1%, 95% CI: 1.7-8.3%) would have been missed using the decision model. The decision model may be a valuable tool to decide whether radiography in children after wrist trauma is required. (orig.)

  12. A clinical decision rule for the use of plain radiography in children after acute wrist injury: development and external validation of the Amsterdam Pediatric Wrist Rules

    Energy Technology Data Exchange (ETDEWEB)

    Slaar, Annelie; Maas, Mario; Rijn, Rick R. van [University of Amsterdam, Department of Radiology, Academic Medical Centre, Meibergdreef 9, 1105, AZ, Amsterdam (Netherlands); Walenkamp, Monique M.J.; Bentohami, Abdelali; Goslings, J.C. [University of Amsterdam, Trauma Unit, Department of Surgery, Academic Medical Centre, Amsterdam (Netherlands); Steyerberg, Ewout W. [Erasmus MC - University Medical Centre, Department of Public Health, Rotterdam (Netherlands); Jager, L.C. [University of Amsterdam, Emergency Department, Academic Medical Centre, Amsterdam (Netherlands); Sosef, Nico L. [Spaarne Hospital, Department of Surgery, Hoofddorp (Netherlands); Velde, Romuald van [Tergooi Hospitals, Department of Surgery, Hilversum (Netherlands); Ultee, Jan M. [Sint Lucas Andreas Hospital, Department of Surgery, Amsterdam (Netherlands); Schep, Niels W.L. [University of Amsterdam, Trauma Unit, Department of Surgery, Academic Medical Centre, Amsterdam (Netherlands); Maasstadziekenhuis Rotterdam, Department of Surgery, Rotterdam (Netherlands)

    2016-01-15

    In most hospitals, children with acute wrist trauma are routinely referred for radiography. To develop and validate a clinical decision rule to decide whether radiography in children with wrist trauma is required. We prospectively developed and validated a clinical decision rule in two study populations. All children who presented in the emergency department of four hospitals with pain following wrist trauma were included and evaluated for 18 clinical variables. The outcome was a wrist fracture diagnosed by plain radiography. Included in the study were 787 children. The prediction model consisted of six variables: age, swelling of the distal radius, visible deformation, distal radius tender to palpation, anatomical snuffbox tender to palpation, and painful or abnormal supination. The model showed an area under the receiver operator characteristics curve of 0.79 (95% CI: 0.76-0.83). The sensitivity and specificity were 95.9% and 37.3%, respectively. The use of this model would have resulted in a 22% absolute reduction of radiographic examinations. In a validation study, 7/170 fractures (4.1%, 95% CI: 1.7-8.3%) would have been missed using the decision model. The decision model may be a valuable tool to decide whether radiography in children after wrist trauma is required. (orig.)

  13. Importance of clinical microbiologists for U.S. healthcare infrastructure.

    Science.gov (United States)

    Carvalho, John

    2011-01-01

    Clinical microbiologists are highly skilled scientists within national hospitals and reference laboratories who diagnose patients with infections by emerging pathogens. Most advanced training for clinical microbiologists occurs at universities, where an individual can receive certification as a "Medical Laboratory Scientist" (MLS). Unfortunately, many MLS programs have closed in the United States and this has caused a shortage of clinical microbiologists at U.S. hospitals and reference laboratories. This paper explores the present crisis in MLS training and its ramifications for the emergence of antibiotic-resistant bacteria, the economics of hospitals, and the overall health of the nation, and provides resolutions for better public health policy with respect to MLS education.

  14. Highly Efficient Training, Refinement, and Validation of a Knowledge-based Planning Quality-Control System for Radiation Therapy Clinical Trials

    Energy Technology Data Exchange (ETDEWEB)

    Li, Nan; Carmona, Ruben [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States); Sirak, Igor; Kasaova, Linda [Department of Oncology and Radiotherapy, University Hospital, Hradec Kralove (Czech Republic); Followill, David [Department of Radiation Physics, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Michalski, Jeff; Bosch, Walter; Straube, William [Department of Radiation Oncology, Washington University in St Louis, St Louis, Missouri (United States); Mell, Loren K. [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States); Moore, Kevin L., E-mail: kevinmoore@ucsd.edu [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States)

