Clinical utility of measures of breathlessness.

PubMed

Cullen, Deborah L; Rodak, Bernadette

2002-09-01

The clinical utility of measures of dyspnea has been debated in the health care community. Although breathlessness can be evaluated with various instruments, the most effective dyspnea measurement tool for patients with chronic lung disease or for measuring treatment effectiveness remains uncertain. Understanding the evidence for the validity and reliability of these instruments may provide a basis for appropriate clinical application. Evaluate instruments designed to measure breathlessness, either as single-symptom or multidimensional instruments, based on psychometrics foundations such as validity, reliability, and discriminative and evaluative properties. Classification of each dyspnea measurement instrument will recommend clinical application in terms of exercise, benchmarking patients, activities of daily living, patient outcomes, clinical trials, and responsiveness to treatment. Eleven dyspnea measurement instruments were selected. Each instrument was assessed as discriminative or evaluative and then analyzed as to its psychometric properties and purpose of design. Descriptive data from all studies were described according to their primary patient application (ie, chronic obstructive pulmonary disease, asthma, or other patient populations). The Borg Scale and the Visual Analogue Scale are applicable to exertion and thus can be applied to any cardiopulmonary patient to determine dyspnea. All other measures were determined appropriate for chronic obstructive pulmonary disease, whereas the Shortness of Breath Questionnaire can be applied to cystic fibrosis and lung transplant patients. The most appropriate utility for all instruments was measuring the effects on activities of daily living and for benchmarking patient progress. Instruments that quantify function and health-related quality of life have great utility for documenting outcomes but may be limited as to documenting treatment responsiveness in terms of clinically important changes. The dyspnea measurement instruments we studied meet important standards of validity and reliability. Discriminative measures have limited clinical utility and, when used for populations or conditions for which they are not designed or validated, the data collected may not be clinically relevant. Evaluative measures have greater clinical utility and can be applied for outcome purposes. Measures should be applied to the populations and conditions for which they were designed. The relationship between clinical therapies and the measurement of dyspnea as an outcome can develop as respiratory therapists become more comfortable with implementing dyspnea measurement instruments and use the data to improve patient treatment. Dyspnea evaluation should be considered for all clinical practice guidelines and care pathways.

Body fluid analysis: clinical utility and applicability of published studies to guide interpretation of today's laboratory testing in serous fluids.

PubMed

Block, Darci R; Algeciras-Schimnich, Alicia

2013-01-01

Requests for testing various analytes in serous fluids (e.g., pleural, peritoneal, pericardial effusions) are submitted daily to clinical laboratories. Testing of these fluids deviates from assay manufacturers' specifications, as most laboratory assays are optimized for testing blood or urine specimens. These requests add a burden to clinical laboratories, which need to validate assay performance characteristics in these fluids to exclude matrix interferences (given the different composition of body fluids) while maintaining regulatory compliance. Body fluid testing for a number of analytes has been reported in the literature; however, understanding the clinical utility of these analytes is critical because laboratories must address the analytic and clinical validation requirements, while educating clinicians on proper test utilization. In this article, we review the published data to evaluate the clinical utility of testing for numerous analytes in body fluid specimens. We also highlight the pre-analytic and analytic variables that need to be considered when reviewing published studies in body fluid testing. Finally, we provide guidance on how published studies might (or might not) guide interpretation of test results in today's clinical laboratories.

Patient perspective on quality of geriatric care and rehabilitation--development and psychometric testing of a questionnaire.

PubMed

Wressle, Ewa; Eriksson, Lennart; Fahlander, Amie; Rasmusson, Ing-Marie; Tedemalm, Ulla; Tängmark, Karin

2006-06-01

The aim was to develop and test a questionnaire for use in telephone interviews concerning patient evaluation of geriatric care and rehabilitation. Instrument development was performed comprising qualitative interviews, construction of items, content validation, pilot study and data collection for evaluation of care and rehabilitation, clinical utility, reliability and construct validity. Qualitative interviews were performed with 12 elderly participants. The qualitative interviews formed the basis for the construction of 45 items. An expert panel performed a content validation of the questionnaire resulting in a revised version. A pilot study comprised 29 participants recently discharged from geriatric wards and the main data collection comprised 221 participants. Inclusion criteria were being able to perform a telephone interview and willingness to participate. Clinical utility was examined through questions to the interviewers, answered in writing. Cronbach's alpha coefficient was 0.79. According to a factor analysis and the evaluation of clinical utility, the underlying dimensions of the final revised questionnaire concern 'Respect and safety', 'Information and participation' and 'Rehabilitation interventions', scored in 18 items. In addition, one global item concerns satisfaction with care, resulting in 19 items in total. The revised questionnaire was named PaPeR, Patient Perspective on care and Rehabilitation. The questionnaire is considered valid, reliable and judged to have good clinical utility. The time consumption for the telephone interview is about 10-20 minutes. The questionnaire is useful in defining areas for potential quality improvement in geriatric wards.

The analytical validation of the Oncotype DX Recurrence Score assay

PubMed Central

Baehner, Frederick L

2016-01-01

In vitro diagnostic multivariate index assays are highly complex molecular assays that can provide clinically actionable information regarding the underlying tumour biology and facilitate personalised treatment. These assays are only useful in clinical practice if all of the following are established: analytical validation (i.e., how accurately/reliably the assay measures the molecular characteristics), clinical validation (i.e., how consistently/accurately the test detects/predicts the outcomes of interest), and clinical utility (i.e., how likely the test is to significantly improve patient outcomes). In considering the use of these assays, clinicians often focus primarily on the clinical validity/utility; however, the analytical validity of an assay (e.g., its accuracy, reproducibility, and standardisation) should also be evaluated and carefully considered. This review focuses on the rigorous analytical validation and performance of the Oncotype DX® Breast Cancer Assay, which is performed at the Central Clinical Reference Laboratory of Genomic Health, Inc. The assay process includes tumour tissue enrichment (if needed), RNA extraction, gene expression quantitation (using a gene panel consisting of 16 cancer genes plus 5 reference genes and quantitative real-time RT-PCR), and an automated computer algorithm to produce a Recurrence Score® result (scale: 0–100). This review presents evidence showing that the Recurrence Score result reported for each patient falls within a tight clinically relevant confidence interval. Specifically, the review discusses how the development of the assay was designed to optimise assay performance, presents data supporting its analytical validity, and describes the quality control and assurance programmes that ensure optimal test performance over time. PMID:27729940

The analytical validation of the Oncotype DX Recurrence Score assay.

PubMed

Baehner, Frederick L

2016-01-01

In vitro diagnostic multivariate index assays are highly complex molecular assays that can provide clinically actionable information regarding the underlying tumour biology and facilitate personalised treatment. These assays are only useful in clinical practice if all of the following are established: analytical validation (i.e., how accurately/reliably the assay measures the molecular characteristics), clinical validation (i.e., how consistently/accurately the test detects/predicts the outcomes of interest), and clinical utility (i.e., how likely the test is to significantly improve patient outcomes). In considering the use of these assays, clinicians often focus primarily on the clinical validity/utility; however, the analytical validity of an assay (e.g., its accuracy, reproducibility, and standardisation) should also be evaluated and carefully considered. This review focuses on the rigorous analytical validation and performance of the Oncotype DX ® Breast Cancer Assay, which is performed at the Central Clinical Reference Laboratory of Genomic Health, Inc. The assay process includes tumour tissue enrichment (if needed), RNA extraction, gene expression quantitation (using a gene panel consisting of 16 cancer genes plus 5 reference genes and quantitative real-time RT-PCR), and an automated computer algorithm to produce a Recurrence Score ® result (scale: 0-100). This review presents evidence showing that the Recurrence Score result reported for each patient falls within a tight clinically relevant confidence interval. Specifically, the review discusses how the development of the assay was designed to optimise assay performance, presents data supporting its analytical validity, and describes the quality control and assurance programmes that ensure optimal test performance over time.

The Validity and Utility of the Positive Presentation Management and Negative Presentation Management Scales for the Revised NEO Personality Inventory

ERIC Educational Resources Information Center

Sellbom, Martin; Bagby, R. Michael

2008-01-01

Schinka, Kinder, and Kremer developed "validity" scales for the "Revised NEO Personality Inventory" (NEO PI-R; Costa & McCrae) to detect underreporting--the Positive Presentation Management (PPM) Scale and overreporting--the Negative Presentation Management (NPM) Scale. In this investigation, the clinical utility of these…

Personal genome testing: Test characteristics to clarify the discourse on ethical, legal and societal issues

PubMed Central

2011-01-01

Background As genetics technology proceeds, practices of genetic testing have become more heterogeneous: many different types of tests are finding their way to the public in different settings and for a variety of purposes. This diversification is relevant to the discourse on ethical, legal and societal issues (ELSI) surrounding genetic testing, which must evolve to encompass these differences. One important development is the rise of personal genome testing on the basis of genetic profiling: the testing of multiple genetic variants simultaneously for the prediction of common multifactorial diseases. Currently, an increasing number of companies are offering personal genome tests directly to consumers and are spurring ELSI-discussions, which stand in need of clarification. This paper presents a systematic approach to the ELSI-evaluation of personal genome testing for multifactorial diseases along the lines of its test characteristics. Discussion This paper addresses four test characteristics of personal genome testing: its being a non-targeted type of testing, its high analytical validity, low clinical validity and problematic clinical utility. These characteristics raise their own specific ELSI, for example: non-targeted genetic profiling poses serious problems for information provision and informed consent. Questions about the quantity and quality of the necessary information, as well as about moral responsibilities with regard to the provision of information are therefore becoming central themes within ELSI-discussions of personal genome testing. Further, the current low level of clinical validity of genetic profiles raises questions concerning societal risks and regulatory requirements, whereas simultaneously it causes traditional ELSI-issues of clinical genetics, such as psychological and health risks, discrimination, and stigmatization, to lose part of their relevance. Also, classic notions of clinical utility are challenged by the newer notion of 'personal utility.' Summary Consideration of test characteristics is essential to any valuable discourse on the ELSI of personal genome testing for multifactorial diseases. Four key characteristics of the test - targeted/non-targeted testing, analytical validity, clinical validity and clinical utility - together determine the applicability and the relevance of ELSI to specific tests. The paper identifies and discusses four areas of interest for the ELSI-debate on personal genome testing: informational problems, risks, regulatory issues, and the notion of personal utility. PMID:21672210

EQ-5D-5L and SF-6D Utility Measures in Symptomatic benign Thyroid Nodules: Acceptability and Psychometric Evaluation.

PubMed

Wong, Carlos K H; Lang, Brian H H; Yu, Hill M S; Lam, Cindy L K

2017-08-01

The aim of this study was to examine the acceptability, validity, and reliability of the EuroQoL Five-Dimension Five-Level (EQ-5D-5L) and Short-Form Six-Dimension (SF-6D) health utility measures in patients with symptomatic benign thyroid nodules. Data from a randomized controlled trial (ClinicalTrials.gov identifier: NCT02398721) of 294 patients with symptomatic benign thyroid nodules were utilized for this psychometric evaluation of health-related quality of life (HR-QOL) measurement. Three HR-QOL questionnaires-the generic 12-item Short Form Health Survey (SF-12v2), EQ-5D-5L, and SF-6D-were interviewer-administered at baseline and 2 weeks afterwards. Responses to SF-6D were transformed to SF-6D utility scores using a Hong Kong population scoring algorithm derived by standard gamble, whereas responses to EQ-5D-5L were mapped onto EQ-5D-3L response via interim mapping algorithms and then converted to EQ-5D-5L utility scores using a Chinese-specific value set. Construct validity was determined by evaluating Spearman correlation between SF-12v2 scores and utility scores. Two-week test-retest reliability was assessed using intra-class correlation coefficient. No significant (>15%) floor and ceiling effects were observed for SF-6D utility scores. The SF-6D utility scores had a moderate Spearman rank correlation with the SF-12v2 domain score providing evidence for adequate construct validity. The SF-6D utility scores showed good test-retest reliability (0.794; range 0.696-0.860). Better reliability was observed in SF-6D utility scores than in EQ-5D-5L utility scores. While the EQ-5D-5L instrument was less reproducible, the SF-6D instrument appeared to be an applicable, valid, and reliable measure in assessing the HR-QOL of Chinese patients with symptomatic benign thyroid nodules. The impact of utility score selection on the effectiveness and cost effectiveness of clinical interventions targeted to these patients needs further exploration. NCT02398721, ClinicalTrials.gov.

Borderline Personality Traits and Disorder: Predicting Prospective Patient Functioning

ERIC Educational Resources Information Center

Hopwood, Christopher J.; Zanarini, Mary C.

2010-01-01

Objective: Decisions about the composition of personality assessment in the "Diagnostic and Statistical Manual of Mental Disorders" (5th ed.; DSM-V) will be heavily influenced by the clinical utility of candidate constructs. In this study, we addressed 1 aspect of clinical utility by testing the incremental validity of 5-factor model (FFM)…

An examination of the relationships between physicians' clinical and hospital-utilization performance.

PubMed Central

Saywell, R M; Bean, J A; Ludke, R L; Redman, R W; McHugh, G J

1981-01-01

To examine the relationships between measures of attending physician teams' clinical and utilization performance, inpatient hospital audits were conducted in 22 Maryland and western Pennsylvania nonfederal short-term hospitals. A total of 6,980 medical records were abstracted from eight diagnostic categories using the Payne and JCAH PEP medical audit procedures. The results indicate weak statistical associations between the two medical care evaluation audits; between clinical performance and utilization performance, as measured by appropriateness of admissions and length of stay; and between three utilization measures. Based on these findings, it does not appear valid to use performance in one area to evaluate performance in the other in order to measure or evaluate and ultimately improve physicians; clinical or utilization performance. PMID:6946048

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

PubMed

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

2016-01-01

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

Molecular Indicators of Castration-Resistant Prostate Cancer

DTIC Science & Technology

2015-12-01

hypothesis- generating. To evaluate the clinical utility of AR-V7/AR- FL ratio measurement, a more in-depth investigation will be necessary but would be...V7, supporting expanded validation studies aimed at evaluating the clinical utility of this blood-based treatment selection marker. References...engl j med 371;11 nejm.org september 11, 2014 1035 mained marginally predictive of shorter clinical or radiographic progression–free survival (hazard

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

PubMed

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

2018-04-01

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

The Scientific Foundation for Personal Genomics: Recommendations from a National Institutes of Health–Centers for Disease Control and Prevention Multidisciplinary Workshop

PubMed Central

Khoury, Muin J.; McBride, Colleen M.; Schully, Sheri D.; Ioannidis, John P. A.; Feero, W. Gregory; Janssens, A. Cecile J. W.; Gwinn, Marta; Simons-Morton, Denise G.; Bernhardt, Jay M.; Cargill, Michele; Chanock, Stephen J.; Church, George M.; Coates, Ralph J.; Collins, Francis S.; Croyle, Robert T.; Davis, Barry R.; Downing, Gregory J.; DuRoss, Amy; Friedman, Susan; Gail, Mitchell H.; Ginsburg, Geoffrey S.; Green, Robert C.; Greene, Mark H.; Greenland, Philip; Gulcher, Jeffrey R.; Hsu, Andro; Hudson, Kathy L.; Kardia, Sharon L. R.; Kimmel, Paul L.; Lauer, Michael S.; Miller, Amy M.; Offit, Kenneth; Ransohoff, David F.; Roberts, J. Scott; Rasooly, Rebekah S.; Stefansson, Kari; Terry, Sharon F.; Teutsch, Steven M.; Trepanier, Angela; Wanke, Kay L.; Witte, John S.; Xu, Jianfeng

2010-01-01

The increasing availability of personal genomic tests has led to discussions about the validity and utility of such tests and the balance of benefits and harms. A multidisciplinary workshop was convened by the National Institutes of Health and the Centers for Disease Control and Prevention to review the scientific foundation for using personal genomics in risk assessment and disease prevention and to develop recommendations for targeted research. The clinical validity and utility of personal genomics is a moving target with rapidly developing discoveries but little translation research to close the gap between discoveries and health impact. Workshop participants made recommendations in five domains: (1) developing and applying scientific standards for assessing personal genomic tests; (2) developing and applying a multidisciplinary research agenda, including observational studies and clinical trials to fill knowledge gaps in clinical validity and utility; (3) enhancing credible knowledge synthesis and information dissemination to clinicians and consumers; (4) linking scientific findings to evidence-based recommendations for use of personal genomics; and (5) assessing how the concept of personal utility can affect health benefits, costs, and risks by developing appropriate metrics for evaluation. To fulfill the promise of personal genomics, a rigorous multidisciplinary research agenda is needed. PMID:19617843

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

ERIC Educational Resources Information Center

Vu, Nu Viet; And Others

1992-01-01

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

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

NASA Technical Reports Server (NTRS)

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

2001-01-01

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

Validity of EuroQOL-5D, time trade-off, and standard gamble for age-related macular degeneration in the Singapore population

PubMed Central

Au Eong, K G; Chan, E W; Luo, N; Wong, S H; Tan, N W H; Lim, T H; Wagle, A M

2012-01-01

Background/aims Utility values of age-related macular degeneration (AMD) in Asian patients are unknown. This study aims to assess utility values and construct validity of the EuroQOL-5D (EQ-5D), time trade-off (TTO), and standard gamble (SG) instruments in the Singapore multi-ethnic AMD population. Methods Cross-sectional, two-centre, institution-based study. Visual acuity (VA), clinical AMD severity, and utility scores on the EQ-5D, TTO, and SG were obtained from 338 AMD patients. VA was analysed in terms of the better-seeing eye (BEVA), worse-seeing eye (WEVA), and weighted average of both eyes (WVA). We evaluated SG on the perfect health-death (SG(death)) and binocular perfect vision-binocular blindness (SG(blindness)) scales. Construct validity was determined by testing a priorihypotheses relating the EQ-5D, TTO, and SG utility scores to VA and clinical AMD severity. Results The mean utilities on the EQ-5D, TTO, SG(death), and SG(blindness) were 0.89, 0.81, 0.86, and 0.90, respectively. EQ-5D scores correlated weakly with BEVA, WEVA, and WVA (Pearson's correlation coefficients −0.291, −0.247, and −0.305 respectively, P<0.001 for all). SG(death) and SG(blindness) demonstrated no correlation with BEVA, WEVA, or WVA (Pearson's correlation coefficients, range −0.06 to −0.125). TTO showed weak association only with WEVA and WVA (correlation coefficients −0.237, −0.228, P<0.0001), but not with BEVA (correlation coefficient −0.161). Clinical AMD severity correlated with EQ-5D and SG(death), but not with TTO and SG(blindness) (P=0.004, 0.002, 0.235, and 0.069, respectively). Conclusions AMD has a negative impact on utilities, although utility scores were high compared with Western cohorts. EQ-5D, TTO, and SG showed suboptimal construct validity, suggesting that health status utilities may not be sufficiently robust for cost-utility analyses in this population. PMID:22222257

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

PubMed Central

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

2017-01-01

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

The predictive utility of neuropsychological symptom validity testing as it relates to psychological presentation.

PubMed

Zakzanis, Konstantine K; Gammada, Emnet; Jeffay, Eliyas

2012-01-01

The present study examined the relationship between multiple neuropsychological symptom validity tests (SVTs) and psychological presentation. More formally, we set out to determine if performance on neuropsychological SVTs was related to psychological symptom credibility and which specific neuropsychological SVTs were most associated with noncredible psychological presentation. Archival records from 106 litigating examinees were utilized in this study. Our results illustrate that neuropsychological SVTs are modestly related to psychological symptom credibility and that specific neuropsychological SVTs are variably associated to this end. We conclude that when multiple, but not independent, neuropsychological SVTs are employed within the context of a neuropsychological examination, they do have clinical utility as it relates to credibility of psychological presentation and these constructs do share variance reciprocally in clinically meaningful ways. When independently employed, however, the observed relationship is modest at best. Hence, to place clinical opinion on firmer scientific grounds within the context of a neuropsychological examination, multiple cognitive SVTs, in hand with psychological test instruments that include validity indexes, are essential to derive opinion that is based on science rather than faith in the instance of litigation when an incentive to manifest disability for the sake of an external reward holds probable.

(Very) Early technology assessment and translation of predictive biomarkers in breast cancer.

PubMed

Miquel-Cases, Anna; Schouten, Philip C; Steuten, Lotte M G; Retèl, Valesca P; Linn, Sabine C; van Harten, Wim H

2017-01-01

Predictive biomarkers can guide treatment decisions in breast cancer. Many studies are undertaken to discover and translate these biomarkers, yet few biomarkers make it to practice. Before use in clinical decision making, predictive biomarkers need to demonstrate analytical validity, clinical validity and clinical utility. While attaining analytical and clinical validity is relatively straightforward, by following methodological recommendations, the achievement of clinical utility is extremely challenging. It requires demonstrating three associations: the biomarker with the outcome (prognostic association), the effect of treatment independent of the biomarker, and the differential treatment effect between the prognostic and the predictive biomarker (predictive association). In addition, economical, ethical, regulatory, organizational and patient/doctor-related aspects are hampering the translational process. Traditionally, these aspects do not receive much attention until formal approval or reimbursement of a biomarker test (informed by Health Technology Assessment (HTA)) is at stake, at which point the clinical utility and sometimes price of the test can hardly be influenced anymore. When HTA analyses are performed earlier, during biomarker research and development, they may prevent further development of those biomarkers unlikely to ever provide sufficient added value to society, and rather facilitate translation of the promising ones. Early HTA is particularly relevant for the predictive biomarker field, as expensive medicines are under pressure and the need for biomarkers to guide their appropriate use is huge. Closer interaction between clinical researchers and HTA experts throughout the translational research process will ensure that available data and methodologies will be used most efficiently to facilitate biomarker translation. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Is Personalized Medicine Achievable in Obstetrics?

PubMed Central

Quinney, Sara K; Flockhart, David A; Patil, Avinash S

2014-01-01

Personalized medicine seeks to identify the right dose of the right drug for the right patient at the right time. Typically, individualization of therapy is based on the pharmacogenomic make-up of the individual and environmental factors that alter drug disposition and response. In addition to these factors, during pregnancy a woman’s body undergoes many changes that can impact the therapeutic efficacy of medications. Yet, there is minimal research regarding personalized medicine in obstetrics. Adoption of pharmacogenetic testing into the obstetrical care is dependent on evidence of analytical validity, clinical validity, and clinical utility. Here, we briefly present information regarding the potential utility of personalized medicine for treating the obstetric patient for pain with narcotics, hypertension, and preterm labor and discuss the impediments of bringing personalized medicine to the obstetrical clinic. PMID:25282474

Visualizing and Validating Metadata Traceability within the CDISC Standards.

PubMed

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

2017-01-01

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

Visualizing and Validating Metadata Traceability within the CDISC Standards

PubMed Central

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

2017-01-01

The Food & Drug Administration has begun requiring that electronic submissions of regulated clinical studies utilize the Clinical Data Information Standards Consortium data standards. Within regulated clinical research, traceability is a requirement and indicates that the analysis results can be traced back to the original source data. Current solutions for clinical research data traceability are limited in terms of querying, validation and visualization capabilities. This paper describes (1) the development of metadata models to support computable traceability and traceability visualizations that are compatible with industry data standards for the regulated clinical research domain, (2) adaptation of graph traversal algorithms to make them capable of identifying traceability gaps and validating traceability across the clinical research data lifecycle, and (3) development of a traceability query capability for retrieval and visualization of traceability information. PMID:28815125

Asthma Outcomes: Healthcare Utilization and Costs

PubMed Central

Akinbami, Lara J.; Sullivan, Sean D.; Campbell, Jonathan D.; Grundmeier, Robert W.; Hartert, Tina V.; Lee, Todd A.; Smith, Robert A.

2014-01-01

Background Measures of healthcare utilization and indirect impact of asthma morbidity are used to assess clinical interventions and estimate cost. Objective National Institutes of Health (NIH) institutes and other federal agencies convened an expert group to propose standardized measurement, collection, analysis, and reporting of healthcare utilization and cost outcomes in future asthma studies. Methods We used comprehensive literature reviews and expert opinion to compile a list of asthma healthcare utilization outcomes that we classified as core (required in future studies), supplemental (used according to study aims and standardized) and emerging (requiring validation and standardization). We also have identified methodology to assign cost to these outcomes. This work was discussed at an NIH-organized workshop in March 2010 and finalized in September 2011. Results We identified 3 ways to promote comparability across clinical trials for measures of healthcare utilization, resource use, and cost: (1) specify the study perspective (patient, clinician, payer, society), (2) standardize the measurement period (ideally, 12 months), and (3) use standard units to measure healthcare utilization and other asthma-related events. Conclusions Large clinical trials and observational studies should collect and report detailed information on healthcare utilization, intervention resources, and indirect impact of asthma, so that costs can be calculated and cost-effectiveness analyses can be conducted across several studies. Additional research is needed to develop standard, validated survey instruments for collection of provider-reported and participant-reported data regarding asthma-related health care. PMID:22386509

The headache under-response to treatment (HURT) questionnaire, an outcome measure to guide follow-up in primary care: development, psychometric evaluation and assessment of utility.

PubMed

Steiner, T J; Buse, D C; Al Jumah, M; Westergaard, M L; Jensen, R H; Reed, M L; Prilipko, L; Mennini, F S; Láinez, M J A; Ravishankar, K; Sakai, F; Yu, S-Y; Fontebasso, M; Al Khathami, A; MacGregor, E A; Antonaci, F; Tassorelli, C; Lipton, R B

2018-02-14

Headache disorders are both common and burdensome but, given the many people affected, provision of health care to all is challenging. Structured headache services based in primary care are the most efficient, equitable and cost-effective solution but place responsibility for managing most patients on health-care providers with limited training in headache care. The development of practical management aids for primary care is therefore a purpose of the Global Campaign against Headache. This manuscript presents an outcome measure, the Headache Under-Response to Treatment (HURT) questionnaire, describing its purpose, development, psychometric evaluation and assessment for clinical utility. The objective was a simple-to-use instrument that would both assess outcome and provide guidance to improving outcome, having utility across the range of headache disorders, across clinical settings and across countries and cultures. After literature review, an expert consensus group drawn from all six world regions formulated HURT through item development and item reduction using item-response theory. Using the American Migraine Prevalence and Prevention Study's general-population respondent panel, two mailed surveys assessed the psychometric properties of HURT, comparing it with other instruments as external validators. Reliability was assessed in patients in two culturally-contrasting clinical settings: headache specialist centres in Europe (n = 159) and primary-care centres in Saudi Arabia (n = 40). Clinical utility was assessed in similar settings (Europe n = 201; Saudi Arabia n = 342). The final instrument, an 8-item self-administered questionnaire, addressed headache frequency, disability, medication use and effect, patients' perceptions of headache "control" and their understanding of their diagnoses. Psychometric evaluation revealed a two-factor model (headache frequency, disability and medication use; and medication efficacy and headache control), with scale properties apparently stable across disorders and correlating well and in the expected directions with external validators. The literature review found few instruments linking assessment to clinical advice or suggested actions: HURT appeared to fill this gap. In European specialist care, it showed utility as an outcome measure across headache disorders. In Saudi Arabian primary care, HURT (translated into Arabic) was reliable and responsive to clinical change. With demonstrated validity and clinical utility across disorders, cultures and settings, HURT is available for clinical and research purposes.

Convergent Validity of the Early Memory Index in Two Primary Care Samples.

PubMed

Porcerelli, John H; Cogan, Rosemary; Melchior, Katherine A; Jasinski, Matthew J; Richardson, Laura; Fowler, Shannon; Morris, Pierre; Murdoch, William

2016-01-01

Karliner, Westrich, Shedler, and Mayman (1996) developed the Early Memory Index (EMI) to assess mental health, narrative coherence, and traumatic experiences in reports of early memories. We assessed the convergent validity of EMI scales with data from 103 women from an urban primary care clinic (Study 1) and data from 48 women and 24 men from a suburban primary care clinic (Study 2). Patients provided early memory narratives and completed self-report measures of psychopathology, trauma, and health care utilization. In both studies, lower scores on the Mental Health scale and higher scores on the Traumatic Experiences scale were related to higher scores on measures of psychopathology and childhood trauma. Less consistent associations were found between the Mental Health and Traumatic Experiences scores and measures of health care utilization. The Narrative Coherence scale showed inconsistent relationships across measures in both samples. In analyses assessing the overall fit between hypothesized and actual correlations between EMI scores and measures of psychopathology, severity of trauma symptoms, and health care utilization, the Mental Health scale of the EMI demonstrated stronger convergent validity than the EMI Traumatic Experiences scale. The results provide support for the convergent validity of the Mental Health scale of the EMI.

The Adolescent Substance Abuse Goal Commitment (ASAGC) Questionnaire: An Examination of Clinical Utility and Psychometric Properties.

PubMed

Kaminer, Yifrah; Ohannessian, Christine McCauley; McKay, James R; Burke, Rebecca H

2016-02-01

Commitment to change is an innovative potential mediator or mechanism of behavior change that has not been examined in adolescents with substance use disorders (SUD). The Adolescent Substance Abuse Goal Commitment (ASAGC) questionnaire is a 16-item measure developed to assess an individual's commitment to his/her stated treatment goal. The objectives of this study are to explore the research and clinical utility of the commitment construct as measured by the ASAGC. During sessions 3 and 9 of a 10-week SUD treatment, therapists completed the ASAGC for 170 13-18 year-old adolescents. An exploratory factor analysis was conducted on the ATAGC items. Concurrent validity with related constructs, self-efficacy and motivation for change, was examined as well. At both sessions, the factor analysis resulted in two scales--Commitment to Recovery and Commitment to Harm Reduction. The ASAGC scales were found to demonstrate a high level of internal consistency (alpha coefficients ranged from .92 to .96 over time). In contrast to the Commitment to Harm Reduction scale, the Commitment to Recovery scale consistently correlated with scales from the Situational Confidence Questionnaire assessing self-efficacy, evidencing concurrent validity. Similarly, the Commitment to Recovery scale was related to the Problem Recognition Questionnaire, providing further evidence of the validity of the ASAGC. The ASAGC is a reliable and valid clinical research instrument for the assessment of adolescents' commitment to their substance abuse treatment goal. Clinical researchers may take advantage of the clinical utility of the ASAGC including its ability to differentiate between commitment to abstinence versus commitment to harm reduction. Copyright © 2015 Elsevier Inc. All rights reserved.

Assessment of validity with polytrauma Veteran populations.

PubMed

Bush, Shane S; Bass, Carmela

2015-01-01

Veterans with polytrauma have suffered injuries to multiple body parts and organs systems, including the brain. The injuries can generate a triad of physical, neurologic/cognitive, and emotional symptoms. Accurate diagnosis is essential for the treatment of these conditions and for fair allocation of benefits. To accurately diagnose polytrauma disorders and their related problems, clinicians take into account the validity of reported history and symptoms, as well as clinical presentations. The purpose of this article is to describe the assessment of validity with polytrauma Veteran populations. Review of scholarly and other relevant literature and clinical experience are utilized. A multimethod approach to validity assessment that includes objective, standardized measures increases the confidence that can be placed in the accuracy of self-reported symptoms and physical, cognitive, and emotional test results. Due to the multivariate nature of polytrauma and the multiple disciplines that play a role in diagnosis and treatment, an ideal model of validity assessment with polytrauma Veteran populations utilizes neurocognitive, neurological, neuropsychiatric, and behavioral measures of validity. An overview of these validity assessment approaches as applied to polytrauma Veteran populations is presented. Veterans, the VA, and society are best served when accurate diagnoses are made.

Measurement properties, feasibility and clinical utility of the Doloplus-2 pain scale in older adults with cognitive impairment: a systematic review.

PubMed

Rostad, Hanne Marie; Utne, Inger; Grov, Ellen Karine; Puts, Martine; Halvorsrud, Liv

2017-11-02

The Doloplus-2 is a pain assessment scale for assessing pain in older adults with cognitive impairment. It is used in clinical practice and research. However, evidence for its measurement properties, feasibility and clinical utility remain incomplete. This systematic review synthesizes previous research on the measurement properties, feasibility and clinical utility of the scale. We conducted a systematic search in three databases (CINAHL, Medline and PsycINFO) for studies published in English, French, German, Dutch/Flemish or a Scandinavian language between 1990 and April 2017. We also reviewed the Doloplus-2 homepage and reference lists of included studies to supplement our search. Two reviewers independently reviewed titles and abstracts and performed the quality assessment and data abstraction. A total of 24 studies were included in this systematic review. The quality of the studies varied, but many lacked sufficient detail about the samples and response rates. The Doloplus-2 has been studied using diverse samples in a variety of settings; most study participants were in long-term care and in people with dementia. Sixteen studies addressed various aspects of the scale's feasibility and clinical utility, but their results are limited and inconsistent across settings and samples. Support for the scale's reliability, validity and responsiveness varied widely across the studies. Generally, the reliability coefficients reached acceptable benchmarks, but the evidence for different aspects of the scale's validity and responsiveness was incomplete. Additional high-quality studies are warranted to determine in which populations of older adults with cognitive impairment the Doloplus-2 is reliable, valid and feasible. The ability of the Doloplus-2 to meaningfully quantify pain, measure treatment response and improve patient outcomes also needs further investigation. PROSPERO reg. no.: CRD42016049697 registered 20. Oct. 2016.

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

ERIC Educational Resources Information Center

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

2012-01-01

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

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

PubMed

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

2011-01-01

Feedback to aid teachers in improving their teaching requires validated evaluation instruments. When implementing an evaluation instrument in a different context, it is important to collect validity evidence from multiple sources. We examined the validity and reliability of the Maastricht Clinical Teaching Questionnaire (MCTQ) as an instrument to evaluate individual clinical teachers during short clinical rotations in veterinary education. We examined four sources of validity evidence: (1) Content was examined based on theory of effective learning. (2) Response process was explored in a pilot study. (3) Internal structure was assessed by confirmatory factor analysis using 1086 student evaluations and reliability was examined utilizing generalizability analysis. (4) Relations with other relevant variables were examined by comparing factor scores with other outcomes. Content validity was supported by theory underlying the cognitive apprenticeship model on which the instrument is based. The pilot study resulted in an additional question about supervision time. A five-factor model showed a good fit with the data. Acceptable reliability was achievable with 10-12 questionnaires per teacher. Correlations between the factors and overall teacher judgement were strong. The MCTQ appears to be a valid and reliable instrument to evaluate clinical teachers' performance during short rotations.

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

Cancer.gov

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

Estimation of utilities in attention-deficit hyperactivity disorder for economic evaluations.

PubMed

Lloyd, Andrew; Hodgkins, Paul; Sasane, Rahul; Akehurst, Ron; Sonuga-Barke, Edmund J S; Fitzgerald, Patrick; Nixon, Annabel; Erder, Haim; Brazier, John

2011-01-01

Attempts to estimate the cost effectiveness of attention-deficit hyperactivity disorder (ADHD) treatments in the past have relied on classifying ADHD patients as responders or non-responders to treatment. Responder status has been associated with a small gain in health-related quality of life (HR-QOL) [or utility, as measured using the generic QOL measure EQ-5D] of 0.06 (on a scale from 0 being dead to 1.0 being full health). The goal of the present study was to develop and validate several ADHD-related health states, and to estimate utility values measured amongst the general public for those states and to re-estimate utility values associated with responder status. Detailed qualitative interview data were collected from 20 young ADHD patients to characterize their HR-QOL. In addition, item-by-item clinical and HR-QOL data from a clinical trial were used to define and describe four health states (normal; borderline to mildly ill; moderately to markedly ill; and severely ill). ADHD experts assessed the content validity of the descriptions. The states were rated by 100 members of the UK general public using the time trade-off (TTO) interview and visual analog scale. Statistical mapping was also undertaken to estimate Clinical Global Impression-Improvement (CGI-I) utilities (i.e. response status) from Clinical Global Impression-Severity (CGI-S) defined states. The mapping work estimated changes in utilities from study baseline to last visit for patients with a CGI-I score of ≤ 2 or ≤ 3. The validity of the four health states developed in this study was supported by in-depth interviews with ADHD experts and patients, and clinical trial data. TTO-derived utilities for the four health states ranged from 0.839 (CGI-S state 'normal') to 0.444 (CGI-S state 'severely ill'). From the mapping work, the change in utility for treatment responders was 0.19 for patients with a CGI-I score of ≤ 2 and 0.15 for patients with a CGI-I score of ≤ 3. The present study provides utilities for different severity levels of ADHD estimated in a TTO study. This approach provides a more granular assessment of the impact of ADHD on HR-QOL than binary approaches employed in previous economic analyses. Change in utility for responders and non-responders at different levels of CGI-I was estimated, and thus these utilities may be used to compare health gains of different ADHD interventions.

Clinical evidence supporting pharmacogenomic biomarker testing provided in US Food and Drug Administration drug labels.

PubMed

Wang, Bo; Canestaro, William J; Choudhry, Niteesh K

2014-12-01

Genetic biomarkers that predict a drug's efficacy or likelihood of toxicity are assuming increasingly important roles in the personalization of pharmacotherapy, but concern exists that evidence that links use of some biomarkers to clinical benefit is insufficient. Nevertheless, information about the use of biomarkers appears in the labels of many prescription drugs, which may add confusion to the clinical decision-making process. To evaluate the evidence that supports pharmacogenomic biomarker testing in drug labels and how frequently testing is recommended. Publicly available US Food and Drug Administration databases. We identified drug labels that described the use of a biomarker and evaluated whether the label contained or referenced convincing evidence of its clinical validity (ie, the ability to predict phenotype) and clinical utility (ie, the ability to improve clinical outcomes) using guidelines published by the Evaluation of Genomic Applications in Practice and Prevention Working Group. We graded the completeness of the citation of supporting studies and determined whether the label recommended incorporation of biomarker test results in therapeutic decision making. Of the 119 drug-biomarker combinations, only 43 (36.1%) had labels that provided convincing clinical validity evidence, whereas 18 (15.1%) provided convincing evidence of clinical utility. Sixty-one labels (51.3%) made recommendations about how clinical decisions should be based on the results of a biomarker test; 36 (30.3%) of these contained convincing clinical utility data. A full description of supporting studies was included in 13 labels (10.9%). Fewer than one-sixth of drug labels contained or referenced convincing evidence of clinical utility of biomarker testing, whereas more than half made recommendations based on biomarker test results. It may be premature to include biomarker testing recommendations in drug labels when convincing data that link testing to patient outcomes do not exist.

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

PubMed

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

2010-01-01

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

Personal Care Participation Assessment and Resource Tool: Clinical utility for inpatient rehabilitation.

PubMed

Darzins, Susan W; Imms, Christine; Stefano, Marilyn Di; Radia-George, Camilla A

2016-10-01

Evidence supports validity of the Personal Care Participation Assessment and Resource Tool (PC-PART), but clinical utility remains unverified. This study aimed to investigate occupational therapists' perceptions about the PC-PART's clinical utility for inpatient rehabilitation. Using mixed methods, occupational therapists who had used the PC-PART as part of a research study in an inpatient rehabilitation setting completed a questionnaire ( n = 9) and participated in a focus group ( n = 6) to explore their perspectives about its clinical utility. Quantitative data were summarized and qualitative data analyzed using inductive thematic analysis. Quantitative data highlighted both positive and negative aspects of the PC-PART's clinical utility. Five themes emerged from the qualitative data: nature of information gathered; familiarity with the instrument; perceived time and effort; item phrasing, interpretation, and presentation; and external influences on clinical use. The PC-PART was perceived to support gathering of clinically useful information, helpful to intervention and discharge planning. Recommendations for improving some item phrasing, operational definitions, and instructions were identified. Although standardized assessments were valued, use in routine practice was challenging, requiring a knowledge translation strategy.

The impact of clinical nurse specialists on clinical pathways in the application of evidence-based practice.

PubMed

Gurzick, Martha; Kesten, Karen S

2010-01-01

The purpose of this article was to address the call for evidence-based practice through the development of clinical pathways and to assert the role of the clinical nurse specialist (CNS) as a champion in clinical pathway implementation. In the current health care system, providing quality of care while maintaining cost-effectiveness is an ever-growing battle that institutions face. The CNS's role is central to meeting these demands. An extensive literature review has been conducted to validate the use of clinical pathways as a means of improving patient outcomes. This literature also suggests that clinical pathways must be developed, implemented, and evaluated utilizing validated methods including the use of best practice standards. Execution of clinical pathways should include a clinical expert, who has the ability to look at the system as a whole and can facilitate learning and change by employing a multitude of competencies while maintaining a sphere of influence over patient and families, nurses, and the system. The CNS plays a pivotal role in influencing effective clinical pathway development, implementation, utilization, and ongoing evaluation to ensure improved patient outcomes and reduced costs. This article expands upon the call for evidence-based practice through the utilization of clinical pathways to improve patient outcomes and reduce costs and stresses the importance of the CNS as a primary figure for ensuring proper pathway development, implementation, and ongoing evaluation. Copyright 2010 Elsevier Inc. All rights reserved.

Utility analysis and calibration of QOL assessment in disease management.

PubMed

Liu, Mo

2018-05-02

In clinical trials, the assessment of health-related quality of life (QOL) (or patient-reported outcome [PRO] measure) has become very popular especially for clinical studies conducted for evaluating clinical benefits of patients with chronic, severe, and/or life threatening diseases. Health-related QOL information and PRO measures are useful for disease management for achieving best clinical practice. In this article, we will focus on health-related QOL assessment. The concept, design, and analysis of health-related QOL in clinical trials are reviewed. Validation of the use of health-related QOL instrument in terms of some key performance characteristics such as accuracy, reliability, sensitivity, and responsibility for assuring quality, integrity, and validity of collected QOL data are discussed. The concept of utility analysis and calibration (e.g., with respect to life events) for achieving the optimization of disease management are proposed. The change of the QOL could be translated into different life events for effective disease management. These translations could evaluate the treatment effect by more directly displaying the change of the QOL.

Is personalized medicine achievable in obstetrics?

PubMed

Quinney, Sara K; Patil, Avinash S; Flockhart, David A

2014-12-01

Personalized medicine seeks to identify the right dose of the right drug for the right patient at the right time. Typically, individualization of therapy is based on the pharmacogenomic makeup of the individual and environmental factors that alter drug disposition and response. In addition to these factors, during pregnancy, a woman's body undergoes many changes that can impact the therapeutic efficacy of medications. Yet, there is minimal research regarding personalized medicine in obstetrics. Adoption of pharmacogenetic testing into the obstetrical care is dependent on evidence of analytical validity, clinical validity, and clinical utility. Here, we briefly present information regarding the potential utility of personalized medicine for treating the obstetric patient for pain with narcotics, hypertension, and preterm labor, and discuss the impediments of bringing personalized medicine to the obstetrical clinic. Copyright © 2014 Elsevier Inc. All rights reserved.

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

PubMed

Greenslade, Kathryn J; Coggins, Truman E

2014-01-01

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

The MMPI-2 Restructured Clinical Scales in the Assessment of Posttraumatic Stress Disorder and Comorbid Disorders

PubMed Central

Wolf, Erika J.; Miller, Mark W.; Orazem, Robert J.; Weierich, Mariann R.; Castillo, Diane T.; Milford, Jaime; Kaloupek, Danny G.; Keane, Terence M.

2008-01-01

This study examined the psychometric properties of the Minnesota Multiphasic Personality Inventory-2 (MMPI-2) Restructured Clinical Scales (RCSs) in individuals with posttraumatic stress disorder (PTSD) receiving clinical services at Veterans Affairs medical centers. Study 1 included 1,098 men who completed the MMPI-2 and were assessed for a range of psychological disorders via structured clinical interview. Study 2 included 136 women who completed the MMPI-2 and were interviewed with the Clinician Administered Scale for PTSD. The utility of the RCSs was compared to that of the Clinical Scales (CSs) and the Keane PTSD (PK) scale. The RCSs demonstrated good psychometric properties along with patterns of associations with other measures of psychopathology that corresponded to current theory regarding the structure of comorbidity. A notable advantage of the RCSs compared to the MMPI-2 CSs was their enhanced construct validity and clinical utility in the assessment of comorbid internalizing and externalizing psychopathology. The PK scale demonstrated incremental validity in the prediction of PTSD beyond that of the RCSs or CSs. PMID:19086756

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

PubMed

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

2015-01-01

The purpose of this study was to examine the clinical utility of three recently developed validity scales (Validity-10, NIM5, and LOW6) designed to screen for symptom exaggeration using the Neurobehavioral Symptom Inventory (NSI). Participants were 272 U.S. military service members who sustained a mild, moderate, severe, or penetrating traumatic brain injury (TBI) and who were evaluated by the neuropsychology service at Walter Reed Army Medical Center within 199 weeks post injury. Participants were divided into two groups based on the Negative Impression Management scale of the Personality Assessment Inventory: (a) those who failed symptom validity testing (SVT-fail; n = 27) and (b) those who passed symptom validity testing (SVT-pass; n = 245). Participants in the SVT-fail group had significantly higher scores (p<.001) on the Validity-10, NIM5, LOW6, NSI total, and Personality Assessment Inventory (PAI) clinical scales (range: d = 0.76 to 2.34). Similarly high sensitivity, specificity, positive predictive power (PPP), and negative predictive (NPP) values were found when using all three validity scales to differentiate SVT-fail versus SVT-pass groups. However, the Validity-10 scale consistently had the highest overall values. The optimal cutoff score for the Validity-10 scale to identify possible symptom exaggeration was ≥19 (sensitivity = .59, specificity = .89, PPP = .74, NPP = .80). For the majority of people, these findings provide support for the use of the Validity-10 scale as a screening tool for possible symptom exaggeration. When scores on the Validity-10 exceed the cutoff score, it is recommended that (a) researchers and clinicians do not interpret responses on the NSI, and (b) clinicians follow up with a more detailed evaluation, using well-validated symptom validity measures (e.g., Minnesota Multiphasic Personality Inventory-2 Restructured Form, MMPI-2-RF, validity scales), to seek confirmatory evidence to support an hypothesis of symptom exaggeration.

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

DTIC Science & Technology

2016-10-01

Study (PASS). We are in the process of evaluating these three biomarker panels in tissue, blood, and urine samples with well annotated clinical and...impacting both the initial choice of therapy and decision-making during AS. The objective of the study is to utilize analytically validated assays that...predict reclassification from Gleason 6 cancer to Gleason 7 or greater. The analysis plan was determined before specimens were selected for the study

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

DTIC Science & Technology

2016-10-01

Study (PASS). We are in the process of evaluating these three biomarker panels in tissue, blood, and urine samples with well annotated clinical and...choice of therapy and decision-making during AS. The objective of the study is to utilize analytically validated assays that take into account tumor...Gleason 6 cancer to Gleason 7 or greater. The analysis plan was determined before specimens were selected for the study , and included 7 breaking

Evaluating a Dental Diagnostic Terminology in an Electronic Health Record

PubMed Central

White, Joel M.; Kalenderian, Elsbeth; Stark, Paul C.; Ramoni, Rachel L.; Vaderhobli, Ram; Walji, Muhammad F.

2011-01-01

Standardized treatment procedure codes and terms are routinely used in dentistry. Utilization of a diagnostic terminology is common in medicine, but there is not a satisfactory or commonly standardized dental diagnostic terminology available at this time. Recent advances in dental informatics have provided an opportunity for inclusion of diagnostic codes and terms as part of treatment planning and documentation in the patient treatment history. This article reports the results of the use of a diagnostic coding system in a large dental school’s predoctoral clinical practice. A list of diagnostic codes and terms, called Z codes, was developed by dental faculty members. The diagnostic codes and terms were implemented into an electronic health record (EHR) for use in a predoctoral dental clinic. The utilization of diagnostic terms was quantified. The validity of Z code entry was evaluated by comparing the diagnostic term entered to the procedure performed, where valid diagnosis-procedure associations were determined by consensus among three calibrated academically based dentists. A total of 115,004 dental procedures were entered into the EHR during the year sampled. Of those, 43,053 were excluded from this analysis because they represent diagnosis or other procedures unrelated to treatments. Among the 71,951 treatment procedures, 27,973 had diagnoses assigned to them with an overall utilization of 38.9 percent. Of the 147 available Z codes, ninety-three were used (63.3 percent). There were 335 unique procedures provided and 2,127 procedure/diagnosis pairs captured in the EHR. Overall, 76.7 percent of the diagnoses entered were valid. We conclude that dental diagnostic terminology can be incorporated within an electronic health record and utilized in an academic clinical environment. Challenges remain in the development of terms and implementation and ease of use that, if resolved, would improve the utilization. PMID:21546594

Systematic review of the clinical and economic value of gene expression profiles for invasive early breast cancer available in Europe.

PubMed

Blok, E J; Bastiaannet, E; van den Hout, W B; Liefers, G J; Smit, V T H B M; Kroep, J R; van de Velde, C J H

2018-01-01

Gene expression profiles with prognostic capacities have shown good performance in multiple clinical trials. However, with multiple assays available and numerous types of validation studies performed, the added value for daily clinical practice is still unclear. In Europe, the MammaPrint, OncotypeDX, PAM50/Prosigna and Endopredict assays are commercially available. In this systematic review, we aim to assess these assays on four important criteria: Assay development and methodology, clinical validation, clinical utility and economic value. We performed a literature search covering PubMed, Embase, Web of Science and Cochrane, for studies related to one or more of the four selected assays. We identified 147 papers for inclusion in this review. MammaPrint and OncotypeDX both have evidence available, including level IA clinical trial results for both assays. Both assays provide prognostic information. Predictive value has only been shown for OncotypeDX. In the clinical utility studies, a higher reduction in chemotherapy was achieved by OncotypeDX, although the number of available studies differ considerably between tests. On average, economic evaluations estimate that genomic testing results in a moderate increase in total costs, but that these costs are acceptable in relation to the expected improved patient outcome. PAM50/prosigna and EndoPredict showed comparable prognostic capacities, but with less economical and clinical utility studies. Furthermore, for these assays no level IA trial data are available yet. In summary, all assays have shown excellent prognostic capacities. The differences in the quantity and quality of evidence are discussed. Future studies shall focus on the selection of appropriate subgroups for testing and long-term outcome of validation trials, in order to determine the place of these assays in daily clinical practice. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

75 FR 23781 - Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-04

... for the Clinical Laboratory Improvement Amendments of 1988 Categorization AGENCY: Food and Drug... notice solicits comments on administrative procedures for the Clinical Laboratory Improvement Amendments..., including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility...

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

DTIC Science & Technology

2017-10-01

mRNA and has been shown in many studies to improve predictive accuracy for cancer on initial biopsy,3,7-9 and to be correlated with more aggressive... Study (PASS). We are in the process of evaluating these three biomarker panels in tissue, blood, and urine samples with well annotated clinical and...during AS. The objective of the study is to utilize analytically validated assays that take into account tumor heterogeneity to measure biomarkers in

Longitudinal construct validity of the minimum data set health status index.

PubMed

Jones, Aaron; Feeny, David; Costa, Andrew P

2018-05-24

The Minimum Data Set Health Status Index (MDS-HSI) is a generic, preference-based health-related quality of life (HRQOL) measure derived by mapping items from the Resident Assessment Instrument - Minimum Data Set (RAI-MDS) assessment onto the Health Utilities Index Mark 2 classification system. While the validity of the MDS-HSI has been examined in cross-sectional settings, the longitudinal validity has not been explored. The objective of this study was to investigate the longitudinal construct validity of the MDS-HSI in a home care population. This study utilized a retrospective cohort of home care patients in the Hamilton-Niagara-Haldimand-Brant health region of Ontario, Canada with at least two RAI-MDS Home Care assessments between January 2010 and December 2014. Convergent validity was assessed by calculating Spearman rank correlations between the change in MDS-HSI and changes in six validated indices of health domains that can be calculated from the RAI-MDS assessment. Known-groups validity was investigated by fitting multivariable linear regression models to estimate the mean change in MDS-HSI associated with clinically important changes in the six health domain indices and 15 disease symptoms from the RAI-MDS Home Care assessment, controlling for age and sex. The cohort contained 25,182 patients with two RAI-MDS Home Care assessments. Spearman correlations between the MDS-HSI change and changes in the health domain indices were all statistically significant and in the hypothesized small to moderate range [0.1 < ρ < 0.5]. Clinically important changes in all of the health domain indices and 13 of the 15 disease symptoms were significantly associated with clinically important changes in the MDS-HSI. The findings of this study support the longitudinal construct validity of the MDS-HSI in home care populations. In addition to evaluating changes in HRQOL among home care patients in clinical research, economic evaluation, and health technology assessment, the MDS-HSI may be used in system-level applications using routinely collected population-level data.

Reading the Road Signs: The Utility of the MMPI-2 Restructured Form Validity Scales in Prediction of Premature Termination.

PubMed

Anestis, Joye C; Finn, Jacob A; Gottfried, Emily; Arbisi, Paul A; Joiner, Thomas E

2015-06-01

This study examined the utility of the Minnesota Multiphasic Personality Inventory-2 Restructured Form (MMPI-2-RF) Validity Scales in prediction of premature termination in a sample of 511 individuals seeking services from a university-based psychology clinic. Higher scores on True Response Inconsistency-Revised and Infrequent Psychopathology Responses increased the risk of premature termination, whereas higher scores on Adjustment Validity lowered the risk of premature termination. Additionally, when compared with individuals who did not prematurely terminate, individuals who prematurely terminated treatment had lower Global Assessment of Functioning scores at both intake and termination and made fewer improvements. Implications of these findings for the use of the MMPI-2-RF Validity Scales in promoting treatment compliance are discussed. © The Author(s) 2014.

The Clinical Utility of Personality Subtypes in Patients with Anorexia Nervosa

ERIC Educational Resources Information Center

Wildes, Jennifer E.; Marcus, Marsha D.; Crosby, Ross D.; Ringham, Rebecca M.; Dapelo, Marcela Marin; Gaskill, Jill A.; Forbush, Kelsie T.

2011-01-01

Objective: Elucidation of clinically relevant subtypes has been proposed as a means of advancing treatment research, but classifying anorexia nervosa (AN) patients into restricting and binge-eating/purging types has demonstrated limited predictive validity. This study aimed to evaluate whether an approach to classifying eating disorder patients on…

Item Analysis to Improve Reliability for an Internal Medicine Undergraduate OSCE

ERIC Educational Resources Information Center

Auewarakul, Chirayu; Downing, Steven M.; Praditsuwan, Rungnirand; Jaturatamrong, Uapong

2005-01-01

Utilization of objective structured clinical examinations (OSCEs) for final assessment of medical students in Internal Medicine requires a representative sample of OSCE stations. The reliability and generalizability of OSCE scores provides validity evidence for OSCE scores and supports its contribution to the final clinical grade of medical…

Clinical utility and validation of the Couple's Communicative Evaluation Scale.

PubMed

West, Craig E

2005-10-01

This study assessed the validity and clinical utility of a new test, the Couple's Communicative Evaluation Scale. With 24 couples from a variety of resources, e.g., churches, newspaper, and colleges, a discriminant analysis using the Dyadic Adjustment Scale, indicated that satisfied couples could be discriminated from issatisfied couples with 91-96% accuracy. Significant differences on the scale were found for means between 7 distressed and 16 nondistressed couples using the satisfaction/dissatisfaction cutoff score of 200 on the Dyadic Adjustment Scale and significant differences on the individual scales were found for means between 16 distressed and 31 nondistressed individuals using the satisfaction/dissatisfaction cutoff score of 100 on the Dyadic Adjustment Scale. Demographic variables, e.g., age, marriage length, were statistically significant. Scale scores were highly correlated with those on the Dyadic Adjustment Scale, indicating good validity. Using all 400 items, an alpha of .99 indicated good internal consistency for the verbal, nonverbal, and listening communication scores.

Consumer Sleep Technology: An American Academy of Sleep Medicine Position Statement.

PubMed

Khosla, Seema; Deak, Maryann C; Gault, Dominic; Goldstein, Cathy A; Hwang, Dennis; Kwon, Younghoon; O'Hearn, Daniel; Schutte-Rodin, Sharon; Yurcheshen, Michael; Rosen, Ilene M; Kirsch, Douglas B; Chervin, Ronald D; Carden, Kelly A; Ramar, Kannan; Aurora, R Nisha; Kristo, David A; Malhotra, Raman K; Martin, Jennifer L; Olson, Eric J; Rosen, Carol L; Rowley, James A

2018-05-15

Consumer sleep technologies (CSTs) are widespread applications and devices that purport to measure and even improve sleep. Sleep clinicians may frequently encounter CST in practice and, despite lack of validation against gold standard polysomnography, familiarity with these devices has become a patient expectation. This American Academy of Sleep Medicine position statement details the disadvantages and potential benefits of CSTs and provides guidance when approaching patient-generated health data from CSTs in a clinical setting. Given the lack of validation and United States Food and Drug Administration (FDA) clearance, CSTs cannot be utilized for the diagnosis and/or treatment of sleep disorders at this time. However, CSTs may be utilized to enhance the patient-clinician interaction when presented in the context of an appropriate clinical evaluation. The ubiquitous nature of CSTs may further sleep research and practice. However, future validation, access to raw data and algorithms, and FDA oversight are needed. © 2018 American Academy of Sleep Medicine.

External validation of a simple clinical tool used to predict falls in people with Parkinson disease

PubMed Central

Duncan, Ryan P.; Cavanaugh, James T.; Earhart, Gammon M.; Ellis, Terry D.; Ford, Matthew P.; Foreman, K. Bo; Leddy, Abigail L.; Paul, Serene S.; Canning, Colleen G.; Thackeray, Anne; Dibble, Leland E.

2015-01-01

Background Assessment of fall risk in an individual with Parkinson disease (PD) is a critical yet often time consuming component of patient care. Recently a simple clinical prediction tool based only on fall history in the previous year, freezing of gait in the past month, and gait velocity <1.1 m/s was developed and accurately predicted future falls in a sample of individuals with PD. METHODS We sought to externally validate the utility of the tool by administering it to a different cohort of 171 individuals with PD. Falls were monitored prospectively for 6 months following predictor assessment. RESULTS The tool accurately discriminated future fallers from non-fallers (area under the curve [AUC] = 0.83; 95% CI 0.76 –0.89), comparable to the developmental study. CONCLUSION The results validated the utility of the tool for allowing clinicians to quickly and accurately identify an individual’s risk of an impending fall. PMID:26003412

External validation of a simple clinical tool used to predict falls in people with Parkinson disease.

PubMed

Duncan, Ryan P; Cavanaugh, James T; Earhart, Gammon M; Ellis, Terry D; Ford, Matthew P; Foreman, K Bo; Leddy, Abigail L; Paul, Serene S; Canning, Colleen G; Thackeray, Anne; Dibble, Leland E

2015-08-01

Assessment of fall risk in an individual with Parkinson disease (PD) is a critical yet often time consuming component of patient care. Recently a simple clinical prediction tool based only on fall history in the previous year, freezing of gait in the past month, and gait velocity <1.1 m/s was developed and accurately predicted future falls in a sample of individuals with PD. We sought to externally validate the utility of the tool by administering it to a different cohort of 171 individuals with PD. Falls were monitored prospectively for 6 months following predictor assessment. The tool accurately discriminated future fallers from non-fallers (area under the curve [AUC] = 0.83; 95% CI 0.76-0.89), comparable to the developmental study. The results validated the utility of the tool for allowing clinicians to quickly and accurately identify an individual's risk of an impending fall. Copyright © 2015 Elsevier Ltd. All rights reserved.

Prospective pilots of routine data capture by paediatricians in clinics and validation of the Disabilities Complexity Scale.

PubMed

Horridge, Karen A; Mcgarry, Kenneth; Williams, Jane; Whitlingum, Gabriel

2016-06-01

To pilot prospective data collection by paediatricians at the point of care across England using a defined terminology set; demonstrate feasibility of data collection and utility of data outputs; and confirm that counting the number of needs per child is valid for quantifying complexity. Paediatricians in 16 hospital and community settings collected and anonymized data. Participants completed a survey regarding the process. Data were analysed using R version 3.1.2. Overall, 8117 needs captured from 1224 consultations were recorded. Sixteen clinicians responded positively about the process and utility of data collection. The sum of needs varied significantly (p<0.01) by level of gross motor function ascertained using the Gross Motor Function Classification System for children with cerebral palsy; epilepsy severity as defined by level of expertise required to manage it; and by severity of intellectual disability. Prospective data collection at the point of clinical care proved possible without disrupting clinics, even for those with the most complex needs, and took the least time when done electronically. Counting the number of needs was easy to do, and quantified complexity in a way that informed clinical care for individuals and related directly to validated scales of functioning. Data outputs could inform more appropriate design and commissioning of quality services. © 2016 Mac Keith Press.

Prognostic and Prediction Tools in Bladder Cancer: A Comprehensive Review of the Literature.

PubMed

Kluth, Luis A; Black, Peter C; Bochner, Bernard H; Catto, James; Lerner, Seth P; Stenzl, Arnulf; Sylvester, Richard; Vickers, Andrew J; Xylinas, Evanguelos; Shariat, Shahrokh F

2015-08-01

This review focuses on risk assessment and prediction tools for bladder cancer (BCa). To review the current knowledge on risk assessment and prediction tools to enhance clinical decision making and counseling of patients with BCa. A literature search in English was performed using PubMed in July 2013. Relevant risk assessment and prediction tools for BCa were selected. More than 1600 publications were retrieved. Special attention was given to studies that investigated the clinical benefit of a prediction tool. Most prediction tools for BCa focus on the prediction of disease recurrence and progression in non-muscle-invasive bladder cancer or disease recurrence and survival after radical cystectomy. Although these tools are helpful, recent prediction tools aim to address a specific clinical problem, such as the prediction of organ-confined disease and lymph node metastasis to help identify patients who might benefit from neoadjuvant chemotherapy. Although a large number of prediction tools have been reported in recent years, many of them lack external validation. Few studies have investigated the clinical utility of any given model as measured by its ability to improve clinical decision making. There is a need for novel biomarkers to improve the accuracy and utility of prediction tools for BCa. Decision tools hold the promise of facilitating the shared decision process, potentially improving clinical outcomes for BCa patients. Prediction models need external validation and assessment of clinical utility before they can be incorporated into routine clinical care. We looked at models that aim to predict outcomes for patients with bladder cancer (BCa). We found a large number of prediction models that hold the promise of facilitating treatment decisions for patients with BCa. However, many models are missing confirmation in a different patient cohort, and only a few studies have tested the clinical utility of any given model as measured by its ability to improve clinical decision making. Copyright © 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Validation in the clinical process: four settings for objectification of the subjectivity of understanding.

PubMed

Beland, H

1994-12-01

Clinical material is presented for discussion with the aim of exemplifying the author's conceptions of validation in a number of sessions and in psychoanalytic research and of making them verifiable, susceptible to consensus and/or falsifiable. Since Freud's postscript to the Dora case, the first clinical validation in the history of psychoanalysis, validation has been group-related and society-related, that is to say, it combines the evidence of subjectivity with the consensus of the research community (the scientific community). Validation verifies the conformity of the unconscious transference meaning with the analyst's understanding. The deciding criterion is the patient's reaction to the interpretation. In terms of the theory of science, validation in the clinical process corresponds to experimental testing of truth in the sphere of inanimate nature. Four settings of validation can be distinguished: the analyst's self-supervision during the process of understanding, which goes from incomprehension to comprehension (container-contained, PS-->D, selected fact); the patient's reaction to the interpretation (insight) and the analyst's assessment of the reaction; supervision and second thoughts; and discussion in groups and publications leading to consensus. It is a peculiarity of psychoanalytic research that in the event of positive validation the three criteria of truth (evidence, consensus and utility) coincide.

The Reliability and Validity of Self- and Investigator Ratings of ADHD in Adults

ERIC Educational Resources Information Center

Adler, Lenard A.; Faraone, Stephen V.; Spencer, Thomas J.; Michelson, David; Reimherr, Frederick W.; Glatt, Stephen J.; Marchant, Barrie K.; Biederman, Joseph

2008-01-01

Objective: Little information is available comparing self- versus investigator ratings of symptoms in adult ADHD. The authors compared the reliability, validity, and utility in a sample of adults with ADHD and also as an index of clinical improvement during treatment of self- and investigator ratings of ADHD symptoms via the Conners Adult ADHD…

The Mini Alcohol Craving Experience Questionnaire: Development and Clinical Application.

PubMed

Coates, Jason M; Gullo, Matthew J; Feeney, Gerald F X; Kavanagh, David J; Young, Ross McD; Dingle, Genevieve A; May, Jon; Andrade, Jackie; Statham, Dixie J; Connor, Jason P

2017-01-01

Standardized alcohol craving scales are rarely used outside of research environments despite recognized clinical utility. Scale length is a key barrier to more widespread application. A brief measure of alcohol craving is needed to improve research and treatment of alcohol use disorders (AUDs). Grounded in the Elaborated Intrusion Theory of Desire, the Alcohol Craving Experience (ACE) Questionnaire comprises two 11-item self-report scales that assess past-week frequency and maximum strength of alcohol craving. This study aimed to create a brief version of the ACE while maintaining psychometric integrity and clinical utility. Patients attending a university hospital alcohol and drug outpatient service for the treatment of AUD completed the ACE as part of a questionnaire battery. Three patient samples were utilized: 519 patients with pretreatment and outcome data, 228 patients with pretreatment data, and 66 patients who completed the ACE at treatment sessions 1 and 2. The Frequency scale of the ACE possessed greater clinical utility and predictive validity than the Strength scale. Revision of the Frequency measure produced a 5-item "Mini Alcohol Craving Experience" (MACE) Questionnaire. Satisfactory validity (construct, predictive, concurrent, convergent, and incremental) and reliability (internal and test-retest) were maintained. A 1 standard deviation increase in pretreatment MACE score was associated with a 54 percentage increase in the odds of patient lapse or dropout. The MACE provides a brief, theoretically, and psychometrically robust measure of alcohol craving suitable for use with AUD populations in time-limited clinical and research settings. Copyright © 2016 by the Research Society on Alcoholism.

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

PubMed

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

2018-04-24

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

Pain assessment for people with dementia: a systematic review of systematic reviews of pain assessment tools.

PubMed

Lichtner, Valentina; Dowding, Dawn; Esterhuizen, Philip; Closs, S José; Long, Andrew F; Corbett, Anne; Briggs, Michelle

2014-12-17

There is evidence of under-detection and poor management of pain in patients with dementia, in both long-term and acute care. Accurate assessment of pain in people with dementia is challenging and pain assessment tools have received considerable attention over the years, with an increasing number of tools made available. Systematic reviews on the evidence of their validity and utility mostly compare different sets of tools. This review of systematic reviews analyses and summarises evidence concerning the psychometric properties and clinical utility of pain assessment tools in adults with dementia or cognitive impairment. We searched for systematic reviews of pain assessment tools providing evidence of reliability, validity and clinical utility. Two reviewers independently assessed each review and extracted data from them, with a third reviewer mediating when consensus was not reached. Analysis of the data was carried out collaboratively. The reviews were synthesised using a narrative synthesis approach. We retrieved 441 potentially eligible reviews, 23 met the criteria for inclusion and 8 provided data for extraction. Each review evaluated between 8 and 13 tools, in aggregate providing evidence on a total of 28 tools. The quality of the reviews varied and the reporting often lacked sufficient methodological detail for quality assessment. The 28 tools appear to have been studied in a variety of settings and with varied types of patients. The reviews identified several methodological limitations across the original studies. The lack of a 'gold standard' significantly hinders the evaluation of tools' validity. Most importantly, the samples were small providing limited evidence for use of any of the tools across settings or populations. There are a considerable number of pain assessment tools available for use with the elderly cognitive impaired population. However there is limited evidence about their reliability, validity and clinical utility. On the basis of this review no one tool can be recommended given the existing evidence.

Brief reasons for living inventory: a psychometric investigation.

PubMed

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

2017-11-06

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

Biomarker-Guided Adaptive Trial Designs in Phase II and Phase III: A Methodological Review

PubMed Central

Antoniou, Miranta; Jorgensen, Andrea L; Kolamunnage-Dona, Ruwanthi

2016-01-01

Background Personalized medicine is a growing area of research which aims to tailor the treatment given to a patient according to one or more personal characteristics. These characteristics can be demographic such as age or gender, or biological such as a genetic or other biomarker. Prior to utilizing a patient’s biomarker information in clinical practice, robust testing in terms of analytical validity, clinical validity and clinical utility is necessary. A number of clinical trial designs have been proposed for testing a biomarker’s clinical utility, including Phase II and Phase III clinical trials which aim to test the effectiveness of a biomarker-guided approach to treatment; these designs can be broadly classified into adaptive and non-adaptive. While adaptive designs allow planned modifications based on accumulating information during a trial, non-adaptive designs are typically simpler but less flexible. Methods and Findings We have undertaken a comprehensive review of biomarker-guided adaptive trial designs proposed in the past decade. We have identified eight distinct biomarker-guided adaptive designs and nine variations from 107 studies. Substantial variability has been observed in terms of how trial designs are described and particularly in the terminology used by different authors. We have graphically displayed the current biomarker-guided adaptive trial designs and summarised the characteristics of each design. Conclusions Our in-depth overview provides future researchers with clarity in definition, methodology and terminology for biomarker-guided adaptive trial designs. PMID:26910238

Quality Management Tools: Facilitating Clinical Research Data Integrity by Utilizing Specialized Reports with Electronic Case Report Forms

PubMed Central

Trocky, NM; Fontinha, M

2005-01-01

Data collected throughout the course of a clinical research trial must be reviewed for accuracy and completeness continually. The Oracle Clinical® (OC) data management application utilized to capture clinical data facilitates data integrity through pre-programmed validations, edit and range checks, and discrepancy management modules. These functions were not enough. Coupled with the use of specially created reports in Oracle Discoverer® and Integrated Review TM, both ad-hoc query and reporting tools, research staff have enhanced their ability to clean, analyze and report more accurate data captured within and among Case Report Forms (eCRFs) by individual study or across multiple studies. PMID:16779428

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

PubMed

Mayo, Ann M

2015-01-01

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

Identifying role of perceived quality and satisfaction on the utilization status of the community clinic services; Bangladesh context.

PubMed

Karim, Rizwanul M; Abdullah, Mamun S; Rahman, Anisur M; Alam, Ashraful M

2016-06-24

Bangladesh is one among the few countries of the world that provides free medical services at the community level through various public health facilities. It is now evident that, clients' perceived quality of services and their expectations of service standards affect health service utilization to a great extent. The aim of the study was to develop and validate the measures for perception and satisfaction of primary health care quality in Bangladesh context and to identify their aspects on the utilization status of the Community Clinic services. This mixed method cross sectional survey was conducted from January to June 2012, in the catchment area of 12 community clinics. Since most of the outcome indicators focus mainly on women and children, women having children less than 2 years of age were randomly assigned and interviewed for the study purpose. Data were collected through FGD, Key informants interview and a pretested semi- structured questionnaire. About 95 % of the respondents were Muslims and 5 % were Hindus. The average age of the respondents was 23.38 (SD 4.15) and almost all of them are home makers. The average monthly expenditure of their family was 95US $ (SD 32US$). At the beginning of the study, two psychometric research instruments; 24 items perceived quality of primary care services PQPCS scale (chronbach's α = .89) and 22 items community clinic service satisfaction CCSS scale (chronbach's α = .97), were constructed and validated. This study showed less educated, poor, landless mothers utilized the community clinic services more than their educated and wealthier counterpart. Women who lived in their own residence used the community clinic services more frequently than those who lived in a rental house. Perceptions concerning skill and competence of the health care provider and satisfaction indicating interpersonal communication and attitude of the care provider were important predictors for community clinic service utilization. Perception related to the quality of management, administration, physical environment of the service point and satisfaction addressing health promotion and women health issues played significant role on community clinic's services utilization. Besides parental education and income, client's perception and satisfaction played significant role in community clinic service utilization. Provider's perception of service quality should be studied. The study findings will enable policy-makers to improve quality of primary health care services, realizing providers' and patients' ideas of community clinic service quality.

Making genomic medicine evidence-based and patient-centered: a structured review and landscape analysis of comparative effectiveness research.

PubMed

Phillips, Kathryn A; Deverka, Patricia A; Sox, Harold C; Khoury, Muin J; Sandy, Lewis G; Ginsburg, Geoffrey S; Tunis, Sean R; Orlando, Lori A; Douglas, Michael P

2017-10-01

Comparative effectiveness research (CER) in genomic medicine (GM) measures the clinical utility of using genomic information to guide clinical care in comparison to appropriate alternatives. We summarized findings of high-quality systematic reviews that compared the analytic and clinical validity and clinical utility of GM tests. We focused on clinical utility findings to summarize CER-derived evidence about GM and identify evidence gaps and future research needs. We abstracted key elements of study design, GM interventions, results, and study quality ratings from 21 systematic reviews published in 2010 through 2015. More than half (N = 13) of the reviews were of cancer-related tests. All reviews identified potentially important clinical applications of the GM interventions, but most had significant methodological weaknesses that largely precluded any conclusions about clinical utility. Twelve reviews discussed the importance of patient-centered outcomes, although few described evidence about the impact of genomic medicine on these outcomes. In summary, we found a very limited body of evidence about the effect of using genomic tests on health outcomes and many evidence gaps for CER to address.Genet Med advance online publication 13 April 2017.

Evidence of clinical utility: an unmet need in molecular diagnostics for patients with cancer.

PubMed

Parkinson, David R; McCormack, Robert T; Keating, Susan M; Gutman, Steven I; Hamilton, Stanley R; Mansfield, Elizabeth A; Piper, Margaret A; Deverka, Patricia; Frueh, Felix W; Jessup, J Milburn; McShane, Lisa M; Tunis, Sean R; Sigman, Caroline C; Kelloff, Gary J

2014-03-15

This article defines and describes best practices for the academic and business community to generate evidence of clinical utility for cancer molecular diagnostic assays. Beyond analytical and clinical validation, successful demonstration of clinical utility involves developing sufficient evidence to demonstrate that a diagnostic test results in an improvement in patient outcomes. This discussion is complementary to theoretical frameworks described in previously published guidance and literature reports by the U.S. Food and Drug Administration, Centers for Disease Control and Prevention, Institute of Medicine, and Center for Medical Technology Policy, among others. These reports are comprehensive and specifically clarify appropriate clinical use, adoption, and payer reimbursement for assay manufacturers, as well as Clinical Laboratory Improvement Amendments-certified laboratories, including those that develop assays (laboratory developed tests). Practical criteria and steps for establishing clinical utility are crucial to subsequent decisions for reimbursement without which high-performing molecular diagnostics will have limited availability to patients with cancer and fail to translate scientific advances into high-quality and cost-effective cancer care. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development." ©2014 AACR.

Making genomic medicine evidence-based and patient-centered: a structured review and landscape analysis of comparative effectiveness research

PubMed Central

Phillips, Kathryn A.; Deverka, Patricia A.; Sox, Harold C.; Khoury, Muin J.; Sandy, Lewis G.; Ginsburg, Geoffrey S.; Tunis, Sean R.; Orlando, Lori A.; Douglas, Michael P.

2017-01-01

Comparative effectiveness research (CER) in genomic medicine (GM) measures the clinical utility of using genomic information to guide clinical care in comparison to appropriate alternatives. We summarized findings of high-quality systematic reviews that compared the analytic and clinical validity and clinical utility of GM tests. We focused on clinical utility findings to summarize CER-derived evidence about GM and identify evidence gaps and future research needs. We abstracted key elements of study design, GM interventions, results, and study quality ratings from 21 systematic reviews published in 2010 through 2015. More than half (N = 13) of the reviews were of cancer-related tests. All reviews identified potentially important clinical applications of the GM interventions, but most had significant methodological weaknesses that largely precluded any conclusions about clinical utility. Twelve reviews discussed the importance of patient-centered outcomes, although few described evidence about the impact of genomic medicine on these outcomes. In summary, we found a very limited body of evidence about the effect of using genomic tests on health outcomes and many evidence gaps for CER to address. Genet Med advance online publication 13 April 2017 PMID:28406488

Transformative learning and research utilization in nursing practice: a missing link?

