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

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.

Clinical Studies

DEFF Research Database (Denmark)

Pallesen, Ulla

universities and practicing dentists restore millions of teeth throughout the World with composite resin materials. Do we know enough about the clinical performance of these restorations over time? Numerous in vitro studies are being published on resin materials and adhesion, some of them attempting to imitate...... in vivo conditions. But real life is different and in vitro studies cannot include all variables. Only clinical studies can provide valid information on the clinical performance of restorations over time. What do we know about longevity of posterior resin restorations? What are the reasons for replacement...... and results from own up to 30-year prospective clinical university studies and practice based studies from Public Dental Health Service on the clinical performance of posterior composite resin restorations....

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

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.

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

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.

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

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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.

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.

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…

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....

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...

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

'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.

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…

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.

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.

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...

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…

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

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.

How valid are claims for synergy in published clinical studies?

Science.gov (United States)

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

2012-08-01

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

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.

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.

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.

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.

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

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.

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

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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.

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

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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

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.

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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.

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

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Zariffa, Jose; Kramer, John L.K.

2011-01-01

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

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

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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.

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.

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

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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.

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.

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...

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.

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.…

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

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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…

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.

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.

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

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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

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

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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).

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

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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.

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

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

2015-10-01

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

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.

Validation studies of nursing diagnoses in neonatology

Directory of Open Access Journals (Sweden)

Pavlína Rabasová

2016-03-01

Full Text Available Aim: The objective of the review was the analysis of Czech and foreign literature sources and professional periodicals to obtain a relevant comprehensive overview of validation studies of nursing diagnoses in neonatology. Design: Review. Methods: The selection criterion was studies concerning the validation of nursing diagnoses in neonatology. To obtain data from relevant sources, the licensed professional databases EBSCO, Web of Science and Scopus were utilized. The search criteria were: date of publication - unlimited; academic periodicals - full text; peer-reviewed periodicals; search language - English, Czech and Slovak. Results: A total of 788 studies were found. Only 5 studies were eligible for content analysis, dealing specifically with validation of nursing diagnoses in neonatology. The analysis of the retrieved studies suggests that authors are most often concerned with identifying the defining characteristics of nursing diagnoses applicable to both the mother (parents and the newborn. The diagnoses were validated in the domains Role Relationship; Coping/Stress tolerance; Activity/Rest, and Elimination and Exchange. Diagnoses represented were from the field of dysfunctional physical needs as well as the field of psychosocial and spiritual needs. The diagnoses were as follows: Parental role conflict (00064; Impaired parenting (00056; Grieving (00136; Ineffective breathing pattern (00032; Impaired gas exchange (00030; and Impaired spontaneous ventilation (00033. Conclusion: Validation studies enable effective planning of interventions with measurable results and support clinical nursing practice.

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

Using wound care algorithms: a content validation study.

Science.gov (United States)

Beitz, J M; van Rijswijk, L

1999-09-01

Valid and reliable heuristic devices facilitating optimal wound care are lacking. The objectives of this study were to establish content validation data for a set of wound care algorithms, to identify their associated strengths and weaknesses, and to gain insight into the wound care decision-making process. Forty-four registered nurse wound care experts were surveyed and interviewed at national and regional educational meetings. Using a cross-sectional study design and an 83-item, 4-point Likert-type scale, this purposive sample was asked to quantify the degree of validity of the algorithms' decisions and components. Participants' comments were tape-recorded, transcribed, and themes were derived. On a scale of 1 to 4, the mean score of the entire instrument was 3.47 (SD +/- 0.87), the instrument's Content Validity Index was 0.86, and the individual Content Validity Index of 34 of 44 participants was > 0.8. Item scores were lower for those related to packing deep wounds (P valid and reliable definitions. The wound care algorithms studied proved valid. However, the lack of valid and reliable wound assessment and care definitions hinders optimal use of these instruments. Further research documenting their clinical use is warranted. Research-based practice recommendations should direct the development of future valid and reliable algorithms designed to help nurses provide optimal wound care.

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.

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...

Validation of a clinical critical thinking skills test in nursing

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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.

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

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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.

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

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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.

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

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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.

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.

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

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

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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

Construction and validation of clinical contents for development of learning objects

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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.

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

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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.

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."

Content Validation of Athletic Therapy Clinical Presentations in Canada

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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:…

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

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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.

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....

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

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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.

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

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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.

A clinical decision support system algorithm for intravenous to oral antibiotic switch therapy: validity, clinical relevance and usefulness in a three-step evaluation study.

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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.

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

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

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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…

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

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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

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

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

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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.

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

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Chapple Cathy

2005-11-01

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

The script concordance test in radiation oncology: validation study of a new tool to assess clinical reasoning

International Nuclear Information System (INIS)

Lambert, Carole; Gagnon, Robert; Nguyen, David; Charlin, Bernard

2009-01-01

The Script Concordance test (SCT) is a reliable and valid tool to evaluate clinical reasoning in complex situations where experts' opinions may be divided. Scores reflect the degree of concordance between the performance of examinees and that of a reference panel of experienced physicians. The purpose of this study is to demonstrate SCT's usefulness in radiation oncology. A 90 items radiation oncology SCT was administered to 155 participants. Three levels of experience were tested: medical students (n = 70), radiation oncology residents (n = 38) and radiation oncologists (n = 47). Statistical tests were performed to assess reliability and to document validity. After item optimization, the test comprised 30 cases and 70 questions. Cronbach alpha was 0.90. Mean scores were 51.62 (± 8.19) for students, 71.20 (± 9.45) for residents and 76.67 (± 6.14) for radiation oncologists. The difference between the three groups was statistically significant when compared by the Kruskall-Wallis test (p < 0.001). The SCT is reliable and useful to discriminate among participants according to their level of experience in radiation oncology. It appears as a useful tool to document the progression of reasoning during residency training

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

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

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Ghaedi Gholam

2009-07-01

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

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

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

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.

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.

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.

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.

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...

A Korean validation study of the Clinically Useful Anxiety Outcome Scale: Comorbidity and differentiation of anxiety and depressive disorders

Science.gov (United States)

Jeon, Sang Won; Ko, Young-Hoon; Yoon, Seoyoung; Pae, Chi-Un; Choi, Joonho; Kim, Jae-Min; Yoon, Ho-Kyoung; Lee, Hoseon; Patkar, Ashwin A.; Zimmerman, Mark

2017-01-01

Background This study aimed to evaluate the psychometric properties of the Korean version of the Clinically Useful Anxiety Outcome Scale (CUXOS) and to examine the current diagnostic comorbidity and differential severity of anxiety symptoms between major depressive disorder (MDD) and anxiety disorders. Methodology In total, 838 psychiatric outpatients were analyzed at their intake appointment. Diagnostic characteristics were examined using the structured clinical interview from the DSM-IV because the DSM5 was not available at the start of the study. The CUXOS score was measured and compared with that of 3 clinician rating scales and 4 self-report scales. Principal findings The CUXOS showed excellent results for internal consistency (Cronbach’s α = 0.90), test–retest reliability (r = 0.74), and discriminant and convergent validity. The CUXOS significantly discriminated between different levels of anxiety severity, and the measure was sensitive to change after treatment. Approximately 45% of patients with MDD were additionally diagnosed with anxiety disorders while 55% of patients with anxiety disorders additionally reported an MDD. There was a significant difference in CUXOS scores between diagnostic categories (MDD only, anxiety only, both disorders, and no MDD or anxiety disorder). The CUXOS scores differed significantly between all categories of depression (major, minor, and non-depression) except for the comparison between minor depression and non-depression groups. Conclusions The Korean version of the CUXOS is a reliable and valid measure of the severity of anxiety symptoms. The use of the CUXOS could broaden the understanding of coexisting and differentiating characteristics of anxiety and depression. PMID:28604808

A Korean validation study of the Clinically Useful Anxiety Outcome Scale: Comorbidity and differentiation of anxiety and depressive disorders.

Directory of Open Access Journals (Sweden)

Sang Won Jeon

Full Text Available This study aimed to evaluate the psychometric properties of the Korean version of the Clinically Useful Anxiety Outcome Scale (CUXOS and to examine the current diagnostic comorbidity and differential severity of anxiety symptoms between major depressive disorder (MDD and anxiety disorders.In total, 838 psychiatric outpatients were analyzed at their intake appointment. Diagnostic characteristics were examined using the structured clinical interview from the DSM-IV because the DSM5 was not available at the start of the study. The CUXOS score was measured and compared with that of 3 clinician rating scales and 4 self-report scales.The CUXOS showed excellent results for internal consistency (Cronbach's α = 0.90, test-retest reliability (r = 0.74, and discriminant and convergent validity. The CUXOS significantly discriminated between different levels of anxiety severity, and the measure was sensitive to change after treatment. Approximately 45% of patients with MDD were additionally diagnosed with anxiety disorders while 55% of patients with anxiety disorders additionally reported an MDD. There was a significant difference in CUXOS scores between diagnostic categories (MDD only, anxiety only, both disorders, and no MDD or anxiety disorder. The CUXOS scores differed significantly between all categories of depression (major, minor, and non-depression except for the comparison between minor depression and non-depression groups.The Korean version of the CUXOS is a reliable and valid measure of the severity of anxiety symptoms. The use of the CUXOS could broaden the understanding of coexisting and differentiating characteristics of anxiety and depression.

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.

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

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.

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.

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.

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.

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

The Sydney Triage to Admission Risk Tool (START): A prospective validation study.

Science.gov (United States)

Ebker-White, Anja A; Bein, Kendall J; Dinh, Michael M

2018-02-08

The present study aims to prospectively validate the Sydney Triage to Admission Risk Tool (START) to predict ED disposition. This was a prospective validation study at two metropolitan EDs in Sydney, Australia. Consecutive triage encounters were observed by a trained researcher and START scores calculated. The primary outcome was patient disposition (discharge or inpatient admission) from the ED. Multivariable logistic regression was used to estimate area under curve of receiver operator characteristic (AUC ROC) for START scores as well as START score in combination with other variables such as frailty, general practitioner referral, overcrowding and major medical comorbidities. There were 894 patients analysed during the study period. The START score when applied to the data had AUC ROC of 0.80 (95% CI 0.77-0.83). The inclusion of other clinical variables identified at triage did not improve the overall performance of the model with an AUC ROC of 0.81 (95% CI 0.78-0.84) in the present study. The overall performance of the START tool with respect to model discrimination and accuracy has been prospectively validated. Further clinical trials are required to test the clinical effectiveness of the tool in improving patient flow and overall ED performance. © 2018 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

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

Science.gov (United States)

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

2009-07-09

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

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

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.

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.

Validity Evidence and Scoring Guidelines for Standardized Patient Encounters and Patient Notes From a Multisite Study of Clinical Performance Examinations in Seven Medical Schools.

Science.gov (United States)

Park, Yoon Soo; Hyderi, Abbas; Heine, Nancy; May, Win; Nevins, Andrew; Lee, Ming; Bordage, Georges; Yudkowsky, Rachel

2017-11-01

To examine validity evidence of local graduation competency examination scores from seven medical schools using shared cases and to provide rater training protocols and guidelines for scoring patient notes (PNs). Between May and August 2016, clinical cases were developed, shared, and administered across seven medical schools (990 students participated). Raters were calibrated using training protocols, and guidelines were developed collaboratively across sites to standardize scoring. Data included scores from standardized patient encounters for history taking, physical examination, and PNs. Descriptive statistics were used to examine scores from the different assessment components. Generalizability studies (G-studies) using variance components were conducted to estimate reliability for composite scores. Validity evidence was collected for response process (rater perception), internal structure (variance components, reliability), relations to other variables (interassessment correlations), and consequences (composite score). Student performance varied by case and task. In the PNs, justification of differential diagnosis was the most discriminating task. G-studies showed that schools accounted for less than 1% of total variance; however, for the PNs, there were differences in scores for varying cases and tasks across schools, indicating a school effect. Composite score reliability was maximized when the PN was weighted between 30% and 40%. Raters preferred using case-specific scoring guidelines with clear point-scoring systems. This multisite study presents validity evidence for PN scores based on scoring rubric and case-specific scoring guidelines that offer rigor and feedback for learners. Variability in PN scores across participating sites may signal different approaches to teaching clinical reasoning among medical schools.

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.

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...

Validation of mismatch negativity and P3a for use in multi-site studies of schizophrenia: characterization of demographic, clinical, cognitive, and functional correlates in COGS-2.