    2017-01-01

    Purpose: To demonstrate an efficient method for training and validation of a knowledge-based planning (KBP) system as a radiation therapy clinical trial plan quality-control system. Methods and Materials: We analyzed 86 patients with stage IB through IVA cervical cancer treated with intensity modulated radiation therapy at 2 institutions according to the standards of the INTERTECC (International Evaluation of Radiotherapy Technology Effectiveness in Cervical Cancer, National Clinical Trials Network identifier: 01554397) protocol. The protocol used a planning target volume and 2 primary organs at risk: pelvic bone marrow (PBM) and bowel. Secondary organs at risk were rectum and bladder. Initial unfiltered dose-volume histogram (DVH) estimation models were trained using all 86 plans. Refined training sets were created by removing sub-optimal plans from the unfiltered sample, and DVH estimation models… and DVH estimation models were constructed by identifying 30 of 86 plans emphasizing PBM sparing (comparing protocol-specified dosimetric cutpoints V{sub 10} (percentage volume of PBM receiving at least 10 Gy dose) and V{sub 20} (percentage volume of PBM receiving at least 20 Gy dose) with unfiltered predictions) and another 30 of 86 plans emphasizing bowel sparing (comparing V{sub 40} (absolute volume of bowel receiving at least 40 Gy dose) and V{sub 45} (absolute volume of bowel receiving at least 45 Gy dose), 9 in common with the PBM set). To obtain deliverable KBP plans, refined models must inform patient-specific optimization objectives and/or priorities (an auto-planning “routine”). Four candidate routines emphasizing different tradeoffs were composed, and a script was developed to automatically re-plan multiple patients with each routine. After selection of the routine that best met protocol objectives in the 51-patient training sample (KBP{sub FINAL}), protocol-specific DVH metrics and normal tissue complication probability were compared for original

  15. The importance of communication for clinical leaders in mental health nursing: the perspective of nurses working in mental health.

    Science.gov (United States)

    Ennis, Gary; Happell, Brenda; Broadbent, Marc; Reid-Searl, Kerry

    2013-11-01

    Communication has been identified as an important attribute of clinical leadership in nursing. However, there is a paucity of research on its relevance in mental health nursing. This article presents the findings of a grounded theory informed study exploring the attributes and characteristics required for effective clinical leadership in mental health nursing, specifically the views of nurses working in mental health about the importance of effective communication in day to day clinical leadership. In-depth interviews were conducted to gain insight into the participants' experiences and views on clinical leadership in mental health nursing. The data that emerged from these interviews were constantly compared and reviewed, ensuring that any themes that emerged were based on the participants' own experiences and views. Participants recognized that effective communication was one of the attributes of effective clinical leadership and they considered communication as essential for successful working relationships and improved learning experiences for junior staff and students in mental health nursing. Four main themes emerged: choice of language; relationships; nonverbal communication, and listening and relevance. Participants identified that clinical leadership in mental health nursing requires effective communication skills, which enables the development of effective working relationships with others that allows them to contribute to the retention of staff, improved outcomes for clients, and the development of the profession.

  16. Assessment of validity with polytrauma Veteran populations.

    Science.gov (United States)

    Bush, Shane S; Bass, Carmela

    2015-01-01

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

  17. 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.

  18. Cross-cultural adaptation of Kerlan-Jobe Orthopaedic Clinic shoulder and elbow score: Reliability and validity in Turkish-speaking overhead athletes.

    Science.gov (United States)

    Turgut, Elif; Tunay, Volga Bayrakci

    2018-03-09

    Kerlan-Jobe Orthopaedic Clinic Shoulder and Elbow Score (KJOC-SES) is a subjective assessment tool to measure functional status of the upper extremities in overhead athletes. The aim was to translate and culturally adapt the KJOC-SES and to evaluate the psychometric properties of the Turkish version (KJOC-SES-Tr) in overhead athletes. The forward and back-translation method was followed. One hundred and twenty-three overhead athletes completed the KJOC-SES-Tr, the Disabilities of the Arm, Shoulder, and Hand (DASH), and the American Shoulder and Elbow Surgeons Evaluation Form (ASES). Participants were assigned to one of the following subgroups: asymptomatic (playing without pain) or symptomatic (playing with pain, or not playing due to pain). Internal consistency, reliability, construct validity, discriminant validity, and content validity of the KJOC-SES-Tr were tested. The test-retest reliability of the KJOC-SES-Tr was excellent with an interclass coefficient of 0.93. There was a strong correlation between the KJOC-SES-Tr and the DASH and the ASES, indicating that the construct validity was good for all participants. Results of the KJOC-SES-Tr significantly differed between different subgroups and categories of athletes. The floor and ceiling effects were acceptable for symptomatic athletes. The KJOC-SES-Tr was shown to be valid, reliable tool to monitor the return to sports following injuries in athletes. Copyright © 2018 Turkish Association of Orthopaedics and Traumatology. Production and hosting by Elsevier B.V. All rights reserved.

