The Development and Validation of a Teacher Preparation Program: Follow-Up Survey

ERIC Educational Resources Information Center

Schulte, Laura E.

2008-01-01

Students in my applied advanced statistics course for educational administration doctoral students developed a follow-up survey for teacher preparation programs, using the following scale development processes: adopting a framework; developing items; providing evidence of content validity; conducting a pilot test; and analyzing data. The students…

Guidelines to validate control of cross-contamination during washing of fresh-cut leafy vegetables

USDA-ARS?s Scientific Manuscript database

The U.S. Food and Drug Administration requires food processors to implement and validate processes that will result in significantly minimizing or preventing the occurrence of hazards that are likely to occur in food production. During production of fresh-cut leafy vegetables, microbial contaminati...

77 FR 38019 - Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/TRICARE: TRICARE Retail...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-26

... prescriptions approved through the non-formulary special approval process that validates the medical necessity... the process for formulary placement of newly approved drugs; streamline the process for updating... clarify the process for formulary placement of newly approved drugs by the Food and Drug Administration...

Large Aircraft Robotic Paint Stripping (LARPS) system and the high pressure water process

NASA Astrophysics Data System (ADS)

See, David W.; Hofacker, Scott A.; Stone, M. Anthony; Harbaugh, Darcy

1993-03-01

The aircraft maintenance industry is beset by new Environmental Protection Agency (EPA) guidelines on air emissions, Occupational Safety and Health Administration (OSHA) standards, dwindling labor markets, Federal Aviation Administration (FAA) safety guidelines, and increased operating costs. In light of these factors, the USAF's Wright Laboratory Manufacturing Technology Directorate and the Aircraft Division of the Oklahoma City Air Logistics Center initiated a MANTECH/REPTECH effort to automate an alternate paint removal method and eliminate the current manual methylene chloride chemical stripping methods. This paper presents some of the background and history of the LARPS program, describes the LARPS system, documents the projected operational flow, quantifies some of the projected system benefits and describes the High Pressure Water Stripping Process. Certification of an alternative paint removal method to replace the current chemical process is being performed in two phases: Process Optimization and Process Validation. This paper also presents the results of the Process Optimization for metal substrates. Data on the coating removal rate, residual stresses, surface roughness, preliminary process envelopes, and technical plans for process Validation Testing will be discussed.

Process Evaluation in Corrections-Based Substance Abuse Treatment.

ERIC Educational Resources Information Center

Wolk, James L.; Hartmann, David J.

1996-01-01

Argues that process evaluation is needed to validate prison-based substance abuse treatment effectiveness. Five groups--inmates, treatment staff, prison staff, prison administration, and the parole board--should be a part of this process evaluation. Discusses these five groups relative to three stages of development of substance abuse treatment in…

Instrument Development and Validation of the Infant and Toddler Assessment for Quality Improvement

ERIC Educational Resources Information Center

Perlman, Michal; Brunsek, Ashley; Hepditch, Anne; Gray, Karen; Falenchuck, Olesya

2017-01-01

Research Findings: There is a growing need for accurate and efficient measures of classroom quality in early childhood education and care (ECEC) settings. Observational measures are costly, as their administration generally takes 3-5 hr per classroom. This article outlines the process of development and preliminary concurrent validity testing of…

Management of the General Process of Parenteral Nutrition Using mHealth Technologies: Evaluation and Validation Study.

PubMed

Cervera Peris, Mercedes; Alonso Rorís, Víctor Manuel; Santos Gago, Juan Manuel; Álvarez Sabucedo, Luis; Wanden-Berghe, Carmina; Sanz-Valero, Javier

2018-04-03

Any system applied to the control of parenteral nutrition (PN) ought to prove that the process meets the established requirements and include a repository of records to allow evaluation of the information about PN processes at any time. The goal of the research was to evaluate the mobile health (mHealth) app and validate its effectiveness in monitoring the management of the PN process. We studied the evaluation and validation of the general process of PN using an mHealth app. The units of analysis were the PN bags prepared and administered at the Son Espases University Hospital, Palma, Spain, from June 1 to September 6, 2016. For the evaluation of the app, we used the Poststudy System Usability Questionnaire and subsequent analysis with the Cronbach alpha coefficient. Validation was performed by checking the compliance of control for all operations on each of the stages (validation and transcription of the prescription, preparation, conservation, and administration) and by monitoring the operative control points and critical control points. The results obtained from 387 bags were analyzed, with 30 interruptions of administration. The fulfillment of stages was 100%, including noncritical nonconformities in the storage control. The average deviation in the weight of the bags was less than 5%, and the infusion time did not present deviations greater than 1 hour. The developed app successfully passed the evaluation and validation tests and was implemented to perform the monitoring procedures for the overall PN process. A new mobile solution to manage the quality and traceability of sensitive medicines such as blood-derivative drugs and hazardous drugs derived from this project is currently being deployed. ©Mercedes Cervera Peris, Víctor Manuel Alonso Rorís, Juan Manuel Santos Gago, Luis Álvarez Sabucedo, Carmina Wanden-Berghe, Javier Sanz-Valero. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 03.04.2018.

The Interview and Personnel Selection: Is the Process Valid and Reliable?

ERIC Educational Resources Information Center

Niece, Richard

1983-01-01

Reviews recent literature concerning the job interview. Concludes that such interviews are generally ineffective and proposes that school administrators devise techniques for improving their interviewing systems. (FL)

FRAMEWORK FOR VALIDATION AND IMPLEMENTATION OF IN VITRO TOXICITY TESTS: REPORT OF THE VALIDATION AND TECHNOLOGY TRANSFER COMMITTEE OF THE JOHNS HOPKINS CENTER FOR ALTERNATIVES TO ANIMAL TESTING

EPA Science Inventory

In toxicology the development and application of in vitro alternatives to reduce or replace animal testing, or to lessen the distress and discomfort of laboratory animals, is a rapidly developing trend. owever, at present there is no formal administrative process to organize, coo...

Assessing working memory in children with ADHD: Minor administration and scoring changes may improve digit span backward's construct validity.

PubMed

Wells, Erica L; Kofler, Michael J; Soto, Elia F; Schaefer, Hillary S; Sarver, Dustin E

2018-01-01

Pediatric ADHD is associated with impairments in working memory, but these deficits often go undetected when using clinic-based tests such as digit span backward. The current study pilot-tested minor administration/scoring modifications to improve digit span backward's construct and predictive validities in a well-characterized sample of children with ADHD. WISC-IV digit span was modified to administer all trials (i.e., ignore discontinue rule) and count digits rather than trials correct. Traditional and modified scores were compared to a battery of criterion working memory (construct validity) and academic achievement tests (predictive validity) for 34 children with ADHD ages 8-13 (M=10.41; 11 girls). Traditional digit span backward scores failed to predict working memory or KTEA-2 achievement (allns). Alternate administration/scoring of digit span backward significantly improved its associations with working memory reordering (r=.58), working memory dual-processing (r=.53), working memory updating (r=.28), and KTEA-2 achievement (r=.49). Consistent with prior work, these findings urge caution when interpreting digit span performance. Minor test modifications may address test validity concerns, and should be considered in future test revisions. Digit span backward becomes a valid measure of working memory at exactly the point that testing is traditionally discontinued. Copyright © 2017 Elsevier Ltd. All rights reserved.

Volpe Aircraft Noise Certification Software & Methodology Validation/Audit General Information, Data Submittal Guidelines, and Process Details; Letter Report V324-FB48B3-LR2

DOT National Transportation Integrated Search

2017-08-18

As required by Federal Aviation Administration (FAA) Order 8110.4C: Type Certification Process (most recently revised as Change 5, 20 December, 2011), the Volpe Center Acoustics Facility (Volpe), in support of the FAA Office of Environmen...

A discrete event simulation tool to support and predict hospital and clinic staffing.

PubMed

DeRienzo, Christopher M; Shaw, Ryan J; Meanor, Phillip; Lada, Emily; Ferranti, Jeffrey; Tanaka, David

2017-06-01

We demonstrate how to develop a simulation tool to help healthcare managers and administrators predict and plan for staffing needs in a hospital neonatal intensive care unit using administrative data. We developed a discrete event simulation model of nursing staff needed in a neonatal intensive care unit and then validated the model against historical data. The process flow was translated into a discrete event simulation model. Results demonstrated that the model can be used to give a respectable estimate of annual admissions, transfers, and deaths based upon two different staffing levels. The discrete event simulation tool model can provide healthcare managers and administrators with (1) a valid method of modeling patient mix, patient acuity, staffing needs, and costs in the present state and (2) a forecast of how changes in a unit's staffing, referral patterns, or patient mix would affect a unit in a future state.

Development and Validation of Instruments to Measure Learning of Expert-Like Thinking

NASA Astrophysics Data System (ADS)

Adams, Wendy K.; Wieman, Carl E.

2011-06-01

This paper describes the process for creating and validating an assessment test that measures the effectiveness of instruction by probing how well that instruction causes students in a class to think like experts about specific areas of science. The design principles and process are laid out and it is shown how these align with professional standards that have been established for educational and psychological testing and the elements of assessment called for in a recent National Research Council study on assessment. The importance of student interviews for creating and validating the test is emphasized, and the appropriate interview procedures are presented. The relevance and use of standard psychometric statistical tests are discussed. Additionally, techniques for effective test administration are presented.

Geriatric Patient Safety Indicators Based on Linked Administrative Health Data to Assess Anticoagulant-Related Thromboembolic and Hemorrhagic Adverse Events in Older Inpatients: A Study Proposal

PubMed Central

Quantin, Catherine; Reich, Oliver; Tuppin, Philippe; Fagot-Campagna, Anne; Paccaud, Fred; Peytremann-Bridevaux, Isabelle; Burnand, Bernard

2017-01-01

Background Frail older people with multiple interacting conditions, polypharmacy, and complex care needs are particularly exposed to health care-related adverse events. Among these, anticoagulant-related thromboembolic and hemorrhagic events are particularly frequent and serious in older inpatients. The growing use of anticoagulants in this population and their substantial risk of toxicity and inefficacy have therefore become an important patient safety and public health concern worldwide. Anticoagulant-related adverse events and the quality of anticoagulation management should thus be routinely assessed to improve patient safety in vulnerable older inpatients. Objective This project aims to develop and validate a set of outcome and process indicators based on linked administrative health data (ie, insurance claims data linked to hospital discharge data) assessing older inpatient safety related to anticoagulation in both Switzerland and France, and enabling comparisons across time and among hospitals, health territories, and countries. Geriatric patient safety indicators (GPSIs) will assess anticoagulant-related adverse events. Geriatric quality indicators (GQIs) will evaluate the management of anticoagulants for the prevention and treatment of arterial or venous thromboembolism in older inpatients. Methods GPSIs will measure cumulative incidences of thromboembolic and bleeding adverse events based on hospital discharge data linked to insurance claims data. Using linked administrative health data will improve GPSI risk adjustment on patients’ conditions that are present at admission and will capture in-hospital and postdischarge adverse events. GQIs will estimate the proportion of index hospital stays resulting in recommended anticoagulation at discharge and up to various time frames based on the same electronic health data. The GPSI and GQI development and validation process will comprise 6 stages: (1) selection and specification of candidate indicators, (2) definition of administrative data-based algorithms, (3) empirical measurement of indicators using linked administrative health data, (4) validation of indicators, (5) analyses of geographic and temporal variations for reliable and valid indicators, and (6) data visualization. Results Study populations will consist of 166,670 Swiss and 5,902,037 French residents aged 65 years and older admitted to an acute care hospital at least once during the 2012-2014 period and insured for at least 1 year before admission and 1 year after discharge. We will extract Swiss data from the Helsana Group data warehouse and French data from the national health insurance information system (SNIIR-AM). The study has been approved by Swiss and French ethics committees and regulatory organizations for data protection. Conclusions Validated GPSIs and GQIs should help support and drive quality and safety improvement in older inpatients, inform health care stakeholders, and enable international comparisons. We discuss several limitations relating to the representativeness of study populations, accuracy of administrative health data, methods used for GPSI criterion validity assessment, and potential confounding bias in comparisons based on GQIs, and we address these limitations to strengthen study feasibility and validity. PMID:28495660