Science.gov (United States)

Light, Gregory A; Swerdlow, Neal R; Thomas, Michael L; Calkins, Monica E; Green, Michael F; Greenwood, Tiffany A; Gur, Raquel E; Gur, Ruben C; Lazzeroni, Laura C; Nuechterlein, Keith H; Pela, Marlena; Radant, Allen D; Seidman, Larry J; Sharp, Richard F; Siever, Larry J; Silverman, Jeremy M; Sprock, Joyce; Stone, William S; Sugar, Catherine A; Tsuang, Debby W; Tsuang, Ming T; Braff, David L; Turetsky, Bruce I

2015-04-01

Mismatch negativity (MMN) and P3a are auditory event-related potential (ERP) components that show robust deficits in schizophrenia (SZ) patients and exhibit qualities of endophenotypes, including substantial heritability, test-retest reliability, and trait-like stability. These measures also fulfill criteria for use as cognition and function-linked biomarkers in outcome studies, but have not yet been validated for use in large-scale multi-site clinical studies. This study tested the feasibility of adding MMN and P3a to the ongoing Consortium on the Genetics of Schizophrenia (COGS) study. The extent to which demographic, clinical, cognitive, and functional characteristics contribute to variability in MMN and P3a amplitudes was also examined. Participants (HCS n=824, SZ n=966) underwent testing at 5 geographically distributed COGS laboratories. Valid ERP recordings were obtained from 91% of HCS and 91% of SZ patients. Highly significant MMN (d=0.96) and P3a (d=0.93) amplitude reductions were observed in SZ patients, comparable in magnitude to those observed in single-lab studies with no appreciable differences across laboratories. Demographic characteristics accounted for 26% and 18% of the variance in MMN and P3a amplitudes, respectively. Significant relationships were observed among demographically-adjusted MMN and P3a measures and medication status as well as several clinical, cognitive, and functional characteristics of the SZ patients. This study demonstrates that MMN and P3a ERP biomarkers can be feasibly used in multi-site clinical studies. As with many clinical tests of brain function, demographic factors contribute to MMN and P3a amplitudes and should be carefully considered in future biomarker-informed clinical studies. Published by Elsevier B.V.

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

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

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Hee-Jin Kim

2016-06-01

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

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...

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

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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.

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

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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...

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

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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.

Clinical validation of immunoglobulin A nephropathy diagnosis in Swedish biopsy registers

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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

Microbiological/clinical characteristics and validation of topical therapy with kanamycin in aerobic vaginitis: a pilot study.

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Tempera, G; Bonfiglio, G; Cammarata, E; Corsello, S; Cianci, A

2004-07-01

The term 'aerobic vaginitis' defines a 'new' vaginal pathology that is neither classifiable as specific vaginitis nor as bacterial vaginosis. We studied a sample of 30 women with a clinical and microbiological diagnosis of aerobic vaginitis and compared the efficacy and tolerability of kanamycin and meclocycline, two products commercially available in Italy in the form of vaginal pessaries. In chronological order of enrollment, the patients were alternately treated with kanamycin or meclocycline; the dose of administration in both groups was of one pessary per day for 6 days. The evaluation of the therapeutic efficacy was carried out both at the first check-up (7th-8th day) and at a second check-up (13th-16th day). At the first follow-up carried out immediately at the end of therapy, the percentage of normalisation of clinical signs and symptoms was increased independently of the type of treatment in the case of moderate grade aerobic vaginitis, while kanamycin was produced a better effect in the group with severe aerobic vaginitis. Furthermore, at the second follow-up, a direct correlation with recovery of vaginal homeostasis was demonstrated by the normalisation of the vaginal pH and by the presence of lactobacilli, only in kanamycin treated group. In conclusion, our results showed the validity of the treatment with kanamycin intravaginally in this recently recognised disease.

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

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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.

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

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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

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

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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

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.

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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

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

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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.

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

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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.

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

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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.

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

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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…

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.

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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.

Facilitating Case Studies in Massage Therapy Clinical Education

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Baskwill, Amanda

2013-01-01

The integration of evidence into reflective health care practice has been on the rise in recent years and is a phenomenon that has affected all health care professions, including massage therapy. Clinical case studies are a research design that follows one patient or subject, making the studies ideal for use in clinical practice. They are valuable for communicating information from clinical practice to the broader community. Case studies have face validity that may be more valuable to individual practitioners than homogeneous randomized controlled trials, as the practitioner may recognize a complex patient in the case report. At Humber College, Student Massage Therapists (SMTs) create, conduct, and communicate results of a clinical case study prior to graduation. This article describes the process and experience. PMID:23730397

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

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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.

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.

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.

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

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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.

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

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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…

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

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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.

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

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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.

External Validation of the HERNIAscore: An Observational Study.

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

2017-09-01

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

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

Reliability and validity study of the Finnish version 2.0 of the oswestry disability index.

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Pekkanen, Liisa; Kautiainen, Hannu; Ylinen, Jari; Salo, Petri; Häkkinen, Arja

2011-02-15

Prospective clinical validation study. The aims of this study were to translate into Finnish and culturally adapt and study the psycho-metric properties of the Oswestry Disability Index (ODI) version 2.0. The ODI is one of the most commonly reported back-specific disability questionnaires. It is widely used both in clinical work and in medical studies. To date, no validated Finnish version of the ODI version 2.0 has been reported. The ODI version 2.0 was translated into the Finnish language. A total of 115 patients with back pain, referred by the primary care physician to the outpatient clinic of the department of physical medicine and rehabilitation, were recruited for this study. The patients answered a questionnaire package that included the Finnish ODI 2.0, Back Pain Questionnaire for Visual Analogue Assessment (Million-VAS), Visual Analogue Scales of back and leg pain (VASback, VASleg), the Depressions Scale, and a question on their subjectively perceived health. The package was administered twice; 2 weeks before and at the arrival to the clinic. Reproducibility of the ODI was 0.90 (95% confidence interval [CI] = 0.85-0.94) and the internal consistency was 0.86 (95% CI = 0.81-0.90). Factor analysis showed that the ODI was loaded on 2 factors, which explained 51% of the total variance. In testing convergent validity ODI correlated with Million-VAS, r = 0.75 (95% CI = 0.64-0.84); VASback, r = 0.48 (95% CI = 0.32-0.62); and VAS leg, r = 0.41 (95% CI = 0.23-0.57). The Finnish ODI version 2.0 proved to be a valid and reliable instrument that showed psychometric properties comparable with the original English version. Therefore, it can be used in assessing the disability among Finnish-speaking patients with back pain for both clinical and scientific purposes.

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

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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).

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

Patient safety risk factors in minimally invasive surgery : A validation study

NARCIS (Netherlands)

Rodrigues, S.P.; Ter Kuile, M.; Dankelman, J.; Jansen, F.W.

2012-01-01

This study was conducted to adapt and validate a patient safety (PS) framework for minimally invasive surgery (MIS) as a first step in understanding the clinical relevance of various PS risk factors in MIS. Eight patient safety risk factor domains were identified using frameworks from a systems

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

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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.

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

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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.

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

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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.

Health-related quality-of-life questionnaire for women with polycystic ovary syndrome: a Chinese translation and validation study.

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Chung, Jpw; Kwan, Ahw; Kwok, Jwk; Chan, Ssc

2016-09-01

To evaluate the reliability, validity, and responsiveness of the Chinese version of the polycystic ovary syndrome questionnaire (PCOSQ). Translation and validation study. Gynaecology clinic and paediatric adolescent gynaecology clinic at the study institute. Chinese women, 16 years of age or older, with polycystic ovary syndrome (PCOS). Women completed the Chinese version of the PCOSQ and the Short-Form Health Survey (SF-36). Their sociodemographic details, clinical parameters, and biochemical results were recorded. A subset of 50 women repeated the PCOSQ 1 week later to evaluate test-retest reliability. Women subsequently received treatment for the symptoms of PCOS. Six months later, 100 women completed the PCOSQ and clinical parameters were assessed to evaluate the responsiveness of the PCOSQ. Internal reliability, test-retest reliability, convergent validity, criterion validity, and responsiveness. A total of 262 Chinese women completed the study. Values of Cronbach's alpha coefficient were all above 0.7, demonstrating a good standard of internal consistency in all subscales. For the test-retest reliability, intraclass correlation coefficients showed excellent stability among the subscales (range 0.82-0.92, P PCOSQ scores was seen in women with improvements in BMI and menstrual patterns; however, these findings did not reach statistical significance. The Chinese version of PCOSQ is reliable and valid for use in women with PCOS. The Chinese version of the PCOSQ is reliable and valid for use. © 2016 Royal College of Obstetricians and Gynaecologists.

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.

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.

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

LENUS (Irish Health Repository)

Kelleher, Ian

2012-02-01

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

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

LENUS (Irish Health Repository)

Kelleher, Ian

2011-03-01

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

Assessing Discriminative Performance at External Validation of Clinical Prediction Models.

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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.

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

International Nuclear Information System (INIS)

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

2008-01-01

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

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

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

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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.

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

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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.

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

NARCIS (Netherlands)

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

2013-01-01

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

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

NARCIS (Netherlands)

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

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

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.

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.

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.

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...

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...

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...

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…

[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.

Antisocial Personality Disorder Subscale (Chinese Version) of the Structured Clinical Interview for the DSM-IV Axis II disorders: validation study in Cantonese-speaking Hong Kong Chinese.

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Tang, D Y Y; Liu, A C Y; Leung, M H T; Siu, B W M

2013-06-01

OBJECTIVE. Antisocial personality disorder (ASPD) is a risk factor for violence and is associated with poor treatment response when it is a co-morbid condition with substance abuse. It is an under-recognised clinical entity in the local Hong Kong setting, for which there are only a few available Chinese-language diagnostic instruments. None has been tested for its psychometric properties in the Cantonese-speaking population in Hong Kong. This study therefore aimed to assess the reliability and validity of the Chinese version of the ASPD subscale of the Structured Clinical Interview for the DSM-IV Axis II Disorders (SCID-II) in Hong Kong Chinese. METHODS. This assessment tool was modified according to dialectal differences between Mainland China and Hong Kong. Inpatients in Castle Peak Hospital, Hong Kong, who were designated for priority follow-up based on their assessed propensity for violence and who fulfilled the inclusion criteria for the study, were recruited. To assess the level of agreement, best-estimate diagnosis made by a multidisciplinary team was compared with diagnostic status determined by the SCID-II ASPD subscale. The internal consistency, sensitivity, and specificity of the subscale were also calculated. RESULTS. The internal consistency of the subscale was acceptable at 0.79, whereas the test-retest reliability and inter-rater reliability showed an excellent and good agreement of 0.90 and 0.86, respectively. Best-estimate clinical diagnosis-SCID diagnosis agreement was acceptable at 0.76. The sensitivity, specificity, positive and negative predictive values were 0.91, 0.86, 0.83, and 0.93, respectively. CONCLUSION. The Chinese version of the SCID-II ASPD subscale is reliable and valid for diagnosing ASPD in a Cantonese-speaking clinical population.

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.

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

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

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

2017-06-01

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

Clinical 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. �

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.

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.

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.

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

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.

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.

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.

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.

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.

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

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.

The Depression Anxiety and Stress Scale (DASS): The Study of Validity and Reliability

Science.gov (United States)

Akin, Ahmet; Cetin, Bayram

2007-01-01

This study investigated the validity and reliability of the Turkish version of the Depression Anxiety Stress Scale (DASS). The sample of the study consisted of 590 university students, 121 English teachers and 136 emotionally disturbed individuals who sought treatment in various clinics and counseling centers. Factor loadings of the scale ranged…

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

Clinical validation of a public health policy-making platform for hearing loss (EVOTION): protocol for a big data study.

Science.gov (United States)

Dritsakis, Giorgos; Kikidis, Dimitris; Koloutsou, Nina; Murdin, Louisa; Bibas, Athanasios; Ploumidou, Katherine; Laplante-Lévesque, Ariane; Pontoppidan, Niels Henrik; Bamiou, Doris-Eva

2018-02-15

The holistic management of hearing loss (HL) requires an understanding of factors that predict hearing aid (HA) use and benefit beyond the acoustics of listening environments. Although several predictors have been identified, no study has explored the role of audiological, cognitive, behavioural and physiological data nor has any study collected real-time HA data. This study will collect 'big data', including retrospective HA logging data, prospective clinical data and real-time data via smart HAs, a mobile application and biosensors. The main objective is to enable the validation of the EVOTION platform as a public health policy-making tool for HL. This will be a big data international multicentre study consisting of retrospective and prospective data collection. Existing data from approximately 35 000 HA users will be extracted from clinical repositories in the UK and Denmark. For the prospective data collection, 1260 HA candidates will be recruited across four clinics in the UK and Greece. Participants will complete a battery of audiological and other assessments (measures of patient-reported HA benefit, mood, cognition, quality of life). Patients will be offered smart HAs and a mobile phone application and a subset will also be given wearable biosensors, to enable the collection of dynamic real-life HA usage data. Big data analytics will be used to detect correlations between contextualised HA usage and effectiveness, and different factors and comorbidities affecting HL, with a view to informing public health decision-making. Ethical approval was received from the London South East Research Ethics Committee (17/LO/0789), the Hippokrateion Hospital Ethics Committee (1847) and the Athens Medical Center's Ethics Committee (KM140670). Results will be disseminated through national and international events in Greece and the UK, scientific journals, newsletters, magazines and social media. Target audiences include HA users, clinicians, policy-makers and the

Validity and Reliability Study of Bahasa Malaysia Version of Voice Handicap Index-10.