  19. A clinical decision support system algorithm for intravenous to oral antibiotic switch therapy: validity, clinical relevance and usefulness in a three-step evaluation study.

    Science.gov (United States)

    Akhloufi, H; Hulscher, M; van der Hoeven, C P; Prins, J M; van der Sijs, H; Melles, D C; Verbon, A

    2018-04-26

    To evaluate a clinical decision support system (CDSS) based on consensus-based intravenous to oral switch criteria, which identifies intravenous to oral switch candidates. A three-step evaluation study of a stand-alone CDSS with electronic health record interoperability was performed at the Erasmus University Medical Centre in the Netherlands. During the first step, we performed a technical validation. During the second step, we determined the sensitivity, specificity, negative predictive value and positive predictive value in a retrospective cohort of all hospitalized adult patients starting at least one therapeutic antibacterial drug between 1 and 16 May 2013. ICU, paediatric and psychiatric wards were excluded. During the last step the clinical relevance and usefulness was prospectively assessed by reports to infectious disease specialists. An alert was considered clinically relevant if antibiotics could be discontinued or switched to oral therapy at the time of the alert. During the first step, one technical error was found. The second step yielded a positive predictive value of 76.6% and a negative predictive value of 99.1%. The third step showed that alerts were clinically relevant in 53.5% of patients. For 43.4% it had already been decided to discontinue or switch the intravenous antibiotics by the treating physician. In 10.1%, the alert resulted in advice to change antibiotic policy and was considered useful. This prospective cohort study shows that the alerts were clinically relevant in >50% (n = 449) and useful in 10% (n = 85). The CDSS needs to be evaluated in hospitals with varying activity of infectious disease consultancy services as this probably influences usefulness.

  20. Sci-Thur AM: YIS – 04: Stopping power-to-Cherenkov power ratios and beam quality specification for clinical Cherenkov emission dosimetry of electrons: beam-specific effects and experimental validation

    International Nuclear Information System (INIS)

    Zlateva, Yana; Seuntjens, Jan; El Naqa, Issam

    2016-01-01

    Purpose: To advance towards clinical Cherenkov emission (CE)-based dosimetry by investigating beam-specific effects on Monte Carlo-calculated electron-beam stopping power-to-CE power ratios (SCRs), addressing electron beam quality specification in terms of CE, and validating simulations with measurements. Methods: The EGSnrc user code SPRRZnrc, used to calculate Spencer-Attix stopping-power ratios, was modified to instead calculate SCRs. SCRs were calculated for 6- to 22-MeV clinical electron beams from Varian TrueBeam, Clinac 21EX, and Clinac 2100C/D accelerators. Experiments were performed with a 20-MeV electron beam from a Varian TrueBeam accelerator, using a diffraction grating spectrometer with optical fiber input and a cooled back-illuminated CCD. A fluorophore was dissolved in the water to remove CE signal anisotropy. Results: It was found that angular spread of the incident beam has little effect on the SCR (≤ 0.3% at d max ), while both the electron spectrum and photon contamination increase the SCR at shallow depths and decrease it at large depths. A universal data fit of R 50 in terms of C 50 (50% CE depth) revealed a strong linear dependence (R 2 > 0.9999). The SCR was fit with a Burns-type equation (R 2 = 0.9974, NRMSD = 0.5%). Below-threshold incident radiation was found to have minimal effect on beam quality specification (< 0.1%). Experiments and simulations were in good agreement. Conclusions: Our findings confirm the feasibility of the proposed CE dosimetry method, contingent on computation of SCRs from additional accelerators and on further experimental validation. This work constitutes an important step towards clinical high-resolution out-of-beam CE dosimetry.