PubMed

Matthew-Maich, Nancy; Ploeg, Jenny; Jack, Susan; Dobbins, Maureen

2010-03-01

Poor or inconsistent research utilization into clinical practice is a recurrent theme across study contexts, rendering leaders disillusioned with how best to foster the uptake of research into nursing practice. This makes it imperative to look to new approaches. Research utilization involves a learning process engaging attitudes, beliefs, and behaviors; yet, this is often overlooked in approaches and models used to facilitate research use. This oversight may offer some explanation to the limited progress in research utilization to date. Transformation Theory offers an explanatory theory and specific strategies (critical reflection and critical discourse) to explore attitudes, beliefs, and behaviors so that they are understood, validated, and can better guide actions. The purpose of this article was to explore what Transformation Theory can contribute to research utilization initiatives in nursing practice. Transformation Theory and transformative learning strategies are discussed and critically analyzed in consideration of their potential roles in fostering research utilization in clinical nursing practice. (1) Research utilization is a learning process that involves knowledge, skills, feelings, attitudes, and beliefs. (2) Transformative learning strategies of critical reflection and discourse can facilitate insight into experiences, finding shared meanings among groups of people, and understanding/validating beliefs, attitudes, and feelings so they can more consciously guide future actions. This dimension is frequently neglected in research utilization efforts. (3) In combination with research utilization theories, Transformation Theory may be a missing link to make research utilization initiatives more effective in rendering and sustaining nursing practice change, thus enhancing client care and well-being. (4) Research and further consideration are both warranted and needed.

Utility of the Trauma Symptom Inventory's Atypical Response Scale in Detecting Malingered Post-Traumatic Stress Disorder

ERIC Educational Resources Information Center

Elhai, Jon D.; Gray, Matthew J.; Naifeh, James A.; Butcher, Jimmie J.; Davis, Joanne L.; Falsetti, Sherry A.; Best, Connie L.

2005-01-01

The authors examined the Trauma Symptom Inventorys (TSI) ability to discriminate 88 student post-traumatic stress disorder (PTSD) simulators screened for genuine PTSD from 48 clinical PTSD-diagnosed outpatients. Results demonstrated between-group differences on several TSI clinical scales and the Atypical Response (ATR) validity scale.…

A critical evaluation of validity and utility of translational imaging in pain and analgesia: Utilizing functional imaging to enhance the process.

PubMed

Upadhyay, Jaymin; Geber, Christian; Hargreaves, Richard; Birklein, Frank; Borsook, David

2018-01-01

Assessing clinical pain and metrics related to function or quality of life predominantly relies on patient reported subjective measures. These outcome measures are generally not applicable to the preclinical setting where early signs pointing to analgesic value of a therapy are sought, thus introducing difficulties in animal to human translation in pain research. Evaluating brain function in patients and respective animal model(s) has the potential to characterize mechanisms associated with pain or pain-related phenotypes and thereby provide a means of laboratory to clinic translation. This review summarizes the progress made towards understanding of brain function in clinical and preclinical pain states elucidated using an imaging approach as well as the current level of validity of translational pain imaging. We hypothesize that neuroimaging can describe the central representation of pain or pain phenotypes and yields a basis for the development and selection of clinically relevant animal assays. This approach may increase the probability of finding meaningful new analgesics that can help satisfy the significant unmet medical needs of patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

The unbridged gap between clinical diagnosis and contemporary research on aphasia: A short discussion on the validity and clinical utility of taxonomic categories.

PubMed

Kasselimis, Dimitrios S; Simos, Panagiotis G; Peppas, Christos; Evdokimidis, Ioannis; Potagas, Constantin

2017-01-01

Even if the traditional aphasia classification is continuously questioned by many scholars, it remains widely accepted among clinicians and included in textbooks as the gold standard. The present study aims to investigate the validity and clinical utility of this taxonomy. For this purpose, 65 left-hemisphere stroke patients were assessed and classified with respect to aphasia type based on performance on a Greek adaptation of the Boston Diagnostic Aphasia Examination. MRI and/or CT scans were obtained for each patient and lesions were identified and coded according to location. Results indicate that 26.5% of the aphasic profiles remained unclassified. More importantly, we failed to confirm the traditional lesion-to-syndrome correspondence for 63.5% of patients. Overall, our findings elucidate crucial vulnerabilities of the neo-associationist classification, and further support a deficit-rather than a syndrome-based approach. The issue of unclassifiable patients is also discussed. Copyright © 2016 Elsevier Inc. All rights reserved.

Preliminary psychometric properties of the brief Negative Symptom Scale in youth at Clinical High-Risk for psychosis.

PubMed

Strauss, Gregory P; Chapman, Hannah C

2018-03-01

Preliminary psychometric properties of an adapted version of the Brief Negative Symptom Scale (BNSS) are reported in youth at Clinical High-Risk for psychosis (CHR). Participants included 29 CHR youth who met criteria for a prodromal syndrome on the Structured Interview for Prodromal Syndromes (SIPS). The adapted BNSS demonstrated excellent internal consistency, convergent validity, and discriminant validity, suggesting that the BNSS has utility for assessing negative symptoms in a CHR population. Copyright © 2017 Elsevier B.V. All rights reserved.

Research to Establish the Validity, Reliability, and Clinical Utility of a Comprehensive Language Assessment of Mandarin

ERIC Educational Resources Information Center

Liu, Xueman Lucy; de Villiers, Jill; Ning, Chunyan; Rolfhus, Eric; Hutchings, Teresa; Lee, Wendy; Jiang, Fan; Zhang, Yi Wen

2017-01-01

Purpose: With no existing gold standard for comparison, challenges arise for establishing the validity of a new standardized Mandarin language assessment normed in mainland China. Method: A new assessment, Diagnostic Receptive and Expressive Assessment of Mandarin (DREAM), was normed with a stratified sample of 969 children ages 2;6 (years;months)…

Online Prediction of Health Care Utilization in the Next Six Months Based on Electronic Health Record Information: A Cohort and Validation Study.

PubMed

Hu, Zhongkai; Hao, Shiying; Jin, Bo; Shin, Andrew Young; Zhu, Chunqing; Huang, Min; Wang, Yue; Zheng, Le; Dai, Dorothy; Culver, Devore S; Alfreds, Shaun T; Rogow, Todd; Stearns, Frank; Sylvester, Karl G; Widen, Eric; Ling, Xuefeng

2015-09-22

The increasing rate of health care expenditures in the United States has placed a significant burden on the nation's economy. Predicting future health care utilization of patients can provide useful information to better understand and manage overall health care deliveries and clinical resource allocation. This study developed an electronic medical record (EMR)-based online risk model predictive of resource utilization for patients in Maine in the next 6 months across all payers, all diseases, and all demographic groups. In the HealthInfoNet, Maine's health information exchange (HIE), a retrospective cohort of 1,273,114 patients was constructed with the preceding 12-month EMR. Each patient's next 6-month (between January 1, 2013 and June 30, 2013) health care resource utilization was retrospectively scored ranging from 0 to 100 and a decision tree-based predictive model was developed. Our model was later integrated in the Maine HIE population exploration system to allow a prospective validation analysis of 1,358,153 patients by forecasting their next 6-month risk of resource utilization between July 1, 2013 and December 31, 2013. Prospectively predicted risks, on either an individual level or a population (per 1000 patients) level, were consistent with the next 6-month resource utilization distributions and the clinical patterns at the population level. Results demonstrated the strong correlation between its care resource utilization and our risk scores, supporting the effectiveness of our model. With the online population risk monitoring enterprise dashboards, the effectiveness of the predictive algorithm has been validated by clinicians and caregivers in the State of Maine. The model and associated online applications were designed for tracking the evolving nature of total population risk, in a longitudinal manner, for health care resource utilization. It will enable more effective care management strategies driving improved patient outcomes.

Online Prediction of Health Care Utilization in the Next Six Months Based on Electronic Health Record Information: A Cohort and Validation Study

PubMed Central

Hu, Zhongkai; Hao, Shiying; Jin, Bo; Shin, Andrew Young; Zhu, Chunqing; Huang, Min; Wang, Yue; Zheng, Le; Dai, Dorothy; Culver, Devore S; Alfreds, Shaun T; Rogow, Todd; Stearns, Frank

2015-01-01

Background The increasing rate of health care expenditures in the United States has placed a significant burden on the nation’s economy. Predicting future health care utilization of patients can provide useful information to better understand and manage overall health care deliveries and clinical resource allocation. Objective This study developed an electronic medical record (EMR)-based online risk model predictive of resource utilization for patients in Maine in the next 6 months across all payers, all diseases, and all demographic groups. Methods In the HealthInfoNet, Maine’s health information exchange (HIE), a retrospective cohort of 1,273,114 patients was constructed with the preceding 12-month EMR. Each patient’s next 6-month (between January 1, 2013 and June 30, 2013) health care resource utilization was retrospectively scored ranging from 0 to 100 and a decision tree–based predictive model was developed. Our model was later integrated in the Maine HIE population exploration system to allow a prospective validation analysis of 1,358,153 patients by forecasting their next 6-month risk of resource utilization between July 1, 2013 and December 31, 2013. Results Prospectively predicted risks, on either an individual level or a population (per 1000 patients) level, were consistent with the next 6-month resource utilization distributions and the clinical patterns at the population level. Results demonstrated the strong correlation between its care resource utilization and our risk scores, supporting the effectiveness of our model. With the online population risk monitoring enterprise dashboards, the effectiveness of the predictive algorithm has been validated by clinicians and caregivers in the State of Maine. Conclusions The model and associated online applications were designed for tracking the evolving nature of total population risk, in a longitudinal manner, for health care resource utilization. It will enable more effective care management strategies driving improved patient outcomes. PMID:26395541

Beyond discrimination: A comparison of calibration methods and clinical usefulness of predictive models of readmission risk.

PubMed

Walsh, Colin G; Sharman, Kavya; Hripcsak, George

2017-12-01

Prior to implementing predictive models in novel settings, analyses of calibration and clinical usefulness remain as important as discrimination, but they are not frequently discussed. Calibration is a model's reflection of actual outcome prevalence in its predictions. Clinical usefulness refers to the utilities, costs, and harms of using a predictive model in practice. A decision analytic approach to calibrating and selecting an optimal intervention threshold may help maximize the impact of readmission risk and other preventive interventions. To select a pragmatic means of calibrating predictive models that requires a minimum amount of validation data and that performs well in practice. To evaluate the impact of miscalibration on utility and cost via clinical usefulness analyses. Observational, retrospective cohort study with electronic health record data from 120,000 inpatient admissions at an urban, academic center in Manhattan. The primary outcome was thirty-day readmission for three causes: all-cause, congestive heart failure, and chronic coronary atherosclerotic disease. Predictive modeling was performed via L1-regularized logistic regression. Calibration methods were compared including Platt Scaling, Logistic Calibration, and Prevalence Adjustment. Performance of predictive modeling and calibration was assessed via discrimination (c-statistic), calibration (Spiegelhalter Z-statistic, Root Mean Square Error [RMSE] of binned predictions, Sanders and Murphy Resolutions of the Brier Score, Calibration Slope and Intercept), and clinical usefulness (utility terms represented as costs). The amount of validation data necessary to apply each calibration algorithm was also assessed. C-statistics by diagnosis ranged from 0.7 for all-cause readmission to 0.86 (0.78-0.93) for congestive heart failure. Logistic Calibration and Platt Scaling performed best and this difference required analyzing multiple metrics of calibration simultaneously, in particular Calibration Slopes and Intercepts. Clinical usefulness analyses provided optimal risk thresholds, which varied by reason for readmission, outcome prevalence, and calibration algorithm. Utility analyses also suggested maximum tolerable intervention costs, e.g., $1720 for all-cause readmissions based on a published cost of readmission of $11,862. Choice of calibration method depends on availability of validation data and on performance. Improperly calibrated models may contribute to higher costs of intervention as measured via clinical usefulness. Decision-makers must understand underlying utilities or costs inherent in the use-case at hand to assess usefulness and will obtain the optimal risk threshold to trigger intervention with intervention cost limits as a result. Copyright © 2017 Elsevier Inc. All rights reserved.

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

PubMed

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

2016-02-01

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

Concurrent and prognostic utility of subtyping anorexia nervosa along dietary and negative affect dimensions.

PubMed

Forbush, Kelsie T; Hagan, Kelsey E; Salk, Rachel H; Wildes, Jennifer E

2017-03-01

Bulimia nervosa can be reliably classified into subtypes based on dimensions of dietary restraint and negative affect. Community and clinical studies have shown that dietary-negative affect subtypes have greater test-retest reliability and concurrent and predictive validity compared to subtypes based on the Diagnostic and Statistical Manual of Mental Disorders (DSM). Although dietary-negative affect subtypes have shown utility for characterizing eating disorders that involve binge eating, this framework may have broader implications for understanding restrictive eating disorders. The purpose of this study was to test the concurrent and predictive validity of dietary-negative affect subtypes among patients with anorexia nervosa (AN; N = 194). Latent profile analysis was used to identify subtypes of AN based on dimensions of dietary restraint and negative affect. Chi-square and multivariate analysis of variance were used to characterize baseline differences between identified subtypes. Structural equation modeling was used to test whether dietary-negative affect subtypes would outperform DSM categories in predicting clinically relevant outcomes. Results supported a 2-profile model that replicated dietary-negative affect subtypes: Latent Profile 1 (n = 68) had clinically elevated scores on restraint only; Latent Profile 2 (n = 126) had elevated scores on both restraint and negative affect. Validation analyses showed that membership in the dietary-negative affect profile was associated with greater lifetime psychiatric comorbidity and psychosocial impairment compared to the dietary class. Dietary-negative affect subtypes only outperformed DSM categories in predicting quality-of-life impairment at 1-year follow-up. Findings highlight the clinical utility of subtyping AN based on dietary restraint and negative affect for informing future treatment-matching or personalized medicine strategies. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

A Shortened Version of the Reasons for Living-Older Adults Scale for Clinical and Research Utility.

PubMed

Lutz, Julie; Edelstein, Barry; Katz, Emma; Gallegos, Jarred V

2018-02-26

Older adults have elevated suicide rates, and identification of protective factors, such as reasons for living, is important in preventing suicide. The Reasons for Living-Older Adults scale (RFL-OA) is a 69-item measure of these protective factors in late life, which yields good psychometric properties. However, its length limits its utility in some clinical and research contexts where a shorter measure is ideal. The objective of this study was to create a shortened version of the RFL-OA. First, data collected previously during validation of the original RFL-OA (n = 199, age 65 and older, 65% female) were used to select 30 items, spanning all content areas, that were highly endorsed. Second, new data were collected (n = 219, age 60 and older, 52% female) with the 30-item RFL-OA and measures of depression, hopelessness, suicidal ideation, religiosity, health, and social desirability to examine the measure's internal consistency and convergent and discriminant validity. Scores on the 30-item RFL-OA exhibited strong internal consistency. The short RFL-OA demonstrated good convergent validity via significant, moderate correlations with suicidal ideation, hopelessness, depression, and religiosity. It demonstrated adequate discriminant validity via only small correlations with disability, subjective health, and social desirability. The shorter RFL-OA has good psychometric properties among community-dwelling older adults. It may have greater utility, compared to the original 69-item measure, for clinicians and researchers with limited time but who want to assess protective factors against suicidal behavior in late life.

[Validity 'and Utilities' clinic of a grid observation (PACSLAC-F) to evaluate the pain in seniors with dementia's living in the Long-Term Care ].

PubMed

Aubin, Michèle; Verreault, René; Savoie, Maryse; LeMay, Sylvie; Hadjistavropoulos, Thomas; Fillion, Lise; Beaulieu, Marie; Viens, Chantal; Bergeron, Rénald; Vézina, Lucie; Misson, Lucie; Fuchs-Lacelle, Shannon

2008-01-01

This study presents the validation of the French Canadian version (PACLSAC-F) of the Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC). Unlike the published validation of the English version of the PACSLAC, which was validated retrospectively, the French version was validated prospectively. The PACSLAC-F was completed by nurses working in long-term care facilities after observing 86 seniors, with severe cognitive impairment, in calm, painful or distressing but non-painful situations. The test-retest and inter-observer reliability, the internal consistency, and the discriminent validity were found to be satisfactory. To evaluate the convergent validity with the DOLOPLUS-2 and the clinical relevance of the PACSLAC, it was also completed by nurses during their work shift, with 26 additional patients, for three days per week during a period of four weeks. These results encourage us to test the PACSLAC in a comprehensive program of pain management targeting this population.

Personality-based subtypes of anorexia nervosa: examining validity and utility using baseline clinical variables and ecological momentary assessment.

PubMed

Lavender, Jason M; Wonderlich, Stephen A; Crosby, Ross D; Engel, Scott G; Mitchell, James E; Crow, Scott J; Peterson, Carol B; Le Grange, Daniel

2013-08-01

This study sought to empirically derive and validate clinically relevant personality-based subtypes of anorexia nervosa (AN). Women (N = 116) with full or subthreshold AN completed baseline measures of personality, clinical variables, and eating disorder (ED) symptoms, followed by two weeks of ecological momentary assessment (EMA). A latent profile analysis was conducted to identify personality subtypes, which were compared on baseline clinical variables and EMA variables. The best-fitting model supported three subtypes: underregulated, overregulated, and low psychopathology. The underregulated subtype (characterized by high Stimulus Seeking, Self-Harm, and Oppositionality) displayed greater baseline ED symptoms, as well as lower positive affect and greater negative affect, self-discrepancy, and binge eating in the natural environment. The overregulated subtype (characterized by high Compulsivity and low Stimulus Seeking) was more likely to have a lifetime obsessive-compulsive disorder diagnosis and exhibited greater perfectionism; levels of negative affect, positive affect, and self-discrepancy in this group were intermediate between the other subtypes. The low psychopathology subtype (characterized by normative personality) displayed the lowest levels of baseline ED symptoms, co-occurring disorders, and ED behaviors measured via EMA. Findings support the validity of these personality-based subtypes, suggesting the potential utility of addressing within-diagnosis heterogeneity in the treatment of AN. Copyright © 2013 Elsevier Ltd. All rights reserved.

Measurement properties of the upright motor control test for adults with stroke: a systematic review.

PubMed

Gorgon, Edward James R; Lazaro, Rolando T

2016-01-01

The Upright Motor Control Test (UMCT) has been used in clinical practice and research to assess functional strength of the hemiparetic lower limb in adults with stroke. It is unclear if evidence is sufficient to warrant its use. The purpose of this systematic review was to synthesize available evidence on the measurement properties of the UMCT for stroke rehabilitation. Electronic databases that indexed biomedical literature were systematically searched from inception until October 2015 (week 4): Embase, PubMed, Web of Science, CINAHL, PEDro, Cochrane Library, Scopus, ScienceDirect, SPORTDiscus, LILACS, DOAJ, and Google Scholar. All studies that had used the UMCT in the time period covered underwent hand searching for any additional study. Observational studies involving adults with stroke that explored any measurement property of the UMCT were included. The COnsensus-based Standards for the selection of health Measurement INstruments was used to assess the methodological quality of included studies. The CanChild Outcome Measures Rating Form was used for extracting data on measurement properties and clinical utility. The search yielded three methodologic studies that addressed criterion-related validity and contruct validity. Two studies of fair methodological quality demonstrated moderate-level evidence that Knee Extension and Knee Flexion subtest scores were predictive of community-level and household-level ambulation. One study of fair methodological quality provided limited-level evidence for the correlation of Knee Extension subtest scores with a laboratory measure of ground reaction forces. No published studies formally assessed reliability, responsiveness, or clinical utility. Limited information on responsiveness and clinical utility dimensions could be inferred from the included studies. The UMCT is a practical assessment tool for voluntary control or functional strength of the hemiparetic lower limb in standing in adults with stroke. Although different levels of evidence suggest that the Knee Extension and Knee Flexion subtests may possess criterion and construct validity, the lack of published literature examining content validity, reliability, and responsiveness raises questions regarding the use of the UMCT in routine clinical practice. These key findings highlight the need to further investigate the UMCT's measurement properties toward enhancing its standardization.

Germline determinants of clinical outcome of cutaneous melanoma

PubMed Central

Vogelsang, Matjaz; Wilson, Melissa; Kirchhoff, Tomas

2016-01-01

Cutaneous melanoma (CM) is the most lethal form of skin cancer. Despite the constant increase of melanoma incidence, which is in part due to incremental advances in early diagnostic modalities, mortality rates have not improved over the last decade and for advanced stages remain steadily high. While conventional prognostic biomarkers currently in use find significant utility for predicting overall general survival probabilities, they are not sensitive enough for a more personalized clinical assessment on an individual level. In recent years, the advent of genomic technologies has brought the promise of identification of germline DNA alterations that may associate with CM outcomes and hence represent novel biomarkers for clinical utilization. This review attempts to summarize the current state of knowledge of germline genetic factors studied for their impact on melanoma clinical outcomes. We also discuss ongoing problems and hurdles in validating such surrogates, and we also project future directions in discovery of more powerful germline genetic factors with clinical utility in melanoma prognostication. PMID:26342156

Pharmacological validation of a novel nonhuman primate measure of thermal responsivity with utility for predicting analgesic effects.

PubMed

Vardigan, Joshua D; Houghton, Andrea K; Lange, Henry S; Adarayan, Emily D; Pall, Parul S; Ballard, Jeanine E; Henze, Darrell A; Uslaner, Jason M

2018-01-01

The development of novel analgesics to treat acute or chronic pain has been a challenge due to a lack of translatable measurements. Preclinical end points with improved translatability are necessary to more accurately inform clinical testing paradigms, which may help guide selection of viable drug candidates. In this study, a nonhuman primate biomarker which is sensitive to standard analgesics at clinically relevant plasma concentrations, can differentiate analgesia from sedation and utilizes a protocol very similar to that which can be employed in human clinical studies is described. Specifically, acute heat stimuli were delivered to the volar forearm using a contact heat thermode in the same manner as the clinical setting. Clinically efficacious exposures of morphine, fentanyl, and tramadol produced robust analgesic effects, whereas doses of diazepam that produce sedation had no effect. We propose that this assay has predictive utility that can help improve the probability of success for developing novel analgesics.

Pharmacological validation of a novel nonhuman primate measure of thermal responsivity with utility for predicting analgesic effects

PubMed Central

Vardigan, Joshua D; Houghton, Andrea K; Lange, Henry S; Adarayan, Emily D; Pall, Parul S; Ballard, Jeanine E; Henze, Darrell A; Uslaner, Jason M

2018-01-01

Introduction The development of novel analgesics to treat acute or chronic pain has been a challenge due to a lack of translatable measurements. Preclinical end points with improved translatability are necessary to more accurately inform clinical testing paradigms, which may help guide selection of viable drug candidates. Methods In this study, a nonhuman primate biomarker which is sensitive to standard analgesics at clinically relevant plasma concentrations, can differentiate analgesia from sedation and utilizes a protocol very similar to that which can be employed in human clinical studies is described. Specifically, acute heat stimuli were delivered to the volar forearm using a contact heat thermode in the same manner as the clinical setting. Results Clinically efficacious exposures of morphine, fentanyl, and tramadol produced robust analgesic effects, whereas doses of diazepam that produce sedation had no effect. Conclusion We propose that this assay has predictive utility that can help improve the probability of success for developing novel analgesics. PMID:29692626

Validity of the WISC-IV Spanish for a Clinically Referred Sample of Hispanic Children

ERIC Educational Resources Information Center

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

2010-01-01

The Wechsler Intelligence Scale for Children (WISC) is the most commonly used intelligence test for children. Five years ago, a Spanish version of the WISC-IV was published (WISC-IV Spanish; Wechsler, 2005), but a limited amount of published information is available regarding its utility when assessing clinical samples. The current study included…

Evaluation of Three Pain Assessment Scales Used for Ventilated Neonates.

PubMed

Huang, Xiao-Zhi; Li, Li; Zhou, Jun; He, Fang; Zhong, Chun-Xia; Wang, Bin

2018-06-26

To compare and evaluate the reliability, validity, feasibility, clinical utility, and nurses' preference of the Premature Infant Pain Profile-Revised (PIPP-R), the Neonatal Pain, Agitation, and Sedation Scale (N-PASS), and the Neonatal Infant Acute Pain Assessment Scale (NIAPAS) used for procedural pain in ventilated neonates. Procedural pain is a common phenomenon but is undermanaged and underassessed in hospitalized neonates. Information for clinician selecting pain measurements to improve neonatal care and outcomes are still limited. A prospective observational study and adheres to the relevant EQUATOR guidelines. A total of 1080 pain assessments were made at 90 neonates by two nurses independently, using three scales viewing three phases of videotaped painful (arterial blood sampling) and non-painful procedures (diaper change). Internal consistency, inter-rater reliability, discriminant validity, concurrent validity and convergent validity of scales were analyzed. Feasibility, clinical utility, and nurses' preference of scales were also investigated. All three scales showed excellent inter-raters coefficients (from 0.991 to 0.992) and good internal consistency (0.733 for the PIPP-R, 0.837 for the N-PASS and 0.836 for the NIAPAS, respectively). Scores of painful and nonpainful procedures on the three scales changed significantly across the phases. There was a strong correlation between the three scales with adequate limits of agreement. The mean scores of the N-PASS for feasibility and utility were significantly higher than those of the NIAPAS, but not significantly higher than those of the PIPP-R. The N-PASS was mostly preferred by 55.9% of the nurses, followed by the NIAPAS (23.5%) and the PIPP-R (20.6%). The three scales are all reliable and valid, but the N-PASS and the NIAPAS performs better in reliability. The N-PASS appears to be a better choice for frontier nurses to assess procedural pain in ventilated neonates based on its good feasibility, utility, and nurses' preference. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Rapid stepping test towards virtual visual objects: Feasibility and convergent validity in older adults.

PubMed

Hutzler, Yeshayahu; Korsensky, Olga; Laufer, Yocheved

2017-01-01

Rapid voluntary stepping has been recognized as an important measure of balance control. The purpose of this study was to assess the feasibility and convergent validity of a Rapid Stepping Test protocol utilizing a virtual reality SeeMeTM system (VR-RST) in elderly ambulatory and independent individuals living in a community residential home. Associations between step execution times determined by the system and the Activities-specific Balance Confidence (ABC) Questionnaire, and clinical measures of balance performance in the MiniBESTest and Timed Up and Go (TUG) test, were established in 60 participants (mean age 88.2 ± 5.0 years). All participants completed the study. The correlations of the ABC questionnaire and the clinical tests with VR-RST forward and backward stepping were moderate (ρ rage 0.42-0.52), and weak to moderate with sideward stepping (ρ rage 0.32-0.52). Moderate to strong correlations were found across stepping directions (ρ rage 0.45-0.87). Findings support the test's feasibility and validity and confirm the utility of the VR-RST as an assessment tool in an elderly population.

Family history in public health practice: a genomic tool for disease prevention and health promotion.

PubMed

Valdez, Rodolfo; Yoon, Paula W; Qureshi, Nadeem; Green, Ridgely Fisk; Khoury, Muin J

2010-01-01

Family history is a risk factor for many chronic diseases, including cancer, cardiovascular disease, and diabetes. Professional guidelines usually include family history to assess health risk, initiate interventions, and motivate behavioral changes. The advantages of family history over other genomic tools include a lower cost, greater acceptability, and a reflection of shared genetic and environmental factors. However, the utility of family history in public health has been poorly explored. To establish family history as a public health tool, it needs to be evaluated within the ACCE framework (analytical validity; clinical validity; clinical utility; and ethical, legal, and social issues). Currently, private and public organizations are developing tools to collect standardized family histories of many diseases. Their goal is to create family history tools that have decision support capabilities and are compatible with electronic health records. These advances will help realize the potential of family history as a public health tool.

The validity and utility of subtyping bulimia nervosa.

PubMed

van Hoeken, Daphne; Veling, Wim; Sinke, Sjoukje; Mitchell, James E; Hoek, Hans W

2009-11-01

To review the evidence for the validity and utility of subtyping bulimia nervosa (BN) into a purging (BN-P) and a nonpurging subtype (BN-NP), and of distinguishing BN-NP from binge eating disorder (BED), by comparing course, complications, and treatment. A literature search of psychiatry databases for studies published in peer-reviewed journals that used the DSM-definitions of BN and BED, and included both individuals with BN-NP and individuals with BN-P and/or BED. Twenty-three studies compared individuals with BN-NP (N = 671) to individuals with BN-P (N = 1795) and/or individuals with BED (N = 1921), two of which reported on course, 12 on comorbidity and none on treatment response-the indicators for validity and clinical utility. The differences found were mainly quantitative rather than qualitative, suggesting a gradual difference in severity from BN-P (most severe) through BN-NP to BED (least severe). None of the comparisons provided convincing evidence for the validity or utility of the BN-NP diagnosis. Three options for the position of BN-NP in DSM-V were suggested: (1) maintaining the BN-NP subtype, (2) dropping nonpurging compensatory behavior as a criterion for BN, so that individuals currently designated as having BN-NP would be designated as having BED, and (3) including BN-NP in a broad BN category.

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

PubMed

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.

A Comparison of EQ-5D-3L Index Scores Using Malaysian, Singaporean, Thai, and UK Value Sets in Indonesian Cervical Cancer Patients.

PubMed

Endarti, Dwi; Riewpaiboon, Arthorn; Thavorncharoensap, Montarat; Praditsitthikorn, Naiyana; Hutubessy, Raymond; Kristina, Susi Ari

2018-05-01

To gain insight into the most suitable foreign value set among Malaysian, Singaporean, Thai, and UK value sets for calculating the EuroQol five-dimensional questionnaire index score (utility) among patients with cervical cancer in Indonesia. Data from 87 patients with cervical cancer recruited from a referral hospital in Yogyakarta province, Indonesia, from an earlier study of health-related quality of life were used in this study. The differences among the utility scores derived from the four value sets were determined using the Friedman test. Performance of the psychometric properties of the four value sets versus visual analogue scale (VAS) was assessed. Intraclass correlation coefficients and Bland-Altman plots were used to test the agreement among the utility scores. Spearman ρ correlation coefficients were used to assess convergent validity between utility scores and patients' sociodemographic and clinical characteristics. With respect to known-group validity, the Kruskal-Wallis test was used to examine the differences in utility according to the stages of cancer. There was significant difference among utility scores derived from the four value sets, among which the Malaysian value set yielded higher utility than the other three value sets. Utility obtained from the Malaysian value set had more agreements with VAS than the other value sets versus VAS (intraclass correlation coefficients and Bland-Altman plot tests results). As for the validity, the four value sets showed equivalent psychometric properties as those that resulted from convergent and known-group validity tests. In the absence of an Indonesian value set, the Malaysian value set was more preferable to be used compared with the other value sets. Further studies on the development of an Indonesian value set need to be conducted. Copyright © 2018. Published by Elsevier Inc.

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

PubMed

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

2018-01-01

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

Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries.

PubMed

Tomlinson, Lindsay; Boone, Laura I; Ramaiah, Lila; Penraat, Kelley A; von Beust, Barbara R; Ameri, Mehrdad; Poitout-Belissent, Florence M; Weingand, Kurt; Workman, Heather C; Aulbach, Adam D; Meyer, Dennis J; Brown, Diane E; MacNeill, Amy L; Bolliger, Anne Provencher; Bounous, Denise I

2013-09-01

The purpose of this paper by the Regulatory Affairs Committee (RAC) of the American Society for Veterinary Clinical Pathology (ASVCP) is to review the current regulatory guidances (eg, guidelines) and published recommendations for best practices in veterinary toxicologic clinical pathology, particularly in the pharmaceutical and biotechnology industries, and to utilize the combined experience of ASVCP RAC to provide updated recommendations. Discussion points include (1) instrumentation, validation, and sample collection, (2) routine laboratory variables, (3) cytologic laboratory variables, (4) data interpretation and reporting (including peer review, reference intervals and statistics), and (5) roles and responsibilities of clinical pathologists and laboratory personnel. Revision and improvement of current practices should be in alignment with evolving regulatory guidance documents, new technology, and expanding understanding and utility of clinical pathology. These recommendations provide a contemporary guide for the refinement of veterinary toxicologic clinical pathology best practices. © 2013 American Society for Veterinary Clinical Pathology.

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

PubMed

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

2011-12-01

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

Parent proxy-report of their children's health-related quality of life: an analysis of 13,878 parents' reliability and validity across age subgroups using the PedsQL 4.0 Generic Core Scales.

PubMed

Varni, James W; Limbers, Christine A; Burwinkle, Tasha M

2007-01-03

Health-related quality of life (HRQOL) measurement has emerged as an important health outcome in clinical trials, clinical practice improvement strategies, and healthcare services research and evaluation. While pediatric patient self-report should be considered the standard for measuring perceived HRQOL, there are circumstances when children are too young, too cognitively impaired, too ill or fatigued to complete a HRQOL instrument, and reliable and valid parent proxy-report instruments are needed in such cases. Further, it is typically parents' perceptions of their children's HRQOL that influences healthcare utilization. Data from the PedsQL DatabaseSM were utilized to test the reliability and validity of parent proxy-report at the individual age subgroup level for ages 2-16 years as recommended by recent FDA guidelines. The sample analyzed represents parent proxy-report age data on 13,878 children ages 2 to 16 years from the PedsQL 4.0 Generic Core Scales DatabaseSM. Parents were recruited from general pediatric clinics, subspecialty clinics, and hospitals in which their children were being seen for well-child checks, mild acute illness, or chronic illness care (n = 3,718, 26.8%), and from a State Children's Health Insurance Program (SCHIP) in California (n = 10,160, 73.2%). The percentage of missing item responses for the parent proxy-report sample as a whole was 2.1%, supporting feasibility. The majority of the parent proxy-report scales across the age subgroups exceeded the minimum internal consistency reliability standard of 0.70 required for group comparisons, while the Total Scale Scores across the age subgroups approached or exceeded the reliability criterion of 0.90 recommended for analyzing individual patient scale scores. Construct validity was demonstrated utilizing the known groups approach. For each PedsQL scale and summary score, across age subgroups, healthy children demonstrated a statistically significant difference in HRQOL (better HRQOL) than children with a known chronic health condition, with most effect sizes in the medium to large effect size range. The results demonstrate the feasibility, reliability, and validity of parent proxy-report at the individual age subgroup for ages 2-16 years. These analyses are consistent with recent FDA guidelines which require instrument development and validation testing for children and adolescents within fairly narrow age groupings and which determine the lower age limit at which reliable and valid responses across age categories are achievable. Even as pediatric patient self-report is advocated, there remains a fundamental role for parent proxy-report in pediatric clinical trials and health services research.

Preschool ADHD: exploring uncertainties in diagnostic validity and utility, and treatment efficacy and safety.

PubMed

Sonuga-Barke, Edmund J S; Daley, David; Thompson, Margaret; Swanson, Jim

2003-07-01

The current scientific and clinical status of preschool attention deficit hyperactivity disorder and its management is reviewed. Recent clinical and neuropsychological research supporting the utility of the construct will be presented along with a critical analysis of diagnostic issues. The published literature on treatment efficacy (both pharmacological and nonpharmacological) will be reviewed with a special focus on the issue of the safety and side effects of psycho-stimulants. The need for early identification and preventative intervention is indicated but caution should be employed in the use of psychostimulants with this age group.

Validating a measure to assess factors that affect assistive technology use by students with disabilities in elementary and secondary education.

PubMed

Zapf, Susan A; Scherer, Marcia J; Baxter, Mary F; H Rintala, Diana

2016-01-01

The purpose of this study was to measure the predictive validity, internal consistency and clinical utility of the Matching Assistive Technology to Child & Augmentative Communication Evaluation Simplified (MATCH-ACES) assessment. Twenty-three assistive technology team evaluators assessed 35 children using the MATCH-ACES assessment. This quasi-experimental study examined the internal consistency, predictive validity and clinical utility of the MATCH-ACES assessment. The MATCH-ACES assessment predisposition scales had good internal consistency across all three scales. A significant relationship was found between (a) high student perseverance and need for assistive technology and (b) high teacher comfort and interest in technology use (p = (0).002). Study results indicate that the MATCH-ACES assessment has good internal consistency and validity. Predisposition characteristics of student and teacher combined can influence the level of assistive technology use; therefore, assistive technology teams should assess predisposition factors of the user when recommending assistive technology. Implications for Rehabilitation Educational and medical professionals should be educated on evidence-based assistive technology assessments. Personal experience and psychosocial factors can influence the outcome use of assistive technology. Assistive technology assessments must include an intervention plan for assistive technology service delivery to measure effective outcome use.

Development and preliminary validation of the Level of Care Index (LOCI) from the Personality Assessment Inventory (PAI) in a psychiatric sample.

PubMed

Sinclair, Samuel Justin; Slavin-Mulford, Jenelle; Antonius, Daniel; Stein, Michelle B; Siefert, Caleb J; Haggerty, Greg; Malone, Johanna C; O'Keefe, Sheila; Blais, Mark A

2013-06-01

Research over the last decade has been promising in terms of the incremental utility of psychometric tools in predicting important clinical outcomes, such as mental health service utilization and inpatient psychiatric hospitalization. The purpose of this study was to develop and validate a new Level of Care Index (LOCI) from the Personality Assessment Inventory (PAI). Logistic regression was initially used in a development sample (n = 253) of psychiatric patients to identify unique PAI indicators associated with inpatient (n = 75) as opposed to outpatient (n = 178) status. Five PAI variables were ultimately retained (Suicidal Ideation, Antisocial Personality-Stimulus Seeking, Paranoia-Persecution, Negative Impression Management, and Depression-Affective) and were then aggregated into a single LOCI and independently evaluated in a second validation sample (n = 252). Results indicated the LOCI effectively differentiated inpatients from outpatients after controlling for demographic variables and was significantly associated with both internalizing and externalizing risk factors for psychiatric admission (range of ds = 0.46 for history of arrests to 0.88 for history of suicidal ideation). The LOCI was additionally found to be meaningfully associated with measures of normal personality, performance-based tests of psychological functioning, and measures of neurocognitive (executive) functioning. The clinical implications of these findings and potential utility of the LOCI are discussed. PsycINFO Database Record (c) 2013 APA, all rights reserved.

Validation and diagnostic utility of the dementia rating scale in a mixed dementia population.

PubMed

McCulloch, Katie; Collins, Robert L; Maestas, Kacey L; LeMaire, Ashley W; Pacheco, Vitor

2014-01-01

The Dementia Severity Rating Scale (DSRS), a previously validated caregiver-based measure assessing dementia severity, was recently revised to improve clarity. Our study aims included: (1) identifying the DSRS factor structure, (2) examining the relation between neuropsychological measures, the Mini-Mental State Examination, and clinical diagnoses with the DSRS, and (3) determining the clinical utility of the DSRS in a mixed clinical sample. A total of 270 veterans were referred to a cognitive disorders clinic at a VA medical center and completed neuropsychological, affective, and cognitive screening measures. Caregivers completed the DSRS. Principal components analysis identified a 2-factor solution. After controlling for age and education, memory and language were related to the Cognitive factor, whereas attention, processing speed, visuospatial processing, and executive functioning were related to both Cognitive and Self-Care factors. Neither factors correlated with depression. The total DSRS score was able to differentiate patients by the Mini-Mental State Examination scores and diagnoses of mild cognitive impairment and dementia (mixed vascular Alzheimer, vascular dementia, and Alzheimer disease). A cut-score >15 was optimal for detecting dementia in a mixed clinical sample (sensitivity=0.41, specificity=0.79), with a posttest probability of 74%. This study suggests that the DSRS improves detection of dementia and requires minimal effort to implement.

The Utility of the Mayo-Portland Adaptability Inventory Participation Index (M2PI) in US Military Veterans With a History of Mild Traumatic Brain Injury.

PubMed

OʼRourke, Justin; Critchfield, Edan; Soble, Jason; Bain, Kathleen; Fullen, Chrystal; Eapen, Blessen

2018-05-31

To examine the utility of the Mayo-Portland Adaptability Inventory-4th Edition Participation Index (M2PI) as a self-report measure of functional outcome following mild traumatic brain injury (mTBI) in US Military veterans. Department of Veterans Affairs Polytrauma Rehabilitation Center specialty hospital. On hundred thirty-nine veterans with a history of self-reported mTBI. Retrospective cross-sectional examination of data collected from regular clinical visits. M2PI, Neurobehavioral Symptoms Inventory with embedded validity measures, Posttraumatic Stress Disorder Checklist-Military Version. Forty-one percent of the sample provided symptom reports that exceeded established cut scores on embedded symptom validity tests. Invalid responders had higher levels of unemployment and endorsed significantly greater functional impairment, posttraumatic stress symptoms, and postconcussive complaints. For valid responders, regression analyses revealed that self-reported functioning was primarily related to posttraumatic stress complaints, followed by postconcussive cognitive complaints. For invalid responders, posttraumatic stress complaints also predicted self-reported functioning. Caution is recommended when utilizing the M2PI to measure functional outcome following mTBI in military veterans, particularly in the absence of symptom validity tests.

Ethical and clinical practice considerations for genetic counselors related to direct-to-consumer marketing of genetic tests.

PubMed

Wade, Christopher H; Wilfond, Benjamin S

2006-11-15

Several companies utilize direct-to-consumer (DTC) advertising for genetic tests and some, but not all, bypass clinician involvement by offering DTC purchase of the tests. This article examines how DTC marketing strategies may affect genetic counselors, using available cardiovascular disease susceptibility tests as an illustration. The interpretation of these tests is complex and includes consideration of clinical validity and utility, and the further complications of gene-environment interactions and pleiotropy. Although it is unclear to what extent genetic counselors will encounter clients who have been exposed to DTC marketing strategies, these strategies may influence genetic counseling interactions if they produce directed interest in specific tests and unrealistic expectations for the tests' capacity to predict disease. Often, a client's concern about risk for cardiovascular diseases is best addressed by established clinical tests and a family history assessment. Ethical dilemmas may arise for genetic counselors who consider whether to accept clients who request test interpretation or to order DTC-advertised tests that require a clinician's authorization. Genetic counselors' obligations to care for clients extend to interpreting DTC tests, although this obligation may be fulfilled by referral or consultation with specialists. Genetic counselors do not have an obligation to order DTC-advertised tests that have minimal clinical validity and utility at a client's request. This can be a justified restriction on autonomy based on consideration of risks to the client, the costs, and the implications for society. Published 2006 Wiley-Liss, Inc.

Evidence-based medicine and big genomic data.

PubMed

Ioannidis, John P A; Khoury, Muin J

2018-05-01

Genomic and other related big data (Big Genomic Data, BGD for short) are ushering a new era of precision medicine. This overview discusses whether principles of evidence-based medicine hold true for BGD and how they should be operationalized in the current era. Major evidence-based medicine principles include the systematic identification, description and analysis of the validity and utility of BGD, the combination of individual clinical expertise with individual patient needs and preferences, and the focus on obtaining experimental evidence, whenever possible. BGD emphasize information of single patients with an overemphasis on N-of-1 trials to personalize treatment. However, large-scale comparative population data remain indispensable for meaningful translation of BGD personalized information. The impact of BGD on population health depends on its ability to affect large segments of the population. While several frameworks have been proposed to facilitate and standardize decision making for use of genomic tests, there are new caveats that arise from BGD that extend beyond the limitations that were applicable for more simple genetic tests. Non-evidence-based use of BGD may be harmful and result in major waste of healthcare resources. Randomized controlled trials will continue to be the strongest arbitrator for the clinical utility of genomic technologies, including BGD. Research on BGD needs to focus not only on finding robust predictive associations (clinical validity) but also more importantly on evaluating the balance of health benefits and potential harms (clinical utility), as well as implementation challenges. Appropriate features of such useful research on BGD are discussed.

Psychometric Assessment of the Chinese Version of the Abbreviated Expanded Prostate Cancer Index Composite (EPIC-26) and the Clinical Practice Version (EPIC-CP) in Chinese Men With Prostate Cancer.

PubMed

Lam, Wendy W T; Tse, Michael A; Ng, Chris N L; Chung, Edward K M; Fielding, Richard

2017-06-01

The Expanded Prostate Cancer Index Composite (EPIC) instrument was designed to assess a range of health-related quality-of-life issues specifically relevant to patients with prostate cancer. This study examined the validity and reliability of Chinese versions of the 26-item EPIC and of the 16-item EPIC for Clinical Practice (EPIC-CP) in Chinese patients with prostate cancer. A Chinese version of the 26-item EPIC and the 16-item EPIC-CP were self-completed by 252 Chinese patients with prostate cancer who were recruited from three community-based cancer service centers. Confirmatory factors analysis assessed the factor structures of the EPIC and the EPIC-CP. Internal consistency and construct and clinical validities of the factor structures were assessed. Confirmatory factor analysis revealed that the original factor structure of both EPIC-26 and EPIC-CP showed good fit to this sample. A correlated model was superior to a hierarchical model in both EPIC-26 and EPIC-CP supporting the utility of the domain scores over the total scores. Cronbach α ranged from 0.55 to 0.91 for EPIC-26 and 0.44 to 0.67 for EPIC-CP. Construct validity was supported by correlations between EPIC-26/EPIC-CP and psychological distress measures. Clinical validity was supported by differentiation between patients with and without prostatectomy. These Chinese versions of the five-factor EPIC-26 and the EPIC-CP are valid and practical measures for assessing a range of health-related quality-of-life issues related to the diagnosis and treatment of prostate cancer, highlighting their utility in assessing health-related quality of life for patients diagnosed with prostate cancer. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

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

PubMed

Greher, Michael R; Wodushek, Thomas R

2017-03-01

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

Utility of the response bias scale (RBS) and other MMPI-2 validity scales in predicting TOMM performance.

PubMed

Whitney, Kriscinda A; Davis, Jeremy J; Shepard, Polly H; Herman, Steven M

2008-01-01

The present study represents a replication and extension of the original Response Bias Scale (RBS) validation study. In addition to examining the relationship between the Test of Memory Malingering (TOMM), RBS, and several other well-researched Minnesota Multiphasic Personality Inventory 2 (MMPI-2) validity scales (i.e., F, Fb, Fp, and the Fake Bad Scale), the present study also included the recently developed Infrequency Post-Traumatic Stress Disorder Scale and the Henry-Heilbronner Index (HHI) of the MMPI-2. Findings from this retrospective data analysis (N=46) demonstrated the superiority of the RBS, and to a certain extent the HHI, over other MMPI-2 validity scales in predicting TOMM failure within the outpatient Veterans Affairs population. Results of the current study confirm the clinical utility of the RBS and suggest that, particularly if the MMPI-2 is an existing part of the neuropsychological assessment, examination of RBS scores is an efficient means of detecting negative response bias.

Free-living monitoring of Parkinson's disease: Lessons from the field.

PubMed

Del Din, Silvia; Godfrey, Alan; Mazzà, Claudia; Lord, Sue; Rochester, Lynn

2016-09-01

Wearable technology comprises miniaturized sensors (eg, accelerometers) worn on the body and/or paired with mobile devices (eg, smart phones) allowing continuous patient monitoring in unsupervised, habitual environments (termed free-living). Wearable technologies are revolutionizing approaches to health care as a result of their utility, accessibility, and affordability. They are positioned to transform Parkinson's disease (PD) management through the provision of individualized, comprehensive, and representative data. This is particularly relevant in PD where symptoms are often triggered by task and free-living environmental challenges that cannot be replicated with sufficient veracity elsewhere. This review concerns use of wearable technology in free-living environments for people with PD. It outlines the potential advantages of wearable technologies and evidence for these to accurately detect and measure clinically relevant features including motor symptoms, falls risk, freezing of gait, gait, functional mobility, and physical activity. Technological limitations and challenges are highlighted, and advances concerning broader aspects are discussed. Recommendations to overcome key challenges are made. To date there is no fully validated system to monitor clinical features or activities in free-living environments. Robust accuracy and validity metrics for some features have been reported, and wearable technology may be used in these cases with a degree of confidence. Utility and acceptability appears reasonable, although testing has largely been informal. Key recommendations include adopting a multidisciplinary approach for standardizing definitions, protocols, and outcomes. Robust validation of developed algorithms and sensor-based metrics is required along with testing of utility. These advances are required before widespread clinical adoption of wearable technology can be realized. © 2016 International Parkinson and Movement Disorder Society. © 2016 International Parkinson and Movement Disorder Society.

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

PubMed Central

Mandrekar, Sumithra J.; Sargent, Daniel J.

2014-01-01

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

Clinical utility of the Chinese version of the Pediatric Daytime Sleepiness Scale in children with obstructive sleep apnea syndrome and narcolepsy.

PubMed

Yang, Chien-Ming; Huang, Yu-Shu; Song, Yu-Chen

2010-04-01

The present study examined the psychometric properties of the Chinese version of the Pediatric Daytime Sleepiness Scale (PDSS) and the utility of the PDSS as a screening tool for pathological daytime sleepiness in teenagers with obstructive sleep apnea (OSA) and narcolepsy. The PDSS was first administered to 238 middle and high school students to assess the reliability of the scale, and then administered to 28 teenagers with OSA, 31 teenagers with narcolepsy, and 34 normal controls to evaluate its clinical utility. Test-retest reliability and internal consistency were acceptable. The PDSS scores were significantly higher in narcoleptic subjects than in subjects with OSA, and higher in OSA syndrome (OSAS) subjects than normal controls. Furthermore, the scores decreased in narcoleptic subjects after medical treatment. Both reliability and validity were proven to be good. As a screening tool for narcolepsy, receiver operator characteristic (ROC) curve analysis showed that the PDSS, with a cut-off score of 16/17, had good sensitivity (87.1%) and fair specificity (74.3%) for identifying individuals with narcolepsy. When used for screening OSA, however, the differentiating power was not as good. The PDSS is a reliable and valid tool for the measurement of sleepiness in clinical youth populations. When used as a screening tool, it is useful for sleep disorders involving more severe pathological sleepiness, as in narcolepsy.

Diagnostic utility of the HIV dementia scale and the international HIV dementia scale in screening for HIV-associated neurocognitive disorders among Spanish-speaking adults

PubMed Central

López, Enrique; Steiner, Alexander J.; Smith, Kimberly; Thaler, Nicholas S.; Hardy, David J.; Levine, Andrew J.; Al-Kharafi, Hussah T.; Yamakawa, Cristina; Goodkin, Karl

2018-01-01

Given that neurocognitive impairment is a frequent complication of HIV-1 infection in Spanish-speaking adults, the limited number of studies assessing HIV-associated neurocognitive disorders (HAND) in this population raises serious clinical concern. In addition to being appropriately translated, instruments need to be modified, normed, and validated accordingly. The purpose of the current study was to examine the diagnostic utility of the HIV Dementia Scale (HDS) and International HIV Dementia Scale (IHDS) to screen for HAND in Spanish-speaking adults living with HIV infection. Participants were classified as either HAND (N = 47) or No-HAND (N = 53) after completing a comprehensive neuropsychological evaluation. Receiver operating characteristic analyses found the HDS (AUC = .706) was more sensitive to detecting HAND than the IHDS (AUC = .600). Optimal cutoff scores were 9.5 for the HDS (PPV = 65.2%, NPV = 71.4%) and 9.0 for the IHDS (PPV = 59.4%, NPV = 59.1%). Canonical Correlation Analysis found the HDS converged with attention and executive functioning. Findings suggest that while the IHDS may not be an appropriate screening instrument with this population, the HDS retains sufficient statistical validity and clinical utility to screen for HAND in Spanish-speaking adults as a time-efficient and cost-effective measure in clinical settings with limited resources. PMID:27712132

A Public-Private Partnership Develops and Externally Validates a 30-Day Hospital Readmission Risk Prediction Model

PubMed Central

Choudhry, Shahid A.; Li, Jing; Davis, Darcy; Erdmann, Cole; Sikka, Rishi; Sutariya, Bharat

2013-01-01

Introduction: Preventing the occurrence of hospital readmissions is needed to improve quality of care and foster population health across the care continuum. Hospitals are being held accountable for improving transitions of care to avert unnecessary readmissions. Advocate Health Care in Chicago and Cerner (ACC) collaborated to develop all-cause, 30-day hospital readmission risk prediction models to identify patients that need interventional resources. Ideally, prediction models should encompass several qualities: they should have high predictive ability; use reliable and clinically relevant data; use vigorous performance metrics to assess the models; be validated in populations where they are applied; and be scalable in heterogeneous populations. However, a systematic review of prediction models for hospital readmission risk determined that most performed poorly (average C-statistic of 0.66) and efforts to improve their performance are needed for widespread usage. Methods: The ACC team incorporated electronic health record data, utilized a mixed-method approach to evaluate risk factors, and externally validated their prediction models for generalizability. Inclusion and exclusion criteria were applied on the patient cohort and then split for derivation and internal validation. Stepwise logistic regression was performed to develop two predictive models: one for admission and one for discharge. The prediction models were assessed for discrimination ability, calibration, overall performance, and then externally validated. Results: The ACC Admission and Discharge Models demonstrated modest discrimination ability during derivation, internal and external validation post-recalibration (C-statistic of 0.76 and 0.78, respectively), and reasonable model fit during external validation for utility in heterogeneous populations. Conclusions: The ACC Admission and Discharge Models embody the design qualities of ideal prediction models. The ACC plans to continue its partnership to further improve and develop valuable clinical models. PMID:24224068

MMPI-2-RF characteristics of individuals with interstitial cystitis.

PubMed

Fazio, Rachel L; Wunderlich, Ted; Wilson, Nicolas; Akeson, Steven

2014-11-01

This study aimed to describe the psychological functioning of interstitial cystitis/bladder pain syndrome patients utilizing MMPI-2-RF scoring. The MMPI-2 was administered to 60 individuals who reported a diagnosis of IC. Responses were scored in the MMPI-2-RF format. Fifty-one protocols were deemed valid. Elevations were discovered on scales FBS-r (symptom validity), RC1 (somatic complaints), and MLS (malaise). Participants were split into two groups based on extreme elevations on RC1; the high RC1 group produced higher scores on 39 scales including clinically significant elevations on 17 scales. Over 25% of this sample had an emotional component to their physical concerns. This knowledge about the psychological characteristics of IC patients may have clinical utility for physicians and other treatment providers. The results argue strongly for psychological evaluation as a component of IC diagnosis and treatment. Those with significant emotional overlay to their somatic complaints may be best managed through psychological interventions and minimally invasive treatments. Copyright © 2014 Elsevier Inc. All rights reserved.

Bispectral Index Monitoring: validity and utility in pediatric dentistry.

PubMed

Goyal, Ashima; Mittal, Neeti; Mittal, Parteek; Gauba, K

2014-01-01

Reliable and safe provision of sedation and general anesthesia is dependent on continuous vigilance of patient's sedation depth. Failure to do so may result in unintended oversedation or undersedation. It is a common practice to observe sedation depth by applying subjective sedation scales and in case of general anesthesia, practitioner is dependent on vital sign assessment. The Bispectral Index System (BIS) is a recently introduced objective, quantitative, easy to use, and free from observer bias, and clinically useful tool to assess sedation depth and it precludes the need to stimulate the patient to assess his sedation level. The present article is an attempt to orient the readers towards utility and validity of BIS for sedation and general anesthesia in pediatric dentistry. In this article, we attempt to make the readers understand the principle of BIS, its variation across sedation continuum, its validity across different age groups and for a variety of sedative drugs.

Validation of the Integrated Medical Model Using Historical Space Flight Data

NASA Technical Reports Server (NTRS)

Kerstman, Eric L.; Minard, Charles G.; FreiredeCarvalho, Mary H.; Walton, Marlei E.; Myers, Jerry G., Jr.; Saile, Lynn G.; Lopez, Vilma; Butler, Douglas J.; Johnson-Throop, Kathy A.

2010-01-01

The Integrated Medical Model (IMM) utilizes Monte Carlo methodologies to predict the occurrence of medical events, utilization of resources, and clinical outcomes during space flight. Real-world data may be used to demonstrate the accuracy of the model. For this analysis, IMM predictions were compared to data from historical shuttle missions, not yet included as model source input. Initial goodness of fit test-ing on International Space Station data suggests that the IMM may overestimate the number of occurrences for three of the 83 medical conditions in the model. The IMM did not underestimate the occurrence of any medical condition. Initial comparisons with shuttle data demonstrate the importance of understanding crew preference (i.e., preferred analgesic) for accurately predicting the utilization of re-sources. The initial analysis demonstrates the validity of the IMM for its intended use and highlights areas for improvement.

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

DTIC Science & Technology

2017-10-01

been shown in many studies to improve predictive accuracy for cancer on initial biopsy,3,7-9 and to be correlated with more aggressive cancer at...our multi-center, prospectively accrued prostate cancer active surveillance cohort – the Canary Prostate Active Surveillance Study (PASS). We are in...objective of the study is to utilize analytically validated assays that take into account tumor heterogeneity to measure biomarkers in specimens that were

The Validity of a New Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) for Evaluating Symptoms in the Clinical Setting.

PubMed

Koloski, N A; Jones, M; Hammer, J; von Wulffen, M; Shah, A; Hoelz, H; Kutyla, M; Burger, D; Martin, N; Gurusamy, S R; Talley, N J; Holtmann, G

2017-08-01

The clinical assessments of patients with gastrointestinal symptoms can be time-consuming, and the symptoms captured during the consultation may be influenced by a variety of patient and non-patient factors. To facilitate standardized symptom assessment in the routine clinical setting, we developed the Structured Assessment of Gastrointestinal Symptom (SAGIS) instrument to precisely characterize symptoms in a routine clinical setting. We aimed to validate SAGIS including its reliability, construct and discriminant validity, and utility in the clinical setting. Development of the SAGIS consisted of initial interviews with patients referred for the diagnostic work-up of digestive symptoms and relevant complaints identified. The final instrument consisted of 22 items as well as questions on extra intestinal symptoms and was given to 1120 consecutive patients attending a gastroenterology clinic randomly split into derivation (n = 596) and validation datasets (n = 551). Discriminant validity along with test-retest reliability was assessed. The time taken to perform a clinical assessment with and without the SAGIS was recorded along with doctor satisfaction with this tool. Exploratory factor analysis conducted on the derivation sample suggested five symptom constructs labeled as abdominal pain/discomfort (seven items), gastroesophageal reflux disease/regurgitation symptoms (four items), nausea/vomiting (three items), diarrhea/incontinence (five items), and difficult defecation and constipation (2 items). Confirmatory factor analysis conducted on the validation sample supported the initially developed five-factor measurement model ([Formula: see text], p < 0.0001, χ 2 /df = 4.6, CFI = 0.90, TLI = 0.88, RMSEA = 0.08). All symptom groups demonstrated differentiation between disease groups. The SAGIS was shown to be reliable over time and resulted in a 38% reduction of the time required for clinical assessment. The SAGIS instrument has excellent psychometric properties and supports the clinical assessment of and symptom-based categorization of patients with a wide spectrum of gastrointestinal symptoms.

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

PubMed

Ward, Amanda M

2016-11-01

Episodic future thinking is defined as the ability to mentally simulate a future event. Although episodic future thinking has been studied extensively in neuroscience, this construct has not been explored in depth from the perspective of clinical neuropsychology. The aim of this critical narrative review is to assess the validity and clinical implications of episodic future thinking. A systematic review of episodic future thinking literature was conducted. PubMed and PsycInfo were searched through July 2015 for review and empirical articles with the following search terms: "episodic future thinking," "future mental simulation," "imagining the future," "imagining new experiences," "future mental time travel," "future autobiographical experience," and "prospection." The review discusses evidence that episodic future thinking is important for adaptive functioning, which has implications for neurological populations. To determine the validity of episodic future thinking, the construct is evaluated with respect to related constructs, such as imagination, episodic memory, autobiographical memory, prospective memory, narrative construction, and working memory. Although it has been minimally investigated, there is evidence of convergent and discriminant validity for episodic future thinking. Research has not addressed the incremental validity of episodic future thinking. Practical considerations of episodic future thinking tasks and related constructs in a clinical neuropsychological setting are considered. The utility of episodic future thinking is currently unknown due to the lack of research investigating the validity of episodic future thinking. Future work is discussed, which could determine whether episodic future thinking is an important missing piece in standard clinical neuropsychological assessment. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Preventing patient absenteeism: validation of a predictive overbooking model.

PubMed

Reid, Mark W; Cohen, Samuel; Wang, Hank; Kaung, Aung; Patel, Anish; Tashjian, Vartan; Williams, Demetrius L; Martinez, Bibiana; Spiegel, Brennan M R

2015-12-01

To develop a model that identifies patients at high risk for missing scheduled appointments ("no-shows" and cancellations) and to project the impact of predictive overbooking in a gastrointestinal endoscopy clinic-an exemplar resource-intensive environment with a high no-show rate. We retrospectively developed an algorithm that uses electronic health record (EHR) data to identify patients who do not show up to their appointments. Next, we prospectively validated the algorithm at a Veterans Administration healthcare network clinic. We constructed a multivariable logistic regression model that assigned a no-show risk score optimized by receiver operating characteristic curve analysis. Based on these scores, we created a calendar of projected open slots to offer to patients and compared the daily performance of predictive overbooking with fixed overbooking and typical "1 patient, 1 slot" scheduling. Data from 1392 patients identified several predictors of no-show, including previous absenteeism, comorbid disease burden, and current diagnoses of mood and substance use disorders. The model correctly classified most patients during the development (area under the curve [AUC] = 0.80) and validation phases (AUC = 0.75). Prospective testing in 1197 patients found that predictive overbooking averaged 0.51 unused appointments per day versus 6.18 for typical booking (difference = -5.67; 95% CI, -6.48 to -4.87; P < .0001). Predictive overbooking could have increased service utilization from 62% to 97% of capacity, with only rare clinic overflows. Information from EHRs can accurately predict whether patients will no-show. This method can be used to overbook appointments, thereby maximizing service utilization while staying within clinic capacity.

Genetic improvement of mastitis resistance: validation of somatic cell score and clinical mastitis as selection criteria.

PubMed

Odegård, J; Klemetsdal, G; Heringstad, B

2003-12-01

Mean daughter deviations for clinical mastitis among second-crop daughters were regressed on predicted transmitting abilities for clinical mastitis and lactation mean somatic cell score in first-crop daughters to validate the predictive ability of these traits as selection criteria for reduced incidence of clinical mastitis. A total of 321 sires had 684,897 second-crop daughters, while predicted transmitting abilities were calculated for 2159 sires, based on 495,681 records of first-crop daughters. Predictive ability, as a measure of efficiency of selection, was 23 to 43% higher for clinical mastitis than for lactation mean somatic cell score. Compared to single-trait selection, predictive ability improved 8 to 13% from utilizing information on both traits. The relative weight that should be assigned to standardized predicted transmitting abilities from univariate genetic analyses were 60 to 67% for clinical mastitis and 33 to 40% for lactation mean somatic cell score. No significant nonlinear genetic relationship between the two traits was found.

Multimethod Investigation of Interpersonal Functioning in Borderline Personality Disorder

PubMed Central

Stepp, Stephanie D.; Hallquist, Michael N.; Morse, Jennifer Q.; Pilkonis, Paul A.

2011-01-01

Even though interpersonal functioning is of great clinical importance for patients with borderline personality disorder (BPD), the comparative validity of different assessment methods for interpersonal dysfunction has not yet been tested. This study examined multiple methods of assessing interpersonal functioning, including self- and other-reports, clinical ratings, electronic diaries, and social cognitions in three groups of psychiatric patients (N=138): patients with (1) BPD, (2) another personality disorder, and (3) Axis I psychopathology only. Using dominance analysis, we examined the predictive validity of each method in detecting changes in symptom distress and social functioning six months later. Across multiple methods, the BPD group often reported higher interpersonal dysfunction scores compared to other groups. Predictive validity results demonstrated that self-report and electronic diary ratings were the most important predictors of distress and social functioning. Our findings suggest that self-report scores and electronic diary ratings have high clinical utility, as these methods appear most sensitive to change. PMID:21808661

Defining and validating a short form Montreal Cognitive Assessment (s-MoCA) for use in neurodegenerative disease

PubMed Central

Roalf, David R; Moore, Tyler M; Wolk, David A; Arnold, Steven E; Mechanic-Hamilton, Dawn; Rick, Jacqueline; Kabadi, Sushila; Ruparel, Kosha; Chen-Plotkin, Alice S; Chahine, Lama M; Dahodwala, Nabila A; Duda, John E; Weintraub, Daniel A; Moberg, Paul J

2016-01-01

Introduction Screening for cognitive deficits is essential in neurodegenerative disease. Screening tests, such as the Montreal Cognitive Assessment (MoCA), are easily administered, correlate with neuropsychological performance and demonstrate diagnostic utility. Yet, administration time is too long for many clinical settings. Methods Item response theory and computerised adaptive testing simulation were employed to establish an abbreviated MoCA in 1850 well-characterised community-dwelling individuals with and without neurodegenerative disease. Results 8 MoCA items with high item discrimination and appropriate difficulty were identified for use in a short form (s-MoCA). The s-MoCA was highly correlated with the original MoCA, showed robust diagnostic classification and cross-validation procedures substantiated these items. Discussion Early detection of cognitive impairment is an important clinical and public health concern, but administration of screening measures is limited by time constraints in demanding clinical settings. Here, we provide as-MoCA that is valid across neurological disorders and can be administered in approximately 5 min. PMID:27071646

The gender identity/gender dysphoria questionnaire for adolescents and adults: further validity evidence.

PubMed

Singh, Devita; Deogracias, Joseph J; Johnson, Laurel L; Bradley, Susan J; Kibblewhite, Sarah J; Owen-Anderson, Allison; Peterson-Badali, Michele; Meyer-Bahlburg, Heino F L; Zucker, Kenneth J

2010-01-01

This study aimed to provide further validity evidence for the dimensional measurement of gender identity and gender dysphoria in both adolescents and adults. Adolescents and adults with gender identity disorder (GID) were compared to clinical control (CC) adolescents and adults on the Gender Identity/Gender Dysphoria Questionnaire for Adolescents and Adults (GIDYQ-AA), a 27-item scale originally developed by Deogracias et al. (2007). In Study 1, adolescents with GID (n = 44) were compared to CC adolescents (n = 98); and in Study 2, adults with GID (n = 41) were compared to CC adults (n = 94). In both studies, clients with GID self-reported significantly more gender dysphoria than did the CCs, with excellent sensitivity and specificity rates. In both studies, degree of self-reported gender dysphoria was significantly correlated with recall of cross-gender behavior in childhood-a test of convergent validity. The research and clinical utility of the GIDYQ-AA is discussed, including directions for further research in distinct clinical populations.

Targeting IL-2: an unexpected effect in treating immunological diseases.

PubMed

Ye, Congxiu; Brand, David; Zheng, Song G

2018-01-01

Regulatory T cells (Treg) play a crucial role in maintaining immune homeostasis since Treg dysfunction in both animals and humans is associated with multi-organ autoimmune and inflammatory disease. While IL-2 is generally considered to promote T-cell proliferation and enhance effector T-cell function, recent studies have demonstrated that treatments that utilize low-dose IL-2 unexpectedly induce immune tolerance and promote Treg development resulting in the suppression of unwanted immune responses and eventually leading to treatment of some autoimmune disorders. In the present review, we discuss the biology of IL-2 and its signaling to help define the key role played by IL-2 in the development and function of Treg cells. We also summarize proof-of-concept clinical trials which have shown that low-dose IL-2 can control autoimmune diseases safely and effectively by specifically expanding and activating Treg. However, future studies will be needed to validate a better and safer dosing strategy for low-dose IL-2 treatments utilizing well-controlled clinical trials. More studies will also be needed to validate the appropriate dose of IL-2/anti-cytokine or IL-2/anti-IL-2 complex in the experimental animal models before moving to the clinic.

To Cough or Not to Cough? Examining the Potential Utility of Cough Testing in the Clinical Evaluation of Swallowing

PubMed Central

Watts, Stephanie A.; Tabor, Lauren

2016-01-01

Purpose The clinical swallowing evaluation (CSE) represents a critical component of a comprehensive assessment of deglutition. Although universally utilized across clinical settings, the CSE demonstrates limitations in its ability to accurately identify all individuals with dysphagia. There exists a need to improve assessment and screening techniques to improve health outcomes, treatment recommendations and ultimately mortality in individuals at risk for dysphagia. The following narrative review provides a summary of currently used validated CSE’s and examines the potential role of cough testing and screening in the CSE. Recent findings Recent evidence highlights a relationship between objective physiologic measurements of both voluntarily and reflexively induced cough and swallowing safety status across several patient populations. Although more research is needed across a wider range of patient populations to validate these findings; emerging data supports the consideration of inclusion of cough testing during the CSE as an index of airway defense mechanisms and capabilities in individuals at risk for aspiration. Summary The sensorimotor processes of cough and swallowing share common neuroanatomical and functional substrates. Inclusion of voluntarily or reflexively induced cough testing in the CSE may aide in the identification of dysphagia and reduced airway protection capabilities. PMID:28529824

Revised NEO Personality Inventory profiles of male and female U.S. Air Force pilots.

PubMed

Callister, J D; King, R E; Retzlaff, P D; Marsh, R W

1999-12-01

The study of pilot personality characteristics has a long and controversial history. Personality characteristics seem to be fairly poor predictors of training outcome; however, valid personality assessment is essential to clinical psychological evaluations. Therefore, the personality characteristics of pilots must be studied to ensure valid clinical assessment. This paper describes normative personality characteristics of U.S. Air Force pilots based on the Revised NEO Personality Inventory profiles of 1,301 U.S. Air Force student pilots. Compared with male adult norms, male student pilots had higher levels of extraversion and lower levels of agreeableness. Compared with female adult norms, female student pilots had higher levels of extraversion and openness and lower levels of agreeableness. Descriptive statistics and percentile tables for the five domain scores and 30 facet scores are provided for clinical use, and a case vignette is provided as an example of the clinical utility of these U.S. Air Force norms.

Development of a pharmacogenetic-guided warfarin dosing algorithm for Puerto Rican patients.

PubMed

Ramos, Alga S; Seip, Richard L; Rivera-Miranda, Giselle; Felici-Giovanini, Marcos E; Garcia-Berdecia, Rafael; Alejandro-Cowan, Yirelia; Kocherla, Mohan; Cruz, Iadelisse; Feliu, Juan F; Cadilla, Carmen L; Renta, Jessica Y; Gorowski, Krystyna; Vergara, Cunegundo; Ruaño, Gualberto; Duconge, Jorge

2012-12-01

This study was aimed at developing a pharmacogenetic-driven warfarin-dosing algorithm in 163 admixed Puerto Rican patients on stable warfarin therapy. A multiple linear-regression analysis was performed using log-transformed effective warfarin dose as the dependent variable, and combining CYP2C9 and VKORC1 genotyping with other relevant nongenetic clinical and demographic factors as independent predictors. The model explained more than two-thirds of the observed variance in the warfarin dose among Puerto Ricans, and also produced significantly better 'ideal dose' estimates than two pharmacogenetic models and clinical algorithms published previously, with the greatest benefit seen in patients ultimately requiring <7 mg/day. We also assessed the clinical validity of the model using an independent validation cohort of 55 Puerto Rican patients from Hartford, CT, USA (R(2) = 51%). Our findings provide the basis for planning prospective pharmacogenetic studies to demonstrate the clinical utility of genotyping warfarin-treated Puerto Rican patients.

Do Circulating Tumor Cells, Exosomes, and Circulating Tumor Nucleic Acids Have Clinical Utility?

PubMed Central

Gold, Bert; Cankovic, Milena; Furtado, Larissa V.; Meier, Frederick; Gocke, Christopher D.

2016-01-01

Diagnosing and screening for tumors through noninvasive means represent an important paradigm shift in precision medicine. In contrast to tissue biopsy, detection of circulating tumor cells (CTCs) and circulating tumor nucleic acids provides a minimally invasive method for predictive and prognostic marker detection. This allows early and serial assessment of metastatic disease, including follow-up during remission, characterization of treatment effects, and clonal evolution. Isolation and characterization of CTCs and circulating tumor DNA (ctDNA) are likely to improve cancer diagnosis, treatment, and minimal residual disease monitoring. However, more trials are required to validate the clinical utility of precise molecular markers for a variety of tumor types. This review focuses on the clinical utility of CTCs and ctDNA testing in patients with solid tumors, including somatic and epigenetic alterations that can be detected. A comparison of methods used to isolate and detect CTCs and some of the intricacies of the characterization of the ctDNA are also provided. PMID:25908243

The use of the sexual function questionnaire as a screening tool for women with sexual dysfunction.

PubMed

Quirk, Frances; Haughie, Scott; Symonds, Tara

2005-07-01

To determine if the validated Sexual Function Questionnaire (SFQ), developed to assess efficacy in female sexual dysfunction (FSD) clinical trials, may also have utility in identifying target populations for such studies. Data from five clinical trials and two general population surveys were used to analyze the utility of the SFQ as a tool to discriminate between the presence of specific components of FSD (i.e., hypoactive sexual desire disorder, female sexual arousal disorder, female orgasmic disorder, and dyspareunia). Sensitivity/specificity analysis and logistic regression analysis, using data from all five clinical studies and the general population surveys, confirmed that the SFQ domains have utility in detecting the presence of specific components of FSD and provide scores indicative of the presence of a specific sexual disorder. The SFQ is a valuable new tool for detecting the presence of FSD and identifying the specific components of sexual functions affected (desire, arousal, orgasm, or dyspareunia).

Assessment of acquired capability for suicide in clinical practice.

PubMed

Rimkeviciene, Jurgita; Hawgood, Jacinta; O'Gorman, John; De Leo, Diego

2016-12-01

The Interpersonal Psychological Theory of suicide proposes that the interaction between Thwarted Belongingness, Perceived Burdensomeness, and Acquired Capability for Suicide (ACS) predicts proximal risk of death by suicide. Instruments to assess all three constructs are available. However, research on the validity of one of them, the acquired capability for suicide scale (ACSS), has been limited, especially in terms of its clinical relevance. This study aimed to explore the utility of the different versions of the ACSS in clinical assessment. Three versions of the scale were investigated, the full 20-item version, a 7-item version and a single item version representing self-perceived capability for suicide. In a sample of patients recruited from a clinic specialising in the treatment of suicidality and in a community sample, all versions of the ACSS were found to show reasonable levels of reliability and to correlate as expected with reports of suicidal ideation, self-harm, and attempted suicide. The item assessing self-perceived acquired capacity for suicide showed highest correlations with all levels of suicidal behaviour. However, no version of the ACSS on its own showed a capacity to indicate suicide attempts in the combined sample. It is concluded that the versions of the scale have construct validity, but their clinical utility is limited. An assessment using a single item on self-perceived ACS outperforms the full and shortened versions of ACSS in clinical settings and can be recommended with caution for clinicians interested in assessing this characteristic.

MEASURING COERCION TO PARTICIPATE IN RESEARCH WITHIN A DOUBLY VULNERABLE POPULATION: INITIAL DEVELOPMENT OF THE COERCION ASSESSMENT SCALE

PubMed Central

Dugosh, Karen Leggett; Festinger, David S.; Croft, Jason R.; Marlowe, Douglas B.

2011-01-01

Despite many efforts aimed to ensure that research participation is autonomous and not coerced, there exists no reliable and valid measure of perceived coercion for the doubly vulnerable population of substance-abusing offenders. The current study describes the development and initial validation of an instrument measuring perceived coercion to participate in research among substance-abusing offenders. The results indicated that a substantial number of individuals report feeling coerced to participate in the study. In addition, the instrument has adequate levels of internal consistency, a one-dimensional factor structure, and evidence of discriminative validity. This study provides initial support for the instrument’s validity and clinical utility. PMID:20235867

Clinical utilization and cost outcomes from an integrative medicine independent physician association: an additional 3-year update.

PubMed

Sarnat, Richard L; Winterstein, James; Cambron, Jerrilyn A

2007-05-01

Our initial report analyzed clinical and cost utilization data from the years 1999 to 2002 for an integrative medicine independent physician association (IPA) whose primary care physicians (PCPs) were exclusively doctors of chiropractic. This report updates the subsequent utilization data from the IPA for the years 2003 to 2005 and includes first-time comparisons in data points among PCPs of different licensures who were oriented toward complementary and alternative medicine (CAM). Independent physician association-incurred claims and stratified random patient surveys were descriptively analyzed for clinical utilization, cost offsets, and member satisfaction compared with conventional medical IPA normative values. Comparisons to our original publication's comparative blinded data, using nonrandom matched comparison groups, were descriptively analyzed for differences in age/sex demographics and disease profiles to examine sample bias. Clinical and cost utilization based on 70,274 member-months over a 7-year period demonstrated decreases of 60.2% in-hospital admissions, 59.0% hospital days, 62.0% outpatient surgeries and procedures, and 85% pharmaceutical costs when compared with conventional medicine IPA performance for the same health maintenance organization product in the same geography and time frame. During the past 7 years, and with a larger population than originally reported, the CAM-oriented PCPs using a nonsurgical/nonpharmaceutical approach demonstrated reductions in both clinical and cost utilization when compared with PCPs using conventional medicine alone. Decreased utilization was uniformly achieved by all CAM-oriented PCPs, regardless of their licensure. The validity and generalizability of this observation are guarded given the lack of randomization, lack of statistical analysis possible, and potentially biased data in this population.