Science.gov (United States)

Ong, Fei Ming; Husna Nik Hassan, Nik Fariza; Azman, Mawaddah; Sani, Abdullah; Mat Baki, Marina

2018-05-21

This study aimed to determine the validity and reliability of Bahasa Malaysia version of Voice Handicap Index-10 (mVHI-10). This cross-sectional study was carried out in the Otorhinolaryngology, Head and Neck Surgery Department of Universiti Kebangsaan Malaysia Medical Centre (UKMMC) from June 2015 to May 2016. The mVHI-10 was produced following a rigorous forward and backward translation. One hundred participants, including 50 healthy volunteers (17 male, 33 female) and 50 patients with voice disorders (26 male, 24 female), were recruited to complete the mVHI-10 before flexible laryngoscopic examinations and acoustic analysis. The mVHI-10 was repeated in 2 weeks via telephone interview or clinic visit. Its reliability and validity were assessed using interclass correlation. The test-retest reliability for total mVHI-10 and each item score was high, with the Cronbach alpha of >0.90. The total mVHI-10 score and domain scores were significantly higher (P Kaiser-Meyer-Olkin measure was 0.92, which depicted excellent construct validity. There was a significant positive correlation between the mVHI-10 score and jitter and shimmer result (P < 0.001). The present study showed good reliability and validity of the mVHI-10 when applied to both healthy volunteers and patients with voice disorders. We recommend the use of the mVHI-10 in daily clinical practice among Bahasa Malaysia-speaking population. Copyright © 2018 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

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.

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

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

Factorial Validity of the Toronto Alexithymia Scale (TAS-20) in Clinical Samples: A Critical Examination of the Literature and a Psychometric Study in Anorexia Nervosa.

Science.gov (United States)

Torres, Sandra; Guerra, Marina P; Miller, Kylee; Costa, Patrício; Cruz, Inês; Vieira, Filipa M; Brandão, Isabel; Roma-Torres, António; Rocha, Magda

2018-03-30

There is extensive use of the 20-item Toronto Alexithymia Scale (TAS-20) in research and clinical practice in anorexia nervosa (AN), though it is not empirically established in this population. This study aims to examine the factorial validity of the TAS-20 in a Portuguese AN sample (N = 125), testing four different models (ranging from 1 to 4 factors) that were identified in critical examination of existing factor analytic studies. Results of confirmatory factor analysis (CFA) suggested that the three-factor solution, measuring difficulty identifying (DIF) and describing feelings (DDF), and externally oriented thinking (EOT), was the best fitting model. The quality of measurement improves if two EOT items (16 and 18) are eliminated. Internal consistency of EOT was low and decreased with age. The results provide support for the factorial validity of the TAS-20 in AN. Nevertheless, the measurement of EOT requires some caution and may be problematic in AN adolescents.

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

External Validation Study of First Trimester Obstetric Prediction Models (Expect Study I): Research Protocol and Population Characteristics.

Science.gov (United States)

Meertens, Linda Jacqueline Elisabeth; Scheepers, Hubertina Cj; De Vries, Raymond G; Dirksen, Carmen D; Korstjens, Irene; Mulder, Antonius Lm; Nieuwenhuijze, Marianne J; Nijhuis, Jan G; Spaanderman, Marc Ea; Smits, Luc Jm

2017-10-26

A number of first-trimester prediction models addressing important obstetric outcomes have been published. However, most models have not been externally validated. External validation is essential before implementing a prediction model in clinical practice. The objective of this paper is to describe the design of a study to externally validate existing first trimester obstetric prediction models, based upon maternal characteristics and standard measurements (eg, blood pressure), for the risk of pre-eclampsia (PE), gestational diabetes mellitus (GDM), spontaneous preterm birth (PTB), small-for-gestational-age (SGA) infants, and large-for-gestational-age (LGA) infants among Dutch pregnant women (Expect Study I). The results of a pilot study on the feasibility and acceptability of the recruitment process and the comprehensibility of the Pregnancy Questionnaire 1 are also reported. A multicenter prospective cohort study was performed in The Netherlands between July 1, 2013 and December 31, 2015. First trimester obstetric prediction models were systematically selected from the literature. Predictor variables were measured by the Web-based Pregnancy Questionnaire 1 and pregnancy outcomes were established using the Postpartum Questionnaire 1 and medical records. Information about maternal health-related quality of life, costs, and satisfaction with Dutch obstetric care was collected from a subsample of women. A pilot study was carried out before the official start of inclusion. External validity of the models will be evaluated by assessing discrimination and calibration. Based on the pilot study, minor improvements were made to the recruitment process and online Pregnancy Questionnaire 1. The validation cohort consists of 2614 women. Data analysis of the external validation study is in progress. This study will offer insight into the generalizability of existing, non-invasive first trimester prediction models for various obstetric outcomes in a Dutch obstetric population

Virtual faces expressing emotions: an initial concomitant and construct validity study.

Science.gov (United States)

Joyal, Christian C; Jacob, Laurence; Cigna, Marie-Hélène; Guay, Jean-Pierre; Renaud, Patrice

2014-01-01

Facial expressions of emotions represent classic stimuli for the study of social cognition. Developing virtual dynamic facial expressions of emotions, however, would open-up possibilities, both for fundamental and clinical research. For instance, virtual faces allow real-time Human-Computer retroactions between physiological measures and the virtual agent. The goal of this study was to initially assess concomitants and construct validity of a newly developed set of virtual faces expressing six fundamental emotions (happiness, surprise, anger, sadness, fear, and disgust). Recognition rates, facial electromyography (zygomatic major and corrugator supercilii muscles), and regional gaze fixation latencies (eyes and mouth regions) were compared in 41 adult volunteers (20 ♂, 21 ♀) during the presentation of video clips depicting real vs. virtual adults expressing emotions. Emotions expressed by each set of stimuli were similarly recognized, both by men and women. Accordingly, both sets of stimuli elicited similar activation of facial muscles and similar ocular fixation times in eye regions from man and woman participants. Further validation studies can be performed with these virtual faces among clinical populations known to present social cognition difficulties. Brain-Computer Interface studies with feedback-feedforward interactions based on facial emotion expressions can also be conducted with these stimuli.

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.

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.

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.

Food Frequency Questionnaire to Determine the Intake of Vitamin C: A Pilot Validation Study

Directory of Open Access Journals (Sweden)

Santosh Holenarasipur Nagesh

2017-06-01

Full Text Available Background and Aims: The aim of this study was to validate a food frequency questionnaire (FFQ specific to diabetic population wherein the frequency of intake of vitamin C would be examined. Material and Methods: The study is registered with Clinical Trial Registry of India (CTRI with CTRI number CTRI/2016/03/006764. The FFQ was validated against intakes derived from a 24 Hour Dietary Recall (24 DR. 50 subjects were chosen and a FFQ with 24-hour dietary recall was done. The FFQ had a list of commonly used food items. The vitamin C yield from each food item was precalculated. Result and conclusion: Strong correlations between the FFQ and 24 dietary recall were observed for all vitamin C containing food list (Pearson Correlation Coefficient r = 0.997. The p value was significant between the FFQ and 24Hour dietary recall (p = 0.028. Cross classification analysis showed uniform classification of the respondents and there was no misclassification into quartiles. This pilot study showed promising validation evidence for the use of this FFQ, which focuses vitamin C intake in patients with type 2 Diabetes Mellitus, as a screening tool in clinical and research settings.

Can relaxation interventions reduce anxiety in patients receiving radiotherapy? outcomes and study validity

International Nuclear Information System (INIS)

Elith, C.A.; Perkins, B.A.; Johnson, L.S.; Skelly, M.H.; Dempsey, S.

2001-01-01

This study piloted the use of three relaxation interventions in an attempt to reduce levels of anxiety in patients who are immobilised for radiotherapy treatment of head and neck cancers, as well as trying to validate the study methodology. In addition to receiving normal radiation therapy treatment, 14 patients were assigned to either a control group not receiving the relaxation intervention or one of three validated relaxation intervention techniques; music therapy, aromatherapy or guided imagery. Patients in the intervention groups underwent the relaxation technique daily for the first seven days of treatment. On days 1, 3, 5 and 7 of treatment patients were required to complete the State Anxiety Inventory survey. While caution should be taken in accepting the results due to the small numbers of patients involved in the study and the non-randomised assignment of patients within the study, the results of the study demonstrate a clinically significant reduction in anxiety levels in each of the three relaxation interventions compared to the control group. The study demonstrated good study validity due to the ease of implementation, the unambiguous results generated, and the use of already validated anxiety intersections and measurement tools. Copyright (2001) Australian Institute of Radiography

RhinAsthma patient perspective: A Rasch validation study.

Science.gov (United States)

Molinengo, Giorgia; Baiardini, Ilaria; Braido, Fulvio; Loera, Barbara

2018-02-01

In daily practice, Health-Related Quality of Life (HRQoL) tools are useful for supplementing clinical data with the patient's perspective. To encourage their use by clinicians, the availability of tools that can quickly provide valid results is crucial. A new HRQoL tool has been proposed for patients with asthma and rhinitis: the RhinAsthma Patient Perspective-RAPP. The aim of this study was to evaluate the psychometric robustness of the RAPP using the Item Response Theory (IRT) approach, to evaluate the scalability of items and test whether or not patients use the items response scale correctly. 155 patients (53.5% women, mean age 39.1, range 16-76) were recruited during a multicenter study. RAPP metric properties were investigated using IRT models. Differential item functioning (DIF) was used for gender, age, and asthma control test (ACT). The RAPP adequately fitted the Rating Scale model, demonstrating the equality of the rating scale structure for all items. All statistics on items were satisfactory. The RAPP had adequate internal reliability and showed good ability to discriminate among different groups of participants. DIF analysis indicated that there were no differential item functioning issues for gender. One item showed a DIF by age and four items by ACT. The psychometric evaluation performed using IRT models demonstrated that the RAPP met all the criteria to be considered a reliable and valid method of measurement. From a clinical perspective, this will allow physicians to confidently interpret scores as good indicators of Quality of Life of patients with asthma.

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.

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

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.

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.

Clinical validity of the estimated energy requirement and the average protein requirement for nutritional status change and wound healing in older patients with pressure ulcers: A multicenter prospective cohort study.

Science.gov (United States)

Iizaka, Shinji; Kaitani, Toshiko; Nakagami, Gojiro; Sugama, Junko; Sanada, Hiromi

2015-11-01

Adequate nutritional intake is essential for pressure ulcer healing. Recently, the estimated energy requirement (30 kcal/kg) and the average protein requirement (0.95 g/kg) necessary to maintain metabolic balance have been reported. The purpose was to evaluate the clinical validity of these requirements in older hospitalized patients with pressure ulcers by assessing nutritional status and wound healing. This multicenter prospective study carried out as a secondary analysis of a clinical trial included 194 patients with pressure ulcers aged ≥65 years from 29 institutions. Nutritional status including anthropometry and biochemical tests, and wound status by a structured severity tool, were evaluated over 3 weeks. Energy and protein intake were determined from medical records on a typical day and dichotomized by meeting the estimated average requirement. Longitudinal data were analyzed with a multivariate mixed-effects model. Meeting the energy requirement was associated with changes in weight (P clinically validated for prevention of nutritional decline and of impaired healing of deep pressure ulcers. © 2014 Japan Geriatrics Society.

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.

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.

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

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

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

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.

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

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.

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...

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

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

PRELIMINARY CLINICAL STUDY OF KALANCHOE SPATHULATA DC. ON INFLAMMATORY WOUND

Science.gov (United States)

Yadav, C. L.; Yadav, C. S.