An assessment of space shuttle flight software development processes

NASA Technical Reports Server (NTRS)

1993-01-01

In early 1991, the National Aeronautics and Space Administration's (NASA's) Office of Space Flight commissioned the Aeronautics and Space Engineering Board (ASEB) of the National Research Council (NRC) to investigate the adequacy of the current process by which NASA develops and verifies changes and updates to the Space Shuttle flight software. The Committee for Review of Oversight Mechanisms for Space Shuttle Flight Software Processes was convened in Jan. 1992 to accomplish the following tasks: (1) review the entire flight software development process from the initial requirements definition phase to final implementation, including object code build and final machine loading; (2) review and critique NASA's independent verification and validation process and mechanisms, including NASA's established software development and testing standards; (3) determine the acceptability and adequacy of the complete flight software development process, including the embedded validation and verification processes through comparison with (1) generally accepted industry practices, and (2) generally accepted Department of Defense and/or other government practices (comparing NASA's program with organizations and projects having similar volumes of software development, software maturity, complexity, criticality, lines of code, and national standards); (4) consider whether independent verification and validation should continue. An overview of the study, independent verification and validation of critical software, and the Space Shuttle flight software development process are addressed. Findings and recommendations are presented.

Validation of Case Finding Algorithms for Hepatocellular Cancer From Administrative Data and Electronic Health Records Using Natural Language Processing.

PubMed

Sada, Yvonne; Hou, Jason; Richardson, Peter; El-Serag, Hashem; Davila, Jessica

2016-02-01

Accurate identification of hepatocellular cancer (HCC) cases from automated data is needed for efficient and valid quality improvement initiatives and research. We validated HCC International Classification of Diseases, 9th Revision (ICD-9) codes, and evaluated whether natural language processing by the Automated Retrieval Console (ARC) for document classification improves HCC identification. We identified a cohort of patients with ICD-9 codes for HCC during 2005-2010 from Veterans Affairs administrative data. Pathology and radiology reports were reviewed to confirm HCC. The positive predictive value (PPV), sensitivity, and specificity of ICD-9 codes were calculated. A split validation study of pathology and radiology reports was performed to develop and validate ARC algorithms. Reports were manually classified as diagnostic of HCC or not. ARC generated document classification algorithms using the Clinical Text Analysis and Knowledge Extraction System. ARC performance was compared with manual classification. PPV, sensitivity, and specificity of ARC were calculated. A total of 1138 patients with HCC were identified by ICD-9 codes. On the basis of manual review, 773 had HCC. The HCC ICD-9 code algorithm had a PPV of 0.67, sensitivity of 0.95, and specificity of 0.93. For a random subset of 619 patients, we identified 471 pathology reports for 323 patients and 943 radiology reports for 557 patients. The pathology ARC algorithm had PPV of 0.96, sensitivity of 0.96, and specificity of 0.97. The radiology ARC algorithm had PPV of 0.75, sensitivity of 0.94, and specificity of 0.68. A combined approach of ICD-9 codes and natural language processing of pathology and radiology reports improves HCC case identification in automated data.

A systematic review of validated methods for identifying hypersensitivity reactions other than anaphylaxis (fever, rash, and lymphadenopathy), using administrative and claims data.

PubMed

Schneider, Gary; Kachroo, Sumesh; Jones, Natalie; Crean, Sheila; Rotella, Philip; Avetisyan, Ruzan; Reynolds, Matthew W

2012-01-01

The Food and Drug Administration's Mini-Sentinel pilot program aims to conduct active surveillance to refine safety signals that emerge for marketed medical products. A key facet of this surveillance is to develop and understand the validity of algorithms for identifying health outcomes of interest from administrative and claims data. This article summarizes the process and findings of the algorithm review of hypersensitivity reactions. PubMed and Iowa Drug Information Service searches were conducted to identify citations applicable to the hypersensitivity reactions of health outcomes of interest. Level 1 abstract reviews and Level 2 full-text reviews were conducted to find articles using administrative and claims data to identify hypersensitivity reactions and including validation estimates of the coding algorithms. We identified five studies that provided validated hypersensitivity-reaction algorithms. Algorithm positive predictive values (PPVs) for various definitions of hypersensitivity reactions ranged from 3% to 95%. PPVs were high (i.e. 90%-95%) when both exposures and diagnoses were very specific. PPV generally decreased when the definition of hypersensitivity was expanded, except in one study that used data mining methodology for algorithm development. The ability of coding algorithms to identify hypersensitivity reactions varied, with decreasing performance occurring with expanded outcome definitions. This examination of hypersensitivity-reaction coding algorithms provides an example of surveillance bias resulting from outcome definitions that include mild cases. Data mining may provide tools for algorithm development for hypersensitivity and other health outcomes. Research needs to be conducted on designing validation studies to test hypersensitivity-reaction algorithms and estimating their predictive power, sensitivity, and specificity. Copyright © 2012 John Wiley & Sons, Ltd.

An appraisal of the psychometric properties of the Clinician version of the Apathy Evaluation Scale (AES-C).

PubMed

Clarke, Diana E; Van Reekum, Robert; Patel, Jigisha; Simard, Martine; Gomez, Everlyne; Streiner, David L

2007-01-01

This article examines the psychometric properties of the clinician version of the Apathy Evaluation Scale (AES-C) to determine its ability to characterize, quantify and differentiate apathy. Critical appraisals of the item-reduction processes, effectiveness of the administration, coding and scoring procedures, and the reliability and validity of the scale were carried out. For training, administration and rating of the AES-C, clearer guidelines, including a more standardized list of verbal and non-verbal apathetic cues, are needed. There is evidence of high internal consistency for the scale across studies. In addition, the original study reported good test-retest and inter-rater reliability coefficients. However, there is a lack of replication on these more stable and informative measures of reliability and as such they warrant further investigation. The research evidence confirms that the AES-C shows good discriminant, convergent and criterion validity. However, evidence of its predictive validity is limited. As this aspect of validity refers to the scale's ability to predict future outcomes, which is important for treatment and rehabilitation planning, further assessment of the predictive validity of the AES-C is needed. In conclusion, the AES-C is a reliable and valid measure for the characterization and quantification of apathy. Copyright (c) 2007 John Wiley & Sons, Ltd.

Diagnosing comorbidity in psychiatric hospital: challenging the validity of administrative registers.

PubMed

Oiesvold, Terje; Nivison, Mary; Hansen, Vidje; Skre, Ingunn; Ostensen, Line; Sørgaard, Knut W

2013-01-08

This study will explore the validity of psychiatric diagnoses in administrative registers with special emphasis on comorbid anxiety and substance use disorders. All new patients admitted to psychiatric hospital in northern Norway during one year were asked to participate. Of 477 patients found eligible, 272 gave their informed consent. 250 patients (52%) with hospital diagnoses comprised the study sample. Expert diagnoses were given on the basis of a structured diagnostic interview (M.I.N.I.PLUS) together with retrospective checking of the records. The hospital diagnoses were blind to the expert. The agreement between the expert's and the clinicians' diagnoses was estimated using Cohen's kappa statistics. The expert gave a mean of 3.4 diagnoses per patient, the clinicians gave 1.4. The agreement ranged from poor to good (schizophrenia). For anxiety disorders (F40-41) the agreement is poor (kappa = 0.12). While the expert gave an anxiety disorder diagnosis to 122 patients, the clinicians only gave it to 17. The agreement is fair concerning substance use disorders (F10-19) (kappa = 0.27). Only two out of 76 patients with concurrent anxiety and substance use disorders were identified by the clinicians. The validity of administrative registers in psychiatry seems dubious for research purposes and even for administrative and clinical purposes. The diagnostic process in the clinic should be more structured and treatment guidelines should include comorbidity.

Development and validation of a sensitive and fast UPLC-MS/MS method for simultaneous determination of seven bioactive compounds in rat plasma after oral administration of Guizhi-gancao decoction.

PubMed

Ji, Bin; Zhuo, Limeng; Yang, Bin; Wang, Yang; Li, Lin; Yu, Miao; Zhao, Yunli; Yu, Zhiguo

2017-04-15

Rapid, sensitive, selective and accurate UPLC-MS/MS method was developed and fully validated for simultaneous determination of cinnamaldehyde, cinnamic acid, 2-methoxy cinnamic acid, glycyrrhizic acid, glycyrrhetinic acid, liquiritigenin and isoliquiritin in rat plasma after oral administration of Guizhi-gancao decoction. Plasma samples were processed with a simple protein precipitation technique using acetonitrile, followed by chromatographic separation using a Thermo Hypersil GOLD C 18 column. A 11.0min linear gradient elution was used at a flow rate of 0.2mL/min with a mobile phase of 0.1% acetic acid containing 0.2mM ammonium acetate in water and acetonitrile. The analytes and internal standard, schisandrin, were detected using both positive and negative ion electrospray ionization in multiple reaction monitoring mode. The developed method was validated for intra-day and inter-day accuracy and precision whose values fell in the acceptable limits. Matrix effect was found to be minimal. Recovery efficiency of all the analytes was found to be >60%. Stability results showed that the analytes were stable at all the conditions. This validated method was successfully used to study the pharmacokinetics of multiple compounds in rat plasma after oral administration of Guizhi-gancao decoction. Copyright © 2017 Elsevier B.V. All rights reserved.

Geriatric Patient Safety Indicators Based on Linked Administrative Health Data to Assess Anticoagulant-Related Thromboembolic and Hemorrhagic Adverse Events in Older Inpatients: A Study Proposal.