Measures of Self-Care Independence for Children with Osteochondrodysplasia: A Clinimetric Review

ERIC Educational Resources Information Center

Ireland, Penelope; Johnston, Leanne M.

2012-01-01

This systematic review evaluates the validity, reliability, and clinical utility of outcome measures used to assess self-care skills among children with congenital musculoskeletal conditions and assesses the applicability of these measures for children with osteochondrodysplasia aged 0-12 years. Electronic databases were searched to identify…

Improving Efficiency using a Hybrid Approach: Revising an IV/Blood Workshop in a Clinical Research Environment

PubMed Central

Parchen, Debra A.; Phelps, Sandra E.; Johnson, Eunice M.; Fisher, Cheryl A.

2016-01-01

Orienting to a new job can be overwhelming, especially if the nurse is required to develop or refine new skills, such as intravenous (IV) therapy or blood administration. At the National Institutes of Health Clinical Center Nursing Department, a group of nurse educators redesigned the IV/Blood Workshop to prepare nurses with skills needed when caring for patients on protocol in a research intensive environment. Innovative teaching strategies and a hybrid instructional approach were utilized along with a pre-workshop activity, skills lab practice, and follow up skill validation at the unit level to provide a comprehensive curriculum while decreasing resource utilization. PMID:27187829

Inferior turbinate classification system, grades 1 to 4: development and validation study.

PubMed

Camacho, Macario; Zaghi, Soroush; Certal, Victor; Abdullatif, Jose; Means, Casey; Acevedo, Jason; Liu, Stanley; Brietzke, Scott E; Kushida, Clete A; Capasso, Robson

2015-02-01

To develop a validated inferior turbinate grading scale. Development and validation study. Phase 1 development (alpha test) consisted of a proposal of 10 different inferior turbinate grading scales (>1,000 clinic patients). Phase 2 validation (beta test) utilized 10 providers grading 27 standardized endoscopic photos of inferior turbinates using two different classification systems. Phase 3 validation (pilot study) consisted of 100 live consecutive clinic patients (n = 200 inferior turbinates) who were each prospectively graded by 18 different combinations of two independent raters, and grading was repeated by each of the same two raters, two separate times for each patient. In the development phase, 25% (grades 1-4) and 33% (grades 1-4) were the most useful systems. In the validation phase, the 25% classification system was found to be the best balance between potential clinical utility and ability to grade; the photo grading demonstrated a Cohen's kappa (κ) = 0.4671 ± 0.0082 (moderate inter-rater agreement). Live-patient grading with the 25% classification system demonstrated an overall inter-rater reliability of 71.5% (95% confidence interval [CI]: 64.8-77.3), with overall substantial agreement (κ = 0.704 ± 0.028). Intrarater reliability was 91.5% (95% CI: 88.7-94.3). Distribution for the 200 inferior turbinates was as follows: 25% quartile = grade 1, 50% quartile (median) = grade 2, 75% quartile = grade 3, and 90% quartile = grade 4. Mean turbinate size was 2.22 (95% CI: 2.07-2.34; standard deviation 1.02). Categorical κ was as follows: grade 1, 0.8541 ± 0.0289; grade 2, 0.7310 ± 0.0289; grade 3, 0.6997 ± 0.0289, and grade 4, 0.7760 ± 0.0289. The 25% (grades 1-4) inferior turbinate classification system is a validated grading scale with high intrarater and inter-rater reliability. This system can facilitate future research by tracking the effect of interventions on inferior turbinates. 2c. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

Computerized Neuropsychological Assessment Devices: Joint Position Paper of the American Academy of Clinical Neuropsychology and the National Academy of Neuropsychology†

PubMed Central

Bauer, Russell M.; Iverson, Grant L.; Cernich, Alison N.; Binder, Laurence M.; Ruff, Ronald M.; Naugle, Richard I.

2012-01-01

This joint position paper of the American Academy of Clinical Neuropsychology and the National Academy of Neuropsychology sets forth our position on appropriate standards and conventions for computerized neuropsychological assessment devices (CNADs). In this paper, we first define CNADs and distinguish them from examiner-administered neuropsychological instruments. We then set forth position statements on eight key issues relevant to the development and use of CNADs in the healthcare setting. These statements address (a) device marketing and performance claims made by developers of CNADs; (b) issues involved in appropriate end-users for administration and interpretation of CNADs; (c) technical (hardware/software/firmware) issues; (d) privacy, data security, identity verification, and testing environment; (e) psychometric development issues, especially reliability, and validity; (f) cultural, experiential, and disability factors affecting examinee interaction with CNADs; (g) use of computerized testing and reporting services; and (h) the need for checks on response validity and effort in the CNAD environment. This paper is intended to provide guidance for test developers and users of CNADs that will promote accurate and appropriate use of computerized tests in a way that maximizes clinical utility and minimizes risks of misuse. The positions taken in this paper are put forth with an eye toward balancing the need to make validated CNADs accessible to otherwise underserved patients with the need to ensure that such tests are developed and utilized competently, appropriately, and with due concern for patient welfare and quality of care. PMID:22382386

Computerized Neuropsychological Assessment Devices: Joint Position Paper of the American Academy of Clinical Neuropsychology and the National Academy of Neuropsychology†

PubMed Central

Bauer, Russell M.; Iverson, Grant L.; Cernich, Alison N.; Binder, Laurence M.; Ruff, Ronald M.; Naugle, Richard I.

2013-01-01

This joint position paper of the American Academy of Clinical Neuropsychology and the National Academy of Neuropsychology sets forth our position on appropriate standards and conventions for computerized neuropsychological assessment devices (CNADs). In this paper, we first define CNADs and distinguish them from examiner-administered neuropsychological instruments. We then set forth position statements on eight key issues relevant to the development and use of CNADs in the healthcare setting. These statements address (a) device marketing and performance claims made by developers of CNADs; (b) issues involved in appropriate end-users for administration and interpretation of CNADs; (c) technical (hardware/software/firmware) issues; (d) privacy, data security, identity verification, and testing environment; (e) psychometric development issues, especially reliability and validity; (f) cultural, experiential, and disability factors affecting examinee interaction with CNADs; (g) use of computerized testing and reporting services; and (h) the need for checks on response validity and effort in the CNAD environment. This paper is intended to provide guidance for test developers and users of CNADs that will promote accurate and appropriate use of computerized tests in a way that maximizes clinical utility and minimizes risks of misuse. The positions taken in this paper are put forth with an eye toward balancing the need to make validated CNADs accessible to otherwise underserved patients with the need to ensure that such tests are developed and utilized competently, appropriately, and with due concern for patient welfare and quality of care. PMID:22394228

[Hand fine motor skills and use of both hand and arm in subjects after a stroke: a systematic review].

PubMed

Ostolaza, M; Abudarham, J; Dilascio, S; Drault-Boedo, E; Gallo, S; Garcete, A; Kramer, M; Maiaru, M; Mendelevich, A; Modica, M; Peralta, F; Sanchez-Correa, C

2017-04-01

In clinical practice it is important to be able to assess the function of the upper limb of the patient who has suffered a stroke. There is currently no systemic review that could identify assessment tools for the 'fine use of the hand' and 'use of both hand and arm'. Primary, to identify observational tools which can assess the fine use of the hand and the use of both hand and arm in patients with stroke sequels. Secondary, to analyze the bias risk in the included articles, describing and categorizing the clinical utility, validity and reliability. A search was carried in Medline, LILACS, SciELO and Open Grey, which included articles published until October 2015. Studies that validate assessing tools of the upper limb in subjects with a stroke sequel which evaluate the fine use of the hand and the use of both hand and arm were included. Eleven tools in evaluate observational haven been selected, which assess the fine use of the hand and the use of hand and arm. In every case both validity and reliability have been reported, but clinical utility has been less considered for assessment. The studies that researched these tools showed a high risk of bias in their development. ARAT-19 showed a lower bias risk, but when it has to do with applicability and the reference trial is taken into account, the level of concern is high.

The EQ-5D-5L health status questionnaire in COPD: validity, responsiveness and minimum important difference.

PubMed

Nolan, Claire M; Longworth, Louise; Lord, Joanne; Canavan, Jane L; Jones, Sarah E; Kon, Samantha S C; Man, William D-C

2016-06-01

The EQ-5D, a generic health status questionnaire that is widely used in health economic evaluation, was recently expanded to the EQ-5D-5L to address criticisms of unresponsiveness and ceiling effect. To describe the validity, responsiveness and minimum important difference of the EQ-5D-5L in COPD. Study 1: The validity of the EQ-5D-5L utility index and visual analogue scale (EQ-VAS) was compared with four established disease-specific health status questionnaires and other measures of disease severity in 616 stable outpatients with COPD. Study 2: The EQ-5D-5L utility index and EQ-VAS were measured in 324 patients with COPD before and after 8 weeks of pulmonary rehabilitation. Distribution and anchor-based approaches were used to estimate the minimum important difference. There were moderate-to-strong correlations between utility index and EQ-VAS with disease-specific questionnaires (Pearson's r=0.47-0.72). A ceiling effect was seen in 7% and 2.6% of utility index and EQ-VAS. Utility index decreased (worsening health status) with indices of worsening disease severity. With rehabilitation, mean (95% CI) changes in utility index and EQ-VAS were 0.065 (0.047 to 0.083) and 8.6 (6.5 to 10.7), respectively, with standardised response means of 0.39 and 0.44. The mean (range) anchor estimates of the minimum important difference for utility index and EQ-VAS were 0.051 (0.037 to 0.063) and 6.9 (6.5 to 8.0), respectively. The EQ-5D-5L is a valid and responsive measure of health status in COPD and may provide useful additional cost-effectiveness data in clinical trials. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Distinguishing simulated from genuine dissociative identity disorder on the MMPI-2.

PubMed

Brand, Bethany L; Chasson, Gregory S

2015-01-01

Due to high elevations on validity and clinical scales on personality and forensic measures, it is challenging to determine if individuals presenting with symptoms of dissociative identity disorder (DID) are genuine or not. Little research has focused on malingering DID, or on the broader issue of the profiles these patients obtain on the Minnesota Multiphasic Personality Inventory (MMPI-2), despite increasing awareness of dissociation. This study sought to characterize the MMPI-2 profiles of DID patients and to determine the utility of the MMPI-2 in distinguishing DID patients from uncoached and coached DID simulators. The analyses revealed that Infrequency, Back Infrequency, and Infrequency-Psychopathology (Fp) distinguished simulators from genuine DID patients. Fp was best able to discriminate simulated DID. Utility statistics and classification functions are provided for classifying individual profiles as indicative of genuine or simulated DID. Despite exposure to information about DID, the simulators were not able to accurately feign DID, which is inconsistent with the iatrogenic/sociocultural model of DID. Given that dissociation was strongly associated with elevations in validity, as well as clinical scales, including Scale 8 (i.e., Schizophrenia), considerable caution should be used in interpreting validity scales as indicative of feigning, and Scale 8 as indicative of schizophrenia, among highly dissociative individuals. (c) 2015 APA, all rights reserved).

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

PubMed Central

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

2018-01-01

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

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

PubMed

Szucs, Kimberly A; Brown, Elena V Donoso

2018-01-01

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

Designing and validation of a yoga-based intervention for schizophrenia.

PubMed

Govindaraj, Ramajayam; Varambally, Shivarama; Sharma, Manjunath; Gangadhar, Bangalore Nanjundaiah

2016-06-01

Schizophrenia is a chronic mental illness which causes significant distress and dysfunction. Yoga has been found to be effective as an add-on therapy in schizophrenia. Modules of yoga used in previous studies were based on individual researcher's experience. This study aimed to develop and validate a specific generic yoga-based intervention module for patients with schizophrenia. The study was conducted at NIMHANS Integrated Centre for Yoga (NICY). A yoga module was designed based on traditional and contemporary yoga literature as well as published studies. The yoga module along with three case vignettes of adult patients with schizophrenia was sent to 10 yoga experts for their validation. Experts (n = 10) gave their opinion on the usefulness of a yoga module for patients with schizophrenia with some modifications. In total, 87% (13 of 15 items) of the items in the initial module were retained, with modification in the remainder as suggested by the experts. A specific yoga-based module for schizophrenia was designed and validated by experts. Further studies are needed to confirm efficacy and clinical utility of the module. Additional clinical validation is suggested.

Clinical decision making in response to performance validity test failure in a psychiatric setting.

PubMed

Marcopulos, Bernice A; Caillouet, Beth A; Bailey, Christopher M; Tussey, Chriscelyn; Kent, Julie-Ann; Frederick, Richard

2014-01-01

This study examined the clinical utility of a performance validity test (PVT) for screening consecutive referrals (N = 436) to a neuropsychology service at a state psychiatric hospital treating both civilly committed and forensic patients. We created a contingency table with Test of Memory Malingering (TOMM) pass/fail (355/81) and secondary gain present/absent (181/255) to examine pass rates associated with patient demographic, clinical and forensic status characteristics. Of the 81 failed PVTs, 48 had secondary gain defined as active criminal legal charges; 33 failed PVTs with no secondary gain. These individuals tended to be older, female, Caucasian, and civilly committed compared with the group with secondary gain who failed. From estimations of TOMM False Positive Rate and True Positive Rate we estimated base rates of neurocognitive malingering for our clinical population using the Test Validation Summary (TVS; Frederick & Bowden, 2009 ). Although PVT failure is clearly more common in a group with secondary gain (31%), there were a number of false positives (11%). Clinical ratings of patients without gain who failed suggested cognitive deficits, behavioral issues, and inattention. Low scores on PVTs in the absence of secondary gain provide useful information on test engagement and can inform clinical decisions about testing.

The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI): Revision for Clinical Use, Content Validation, and Inter-rater Reliability.

PubMed

Rosenson, Robert S; Miller, Kate; Bayliss, Martha; Sanchez, Robert J; Baccara-Dinet, Marie T; Chibedi-De-Roche, Daniela; Taylor, Beth; Khan, Irfan; Manvelian, Garen; White, Michelle; Jacobson, Terry A

2017-04-01

The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) is a method for assessing the likelihood that a patient's muscle symptoms (e.g., myalgia or myopathy) were caused or worsened by statin use. The objectives of this study were to prepare the SAMS-CI for clinical use, estimate its inter-rater reliability, and collect feedback from physicians on its practical application. For content validity, we conducted structured in-depth interviews with its original authors as well as with a panel of independent physicians. Estimation of inter-rater reliability involved an analysis of 30 written clinical cases which were scored by a sample of physicians. A separate group of physicians provided feedback on the clinical use of the SAMS-CI and its potential utility in practice. Qualitative interviews with providers supported the content validity of the SAMS-CI. Feedback on the clinical use of the SAMS-CI included several perceived benefits (such as brevity, clear wording, and simple scoring process) and some possible concerns (workflow issues and applicability in primary care). The inter-rater reliability of the SAMS-CI was estimated to be 0.77 (confidence interval 0.66-0.85), indicating high concordance between raters. With additional provider feedback, a revised SAMS-CI instrument was created suitable for further testing, both in the clinical setting and in prospective validation studies. With standardized questions, vetted language, easily interpreted scores, and demonstrated reliability, the SAMS aims to estimate the likelihood that a patient's muscle symptoms were attributable to statins. The SAMS-CI may support better detection of statin-associated muscle symptoms in clinical practice, optimize treatment for patients experiencing muscle symptoms, and provide a useful tool for further clinical research.

The development and psychometric properties of the selective mutism questionnaire.

PubMed

Bergman, R Lindsey; Keller, Melody L; Piacentini, John; Bergman, Andrea J

2008-04-01

Research on selective mutism (SM) has been limited by the absence of standardized, psychometrically sound assessment measures. The purpose of our investigation was to present two studies that examined the factor structure and initial reliability and validity of the Selective Mutism Questionnaire (SMQ), a 17-item parent report measure of failure to speak related to SM. Study 1 (N = 589) utilized an Internet sample of parents of children ages 3 to 11 to demonstrate that the SMQ has a theoretically and clinically meaningful factor structure accounting for a significant portion of variance in responses with good internal consistency. Study 2 (N = 66) supported the validity of the SMQ in that scores discriminated clinic-referred children with SM from children with other anxiety disorders. Scores on the SMQ were correlated with measures of several theoretically and clinically important dimensions.

Correlation of PROMIS Physical Function and Pain CAT Instruments With Oswestry Disability Index and Neck Disability Index in Spine Patients.

PubMed

Papuga, Mark O; Mesfin, Addisu; Molinari, Robert; Rubery, Paul T

2016-07-15

A prospective and retrospective cross-sectional cohort analysis. The aim of this study was to show that Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive testing (CAT) assessments for physical function and pain interference can be efficiently collected in a standard office visit and to evaluate these scores with scores from previously validated Oswestry Disability Index (ODI) and Neck Disability Index (NDI) providing evidence of convergent validity for use in patients with spine pathology. Spinal surgery outcomes are highly variable, and substantial debate continues regarding the role and value of spine surgery. The routine collection of patient-based outcomes instruments in spine surgery patients may inform this debate. Traditionally, the inefficiency associated with collecting standard validated instruments has been a barrier to routine use in outpatient clinics. We utilized several CAT instruments available through PROMIS and correlated these with the results obtained using "gold standard" legacy outcomes measurement instruments. All measurements were collected at a routine clinical visit. The ODI and the NDI assessments were used as "gold standard" comparisons for patient-reported outcomes. PROMIS CAT instruments required 4.5 ± 1.8 questions and took 35 ± 16 seconds to complete, compared with ODI/NDI requiring 10 questions and taking 188 ± 85 seconds when administered electronically. Linear regression analysis of retrospective scores involving a primary back complaint revealed moderate to strong correlations between ODI and PROMIS physical function with r values ranging from 0.5846 to 0.8907 depending on the specific assessment and patient subsets examined. Routine collection of physical function outcome measures in clinical practice offers the ability to inform and improve patient care. We have shown that several PROMIS CAT instruments can be efficiently administered during routine clinical visits. The moderate to strong correlations found validate the utility of computer adaptive testing when compared with the gold standard "static" legacy assessments. 4.

Survey design research: a tool for answering nursing research questions.

PubMed

Siedlecki, Sandra L; Butler, Robert S; Burchill, Christian N

2015-01-01

The clinical nurse specialist is in a unique position to identify and study clinical problems in need of answers, but lack of time and resources may discourage nurses from conducting research. However, some research methods can be used by the clinical nurse specialist that are not time-intensive or cost prohibitive. The purpose of this article is to explain the utility of survey methodology for answering a number of nursing research questions. The article covers survey content, reliability and validity issues, sample size considerations, and methods of survey delivery.

The English and Chinese versions of the five-level EuroQoL Group's five-dimension questionnaire (EQ-5D) were valid and reliable and provided comparable scores in Asian breast cancer patients.

PubMed

Lee, Chun Fan; Ng, Raymond; Luo, Nan; Wong, Nan Soon; Yap, Yoon Sim; Lo, Soo Kien; Chia, Whay Kuang; Yee, Alethea; Krishna, Lalit; Wong, Celest; Goh, Cynthia; Cheung, Yin Bun

2013-01-01

To examine the measurement properties of and comparability between the English and Chinese versions of the five-level EuroQoL Group's five-dimension questionnaire (EQ-5D) in breast cancer patients in Singapore. This is an observational study of 269 patients. Known-group validity and responsiveness of the EQ-5D utility index and visual analog scale (VAS) were assessed in relation to various clinical characteristics and longitudinal change in performance status, respectively. Convergent and divergent validity was examined by correlation coefficients between the EQ-5D and a breast cancer-specific instrument. Test-retest reliability was evaluated. The two language versions were compared by multiple regression analyses. For both English and Chinese versions, the EQ-5D utility index and VAS demonstrated known-group validity and convergent and divergent validity, and presented sufficient test-retest reliability (intraclass correlation = 0.72 to 0.83). The English version was responsive to changes in performance status. The Chinese version was responsive to decline in performance status, but there was no conclusive evidence about its responsiveness to improvement in performance status. In the comparison analyses of the utility index and VAS between the two language versions, borderline results were obtained, and equivalence cannot be definitely confirmed. The five-level EQ-5D is valid, responsive, and reliable in assessing health outcome of breast cancer patients. The English and Chinese versions provide comparable measurement results.

Retention or deletion of personality disorder diagnoses for DSM-5: an expert consensus approach.

PubMed

Mullins-Sweatt, Stephanie N; Bernstein, David P; Widiger, Thomas A

2012-10-01

One of the official proposals for the fifth edition of the American Psychiatric Association's (APA) diagnostic manual (DSM-5) is to delete half of the existing personality disorders (i.e., dependent, histrionic, narcissistic, paranoid, and schizoid). Within the APA guidelines for DSM-5 decisions, it is stated that there should be expert consensus agreement for the deletion of a diagnostic category. Additionally, categories to be deleted should have low clinical utility and/or minimal evidence for validity. The current study surveyed members of two personality disorder associations (n = 146) with respect to the utility, validity, and status of each DSM-IV-TR personality disorder diagnosis. Findings indicated that the proposal to delete five of the personality disorders lacks consensus support within the personality disorder community.

Pharmacogenetics in Cardiovascular Medicine

PubMed Central

Tuteja, Sony; Limdi, Nita

2017-01-01

Purpose of review Pharmacogenetics is an important component of precision medicine. Even within the genomic era, several challenges lie ahead in the road towards clinical implementation of pharmacogenetics in the clinic. This review will summarize the current state of knowledge regarding pharmacogenetics of cardiovascular drugs, focusing on those with the most evidence supporting clinical implementation- clopidogrel, warfarin and simvastatin. Recent findings There is limited translation of pharmacogenetics into clinical practice primarily due to the absence of outcomes data from prospective, randomized, genotype-directed clinical trials. There are several ongoing randomized controlled trials that will provide some answers as to the clinical utility of genotype-directed strategies. Several academic medical centers have pushed towards clinical implementation where the clinical validity data are strong. Their experiences will inform operational requirements of a clinical pharmacogenetics testing including the timing of testing, incorporation of test results into the electronic health record, reimbursement and ethical issues. Summary Pharmacogenetics of clopidogrel, warfarin and simvastatin are three examples where pharmacogenetics testing may provide added clinical value. Continued accumulation of evidence surrounding clinical utility of pharmacogenetics markers is imperative as this will inform reimbursement policy and drive adoption of pharamcogenetics into routine care. PMID:29057167

Stroke-Associated Pneumonia Risk Score: Validity in a French Stroke Unit.

PubMed

Cugy, Emmanuelle; Sibon, Igor

2017-01-01

Stroke-associated pneumonia is a leading cause of in-hospital death and post-stroke outcome. Screening patients at high risk is one of the main challenges in acute stroke units. Several screening tests have been developed, but their feasibility and validity still remain unclear. The aim of our study was to evaluate the validity of four risk scores (Pneumonia score, A2DS2, ISAN score, and AIS-APS) in a population of ischemic stroke patients admitted in a French stroke unit. Consecutive ischemic stroke patients admitted to a stroke unit were retrospectively analyzed. Data that allowed to retrospectively calculate the different pneumonia risk scores were recorded. Sensitivity and specificity of each score were assessed for in-hospital stroke-associated pneumonia and mortality. The qualitative and quantitative accuracy and utility of each diagnostic screening test were assessed by measuring the Youden Index and the Clinical Utility Index. Complete data were available for only 1960 patients. Pneumonia was observed in 8.6% of patients. Sensitivity and specificity were, respectively, .583 and .907 for Pneumonia score, .744 and .796 for A2DS2, and .696 and .812 for ISAN score. Data were insufficient to test AIS-APS. Stroke-associated pneumonia risk scores had an excellent negative Clinical Utility Index (.77-.87) to screen for in-hospital risk of pneumonia after acute ischemic stroke. All scores might be useful and applied to screen stroke-associated pneumonia in stroke patients treated in French comprehensive stroke units. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2018-01-08

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

Evaluation of a web based informatics system with data mining tools for predicting outcomes with quantitative imaging features in stroke rehabilitation clinical trials

NASA Astrophysics Data System (ADS)

Wang, Ximing; Kim, Bokkyu; Park, Ji Hoon; Wang, Erik; Forsyth, Sydney; Lim, Cody; Ravi, Ragini; Karibyan, Sarkis; Sanchez, Alexander; Liu, Brent

2017-03-01

Quantitative imaging biomarkers are used widely in clinical trials for tracking and evaluation of medical interventions. Previously, we have presented a web based informatics system utilizing quantitative imaging features for predicting outcomes in stroke rehabilitation clinical trials. The system integrates imaging features extraction tools and a web-based statistical analysis tool. The tools include a generalized linear mixed model(GLMM) that can investigate potential significance and correlation based on features extracted from clinical data and quantitative biomarkers. The imaging features extraction tools allow the user to collect imaging features and the GLMM module allows the user to select clinical data and imaging features such as stroke lesion characteristics from the database as regressors and regressands. This paper discusses the application scenario and evaluation results of the system in a stroke rehabilitation clinical trial. The system was utilized to manage clinical data and extract imaging biomarkers including stroke lesion volume, location and ventricle/brain ratio. The GLMM module was validated and the efficiency of data analysis was also evaluated.

Accurate Identification of Fatty Liver Disease in Data Warehouse Utilizing Natural Language Processing.

PubMed

Redman, Joseph S; Natarajan, Yamini; Hou, Jason K; Wang, Jingqi; Hanif, Muzammil; Feng, Hua; Kramer, Jennifer R; Desiderio, Roxanne; Xu, Hua; El-Serag, Hashem B; Kanwal, Fasiha

2017-10-01

Natural language processing is a powerful technique of machine learning capable of maximizing data extraction from complex electronic medical records. We utilized this technique to develop algorithms capable of "reading" full-text radiology reports to accurately identify the presence of fatty liver disease. Abdominal ultrasound, computerized tomography, and magnetic resonance imaging reports were retrieved from the Veterans Affairs Corporate Data Warehouse from a random national sample of 652 patients. Radiographic fatty liver disease was determined by manual review by two physicians and verified with an expert radiologist. A split validation method was utilized for algorithm development. For all three imaging modalities, the algorithms could identify fatty liver disease with >90% recall and precision, with F-measures >90%. These algorithms could be used to rapidly screen patient records to establish a large cohort to facilitate epidemiological and clinical studies and examine the clinic course and outcomes of patients with radiographic hepatic steatosis.

Citrate-based fluorescent materials for low-cost chloride sensing in the diagnosis of Cystic Fibrosis.

PubMed

Kim, Jimin P; Xie, Zhiwei; Creer, Michael; Liu, Zhiwen; Yang, Jian

2017-01-01

Chloride is an essential electrolyte that maintains homeostasis within the body, where abnormal chloride levels in biological fluids may indicate various diseases such as Cystic Fibrosis. However, current analytical solutions for chloride detection fail to meet the clinical needs of both high performance and low material or labor costs, hindering translation into clinical settings. Here we present a new class of fluorescence chloride sensors derived from a facile citrate -based synthesis platform that utilize dynamic quenching mechanisms. Based on this low-cost platform, we demonstrate for the first time a selective sensing strategy that uses a single fluorophore to detect multiple halides simultaneously, promising both selectivity and automation to improve performance and reduce labor costs. We also demonstrate the clinical utility of citrate-based sensors as a new sweat chloride test method for the diagnosis of Cystic Fibrosis by performing analytical validation with sweat controls and clinical validation with sweat from individuals with or without Cystic Fibrosis. Lastly, molecular modeling studies reveal the structural mechanism behind chloride sensing, serving to expand this class of fluorescence sensors with improved chloride sensitivities. Thus citrate-based fluorescent materials may enable low-cost, automated multi-analysis systems for simpler, yet accurate, point-of-care diagnostics that can be readily translated into clinical settings. More broadly, a wide range of medical, industrial, and environmental applications can be achieved with such a facile synthesis platform, demonstrated in our citrate-based biodegradable polymers with intrinsic fluorescence sensing.

Assessment of Psychiatrically Hospitalized Suicidal Adolescents: Self-Report Instruments as Predictors of Suicidal Thoughts and Behavior

ERIC Educational Resources Information Center

Huth-Bocks, Alissa C.; Kerr, David C. R.; Ivey, Asha Z.; Kramer, Anne C.; King, Cheryl A.

2007-01-01

Objective: The validity and clinical utility of the Reynolds Adolescent Depression Scale, Beck Hopelessness Scale, Suicidal Ideation Questionnaire-Junior, and Suicide Probability Scale (SPS) were examined longitudinally among suicidal adolescents. Method: Between 1998 and 2000, 289 psychiatrically hospitalized, suicidal youth, ages 12 to 17 years,…

Measuring suicidality using the personality assessment inventory: a convergent validity study with federal inmates.

PubMed

Patry, Marc W; Magaletta, Philip R

2015-02-01

Although numerous studies have examined the psychometric properties and clinical utility of the Personality Assessment Inventory in correctional contexts, only two studies to date have specifically focused on suicide ideation. This article examines the convergent validity of the Suicide Ideation Scale and the Suicide Potential Index on the Personality Assessment Inventory in a large, nontreatment sample of male and female federal inmates (N = 1,120). The data indicated robust validity support for both the Suicide Ideation Scale and Suicide Potential Index, which were each correlated with a broad group of validity indices representing multiple assessment modalities. Recommendations for future research to build upon these findings through replication and extension are made. © The Author(s) 2014.

The development and evaluation of a five-language multi-perspective standardised measure: clinical decision-making involvement and satisfaction (CDIS)

PubMed Central

2014-01-01

Background The aim of this study was to develop and evaluate a brief quantitative five-language measure of involvement and satisfaction in clinical decision-making (CDIS) – with versions for patients (CDIS-P) and staff (CDIS-S) – for use in mental health services. Methods An English CDIS was developed by reviewing existing measures, focus groups, semistructured interviews and piloting. Translations into Danish, German, Hungarian and Italian followed the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Task Force principles of good practice for translation and cultural adaptation. Psychometricevaluation involved testing the measure in secondary mental health services in Aalborg, Debrecen, London, Naples, Ulm and Zurich. Results After appraising 14 measures, the Control Preference Scale and Satisfaction With Decision-making English-language scales were modified and evaluated in interviews (n = 9), focus groups (n = 22) and piloting (n = 16). Translations were validated through focus groups (n = 38) and piloting (n = 61). A total of 443 service users and 403 paired staff completed CDIS. The Satisfaction sub-scale had internal consistency of 0.89 (0.86-0.89 after item-level deletion) for staff and 0.90 (0.87-0.90) for service users, both continuous and categorical (utility) versions were associated with symptomatology and both staff-rated and service userrated therapeutic alliance (showing convergent validity), and not with social disability (showing divergent validity), and satisfaction predicted staff-rated (OR 2.43, 95%CI 1.54- 3.83 continuous, OR 5.77, 95%CI 1.90-17.53 utility) and service user-rated (OR 2.21, 95%CI 1.51-3.23 continuous, OR 3.13, 95%CI 1.10-8.94 utility) decision implementation two months later. The Involvement sub-scale had appropriate distribution and no floor or ceiling effects, was associated with stage of recovery, functioning and quality of life (staff only) (showing convergent validity), and not with symptomatology or social disability (showing divergent validity), and staff-rated passive involvement by the service user predicted implementation (OR 3.55, 95%CI 1.53-8.24). Relationships remained after adjusting for clustering by staff. Conclusions CDIS demonstrates adequate internal consistency, no evidence of item redundancy, appropriate distribution, and face, content, convergent, divergent and predictive validity. It can be recommended for research and clinical use. CDIS-P and CDIS-S in all 3 five languages can be downloaded at http://www.cedar-net.eu/instruments. Trial registration ISRCTN75841675. PMID:25066212

How young can children reliably and validly self-report their health-related quality of life?: an analysis of 8,591 children across age subgroups with the PedsQL 4.0 Generic Core Scales.

PubMed

Varni, James W; Limbers, Christine A; Burwinkle, Tasha M

2007-01-03

The last decade has evidenced a dramatic increase in the development and utilization of pediatric health-related quality of life (HRQOL) measures in an effort to improve pediatric patient health and well-being and determine the value of healthcare services. The emerging paradigm shift toward patient-reported outcomes (PROs) in clinical trials has provided the opportunity to further emphasize the value and essential need for pediatric patient self-reported outcomes measurement. Data from the PedsQL DatabaseSM were utilized to test the hypothesis that children as young as 5 years of age can reliably and validly report their HRQOL. The sample analyzed represented child self-report age data on 8,591 children ages 5 to 16 years from the PedsQL 4.0 Generic Core Scales DatabaseSM. Participants were recruited from general pediatric clinics, subspecialty clinics, and hospitals in which children were being seen for well-child checks, mild acute illness, or chronic illness care (n = 2,603, 30.3%), and from a State Children's Health Insurance Program (SCHIP) in California (n = 5,988, 69.7%). Items on the PedsQL 4.0 Generic Core Scales had minimal missing responses for children as young as 5 years old, supporting feasibility. The majority of the child self-report scales across the age subgroups, including for children as young as 5 years, exceeded the minimum internal consistency reliability standard of 0.70 required for group comparisons, while the Total Scale Scores across the age subgroups approached or exceeded the reliability criterion of 0.90 recommended for analyzing individual patient scale scores. Construct validity was demonstrated utilizing the known groups approach. For each PedsQL scale and summary score, across age subgroups, including children as young as 5 years, healthy children demonstrated a statistically significant difference in HRQOL (better HRQOL) than children with a known chronic health condition, with most effect sizes in the medium to large effect size range. The results demonstrate that children as young as the 5 year old age subgroup can reliably and validly self-report their HRQOL when given the opportunity to do so with an age-appropriate instrument. These analyses are consistent with recent FDA guidelines which require instrument development and validation testing for children and adolescents within fairly narrow age groupings and which determine the lower age limit at which children can provide reliable and valid responses across age categories.

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

PubMed Central

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

2011-01-01

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

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

PubMed

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

2011-01-01

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

Analytical validation and establishment of reference intervals for a 'high-sensitivity' cardiac troponin-T assay in horses.

PubMed

Shields, E; Seiden-Long, I; Massie, S; Passante, S; Leguillette, R

2016-06-13

Cardiac troponin-I assays have been validated in horses.'High-sensitivity' cardiac troponin assays are now the standard in human cardiology. Appropriately validate the'high-sensitivity' cardiac Troponin-T (hscTnT) assay for clinical use in horses, establish reference intervals, determine the biological variation, and demonstrate assay utility in selected clinical cases. Analytical validation of the Roche hscTnT assay included within- and between-run precision, linear dose response, limit of quantitation (LoQ), stability, and comparison with cTn-I (iSTAT). Reference intervals and biological variation were determined using adult, healthy, Non-Competition Horses (N = 125) and Racing-Thoroughbreds (N = 178). HscTnT levels were measured in two horses with cardiac pathology. The hscTnT demonstrates acceptable within-run (L1 = 6.5 ng/L, CV 14.9 %, L2 = 10.1 ng/L, CV 8.7 %, L3 = 15.3 ng/L, CV 5.4 %) and between-run precision (L1 = 12.2 ng/L, CV 8.4 %, L2 = 57.0 ng/L, CV 8.4 %, L3 = 256.0 ng/L, CV 9.0 %). The assay was linear from 3 to 391 ng/L. The LoQ was validated at 3 ng/L. Samples demonstrated insignificant decay over freeze-thaw cycle. Comparison with cTnI assay showed excellent correlation (range: 8.0-3535.0 ng/L, R(2) = 0.9996). Reference intervals: The upper 95(th) and 99(th) percentile of the hscTnT population distribution were 6.8 and 16.2 ng/L in Non-Competition Horses, and 14.0 and 23.2 ng/L in Racing-Thoroughbreds. Between-breed, diurnal effect, and between-day variation was below LoQ. Two clinical cases with presumed cardiac pathology had hscTnT levels of 220.9 ng/L and 5723.0 ng/L. This benchmark study is the first to comply with CLSI guidelines, thus further establishing the performance characteristics of the hscTnT assay, and reference intervals in healthy horses. Two clinical cases demonstrated further the clinical utility of the assay.

Reexamining the domain of hypochondriasis: comparing the Illness Attitudes Scale to other approaches.

PubMed

Fergus, Thomas A; Valentiner, David P

2009-08-01

The present study examined utility of the Illness Attitudes Scale (IAS; [Kellner, R. (1986). Somatization and hypochondriasis. New York: Praeger Publishers]) in a non-clinical college sample (N=235). Relationships among five recently identified IAS dimensions (fear of illness and pain, symptom effects, treatment experience, disease conviction, and health habits) and self-report measures of several anxiety-related constructs (health anxiety, body vigilance, intolerance of uncertainty, anxiety sensitivity, and non-specific anxiety symptoms) were examined. In addition, this study investigated the incremental validity of the IAS dimensions in predicting medical utilization. The fear of illness and pain dimension and the symptom effects dimension consistently shared stronger relations with the anxiety-related constructs compared to the other three IAS dimensions. The symptom effects dimension, the disease conviction dimension, and the health habits dimension showed incremental validity over the anxiety-related constructs in predicting medical utilization. Implications for the IAS and future conceptualizations of HC are discussed.

Screening utility of the social anxiety screening scale in Spanish speaking adolescents.

PubMed

Piqueras, José Antonio; Olivares, José; Hidalgo, María Dolores

2012-07-01

The aim of this study was to analyse the screening utility of the Social Anxiety Screening Scale (SASS/EDAS) in a sample of 227 adolescents with social anxiety disorder and 156 Without it (14-17 years). Results showed that the EDAS subscales (Avoidance, Distress and Interference) scores were reliable in terms of internal consistency (alpha > .80). All the subscales discriminated between adolescents with and without the disorder. They also showed a positive and significant correlation with other empirically validated measures of social anxiety. The three subscales indicated relevant sensitivity (69.16-84.14%), specificity (63.46-66.03%) and areas under the curve (.74-.81%). Binary logistic regression analyses indicated the adequate predictive utility of EDAS subscales, with the Distress subscale as the best diagnostic predictor. The data provide empirical evidence of the usefulness of EDAS as a screener for adolescent social anxiety disorder in terms of reliability, convergent and discriminant validity, diagnostic accuracy and clinical usefulness.

Prevalence of Invalid Performance on Baseline Testing for Sport-Related Concussion by Age and Validity Indicator.

PubMed

Abeare, Christopher A; Messa, Isabelle; Zuccato, Brandon G; Merker, Bradley; Erdodi, Laszlo

2018-03-12

Estimated base rates of invalid performance on baseline testing (base rates of failure) for the management of sport-related concussion range from 6.1% to 40.0%, depending on the validity indicator used. The instability of this key measure represents a challenge in the clinical interpretation of test results that could undermine the utility of baseline testing. To determine the prevalence of invalid performance on baseline testing and to assess whether the prevalence varies as a function of age and validity indicator. This retrospective, cross-sectional study included data collected between January 1, 2012, and December 31, 2016, from a clinical referral center in the Midwestern United States. Participants included 7897 consecutively tested, equivalently proportioned male and female athletes aged 10 to 21 years, who completed baseline neurocognitive testing for the purpose of concussion management. Baseline assessment was conducted with the Immediate Postconcussion Assessment and Cognitive Testing (ImPACT), a computerized neurocognitive test designed for assessment of concussion. Base rates of failure on published ImPACT validity indicators were compared within and across age groups. Hypotheses were developed after data collection but prior to analyses. Of the 7897 study participants, 4086 (51.7%) were male, mean (SD) age was 14.71 (1.78) years, 7820 (99.0%) were primarily English speaking, and the mean (SD) educational level was 8.79 (1.68) years. The base rate of failure ranged from 6.4% to 47.6% across individual indicators. Most of the sample (55.7%) failed at least 1 of 4 validity indicators. The base rate of failure varied considerably across age groups (117 of 140 [83.6%] for those aged 10 years to 14 of 48 [29.2%] for those aged 21 years), representing a risk ratio of 2.86 (95% CI, 2.60-3.16; P < .001). The results for base rate of failure were surprisingly high overall and varied widely depending on the specific validity indicator and the age of the examinee. The strong age association, with 3 of 4 participants aged 10 to 12 years failing validity indicators, suggests that the clinical interpretation and utility of baseline testing in this age group is questionable. These findings underscore the need for close scrutiny of performance validity indicators on baseline testing across age groups.

Mapping the functional assessment of cancer therapy-breast (FACT-B) to the 5-level EuroQoL Group's 5-dimension questionnaire (EQ-5D-5L) utility index in a multi-ethnic Asian population.

PubMed

Cheung, Yin Bun; Luo, Nan; Ng, Raymond; Lee, Chun Fan

2014-12-12

To develop an algorithm for mapping the Functional Assessment of Cancer Therapy-Breast (FACT-B) to the 5-level EuroQoL Group's 5-dimension questionnaire (EQ-5D-5L) utility index. A survey of 238 breast cancer patients in Singapore was conducted. Models using various regression methods with or without recognizing the upper boundary of utility values at 1 were fitted to predict the EQ-5D-5L utility index based on the five subscale scores of the FACT-B. Data from a follow-up survey of these patients were used to validate the results. A model that maps the physical, emotional, functional well-being and the breast cancer concerns subscales of the FACT-B to the EQ-5D-5L utility index was derived. The social well-being subscale was not associated to the utility index. Although theoretical assumptions may not be valid, ordinary least square outperformed other regression methods. The mean predicted utility index within each performance status level at follow-up deviated from the observed mean less than the minimally important difference of EQ-5D for cancer patients. The mapping algorithm converts the FACT-B to the EQ-5D utility index. This enables oncologists, clinical researchers and policy makers to obtain a quantitative utility summary of a patient's health status when only the FACT-B is assessed.

The Teamwork Mini-Clinical Evaluation Exercise (T-MEX): a workplace-based assessment focusing on collaborative competencies in health care.

PubMed

Olupeliyawa, Asela M; O'Sullivan, Anthony J; Hughes, Chris; Balasooriya, Chinthaka D

2014-02-01

Teamwork is an important and challenging area of learning during the transition from medical graduate to intern. This preliminary investigation examined the psychometric and logistic properties of the Teamwork Mini-Clinical Evaluation Exercise (T-MEX) for the workplace-based assessment of key competencies in working with health care teams. The authors designed the T-MEX for direct observation and assessment of six collaborative behaviors in seven clinical situations important for teamwork, feedback, and reflection. In 2010, they tested it on University of New South Wales senior medical students during their last six-week clinical term to investigate its overall utility, including validity and reliability. Assessors rated students in different situations on the extent to which they met expectations for interns for each collaborative behavior. Both assessors and students rated the tool's usefulness and feasibility. Assessment forms for 88 observed encounters were submitted by 25 students. The T-MEX was suited to a broad range of collaborative clinical practice situations, as evidenced by the encounter types and the behaviors assessed by health care team members. The internal structure of the behavior ratings indicated construct validity. A generalizability study found that eight encounters were adequate for high-stakes measurement purposes. The mean times for observation and feedback and the participants' perceptions suggested usefulness for feedback and feasibility in busy clinical settings. Findings suggest that the T-MEX has good utility for assessing trainee competence in working with health care teams. It fills a gap within the suite of existing tools for workplace-based assessment of professional attributes.

Measuring pain in patients undergoing hemodialysis: a review of pain assessment tools

PubMed Central

Upadhyay, Chandani; Cameron, Karen; Murphy, Laura; Battistella, Marisa

2014-01-01

Background Patients undergoing hemodialysis frequently report pain with multifactorial causes, not limited to that experienced directly from hemodialysis treatment. Their pain may be nociceptive, neuropathic, somatic or visceral in nature. Despite this, pain in this population remains under-recognized and under-treated. Although several tools have been used to measure pain in patients undergoing hemodialysis as reported in the literature, none of them have been validated specifically in this population. The objective for this review was to compare and contrast these pain assessment tools and discuss their clinical utility in this patient population. Methods To identify pain assessment tools studied in patients undergoing hemodialysis, a literature search was performed in PubMed and Medline. An expert panel of dialysis and pain clinicians reviewed each tool. Each pain assessment tool was assessed on how it is administered and scored, its psychometric properties such as reliability, validity and responsiveness to change, and its clinical utility in a hemodialysis population. Brief Pain Inventory, McGill Pain Questionnaire, Pain Management Index, Edmonton Symptom Assessment System, Visual Analogue Scale and Faces Pain Scale were evaluated and compared. Results This assessment will help clinicians practicing in nephrology to determine which of these pain assessment tools is best suited for use in their individual clinical practice. PMID:25852910

The Italian version of the Depression Anxiety Stress Scales-21: Factor structure and psychometric properties on community and clinical samples.

PubMed

Bottesi, Gioia; Ghisi, Marta; Altoè, Gianmarco; Conforti, Erica; Melli, Gabriele; Sica, Claudio

2015-07-01

The Depression Anxiety Stress Scales-21 (DASS-21) is the short version of a self-report measure that was originally developed to provide maximum differentiation between depressive and anxious symptoms. Despite encouraging evidence, the factor structure and other features of the DASS-21 are yet to be firmly established. A community sample of 417 participants and two clinical groups (32 depressive patients and 25 anxious patients) completed the Italian version of the DASS-21 along with several measures of psychopathology. Confirmatory factor analyses suggested that the DASS-21 is a measure of general distress plus three additional orthogonal dimensions (anxiety, depression, and stress). The internal consistency and temporal stability of the measure were good; each DASS-21 scale correlated more strongly with a measure of a similar construct, demonstrating good convergent and divergent validity. Lastly, the DASS-21 demonstrated good criterion-oriented validity. The validity of the Italian DASS-21 and its utility, both for community and clinical individuals, are supported. Copyright © 2015 Elsevier Inc. All rights reserved.

Cultural adaptation, standardization and clinical validity of the test your memory dementia screening instrument in Greek.

PubMed

Iatraki, Eliza; Simos, Panagiotis G; Lionis, Christos; Zaganas, Ioannis; Symvoulakis, Emmanouil K; Papastefanakis, Emmanouil; Panagiotakis, Simeon; Pantelidakis, Heraklis; Papadopoulos, Konstantinos; Tziraki, Chariklia

2014-01-01

To adapt and standardize the Test Your Memory (TYM) dementia screening instrument in Greek. Normative data on the Greek version of the TYM were obtained from a community sample of 239 adults aged 21-92 years. Clinical validity was assessed in a cohort of 134 Neurology Clinic patients. Concurrent validity was examined through comparisons with the Mini-Mental State Examination (MMSE) and the Greek Everyday Function Scale. Correlations between the TYM and the MMSE were 0.73 and 0.82 in the community and patient samples, respectively. Scores on both tests were moderately associated with everyday functional capacity. Using age- and education-corrected cutoff scores ranging from 26/50 to 45/50 points, the sensitivity of the TYM for Alzheimer's disease detection was found to be higher than that of the MMSE (0.82 vs. 0.70), although its specificity was lower (0.71 vs. 0.90). Findings are consistent with previous reports in a variety of cultural settings supporting the potential utility of the TYM as a dementia screening tool.

Old wine in new bottles: validating the clinical utility of SPECT in predicting cognitive performance in mild traumatic brain injury.

PubMed

Romero, Kristoffer; Lobaugh, Nancy J; Black, Sandra E; Ehrlich, Lisa; Feinstein, Anthony

2015-01-30

The neural underpinnings of cognitive dysfunction in mild traumatic brain injury (TBI) are not fully understood. Consequently, patient prognosis using existing clinical imaging is somewhat imprecise. Single photon emission computed tomography (SPECT) is a frequently employed investigation in this population, notwithstanding uncertainty over the clinical utility of the data obtained. In this study, subjects with mild TBI underwent (99m)Tc-ECD SPECT scanning, and were administered a brief battery of cognitive tests and self-report symptom scales of concussion and emotional distress. Testing took place 2 weeks (n=84) and 1 year (n=49) post-injury. Multivariate analysis (i.e., partial least squares analysis) revealed that frontal perfusion in right superior frontal and middle frontal gyri predicted poorer performance on the Stroop test, an index of executive function, both at initial and follow-up testing. Conversely, SPECT scans categorized as normal or abnormal by radiologists did not differentiate cognitively impaired from intact subjects. These results demonstrate the clinical utility of SPECT in mild TBI, but only when data are subjected to blood flow quantification analysis. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Pancreatic cancer early detection: Expanding higher-risk group with clinical and metabolomics parameters

PubMed Central

Urayama, Shiro

2015-01-01

Pancreatic ductal adenocarcinoma (PDAC) is the fourth and fifth leading cause of cancer death for each gender in developed countries. With lack of effective treatment and screening scheme available for the general population, the mortality rate is expected to increase over the next several decades in contrast to the other major malignancies such as lung, breast, prostate and colorectal cancers. Endoscopic ultrasound, with its highest level of detection capacity of smaller pancreatic lesions, is the commonly employed and preferred clinical imaging-based PDAC detection method. Various molecular biomarkers have been investigated for characterization of the disease, but none are shown to be useful or validated for clinical utilization for early detection. As seen from studies of a small subset of familial or genetically high-risk PDAC groups, the higher yield and utility of imaging-based screening methods are demonstrated for these groups. Multiple recent studies on the unique cancer metabolism including PDAC, demonstrate the potential for utility of the metabolites as the discriminant markers for this disease. In order to generate an early PDAC detection screening strategy available for a wider population, we propose to expand the population of higher risk PDAC group with combination clinical and metabolomics parameters. PMID:25684935

[Issues on business of genetic testing in near future].

PubMed

Takada, Fumio

2009-06-01

Since 1990's, a business condition that company sells genetic testing services directly to consumers without through medical facility, so called "direct-to-consumers (DTC) genetic testing", has risen. They provide genetic testing for obesity, disease susceptibility or paternity, etc. There are serious problems in this kind of business. Most of the providers do not make sales with face-to-face selling, and do through internet instead. They do not provide genetic counseling by certified genetic counselor or clinical geneticist. Most DTC genetic testing services for disease susceptibility or predispositions including obesity, lack scientific validity, clinical validity and clinical utility. And also including paternity genetic testing, they all have risks of ethical legal and social issues (ELSI) in genetic discrimination and/or eugenics. The specific problem in Japan is that the healthcare section of the government still has not paid attention and not taken seriously the requirement to deploy safety net.

Predicting Persistent Back Symptoms by Psychosocial Risk Factors: Validity Criteria for the ÖMPSQ and the HKF-R 10 in Germany.

PubMed

Riewe, E; Neubauer, E; Pfeifer, A C; Schiltenwolf, M

2016-01-01

10% of all individuals in Germany develop persistent symptoms due to nonspecific back pain (NSBP) causing up to 90% of direct and indirect expenses for health care systems. Evidence indicates a strong relationship between chronic nonspecific back pain and psychosocial risk factors. The Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ) and the German Heidelberger Kurzfragebogen Rückenschmerz (HKF-R 10) are deemed valid in prediction of persistent pain, functional loss or amount of sick leave. This study provides and discusses validity criteria for these questionnaires using ROC-curve analyses. Quality measurements included sensitivity and specificity, likelihood-ratio related test-efficiencies and clinical utility in regard to predictive values. 265 patients recruited from primary and secondary care units completed both questionnaires during the same timeframe. From the total, 133 patients returned a 6-month follow-up questionnaire to assess the validity criteria for outcomes of pain, function and sick leave. Based on heterogeneous cut-offs for the ÖMPSQ, sensitivity and specificity were moderate for outcome of pain (72%/75%). Very high sensitivity was observed for function (97%/57%) and high specificity for sick leave (63%/85%). The latter also applied to the HKF-R 10 (pain 50%/84%). Proportions between sensitivity and specificity were unbalanced except for the ÖMPSQ outcome of pain. Likelihood-ratios and positive predictive values ranged from low to moderate. Although the ÖMPSQ may be considered useful in identification of long-term functional loss or pain, over- and underestimation of patients at risk of chronic noncspecific back pain led to limited test-efficiencies and clinical utility for both questionnaires. Further studies are required to quantify the predictive validity of both questionnaires in Germany.

The Eating Disorder Assessment for DSM-5 (EDA-5): Development and Validation of a Structured Interview for Feeding and Eating Disorders

PubMed Central

Sysko, Robyn; Glasofer, Deborah R.; Hildebrandt, Tom; Klimek, Patrycja; Mitchell, James E.; Berg, Kelly C.; Peterson, Carol B.; Wonderlich, Stephen A.; Walsh, B. Timothy

2016-01-01

Objective Existing measures for DSM-IV eating disorder diagnoses have notable limitations, and there are important differences between DSM-IV and DSM-5 feeding and eating disorders. This study developed and validated a new semi-structured interview, the Eating Disorders Assessment for DSM-5 (EDA-5). Method Two studies evaluated the utility of the EDA-5. Study 1 compared the diagnostic validity of the EDA-5 to the Eating Disorder Examination (EDE) and evaluated the test-retest reliability of the new measure. Study 2 compared the diagnostic validity of an EDA-5 electronic application (“app”) to clinician interview and self-report assessments. Results In Study 1, the kappa for EDE and EDA-5 eating disorder diagnoses was 0.74 across all diagnoses (n= 64), with a range of κ=0.65 for Other Specified Feeding or Eating Disorder (OSFED)/Unspecified Feeding or Eating Disorder (USFED) to κ=0.90 for Binge Eating Disorder (BED). The EDA-5 test-retest kappa coefficient was 0.87 across diagnoses. For Study 2, clinical interview versus “app” conditions revealed a kappa of 0.83 for all eating disorder diagnoses (n=71). Across individual diagnostic categories, kappas ranged from 0.56 for OSFED/USFED to 0.94 for BN. Discussion High rates of agreement were found between diagnoses by EDA-5 and the EDE, and EDA-5 and clinical interviews. As this study supports the validity of the EDA-5 to generate DSM-5 eating disorders and the reliability of these diagnoses, the EDA-5 may be an option for the assessment of Anorexia Nervosa, Bulimia Nervosa, and BED. Additional research is needed to evaluate the utility of the EDA-5 in assessing DSM-5 feeding disorders. PMID:25639562

Implications of the Institute of Medicine Report: Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease.

PubMed

Wagner, J A; Ball, J R

2015-07-01

The Institute of Medicine (IOM) released a groundbreaking 2010 report, Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Key recommendations included a harmonized scientific process and a general framework for biomarker evaluation with three interrelated steps: (1) Analytical validation -- is the biomarker measurement accurate? (2) Qualification -- is the biomarker associated with the clinical endpoint of concern? (3) Utilization -- what is the specific context of the proposed use? © 2015 American Society for Clinical Pharmacology and Therapeutics.

The clinical utility of a 30-minute neuropsychological assessment battery in inpatient stroke rehabilitation.

PubMed

Jaywant, Abhishek; Toglia, Joan; Gunning, Faith M; O'Dell, Michael W

2018-07-15

Cognitive assessment is an important component of inpatient stroke rehabilitation. Few studies have empirically evaluated the clinical utility of specific neuropsychological measures in this setting. We investigated the psychometric properties and clinical utility of a 30-minute neuropsychological battery developed by the National Institute of Neurologic Disorders and Stroke (NINDS) and the Canadian Stroke Network (CSN). Clinical data were analyzed from 100 individuals with mild-moderate stroke severity on an acute inpatient rehabilitation unit who completed the NINDS-CSN battery at admission. The battery comprised the Symbol-Digit Modalities Test (SDMT), Trail Making Test, Controlled Oral Word Association Test, Animal Naming, and the Hopkins Verbal Learning Test-Revised. We evaluated the battery's distribution of scores, frequency of impaired performance, internal consistency, and ability to predict rehabilitation gain and independence in cognitively-based instrumental activities of daily living (IADL) at discharge. Results indicated that the NINDS-CSN battery was sensitive to cognitive impairment, demonstrated moderately strong internal consistency, and predicted discharge IADL. The SDMT demonstrated the strongest sensitivity to impairment and predictive validity. The NINDS-CSN battery is a clinically useful assessment battery in acute inpatient stroke rehabilitation. Complex attention and processing speed performance may be most informative in predicting amount of rehabilitation gain and IADL functioning at discharge. Copyright © 2018 Elsevier B.V. All rights reserved.

Pain assessment in children: theoretical and empirical validity.

PubMed

Villarruel, A M; Denyes, M J

1991-12-01

Valid assessment of pain in children is foundational for both the nursing practice and research domains, yet few validated methods of pain measurement are currently available for young children. This article describes an innovative research approach used in the development of photographic instruments to measure pain intensity in young African-American and Hispanic children. The instruments were designed to enable children to participate actively in their own care and to do so in ways that are congruent with their developmental and cultural heritage. Conceptualization of the instruments, methodological development, and validation processes grounded in Orem's Self-Care Deficit Theory of Nursing are described. The authors discuss the ways in which the gaps between nursing theory, research, and practice are narrowed when development of instruments to measure clinical nursing phenomena are grounded in nursing theory, validated through research and utilized in practice settings.

Development of a pharmacogenetic-guided warfarin dosing algorithm for Puerto Rican patients

PubMed Central

Ramos, Alga S; Seip, Richard L; Rivera-Miranda, Giselle; Felici-Giovanini, Marcos E; Garcia-Berdecia, Rafael; Alejandro-Cowan, Yirelia; Kocherla, Mohan; Cruz, Iadelisse; Feliu, Juan F; Cadilla, Carmen L; Renta, Jessica Y; Gorowski, Krystyna; Vergara, Cunegundo; Ruaño, Gualberto; Duconge, Jorge

2012-01-01

Aim This study was aimed at developing a pharmacogenetic-driven warfarin-dosing algorithm in 163 admixed Puerto Rican patients on stable warfarin therapy. Patients & methods A multiple linear-regression analysis was performed using log-transformed effective warfarin dose as the dependent variable, and combining CYP2C9 and VKORC1 genotyping with other relevant nongenetic clinical and demographic factors as independent predictors. Results The model explained more than two-thirds of the observed variance in the warfarin dose among Puerto Ricans, and also produced significantly better ‘ideal dose’ estimates than two pharmacogenetic models and clinical algorithms published previously, with the greatest benefit seen in patients ultimately requiring <7 mg/day. We also assessed the clinical validity of the model using an independent validation cohort of 55 Puerto Rican patients from Hartford, CT, USA (R2 = 51%). Conclusion Our findings provide the basis for planning prospective pharmacogenetic studies to demonstrate the clinical utility of genotyping warfarin-treated Puerto Rican patients. PMID:23215886

Refining prognosis in lung cancer: A report on the quality and relevance of clinical prognostic tools

PubMed Central

Mahar, Alyson L.; Compton, Carolyn; McShane, Lisa M.; Halabi, Susan; Asamura, Hisao; Rami-Porta, Ramon; Groome, Patti A.

2015-01-01

Introduction Accurate, individualized prognostication for lung cancer patients requires the integration of standard patient and pathologic factors, biologic, genetic, and other molecular characteristics of the tumor. Clinical prognostic tools aim to aggregate information on an individual patient to predict disease outcomes such as overall survival, but little is known about their clinical utility and accuracy in lung cancer. Methods A systematic search of the scientific literature for clinical prognostic tools in lung cancer published Jan 1, 1996-Jan 27, 2015 was performed. In addition, web-based resources were searched. A priori criteria determined by the Molecular Modellers Working Group of the American Joint Committee on Cancer were used to investigate the quality and usefulness of tools. Criteria included clinical presentation, model development approaches, validation strategies, and performance metrics. Results Thirty-two prognostic tools were identified. Patients with metastases were the most frequently considered population in non-small cell lung cancer. All tools for small cell lung cancer covered that entire patient population. Included prognostic factors varied considerably across tools. Internal validity was not formally evaluated for most tools and only eleven were evaluated for external validity. Two key considerations were highlighted for tool development: identification of an explicit purpose related to a relevant clinical population and clear decision-points, and prioritized inclusion of established prognostic factors over emerging factors. Conclusions Prognostic tools will contribute more meaningfully to the practice of personalized medicine if better study design and analysis approaches are used in their development and validation. PMID:26313682

Reliability, Validity and Treatment Sensitivity of the Schizophrenia Cognition Rating Scale

PubMed Central

Keefe, Richard S.E.; Davis, Vicki G.; Spagnola, Nathan B.; Hilt, Dana; Dgetluck, Nancy; Ruse, Stacy; Patterson, Thomas L.; Narasimhan, Meera; Harvey, Philip D.

2014-01-01

Cognitive functioning can be assessed with performance-based assessments such as neuropsychological tests and with interview-based assessments. Both assessment methods have the potential to assess whether treatments for schizophrenia improve clinically relevant aspects of cognitive impairment. However, little is known about the reliability, validity and treatment responsiveness of interview-based measures, especially in the context of clinical trials. Data from two studies were utilized to assess these features of the Schizophrenia Cognition Rating Scale (SCoRS). One of the studies was a validation study involving 79 patients with schizophrenia assessed at 3 academic research centers in the US. The other study was a 32-site clinical trial conducted in the US and Europe comparing the effects of encenicline, an alpha-7 nicotine agonist, to placebo in 319 patients with schizophrenia. The SCoRS interviewer ratings demonstrated excellent test-retest reliability in several different circumstances, including those that did not involve treatment (ICC> 0.90), and during treatment (ICC>0.80). SCoRS interviewer ratings were related to cognitive performance as measured by the MCCB (r= −0.35), and demonstrated significant sensitivity to treatment with encenicline compared to placebo (P<.001). These data suggest that the SCoRS has potential as a clinically relevant measure in clinical trials aiming to improve cognition in schizophrenia, and may be useful for clinical practice. The weaknesses of the SCoRS include its reliance on informant information, which is not available for some patients, and reduced validity when patient self-report is the sole information source. PMID:25028065

Reliability, validity and treatment sensitivity of the Schizophrenia Cognition Rating Scale.

PubMed

Keefe, Richard S E; Davis, Vicki G; Spagnola, Nathan B; Hilt, Dana; Dgetluck, Nancy; Ruse, Stacy; Patterson, Thomas D; Narasimhan, Meera; Harvey, Philip D

2015-02-01

Cognitive functioning can be assessed with performance-based assessments such as neuropsychological tests and with interview-based assessments. Both assessment methods have the potential to assess whether treatments for schizophrenia improve clinically relevant aspects of cognitive impairment. However, little is known about the reliability, validity and treatment responsiveness of interview-based measures, especially in the context of clinical trials. Data from two studies were utilized to assess these features of the Schizophrenia Cognition Rating Scale (SCoRS). One of the studies was a validation study involving 79 patients with schizophrenia assessed at 3 academic research centers in the US. The other study was a 32-site clinical trial conducted in the US and Europe comparing the effects of encenicline, an alpha-7 nicotine agonist, to placebo in 319 patients with schizophrenia. The SCoRS interviewer ratings demonstrated excellent test-retest reliability in several different circumstances, including those that did not involve treatment (ICC> 0.90), and during treatment (ICC>0.80). SCoRS interviewer ratings were related to cognitive performance as measured by the MCCB (r=-0.35), and demonstrated significant sensitivity to treatment with encenicline compared to placebo (P<.001). These data suggest that the SCoRS has potential as a clinically relevant measure in clinical trials aiming to improve cognition in schizophrenia, and may be useful for clinical practice. The weaknesses of the SCoRS include its reliance on informant information, which is not available for some patients, and reduced validity when patient's self-report is the sole information source. Copyright © 2014 Elsevier B.V. and ECNP. All rights reserved.

The Sound Access Parent Outcomes Instrument (SAPOI): Construction of a new instrument for children with severe multiple disabilities who use cochlear implants or hearing aids.

PubMed

Hayward, Denyse V; Ritter, Kathryn; Mousavi, Amin; Vatanapour, Shabnam

2016-01-01

To report on the Phase 2 development of the Sound Access Parent Outcomes Instrument (SAPOI), a new instrument focused on formalizing outcomes that parents of children with severe multiple disabilities (SMD) who use amplification prioritize as important. Phase 2 of this project involved item selection and refinement of the SAPOI based on (a) Phase 1 study participant input, (b) clinical specialist feedback, and (c) test-retest instrument reliability. Phase 1 participant responses were utilized to construct a draft version of the SAPOI. Next, clinical specialists examined the instrument for content validity and utility and instrument reliability was examined through a test-retest process with parents of children with SMD. The draft SAPOI was constructed based on Phase 1 participant input. Clinical specialists supported content validity and utility of the instrument and the inclusion of 19 additional items across four categories, namely Child Affect, Child Interaction, Parent Well-being, and Child's Device Use. The SAPOI was completed twice at one-month intervals by parents of children with SMD to examine instrument reliability across the four categories (Child Affect, Child Interaction, Parent Well-being, and Child's Device Use). Instrument reliability was strong-to-excellent across all four sections. The SAPOI shows promise as a much-needed addition to the assessment battery currently used for children with SMD who use cochlear implants and hearing aids. It provides valuable information regarding outcomes resulting from access to sound in this population that currently used assessments do not identify.

Reliability, Validity, and Predictive Utility of the 25-Item Criminogenic Cognitions Scale (CCS).

PubMed

Tangney, June Price; Stuewig, Jeffrey; Furukawa, Emi; Kopelovich, Sarah; Meyer, Patrick; Cosby, Brandon

2012-10-01

Theory, research, and clinical reports suggest that moral cognitions play a role in initiating and sustaining criminal behavior. The 25 item Criminogenic Cognitions Scale (CCS) was designed to tap 5 dimensions: Notions of entitlement; Failure to Accept Responsibility; Short-Term Orientation; Insensitivity to Impact of Crime; and Negative Attitudes Toward Authority. Results from 552 jail inmates support the reliability, validity, and predictive utility of the measure. The CCS was linked to criminal justice system involvement, self-report measures of aggression, impulsivity, and lack of empathy. Additionally, the CCS was associated with violent criminal history, antisocial personality, and clinicians' ratings of risk for future violence and psychopathy (PCL:SV). Furthermore, criminogenic thinking upon incarceration predicted subsequent official reports of inmate misconduct during incarceration. CCS scores varied somewhat by gender and race. Research and applied uses of CCS are discussed.

Psychometric Properties of the Consensus Sleep Diary in Those With Insomnia Disorder.

PubMed

Maich, Kristin H G; Lachowski, Angela M; Carney, Colleen E

2018-01-01

The Consensus Sleep Diary (CSD) is a standardized, prospective tool for tracking nightly subjective sleep. The current study evaluated the validity and utility of the CSD, with consideration for challenges inherent to psychometric evaluation of diary measures. Results showed that the CSD indices differentiated good sleepers from those with insomnia and were associated with similar objective indices and a subjective insomnia severity measure. The ability to detect treatment improvements after cognitive behavior therapy for insomnia (CBT-I) was tested by comparing pre- and post-CBT-I CSD indices with a subjective rating of insomnia symptom severity. Improvement in insomnia symptom severity was significantly related to improvement on the CSD indices. Completion rate of the CSD amongst participants across all 14 days was 99.8%. These findings provide support for the validity, clinical utility, and usability of the CSD.

An empirical comparison of the measurement properties of the EQ-5D-5L, DEMQOL-U and DEMQOL-Proxy-U for older people in residential care.

PubMed

Easton, Tiffany; Milte, Rachel; Crotty, Maria; Ratcliffe, Julie

2018-05-01

This study aimed to empirically compare the measurement properties of self-reported and proxy-reported (in cases of severe cognitive impairment) generic (EQ-5D-5L) and condition-specific (DEMQOL-U and DEMQOL-Proxy-U) preference-based HRQoL instruments in residential care, where the population is characterised by older people with high rates of cognitive impairment, dementia and disability. Participants were recruited from seventeen residential care facilities across four Australian states. One hundred and forty-three participants self-completed the EQ-5D-5L and the DEMQOL-U while three hundred and eight-seven proxy completed (due to the presence of severe dementia) the EQ-5D-5L and DEMQOL-Proxy-U. The convergent validity of the outcome measures and known group validity relative to a series of clinical outcome measures were assessed. Results satisfy convergent validity among the outcome measures. EQ-5D-5L and DEMQOL-U utilities were found to be significantly correlated with each other (p < 0.01) as were EQ-5D-5L and DEMQOL-Proxy-U utilities (p < 0.01). Both self-reported and proxy-reported EQ-5D-5L utilities demonstrated strong known group validity in relation to clinically recognised thresholds of cognition and physical functioning, while in contrast neither DEMQOL-U nor DEMQOL-Proxy-U demonstrated this association. The findings suggest that the EQ-5D-5L, DEMQOL-U and DEMQOL-Proxy-U capture distinct aspects of HRQoL for this population. The measurement and valuation of HRQoL form an essential component of economic evaluation in residential care. However, high levels of cognitive impairment may preclude self-completion for a majority. Further research is needed to determine cognition thresholds beyond which an individual is unable to reliably self-report their own health-related quality of life.

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

PubMed

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

2013-01-01

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

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

PubMed Central

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

2013-01-01

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

Comprehensive Psychometric Analysis of the Eyberg Child Behavior Inventory in Children with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Jeter, Kathryn; Zlomke, Kimberly; Shawler, Paul; Sullivan, Maureen

2017-01-01

Many assessment measures have only been validated for one specific diagnostic population, which is costly and reduces the clinical utility of assessments. The Eyberg Child Behavior Inventory (ECBI) is one popular measure designed to assess disruptive behavior problems in youth. The ECBI has sound psychometric properties in typically developing…

Outcome Rating Scale and Session Rating Scale in Psychological Practice: Clinical Utility of Ultra-Brief Measures

ERIC Educational Resources Information Center

Campbell, Alistair; Hemsley, Samantha

2009-01-01

The validity and reliability of the Outcome Rating Scale (ORS) and the Session Rating Scale (SRS) were evaluated against existing longer measures, including the Outcome Questionnaire-45, Working Alliance Inventory, Depression Anxiety Stress Scale-21, Quality of Life Scale, Rosenberg Self-Esteem Scale and General Self-efficacy Scale. The measures…

Refining the Assessment of Hopelessness: An Improved Way to Look to the Future

ERIC Educational Resources Information Center

Fisher, Lauren B.; Overholser, James C.

2013-01-01

Despite its high sensitivity, the Beck Hopelessness Scale (BHS) has demonstrated low specificity, has an ambiguous factor structure, and includes inadequate items. The current study examined the psychometric properties of a modified BHS (mBHS) using a Likert scale format that would allow for improved reliability, validity, and clinical utility.…

Cross-Cultural Adaptation of the Intelligibility in Context Scale for South Africa

ERIC Educational Resources Information Center

Pascoe, Michelle; McLeod, Sharynne

2016-01-01

The Intelligibility in Context Scale (ICS) is a screening questionnaire that focuses on parents' perceptions of children's speech in different contexts. Originally developed in English, it has been translated into 60 languages and the validity and clinical utility of the scale has been documented in a range of countries. In South Africa, there are…

Social preferences for health states associated with acute myeloid leukemia for patients undergoing treatment in the United Kingdom.

PubMed

Castejón, Nacho; Cappelleri, Joseph C; Cuervo, Jesús; Lang, Kathryn; Mehta, Priyanka; Mokgokong, Ruth; Mamolo, Carla

2018-04-18

Health state (HS) utility values for patients with acute myeloid leukemia (AML), a hematological malignancy, are not available in the United Kingdom (UK). This study aims to develop clinically sound HSs for previously untreated patients with AML and to assign utility values based on preferences of the general UK population. This study was conducted in the UK and comprised 2 stages. During the first stage, AML HSs were drafted based on evidence from a literature review of AML clinical and health-related quality-of-life studies (published January 2000-June 2016) and patient-reported outcome measures previously used in this population. A panel of UK hematologists with AML experience validated the clinical relevance and accuracy of the HSs. During the second stage, validated HSs were valued in an elicitation survey with a representative UK population sample using the time trade-off (TTO) method. Descriptive statistics and bivariate tests were obtained and performed. A total of eight HSs were developed and clinically validated, including treatment with chemotherapy, consolidation therapy, transplant, graft-vs-host disease (GvHD), remission, relapse, refractory, and functionally cured. In total, 125 adults participated (mean age, 49.6 years [range, 18-87 years], 52.8% female). Mean (95% confidence interval [CI]) TTO preference values (n = 120), ranked from lowest (worst HS) to highest (best HS) were as follows: refractory - 0.11 (- 0.21 to - 0.01), relapse 0.10 (0.00-0.20), transplant 0.28 (0.20-0.37), treatment with chemotherapy 0.36 (0.28-0.43), GvHD 0.43 (0.36-0.50), consolidation 0.46 (0.40-0.53), remission 0.62 (0.57-0.67), and functionally cured 0.76 (0.72-0.79). Mean (95% CI) visual analog scale preference values followed the same rank order, ranging from 0.15 (0.13-0.17) for refractory to 0.71 (0.68-0.73) for functionally cured. To our knowledge, this is the first study to report utility values for AML from the UK societal perspective. Participants were able to distinguish differences in severity among AML HSs, and preference values were consistent with clinical perception of HS severity. HS preference values observed in this study may be useful in future evaluations of treatment benefit, including cost-effectiveness analyses and improved patient well-being.

Development and Characterization of Reference Materials for Genetic Testing: Focus on Public Partnerships.

PubMed

Kalman, Lisa V; Datta, Vivekananda; Williams, Mickey; Zook, Justin M; Salit, Marc L; Han, Jin Yeong

2016-11-01

Characterized reference materials (RMs) are needed for clinical laboratory test development and validation, quality control procedures, and proficiency testing to assure their quality. In this article, we review the development and characterization of RMs for clinical molecular genetic tests. We describe various types of RMs and how to access and utilize them, especially focusing on the Genetic Testing Reference Materials Coordination Program (Get-RM) and the Genome in a Bottle (GIAB) Consortium. This review also reinforces the need for collaborative efforts in the clinical genetic testing community to develop additional RMs.

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

PubMed Central

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

2010-01-01

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

The impact of RTOG 0614 and RTOG 0933 trials in routine clinical practice: The US Survey of Utilization of Memantine and IMRT planning for hippocampus sparing in patients receiving whole brain radiotherapy for brain metastases.

PubMed

Slade, Alexander N; Stanic, Sinisa

2016-03-01

Two recent clinical trials, phase III RTOG 0614 and phase II RTOG 0933, showed some effectiveness of Memantine and IMRT planning for hippocampus sparing, among patients receiving whole brain radiotherapy (WBRT) for brain metastases; however, their use in routine clinical practice is unknown. A survey was sent to 1933 radiation oncologists in the US. Data collected included utilization of Memantine and hippocampus sparing, reasons for adoption and non-adoption, and demographic variables. A total of 196 radiation oncologists responded to the survey, with 64% reporting using Memantine in almost none of the patients receiving WBRT for brain metastases, and only 11% considering Memantine for <10% of their patients. The most common reason for not using Memantine was a poor patient performance status, and limited life expectancy. Likewise, 56% of radiation oncologists would not change their clinical practice to include hippocampus sparing IMRT in patients receiving WBRT based on the results of RTOG 0933. Further validation of hippocampus sparing in a phase III trial was supported by 71% of radiation oncologists, whereas further exploration of Memantine for this purpose in a phase III trial was supported by 42%. At this time, the majority of surveyed radiation oncologists in the US do not use Memantine, or IMRT planning for hippocampus sparing in patients receiving WBRT. Further validation of the hippocampus sparing concept in a phase III trial was supported, before adopting it in routine clinical practice. Copyright © 2015 Elsevier Inc. All rights reserved.

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

PubMed

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

2015-04-01

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

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

PubMed Central

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

2015-01-01

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

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

PubMed Central

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

2008-01-01

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

Personal utility in genomic testing: is there such a thing?