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

    Science.gov (United States)

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

    2007-12-01

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

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

    Science.gov (United States)

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

    2010-12-01

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

  3. Validation of an instrument to measure inter-organisational linkages in general practice.

    Science.gov (United States)

    Amoroso, Cheryl; Proudfoot, Judith; Bubner, Tanya; Jayasinghe, Upali W; Holton, Christine; Winstanley, Julie; Beilby, Justin; Harris, Mark F

    2007-12-03

    Linkages between general medical practices and external services are important for high quality chronic disease care. The purpose of this research is to describe the development, evaluation and use of a brief tool that measures the comprehensiveness and quality of a general practice's linkages with external providers for the management of patients with chronic disease. In this study, clinical linkages are defined as the communication, support, and referral arrangements between services for the care and assistance of patients with chronic disease. An interview to measure surgery-level (rather than individual clinician-level) clinical linkages was developed, piloted, reviewed, and evaluated with 97 Australian general practices. Two validated survey instruments were posted to patients, and a survey of locally available services was developed and posted to participating Divisions of General Practice (support organisations). Hypotheses regarding internal validity, association with local services, and patient satisfaction were tested using factor analysis, logistic regression and multilevel regression models. The resulting General Practice Clinical Linkages Interview (GP-CLI) is a nine-item tool with three underlying factors: referral and advice linkages, shared care and care planning linkages, and community access and awareness linkages. Local availability of chronic disease services has no affect on the comprehensiveness of services with which practices link, however, comprehensiveness of clinical linkages has an association with patient assessment of access, receptionist services, and of continuity of care in their general practice. The GP-CLI may be useful to researchers examining comparable health care systems for measuring the comprehensiveness and quality of linkages at a general practice-level with related services, possessing both internal and external validity. The tool can be used with large samples exploring the impact, outcomes, and facilitators of high

  4. Validation of an instrument to measure inter-organisational linkages in general practice

    Directory of Open Access Journals (Sweden)

    Cheryl Amoroso

    2007-11-01

    Full Text Available Purpose: Linkages between general medical practices and external services are important for high quality chronic disease care. The purpose of this research is to describe the development, evaluation and use of a brief tool that measures the comprehensiveness and quality of a general practice’s linkages with external providers for the management of patients with chronic disease. In this study, clinical linkages are defined as the communication, support, and referral arrangements between services for the care and assistance of patients with chronic disease. Methods: An interview to measure surgery-level (rather than individual clinician-level clinical linkages was developed, piloted, reviewed, and evaluated with 97 Australian general practices. Two validated survey instruments were posted to patients, and a survey of locally available services was developed and posted to participating Divisions of General Practice (support organisations. Hypotheses regarding internal validity, association with local services, and patient satisfaction were tested using factor analysis, logistic regression and multilevel regression models. Results: The resulting General Practice Clinical Linkages Interview (GP-CLI is a nine-item tool with three underlying factors: referral and advice linkages, shared care and care planning linkages, and community access and awareness linkages. Local availability of chronic disease services has no affect on the comprehensiveness of services with which practices link, however comprehensiveness of clinical linkages has an association with patient assessment of access, receptionist services, and of continuity of care in their general practice. Conclusions: The GP-CLI may be useful to researchers examining comparable health care systems for measuring the comprehensiveness and quality of linkages at a general practice-level with related services, possessing both internal and external validity. The tool can be used with large samples

  5. Spanish validation of the adult Attention Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS): relevance of clinical subtypes.

    Science.gov (United States)

    Richarte, Vanesa; Corrales, Montserrat; Pozuelo, Marian; Serra-Pla, Juanfran; Ibáñez, Pol; Calvo, Eva; Corominas, Margarida; Bosch, Rosa; Casas, Miquel; Ramos-Quiroga, Josep Antoni