1985-01-01

Here, an attempt is made to study the clinical aspect of Kalanchoe spathulata Dc. It has been observed that would heals rapidly leaving no scar. The study clearly validates the ancient concept of Ayurveda, that without taking the help of surgery, there are several medicinal plants which may cure diseases very well. PMID:22557495

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.

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…

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.

A study on construction, validation and determination of normalization of adolescents depression scale

Directory of Open Access Journals (Sweden)

Khadijeh Babakhani

2014-01-01

Full Text Available This paper presents an empirical investigation to construct, to validate and to determine normalization factors associated with adolescents depression scale. The study is performed among 750 randomly selected guided and high school students, 364 male and 386 female, who live in city of Zanjan, Iran. Validity of Beck Depression Inventory (BDI, Validity of Simpson-Angus Scale (SAS and divergence validity of the Coopersmith self- esteem coefficients are 0.72, 0.37 and -0.71, respectively. Result suggests that adolescents’ depression test is a reliable and valid tool for assessing depression, with utility in both research and clinical settings, counseling centers. In addition, the results of correlation test indicate there are some meaningful differences between depression levels of female and male students. In fact, our survey indicates that female students have more depression than male students do (F-value = 33.06, Sig. = 0.000. In addition, there are some meaningful differences between depression levels in various educational levels (F-value = 8.59, Sig. = 0.000. However, the study does not find sufficient evidence to believe there is any meaningful correlation between educational backgrounds and gender.

Virtual facial expressions of emotions: An initial concomitant and construct validity study.

Directory of Open Access Journals (Sweden)

Christian eJoyal

2014-09-01

Full Text Available Abstract. Background. Facial expressions of emotions represent classic stimuli for the study of social cognition. Developing virtual dynamic facial expressions of emotions, however, would open-up possibilities, both for fundamental and clinical research. For instance, virtual faces allow real-time Human-Computer retroactions between physiological measures and the virtual agent. Objectives. The goal of this study was to initially assess concomitant and construct validity of a newly developed set of virtual faces expressing 6 fundamental emotions (happiness, surprise, anger, sadness, fear, or disgust. Recognition rates, facial electromyography (zygomatic major and corrugator supercilii muscles, and regional gaze fixation latencies (eyes and mouth regions were compared in 41 adult volunteers (20 ♂, 21 ♀ during the presentation of video clips depicting real vs. virtual adults expressing emotions. Results. Emotions expressed by each sets of stimuli were similarly recognized, both by men and women. Accordingly, both sets of stimuli elicited similar activation of facial muscles and similar ocular fixation times in eye regions from man and woman participants. Conclusion. Further validation studies can be performed with these virtual faces among clinical populations known to present social cognition difficulties. Brain-Computer Interface studies with feedback-feed forward interactions based on facial emotion expressions can also be conducted with these stimuli.

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.

[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.

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

Science.gov (United States)

Badran, Hani; Pluye, Pierre; Grad, Roland

2017-03-14

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

The Arabic Version of the Mayo-Portland Adaptability Inventory 4: A Validation Study

Science.gov (United States)

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

2012-01-01

The Mayo-Portland Adaptability Inventory 4 (MPAI-4) is a valid and reliable assessment tool to detect clinical impairments in patients with acquired brain injury. The tool is widely used by rehabilitation therapists worldwide, given its good psychometric properties and its availability in several languages. The purpose of this study was to…

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.

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.

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

NVN 5694 intra laboratory validation. Feasibility study for interlaboratory- validation

International Nuclear Information System (INIS)

Voors, P.I.; Baard, J.H.

1998-11-01

Within the project NORMSTAR 2 a number of Dutch prenormative protocols have been defined for radioactivity measurements. Some of these protocols, e.g. the Dutch prenormative protocol NVN 5694, titled Methods for radiochemical determination of polonium-210 and lead-210, have not been validated, neither by intralaboratory nor interlaboratory studies. Validation studies are conducted within the framework of the programme 'Normalisatie and Validatie van Milieumethoden 1993-1997' (Standardization and Validation of test methods for environmental parameters) of the Dutch Ministry of Housing, Physical Planning and the Environment (VROM). The aims of this study were (a) a critical evaluation of the protocol, (b) investigation on the feasibility of an interlaboratory study, and (c) the interlaboratory validation of NVN 5694. The evaluation of the protocol resulted in a list of deficiencies varying from missing references to incorrect formulae. From the survey by interview it appeared that for each type of material, there are 4 to 7 laboratories willing to participate in a interlaboratory validation study. This reflects the situation in 1997. Consequently, if 4 or 6 (the minimal number) laboratories are participating and each laboratory analyses 3 subsamples, the uncertainty in the repeatability standard deviation is 49 or 40 %, respectively. If the ratio of reproducibility standard deviation to the repeatability standard deviation is equal to 1 or 2, then the uncertainty in the reproducibility standard deviation increases from 42 to 67 % and from 34 to 52 % for 4 or 6 laboratories, respectively. The intralaboratory validation was established on four different types of materials. Three types of materials (milkpowder condensate and filter) were prepared in the laboratory using the raw material and certified Pb-210 solutions, and one (sediment) was obtained from the IAEA. The ECN-prepared reference materials were used after testing on homogeneity. The pre-normative protocol can

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

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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.

Large-scale identification of clinical and genetic predictors of motor progression in patients with newly diagnosed Parkinson's disease: a longitudinal cohort study and validation.

Science.gov (United States)

Latourelle, Jeanne C; Beste, Michael T; Hadzi, Tiffany C; Miller, Robert E; Oppenheim, Jacob N; Valko, Matthew P; Wuest, Diane M; Church, Bruce W; Khalil, Iya G; Hayete, Boris; Venuto, Charles S

2017-11-01

Better understanding and prediction of progression of Parkinson's disease could improve disease management and clinical trial design. We aimed to use longitudinal clinical, molecular, and genetic data to develop predictive models, compare potential biomarkers, and identify novel predictors for motor progression in Parkinson's disease. We also sought to assess the use of these models in the design of treatment trials in Parkinson's disease. A Bayesian multivariate predictive inference platform was applied to data from the Parkinson's Progression Markers Initiative (PPMI) study (NCT01141023). We used genetic data and baseline molecular and clinical variables from patients with Parkinson's disease and healthy controls to construct an ensemble of models to predict the annual rate of change in combined scores from the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) parts II and III. We tested our overall explanatory power, as assessed by the coefficient of determination (R 2 ), and replicated novel findings in an independent clinical cohort from the Longitudinal and Biomarker Study in Parkinson's disease (LABS-PD; NCT00605163). The potential utility of these models for clinical trial design was quantified by comparing simulated randomised placebo-controlled trials within the out-of-sample LABS-PD cohort. 117 healthy controls and 312 patients with Parkinson's disease from the PPMI study were available for analysis, and 317 patients with Parkinson's disease from LABS-PD were available for validation. Our model ensemble showed strong performance within the PPMI cohort (five-fold cross-validated R 2 41%, 95% CI 35-47) and significant-albeit reduced-performance in the LABS-PD cohort (R 2 9%, 95% CI 4-16). Individual predictive features identified from PPMI data were confirmed in the LABS-PD cohort. These included significant replication of higher baseline MDS-UPDRS motor score, male sex, and increased age, as well as a novel Parkinson's disease

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

Science.gov (United States)

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

2015-01-01

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

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.

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.

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)

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.

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.

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

Science.gov (United States)

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

2017-05-01

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

Recommendations for the definition of clinical responder in insulin preservation studies.

Science.gov (United States)

Beam, Craig A; Gitelman, Stephen E; Palmer, Jerry P

2014-09-01

Clinical responder studies should contribute to the translation of effective treatments and interventions to the clinic. Since ultimately this translation will involve regulatory approval, we recommend that clinical trials prespecify a responder definition that can be assessed against the requirements and suggestions of regulatory agencies. In this article, we propose a clinical responder definition to specifically assist researchers and regulatory agencies in interpreting the clinical importance of statistically significant findings for studies of interventions intended to preserve β-cell function in newly diagnosed type 1 diabetes. We focus on studies of 6-month β-cell preservation in type 1 diabetes as measured by 2-h-stimulated C-peptide. We introduce criteria (bias, reliability, and external validity) for the assessment of responder definitions to ensure they meet U.S. Food and Drug Administration and European Medicines Agency guidelines. Using data from several published TrialNet studies, we evaluate our definition (no decrease in C-peptide) against published alternatives and determine that our definition has minimum bias with external validity. We observe that reliability could be improved by using changes in C-peptide later than 6 months beyond baseline. In sum, to support efficacy claims of β-cell preservation therapies in type 1 diabetes submitted to U.S. and European regulatory agencies, we recommend use of our definition. © 2014 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

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....

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.

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

NARCIS (Netherlands)

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

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

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

NARCIS (Netherlands)

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

2000-01-01

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

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

Reasoning with Inductive Argument Test: A Study of Validity and Reliability

Directory of Open Access Journals (Sweden)

Mehmet Emrah Karadere

2013-11-01

Full Text Available Reasoning with Inductive Argument Test:A Study of Validity and Reliability Objective: The aim of our study is to research reliability and validity and to evaluate the usability of Turkish version of Reasoning with Inductive Argument Test (RIAT in Turkish healty population. Method: 51 healty volunteers who work in Ankara Dıskapi Yildirim Beyazit Research and Training Hospital participated in this study. Reasoning with Inductive Argument Test (RIAT was translated into Turkish by three clinical good knowledge of English. Participants were given a sociodemographic data form, and RIAT were performed by clinicians. To test the reliability of the Turkish version of RIAT, Cronbach’s alpha coefficient was calculated and the halving method was used for the test. Results: The internal consistency of the Reasoning with Inductive Argument Test (RIAT items, Cronbach’s alpha internal consistency coefficient measurements of 0.73 was found to be statistically significant. Spearman-Brown coefficient that determines the reliability of the whole test r=0.74 was found. Kurtosis values of all the items was below 1.5 and the percentages in the second evaluation were mainly lower. At the same time, both change in belief between self produced RIAT options and given RIAT options (p=0.02, z=-2296 as well as changes in beliefs between related and unrelated items for Obsessive Compulsive Disorder (OCD difference (p=0.03, z=-2.199 were significant. Conclusion: The preliminary data obtained from the study of reliability and validity of the scale shows that ‘Reasoning with Inductive Argument Test’ supports reliability and validity in Turkish population.

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.

Inter-observer reliability assessments in time motion studies: the foundation for meaningful clinical workflow analysis.

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Lopetegui, Marcelo A; Bai, Shasha; Yen, Po-Yin; Lai, Albert; Embi, Peter; Payne, Philip R O

2013-01-01

Understanding clinical workflow is critical for researchers and healthcare decision makers. Current workflow studies tend to oversimplify and underrepresent the complexity of clinical workflow. Continuous observation time motion studies (TMS) could enhance clinical workflow studies by providing rich quantitative data required for in-depth workflow analyses. However, methodological inconsistencies have been reported in continuous observation TMS, potentially reducing the validity of TMS' data and limiting their contribution to the general state of knowledge. We believe that a cornerstone in standardizing TMS is to ensure the reliability of the human observers. In this manuscript we review the approaches for inter-observer reliability assessment (IORA) in a representative sample of TMS focusing on clinical workflow. We found that IORA is an uncommon practice, inconsistently reported, and often uses methods that provide partial and overestimated measures of agreement. Since a comprehensive approach to IORA is yet to be proposed and validated, we provide initial recommendations for IORA reporting in continuous observation TMS.

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

Science.gov (United States)

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

2008-01-01

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

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.

Italian version of Dyspnoea-12: cultural-linguistic validation, quantitative and qualitative content validity study.

Science.gov (United States)

Caruso, Rosario; Arrigoni, Cristina; Groppelli, Katia; Magon, Arianna; Dellafiore, Federica; Pittella, Francesco; Grugnetti, Anna Maria; Chessa, Massimo; Yorke, Janelle

2018-01-16

Dyspnoea-12 is a valid and reliable scale to assess dyspneic symptom, considering its severity, physical and emotional components. However, it is not available in Italian version due to it was not yet translated and validated. For this reason, the aim of this study was to develop an Italian version Dyspnoea-12, providing a cultural and linguistic validation, supported by the quantitative and qualitative content validity. This was a methodological study, divided into two phases: phase one is related to the cultural and linguistic validation, phase two is related to test the quantitative and qualitative content validity. Linguistic validation followed a standardized translation process. Quantitative content validity was assessed computing content validity ratio (CVR) and index (I-CVIs and S-CVI) from expert panellists response. Qualitative content validity was assessed by the narrative analysis on the answers of three open-ended questions to the expert panellists, aimed to investigate the clarity and the pertinence of the Italian items. The translation process found a good agreement in considering clear the items in both the six involved bilingual expert translators and among the ten voluntary involved patients. CVR, I-CVIs and S-CVI were satisfactory for all the translated items. This study has represented a pivotal step to use Dyspnoea-12 amongst Italian patients. Future researches are needed to deeply investigate the Italian version of  Dyspnoea-12 construct validity and its reliability, and to describe how dyspnoea components (i.e. physical and emotional) impact the life of patients with cardiorespiratory diseases.