PubMed

Bunnik, Eline M; Janssens, A Cecile J W; Schermer, Maartje H N

2015-04-01

In ethical and regulatory discussions on new applications of genomic testing technologies, the notion of 'personal utility' has been mentioned repeatedly. It has been used to justify direct access to commercially offered genomic testing or feedback of individual research results to research or biobank participants. Sometimes research participants or consumers claim a right to genomic information with an appeal to personal utility. As of yet, no systematic account of the umbrella notion of personal utility has been given. This paper offers a definition of personal utility that places it in the middle of the spectrum between clinical utility and personal perceptions of utility, and that acknowledges its normative charge. The paper discusses two perspectives on personal utility, the healthcare perspective and the consumer perspective, and argues that these are too narrow and too wide, respectively. Instead, it proposes a normative definition of personal utility that postulates information and potential use as necessary conditions of utility. This definition entails that perceived utility does not equal personal utility, and that expert judgment may be necessary to help determine whether a genomic test can have personal utility for someone. Two examples of genomic tests are presented to illustrate the discrepancies between perceived utility and our proposed definition of personal utility. The paper concludes that while there is room for the notion of personal utility in the ethical evaluation and regulation of genomic tests, the justificatory role of personal utility is not unlimited. For in the absence of clinical validity and reasonable potential use of information, there is no personal utility. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

An informatics approach to analyzing the incidentalome.

PubMed

Berg, Jonathan S; Adams, Michael; Nassar, Nassib; Bizon, Chris; Lee, Kristy; Schmitt, Charles P; Wilhelmsen, Kirk C; Evans, James P

2013-01-01

Next-generation sequencing has transformed genetic research and is poised to revolutionize clinical diagnosis. However, the vast amount of data and inevitable discovery of incidental findings require novel analytic approaches. We therefore implemented for the first time a strategy that utilizes an a priori structured framework and a conservative threshold for selecting clinically relevant incidental findings. We categorized 2,016 genes linked with Mendelian diseases into "bins" based on clinical utility and validity, and used a computational algorithm to analyze 80 whole-genome sequences in order to explore the use of such an approach in a simulated real-world setting. The algorithm effectively reduced the number of variants requiring human review and identified incidental variants with likely clinical relevance. Incorporation of the Human Gene Mutation Database improved the yield for missense mutations but also revealed that a substantial proportion of purported disease-causing mutations were misleading. This approach is adaptable to any clinically relevant bin structure, scalable to the demands of a clinical laboratory workflow, and flexible with respect to advances in genomics. We anticipate that application of this strategy will facilitate pretest informed consent, laboratory analysis, and posttest return of results in a clinical context.

Development of a risk-adjustment model for antimicrobial utilization data in 21 public hospitals in Queensland, Australia (2006-11).

PubMed

Rajmokan, M; Morton, A; Marquess, J; Playford, E G; Jones, M

2013-10-01

Making valid comparisons of antimicrobial utilization between hospitals requires risk adjustment for each hospital's case mix. Data on individual patients may be unavailable or difficult to process. Therefore, risk adjustment for antimicrobial usage frequently needs to be based on a hospital's services. This study evaluated such a strategy for hospital antimicrobial utilization. Data were obtained on five broad subclasses of antibiotics [carbapenems, β-lactam/β-lactamase inhibitor combinations (BLBLIs), fluoroquinolones, glycopeptides and third-generation cephalosporins] from the Queensland pharmacy database (MedTrx) for 21 acute public hospitals (2006-11). Eleven clinical services and a variable for hospitals from the tropical region were employed for risk adjustment. Multivariable regression models were used to identify risk and protective services for these antibiotics. Funnel plots were used to display hospitals' antimicrobial utilization. Total inpatient antibiotic utilization for these antibiotics increased from 130.6 defined daily doses (DDDs)/1000 patient-days in 2006 to 155.8 DDDs/1000 patient-days in 2011 (P < 0.0001). Except for third-generation cephalosporins, the average utilization rate was higher for intensive care, renal/nephrology, cardiac, burns/plastic surgery, neurosurgery, transplant and acute spinal services than for the respective reference group (no service). In addition, oncology, high-activity infectious disease and coronary care services were associated with higher utilization of carbapenems, BLBLIs and glycopeptides. Our model predicted antimicrobial utilization rates by hospital services. The funnel plots displayed hospital utilization data after adjustment for variation among the hospitals. However, the methodology needs to be validated in other populations, ideally using a larger group of hospitals.

The clinical effectiveness and cost-effectiveness of the PROGENSA® prostate cancer antigen 3 assay and the Prostate Health Index in the diagnosis of prostate cancer: a systematic review and economic evaluation.

PubMed

Nicholson, Amanda; Mahon, James; Boland, Angela; Beale, Sophie; Dwan, Kerry; Fleeman, Nigel; Hockenhull, Juliet; Dundar, Yenal

2015-10-01

There is no single definitive test to identify prostate cancer in men. Biopsies are commonly used to obtain samples of prostate tissue for histopathological examination. However, this approach frequently misses cases of cancer, meaning that repeat biopsies may be necessary to obtain a diagnosis. The PROGENSA(®) prostate cancer antigen 3 (PCA3) assay (Hologic Gen-Probe, Marlborough, MA, USA) and the Prostate Health Index (phi; Beckman Coulter Inc., Brea, CA, USA) are two new tests (a urine test and a blood test, respectively) that are designed to be used to help clinicians decide whether or not to recommend a repeat biopsy. To evaluate the clinical effectiveness and cost-effectiveness of the PCA3 assay and the phi in the diagnosis of prostate cancer. Multiple publication databases and trial registers were searched in May 2014 (from 2000 to May 2014), including MEDLINE, EMBASE, The Cochrane Library, ISI Web of Science, Medion, Aggressive Research Intelligence Facility database, ClinicalTrials.gov, International Standard Randomised Controlled Trial Number Register and World Health Organization International Clinical Trials Registry Platform. The assessment of clinical effectiveness involved three separate systematic reviews, namely reviews of the analytical validity, the clinical validity of these tests and the clinical utility of these tests. The assessment of cost-effectiveness comprised a systematic review of full economic evaluations and the development of a de novo economic model. The perspective of the evaluation was the NHS in England and Wales. Men suspected of having prostate cancer for whom the results of an initial prostate biopsy were negative or equivocal. The use of the PCA3 score or phi in combination with existing tests (including histopathology results, prostate-specific antigen level and digital rectal examination), multiparametric magnetic resonance imaging and clinical judgement. In addition to documents published by the manufacturers, six studies were identified for inclusion in the analytical validity review. The review identified issues concerning the precision of the PCA3 assay measurements. It also highlighted issues relating to the storage requirements and stability of samples intended for analysis using the phi assay. Fifteen studies met the inclusion criteria for the clinical validity review. These studies reported results for 10 different clinical comparisons. There was insufficient evidence to enable the identification of appropriate test threshold values for use in a clinical setting. In addition, the implications of adding either the PCA3 assay or the phi to clinical assessment were not clear. Furthermore, the addition of the PCA3 assay or the phi to clinical assessment plus magnetic resonance imaging was not found to improve discrimination. No published papers met the inclusion criteria for either the clinical utility review or the cost-effectiveness review. The results from the cost-effectiveness analyses indicated that using either the PCA3 assay or the phi in the NHS was not cost-effective. The main limitations of the systematic review of clinical validity are that the review conclusions are over-reliant on findings from one study, the descriptions of clinical assessment vary widely within reviewed studies and many of the reported results for the clinical validity outcomes do not include either standard errors or confidence intervals. The clinical benefit of using the PCA3 assay or the phi in combination with existing tests, scans and clinical judgement has not yet been confirmed. The results from the cost-effectiveness analyses indicate that the use of these tests in the NHS would not be cost-effective. This study is registered as PROSPERO CRD42014009595. The National Institute for Health Research Health Technology Assessment programme.

Development and Validation of the Pediatric Diabetes Routines Questionnaire for Adolescents.

PubMed

Pierce, Jessica S; Jordan, Sara S; Arnau, Randolph C

2018-04-06

This study describes the development and psychometric evaluation of an adolescent self-report version of the Pediatric Diabetes Routines Questionnaire (PDRQ:A), a measure of diabetes-specific routines for youth with type 1 diabetes, and further validation of the parent-version (PDRQ:P) in an adolescent sample. Participants included 120 parent-adolescent dyads (ages 12-17) and an additional 24 parents who completed measures of diabetes-specific adolescent routines, general adolescent routines, diabetes self-care, and family support of youth diabetes care. The PDRQ:P/A demonstrated good internal consistency, test-retest reliability, and parent-child agreement, and adequate validity coefficients. Confirmatory factor analysis supported a one-factor model. Promising results were obtained. The PDRQ:P/A is a clinically feasible parent- and self-report measure that can provide valuable information regarding how frequently adolescents engage in their diabetes management tasks in a consistent manner. Addition of an adolescent report format will enhance the utility of the measure for clinical and research use.

Emotional suppression and breast cancer: validation research on the Spanish Adaptation of the Courtauld Emotional Control Scale (CECS).

PubMed

Durá, Estrella; Andreu, Yolanda; Galdón, Maria José; Ibáñez, Elena; Pérez, Sandra; Ferrando, Maite; Murgui, Sergio; Martínez, Paula

2010-05-01

Emotional suppression has played an important role in the research on psychosocial factors related to cancer. It has been argued to be an important psychological factor predicting worse psychosocial adjustment in people with cancer and it may mediate health outcomes. The reference instrument in the research on emotional suppression is the Courtauld Emotional Control Scale (CECS). The present study analysed construct validity of a new Spanish adaptation of the CECS in a sample of 175 breast cancer patients. The results confirmed the proposal by Watson and Greer claiming that the CECS is composed of three subscales that measure different dimensions, but not independent, from emotional control. The present Spanish version of the CECS showed high internal consistency in each subseale as well as the total score. According to Derogatis (BSI-18) criteria, emotional suppression predicts clinically significant distress. In short, our results support the reliability, validity and utility of this Spanish adaptation of the CECS in clinical and research settings.

Diagnosis of borderline personality disorder in China: current status and future directions.

PubMed

Zhong, Jie; Leung, Freedom

2009-02-01

This paper reviews the current status and future directions of borderline personality disorder (BPD) research in China. Although the committee of the third version of the Chinese Classification of Mental Disorders (CCMD-3) rejected BPD as a valid diagnostic category and instead adopted the term impulsive personality disorder (IPD), our literature review on personality disorders from 1979 to 2008 in China indicated that BPD was the most popular research topic among researchers and clinicians. Available empiric evidence on BPD in China provided preliminary support for the construct validity and clinical utility of BPD in clinical and nonclinical Chinese samples. Future studies in the following areas are suggested: 1) developing reliable assessment instruments for measuring BPD pathology in China, 2) comparing the construct validity and phenomenology of CCMD IPD and DSM BPD among Chinese patients, 3) examining potential cultural differences in symptom expression of BPD pathology among the Chinese, and 4) exploring indigenous and imported methods for treating BPD patients in China.

Construction and Initial Validation of the Multiracial Experiences Measure (MEM)

PubMed Central

Yoo, Hyung Chol; Jackson, Kelly; Guevarra, Rudy P.; Miller, Matthew J.; Harrington, Blair

2015-01-01

This article describes the development and validation of the Multiracial Experiences Measure (MEM): a new measure that assesses uniquely racialized risks and resiliencies experienced by individuals of mixed racial heritage. Across two studies, there was evidence for the validation of the 25-item MEM with 5 subscales including Shifting Expressions, Perceived Racial Ambiguity, Creating Third Space, Multicultural Engagement, and Multiracial Discrimination. The 5-subscale structure of the MEM was supported by a combination of exploratory and confirmatory factor analyses. Evidence of criterion-related validity was partially supported with MEM subscales correlating with measures of racial diversity in one’s social network, color-blind racial attitude, psychological distress, and identity conflict. Evidence of discriminant validity was supported with MEM subscales not correlating with impression management. Implications for future research and suggestions for utilization of the MEM in clinical practice with multiracial adults are discussed. PMID:26460977

Construction and initial validation of the Multiracial Experiences Measure (MEM).

PubMed

Yoo, Hyung Chol; Jackson, Kelly F; Guevarra, Rudy P; Miller, Matthew J; Harrington, Blair

2016-03-01

This article describes the development and validation of the Multiracial Experiences Measure (MEM): a new measure that assesses uniquely racialized risks and resiliencies experienced by individuals of mixed racial heritage. Across 2 studies, there was evidence for the validation of the 25-item MEM with 5 subscales including Shifting Expressions, Perceived Racial Ambiguity, Creating Third Space, Multicultural Engagement, and Multiracial Discrimination. The 5-subscale structure of the MEM was supported by a combination of exploratory and confirmatory factor analyses. Evidence of criterion-related validity was partially supported with MEM subscales correlating with measures of racial diversity in one's social network, color-blind racial attitude, psychological distress, and identity conflict. Evidence of discriminant validity was supported with MEM subscales not correlating with impression management. Implications for future research and suggestions for utilization of the MEM in clinical practice with multiracial adults are discussed. (c) 2016 APA, all rights reserved).

A prospective, longitudinal study to evaluate the clinical utility of a predictive algorithm that detects risk of opioid use disorder.

PubMed

Brenton, Ashley; Lee, Chee; Lewis, Katrina; Sharma, Maneesh; Kantorovich, Svetlana; Smith, Gregory A; Meshkin, Brian

2018-01-01

The purpose of this study was to determine the clinical utility of an algorithm-based decision tool designed to assess risk associated with opioid use. Specifically, we sought to assess how physicians were using the profile in patient care and how its use affected patient outcomes. A prospective, longitudinal study was conducted to assess the utility of precision medicine testing in 5,397 patients across 100 clinics in the USA. Using a patent-protected, validated algorithm combining specific genetic risk factors with phenotypic traits, patients were categorized into low-, moderate-, and high-risk patients for opioid abuse. Physicians who ordered precision medicine testing were asked to complete patient evaluations and document their actions, decisions, and perceptions regarding the utility of the precision medicine tests. The patient outcomes associated with each treatment action were carefully documented. Physicians used the profile to guide treatment decisions for over half of the patients. Of those, guided treatment decisions for 24.5% of the patients were opioid related, including changing the opioid prescribed, starting an opioid, or titrating a patient off the opioid. Treatment guidance was strongly influenced by profile-predicted opioid use disorder (OUD) risk. Most importantly, patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, including better pain management by medication adjustments, with an average pain decrease of 3.4 points on a scale of 1-10. Patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, as measured by decreased pain levels resulting from better pain management with prescribed medications. The clinical utility of the profile is twofold. It provides clinically actionable recommendations that can be used to 1) prevent OUD through limiting initial opioid prescriptions and 2) reduce pain in patients at low risk of developing OUD.

A prospective, longitudinal study to evaluate the clinical utility of a predictive algorithm that detects risk of opioid use disorder

PubMed Central

Brenton, Ashley; Lee, Chee; Lewis, Katrina; Sharma, Maneesh; Kantorovich, Svetlana; Smith, Gregory A; Meshkin, Brian

2018-01-01

Purpose The purpose of this study was to determine the clinical utility of an algorithm-based decision tool designed to assess risk associated with opioid use. Specifically, we sought to assess how physicians were using the profile in patient care and how its use affected patient outcomes. Patients and methods A prospective, longitudinal study was conducted to assess the utility of precision medicine testing in 5,397 patients across 100 clinics in the USA. Using a patent-protected, validated algorithm combining specific genetic risk factors with phenotypic traits, patients were categorized into low-, moderate-, and high-risk patients for opioid abuse. Physicians who ordered precision medicine testing were asked to complete patient evaluations and document their actions, decisions, and perceptions regarding the utility of the precision medicine tests. The patient outcomes associated with each treatment action were carefully documented. Results Physicians used the profile to guide treatment decisions for over half of the patients. Of those, guided treatment decisions for 24.5% of the patients were opioid related, including changing the opioid prescribed, starting an opioid, or titrating a patient off the opioid. Treatment guidance was strongly influenced by profile-predicted opioid use disorder (OUD) risk. Most importantly, patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, including better pain management by medication adjustments, with an average pain decrease of 3.4 points on a scale of 1–10. Conclusion Patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, as measured by decreased pain levels resulting from better pain management with prescribed medications. The clinical utility of the profile is twofold. It provides clinically actionable recommendations that can be used to 1) prevent OUD through limiting initial opioid prescriptions and 2) reduce pain in patients at low risk of developing OUD. PMID:29379313

Development and validation of a whole-exome sequencing test for simultaneous detection of point mutations, indels and copy-number alterations for precision cancer care

PubMed Central

Rennert, Hanna; Eng, Kenneth; Zhang, Tuo; Tan, Adrian; Xiang, Jenny; Romanel, Alessandro; Kim, Robert; Tam, Wayne; Liu, Yen-Chun; Bhinder, Bhavneet; Cyrta, Joanna; Beltran, Himisha; Robinson, Brian; Mosquera, Juan Miguel; Fernandes, Helen; Demichelis, Francesca; Sboner, Andrea; Kluk, Michael; Rubin, Mark A; Elemento, Olivier

2016-01-01

We describe Exome Cancer Test v1.0 (EXaCT-1), the first New York State-Department of Health-approved whole-exome sequencing (WES)-based test for precision cancer care. EXaCT-1 uses HaloPlex (Agilent) target enrichment followed by next-generation sequencing (Illumina) of tumour and matched constitutional control DNA. We present a detailed clinical development and validation pipeline suitable for simultaneous detection of somatic point/indel mutations and copy-number alterations (CNAs). A computational framework for data analysis, reporting and sign-out is also presented. For the validation, we tested EXaCT-1 on 57 tumours covering five distinct clinically relevant mutations. Results demonstrated elevated and uniform coverage compatible with clinical testing as well as complete concordance in variant quality metrics between formalin-fixed paraffin embedded and fresh-frozen tumours. Extensive sensitivity studies identified limits of detection threshold for point/indel mutations and CNAs. Prospective analysis of 337 cancer cases revealed mutations in clinically relevant genes in 82% of tumours, demonstrating that EXaCT-1 is an accurate and sensitive method for identifying actionable mutations, with reasonable costs and time, greatly expanding its utility for advanced cancer care. PMID:28781886

The biomedical model of mental disorder: a critical analysis of its validity, utility, and effects on psychotherapy research.

PubMed

Deacon, Brett J

2013-11-01

The biomedical model posits that mental disorders are brain diseases and emphasizes pharmacological treatment to target presumed biological abnormalities. A biologically-focused approach to science, policy, and practice has dominated the American healthcare system for more than three decades. During this time, the use of psychiatric medications has sharply increased and mental disorders have become commonly regarded as brain diseases caused by chemical imbalances that are corrected with disease-specific drugs. However, despite widespread faith in the potential of neuroscience to revolutionize mental health practice, the biomedical model era has been characterized by a broad lack of clinical innovation and poor mental health outcomes. In addition, the biomedical paradigm has profoundly affected clinical psychology via the adoption of drug trial methodology in psychotherapy research. Although this approach has spurred the development of empirically supported psychological treatments for numerous mental disorders, it has neglected treatment process, inhibited treatment innovation and dissemination, and divided the field along scientist and practitioner lines. The neglected biopsychosocial model represents an appealing alternative to the biomedical approach, and an honest and public dialog about the validity and utility of the biomedical paradigm is urgently needed. Copyright © 2013 Elsevier Ltd. All rights reserved.

Measurement properties of existing clinical assessment methods evaluating scapular positioning and function. A systematic review.

PubMed

Larsen, Camilla Marie; Juul-Kristensen, Birgit; Lund, Hans; Søgaard, Karen

2014-10-01

The aims were to compile a schematic overview of clinical scapular assessment methods and critically appraise the methodological quality of the involved studies. A systematic, computer-assisted literature search using Medline, CINAHL, SportDiscus and EMBASE was performed from inception to October 2013. Reference lists in articles were also screened for publications. From 50 articles, 54 method names were identified and categorized into three groups: (1) Static positioning assessment (n = 19); (2) Semi-dynamic (n = 13); and (3) Dynamic functional assessment (n = 22). Fifteen studies were excluded for evaluation due to no/few clinimetric results, leaving 35 studies for evaluation. Graded according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN checklist), the methodological quality in the reliability and validity domains was "fair" (57%) to "poor" (43%), with only one study rated as "good". The reliability domain was most often investigated. Few of the assessment methods in the included studies that had "fair" or "good" measurement property ratings demonstrated acceptable results for both reliability and validity. We found a substantially larger number of clinical scapular assessment methods than previously reported. Using the COSMIN checklist the methodological quality of the included measurement properties in the reliability and validity domains were in general "fair" to "poor". None were examined for all three domains: (1) reliability; (2) validity; and (3) responsiveness. Observational evaluation systems and assessment of scapular upward rotation seem suitably evidence-based for clinical use. Future studies should test and improve the clinimetric properties, and especially diagnostic accuracy and responsiveness, to increase utility for clinical practice.

The reliability and validity of patient-reported chronic obstructive pulmonary disease exacerbations.

PubMed

Mohan, Arjun; Sethi, Sanjay

2014-03-01

Despite the increasing awareness of their pathogenesis and clinical consequences, research on and clinical management of acute exacerbations of chronic obstructive lung disease (AECOPDs) have been hindered by the lack of a consistent and reliable definition. Symptom-based definitions of exacerbations are sensitive to events and account for unreported exacerbations. Event (healthcare utilization)-based definitions are somewhat more definitive but miss unreported events. Objective quantification of symptoms in AECOPD is now possible with the development of the Exacerbations of Chronic Obstructive Pulmonary Disease Tool (EXACT-PRO), a patient-reported outcome (PRO) measure. Several studies have revealed that unreported AECOPDs are more frequent than reported events and are associated with long-term adverse consequences. New antibiotic development for AECOPD has been hampered by the lack of validated measures for resolution of exacerbations. As a result of these observations, a unique collaborative effort between academia, industry and regulatory agencies resulted in the development of the EXACT-PRO. It consists of 14 questions that generate a score between 0 and 100, and it has been shown to have excellent reliability and validity. In the absence of a reliable biomarker, the definition and measurement of exacerbations has been subjective and imprecise. PRO measures such as EXACT can provide much needed objectivity in assessing symptom-defined exacerbations, which may translate into a uniform outcome measure in clinical trials. With further development and validation, it may have a role in clinical practice in the earlier detection of exacerbations, stratification of an exacerbation severity and the assessment of clinical response to treatment.

The exposure hierarchy as a measure of progress and efficacy in the treatment of social anxiety disorder.

PubMed

Katerelos, Marina; Hawley, Lance L; Antony, Martin M; McCabe, Randi E

2008-07-01

This study explored the psychometric properties and utility of the exposure hierarchy as a measure of treatment outcome for social anxiety disorder (SAD). An exposure hierarchy was created for each of 103 individuals with a diagnosis of SAD who completed a course of cognitive behavioral group therapy. Exposure hierarchy ratings were collected on a weekly basis, and a series of self-report measures were collected before and after treatment. Results indicated that the exposure hierarchy demonstrated high test-retest reliability, as well as significant convergent validity, as participants' exposure hierarchy ratings correlated positively with scores on conceptually related measures. Hierarchy ratings were significantly associated with changes in SAD symptoms over time. However, exposure hierarchy ratings were correlated to general measures of psychopathology, suggesting limited discriminant validity. The study highlights the clinical and scientific utility of the exposure hierarchy.

Examining the Psychometric Properties of the Family Accommodation Scale-Parent-Report (FAS-PR)

PubMed Central

Sapyta, Jeffrey; Garcia, Abbe; Freeman, Jennifer B.; Franklin, Martin E.; Foa, Edna; March, John

2011-01-01

Growing research has examined parental accommodation among the families of children with obsessive-compulsive disorder (OCD). However, these studies have utilized a parent-report (PR) version of a measure, the Family Accommodation Scale (FAS) that has never received proper psychometric validation. In turn, previously derived subscales have been developed via clinical rather than empirical evidence. This study aims to conduct a comprehensive psychometric analysis of the FAS-PR utilizing data collected from 96 youths with OCD. Exploratory factors analysis was conducted and revealed a 12-item scale yielding two separate, yet related subscales, Avoidance of Triggers (AT) and Involvement in Compulsions (IC). Subsequent analyses revealed good internal consistency and convergent and discriminant validity. These findings suggest that future research should seek to examine factors that may impact various facets to accommodation as well as the role these facets plays in predicting treatment outcome. Limitations are discussed. PMID:21743772

Reliability, Validity, and Predictive Utility of the 25-Item Criminogenic Cognitions Scale (CCS)

PubMed Central

Tangney, June Price; Stuewig, Jeffrey; Furukawa, Emi; Kopelovich, Sarah; Meyer, Patrick; Cosby, Brandon

2013-01-01

Theory, research, and clinical reports suggest that moral cognitions play a role in initiating and sustaining criminal behavior. The 25 item Criminogenic Cognitions Scale (CCS) was designed to tap 5 dimensions: Notions of entitlement; Failure to Accept Responsibility; Short-Term Orientation; Insensitivity to Impact of Crime; and Negative Attitudes Toward Authority. Results from 552 jail inmates support the reliability, validity, and predictive utility of the measure. The CCS was linked to criminal justice system involvement, self-report measures of aggression, impulsivity, and lack of empathy. Additionally, the CCS was associated with violent criminal history, antisocial personality, and clinicians’ ratings of risk for future violence and psychopathy (PCL:SV). Furthermore, criminogenic thinking upon incarceration predicted subsequent official reports of inmate misconduct during incarceration. CCS scores varied somewhat by gender and race. Research and applied uses of CCS are discussed. PMID:24072946

Using stroboscopic flow imaging to validate large-scale computational fluid dynamics simulations

NASA Astrophysics Data System (ADS)

Laurence, Ted A.; Ly, Sonny; Fong, Erika; Shusteff, Maxim; Randles, Amanda; Gounley, John; Draeger, Erik

2017-02-01

The utility and accuracy of computational modeling often requires direct validation against experimental measurements. The work presented here is motivated by taking a combined experimental and computational approach to determine the ability of large-scale computational fluid dynamics (CFD) simulations to understand and predict the dynamics of circulating tumor cells in clinically relevant environments. We use stroboscopic light sheet fluorescence imaging to track the paths and measure the velocities of fluorescent microspheres throughout a human aorta model. Performed over complex physiologicallyrealistic 3D geometries, large data sets are acquired with microscopic resolution over macroscopic distances.

Assessing the clinical utility of agoraphobia in the context of panic disorder.

PubMed

Schmidt, Norman B; Cromer, Kiara R

2008-01-01

In the DSM-IV, a panic disorder (PD) diagnosis includes specification of agoraphobia, which is primarily an index of situational avoidance due to fear of panic. No other anxiety diagnosis requires specification of level of avoidance. This raises the question as to whether agoraphobia provides unique information beyond the core features of PD (i.e., panic attacks and panic-related worry). The incremental validity of agoraphobia, defined using DSM-IV specifiers versus level of situational avoidance, was examined in relation to the expression and treatment of PD (N=146). Analyses indicate that agoraphobia status adds uniquely to the prediction of PD symptoms, impairment, and response to treatment. However, level of situational avoidance, defined either as a continuous or dichotomous variable, appears to have greater utility compared to the DSM-IV method of classifying agoraphobia. In summary, the agoraphobia specifier seems to have clinical utility but this could be improved by focusing on a dimensional assessment of situational avoidance.

Development of a Drug-Response Modeling Framework to Identify Cell Line Derived Translational Biomarkers That Can Predict Treatment Outcome to Erlotinib or Sorafenib

PubMed Central

Li, Bin; Shin, Hyunjin; Gulbekyan, Georgy; Pustovalova, Olga; Nikolsky, Yuri; Hope, Andrew; Bessarabova, Marina; Schu, Matthew; Kolpakova-Hart, Elona; Merberg, David; Dorner, Andrew; Trepicchio, William L.

2015-01-01

Development of drug responsive biomarkers from pre-clinical data is a critical step in drug discovery, as it enables patient stratification in clinical trial design. Such translational biomarkers can be validated in early clinical trial phases and utilized as a patient inclusion parameter in later stage trials. Here we present a study on building accurate and selective drug sensitivity models for Erlotinib or Sorafenib from pre-clinical in vitro data, followed by validation of individual models on corresponding treatment arms from patient data generated in the BATTLE clinical trial. A Partial Least Squares Regression (PLSR) based modeling framework was designed and implemented, using a special splitting strategy and canonical pathways to capture robust information for model building. Erlotinib and Sorafenib predictive models could be used to identify a sub-group of patients that respond better to the corresponding treatment, and these models are specific to the corresponding drugs. The model derived signature genes reflect each drug’s known mechanism of action. Also, the models predict each drug’s potential cancer indications consistent with clinical trial results from a selection of globally normalized GEO expression datasets. PMID:26107615

Development of a Drug-Response Modeling Framework to Identify Cell Line Derived Translational Biomarkers That Can Predict Treatment Outcome to Erlotinib or Sorafenib.

PubMed

Li, Bin; Shin, Hyunjin; Gulbekyan, Georgy; Pustovalova, Olga; Nikolsky, Yuri; Hope, Andrew; Bessarabova, Marina; Schu, Matthew; Kolpakova-Hart, Elona; Merberg, David; Dorner, Andrew; Trepicchio, William L

2015-01-01

Development of drug responsive biomarkers from pre-clinical data is a critical step in drug discovery, as it enables patient stratification in clinical trial design. Such translational biomarkers can be validated in early clinical trial phases and utilized as a patient inclusion parameter in later stage trials. Here we present a study on building accurate and selective drug sensitivity models for Erlotinib or Sorafenib from pre-clinical in vitro data, followed by validation of individual models on corresponding treatment arms from patient data generated in the BATTLE clinical trial. A Partial Least Squares Regression (PLSR) based modeling framework was designed and implemented, using a special splitting strategy and canonical pathways to capture robust information for model building. Erlotinib and Sorafenib predictive models could be used to identify a sub-group of patients that respond better to the corresponding treatment, and these models are specific to the corresponding drugs. The model derived signature genes reflect each drug's known mechanism of action. Also, the models predict each drug's potential cancer indications consistent with clinical trial results from a selection of globally normalized GEO expression datasets.

Staging in bipolar disorder: from theoretical framework to clinical utility

PubMed Central

Berk, Michael; Post, Robert; Ratheesh, Aswin; Gliddon, Emma; Singh, Ajeet; Vieta, Eduard; Carvalho, Andre F.; Ashton, Melanie M.; Berk, Lesley; Cotton, Susan M.; McGorry, Patrick D.; Fernandes, Brisa S.; Yatham, Lakshmi N.; Dodd, Seetal

2017-01-01

Illness staging is widely utilized in several medical disciplines to help predict course or prognosis, and optimize treatment. Staging models in psychiatry in general, and bipolar disorder in particular, depend on the premise that psychopathology moves along a predictable path: an at‐risk or latency stage, a prodrome progressing to a first clinical threshold episode, and one or more recurrences with the potential to revert or progress to late or end‐stage manifestations. The utility and validity of a staging model for bipolar disorder depend on its linking to clinical outcome, treatment response and neurobiological measures. These include progressive biochemical, neuroimaging and cognitive changes, and potentially stage‐specific differences in response to pharmacological and psychosocial treatments. Mechanistically, staging models imply the presence of an active disease process that, if not remediated, can lead to neuroprogression, a more malignant disease course and functional deterioration. Biological elements thought to be operative in bipolar disorder include a genetic diathesis, physical and psychic trauma, epigenetic changes, altered neurogenesis and apoptosis, mitochondrial dysfunction, inflammation, and oxidative stress. Many available agents, such as lithium, have effects on these targets. Staging models also suggest the utility of stage‐specific treatment approaches that may not only target symptom reduction, but also impede illness neuroprogression. These treatment approaches range from prevention for at‐risk individuals, to early intervention strategies for prodromal and newly diagnosed individuals, complex combination therapy for rapidly recurrent illness, and palliative‐type approaches for those at chronic, late stages of illness. There is hope that prompt initiation of potentially disease modifying therapies may preclude or attenuate the cognitive and structural changes seen in the later stages of bipolar disorder. The aims of this paper are to: a) explore the current level of evidence supporting the descriptive staging of the syndromal pattern of bipolar disorder; b) describe preliminary attempts at validation; c) make recommendations for the direction of further studies; and d) provide a distillation of the potential clinical implications of staging in bipolar disorder within a broader transdiagnostic framework. PMID:28941093

Staging in bipolar disorder: from theoretical framework to clinical utility.

PubMed

Berk, Michael; Post, Robert; Ratheesh, Aswin; Gliddon, Emma; Singh, Ajeet; Vieta, Eduard; Carvalho, Andre F; Ashton, Melanie M; Berk, Lesley; Cotton, Susan M; McGorry, Patrick D; Fernandes, Brisa S; Yatham, Lakshmi N; Dodd, Seetal

2017-10-01

Illness staging is widely utilized in several medical disciplines to help predict course or prognosis, and optimize treatment. Staging models in psychiatry in general, and bipolar disorder in particular, depend on the premise that psychopathology moves along a predictable path: an at-risk or latency stage, a prodrome progressing to a first clinical threshold episode, and one or more recurrences with the potential to revert or progress to late or end-stage manifestations. The utility and validity of a staging model for bipolar disorder depend on its linking to clinical outcome, treatment response and neurobiological measures. These include progressive biochemical, neuroimaging and cognitive changes, and potentially stage-specific differences in response to pharmacological and psychosocial treatments. Mechanistically, staging models imply the presence of an active disease process that, if not remediated, can lead to neuroprogression, a more malignant disease course and functional deterioration. Biological elements thought to be operative in bipolar disorder include a genetic diathesis, physical and psychic trauma, epigenetic changes, altered neurogenesis and apoptosis, mitochondrial dysfunction, inflammation, and oxidative stress. Many available agents, such as lithium, have effects on these targets. Staging models also suggest the utility of stage-specific treatment approaches that may not only target symptom reduction, but also impede illness neuroprogression. These treatment approaches range from prevention for at-risk individuals, to early intervention strategies for prodromal and newly diagnosed individuals, complex combination therapy for rapidly recurrent illness, and palliative-type approaches for those at chronic, late stages of illness. There is hope that prompt initiation of potentially disease modifying therapies may preclude or attenuate the cognitive and structural changes seen in the later stages of bipolar disorder. The aims of this paper are to: a) explore the current level of evidence supporting the descriptive staging of the syndromal pattern of bipolar disorder; b) describe preliminary attempts at validation; c) make recommendations for the direction of further studies; and d) provide a distillation of the potential clinical implications of staging in bipolar disorder within a broader transdiagnostic framework. © 2017 World Psychiatric Association.

Optimized multiparametric flow cytometric analysis of circulating endothelial cells and their subpopulations in peripheral blood of patients with solid tumors: a technical analysis.

PubMed

Zhou, Fangbin; Zhou, Yaying; Yang, Ming; Wen, Jinli; Dong, Jun; Tan, Wenyong

2018-01-01

Circulating endothelial cells (CECs) and their subpopulations could be potential novel biomarkers for various malignancies. However, reliable enumerable methods are warranted to further improve their clinical utility. This study aimed to optimize a flow cytometric method (FCM) assay for CECs and subpopulations in peripheral blood for patients with solid cancers. An FCM assay was used to detect and identify CECs. A panel of 60 blood samples, including 44 metastatic cancer patients and 16 healthy controls, were used in this study. Some key issues of CEC enumeration, including sample material and anticoagulant selection, optimal titration of antibodies, lysis/wash procedures of blood sample preparation, conditions of sample storage, sufficient cell events to enhance the signal, fluorescence-minus-one controls instead of isotype controls to reduce background noise, optimal selection of cell surface markers, and evaluating the reproducibility of our method, were integrated and investigated. Wilcoxon and Mann-Whitney U tests were used to determine statistically significant differences. In this validation study, we refined a five-color FCM method to detect CECs and their subpopulations in peripheral blood of patients with solid tumors. Several key technical issues regarding preanalytical elements, FCM data acquisition, and analysis were addressed. Furthermore, we clinically validated the utility of our method. The baseline levels of mature CECs, endothelial progenitor cells, and activated CECs were higher in cancer patients than healthy subjects ( P <0.01). However, there was no significant difference in resting CEC levels between healthy subjects and cancer patients ( P =0.193). We integrated and comprehensively addressed significant technical issues found in previously published assays and validated the reproducibility and sensitivity of our proposed method. Future work is required to explore the potential of our optimized method in clinical oncologic applications.

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

PubMed

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

2017-12-01

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

Using circulating tumor cells to inform on prostate cancer biology and clinical utility

PubMed Central

Li, Jing; Gregory, Simon G.; Garcia-Blanco, Mariano A.; Armstrong, Andrew J.

2016-01-01

Substantial advances in the molecular biology of prostate cancer have led to the approval of multiple new systemic agents to treat men with metastatic castration-resistant prostate cancer (mCRPC). These treatments encompass androgen receptor directed therapies, immunotherapies, bone targeting radiopharmaceuticals and cytotoxic chemotherapies. There is, however, great heterogeneity in the degree of patient benefit with these agents, thus fueling the need to develop predictive biomarkers that are able to rationally guide therapy. Circulating tumor cells (CTCs) have the potential to provide an assessment of tumor-specific biomarkers through a non-invasive, repeatable “liquid biopsy” of a patient’s cancer at a given point in time. CTCs have been extensively studied in men with mCRPC, where CTC enumeration using the Cellsearch® method has been validated and FDA approved to be used in conjunction with other clinical parameters as a prognostic biomarker in metastatic prostate cancer. In addition to enumeration, more sophisticated molecular profiling of CTCs is now feasible and may provide more clinical utility as it may reflect tumor evolution within an individual particularly under the pressure of systemic therapies. Here, we review technologies used to detect and characterize CTCs, and the potential biological and clinical utility of CTC molecular profiling in men with metastatic prostate cancer. PMID:26079252

Sex offender polygraph examination: an evidence-based case management tool for social workers.

PubMed

Levenson, Jill S

2009-10-01

This article will review the use of polygraphy in the assessment and treatment of sexual perpetrators. Such information can be utilized by social workers who are involved in the treatment and case management of child sexual abuse cases. First, the controversial literature regarding the validity and reliability of polygraph examination in general will be reviewed. Next, an emerging body of evidence supporting the utility of polygraph testing with sex offenders will be discussed. Finally, ways that social workers can incorporate this knowledge into their case management and clinical roles will be offered.

Research Driven Policy: Is Financial Capacity Related to Dangerousness?

PubMed

DeLeon, Patrick H; Paxton, Maegan M; Spencer, Tonya; Bajjani-Gebara, Jouhayna E

2018-05-22

Current Veterans administration policy directly links a Veteran's adjudged capacity to manage personal financial resources with their ability to purchase or possess a firearm, pursuant to the regulatory authority of the National Instant Criminal Background Check System (NICS). Preventing Veterans' suicide is a highly laudable public health objective. Effectively utilizing scientific research to "inform" public policy is equally important. The authors should be congratulated for their efforts. However, it is important in utilizing large set population-based data, especially social science data, to evaluate policy alternatives that there be substantial face (i.e., clinical) validity. Correlation does not necessarily represent causation.

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

PubMed

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

2011-01-01

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

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

PubMed

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

2018-03-21

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

Clinical validity of new genetic biomarkers of irinotecan neutropenia: an independent replication study.

PubMed

Crona, D J; Ramirez, J; Qiao, W; de Graan, A-J; Ratain, M J; van Schaik, R H N; Mathijssen, R H J; Rosner, G L; Innocenti, F

2016-02-01

The overall goal of this study was to provide evidence for the clinical validity of nine genetic variants in five genes previously associated with irinotecan neutropenia and pharmacokinetics. Variants associated with absolute neutrophil count (ANC) nadir and/or irinotecan pharmacokinetics in a discovery cohort of cancer patients were genotyped in an independent replication cohort of 108 cancer patients. Patients received single-agent irinotecan every 3 weeks. For ANC nadir, we replicated UGT1A1*28, UGT1A1*93 and SLCO1B1*1b in univariate analyses. For irinotecan area under the concentration-time curve (AUC0-24), we replicated ABCC2 -24C>T; however, ABCC2 -24C>T only predicted a small fraction of the variance. For SN-38 AUC0-24 and the glucuronidation ratio, we replicated UGT1A1*28 and UGT1A1*93. In addition to UGT1A1*28, this study independently validated UGT1A1*93 and SLCO1B1*1b as new predictors of irinotecan neutropenia. Further demonstration of their clinical utility will optimize irinotecan therapy in cancer patients.

Use of a 17-Gene Prognostic Assay in Contemporary Urologic Practice: Results of an Interim Analysis in an Observational Cohort.

PubMed

Eure, Gregg; Germany, Raymond; Given, Robert; Lu, Ruixiao; Shindel, Alan W; Rothney, Megan; Glowacki, Richard; Henderson, Jonathan; Richardson, Tim; Goldfischer, Evan; Febbo, Phillip G; Denes, Bela S

2017-09-01

To study the impact of genomic testing in shared decision making for men with clinically low-risk prostate cancer (PCa). Patients with clinically low-risk PCa were enrolled in a prospective, multi-institutional study of a validated 17-gene tissue-based reverse transcription polymerase chain reaction assay (Genomic Prostate Score [GPS]). In this paper we report on outcomes in the first 297 patients enrolled in the study with valid 17-gene assay results and decision-change data. The primary end points were shared decision on initial management and persistence on active surveillance (AS) at 1 year post diagnosis. AS utilization and persistence were compared with similar end points in a group of patients who did not have genomic testing (baseline cohort). Secondary end points included perceived utility of the assay and patient decisional conflict before and after testing. One-year results were available on 258 patients. Shift between initial recommendation and shared decision occurred in 23% of patients. Utilization of AS was higher in the GPS-tested cohort than in the untested baseline cohort (62% vs 40%). The proportion of men who selected and persisted on AS at 1 year was 55% and 34% in the GPS and baseline cohorts, respectively. Physicians reported that GPS was useful in 90% of cases. Mean decisional conflict scores declined in patients after GPS testing. Patients who received GPS testing were more likely to select and persist on AS for initial management compared with a matched baseline group. These data indicate that GPS help guide shared decisions in clinically low-risk PCa. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

An Assessment of Five (PANSS, SAPS, SANS, NSA-16, CGI-SCH) commonly used Symptoms Rating Scales in Schizophrenia and Comparison to Newer Scales (CAINS, BNSS).

PubMed

Kumari, Suneeta; Malik, Mansoor; Florival, Christina; Manalai, Partam; Sonje, Snezana

2017-01-01

Scales measuring positive and negative symptoms in schizophrenia remain the primary mo Scales measuring positive and negative symptoms in schizophrenia remain the primary mode of assessing and diagnosing schizophrenia by clinicians and researchers. The scales are mainly used to monitor the severity of positive and negative symptoms and track treatment response in schizophrenics. Although these scales are widely used, quality as well as general utility of each scale varies. The quality is determined by the validity and reliability of the scales. The utility of the scale is determined by the time of administration and the settings for which the scales can be administered in research or clinical settings. There are relatively fewer articles on the utility of newer scales like CAINS (Clinical Assessment Interview for Negative Symptoms) and the BNSS (Brief Negative Symptom Scale) that compare them to the older scales PANSS (Positive and Negative Symptoms Scale), SAPS (Scale for the Assessment of Positive Symptoms) SANS (the Scale for the Assessment of Negative Symptoms), NSA-16 (Negative Symptom Assessment-16) and CGI-SCH (Clinical Global Impression Schizophrenia. The older scales were developed more than 30 years ago. Since then, our understanding of negative symptoms has evolved and currently there are newer rating scales evaluating the validity of negative symptoms. The older scales do not incorporate the latest research on negative symptoms. CAINS and BNSS are attractive for both their reliability and their concise accessible format, however, a scale that is simpler, accessible, user-friendly, that incorporates a multidimensional model of schizophrenia, addresses the psychosocial and cognitive component has yet to be developed.

An Assessment of Five (PANSS, SAPS, SANS, NSA-16, CGI-SCH) commonly used Symptoms Rating Scales in Schizophrenia and Comparison to Newer Scales (CAINS, BNSS)

PubMed Central

Kumari, Suneeta; Malik, Mansoor; Florival, Christina; Manalai, Partam; Sonje, Snezana

2017-01-01

Scales measuring positive and negative symptoms in schizophrenia remain the primary mo Scales measuring positive and negative symptoms in schizophrenia remain the primary mode of assessing and diagnosing schizophrenia by clinicians and researchers. The scales are mainly used to monitor the severity of positive and negative symptoms and track treatment response in schizophrenics. Although these scales are widely used, quality as well as general utility of each scale varies. The quality is determined by the validity and reliability of the scales. The utility of the scale is determined by the time of administration and the settings for which the scales can be administered in research or clinical settings. There are relatively fewer articles on the utility of newer scales like CAINS (Clinical Assessment Interview for Negative Symptoms) and the BNSS (Brief Negative Symptom Scale) that compare them to the older scales PANSS (Positive and Negative Symptoms Scale), SAPS (Scale for the Assessment of Positive Symptoms) SANS (the Scale for the Assessment of Negative Symptoms), NSA-16 (Negative Symptom Assessment-16) and CGI-SCH (Clinical Global Impression Schizophrenia. The older scales were developed more than 30 years ago. Since then, our understanding of negative symptoms has evolved and currently there are newer rating scales evaluating the validity of negative symptoms. The older scales do not incorporate the latest research on negative symptoms. CAINS and BNSS are attractive for both their reliability and their concise accessible format, however, a scale that is simpler, accessible, user-friendly, that incorporates a multidimensional model of schizophrenia, addresses the psychosocial and cognitive component has yet to be developed. PMID:29430333

Clinical Utility of Risk Models to Refer Patients with Adnexal Masses to Specialized Oncology Care: Multicenter External Validation Using Decision Curve Analysis.

PubMed

Wynants, Laure; Timmerman, Dirk; Verbakel, Jan Y; Testa, Antonia; Savelli, Luca; Fischerova, Daniela; Franchi, Dorella; Van Holsbeke, Caroline; Epstein, Elisabeth; Froyman, Wouter; Guerriero, Stefano; Rossi, Alberto; Fruscio, Robert; Leone, Francesco Pg; Bourne, Tom; Valentin, Lil; Van Calster, Ben

2017-09-01

Purpose: To evaluate the utility of preoperative diagnostic models for ovarian cancer based on ultrasound and/or biomarkers for referring patients to specialized oncology care. The investigated models were RMI, ROMA, and 3 models from the International Ovarian Tumor Analysis (IOTA) group [LR2, ADNEX, and the Simple Rules risk score (SRRisk)]. Experimental Design: A secondary analysis of prospectively collected data from 2 cross-sectional cohort studies was performed to externally validate diagnostic models. A total of 2,763 patients (2,403 in dataset 1 and 360 in dataset 2) from 18 centers (11 oncology centers and 7 nononcology hospitals) in 6 countries participated. Excised tissue was histologically classified as benign or malignant. The clinical utility of the preoperative diagnostic models was assessed with net benefit (NB) at a range of risk thresholds (5%-50% risk of malignancy) to refer patients to specialized oncology care. We visualized results with decision curves and generated bootstrap confidence intervals. Results: The prevalence of malignancy was 41% in dataset 1 and 40% in dataset 2. For thresholds up to 10% to 15%, RMI and ROMA had a lower NB than referring all patients. SRRisks and ADNEX demonstrated the highest NB. At a threshold of 20%, the NBs of ADNEX, SRrisks, and RMI were 0.348, 0.350, and 0.270, respectively. Results by menopausal status and type of center (oncology vs. nononcology) were similar. Conclusions: All tested IOTA methods, especially ADNEX and SRRisks, are clinically more useful than RMI and ROMA to select patients with adnexal masses for specialized oncology care. Clin Cancer Res; 23(17); 5082-90. ©2017 AACR . ©2017 American Association for Cancer Research.

Molecular testing practices and perceptions among dermatopathologists.

PubMed

Torre, Kristin; Jhorar, Preeti; Wu, Rong; Pfeifer, John; Elaba, Zendee; Murphy, Michael

2018-06-01

We evaluated how dermatopathologists are employing molecular testing in the setting of neoplastic skin diseases, and assessed their opinions of the broader role and utility of molecular technologies in clinical practice. A 15-question online survey was sent to Fellows of the American Society of Dermatopathology in April 2017. One hundred and thirty-six dermatopathologists completed the survey (response rate = 16%). A majority (94%) of respondents reported experience with one or more molecular testing strategies. Sixty-two percent of dermatopathologists order 12 or more molecular tests per year, while 5% of respondents order 2 or fewer assays per year. More frequent utilization of molecular testing is associated with relevant instruction during residency training (P = .009), primary board certification in pathology (P = .008), academic medical center affiliation (P = <.0001), higher volume clinical practice (P = .0004), presence of on-site clinical molecular pathology/cytogenetics laboratory (P = .007), and greater physician confidence incorporating test results into histopathological assessments (P = <.0001). Wider adoption of molecular testing in dermatopathology may be limited by factors such as physician training, test costs/insurance coverage, logistical issues and lack of evidence-based clinical practice guidelines. Dermatopathologists have concerns regarding clinical validity/utility and inappropriate/overuse of some molecular tests. The importance of longitudinal education in molecular technologies and their applications for trainee and practicing physicians is highlighted. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Amyloid PET in clinical practice: Its place in the multidimensional space of Alzheimer's disease☆

PubMed Central

Vandenberghe, Rik; Adamczuk, Katarzyna; Dupont, Patrick; Laere, Koen Van; Chételat, Gaël

2013-01-01

Amyloid imaging is currently introduced to the market for clinical use. We will review the evidence demonstrating that the different amyloid PET ligands that are currently available are valid biomarkers for Alzheimer-related β amyloidosis. Based on recent findings from cross-sectional and longitudinal imaging studies using different modalities, we will incorporate amyloid imaging into a multidimensional model of Alzheimer's disease. Aside from the critical role in improving clinical trial design for amyloid-lowering drugs, we will also propose a tentative algorithm for when it may be useful in a memory clinic environment. Gaps in our evidence-based knowledge of the added value of amyloid imaging in a clinical context will be identified and will need to be addressed by dedicated studies of clinical utility. PMID:24179802

Practical mental health assessment in primary care. Validity and utility of the Quick PsychoDiagnostics Panel.

PubMed

Shedler, J; Beck, A; Bensen, S

2000-07-01

Many case-finding instruments are available to help primary care physicians (PCPs) diagnose depression, but they are not widely used. Physicians often consider these instruments too time consuming or feel they do not provide sufficient diagnostic information. Our study examined the validity and utility of the Quick PsychoDiagnostics (QPD) Panel, an automated mental health test designed to meet the special needs of PCPs. The test screens for 9 common psychiatric disorders and requires no physician time to administer or score. We evaluated criterion validity relative to the Structured Clinical Interview for DSM-IV (SCID), and evaluated convergent validity by correlating QPD Panel scores with established mental health measures. Sensitivity to change was examined by readministering the test to patients pretreatment and posttreatment. Utility was evaluated through physician and patient satisfaction surveys. For major depression, sensitivity and specificity were 81% and 96%, respectively. For other disorders, sensitivities ranged from 69% to 98%, and specificities ranged from 90% to 97%. The depression severity score correlated highly with the Beck, Hamilton, Zung, and CES-D depression scales, and the anxiety score correlated highly with the Spielberger State-Trait Anxiety Inventory and the anxiety subscale of the Symptom Checklist 90 (Ps <.001). The test was sensitive to change. All PCPs agreed or strongly agreed that the QPD Panel "is convenient and easy to use," "can be used immediately by any physician," and "helps provide better patient care." Patients also rated the test favorably. The QPD Panel is a valid mental health assessment tool that can diagnose a range of common psychiatric disorders and is practical for routine use in primary care.

Portable recording in the assessment of obstructive sleep apnea. ASDA standards of practice.

PubMed

Ferber, R; Millman, R; Coppola, M; Fleetham, J; Murray, C F; Iber, C; McCall, V; Nino-Murcia, G; Pressman, M; Sanders, M

1994-06-01

The objective assessment of patients with a presumptive diagnosis of obstructive sleep apnea (OSA) has primarily used attended polysomnographic study. Recent technologic advances and issues of availability, convenience and cost have led to a rapid increase in the use of portable recording devices. However, limited scientific information has been published regarding the evaluation of the efficacy, accuracy, validity, utility, cost effectiveness and limitations of this portable equipment. Attaining a clear assessment of the role of portable devices is complicated by the multiplicity of recording systems and the variability of clinical settings in which they have been analyzed. This paper reviews the current knowledge base regarding portable recording in the assessment of OSA, including technical considerations, validation studies, potential advantages and disadvantages, issues of safety, current clinical usage and areas most in need of further study.

A review of health utilities using the EQ-5D in studies of cardiovascular disease

PubMed Central

2010-01-01

Background The EQ-5D has been extensively used to assess patient utility in trials of new treatments within the cardiovascular field. The aims of this study were to review evidence of the validity and reliability of the EQ-5D, and to summarise utility scores based on the use of the EQ-5D in clinical trials and in studies of patients with cardiovascular disease. Methods A structured literature search was conducted using keywords related to cardiovascular disease and EQ-5D. Original research studies of patients with cardiovascular disease that reported EQ-5D results and its measurement properties were included. Results Of 147 identified papers, 66 met the selection criteria, with 10 studies reporting evidence on validity or reliability and 60 reporting EQ-5D responses (VAS or self-classification). Mean EQ-5D index-based scores ranged from 0.24 (SD 0.39) to 0.90 (SD 0.16), while VAS scores ranged from 37 (SD 21) to 89 (no SD reported). Stratification of EQ-5D index scores by disease severity revealed that scores decreased from a mean of 0.78 (SD 0.18) to 0.51 (SD 0.21) for mild to severe disease in heart failure patients and from 0.80 (SD 0.05) to 0.45 (SD 0.22) for mild to severe disease in angina patients. Conclusions The published evidence generally supports the validity and reliability of the EQ-5D as an outcome measure within the cardiovascular area. This review provides utility estimates across a range of cardiovascular subgroups and treatments that may be useful for future modelling of utilities and QALYs in economic evaluations within the cardiovascular area. PMID:20109189

Do circulating tumor cells, exosomes, and circulating tumor nucleic acids have clinical utility? A report of the association for molecular pathology.

PubMed

Gold, Bert; Cankovic, Milena; Furtado, Larissa V; Meier, Frederick; Gocke, Christopher D

2015-05-01

Diagnosing and screening for tumors through noninvasive means represent an important paradigm shift in precision medicine. In contrast to tissue biopsy, detection of circulating tumor cells (CTCs) and circulating tumor nucleic acids provides a minimally invasive method for predictive and prognostic marker detection. This allows early and serial assessment of metastatic disease, including follow-up during remission, characterization of treatment effects, and clonal evolution. Isolation and characterization of CTCs and circulating tumor DNA (ctDNA) are likely to improve cancer diagnosis, treatment, and minimal residual disease monitoring. However, more trials are required to validate the clinical utility of precise molecular markers for a variety of tumor types. This review focuses on the clinical utility of CTCs and ctDNA testing in patients with solid tumors, including somatic and epigenetic alterations that can be detected. A comparison of methods used to isolate and detect CTCs and some of the intricacies of the characterization of the ctDNA are also provided. Copyright © 2015 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

Telepathology in cytopathology: challenges and opportunities.

PubMed

Collins, Brian T

2013-01-01

Telepathology in cytopathology is becoming more commonly utilized, and newer technologic infrastructures afford the laboratory a variety of options. The options and design of a telepathology system are driven by the clinical needs. This is primarily focused on providing rapid on-site evaluation service for fine needle aspiration. The clinical requirements and needs of a system are described. Available tools to design and implement a telepathology system are covered, including methods of image capture, network connectivity and remote viewing options. The primary telepathology method currently used and described involves the delivery via a network connection of a live video image to a remote site which is passively viewed by an internet web-based browser. By utilizing live video information and a voice connection to the on-site location, the remote viewer can collect clinical information and direct their view of the slides. Telepathology systems for use in cytopathology can be designed and implemented with commercially available infrastructure. It is necessary for the laboratory to validate the designed system and adhere to the required regulatory requirements. Telepathology for cytopathology can be reliably utilized by adapting existing technology, and newer advances hold great promise for further applications in the cytopathology laboratory. Copyright © 2013 S. Karger AG, Basel.

Linguistic and psychometric validation of the Malaysian version of Diabetes Quality of Life-Brief Clinical Inventory (DQoL-BCI).

PubMed

Samah, Syamimi; Neoh, Chin Fen; Wong, Yuet Yen; Hassali, Mohamed Azmi; Shafie, Asrul Akmal; Lim, Siong Meng; Ramasamy, Kalavathy; Mat Nasir, Nafiza; Han, Yung Wen; Burroughs, Thomas

2017-11-01

Quality of life (QoL) assessment provides valuable outcome to support clinical decision-making, particularly for patients with chronic diseases that are incurable. A brief, 15-item diabetes-specific tool [i.e. Diabetes Quality of Life-Brief Clinical Inventory (DQoL-BCI)] is known to be developed in English and validated for use in clinical practice. This simplified tool, however, is not readily available for use in the Malaysian setting. To translate the DQoL-BCI into a Malaysian version and to assess its construct validity (factorial validity, convergent validity and discriminant validity), reliability (internal consistency) and floor and ceiling effects among the Malaysian diabetic population. A forward-backward translation, involving professional translators and experts with vast experience in translation of patient reported outcome measures, was conducted. A total of 202 patients with Type 2 diabetes mellitus (T2DM) who fulfilled the inclusion criteria were invited to complete the translated DQoL-BCI. Data were analysed using SPSS for exploratory factor analysis (EFA), convergent and discriminant validity, reliability and test-retest, and AMOS software for confirmatory factor analysis (CFA). Findings from EFA indicated that the 4-factor structure of the Malaysian version of DQoL-BCI was optimal and explained 50.9% of the variance; CFA confirmed the 4-factor model fit. There was negative, moderate correlation between the scores of DQoL-BCI (Malaysian version) and EQ-5D-3L utility score (r = -0.329, p = 0.003). Patients with higher glycated haemoglobin levels (p = 0.008), diabetes macrovascular (p = 0.017) and microvascular (p = 0.013) complications reported poorer QoL. Cronbach's alpha coefficient and intraclass coefficient correlations (range) obtained were 0.703 and 0.86 (0.734-0.934), indicating good reliability and stability of the translated DQoL-BCI. This study had validated the linguistic and psychometric properties of DQoL-BCI (Malaysian version), thus providing a valid and reliable brief tool for assessing the QoL of Malaysian T2DM patients. Copyright © 2016 Elsevier Inc. All rights reserved.

Development and Validation of a qRT-PCR Classifier for Lung Cancer Prognosis

PubMed Central

Chen, Guoan; Kim, Sinae; Taylor, Jeremy MG; Wang, Zhuwen; Lee, Oliver; Ramnath, Nithya; Reddy, Rishindra M; Lin, Jules; Chang, Andrew C; Orringer, Mark B; Beer, David G

2011-01-01

Purpose This prospective study aimed to develop a robust and clinically-applicable method to identify high-risk early stage lung cancer patients and then to validate this method for use in future translational studies. Patients and Methods Three published Affymetrix microarray data sets representing 680 primary tumors were used in the survival-related gene selection procedure using clustering, Cox model and random survival forest (RSF) analysis. A final set of 91 genes was selected and tested as a predictor of survival using a qRT-PCR-based assay utilizing an independent cohort of 101 lung adenocarcinomas. Results The RSF model built from 91 genes in the training set predicted patient survival in an independent cohort of 101 lung adenocarcinomas, with a prediction error rate of 26.6%. The mortality risk index (MRI) was significantly related to survival (Cox model p < 0.00001) and separated all patients into low, medium, and high-risk groups (HR = 1.00, 2.82, 4.42). The MRI was also related to survival in stage 1 patients (Cox model p = 0.001), separating patients into low, medium, and high-risk groups (HR = 1.00, 3.29, 3.77). Conclusions The development and validation of this robust qRT-PCR platform allows prediction of patient survival with early stage lung cancer. Utilization will now allow investigators to evaluate it prospectively by incorporation into new clinical trials with the goal of personalized treatment of lung cancer patients and improving patient survival. PMID:21792073

Psychometric validation of the Pediatric Symptom Checklist-17 in a pediatric population with epilepsy: A methods study.

PubMed

Wagner, Janelle L; Guilfoyle, Shanna M; Rausch, Joseph; Modi, Avani C

2015-10-01

The purpose of this study was to address critical gaps in behavioral health care of youth with epilepsy by examining the utility of a brief, well-validated screening instrument, the PSC-17, in a pediatric population with epilepsy. One hundred eighty-seven caregivers of youth with epilepsy ages 2-17years completed the PSC-17 for their child/adolescent during a routine epilepsy visit. Demographic and seizure information was abstracted from electronic medical record review. Confirmatory factor analyses for the PSC-17 revealed an acceptable fit with the 3-factor model, χ(2) (116 [N=187]=204.54, p<0.001, CFI=0.90, TLI=0.88, RMSEA=0.064, SRMSR=0.078). Scale level reliabilities were excellent (0.72-0.85). Interscale correlations were moderate (0.48-0.69). Approximately 1/5th of the sample met clinical cut-offs for the total score of behavioral health concerns. However, an additional 20% of the sample had at least one elevated subscale score despite the total score being in the normative/nonclinical range. The PSC-17 is a brief, free behavioral health screening tool with adequate to strong validity, reliability, and clinical utility for pediatric populations with epilepsy. Clinicians should consider using the 3 PSC-17 subscale scores instead of the total score to guide referrals for further evaluation as the subscales may provide a more accurate picture of functioning in particular domains. Copyright © 2015 Elsevier Inc. All rights reserved.

CANARY Risk Management of Adenocarcinoma: The Future of Imaging?

PubMed Central

Foley, Finbar; Rajagopalan, Srinivasan; Raghunath, Sushravya M; Boland, Jennifer M; Karwoski, Ronald A.; Maldonado, Fabien; Bartholmai, Brian J; Peikert, Tobias

2016-01-01

Increased clinical utilization of chest high resolution computed tomography results in increased identification of lung adenocarcinomas and persistent sub-solid opacities. However, these lesions range from very indolent to extremely aggressive tumors. Clinically relevant diagnostic tools to non-invasively risk stratify and guide individualized management of these lesions are lacking. Research efforts investigating semi-quantitative measures to decrease inter- and intra-rater variability are emerging, and in some cases steps have been taken to automate this process. However, many such methods currently are still sub-optimal, require validation and are not yet clinically applicable. The Computer-Aided Nodule Assessment and Risk Yield (CANARY) software application represents a validated tool for the automated, quantitative, non-invasive tool for risk stratification of adenocarcinoma lung nodules. CANARY correlates well with consensus histology and post-surgical patient outcomes and therefore may help to guide individualized patient management e.g. in identification of nodules amenable to radiological surveillance, or in need of adjunctive therapy. PMID:27568149

Computerized neurocognitive testing in the management of sport-related concussion: an update.

PubMed

Resch, Jacob E; McCrea, Michael A; Cullum, C Munro

2013-12-01

Since the late nineties, computerized neurocognitive testing has become a central component of sport-related concussion (SRC) management at all levels of sport. In 2005, a review of the available evidence on the psychometric properties of four computerized neuropsychological test batteries concluded that the tests did not possess the necessary criteria to warrant clinical application. Since the publication of that review, several more computerized neurocognitive tests have entered the market place. The purpose of this review is to summarize the body of published studies on psychometric properties and clinical utility of computerized neurocognitive tests available for use in the assessment of SRC. A review of the literature from 2005 to 2013 was conducted to gather evidence of test-retest reliability and clinical validity of these instruments. Reviewed articles included both prospective and retrospective studies of primarily sport-based adult and pediatric samples. Summaries are provided regarding the available evidence of reliability and validity for the most commonly used computerized neurocognitive tests in sports settings.

Biomarkers as drug development tools: discovery, validation, qualification and use.

PubMed

Kraus, Virginia B

2018-06-01

The 21st Century Cures Act, approved in the USA in December 2016, has encouraged the establishment of the national Precision Medicine Initiative and the augmentation of efforts to address disease prevention, diagnosis and treatment on the basis of a molecular understanding of disease. The Act adopts into law the formal process, developed by the FDA, of qualification of drug development tools, including biomarkers and clinical outcome assessments, to increase the efficiency of clinical trials and encourage an era of molecular medicine. The FDA and European Medicines Agency (EMA) have developed similar processes for the qualification of biomarkers intended for use as companion diagnostics or for development and regulatory approval of a drug or therapeutic. Biomarkers that are used exclusively for the diagnosis, monitoring or stratification of patients in clinical trials are not subject to regulatory approval, although their qualification can facilitate the conduct of a trial. In this Review, the salient features of biomarker discovery, analytical validation, clinical qualification and utilization are described in order to provide an understanding of the process of biomarker development and, through this understanding, convey an appreciation of their potential advantages and limitations.

Cross-cultural validation of the Depression Anxiety Stress Scale-21 in China.

PubMed

Wang, Kui; Shi, Hai-Song; Geng, Fu-Lei; Zou, Lai-Quan; Tan, Shu-Ping; Wang, Yi; Neumann, David L; Shum, David H K; Chan, Raymond C K

2016-05-01

The gap between the demand and delivery of mental health services in mainland China can be reduced by validating freely available and psychometrically sound psychological instruments. The present research examined the Chinese version of the 21-item Depression Anxiety Stress Scales (DASS-21). Study 1 administered the DASS-21 to 1,815 Chinese college students and found internal consistency indices (Cronbach's alpha) of .83, .80, and .82 for the Depression, Anxiety, and Stress subscales, respectively, and .92 for the total DASS total. Test-retest reliability over a 6-month interval was .39 to .46 for each of the 3 subscales and .46 for the total DASS. Moderate convergent validity of the Depression and Anxiety subscales was demonstrated via significant correlations with the Chinese Beck Depression Inventory (r = .51 at Time 1 and r = .64 at Time 2) and the Chinese State-Trait Anxiety Inventory (r = .41), respectively. Confirmatory factor analyses supported the original 3-factor model with 1 minor change (nonnormed fit index [NNFI] = .964, comparative fit index [CFI] = .968, and root mean square error of approximation [RMSEA] = .079). Study 2 examined the clinical utility of the Chinese DASS-21 in 166 patients with schizophrenia and 90 matched healthy controls. Patients had higher Depression and Anxiety but not Stress subscale scores than healthy controls. A discriminant function composed of the linear combination of 3 subscale scores correctly discriminated 69.92% of participants, which again supported the potential clinical utility of the DASS in mainland China. Taken together, findings in these studies support the cross-cultural validity of the DASS-21 in China. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Reliability, Validity, and Clinical Utility of the Dominic Interactive for Adolescents-RevisedA DSM-5-Based Self-Report Screen for Mental Disorders, Borderline Personality Traits, and Suicidality.

PubMed

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

2017-03-01

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

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

PubMed Central

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

2017-01-01

Introduction 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. Methods 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. Ethics 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. PMID:28821511

Brief Report: Screening Tool for Autism in Two-Year-Olds (STAT): Development and Preliminary Data.

ERIC Educational Resources Information Center

Stone, Wendy L.; Coonrod, Elaine E.; Ousley, Opal Y.

2000-01-01

A study examined the validity of the Screening Tool for Autism in Two-Year-Olds (STAT) as a stage 2 screening instrument in a clinic-based sample of two-year-olds with autism (n=12) and with nonautistic developmental disorders (n=21). Results provide preliminary support for the utility of the STAT as an early screening of autism. (Contains…

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

ERIC Educational Resources Information Center

Souroulla, Andry Vrachimi; Panayiotou, Georgia

2017-01-01

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

Latent Factor Structure of the Das-Naglieri Cognitive Assessment System: A Confirmatory Factor Analysis in a Chinese Setting

ERIC Educational Resources Information Center

Deng, Ci-ping; Liu, Ming; Wei, Wei; Chan, Raymond C. K.; Das, J. P.

2011-01-01

This study aims to measure the psychometric properties of the Das-Naglieri Cognitive Assessment System (D-N CAS) and to determine its clinical utility in a Chinese context. Confirmatory factor analysis (CFA) was conducted to examine the construct validity of the Chinese version of the D-N CAS among a group of 567, normally developed children.…

Development and Validation of a Quantitative PCR Assay Using Multiplexed Hydrolysis Probes for Detection and Quantification of Theileria orientalis Isolates and Differentiation of Clinically Relevant Subtypes

PubMed Central

Bogema, D. R.; Deutscher, A. T.; Fell, S.; Collins, D.; Eamens, G. J.

2015-01-01

Theileria orientalis is an emerging pathogen of cattle in Asia, Australia, and New Zealand. This organism is a vector-borne hemoprotozoan that causes clinical disease characterized by anemia, abortion, and death, as well as persistent subclinical infections. Molecular methods of diagnosis are preferred due to their sensitivity and utility in differentiating between pathogenic and apathogenic genotypes. Conventional PCR (cPCR) assays for T. orientalis detection and typing are laborious and do not provide an estimate of parasite load. Current real-time PCR assays cannot differentiate between clinically relevant and benign genotypes or are only semiquantitative without a defined clinical threshold. Here, we developed and validated a hydrolysis probe quantitative PCR (qPCR) assay which universally detects and quantifies T. orientalis and identifies the clinically associated Ikeda and Chitose genotypes (UIC assay). Comparison of the UIC assay results with previously validated universal and genotype-specific cPCR results demonstrated that qPCR detects and differentiates T. orientalis with high sensitivity and specificiy. Comparison of quantitative results based on percent parasitemia, determined via blood film analysis and packed cell volume (PCV) revealed significant positive and negative correlations, respectively. One-way analysis of variance (ANOVA) indicated that blood samples from animals with clinical signs of disease contained statistically higher concentrations of T. orientalis DNA than animals with subclinical infections. We propose clinical thresholds to assist in classifying high-, moderate-, and low-level infections and describe how parasite load and the presence of the Ikeda and Chitose genotypes relate to disease. PMID:25588653

Routine pharmacogenetic testing in clinical practice: dream or reality?

PubMed

Grossman, Iris

2007-10-01

Pharmacogenetics (PGx) has become progressively popular in recent years, thanks to growing anticipation among scientists, healthcare providers and the general public for the incorporation of genetic tests into the diagnostic arsenal at the physician's disposal. Indeed, much research has been dedicated to elucidation of genetic determinants underlying interindividual variability in pharmacokinetic parameters, as well as drug safety and efficacy. However, few PGx applications have thus far been realized in healthcare management. This review uses examples from PGx research of psychiatric drugs to illustrate why the current published findings are inadequate and insufficient for utilization as routine clinical predictors of treatment safety, efficacy or dosing. I therefore suggest the necessary steps to demonstrate the validity, utility and cost-effectiveness of PGx. These recommendations include a whole range of aspects, starting from standardization of criteria and assessment of the technical quality of genotyping assays, up to design of prospective PGx studies, providing the basis for reimbursement programs to be recognized in routine clinical practice.

An Update on the Clinical Utility of the Children's Post-Traumatic Cognitions Inventory.

PubMed

McKinnon, Anna; Smith, Patrick; Bryant, Richard; Salmon, Karen; Yule, William; Dalgleish, Tim; Dixon, Clare; Nixon, Reginald D V; Meiser-Stedman, Richard

2016-06-01

The Children's Post-Traumatic Cognitions Inventory (CPTCI) is a self-report questionnaire that measures maladaptive cognitions in children and young people following exposure to trauma. In this study, the psychometric properties of the CPTCI were examined in further detail with the objective of furthering its utility as a clinical tool. Specifically, we investigated the CPTCI's discriminant validity, test-retest reliability, and the potential for the development of a short form of the measure. Three samples (London, East Anglia, Australia) of children and young people exposed to trauma (N = 535; 7-17 years old) completed the CPTCI and a structured clinical interview to measure posttraumatic stress disorder (PTSD) symptoms between 1 and 6 months following trauma. Test-retest reliability was investigated in a subsample of 203 cases. The results showed that a score in the range of 46 to 48 on the CPTCI was indicative of clinically significant appraisals as determined by the presence of PTSD. The measure also had moderate-to-high test-retest reliability (r = .78) over a 2-month period. The Children's Post-Traumatic Cognitions Inventory-Short Form (CPTCI-S) had excellent internal consistency (α = .92), and moderate-to-high test-retest reliability (r = .78). The examination of construct validity showed the model had an excellent fitting factor structure (Comparative Fit index = 0.95, Tucker-Lewis index = 0.91, Root Mean Square Error of Approximation = .07). A score ranging from 16 to 18 was the best cutoff point on the CPTCI-S, in that it was indicative of clinically significant appraisals as determined by the presence of PTSD. Based on these results, we concluded that the CPTCI is a useful tool to support the practice of clinicians and that the CPTCI-S has excellent psychometric properties. Copyright © 2016 International Society for Traumatic Stress Studies.

The Scientific Status of Projective Techniques.

PubMed

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

2000-11-01

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

Development and initial validation of the appropriate antibiotic use self-efficacy scale.

PubMed

Hill, Erin M; Watkins, Kaitlin

2018-06-04

While there are various medication self-efficacy scales that exist, none assess self-efficacy for appropriate antibiotic use. The Appropriate Antibiotic Use Self-Efficacy Scale (AAUSES) was developed, pilot tested, and its psychometric properties were examined. Following pilot testing of the scale, a 28-item questionnaire was examined using a sample (n = 289) recruited through the Amazon Mechanical Turk platform. Participants also completed other scales and items, which were used in assessing discriminant, convergent, and criterion-related validity. Test-retest reliability was also examined. After examining the scale and removing items that did not assess appropriate antibiotic use, an exploratory factor analysis was conducted on 13 items from the original scale. Three factors were retained that explained 65.51% of the variance. The scale and its subscales had adequate internal consistency. The scale had excellent test-retest reliability, as well as demonstrated convergent, discriminant, and criterion-related validity. The AAUSES is a valid and reliable scale that assesses three domains of appropriate antibiotic use self-efficacy. The AAUSES may have utility in clinical and research settings in understanding individuals' beliefs about appropriate antibiotic use and related behavioral correlates. Future research is needed to examine the scale's utility in these settings. Copyright © 2018 Elsevier B.V. All rights reserved.

Gene expression-based molecular diagnostic system for malignant gliomas is superior to histological diagnosis.

PubMed

Shirahata, Mitsuaki; Iwao-Koizumi, Kyoko; Saito, Sakae; Ueno, Noriko; Oda, Masashi; Hashimoto, Nobuo; Takahashi, Jun A; Kato, Kikuya

2007-12-15

Current morphology-based glioma classification methods do not adequately reflect the complex biology of gliomas, thus limiting their prognostic ability. In this study, we focused on anaplastic oligodendroglioma and glioblastoma, which typically follow distinct clinical courses. Our goal was to construct a clinically useful molecular diagnostic system based on gene expression profiling. The expression of 3,456 genes in 32 patients, 12 and 20 of whom had prognostically distinct anaplastic oligodendroglioma and glioblastoma, respectively, was measured by PCR array. Next to unsupervised methods, we did supervised analysis using a weighted voting algorithm to construct a diagnostic system discriminating anaplastic oligodendroglioma from glioblastoma. The diagnostic accuracy of this system was evaluated by leave-one-out cross-validation. The clinical utility was tested on a microarray-based data set of 50 malignant gliomas from a previous study. Unsupervised analysis showed divergent global gene expression patterns between the two tumor classes. A supervised binary classification model showed 100% (95% confidence interval, 89.4-100%) diagnostic accuracy by leave-one-out cross-validation using 168 diagnostic genes. Applied to a gene expression data set from a previous study, our model correlated better with outcome than histologic diagnosis, and also displayed 96.6% (28 of 29) consistency with the molecular classification scheme used for these histologically controversial gliomas in the original article. Furthermore, we observed that histologically diagnosed glioblastoma samples that shared anaplastic oligodendroglioma molecular characteristics tended to be associated with longer survival. Our molecular diagnostic system showed reproducible clinical utility and prognostic ability superior to traditional histopathologic diagnosis for malignant glioma.

Detection of Pathological Voice Using Cepstrum Vectors: A Deep Learning Approach.