    Adult attention deficit hyperactivity disorder (ADHD) has a prevalence between 2.5% and 4% of the general adult population. Over the past few decades, self-report measures have been developed for the current evaluation of adult ADHD. The ADHD-RS is a 18-items scale self-report version for assessing symptoms for ADHD DSM-IV. A validation of Spanish version of the ADHD-RS was performed. The sample consisted of 304 adult with ADHD and 94 controls. A case control study was carried out (adult ADHD vs. non ADHD). The diagnosis of ADHD was evaluated with the Structured Clinical Interview for DSM-IV (SCID-I) and the Conners Adult ADHD Diagnostic Interview for DSM-IV (CAADID-II). To determinate the internal validity of the two dimensions structure of ADHD-RS an exploratory factor analysis was performed. The α-coefficients were taken as a measure of the internal consistency of the dimensions considered. A logistic regression study was carried out to evaluate the model in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive values (NPV). Average age was 33.29 (SD=10.50) and 66% of subjects were men (there were no significant differences between the two groups). Factor analysis was done with a principal component analysis followed by a normalized varimax rotation. The Kaiser-Meyer-Olkin measure of sampling adequacy tests was .868 (remarkable) and the Bartlett's test of sphericity was 2 (153)=1,835.76, P<.0005, indicating the appropriateness of the factor analysis. This two-factor model accounted for 37.81% of the explained variance. The α-coefficient of the two factors was .84 and .82. The original strategy proposed 24 point for cut-off: sensitivity (81.9%), specificity (74.7%), PPV (50.0%), NPV (93.0%), kappa coefficient .78 and area under the curve (AUC) .89. The new score strategy proposed by our group suggests different cut-off for different clinical presentations. The 24 point is the best cut-off for ADHD combined presentation

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

    Science.gov (United States)

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

    2006-07-01

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

  7. The “DOC” screen: Feasible and valid screening for depression, Obstructive Sleep Apnea (OSA) and cognitive impairment in stroke prevention clinics

    Science.gov (United States)

    Swartz, Richard H.; Cayley, Megan L.; Lanctôt, Krista L.; Murray, Brian J.; Cohen, Ashley; Thorpe, Kevin E.; Sicard, Michelle N.; Lien, Karen; Sahlas, Demetrios J.; Herrmann, Nathan

    2017-01-01

    Background Post-stroke Depression, Obstructive sleep apnea (OSA) and Cognitive impairment (“DOC”) are associated with greater mortality, worse recovery and poorer quality of life. Best practice recommendations endorse routine screening for each condition; yet, all are under-assessed, diagnosed and treated. We seek to determine the feasibility and validity of an integrated tool (“DOC” screen) to identify stroke clinic patients at high-risk of depression, OSA, and cognitive impairment. Methods All consecutive new referrals to a regional Stroke Prevention Clinic who were English-speaking and non-aphasic were eligible to be screened. Time for screen completion was logged. DOC screen results were compared to the neuropsychological battery and polysomnogram assessments using a modified receiver operator characteristic and area under the curve analysis. Data is reported to conform to STARD guidelines. Findings 1503 people were screened over 2 years. 89% of eligible patients completed the screen in 5 minutes or less (mean 4.2 minutes), less than half the time it takes to complete the Montreal Cognitive Assessment (MoCA). 437 people consented to detailed testing. Of those, 421 completed the Structured Clinical Interview for Depression within 3 months of screening, 387 completed detailed neuropsychological testing within 3 months, and 88 had overnight polysomnograms. Screening scores combined with demographic variables (age, sex, education, body mass index), had excellent validity compared to gold standard diagnoses: DOC-Mood AUC 0.90; DOC-Apnea AUC 0.80; DOC-Cog AUC 0.81. DOC screen scores can reliably categorize patients in to low-, intermediate- or high-risk groups for further action and can do so with comparable accuracy to more time-consuming screens. Conclusions Systematic screening of depression, obstructive sleep apnea, and cognitive impairment in 5 minutes or less is feasible and valid in a high volume stroke clinic using the DOC screen. The DOC screen may

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

    Science.gov (United States)

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

    2014-01-01

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

  9. Validity and everyday clinical applicability of lumbar muscle fatigue assessment methods in patients with chronic non-specific low back pain: a systematic review.