PubMed

Le Pogam, Marie-Annick; Quantin, Catherine; Reich, Oliver; Tuppin, Philippe; Fagot-Campagna, Anne; Paccaud, Fred; Peytremann-Bridevaux, Isabelle; Burnand, Bernard

2017-05-11

Frail older people with multiple interacting conditions, polypharmacy, and complex care needs are particularly exposed to health care-related adverse events. Among these, anticoagulant-related thromboembolic and hemorrhagic events are particularly frequent and serious in older inpatients. The growing use of anticoagulants in this population and their substantial risk of toxicity and inefficacy have therefore become an important patient safety and public health concern worldwide. Anticoagulant-related adverse events and the quality of anticoagulation management should thus be routinely assessed to improve patient safety in vulnerable older inpatients. This project aims to develop and validate a set of outcome and process indicators based on linked administrative health data (ie, insurance claims data linked to hospital discharge data) assessing older inpatient safety related to anticoagulation in both Switzerland and France, and enabling comparisons across time and among hospitals, health territories, and countries. Geriatric patient safety indicators (GPSIs) will assess anticoagulant-related adverse events. Geriatric quality indicators (GQIs) will evaluate the management of anticoagulants for the prevention and treatment of arterial or venous thromboembolism in older inpatients. GPSIs will measure cumulative incidences of thromboembolic and bleeding adverse events based on hospital discharge data linked to insurance claims data. Using linked administrative health data will improve GPSI risk adjustment on patients' conditions that are present at admission and will capture in-hospital and postdischarge adverse events. GQIs will estimate the proportion of index hospital stays resulting in recommended anticoagulation at discharge and up to various time frames based on the same electronic health data. The GPSI and GQI development and validation process will comprise 6 stages: (1) selection and specification of candidate indicators, (2) definition of administrative data-based algorithms, (3) empirical measurement of indicators using linked administrative health data, (4) validation of indicators, (5) analyses of geographic and temporal variations for reliable and valid indicators, and (6) data visualization. Study populations will consist of 166,670 Swiss and 5,902,037 French residents aged 65 years and older admitted to an acute care hospital at least once during the 2012-2014 period and insured for at least 1 year before admission and 1 year after discharge. We will extract Swiss data from the Helsana Group data warehouse and French data from the national health insurance information system (SNIIR-AM). The study has been approved by Swiss and French ethics committees and regulatory organizations for data protection. Validated GPSIs and GQIs should help support and drive quality and safety improvement in older inpatients, inform health care stakeholders, and enable international comparisons. We discuss several limitations relating to the representativeness of study populations, accuracy of administrative health data, methods used for GPSI criterion validity assessment, and potential confounding bias in comparisons based on GQIs, and we address these limitations to strengthen study feasibility and validity. ©Marie-Annick Le Pogam, Catherine Quantin, Oliver Reich, Philippe Tuppin, Anne Fagot-Campagna, Fred Paccaud, Isabelle Peytremann-Bridevaux, Bernard Burnand. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 11.05.2017.

Evacuation performance evaluation tool.

PubMed

Farra, Sharon; Miller, Elaine T; Gneuhs, Matthew; Timm, Nathan; Li, Gengxin; Simon, Ashley; Brady, Whittney

2016-01-01

Hospitals conduct evacuation exercises to improve performance during emergency events. An essential aspect in this process is the creation of reliable and valid evaluation tools. The objective of this article is to describe the development and implications of a disaster evacuation performance tool that measures one portion of the very complex process of evacuation. Through the application of the Delphi technique and DeVellis's framework, disaster and neonatal experts provided input in developing this performance evaluation tool. Following development, content validity and reliability of this tool were assessed. Large pediatric hospital and medical center in the Midwest. The tool was pilot tested with an administrative, medical, and nursing leadership group and then implemented with a group of 68 healthcare workers during a disaster exercise of a neonatal intensive care unit (NICU). The tool has demonstrated high content validity with a scale validity index of 0.979 and inter-rater reliability G coefficient (0.984, 95% CI: 0.948-0.9952). The Delphi process based on the conceptual framework of DeVellis yielded a psychometrically sound evacuation performance evaluation tool for a NICU.

Examining the validity of AHRQ's patient safety indicators (PSIs): is variation in PSI composite score related to hospital organizational factors?

PubMed

Shin, Marlena H; Sullivan, Jennifer L; Rosen, Amy K; Solomon, Jeffrey L; Dunn, Edward J; Shimada, Stephanie L; Hayes, Jennifer; Rivard, Peter E

2014-12-01

Increasing use of Agency for Healthcare Research and Quality's Patient Safety Indicators (PSIs) for hospital performance measurement intensifies the need to critically assess their validity. Our study examined the extent to which variation in PSI composite score is related to differences in hospital organizational structures or processes (i.e., criterion validity). In site visits to three Veterans Health Administration hospitals with high and three with low PSI composite scores ("low performers" and "high performers," respectively), we interviewed a cross-section of hospital staff. We then coded interview transcripts for evidence in 13 safety-related domains and assessed variation across high and low performers. Evidence of leadership and coordination of work/communication (organizational process domains) was predominantly favorable for high performers only. Evidence in the other domains was either mixed, or there were insufficient data to rate the domains. While we found some evidence of criterion validity, the extent to which variation in PSI rates is related to differences in hospitals' organizational structures/processes needs further study. © The Author(s) 2014.

Development and psychometric evaluation of a cardiovascular risk and disease management knowledge assessment tool.

PubMed

Rosneck, James S; Hughes, Joel; Gunstad, John; Josephson, Richard; Noe, Donald A; Waechter, Donna

2014-01-01

This article describes the systematic construction and psychometric analysis of a knowledge assessment instrument for phase II cardiac rehabilitation (CR) patients measuring risk modification disease management knowledge and behavioral outcomes derived from national standards relevant to secondary prevention and management of cardiovascular disease. First, using adult curriculum based on disease-specific learning outcomes and competencies, a systematic test item development process was completed by clinical staff. Second, a panel of educational and clinical experts used an iterative process to identify test content domain and arrive at consensus in selecting items meeting criteria. Third, the resulting 31-question instrument, the Cardiac Knowledge Assessment Tool (CKAT), was piloted in CR patients to ensure use of application. Validity and reliability analyses were performed on 3638 adults before test administrations with additional focused analyses on 1999 individuals completing both pretreatment and posttreatment administrations within 6 months. Evidence of CKAT content validity was substantiated, with 85% agreement among content experts. Evidence of construct validity was demonstrated via factor analysis identifying key underlying factors. Estimates of internal consistency, for example, Cronbach's α = .852 and Spearman-Brown split-half reliability = 0.817 on pretesting, support test reliability. Item analysis, using point biserial correlation, measured relationships between performance on single items and total score (P < .01). Analyses using item difficulty and item discrimination indices further verified item stability and validity of the CKAT. A knowledge instrument specifically designed for an adult CR population was systematically developed and tested in a large representative patient population, satisfying psychometric parameters, including validity and reliability.

Design process and preliminary psychometric study of a video game to detect cognitive impairment in senior adults.

PubMed

Valladares-Rodriguez, Sonia; Perez-Rodriguez, Roberto; Facal, David; Fernandez-Iglesias, Manuel J; Anido-Rifon, Luis; Mouriño-Garcia, Marcos

2017-01-01

Assessment of episodic memory has been traditionally used to evaluate potential cognitive impairments in senior adults. Typically, episodic memory evaluation is based on personal interviews and pen-and-paper tests. This article presents the design, development and a preliminary validation of a novel digital game to assess episodic memory intended to overcome the limitations of traditional methods, such as the cost of its administration, its intrusive character, the lack of early detection capabilities, the lack of ecological validity, the learning effect and the existence of confounding factors. Our proposal is based on the gamification of the California Verbal Learning Test (CVLT) and it has been designed to comply with the psychometric characteristics of reliability and validity. Two qualitative focus groups and a first pilot experiment were carried out to validate the proposal. A more ecological, non-intrusive and better administrable tool to perform cognitive assessment was developed. Initial evidence from the focus groups and pilot experiment confirmed the developed game's usability and offered promising results insofar its psychometric validity is concerned. Moreover, the potential of this game for the cognitive classification of senior adults was confirmed, and administration time is dramatically reduced with respect to pen-and-paper tests. Additional research is needed to improve the resolution of the game for the identification of specific cognitive impairments, as well as to achieve a complete validation of the psychometric properties of the digital game. Initial evidence show that serious games can be used as an instrument to assess the cognitive status of senior adults, and even to predict the onset of mild cognitive impairments or Alzheimer's disease.

Design process and preliminary psychometric study of a video game to detect cognitive impairment in senior adults

PubMed Central

Perez-Rodriguez, Roberto; Facal, David; Fernandez-Iglesias, Manuel J.; Anido-Rifon, Luis; Mouriño-Garcia, Marcos

2017-01-01

Introduction Assessment of episodic memory has been traditionally used to evaluate potential cognitive impairments in senior adults. Typically, episodic memory evaluation is based on personal interviews and pen-and-paper tests. This article presents the design, development and a preliminary validation of a novel digital game to assess episodic memory intended to overcome the limitations of traditional methods, such as the cost of its administration, its intrusive character, the lack of early detection capabilities, the lack of ecological validity, the learning effect and the existence of confounding factors. Materials and Methods Our proposal is based on the gamification of the California Verbal Learning Test (CVLT) and it has been designed to comply with the psychometric characteristics of reliability and validity. Two qualitative focus groups and a first pilot experiment were carried out to validate the proposal. Results A more ecological, non-intrusive and better administrable tool to perform cognitive assessment was developed. Initial evidence from the focus groups and pilot experiment confirmed the developed game’s usability and offered promising results insofar its psychometric validity is concerned. Moreover, the potential of this game for the cognitive classification of senior adults was confirmed, and administration time is dramatically reduced with respect to pen-and-paper tests. Limitations Additional research is needed to improve the resolution of the game for the identification of specific cognitive impairments, as well as to achieve a complete validation of the psychometric properties of the digital game. Conclusion Initial evidence show that serious games can be used as an instrument to assess the cognitive status of senior adults, and even to predict the onset of mild cognitive impairments or Alzheimer’s disease. PMID:28674661

5 CFR 838.1121 - Procedures and requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... REGULATIONS (CONTINUED) COURT ORDERS AFFECTING RETIREMENT BENEFITS Court Orders Under the Child Abuse... requirements applicable to legal process under part 581 of this chapter apply to OPM's administration of child... 581 of this chapter that appears valid on its face. (2)(i) After OPM has determined that a child abuse...

78 FR 25750 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-02

... technology and systems for the purpose of collecting, validating and verifying information, processing and... Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request ACTION....C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information...

Measurement in Sensory Modulation: The Sensory Processing Scale Assessment

PubMed Central

Miller, Lucy J.; Sullivan, Jillian C.

2014-01-01

OBJECTIVE. Sensory modulation issues have a significant impact on participation in daily life. Moreover, understanding phenotypic variation in sensory modulation dysfunction is crucial for research related to defining homogeneous groups and for clinical work in guiding treatment planning. We thus evaluated the new Sensory Processing Scale (SPS) Assessment. METHOD. Research included item development, behavioral scoring system development, test administration, and item analyses to evaluate reliability and validity across sensory domains. RESULTS. Items with adequate reliability (internal reliability >.4) and discriminant validity (p < .01) were retained. Feedback from the expert panel also contributed to decisions about retaining items in the scale. CONCLUSION. The SPS Assessment appears to be a reliable and valid measure of sensory modulation (scale reliability >.90; discrimination between group effect sizes >1.00). This scale has the potential to aid in differential diagnosis of sensory modulation issues. PMID:25184464

Guidelines To Validate Control of Cross-Contamination during Washing of Fresh-Cut Leafy Vegetables.