PubMed

Fang, Shih-Hau; Tsao, Yu; Hsiao, Min-Jing; Chen, Ji-Ying; Lai, Ying-Hui; Lin, Feng-Chuan; Wang, Chi-Te

2018-03-19

Computerized detection of voice disorders has attracted considerable academic and clinical interest in the hope of providing an effective screening method for voice diseases before endoscopic confirmation. This study proposes a deep-learning-based approach to detect pathological voice and examines its performance and utility compared with other automatic classification algorithms. This study retrospectively collected 60 normal voice samples and 402 pathological voice samples of 8 common clinical voice disorders in a voice clinic of a tertiary teaching hospital. We extracted Mel frequency cepstral coefficients from 3-second samples of a sustained vowel. The performances of three machine learning algorithms, namely, deep neural network (DNN), support vector machine, and Gaussian mixture model, were evaluated based on a fivefold cross-validation. Collective cases from the voice disorder database of MEEI (Massachusetts Eye and Ear Infirmary) were used to verify the performance of the classification mechanisms. The experimental results demonstrated that DNN outperforms Gaussian mixture model and support vector machine. Its accuracy in detecting voice pathologies reached 94.26% and 90.52% in male and female subjects, based on three representative Mel frequency cepstral coefficient features. When applied to the MEEI database for validation, the DNN also achieved a higher accuracy (99.32%) than the other two classification algorithms. By stacking several layers of neurons with optimized weights, the proposed DNN algorithm can fully utilize the acoustic features and efficiently differentiate between normal and pathological voice samples. Based on this pilot study, future research may proceed to explore more application of DNN from laboratory and clinical perspectives. Copyright © 2018 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Development of a severity score for CRPS.

PubMed

Harden, R Norman; Bruehl, Stephen; Perez, Roberto S G M; Birklein, Frank; Marinus, Johan; Maihofner, Christian; Lubenow, Timothy; Buvanendran, Asokumar; Mackey, Sean; Graciosa, Joseph; Mogilevski, Mila; Ramsden, Christopher; Schlereth, Tanja; Chont, Melissa; Vatine, Jean-Jacques

2010-12-01

The clinical diagnosis of Complex Regional Pain Syndrome (CRPS) is a dichotomous (yes/no) categorization necessary for clinical decision-making. However, such dichotomous diagnostic categories do not convey an individual's subtle and temporal gradations in severity of the condition, and have poor statistical power when used as an outcome measure in research. This study evaluated the validity and potential utility of a continuous type score to index severity of CRPS. Psychometric and medical evaluations were conducted in 114 CRPS patients and 41 non-CRPS neuropathic pain patients. Based on the presence/absence of 17 clinically-assessed signs and symptoms of CRPS, an overall CRPS Severity Score (CSS) was derived. The CSS discriminated well between CRPS and non-CRPS patients (p<.001), and displayed strong associations with dichotomous CRPS diagnoses using both IASP diagnostic criteria (Eta=0.69) and proposed revised criteria (Eta=0.77-0.88). Higher CSS was associated with significantly higher clinical pain intensity, distress, and functional impairments, as well as greater bilateral temperature asymmetry and thermal perception abnormalities (p's<.05). In an archival prospective dataset, increases in anxiety and depression from pre-surgical baseline to 4 weeks post-knee arthroplasty were found to predict significantly higher CSS at 6- and 12-month follow-up (p's<.05). Results indicate the CSS corresponds with and complements currently accepted dichotomous diagnostic criteria for CRPS, and support its validity as an index of CRPS severity. Its utility as an outcome measure in research studies is also suggested, with potential statistical advantages over dichotomous diagnostic criteria. Copyright © 2010. Published by Elsevier B.V.

A parent-child dyad approach to the assessment of health status and health-related quality of life in children with asthma.

PubMed

Ungar, Wendy J; Boydell, Katherine; Dell, Sharon; Feldman, Brian M; Marshall, Deborah; Willan, Andrew; Wright, James G

2012-08-01

Assessment of health state and health-related quality of life (HR-QOL) are limited by a child's age and cognitive ability. Parent-proxy reports are known to differ from children's reports. Simultaneous assessment using a parent-child dyad is an alternative approach. Our objective was to assess the validity, reliability and responsiveness of a parent-child dyad approach to utility and HR-QOL assessment of paediatric asthma health states. The setting was specialist care in a hospital-based asthma clinic. Participants were 91 girls and boys with asthma aged 8 to 17 years and 91 parents. The intervention employed was parent-child dyad administration of the Health Utilities Index (HUI) 2 and 3, the Pediatric Quality of Life Inventory™ (PedsQL™) Core and Asthma modules, and the Pediatric Asthma Quality of Life Questionnaire (PAQLQ). Questionnaires were administered by interview to children and parents separately and then together as a dyad to assess the child's health state. The dyad interview was repeated at the next clinic visit. Dyad-child agreement was measured by intra-class correlation (ICC) coefficient; Spearman correlations were used to assess convergent validity. Test-retest reliability was assessed in 28 children who remained clinically stable between visits with a two-way ICC coefficient. Responsiveness to change from baseline was assessed with Spearman coefficients in 30 children who demonstrated clinical change between visits. There was no significant agreement between parent and child for the HUI2 or HUI3 whereas agreement between dyad and child was 0.55 (95% confidence interval [CI] 0.36, 0.69) for the HUI2 and 0.74 (95% CI 0.61, 0.82) for the HUI3 overall. With respect to dyad performance characteristics, both HUI2 and HUI3 overall scores demonstrated moderate convergent validity with the generic PedsQL™ Core domains (range r = 0.30-0.52; p < 0.01). Dyad HUI2 attributes demonstrated moderate convergent validity with the generic PedsQL™ Core domains of similar constructs (range r = 0.35-0.43; p < 0.001) and weaker convergent validity with disease-specific domains (range r = 0.13-0.32). Dyad HUI3 attributes demonstrated weaker convergent validity compared with the HUI2. For the assessment of test-retest reliability, significant agreement between baseline and follow-up was observed for dyad HUI2 total (r = 0.53), dyad PedsQL™ Core summary (r = 0.70) and select dyad disease-specific domains. Significant responsiveness (r > 0.4; p < 0.05) was observed for dyad HUI2 total score change over time as correlated with dyad HUI3, dyad PedsQL™ Core summary and select disease-specific domains. The parent-child dyad approach demonstrated moderate to strong performance characteristics in generic and disease-specific questionnaires suggesting it may be a valuable alternative to relying on parent proxies for assessing children's utility and HR-QOL. Future research in additional paediatric populations, younger children and a population-based sample would be useful.

A Parent-Child Dyad Approach to the Assessment of Health Status and Health-Related Quality of Life in Children with Asthma

PubMed Central

Ungar, Wendy J.; Boydell, Katherine; Dell, Sharon; Feldman, Brian M.; Marshall, Deborah; Willan, Andrew; Wright, James G.

2016-01-01

Background Assessment of health state and health-related quality of life (HR-QOL) are limited by a child’s age and cognitive ability. Parent-proxy reports are known to differ from children’s reports. Simultaneous assessment using a parent-child dyad is an alternative approach. Objective Our objective was to assess the validity, reliability and responsiveness of a parent-child dyad approach to utility and HR-QOL assessment of paediatric asthma health states. Methods The setting was specialist care in a hospital-based asthma clinic. Participants were 91 girls and boys with asthma aged 8 to 17 years and 91 parents. The intervention employed was parent-child dyad administration of the Health Utilities Index (HUI) 2 and 3, the Pediatric Quality of Life Inventory™ (PedsQL™) Core and Asthma modules, and the Pediatric Asthma Quality of Life Questionnaire (PAQLQ). Questionnaires were administered by interview to children and parents separately and then together as a dyad to assess the child’s health state. The dyad interview was repeated at the next clinic visit. Dyad-child agreement was measured by intra-class correlation (ICC) coefficient; Spearman correlations were used to assess convergent validity. Test-retest reliability was assessed in 28 children who remained clinically stable between visits with a two-way ICC coefficient. Responsiveness to change from baseline was assessed with Spearman coefficients in 30 children who demonstrated clinical change between visits. Results There was no significant agreement between parent and child for the HUI2 or HUI3 whereas agreement between dyad and child was 0.55 (95% confidence interval [CI] 0.36, 0.69) for the HUI2 and 0.74 (95% CI 0.61, 0.82) for the HUI3 overall. With respect to dyad performance characteristics, both HUI2 and HUI3 overall scores demonstrated moderate convergent validity with the generic PedsQL™ Core domains (range r = 0.30–0.52; p < 0.01). Dyad HUI2 attributes demonstrated moderate convergent validity with the generic PedsQL™ Core domains of similar constructs (range r = 0.35–0.43; p < 0.001) and weaker convergent validity with disease-specific domains (range r = 0.13–0.32). Dyad HUI3 attributes demonstrated weaker convergent validity compared with the HUI2. For the assessment of test-retest reliability, significant agreement between baseline and follow-up was observed for dyad HUI2 total (r = 0.53), dyad PedsQL™ Core summary (r = 0.70) and select dyad disease-specific domains. Significant responsiveness (r > 0.4; p < 0.05) was observed for dyad HUI2 total score change over time as correlated with dyad HUI3, dyad PedsQL™ Core summary and select disease-specific domains. Conclusions The parent-child dyad approach demonstrated moderate to strong performance characteristics in generic and disease-specific questionnaires suggesting it may be a valuable alternative to relying on parent proxies for assessing children’s utility and HR-QOL. Future research in additional paediatric populations, younger children and a population-based sample would be useful. PMID:22788260

Validation of classification algorithms for childhood diabetes identified from administrative data.

PubMed

Vanderloo, Saskia E; Johnson, Jeffrey A; Reimer, Kim; McCrea, Patrick; Nuernberger, Kimberly; Krueger, Hans; Aydede, Sema K; Collet, Jean-Paul; Amed, Shazhan

2012-05-01

Type 1 diabetes is the most common form of diabetes among children; however, the proportion of cases of childhood type 2 diabetes is increasing. In Canada, the National Diabetes Surveillance System (NDSS) uses administrative health data to describe trends in the epidemiology of diabetes, but does not specify diabetes type. The objective of this study was to validate algorithms to classify diabetes type in children <20 yr identified using the NDSS methodology. We applied the NDSS case definition to children living in British Columbia between 1 April 1996 and 31 March 2007. Through an iterative process, four potential classification algorithms were developed based on demographic characteristics and drug-utilization patterns. Each algorithm was then validated against a gold standard clinical database. Algorithms based primarily on an age rule (i.e., age <10 at diagnosis categorized type 1 diabetes) were most sensitive in the identification of type 1 diabetes; algorithms with restrictions on drug utilization (i.e., no prescriptions for insulin ± glucose monitoring strips categorized type 2 diabetes) were most sensitive for identifying type 2 diabetes. One algorithm was identified as having the optimal balance of sensitivity (Sn) and specificity (Sp) for the identification of both type 1 (Sn: 98.6%; Sp: 78.2%; PPV: 97.8%) and type 2 diabetes (Sn: 83.2%; Sp: 97.5%; PPV: 73.7%). Demographic characteristics in combination with drug-utilization patterns can be used to differentiate diabetes type among cases of pediatric diabetes identified within administrative health databases. Validation of similar algorithms in other regions is warranted. © 2011 John Wiley & Sons A/S.

Global Health Innovation Technology Models.

PubMed

Harding, Kimberly

2016-01-01

Chronic technology and business process disparities between High Income, Low Middle Income and Low Income (HIC, LMIC, LIC) research collaborators directly prevent the growth of sustainable Global Health innovation for infectious and rare diseases. There is a need for an Open Source-Open Science Architecture Framework to bridge this divide. We are proposing such a framework for consideration by the Global Health community, by utilizing a hybrid approach of integrating agnostic Open Source technology and healthcare interoperability standards and Total Quality Management principles. We will validate this architecture framework through our programme called Project Orchid. Project Orchid is a conceptual Clinical Intelligence Exchange and Virtual Innovation platform utilizing this approach to support clinical innovation efforts for multi-national collaboration that can be locally sustainable for LIC and LMIC research cohorts. The goal is to enable LIC and LMIC research organizations to accelerate their clinical trial process maturity in the field of drug discovery, population health innovation initiatives and public domain knowledge networks. When sponsored, this concept will be tested by 12 confirmed clinical research and public health organizations in six countries. The potential impact of this platform is reduced drug discovery and public health innovation lag time and improved clinical trial interventions, due to reliable clinical intelligence and bio-surveillance across all phases of the clinical innovation process.

Global Health Innovation Technology Models

PubMed Central

Harding, Kimberly

2016-01-01

Chronic technology and business process disparities between High Income, Low Middle Income and Low Income (HIC, LMIC, LIC) research collaborators directly prevent the growth of sustainable Global Health innovation for infectious and rare diseases. There is a need for an Open Source-Open Science Architecture Framework to bridge this divide. We are proposing such a framework for consideration by the Global Health community, by utilizing a hybrid approach of integrating agnostic Open Source technology and healthcare interoperability standards and Total Quality Management principles. We will validate this architecture framework through our programme called Project Orchid. Project Orchid is a conceptual Clinical Intelligence Exchange and Virtual Innovation platform utilizing this approach to support clinical innovation efforts for multi-national collaboration that can be locally sustainable for LIC and LMIC research cohorts. The goal is to enable LIC and LMIC research organizations to accelerate their clinical trial process maturity in the field of drug discovery, population health innovation initiatives and public domain knowledge networks. When sponsored, this concept will be tested by 12 confirmed clinical research and public health organizations in six countries. The potential impact of this platform is reduced drug discovery and public health innovation lag time and improved clinical trial interventions, due to reliable clinical intelligence and bio-surveillance across all phases of the clinical innovation process.

A Molecular Host Response Assay to Discriminate Between Sepsis and Infection-Negative Systemic Inflammation in Critically Ill Patients: Discovery and Validation in Independent Cohorts

PubMed Central

McHugh, Leo; Seldon, Therese A.; Brandon, Roslyn A.; Kirk, James T.; Rapisarda, Antony; Sutherland, Allison J.; Presneill, Jeffrey J.; Venter, Deon J.; Lipman, Jeffrey; Thomas, Mervyn R.; Klein Klouwenberg, Peter M. C.; van Vught, Lonneke; Scicluna, Brendon; Bonten, Marc; Cremer, Olaf L.; Schultz, Marcus J.; van der Poll, Tom; Yager, Thomas D.; Brandon, Richard B.

2015-01-01

Background Systemic inflammation is a whole body reaction having an infection-positive (i.e., sepsis) or infection-negative origin. It is important to distinguish between these two etiologies early and accurately because this has significant therapeutic implications for critically ill patients. We hypothesized that a molecular classifier based on peripheral blood RNAs could be discovered that would (1) determine which patients with systemic inflammation had sepsis, (2) be robust across independent patient cohorts, (3) be insensitive to disease severity, and (4) provide diagnostic utility. The goal of this study was to identify and validate such a molecular classifier. Methods and Findings We conducted an observational, non-interventional study of adult patients recruited from tertiary intensive care units (ICUs). Biomarker discovery utilized an Australian cohort (n = 105) consisting of 74 cases (sepsis patients) and 31 controls (post-surgical patients with infection-negative systemic inflammation) recruited at five tertiary care settings in Brisbane, Australia, from June 3, 2008, to December 22, 2011. A four-gene classifier combining CEACAM4, LAMP1, PLA2G7, and PLAC8 RNA biomarkers was identified. This classifier, designated SeptiCyte Lab, was validated using reverse transcription quantitative PCR and receiver operating characteristic (ROC) curve analysis in five cohorts (n = 345) from the Netherlands. Patients for validation were selected from the Molecular Diagnosis and Risk Stratification of Sepsis study (ClinicalTrials.gov, NCT01905033), which recruited ICU patients from the Academic Medical Center in Amsterdam and the University Medical Center Utrecht. Patients recruited from November 30, 2012, to August 5, 2013, were eligible for inclusion in the present study. Validation cohort 1 (n = 59) consisted entirely of unambiguous cases and controls; SeptiCyte Lab gave an area under curve (AUC) of 0.95 (95% CI 0.91–1.00) in this cohort. ROC curve analysis of an independent, more heterogeneous group of patients (validation cohorts 2–5; 249 patients after excluding 37 patients with an infection likelihood of “possible”) gave an AUC of 0.89 (95% CI 0.85–0.93). Disease severity, as measured by Sequential Organ Failure Assessment (SOFA) score or Acute Physiology and Chronic Health Evaluation (APACHE) IV score, was not a significant confounding variable. The diagnostic utility of SeptiCyte Lab was evaluated by comparison to various clinical and laboratory parameters available to a clinician within 24 h of ICU admission. SeptiCyte Lab was significantly better at differentiating cases from controls than all tested parameters, both singly and in various logistic combinations, and more than halved the diagnostic error rate compared to procalcitonin in all tested cohorts and cohort combinations. Limitations of this study relate to (1) cohort compositions that do not perfectly reflect the composition of the intended use population, (2) potential biases that could be introduced as a result of the current lack of a gold standard for diagnosing sepsis, and (3) lack of a complete, unbiased comparison to C-reactive protein. Conclusions SeptiCyte Lab is a rapid molecular assay that may be clinically useful in managing ICU patients with systemic inflammation. Further study in population-based cohorts is needed to validate this assay for clinical use. PMID:26645559

Protein Biomarkers for Early Detection of Pancreatic Ductal Adenocarcinoma: Progress and Challenges.

PubMed

Root, Alex; Allen, Peter; Tempst, Paul; Yu, Kenneth

2018-03-07

Approximately 75% of patients with pancreatic ductal adenocarcinoma are diagnosed with advanced cancer, which cannot be safely resected. The most commonly used biomarker CA19-9 has inadequate sensitivity and specificity for early detection, which we define as Stage I/II cancers. Therefore, progress in next-generation biomarkers is greatly needed. Recent reports have validated a number of biomarkers, including combination assays of proteins and DNA mutations; however, the history of translating promising biomarkers to clinical utility suggests that several major hurdles require careful consideration by the medical community. The first set of challenges involves nominating and verifying biomarkers. Candidate biomarkers need to discriminate disease from benign controls with high sensitivity and specificity for an intended use, which we describe as a two-tiered strategy of identifying and screening high-risk patients. Community-wide efforts to share samples, data, and analysis methods have been beneficial and progress meeting this challenge has been achieved. The second set of challenges is assay optimization and validating biomarkers. After initial candidate validation, assays need to be refined into accurate, cost-effective, highly reproducible, and multiplexed targeted panels and then validated in large cohorts. To move the most promising candidates forward, ideally, biomarker panels, head-to-head comparisons, meta-analysis, and assessment in independent data sets might mitigate risk of failure. Much more investment is needed to overcome these challenges. The third challenge is achieving clinical translation. To moonshot an early detection test to the clinic requires a large clinical trial and organizational, regulatory, and entrepreneurial know-how. Additional factors, such as imaging technologies, will likely need to improve concomitant with molecular biomarker development. The magnitude of the clinical translational challenge is uncertain, but interdisciplinary cooperation within the PDAC community is poised to confront it.

Development and psychometric validation of a cystic fibrosis knowledge scale.

PubMed

Balfour, Louise; Armstrong, Michael; Holly, Crystal; Gaudet, Ena; Aaron, Shawn; Tasca, George; Cameron, William; Pakhale, Smita

2014-11-01

Well-developed and validated measures of cystic fibrosis (CF) knowledge are scarce. The purpose of the present study is to develop and validate a CF knowledge scale that is brief, easy to use, self-administered and demonstrates clinical utility. A comprehensive literature search generated a pool of scale items; an expert panel of CF team members reviewed and provided recommendations for item inclusion. A focus group of CF patients and family members (n = 12) then reviewed the items for face validity and reading clarity. To evaluate the validity and reliability of the newly developed CF knowledge scale, it was administered to several different samples including CF patients (n = 45), respirology patients (n = 100), health-care providers (n = 74) and university student samples (psychology students, n = 71; medical students, n = 36). Internal consistency of the scale was high, with an alpha coefficient for the overall sample of .95 (n = 326). The scale also demonstrated excellent construct validity. This study is an important first step in a line of research that aims to develop and empirically validate a psycho-educational adherence intervention for improving quality of life and treatment outcomes among adult CF patients. The CF knowledge scale has potential applications as a clinical teaching tool with patients and health-care providers and could be used as an outcome measure in CF educational intervention studies aimed at optimizing CF treatment knowledge, adherence and quality of life among CF patients. © 2014 Asian Pacific Society of Respirology.

The Component Timed-Up-and-Go test: the utility and psychometric properties of using a mobile application to determine prosthetic mobility in people with lower limb amputations.

PubMed

Clemens, Sheila M; Gailey, Robert S; Bennett, Christopher L; Pasquina, Paul F; Kirk-Sanchez, Neva J; Gaunaurd, Ignacio A

2018-03-01

Using a custom mobile application to evaluate the reliability and validity of the Component Timed-Up-and-Go test to assess prosthetic mobility in people with lower limb amputation. Cross-sectional design. National conference for people with limb loss. A total of 118 people with non-vascular cause of lower limb amputation participated. Subjects had a mean age of 48 (±13.7) years and were an average of 10 years post amputation. Of them, 54% ( n = 64) of subjects were male. None. The Component Timed-Up-and-Go was administered using a mobile iPad application, generating a total time to complete the test and five component times capturing each subtask (sit to stand transitions, linear gait, turning) of the standard timed-up-and-go test. The outcome underwent test-retest reliability using intraclass correlation coefficients (ICCs) and convergent validity analyses through correlation with self-report measures of balance and mobility. The Component Timed-Up-and-Go exhibited excellent test-retest reliability with ICCs ranging from .98 to .86 for total and component times. Evidence of discriminative validity resulted from significant differences in mean total times between people with transtibial (10.1 (SD: ±2.3)) and transfemoral (12.76 (SD: ±5.1) amputation, as well as significant differences in all five component times ( P < .05). Convergent validity of the Component Timed-Up-and-Go was demonstrated through moderate correlations with the PLUS-M ( r s  = -.56). The Component Timed-Up-and-Go is a reliable and valid clinical tool for detailed assessment of prosthetic mobility in people with non-vascular lower limb amputation. The iPad application provided a means to easily record data, contributing to clinical utility.

Development and validation of the Pediatric Stroke Quality of Life Measure.

PubMed

Fiume, Andrea; Deveber, Gabrielle; Jang, Shu-Hyun; Fuller, Colleen; Viner, Shani; Friefeld, Sharon

2018-06-01

To develop and validate a disease-specific parent proxy and child quality of life (QoL) measure for patients aged 2 to 18 years surviving cerebral sinovenous thrombosis (CSVT) and arterial ischaemic stroke (AIS). Utilizing qualitative and quantitative methods, we developed a 75-item Pediatric Stroke Quality of Life Measure (PSQLM) questionnaire. We mailed the PSQLM and a standardized generic QoL measure, Pediatric Quality of Life Inventory (PedsQL), to 353 families. Stroke type, age at stroke, and neurological outcome on the Pediatric Stroke Outcome Measure were documented. We calculated the internal consistency, validity, and reliability of the PSQLM. The response rate was 29%, yielding a sample of 101 patients (mean age 9y 9mo [SD 4.30]; 69 AIS [68.3%], 32 CSVT [31.7%]). The internal consistency of the PSQLM was high (Cronbach's α=0.94-0.97). Construct validity for the PSQLM was moderately strong (r=0.3-0.4; p<0.003) and, as expected, correlation with the PedsQL was moderate, suggesting the PSQLM operationalizes QoL distinct from the PedsQL. Test-retest reliability at 2 weeks was very good (intraclass correlation coefficient [ICC] 0.85-0.95; 95% confidence interval 0.83-0.97) and good agreement was established between parent and child report (ICC 0.63-0.76). The PSQLM demonstrates sound psychometric properties. Further research will seek to increase its clinical utility by reducing length and establishing responsiveness for descriptive and longitudinal evaluative assessment. A pediatric stroke-specific quality of life (QoL) measurement tool for assessments based on perceptions of importance and satisfaction. Moderate-to-high reliability and validity established for a new clinical scale evaluating QoL among children with stroke. Perceived QoL measured using the Pediatric Stroke Quality of Life Measure appears lower in children with neurological impairment. © 2018 Mac Keith Press.

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

PubMed

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 < 0.0001; and 7.4 ± 0.2 vs. 5.6 ± 0.2 L/min, P < 0.0001; respectively). There is no 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.

A health economic model to determine the long-term costs and clinical outcomes of raising low HDL-cholesterol in the prevention of coronary heart disease.

PubMed

Roze, S; Liens, D; Palmer, A; Berger, W; Tucker, D; Renaudin, C

2006-12-01

The aim of this study was to describe a health economic model developed to project lifetime clinical and cost outcomes of lipid-modifying interventions in patients not reaching target lipid levels and to assess the validity of the model. The internet-based, computer simulation model is made up of two decision analytic sub-models, the first utilizing Monte Carlo simulation, and the second applying Markov modeling techniques. Monte Carlo simulation generates a baseline cohort for long-term simulation by assigning an individual lipid profile to each patient, and applying the treatment effects of interventions under investigation. The Markov model then estimates the long-term clinical (coronary heart disease events, life expectancy, and quality-adjusted life expectancy) and cost outcomes up to a lifetime horizon, based on risk equations from the Framingham study. Internal and external validation analyses were performed. The results of the model validation analyses, plotted against corresponding real-life values from Framingham, 4S, AFCAPS/TexCAPS, and a meta-analysis by Gordon et al., showed that the majority of values were close to the y = x line, which indicates a perfect fit. The R2 value was 0.9575 and the gradient of the regression line was 0.9329, both very close to the perfect fit (= 1). Validation analyses of the computer simulation model suggest the model is able to recreate the outcomes from published clinical studies and would be a valuable tool for the evaluation of new and existing therapy options for patients with persistent dyslipidemia.

Convergent, discriminant, and criterion validity of DSM-5 traits.

PubMed

Yalch, Matthew M; Hopwood, Christopher J

2016-10-01

Section III of the Diagnostic and Statistical Manual of Mental Disorders (5th edi.; DSM-5; American Psychiatric Association, 2013) contains a system for diagnosing personality disorder based in part on assessing 25 maladaptive traits. Initial research suggests that this aspect of the system improves the validity and clinical utility of the Section II Model. The Computer Adaptive Test of Personality Disorder (CAT-PD; Simms et al., 2011) contains many similar traits as the DSM-5, as well as several additional traits seemingly not covered in the DSM-5. In this study we evaluate the convergent and discriminant validity between the DSM-5 traits, as assessed by the Personality Inventory for DSM-5 (PID-5; Krueger et al., 2012), and CAT-PD in an undergraduate sample, and test whether traits included in the CAT-PD but not the DSM-5 provide incremental validity in association with clinically relevant criterion variables. Results supported the convergent and discriminant validity of the PID-5 and CAT-PD scales in their assessment of 23 out of 25 DSM-5 traits. DSM-5 traits were consistently associated with 11 criterion variables, despite our having intentionally selected clinically relevant criterion constructs not directly assessed by DSM-5 traits. However, the additional CAT-PD traits provided incremental information above and beyond the DSM-5 traits for all criterion variables examined. These findings support the validity of pathological trait models in general and the DSM-5 and CAT-PD models in particular, while also suggesting that the CAT-PD may include additional traits for consideration in future iterations of the DSM-5 system. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Implementing the undergraduate mini-CEX: a tailored approach at Southampton University.

PubMed

Hill, Faith; Kendall, Kathleen; Galbraith, Kevin; Crossley, Jim

2009-04-01

The mini-clinical evaluation exercise (mini-CEX) is widely used in the UK to assess clinical competence, but there is little evidence regarding its implementation in the undergraduate setting. This study aimed to estimate the validity and reliability of the undergraduate mini-CEX and discuss the challenges involved in its implementation. A total of 3499 mini-CEX forms were completed. Validity was assessed by estimating associations between mini-CEX score and a number of external variables, examining the internal structure of the instrument, checking competency domain response rates and profiles against expectations, and by qualitative evaluation of stakeholder interviews. Reliability was evaluated by overall reliability coefficient (R), estimation of the standard error of measurement (SEM), and from stakeholders' perceptions. Variance component analysis examined the contribution of relevant factors to students' scores. Validity was threatened by various confounding variables, including: examiner status; case complexity; attachment specialty; patient gender, and case focus. Factor analysis suggested that competency domains reflect a single latent variable. Maximum reliability can be achieved by aggregating scores over 15 encounters (R = 0.73; 95% confidence interval [CI] +/- 0.28 based on a 6-point assessment scale). Examiner stringency contributed 29% of score variation and student attachment aptitude 13%. Stakeholder interviews revealed staff development needs but the majority perceived the mini-CEX as more reliable and valid than the previous long case. The mini-CEX has good overall utility for assessing aspects of the clinical encounter in an undergraduate setting. Strengths include fidelity, wide sampling, perceived validity, and formative observation and feedback. Reliability is limited by variable examiner stringency, and validity by confounding variables, but these should be viewed within the context of overall assessment strategies.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Walsh, Seán, E-mail: walshsharp@gmail.com; Department of Oncology, Gray Institute for Radiation Oncology and Biology, University of Oxford, Oxford OX3 7DQ; Roelofs, Erik

Purpose: A fully heterogeneous population averaged mechanistic tumor control probability (TCP) model is appropriate for the analysis of external beam radiotherapy (EBRT). This has been accomplished for EBRT photon treatment of intermediate-risk prostate cancer. Extending the TCP model for low and high-risk patients would be beneficial in terms of overall decision making. Furthermore, different radiation treatment modalities such as protons and carbon-ions are becoming increasingly available. Consequently, there is a need for a complete TCP model. Methods: A TCP model was fitted and validated to a primary endpoint of 5-year biological no evidence of disease clinical outcome data obtained frommore » a review of the literature for low, intermediate, and high-risk prostate cancer patients (5218 patients fitted, 1088 patients validated), treated by photons, protons, or carbon-ions. The review followed the preferred reporting item for systematic reviews and meta-analyses statement. Treatment regimens include standard fractionation and hypofractionation treatments. Residual analysis and goodness of fit statistics were applied. Results: The TCP model achieves a good level of fit overall, linear regression results in a p-value of <0.000 01 with an adjusted-weighted-R{sup 2} value of 0.77 and a weighted root mean squared error (wRMSE) of 1.2%, to the fitted clinical outcome data. Validation of the model utilizing three independent datasets obtained from the literature resulted in an adjusted-weighted-R{sup 2} value of 0.78 and a wRMSE of less than 1.8%, to the validation clinical outcome data. The weighted mean absolute residual across the entire dataset is found to be 5.4%. Conclusions: This TCP model fitted and validated to clinical outcome data, appears to be an appropriate model for the inclusion of all clinical prostate cancer risk categories, and allows evaluation of current EBRT modalities with regard to tumor control prediction.« less

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

PubMed Central

Tielen, Deirdre; Wollmann, Lisa

2014-01-01

The social interaction anxiety scale (SIAS) and the social phobia scale (SPS) assess anxiety in social interactions and fear of scrutiny by others. This study examines the psychometric properties of the Dutch versions of the SIAS and SPS using data from a large group of patients with social phobia and a community-based sample. Confirmatory factor analysis revealed that the SIAS is unidimensional, whereas the SPS is comprised of three subscales. The internal consistency of the scales and subscales was good. The concurrent and discriminant validity was supported and the scales were well able to discriminate between patients and community-based respondents. Cut-off values with excellent sensitivity and specificity are presented. Of all self-report measures included, the SPS was the most sensitive for treatment effects. Normative data are provided which can be used to assess whether clinically significant change has occurred in individual patients. PMID:24701560

[Development and validation of an instrument for initial nursing assessment].

PubMed

Fernández-Sola, Cayetano; Granero-Molina, José; Mollinedo-Mallea, Judith; de Gonzales, María Hilda Peredo; Aguilera-Manrique, Gabriel; Ponce, Mara Luna

2012-12-01

The objective of this study, conducted in Bolivia from April to July of 2008, is the design and validation of an initial nursing assessment instrument to be used in clinical and educational environments in Santa Cruz (Bolivia). Twelve Bolivian nurses participated; both document analysis as well as consensus techniques were used to determine the categories and criteria to be assessed. Categories included in the nursing assessment instrument are a physical assessment and the eleven Gordon's Functional Health Patterns. The nursing assessment instrument stands out as being concise, easy to complete and utilizing a nursing approach. It does not include items for advanced nursing assessment. However, it incorporates items regarding lifestyle and the patient's autonomy. The nursing assessment instrument contributes to improving the quality of clinical records, supports the nursing diagnosis and implementation of the nursing process, promotes the nurse's role and helps to standardize practice.

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

PubMed

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

2014-01-01

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

Consumer sleep monitors: is there a baby in the bathwater?

PubMed Central

Russo, Kathryn; Goparaju, Balaji; Bianchi, Matt T

2015-01-01

The rapid expansion of consumer sleep devices is outpacing the validation data necessary to assess the potential use of these devices in clinical and research settings. Common sleep monitoring devices utilize a variety of sensors to track movement as well as cardiac and respiratory physiology. The variety of sensors and user-specific factors offer the potential, at least theoretically, for clinically relevant information. We describe the current challenges for interpretation of consumer sleep monitoring data, since the devices are mainly used in non-medical contexts (consumer use) although medically-definable sleep disorders may commonly occur in this setting. A framework for addressing questions of how certain devices might be useful is offered. We suggest that multistage validation efforts are crucially needed, from the level of sensor data and algorithm output, to extrapolations beyond healthy adults and into other populations and real-world environments. PMID:26604847

Comprehensive Carrier Screening and Molecular Diagnostic Testing for Recessive Childhood Diseases

PubMed Central

Kingsmore, Stephen

2012-01-01

Of 7,028 disorders with suspected Mendelian inheritance, 1,139 are recessive and have an established molecular basis. Although individually uncommon, Mendelian diseases collectively account for ~20% of infant mortality and ~18% of pediatric hospitalizations. Molecular diagnostic testing is currently available for only ~300 recessive disorders. Preconception screening, together with genetic counseling of carriers, has resulted in remarkable declines in the incidence of several severe recessive diseases including Tay-Sachs disease and cystic fibrosis. However, extension of preconception screening and molecular diagnostic testing to most recessive disease genes has hitherto been impractical. Recently, we reported a preconception carrier screen / molecular diagnostic test for 448 recessive childhood diseases. The current status of this test is reviewed here. Currently, this reports analytical validity of the comprehensive carrier test. As the clinical validity and clinical utility in the contexts described is ascertained, this article will be updated. PMID:22872815

IMPROVING THE REPORTING OF THERAPEUTIC EXERCISE INTERVENTIONS IN REHABILITATION RESEARCH.

PubMed

Page, Phil; Hoogenboom, Barb; Voight, Michael

2017-04-01

The foundation of evidence-based practice lies in clinical research, which is based on the utilization of the scientific method. The scientific method requires that all details of the experiment be provided in publications to support replication of the study in order to evaluate and validate the results. More importantly, clinical research can only be translated into practice when researchers provide explicit details of the study. Too often, rehabilitation exercise intervention studies lack the appropriate detail to allow clinicians to replicate the exercise protocol in their patient populations. Therefore, the purpose of this clinical commentary is to provide guidelines for optimal reporting of therapeutic exercise interventions in rehabilitation research. 5.

Clinical application of pharmacogenetics: focusing on practical issues.

PubMed

Chang, Matthew T; McCarthy, Jeanette J; Shin, Jaekyu

2015-01-01

Recent large-scale genetic-based studies have transformed the field of pharmacogenetics to identify, characterize and leverage genetic information to inform patient care. Genetic testing can be used to alter drug selection, optimize drug dosing and prevent unnecessary adverse events. As precision medicine becomes the mainstay in the clinic, it becomes critical for clinicians to utilize pharmacogenetics to guide patient care. One primary challenge is identifying patients where genetic tests that can potentially impact patient care. To address this challenge, our review highlights many practical issues clinicians may encounter: identifying candidate patients and clinical laboratories for pharmacogenetic testing, selecting highly curated resources to help asses test validity, reimbursing costs of pharmacogenetic tests, and interpreting of pharmacogenetic test results.

Psychometric Properties of the Persian Version of Spiritual Well-Being Scale in Patients with Acute Myocardial Infarction.

PubMed

Soleimani, Mohammad Ali; Pahlevan Sharif, Saeed; Allen, Kelly A; Yaghoobzadeh, Ameneh; Sharif Nia, Hamid; Gorgulu, Ozkan

2017-12-01

The purpose of this study was to assess the psychometric properties of the Persian version of Spiritual Well-Being Scale (SWBS) in patients with acute myocardial infarction. A multisite, cross-sectional survey was employed to determine the instrument's reliability (Cronbach's α and construct reliability) and validity (face, content, and construct). Using systematic sampling of adult outpatients at primary care clinic sites in the Qazvin City, Iran (N = 300), it was found that the Cronbach's alpha and construct reliability of both factors associated with the SWBS were above 0.7. The construct validity of the scale was determined using exploratory factor analysis. The findings supported two factors: relation with God and relation with life. Further investigation through confirmatory factor analysis (eigenvalues of greater than one) confirmed a third factor construct associated with the SWBS. A total of 50.65 % of the variance were explained by these three factors. The overall findings of the study demonstrated that the SWBS is a valid and reliable instrument that has potential utility in future research and clinical practice settings.

Implementation and utilization of genetic testing in personalized medicine

PubMed Central

Abul-Husn, Noura S; Owusu Obeng, Aniwaa; Sanderson, Saskia C; Gottesman, Omri; Scott, Stuart A

2014-01-01

Clinical genetic testing began over 30 years ago with the availability of mutation detection for sickle cell disease diagnosis. Since then, the field has dramatically transformed to include gene sequencing, high-throughput targeted genotyping, prenatal mutation detection, preimplantation genetic diagnosis, population-based carrier screening, and now genome-wide analyses using microarrays and next-generation sequencing. Despite these significant advances in molecular technologies and testing capabilities, clinical genetics laboratories historically have been centered on mutation detection for Mendelian disorders. However, the ongoing identification of deoxyribonucleic acid (DNA) sequence variants associated with common diseases prompted the availability of testing for personal disease risk estimation, and created commercial opportunities for direct-to-consumer genetic testing companies that assay these variants. This germline genetic risk, in conjunction with other clinical, family, and demographic variables, are the key components of the personalized medicine paradigm, which aims to apply personal genomic and other relevant data into a patient’s clinical assessment to more precisely guide medical management. However, genetic testing for disease risk estimation is an ongoing topic of debate, largely due to inconsistencies in the results, concerns over clinical validity and utility, and the variable mode of delivery when returning genetic results to patients in the absence of traditional counseling. A related class of genetic testing with analogous issues of clinical utility and acceptance is pharmacogenetic testing, which interrogates sequence variants implicated in interindividual drug response variability. Although clinical pharmacogenetic testing has not previously been widely adopted, advances in rapid turnaround time genetic testing technology and the recent implementation of preemptive genotyping programs at selected medical centers suggest that personalized medicine through pharmacogenetics is now a reality. This review aims to summarize the current state of implementing genetic testing for personalized medicine, with an emphasis on clinical pharmacogenetic testing. PMID:25206309

Clinical implications of risk aversion: an online study of risk-avoidance and treatment utilization in pathological anxiety.

PubMed

Lorian, Carolyn N; Grisham, Jessica R

2011-08-01

Previous research suggests that the pervasive tendency to avoid perceived risks (i.e., the safety bias) may be implicated in the maintenance of pathological anxiety. These studies have not explored, however, the potential clinical implications of such a bias, such as the influence of risk aversion on treatment seeking. The aim of this study was to investigate how risk-avoidance is related to willingness to seek treatment in an online sample of clinically anxious individuals with social phobia (SP), obsessive-compulsive disorder (OCD) and generalized anxiety disorder (GAD). Healthy control participants (n=117) and those endorsing criteria for one or more anxiety disorder(s) (n=92; SP, n=33; OCD, n=19; GAD, n=40) were recruited from various online sources. Respondents completed an online survey comprised of a validated diagnostic interview, self-report measures assessing for symptom severity, risk-taking across various domains, a generalized index of risk-taking and treatment utilization. Consistent with hypotheses, SP and GAD individuals reported significantly more risk-avoidance when compared to non-clinical controls. Furthermore, willingness to seek treatment was found to be positively associated with social risk-taking and generalized risk-taking orientation in clinically anxious individuals who had never sought treatment. These results suggest that certain individual cognitive factors may contribute to the decision to seek treatment and may provide an interesting avenue of future investigation for increasing service utilization and treatment seeking in anxious populations. Copyright © 2011 Elsevier Ltd. All rights reserved.

The factor structure and clinical utility of formal thought disorder in first episode psychosis.

PubMed

Roche, Eric; Lyne, John Paul; O'Donoghue, Brian; Segurado, Ricardo; Kinsella, Anthony; Hannigan, Ailish; Kelly, Brendan D; Malone, Kevin; Clarke, Mary

2015-10-01

Formal thought disorder (FTD) is a core feature of psychosis, however there are gaps in our knowledge about its prevalence and factor structure. We had two aims: first, to establish the factor structure of FTD; second, to explore the clinical utility of dimensions of FTD in order to further the understanding of its nosology. A cross-validation study was undertaken to establish the factor structure of FTD in first episode psychosis (FEP). The relative utility of FTD categories vs. dimensions across diagnostic categories was investigated. The prevalence of clinically significant FTD in this FEP sample was 21%, although 41% showed evidence of disorganised speech, 20% displayed verbosity and 24% displayed impoverished speech. A 3-factor model was identified as the best fit for FTD, with disorganisation, poverty and verbosity dimensions (GFI=0.99, RMR=0.07). These dimensions of FTD accurately distinguished affective from non-affective diagnostic categories. A categorical approach to FTD assessment was useful in identifying markers of clinical acuteness, as identified by short duration of untreated psychosis (OR=2.94, P<0.01) and inpatient treatment status (OR=3.98, P<0.01). FTD is moderately prevalent and multi-dimensional in FEP. Employing both a dimensional and categorical assessment of FTD gives valuable clinical information, however there may be a need to revise our conceptualisation of the nosology of FTD. The prognostic value of FTD, as well as its neural basis, requires elucidation. Copyright © 2015 Elsevier B.V. All rights reserved.

Using Discrete-Event Simulation to Promote Quality Improvement and Efficiency in a Radiation Oncology Treatment Center.

PubMed

Famiglietti, Robin M; Norboge, Emily C; Boving, Valentine; Langabeer, James R; Buchholz, Thomas A; Mikhail, Osama

To meet demand for radiation oncology services and ensure patient-centered safe care, management in an academic radiation oncology department initiated quality improvement efforts using discrete-event simulation (DES). Although the long-term goal was testing and deploying solutions, the primary aim at the outset was characterizing and validating a computer simulation model of existing operations to identify targets for improvement. The adoption and validation of a DES model of processes and procedures affecting patient flow and satisfaction, employee experience, and efficiency were undertaken in 2012-2013. Multiple sources were tapped for data, including direct observation, equipment logs, timekeeping, and electronic health records. During their treatment visits, patients averaged 50.4 minutes in the treatment center, of which 38% was spent in the treatment room. Patients with appointments between 10 AM and 2 PM experienced the longest delays before entering the treatment room, and those in the clinic in the day's first and last hours, the shortest (<5 minutes). Despite staffed for 14.5 hours daily, the clinic registered only 20% of patients after 2:30 PM. Utilization of equipment averaged 58%, and utilization of staff, 56%. The DES modeling quantified operations, identifying evidence-based targets for next-phase remediation and providing data to justify initiatives.

A comparison of four embedded validity indices for the RBANS in a memory disorders clinic.

PubMed

Paulson, Daniel; Horner, Michael David; Bachman, David

2015-05-01

This examination of four embedded validity indices for the Repeated Battery for the Assessment of Neuropsychological Status (RBANS) explores the potential utility of integrating cognitive and self-reported depressive measures. Examined indices include the proposed RBANS Performance Validity Index (RBANS PVI) and the Charleston Revised Index of Effort for the RBANS (CRIER). The CRIER represented the novel integration of cognitive test performance and depression self-report information. The sample included 234 patients without dementia who could be identified as having demonstrated either valid or invalid responding, based on standardized criteria. Sensitivity and specificity for invalid responding varied widely, with the CRIER emerging as the best all-around index (sensitivity = 0.84, specificity = 0.90, AUC = 0.94). Findings support the use of embedded response validity indices, and suggest that the integration of cognitive and self-report depression data may optimize detection of invalid responding among older Veterans. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Reliability and Validity of the Lichtenberg Financial Decision Screening Scale.

PubMed

Lichtenberg, Peter A; Teresi, Jeanne A; Ocepek-Welikson, Katja; Eimicke, Joseph P

2017-03-01

The scarcity of empirically validated assessment instruments continues to impede the work of professionals in a number of fields, including medicine, finance, and estate planning; adult protective services; and criminal justice-and, more importantly, it impedes their ability to effectively assist and, in some case, protect their clients. Other professionals (e.g. legal, financial, medical, mental health services) are in a position to prevent financial exploitation and would benefit from access to new instruments. The Lichtenberg Financial Decision Screening Scale (LFDSS) was introduced in 2016, along with evidence for its convergent validity (Lichtenberg et al., 2016). Using a sample of 213 participants, this study investigated the internal consistency of the LFDSS and its criterion validity based on ratings by professionals using the scale. Results demonstrate that the LFDSS has excellent internal consistency and clinical utility properties. This paper provides support for use of the LFDSS as a reliable and valid instrument. The LFDSS and instructions for its use are included in the article, along with information about online tools and support.

False memories, negative affects, and psychic reality: the role of extra-clinical data in psychoanalysis.

PubMed

Good, Michael I; Dayand, Max; Rowell, Eve

2005-12-01

Psychoanalysis as a treatment originated in the idea that neurosis is related to the ways in which individual psychic reality departs from actuality. Psychic reality includes memories, beliefs and their associated affects and fantasies connected with an individual's experience of the inner and outer world. The psychoanalytic determination of what meaningful memories or beliefs are inaccurate, distorted or false ordinarily relies upon principles of intra-clinical validation. By itself, however, intra-clinical validation is subject to limitations and pitfalls that conviction alone about what is actual cannot circumvent. Despite this fact, there are remarkably few analytic case reports demonstrating false or significantly distorted memories through the use of data obtained from outside the consulting room. This paucity of reports may be related, at least in part, to the belief that the use of extra-clinical data is essentially unanalytic or supports resistance. Based on the views that (a) psychic reality cannot be regarded as exclusively subjective or objective but is inherently both; and that (b) a goal of analysis is to achieve a different, acceptable and more accurate view of reality, the authors report a clinical case involving a confirmably false pivotal memory and its associated negative affects. They discuss theoretical and technical considerations in utilizing extra-clinical data during the treatment process.

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

PubMed

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.

Assessing Anxiety in Youth with the Multidimensional Anxiety Scale for Children (MASC)

PubMed Central

Wei, Chiaying; Hoff, Alexandra; Villabø, Marianne A.; Peterman, Jeremy; Kendall, Philip C.; Piacentini, John; McCracken, James; Walkup, John T.; Albano, Anne Marie; Rynn, Moira; Sherrill, Joel; Sakolsky, Dara; Birmaher, Boris; Ginsburg, Golda; Keaton, Courtney; Gosch, Elizabeth; Compton, Scott N.; March, John

2013-01-01

The present study examined the psychometric properties, including discriminant validity and clinical utility, of the youth self-report and parent-report forms of the Multidimensional Anxiety Scale for Children (MASC) among youth with anxiety disorders. The sample included parents and youth (N= 488, 49.6% male) ages 7 – 17 who participated in the Child/Adolescent Anxiety Multimodal Study (CAMS). Although the typical low agreement between parent and youth self-reports was found, the MASC evidenced good internal reliability across MASC subscales and informants. The main MASC subscales (i.e., Physical Symptoms, Harm Avoidance, Social Anxiety, and Separation/Panic) were examined. The Social Anxiety and Separation/Panic subscales were found to be significantly predictive of the presence and severity of social phobia and separation anxiety disorder, respectively. Using multiple informants improved the accuracy of prediction. The MASC subscales demonstrated good psychometric properties and clinical utilities in identifying youth with anxiety disorders. PMID:23845036

DSM-V from the perspective of the DSM-IV experience.

PubMed

Walsh, B Timothy

2007-11-01

This article provides a brief overview of the development of the diagnostic criteria for eating disorders in DSM-IV. The process by which DSM-IV was developed is reviewed, including perspectives on what constitutes diagnostic validity and clinical utility, and their importance in assessing proposed changes in diagnostic criteria. The question of whether alterations in diagnostic criteria would clearly improve clinical utility was a major consideration in the DSM-IV process. Because of concerns that changes in diagnostic criteria would be disruptive and might entail loss of established knowledge, the DSM-IV Task Force assumed a generally conservative stance vis-à-vis change. The process of developing DSM-V is just beginning, and it is far from clear what alterations in diagnostic criteria for eating disorders will occur. However, the evolution of DSM-IV may provide a useful perspective on the development of DSM-V. (c) 2007 by Wiley Periodicals, Inc.

Novel algorithmic approach predicts tumor mutation load and correlates with immunotherapy clinical outcomes using a defined gene mutation set.

PubMed

Roszik, Jason; Haydu, Lauren E; Hess, Kenneth R; Oba, Junna; Joon, Aron Y; Siroy, Alan E; Karpinets, Tatiana V; Stingo, Francesco C; Baladandayuthapani, Veera; Tetzlaff, Michael T; Wargo, Jennifer A; Chen, Ken; Forget, Marie-Andrée; Haymaker, Cara L; Chen, Jie Qing; Meric-Bernstam, Funda; Eterovic, Agda K; Shaw, Kenna R; Mills, Gordon B; Gershenwald, Jeffrey E; Radvanyi, Laszlo G; Hwu, Patrick; Futreal, P Andrew; Gibbons, Don L; Lazar, Alexander J; Bernatchez, Chantale; Davies, Michael A; Woodman, Scott E

2016-10-25

While clinical outcomes following immunotherapy have shown an association with tumor mutation load using whole exome sequencing (WES), its clinical applicability is currently limited by cost and bioinformatics requirements. We developed a method to accurately derive the predicted total mutation load (PTML) within individual tumors from a small set of genes that can be used in clinical next generation sequencing (NGS) panels. PTML was derived from the actual total mutation load (ATML) of 575 distinct melanoma and lung cancer samples and validated using independent melanoma (n = 312) and lung cancer (n = 217) cohorts. The correlation of PTML status with clinical outcome, following distinct immunotherapies, was assessed using the Kaplan-Meier method. PTML (derived from 170 genes) was highly correlated with ATML in cutaneous melanoma and lung adenocarcinoma validation cohorts (R 2  = 0.73 and R 2  = 0.82, respectively). PTML was strongly associated with clinical outcome to ipilimumab (anti-CTLA-4, three cohorts) and adoptive T-cell therapy (1 cohort) clinical outcome in melanoma. Clinical benefit from pembrolizumab (anti-PD-1) in lung cancer was also shown to significantly correlate with PTML status (log rank P value < 0.05 in all cohorts). The approach of using small NGS gene panels, already applied to guide employment of targeted therapies, may have utility in the personalized use of immunotherapy in cancer.

BBD Reference Set Application: Jeffery Marks-Duke (2015) — EDRN Public Portal

Cancer.gov

We propose a pre-validation study for markers that could predict the likelihood of invasive breast cancer following a tissue diagnosis of benign breast pathology (any diagnosis that is less severe than carcinoma in situ). The study is designed to test the utility of a series of markers that were shown to have some predictive value by immunohistochemical staining in other cohorts. These markers include the proliferation associated antigen KI-67, EZH2, PTGS2 (COX2), ALDH1, CDKN2A (p16), HYAL1, MMP1, CEACAM6, and TP53. In addition, we propose analyzing two markers that comprise part of the DCIS Oncotype panel, GSTM1 and progesterone receptor (PR). The study will occur in two EDRN clinical validation center (CVC) laboratories, namely Duke and University of Kansas, and utilize specimens from Northwestern University and Geisinger Health System that have been identified and are either already sectioned or waiting to be sectioned. Results will be scored and returned to the DMCC to determine whether any of the markers or combinations of these markers may have sufficient value to proceed to a second stage validation with large numbers of samples from Geisenger Health Systems and the Henry Ford Hospital.

US Food and Drug Administration Perspectives on Clinical Mass Spectrometry.

PubMed

Lathrop, Julia Tait; Jeffery, Douglas A; Shea, Yvonne R; Scholl, Peter F; Chan, Maria M

2016-01-01

Mass spectrometry-based in vitro diagnostic devices that measure proteins and peptides are underutilized in clinical practice, and none has been cleared or approved by the Food and Drug Administration (FDA) for marketing or for use in clinical trials. One way to increase their utilization is through enhanced interactions between the FDA and the clinical mass spectrometry community to improve the validation and regulatory review of these devices. As a reference point from which to develop these interactions, this article surveys the FDA's regulation of mass spectrometry-based devices, explains how the FDA uses guidance documents and standards in the review process, and describes the FDA's previous outreach to stakeholders. Here we also discuss how further communication and collaboration with the clinical mass spectrometry communities can identify opportunities for the FDA to provide help in the development of mass spectrometry-based devices and enhance their entry into the clinic. © 2015 American Association for Clinical Chemistry.

Emerging Utility of Virtual Reality as a Multidisciplinary Tool in Clinical Medicine.

PubMed

Pourmand, Ali; Davis, Steven; Lee, Danny; Barber, Scott; Sikka, Neal

2017-10-01

Among the more recent products borne of the evolution of digital technology, virtual reality (VR) is gaining a foothold in clinical medicine as an adjunct to traditional therapies. Early studies suggest a growing role for VR applications in pain management, clinical skills training, cognitive assessment and cognitive therapy, and physical rehabilitation. To complete a review of the literature, we searched PubMed and MEDLINE databases with the following search terms: "virtual reality," "procedural medicine," "oncology," "physical therapy," and "burn." We further limited our search to publications in the English language. Boolean operators were used to combine search terms. The included search terms yielded 97 potential articles, of which 45 were identified as meeting study criteria, and are included in this review. These articles provide data, which strongly support the hypothesis that VR simulations can enhance pain management (by reducing patient perception of pain and anxiety), can augment clinical training curricula and physical rehabilitation protocols (through immersive audiovisual environments), and can improve clinical assessment of cognitive function (through improved ecological validity). Through computer-generated, life-like digital landscapes, VR stands to change the current approach to pain management, medical training, neurocognitive diagnosis, and physical rehabilitation. Additional studies are needed to help define best practices in VR utilization, and to explore new therapeutic uses for VR in clinical practice.

Optical diagnosis of malaria infection in human plasma using Raman spectroscopy

NASA Astrophysics Data System (ADS)

Bilal, Muhammad; Saleem, Muhammad; Amanat, Samina Tufail; Shakoor, Huma Abdul; Rashid, Rashad; Mahmood, Arshad; Ahmed, Mushtaq

2015-01-01

We present the prediction of malaria infection in human plasma using Raman spectroscopy. Raman spectra of malaria-infected samples are compared with those of healthy and dengue virus infected ones for disease recognition. Raman spectra were acquired using a laser at 532 nm as an excitation source and 10 distinct spectral signatures that statistically differentiated malaria from healthy and dengue-infected cases were found. A multivariate regression model has been developed that utilized Raman spectra of 20 malaria-infected, 10 non-malarial with fever, 10 healthy, and 6 dengue-infected samples to optically predict the malaria infection. The model yields the correlation coefficient r2 value of 0.981 between the predicted values and clinically known results of trainee samples, and the root mean square error in cross validation was found to be 0.09; both these parameters validated the model. The model was further blindly tested for 30 unknown suspected samples and found to be 86% accurate compared with the clinical results, with the inaccuracy due to three samples which were predicted in the gray region. Standard deviation and root mean square error in prediction for unknown samples were found to be 0.150 and 0.149, which are accepted for the clinical validation of the model.

A Psychometric Review of the Personality Inventory for DSM-5 (PID-5): Current Status and Future Directions.

PubMed

Al-Dajani, Nadia; Gralnick, Tara M; Bagby, R Michael

2016-01-01

The paradigm of personality psychopathology is shifting from one that is purely categorical in nature to one grounded in dimensional individual differences. Section III (Emerging Measures and Models) of the Diagnostic and Statistical Manual of Mental Disorders (5th ed. [DSM-5]; American Psychiatric Association, 2013), for example, includes a hybrid categorical/dimensional model of personality disorder classification. To inform the hybrid model, the DSM-5 Personality and Personality Disorders Work Group developed a self-report instrument to assess pathological personality traits-the Personality Inventory for the DSM-5 (PID-5). Since its recent introduction, 30 papers (39 samples) have been published examining various aspects of its psychometric properties. In this article, we review the psychometric characteristics of the PID-5 using the Standards for Educational and Psychological Testing as our framework. The PID-5 demonstrates adequate psychometric properties, including a replicable factor structure, convergence with existing personality instruments, and expected associations with broadly conceptualized clinical constructs. More research is needed with specific consideration to clinical utility, additional forms of reliability and validity, relations with psychopathological personality traits using clinical samples, alternative methods of criterion validation, effective employment of cut scores, and the inclusion of validity scales to propel this movement forward.

Utility of the Personality Assessment Inventory for Detecting Malingered ADHD in College Students.

PubMed

Musso, Mandi W; Hill, Benjamin D; Barker, Alyse A; Pella, Russell D; Gouvier, Wm Drew

2016-09-01

The purpose of the current study is to examine the utility of the Personality Assessment Inventory (PAI) for detecting feigned ADHD in college students. A sample of 238 undergraduate students was recruited and asked to simulate ADHD (ADHD simulators) or respond honestly (controls) on the PAI. Archival data (n = 541) from individuals diagnosed with clinical ADHD, no diagnosis, learning disorder, mood/anxiety, comorbid ADHD-mood/anxiety, or suspect effort were used. Few individuals scored above the cutoffs on PAI validity scales. When alternative cutoff scores were examined, cutoffs of ≥77 on the Negative Impression Management (NIM) scale, ≥3 on the Malingering Index (MAL), and ≥1 on the Rogers Discriminant Function (RDF) yielded excellent specificity in all groups and sensitivities of .33, .30, and .20, respectively. Individuals who were asked to simulate ADHD easily manipulate the PAI; however, alternative cutoff scores proposed for PAI validity indices may improve the detection of feigned ADHD symptoms. © The Author(s) 2014.

Consideration of species differences in developing novel molecules as cognition enhancers.

PubMed

Young, Jared W; Jentsch, J David; Bussey, Timothy J; Wallace, Tanya L; Hutcheson, Daniel M

2013-11-01

The NIH-funded CNTRICS initiative has coordinated efforts to promote the vertical translation of novel procognitive molecules from testing in mice, rats and non-human primates, to clinical efficacy in patients with schizophrenia. CNTRICS highlighted improving construct validation of tasks across species to increase the likelihood that the translation of a candidate molecule to humans will be successful. Other aspects of cross-species behaviors remain important however. This review describes cognitive tasks utilized across species, providing examples of differences and similarities of innate behavior between species, as well as convergent construct and predictive validity. Tests of attention, olfactory discrimination, reversal learning, and paired associate learning are discussed. Moreover, information on the practical implication of species differences in drug development research is also provided. The issues covered here will aid in task development and utilization across species as well as reinforcing the positive role preclinical research can have in developing procognitive treatments for psychiatric disorders. Copyright © 2012 Elsevier Ltd. All rights reserved.

Utility of a New Model to Diagnose an Alcohol Basis for Steatohepatitis

PubMed Central

Dunn, Winston; Angulo, Paul; Sanderson, Schuyler; Jamil, Laith H.; Stadheim, Linda; Rosen, Charles; Malinchoc, Michael; Kamath, Patrick S.; Shah, Vijay

2007-01-01

Background and Aims Distinguishing an alcohol basis from a nonalcoholic basis for the clinical and histological spectrum of steatohepatitic liver disease is difficult owing to unreliability of alcohol consumption history. Unfortunately, various biomarkers have had limited utility in distinguishing alcoholic liver disease (ALD) from nonalcoholic fatty liver disease (NAFLD). Thus, the aim of our study was to create and validate a model to diagnose ALD in patients with steatohepatitis. Methods Cross-sectional cohort study was performed at Mayo Clinic; Rochester, Minnesota to create a model using multivariable logistic regression analysis. This model was validated in three independent data-sets comprising patients of varying severity of steatohepatitis spanning over 10 years. Results Logistic regression identified mean corpuscular volume, AST/ALT ratio, body-mass index, and gender as the most important variables that separated patients with ALD from NAFLD. These variables were used to generate the ALD/NAFLD Index (ANI); with ANI of greater than 0 incrementally favoring ALD, and ANI of less than 0 incrementally favoring a diagnosis of NAFLD, thus making ALD unlikely. ANI had a c-statistic of 0.989 in the derivation sample, and 0.974, 0.989, 0.767 in the three validation samples. ANI performance characteristics were significantly better than several conventional and recently proposed biomarkers used to differentiate ALD from NAFLD including the histopathological marker Protein Tyrosine Phosphatase 1b, AST/ALT ratio, gamma-glutamyl transferase and Carbohydrate Deficient Transferrin. Conclusion ANI, derived from easily available objective variables, accurately differentiates ALD from NAFLD in hospitalized, ambulatory and pre-transplant patients and compares favorably to other traditional and proposed biomarkers. PMID:17030176

Preliminary validation of the Malay Yale Food Addiction Scale: Factor structure and item analysis in an obese population.

PubMed

Swarna Nantha, Yogarabindranath; Abd Patah, Norafidza Ashiquin; Ponnusamy Pillai, Mahalakshmi

2016-12-01

Researchers suggest that the rise in obesity rates may be explained by the addictive properties of certain types of food. In view of the growing obesity epidemic in South-East Asia, there is a need for a psychometric tool to assess the concept of food addiction amongst high-risk populations. The objective of this study is to translate the Yale Food Addiction Scale (YFAS) into the Malay language and subsequently validate its use in an obese population. Between the year 2014 and 2015, a total of 250 obese adults were assessed for food addiction utilizing the Malay version of the YFAS at a primary care clinic. An assessment of the psychometric properties of the scale was performed to determine the factor structure, item statistics and internal consistency of the scale. A one factorial structure of YFAS was confirmed in this study through factor analysis. All items except 4 (items 19, 22, 24 and 25) had factor loadings >0.42. The internal reliability (KR-20) coefficient of the one-factor solution was α = 0.76. The mean YFAS symptom count was M = 2.74 (SD = 1.57) with 10.4% (N = 26) of the participants received the diagnosis of food addiction. The determination of construct validity and the identification of other latent variables in the Malay food addiction model is necessary prior to the formal utilization of the scale as a tool to detect addictive eating patterns in the community. Copyright © 2016 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

Applicability of Type A/B alcohol dependence in the general population.

PubMed

Tam, Tammy W; Mulia, Nina; Schmidt, Laura A

2014-05-01

This study examined the concurrent and predictive validity of Type A/B alcohol dependence in the general population-a typology developed in clinical populations to gauge severity of dependence. Data were drawn from Waves 1 and 2 of the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC). The sample included 1,172 alcohol-dependent drinkers at baseline who were reinterviewed three years later. Latent class analysis was used to derive Type A/B classification using variables replicating the original Type A/B typology. Predictive validity of the Type A/B classification was assessed by multivariable linear and logistic regressions. A two-class solution consistent with Babor's original Type A/B typology adequately fit the data. Type B alcoholics in the general population, compared to Type As, had higher alcohol severity and more co-occurring drug, mental, and physical health problems. In the absence of treatment services utilization, Type B drinkers had two times the odds of being alcohol dependent three years later. Among those who utilized alcohol treatment services, Type B membership was predictive of heavy drinking and drug dependence, but not alcohol dependence, three years later. Findings suggest that Type A/B classification is both generalizable to, and valid within, the US general population of alcohol dependent drinkers. Results highlight the value of treatment for mitigating the persistence of dependence among Type B alcoholics in the general population. Screening for markers of vulnerability to Type B dependence could be of clinical value for health care providers to determine appropriate intervention. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

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

PubMed

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

2010-01-01

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

Validation of the MD Anderson Symptom Inventory-Head-and-Neck-Filipino (MDASI-HN-F): clinical utility of symptom screening among patients with head-and-neck cancer.

PubMed

Bacorro, Warren R; Sy Ortin, Teresa T; Suarez, Consuelo G; Mendoza, Tito R; Que, Jocelyn C

2017-06-01

Symptom burden and quality of life (QOL) are of particular importance in head-and-neck cancer treatment. The MD Anderson Symptom Inventory-Head-and-Neck (MDASI-HN) is a simple symptom assessment tool practicable for patient follow-up, but a validated Filipino translation was previously unavailable. The objectives of this study were to develop a valid Filipino translation of the MDASI-HN, to test the sensitivity of the validated MDASI core-F, and to report the prevalence and pattern of head-and-neck symptoms in our cohort. An MDASI-HN-Filipino (MDASI-HN-F) version was developed and examined for convergent validity, internal consistency, test-retest reliability, known-group validity and sensitivity to change. Eligible participants were aged 18-80 years, with histopathologically-proven head-and-neck (except thyroid) cancer, able to understand and read English and Filipino, and without cognitive impairment or other conditions precluding self-administration of the questionnaire. Participants (n=100) were aged 18-76 years; the majority were aged <60, male, married, had college schooling, or were from a Tagalog-speaking region. The validity of the MDASI HN-F was demonstrated in all parameters. Age or educational attainment did not affect convergent validity or test-retest reliability. At baseline, 48% had multiple moderate/severe symptoms and 38% had at least one severe symptom. The MDASI-HN-F is valid, reliable and sensitive. The sensitivity of the MDASI core-F is demonstrated, and its validity and reliability reaffirmed. Moderate and severe head-and-neck symptoms are prevalent in early-stage and advanced-stage head-and-neck cancers, reflecting the utility of symptom screening for improvement of symptom management, QOL and compliance to treatment. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Detecting Blood-Based Biomarkers in Metastatic Breast Cancer: A Systematic Review of Their Current Status and Clinical Utility

PubMed Central

Berghuis, A. M. Sofie; Koffijberg, Hendrik; Prakash, Jai; Terstappen, Leon W. M. M.; IJzerman, Maarten J.

2017-01-01

Reviews on circulating biomarkers in breast cancer usually focus on one single biomarker or a selective group of biomarkers. An overview summarizing the discovery and evaluation of all blood-based biomarkers in metastatic breast cancer is lacking. This systematic review aims to identify the available evidence of known blood-based biomarkers in metastatic breast cancer, regarding their clinical utility and state-of-the-art position in the validation process. The initial search yielded 1078 original studies, of which 420 were assessed for eligibility. A total of 320 studies were included in the final synthesis. A Development, Evaluation and Application Chart (DEAC) of all biomarkers was developed. Most studies focus on identifying new biomarkers and search for relations between these biomarkers and traditional molecular characteristics. Biomarkers are usually investigated in only one study (68.8%). Only 9.8% of all biomarkers was investigated in more than five studies. Circulating tumor cells, gene expression within tumor cells and the concentration of secreted proteins are the most frequently investigated biomarkers in liquid biopsies. However, there is a lack of studies focusing on identifying the clinical utility of these biomarkers, by which the additional value still seems to be limited according to the investigated evidence. PMID:28208771

Development of a Bayesian model to estimate health care outcomes in the severely wounded

PubMed Central

Stojadinovic, Alexander; Eberhardt, John; Brown, Trevor S; Hawksworth, Jason S; Gage, Frederick; Tadaki, Douglas K; Forsberg, Jonathan A; Davis, Thomas A; Potter, Benjamin K; Dunne, James R; Elster, E A

2010-01-01

Background: Graphical probabilistic models have the ability to provide insights as to how clinical factors are conditionally related. These models can be used to help us understand factors influencing health care outcomes and resource utilization, and to estimate morbidity and clinical outcomes in trauma patient populations. Study design: Thirty-two combat casualties with severe extremity injuries enrolled in a prospective observational study were analyzed using step-wise machine-learned Bayesian belief network (BBN) and step-wise logistic regression (LR). Models were evaluated using 10-fold cross-validation to calculate area-under-the-curve (AUC) from receiver operating characteristics (ROC) curves. Results: Our BBN showed important associations between various factors in our data set that could not be developed using standard regression methods. Cross-validated ROC curve analysis showed that our BBN model was a robust representation of our data domain and that LR models trained on these findings were also robust: hospital-acquired infection (AUC: LR, 0.81; BBN, 0.79), intensive care unit length of stay (AUC: LR, 0.97; BBN, 0.81), and wound healing (AUC: LR, 0.91; BBN, 0.72) showed strong AUC. Conclusions: A BBN model can effectively represent clinical outcomes and biomarkers in patients hospitalized after severe wounding, and is confirmed by 10-fold cross-validation and further confirmed through logistic regression modeling. The method warrants further development and independent validation in other, more diverse patient populations. PMID:21197361

Psychometric properties and clinical utility of the Scale for Suicidal Ideation (SSI) in adolescents

PubMed Central

Holi, Matti M; Pelkonen, Mirjami; Karlsson, Linnea; Kiviruusu, Olli; Ruuttu, Titta; Heilä, Hannele; Tuisku, Virpi; Marttunen, Mauri

2005-01-01

Background Accurate assessment of suicidality is of major importance in both clinical and research settings. The Scale for Suicidal Ideation (SSI) is a well-established clinician-rating scale but its suitability to adolescents has not been studied. The aim of this study was to evaluate the reliability and validity, and to test an appropriate cutoff threshold for the SSI in a depressed adolescent outpatient population and controls. Methods 218 adolescent psychiatric outpatient clinic patients suffering from depressive disorders and 200 age- and sex-matched school-attending controls were evaluated by the SSI for presence and severity of suicidal ideation. Internal consistency, discriminative-, concurrent-, and construct validity as well as the screening properties of the SSI were evaluated. Results Cronbach's α for the whole SSI was 0.95. The SSI total score differentiated patients and controls, and increased statistically significantly in classes with increasing severity of suicidality derived from the suicidality items of the K-SADS-PL diagnostic interview. Varimax-rotated principal component analysis of the SSI items yielded three theoretically coherent factors suggesting construct validity. Area under the receiver operating characteristic (ROC) curve was 0.84 for the whole sample and 0.80 for the patient sample. The optimal cutoff threshold for the SSI total score was 3/4 yielding sensitivity of 75% and specificity of 88.9% in this population. Conclusions SSI appears to be a reliable and a valid measure of suicidal ideation for depressed adolescents. PMID:15691388

Psychometric properties and clinical utility of the Scale for Suicidal Ideation (SSI) in adolescents.

PubMed

Holi, Matti M; Pelkonen, Mirjami; Karlsson, Linnea; Kiviruusu, Olli; Ruuttu, Titta; Heilä, Hannele; Tuisku, Virpi; Marttunen, Mauri

2005-02-03

Accurate assessment of suicidality is of major importance in both clinical and research settings. The Scale for Suicidal Ideation (SSI) is a well-established clinician-rating scale but its suitability to adolescents has not been studied. The aim of this study was to evaluate the reliability and validity, and to test an appropriate cutoff threshold for the SSI in a depressed adolescent outpatient population and controls. 218 adolescent psychiatric outpatient clinic patients suffering from depressive disorders and 200 age- and sex-matched school-attending controls were evaluated by the SSI for presence and severity of suicidal ideation. Internal consistency, discriminative-, concurrent-, and construct validity as well as the screening properties of the SSI were evaluated. Cronbach's alpha for the whole SSI was 0.95. The SSI total score differentiated patients and controls, and increased statistically significantly in classes with increasing severity of suicidality derived from the suicidality items of the K-SADS-PL diagnostic interview. Varimax-rotated principal component analysis of the SSI items yielded three theoretically coherent factors suggesting construct validity. Area under the receiver operating characteristic (ROC) curve was 0.84 for the whole sample and 0.80 for the patient sample. The optimal cutoff threshold for the SSI total score was 3/4 yielding sensitivity of 75% and specificity of 88.9% in this population. SSI appears to be a reliable and a valid measure of suicidal ideation for depressed adolescents.

Opportunities and challenges in developing risk prediction models with electronic health records data: a systematic review.

PubMed

Goldstein, Benjamin A; Navar, Ann Marie; Pencina, Michael J; Ioannidis, John P A

2017-01-01

Electronic health records (EHRs) are an increasingly common data source for clinical risk prediction, presenting both unique analytic opportunities and challenges. We sought to evaluate the current state of EHR based risk prediction modeling through a systematic review of clinical prediction studies using EHR data. We searched PubMed for articles that reported on the use of an EHR to develop a risk prediction model from 2009 to 2014. Articles were extracted by two reviewers, and we abstracted information on study design, use of EHR data, model building, and performance from each publication and supplementary documentation. We identified 107 articles from 15 different countries. Studies were generally very large (median sample size = 26 100) and utilized a diverse array of predictors. Most used validation techniques (n = 94 of 107) and reported model coefficients for reproducibility (n = 83). However, studies did not fully leverage the breadth of EHR data, as they uncommonly used longitudinal information (n = 37) and employed relatively few predictor variables (median = 27 variables). Less than half of the studies were multicenter (n = 50) and only 26 performed validation across sites. Many studies did not fully address biases of EHR data such as missing data or loss to follow-up. Average c-statistics for different outcomes were: mortality (0.84), clinical prediction (0.83), hospitalization (0.71), and service utilization (0.71). EHR data present both opportunities and challenges for clinical risk prediction. There is room for improvement in designing such studies. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Incremental validity of estimated cannabis grams as a predictor of problems and cannabinoid biomarkers: Evidence from a clinical trial.

PubMed

Tomko, Rachel L; Baker, Nathaniel L; McClure, Erin A; Sonne, Susan C; McRae-Clark, Aimee L; Sherman, Brian J; Gray, Kevin M

2018-01-01

Quantifying cannabis use is complex due to a lack of a standardized packaging system that contains specified amounts of constituents. A laboratory procedure has been developed for estimating physical quantity of cannabis use by utilizing a surrogate substance to represent cannabis, and weighing the amount of the surrogate to determine typical use in grams. This secondary analysis utilized data from a multi-site, randomized, controlled pharmacological trial for adult cannabis use disorder (N=300), sponsored by the National Drug Abuse Treatment Clinical Trials Network, to test the incremental validity of this procedure. In conjunction with the Timeline Followback, this physical scale-based procedure was used to determine whether average grams per cannabis administration predicted urine cannabinoid levels (11-nor-9-carboxy-Δ9-tetrahydrocannabinol) and problems due to use, after accounting for self-reported number of days used (in the past 30 days) and number of administrations per day in a 12-week clinical trial for cannabis use disorder. Likelihood ratio tests suggest that model fit was significantly improved when grams per administration and relevant interactions were included in the model predicting urine cannabinoid level (X 2 =98.3; p<0.05) and in the model predicting problems due to cannabis use (X 2 =6.4; p<0.05), relative to a model that contained only simpler measures of quantity and frequency. This study provides support for the use of a scale-based method for quantifying cannabis use in grams. This methodology may be useful when precise quantification is necessary (e.g., measuring reduction in use in a clinical trial). Copyright © 2017 Elsevier B.V. All rights reserved.

Predicting stress urinary incontinence during pregnancy: combination of pelvic floor ultrasound parameters and clinical factors.

PubMed

Chen, Ling; Luo, Dan; Yu, Xiajuan; Jin, Mei; Cai, Wenzhi

2018-05-12

The aim of this study was to develop and validate a predictive tool that combining pelvic floor ultrasound parameters and clinical factors for stress urinary incontinence during pregnancy. A total of 535 women in first or second trimester were included for an interview and transperineal ultrasound assessment from two hospitals. Imaging data sets were analyzed offline to assess for bladder neck vertical position, urethra angles (α, β, and γ angles), hiatal area and bladder neck funneling. All significant continuous variables at univariable analysis were analyzed by receiver-operating characteristics. Three multivariable logistic models were built on clinical factor, and combined with ultrasound parameters. The final predictive model with best performance and fewest variables was selected to establish a nomogram. Internal and external validation of the nomogram were performed by both discrimination represented by C-index and calibration measured by Hosmer-Lemeshow test. A decision curve analysis was conducted to determine the clinical utility of the nomogram. After excluding 14 women with invalid data, 521 women were analyzed. β angle, γ angle and hiatal area had limited predictive value for stress urinary incontinence during pregnancy, with area under curves of 0.558-0.648. The final predictive model included body mass index gain since pregnancy, constipation, previous delivery mode, β angle at rest, and bladder neck funneling. The nomogram based on the final model showed good discrimination with a C-index of 0.789 and satisfactory calibration (P=0.828), both of which were supported by external validation. Decision curve analysis showed that the nomogram was clinical useful. The nomogram incorporating both the pelvic floor ultrasound parameters and clinical factors has been validated to show good discrimination and calibration, and could be an important tool for stress urinary incontinence risk prediction at an early stage of pregnancy. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Assessing severity of patients with community-acquired pneumonia.