    Science.gov (United States)

    Villafañe, Jorge H; Gobbo, Massimiliano; Peranzoni, Matteo; Naik, Ganesh; Imperio, Grace; Cleland, Joshua A; Negrini, Stefano

    2016-09-01

    This systematic literature review aimed at examining the validity and applicability in everyday clinical rehabilitation practise of methods for the assessment of back muscle fatiguability in patients with chronic non-specific low back pain (CNSLBP). Extensive research was performed in MEDLINE, Cumulative Index of Nursing and Allied Health Literature (CINAHL), Embase, Physiotherapy Evidence Database (PEDro) and Cochrane Central Register of Controlled Trials (CENTRAL) databases from their inception to September 2014. Potentially relevant articles were also manually looked for in the reference lists of the identified publications. Studies examining lumbar muscle fatigue in people with CNSLBP were selected. Two reviewers independently selected the articles, carried out the study quality assessment and extracted the results. A modified Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) scale was used to evaluate the scientific rigour of the selected works. Twenty-four studies fulfilled the selection criteria and were included in the systematic review. We found conflicting data regarding the validity of methods used to examine back muscle fatigue. The Biering-Sorensen test, performed in conjunction with surface electromyography spectral analysis, turned out to be the most widely used and comparatively, the most optimal modality currently available to assess objective back muscle fatigue in daily clinical practise, even though critical limitations are discussed. Future research should address the identification of an advanced method for lower back fatigue assessment in patients with CNSLBP which, eventually, might provide physical therapists with an objective and reliable test usable in everyday clinical practise. Implications for Rehabilitation Despite its limitations, the Biering-Sorensen test is currently the most used, convenient and easily available fatiguing test for lumbar muscles. To increase validity and reliability of the Biering

  10. Deep brain stimulation may reduce the relative risk of clinically important worsening in early stage Parkinson's disease.

    Science.gov (United States)

    Hacker, Mallory L; Tonascia, James; Turchan, Maxim; Currie, Amanda; Heusinkveld, Lauren; Konrad, Peter E; Davis, Thomas L; Neimat, Joseph S; Phibbs, Fenna T; Hedera, Peter; Wang, Lily; Shi, Yaping; Shade, David M; Sternberg, Alice L; Drye, Lea T; Charles, David

    2015-10-01

    The Vanderbilt pilot trial of deep brain stimulation (DBS) in early Parkinson's disease (PD) enrolled patients on medications six months to four years without motor fluctuations or dyskinesias. We conducted a patient-centered analysis based on clinically important worsening of motor symptoms and complications of medical therapy for all subjects and a subset of subjects with a more focused medication duration. Continuous outcomes were also analyzed for this focused cohort. A post hoc analysis was conducted on all subjects from the pilot and a subset of subjects taking PD medications 1-4 years at enrollment. Clinically important worsening is defined as both a ≥ 3 point increase in UPDRS Part III and a ≥ 1 point increase in Part IV. DBS plus optimal drug therapy (DBS + ODT) subjects experienced a 50-80% reduction in the relative risk of worsening after two years. The DBS + ODT group was improved compared to optimal drug therapy (ODT) at each time point on Total UPDRS and Part III (p = 0.04, p = 0.02, respectively, at 24 months). Total UPDRS, Part IV, and PDQ-39 scores significantly worsened in the ODT group after two years (p < 0.003), with no significant change in the DBS + ODT group. DBS + ODT in early PD may reduce the risk of clinically important worsening. These findings further confirm the need to determine if DBS + ODT is superior to medical therapy for managing symptoms, reducing the complications of medications, and improving quality of life. The FDA has approved the conduct of a large-scale, pivotal clinical trial of DBS in early stage PD. Copyright © 2015 Elsevier Ltd. All rights reserved.

  11. Development and Validation of a Tool to Evaluate the Evolution of Clinical Reasoning in Trauma Using Virtual Patients.

    Science.gov (United States)