PubMed

Gombas, D; Luo, Y; Brennan, J; Shergill, G; Petran, R; Walsh, R; Hau, H; Khurana, K; Zomorodi, B; Rosen, J; Varley, R; Deng, K

2017-02-01

The U.S. Food and Drug Administration requires food processors to implement and validate processes that will result in significantly minimizing or preventing the occurrence of hazards that are reasonably foreseeable in food production. During production of fresh-cut leafy vegetables, microbial contamination that may be present on the product can spread throughout the production batch when the product is washed, thus increasing the risk of illnesses. The use of antimicrobials in the wash water is a critical step in preventing such water-mediated cross-contamination; however, many factors can affect antimicrobial efficacy in the production of fresh-cut leafy vegetables, and the procedures for validating this key preventive control have not been articulated. Producers may consider three options for validating antimicrobial washing as a preventive control for cross-contamination. Option 1 involves the use of a surrogate for the microbial hazard and the demonstration that cross-contamination is prevented by the antimicrobial wash. Option 2 involves the use of antimicrobial sensors and the demonstration that a critical antimicrobial level is maintained during worst-case operating conditions. Option 3 validates the placement of the sensors in the processing equipment with the demonstration that a critical antimicrobial level is maintained at all locations, regardless of operating conditions. These validation options developed for fresh-cut leafy vegetables may serve as examples for validating processes that prevent cross-contamination during washing of other fresh produce commodities.

A self-report measure of legal and administrative aggression within intimate relationships.

PubMed

Hines, Denise A; Douglas, Emily M; Berger, Joshua L

2015-01-01

Although experts agree that intimate partner violence (IPV) is a multidimensional phenomenon comprised of both physical and non-physical acts, there is no measure of legal and administrative (LA) forms of IPV. LA aggression is when one partner manipulates the legal and other administrative systems to the detriment of his/her partner. Our measure was developed using the qualitative literature on male IPV victims' experiences. We tested the reliability and validity of our LA aggression measure on two samples of men: 611 men who sustained IPV and sought help, and 1,601 men in a population-based sample. Construct validity of the victimization scale was supported through factor analyses, correlations with other forms of IPV victimization, and comparisons of the rates of LA aggression between the two samples; reliability was established through Cronbach's alpha. Evidence for the validity and reliability of the perpetration scale was mixed and therefore needs further analyses and revisions before we can recommend its use in empirical work. There is initial support for the victimization scale as a valid and reliable measure of LA aggression victimization among men, but work is needed using women's victimization's experiences to establish reliability and validity of this measure for women. An LA aggression measure should be developed using LGBTQ victims' experiences, and for couples who are well into the divorce and child custody legal process. Legal personnel and practitioners should be educated on this form of IPV so that they can appropriately work with clients who have been victimized or perpetrate LA aggression. © 2014 Wiley Periodicals, Inc.

Measuring quality of dental care: Caries prevention services for children.

PubMed

Herndon, Jill Boylston; Tomar, Scott L; Catalanotto, Frank A; Rudner, Nancy; Huang, I-Chan; Aravamudhan, Krishna; Shenkman, Elizabeth A; Crall, James J

2015-08-01

The authors conducted a study to validate the following 3 evidence-based, process-of-care quality measures focused on dental caries prevention for children with an elevated risk of experiencing caries: sealants for 6- to 9-year-olds, sealants for 10- to 14-year-olds, and topical fluoride. Using evidence-based guidelines, the Dental Quality Alliance developed measures for implementation with administrative data at the plan and program levels. To validate the measures, the authors used data from the Florida and Texas Medicaid programs and Children's Health Insurance Programs and from national commercial dental benefit plans. Data were extracted from 414 randomly selected dental office records to validate the use of administrative data to accurately calculate the measures. The authors also assessed statistically significant variations in overall measure performance. Agreement between administrative data and dental records was 95% for sealants (κ = 0.82) and 90% for topical fluoride (κ = 0.78). Sensitivity and specificity were 90.7% and 88.5% for topical fluoride and 77.8% and 98.8% for sealants, respectively. Variation in overall measure performance was greatest for topical fluoride (χ(2) = 5,887.1; P < .01); 18% to 37% of children with an elevated risk of experiencing caries received at least 2 topical fluoride applications during the reporting year. Although there was greater variation in performance for sealants for 6- to 9-year-olds (range, 21.0-31.3%; χ(2) = 548.6; P < .01) compared with sealants for 10- to 14-year-olds (range, 8.4-11.1%; χ(2) = 22.7; P < .01), overall sealant placement rates were lower for 10- to 14-year-olds. These evidence-based, caries prevention process-of-care quality measures can be implemented feasibly and validly using administrative claims data. The measures can be used to assess, monitor, and improve the proportion of children with an elevated risk of experiencing dental caries who receive evidence-based caries prevention services. Copyright © 2015 American Dental Association. Published by Elsevier Inc. All rights reserved.

Derivation and Validation of the Surgical Site Infections Risk Model Using Health Administrative Data.

PubMed

van Walraven, Carl; Jackson, Timothy D; Daneman, Nick

2016-04-01

OBJECTIVE Surgical site infections (SSIs) are common hospital-acquired infections. Tracking SSIs is important to monitor their incidence, and this process requires primary data collection. In this study, we derived and validated a method using health administrative data to predict the probability that a person who had surgery would develop an SSI within 30 days. METHODS All patients enrolled in the National Surgical Quality Improvement Program (NSQIP) from 2 sites were linked to population-based administrative datasets in Ontario, Canada. We derived a multivariate model, stratified by surgical specialty, to determine the independent association of SSI status with patient and hospitalization covariates as well as physician claim codes. This SSI risk model was validated in 2 cohorts. RESULTS The derivation cohort included 5,359 patients with a 30-day SSI incidence of 6.0% (n=118). The SSI risk model predicted the probability that a person had an SSI based on 7 covariates: index hospitalization diagnostic score; physician claims score; emergency visit diagnostic score; operation duration; surgical service; and potential SSI codes. More than 90% of patients had predicted SSI risks lower than 10%. In the derivation group, model discrimination and calibration was excellent (C statistic, 0.912; Hosmer-Lemeshow [H-L] statistic, P=.47). In the 2 validation groups, performance decreased slightly (C statistics, 0.853 and 0.812; H-L statistics, 26.4 [P=.0009] and 8.0 [P=.42]), but low-risk patients were accurately identified. CONCLUSION Health administrative data can effectively identify postoperative patients with a very low risk of surgical site infection within 30 days of their procedure. Records of higher-risk patients can be reviewed to confirm SSI status.

45 CFR 162.1011 - Valid code sets.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 1 2012-10-01 2012-10-01 false Valid code sets. 162.1011 Section 162.1011 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES ADMINISTRATIVE DATA STANDARDS AND RELATED REQUIREMENTS ADMINISTRATIVE REQUIREMENTS Code Sets § 162.1011 Valid code sets. Each code set is valid within the dates...

45 CFR 162.1011 - Valid code sets.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 1 2013-10-01 2013-10-01 false Valid code sets. 162.1011 Section 162.1011 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES ADMINISTRATIVE DATA STANDARDS AND RELATED REQUIREMENTS ADMINISTRATIVE REQUIREMENTS Code Sets § 162.1011 Valid code sets. Each code set is valid within the dates...

45 CFR 162.1011 - Valid code sets.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 1 2010-10-01 2010-10-01 false Valid code sets. 162.1011 Section 162.1011 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES ADMINISTRATIVE DATA STANDARDS AND RELATED REQUIREMENTS ADMINISTRATIVE REQUIREMENTS Code Sets § 162.1011 Valid code sets. Each code set is valid within the dates...

45 CFR 162.1011 - Valid code sets.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 1 2014-10-01 2014-10-01 false Valid code sets. 162.1011 Section 162.1011 Public Welfare Department of Health and Human Services ADMINISTRATIVE DATA STANDARDS AND RELATED REQUIREMENTS ADMINISTRATIVE REQUIREMENTS Code Sets § 162.1011 Valid code sets. Each code set is valid within the dates...

45 CFR 162.1011 - Valid code sets.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 1 2011-10-01 2011-10-01 false Valid code sets. 162.1011 Section 162.1011 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES ADMINISTRATIVE DATA STANDARDS AND RELATED REQUIREMENTS ADMINISTRATIVE REQUIREMENTS Code Sets § 162.1011 Valid code sets. Each code set is valid within the dates...

77 FR 56650 - Food and Drug Administration/American Glaucoma Society Workshop on the Validity, Reliability, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-13

...] Food and Drug Administration/American Glaucoma Society Workshop on the Validity, Reliability, and... entitled ``FDA/American Glaucoma Society (AGS) Workshop on the Validity, Reliability, and Usability of... research. The purpose of this public workshop is to provide a forum for discussing the validity...

New Directions in Library and Information Science Education. Final Report. Volume 2.6: Database Distributor/Service Professional Competencies.

ERIC Educational Resources Information Center

Griffiths, Jose-Marie; And Others

This document contains validated activities and competencies needed by librarians working in a database distributor/service organization. The activities of professionals working in database distributor/service organizations are listed by function: Database Processing; Customer Support; System Administration; and Planning. The competencies are…

Federating Clinical Data from Six Pediatric Hospitals: Process and Initial Results from the PHIS+ Consortium

PubMed Central

Narus, Scott P.; Srivastava, Rajendu; Gouripeddi, Ramkiran; Livne, Oren E.; Mo, Peter; Bickel, Jonathan P.; de Regt, David; Hales, Joseph W.; Kirkendall, Eric; Stepanek, Richard L.; Toth, Jamie; Keren, Ron

2011-01-01

Integrating clinical data with administrative data across disparate electronic medical record systems will help improve the internal and external validity of comparative effectiveness research. The Pediatric Health Information System (PHIS) currently collects administrative information from 43 pediatric hospital members of the Child Health Corporation of America (CHCA). Members of the Pediatric Research in Inpatient Settings (PRIS) network have partnered with CHCA and the University of Utah Biomedical Informatics Core to create an enhanced version of PHIS that includes clinical data. A specialized version of a data federation architecture from the University of Utah (“FURTHeR”) is being developed to integrate the clinical data from the member hospitals into a common repository (“PHIS+”) that is joined with the existing administrative data. We report here on our process for the first phase of federating lab data, and present initial results. PMID:22195159

Safety and Traceability in Patient Healthcare through the Integration of RFID Technology for Intravenous Mixtures in the Prescription-Validation-Elaboration-Dispensation-Administration Circuit to Day Hospital Patients.

PubMed

Martínez Pérez, María; Vázquez González, Guillermo; Dafonte, Carlos

2016-07-28

This work presents the integration of the RFID technology with the aim of ensuring the traceability of patients and minimization of adverse events during the process of prescription-validation-elaboration-dispensation-administration of medication by means of the implementation of various passive and active WIFI RFID systems in the Pharmacy and Day Hospital services of the Complejo Hospitalario Universitario A Coruña. Obtaining patient traceability and using the patient/drug binomial during this process allows us to minimize the occurrence of adverse events. The key points in this work are the unmistakably unique identification and accurate real time location of the controlled items (patients and medication). RFID technology has proved to be invaluable in assisting with the everyday clinical practice of a hospital, and has been successfully implemented in this environment and others. In services such as the day hospital, the implementation of said technology is further justified by the high costs of the service and the high risk to the patient.