PubMed

Pereira, Jose Manuel; Paiva, Jose Artur; Rello, Jordi

2012-06-01

Despite all advances in its management, community-acquired pneumonia (CAP) is still an important cause of morbidity and mortality requiring a great consumption of health, social, and economic resources. An early and adequate severity assessment is of paramount importance to provide optimized care to these patients. In the last 2 decades, this issue has been the subject of extensive research. Based on 30 day mortality, several prediction rules have been proposed to aid clinicians in deciding on the appropriate site of care. In spite of being well validated, their sensitivity and specificity vary, which limits their widespread use. The utility of biomarkers to overcome this problem has been investigated. At this moment, their full clinical value remains undetermined, and no single biomarker is consistently ideal for assessing CAP severity. Biomarkers should be seen as a complement rather than superseding clinical judgment or validated clinical scores. The search for a gold standard is not over, and new tools, like bacterial DNA load, are in the pipeline. Until then, CAP severity assessment should be based in three key points: a pneumonia-specific score, biomarkers, and clinical judgment. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

The genomic applications in practice and prevention network.

PubMed

Khoury, Muin J; Feero, W Gregory; Reyes, Michele; Citrin, Toby; Freedman, Andrew; Leonard, Debra; Burke, Wylie; Coates, Ralph; Croyle, Robert T; Edwards, Karen; Kardia, Sharon; McBride, Colleen; Manolio, Teri; Randhawa, Gurvaneet; Rasooly, Rebekah; St Pierre, Jeannette; Terry, Sharon

2009-07-01

The authors describe the rationale and initial development of a new collaborative initiative, the Genomic Applications in Practice and Prevention Network. The network convened by the Centers for Disease Control and Prevention and the National Institutes of Health includes multiple stakeholders from academia, government, health care, public health, industry and consumers. The premise of Genomic Applications in Practice and Prevention Network is that there is an unaddressed chasm between gene discoveries and demonstration of their clinical validity and utility. This chasm is due to the lack of readily accessible information about the utility of most genomic applications and the lack of necessary knowledge by consumers and providers to implement what is known. The mission of Genomic Applications in Practice and Prevention Network is to accelerate and streamline the effective integration of validated genomic knowledge into the practice of medicine and public health, by empowering and sponsoring research, evaluating research findings, and disseminating high quality information on candidate genomic applications in practice and prevention. Genomic Applications in Practice and Prevention Network will develop a process that links ongoing collection of information on candidate genomic applications to four crucial domains: (1) knowledge synthesis and dissemination for new and existing technologies, and the identification of knowledge gaps, (2) a robust evidence-based recommendation development process, (3) translation research to evaluate validity, utility and impact in the real world and how to disseminate and implement recommended genomic applications, and (4) programs to enhance practice, education, and surveillance.

Impact of imaging measurements on response assessment in glioblastoma clinical trials

PubMed Central

Reardon, David A.; Ballman, Karla V.; Buckner, Jan C.; Chang, Susan M.; Ellingson, Benjamin M.

2014-01-01

We provide historical and scientific guidance on imaging response assessment for incorporation into clinical trials to stimulate effective and expedited drug development for recurrent glioblastoma by addressing 3 fundamental questions: (i) What is the current validation status of imaging response assessment, and when are we confident assessing response using today's technology? (ii) What imaging technology and/or response assessment paradigms can be validated and implemented soon, and how will these technologies provide benefit? (iii) Which imaging technologies need extensive testing, and how can they be prospectively validated? Assessment of T1 +/− contrast, T2/FLAIR, diffusion, and perfusion-imaging sequences are routine and provide important insight into underlying tumor activity. Nonetheless, utility of these data within and across patients, as well as across institutions, are limited by challenges in quantifying measurements accurately and lack of consistent and standardized image acquisition parameters. Currently, there exists a critical need to generate guidelines optimizing and standardizing MRI sequences for neuro-oncology patients. Additionally, more accurate differentiation of confounding factors (pseudoprogression or pseudoresponse) may be valuable. Although promising, diffusion MRI, perfusion MRI, MR spectroscopy, and amino acid PET require extensive standardization and validation. Finally, additional techniques to enhance response assessment, such as digital T1 subtraction maps, warrant further investigation. PMID:25313236

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

NASA Astrophysics Data System (ADS)

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

2016-04-01

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

Culture and personality disorder: a focus on Indigenous Australians.

PubMed

Balaratnasingam, Sivasankaran; Janca, Aleksandar

2017-01-01

To examine the validity of concept and diagnosis of personality disorder in transcultural settings using Indigenous Australian people as an example. There are significant deficits in comparative research on personality disorders across cultures. There is also a dearth of information regarding Indigenous Australians, and cultural applicability and clinical utility of the diagnosis of personality disorder in this group. The concept of culture is generally ignored when making a diagnosis of personality disorder. A valid diagnosis should incorporate what would be considered understandable and adaptive behavior in a person's culture. In Indigenous Australian culture, making diagnosis of a personality disorder is complicated by historical trauma from colonization, disruption of kinship networks, and ongoing effects of poverty and social marginalization.

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

PubMed

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

2014-04-01

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

Predicting prolonged dose titration in patients starting warfarin.

PubMed

Finkelman, Brian S; French, Benjamin; Bershaw, Luanne; Brensinger, Colleen M; Streiff, Michael B; Epstein, Andrew E; Kimmel, Stephen E

2016-11-01

Patients initiating warfarin therapy generally experience a dose-titration period of weeks to months, during which time they are at higher risk of both thromboembolic and bleeding events. Accurate prediction of prolonged dose titration could help clinicians determine which patients might be better treated by alternative anticoagulants that, while more costly, do not require dose titration. A prediction model was derived in a prospective cohort of patients starting warfarin (n = 390), using Cox regression, and validated in an external cohort (n = 663) from a later time period. Prolonged dose titration was defined as a dose-titration period >12 weeks. Predictor variables were selected using a modified best subsets algorithm, using leave-one-out cross-validation to reduce overfitting. The final model had five variables: warfarin indication, insurance status, number of doctor's visits in the previous year, smoking status, and heart failure. The area under the ROC curve (AUC) in the derivation cohort was 0.66 (95%CI 0.60, 0.74) using leave-one-out cross-validation, but only 0.59 (95%CI 0.54, 0.64) in the external validation cohort, and varied across clinics. Including genetic factors in the model did not improve the area under the ROC curve (0.59; 95%CI 0.54, 0.65). Relative utility curves indicated that the model was unlikely to provide a clinically meaningful benefit compared with no prediction. Our results suggest that prolonged dose titration cannot be accurately predicted in warfarin patients using traditional clinical, social, and genetic predictors, and that accurate prediction will need to accommodate heterogeneities across clinical sites and over time. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

A clinical risk stratification tool for predicting treatment resistance in major depressive disorder.

PubMed

Perlis, Roy H

2013-07-01

Early identification of depressed individuals at high risk for treatment resistance could be helpful in selecting optimal setting and intensity of care. At present, validated tools to facilitate this risk stratification are rarely used in psychiatric practice. Data were drawn from the first two treatment levels of a multicenter antidepressant effectiveness study in major depressive disorder, the STAR*D (Sequenced Treatment Alternatives to Relieve Depression) cohort. This cohort was divided into training, testing, and validation subsets. Only clinical or sociodemographic variables available by or readily amenable to self-report were considered. Multivariate models were developed to discriminate individuals reaching remission with a first or second pharmacological treatment trial from those not reaching remission despite two trials. A logistic regression model achieved an area under the receiver operating characteristic curve exceeding .71 in training, testing, and validation cohorts and maintained good calibration across cohorts. Performance of three alternative models with machine learning approaches--a naïve Bayes classifier and a support vector machine, and a random forest model--was less consistent. Similar performance was observed between more and less severe depression, men and women, and primary versus specialty care sites. A web-based calculator was developed that implements this tool and provides graphical estimates of risk. Risk for treatment resistance among outpatients with major depressive disorder can be estimated with a simple model incorporating baseline sociodemographic and clinical features. Future studies should examine the performance of this model in other clinical populations and its utility in treatment selection or clinical trial design. Copyright © 2013 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

Psychometric Validation of the Leeds Dependence Questionnaire (LDQ) in a Young Adult Clinical Sample

PubMed Central

Kelly, John F.; Magill, Molly; Slaymaker, Valerie; Kahler, Christopher

2013-01-01

Objective Measures of substance dependence severity that are both clinically efficient and sensitive to change can facilitate assessment of clinical innovation necessary for improving current evidence-based practices. The Leeds Dependence Questionnaire (LDQ) is a 10-item, continuous, self-report measure of dependence that is not specific to any particular substance and has shown promise in preliminary psychometric research. The present study investigates its psychometric properties in a large clinical sample of young adults. Method Emerging adults (N = 300) were enrolled in a naturalistic treatment process and outcome study of residential substance dependence treatment (mean age 20.4 [1.6], range 18–25; 27% female; 95% White). Dependence severity by demographic and diagnostic groupings, factor structure and internal consistency, and criterion- and construct-related validity were examined. Results Dependence severity in this cohort of youth overall was high (M = 18.65 [8.65]). LDQ scores were highest among opiate and stimulant users, and there was a trend for higher scores among women compared to men (t = 1.869, p = .063). Factor analysis using a robust alpha factoring extraction revealed a single factor accounting for 63% of the variance in reported dependence severity. The internal consistency was also very high (alpha = .93). Concurrent and convergent validity with dependence criteria, substance use frequency, and general symptom severity, respectively, were also acceptable. Conclusions The LDQ shows considerable promise as a brief, psychometrically sound, measure of substance dependence useful across a variety of substances, that has clinical and research utility. This study supports its use among emerging adults. PMID:20004062

Validation of the Chronic Pain Acceptance Questionnaire-8 in an Australian pain clinic sample.

PubMed

Baranoff, John; Hanrahan, Stephanie J; Kapur, Dilip; Connor, Jason P

2014-02-01

Recently, an 8-item short-form version of the Chronic Pain Acceptance Questionnaire (CPAQ-8) was developed predominantly in an internet sample. Further investigation of the factor structure in a multidisciplinary pain clinic sample is required. Investigation of the concurrent validity of the CPAQ-8 after accounting for the effects of variables commonly measured in the pain clinic setting is also necessary. This study examines the factor structure and concurrent validity of the CPAQ-8 in a sample of treatment-seeking patients who attended a multidisciplinary pain clinic. Participants were 334 patients who attended an Australian multidisciplinary pain service. Participants completed the CPAQ, a demographic questionnaire, and measures of patient adjustment and functioning. Confirmatory factor analysis identified a two-factor 8-item model consisting of Activity Engagement and Pain Willingness factors (SRMR = 0.039, RMSEA = 0.063, CFI = 0.973, TLI = 0.960) was superior to both the CPAQ and CPAQ with an item removed. The CPAQ and CPAQ-8 total scores were highly correlated (r = 0.93). After accounting for pain intensity, the CPAQ-8 was a significant predictor of depression, anxiety, stress, and disability. The subscales of the CPAQ-8 were both unique contributors to depression and disability in regression analyses, after accounting for pain intensity and kinesiophobia, and after accounting for pain intensity and catastrophizing. The CPAQ-8 has a sound factor structure and similar psychometric properties to the CPAQ; it may have clinical utility as a measure of pain acceptance in treatment-seeking, chronic pain patients.

Patient-Reported Measures of Narcolepsy: The Need for Better Assessment.

PubMed

Kallweit, Ulf; Schmidt, Markus; Bassetti, Claudio L

2017-05-15

Narcolepsy, a chronic disorder of the central nervous system, is clinically characterized by a symptom pentad that includes excessive daytime sleepiness, cataplexy, sleep paralysis, hypnopompic/hypnagogic hallucinations, and disrupted nighttime sleep. Ideally, screening and diagnosis instruments that assist physicians in evaluating a patient for type 1 or type 2 narcolepsy would be brief, easy for patients to understand and physicians to score, and would identify or rule out the need for electrophysiological testing. A search of the literature was conducted to review patient-reported measures used for the assessment of narcolepsy, mainly in clinical trials, with the goal of summarizing existing scales and identifying areas that may require additional screening questions and clinical practice scales. Of the seven scales reviewed, the Epworth Sleepiness Scale continues to be an important outcome measure to screen adults for excessive daytime sleepiness, which may be associated with narcolepsy. Several narcolepsy-specific scales have demonstrated utility, such as the Ullanlinna Narcolepsy Scale, Swiss Narcolepsy Scale, and Narcolepsy Symptom Assessment Questionnaire, but further validation is required. Although the narcolepsy-specific scales currently in use may identify type 1 narcolepsy, there are no validated questionnaires to identify type 2 narcolepsy. Thus, there remains a need for short, easily understood, and well-validated instruments that can be readily used in clinical practice to distinguish narcolepsy subtypes, as well as other hypersomnias, and for assessing symptoms of these conditions during treatment. © 2017 American Academy of Sleep Medicine

Angle-resolved low-coherence interferometry: an optical biopsy technique for clinical detection of dysplasia in Barrett’s esophagus

PubMed Central

Zhu, Yizheng; Terry, Neil G; Wax, Adam

2012-01-01

Angle-resolved low-coherence interferometry (a/LCI) is an optical biopsy technique that measures scattered light from tissue to determine nuclear size with submicron-level accuracy. The a/LCI probe can be deployed through the accessory channel of a standard endoscope and provides feedback to physicians to guide physical biopsies. The technique has been validated in animal and ex vivo human studies, and has been used to detect dysplasia in Barrett’s esophagus patients in vivo. In a recent clinical study of 46 Barrett’s esophagus patients, a/LCI was able to detect dysplasia with 100% sensitivity and 84% specificity. This report reviews the technique and discusses its potential clinical utility. PMID:22149580

Multicenter Comparison of Machine Learning Methods and Conventional Regression for Predicting Clinical Deterioration on the Wards.

PubMed

Churpek, Matthew M; Yuen, Trevor C; Winslow, Christopher; Meltzer, David O; Kattan, Michael W; Edelson, Dana P

2016-02-01

Machine learning methods are flexible prediction algorithms that may be more accurate than conventional regression. We compared the accuracy of different techniques for detecting clinical deterioration on the wards in a large, multicenter database. Observational cohort study. Five hospitals, from November 2008 until January 2013. Hospitalized ward patients None Demographic variables, laboratory values, and vital signs were utilized in a discrete-time survival analysis framework to predict the combined outcome of cardiac arrest, intensive care unit transfer, or death. Two logistic regression models (one using linear predictor terms and a second utilizing restricted cubic splines) were compared to several different machine learning methods. The models were derived in the first 60% of the data by date and then validated in the next 40%. For model derivation, each event time window was matched to a non-event window. All models were compared to each other and to the Modified Early Warning score, a commonly cited early warning score, using the area under the receiver operating characteristic curve (AUC). A total of 269,999 patients were admitted, and 424 cardiac arrests, 13,188 intensive care unit transfers, and 2,840 deaths occurred in the study. In the validation dataset, the random forest model was the most accurate model (AUC, 0.80 [95% CI, 0.80-0.80]). The logistic regression model with spline predictors was more accurate than the model utilizing linear predictors (AUC, 0.77 vs 0.74; p < 0.01), and all models were more accurate than the MEWS (AUC, 0.70 [95% CI, 0.70-0.70]). In this multicenter study, we found that several machine learning methods more accurately predicted clinical deterioration than logistic regression. Use of detection algorithms derived from these techniques may result in improved identification of critically ill patients on the wards.

Validity of Exercise Measures in Adults with Anorexia Nervosa: The EDE, Compulsive Exercise Test and Other Self-Report Scales.

PubMed

Young, Sarah; Touyz, Stephen; Meyer, Caroline; Arcelus, Jon; Rhodes, Paul; Madden, Sloane; Pike, Kathleen; Attia, Evelyn; Crosby, Ross D; Wales, Jackie; Hay, Phillipa

2017-05-01

Compulsive exercise is a prominent feature for the majority of patients with Anorexia Nervosa (AN), but there is a dearth of research evaluating assessment instruments. This study assessed the concurrent validity of the exercise items of the Eating Disorder Examination (EDE) and Eating Disorder Examination-Questionnaire (EDE-Q), with the Compulsive Exercise Test (CET) and other self-report exercise measures in patients with AN. We also aimed to perform validation of the CET in an adult clinical sample. The sample consisted of 78 adults with AN, recruited for the randomized controlled trial "Taking a LEAP forward in the treatment of anorexia nervosa." At baseline, participants completed the EDE, EDE-Q, CET, Reasons for Exercise Inventory (REI), Commitment to Exercise Scale (CES) and Exercise Beliefs Questionnaire (EBQ). Correlational and regression analyses were performed. EDE exercise days and exercise time per day were positively correlated with each other and with all CET subscales (except Lack of exercise enjoyment), CES mean, EBQ total and REI total. Exercise time per day was associated with a higher EDE global score. The CET demonstrated good concurrent validity with the CES, the REI and the EBQ. Of the self-reports, the CET explained the greatest variance in eating disorder psychopathology and demonstrated good to excellent reliability in this sample. The EDE and EDE-Q demonstrated good concurrent validity with the CET. Further research is required to evaluate the CET's factor structure in a large clinical sample. However, the CET has demonstrated strong clinical utility in adult patients with AN. © 2016 Wiley Periodicals, Inc.(Int J Eat Disord 2017; 50:533-541). © 2016 Wiley Periodicals, Inc.

The European Heart Rhythm Association symptom classification for atrial fibrillation: validation and improvement through a simple modification.

PubMed

Wynn, Gareth J; Todd, Derick M; Webber, Matthew; Bonnett, Laura; McShane, James; Kirchhof, Paulus; Gupta, Dhiraj

2014-07-01

To validate the European Heart Rhythm Association (EHRA) symptom classification in atrial fibrillation (AF) and test whether its discriminative ability could be improved by a simple modification. We compared the EHRA classification with three quality of life (QoL) measures: the AF-specific Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire; two components of the EQ-5D instrument, a health-related utility which can be used to calculate cost-effectiveness, and the visual analogue scale (VAS) which demonstrates patients' own assessment of health status. We then proposed a simple modification [modified EHRA (mEHRA)] to improve discrimination at the point where major treatment decisions are made. quality of life data and clinician-allocated EHRA class were prospectively collected on 362 patients with AF. A step-wise, negative association was seen between the EHRA class and both the AFEQT and the VAS scores. Health-related utility was only significantly different between Classes 2 and 3 (P < 0.001). We developed and validated the mEHRA score separating Class 2 (symptomatic AF not limiting daily activities), based on whether the patients were 'troubled by their AF' (Class 2b) or not (Class 2a). This produced two distinct groups with lower AFEQT and VAS scores and, importantly, both clinically and statistically significant lower health utility (Δutility 0.9, P = 0.01) in Class 2b than Class 2a. Based on patients' own assessment of their health status and the disease-specific AFEQT, the EHRA score can be considered a useful semi-quantitative classification. The mEHRA score has a clearer separation in health utility to assess the cost efficacy of interventions such as ablation, where Class 2b symptoms appear to be the appropriate treatment threshold. © The Author 2014. Published by Oxford University Press on behalf of the European Society of Cardiology.

Mapping the Paediatric Quality of Life Inventory (PedsQL™) Generic Core Scales onto the Child Health Utility Index-9 Dimension (CHU-9D) Score for Economic Evaluation in Children.

PubMed

Lambe, Tosin; Frew, Emma; Ives, Natalie J; Woolley, Rebecca L; Cummins, Carole; Brettell, Elizabeth A; Barsoum, Emma N; Webb, Nicholas J A

2018-04-01

The Paediatric Quality of Life Inventory (PedsQL™) questionnaire is a widely used, generic instrument designed for measuring health-related quality of life (HRQoL); however, it is not preference-based and therefore not suitable for cost-utility analysis. The Child Health Utility Index-9 Dimension (CHU-9D), however, is a preference-based instrument that has been primarily developed to support cost-utility analysis. This paper presents a method for estimating CHU-9D index scores from responses to the PedsQL™ using data from a randomised controlled trial of prednisolone therapy for treatment of childhood corticosteroid-sensitive nephrotic syndrome. HRQoL data were collected from children at randomisation, week 16, and months 12, 18, 24, 36 and 48. Observations on children aged 5 years and older were pooled across all data collection timepoints and were then randomised into an estimation (n = 279) and validation (n = 284) sample. A number of models were developed using the estimation data before internal validation. The best model was chosen using multi-stage selection criteria. Most of the models developed accurately predicted the CHU-9D mean index score. The best performing model was a generalised linear model (mean absolute error = 0.0408; mean square error = 0.0035). The proportion of index scores deviating from the observed scores by <  0.03 was 53%. The mapping algorithm provides an empirical tool for estimating CHU-9D index scores and for conducting cost-utility analyses within clinical studies that have only collected PedsQL™ data. It is valid for children aged 5 years or older. Caution should be exercised when using this with children younger than 5 years, older adolescents (>  13 years) or patient groups with particularly poor quality of life. 16645249.

The utility of the Total Neuropathy Score as an instrument to assess neuropathy severity in chronic kidney disease: A validation study.

PubMed

Issar, Tushar; Arnold, Ria; Kwai, Natalie C G; Pussell, Bruce A; Endre, Zoltan H; Poynten, Ann M; Kiernan, Matthew C; Krishnan, Arun V

2018-05-01

To demonstrate construct validity of the Total Neuropathy Score (TNS) in assessing peripheral neuropathy in subjects with chronic kidney disease (CKD). 113 subjects with CKD and 40 matched controls were assessed for peripheral neuropathy using the TNS. An exploratory factor analysis was conducted and internal consistency of the scale was evaluated using Cronbach's alpha. Construct validity of the TNS was tested by comparing scores between case and control groups. Factor analysis revealed valid item correlations and internal consistency of the TNS was good with a Cronbach's alpha of 0.897. Subjects with CKD scored significantly higher on the TNS (CKD: median, 6, interquartile range, 1-13; controls: median, 0, interquartile range, 0-1; p < 0.001). Subgroup analysis revealed construct validity was maintained for subjects with stages 3-5 CKD with and without diabetes. The TNS is a valid measure of peripheral neuropathy in patients with CKD. The TNS is the first neuropathy scale to be formally validated in patients with CKD. Copyright © 2018 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

Improving surgeon utilization in an orthopedic department using simulation modeling

PubMed Central

Simwita, Yusta W; Helgheim, Berit I

2016-01-01

Purpose Worldwide more than two billion people lack appropriate access to surgical services due to mismatch between existing human resource and patient demands. Improving utilization of existing workforce capacity can reduce the existing gap between surgical demand and available workforce capacity. In this paper, the authors use discrete event simulation to explore the care process at an orthopedic department. Our main focus is improving utilization of surgeons while minimizing patient wait time. Methods The authors collaborated with orthopedic department personnel to map the current operations of orthopedic care process in order to identify factors that influence poor surgeons utilization and high patient waiting time. The authors used an observational approach to collect data. The developed model was validated by comparing the simulation output with the actual patient data that were collected from the studied orthopedic care process. The authors developed a proposal scenario to show how to improve surgeon utilization. Results The simulation results showed that if ancillary services could be performed before the start of clinic examination services, the orthopedic care process could be highly improved. That is, improved surgeon utilization and reduced patient waiting time. Simulation results demonstrate that with improved surgeon utilizations, up to 55% increase of future demand can be accommodated without patients reaching current waiting time at this clinic, thus, improving patient access to health care services. Conclusion This study shows how simulation modeling can be used to improve health care processes. This study was limited to a single care process; however the findings can be applied to improve other orthopedic care process with similar operational characteristics. PMID:29355193

How to Appropriately Extrapolate Costs and Utilities in Cost-Effectiveness Analysis.

PubMed

Bojke, Laura; Manca, Andrea; Asaria, Miqdad; Mahon, Ronan; Ren, Shijie; Palmer, Stephen

2017-08-01

Costs and utilities are key inputs into any cost-effectiveness analysis. Their estimates are typically derived from individual patient-level data collected as part of clinical studies the follow-up duration of which is often too short to allow a robust quantification of the likely costs and benefits a technology will yield over the patient's entire lifetime. In the absence of long-term data, some form of temporal extrapolation-to project short-term evidence over a longer time horizon-is required. Temporal extrapolation inevitably involves assumptions regarding the behaviour of the quantities of interest beyond the time horizon supported by the clinical evidence. Unfortunately, the implications for decisions made on the basis of evidence derived following this practice and the degree of uncertainty surrounding the validity of any assumptions made are often not fully appreciated. The issue is compounded by the absence of methodological guidance concerning the extrapolation of non-time-to-event outcomes such as costs and utilities. This paper considers current approaches to predict long-term costs and utilities, highlights some of the challenges with the existing methods, and provides recommendations for future applications. It finds that, typically, economic evaluation models employ a simplistic approach to temporal extrapolation of costs and utilities. For instance, their parameters (e.g. mean) are typically assumed to be homogeneous with respect to both time and patients' characteristics. Furthermore, costs and utilities have often been modelled to follow the dynamics of the associated time-to-event outcomes. However, cost and utility estimates may be more nuanced, and it is important to ensure extrapolation is carried out appropriately for these parameters.

Multiattribute health utility scoring for the computerized adaptive measure CAT-5D-QOL was developed and validated.

PubMed

Kopec, Jacek A; Sayre, Eric C; Rogers, Pamela; Davis, Aileen M; Badley, Elizabeth M; Anis, Aslam H; Abrahamowicz, Michal; Russell, Lara; Rahman, Md Mushfiqur; Esdaile, John M

2015-10-01

The CAT-5D-QOL is a previously reported item response theory (IRT)-based computerized adaptive tool to measure five domains (attributes) of health-related quality of life. The objective of this study was to develop and validate a multiattribute health utility (MAHU) scoring method for this instrument. The MAHU scoring system was developed in two stages. In phase I, we obtained standard gamble (SG) utilities for 75 hypothetical health states in which only one domain varied (15 states per domain). In phase II, we obtained SG utilities for 256 multiattribute states. We fit a multiplicative regression model to predict SG utilities from the five IRT domain scores. The prediction model was constrained using data from phase I. We validated MAHU scores by comparing them with the Health Utilities Index Mark 3 (HUI3) and directly measured utilities and by assessing between-group discrimination. MAHU scores have a theoretical range from -0.842 to 1. In the validation study, the scores were, on average, higher than HUI3 utilities and lower than directly measured SG utilities. MAHU scores correlated strongly with the HUI3 (Spearman ρ = 0.78) and discriminated well between groups expected to differ in health status. Results reported here provide initial evidence supporting the validity of the MAHU scoring system for the CAT-5D-QOL. Copyright © 2015 Elsevier Inc. All rights reserved.

Clinical Sequencing Exploratory Research Consortium: Accelerating Evidence-Based Practice of Genomic Medicine.

PubMed

Green, Robert C; Goddard, Katrina A B; Jarvik, Gail P; Amendola, Laura M; Appelbaum, Paul S; Berg, Jonathan S; Bernhardt, Barbara A; Biesecker, Leslie G; Biswas, Sawona; Blout, Carrie L; Bowling, Kevin M; Brothers, Kyle B; Burke, Wylie; Caga-Anan, Charlisse F; Chinnaiyan, Arul M; Chung, Wendy K; Clayton, Ellen W; Cooper, Gregory M; East, Kelly; Evans, James P; Fullerton, Stephanie M; Garraway, Levi A; Garrett, Jeremy R; Gray, Stacy W; Henderson, Gail E; Hindorff, Lucia A; Holm, Ingrid A; Lewis, Michelle Huckaby; Hutter, Carolyn M; Janne, Pasi A; Joffe, Steven; Kaufman, David; Knoppers, Bartha M; Koenig, Barbara A; Krantz, Ian D; Manolio, Teri A; McCullough, Laurence; McEwen, Jean; McGuire, Amy; Muzny, Donna; Myers, Richard M; Nickerson, Deborah A; Ou, Jeffrey; Parsons, Donald W; Petersen, Gloria M; Plon, Sharon E; Rehm, Heidi L; Roberts, J Scott; Robinson, Dan; Salama, Joseph S; Scollon, Sarah; Sharp, Richard R; Shirts, Brian; Spinner, Nancy B; Tabor, Holly K; Tarczy-Hornoch, Peter; Veenstra, David L; Wagle, Nikhil; Weck, Karen; Wilfond, Benjamin S; Wilhelmsen, Kirk; Wolf, Susan M; Wynn, Julia; Yu, Joon-Ho

2016-06-02

Despite rapid technical progress and demonstrable effectiveness for some types of diagnosis and therapy, much remains to be learned about clinical genome and exome sequencing (CGES) and its role within the practice of medicine. The Clinical Sequencing Exploratory Research (CSER) consortium includes 18 extramural research projects, one National Human Genome Research Institute (NHGRI) intramural project, and a coordinating center funded by the NHGRI and National Cancer Institute. The consortium is exploring analytic and clinical validity and utility, as well as the ethical, legal, and social implications of sequencing via multidisciplinary approaches; it has thus far recruited 5,577 participants across a spectrum of symptomatic and healthy children and adults by utilizing both germline and cancer sequencing. The CSER consortium is analyzing data and creating publically available procedures and tools related to participant preferences and consent, variant classification, disclosure and management of primary and secondary findings, health outcomes, and integration with electronic health records. Future research directions will refine measures of clinical utility of CGES in both germline and somatic testing, evaluate the use of CGES for screening in healthy individuals, explore the penetrance of pathogenic variants through extensive phenotyping, reduce discordances in public databases of genes and variants, examine social and ethnic disparities in the provision of genomics services, explore regulatory issues, and estimate the value and downstream costs of sequencing. The CSER consortium has established a shared community of research sites by using diverse approaches to pursue the evidence-based development of best practices in genomic medicine. Copyright © 2016 American Society of Human Genetics. All rights reserved.

The Clinical Utility and Diagnostic Performance of MRI for Identification of Early and Advanced Knee Osteoarthritis: A Systematic Review

PubMed Central

Quatman, Carmen E.; Hettrich, Carolyn M.; Schmitt, Laura C.; Spindler, Kurt P.

2013-01-01

Background Current diagnostic strategies for detection of structural articular cartilage abnormalities, the earliest structural signs of osteoarthritis, often do not capture the condition until it is too far advanced for the most potential benefit of non-invasive interventions. Purpose Systematically review the literature relative to the following questions: (1) Is MRI a valid, sensitive, specific, accurate and reliable instrument to identify knee articular cartilage abnormalities compared to arthroscopy? (2) Is MRI a sensitive tool that can be utilized to identify early cartilage degeneration? Study Design Systematic Review Methods A systematic search was performed in November 2010 using PubMed MEDLINE (from 1966), CINAHL (from 1982), SPORTDiscus (from 1985), and SCOPUS (from 1996) databases. Results Fourteen level I and 13 level II studies were identified that met inclusion criteria and provided information related to diagnostic performance of MRI compared to arthroscopic evaluation. The diagnostic performance of MRI demonstrated a large range of sensitivities, specificities, and accuracies. The sensitivity for identifying articular cartilage abnormalities in the knee joint was reported between 26–96%. Specificity and accuracy was reported between 50–100% and 49–94%, respectively. The sensitivity, specificity, and accuracy for identifying early osteoarthritis were reported between 0–86%, 48–95%, and 5–94%, respectively. As a result of inconsistencies between imaging techniques and methodological shortcomings of many of the studies, a meta-analysis was not performed and it was difficult to fully synthesize the information to state firm conclusions about the diagnostic performance of MRI. Conclusions There is evidence in some MRI protocols that MRI is a relatively valid, sensitive, specific, accurate, and reliable clinical tool for identifying articular cartilage degeneration. Due to heterogeneity of MRI sequences it is not possible to make definitive conclusions regarding its global clinical utility for guiding diagnosis and treatment strategies. Clinical Relevance Traumatic sports injuries to the knee may be significant precursor events to early onset of posttraumatic osteoarthritis. MRI may aid in early identification of structural injuries to articular cartilage as evidenced by articular cartilage degeneration grading. PMID:21730207

Improving Efficiency Using a Hybrid Approach: Revising an Intravenous/Blood Workshop in a Clinical Research Environment.

PubMed

Parchen, Debra A; Phelps, Sandra E; Johnson, Eunice M; Fisher, Cheryl A

2016-01-01

Orienting to a new job can be overwhelming, especially if the nurse is required to develop or refine new skills, such as intravenous (IV) therapy or blood administration. At the National Institutes of Health Clinical Center Nursing Department, a group of nurse educators redesigned their IV/Blood Workshop to prepare nurses with skills needed when caring for patients on protocol in a research intensive environment. Innovative teaching strategies and a hybrid instructional approach were used along with a preworkshop activity, skills lab practice, and follow-up skill validation at the unit level to provide a comprehensive curriculum while decreasing resource utilization.

A Contemporary Prostate Biopsy Risk Calculator Based on Multiple Heterogeneous Cohorts.

PubMed

Ankerst, Donna P; Straubinger, Johanna; Selig, Katharina; Guerrios, Lourdes; De Hoedt, Amanda; Hernandez, Javier; Liss, Michael A; Leach, Robin J; Freedland, Stephen J; Kattan, Michael W; Nam, Robert; Haese, Alexander; Montorsi, Francesco; Boorjian, Stephen A; Cooperberg, Matthew R; Poyet, Cedric; Vertosick, Emily; Vickers, Andrew J

2018-05-16

Prostate cancer prediction tools provide quantitative guidance for doctor-patient decision-making regarding biopsy. The widely used online Prostate Cancer Prevention Trial Risk Calculator (PCPTRC) utilized data from the 1990s based on six-core biopsies and outdated grading systems. We prospectively gathered data from men undergoing prostate biopsy in multiple diverse North American and European institutions participating in the Prostate Biopsy Collaborative Group (PBCG) in order to build a state-of-the-art risk prediction tool. We obtained data from 15 611 men undergoing 16 369 prostate biopsies during 2006-2017 at eight North American institutions for model-building and three European institutions for validation. We used multinomial logistic regression to estimate the risks of high-grade prostate cancer (Gleason score ≥7) on biopsy based on clinical characteristics, including age, prostate-specific antigen, digital rectal exam, African ancestry, first-degree family history, and prior negative biopsy. We compared the PBCG model to the PCPTRC using internal cross-validation and external validation on the European cohorts. Cross-validation on the North American cohorts (5992 biopsies) yielded the PBCG model area under the receiver operating characteristic curve (AUC) as 75.5% (95% confidence interval: 74.2-76.8), a small improvement over the AUC of 72.3% (70.9-73.7) for the PCPTRC (p<0.0001). However, calibration and clinical net benefit were far superior for the PBCG model. Using a risk threshold of 10%, clinical use of the PBCG model would lead to the equivalent of 25 fewer biopsies per 1000 patients without missing any high-grade cancers. Results were similar on external validation on 10 377 European biopsies. The PBCG model should be used in place of the PCPTRC for prediction of prostate biopsy outcome. A contemporary risk tool for outcomes on prostate biopsy based on the routine clinical risk factors is now available for informed decision-making. Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.

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

PubMed

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.

Prostate-Specific Antigen (PSA) Screening and New Biomarkers for Prostate Cancer (PCa)

PubMed Central

Rittenhouse, Harry; Hu, Xinhai; Cammann, Henning; Jung, Klaus

2014-01-01

Abstract PSA screening reduces PCa-mortality but the disadvantages overdiagnosis and overtreatment require multivariable risk-prediction tools to select appropriate treatment or active surveillance. This review explains the differences between the two largest screening trials and discusses the drawbacks of screening and its meta-analysisxs. The current American and European screening strategies are described. Nonetheless, PSA is one of the most widely used tumor markers and strongly correlates with the risk of harboring PCa. However, while PSA has limitations for PCa detection with its low specificity there are several potential biomarkers presented in this review with utility for PCa currently being studied. There is an urgent need for new biomarkers especially to detect clinically significant and aggressive PCa. From all PSA-based markers, the FDA-approved prostate health index (phi) shows improved specificity over percent free and total PSA. Another kallikrein panel, 4K, which includes KLK2 has recently shown promise in clinical research studies but has not yet undergone formal validation studies. In urine, prostate cancer gene 3 (PCA3) has also been validated and approved by the FDA for its utility to detect PCa. The potential correlation of PCA3 with cancer aggressiveness requires more clinical studies. The detection of the fusion of androgen-regulated genes with genes of the regulatory transcription factors in tissue of ~50% of all PCa-patients is a milestone in PCa research. A combination of the urinary assays for TMPRSS2:ERG gene fusion and PCA3 shows an improved accuracy for PCa detection. Overall, the field of PCa biomarker discovery is very exciting and prospective. PMID:27683457

Utility of Post-Mortem Genetic Testing in Cases of Sudden Arrhythmic Death Syndrome.

PubMed

Lahrouchi, Najim; Raju, Hariharan; Lodder, Elisabeth M; Papatheodorou, Efstathios; Ware, James S; Papadakis, Michael; Tadros, Rafik; Cole, Della; Skinner, Jonathan R; Crawford, Jackie; Love, Donald R; Pua, Chee J; Soh, Bee Y; Bhalshankar, Jaydutt D; Govind, Risha; Tfelt-Hansen, Jacob; Winkel, Bo G; van der Werf, Christian; Wijeyeratne, Yanushi D; Mellor, Greg; Till, Jan; Cohen, Marta C; Tome-Esteban, Maria; Sharma, Sanjay; Wilde, Arthur A M; Cook, Stuart A; Bezzina, Connie R; Sheppard, Mary N; Behr, Elijah R

2017-05-02

Sudden arrhythmic death syndrome (SADS) describes a sudden death with negative autopsy and toxicological analysis. Cardiac genetic disease is a likely etiology. This study investigated the clinical utility and combined yield of post-mortem genetic testing (molecular autopsy) in cases of SADS and comprehensive clinical evaluation of surviving relatives. We evaluated 302 expertly validated SADS cases with suitable DNA (median age: 24 years; 65% males) who underwent next-generation sequencing using an extended panel of 77 primary electrical disorder and cardiomyopathy genes. Pathogenic and likely pathogenic variants were classified using American College of Medical Genetics (ACMG) consensus guidelines. The yield of combined molecular autopsy and clinical evaluation in 82 surviving families was evaluated. A gene-level rare variant association analysis was conducted in SADS cases versus controls. A clinically actionable pathogenic or likely pathogenic variant was identified in 40 of 302 cases (13%). The main etiologies established were catecholaminergic polymorphic ventricular tachycardia and long QT syndrome (17 [6%] and 11 [4%], respectively). Gene-based rare variants association analysis showed enrichment of rare predicted deleterious variants in RYR2 (p = 5 × 10 -5 ). Combining molecular autopsy with clinical evaluation in surviving families increased diagnostic yield from 26% to 39%. Molecular autopsy for electrical disorder and cardiomyopathy genes, using ACMG guidelines for variant classification, identified a modest but realistic yield in SADS. Our data highlighted the predominant role of catecholaminergic polymorphic ventricular tachycardia and long QT syndrome, especially the RYR2 gene, as well as the minimal yield from other genes. Furthermore, we showed the enhanced utility of combined clinical and genetic evaluation. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Two-Tiered Violence Risk Estimates: a validation study of an integrated-actuarial risk assessment instrument.

PubMed

Mills, Jeremy F; Gray, Andrew L

2013-11-01

This study is an initial validation study of the Two-Tiered Violence Risk Estimates instrument (TTV), a violence risk appraisal instrument designed to support an integrated-actuarial approach to violence risk assessment. The TTV was scored retrospectively from file information on a sample of violent offenders. Construct validity was examined by comparing the TTV with instruments that have shown utility to predict violence that were prospectively scored: The Historical-Clinical-Risk Management-20 (HCR-20) and Lifestyle Criminality Screening Form (LCSF). Predictive validity was examined through a long-term follow-up of 12.4 years with a sample of 78 incarcerated offenders. Results show the TTV to be highly correlated with the HCR-20 and LCSF. The base rate for violence over the follow-up period was 47.4%, and the TTV was equally predictive of violent recidivism relative to the HCR-20 and LCSF. Discussion centers on the advantages of an integrated-actuarial approach to the assessment of violence risk.

From ClinicalTrials.gov trial registry to an analysis-ready database of clinical trial results.

PubMed

Cepeda, M Soledad; Lobanov, Victor; Berlin, Jesse A

2013-04-01

The ClinicalTrials.gov web site provides a convenient interface to look up study results, but it does not allow downloading data in a format that can be readily used for quantitative analyses. To develop a system that automatically downloads study results from ClinicalTrials.gov and provides an interface to retrieve study results in a spreadsheet format ready for analysis. Sherlock(®) identifies studies by intervention, population, or outcome of interest and in seconds creates an analytic database of study results ready for analyses. The outcome classification algorithms used in Sherlock were validated against a classification by an expert. Having a database ready for analysis that can be updated automatically, dramatically extends the utility of the ClinicalTrials.gov trial registry. It increases the speed of comparative research, reduces the need for manual extraction of data, and permits answering a vast array of questions.

A physical function test for use in the intensive care unit: validity, responsiveness, and predictive utility of the physical function ICU test (scored).

PubMed

Denehy, Linda; de Morton, Natalie A; Skinner, Elizabeth H; Edbrooke, Lara; Haines, Kimberley; Warrillow, Stephen; Berney, Sue

2013-12-01

Several tests have recently been developed to measure changes in patient strength and functional outcomes in the intensive care unit (ICU). The original Physical Function ICU Test (PFIT) demonstrates reliability and sensitivity. The aims of this study were to further develop the original PFIT, to derive an interval score (the PFIT-s), and to test the clinimetric properties of the PFIT-s. A nested cohort study was conducted. One hundred forty-four and 116 participants performed the PFIT at ICU admission and discharge, respectively. Original test components were modified using principal component analysis. Rasch analysis examined the unidimensionality of the PFIT, and an interval score was derived. Correlations tested validity, and multiple regression analyses investigated predictive ability. Responsiveness was assessed using the effect size index (ESI), and the minimal clinically important difference (MCID) was calculated. The shoulder lift component was removed. Unidimensionality of combined admission and discharge PFIT-s scores was confirmed. The PFIT-s displayed moderate convergent validity with the Timed "Up & Go" Test (r=-.60), the Six-Minute Walk Test (r=.41), and the Medical Research Council (MRC) sum score (rho=.49). The ESI of the PFIT-s was 0.82, and the MCID was 1.5 points (interval scale range=0-10). A higher admission PFIT-s score was predictive of: an MRC score of ≥48, increased likelihood of discharge home, reduced likelihood of discharge to inpatient rehabilitation, and reduced acute care hospital length of stay. Scoring of sit-to-stand assistance required is subjective, and cadence cutpoints used may not be generalizable. The PFIT-s is a safe and inexpensive test of physical function with high clinical utility. It is valid, responsive to change, and predictive of key outcomes. It is recommended that the PFIT-s be adopted to test physical function in the ICU.

An appraisal of the utility or futility of ENT consultant postal questionnaires.

PubMed

Ryan, Stephen; Saunders, J; Clarke, E; Fenton, J E

2013-03-01

Despite an increase in ENT postal questionnaires, the quality of their methodology has been questioned (Ramphul et al. in J Laryngol Otol 119:175-178, 1). This retrospective study examined whether quality and utility of such questionnaires published since 2005 has improved. Seventeen consultant postal questionnaires published between 2005 and 2012 were reviewed. Quality of questionnaires was assessed using a 30-point score based on compliance with 15 criteria previously established to evaluate postal questionnaire study-design (Ramphul et al. in J Laryngol Otol 119:175-178, 1). Citation rates were used as an indicator of utility. The specific comments made in each citing paper was reviewed providing information on whether questionnaire findings (a) had an impact on clinical practice, (b) were the citing comments positive, (c) negative or (d) non-specific. Recurrent methodological flaws were identified in all questionnaires. The average score assigned was 44 %, versus 32 % previously reported (Ramphul et al. in J Laryngol Otol 119:175-178, 1) (P < 0.01, Student's t test). The low citation rate demonstrates poor utility for postal questionnaires. Citations were general non-specific referencing with no clear indication that questionnaire findings positively impacted clinical practice. In conclusion, although the quality of ENT postal questionnaire has improved since the original study (Ramphul et al. in J Laryngol Otol 119:175-178, 1), important recurring methodological flaws still exist. The poor utility, based on low citation rates, also reflects the continued deficiencies in design quality. It is recommended that authors of questionnaire-based research should ensure that guidelines for questionnaire design are adhered in order to improve the validity of findings and hence impact on clinical practice.

Polarimetry noise in fiber-based optical coherence tomography instrumentation

PubMed Central

Zhang, Ellen Ziyi; Vakoc, Benjamin J.

2011-01-01

High noise levels in fiber-based polarization-sensitive optical coherence tomography (PS-OCT) have broadly limited its clinical utility. In this study we investigate contribution of polarization mode dispersion (PMD) to the polarimetry noise. We develop numerical models of the PS-OCT system including PMD and validate these models with empirical data. Using these models, we provide a framework for predicting noise levels, for processing signals to reduce noise, and for designing an optimized system. PMID:21935044

Clinical Utility of Fungal Screening Assays in Adults with Severe Burns

DTIC Science & Technology

2013-01-01

available test, FungitellTM Glucan Assay for (1,3) b D glucan (BG) in serum (Associates of Cape Cod Inc., East Falmouth, MA), is a qualitative...considered a positive test in the United States and was used as a positive value in this study. A positive test is reported with a b D glucan concentration... Glucan as a diagnostic adjunct for invasive fungal infections: validation, cutoff development, and performance in patients with acute myelogenous

Pharmacogenetics and Stroke

PubMed Central

Meschia, James F.

2009-01-01

Genetic variations have been shown to influence drug metabolism, risk of adverse drug events, and pharmacodynamic responses for many drugs routinely used to treat patients with stroke or at risk for stroke. Examples include clopidogrel, statins, antihypertensive medications, and coumadin. Further validation studies are needed to assess the clinical utility of selecting drugs and doses based on genetic tests. Physicians, pharmaceutical companies, regulatory agencies, and health insurers continue to grapple with how best to translate this burgeoning field into effective individualized medicine. PMID:19762696

Commercially available gaming systems as clinical assessment tools to improve value in the orthopaedic setting: a systematic review.

PubMed

Ruff, Jessica; Wang, Tiffany L; Quatman-Yates, Catherine C; Phieffer, Laura S; Quatman, Carmen E

2015-02-01

Commercially available gaming systems (CAGS) such as the Wii Balance Board (WBB) and Microsoft Xbox with Kinect (Xbox Kinect) are increasingly used as balance training and rehabilitation tools. The purpose of this review was to answer the question, "Are commercially available gaming systems valid and reliable instruments for use as clinical diagnostic and functional assessment tools in orthopaedic settings?" and provide a summary of relevant studies, identify their strengths and weaknesses, and generate conclusions regarding general validity/reliability of WBB and Xbox Kinect in orthopaedics. A systematic search was performed using MEDLINE (1996-2013) and Scopus (1996-2013). Inclusion criteria were minimum of 5 subjects, full manuscript provided in English or translated, and studies incorporating investigation of CAG measurement properties. Exclusion criteria included reviews, systematic reviews, summary/clinical commentaries, or case studies; conference proceedings/presentations; cadaveric studies; studies of non-reversible, non-orthopaedic-related musculoskeletal disease; non-human trials; and therapeutic studies not reporting comparative evaluation to already established functional assessment criteria. All studies meeting inclusion and exclusion criteria were appraised for quality by two independent reviewers. Evidence levels (I-V) were assigned to each study based on established methodological criteria. 3 Level II, 7 level III, and 1 Level IV studies met inclusion criteria and provided information related to the use of the WBB and Xbox Kinect as clinical assessment tools in the field of orthopaedics. Studies have used the WBB in a variety of clinical applications, including the measurement of center of pressure (COP), measurement of medial-to-lateral (M/L) or anterior-to-posterior (A/P) symmetry, assessment anatomic landmark positioning, and assessment of fall risk. However, no uniform protocols or outcomes were used to evaluate the quality of the WBB as a clinical assessment tool; therefore a wide range of sensitivities, specificities, accuracies, and validities were reported. Currently it is not possible to make a universal generalization about the clinical utility of CAGS in the field of orthopaedics. However, there is evidence to support using the WBB and the Xbox Kinect as tools to obtain reliable and valid COP measurements. The Wii Fit Game may specifically provide reliable and valid measurements for predicting fall risk. Copyright © 2014 Elsevier Ltd. All rights reserved.

Massage therapy for home care patients using the health insurance system in Japan.

PubMed

Kondo, H; Ogawa, S; Nishimura, H; Ono, A

2018-02-01

To clarify the status of home care massage services provided to patients. This will help in understanding how many patients utilize this service and the circumstances under which treatment is provided. A retrospective study. Fifty-four acupuncture, moxibustion, and massage clinics. Participants were patients who had received home care massage for six months or more. We collected a total of 1587 responses from these 54 massage clinics; of these, 1415 responses (mean age = 79.1 ± 11.5 years) were valid (valid response rate 89.2%). Actual patients and actual care services. The most common disorder observed among patients who utilized home care massage services was cerebrovascular disease (at approximately 36%), while the second most common were arthropathy-related disorders (16.3%). Although most patients received massage, approximately 30% received manual therapy (e.g. manual correction) and hot fomentation as part of thermotherapy. Notably, only around 10% of patients received massage alone; the majority received treatment in combination with range of motion and muscle-strengthening exercises. This study helped to clarify the actual state of patients receiving home care massage and the details of the massage services provided. This study clearly showed the treatment effectiveness of massage, which can be used by home medical care stakeholders to develop more effective interventions. Copyright © 2018 Elsevier Ltd. All rights reserved.

Biomarkers of systemic lupus erythematosus identified using mass spectrometry-based proteomics: a systematic review.

PubMed

Nicolaou, Orthodoxia; Kousios, Andreas; Hadjisavvas, Andreas; Lauwerys, Bernard; Sokratous, Kleitos; Kyriacou, Kyriacos

2017-05-01

Advances in mass spectrometry technologies have created new opportunities for discovering novel protein biomarkers in systemic lupus erythematosus (SLE). We performed a systematic review of published reports on proteomic biomarkers identified in SLE patients using mass spectrometry-based proteomics and highlight their potential disease association and clinical utility. Two electronic databases, MEDLINE and EMBASE, were systematically searched up to July 2015. The methodological quality of studies included in the review was performed according to Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Twenty-five studies were included in the review, identifying 241 SLE candidate proteomic biomarkers related to various aspects of the disease including disease diagnosis and activity or pinpointing specific organ involvement. Furthermore, 13 of the 25 studies validated their results for a selected number of biomarkers in an independent cohort, resulting in the validation of 28 candidate biomarkers. It is noteworthy that 11 candidate biomarkers were identified in more than one study. A significant number of potential proteomic biomarkers that are related to a number of aspects of SLE have been identified using mass spectrometry proteomic approaches. However, further studies are required to assess the utility of these biomarkers in routine clinical practice. © 2016 The Authors. Journal of Cellular and Molecular Medicine published by John Wiley & Sons Ltd and Foundation for Cellular and Molecular Medicine.

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

PubMed

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

2016-03-08

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

A Stochastic Framework for Evaluating Seizure Prediction Algorithms Using Hidden Markov Models

PubMed Central

Wong, Stephen; Gardner, Andrew B.; Krieger, Abba M.; Litt, Brian

2007-01-01

Responsive, implantable stimulation devices to treat epilepsy are now in clinical trials. New evidence suggests that these devices may be more effective when they deliver therapy before seizure onset. Despite years of effort, prospective seizure prediction, which could improve device performance, remains elusive. In large part, this is explained by lack of agreement on a statistical framework for modeling seizure generation and a method for validating algorithm performance. We present a novel stochastic framework based on a three-state hidden Markov model (HMM) (representing interictal, preictal, and seizure states) with the feature that periods of increased seizure probability can transition back to the interictal state. This notion reflects clinical experience and may enhance interpretation of published seizure prediction studies. Our model accommodates clipped EEG segments and formalizes intuitive notions regarding statistical validation. We derive equations for type I and type II errors as a function of the number of seizures, duration of interictal data, and prediction horizon length and we demonstrate the model’s utility with a novel seizure detection algorithm that appeared to predicted seizure onset. We propose this framework as a vital tool for designing and validating prediction algorithms and for facilitating collaborative research in this area. PMID:17021032

Psychometric properties of a brief version of the Penn State Worry Questionnaire in African Americans and European Americans.

PubMed

DeLapp, Ryan C T; Chapman, L Kevin; Williams, Monnica T

2016-05-01

The reliable and valid assessment of chronic worry in African Americans is vital when attempting to draw cross-cultural comparisons between African Americans and other ethnic groups. As such, the current study examined the psychometric properties of a brief version of a gold standard assessment of chronic worry, specifically the Penn State Worry Questionnaire-Abbreviated (PSWQ-A; Hopko et al., 2003) in a college sample of African Americans (n = 100) and European Americans (n = 121). Results indicated that the PSWQ-A total score has good internal consistency and convergent validity with another measure of anxiety, but less than favorable discriminant validity with a measure of depression in African American and European American students. Also, the 1-factor solution for the 8-item PSWQ-A had excellent model fit in our full sample and was partially invariant between ethnic groups. Collectively, the present study provides evidence that the PSWQ-A is a psychometrically sound option for assessing chronic worry and suggests that this brief measure may enhance the time efficiency and clinical utility of research and clinical assessments in ethnically diverse samples. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Ginseng and Anticancer Drug Combination to Improve Cancer Chemotherapy: A Critical Review

PubMed Central

Chen, Shihong; Huang, Ying; O'Barr, Stephen A.; Wong, Rebecca A.; Chow, Moses Sing Sum

2014-01-01

Ginseng, a well-known herb, is often used in combination with anticancer drugs to enhance chemotherapy. Its wide usage as well as many documentations are often cited to support its clinical benefit of such combination therapy. However the literature based on objective evidence to make such recommendation is still lacking. The present review critically evaluated relevant studies reported in English and Chinese literature on such combination. Based on our review, we found good evidence from in vitro and in vivo animal studies showing enhanced antitumor effect when ginseng is used in combination with some anticancer drugs. However, there is insufficient clinical evidence of such benefit as very few clinical studies are available. Future research should focus on clinically relevant studies of such combination to validate the utility of ginseng in cancer. PMID:24876866

Development of a transformation model to derive general population-based utility: Mapping the pruritus-visual analog scale (VAS) to the EQ-5D utility.

PubMed

Park, Sun-Young; Park, Eun-Ja; Suh, Hae Sun; Ha, Dongmun; Lee, Eui-Kyung

2017-08-01

Although nonpreference-based disease-specific measures are widely used in clinical studies, they cannot generate utilities for economic evaluation. A solution to this problem is to estimate utilities from disease-specific instruments using the mapping function. This study aimed to develop a transformation model for mapping the pruritus-visual analog scale (VAS) to the EuroQol 5-Dimension 3-Level (EQ-5D-3L) utility index in pruritus. A cross-sectional survey was conducted with a sample (n = 268) drawn from the general population of South Korea. Data were randomly divided into 2 groups, one for estimating and the other for validating mapping models. To select the best model, we developed and compared 3 separate models using demographic information and the pruritus-VAS as independent variables. The predictive performance was assessed using the mean absolute deviation and root mean square error in a separate dataset. Among the 3 models, model 2 using age, age squared, sex, and the pruritus-VAS as independent variables had the best performance based on the goodness of fit and model simplicity, with a log likelihood of 187.13. The 3 models had similar precision errors based on mean absolute deviation and root mean square error in the validation dataset. No statistically significant difference was observed between the mean observed and predicted values in all models. In conclusion, model 2 was chosen as the preferred mapping model. Outcomes measured as the pruritus-VAS can be transformed into the EQ-5D-3L utility index using this mapping model, which makes an economic evaluation possible when only pruritus-VAS data are available. © 2017 John Wiley & Sons, Ltd.

Reexamining the Validity and Dimensionality of the Moorong Self-Efficacy Scale: Improving Its Clinical Utility.

PubMed

Middleton, James W; Tran, Yvonne; Lo, Charles; Craig, Ashley

2016-12-01

To improve the clinical utility of the Moorong Self-Efficacy Scale (MSES) by reexamining its factor structure and comparing its performance against a measure of general self-efficacy in persons with spinal cord injury (SCI). Cross-sectional survey design. Community. Adults with SCI (N=161; 118 men and 43 women) recruited from Australia (n=82) and the United States (n=79), including 86 with paraplegia and 75 with tetraplegia. None. Confirmatory factor analysis deriving fit indices on reported 1-, 2-, and 3-factor structures for the MSES. Exploratory factor analysis of MSES using principal component analysis with promax oblique rotation and structure validation, with correlations and multiple regression using cross-sectional data from the Sherer General Self-Efficacy Scale and Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). The MSES was confirmed to have a 3-factor structure, explaining 61% of variance. Two of the factors, labeled social function self-efficacy and personal function self-efficacy, were SCI condition-specific, whereas the other factor (accounting for 9.7% of variance) represented general self-efficacy, correlating most strongly with the Sherer General Self-Efficacy Scale. Correlations and multiple regression analyses between MSES factors, Sherer General Self-Efficacy Scale total score, SF-36 Physical and Mental Component Summary scores, and SF-36 domain scores support validity of this MSES factor structure. No significant cross-cultural differences existed between Australia and the United States in total MSES or factor scores. The findings support a 3-factor structure encompassing general and SCI domain-specific self-efficacy beliefs and better position the MSES to assist SCI rehabilitation assessment, planning, and research. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Validation of the MEDFICTS dietary assessment questionnaire in a diverse population.

PubMed

Mochari, Heidi; Gao, Qian; Mosca, Lori

2008-05-01

The National Cholesterol Education Program (NCEP) recommends MEDFICTS, a rapid screening instrument for dietary fat, to assess adherence to the Adult Treatment Panel (ATP) III Therapeutic Lifestyle Changes (TLC) diet (score <40 points indicates intake of <7% of energy from saturated fat, <30% of energy from total fat, and <200 mg dietary cholesterol/day). MEDFICTS has only been validated in small, select populations and its utility in diverse clinical settings is unknown. To evaluate the ability of MEDFICTS to identify individuals who are nonadherent to a TLC diet in an ethnically diverse population that includes both English- and Spanish-speakers. MEDFICTS was administered concurrently with the Gladys Block Food Frequency Questionnaire to participants (n=501; mean age 48+/-13.5 years; 36% nonwhite; 66% female) in the National Heart, Lung, and Blood Institute Family Intervention Trial for Heart Health (FIT Heart) at the baseline screening visit. Reliability and validity analyses were conducted overall and by sex, age, and race/ethnicity. MEDFICTS score correlated significantly with percentage of energy from saturated fat (r=0.52, P<0.0001), percentage of energy from total fat (r=0.31, P<0.0001), and milligrams per day of dietary cholesterol (r=0.54, P<0.0001). Sensitivity of MEDFICTS to correctly identify TLC diet adherence was 85.7% and did not differ significantly by sex, age, or race/ethnicity. Specificity of MEDFICTS to correctly identify nonadherence to the TLC diet was low (56.9%) and significantly worse for women than men (48.4% vs 72.9%; P<0.0001), but did not differ significantly in older vs younger participants or among white, black, or Hispanic participants. Our data suggest that sex-specific recalibration of MEDFICTS may improve specificity and clinical utility.

Comparing a combination of validated questionnaires and level III portable monitor with polysomnography to diagnose and exclude sleep apnea.

PubMed

Pereira, Effie J; Driver, Helen S; Stewart, Steven C; Fitzpatrick, Michael F

2013-12-15

Questionnaires have been validated as screening tools in adult populations at risk for obstructive sleep apnea (OSA). Portable monitors (PM) have gained acceptance for confirmation of OSA in some patients with a high pretest probability of the disorder. We evaluated the combined diagnostic utility of 3 validated questionnaires and a Level III PM in the diagnosis and exclusion of OSA, as compared with in-laboratory polysomnography (PSG) derived apnea hypopnea index (AHI). Consecutive patients referred to the Sleep Disorders Clinic completed 3 testing components: (1) 3 questionnaires (Berlin, STOP-Bang, and Sleep Apnea Clinical Score [SACS]); (2) Level III at-home PM (MediByte) study; and (3) Level I in-laboratory PSG. The utility of individual questionnaires, the Level III device alone, and the combination of questionnaires and the Level III device were compared with the PSG. One hundred twenty-eight patients participated in the study (84M, 44F), mean ± SD age 50 ± 12.3years, BMI 31 ± 6.6 kg/m(2). At a PSG threshold AHI = 10, the PM derived respiratory disturbance index (RDI) had a sensitivity and specificity of 79% and 86%, respectively. The sensitivity and specificity for the other screening tools were: Berlin 88%, 25%; STOP-Bang 90%, 25%; SACS 33%, 75%. The sensitivity and specificity at a PSG AHI = 15 were: PM 77%, 95%; Berlin 91%, 28%; STOP-Bang 93%, 28%; SACS 35%, 78%. Questionnaires alone, possibly given a reliance on sleepiness as a symptom, cannot reliably rule out the presence of OSA. Objective physiological measurement is critical for the diagnosis and exclusion of OSA.

Validating and assessing the sensitivity of the Health Assessment Questionnaire-Disability Index-derived Short Form-6D in patients with early aggressive rheumatoid arthritis.

PubMed

Amjadi, Sogol S; Maranian, Paul M; Paulus, Harold E; Kaplan, Robert M; Ranganath, Veena K; Furst, Daniel E; Khanna, Puja P; Khanna, Dinesh

2009-06-01

New methodologies allow the scores for the Health Assessment Questionnaire-Disability Index (HAQ-DI) to be translated into preferences/utility scores. We evaluated the construct validity of the HAQ-DI-derived Short Form-6D (SF-6D) score and assessed its responsiveness to change over 6- and 12-month followup periods in patients with early aggressive rheumatoid arthritis (RA). Patients (n=277) participating in an RA observational study completed self-reported measures of symptoms and the HAQ-DI at baseline and at 6 and 12 months. Total Sharp scores, C-reactive protein, and erythrocyte sedimentation rate were assessed along with clinical data. Construct validity was assessed by examining the association between SF-6D score and patient-reported and clinical measures using Spearman correlation coefficients. The responsiveness of SF-6D to change was assessed using patient and physician assessments of the disease as clinical anchors. The magnitude of responsiveness was calculated using SF-6D effect size (ES). Mean SF-6D scores were 0.690, 0.720, and 0.723 at baseline and 6 and 12-month followup, respectively. Baseline patient-reported measures had moderate to high correlations with baseline SF-6D (r=0.43 to 0.52); whereas clinical measures had negligible to low correlations with SF-6D (r=0.001 to 0.32). ES was moderate for the groups that were deemed to have improved (ES 0.63-0.75) but negligible to small for those that did not (ES 0.13-0.46). Our data support the validity and responsiveness of the HAQ-DI derived SF-6D score in an early RA cohort. These results support the use of the HAQ-DI derived SF-6D in RA cohorts and clinical trials lacking preference-based measures.

Development and validation of the Overall Depression Severity and Impairment Scale.

PubMed

Bentley, Kate H; Gallagher, Matthew W; Carl, Jenna R; Barlow, David H

2014-09-01

The need to capture severity and impairment of depressive symptomatology is widespread. Existing depression scales are lengthy and largely focus on individual symptoms rather than resulting impairment. The Overall Depression Severity and Impairment Scale (ODSIS) is a 5-item, continuous measure designed for use across heterogeneous mood disorders and with subthreshold depressive symptoms. This study examined the psychometric properties of the ODSIS in outpatients in a clinic for emotional disorders (N = 100), undergraduate students (N = 566), and community-based adults (N = 189). Internal consistency, latent structure, item response theory, classification accuracy, convergent and discriminant validity, and differential item functioning analyses were conducted. ODSIS scores exhibited excellent internal consistency, and confirmatory factor analyses supported a unidimensional structure. Item response theory results demonstrated that the ODSIS provides more information about individuals with high levels of depression than those with low levels of depression. Responses on the ODSIS discriminated well between individuals with and without a mood disorder and depression-related severity across clinical and subclinical levels. A cut score of 8 correctly classified 82% of outpatients as with or without a mood disorder; it evidenced a favorable balance of sensitivity and specificity and of positive and negative predictive values. The ODSIS demonstrated good convergent and discriminant validity, and results indicate that items function similarly across clinical and nonclinical samples. Overall, findings suggest that the ODSIS is a valid tool for measuring depression-related severity and impairment. The brevity and ease of use of the ODSIS support its utility for screening and monitoring treatment response across a variety of settings. PsycINFO Database Record (c) 2014 APA, all rights reserved.

Psychometric evaluation of the PainCAS Interference with Daily Activities, Psychological/Emotional Distress, and Pain scales.

PubMed

McCaffrey, Stacey A; Black, Ryan A; Butler, Stephen F

2018-03-01

The PainCAS is a web-based clinical tool for assessing and tracking pain and opioid risk in chronic pain patients. Despite evidence for its utility within the clinical setting, the PainCAS scales have never been subject to psychometric evaluation. The current study is the first to evaluate the psychometric properties of the PainCAS Interference with Daily Activities, Psychological/Emotional Distress, and Pain scales. Patients (N = 4797) from treatment centers and hospitals in 16 different states completed the PainCAS as part of routine clinical assessment. A subsample (n = 73) from two hospital-based treatment centers also completed comparator measures. Rasch Rating Scale Models were employed to evaluate the Interference with Daily Activities and Psychological/Emotional Distress scales, and empirical evaluation included assessment of dimensionality, discrimination, item fit, reliability, information, and person-to-item targeting. Additionally, convergent and discriminant validity were evaluated through classical test theory approaches. Convergent validity of the Pain scales was evaluated through correlations with corresponding comparator items. One Interference with Daily Activities item was removed due to poor functioning and discrimination. The retained items from the Interference with Daily Activities and Psychological/Emotional Distress scales conformed to unidimensional Rasch measurement models, yielding satisfactory item fit, reliability, precision, and coverage. Further, results provided support for the convergent and discriminant validity of these two scales. Convergent validity between the PainCAS Pain and BPI Pain items was also strong. Taken together, results provide strong psychometric support for these PainCAS Pain scales. Strengths and limitations of the current study are discussed.

Predicting health-related quality of life (EQ-5D-5 L) and capability wellbeing (ICECAP-A) in the context of opiate dependence using routine clinical outcome measures: CORE-OM, LDQ and TOP.

PubMed

Peak, Jasmine; Goranitis, Ilias; Day, Ed; Copello, Alex; Freemantle, Nick; Frew, Emma

2018-05-30

Economic evaluation normally requires information to be collected on outcome improvement using utility values. This is often not collected during the treatment of substance use disorders making cost-effectiveness evaluations of therapy difficult. One potential solution is the use of mapping to generate utility values from clinical measures. This study develops and evaluates mapping algorithms that could be used to predict the EuroQol-5D (EQ-5D-5 L) and the ICEpop CAPability measure for Adults (ICECAP-A) from the three commonly used clinical measures; the CORE-OM, the LDQ and the TOP measures. Models were estimated using pilot trial data of heroin users in opiate substitution treatment. In the trial the EQ-5D-5 L, ICECAP-A, CORE-OM, LDQ and TOP were administered at baseline, three and twelve month time intervals. Mapping was conducted using estimation and validation datasets. The normal estimation dataset, which comprised of baseline sample data, used ordinary least squares (OLS) and tobit regression methods. Data from the baseline and three month time periods were combined to create a pooled estimation dataset. Cluster and mixed regression methods were used to map from this dataset. Predictive accuracy of the models was assessed using the root mean square error (RMSE) and the mean absolute error (MAE). Algorithms were validated using sample data from the follow-up time periods. Mapping algorithms can be used to predict the ICECAP-A and the EQ-5D-5 L in the context of opiate dependence. Although both measures can be predicted, the ICECAP-A was better predicted by the clinical measures. There were no advantages of pooling the data. There were 6 chosen mapping algorithms, which had MAE scores ranging from 0.100 to 0.138 and RMSE scores ranging from 0.134 to 0.178. It is possible to predict the scores of the ICECAP-A and the EQ-5D-5 L with the use of mapping. In the context of opiate dependence, these algorithms provide the possibility of generating utility values from clinical measures and thus enabling economic evaluation of alternative therapy options. ISRCTN22608399 . Date of registration: 27/04/2012. Date of first randomisation: 14/08/2012.

Evaluating process in child and family interventions: aggression prevention as an example.

PubMed

Tolan, Patrick H; Hanish, Laura D; McKay, Mary M; Dickey, Mitchell H

2002-06-01

This article reports on 2 studies designed to develop and validate a set of measures for use in evaluating processes of child and family interventions. In Study 1 responses from 187 families attending an outpatient clinic for child behavior problems were factor analyzed to identify scales, consistent across sources: Alliance (Satisfactory Relationship with Interventionist and Program Satisfaction), Parenting Skill Attainment, Child Cooperation During Session, Child Prosocial Behavior, and Child Aggressive Behavior. Study 2 focused on patterns of scale scores among 78 families taking part in a 22-week preventive intervention designed to affect family relationships, parenting, and child antisocial and prosocial behaviors. The factor structure identified in Study 1 was replicated. Scale construct validity was demonstrated through across-source convergence, sensitivity to intervention change, and ability to discriminate individual differences. Path analysis validated the scales' utility in explaining key aspects of the intervention process. Implications for evaluating processes in family interventions are discussed.

Sexual Behavior Among Persons With Cognitive Impairments.

PubMed

Thom, Robyn P; Grudzinskas, Albert J; Saleh, Fabian M

2017-05-01

Although the cognitively impaired are frequently included in heterogeneous studies of problematic sexual behavior, the epidemiology, etiology, and approach to assessment and treatment of persons with dementia and intellectual disability are distinct from those of the general population. The incidence of inappropriate sexual behavior among the intellectually disabled is 15-33%; however, the nature tends to be more socially inappropriate than with violative intent. Limited sociosexual education is a large contributor, and better addressing this area offers a target for prevention and treatment. A thorough clinical assessment of problematic sexual behaviors in the cognitively impaired requires understanding the patient's internal experience, which can be challenging. Assessment tools validated for the general population have not been validated for this population. Very few studies have assessed treatment approaches specifically among the cognitively impaired; however, research does suggest utility in habilitative, psychotherapeutic, and pharmacologic approaches which have been validated among the general population.

Poor Validity of the DSM-IV Schizoid Personality Disorder Construct as a Diagnostic Category.

PubMed

Hummelen, Benjamin; Pedersen, Geir; Wilberg, Theresa; Karterud, Sigmund

2015-06-01

This study sought to evaluate the construct validity of schizoid personality disorder (SZPD) by investigating a sample of 2,619 patients from the Norwegian Network of Personality-Focused Treatment Programs by a variety of statistical techniques. Nineteen patients (0.7%) reached the diagnostic threshold of SZPD. Results from the factor analyses indicated that SZPD consists of three factors: social detachment, withdrawal, and restricted affectivity/ anhedonia. Overall, internal consistency and diagnostic efficiency were poor and best for the criteria that belong to the social detachment factor. These findings pose serious questions about the clinical utility of SZPD as a diagnostic category. On the other hand, the three factors were in concordance with findings from previous studies and with the trait model for personality disorders in DSM-5, supporting the validity of SZPD as a dimensional construct. The authors recommend that SZPD should be deleted as a diagnostic category in future editions of DSM-5.

Obsessive-compulsive aspects of craving: development of the Obsessive Compulsive Drinking Scale.

PubMed

Anton, R F

2000-08-01

"Craving" for alcohol needs improved definition and measurement. This review provides a rationale for considering at least certain aspects of craving as having obsessive and compulsive features. As such, there may be phenomenological, but not necessarily etiological, overlap with obsessive-compulsive disorder. There are increasing data that suggest a neuroanatomical overlap between addiction/craving and obsessive-compulsive symptoms. The self-rated Obsessive Compulsive Drinking Scale (OCDS), based on the Yale-Brown Obsessive Compulsive Scale for heavy drinking interview (YBOCS-hd), was developed to assist in the examination of certain aspects of "craving" in alcoholics. The development, reliability, face validity, congruent validity and predictive validity of the OCDS are presented and discussed in this paper. The utility of the OCDS as a measurement tool in cognitive-behavioral and pharmacological alcoholism treatment research is highlighted. The potential of this instrument as a research and clinical tool for the understanding and evaluation of alcohol dependence needs further evaluation.

Evaluation of magical thinking: validation of the Illusory Beliefs Inventory.

PubMed

Shihata, Sarah; Egan, Sarah J; Rees, Clare S

2014-01-01

Magical thinking has been related to obsessive-compulsive disorder; yet, little research has examined this construct in other anxiety disorders. The Illusory Beliefs Inventory (IBI) is a recently developed measure of magical thinking. The aim of this study was to investigate the psychometric properties of this new measure and to determine if magical thinking accounts for pathological worry beyond the well-researched constructs of intolerance of uncertainty (IU) and perfectionism. A sample of 502 participants completed an online survey. Confirmatory factor analysis identified a three-factor solution for the IBI, and the measure had good internal consistency (α = .92), test-retest reliability (r = .94) and discriminant validity. Magical thinking, IU, and perfectionism all predicted pathological worry; however, magical thinking accounted for less than 1% of unique variance in worry, suggesting that it is not strongly related to worry. Further investigation regarding the validity and clinical utility of the IBI is required.

Assessing lesbian, gay, and bisexual affirmative training in couple and family therapy: establishing the validity of the Faculty Version of the Affirmative Training Inventory.

PubMed

McGeorge, Christi R; Carlson, Thomas S; Toomey, Russell B

2015-01-01

This study established the validity and factor structure of the Faculty Version of the Affirmative Training Inventory (ATI-F), which assesses faculty members' perceptions of the level of lesbian, gay, and bisexual (LGB) affirmative training that occurs in clinical programs. Additionally, this study examined the latent associations among the subscales of the ATI-F and three convergent validity items utilizing a sample of 117 faculty members from accredited family therapy programs. The findings provide empirical support for the relationship between including classroom content on LGB affirmative therapy and faculty members' beliefs about LGB individuals and relationships. Specifically, faculty members who report more positive beliefs about LGB clients appear to be more likely to include LGB affirmative therapy content in the courses they teach. © 2013 American Association for Marriage and Family Therapy.

Prediction of Low Birth Weight Delivery by Maternal Status and Its Validation: Decision Curve Analysis.

PubMed

Rejali, Mehri; Mansourian, Marjan; Babaei, Zohre; Eshrati, Babak

2017-01-01

In this study, we evaluated assessed elements connected with low birth weight (LBW) and used decision curve analysis (DCA) to define a scale to anticipate the probability of having a LBW newborn child. This hospital-based case-control study was led in Arak Hospital in Iran. The study included 470 mothers with LBW neonate and 470 mothers with natural neonates. Information were gathered by meeting moms utilizing preplanned organized questionnaire and from hospital records. The estimated probabilities of detecting LBW were calculated using the logistic regression and DCA to quantify the clinical consequences and its validation. Factors significantly associated with LBW were premature membrane rupture (odds ratio [OR] = 3.18 [1.882-5.384]), former LBW infants (OR = 2.99 [1.510-5.932]), premature pain (OR = 2.70 [1.659-4.415]), hypertension in pregnancy (OR = 2.39 [1.429-4.019]), last trimester of pregnancy bleeding (OR = 2.58 [1.018-6.583]), mother age >30 (OR = 2.17 [1.350-3.498]). However, with DCA, the prediction model made on these 15 variables has a net benefit (NB) of 0.3110 is best predictive with the highest NB. NB has simple clinical interpretation and utilizing the model is what might as well be called a procedure that distinguished what might as well be called 31.1 LBW per 100 cases with no superfluous recognize. It is conceivable to foresee LBW utilizing a prediction model show in light of noteworthy hazard components connected with LBW. The majority of the hazard elements for LBW are preventable, and moms can be alluded amid early pregnancy to a middle which is furnished with facilities for administration of high hazard pregnancy and LBW infant.