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

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

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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.

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

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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

Validation of dengue infection severity score

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Pongpan S

2014-03-01

clinical practice should be a topic for further study. Keywords: dengue hemorrhagic fever, dengue shock syndrome, validation, clinical prediction rule

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

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

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.

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

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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.

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

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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.

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

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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.

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

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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.

The validity of the variable "NICU admission" as an outcome measure for neonatal morbidity: a retrospective study

NARCIS (Netherlands)

Wiegerinck, Melanie M. J.; Danhof, Nora A.; van Kaam, Anton H.; Tamminga, Pieter; Mol, Ben Willem J.

2014-01-01

To determine whether "neonatal intensive care unit (NICU) admission" is a valid surrogate outcome measure to assess neonatal condition in clinical studies. Retrospective study. Tertiary hospital in the Netherlands. Neonates admitted to NICU during a 10-year period. Inclusion was restricted to

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

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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.

Predictive validity of the Biomedical Admissions Test: an evaluation and case study.

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McManus, I C; Ferguson, Eamonn; Wakeford, Richard; Powis, David; James, David

2011-01-01

There has been an increase in the use of pre-admission selection tests for medicine. Such tests need to show good psychometric properties. Here, we use a paper by Emery and Bell [2009. The predictive validity of the Biomedical Admissions Test for pre-clinical examination performance. Med Educ 43:557-564] as a case study to evaluate and comment on the reporting of psychometric data in the field of medical student selection (and the comments apply to many papers in the field). We highlight pitfalls when reliability data are not presented, how simple zero-order associations can lead to inaccurate conclusions about the predictive validity of a test, and how biases need to be explored and reported. We show with BMAT that it is the knowledge part of the test which does all the predictive work. We show that without evidence of incremental validity it is difficult to assess the value of any selection tests for medicine.

Time to Angiographic Reperfusion and Clinical Outcome after Acute Ischemic Stroke in the Interventional Management of Stroke Phase III (IMS III) Trial: A Validation Study

Science.gov (United States)

Khatri, Pooja; Yeatts, Sharon D.; Mazighi, Mikael; Broderick, Joseph P.; Liebeskind, David S.; Demchuk, Andrew M.; Amarenco, Pierre; Carrozzella, Janice; Spilker, Judith; Foster, Lydia D.; Goyal, Mayank; Hill, Michael D.; Palesch, Yuko Y.; Jauch, Edward C.; Haley, E. Clarke; Vagal, Achala; Tomsick, Thomas A.

2014-01-01

BACKGROUND The IMS III Trial did not demonstrate clinical benefit of the endovascular approach compared to IV rt-PA alone for moderate or severe ischemic strokes (NIHSS≥8) enrolled within three hours of stroke onset. Late reperfusion of tissue that is no longer salvageable may be one explanation, as suggested by prior exploratory studies showing an association between time to reperfusion and good clinical outcome. We sought to validate this relationship in the large-scale IMS III trial, and consider its implications for future endovascular trials. METHODS The analysis consisted of the endovascular cohort with proximal arterial occlusions in the anterior circulation that achieved angiographic reperfusion (TICI 2–3) during the endovascular procedure (within 7 hours from the onset of symptoms). Logistic regression was used to model good clinical outcome (90-day modified Rankin 0–2) as a function of the time to reperfusion, and prespecified variables were considered for adjustment. FINDINGS Among 240 proximal vessel occlusions, angiographic reperfusion (TICI 2–3) was achieved in 182 (76%). Mean time to reperfusion was 325 minutes (range 180–418 minutes). Longer time for reperfusion was associated with a decreased likelihood of good clinical outcome (RR [95% CI] for every 30 minute delay: unadjusted 0·85 [0·77–0·94]; adjusted 0·88 [0·80–0·98]). INTERPRETATION We confirm that delay in time to angiographic reperfusion leads to a decreased likelihood of good clinical outcome. Achieving rapid reperfusion may be critical for the successes of future acute endovascular trials. FUNDING: NIH/NINDS (study sponsor), Genentech Inc. (study drug - intra-arterial t-PA), EKOS Corp. (device), Concentric Inc. (device), Cordis Neurovascular, Inc. (device), and Boehringer Ingelheim (European Investigator Meeting support). PMID:24784550

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.

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.

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

OpenAIRE

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

2009-01-01

Abstract Background The Brief Fear of Negative Evaluation Scale (BFNE) is a commonly used instrument to measure social anxiety. This study aimed to translate and to test the reliability and validity of the BFNE in Iran. Methods The English language version of the BFNE was translated into Persian (Iranian language) and was used in this study. The questionnaire was administered to a consecutive sample of 235 students with (n = 33, clinical group) and without social phobia (n = 202, non-clinical...

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.

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.

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.

Validation of liquid biopsy: plasma cell-free DNA testing in clinical management of advanced non-small cell lung cancer

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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

The Richmond Agitation-Sedation Scale modified for palliative care inpatients (RASS-PAL): a pilot study exploring validity and feasibility in clinical practice

OpenAIRE

Bush, Shirley H; Grassau, Pamela A; Yarmo, Michelle N; Zhang, Tinghua; Zinkie, Samantha J; Pereira, José L

2014-01-01

Background The Richmond Agitation-Sedation Scale (RASS), which assesses level of sedation and agitation, is a simple observational instrument which was developed and validated for the intensive care setting. Although used and recommended in palliative care settings, further validation is required in this patient population. The aim of this study was to explore the validity and feasibility of a version of the RASS modified for palliative care populations (RASS-PAL). Methods A prospective study...

A Selected Reaction Monitoring Mass Spectrometry Protocol for Validation of Proteomic Biomarker Candidates in Studies of Psychiatric Disorders.

Science.gov (United States)

Reis-de-Oliveira, Guilherme; Garcia, Sheila; Guest, Paul C; Cassoli, Juliana S; Martins-de-Souza, Daniel

2017-01-01

Most biomarker candidates arising from proteomic studies of psychiatric disorders have not progressed for use in clinical studies due to insufficient validation steps. Here we describe a selective reaction monitoring mass spectrometry (SRM-MS) approach that could be used as a follow-up validation tool of proteins identified in blood serum or plasma. This protocol specifically covers the stages of peptide selection and optimization. The increasing application of SRM-MS should enable fast, sensitive, and robust methods with the potential for use in clinical studies involving sampling of serum or plasma. Understanding the molecular mechanisms and identifying potential biomarkers for risk assessment, diagnosis, prognosis, and prediction of drug response goes toward the implementation of translational medicine strategies for improved treatment of patients with psychiatric disorders and other debilitating diseases.

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

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.

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...

[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.

[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.

Screening for cognitive impairment in older individuals. Validation study of a computer-based test.

Science.gov (United States)

Green, R C; Green, J; Harrison, J M; Kutner, M H

1994-08-01

This study examined the validity of a computer-based cognitive test that was recently designed to screen the elderly for cognitive impairment. Criterion-related validity was examined by comparing test scores of impaired patients and normal control subjects. Construct-related validity was computed through correlations between computer-based subtests and related conventional neuropsychological subtests. University center for memory disorders. Fifty-two patients with mild cognitive impairment by strict clinical criteria and 50 unimpaired, age- and education-matched control subjects. Control subjects were rigorously screened by neurological, neuropsychological, imaging, and electrophysiological criteria to identify and exclude individuals with occult abnormalities. Using a cut-off total score of 126, this computer-based instrument had a sensitivity of 0.83 and a specificity of 0.96. Using a prevalence estimate of 10%, predictive values, positive and negative, were 0.70 and 0.96, respectively. Computer-based subtests correlated significantly with conventional neuropsychological tests measuring similar cognitive domains. Thirteen (17.8%) of 73 volunteers with normal medical histories were excluded from the control group, with unsuspected abnormalities on standard neuropsychological tests, electroencephalograms, or magnetic resonance imaging scans. Computer-based testing is a valid screening methodology for the detection of mild cognitive impairment in the elderly, although this particular test has important limitations. Broader applications of computer-based testing will require extensive population-based validation. Future studies should recognize that normal control subjects without a history of disease who are typically used in validation studies may have a high incidence of unsuspected abnormalities on neurodiagnostic studies.

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...

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.)

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.)

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

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

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

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)

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.

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).

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

Science.gov (United States)

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

2014-01-01

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

Reliability and validity study of the Gujarati version of the Oswestry Disability Index 2.1a.

Science.gov (United States)

Shah, Sweni; Balaganapathy, M

2017-09-22

Among all musculoskeletal disorders back pain is the most common reason for functional limitation in working age. It is due to low back pain (LBP) that the ODI has become one of the principal outcome measures for evaluation of disability and has been widely used in research as well as in clinical practice. So far, validated Gujarati version of the ODI 2.1a has not been reported. To accomplish the translation and validation of the Oswestry Disability Index (ODI) version 2.1a into the Gujarati language. Cross-sectional study. The validation of the ODI-Gujarati was tested in 120 patients diagnosed with non-specific LBP, who were receiving physiotherapy at a clinic in Gujarat, India. Data was collected at on initial visit and after 48 hours. During both visits, patients completed the Oswestry Disability Index-Gujarati (ODI-G), Roland-Morris Disability Questionnaire-Gujarati (RMDQ-G), and Visual Analogue Scale-Pain (VAS-P). Internal consistency was measured by Cronbach's alpha. The Gujarati version indicated high internal consistency (α= 0.96). Test-retest reliability was measured by intra-class correlation coefficient and it revealed very high correlation (ICC = 0.92). Construct validity was confirmed by strong correlation with RMDQ-G (r= 0.76), and concurrent validity indicated moderate correlation with VAS-P (r= 0.50). Factor analysis explained that the ODI was loaded on 1 factor. The Oswestry disability index version 2.1a was successfully translated into Gujarati language, showing excellent psychometric properties. Therefore, it can be used in evaluating the disability amongst Gujarati population with LBP for both clinical and research purposes.

Legitimating Clinical Research in the Study of Organizational Culture.

Science.gov (United States)

Schein, Edgar H.

1993-01-01

Argues that traditional research model used in industrial-organizational psychology is not useful in understanding deeper dynamics of organizations, especially those phenomena labeled as "cultural." Contends that use of data obtained during clinical and consulting work should be legitimated as valid research data. Spells out clinical model and…

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…

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

Development and validation of a liquid chromatography-tandem mass spectrometry method for the simultaneous quantification of tamoxifen, anastrozole, and letrozole in human plasma and its application to a clinical study.

Science.gov (United States)

Beer, Beate; Schubert, Birthe; Oberguggenberger, Anne; Meraner, Verena; Hubalek, Michael; Oberacher, Herbert

2010-10-01

There is substantial evidence that circulating estrogens promote the proliferation of breast cancer. Consequently, adjuvant hormonal treatment strategies targeting estrogen action have been established. Such hormonal therapies include selective estrogen receptor modulators, such as tamoxifen, which interfere at the estrogen receptors directly, or non-steroidal aromatase inhibitors, such as anastrozole and letrozole, which inhibit estrogen synthesis through blocking the aromatase, a key enzyme of estrogen production. Despite considerable therapeutic success, in several cases, the use of these drugs is limited by side effects that have been described to significantly impair the adherence of patients to endocrine treatment. However, objective data concerning patient adherence and its clinical relevance are limited. One promising approach to check patient-reported adherence is drug monitoring in human plasma. Therefore, a liquid chromatography-tandem mass spectrometry method to determine the plasma concentrations of tamoxifen, anastrozole, and letrozole has been developed and fully validated according to guidelines for clinical and forensic toxicology. The validation criteria evaluated were selectivity, linearity, accuracy and precision, limit of quantification, recovery and matrix effects, sample stability, and carryover. The six-point calibration curves showed linearity over the range of concentrations from 25 to 500 ng/ml for tamoxifen, 5 to 200 ng/ml for anastrozole, and 10 to 300 ng/ml for letrozole. The intra- and inter-day precision and accuracies were always better than 15%. The validated procedure was successfully applied to a clinical study (Patient-Reported Outcomes in Breast Cancer Patients undergoing Endocrine Therapy, PRO-BETh). A major aim of PRO-BETh study is the comprehensive evaluation of adherence to treatment in pre- and post-menopausal women with breast cancer. Plasma samples of 310 breast cancer patients undergoing anti-estrogen therapy were

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.