    Fleiszer, David; Hoover, Michael L; Posel, Nancy; Razek, Tarek; Bergman, Simon

    Undergraduate medical students at a large academic trauma center are required to manage a series of online virtual trauma patients as a mandatory exercise during their surgical rotation. Clinical reasoning during undergraduate medical education can be difficult to assess. The purpose of the study was to determine whether we could use components of the students' virtual patient management to measure changes in their clinical reasoning over the course of the clerkship year. In order to accomplish this, we decided to determine if the use of scoring rubrics could change the traditional subjective assessment to a more objective evaluation. Two groups of students, one at the beginning of clerkship (Juniors) and one at the end of clerkship (Seniors), were chosen. Each group was given the same virtual patient case, a clinical scenario based on the Advanced Trauma Life Support (ATLS) Primary Trauma Survey, which had to be completed during their trauma rotation. The learner was required to make several key patient management choices based on their clinical reasoning, which would take them along different routes through the case. At the end of the case they had to create a summary report akin to sign-off. These summaries were graded independently by two domain "Experts" using a traditional subjective surgical approach to assessment and by two "Non-Experts" using two internally validated scoring rubrics. One rubric assessed procedural or domain knowledge (Procedural Rubric), while the other rubric highlighted semantic qualifiers (Semantic Rubric). Each of the rubrics was designed to reflect established components of clinical reasoning. Student's t-tests were used to compare the rubric scores for the two groups and Cohen's d was used to determine effect size. Kendall's τ was used to compare the difference between the two groups based on the "Expert's" subjective assessment. Inter-rater reliability (IRR) was determined using Cronbach's alpha. The Seniors did better than the

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

    Science.gov (United States)

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

    2014-06-12

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

  13. Relations of the Big-Five personality dimensions to autodestructive behavior in clinical and non-clinical adolescent populations

    Science.gov (United States)

    Kotrla Topić, Marina; Perković Kovačević, Marina; Mlačić, Boris

    2012-01-01

    Aim To examine the relationship between the Big-Five personality model and autodestructive behavior symptoms, namely Autodestructiveness and Suicidal Depression in two groups of participants: clinical and non-clinical adolescents. Methods Two groups of participants, clinical (adolescents with diagnosis of psychiatric disorder based on clinical impression and according to valid diagnostic criteria, N = 92) and non-clinical (high-school students, N = 87), completed two sets of questionnaires: the Autodestructiveness Scale which provided data on Autodestructiveness and Suicidal Depression, and the International Personality Item Pool (IPIP), which provided data on the Big -Five personality dimensions. Results Clinical group showed significantly higher values on the Autodestructiveness scale in general, as well as on Suicidal Depression, Aggressiveness, and Borderline subscales than the non-clinical group. Some of the dimensions of the Big-Five personality model, ie, Emotional Stability, Conscientiousness, and Agreeableness showed significant relationship (hierarchical regression analyses, P values for β coefficients from Big-Five model are important when evaluating adolescent psychiatric patients and adolescents from general population at risk of self-destructive behavior. PMID:23100207

  14. Measuring health-related quality of life in patients with mild to moderate eczema and psoriasis: clinical validity, reliability and sensitivity to change of the DLQI. The Cavide Research Group.

    Science.gov (United States)

    Badia, X; Mascaró, J M; Lozano, R

    1999-10-01

    The aim of this study was to assess the feasibility, validity, reliability and sensitivity to change of a Spanish version of the Dermatology Life Quality Index (DLQI) in patients with mild to moderate eczema and psoriasis who were treated with topical corticosteroids. The final study sample comprised 237 patients (48% eczema). Discriminant validity was tested by comparing patients' scores with those of a random sample of the general population (n = 100), and convergent validity by analysing correlations between DLQI scores, measures of clinical severity, and domain scores on the Nottingham Health Profile (NHP). Internal consistency and test-retest reliability were tested in clinically stable patients (n = 94), and responsiveness in a clinically unstable group (n = 143) initiating treatment with topical corticosteroids. Patient scores were significantly higher than general population scores (4.3 vs. 0. 27, P effect size for the total group of de novo patients = 0.70), though the great majority of changes occurred in items 1 and 2. The NHP Emotional Reactions and Mobility domains were more responsive than some DLQI domains. In clinical trials of treatments for mild to moderate eczema and psoriasis, it is likely that only items 1 and 2 of the DLQI will be needed, and it is probably advisable to include generic instruments alongside the DLQI.