Prediction of Low Birth Weight Delivery by Maternal Status and Its Validation: Decision Curve Analysis

PubMed Central

Rejali, Mehri; Mansourian, Marjan; Babaei, Zohre; Eshrati, Babak

2017-01-01

Background: In this study, we evaluated assessed elements connected with low birth weight (LBW) and used decision curve analysis (DCA) to define a scale to anticipate the probability of having a LBW newborn child. Methods: This hospital-based case–control study was led in Arak Hospital in Iran. The study included 470 mothers with LBW neonate and 470 mothers with natural neonates. Information were gathered by meeting moms utilizing preplanned organized questionnaire and from hospital records. The estimated probabilities of detecting LBW were calculated using the logistic regression and DCA to quantify the clinical consequences and its validation. Results: Factors significantly associated with LBW were premature membrane rupture (odds ratio [OR] = 3.18 [1.882–5.384]), former LBW infants (OR = 2.99 [1.510–5.932]), premature pain (OR = 2.70 [1.659–4.415]), hypertension in pregnancy (OR = 2.39 [1.429–4.019]), last trimester of pregnancy bleeding (OR = 2.58 [1.018–6.583]), mother age >30 (OR = 2.17 [1.350–3.498]). However, with DCA, the prediction model made on these 15 variables has a net benefit (NB) of 0.3110 is best predictive with the highest NB. NB has simple clinical interpretation and utilizing the model is what might as well be called a procedure that distinguished what might as well be called 31.1 LBW per 100 cases with no superfluous recognize. Conclusions: It is conceivable to foresee LBW utilizing a prediction model show in light of noteworthy hazard components connected with LBW. The majority of the hazard elements for LBW are preventable, and moms can be alluded amid early pregnancy to a middle which is furnished with facilities for administration of high hazard pregnancy and LBW infant. PMID:28928911

An investigation of normal urine with a creatinine concentration under the cutoff of 20 mg/dL for specimen validity testing in a toxicology laboratory.

PubMed

Holden, Brad; Guice, Erica A

2014-05-01

In clinical and forensic toxicology laboratories, one commonly used method for urine specimen validity testing is creatinine concentration. In this study, workplace guidelines are examined to determine their relevance to forensic and clinical toxicology samples. Specifically, it investigates the occurrence of urine creatinine concentrations under 20 mg/dL and notes potential issues with factors influencing creatinine concentration by utilizing a simple, novel method consisting of cation-paring high-pressure liquid chromatography in tandem with ultraviolet detection to determine the creatinine concentration in 3019 donors. Of the 4227 sample population in this study, 209 (4.94%) were below the cutoff value of 20 mg/dL for dilute urine. Because there are many factors that can influence the urinary creatinine concentration, samples that have creatinine under the 20 mg/dL cutoff do not always implicate sample adulteration. © 2014 American Academy of Forensic Sciences.

Concepts for the translation of genome-based innovations into public health: a comprehensive overview.

PubMed

Syurina, Elena V; Schulte In den Bäumen, Tobias; Brand, Angela; Ambrosino, Elena; Feron, Frans Jm

2013-03-01

Recent vast and rapid development of genome-related sciences is followed by the development of different assessment techniques or attempts to adapt the existing ones. The aim of this article is to give an overview of existing concepts for the assessment and translation of innovations into healthcare, applying a descriptive analysis of their present use by public health specialists and policy makers. The international literature review identified eight concepts including Health Technology Assessment, analytic validity, clinical validity, clinical utility, ethical, legal and social implications, Public Health Wheel and others. This study gives an overview of these concepts (including the level of current use) applying a descriptive analysis of their present use by public health specialists and policy makers. Despite the heterogeneity of the analyzed concepts and difference in use in everyday healthcare practice, the cross-integration of these concepts is important in order to improve translation speed and quality. Finally, some recommendations are made regarding the most applicable translational concepts.

Updating the OMERACT Filter: Implications for imaging and soluble biomarkers

PubMed Central

D’Agostino, Maria-Antonietta; Boers, Maarten; Kirwan, John; van der Heijde, Desirée; Østergaard, Mikkel; Schett, Georg; Landewé, Robert B.M.; Maksymowych, Walter P.; Naredo, Esperanza; Dougados, Maxime; Iagnocco, Annamaria; Bingham, Clifton O.; Brooks, Peter; Beaton, Dorcas; Gandjbakhch, Frederique; Gossec, Laure; Guillemin, Francis; Hewlett, Sarah; Kloppenburg, Margreet; March, Lyn; Mease, Philip J; Moller, Ingrid; Simon, Lee S; Singh, Jasvinder A; Strand, Vibeke; Wakefield, Richard J; Wells, George; Tugwell, Peter; Conaghan, Philip G

2014-01-01

Objective The OMERACT Filter provides a framework for the validation of outcome measures for use in rheumatology clinical research. However, imaging and biochemical measures may face additional validation challenges due to their technical nature. The Imaging and Soluble Biomarker Session at OMERACT 11 aimed to provide a guide for the iterative development of an imaging or biochemical measurement instrument so it can be used in therapeutic assessment. Methods A hierarchical structure was proposed, reflecting 3 dimensions needed for validating an imaging or biochemical measurement instrument: outcome domain(s), study setting and performance of the instrument. Movement along the axes in any dimension reflects increasing validation. For a given test instrument, the 3-axis structure assesses the extent to which the instrument is a validated measure for the chosen domain, whether it assesses a patient or disease centred-variable, and whether its technical performance is adequate in the context of its application. Some currently used imaging and soluble biomarkers for rheumatoid arthritis, spondyloarthritis and knee osteoarthritis were then evaluated using the original OMERACT filter and the newly proposed structure. Break-out groups critically reviewed the extent to which the candidate biomarkers complied with the proposed step-wise approach, as a way of examining the utility of the proposed 3 dimensional structure. Results Although there was a broad acceptance of the value of the proposed structure in general, some areas for improvement were suggested including clarification of criteria for achieving a certain level of validation and how to deal with extension of the structure to areas beyond clinical trials. Conclusion General support was obtained for a proposed tri-axis structure to assess validation of imaging and soluble biomarkers; nevertheless, additional work is required to better evaluate its place within the OMERACT Filter 2.0. PMID:24584916

Updating the OMERACT filter: implications for imaging and soluble biomarkers.

PubMed

D'Agostino, Maria-Antonietta; Boers, Maarten; Kirwan, John; van der Heijde, Désirée; Østergaard, Mikkel; Schett, Georg; Landewé, Robert B; Maksymowych, Walter P; Naredo, Esperanza; Dougados, Maxime; Iagnocco, Annamaria; Bingham, Clifton O; Brooks, Peter M; Beaton, Dorcas E; Gandjbakhch, Frederique; Gossec, Laure; Guillemin, Francis; Hewlett, Sarah E; Kloppenburg, Margreet; March, Lyn; Mease, Philip J; Moller, Ingrid; Simon, Lee S; Singh, Jasvinder A; Strand, Vibeke; Wakefield, Richard J; Wells, George A; Tugwell, Peter; Conaghan, Philip G

2014-05-01

The Outcome Measures in Rheumatology (OMERACT) Filter provides a framework for the validation of outcome measures for use in rheumatology clinical research. However, imaging and biochemical measures may face additional validation challenges because of their technical nature. The Imaging and Soluble Biomarker Session at OMERACT 11 aimed to provide a guide for the iterative development of an imaging or biochemical measurement instrument so it can be used in therapeutic assessment. A hierarchical structure was proposed, reflecting 3 dimensions needed for validating an imaging or biochemical measurement instrument: outcome domain(s), study setting, and performance of the instrument. Movement along the axes in any dimension reflects increasing validation. For a given test instrument, the 3-axis structure assesses the extent to which the instrument is a validated measure for the chosen domain, whether it assesses a patient-centered or disease-centered variable, and whether its technical performance is adequate in the context of its application. Some currently used imaging and soluble biomarkers for rheumatoid arthritis, spondyloarthritis, and knee osteoarthritis were then evaluated using the original OMERACT Filter and the newly proposed structure. Breakout groups critically reviewed the extent to which the candidate biomarkers complied with the proposed stepwise approach, as a way of examining the utility of the proposed 3-dimensional structure. Although there was a broad acceptance of the value of the proposed structure in general, some areas for improvement were suggested including clarification of criteria for achieving a certain level of validation and how to deal with extension of the structure to areas beyond clinical trials. General support was obtained for a proposed tri-axis structure to assess validation of imaging and soluble biomarkers; nevertheless, additional work is required to better evaluate its place within the OMERACT Filter 2.0.

Novel Signs and Their Clinical Utility in Diagnosing Complex Regional Pain Syndrome (CRPS): A Prospective Observational Cohort Study.

PubMed

Kuttikat, Anoop; Shaikh, Maliha; Oomatia, Amin; Parker, Richard; Shenker, Nicholas

2017-06-01

Delays in diagnosis occur with complex regional pain syndrome (CRPS). We define and prospectively demonstrate that novel bedside tests measuring body perception disruption can identify patients with CRPS postfracture. The objectives of our study were to define and validate 4 bedside tests, to identify the prevalence of positive tests in patients with CRPS and other chronic pain conditions, and to assess the clinical utility (sensitivity, specificity, positive predictive value, negative predictive value) for identifying CRPS within a Fracture cohort. This was a single UK teaching hospital prospective cohort study with 313 recruits from pain-free volunteers and patients with chronic pain conditions.Four novel tests were Finger Perception (FP), Hand Laterality identification (HL), Astereognosis (AS), and Body Scheme (BS) report. Five questionnaires (Brief Pain Inventory, Upper Extremity Functional Index, Lower Extremity Functional Index, Neglect-like Symptom Questionnaire, Hospital Anxiety and Depression Score) assessed the multidimensional pain experience. FP and BS were the best performing tests. Prospective monitoring of fracture patients showed that out of 7 fracture patients (total n=47) who had both finger misperception and abnormal BS report at initial testing, 3 developed persistent pain with 1 having a formal diagnosis of CRPS. Novel signs are reliable, easy to perform, and present in chronic pain patients. FP and BS have significant clinical utility in predicting persistent pain in a fracture group thereby allowing targeted early intervention.

Measuring Resource Utilization: A Systematic Review of Validated Self-Reported Questionnaires.

PubMed

Leggett, Laura E; Khadaroo, Rachel G; Holroyd-Leduc, Jayna; Lorenzetti, Diane L; Hanson, Heather; Wagg, Adrian; Padwal, Raj; Clement, Fiona

2016-03-01

A variety of methods may be used to obtain costing data. Although administrative data are most commonly used, the data available in these datasets are often limited. An alternative method of obtaining costing is through self-reported questionnaires. Currently, there are no systematic reviews that summarize self-reported resource utilization instruments from the published literature.The aim of the study was to identify validated self-report healthcare resource use instruments and to map their attributes.A systematic review was conducted. The search identified articles using terms like "healthcare utilization" and "questionnaire." All abstracts and full texts were considered in duplicate. For inclusion, studies had to assess the validity of a self-reported resource use questionnaire, to report original data, include adult populations, and the questionnaire had to be publically available. Data such as type of resource utilization assessed by each questionnaire, and validation findings were extracted from each study.In all, 2343 unique citations were retrieved; 2297 were excluded during abstract review. Forty-six studies were reviewed in full text, and 15 studies were included in this systematic review. Six assessed resource utilization of patients with chronic conditions; 5 assessed mental health service utilization; 3 assessed resource utilization by a general population; and 1 assessed utilization in older populations. The most frequently measured resources included visits to general practitioners and inpatient stays; nonmedical resources were least frequently measured. Self-reported questionnaires on resource utilization had good agreement with administrative data, although, visits to general practitioners, outpatient days, and nurse visits had poorer agreement.Self-reported questionnaires are a valid method of collecting data on healthcare resource utilization.

Artificial intelligence-assisted occupational lung disease diagnosis.

PubMed

Harber, P; McCoy, J M; Howard, K; Greer, D; Luo, J

1991-08-01

An artificial intelligence expert-based system for facilitating the clinical recognition of occupational and environmental factors in lung disease has been developed in a pilot fashion. It utilizes a knowledge representation scheme to capture relevant clinical knowledge into structures about specific objects (jobs, diseases, etc) and pairwise relations between objects. Quantifiers describe both the closeness of association and risk, as well as the degree of belief in the validity of a fact. An independent inference engine utilizes the knowledge, combining likelihoods and uncertainties to achieve estimates of likelihood factors for specific paths from work to illness. The system creates a series of "paths," linking work activities to disease outcomes. One path links a single period of work to a single possible disease outcome. In a preliminary trial, the number of "paths" from job to possible disease averaged 18 per subject in a general population and averaged 25 per subject in an asthmatic population. Artificial intelligence methods hold promise in the future to facilitate diagnosis in pulmonary and occupational medicine.

[Validity of the Child Psychiatric Hospital Teacher Questionnaire for the assessment of ADHD. Teacher's version].

PubMed

Ulloa, R E; Narváez, M R; Arroyo, E; del Bosque, J; de la Peña, F

2009-01-01

Teacher's rating scales for the evaluation of attention deficit and superactivity disorder (TDAH) and conduct disorders have been shown to be useful and valid tools. The Child Psychiatric Hospital Teacher Questionnaire (CPHTQ) of the Hospital Psiquiátrico Infantil Dr. Juan N. Navarro was designed for the assessment of ADHD symptoms, externalizing symptoms and school functioning difficulties of children and adolescents. Internal consistency, criterion validity, construct validity and sensitivity of the scale to changes in symptom severity were evaluated in this study. The scale was administered to 282 teachers of children and adolescents aged 5 to 17 years who came to a unit specialized in child psychiatry. The validity analysis of the instrument showed that the internal consistency measured by Cronbach's alpha was 0.94. The factorial analysis yielded 5 factors accounting for 59.1% of the variance: hyperactivity and conduct symptoms, predatory, conduct disorder, inattentive, poor functioning and motor disturbances. The CPHTQ scores on the scale showed positive correlation with the Clinical Global impression (CGI) scale in the patients' response to drug treatment. The CPHTQ shows adequate validity characteristics that demonstrate its utility in the evaluation of patients with ADHD and its comorbidity with other behavior disorders.

A comparison of the psychometric properties of the psychopathic personality inventory full-length and short-form versions.

PubMed

Kastner, Rebecca M; Sellbom, Martin; Lilienfeld, Scott O

2012-03-01

The Psychopathic Personality Inventory (PPI) has shown promising construct validity as a measure of psychopathy. Because of its relative efficiency, a short-form version of the PPI (PPI-SF) was developed and has proven useful in many psychopathy studies. The validity of the PPI-SF, however, has not been thoroughly examined, and no studies have directly compared the validity of the short form with that of the full-length version. The current study was designed to compare the psychometric properties of both PPI versions, with an emphasis on convergent and discriminant validity in predicting external criteria conceptually relevant to psychopathy. We used both prison (n = 558) and college samples (n = 322) for this investigation. PPI scale scores were more reliable and more strongly correlated with the conceptually relevant criterion measures compared with the PPI-SF, particularly in the prison sample. There were no differences in relative discriminant validity. Thus, overall, the PPI full-length version showed more evidence of construct validity than did the short form, and the consequences of this psychometric difference should be considered when evaluating the clinical utility of each measure.

Consumer sleep tracking devices: a review of mechanisms, validity and utility.

PubMed

Kolla, Bhanu Prakash; Mansukhani, Subir; Mansukhani, Meghna P

2016-05-01

Consumer sleep tracking devices such as fitness trackers and smartphone apps have become increasingly popular. These devices claim to measure the sleep duration of their users and in some cases purport to measure sleep quality and awaken users from light sleep, potentially improving overall sleep. Most of these devices appear to utilize data generated from in-built accelerometers to determine sleep parameters but the exact mechanisms and algorithms are proprietary. The growing literature comparing these devices against polysomnography/actigraphy shows that they tend to underestimate sleep disruptions and overestimate total sleep times and sleep efficiency in normal subjects. In this review, we evaluate the current literature comparing the accuracy of consumer sleep tracking devices against more conventional methods used to measure sleep duration and quality. We discuss the current technology that these devices utilize as well as summarize the value of these devices in clinical evaluations and their potential limitations.

Identifying influence of perceived quality and satisfaction on the utilization status of the community clinic services; Bangladesh context.

PubMed

Karim, R M; Abdullah, M S; Rahman, A M; Alam, A M

2015-04-01

Bangladesh is one among the few countries of the world that provides free medical services at the community level through various public health facilities. It is now evident that, clients' perceived quality of services and their expectations of service standards affect health service utilization to a great extent. The aim of the study was to develop and validate the measures for perception and satisfaction of primary health care quality in Bangladesh context and to identify their aspects on the utilization status of the Community Clinic (CC) services. This mixed method cross sectional survey was conducted from January to June 2012, in the catchment area of 12 Community Clinics (CCs). Since most of the outcome indicators focus mainly on women and children, women having children less than two years of age were randomly assigned and interviewed for the study purpose. Data for the development of perceived service quality and satisfaction tools were collected through Focus Group Discussion (FGD), key informants interview and data for measuring the utilization status were collected by an interviewer administered pretested semi-structured questionnaire. About 95% of the respondents were Muslims and 5% were Hindus. The average age of the respondents was 23.38 (SD ± 4.15) years and almost all of them are home makers. The average monthly expenditure of their family was 7462.92 (SD ± 2545) BDT equivalent to 95 (SD ± 32) US$. To measure lay peoples' perception and satisfaction regarding primary health care service quality two scales e.g. Slim Haddad's 20-item scale for measuring perceived quality of primary health care services (PQPCS) validated in Guinea and Burkina Fuso and primary care satisfaction survey for women (PCSSW) developed by Scholle and colleagues 2004; is a 24-item survey tool validated in Turkey were chosen as a reference tools. Based on those, two psychometric research instruments; 24 items PQPCS scale (chronbach's α =0.89) and 22-items Community Clinic Service Satisfaction (CCSS) scale (chronbach's α = 0.97), were constructed and validated for measuring perceived service quality and satisfaction in Bangladesh context. This study showed mothers with preprimary education [(χ2 = 4.20, p = 0.04), AOR with 95% CI = 1.89 (1.03, 3.53)] utilized the limited curative care services more than educated mothers. On the contrary, higher income families [for income group 5000-10,000 BDT χ2 = 8.83, p = 0.003 and AOR with 95% CI = 0.37(0.19, 0.71)] and [for income group above 10,000 BDT χ2 = 5.02, p = 0.025 and AOR with 95% CI = 0.40 (0.18, 0.89)] and families having cultivable lands [for 5-10 decimal group χ2 = 5.51, p = 0.19, and AOR with 95% CI = 0.56 (0.35, 0.91)] and [for > 10 decimal group χ2 = 6.70, p = 0.010, and AOR with 95% CI = 0.50 (0.29, 0.84)] utilized the limited curative care services less than their poorer and landless counterpart. The same relationship was observed in case of health education and Antenatal Care (ANC) and Postnatal Care (PNC) services. Women who lived in their own residence used health education services more frequently than those who lived in a rental house [χ2 = 24.00, p = 0.000 and AOR with 95% CI = 1.21, (1.12, 1.30)] and they also increasingly used maternal and child health services χ2 = 27.49, p = 0.000 and AOR with 95% CI 1.61, (1.35, 1.93)]. Perceptions concerning skill and competence of the health care provider [χ2 = 16.90, p = 0.000 and AOR with 95% CI = 1.14, (1.07, 1.22)] and satisfaction indicating interpersonal communication and attitude of the care provider [χ2 = 7.07, p = 0.008 AOR with 95% CI = 1.08, (1.02, 1.15)] were found significant predictors for limited curative care service utilization of CC. Perception related to the quality of management, administration, physical environment of the service point and satisfaction addressing health promotion and women health issues also played significant role on CC's services utilization. Besides parental education and income, client's perception and satisfaction played significant role in CC service utilization. Provider's perception of service quality should be studied. The study findings will enable policy-makers .to improve quality of primary health care services, realizing providers' and patients' ideas of CC service quality.

Medical talent management: a model for physician deployment.

PubMed

Brightman, Baird

2007-01-01

This article aims to provide a focused cost-effective method for triaging physicians into appropriate non-clinical roles to benefit both doctors and healthcare organizations. Reviews a validated career-planning process and customize it for medical talent management. A structured career assessment can differentiate between different physician work styles and direct medical talent into best-fit positions. This allows healthcare organizations to create a more finely tuned career ladder than the familiar "in or out" binary choice. PRACTICAL IMPLICATIONS--Healthcare organizations can invest in cost-effective processes for the optimal utilization of their medical talent. Provides a new use for a well-validated career assessment and planning system. The actual value of this approach should be studied using best-practices in ROI research.

Preliminary validation of the Review of Musculoskeletal System (ROMS) questionnaire.

PubMed

Bershadsky, Boris; Kane, Robert L; Wuerz, Thomas; Jones, Morgan; Brighton, Brian; Stitzlein, Russell; Parker, Richard; Iannotti, Joseph P

2015-04-01

Measurement of clinical outcomes is necessary to define best practice. It requires a validated tool that can be easily applied as part of clinical practice. We present the preliminary validation of a brief self-reported Review of Musculoskeletal System (ROMS) questionnaire that captures functional limitations due to musculoskeletal problems and other medical and emotional conditions. Data were derived from a clinical outcomes database (Orthopaedic Minimal Data Set [OrthoMiDaS]) that combines patient-reported data collected as part of routine care and secondary data extracted from electronic medical records. The study utilized 82,873 encounters collected from 24,116 consecutive patients with problems in the upper and lower extremities. In addition to the ROMS, the study used version 2 of the Short Form-12 (SF-12v2), the Penn Shoulder Score (PSS), the Hip disability and Osteoarthritis Outcome Score (HOOS), and the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaires. Fifteen cross-sectional samples were used to evaluate the floor and ceiling effects as well as the construct and content validity. Five longitudinal cohorts were used to measure test-retest reliability and responsiveness. Standard statistical tests were applied. The floor and ceiling effects of the ROMS questionnaire in patients with shoulder, hip, and knee problems ranged from 1.3% to 8.5%. Construct-validity tests confirmed convergent and divergent validity of the ROMS. The tests also justified its additional value when the ROMS was used with joint-specific tools. When measuring test-retest reliability of the ROMS scales, intraclass correlation ranged from 0.80 to 0.90 at approximately one week and from 0.71 to 0.87 at approximately four weeks. Responsiveness of the ROMS was greater than that of the SF-12 and less than that of the joint-specific questionnaires. The ROMS is compatible with routine clinical process and has good psychometric properties in patients with shoulder, hip, and knee disorders. It can be used as a primary outcome tool for large observational studies and can supplement more specific tools in controlled studies. The ROMS was developed as a tool to measure and monitor the clinical status of the musculoskeletal system in a population of patients during and after treatment as well as over time. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.

Patient-reported outcomes in neurofibromatosis and schwannomatosis clinical trials.

PubMed

Wolters, Pamela L; Martin, Staci; Merker, Vanessa L; Gardner, Kathy L; Hingtgen, Cynthia M; Tonsgard, James H; Schorry, Elizabeth K; Baldwin, Andrea

2013-11-19

Neurofibromatosis (NF) is a genetic disease with multiple clinical manifestations that can significantly impact quality of life (QOL). Clinical trials should include patient-reported outcomes (PROs) as endpoints to assess treatment effects on various aspects of QOL, but there is no consensus on the selection and use of such measures in NF. This article describes the PRO Working Group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) Collaboration, its main goals, methods for identifying appropriate PRO measures for NF clinical trials, and recommendations for assessing pain intensity. The REiNS PRO group selected core endpoint domains important to assess in NF. The members developed criteria to rate PRO measures, including patient characteristics, psychometric properties, and feasibility, and utilized a systematic process to evaluate PROs for NF clinical trials. Within the subdomain of pain intensity, the group reviewed the Numerical Rating Scale-11 (NRS-11), the Visual Analogue Scale, and the Faces Pain Scale-Revised using this process. Based on the review criteria, each of these pain intensity scales is brief, reliable, valid, and widely used. However, the NRS-11 was given the highest rating for use in NF clinical trials due to recommendations from pain experts and other consensus groups, its extensive use in research, strong psychometric data including sensitivity to change, and excellent feasibility in ages ≥ 8 years. The systematic review criteria and process are effective for identifying appropriate PRO measures and provide information utilized by the REiNS Collaboration to achieve consensus regarding PROs in NF clinical trials.

Long-term outcome of hypochondriacal personality disorder.

PubMed

Tyrer, P; Seivewright, N; Seivewright, H

1999-02-01

Hypochondriacal personality disorder diagnosed according to the Personality Assessment Schedule, a structured clinical interview, was related to outcome after 2 years and 5 years in a randomized, controlled trial of treatment of generalized anxiety, panic, and dysthymic disorders. Seventeen individuals (9%) from a population of 181 patients had hypochondriacal personality disorder and they experienced a significantly worse outcome than other patients, including those with other personality disorders, in terms of symptomatic change and health service utilization. This lack of improvement was associated with persistent somatization in hypochondriacal personality disorder. The results give further support to the belief that hypochondriacal personality disorder is a valid clinical diagnosis that has important clinical correlates, but further work is needed to establish the extent of its overlap with hypochondriasis as a mental state disorder.

Oropharyngeal dysphagia: surveying practice patterns of the speech-language pathologist.

PubMed

Martino, Rosemary; Pron, Gaylene; Diamant, Nicholas E

2004-01-01

The present study was designed to obtain a comprehensive view of the dysphagia assessment practice patterns of speech-language pathologists and their opinion on the importance of these practices using survey methods and taking into consideration clinician, patient, and practice-setting variables. A self-administered mail questionnaire was developed following established methodology to maximize response rates. Eight dysphagia experts independently rated the new survey for content validity. Test-retest reliability was assessed with a random sample of 23 participants. The survey was sent to 50 speech-language pathologists randomly selected from the Canadian professional association database of members who practice in dysphagia. Surveys were mailed according to the Dillman Total Design Method and included an incentive offer. High survey (64%) and item response (95%) rates were achieved and clinicians were reliable reporters of their practice behaviors (ICC>0.60). Of all the clinical assessment items, 36% were reported with high (>80%) utilization and 24% with low (<20%) utilization, the former pertaining to tongue motion and vocal quality after food/fluid intake and the latter to testing of oral sensation without food. One-third (33%) of instrumental assessment items were highly utilized and included assessment of bolus movement and laryngeal response to bolus misdirection. Overall, clinician experience and teaching institutions influenced greater utilization. Opinions of importance were similar to utilization behaviors (r = 0.947, p = 0.01). Of all patients referred for dysphagia assessment, full clinical assessments were administered to 71% of patients but instrumental assessments to only 36%. A hierarchical model of practice behavior is proposed to explain this pattern of progressively decreasing item utilization.

Development, validation and utility of an in vitro technique for assessment of potential clinical drug-drug interactions involving P-glycoprotein.

PubMed

Keogh, John P; Kunta, Jeevan R

2006-04-01

Regulatory interest is increasing for drug transporters generally and P-glycoprotein (Pgp) in particular, primarily in the area of drug-drug interactions. To aid in both identifying and discharging the potential liabilities associated with drug-transporter interactions, the pharmaceutical industry has a growing requirement for routine and robust non-clinical assays. An assay was designed, optimised and validated to determine the in vitro inhibitory potency of new chemical entities (NCEs) towards human Pgp-mediated transport. [3H]-Digoxin was established as a suitable probe substrate by investigating its characteristics in the in vitro system (MDCKII-MDR1 cells grown in 24-multiwell inserts). The inhibitory potencies (apparent IC50) of known Pgp inhibitors astemizole, GF120918, ketoconazole, itraconazole, quinidine, verapamil and quinine were determined over at least a 1000-fold concentration range. Validation was carried out using manual and automatic techniques. [3H]-Digoxin was found to be stable and have good mass balance in the system. In contrast to [A-->B] transport, [3H]-digoxin [B-->A] transport rates were readily measured with good reproducibility. There was no evidence of saturation of transport up to 10 microM digoxin and 30 nM digoxin was selected for routine assay use, reflecting clinical therapeutic concentrations. IC50 values ranged over approximately 100-fold with excellent reproducibility. Results from manual and automated versions were in close agreement. This method is suitable for routine use to assess the in vitro inhibitory potency of NCEs on Pgp-mediated digoxin transport. Comparison of IC50 values against clinical interaction profiles for the probe inhibitors indicated the in vitro assay is predictive of clinical digoxin-drug interactions mediated via Pgp.

Detrended fluctuation analysis for major depressive disorder.

PubMed

Mumtaz, Wajid; Malik, Aamir Saeed; Ali, Syed Saad Azhar; Yasin, Mohd Azhar Mohd; Amin, Hafeezullah

2015-01-01

Clinical utility of Electroencephalography (EEG) based diagnostic studies is less clear for major depressive disorder (MDD). In this paper, a novel machine learning (ML) scheme was presented to discriminate the MDD patients and healthy controls. The proposed method inherently involved feature extraction, selection, classification and validation. The EEG data acquisition involved eyes closed (EC) and eyes open (EO) conditions. At feature extraction stage, the de-trended fluctuation analysis (DFA) was performed, based on the EEG data, to achieve scaling exponents. The DFA was performed to analyzes the presence or absence of long-range temporal correlations (LRTC) in the recorded EEG data. The scaling exponents were used as input features to our proposed system. At feature selection stage, 3 different techniques were used for comparison purposes. Logistic regression (LR) classifier was employed. The method was validated by a 10-fold cross-validation. As results, we have observed that the effect of 3 different reference montages on the computed features. The proposed method employed 3 different types of feature selection techniques for comparison purposes as well. The results show that the DFA analysis performed better in LE data compared with the IR and AR data. In addition, during Wilcoxon ranking, the AR performed better than LE and IR. Based on the results, it was concluded that the DFA provided useful information to discriminate the MDD patients and with further validation can be employed in clinics for diagnosis of MDD.

The Depression Anxiety Stress Scales (DASS): normative data and latent structure in a large non-clinical sample.

PubMed

Crawford, John R; Henry, Julie D

2003-06-01

To provide UK normative data for the Depression Anxiety and Stress Scale (DASS) and test its convergent, discriminant and construct validity. Cross-sectional, correlational and confirmatory factor analysis (CFA). The DASS was administered to a non-clinical sample, broadly representative of the general adult UK population (N = 1,771) in terms of demographic variables. Competing models of the latent structure of the DASS were derived from theoretical and empirical sources and evaluated using confirmatory factor analysis. Correlational analysis was used to determine the influence of demographic variables on DASS scores. The convergent and discriminant validity of the measure was examined through correlating the measure with two other measures of depression and anxiety (the HADS and the sAD), and a measure of positive and negative affectivity (the PANAS). The best fitting model (CFI =.93) of the latent structure of the DASS consisted of three correlated factors corresponding to the depression, anxiety and stress scales with correlated error permitted between items comprising the DASS subscales. Demographic variables had only very modest influences on DASS scores. The reliability of the DASS was excellent, and the measure possessed adequate convergent and discriminant validity Conclusions: The DASS is a reliable and valid measure of the constructs it was intended to assess. The utility of this measure for UK clinicians is enhanced by the provision of large sample normative data.

Validity of the Symbol Digit Modalities Test as a cognition performance outcome measure for multiple sclerosis

PubMed Central

Benedict, Ralph HB; DeLuca, John; Phillips, Glenn; LaRocca, Nicholas; Hudson, Lynn D; Rudick, Richard

2017-01-01

Cognitive and motor performance measures are commonly employed in multiple sclerosis (MS) research, particularly when the purpose is to determine the efficacy of treatment. The increasing focus of new therapies on slowing progression or reversing neurological disability makes the utilization of sensitive, reproducible, and valid measures essential. Processing speed is a basic elemental cognitive function that likely influences downstream processes such as memory. The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) includes representatives from advocacy organizations, Food and Drug Administration (FDA), European Medicines Agency (EMA), National Institute of Neurological Disorders and Stroke (NINDS), academic institutions, and industry partners along with persons living with MS. Among the MSOAC goals is acceptance and qualification by regulators of performance outcomes that are highly reliable and valid, practical, cost-effective, and meaningful to persons with MS. A critical step for these neuroperformance metrics is elucidation of clinically relevant benchmarks, well-defined degrees of disability, and gradients of change that are deemed clinically meaningful. This topical review provides an overview of research on one particular cognitive measure, the Symbol Digit Modalities Test (SDMT), recognized as being particularly sensitive to slowed processing of information that is commonly seen in MS. The research in MS clearly supports the reliability and validity of this test and recently has supported a responder definition of SDMT change approximating 4 points or 10% in magnitude. PMID:28206827

Validity of the Symbol Digit Modalities Test as a cognition performance outcome measure for multiple sclerosis.

PubMed

Benedict, Ralph Hb; DeLuca, John; Phillips, Glenn; LaRocca, Nicholas; Hudson, Lynn D; Rudick, Richard

2017-04-01

Cognitive and motor performance measures are commonly employed in multiple sclerosis (MS) research, particularly when the purpose is to determine the efficacy of treatment. The increasing focus of new therapies on slowing progression or reversing neurological disability makes the utilization of sensitive, reproducible, and valid measures essential. Processing speed is a basic elemental cognitive function that likely influences downstream processes such as memory. The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) includes representatives from advocacy organizations, Food and Drug Administration (FDA), European Medicines Agency (EMA), National Institute of Neurological Disorders and Stroke (NINDS), academic institutions, and industry partners along with persons living with MS. Among the MSOAC goals is acceptance and qualification by regulators of performance outcomes that are highly reliable and valid, practical, cost-effective, and meaningful to persons with MS. A critical step for these neuroperformance metrics is elucidation of clinically relevant benchmarks, well-defined degrees of disability, and gradients of change that are deemed clinically meaningful. This topical review provides an overview of research on one particular cognitive measure, the Symbol Digit Modalities Test (SDMT), recognized as being particularly sensitive to slowed processing of information that is commonly seen in MS. The research in MS clearly supports the reliability and validity of this test and recently has supported a responder definition of SDMT change approximating 4 points or 10% in magnitude.

Assessing youth who sexually offended: the predictive validity of the ERASOR, J-SOAP-II, and YLS/CMI in a non-Western context.

PubMed

Chu, Chi Meng; Ng, Kynaston; Fong, June; Teoh, Jennifer

2012-04-01

Recent research suggested that the predictive validity of adult sexual offender risk assessment measures can be affected when used cross-culturally, but there is no published study on the predictive validity of risk assessment measures for youth who sexually offended in a non-Western context. This study compared the predictive validity of three youth risk assessment measures (i.e., the Estimate of Risk of Adolescent Sexual Offense Recidivism [ERASOR], the Juvenile Sex Offender Assessment Protocol-II [J-SOAP-II], and the Youth Level of Service/Case Management Inventory [YLS/CMI]) for sexual and nonviolent recidivism in a sample of 104 male youth who sexually offended within a Singaporean context (M (follow-up) = 1,637 days; SD (follow-up) = 491). Results showed that the ERASOR overall clinical rating and total score significantly predicted sexual recidivism but only the former significantly predicted time to sexual reoffense. All of the measures (i.e., the ERASOR overall clinical rating and total score, the J-SOAP-II total score, as well as the YLS/CMI) significantly predicted nonsexual recidivism and time to nonsexual reoffense for this sample of youth who sexually offended. Overall, the results suggest that the ERASOR appears to be suited for assessing youth who sexually offended in a non-Western context, but the J-SOAP-II and the YLS/CMI have limited utility for such a purpose.

Language-based Measures of Mindfulness: Initial Validity and Clinical Utility

PubMed Central

Collins, Susan E.; Chawla, Neharika; Hsu, Sharon H.; Grow, Joel; Otto, Jacqueline M.; Marlatt, G. Alan

2009-01-01

This study examined relationships among language use, mindfulness, and substance-use treatment outcomes in the context of an efficacy trial of mindfulness-based relapse prevention (MBRP) for adults with alcohol and other drug use (AOD) disorders (see Bowen, Chawla, Collins et al., in press). An expert panel generated two categories of mindfulness language (ML) describing the mindfulness state and the more encompassing “mindfulness journey,” which included words describing challenges of developing a mindfulness practice. MBRP participants (n=48) completed baseline sociodemographic and AOD measures, and participated in the 8-week MBRP program. AOD data were collected during the 4-month follow-up. A word count program assessed the frequency of ML and other linguistic markers in participants’ responses to open-ended questions about their postintervention impressions of mindfulness practice and MBRP. Findings supported concurrent validity of ML categories: ML words appeared more frequently in the MBRP manual compared to the 12-step Big Book. Further, ML categories correlated with other linguistic variables related to the mindfulness construct. Finally, predictive validity was supported: greater use of ML predicted fewer AOD use days during the 4-month follow-up. This study provided initial support for ML as a valid, clinically useful mindfulness measure. If future studies replicate these findings, ML could be used in conjunction with self-report to provide a more complete picture of the mindfulness experience. PMID:20025383

Utility of Teacher-Report Assessments of Autistic Severity in Japanese School Children

PubMed Central

Moriwaki, Aiko; Inada, Naoko

2013-01-01

Recent studies suggest that many children with milder autism spectrum disorder (ASD) are undiagnosed, untreated, and being educated in mainstream classes without support and that school teachers might be the best persons to identify a child's social deviance. At present, only a few screening measures using teacher ratings of ASD have been validated. The aim of this study was to examine the utility of teacher ratings on the Social Responsiveness Scale (SRS), a quantitative measure of ASD. We recruited 130 participants aged 4 to 17 years from local schools or local pediatric outpatient clinics specializing in neurodevelopmental disorders that included 70 children with ASD. We found that the teacher-report SRS can be reliably and validly applied to children as a screening tool or for other research purposes, and it also has cross-cultural comparability. Although parent-teacher agreement was satisfactory overall, a discrepancy existed for children with ASD, especially for girls with ASD. To improve sensitivity in children at higher risk, especially girls, we cannot overstate the importance of using standardized norms specific to gender, informant, and culture. PMID:24392224

A generic minimization random allocation and blinding system on web.

PubMed

Cai, Hongwei; Xia, Jielai; Xu, Dezhong; Gao, Donghuai; Yan, Yongping

2006-12-01

Minimization is a dynamic randomization method for clinical trials. Although recommended by many researchers, the utilization of minimization has been seldom reported in randomized trials mainly because of the controversy surrounding the validity of conventional analyses and its complexity in implementation. However, both the statistical and clinical validity of minimization were demonstrated in recent studies. Minimization random allocation system integrated with blinding function that could facilitate the implementation of this method in general clinical trials has not been reported. SYSTEM OVERVIEW: The system is a web-based random allocation system using Pocock and Simon minimization method. It also supports multiple treatment arms within a trial, multiple simultaneous trials, and blinding without further programming. This system was constructed with generic database schema design method, Pocock and Simon minimization method and blinding method. It was coded with Microsoft Visual Basic and Active Server Pages (ASP) programming languages. And all dataset were managed with a Microsoft SQL Server database. Some critical programming codes were also provided. SIMULATIONS AND RESULTS: Two clinical trials were simulated simultaneously to test the system's applicability. Not only balanced groups but also blinded allocation results were achieved in both trials. Practical considerations for minimization method, the benefits, general applicability and drawbacks of the technique implemented in this system are discussed. Promising features of the proposed system are also summarized.

Using intraindividual variability to detect malingering in cognitive performance.

PubMed

Strauss, E; Hultsch, D F; Hunter, M; Slick, D J; Patry, B; Levy-Bencheton, J

1999-11-01

The utility of measures for detecting malingering was evaluated using a simulation design in which half the participants were encouraged to do their best and half were asked to feign head injury. Particular attention was focused on the utility of repeated assessment (intraindividual variability) in discriminating the groups. Participants were tested on three occasions on measures commonly used to detect malingering including a specific symptom validity test (SVT). The results indicated that multiple measures of malingering obtained in single assessment (occasion one) discriminated the groups effectively. In addition, however, intraindividual variability in performance, particularly of indicators from the SVT, provided unique information beyond level of performance. The results suggest that response inconsistency across testing sessions may be a clinically useful measure for the detection of malingering.

[Validity of psychoprophylaxis in obstetrics. Authors' experience].

PubMed

D'Alfonso, A; Zaurito, V; Facchini, D; Di Stefano, L; Patacchiola, F; Cappa, F

1990-12-01

The Authors report the results based on 20 years of practice on obstetric psycho-prophylaxis (PPO). Data on presence at course, on frequency, on primipares/pluripares ratio, on labour, on timing and mode of delivery, are assembled. Moreover, neonatal status at birth and at 10th day of life, are investigated. The data obtained were compared with a control group, constituted by women without any treatment before delivery. The acquired experience confirm the utility of PPO in the ordinary clinical practice.

How to use: the neonatal neurological examination.

PubMed

Wusthoff, Courtney J

2013-08-01

The neurological exam can be a challenging part of a newborn's full evaluation. At the same time, the neonatal neurological exam is a useful tool in identifying babies needing closer evaluation for potential problems. The Dubowitz assessment is a standardised approach to the neonatal neurological exam designed for use by paediatricians in routine practice. Evidence has validated this technique and delineated its utility as a screening exam in various populations. This paper reviews clinical application of the Dubowitz assessment of the newborn.

Clopidogrel and warfarin pharmacogenetic tests: what is the evidence for use in clinical practice?

PubMed Central

Shahin, Mohamed H.A.; Johnson, Julie A.

2013-01-01

Purpose of review To review the most promising genetic markers associated with the variability in the safety or efficacy of warfarin and clopidogrel and highlight the verification and validation initiatives for translating clopidogrel and warfarin pharmacogenetic tests to clinical practice. Recent findings Rapid advances in pharmacogenetics, continuous decrease in genotyping cost, development of point-of-care devices and the newly established clinical genotyping programs at several institutions hold the promise of individualizing clopidogrel and warfarin based on genotype. Guidelines have been established to assist clinicians in prescribing clopidogrel or warfarin dose based on genotype. However, the clinical utility of clopidogrel and warfarin is still limited. Accordingly, large randomized clinical trials are underway to define the role of clopidogrel and warfarin pharmacogenetics in clinical practice. Summary Pharmacogenetics has offered compelling evidence toward the individualization of clopidogrel and warfarin therapies. The rapid advances in technology make the clinical implementation of clopidogrel and warfarin pharmacogenetics possible. The clinical genotyping programs and the ongoing clinical trials will help in overcoming some of the barriers facing the clinical implementation of clopidogrel and warfarin pharmacogenetics. PMID:23478884

Assessment of published models and prognostic variables in epithelial ovarian cancer at Mayo Clinic

PubMed Central

Hendrickson, Andrea Wahner; Hawthorne, Kieran M.; Goode, Ellen L.; Kalli, Kimberly R.; Goergen, Krista M.; Bakkum-Gamez, Jamie N.; Cliby, William A.; Keeney, Gary L.; Visscher, Dan W.; Tarabishy, Yaman; Oberg, Ann L.; Hartmann, Lynn C.; Maurer, Matthew J.

2015-01-01

Objectives Epithelial ovarian cancer (EOC) is an aggressive disease in which first line therapy consists of a surgical staging/debulking procedure and platinum based chemotherapy. There is significant interest in clinically applicable, easy to use prognostic tools to estimate risk of recurrence and overall survival. In this study we used a large prospectively collected cohort of women with EOC to validate currently published models and assess prognostic variables. Methods Women with invasive ovarian, peritoneal, or fallopian tube cancer diagnosed between 2000-2011 and prospectively enrolled into the Mayo Clinic Ovarian Cancer registry were identified. Demographics and known prognostic markers as well as epidemiologic exposure variables were abstracted from the medical record and collected via questionnaire. Six previously published models of overall and recurrence-free survival were assessed for external validity. In addition, predictors of outcome were assessed in our dataset. Results Previously published models validated with a range of c-statistics (0.587-0.827), though application of models containing variables not part of routine practice were somewhat limited by missing data; utilization of all applicable models and comparison of results is suggested. Examination of prognostic variables identified only the presence of ascites and ASA score to be independent predictors of prognosis in our dataset, albeit with marginal gain in prognostic information, after accounting for stage and debulking. Conclusions Existing prognostic models for newly diagnosed EOC showed acceptable calibration in our cohort for clinical application. However, modeling of prospective variables in our dataset reiterates that stage and debulking remain the most important predictors of prognosis in this setting. PMID:25620544

Computer interviewing in urogynaecology: concept, development and psychometric testing of an electronic pelvic floor assessment questionnaire in primary and secondary care.

PubMed

Radley, S C; Jones, G L; Tanguy, E A; Stevens, V G; Nelson, C; Mathers, N J

2006-02-01

To develop and evaluate a Web-based, electronic pelvic floor symptoms assessment questionnaire (e-PAQ)1 for women. A cross-sectional study in primary and secondary care. Two general practices, two community health clinics and a secondary care urogynaecology clinic. A total of 432 women (204 in primary care and 228 in secondary care) were recruited between June 2003 and January 2004. The e-PAQ was located on a workstation (computer, touchscreen and printer). Women completed the e-PAQ prior to their appointment. Untreated women in primary care were asked to return seven days later to complete the e-PAQ a second time (test-retest). Factor analysis, reliability, validity, patient satisfaction, completion times and system costs. In secondary care, factor analysis identified 14 domains within the four dimensions (urinary, bowel, vaginal and sexual symptoms) with internal consistency (Cronbach's alpha)>or=0.7 in 11 of these. In primary care, alpha values were all>or=0.7 and test-retest analysis found acceptable intraclass correlations of 0.50-0.95 (P<0.001) for all domains. A measure of face validity and utility was gained using a nine-item questionnaire, which yielded strongly positive patient views on relevance and acceptability. The e-PAQ offers a user-friendly clinical tool, which provides valid and reliable data. The system offers comprehensive symptoms and quality of life evaluation and may enhance the clinical episode as well as the quality of care for women with pelvic floor disorders.

Patient-Reported Measures of Narcolepsy: The Need for Better Assessment

PubMed Central

Kallweit, Ulf; Schmidt, Markus; Bassetti, Claudio L.

2017-01-01

Study Objectives: Narcolepsy, a chronic disorder of the central nervous system, is clinically characterized by a symptom pentad that includes excessive daytime sleepiness, cataplexy, sleep paralysis, hypnopompic/hypnagogic hallucinations, and disrupted nighttime sleep. Ideally, screening and diagnosis instruments that assist physicians in evaluating a patient for type 1 or type 2 narcolepsy would be brief, easy for patients to understand and physicians to score, and would identify or rule out the need for electrophysiological testing. Methods: A search of the literature was conducted to review patient-reported measures used for the assessment of narcolepsy, mainly in clinical trials, with the goal of summarizing existing scales and identifying areas that may require additional screening questions and clinical practice scales. Results: Of the seven scales reviewed, the Epworth Sleepiness Scale continues to be an important outcome measure to screen adults for excessive daytime sleepiness, which may be associated with narcolepsy. Several narcolepsy-specific scales have demonstrated utility, such as the Ullanlinna Narcolepsy Scale, Swiss Narcolepsy Scale, and Narcolepsy Symptom Assessment Questionnaire, but further validation is required. Conclusions: Although the narcolepsy-specific scales currently in use may identify type 1 narcolepsy, there are no validated questionnaires to identify type 2 narcolepsy. Thus, there remains a need for short, easily understood, and well-validated instruments that can be readily used in clinical practice to distinguish narcolepsy subtypes, as well as other hypersomnias, and for assessing symptoms of these conditions during treatment. Citation: Kallweit U, Schmidt M, Bassetti CL. Patient-reported measures of narcolepsy: the need for better assessment. J Clin Sleep Med. 2017;13(5):737–744. PMID:28162143

Selecting clinical quality indicators for laboratory medicine.

PubMed

Barth, Julian H

2012-05-01

Quality in laboratory medicine is often described as doing the right test at the right time for the right person. Laboratory processes currently operate under the oversight of an accreditation body which gives confidence that the process is good. However, there are aspects of quality that are not measured by these processes. These are largely focused on ensuring that the most clinically appropriate test is performed and interpreted correctly. Clinical quality indicators were selected through a two-phase process. Firstly, a series of focus groups of clinical scientists were held with the aim of developing a list of quality indicators. These were subsequently ranked in order by an expert panel of primary and secondary care physicians. The 10 top indicators included the communication of critical results, comprehensive education to all users and adequate quality assurance for point-of-care testing. Laboratories should ensure their tests are used to national standards, that they have clinical utility, are calibrated to national standards and have long-term stability for chronic disease management. Laboratories should have error logs and demonstrate evidence of measures introduced to reduce chances of similar future errors. Laboratories should make a formal scientific evaluation of analytical quality. This paper describes the process of selection of quality indicators for laboratory medicine that have been validated sequentially by deliverers and users of the service. They now need to be converted into measureable variables related to outcome and validated in practice.

A data-driven algorithm integrating clinical and laboratory features for the diagnosis and prognosis of necrotizing enterocolitis.

PubMed

Ji, Jun; Ling, Xuefeng B; Zhao, Yingzhen; Hu, Zhongkai; Zheng, Xiaolin; Xu, Zhening; Wen, Qiaojun; Kastenberg, Zachary J; Li, Ping; Abdullah, Fizan; Brandt, Mary L; Ehrenkranz, Richard A; Harris, Mary Catherine; Lee, Timothy C; Simpson, B Joyce; Bowers, Corinna; Moss, R Lawrence; Sylvester, Karl G

2014-01-01

Necrotizing enterocolitis (NEC) is a major source of neonatal morbidity and mortality. Since there is no specific diagnostic test or risk of progression model available for NEC, the diagnosis and outcome prediction of NEC is made on clinical grounds. The objective in this study was to develop and validate new NEC scoring systems for automated staging and prognostic forecasting. A six-center consortium of university based pediatric teaching hospitals prospectively collected data on infants under suspicion of having NEC over a 7-year period. A database comprised of 520 infants was utilized to develop the NEC diagnostic and prognostic models by dividing the entire dataset into training and testing cohorts of demographically matched subjects. Developed on the training cohort and validated on the blind testing cohort, our multivariate analyses led to NEC scoring metrics integrating clinical data. Machine learning using clinical and laboratory results at the time of clinical presentation led to two nec models: (1) an automated diagnostic classification scheme; (2) a dynamic prognostic method for risk-stratifying patients into low, intermediate and high NEC scores to determine the risk for disease progression. We submit that dynamic risk stratification of infants with NEC will assist clinicians in determining the need for additional diagnostic testing and guide potential therapies in a dynamic manner. http://translationalmedicine.stanford.edu/cgi-bin/NEC/index.pl and smartphone application upon request.

Impact of cerebro-spinal fluid biomarkers of Alzheimer's disease in clinical practice: a multicentric study.

PubMed

Mouton-Liger, François; Wallon, David; Troussière, Anne-Cécile; Yatimi, Rachida; Dumurgier, Julien; Magnin, Eloi; de la Sayette, Vincent; Duron, Emannuelle; Philippi, Nathalie; Beaufils, Emilie; Gabelle, Audrey; Croisile, Bernard; Robert, Philippe; Pasquier, Florence; Hannequin, Didier; Hugon, Jacques; Paquet, Claire

2014-01-01

CSF biomarkers of Alzheimer's disease are well validated in clinical research; however, their pragmatic utility in daily practice is still unappreciated. These biomarkers are used in routine practice according to Health Authority Recommendations. In 604 consecutive patients explored for cognitive disorders, questionnaires were prospectively proposed and filled. Before and after CSF biomarker results, clinicians provided a diagnosis and an estimate of their diagnostic confidence. Analysis has compared the frequency of diagnosis before and after CSF biomarker results using the net reclassification improvement (NRI) method. We have evaluated external validity comparing with data of French Bank National of AD (BNA). A total of 561 patients [Alzheimer's disease (AD), n = 253; non-AD, n = 308] were included (mean age, 68.6 years; women, 52 %). Clinically suspected diagnosis and CSF results were concordant in 65.2 % of cases. When clinical hypothesis and biological results were discordant, a reclassification occurred in favour of CSF biomarkers results in 76.9 %. The NRI was 39.5 %. In addition, the results show a statistically significant improvement in clinician confidence for their diagnosis. In comparison with BNA data, patients were younger and more frequently diagnosed with AD. Clinicians tend to heavily rely on the CSF AD biomarkers results and are more confident in their diagnoses using CSF AD biomarkers. Thus, these biomarkers appear as a key tool in clinical practice.

Clinical utility of FDG-PET in amyotrophic lateral sclerosis and Huntington's disease.

PubMed

Agosta, Federica; Altomare, Daniele; Festari, Cristina; Orini, Stefania; Gandolfo, Federica; Boccardi, Marina; Arbizu, Javier; Bouwman, Femke; Drzezga, Alexander; Nestor, Peter; Nobili, Flavio; Walker, Zuzana; Pagani, Marco

2018-05-01

To evaluate the incremental value of FDG-PET over clinical tests in: (i) diagnosis of amyotrophic lateral sclerosis (ALS); (ii) picking early signs of neurodegeneration in patients with a genetic risk of Huntington's disease (HD); and detecting metabolic changes related to cognitive impairment in (iii) ALS and (iv) HD patients. Four comprehensive literature searches were conducted using the PICO model to extract evidence from relevant studies. An expert panel then voted using the Delphi method on these four diagnostic scenarios. The availability of evidence was good for FDG-PET utility to support the diagnosis of ALS, poor for identifying presymptomatic subjects carrying HD mutation who will convert to HD, and lacking for identifying cognitive-related metabolic changes in both ALS and HD. After the Delphi consensual procedure, the panel did not support the clinical use of FDG-PET for any of the four scenarios. Relative to other neurodegenerative diseases, the clinical use of FDG-PET in ALS and HD is still in its infancy. Once validated by disease-control studies, FDG-PET might represent a potentially useful biomarker for ALS diagnosis. FDG-PET is presently not justified as a routine investigation to predict conversion to HD, nor to detect evidence of brain dysfunction justifying cognitive decline in ALS and HD.

The utility of the Historical Clinical Risk-20 Scale as a predictor of outcomes in decisions to transfer patients from high to lower levels of security--a UK perspective.

PubMed

Dolan, Mairead; Blattner, Regine

2010-09-29

Structured Professional Judgment (SPJ) approaches to violence risk assessment are increasingly being adopted into clinical practice in international forensic settings. The aim of this study was to examine the predictive validity of the Historical Clinical Risk -20 (HCR-20) violence risk assessment scale for outcome following transfers from high to medium security in a United Kingdom setting. The sample was predominately male and mentally ill and the majority of cases were detained under the criminal section of the Mental Health Act (1986). The HCR-20 was rated based on detailed case file information on 72 cases transferred from high to medium security. Outcomes were examined, independent of risk score, and cases were classed as "success or failure" based on established criteria. The mean length of follow up was 6 years. The total HCR-20 score was a robust predictor of failure at lower levels of security and return to high security. The Clinical and Risk management items contributed most to predictive accuracy. Although the HCR-20 was designed as a violence risk prediction tool our findings suggest it has potential utility in decisions to transfer patients from high to lower levels of security.

DNA topoisomerase I and DNA gyrase as targets for TB therapy.

PubMed

Nagaraja, Valakunja; Godbole, Adwait A; Henderson, Sara R; Maxwell, Anthony

2017-03-01

Tuberculosis (TB) is the deadliest bacterial disease in the world. New therapeutic agents are urgently needed to replace existing drugs for which resistance is a significant problem. DNA topoisomerases are well-validated targets for antimicrobial and anticancer chemotherapies. Although bacterial topoisomerase I has yet to be exploited as a target for clinical antibiotics, DNA gyrase has been extensively targeted, including the highly clinically successful fluoroquinolones, which have been utilized in TB therapy. Here, we review the exploitation of topoisomerases as antibacterial targets and summarize progress in developing new agents to target DNA topoisomerase I and DNA gyrase from Mycobacterium tuberculosis. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Use of iris recognition camera technology for the quantification of corneal opacification in mucopolysaccharidoses.

PubMed

Aslam, Tariq Mehmood; Shakir, Savana; Wong, James; Au, Leon; Ashworth, Jane

2012-12-01

Mucopolysaccharidoses (MPS) can cause corneal opacification that is currently difficult to objectively quantify. With newer treatments for MPS comes an increased need for a more objective, valid and reliable index of disease severity for clinical and research use. Clinical evaluation by slit lamp is very subjective and techniques based on colour photography are difficult to standardise. In this article the authors present evidence for the utility of dedicated image analysis algorithms applied to images obtained by a highly sophisticated iris recognition camera that is small, manoeuvrable and adapted to achieve rapid, reliable and standardised objective imaging in a wide variety of patients while minimising artefactual interference in image quality.

Development of a dynamic quality assurance testing protocol for multisite clinical trial DCE-CT accreditation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Driscoll, B.; Keller, H.; Jaffray, D.

2013-08-15

Purpose: Credentialing can have an impact on whether or not a clinical trial produces useful quality data that is comparable between various institutions and scanners. With the recent increase of dynamic contrast enhanced-computed tomography (DCE-CT) usage as a companion biomarker in clinical trials, effective quality assurance, and control methods are required to ensure there is minimal deviation in the results between different scanners and protocols at various institutions. This paper attempts to address this problem by utilizing a dynamic flow imaging phantom to develop and evaluate a DCE-CT quality assurance (QA) protocol.Methods: A previously designed flow phantom, capable of producingmore » predictable and reproducible time concentration curves from contrast injection was fully validated and then utilized to design a DCE-CT QA protocol. The QA protocol involved a set of quantitative metrics including injected and total mass error, as well as goodness of fit comparison to the known truth concentration curves. An additional region of interest (ROI) sensitivity analysis was also developed to provide additional details on intrascanner variability and determine appropriate ROI sizes for quantitative analysis. Both the QA protocol and ROI sensitivity analysis were utilized to test variations in DCE-CT results using different imaging parameters (tube voltage and current) as well as alternate reconstruction methods and imaging techniques. The developed QA protocol and ROI sensitivity analysis was then applied at three institutions that were part of clinical trial involving DCE-CT and results were compared.Results: The inherent specificity of robustness of the phantom was determined through calculation of the total intraday variability and determined to be less than 2.2 ± 1.1% (total calculated output contrast mass error) with a goodness of fit (R{sup 2}) of greater than 0.99 ± 0.0035 (n= 10). The DCE-CT QA protocol was capable of detecting significant deviations from the expected phantom result when scanning at low mAs and low kVp in terms of quantitative metrics (Injected Mass Error 15.4%), goodness of fit (R{sup 2}) of 0.91, and ROI sensitivity (increase in minimum input function ROI radius by 146 ± 86%). These tests also confirmed that the ASIR reconstruction process was beneficial in reducing noise without substantially increasing partial volume effects and that vendor specific modes (e.g., axial shuttle) did not significantly affect the phantom results. The phantom and QA protocol were finally able to quickly (<90 min) and successfully validate the DCE-CT imaging protocol utilized at the three separate institutions of a multicenter clinical trial; thereby enhancing the confidence in the patient data collected.Conclusions: A DCE QA protocol was developed that, in combination with a dynamic multimodality flow phantom, allows the intrascanner variability to be separated from other sources of variability such as the impact of injection protocol and ROI selection. This provides a valuable resource that can be utilized at various clinical trial institutions to test conformance with imaging protocols and accuracy requirements as well as ensure that the scanners are performing as expected for dynamic scans.« less

Drug-resistant tuberculosis clinical trials: proposed core research definitions in adults.

PubMed

Furin, J; Alirol, E; Allen, E; Fielding, K; Merle, C; Abubakar, I; Andersen, J; Davies, G; Dheda, K; Diacon, A; Dooley, K E; Dravnice, G; Eisenach, K; Everitt, D; Ferstenberg, D; Goolam-Mahomed, A; Grobusch, M P; Gupta, R; Harausz, E; Harrington, M; Horsburgh, C R; Lienhardt, C; McNeeley, D; Mitnick, C D; Nachman, S; Nahid, P; Nunn, A J; Phillips, P; Rodriguez, C; Shah, S; Wells, C; Thomas-Nyang'wa, B; du Cros, P

2016-03-01

Drug-resistant tuberculosis (DR-TB) is a growing public health problem, and for the first time in decades, new drugs for the treatment of this disease have been developed. These new drugs have prompted strengthened efforts in DR-TB clinical trials research, and there are now multiple ongoing and planned DR-TB clinical trials. To facilitate comparability and maximise policy impact, a common set of core research definitions is needed, and this paper presents a core set of efficacy and safety definitions as well as other important considerations in DR-TB clinical trials work. To elaborate these definitions, a search of clinical trials registries, published manuscripts and conference proceedings was undertaken to identify groups conducting trials of new regimens for the treatment of DR-TB. Individuals from these groups developed the core set of definitions presented here. Further work is needed to validate and assess the utility of these definitions but they represent an important first step to ensure there is comparability in clinical trials on multidrug-resistant TB.

Lost in translation: neuropsychiatric drug development.

PubMed

Becker, Robert E; Greig, Nigel H

2010-12-08

Recent studies have identified troubling method and practice lapses in neuropsychiatric drug developments. These problems have resulted in errors that are of sufficient magnitude to invalidate clinical trial data and interpretations. We identify two potential sources for these difficulties: investigators selectively choosing scientific practices for demonstrations of efficacy in human-testing phases of drug development and investigators failing to anticipate the needs of practitioners who must optimize treatment for the individual patient. When clinical investigators neglect to use clinical trials as opportunities to test hypotheses of disease mechanisms in humans, the neuropsychiatric knowledge base loses both credibility and scope. When clinical investigators do not anticipate the need to translate discoveries into applications, the practitioner cannot provide optimal care for the patient. We conclude from this evidence that clinical trials, and other aspects of neuropsychiatric drug development, must adopt more practices from basic science and show greater responsiveness to conditions of clinical practice. We feel that these changes are necessary to overcome current threats to the validity and utility of studies of neurological and psychiatric drugs.

Review of patient-reported outcome measures in chronic hepatitis C

PubMed Central

2012-01-01

Background Chronic hepatitis C (CHC) and its treatment are associated with a variety of patient-reported symptoms and impacts. Some CHC symptoms and impacts may be difficult to evaluate through objective clinical testing, and more easily measured through patient self-report. This literature review identified concepts raised by CHC patients related to symptoms, impacts, and treatment effects, and evaluated integration of these concepts within patient-reported outcome (PRO) measures. The goal of this work was to provide recommendations for incorporation of PRO measurement of concepts that are relevant to the CHC experience into CHC clinical trial design. Methods A three-tiered literature search was conducted. This included searches on concepts of importance, PRO measures used in clinical trials, and existing PRO measures. The PRO Concept Search focused on reviewing issues raised by CHC patients about CHC symptoms, disease impact, and treatment effects. The CHC Trials with PRO Endpoints Search reviewed clinical trials with PRO endpoints to assess differences between treatments over time. The PRO Measure Search reviewed existing PRO measures associated with the concepts of interest. Results This multi-tiered approach identified five key concepts of interest: depression/anxiety, fatigue, flu-like symptoms, cognitive function, insomnia. Comparing these five concepts of interest to the PRO measures in published CHC clinical trials showed that, while treatment of CHC may decrease health-related quality of life in a number of mental and physical domains, the PRO measures that were utilized in published clinical trials inadequately covered the concepts of interest. Further review of 18 existing PRO measures of the concepts of interest showed only four of the 18 were validated in CHC populations. Conclusions This review identified several gaps in the literature regarding assessment of symptoms and outcomes reported as important by CHC patients. Further research is needed to ensure that CHC clinical trials evaluate concepts that are important to patients and include measures that have evidence supporting content validity, reliability, construct validity, and responsiveness. PMID:22871087

Automating Guidelines for Clinical Decision Support: Knowledge Engineering and Implementation.

PubMed

Tso, Geoffrey J; Tu, Samson W; Oshiro, Connie; Martins, Susana; Ashcraft, Michael; Yuen, Kaeli W; Wang, Dan; Robinson, Amy; Heidenreich, Paul A; Goldstein, Mary K

2016-01-01

As utilization of clinical decision support (CDS) increases, it is important to continue the development and refinement of methods to accurately translate the intention of clinical practice guidelines (CPG) into a computable form. In this study, we validate and extend the 13 steps that Shiffman et al. 5 identified for translating CPG knowledge for use in CDS. During an implementation project of ATHENA-CDS, we encoded complex CPG recommendations for five common chronic conditions for integration into an existing clinical dashboard. Major decisions made during the implementation process were recorded and categorized according to the 13 steps. During the implementation period, we categorized 119 decisions and identified 8 new categories required to complete the project. We provide details on an updated model that outlines all of the steps used to translate CPG knowledge into a CDS integrated with existing health information technology.

Management of convulsive status epilepticus in children: an adapted clinical practice guideline for pediatricians in Saudi Arabia

PubMed Central

Bashiri, Fahad A.; Hamad, Muddathir H.; Amer, Yasser S.; Abouelkheir, Manal M.; Mohamed, Sarar; Kentab, Amal Y.; Salih, Mustafa A.; Nasser, Mohammad N. Al; Al-Eyadhy, Ayman A.; Othman, Mohammed A. Al; Al-Ahmadi, Tahani; Iqbal, Shaikh M.; Somily, Ali M.; Wahabi, Hayfaa A.; Hundallah, Khalid J.; Alwadei, Ali H.; Albaradie, Raidah S.; Al-Twaijri, Waleed A.; Jan, Mohammed M.; Al-Otaibi, Faisal; Alnemri, Abdulrahman M.; Al-Ansary, Lubna A.

2017-01-01

Objective: To increase the use of evidence-based approaches in the diagnosis, investigations and treatment of Convulsive Status Epilepticus (CSE) in children in relevant care settings. Method: A Clinical Practice Guideline (CPG) adaptation group was formulated at a university hospital in Riyadh. The group utilized 2 CPG validated tools including the ADAPTE method and the AGREE II instrument. Results: The group adapted 3 main categories of recommendations from one Source CPG. The recommendations cover; (i)first-line treatment of CSE in the community; (ii)treatment of CSE in the hospital; and (iii)refractory CSE. Implementation tools were built to enhance knowledge translation of these recommendations including a clinical algorithm, audit criteria, and a computerized provider order entry. Conclusion: A clinical practice guideline for the Saudi healthcare context was formulated using a guideline adaptation process to support relevant clinicians managing CSE in children. PMID:28416791

[Generalization of the results of clinical studies through the analysis of subgroups].

PubMed

Costa, João; Fareleira, Filipa; Ascensão, Raquel; Vaz Carneiro, António

2012-01-01

Subgroup analysis in clinical trials are usually performed to define the potential heterogeneity of treatment effect in relation with the baseline risk, physiopathology, practical application of therapy or the under-utilization in clinical practice of effective interventions due to uncertainties of its benefit/risk ratio. When appropriately planned, subgroup analysis are a valid methodology the define benefits in subgroups of patients, thus providing good quality evidence to support clinical decision making. However, in order to be correct, subgroup analysis should be defined a priori, done in small numbers, should be fully reported and, most important, must endure statistical tests for interaction. In this paper we present an example of the treatment of post-menopausal osteoporosis, in which the benefits of an intervention (the higher the fracture risk is, the better the benefit is) with a specific agent (bazedoxifene) was only disclosed after a post-hoc analysis of the initial global trial sample.

Vectra DA for the objective measurement of disease activity in patients with rheumatoid arthritis.

PubMed

Segurado, O G; Sasso, E H

2014-01-01

Quantitative and regular assessment of disease activity in rheumatoid arthritis (RA) is required to achieve treatment targets such as remission and to optimize clinical outcomes. To assess inflammation accurately, predict joint damage and monitor treatment response, a measure of disease activity in RA should reflect the pathological processes resulting in irreversible joint damage and functional disability. The Vectra DA blood test is an objective measure of disease activity for patients with RA. Vectra DA provides an accurate, reproducible score on a scale of 1 to 100 based on the concentrations of 12 biomarkers that reflect the pathophysiologic diversity of RA. The analytical validity, clinical validity, and clinical utility of Vectra DA have been evaluated for patients with RA in registries and prospective and retrospective clinical studies. As a biomarker-based instrument for assessing disease activity in RA, the Vectra DA test can help monitor therapeutic response to methotrexate and biologic agents and assess clinically challenging situations, such as when clinical measures are confounded by non-inflammatory pain from fibromyalgia. Vectra DA scores correlate with imaging of joint inflammation and are predictive for radiographic progression, with high Vectra DA scores being associated with more frequent and severe progression and low scores being predictive for non-progression. In summary, the Vectra DA score is an objective measure of RA disease activity that quantifies inflammatory status. By predicting risk for joint damage more effectively than conventional clinical and laboratory measures, it has the potential to complement these measures and optimise clinical decision making.

Job stress and mental health of permanent and fixed-term workers measured by effort-reward imbalance model, depressive complaints, and clinic utilization.

PubMed

Inoue, Mariko; Tsurugano, Shinobu; Yano, Eiji

2011-01-01

The number of workers with precarious employment has increased globally; however, few studies have used validated measures to investigate the relationship of job status to stress and mental health. Thus, we conducted a study to compare differential job stress experienced by permanent and fixed-term workers using an effort-reward imbalance (ERI) model questionnaire, and by evaluating depressive complaints and clinic utilization. Subjects were permanent or fixed-term male workers at a Japanese research institute (n=756). Baseline data on job stress and depressive complaints were collected in 2007. We followed up with the same population over a 1-year period to assess their utilization of the company clinic for mental health concerns. The ERI ratio was higher among permanent workers than among fixed-term workers. More permanent workers presented with more than two depressive complaints, which is the standard used for the diagnosis of depression. ERI scores indicated that the effort component of permanent work was associated with distress, whereas distress in fixed-term work was related to job promotion and job insecurity. Moreover, over the one-year follow-up period, fixed-term workers visited the on-site clinic for mental concerns 4.04 times more often than permanent workers even after adjusting for age, lifestyle, ERI, and depressive complaints. These contrasting findings reflect the differential workloads and working conditions encountered by permanent and fixed-term workers. The occupational setting where employment status was intermingled, may have contributed to the high numbers of mental health-related issues experienced by workers with different employment status.

How Can We Improve Outcomes for Patients and Families Under Palliative Care? Implementing Clinical Audit for Quality Improvement in Resource Limited Settings

PubMed Central

Selman, Lucy; Harding, Richard

2010-01-01

Palliative care in India has made enormous advances in providing better care for patients and families living with progressive disease, and many clinical services are well placed to begin quality improvement initiatives, including clinical audit. Clinical audit is recognized globally to be essential in all healthcare, as a way of monitoring and improving quality of care. However, it is not common in developing country settings, including India. Clinical audit is a cyclical activity involving: identification of areas of care in need of improvement, through data collection and analysis utilizing an appropriate questionnaire; setting measurable quality of care targets in specific areas; designing and implementing service improvement strategies; and then re-evaluating quality of care to assess progress towards meeting the targets. Outcome measurement is an important component of clinical audit that has additional advantages; for example, establishing an evidence base for the effectiveness of services. In resource limited contexts, outcome measurement in clinical audit is particularly important as it enables service development to be evidence-based and ensures resources are allocated effectively. Key success factors in conducting clinical audit are identified (shared ownership, training, managerial support, inclusion of all members of staff and a positive approach). The choice of outcome measurement tool is discussed, including the need for a culturally appropriate and validated measure which is brief and simple enough to incorporate into clinical practice and reflects the holistic nature of palliative care. Support for clinical audit is needed at a national level, and development and validation of an outcome measurement tool in the Indian context is a crucial next step. PMID:20859465

Different top-down approaches to estimate measurement uncertainty of whole blood tacrolimus mass concentration values.

PubMed

Rigo-Bonnin, Raül; Blanco-Font, Aurora; Canalias, Francesca

2018-05-08

Values of mass concentration of tacrolimus in whole blood are commonly used by the clinicians for monitoring the status of a transplant patient and for checking whether the administered dose of tacrolimus is effective. So, clinical laboratories must provide results as accurately as possible. Measurement uncertainty can allow ensuring reliability of these results. The aim of this study was to estimate measurement uncertainty of whole blood mass concentration tacrolimus values obtained by UHPLC-MS/MS using two top-down approaches: the single laboratory validation approach and the proficiency testing approach. For the single laboratory validation approach, we estimated the uncertainties associated to the intermediate imprecision (using long-term internal quality control data) and the bias (utilizing a certified reference material). Next, we combined them together with the uncertainties related to the calibrators-assigned values to obtain a combined uncertainty for, finally, to calculate the expanded uncertainty. For the proficiency testing approach, the uncertainty was estimated in a similar way that the single laboratory validation approach but considering data from internal and external quality control schemes to estimate the uncertainty related to the bias. The estimated expanded uncertainty for single laboratory validation, proficiency testing using internal and external quality control schemes were 11.8%, 13.2%, and 13.0%, respectively. After performing the two top-down approaches, we observed that their uncertainty results were quite similar. This fact would confirm that either two approaches could be used to estimate the measurement uncertainty of whole blood mass concentration tacrolimus values in clinical laboratories. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Importance of multi-modal approaches to effectively identify cataract cases from electronic health records.

PubMed

Peissig, Peggy L; Rasmussen, Luke V; Berg, Richard L; Linneman, James G; McCarty, Catherine A; Waudby, Carol; Chen, Lin; Denny, Joshua C; Wilke, Russell A; Pathak, Jyotishman; Carrell, David; Kho, Abel N; Starren, Justin B

2012-01-01

There is increasing interest in using electronic health records (EHRs) to identify subjects for genomic association studies, due in part to the availability of large amounts of clinical data and the expected cost efficiencies of subject identification. We describe the construction and validation of an EHR-based algorithm to identify subjects with age-related cataracts. We used a multi-modal strategy consisting of structured database querying, natural language processing on free-text documents, and optical character recognition on scanned clinical images to identify cataract subjects and related cataract attributes. Extensive validation on 3657 subjects compared the multi-modal results to manual chart review. The algorithm was also implemented at participating electronic MEdical Records and GEnomics (eMERGE) institutions. An EHR-based cataract phenotyping algorithm was successfully developed and validated, resulting in positive predictive values (PPVs) >95%. The multi-modal approach increased the identification of cataract subject attributes by a factor of three compared to single-mode approaches while maintaining high PPV. Components of the cataract algorithm were successfully deployed at three other institutions with similar accuracy. A multi-modal strategy incorporating optical character recognition and natural language processing may increase the number of cases identified while maintaining similar PPVs. Such algorithms, however, require that the needed information be embedded within clinical documents. We have demonstrated that algorithms to identify and characterize cataracts can be developed utilizing data collected via the EHR. These algorithms provide a high level of accuracy even when implemented across multiple EHRs and institutional boundaries.

Psychometrics and utility of Psycho-Educational Profile-Revised as a developmental quotient measure among children with the dual disability of intellectual disability and autism.

PubMed

Alwinesh, Merlin Thanka Jemi; Joseph, Rachel Beulah Jansirani; Daniel, Anna; Abel, Julie Sandra; Shankar, Satya Raj; Mammen, Priya; Russell, Sushila; Russell, Paul Swamidhas Sudhakar

2012-09-01

There is no agreement about the measure to quantify the intellectual/developmental level in children with the dual disability of intellectual disability and autism. Therefore, we studied the psychometric properties and utility of Psycho-Educational Profile-Revised (PEP-R) as a developmental test in this population. We identified 116 children with dual disability from the day care and inpatient database of a specialised Autism Clinic. Scale and domain level scores of PEP-R were collected and analyzed. We examined the internal consistency, domain-total correlation of PEP-R and concurrent validity of PEP-R against Gesell's Developmental Schedule, inter-rater and test-retest reliability and utility of PEP-R among children with dual disability in different ages, functional level and severity of autism. Besides the adequate face and content validity, PEP-R demonstrates a good internal consistency (Cronbach's α ranging from 0.91 to 0.93) and domain-total correlation (ranging from 0.75 to 0.90). The inter-rater reliability (intraclass correlation coefficient, ICC = 0.96) and test-retest reliability (ICC = 0.87) for PEP-R is good. There is moderate-to-high concurrent validity with GDS (r ranging from 0.61 to 0.82; all Ps = 0.001). The utility of PEP-R as a developmental measure was good with infants, toddlers, pre-school and primary school children. The ability of PEP-R to measure the developmental age was good, irrespective of the severity of autism but was better with high-functioning children. The PEP-R as an intellectual/developmental test has strong psychometric properties in children with dual disability. It could be used in children with different age groups and severity of autism. PEP-R should be used with caution as a developmental test in children with dual disability who are low functioning.