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...

Portuguese Version of the Pain Beliefs and Perceptions Inventory: A Multicenter Validation Study.

Science.gov (United States)

Azevedo, Luís Filipe; Sampaio, Rute; Camila Dias, Cláudia; Romão, José; Lemos, Laurinda; Agualusa, Luís; Vaz-Serra, Sílvia; Patto, Teresa; Costa-Pereira, Altamiro; Castro-Lopes, José Manuel

2017-07-01

We aimed to perform the translation, cultural adaptation, and validation of the Pain Beliefs and Perceptions Inventory (PBPI) for the European Portuguese language and chronic pain population. This is a longitudinal multicenter validation study. A Portuguese version of the PBPI (PBPI-P) was created through a process of translation, back translation, and expert panel evaluation. The PBPI-P was administered to a total of 122 patients from 13 chronic pain clinics in Portugal, at baseline and after 7 days. Internal consistency and test-retest reliability were assessed by Cronbach's alpha (α) and intraclass correlation coefficient (ICC). Construct (convergent and discriminant) validity was assessed based on a set of previously developed theoretical hypotheses about interrelations between the PBPI-P and other measures. Exploratory and confirmatory factor analyses were performed to test the theoretical structure of the PBPI-P. The internal consistency and test-retest reliability coefficients for each respective subscale were α = 0.620 and ICC = 0.801 for mystery; α = 0.744 and ICC = 0.841 for permanence; α = 0.778 and ICC = 0.791 for constancy; and α = 0.764 and ICC = 0.881 for self-blame. Exploratory and confirmatory factor analysis revealed a four-factor structure (performance, constancy, self-blame, and mystery) that explained 63% of the variance. The construct validity of the PBPI-P was shown to be adequate, with more than 90% of the previously defined hypotheses regarding interrelations with other measures confirmed. The PBPI-P has been shown to be adequate and to have excellent reliability, internal consistency, and validity. It may contribute to a better pain assessment and is suitable for research and clinical use. © 2016 World Institute of Pain.

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

Directory of Open Access Journals (Sweden)

Erica Gobbi

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

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

Science.gov (United States)

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

2016-01-01

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

Body Dysmorphic Symptoms Scale for patients seeking esthetic surgery: cross-cultural validation study.

Science.gov (United States)

Ramos, Tatiana Dalpasquale; Brito, Maria José Azevedo de; Piccolo, Mônica Sarto; Rosella, Maria Fernanda Normanha da Silva Martins; Sabino, Miguel; Ferreira, Lydia Masako

2016-01-01

Rhinoplasty is one of the most sought-after esthetic operations among individuals with body dysmorphic disorder. The aim of this study was to cross-culturally adapt and validate the Body Dysmorphic Symptoms Scale. Cross-cultural validation study conducted in a plastic surgery outpatient clinic of a public university hospital. Between February 2014 and March 2015, 80 consecutive patients of both sexes seeking rhinoplasty were selected. Thirty of them participated in the phase of cultural adaptation of the instrument. Reproducibility was tested on 20 patients and construct validity was assessed on 50 patients, with correlation against the Yale-Brown Obsessive Compulsive Scale for Body Dysmorphic Disorder. The Brazilian version of the instrument showed Cronbach's alpha of 0.805 and excellent inter-rater reproducibility (intraclass correlation coefficient, ICC = 0.873; P Dysmorphic Disorder and the Body Dysmorphic Symptoms Scale. The area under the receiver operating characteristic curve was 0.981, thus showing good accuracy for discriminating between presence and absence of symptoms of body dysmorphic disorder. Forty-six percent of the patients had body dysmorphic symptoms and 54% had moderate to severe appearance-related obsessive-compulsive symptoms. The Brazilian version of the Body Dysmorphic Symptoms Scale is a reproducible instrument that presents face, content and construct validity.

Preliminary study to evaluate the validity of the mini-mental state examination in a normal population in Turkey.

Science.gov (United States)

Küçükdeveci, Ayse A; Kutlay, Sehim; Elhan, Atilla H; Tennant, Alan

2005-03-01

Although the Mini-Mental State Examination (MMSE) is widely used in clinical practice, normative scores for a healthy population have not been documented in Turkey. The aim in this study was to validate the MMSE in a healthy population and to provide normal scores. Internal construct validity of the Turkish version of MMSE among a preliminary sample of 406 normal people was assessed by Rasch unidimensional measurement model. Scores of the normal sample varied according to age and education but not according to sex. The data derived from this sample showed poor fit to the Rasch model (mean item fit, -2.082, SD 3.022). Only four of 11 items met model expectations. There was also differential item functioning by education and age for most items. Thus the internal construct validity of the Turkish MMSE in a normative sample could not be demonstrated by Rasch analysis. The scale failed modern psychometric criteria for scalability. We would therefore suggest other large normative MMSE data sets to be tested in terms of internal construct validity. If these findings are replicated, the validity of MMSE norms and their consequent use in clinical practice should be reconsidered.

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

Science.gov (United States)

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

2015-11-01

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

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.

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

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

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.

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

The Rehabilitation Activities Profile: a validation study of its use as a disability index with stroke patients

NARCIS (Netherlands)

van Bennekom, C. A.; Jelles, F.; Lankhorst, G. J.; Bouter, L. M.

1995-01-01

This study evaluates the criterion, content, and construct validity of the Rehabilitation Activities Profile (RAP) in patients with stroke. This instrument is constructed for screening, monitoring, and prognosis purposes to assist clinical rehabilitation. It consists of 21 activities, covering the

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

Science.gov (United States)

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

2015-02-10

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

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

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

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

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.

Clinical relevance of studies on the accuracy of visual inspection for detecting caries lesions

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Gimenez, Thais; Piovesan, Chaiana; Braga, Mariana M

2015-01-01

Although visual inspection is the most commonly used method for caries detection, and consequently the most investigated, studies have not been concerned about the clinical relevance of this procedure. Therefore, we conducted a systematic review in order to perform a critical evaluation considering...... the clinical relevance and methodological quality of studies on the accuracy of visual inspection for assessing caries lesions. Two independent reviewers searched several databases through July 2013 to identify papers/articles published in English. Other sources were checked to identify unpublished literature...... to clinical relevance and the methodological quality of the studies were evaluated. 96 of the 5,578 articles initially identified met the inclusion criteria. In general, most studies failed in considering some clinically relevant aspects: only 1 included study validated activity status of lesions, no study...

Evaluation of criteria for clinical control in a prospective, international, multicenter study of patients with COPD

DEFF Research Database (Denmark)

Miravitlles, Marc; Sliwinski, Pawel; Rhee, Chin Kook

2018-01-01

BACKGROUND: The concept of clinical control in COPD has been developed to help in treatment decisions, but it requires validation in prospective studies. METHOD: This international, multicenter, prospective study aimed to validate the concept of control in COPD [control = stability (no...... exacerbations or impairment in CAT scores) + low impact (low level of symptoms)]. Data from the screening visit was used to: investigate the level of control, compare characteristics of patients according to the control status, and perform a sensitivity analysis of the levels of control using either clinical...... criteria or questionnaires (COPD Assessment Test -CAT- or Clinical COPD Questionnaire -CCQ-). RESULTS: A total of 314 patients were analysed, mean age was 68.5 years and mean FEV1 was 52.6% of predicted. According to the prespecified criteria 21% of patients were classified as controlled, all of them...

A prospective study evaluating cochlear implant management skills: development and validation of the Cochlear Implant Management Skills survey.

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Bennett, R J; Jayakody, D M P; Eikelboom, R H; Taljaard, D S; Atlas, M D

2016-02-01

To investigate the ability of cochlear implant (CI) recipients to physically handle and care for their hearing implant device(s) and to identify factors that may influence skills. To assess device management skills, a clinical survey was developed and validated on a clinical cohort of CI recipients. Survey development and validation. A prospective convenience cohort design study. Specialist hearing implant clinic. Forty-nine post-lingually deafened, adult CI recipients, at least 12 months postoperative. Survey test-retest reliability, interobserver reliability and responsiveness. Correlations between management skills and participant demographic, audiometric, clinical outcomes and device factors. The Cochlear Implant Management Skills survey was developed, demonstrating high test-retest reliability (0.878), interobserver reliability (0.972) and responsiveness to intervention (skills training) [t(20) = -3.913, P = 0.001]. Cochlear Implant Management Skills survey scores range from 54.69% to 100% (mean: 83.45%, sd: 12.47). No associations were found between handling skills and participant factors. This is the first study to demonstrate a range in cochlear implant device handling skills in CI recipients and offers clinicians and researchers a tool to systematically and objectively identify shortcomings in CI recipients' device handling skills. © 2015 John Wiley & Sons Ltd.

Understanding latent structures of clinical information logistics: A bottom-up approach for model building and validating the workflow composite score.

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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

The predictive validity of selection for entry into postgraduate training in general practice: evidence from three longitudinal studies.

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Patterson, Fiona; Lievens, Filip; Kerrin, Máire; Munro, Neil; Irish, Bill

2013-11-01

The selection methodology for UK general practice is designed to accommodate several thousand applicants per year and targets six core attributes identified in a multi-method job-analysis study To evaluate the predictive validity of selection methods for entry into postgraduate training, comprising a clinical problem-solving test, a situational judgement test, and a selection centre. A three-part longitudinal predictive validity study of selection into training for UK general practice. In sample 1, participants were junior doctors applying for training in general practice (n = 6824). In sample 2, participants were GP registrars 1 year into training (n = 196). In sample 3, participants were GP registrars sitting the licensing examination after 3 years, at the end of training (n = 2292). The outcome measures include: assessor ratings of performance in a selection centre comprising job simulation exercises (sample 1); supervisor ratings of trainee job performance 1 year into training (sample 2); and licensing examination results, including an applied knowledge examination and a 12-station clinical skills objective structured clinical examination (OSCE; sample 3). Performance ratings at selection predicted subsequent supervisor ratings of job performance 1 year later. Selection results also significantly predicted performance on both the clinical skills OSCE and applied knowledge examination for licensing at the end of training. In combination, these longitudinal findings provide good evidence of the predictive validity of the selection methods, and are the first reported for entry into postgraduate training. Results show that the best predictor of work performance and training outcomes is a combination of a clinical problem-solving test, a situational judgement test, and a selection centre. Implications for selection methods for all postgraduate specialties are considered.

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

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

2009-01-01

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

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

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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

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

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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.

Clinical validation of a nanodiamond-embedded thermoplastic biomaterial.

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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.

Assessing children’s competence to consent in research by a standardized tool: a validity study

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2012-01-01

Background Currently over 50% of drugs prescribed to children have not been evaluated properly for use in their age group. One key reason why children have been excluded from clinical trials is that they are not considered able to exercise meaningful autonomy over the decision to participate. Dutch law states that competence to consent can be presumed present at the age of 12 and above; however, in pediatric practice children’s competence is not that clearly presented and the transition from assent to active consent is gradual. A gold standard for competence assessment in children does not exist. In this article we describe a study protocol on the development of a standardized tool for assessing competence to consent in research in children and adolescents. Methods/design In this study we modified the MacCAT-CR, the best evaluated competence assessment tool for adults, for use in children and adolescents. We will administer the tool prospectively to a cohort of pediatric patients from 6 to18 years during the selection stages of ongoing clinical trials. The outcomes of the MacCAT-CR interviews will be compared to a reference standard, established by the judgments of clinical investigators, and an expert panel consisting of child psychiatrists, child psychologists and medical ethicists. The reliability, criterion-related validity and reproducibility of the tool will be determined. As MacCAT-CR is a multi-item scale consisting of 13 items, power was justified at 130–190 subjects, providing a minimum of 10–15 observations per item. MacCAT-CR outcomes will be correlated with age, life experience, IQ, ethnicity, socio-economic status and competence judgment of the parent(s). It is anticipated that 160 participants will be recruited over 2 years to complete enrollment. Discussion A validity study on an assessment tool of competence to consent is strongly needed in research practice, particularly in the child and adolescent population. In this study we will establish

Assessing children’s competence to consent in research by a standardized tool: a validity study

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Hein Irma M

2012-09-01

Full Text Available Abstract Background Currently over 50% of drugs prescribed to children have not been evaluated properly for use in their age group. One key reason why children have been excluded from clinical trials is that they are not considered able to exercise meaningful autonomy over the decision to participate. Dutch law states that competence to consent can be presumed present at the age of 12 and above; however, in pediatric practice children’s competence is not that clearly presented and the transition from assent to active consent is gradual. A gold standard for competence assessment in children does not exist. In this article we describe a study protocol on the development of a standardized tool for assessing competence to consent in research in children and adolescents. Methods/design In this study we modified the MacCAT-CR, the best evaluated competence assessment tool for adults, for use in children and adolescents. We will administer the tool prospectively to a cohort of pediatric patients from 6 to18 years during the selection stages of ongoing clinical trials. The outcomes of the MacCAT-CR interviews will be compared to a reference standard, established by the judgments of clinical investigators, and an expert panel consisting of child psychiatrists, child psychologists and medical ethicists. The reliability, criterion-related validity and reproducibility of the tool will be determined. As MacCAT-CR is a multi-item scale consisting of 13 items, power was justified at 130–190 subjects, providing a minimum of 10–15 observations per item. MacCAT-CR outcomes will be correlated with age, life experience, IQ, ethnicity, socio-economic status and competence judgment of the parent(s. It is anticipated that 160 participants will be recruited over 2 years to complete enrollment. Discussion A validity study on an assessment tool of competence to consent is strongly needed in research practice, particularly in the child and adolescent population. In

Structural refinement and prediction of potential CCR2 antagonists through validated multi-QSAR modeling studies.