Safety and Traceability in Patient Healthcare through the Integration of RFID Technology for Intravenous Mixtures in the Prescription-Validation-Elaboration-Dispensation-Administration Circuit to Day Hospital Patients

PubMed Central

Martínez Pérez, María; Vázquez González, Guillermo; Dafonte, Carlos

2016-01-01

This work presents the integration of the RFID technology with the aim of ensuring the traceability of patients and minimization of adverse events during the process of prescription-validation-elaboration-dispensation-administration of medication by means of the implementation of various passive and active WIFI RFID systems in the Pharmacy and Day Hospital services of the Complejo Hospitalario Universitario A Coruña. Obtaining patient traceability and using the patient/drug binomial during this process allows us to minimize the occurrence of adverse events. The key points in this work are the unmistakably unique identification and accurate real time location of the controlled items (patients and medication). RFID technology has proved to be invaluable in assisting with the everyday clinical practice of a hospital, and has been successfully implemented in this environment and others. In services such as the day hospital, the implementation of said technology is further justified by the high costs of the service and the high risk to the patient. PMID:27483269

Validation of Case Finding Algorithms for Hepatocellular Cancer from Administrative Data and Electronic Health Records using Natural Language Processing

PubMed Central

Sada, Yvonne; Hou, Jason; Richardson, Peter; El-Serag, Hashem; Davila, Jessica

2013-01-01

Background Accurate identification of hepatocellular cancer (HCC) cases from automated data is needed for efficient and valid quality improvement initiatives and research. We validated HCC ICD-9 codes, and evaluated whether natural language processing (NLP) by the Automated Retrieval Console (ARC) for document classification improves HCC identification. Methods We identified a cohort of patients with ICD-9 codes for HCC during 2005–2010 from Veterans Affairs administrative data. Pathology and radiology reports were reviewed to confirm HCC. The positive predictive value (PPV), sensitivity, and specificity of ICD-9 codes were calculated. A split validation study of pathology and radiology reports was performed to develop and validate ARC algorithms. Reports were manually classified as diagnostic of HCC or not. ARC generated document classification algorithms using the Clinical Text Analysis and Knowledge Extraction System. ARC performance was compared to manual classification. PPV, sensitivity, and specificity of ARC were calculated. Results 1138 patients with HCC were identified by ICD-9 codes. Based on manual review, 773 had HCC. The HCC ICD-9 code algorithm had a PPV of 0.67, sensitivity of 0.95, and specificity of 0.93. For a random subset of 619 patients, we identified 471 pathology reports for 323 patients and 943 radiology reports for 557 patients. The pathology ARC algorithm had PPV of 0.96, sensitivity of 0.96, and specificity of 0.97. The radiology ARC algorithm had PPV of 0.75, sensitivity of 0.94, and specificity of 0.68. Conclusion A combined approach of ICD-9 codes and NLP of pathology and radiology reports improves HCC case identification in automated data. PMID:23929403

Methodological Issues in Questionnaire Design.

PubMed

Song, Youngshin; Son, Youn Jung; Oh, Doonam

2015-06-01

The process of designing a questionnaire is complicated. Many questionnaires on nursing phenomena have been developed and used by nursing researchers. The purpose of this paper was to discuss questionnaire design and factors that should be considered when using existing scales. Methodological issues were discussed, such as factors in the design of questions, steps in developing questionnaires, wording and formatting methods for items, and administrations methods. How to use existing scales, how to facilitate cultural adaptation, and how to prevent socially desirable responding were discussed. Moreover, the triangulation method in questionnaire development was introduced. Steps were recommended for designing questions such as appropriately operationalizing key concepts for the target population, clearly formatting response options, generating items and confirming final items through face or content validity, sufficiently piloting the questionnaire using item analysis, demonstrating reliability and validity, finalizing the scale, and training the administrator. Psychometric properties and cultural equivalence should be evaluated prior to administration when using an existing questionnaire and performing cultural adaptation. In the context of well-defined nursing phenomena, logical and systematic methods will contribute to the development of simple and precise questionnaires.

Psychometrics in Support of a Valid Assessment of Linguistic Minorities: Implications for the Test and Sampling Designs

ERIC Educational Resources Information Center

Oliveri, María Elena; von Davier, Alina A.

2016-01-01

In this study, we propose that the unique needs and characteristics of linguistic minorities should be considered throughout the test development process. Unlike most measurement invariance investigations in the assessment of linguistic minorities, which typically are conducted after test administration, we propose strategies that focus on the…

The Reading Span Test and Its Predictive Power for Reading Comprehension Ability

ERIC Educational Resources Information Center

Friedman, Naomi P.; Miyake, Akira

2004-01-01

This study had two major goals: to test the effect of administration method on the criterion validity of a commonly used working memory span test, the reading span task, and to examine the relationship between processing and storage in this task. With respect to the first goal, although experimenter- and participant-administered reading span tasks…

Global approach for the validation of an in-line Raman spectroscopic method to determine the API content in real-time during a hot-melt extrusion process.

PubMed

Netchacovitch, L; Thiry, J; De Bleye, C; Dumont, E; Cailletaud, J; Sacré, P-Y; Evrard, B; Hubert, Ph; Ziemons, E

2017-08-15

Since the Food and Drug Administration (FDA) published a guidance based on the Process Analytical Technology (PAT) approach, real-time analyses during manufacturing processes are in real expansion. In this study, in-line Raman spectroscopic analyses were performed during a Hot-Melt Extrusion (HME) process to determine the Active Pharmaceutical Ingredient (API) content in real-time. The method was validated based on a univariate and a multivariate approach and the analytical performances of the obtained models were compared. Moreover, on one hand, in-line data were correlated with the real API concentration present in the sample quantified by a previously validated off-line confocal Raman microspectroscopic method. On the other hand, in-line data were also treated in function of the concentration based on the weighing of the components in the prepared mixture. The importance of developing quantitative methods based on the use of a reference method was thus highlighted. The method was validated according to the total error approach fixing the acceptance limits at ±15% and the α risk at ±5%. This method reaches the requirements of the European Pharmacopeia norms for the uniformity of content of single-dose preparations. The validation proves that future results will be in the acceptance limits with a previously defined probability. Finally, the in-line validated method was compared with the off-line one to demonstrate its ability to be used in routine analyses. Copyright © 2017 Elsevier B.V. All rights reserved.

(How) do we learn from errors? A prospective study of the link between the ward's learning practices and medication administration errors.

PubMed

Drach-Zahavy, A; Somech, A; Admi, H; Peterfreund, I; Peker, H; Priente, O

2014-03-01

Attention in the ward should shift from preventing medication administration errors to managing them. Nevertheless, little is known in regard with the practices nursing wards apply to learn from medication administration errors as a means of limiting them. To test the effectiveness of four types of learning practices, namely, non-integrated, integrated, supervisory and patchy learning practices in limiting medication administration errors. Data were collected from a convenient sample of 4 hospitals in Israel by multiple methods (observations and self-report questionnaires) at two time points. The sample included 76 wards (360 nurses). Medication administration error was defined as any deviation from prescribed medication processes and measured by a validated structured observation sheet. Wards' use of medication administration technologies, location of the medication station, and workload were observed; learning practices and demographics were measured by validated questionnaires. Results of the mixed linear model analysis indicated that the use of technology and quiet location of the medication cabinet were significantly associated with reduced medication administration errors (estimate=.03, p<.05 and estimate=-.17, p<.01 correspondingly), while workload was significantly linked to inflated medication administration errors (estimate=.04, p<.05). Of the learning practices, supervisory learning was the only practice significantly linked to reduced medication administration errors (estimate=-.04, p<.05). Integrated and patchy learning were significantly linked to higher levels of medication administration errors (estimate=-.03, p<.05 and estimate=-.04, p<.01 correspondingly). Non-integrated learning was not associated with it (p>.05). How wards manage errors might have implications for medication administration errors beyond the effects of typical individual, organizational and technology risk factors. Head nurse can facilitate learning from errors by "management by walking around" and monitoring nurses' medication administration behaviors. Copyright © 2013 Elsevier Ltd. All rights reserved.

NMR-based urine analysis in rats: prediction of proximal tubule kidney toxicity and phospholipidosis.

PubMed

Lienemann, Kai; Plötz, Thomas; Pestel, Sabine

2008-01-01

The aim of safety pharmacology is early detection of compound-induced side-effects. NMR-based urine analysis followed by multivariate data analysis (metabonomics) identifies efficiently differences between toxic and non-toxic compounds; but in most cases multiple administrations of the test compound are necessary. We tested the feasibility of detecting proximal tubule kidney toxicity and phospholipidosis with metabonomics techniques after single compound administration as an early safety pharmacology approach. Rats were treated orally, intravenously, inhalatively or intraperitoneally with different test compounds. Urine was collected at 0-8 h and 8-24 h after compound administration, and (1)H NMR-patterns were recorded from the samples. Variation of post-processing and feature extraction methods led to different views on the data. Support Vector Machines were trained on these different data sets and then aggregated as experts in an Ensemble. Finally, validity was monitored with a cross-validation study using a training, validation, and test data set. Proximal tubule kidney toxicity could be predicted with reasonable total classification accuracy (85%), specificity (88%) and sensitivity (78%). In comparison to alternative histological studies, results were obtained quicker, compound need was reduced, and very importantly fewer animals were needed. In contrast, the induction of phospholipidosis by the test compounds could not be predicted using NMR-based urine analysis or the previously published biomarker PAG. NMR-based urine analysis was shown to effectively predict proximal tubule kidney toxicity after single compound administration in rats. Thus, this experimental design allows early detection of toxicity risks with relatively low amounts of compound in a reasonably short period of time.

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.

Effect of orally administered Lactobacillus brevis HY7401 in a food allergy mouse model.

PubMed

Lee, Jeongmin; Bang, Jieun; Woo, Hee-Jong

2013-11-28

We had found that orally administered Lactobacillus species were effective immune modulators in ovalbumin (OVA)-sensitized mice. To validate these findings, we investigated the effects of orally administered Lactobacillus brevis HY7401 in OVA-T cell receptor transgenic mice. This strain showed a tendency to induce Th1 cytokines and inhibit Th2 cytokines. All assayed isotypes of OVA-specific antibody were effectively reduced. Systemic anaphylaxis was also relatively reduced with the probiotic administration. These results reveal that L. brevis HY7401 might be useful to promote anti-allergic processes through oral administration.

Generic Raman-based calibration models enabling real-time monitoring of cell culture bioreactors.

PubMed

Mehdizadeh, Hamidreza; Lauri, David; Karry, Krizia M; Moshgbar, Mojgan; Procopio-Melino, Renee; Drapeau, Denis

2015-01-01

Raman-based multivariate calibration models have been developed for real-time in situ monitoring of multiple process parameters within cell culture bioreactors. Developed models are generic, in the sense that they are applicable to various products, media, and cell lines based on Chinese Hamster Ovarian (CHO) host cells, and are scalable to large pilot and manufacturing scales. Several batches using different CHO-based cell lines and corresponding proprietary media and process conditions have been used to generate calibration datasets, and models have been validated using independent datasets from separate batch runs. All models have been validated to be generic and capable of predicting process parameters with acceptable accuracy. The developed models allow monitoring multiple key bioprocess metabolic variables, and hence can be utilized as an important enabling tool for Quality by Design approaches which are strongly supported by the U.S. Food and Drug Administration. © 2015 American Institute of Chemical Engineers.

28 CFR 25.5 - Validation and data integrity of records in the system.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 1 2011-07-01 2011-07-01 false Validation and data integrity of records in the system. 25.5 Section 25.5 Judicial Administration DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE INFORMATION SYSTEMS The National Instant Criminal Background Check System § 25.5 Validation and data integrity...

28 CFR 25.5 - Validation and data integrity of records in the system.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Validation and data integrity of records in the system. 25.5 Section 25.5 Judicial Administration DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE INFORMATION SYSTEMS The National Instant Criminal Background Check System § 25.5 Validation and data integrity...