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

    Science.gov (United States)

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

    2018-04-06

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

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

    Science.gov (United States)

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

    2017-11-07

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

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

    Science.gov (United States)

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

    2012-01-01

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

  18. Quality of Life After Cardiac Surgery Based on the Minimal Clinically Important Difference Concept.

    Science.gov (United States)

    Grand, Nathalie; Bouchet, Jean Baptiste; Zufferey, Paul; Beraud, Anne Marie; Awad, Sahar; Sandri, Fabricio; Campisi, Salvator; Fuzellier, Jean François; Molliex, Serge; Vola, Marco; Morel, Jerome

    2018-03-23

    Health-related quality of life (HRQOL) is an increasingly important issue in assessing the consequences of any surgical or medical intervention. Our study aimed to evaluate change in HRQOL 6 months after elective cardiac surgery and to identify specific predictors of poor HRQOL. In this prospective, single-center study, HRQOL was evaluated before and 6 months after surgery using the SF-36 questionnaire and its two components: the physical component summary (PCS) and the mental component summary (MCS). We distinguished patients with worsening of HRQOL according to the minimal clinically important difference. All consecutive adult patients undergoing cardiac surgery were included. 326 patients completed the preoperative and postoperative SF-36 questionnaires and 24 patients died before completing follow-up questionnaires. Based on the definition used, clinically significant deterioration of HRQOL was observed in 93 patients (26.6%) for PCS and 99 patients (28.2%) for MCS. Renal replacement for acute renal failure and mechanical ventilation for longer than 48 hours were independent risk factors for PCS and MCS worsening or death. Although our study showed overall improvement of QOL after cardiac surgery, over a quarter of the patients manifested deterioration of HRQOL at 6 months post-surgery. The findings from this study should help clinicians to inform patients about their likely postoperative functional status and quality of life. Copyright © 2018. Published by Elsevier Inc.

  19. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST).

    Science.gov (United States)

    de Souza, Jonas A; Yap, Bonnie J; Wroblewski, Kristen; Blinder, Victoria; Araújo, Fabiana S; Hlubocky, Fay J; Nicholas, Lauren H; O'Connor, Jeremy M; Brockstein, Bruce; Ratain, Mark J; Daugherty, Christopher K; Cella, David

    2017-02-01

    Cancer and its treatment lead to increased financial distress for patients. To the authors' knowledge, to date, no standardized patient-reported outcome measure has been validated to assess this distress. Patients with AJCC Stage IV solid tumors receiving chemotherapy for at least 2 months were recruited. Financial toxicity was measured by the COmprehensive Score for financial Toxicity (COST) measure. The authors collected data regarding patient characteristics, clinical trial participation, health care use, willingness to discuss costs, psychological distress (Brief Profile of Mood States [POMS]), and health-related quality of life (HRQOL) as measured by the Functional Assessment of Cancer Therapy: General (FACT-G) and the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaires. Test-retest reliability, internal consistency, and validity of the COST measure were assessed using standard-scale construction techniques. Associations between the resulting factors and other variables were assessed using multivariable analyses. A total of 375 patients with advanced cancer were approached, 233 of whom (62.1%) agreed to participate. The COST measure demonstrated high internal consistency and test-retest reliability. Factor analyses revealed a coherent, single, latent variable (financial toxicity). COST values were found to be correlated with income (correlation coefficient [r] = 0.28; Pfinancial toxicity were race (P = .04), employment status (Pcosts was not found to be associated with the degree of financial distress (P = .49). The COST measure demonstrated reliability and validity in measuring financial toxicity. Its correlation with HRQOL indicates that financial toxicity is a clinically relevant patient-centered outcome. Cancer 2017;123:476-484. © 2016 American Cancer Society. © 2016 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.

  20. On the Validity of Beer-Lambert Law and its Significance for Sunscreens.

    Science.gov (United States)

    Herzog, Bernd; Schultheiss, Amélie; Giesinger, Jochen

    2018-03-01

    The sun protection factor (SPF) is the most important quantity to characterize the performance of sunscreens. As the standard method for its determination is based on clinical trials involving irradiation of human volunteers, calculations of sunscreen performance have become quite popular to reduce the number of in vivo studies. Such simulations imply the calculation of UV transmittance of the sunscreen film using the amounts and spectroscopic properties of the UV absorbers employed, and presuppose the validity of the Beer-Lambert law. As sunscreen films on human skin can contain considerable concentrations of UV absorbers, it is questioned whether the Beer-Lambert law is still valid for these systems. The results of this work show that the validity of the Beer-Lambert law is still given at the high concentrations at which UV absorbers occur in sunscreen films on human skin. © 2017 The American Society of Photobiology.