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Amin, Sk Abdul; Adhikari, Nilanjan; Baidya, Sandip Kumar; Gayen, Shovanlal; Jha, Tarun

2018-01-03

Chemokines trigger numerous inflammatory responses and modulate the immune system. The interaction between monocyte chemoattractant protein-1 and chemokine receptor 2 (CCR2) may be the cause of atherosclerosis, obesity, and insulin resistance. However, CCR2 is also implicated in other inflammatory diseases such as rheumatoid arthritis, multiple sclerosis, asthma, and neuropathic pain. Therefore, there is a paramount importance of designing potent and selective CCR2 antagonists despite a number of drug candidates failed in clinical trials. In this article, 83 CCR2 antagonists by Jhonson and Jhonson Pharmaceuticals have been considered for robust validated multi-QSAR modeling studies to get an idea about the structural and pharmacophoric requirements for designing more potent CCR2 antagonists. All these QSAR models were validated and statistically reliable. Observations resulted from different modeling studies correlated and validated results of other ones. Finally, depending on these QSAR observations, some new molecules were proposed that may exhibit higher activity against CCR2.

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

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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.

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

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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.

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

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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.

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

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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

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

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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.

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

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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.

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.

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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.

A simple, rapid and stability indicating validated method for quantification of lamotrigine in human plasma and dry plasma spot using LC-ESI-MS/MS: Application in clinical study.

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Namdev, Kuldeep Kumar; Dwivedi, Jaya; Chilkoti, Deepak Chandra; Sharma, Swapnil

2018-01-01

Lamotrigine (LTZ) is a phenyltriazine derivative which belongs to anti-epileptic drugs (AEDs) class and prescribed as mono- or adjunctive-therapy in treatment of epilepsy. Therapeutic drug monitoring (TDM) of AEDs provides a valid clinical tool in optimization of overall therapy. However, TDM is challenging due to the high biological samples (plasma/blood) storage/shipment costs and the limited availability of laboratories providing TDM services. Sampling in the form of dry plasma spot (DPS) or dry blood spot (DBS) are suitable alternative to overcome these issues. We developed and validated a new method for quantification of LTZ in human plasma and DPS. The extraction of LTZ from plasma and DPS was performed using liquid-liquid extraction with diethyl ether and an extraction solution composed of diethyl ether- methyl tert-butyl ether- acetone (50:30:20, v/v/v), respectively. Lamotrigine- 13C3, d3 was used as internal standard (ISTD) and the chromatographic separation was achieved on Hypurity Advance C18 column (150×4.6mm, 5μm). Quantitative estimation of LTZ and ISTD was performed on a liquid chromatography tandem mass spectrometer coupled with electrospray ionization interface operated under positive mode of ionization. Calibration curves were linear (r 2 >0.99) over the concentration range of 10-3020ng/mL for both plasma and DPS. Statistical analysis provides insignificant difference between LTZ concentration extracted from plasma and DPS samples. The method is found suitable for application in clinical study and in therapeutic monitoring of LTZ. To the best of our knowledge this is the first report which describing a validated stability indicating assay for quantification of LTZ in dry plasma spot. Copyright © 2017 Elsevier B.V. All rights reserved.

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

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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.

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

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

2017-04-01

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

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'.

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van Rooij, Antonius J; Schoenmakers, Tim M; van de Mheen, Dike

2017-01-01

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'. Using C-VAT 2.0, the current study provides a sensitivity analysis of the proposed DSM-5 criteria in a clinical youth sample (13-23years old) in treatment for video gaming disorder (N=32). The study also explores the clinical characteristics of these patients. The patients were all male and reported spending extensive amounts of time on video games. At least half of the patients reported playing online games (n=15). Comorbid problems were common (n=22) and included (social) anxiety disorders, PDD NOS, ADHD/ADD, Parent-Child relationship problem, and various types of depressive mood problems. The sensitivity of the test was good: results further show that the C-VAT correctly identified 91% of the sample at the proposed cut-off score of at least 5 out of 9 of the criteria. As our study did not include healthy, extreme gamers, we could not assess the specificity of the tool: future research should make this a priority. Using the proposed DSM-5 cut-off score, the C-VAT 2.0 shows preliminary validity in a sample of gamers in treatment for gaming disorder, but the discriminating value of the instrument should be studied further. In the meantime, it is crucial that therapists try to avoid false positives by using expert judgment of functional impairment in each case. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

OpenAIRE

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

2000-01-01

The objective of the present study was to determine the clinical and construct validity of the assessment of disabilities in stroke patients with apraxia. Disabilities were assessed by means of observation of activities of daily living (ADL), such as washing the face and upper body and putting on a blouse or shirt. The study was carried out at occupational therapy departments in general hospitals, rehabilitation centres, and nursing homes. Patients diagnosed to have had a stroke in the left h...

Spanish validation of the adult Attention Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS): relevance of clinical subtypes.

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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

Prediction of overall survival for metastatic pancreatic cancer: Development and validation of a prognostic nomogram with data from open clinical trial and real-world study.

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Hang, Junjie; Wu, Lixia; Zhu, Lina; Sun, Zhiqiang; Wang, Ge; Pan, Jingjing; Zheng, Suhua; Xu, Kequn; Du, Jiadi; Jiang, Hua

2018-06-01

It is necessary to develop prognostic tools of metastatic pancreatic cancer (MPC) for optimizing therapeutic strategies. Thus, we tried to develop and validate a prognostic nomogram of MPC. Data from 3 clinical trials (NCT00844649, NCT01124786, and NCT00574275) and 133 Chinese MPC patients were used for analysis. The former 2 trials were taken as the training cohort while NCT00574275 was used as the validation cohort. In addition, 133 MPC patients treated in China were taken as the testing cohort. Cox regression model was used to investigate prognostic factors in the training cohort. With these factors, we established a nomogram and verified it by Harrell's concordance index (C-index) and calibration plots. Furthermore, the nomogram was externally validated in the validation cohort and testing cohort. In the training cohort (n = 445), performance status, liver metastasis, Carbohydrate antigen 19-9 (CA19-9) log-value, absolute neutrophil count (ANC), and albumin were independent prognostic factors for overall survival (OS). A nomogram was established with these factors to predict OS and survival probabilities. The nomogram showed an acceptable discrimination ability (C-index: .683) and good calibration, and was further externally validated in the validation cohort (n = 273, C-index: .699) and testing cohort (n = 133, C-index: .653).The nomogram total points (NTP) had the potential to stratify patients into 3-risk groups with median OS of 11.7, 7.0 and 3.7 months (P < .001), respectively. In conclusion, the prognostic nomogram with NTP can predict OS for patients with MPC with considerable accuracy. © 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

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

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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

Clinical and angiographic predictors of haemodynamically significant angiographic lesions: development and validation of a risk score to predict positive fractional flow reserve.

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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.

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.

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

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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.

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

Science.gov (United States)

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

2016-09-01

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

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.

Dengue score as a diagnostic predictor for pleural effusion and/or ascites: external validation and clinical application.

Science.gov (United States)

Suwarto, Suhendro; Hidayat, Mohammad Jauharsyah; Widjaya, Bing

2018-02-23

The Dengue Score is a model for predicting pleural effusion and/or ascites and uses the hematocrit (Hct), albumin concentration, platelet count and aspartate aminotransferase (AST) ratio as independent variables. As this metric has not been validated, we conducted a study to validate the Dengue Score and assess its clinical application. A retrospective study was performed at a private hospital in Jakarta, Indonesia. Patients with dengue infection hospitalized from January 2011 through March 2016 were included. The Dengue Score was calculated using four parameters: Hct increase≥15.1%, serum albumin≤3.49 mg/dL, platelet count≤49,500/μL and AST ratio ≥ 2.51. Each parameter was scored as 1 if present and 0 if absent. To validate the Dengue Score, goodness-of-fit was used to assess calibration, and the area under the receiver operating characteristic curve (AROC) was used to assess discrimination. Associations between clinical parameters and Dengue Score groups were determined by bivariate analysis. A total of 207 patients were included in this study. The calibration of the Dengue Score was acceptable (Hosmer-Lemeshow test, p = 0.11), and the score's discriminative ability was good (AROC = 0.88 (95% CI: 0.83-0.92)). At a cutoff of ≥2, the Dengue Score had a positive predictive value (PPV) of 79.03% and a negative predictive value (NPV) of 90.36% for the diagnostic prediction of pleural effusion and/or ascites. Compared with the Dengue Score ≤ 1 group, the Dengue Score = 2 group was significantly associated with hemoconcentration> 20% (p = 0.029), severe thrombocytopenia (p = 0.029), and increased length of hospital stay (p = 0.003). Compared with the Dengue Score = 2 group, the Dengue Score ≥ 3 group was significantly associated with hemoconcentration> 20% (p = 0.001), severe thrombocytopenia (p = 0.024), severe dengue (p = 0.039), and increased length of hospital stay (p = 0.011). The Dengue Score performed well and can

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...

The BioFIND study: Characteristics of a clinically typical Parkinson's disease biomarker cohort

Science.gov (United States)

Goldman, Jennifer G.; Alcalay, Roy N.; Xie, Tao; Tuite, Paul; Henchcliffe, Claire; Hogarth, Penelope; Amara, Amy W.; Frank, Samuel; Rudolph, Alice; Casaceli, Cynthia; Andrews, Howard; Gwinn, Katrina; Sutherland, Margaret; Kopil, Catherine; Vincent, Lona; Frasier, Mark

2016-01-01

ABSTRACT Background Identifying PD‐specific biomarkers in biofluids will greatly aid in diagnosis, monitoring progression, and therapeutic interventions. PD biomarkers have been limited by poor discriminatory power, partly driven by heterogeneity of the disease, variability of collection protocols, and focus on de novo, unmedicated patients. Thus, a platform for biomarker discovery and validation in well‐characterized, clinically typical, moderate to advanced PD cohorts is critically needed. Methods BioFIND (Fox Investigation for New Discovery of Biomarkers in Parkinson's Disease) is a cross‐sectional, multicenter biomarker study that established a repository of clinical data, blood, DNA, RNA, CSF, saliva, and urine samples from 118 moderate to advanced PD and 88 healthy control subjects. Inclusion criteria were designed to maximize diagnostic specificity by selecting participants with clinically typical PD symptoms, and clinical data and biospecimen collection utilized standardized procedures to minimize variability across sites. Results We present the study methodology and data on the cohort's clinical characteristics. Motor scores and biospecimen samples including plasma are available for practically defined off and on states and thus enable testing the effects of PD medications on biomarkers. Other biospecimens are available from off state PD assessments and from controls. Conclusion Our cohort provides a valuable resource for biomarker discovery and validation in PD. Clinical data and biospecimens, available through The Michael J. Fox Foundation for Parkinson's Research and the National Institute of Neurological Disorders and Stroke, can serve as a platform for discovering biomarkers in clinically typical PD and comparisons across PD's broad and heterogeneous spectrum. © 2016 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society PMID:27113479

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

Science.gov (United States)

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

2001-01-01

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

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.

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.

The Spanish version of the Emotional Labour Scale (ELS): a validation study.