28 CFR 25.5 - Validation and data integrity of records in the system.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 1 2012-07-01 2012-07-01 false Validation and data integrity of records in the system. 25.5 Section 25.5 Judicial Administration DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE INFORMATION SYSTEMS The National Instant Criminal Background Check System § 25.5 Validation and data integrity...

28 CFR 25.5 - Validation and data integrity of records in the system.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Validation and data integrity of records in the system. 25.5 Section 25.5 Judicial Administration DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE INFORMATION SYSTEMS The National Instant Criminal Background Check System § 25.5 Validation and data integrity...

Rhetorical Approaches to Crisis Communication: The Research, Development, and Validation of an Image Repair Situational Theory for Educational Leaders

ERIC Educational Resources Information Center

Vogelaar, Robert J.

2005-01-01

In this project a product to aid educational leaders in the process of communicating in crisis situations is presented. The product was created and received a formative evaluation using an educational research and development methodology. Ultimately, an administrative training course that utilized an Image Repair Situational Theory was developed.…

Health Facilities: New York State's Oversight of Nursing Homes and Hospitals. Report to the Honorable Bill Green, House of Representatives.

ERIC Educational Resources Information Center

General Accounting Office, New York, NY. Regional Office.

At the request of Congressman William Green, the General Accounting Office (GAO) evaluated the validity of allegations about deficiencies in the New York State Department of Health's nursing home and hospital inspection processes for certification for participation in the Medicare and Medicaid programs. Health Care Financing Administration and…

Validity of breast, lung and colorectal cancer diagnoses in administrative databases: a systematic review protocol.

PubMed

Abraha, Iosief; Giovannini, Gianni; Serraino, Diego; Fusco, Mario; Montedori, Alessandro

2016-03-18

Breast, lung and colorectal cancers constitute the most common cancers worldwide and their epidemiology, related health outcomes and quality indicators can be studied using administrative healthcare databases. To constitute a reliable source for research, administrative healthcare databases need to be validated. The aim of this protocol is to perform the first systematic review of studies reporting the validation of International Classification of Diseases 9th and 10th revision codes to identify breast, lung and colorectal cancer diagnoses in administrative healthcare databases. This review protocol has been developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) 2015 statement. We will search the following databases: MEDLINE, EMBASE, Web of Science and the Cochrane Library, using appropriate search strategies. We will include validation studies that used administrative data to identify breast, lung and colorectal cancer diagnoses or studies that evaluated the validity of breast, lung and colorectal cancer codes in administrative data. The following inclusion criteria will be used: (1) the presence of a reference standard case definition for the disease of interest; (2) the presence of at least one test measure (eg, sensitivity, positive predictive values, etc) and (3) the use of data source from an administrative database. Pairs of reviewers will independently abstract data using standardised forms and will assess quality using a checklist based on the Standards for Reporting of Diagnostic accuracy (STARD) criteria. Ethics approval is not required. We will submit results of this study to a peer-reviewed journal for publication. The results will serve as a guide to identify appropriate case definitions and algorithms of breast, lung and colorectal cancers for researchers involved in validating administrative healthcare databases as well as for outcome research on these conditions that used administrative healthcare databases. CRD42015026881. 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/

An International Comparative Study on Driving Regulations on People with Dementia.

PubMed

Kim, You Joung; An, Hoyoung; Kim, Binna; Park, Young Shin; Kim, Ki Woong

2017-01-01

Over 40% of people with dementia drive, with a two to five times greater accident risk than controls. This has fueled public concerns about the risk of traffic accidents by drivers with dementia (DWD). We compared driving regulations on seniors and DWD between ten European and Asia-Pacific countries to identify key implications for national strategies. Moderate to severe dementia was a reason for driver's license revocation in all countries. However, regulations on mild dementia varied considerably, with most basing their decisions on severity, rather than simply the presence of dementia. Most used validated assessments, but responsibility for triggering the administrative process fell on drivers in some countries and on physicians in others. Administrations should consider the following when developing driving policies: 1) ideal regulations on DWD should ensure that restrictions are implemented only when needed; 2) fitness to drive should be assessed using validated instruments; 3) the use of processes that automatically initiate driving competency examinations following a diagnosis of dementia should be explored; and 4) restrictions should be delicately tailored to a range of driving competence levels, and assistive incentives compensating for lost driving privileges should be provided.

Establishment of an 11-year cohort of 8733 pediatric patients hospitalized at United States free-standing children's hospitals with de novo acute lymphoblastic leukemia from health care administrative data.

PubMed

Fisher, Brian T; Harris, Tracey; Torp, Kari; Seif, Alix E; Shah, Ami; Huang, Yuan-Shung V; Bailey, L Charles; Kersun, Leslie S; Reilly, Anne F; Rheingold, Susan R; Walker, Dana; Li, Yimei; Aplenc, Richard

2014-01-01

Acute lymphoblastic leukemia (ALL) accounts for almost one quarter of pediatric cancer in the United States. Despite cooperative group therapeutic trials, there remains a paucity of large cohort data on which to conduct epidemiology and comparative effectiveness research studies. We designed a 3-step process utilizing International Classification of Diseases-9 Clinical Modification (ICD-9) discharge diagnoses codes and chemotherapy exposure data contained in the Pediatric Health Information System administrative database to establish a cohort of children with de novo ALL. This process was validated by chart review at 1 of the pediatric centers. An ALL cohort of 8733 patients was identified with a sensitivity of 88% [95% confidence interval (CI), 83%-92%] and a positive predictive value of 93% (95% CI, 89%-96%). The 30-day all cause inpatient case fatality rate using this 3-step process was 0.80% (95% CI, 0.63%-1.01%), which was significantly different than the case fatality rate of 1.40% (95% CI, 1.23%-1.60%) when ICD-9 codes alone were used. This is the first report of assembly and validation of a cohort of de novo ALL patients from a database representative of free-standing children's hospitals across the United States. Our data demonstrate that the use of ICD-9 codes alone to establish cohorts will lead to substantial patient misclassification and result in biased outcome estimates. Systematic methods beyond the use of just ICD-9 codes must be used before analysis to establish accurate cohorts of patients with malignancy. A similar approach should be followed when establishing future cohorts from administrative data.

Simultaneous determination of ten alkaloids of crude and wine-processed Rhizoma Coptidis aqueous extracts in rat plasma by UHPLC-ESI-MS/MS and its application to a comparative pharmacokinetic study.

PubMed

Qian, Xiao-Cui; Zhang, Liang; Tao, Yi; Huang, Ping; Li, Jun-Song; Chai, Chuan; Li, Wen; Di, Liu-Qing; Cai, Bao-Chang

2015-02-01

Rhizoma coptidis (R.C.), a widely used traditional Chinese medicine, has been used for centuries in the treatment of hypertension, inflammation, dysentery and liver diseases, etc. Wine-processing is a specialized technology by sautéing crude herbal medicine using Chinese rice wine. This paper was designed to establish a simultaneous quantitative method of ten alkaloids (berberine, coptisine, palmatine, jatrorrhizine, epiberberine, magnoflorine, columbamine, noroxyhydrastinine, oxyberberine and 8-oxocoptisine) in rat plasma. Furthermore, the pharmacokinetics of those alkaloids after administration of crude and wine-processed R.C. aqueous extracts was compared. As a result, a ultra high-performance liquid chromatography-electrospray ionization-tandem mass spectrometry (UHPLC-ESI-MS/MS) method was developed and validated for the first time. Chromatographic separation was achieved on a C18 column using gradient elution with the mobile phase consisting of acetonitrile and water (containing 0.2% formic acid) at a flow rate of 0.2 ml/min. The validated method showed good linearity over a wide concentration range (r>0.99), and lower limits of quantification less than 5.46 ng/ml for the each analyte. The intra- and inter-day assay variability was below 9.9% and 10.5% for all analytes, respectively. The extraction recovery of those alkaloids and I.S. ranged from 65.3% to 90.7%. The validated method has been successfully applied to pharmacokinetic comparison after administration of crude and wine-processed R.C. aqueous extracts. Pharmacokinetic comparative study showed that Cmax of coptisine and 8-oxocoptisine and AUC0-t of coptisine, palmatine and 8-oxocoptisine were increased significantly (p<0.05) after wine-processing, while other compounds didn't show significant difference, which suggested that wine-processing exerted limited effects on the absorption of alkaloids. These results might be helpful for R.C.' clinical reasonable application and further studies on its wine-processing mechanism. Copyright © 2014 Elsevier B.V. All rights reserved.

An administrative claims model for profiling hospital 30-day mortality rates for pneumonia patients.

PubMed

Bratzler, Dale W; Normand, Sharon-Lise T; Wang, Yun; O'Donnell, Walter J; Metersky, Mark; Han, Lein F; Rapp, Michael T; Krumholz, Harlan M

2011-04-12

Outcome measures for patients hospitalized with pneumonia may complement process measures in characterizing quality of care. We sought to develop and validate a hierarchical regression model using Medicare claims data that produces hospital-level, risk-standardized 30-day mortality rates useful for public reporting for patients hospitalized with pneumonia. Retrospective study of fee-for-service Medicare beneficiaries age 66 years and older with a principal discharge diagnosis of pneumonia. Candidate risk-adjustment variables included patient demographics, administrative diagnosis codes from the index hospitalization, and all inpatient and outpatient encounters from the year before admission. The model derivation cohort included 224,608 pneumonia cases admitted to 4,664 hospitals in 2000, and validation cohorts included cases from each of years 1998-2003. We compared model-derived state-level standardized mortality estimates with medical record-derived state-level standardized mortality estimates using data from the Medicare National Pneumonia Project on 50,858 patients hospitalized from 1998-2001. The final model included 31 variables and had an area under the Receiver Operating Characteristic curve of 0.72. In each administrative claims validation cohort, model fit was similar to the derivation cohort. The distribution of standardized mortality rates among hospitals ranged from 13.0% to 23.7%, with 25(th), 50(th), and 75(th) percentiles of 16.5%, 17.4%, and 18.3%, respectively. Comparing model-derived risk-standardized state mortality rates with medical record-derived estimates, the correlation coefficient was 0.86 (Standard Error = 0.032). An administrative claims-based model for profiling hospitals for pneumonia mortality performs consistently over several years and produces hospital estimates close to those using a medical record model.

An Administrative Claims Model for Profiling Hospital 30-Day Mortality Rates for Pneumonia Patients

PubMed Central

Bratzler, Dale W.; Normand, Sharon-Lise T.; Wang, Yun; O'Donnell, Walter J.; Metersky, Mark; Han, Lein F.; Rapp, Michael T.; Krumholz, Harlan M.