Naked-eye fingerprinting of single nucleotide polymorphisms on psoriasis patients

NASA Astrophysics Data System (ADS)

Valentini, Paola; Marsella, Alessandra; Tarantino, Paolo; Mauro, Salvatore; Baglietto, Silvia; Congedo, Maurizio; Paolo Pompa, Pier

2016-05-01

We report a low-cost test, based on gold nanoparticles, for the colorimetric (naked-eye) fingerprinting of a panel of single nucleotide polymorphisms (SNPs), relevant for the personalized therapy of psoriasis. Such pharmacogenomic tests are not routinely performed on psoriasis patients, due to the high cost of standard technologies. We demonstrated high sensitivity and specificity of our colorimetric test by validating it on a cohort of 30 patients, through a double-blind comparison with two state-of-the-art instrumental techniques, namely reverse dot blotting and sequencing, finding 100% agreement. This test offers high parallelization capabilities and can be easily generalized to other SNPs of clinical relevance, finding broad utility in diagnostics and pharmacogenomics.We report a low-cost test, based on gold nanoparticles, for the colorimetric (naked-eye) fingerprinting of a panel of single nucleotide polymorphisms (SNPs), relevant for the personalized therapy of psoriasis. Such pharmacogenomic tests are not routinely performed on psoriasis patients, due to the high cost of standard technologies. We demonstrated high sensitivity and specificity of our colorimetric test by validating it on a cohort of 30 patients, through a double-blind comparison with two state-of-the-art instrumental techniques, namely reverse dot blotting and sequencing, finding 100% agreement. This test offers high parallelization capabilities and can be easily generalized to other SNPs of clinical relevance, finding broad utility in diagnostics and pharmacogenomics. Electronic supplementary information (ESI) available. See DOI: 10.1039/c6nr02200f

Direct-to-consumer genetic testing in Slovenia: availability, ethical dilemmas and legislation.

PubMed

Vrecar, Irena; Peterlin, Borut; Teran, Natasa; Lovrecic, Luca

2015-01-01

Over the last few years, many private companies are advertising direct-to-consumer genetic testing (DTC GT), mostly with no or only minor clinical utility and validity of tests and without genetic counselling. International professional community does not approve provision of DTC GT and situation in some EU countries has been analysed already. The aim of our study was to analyse current situation in the field of DTC GT in Slovenia and related legal and ethical issues. Information was retrieved through internet search, performed independently by two authors, structured according to individual private company and the types of offered genetic testing. Five private companies and three Health Insurance Companies offer DTC GT and it is provided without genetic counselling. Available tests include testing for breast cancer, tests with other health-related information (complex diseases, drug responses) and other tests (nutrigenetic, ancestry, paternity). National legislation is currently being developed and Council of Experts in Medical Genetics has issued an opinion about Genetic Testing and Commercialization of Genetic Tests in Slovenia. Despite the fact that Slovenia has signed the Additional protocol to the convention on human rights and biomedicine, concerning genetic testing for health purposes, DTC GT in Slovenia is present and against all international recommendations. There is lack of or no medical supervision, clinical validity and utility of tests and inappropriate genetic testing of minors is available. There is urgent need for regulation of ethical, legal, and social aspects. National legislation on DTC GT is being prepared.

How do we estimate survival? External validation of a tool for survival estimation in patients with metastatic bone disease-decision analysis and comparison of three international patient populations.

PubMed

Piccioli, Andrea; Spinelli, M Silvia; Forsberg, Jonathan A; Wedin, Rikard; Healey, John H; Ippolito, Vincenzo; Daolio, Primo Andrea; Ruggieri, Pietro; Maccauro, Giulio; Gasbarrini, Alessandro; Biagini, Roberto; Piana, Raimondo; Fazioli, Flavio; Luzzati, Alessandro; Di Martino, Alberto; Nicolosi, Francesco; Camnasio, Francesco; Rosa, Michele Attilio; Campanacci, Domenico Andrea; Denaro, Vincenzo; Capanna, Rodolfo

2015-05-22

We recently developed a clinical decision support tool, capable of estimating the likelihood of survival at 3 and 12 months following surgery for patients with operable skeletal metastases. After making it publicly available on www.PATHFx.org , we attempted to externally validate it using independent, international data. We collected data from patients treated at 13 Italian orthopaedic oncology referral centers between 2010 and 2013, then applied to PATHFx, which generated a probability of survival at three and 12-months for each patient. We assessed accuracy using the area under the receiver-operating characteristic curve (AUC), clinical utility using Decision Curve Analysis (DCA), and compared the Italian patient data to the training set (United States) and first external validation set (Scandinavia). The Italian dataset contained 287 records with at least 12 months follow-up information. The AUCs for the three-month and 12-month estimates was 0.80 and 0.77, respectively. There were missing data, including the surgeon's estimate of survival that was missing in the majority of records. Physiologically, Italian patients were similar to patients in the training and first validation sets. However notable differences were observed in the proportion of those surviving three and 12-months, suggesting differences in referral patterns and perhaps indications for surgery. PATHFx was successfully validated in an Italian dataset containing missing data. This study demonstrates its broad applicability to European patients, even in centers with differing treatment philosophies from those previously studied.

Bayesian Adaptive Trial Design for a Newly Validated Surrogate Endpoint

PubMed Central

Renfro, Lindsay A.; Carlin, Bradley P.; Sargent, Daniel J.

2011-01-01

Summary The evaluation of surrogate endpoints for primary use in future clinical trials is an increasingly important research area, due to demands for more efficient trials coupled with recent regulatory acceptance of some surrogates as ‘valid.’ However, little consideration has been given to how a trial which utilizes a newly-validated surrogate endpoint as its primary endpoint might be appropriately designed. We propose a novel Bayesian adaptive trial design that allows the new surrogate endpoint to play a dominant role in assessing the effect of an intervention, while remaining realistically cautious about its use. By incorporating multi-trial historical information on the validated relationship between the surrogate and clinical endpoints, then subsequently evaluating accumulating data against this relationship as the new trial progresses, we adaptively guard against an erroneous assessment of treatment based upon a truly invalid surrogate. When the joint outcomes in the new trial seem plausible given similar historical trials, we proceed with the surrogate endpoint as the primary endpoint, and do so adaptively–perhaps stopping the trial for early success or inferiority of the experimental treatment, or for futility. Otherwise, we discard the surrogate and switch adaptive determinations to the original primary endpoint. We use simulation to test the operating characteristics of this new design compared to a standard O’Brien-Fleming approach, as well as the ability of our design to discriminate trustworthy from untrustworthy surrogates in hypothetical future trials. Furthermore, we investigate possible benefits using patient-level data from 18 adjuvant therapy trials in colon cancer, where disease-free survival is considered a newly-validated surrogate endpoint for overall survival. PMID:21838811

Validity and Reliability of the Turkish Version for DSM-5 Level 2 Anger Scale (Child Form for Children Aged 11-17 Years and Parent Form for Children Aged 6-17 Years).

PubMed

Yalin Sapmaz, Şermin; Özek Erkuran, Handan; Yalin, Nefize; Önen, Özlem; Öztekin, Siğnem; Kavurma, Canem; Köroğlu, Ertuğrul; Aydemir, Ömer

2017-12-01

This study aimed to assess the validity and reliability of the Turkish version of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Level 2 Anger Scale. The scale was prepared by translation and back translation of DSM-5 Level 2 Anger Scale. Study groups consisted of a clinical sample of cases diagnosed with depressive disorder and treated in a child and adolescent psychiatry unit and a community sample. The study was continued with 218 children and 160 parents. In the assessment process, child and parent forms of DSM-5 Level 2 Anger Scale and Children's Depression Inventory and Strengths and Difficulties Questionnaire-Parent Form were used. In the reliability analyses, the Cronbach alpha internal consistency coefficient values were found very high regarding child and parent forms. Item-total score correlation coefficients were high and very high, respectively, for child and parent forms indicating a statistical significance. As for construct validity, one factor was maintained for each form and was found to be consistent with the original form of the scale. As for concurrent validity, the child form of the scale showed significant correlation with Children's Depression Inventory, while the parent form showed significant correlation with Strengths and Difficulties Questionnaire-Parent Form. It was found that the Turkish version of DSM-5 Level 2 Anger Scale could be utilized as a valid and reliable tool both in clinical practice and for research purposes.

A model of the pre-assessment learning effects of assessment is operational in an undergraduate clinical context

PubMed Central

2012-01-01

Background No validated model exists to explain the learning effects of assessment, a problem when designing and researching assessment for learning. We recently developed a model explaining the pre-assessment learning effects of summative assessment in a theory teaching context. The challenge now is to validate this model. The purpose of this study was to explore whether the model was operational in a clinical context as a first step in this process. Methods Given the complexity of the model, we adopted a qualitative approach. Data from in-depth interviews with eighteen medical students were subject to content analysis. We utilised a code book developed previously using grounded theory. During analysis, we remained alert to data that might not conform to the coding framework and open to the possibility of deploying inductive coding. Ethical clearance and informed consent were obtained. Results The three components of the model i.e., assessment factors, mechanism factors and learning effects were all evident in the clinical context. Associations between these components could all be explained by the model. Interaction with preceptors was identified as a new subcomponent of assessment factors. The model could explain the interrelationships of the three facets of this subcomponent i.e., regular accountability, personal consequences and emotional valence of the learning environment, with previously described components of the model. Conclusions The model could be utilized to analyse and explain observations in an assessment context different to that from which it was derived. In the clinical setting, the (negative) influence of preceptors on student learning was particularly prominent. In this setting, learning effects resulted not only from the high-stakes nature of summative assessment but also from personal stakes, e.g. for esteem and agency. The results suggest that to influence student learning, consequences should accrue from assessment that are immediate, concrete and substantial. The model could have utility as a planning or diagnostic tool in practice and research settings. PMID:22420839

Protocol for a qualitative study exploring perspectives on the INternational CLassification of Diseases (11th revision); Using lived experience to improve mental health Diagnosis in NHS England: INCLUDE study

PubMed Central

Hackmann, Corinna; Green, Amanda; Notley, Caitlin; Perkins, Amorette; Reed, Geoffrey M; Ridler, Joseph; Wilson, Jon; Shakespeare, Tom

2017-01-01

Introduction Developed in dialogue with WHO, this research aims to incorporate lived experience and views in the refinement of the International Classification of Diseases Mental and Behavioural Disorders 11th Revision (ICD-11). The validity and clinical utility of psychiatric diagnostic systems has been questioned by both service users and clinicians, as not all aspects reflect their lived experience or are user friendly. This is critical as evidence suggests that diagnosis can impact service user experience, identity, service use and outcomes. Feedback and recommendations from service users and clinicians should help minimise the potential for unintended negative consequences and improve the accuracy, validity and clinical utility of the ICD-11. Methods and analysis The name INCLUDE reflects the value of expertise by experience as all aspects of the proposed study are co-produced. Feedback on the planned criteria for the ICD-11 will be sought through focus groups with service users and clinicians. The data from these groups will be coded and inductively analysed using a thematic analysis approach. Findings from this will be used to form the basis of co-produced recommendations for the ICD-11. Two service user focus groups will be conducted for each of these diagnoses: Personality Disorder, Bipolar I Disorder, Schizophrenia, Depressive Disorder and Generalised Anxiety Disorder. There will be four focus groups with clinicians (psychiatrists, general practitioners and clinical psychologists). Ethics and dissemination This study has received ethical approval from the Coventry and Warwickshire HRA Research Ethics Committee (16/WM/0479). The output for the project will be recommendations that reflect the views and experiences of experts by experience (service users and clinicians). The findings will be disseminated via conferences and peer-reviewed publications. As the ICD is an international tool, the aim is for the methodology to be internationally disseminated for replication by other groups. Trial registration number ClinicalTrials.gov: NCT03131505. PMID:28871029

A systematic review of the psychometric properties of self-report research utilization measures used in healthcare

PubMed Central

2011-01-01

Background In healthcare, a gap exists between what is known from research and what is practiced. Understanding this gap depends upon our ability to robustly measure research utilization. Objectives The objectives of this systematic review were: to identify self-report measures of research utilization used in healthcare, and to assess the psychometric properties (acceptability, reliability, and validity) of these measures. Methods We conducted a systematic review of literature reporting use or development of self-report research utilization measures. Our search included: multiple databases, ancestry searches, and a hand search. Acceptability was assessed by examining time to complete the measure and missing data rates. Our approach to reliability and validity assessment followed that outlined in the Standards for Educational and Psychological Testing. Results Of 42,770 titles screened, 97 original studies (108 articles) were included in this review. The 97 studies reported on the use or development of 60 unique self-report research utilization measures. Seven of the measures were assessed in more than one study. Study samples consisted of healthcare providers (92 studies) and healthcare decision makers (5 studies). No studies reported data on acceptability of the measures. Reliability was reported in 32 (33%) of the studies, representing 13 of the 60 measures. Internal consistency (Cronbach's Alpha) reliability was reported in 31 studies; values exceeded 0.70 in 29 studies. Test-retest reliability was reported in 3 studies with Pearson's r coefficients > 0.80. No validity information was reported for 12 of the 60 measures. The remaining 48 measures were classified into a three-level validity hierarchy according to the number of validity sources reported in 50% or more of the studies using the measure. Level one measures (n = 6) reported evidence from any three (out of four possible) Standards validity sources (which, in the case of single item measures, was all applicable validity sources). Level two measures (n = 16) had evidence from any two validity sources, and level three measures (n = 26) from only one validity source. Conclusions This review reveals significant underdevelopment in the measurement of research utilization. Substantial methodological advances with respect to construct clarity, use of research utilization and related theory, use of measurement theory, and psychometric assessment are required. Also needed are improved reporting practices and the adoption of a more contemporary view of validity (i.e., the Standards) in future research utilization measurement studies. PMID:21794144

Linguistic validation of the Alberta Context Tool and two measures of research use, for German residential long term care.

PubMed

Hoben, Matthias; Bär, Marion; Mahler, Cornelia; Berger, Sarah; Squires, Janet E; Estabrooks, Carole A; Kruse, Andreas; Behrens, Johann

2014-01-31

To study the association between organizational context and research utilization in German residential long term care (LTC), we translated three Canadian assessment instruments: the Alberta Context Tool (ACT), Estabrooks' Kinds of Research Utilization (RU) items and the Conceptual Research Utilization Scale. Target groups for the tools were health care aides (HCAs), registered nurses (RNs), allied health professionals (AHPs), clinical specialists and care managers. Through a cognitive debriefing process, we assessed response processes validity-an initial stage of validity, necessary before more advanced validity assessment. We included 39 participants (16 HCAs, 5 RNs, 7 AHPs, 5 specialists and 6 managers) from five residential LTC facilities. We created lists of questionnaire items containing problematic items plus items randomly selected from the pool of remaining items. After participants completed the questionnaires, we conducted individual semi-structured cognitive interviews using verbal probing. We asked participants to reflect on their answers for list items in detail. Participants' answers were compared to concept maps defining the instrument concepts in detail. If at least two participants gave answers not matching concept map definitions, items were revised and re-tested with new target group participants. Cognitive debriefings started with HCAs. Based on the first round, we modified 4 of 58 ACT items, 1 ACT item stem and all 8 items of the RU tools. All items were understood by participants after another two rounds. We included revised HCA ACT items in the questionnaires for the other provider groups. In the RU tools for the other provider groups, we used different wording than the HCA version, as was done in the original English instruments. Only one cognitive debriefing round was needed with each of the other provider groups. Cognitive debriefing is essential to detect and respond to problematic instrument items, particularly when translating instruments for heterogeneous, less well educated provider groups such as HCAs. Cognitive debriefing is an important step in research tool development and a vital component of establishing response process validity evidence. Publishing cognitive debriefing results helps researchers to determine potentially critical elements of the translated tools and assists with interpreting scores.

Which Questionnaire Should Be Used to Measure Quality-of-Life Utilities in Patients with Acute Leukemia? An Evaluation of the Validity and Interpretability of the EQ-5D-5L and Preference-Based Questionnaires Derived from the EORTC QLQ-C30.

PubMed

van Dongen-Leunis, Annemieke; Redekop, W Ken; Uyl-de Groot, Carin A

The aim of this study was to assess the validity and interpretability of different preference-based questionnaires (generic 5-level EuroQol five-dimensional questionnaire [EQ-5D-5L], cancer-specific Quality of Life Questionnaire Preference-Based Measure, and European Organization of Randomized Controlled Trials 8 Dimension [EORTC-8D]) in patients with acute leukemia. Patients who participated in Hemato-Oncologie voor Volwassenen Nederland (HOVON - the Haemato Oncology Foundation for Adults in the Netherlands) clinical trials between 1999 and 2011 at a single hospital were invited to complete the questionnaires. Interpretability was evaluated by the frequency of incomplete data and highest and lowest possible scores. Content validity was evaluated by exploring the health-related quality-of-life domains included in the questionnaires. Construct validity was assessed using correlations with other quality-of-life scales (EQ-visual analogue scale score and global quality-of-life scale of the EORTC Quality of Life Questionnaire) and ability to distinguish between patients with different health statuses. Questionnaires were returned by 89% (111 of 125) of the patients. Six to seven respondents did not return full questionnaires. Perfect health on the EQ-5D-5L was reported by 32 respondents and many of them (N = 17) did report health problems on other questionnaires. All questionnaires were strongly correlated (range 0.61-0.78) with other quality-of-life scales and yielded substantially different utility values for patients with different health statuses. Nevertheless, the disease-specific preference-based questionnaires showed greater discriminatory power. Although the Quality of Life Questionnaire Preference-Based Measure and the EORTC-8D appear to have better validity, this study does not provide any strong evidence against the use of the EQ-5D-5L for measuring quality-of-life utilities in acute leukemia. However, our findings need to be confirmed in larger longitudinal studies. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Gene expression profiling and expanded immunohistochemistry tests to guide the use of adjuvant chemotherapy in breast cancer management: a systematic review and cost-effectiveness analysis.

PubMed

Ward, S; Scope, A; Rafia, R; Pandor, A; Harnan, S; Evans, P; Wyld, L

2013-10-01

Gene expression profiling (GEP) and expanded immunohistochemistry (IHC) tests aim to improve decision-making relating to adjuvant chemotherapy for women with early breast cancer. The aim of this report is to assess the clinical effectiveness and cost-effectiveness of nine GEP and expanded IHC tests compared with current prognostic tools in guiding the use of adjuvant chemotherapy in patients with early breast cancer in England and Wales. The nine tests are BluePrint, Breast Cancer Index (BCI), IHC4, MammaPrint, Mammostrat, NPI plus (NPI+), OncotypeDX, PAM50 and Randox Breast Cancer Array. Databases searched included MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE and The Cochrane Library. Databases were searched from January 2009 to May 2011 for the OncotypeDX and MammaPrint tests and from January 2002 to May 2011 for the other tests. A systematic review of the evidence on clinical effectiveness (analytical validity, clinical validity and clinical utility) and cost-effectiveness was conducted. An economic model was developed to evaluate the cost-effectiveness of adjuvant chemotherapy treatment guided by four of the nine test (OncotypeDX, IHC4, MammaPrint and Mammostrat) compared with current clinical practice in England and Wales, using clinicopathological parameters, in women with oestrogen receptor-positive (ER+), lymph node-negative (LN-), human epidermal growth factor receptor type 2-negative (HER2-) early breast cancer. The literature searches for clinical effectiveness identified 5993 citations, of which 32 full-text papers or abstracts (30 studies) satisfied the criteria for the effectiveness review. A narrative synthesis was performed. Evidence for OncotypeDX supported the prognostic capability of the test. There was some evidence on the impact of the test on decision-making and to support the case that OncotypeDX predicts chemotherapy benefit; however, few studies were UK based and limitations in relation to study design were identified. Evidence for MammaPrint demonstrated that the test score was a strong independent prognostic factor, but the evidence is non-UK based and is based on small sample sizes. Evidence on the Mammostrat test showed that the test was an independent prognostic tool for women with ER+, tamoxifen-treated breast cancer. The three studies appeared to be of reasonable quality and provided data from a UK setting (one study). One large study reported on clinical validity of the IHC4 test, with IHC4 score a highly significant predictor of distant recurrence. This study included data from a UK setting and appeared to be of reasonable quality. Evidence for the remaining five tests (PAM50, NPI+, BCI, BluePrint and Randox) was limited. The economic analysis suggests that treatment guided using IHC4 has the greatest potential to be cost-effective at a £20,000 threshold, given the low cost of the test; however, further research is needed on the analytical validity and clinical utility of IHC4, and the exact cost of the test needs to be confirmed. Current limitations in the evidence base produce significant uncertainty in the results. OncotypeDX has a more robust evidence base, but further evidence on its impact on decision-making in the UK and the predictive ability of the test in an ER+, LN-, HER- population receiving current drug regimens is needed. For MammaPrint and Mammostrat there were significant gaps in the available evidence and the estimates of cost-effectiveness produced were not considered to be robust by the External Assessment Group. Methodological weaknesses in the clinical evidence base relate to heterogeneity of patient cohorts and issues arising from the retrospective nature of the evidence. Further evidence is required on the clinical utility of all of the tests and on UK-based populations. A key area of uncertainty relates to whether the tests provide prognostic or predictive ability. The clinical evidence base for OncotypeDX is considered to be the most robust. The economic analysis suggested that treatment guided using IHC4 has the most potential to be cost-effective at a threshold of £20,000; however, the evidence base to support IHC4 needs significant further research. PROSPERO 2011:CRD42011001361, available from www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42011001361.

The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample.

PubMed

Henry, Julie D; Crawford, John R

2005-06-01

To test the construct validity of the short-form version of the Depression anxiety and stress scale (DASS-21), and in particular, to assess whether stress as indexed by this measure is synonymous with negative affectivity (NA) or whether it represents a related, but distinct, construct. To provide normative data for the general adult population. Cross-sectional, correlational and confirmatory factor analysis (CFA). The DASS-21 was administered to a non-clinical sample, broadly representative of the general adult UK population (N = 1,794). Competing models of the latent structure of the DASS-21 were evaluated using CFA. The model with optimal fit (RCFI = 0.94) had a quadripartite structure, and consisted of a general factor of psychological distress plus orthogonal specific factors of depression, anxiety, and stress. This model was a significantly better fit than a competing model that tested the possibility that the Stress scale simply measures NA. The DASS-21 subscales can validly be used to measure the dimensions of depression, anxiety, and stress. However, each of these subscales also taps a more general dimension of psychological distress or NA. The utility of the measure is enhanced by the provision of normative data based on a large sample.

The MMPI-2-RF Personality Psychopathology Five (PSY-5-RF) scales: development and validity research.

PubMed

Harkness, Allan R; McNulty, John L; Finn, Jacob A; Reynolds, Shannon M; Shields, Susan M; Arbisi, Paul

2014-01-01

This article describes the development, internal psychometric, and external validation studies on scales designed to measure the Personality Psychopathology Five (PSY-5) from MMPI-2 Restructured Form (MMPI-2-RF) items. Diverse and comprehensive data sets, representing various clinical and nonclinical populations, were classified into development and validation research samples. Item selection, retention, and exclusion procedures are detailed. The final set of PSY-5-RF scales contain 104 items, with no item overlap between scales (same as the original MMPI-2 PSY-5 scales), and no item overlap with the Demoralization scale. Internal consistency estimates are comparable to the longer MMPI-2 PSY-5 scales. Appropriate convergent and discriminant validity findings utilizing various self-report, collateral rating, and record review data are reported and discussed. A particular emphasis is offered for the unique aspects of the PSY-5 model: psychoticism and disconstraint. The findings are connected to the broader PSY-5 literature and the recommended review of systems (Harkness, Reynolds, & Lilienfeld, this issue) presented in this series of articles.

Measuring cervical cancer risk: development and validation of the CARE Risky Sexual Behavior Index.

PubMed

Reiter, Paul L; Katz, Mira L; Ferketich, Amy K; Ruffin, Mack T; Paskett, Electra D

2009-12-01

To develop and validate a risky sexual behavior index specific to cervical cancer research. Sexual behavior data on 428 women from the Community Awareness Resources and Education (CARE) study were utilized. A weighting scheme for eight risky sexual behaviors was generated and validated in creating the CARE Risky Sexual Behavior Index. Cutpoints were then identified to classify women as having a low, medium, or high level of risky sexual behavior. Index scores ranged from 0 to 35, with women considered to have a low level of risky sexual behavior if their score was less than six (31.3% of sample), a medium level if their score was 6–10 (30.6%), or a high level if their score was 11 or greater (38.1%). A strong association was observed between the created categories and having a previous abnormal Pap smear test (p < 0.001). The CARE Risky Sexual Behavior Index provides a tool for measuring risky sexual behavior level for cervical cancer research. Future studies are needed to validate this index in varied populations and test its use in the clinical setting.

Validation of the Singapore nomogram for outcome prediction in breast phyllodes tumours: an Australian cohort.

PubMed

Chng, Tze Wei; Lee, Jonathan Y H; Lee, C Soon; Li, HuiHua; Tan, Min-Han; Tan, Puay Hoon

2016-12-01

To validate the utility of the Singapore nomogram for outcome prediction in breast phyllodes tumours. Histological parameters, surgical margin status and clinical follow-up data of 34 women diagnosed with phyllodes tumours were analysed. Biostatistics modelling was performed, and the concordance between predicted and observed survivals was calculated. Women with a high nomogram score had an increased risk of developing relapse, which was predicted using the parameters defined by the Singapore nomogram. The Singapore nomogram is useful in predicting outcome in breast phyllodes tumours when applied to an Australian cohort of 34 women. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

EDRN Pre-Validation of Metabolic Biomarkers of Prostate Cancer: Follow up EDRN Challenge — EDRN Public Portal

Cancer.gov

The goal of this EDRN set-asides proposal is to carry out pre-validation studies on sarcosine as a metabolomic biomarker of prostate cancer in urine. Not only does sarcosine have potential as a marker for the early detection of prostate cancer in post-DRE urine specimens-- but since its highest levels are in metastatic disease it might have utility in predicting aggressiveness of clinically localized disease. We will also use these funds to determine if we can add additional metabolites to sarcosine in order to develop a multiplex metabolomic biomarker panel in prostate cancer. In addition to sarcosine, we have 10-12 additional candidate metabolomic biomarkers that could be developed (as seen from our preliminary global metabolite studies).

Test of memory malingering (TOMM) trial 1 as a screening measure for insufficient effort.

PubMed

O'Bryant, Sid E; Engel, Lisa R; Kleiner, Jennifer S; Vasterling, Jennifer J; Black, F William

2007-05-01

The identification of insufficient effort is critical to neuropsychological evaluation, and several existing instruments assess effort on neuropsychological tasks. Yet instruments designed to detect insufficient effort are underutilized in standard neuropsychological assessments, perhaps in part because they typically require significant administration time and are, therefore, not ideally suited to screening contexts. The Test of Memory Malingering (TOMM) is a commonly administered, well-validated symptom validity test. This study evaluates the utility of TOMM Trial 1 as a relatively brief screening measure of insufficient effort. Results suggest that TOMM Trial 1 demonstrates high diagnostic accuracy and is a viable option for screening insufficient effort. Diagnostic accuracy estimates are presented for a range of base rates. The need for more comprehensive SVT assessment in most clinical and forensic situation is discussed.

Preliminary Validation of a German Version of the Sexual Complaints Screener for Women in a Female Population Sample.

PubMed

Burri, Andrea; Porst, Hartmut

2018-06-01

To date, neither the original English nor any of the translated versions of the Sexual Complaints Screener for Women (SCS-W) have been tested for their psychometric properties. To evaluate the validity and utility of the German version of the SCS-W by assessing content, convergent, and discriminant validity. A population sample of 309 women (mean age = 26.9 years) completed the online survey and had matching data available on the SCS-W and the Female Sexual Function Index (FSFI). Spearman bivariate correlations between the SCS-W and FSFI domain scores and exploratory factor analysis with principal component analysis were conducted. Convergent validity was excellent for the domain of orgasm, good for satisfaction, dyspareunia, and the total questionnaire score, and acceptable for desire, lubrication, arousal, and vaginismus. Discriminant validity was present for all domains apart from arousal, lubrication, and vaginismus. Varimax rotation suggested an 8-factor model was the most robust. This brief screener seems suitable to provide a brief overview of female patients' sexual problems in a clinical setting. This is the 1st study to assess the psychometric properties of the German version of the SCS-W. However, available information on the psychometric properties of the German SCS-W was limited because the validity of the screener could not be counterchecked against a clinical diagnosis of female sexual dysfunction. Our results provide preliminary evidence of good validity of the German version of the SCS-W. Overall, the SCS-W can offer support for clinicians who are less familiar with sexual medicine and who might not routinely discuss sexual issues with their patients. Burri A, Porst H. Preliminary Validation of a German Version of the Sexual Complaints Screener for Women in a Female Population Sample. Sex Med 2018;6:123-130. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Validity and reliability of the Turkish version of the DSM-5 Generalized Anxiety Disorder Severity Scale for children aged 11–17 years

PubMed

Yalın Sapmaz, Şermin; Özek Erkuran, Handan; Ergin, Dilek; Öztürk, Masum; Şen Celasin, Nesrin; Karaarslan, Duygu; Aydemir, Ömer

2018-02-23

Background/aim: This study aimed to assess the validity and reliability of the Turkish version of the DSM-5 Generalized Anxiety Disorder Severity Scale - Child Form. Materials and methods: The study sample consisted of 32 patients treated in a child psychiatry unit and diagnosed with generalized anxiety disorder and 98 healthy volunteers who were attending middle or high school during the study period. For the assessment, the Screen for Child Anxiety and Related Emotional Disorders (SCARED) was also used along with the DSM-5 Generalized Anxiety Disorder Severity Scale - Child Form. Results: Regarding reliability analyses, the Cronbach alpha internal consistency coefficient was calculated as 0.932. The test-retest correlation coefficient was calculated as r = 0.707. As for construct validity, one factor that could explain 62.6% of the variance was obtained and this was consistent with the original construct of the scale. As for concurrent validity, the scale showed a high correlation with SCARED. Conclusion: It was concluded that Turkish version of the DSM-5 Generalized Anxiety Disorder Severity Scale - Child Form could be utilized as a valid and reliable tool both in clinical practice and for research purposes.

Decision-making in palliative care: a reflective case study.

PubMed

Birchall, Melissa

2005-01-01

Critical examination of the processes by which we as nurses judge and reach clinical decisions is important. It facilitates the maintenance and refinement of good standards of nursing care and the pinpointing of areas where improvement is needed. In turn this potentially could support broader validation of nurse expertise and contribute to emancipation of the nursing profession. As pure theory, clinical decision-making may appear abstract and alien to nurses struggling in 'the swampy lowlands' (Schon 1983) of the realities of practice. This paper explores some of the key concepts in decision-making theory by introducing, then integrating, them in a reflective case study. The case study, which examines a 'snapshot' of the patient and practitioner's journey, interwoven with theory surrounding clinical decision-making, may aid understanding and utility of concepts and theories in practice.

Clinical assessment of adventitious movements.

PubMed

Brasić, J R; Barnett, J Y; Sheitman, B B; Lafargue, R T; Ahn, S C

1998-12-01

Many procedures with variable validity and reliability have been developed in research settings to evaluate adventitious movements and related phenomena in specific populations, e.g., people with schizophrenia treated with dopamine antagonists, but these only provide global assessments or rate specific movements. A battery for rating individuals with possible movements disorders in a comprehensive way in clinical settings is needed so a protocol to assess briefly and thoroughly potential movement disorders was videotaped for five prepubertal boys with autistic disorder and severe mental retardation in a clinical trial. Utilizing a Movement Assessment Battery, four raters independently scored videotapes of 10-16 movements assessments of each of the five subjects. Experienced raters attained agreement of 59% to 100% on ratings of tardive dyskinesia and 48% to 100% on tics. Hindrances to reliability included poor quality of some tapes, high activity of subjects, and fatigue of raters.

Assuring the Quality of Next-Generation Sequencing in Clinical Microbiology and Public Health Laboratories.

PubMed

Gargis, Amy S; Kalman, Lisa; Lubin, Ira M

2016-12-01

Clinical microbiology and public health laboratories are beginning to utilize next-generation sequencing (NGS) for a range of applications. This technology has the potential to transform the field by providing approaches that will complement, or even replace, many conventional laboratory tests. While the benefits of NGS are significant, the complexities of these assays require an evolving set of standards to ensure testing quality. Regulatory and accreditation requirements, professional guidelines, and best practices that help ensure the quality of NGS-based tests are emerging. This review highlights currently available standards and guidelines for the implementation of NGS in the clinical and public health laboratory setting, and it includes considerations for NGS test validation, quality control procedures, proficiency testing, and reference materials. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

The Clinical Use of Robots for Individuals with Autism Spectrum Disorders: A Critical Review

PubMed Central

Diehl, Joshua J.; Schmitt, Lauren M.; Villano, Michael; Crowell, Charles R.

2011-01-01

We examined peer-reviewed studies in order to understand the current status of empirically-based evidence on the clinical applications of robots in the diagnosis and treatment of Autism Spectrum Disorders (ASD). Studies are organized into four broad categories: (a) the response of individuals with ASD to robots or robot-like behavior in comparison to human behavior, (b) the use of robots to elicit behaviors, (c) the use of robots to model, teach, and/or practice a skill, and (d) the use of robots to provide feedback on performance. A critical review of the literature revealed that most of the findings are exploratory and have methodological limitations that make it difficult to draw firm conclusions about the clinical utility of robots. Finally, we outline the research needed to determine the incremental validity of this technique. PMID:22125579

Aggregated N-of-1 randomized controlled trials: modern data analytics applied to a clinically valid method of intervention effectiveness.

PubMed

Cushing, Christopher C; Walters, Ryan W; Hoffman, Lesa

2014-03-01

Aggregated N-of-1 randomized controlled trials (RCTs) combined with multilevel modeling represent a methodological advancement that may help bridge science and practice in pediatric psychology. The purpose of this article is to offer a primer for pediatric psychologists interested in conducting aggregated N-of-1 RCTs. An overview of N-of-1 RCT methodology is provided and 2 simulated data sets are analyzed to demonstrate the clinical and research potential of the methodology. The simulated data example demonstrates the utility of aggregated N-of-1 RCTs for understanding the clinical impact of an intervention for a given individual and the modeling of covariates to explain why an intervention worked for one patient and not another. Aggregated N-of-1 RCTs hold potential for improving the science and practice of pediatric psychology.

Observing health professionals' workflow patterns for diabetes care - First steps towards an ontology for EHR services.

PubMed

Schweitzer, M; Lasierra, N; Hoerbst, A

2015-01-01

Increasing the flexibility from a user-perspective and enabling a workflow based interaction, facilitates an easy user-friendly utilization of EHRs for healthcare professionals' daily work. To offer such versatile EHR-functionality, our approach is based on the execution of clinical workflows by means of a composition of semantic web-services. The backbone of such architecture is an ontology which enables to represent clinical workflows and facilitates the selection of suitable services. In this paper we present the methods and results after running observations of diabetes routine consultations which were conducted in order to identify those workflows and the relation among the included tasks. Mentioned workflows were first modeled by BPMN and then generalized. As a following step in our study, interviews will be conducted with clinical personnel to validate modeled workflows.

Emergency Physician Attitudes, Preferences, and Risk Tolerance for Stroke as a Potential Cause of Dizziness Symptoms.

PubMed

Kene, Mamata V; Ballard, Dustin W; Vinson, David R; Rauchwerger, Adina S; Iskin, Hilary R; Kim, Anthony S

2015-09-01

We evaluated emergency physicians' (EP) current perceptions, practice, and attitudes towards evaluating stroke as a cause of dizziness among emergency department patients. We administered a survey to all EPs in a large integrated healthcare delivery system. The survey included clinical vignettes, perceived utility of historical and exam elements, attitudes about the value of and requisite post-test probability of a clinical prediction rule for dizziness. We calculated descriptive statistics and post-test probabilities for such a clinical prediction rule. The response rate was 68% (366/535). Respondents' median practice tenure was eight years (37% female, 92% emergency medicine board certified). Symptom quality and typical vascular risk factors increased suspicion for stroke as a cause of dizziness. Most respondents reported obtaining head computed tomography (CT) (74%). Nearly all respondents used and felt confident using cranial nerve and limb strength testing. A substantial minority of EPs used the Epley maneuver (49%) and HINTS (head-thrust test, gaze-evoked nystagmus, and skew deviation) testing (30%); however, few EPs reported confidence in these tests' bedside application (35% and 16%, respectively). Respondents favorably viewed applying a properly validated clinical prediction rule for assessment of immediate and 30-day stroke risk, but indicated it would have to reduce stroke risk to <0.5% to be clinically useful. EPs report relying on symptom quality, vascular risk factors, simple physical exam elements, and head CT to diagnose stroke as the cause of dizziness, but would find a validated clinical prediction rule for dizziness helpful. A clinical prediction rule would have to achieve a 0.5% post-test stroke probability for acceptability.

Analysis of model development strategies: predicting ventral hernia recurrence.

PubMed

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

2016-11-01

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

Reporting Guidelines for Clinical Pharmacokinetic Studies: The ClinPK Statement.

PubMed

Kanji, Salmaan; Hayes, Meghan; Ling, Adam; Shamseer, Larissa; Chant, Clarence; Edwards, David J; Edwards, Scott; Ensom, Mary H H; Foster, David R; Hardy, Brian; Kiser, Tyree H; la Porte, Charles; Roberts, Jason A; Shulman, Rob; Walker, Scott; Zelenitsky, Sheryl; Moher, David

2015-07-01

Transparent reporting of all research is essential for assessing the validity of any study. Reporting guidelines are available and endorsed for many types of research but are lacking for clinical pharmacokinetic studies. Such tools promote the consistent reporting of a minimal set of information for end users, and facilitate knowledge translation of research. The objective of this study was to create a guideline to assist in the transparent and complete reporting of clinical pharmacokinetic studies. Preliminary content to be considered was identified from a systematic search of the literature and regulatory documents. Stakeholders were identified to participate in a modified Delphi exercise and a virtual meeting to generate consensus for items considered essential in the reporting of clinical pharmacokinetic studies. The proposed checklist was pilot tested on 100 recently published clinical pharmacokinetic studies. Overall and itemized compliance with the proposed guidance was determined for each study. Sixty-eight stakeholders from nine countries consented to participate. Four rounds of a modified Delphi survey and a series of small virtual meetings were required to generate consensus for a 24-item checklist considered to be essential to the reporting of clinical pharmacokinetic studies. When applied to the 100 most recently published clinical pharmacokinetic studies, 45 were determined to be compliant with at least 80 % of the checklist items. Explanatory text was prepared using examples of compliant reporting from these and other relevant studies. The reader's ability to judge the validity of pharmacokinetic research can be greatly compromised by the incomplete reporting of study information. Using consensus methods, we have developed a tool to guide transparent and accurate reporting of clinical pharmacokinetic studies. Endorsement and implementation of these guidelines by researchers, clinicians and journals would promote more consistent reporting of these studies and allow for better assessment of utility for clinical applications.

Genetic Testing in Clinical Settings.

PubMed

Franceschini, Nora; Frick, Amber; Kopp, Jeffrey B

2018-04-11

Genetic testing is used for screening, diagnosis, and prognosis of diseases consistent with a genetic cause and to guide drug therapy to improve drug efficacy and avoid adverse effects (pharmacogenomics). This In Practice review aims to inform about DNA-related genetic test availability, interpretation, and recommended clinical actions based on results using evidence from clinical guidelines, when available. We discuss challenges that limit the widespread use of genetic information in the clinical care setting, including a small number of actionable genetic variants with strong evidence of clinical validity and utility, and the need for improving the health literacy of health care providers and the public, including for direct-to-consumer tests. Ethical, legal, and social issues and incidental findings also need to be addressed. Because our understanding of genetic factors associated with disease and drug response is rapidly increasing and new genetic tests are being developed that could be adopted by clinicians in the short term, we also provide extensive resources for information and education on genetic testing. Copyright © 2018 National Kidney Foundation, Inc. All rights reserved.

Analytical validation of a novel multiplex test for detection of advanced adenoma and colorectal cancer in symptomatic patients.

PubMed

Dillon, Roslyn; Croner, Lisa J; Bucci, John; Kairs, Stefanie N; You, Jia; Beasley, Sharon; Blimline, Mark; Carino, Rochele B; Chan, Vicky C; Cuevas, Danissa; Diggs, Jeff; Jennings, Megan; Levy, Jacob; Mina, Ginger; Yee, Alvin; Wilcox, Bruce

2018-05-30

Early detection of colorectal cancer (CRC) is key to reducing associated mortality. Despite the importance of early detection, approximately 40% of individuals in the United States between the ages of 50-75 have never been screened for CRC. The low compliance with colonoscopy and fecal-based screening may be addressed with a non-invasive alternative such as a blood-based test. We describe here the analytical validation of a multiplexed blood-based assay that measures the plasma concentrations of 15 proteins to assess advanced adenoma (AA) and CRC risk in symptomatic patients. The test was developed on an electrochemiluminescent immunoassay platform employing four multi-marker panels, to be implemented in the clinic as a laboratory developed test (LDT). Under the Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) regulations, a United States-based clinical laboratory utilizing an LDT must establish performance characteristics relating to analytical validity prior to releasing patient test results. This report describes a series of studies demonstrating the precision, accuracy, analytical sensitivity, and analytical specificity for each of the 15 assays, as required by CLIA/CAP. In addition, the report describes studies characterizing each of the assays' dynamic range, parallelism, tolerance to common interfering substances, spike recovery, and stability to sample freeze-thaw cycles. Upon completion of the analytical characterization, a clinical accuracy study was performed to evaluate concordance of AA and CRC classifier model calls using the analytical method intended for use in the clinic. Of 434 symptomatic patient samples tested, the percent agreement with original CRC and AA calls was 87% and 92% respectively. All studies followed CLSI guidelines and met the regulatory requirements for implementation of a new LDT. The results provide the analytical evidence to support the implementation of the novel multi-marker test as a clinical test for evaluating CRC and AA risk in symptomatic individuals. Copyright © 2018 Elsevier B.V. All rights reserved.

Psychometric Properties and Utility of the Social Vulnerability Questionnaire for Individuals with Intellectual and Developmental Disabilities.

PubMed

Fisher, Marisa H; Shivers, Carolyn M; Josol, Cynde K

2018-06-05

Although it is well-known that individuals with intellectual and developmental disabilities (IDD) are socially vulnerable, the field lacks valid assessments to identify risk factors for victimization. Parents/caregivers of 428 individuals with IDD (ages 12-53) completed the social vulnerability questionnaire (SVQ), a measure developed to assess specific aspects of social vulnerability among individuals with various forms of IDD. This study examined the psychometric structure of the SVQ (exploratory and confirmatory factor analysis), and the utility of the factors of the SVQ as predictors of diagnostic category (through discriminate function analysis). Results provide psychometric support for use of the SVQ and its factors for further research and as part of a clinical assessment battery to assess social vulnerability and to develop interventions.

Prognostic Biomarkers Used for Localised Prostate Cancer Management: A Systematic Review.

PubMed

Lamy, Pierre-Jean; Allory, Yves; Gauchez, Anne-Sophie; Asselain, Bernard; Beuzeboc, Philippe; de Cremoux, Patricia; Fontugne, Jacqueline; Georges, Agnès; Hennequin, Christophe; Lehmann-Che, Jacqueline; Massard, Christophe; Millet, Ingrid; Murez, Thibaut; Schlageter, Marie-Hélène; Rouvière, Olivier; Kassab-Chahmi, Diana; Rozet, François; Descotes, Jean-Luc; Rébillard, Xavier

2017-03-07

Prostate cancer stratification is based on tumour size, pretreatment PSA level, and Gleason score, but it remains imperfect. Current research focuses on the discovery and validation of novel prognostic biomarkers to improve the identification of patients at risk of aggressive cancer or of tumour relapse. This systematic review by the Intergroupe Coopérateur Francophone de Recherche en Onco-urologie (ICFuro) analysed new evidence on the analytical validity and clinical validity and utility of six prognostic biomarkers (PHI, 4Kscore, MiPS, GPS, Prolaris, Decipher). All available data for the six biomarkers published between January 2002 and April 2015 were systematically searched and reviewed. The main endpoints were aggressive prostate cancer prediction, additional value compared to classical prognostic parameters, and clinical benefit for patients with localised prostate cancer. The preanalytical and analytical validations were heterogeneous for all tests and often not adequate for the molecular signatures. Each biomarker was studied for specific indications (candidates for a first or second biopsy, and potential candidates for active surveillance, radical prostatectomy, or adjuvant treatment) for which the level of evidence (LOE) was variable. PHI and 4Kscore were the biomarkers with the highest LOE for discriminating aggressive and indolent tumours in different indications. Blood biomarkers (PHI and 4Kscore) have the highest LOE for the prediction of more aggressive prostate cancer and could help clinicians to manage patients with localised prostate cancer. The other biomarkers show a potential prognostic value; however, they should be evaluated in additional studies to confirm their clinical validity. We reviewed studies assessing the value of six prognostic biomarkers for prostate cancer. On the basis of the available evidence, some biomarkers could help in discriminating between aggressive and non-aggressive tumours with an additional value compared to the prognostic parameters currently used by clinicians. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

An Interpretable Machine Learning Model for Accurate Prediction of Sepsis in the ICU.

PubMed

Nemati, Shamim; Holder, Andre; Razmi, Fereshteh; Stanley, Matthew D; Clifford, Gari D; Buchman, Timothy G

2018-04-01

Sepsis is among the leading causes of morbidity, mortality, and cost overruns in critically ill patients. Early intervention with antibiotics improves survival in septic patients. However, no clinically validated system exists for real-time prediction of sepsis onset. We aimed to develop and validate an Artificial Intelligence Sepsis Expert algorithm for early prediction of sepsis. Observational cohort study. Academic medical center from January 2013 to December 2015. Over 31,000 admissions to the ICUs at two Emory University hospitals (development cohort), in addition to over 52,000 ICU patients from the publicly available Medical Information Mart for Intensive Care-III ICU database (validation cohort). Patients who met the Third International Consensus Definitions for Sepsis (Sepsis-3) prior to or within 4 hours of their ICU admission were excluded, resulting in roughly 27,000 and 42,000 patients within our development and validation cohorts, respectively. None. High-resolution vital signs time series and electronic medical record data were extracted. A set of 65 features (variables) were calculated on hourly basis and passed to the Artificial Intelligence Sepsis Expert algorithm to predict onset of sepsis in the proceeding T hours (where T = 12, 8, 6, or 4). Artificial Intelligence Sepsis Expert was used to predict onset of sepsis in the proceeding T hours and to produce a list of the most significant contributing factors. For the 12-, 8-, 6-, and 4-hour ahead prediction of sepsis, Artificial Intelligence Sepsis Expert achieved area under the receiver operating characteristic in the range of 0.83-0.85. Performance of the Artificial Intelligence Sepsis Expert on the development and validation cohorts was indistinguishable. Using data available in the ICU in real-time, Artificial Intelligence Sepsis Expert can accurately predict the onset of sepsis in an ICU patient 4-12 hours prior to clinical recognition. A prospective study is necessary to determine the clinical utility of the proposed sepsis prediction model.

The clinical utility and diagnostic performance of magnetic resonance imaging for identification of early and advanced knee osteoarthritis: a systematic review.

PubMed

Quatman, Carmen E; Hettrich, Carolyn M; Schmitt, Laura C; Spindler, Kurt P

2011-07-01

Current diagnostic strategies for detection of structural articular cartilage abnormalities, the earliest structural signs of osteoarthritis, often do not capture the condition until it is too far advanced for the most potential benefit of noninvasive interventions. To systematically review the literature relative to the following questions: (1) Is magnetic resonance imaging (MRI) a valid, sensitive, specific, accurate, and reliable instrument to identify knee articular cartilage abnormalities compared with arthroscopy? (2) Is MRI a sensitive tool that can be utilized to identify early cartilage degeneration? Systematic review. A systematic search was performed in November 2010 using PubMed MEDLINE (from 1966), CINAHL (from 1982), SPORTDiscus (from 1985), SCOPUS (from 1996), and EMBASE (from 1974) databases. Fourteen level I and 13 level II studies were identified that met inclusion criteria and provided information related to diagnostic performance of MRI compared with arthroscopic evaluation. The diagnostic performance of MRI demonstrated a large range of sensitivities, specificities, and accuracies. The sensitivity for identifying articular cartilage abnormalities in the knee joint was reported between 26% and 96%. Specificity and accuracy were reported between 50% and 100% and between 49% and 94%, respectively. The sensitivity, specificity, and accuracy for identifying early osteoarthritis were reported between 0% and 86%, 48% and 95%, and 5% and 94%, respectively. As a result of inconsistencies between imaging techniques and methodological shortcomings of many of the studies, a meta-analysis was not performed, and it was difficult to fully synthesize the information to state firm conclusions about the diagnostic performance of MRI. There is evidence in some MRI protocols that MRI is a relatively valid, sensitive, specific, accurate, and reliable clinical tool for identifying articular cartilage degeneration. Because of heterogeneity of MRI sequences, it is not possible to make definitive conclusions regarding its global clinical utility for guiding diagnosis and treatment strategies. Traumatic sports injuries to the knee may be significant precursor events to early onset of posttraumatic osteoarthritis. Magnetic resonance imaging may aid in early identification of structural injuries to articular cartilage as evidenced by articular cartilage degeneration grading.

Patient-reported outcomes in neurofibromatosis and schwannomatosis clinical trials

PubMed Central

Martin, Staci; Merker, Vanessa L.; Gardner, Kathy L.; Hingtgen, Cynthia M.; Tonsgard, James H.; Schorry, Elizabeth K.; Baldwin, Andrea

2013-01-01

Objectives: Neurofibromatosis (NF) is a genetic disease with multiple clinical manifestations that can significantly impact quality of life (QOL). Clinical trials should include patient-reported outcomes (PROs) as endpoints to assess treatment effects on various aspects of QOL, but there is no consensus on the selection and use of such measures in NF. This article describes the PRO Working Group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) Collaboration, its main goals, methods for identifying appropriate PRO measures for NF clinical trials, and recommendations for assessing pain intensity. Methods: The REiNS PRO group selected core endpoint domains important to assess in NF. The members developed criteria to rate PRO measures, including patient characteristics, psychometric properties, and feasibility, and utilized a systematic process to evaluate PROs for NF clinical trials. Within the subdomain of pain intensity, the group reviewed the Numerical Rating Scale-11 (NRS-11), the Visual Analogue Scale, and the Faces Pain Scale-Revised using this process. Results: Based on the review criteria, each of these pain intensity scales is brief, reliable, valid, and widely used. However, the NRS-11 was given the highest rating for use in NF clinical trials due to recommendations from pain experts and other consensus groups, its extensive use in research, strong psychometric data including sensitivity to change, and excellent feasibility in ages ≥8 years. Conclusions: The systematic review criteria and process are effective for identifying appropriate PRO measures and provide information utilized by the REiNS Collaboration to achieve consensus regarding PROs in NF clinical trials. PMID:24249806

Health State Utility Value in Chronic Obstructive Pulmonary Disease (COPD); The Challenge of Heterogeneity: A Systematic Review and Meta-Analysis.

PubMed

Moayeri, Foruhar; Hsueh, Ya-Seng Arthur; Clarke, Philip; Hua, Xinyang; Dunt, David

2016-06-01

Chronic obstructive pulmonary disease (COPD) has a considerable impact on quality of life and well-being of patients. Health state utility value (HSUV) is a recognized measure for health economic appraisals and is extensively used as an indicator for decision-making studies. This study is a systematic review of literature aimed to estimate mean utility value in COPD using meta-analysis and explore degree of heterogeneity in the utility values across a variety of clinical and study characteristic. The literature review covers studies that used EQ-5D to estimate utility value for patient level research in COPD. Studies that reported utility values elicited by EQ-5D in COPD patients were selected for random-effect meta-analysis addressing inter-study heterogeneity and subgroup analyses. Thirty-two studies were included in the general utility meta-analysis. The estimated general utility value was 0.673 (95% CI 0.653 to 0.693). Meta-analyses of COPD stages utility values showed influence of airway obstruction on utility value. The utility values ranged from 0.820 (95% CI 0.767 to 0.872) for stage I to 0.624 (95% CI 0.571 to 0.677) for stage IV. There was substantial heterogeneity in utility values: I(2) = 97.7%. A more accurate measurement of utility values in COPD is needed to refine valid and generalizable scores of HSUV. Given the limited success of the factors studied to reduce heterogeneity, an approach needs to be developed how best to use mean utility values for COPD in health economic evaluation.

Magnetic resonance neurography and diffusion tensor imaging: origins, history, and clinical impact of the first 50,000 cases with an assessment of efficacy and utility in a prospective 5000-patient study group.

PubMed

Filler, Aaron

2009-10-01

Methods were invented that made it possible to image peripheral nerves in the body and to image neural tracts in the brain. The history, physical basis, and dyadic tensor concept underlying the methods are reviewed. Over a 15-year period, these techniques-magnetic resonance neurography (MRN) and diffusion tensor imaging-were deployed in the clinical and research community in more than 2500 published research reports and applied to approximately 50,000 patients. Within this group, approximately 5000 patients having MRN were carefully tracked on a prospective basis. A uniform Neurography imaging methodology was applied in the study group, and all images were reviewed and registered by referral source, clinical indication, efficacy of imaging, and quality. Various classes of image findings were identified and subjected to a variety of small targeted prospective outcome studies. Those findings demonstrated to be clinically significant were then tracked in the larger clinical volume data set. MRN demonstrates mechanical distortion of nerves, hyperintensity consistent with nerve irritation, nerve swelling, discontinuity, relations of nerves to masses, and image features revealing distortion of nerves at entrapment points. These findings are often clinically relevant and warrant full consideration in the diagnostic process. They result in specific pathological diagnoses that are comparable to electrodiagnostic testing in clinical efficacy. A review of clinical outcome studies with diffusion tensor imaging also shows convincing utility. MRN and diffusion tensor imaging neural tract imaging have been validated as indispensable clinical diagnostic methods that provide reliable anatomic pathological information. There is no alternative diagnostic method in many situations. With the elapsing of 15 years, tens of thousands of imaging studies, and thousands of publications, these methods should no longer be considered experimental.

NASA Countermeasures Evaluation and Validation Project

NASA Technical Reports Server (NTRS)

Lundquist, Charlie M.; Paloski, William H. (Technical Monitor)

2000-01-01

To support its ISS and exploration class mission objectives, NASA has developed a Countermeasure Evaluation and Validation Project (CEVP). The goal of this project is to evaluate and validate the optimal complement of countermeasures required to maintain astronaut health, safety, and functional ability during and after short- and long-duration space flight missions. The CEVP is the final element of the process in which ideas and concepts emerging from basic research evolve into operational countermeasures. The CEVP is accomplishing these objectives by conducting operational/clinical research to evaluate and validate countermeasures to mitigate these maladaptive responses. Evaluation is accomplished by testing in space flight analog facilities, and validation is accomplished by space flight testing. Both will utilize a standardized complement of integrated physiological and psychological tests, termed the Integrated Testing Regimen (ITR) to examine candidate countermeasure efficacy and intersystem effects. The CEVP emphasis is currently placed on validating the initial complement of ISS countermeasures targeting bone, muscle, and aerobic fitness; followed by countermeasures for neurological, psychological, immunological, nutrition and metabolism, and radiation risks associated with space flight. This presentation will review the processes, plans, and procedures that will enable CEVP to play a vital role in transitioning promising research results into operational countermeasures necessary to maintain crew health and performance during long duration space flight.

Development and validation of a brief trauma screening measure for children: The Child Trauma Screen.

PubMed

Lang, Jason M; Connell, Christian M

2017-05-01

Childhood exposure to trauma, including violence and abuse, is a major public health concern that has resulted in increased efforts to promote trauma-informed child-serving systems. Trauma screening is an important component of such trauma-informed systems, yet widespread use of trauma screening is rare in part due to the lack of brief, validated trauma screening measures for children. We describe development and validation of the Child Trauma Screen (CTS), a 10-item screening measure of trauma exposure and posttraumatic stress disorder (PTSD) symptoms for children consistent with the DSM-5 definition of PTSD. Study 1 describes measure development incorporating analysis to derive items based on existing measures from 1,065 children and caregivers together with stakeholder input to finalize item selection. Study 2 describes validation of the CTS with a clinical sample of 74 children and their caregivers. Results support the CTS as an empirically derived, reliable measure to screen children for trauma exposure and PTSD symptoms with strong convergent, divergent, and criterion validity. The CTS is a promising measure for rapidly and reliably screening children for trauma exposure and PTSD symptoms. Future research is needed to confirm validation and to examine feasibility and utility of its use across various child-serving systems. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Validation and clinical utility of the executive function performance test in persons with traumatic brain injury.

PubMed

Baum, C M; Wolf, T J; Wong, A W K; Chen, C H; Walker, K; Young, A C; Carlozzi, N E; Tulsky, D S; Heaton, R K; Heinemann, A W

2017-07-01

This study examined the relationships between the Executive Function Performance Test (EFPT), the NIH Toolbox Cognitive Function tests, and neuropsychological executive function measures in 182 persons with traumatic brain injury (TBI) and 46 controls to evaluate construct, discriminant, and predictive validity. Construct validity: There were moderate correlations between the EFPT and the NIH Toolbox Crystallized (r = -.479), Fluid Tests (r = -.420), and Total Composite Scores (r = -.496). Discriminant validity: Significant differences were found in the EFPT total and sequence scores across control, complicated mild/moderate, and severe TBI groups. We found differences in the organisation score between control and severe, and between mild and severe TBI groups. Both TBI groups had significantly lower scores in safety and judgement than controls. Compared to the controls, the severe TBI group demonstrated significantly lower performance on all instrumental activities of daily living (IADL) tasks. Compared to the mild TBI group, the controls performed better on the medication task, the severe TBI group performed worse in the cooking and telephone tasks. Predictive validity: The EFPT predicted the self-perception of independence measured by the TBI-QOL (beta = -0.49, p < .001) for the severe TBI group. Overall, these data support the validity of the EFPT for use in individuals with TBI.

Evaluating diagnosis-based case-mix measures: how well do they apply to the VA population?

PubMed

Rosen, A K; Loveland, S; Anderson, J J; Rothendler, J A; Hankin, C S; Rakovski, C C; Moskowitz, M A; Berlowitz, D R

2001-07-01

Diagnosis-based case-mix measures are increasingly used for provider profiling, resource allocation, and capitation rate setting. Measures developed in one setting may not adequately capture the disease burden in other settings. To examine the feasibility of adapting two such measures, Adjusted Clinical Groups (ACGs) and Diagnostic Cost Groups (DCGs), to the Department of Veterans Affairs (VA) population. A 60% random sample of veterans who used health care services during FY 1997 was obtained from VA inpatient and outpatient administrative databases. A split-sample technique was used to obtain a 40% sample (n = 1,046,803) for development and a 20% sample (n = 524,461) for validation. Concurrent ACG and DCG risk adjustment models, using 1997 diagnoses and demographics to predict FY 1997 utilization (ambulatory provider encounters, and service days-the sum of a patient's inpatient and outpatient visit days), were fitted and cross-validated. Patients were classified into groupings that indicated a population with multiple psychiatric and medical diseases. Model R-squares explained between 6% and 32% of the variation in service utilization. Although reparameterized models did better in predicting utilization than models with external weights, none of the models was adequate in characterizing the entire population. For predicting service days, DCGs were superior to ACGs in most categories, whereas ACGs did better at discriminating among veterans who had the lowest utilization. Although "off-the-shelf" case-mix measures perform moderately well when applied to another setting, modifications may be required to accurately characterize a population's disease burden with respect to the resource needs of all patients.

Validation of statistical predictive models meant to select melanoma patients for sentinel lymph node biopsy.

PubMed

Sabel, Michael S; Rice, John D; Griffith, Kent A; Lowe, Lori; Wong, Sandra L; Chang, Alfred E; Johnson, Timothy M; Taylor, Jeremy M G

2012-01-01

To identify melanoma patients at sufficiently low risk of nodal metastases who could avoid sentinel lymph node biopsy (SLNB), several statistical models have been proposed based upon patient/tumor characteristics, including logistic regression, classification trees, random forests, and support vector machines. We sought to validate recently published models meant to predict sentinel node status. We queried our comprehensive, prospectively collected melanoma database for consecutive melanoma patients undergoing SLNB. Prediction values were estimated based upon four published models, calculating the same reported metrics: negative predictive value (NPV), rate of negative predictions (RNP), and false-negative rate (FNR). Logistic regression performed comparably with our data when considering NPV (89.4 versus 93.6%); however, the model's specificity was not high enough to significantly reduce the rate of biopsies (SLN reduction rate of 2.9%). When applied to our data, the classification tree produced NPV and reduction in biopsy rates that were lower (87.7 versus 94.1 and 29.8 versus 14.3, respectively). Two published models could not be applied to our data due to model complexity and the use of proprietary software. Published models meant to reduce the SLNB rate among patients with melanoma either underperformed when applied to our larger dataset, or could not be validated. Differences in selection criteria and histopathologic interpretation likely resulted in underperformance. Statistical predictive models must be developed in a clinically applicable manner to allow for both validation and ultimately clinical utility.

Face and construct validity of a computer-based virtual reality simulator for ERCP.

PubMed

Bittner, James G; Mellinger, John D; Imam, Toufic; Schade, Robert R; Macfadyen, Bruce V

2010-02-01

Currently, little evidence supports computer-based simulation for ERCP training. To determine face and construct validity of a computer-based simulator for ERCP and assess its perceived utility as a training tool. Novice and expert endoscopists completed 2 simulated ERCP cases by using the GI Mentor II. Virtual Education and Surgical Simulation Laboratory, Medical College of Georgia. Outcomes included times to complete the procedure, reach the papilla, and use fluoroscopy; attempts to cannulate the papilla, pancreatic duct, and common bile duct; and number of contrast injections and complications. Subjects assessed simulator graphics, procedural accuracy, difficulty, haptics, overall realism, and training potential. Only when performance data from cases A and B were combined did the GI Mentor II differentiate novices and experts based on times to complete the procedure, reach the papilla, and use fluoroscopy. Across skill levels, overall opinions were similar regarding graphics (moderately realistic), accuracy (similar to clinical ERCP), difficulty (similar to clinical ERCP), overall realism (moderately realistic), and haptics. Most participants (92%) claimed that the simulator has definite training potential or should be required for training. Small sample size, single institution. The GI Mentor II demonstrated construct validity for ERCP based on select metrics. Most subjects thought that the simulated graphics, procedural accuracy, and overall realism exhibit face validity. Subjects deemed it a useful training tool. Study repetition involving more participants and cases may help confirm results and establish the simulator's ability to differentiate skill levels based on ERCP-specific metrics.

Validation of Statistical Predictive Models Meant to Select Melanoma Patients for Sentinel Lymph Node Biopsy

PubMed Central

Sabel, Michael S.; Rice, John D.; Griffith, Kent A.; Lowe, Lori; Wong, Sandra L.; Chang, Alfred E.; Johnson, Timothy M.; Taylor, Jeremy M.G.

2013-01-01

Introduction To identify melanoma patients at sufficiently low risk of nodal metastases who could avoid SLN biopsy (SLNB). Several statistical models have been proposed based upon patient/tumor characteristics, including logistic regression, classification trees, random forests and support vector machines. We sought to validate recently published models meant to predict sentinel node status. Methods We queried our comprehensive, prospectively-collected melanoma database for consecutive melanoma patients undergoing SLNB. Prediction values were estimated based upon 4 published models, calculating the same reported metrics: negative predictive value (NPV), rate of negative predictions (RNP), and false negative rate (FNR). Results Logistic regression performed comparably with our data when considering NPV (89.4% vs. 93.6%); however the model’s specificity was not high enough to significantly reduce the rate of biopsies (SLN reduction rate of 2.9%). When applied to our data, the classification tree produced NPV and reduction in biopsies rates that were lower 87.7% vs. 94.1% and 29.8% vs. 14.3%, respectively. Two published models could not be applied to our data due to model complexity and the use of proprietary software. Conclusions Published models meant to reduce the SLNB rate among patients with melanoma either underperformed when applied to our larger dataset, or could not be validated. Differences in selection criteria and histopathologic interpretation likely resulted in underperformance. Development of statistical predictive models must be created in a clinically applicable manner to allow for both validation and ultimately clinical utility. PMID:21822550

Psychometric properties and validation of Nepali version of the Depression Anxiety Stress Scales (DASS-21).

PubMed

Tonsing, Kareen N

2014-04-01

This study investigated the reliability of the Nepali version of the 21-item Depression Anxiety Stress Scale (DASS-21) among non-clinical sample. The purpose of this paper is to report the dimensionality and internal consistency of the DASS-21in a sample of non-clinical adults. This study was conducted in Hong Kong among 212 Nepali adults, aged 18-60 years. Life satisfaction was assessed with the Life Satisfaction Scale. The dimensionality of the DASS-21 scale was investigated using exploratory factor analysis. Construct validity was evaluated using the life satisfaction scale. The intercorrelation among depression, anxiety and stress subscales indicates that symptoms of psychological distress as measured by the DASS-21-N can distinguished between the three constructs in adult community sample. The results also showed inverse correlation among DASS-21-N and life satisfaction scale, supporting the assumption that the higher the life satisfaction, the lower the psychological distress. The results of this study indicate that the Nepali version of the DASS-21 demonstrate adequate psychometric properties in relation to internal consistency and validity, lending support to prior studies and suggest that the DASS-21 can be utilized among diverse groups with confidence. It supports the reliability of the 3-factorial dimensionality of the DASS-21, and highlight that it is a valid and useful tool that can distinguish between depression and anxiety. Copyright © 2013 Elsevier B.V. All rights reserved.

A Technical Note on the PainChek™ System: A Web Portal and Mobile Medical Device for Assessing Pain in People With Dementia.

PubMed

Atee, Mustafa; Hoti, Kreshnik; Hughes, Jeffery D

2018-01-01

Background: Pain in dementia is predominant particularly in the advanced stages or in those who are unable to verbalize. Uncontrolled pain alters the course of behaviors in patients with dementia making them perturbed, unsettled, and devitalized. Current measures of assessing pain in this population group are inadequate and underutilized in clinical practice because they lack systematic evaluation and innovative design. Objective: To describe a novel method and system of pain assessment using a combination of technologies: automated facial recognition and analysis (AFRA), smart computing, affective computing, and cloud computing (Internet of Things) for people with advanced dementia. Methods and Results: Cognification and affective computing were used to conceptualize the system. A computerized clinical system was developed to address the challenging problem of identifying pain in non-verbal patients with dementia. The system is composed of a smart device enabled app (App) linked to a web admin portal (WAP). The App "PainChek™" uses AFRA to identify facial action units indicative of pain presence, and user-fed clinical information to calculate a pain intensity score. The App has various functionalities including: pain assessment, pain monitoring, patient profiling, and data synchronization (into the WAP). The WAP serves as a database that collects the data obtained through the App in the clinical setting. These technologies can assist in addressing the various characteristics of pain (e.g., subjectivity, multidimensionality, and dynamicity). With over 750 paired assessments conducted, the App has been validated in two clinical studies ( n = 74, age: 60-98 y), which showed sound psychometric properties: excellent concurrent validity ( r = 0.882-0.911), interrater reliability (Kw = 0.74-0.86), internal consistency (α = 0.925-0.950), and excellent test-retest reliability (ICC = 0.904), while it possesses good predictive validity and discriminant validity. Clinimetric data revealed high accuracy (95.0%), sensitivity (96.1%), and specificity (91.4%) as well as excellent clinical utility (0.95). Conclusions: PainChek™ is a comprehensive and evidence-based pain management system. This novel approach has the potential to transform pain assessment in people who are unable to verbalize because it can be used by clinicians and carers in everyday clinical practice.

The validity of the SF-12 and SF-6D instruments in people living with HIV/AIDS in Kenya.

PubMed

Patel, Anik R; Lester, Richard T; Marra, Carlo A; van der Kop, Mia L; Ritvo, Paul; Engel, Lidia; Karanja, Sarah; Lynd, Larry D

2017-07-17

Health-related quality of life (HRQoL) and health state utility value (HSUV) measurements are vital components of healthcare clinical and economic evaluations. Accurate measurement of HSUV and HRQoL require validated instruments. The 12-item Short-Form Health Survey (SF-12) is one of few instruments that can evaluate both HRQoL and HSUV, but its validity has not been assessed in people living with HIV/AIDS (PLWHA) in east Africa, where the burden of HIV is high. This cross-sectional study used baseline data from a randomized trial involving PLWHA in Kenya. Data included responses from a translated and adapted SF-12 survey as well as key demographic and clinical data. Construct validity of the survey was examined by testing the SF-12's ability to distinguish between groups known in advance to have differences in their health based on their disease severity. We classified disease severity based on established definitions from the US Center for Disease Control (CDC) and WHO, as well as a previously studied viral load threshold. T-tests and ANOVA were used to test for differences in HRQoL and HSUV scores. Area under the receive operator curve (AUC) was used to test the discriminative ability of the HRQoL and HSUV instruments. Differences in physical component scores met the minimum clinically important difference among participants with more advanced HIV when defined by CD4 count (4.3 units) and WHO criteria (compared to stage 1, stages 2, 3 and 4 were 2.0, 7.2 and 9.8 units lower respectively). Mental score differences met the minimum clinically important difference between WHO stage 1 and stage 4 patients (4.4). Differences in the HSUV were statistically lower in more advanced HIV by all three definitions of severity. The AUC showed poor to weak discriminatory ability in most analyses, but had fair discriminatory ability between WHO clinical stage 1 and clinical stage 4 individuals (AUC = 0.71). Our findings suggest that the Kiswahili translated and adapted version of the SF-12 could be used as an assessment tool for physical health, mental health and HSUV for Kiswahili-speaking PLHWA. Clinical trials.gov identifier: NCT00830622 . Registered 26 January 2009.

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

PubMed

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

2017-12-01

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

Clinical validity of the Me and My School questionnaire: a self-report mental health measure for children and adolescents.

PubMed

Patalay, Praveetha; Deighton, Jessica; Fonagy, Peter; Vostanis, Panos; Wolpert, Miranda

2014-01-01

The Me and My School Questionnaire (M&MS) is a self-report measure for children aged eight years and above that measures emotional difficulties and behavioural difficulties, and has been previously validated in a community sample. The present study aimed to assess its clinical sensitivity to justify its utility as a screening tool in schools. Data were collected from service-users (n = 91, 8-15 years) and accompanying parent/carer in outpatient mental health services in England. A matched community sample (N = 91) were used to assess the measure's ability to discriminate between low- and high-risk samples. Receiver operating curves (area under the curve, emotional difficulties = .79; behavioural difficulties = .78), mean comparisons (effect size, emotional difficulties d = 1.17, behavioural difficulties = 1.12) and proportions above clinical thresholds indicate that the measure satisfactorily discriminates between the samples. The scales have good internal reliability (emotional difficulties α = .84; behavioural difficulties α = .82) and cross-informant agreement with parent-reported symptoms is comparable to existing measures (r = .30). The findings of this study indicate that the M&MS sufficiently discriminates between high-risk (clinic) and low-risk (community) samples, has good internal reliability, compares favourably with existing self-report measures of mental health and has comparable levels of agreement between parent-report and self-report to other measures. Alongside existing validation of the M&MS, these findings justify the measures use as a self-report screening tool for mental health problems in community settings for children aged as young as 8 years.

CLSI-based transference of the CALIPER database of pediatric reference intervals from Abbott to Beckman, Ortho, Roche and Siemens Clinical Chemistry Assays: direct validation using reference samples from the CALIPER cohort.

PubMed

Estey, Mathew P; Cohen, Ashley H; Colantonio, David A; Chan, Man Khun; Marvasti, Tina Binesh; Randell, Edward; Delvin, Edgard; Cousineau, Jocelyne; Grey, Vijaylaxmi; Greenway, Donald; Meng, Qing H; Jung, Benjamin; Bhuiyan, Jalaluddin; Seccombe, David; Adeli, Khosrow

2013-09-01

The CALIPER program recently established a comprehensive database of age- and sex-stratified pediatric reference intervals for 40 biochemical markers. However, this database was only directly applicable for Abbott ARCHITECT assays. We therefore sought to expand the scope of this database to biochemical assays from other major manufacturers, allowing for a much wider application of the CALIPER database. Based on CLSI C28-A3 and EP9-A2 guidelines, CALIPER reference intervals were transferred (using specific statistical criteria) to assays performed on four other commonly used clinical chemistry platforms including Beckman Coulter DxC800, Ortho Vitros 5600, Roche Cobas 6000, and Siemens Vista 1500. The resulting reference intervals were subjected to a thorough validation using 100 reference specimens (healthy community children and adolescents) from the CALIPER bio-bank, and all testing centers participated in an external quality assessment (EQA) evaluation. In general, the transferred pediatric reference intervals were similar to those established in our previous study. However, assay-specific differences in reference limits were observed for many analytes, and in some instances were considerable. The results of the EQA evaluation generally mimicked the similarities and differences in reference limits among the five manufacturers' assays. In addition, the majority of transferred reference intervals were validated through the analysis of CALIPER reference samples. This study greatly extends the utility of the CALIPER reference interval database which is now directly applicable for assays performed on five major analytical platforms in clinical use, and should permit the worldwide application of CALIPER pediatric reference intervals. Copyright © 2013 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Adolescent Balloon Analog Risk Task and Behaviors that Influence Risk of Motor Vehicle Crash Injury

PubMed Central

Vaca, Federico E.; Walthall, Jessica M.; Ryan, Sheryl; Moriarty-Daley, Alison; Riera, Antonio; Crowley, Michael J.; Mayes, Linda C.

2013-01-01

Risk-taking propensity is a pivotal facet of motor vehicle crash involvement and subsequent traumatic injury in adolescents. Clinical encounters are important opportunities to identify teens with high risk-taking propensity who may later experience serious injury. Our objective was to compare self-reports of health risk behavior with performance on the Balloon Analog Risk Task (BART), a validated metric of risk-taking propensity, in adolescents during a clinical encounter. 100 adolescent patients from a hospital emergency department and adolescent health clinic completed a computer-based survey of self-reported risk behaviors including substance use behaviors and behaviors that influence crash involvement. They then completed the BART, a validated laboratory-based risk task in which participants earn points by pumping up a computer-generated balloon with greater pumps leading to increased chance of balloon explosion. 20 trials were undertaken. Mean number of pumps on the BART showed a correlation of .243 (p=.015) with self-reported driver/passenger behaviors and attitudes towards driving that influence risk of crash injury. Regression analyses showed that self-reports of substance use and mean number of pumps on the BART uniquely predict self-reports of behaviors influencing the risk of crash injury. The BART is a promising correlate of real-world risk-taking behavior related to traffic safety. It remains a valid predictor of behaviors influencing risk of crash injury when using just 10 trials, suggesting its utility as a quick and effective screening measure for use in busy clinical environments. This tool may be an important link to prevention interventions for those most at-risk for future motor vehicle crash involvement and injury. PMID:24406948

Development of the Sydney Falls Risk Screening Tool in brain injury rehabilitation: A multisite prospective cohort study.

PubMed

McKechnie, Duncan; Fisher, Murray J; Pryor, Julie; Bonser, Melissa; Jesus, Jhoven De

2018-03-01

To develop a falls risk screening tool (FRST) sensitive to the traumatic brain injury rehabilitation population. Falls are the most frequently recorded patient safety incident within the hospital context. The inpatient traumatic brain injury rehabilitation population is one particular population that has been identified as at high risk of falls. However, no FRST has been developed for this patient population. Consequently in the traumatic brain injury rehabilitation population, there is the real possibility that nurses are using falls risk screening tools that have a poor clinical utility. Multisite prospective cohort study. Univariate and multiple logistic regression modelling techniques (backward elimination, elastic net and hierarchical) were used to examine each variable's association with patients who fell. The resulting FRST's clinical validity was examined. Of the 140 patients in the study, 41 (29%) fell. Through multiple logistic regression modelling, 11 variables were identified as predictors for falls. Using hierarchical logistic regression, five of these were identified for inclusion in the resulting falls risk screening tool: prescribed mobility aid (such as, wheelchair or frame), a fall since admission to hospital, impulsive behaviour, impaired orientation and bladder and/or bowel incontinence. The resulting FRST has good clinical validity (sensitivity = 0.9; specificity = 0.62; area under the curve = 0.87; Youden index = 0.54). The tool was significantly more accurate (p = .037 on DeLong test) in discriminating fallers from nonfallers than the Ontario Modified STRATIFY FRST. A FRST has been developed using a comprehensive statistical framework, and evidence has been provided of this tool's clinical validity. The developed tool, the Sydney Falls Risk Screening Tool, should be considered for use in brain injury rehabilitation populations. © 2017 John Wiley & Sons Ltd.