Science.gov (United States)

Picardo, Juan M; López-Fernández, Consuelo; Hervás, María José Abellán

2013-10-01

To validate the Spanish version of the Emotional Labour Scale (ELS), an instrument widely used to understand how professionals working with people face emotional labor in their daily job. An observational, cross-sectional and multicenter survey was used. Nursing students and their clinical tutors (n=211) completed the self-reported ELS when the clinical practice period was over. First order and second order Confirmatory Factor Analyses (CFA) were estimated in order to test the factor structure of the scale. The results of the CFA confirm a factor structure of the scale with six first order factors (duration, frequency, intensity, variety, surface acting and deep acting) and two larger second order factors named Demands (duration, frequency, intensity and variety) and Acting (surface acting and deep acting) establishing the validity of the Spanish version of the ELS. Copyright © 2012 Elsevier Ltd. All rights reserved.

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.

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.

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.

Validity of the patient-reported Clinical Global Impression of Change as a measure of treatment response in men with premature ejaculation.

Science.gov (United States)

Althof, Stanley E; Brock, Gerald B; Rosen, Raymond C; Rowland, David L; Aquilina, Joseph W; Rothman, Margaret; Tesfaye, Fisseha; Bull, Scott

2010-06-01

The Clinical Global Impression of Change (CGIC) measures have high utility in clinical practice. However, it is unknown whether the CGIC is valued for assessing premature ejaculation (PE) symptoms and/or the relationship between CGIC and other validated PE patient-reported measures. The study aims to assess the validity of the patient-reported CGIC measure in men with PE and to examine the relationship between CGIC ratings and assessments of control, satisfaction, personal distress, and interpersonal difficulty. Data from a randomized, double-blind, 24-week phase 3 trial in 1,162 men with PE who received dapoxetine (30 mg or 60 mg) or placebo on demand provided the basis for the analysis. Patients were ≥18 years, in a stable monogamous relationship for ≥6 months, met the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision criteria for PE for ≥6 months, and had an intravaginal ejaculatory latency time (IELT) ≤2 minutes in ≥75% of intercourse episodes. The CGIC asked patients to rate improvement or worsening of their PE compared with the start of the study using a 7-point response scale; other patient-reported measures were control over ejaculation, satisfaction with sexual intercourse, interpersonal difficulty, and personal distress related to ejaculation. Stopwatch-measured IELT was recorded. Associations between CGIC and change in other measures at study end point were assessed. The magnitude of IELT increased for each category of improvement on the CGIC: 1.63, 4.03, and 7.15 minutes for slightly better, better, and much better, respectively. Higher CGIC ratings were correlated with greater improvement in control (r = 0.73), satisfaction (r = 0.62), greater reduction in distress (r = -0.52), and interpersonal difficulty (r = -0.39). Total variance accounted for was 57.4%: control (48.7%), satisfaction (4.5%), IELT (2.8%), and distress (1.15%). The analyses support the validity of the CGIC measure in men with PE. The CGIC

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.

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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

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

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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.

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

Directory of Open Access Journals (Sweden)

Hatakenaka Y

2016-07-01

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

Obtaining valid laboratory data in clinical trials conducted in resource diverse settings: lessons learned from a microbicide phase III clinical trial.

Directory of Open Access Journals (Sweden)

Tania Crucitti

2010-10-01

Full Text Available Over the last decade several phase III microbicides trials have been conducted in developing countries. However, laboratories in resource constrained settings do not always have the experience, infrastructure, and the capacity to deliver laboratory data meeting the high standards of clinical trials. This paper describes the design and outcomes of a laboratory quality assurance program which was implemented during a phase III clinical trial evaluating the efficacy of the candidate microbicide Cellulose Sulfate 6% (CS [1].In order to assess the effectiveness of CS for HIV and STI prevention, a phase III clinical trial was conducted in 5 sites: 3 in Africa and 2 in India. The trial sponsor identified an International Central Reference Laboratory (ICRL, responsible for the design and management of a quality assurance program, which would guarantee the reliability of laboratory data. The ICRL provided advice on the tests, assessed local laboratories, organized trainings, conducted supervision visits, performed re-tests, and prepared control panels. Local laboratories were provided with control panels for HIV rapid tests and Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG amplification technique. Aliquots from respective control panels were tested by local laboratories and were compared with results obtained at the ICRL.Overall, good results were observed. However, discordances between the ICRL and site laboratories were identified for HIV and CT/NG results. One particular site experienced difficulties with HIV rapid testing shortly after study initiation. At all sites, DNA contamination was identified as a cause of invalid CT/NG results. Both problems were timely detected and solved. Through immediate feedback, guidance and repeated training of laboratory staff, additional inaccuracies were prevented.Quality control guidelines when applied in field laboratories ensured the reliability and validity of final study data. It is essential that sponsors

The Richmond Agitation-Sedation Scale modified for palliative care inpatients (RASS-PAL): a pilot study exploring validity and feasibility in clinical practice.

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Bush, Shirley H; Grassau, Pamela A; Yarmo, Michelle N; Zhang, Tinghua; Zinkie, Samantha J; Pereira, José L

2014-03-31

The Richmond Agitation-Sedation Scale (RASS), which assesses level of sedation and agitation, is a simple observational instrument which was developed and validated for the intensive care setting. Although used and recommended in palliative care settings, further validation is required in this patient population. The aim of this study was to explore the validity and feasibility of a version of the RASS modified for palliative care populations (RASS-PAL). A prospective study, using a mixed methods approach, was conducted. Thirteen health care professionals (physicians and nurses) working in an acute palliative care unit assessed ten consecutive patients with an agitated delirium or receiving palliative sedation. Patients were assessed at five designated time points using the RASS-PAL. Health care professionals completed a short survey and data from semi-structured interviews was analyzed using thematic analysis. The inter-rater intraclass correlation coefficient range of the RASS-PAL was 0.84 to 0.98 for the five time points. Professionals agreed that the tool was useful for assessing sedation and was easy to use. Its role in monitoring delirium however was deemed problematic. Professionals felt that it may assist interprofessional communication. The need for formal education on why and how to use the instrument was highlighted. This study provides preliminary validity evidence for the use of the RASS-PAL by physicians and nurses working in a palliative care unit, specifically for assessing sedation and agitation levels in the management of palliative sedation. Further validity evidence should be sought, particularly in the context of assessing delirium.

The Richmond Agitation-Sedation Scale modified for palliative care inpatients (RASS-PAL): a pilot study exploring validity and feasibility in clinical practice

Science.gov (United States)

2014-01-01

Background The Richmond Agitation-Sedation Scale (RASS), which assesses level of sedation and agitation, is a simple observational instrument which was developed and validated for the intensive care setting. Although used and recommended in palliative care settings, further validation is required in this patient population. The aim of this study was to explore the validity and feasibility of a version of the RASS modified for palliative care populations (RASS-PAL). Methods A prospective study, using a mixed methods approach, was conducted. Thirteen health care professionals (physicians and nurses) working in an acute palliative care unit assessed ten consecutive patients with an agitated delirium or receiving palliative sedation. Patients were assessed at five designated time points using the RASS-PAL. Health care professionals completed a short survey and data from semi-structured interviews was analyzed using thematic analysis. Results The inter-rater intraclass correlation coefficient range of the RASS-PAL was 0.84 to 0.98 for the five time points. Professionals agreed that the tool was useful for assessing sedation and was easy to use. Its role in monitoring delirium however was deemed problematic. Professionals felt that it may assist interprofessional communication. The need for formal education on why and how to use the instrument was highlighted. Conclusion This study provides preliminary validity evidence for the use of the RASS-PAL by physicians and nurses working in a palliative care unit, specifically for assessing sedation and agitation levels in the management of palliative sedation. Further validity evidence should be sought, particularly in the context of assessing delirium. PMID:24684942

Hospital blood bank information systems accurately reflect patient transfusion: results of a validation study.

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McQuilten, Zoe K; Schembri, Nikita; Polizzotto, Mark N; Akers, Christine; Wills, Melissa; Cole-Sinclair, Merrole F; Whitehead, Susan; Wood, Erica M; Phillips, Louise E

2011-05-01

Hospital transfusion laboratories collect information regarding blood transfusion and some registries gather clinical outcomes data without transfusion information, providing an opportunity to integrate these two sources to explore effects of transfusion on clinical outcomes. However, the use of laboratory information system (LIS) data for this purpose has not been validated previously. Validation of LIS data against individual patient records was undertaken at two major centers. Data regarding all transfusion episodes were analyzed over seven 24-hour periods. Data regarding 596 units were captured including 399 red blood cell (RBC), 95 platelet (PLT), 72 plasma, and 30 cryoprecipitate units. They were issued to: inpatient 221 (37.1%), intensive care 109 (18.3%), outpatient 95 (15.9%), operating theater 45 (7.6%), emergency department 27 (4.5%), and unrecorded 99 (16.6%). All products recorded by LIS as issued were documented as transfused to intended patients. Median time from issue to transfusion initiation could be calculated for 535 (89.8%) components: RBCs 16 minutes (95% confidence interval [CI], 15-18 min; interquartile range [IQR], 7-30 min), PLTs 20 minutes (95% CI, 15-22 min; IQR, 10-37 min), fresh-frozen plasma 33 minutes (95% CI, 14-83 min; IQR, 11-134 min), and cryoprecipitate 3 minutes (95% CI, -10 to 42 min; IQR, -15 to 116 min). Across a range of blood component types and destinations comparison of LIS data with clinical records demonstrated concordance. The difference between LIS timing data and patient clinical records reflects expected time to transport, check, and prepare transfusion but does not affect the validity of linkage for most research purposes. Linkage of clinical registries with LIS data can therefore provide robust information regarding individual patient transfusion. This enables analysis of joint data sets to determine the impact of transfusion on clinical outcomes. © 2010 American Association of Blood Banks.

Validating archetypes for the Multiple Sclerosis Functional Composite.

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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

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

NARCIS (Netherlands)

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

2013-01-01

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

Use FlowRepository to share your clinical data upon study publication.

Science.gov (United States)

Spidlen, Josef; Brinkman, Ryan R

2018-01-01

A fundamental tenet of scientific research is that published results including underlying data should be open to independent validation and refutation. Data sharing encourages collaboration, facilitates quality and reduces redundancy in data production. Authors submitting manuscripts to several journals have already adopted the habit of sharing their underlying flow cytometry data by deposition to FlowRepository-a data repository that is jointly supported by the International Society for Advancement of Cytometry, the International Clinical Cytometry Society and the European Society for Clinical Cell Analysis. De-identification is required for publishing data from clinical studies and we discuss ways to satisfy data sharing requirements and patient privacy requirements simultaneously. Scientific communities in the fields of microarray, proteomics, and sequencing have been benefiting from reuse and re-exploration of data in public repositories for over decade. We believe it is time that clinicians follow suit and that de-identified clinical data also become routinely available along with published cytometry-based findings. © 2016 International Clinical Cytometry Society. © 2016 International Clinical Cytometry Society.

Visualizing and Validating Metadata Traceability within the CDISC Standards.

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

2017-01-01

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

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

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

2012-10-01

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

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

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

2016-10-18

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

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.

The validity of the 4-Skills Scan: A double validation study.

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van Kernebeek, W G; de Kroon, M L A; Savelsbergh, G J P; Toussaint, H M

2018-06-01

Adequate gross motor skills are an essential aspect of a child's healthy development. Where physical education (PE) is part of the primary school curriculum, a strong curriculum-based emphasis on evaluation and support of motor skill development in PE is apparent. Monitoring motor development is then a task for the PE teacher. In order to fulfil this task, teachers need adequate tools. The 4-Skills Scan is a quick and easily manageable gross motor skill instrument; however, its validity has never been assessed. Therefore, the purpose of this study is to assess the construct and concurrent validity of both 4-Skills Scans (version 2007 and version 2015). A total of 212 primary school children (6 - 12 years old), was requested to participate in both versions of the 4-Skills Scan. For assessing construct validity, children covered an obstacle course with video recordings for observation by an expert panel. For concurrent validity, a comparison was made with the MABC-2, by calculating Pearson correlations. Multivariable linear regression analyses were performed to determine the contribution of each subscale to the construct of gross motor skills, according to the MABC-2 and the expert panel. Correlations between the 4-Skills Scans and expert valuations were moderate, with coefficients of .47 (version 2007) and .46 (version 2015). Correlations between the 4-Skills Scans and the MABC-2 (gross) were moderate (.56) for version 2007 and high (.64) for version 2015. It is concluded that both versions of the 4-Skills Scans are satisfactory valid instruments for assessing gross motor skills during PE lessons. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

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.