2011-01-01

Background Outcome measures for patients hospitalized with pneumonia may complement process measures in characterizing quality of care. We sought to develop and validate a hierarchical regression model using Medicare claims data that produces hospital-level, risk-standardized 30-day mortality rates useful for public reporting for patients hospitalized with pneumonia. Methodology/Principal Findings Retrospective study of fee-for-service Medicare beneficiaries age 66 years and older with a principal discharge diagnosis of pneumonia. Candidate risk-adjustment variables included patient demographics, administrative diagnosis codes from the index hospitalization, and all inpatient and outpatient encounters from the year before admission. The model derivation cohort included 224,608 pneumonia cases admitted to 4,664 hospitals in 2000, and validation cohorts included cases from each of years 1998–2003. We compared model-derived state-level standardized mortality estimates with medical record-derived state-level standardized mortality estimates using data from the Medicare National Pneumonia Project on 50,858 patients hospitalized from 1998–2001. The final model included 31 variables and had an area under the Receiver Operating Characteristic curve of 0.72. In each administrative claims validation cohort, model fit was similar to the derivation cohort. The distribution of standardized mortality rates among hospitals ranged from 13.0% to 23.7%, with 25th, 50th, and 75th percentiles of 16.5%, 17.4%, and 18.3%, respectively. Comparing model-derived risk-standardized state mortality rates with medical record-derived estimates, the correlation coefficient was 0.86 (Standard Error = 0.032). Conclusions/Significance An administrative claims-based model for profiling hospitals for pneumonia mortality performs consistently over several years and produces hospital estimates close to those using a medical record model. PMID:21532758

Nursing Home Administrator Quality Improvement Self-Efficacy Scale.

PubMed

Siegel, Elena O; Zisberg, Anna; Bakerjian, Debra; Zysberg, Leehu

Nursing home (NH) quality improvement (QI) is challenging. The critical role of NH leaders in successful QI is well established; however, current options for assessing the QI capabilities of leaders such as the licensed NH administrator are limited. This article presents the development and preliminary validation of an instrument to measure NH administrator self-efficacy in QI. We used a mixed-methods cross-sectional design to develop and test the measure. For item generation, 39 NH leaders participated in qualitative interviews. Item reduction and content validity were established with a sample of eight subject matter experts. A random sample of 211 administrators from NHs with the lowest and highest Centers for Medicare and Medicaid Services Five-Star Quality ratings completed the measure. We conducted exploratory and confirmatory factor analyses and tested the measure for internal reliability and convergent, discriminant, and known group validity. The final measure included five subscales and 32 items. Confirmatory factor analysis reaffirmed the factorial structure with good fit indices. The new measure's subscales correlated with valid measures of self-efficacy and locus of control, supporting the measure's convergent and discriminant validity. Significant differences in most of the subscales were found between the objective (Centers for Medicare and Medicaid Services Five-Star Quality rating) and subjective (Self-Rated Facility QI Index) quality outcomes, supporting the measure's known group validity. The instrument has usefulness to both NH organizations and individual NH administrators as a diagnostic tool to identify administrators with higher/lower chances of successfully implementing QI. Organizations and individuals can use this diagnostic to identify the administrator's professional development needs for QI, in general, and specific to the instrument's five subscales, informing directions for in-house training, mentoring, and outside professional development. Attending to NH administrators' QI professional development needs prior to implementing QI holds promise to enhance the chances for successful implementation of QI, which is urgently needed in many NHs.

The statistical validity of nursing home survey findings.

PubMed

Woolley, Douglas C

2011-11-01

The Medicare nursing home survey is a high-stakes process whose findings greatly affect nursing homes, their current and potential residents, and the communities they serve. Therefore, survey findings must achieve high validity. This study looked at the validity of one key assessment made during a nursing home survey: the observation of the rate of errors in administration of medications to residents (med-pass). Statistical analysis of the case under study and of alternative hypothetical cases. A skilled nursing home affiliated with a local medical school. The nursing home administrators and the medical director. Observational study. The probability that state nursing home surveyors make a Type I or Type II error in observing med-pass error rates, based on the current case and on a series of postulated med-pass error rates. In the common situation such as our case, where med-pass errors occur at slightly above a 5% rate after 50 observations, and therefore trigger a citation, the chance that the true rate remains above 5% after a large number of observations is just above 50%. If the true med-pass error rate were as high as 10%, and the survey team wished to achieve 75% accuracy in determining that a citation was appropriate, they would have to make more than 200 med-pass observations. In the more common situation where med pass errors are closer to 5%, the team would have to observe more than 2000 med-passes to achieve even a modest 75% accuracy in their determinations. In settings where error rates are low, large numbers of observations of an activity must be made to reach acceptable validity of estimates for the true rates of errors. In observing key nursing home functions with current methodology, the State Medicare nursing home survey process does not adhere to well-known principles of valid error determination. Alternate approaches in survey methodology are discussed. Copyright © 2011 American Medical Directors Association. Published by Elsevier Inc. All rights reserved.

7 CFR 1.216 - Appearance as a witness or production of documents on behalf of a party other than the United...

Code of Federal Regulations, 2013 CFR

2013-01-01

... Agriculture Office of the Secretary of Agriculture ADMINISTRATIVE REGULATIONS Appearance of USDA Employees as... employee of USDA served with a valid summons, subpoena, or other compulsory process demanding his or her... notify the head of his or her USDA agency and the General Counsel or his or her designee of the existence...

7 CFR 1.216 - Appearance as a witness or production of documents on behalf of a party other than the United...

Code of Federal Regulations, 2011 CFR

2011-01-01

... Agriculture Office of the Secretary of Agriculture ADMINISTRATIVE REGULATIONS Appearance of USDA Employees as... employee of USDA served with a valid summons, subpoena, or other compulsory process demanding his or her... notify the head of his or her USDA agency and the General Counsel or his or her designee of the existence...

7 CFR 1.216 - Appearance as a witness or production of documents on behalf of a party other than the United...

Code of Federal Regulations, 2014 CFR

2014-01-01

... Agriculture Office of the Secretary of Agriculture ADMINISTRATIVE REGULATIONS Appearance of USDA Employees as... employee of USDA served with a valid summons, subpoena, or other compulsory process demanding his or her... notify the head of his or her USDA agency and the General Counsel or his or her designee of the existence...

7 CFR 1.216 - Appearance as a witness or production of documents on behalf of a party other than the United...

Code of Federal Regulations, 2012 CFR

2012-01-01

... Agriculture Office of the Secretary of Agriculture ADMINISTRATIVE REGULATIONS Appearance of USDA Employees as... employee of USDA served with a valid summons, subpoena, or other compulsory process demanding his or her... notify the head of his or her USDA agency and the General Counsel or his or her designee of the existence...

7 CFR 1.216 - Appearance as a witness or production of documents on behalf of a party other than the United...

Code of Federal Regulations, 2010 CFR

2010-01-01

... Agriculture Office of the Secretary of Agriculture ADMINISTRATIVE REGULATIONS Appearance of USDA Employees as... employee of USDA served with a valid summons, subpoena, or other compulsory process demanding his or her... notify the head of his or her USDA agency and the General Counsel or his or her designee of the existence...

In-Trail Procedure Air Traffic Control Procedures Validation Simulation Study

NASA Technical Reports Server (NTRS)

Chartrand, Ryan C.; Hewitt, Katrin P.; Sweeney, Peter B.; Graff, Thomas J.; Jones, Kenneth M.

2012-01-01

In August 2007, Airservices Australia (Airservices) and the United States National Aeronautics and Space Administration (NASA) conducted a validation experiment of the air traffic control (ATC) procedures associated with the Automatic Dependant Surveillance-Broadcast (ADS-B) In-Trail Procedure (ITP). ITP is an Airborne Traffic Situation Awareness (ATSA) application designed for near-term use in procedural airspace in which ADS-B data are used to facilitate climb and descent maneuvers. NASA and Airservices conducted the experiment in Airservices simulator in Melbourne, Australia. Twelve current operational air traffic controllers participated in the experiment, which identified aspects of the ITP that could be improved (mainly in the communication and controller approval process). Results showed that controllers viewed the ITP as valid and acceptable. This paper describes the experiment design and results.

Validity of Administrative Data in Identifying Cancer-related Events in Adolescents and Young Adults: A Population-based Study Using the IMPACT Cohort.

PubMed

Gupta, Sumit; Nathan, Paul C; Baxter, Nancy N; Lau, Cindy; Daly, Corinne; Pole, Jason D

2018-06-01

Despite the importance of estimating population level cancer outcomes, most registries do not collect critical events such as relapse. Attempts to use health administrative data to identify these events have focused on older adults and have been mostly unsuccessful. We developed and tested administrative data-based algorithms in a population-based cohort of adolescents and young adults with cancer. We identified all Ontario adolescents and young adults 15-21 years old diagnosed with leukemia, lymphoma, sarcoma, or testicular cancer between 1992-2012. Chart abstraction determined the end of initial treatment (EOIT) date and subsequent cancer-related events (progression, relapse, second cancer). Linkage to population-based administrative databases identified fee and procedure codes indicating cancer treatment or palliative care. Algorithms determining EOIT based on a time interval free of treatment-associated codes, and new cancer-related events based on billing codes, were compared with chart-abstracted data. The cohort comprised 1404 patients. Time periods free of treatment-associated codes did not validly identify EOIT dates; using subsequent codes to identify new cancer events was thus associated with low sensitivity (56.2%). However, using administrative data codes that occurred after the EOIT date based on chart abstraction, the first cancer-related event was identified with excellent validity (sensitivity, 87.0%; specificity, 93.3%; positive predictive value, 81.5%; negative predictive value, 95.5%). Although administrative data alone did not validly identify cancer-related events, administrative data in combination with chart collected EOIT dates was associated with excellent validity. The collection of EOIT dates by cancer registries would significantly expand the potential of administrative data linkage to assess cancer outcomes.

Mission description and in-flight operations of ERBE instruments on ERBS and NOAA 10 spacecraft, February 1987 - February 1990

NASA Technical Reports Server (NTRS)

Busch, Kathryn A.; Degnan, Keith T.

1994-01-01

Instruments of the Earth Radiation Budget Experiment (ERBE) are operating on three different Earth-orbiting spacecraft. The Earth Radiation Budget Satellite (ERBS) is operated by the National Aeronautics and Space Administration (NASA), and the NOAA 9 and NOAA 10 weather satellites are operated by the National Oceanic and Atmospheric Administration (NOAA). This paper is the third in a series that describes the ERBE mission in-orbit environments, instrument design and operational features, and data processing and validation procedures. This paper describes the in-flight operations for the ERBE instruments aboard the ERBS and NOAA 10 spacecraft for the period from February 1987 through February 1990. Validation and archival of radiation measurements made by ERBE instruments during this period were completed in May 1992. This paper covers normal and special operations of the spacecraft and instruments, operational anomalies, and the responses of the instruments to in-orbit and seasonal variations in the solar environment.

Mission Description and In-Flight Operations of ERBE Instruments on ERBS, NOAA 9, and NOAA 10 Spacecraft

NASA Technical Reports Server (NTRS)

Snyder, Dianne; Bush, Kathryn; Lee, Kam-Pui; Summerville, Jessica

1998-01-01

Instruments of the Earth Radiation Budget Experiment (ERBE) have operated on three different Earth-orbiting spacecraft. The Earth Radiation Budget Satellite (ERBS) is operated by the National Aeronautics and Space Administration (NASA), and the NOAA 9 and NOAA 10 weather satellites are operated by the National Oceanic and Atmospheric Administration (NOAA). This paper is one of a series that describes the ERBE mission, in-orbit environments, instrument design and operational features, and data processing and validation procedures. This paper also describes the in-flight operations for the ERBE nonscanner instruments aboard the ERBS, NOAA 9, and NOAA 10 spacecraft from January 1990 through December 1990. Validation and archives of radiation measurements made by ERBE nonscanner instruments during this period were completed in August 1996. This paper covers normal and special operations of the spacecraft and instruments, operational anomalies, and the responses of the instruments to in-orbit and seasonal variations in the solar environment.

Dental Management Survey Brazil (DMS-BR): creation and validation of a management instrument

PubMed

Gonzales, Paola Sampaio; Martins, Ismar Eduardo; Biazevic, Maria Gabriela Haye; Silva, Paulo Roberto da; Michel-Crosato, Edgard

2017-04-10

Questionnaires for the assessment of knowledge and self-perception can be useful to diagnose what a dentist knows about management and administration. The aim of the present study was to create and validate the Dental Management Survey Brazil (DMS-BR) scale, based on meetings with experts in the field. After having elaborated the first version, 10 audits were performed in dental offices in order to produce the final version, which included nine dimensions: location, patient, finance, marketing, competition, quality, staff, career, and productivity. The accuracy of the instrument was measured by intrarater and interrater reliability. In the validation phase, 247 Brazilian dentists answered a web-based questionnaire. The data were processed using Stata 13.0 and the significance level was set at 95%. The instrument had intrarater and interrater reliability (ICC-0.93 and 0.94). The overall average of respondents for the DMS-BR scale was 3.77 (SD = 0.45). Skewness and kurtosis were below absolute values 3 and 7, respectively. Internal validity measured by Cronbach's alpha was 0.925 and the correlation of each dimension with the final result of the DMS-BR ranged between 0.606 and 0.810. Correlation with the job satisfaction scale was 0.661. The SEM data ranged between 0.80 and 0.56. The questionnaire presented satisfactory indicators of dentists' self-perception about management and administration activities.

Cognitive mechanisms of diazepam administration: a healthy volunteer model of emotional processing.

PubMed

Pringle, A; Warren, M; Gottwald, J; Cowen, P J; Harmer, C J

2016-06-01

Benzodiazepine drugs continue to be prescribed relatively frequently for anxiety disorders, especially where other treatments have failed or when rapid alleviation of anxiety is imperative. The neuropsychological mechanism by which these drugs act to relieve symptoms, however, remains underspecified. Cognitive accounts of anxiety disorders emphasise hypervigilance for threat in the maintenance of the disorders. The current study examined the effects of 7- or 8-day administration of diazepam in healthy participants (n = 36) on a well-validated battery of tasks measuring emotional processing, including measures of vigilance for threat and physiological responses to threat. Compared to placebo, diazepam reduced vigilant-avoidant patterns of emotional attention (p < 0.01) and reduced general startle responses (p < .05). Diazepam administration had limited effects on emotional processing, enhancing the response to positive vs negative words in the emotional categorisation task (p < .05), modulating emotional memory in terms of false accuracy (p < .05) and slowing the recognition of all facial expressions of emotion (p = .01). These results have implications for our understanding of the cognitive mechanisms of benzodiazepine treatment. The data reported here suggests that diazepam modulates emotional attention, an effect which may be involved in its therapeutic actions in anxiety.

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.

Validation of Passive Sampling Devices for Monitoring of Munitions Constituents in Underwater Environments

DTIC Science & Technology

2017-09-01

Compensation, and Liability Act (CERCLA) and U.S. Environmental Policy Act (USEPA) requirements to protect both human health /safety and...former VNTR is based on potential risks to human health and the environment identified via the CERCLA process, together with applicable or relevant and...evaluation. National Oceanic and Atmospheric Administration Data. Isla de Vieques. U.S. Department of Health and Human Services, Agency for Toxic

Web-Based Predictive Analytics to Improve Patient Flow in the Emergency Department

NASA Technical Reports Server (NTRS)

Buckler, David L.

2012-01-01

The Emergency Department (ED) simulation project was established to demonstrate how requirements-driven analysis and process simulation can help improve the quality of patient care for the Veterans Health Administration's (VHA) Veterans Affairs Medical Centers (VAMC). This project developed a web-based simulation prototype of patient flow in EDs, validated the performance of the simulation against operational data, and documented IT requirements for the ED simulation.

Validation of the Federal Aviation Administration Air Traffic Control Specialist Pre-Training Screen.

DOT National Transportation Integrated Search

1994-02-01

Two formal validation studies of the Air Traffic Control Specialist Pre Training Screen (ATCS/PTS), a 5 day computer administered test battery, are described. The ATCS/PTS was designed to replace the 9 week US Federal Aviation Administration (FAA) Ac...

Measuring the Process and Quality of Informed Consent for Clinical Research: Development and Testing

PubMed Central

Cohn, Elizabeth Gross; Jia, Haomiao; Smith, Winifred Chapman; Erwin, Katherine; Larson, Elaine L.

2013-01-01

Purpose/Objectives To develop and assess the reliability and validity of an observational instrument, the Process and Quality of Informed Consent (P-QIC). Design A pilot study of the psychometrics of a tool designed to measure the quality and process of the informed consent encounter in clinical research. The study used professionally filmed, simulated consent encounters designed to vary in process and quality. Setting A major urban teaching hospital in the northeastern region of the United States. Sample 63 students enrolled in health-related programs participated in psychometric testing, 16 students participated in test-retest reliability, and 5 investigator-participant dyads were observed for the actual consent encounters. Methods For reliability and validity testing, students watched and rated videotaped simulations of four consent encounters intentionally varied in process and content and rated them with the proposed instrument. Test-retest reliability was established by raters watching the videotaped simulations twice. Inter-rater reliability was demonstrated by two simultaneous but independent raters observing an actual consent encounter. Main Research Variables The essential elements of information and communication for informed consent. Findings The initial testing of the P-QIC demonstrated reliable and valid psychometric properties in both the simulated standardized consent encounters and actual consent encounters in the hospital setting. Conclusions The P-QIC is an easy-to-use observational tool that provides a quick assessment of the areas of strength and areas that need improvement in a consent encounter. It can be used in the initial trainings of new investigators or consent administrators and in ongoing programs of improvement for informed consent. Implications for Nursing The development of a validated observational instrument will allow investigators to assess the consent process more accurately and evaluate strategies designed to improve it. PMID:21708532

Derivation and validation of in-hospital mortality prediction models in ischaemic stroke patients using administrative data.

PubMed

Lee, Jason; Morishima, Toshitaka; Kunisawa, Susumu; Sasaki, Noriko; Otsubo, Tetsuya; Ikai, Hiroshi; Imanaka, Yuichi

2013-01-01

Stroke and other cerebrovascular diseases are a major cause of death and disability. Predicting in-hospital mortality in ischaemic stroke patients can help to identify high-risk patients and guide treatment approaches. Chart reviews provide important clinical information for mortality prediction, but are laborious and limiting in sample sizes. Administrative data allow for large-scale multi-institutional analyses but lack the necessary clinical information for outcome research. However, administrative claims data in Japan has seen the recent inclusion of patient consciousness and disability information, which may allow more accurate mortality prediction using administrative data alone. The aim of this study was to derive and validate models to predict in-hospital mortality in patients admitted for ischaemic stroke using administrative data. The sample consisted of 21,445 patients from 176 Japanese hospitals, who were randomly divided into derivation and validation subgroups. Multivariable logistic regression models were developed using 7- and 30-day and overall in-hospital mortality as dependent variables. Independent variables included patient age, sex, comorbidities upon admission, Japan Coma Scale (JCS) score, Barthel Index score, modified Rankin Scale (mRS) score, and admissions after hours and on weekends/public holidays. Models were developed in the derivation subgroup, and coefficients from these models were applied to the validation subgroup. Predictive ability was analysed using C-statistics; calibration was evaluated with Hosmer-Lemeshow χ(2) tests. All three models showed predictive abilities similar or surpassing that of chart review-based models. The C-statistics were highest in the 7-day in-hospital mortality prediction model, at 0.906 and 0.901 in the derivation and validation subgroups, respectively. For the 30-day in-hospital mortality prediction models, the C-statistics for the derivation and validation subgroups were 0.893 and 0.872, respectively; in overall in-hospital mortality prediction these values were 0.883 and 0.876. In this study, we have derived and validated in-hospital mortality prediction models for three different time spans using a large population of ischaemic stroke patients in a multi-institutional analysis. The recent inclusion of JCS, Barthel Index, and mRS scores in Japanese administrative data has allowed the prediction of in-hospital mortality with accuracy comparable to that of chart review analyses. The models developed using administrative data had consistently high predictive abilities for all models in both the derivation and validation subgroups. These results have implications in the role of administrative data in future mortality prediction analyses. Copyright © 2013 S. Karger AG, Basel.

Creation of a pediatric mature B-cell non-Hodgkin lymphoma cohort within the Pediatric Health Information System Database.

PubMed

Citrin, Rebecca; Horowitz, Joseph P; Reilly, Anne F; Li, Yimei; Huang, Yuan-Shung; Getz, Kelly D; Seif, Alix E; Fisher, Brian T; Aplenc, Richard

2017-01-01

Mature B-cell non-Hodgkin lymphoma (B-NHL) constitutes a collection of relatively rare pediatric malignancies. In order to utilize administrative data to perform large-scale epidemiologic studies within this population, a two-step process was used to assemble a 12-year cohort of B-NHL patients treated between 2004 and 2015 within the Pediatric Health Information System database. Patients were identified by ICD-9 codes, and their chemotherapy data were then manually reviewed against standard B-NHL treatment regimens. A total of 1,409 patients were eligible for cohort inclusion. This process was validated at a single center, utilizing both an institutional tumor registry and medical record review as the gold standards. The validation demonstrated appropriate sensitivity (91.5%) and positive predictive value (95.1%) to allow for the future use of this cohort for epidemiologic and comparative effectiveness research.

47 CFR 64.615 - TRS User Registration Database and administrator.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 3 2014-10-01 2014-10-01 false TRS User Registration Database and... Registration Database and administrator. (a) TRS User Registration Database. (1) VRS providers shall validate... Database on a per-call basis. Emergency 911 calls are excepted from this requirement. (i) Validation shall...

47 CFR 64.615 - TRS User Registration Database and administrator.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 47 Telecommunication 3 2013-10-01 2013-10-01 false TRS User Registration Database and... Registration Database and administrator. (a) TRS User Registration Database. (1) VRS providers shall validate... Database on a per-call basis. Emergency 911 calls are excepted from this requirement. (i) Validation shall...

Validation of Alternatives to Aliphatic Isocyanate Polyurethanes

NASA Technical Reports Server (NTRS)

Curran, Jerome

2007-01-01

The National Aeronautics and Space Administration (NASA) Headquarters chartered the Acquisition Pollution Prevention (AP2) Office to coordinate agency activities affecting pollution prevention issues identified during system and component acquisition and sustainment processes. The primary objective of this effort is to demonstrate and validate alternatives to aliphatic isocyanate polyurethane coatings. Successful completion of this project will result in one or more isocyanate-free coating systems qualified for use at Air Force Space Command (AFSPC) and NASA centers participating in this study. The objective of this project is to qualify the candidates under the specifications for the standard system. This project will compare coating performance of the proposed alternatives to existing coating systems or standards.

A Systematic Review of Validated Methods for Identifying Cerebrovascular Accident or Transient Ischemic Attack Using Administrative Data

PubMed Central

Andrade, Susan E.; Harrold, Leslie R.; Tjia, Jennifer; Cutrona, Sarah L.; Saczynski, Jane S.; Dodd, Katherine S.; Goldberg, Robert J.; Gurwitz, Jerry H.

2012-01-01

Purpose To perform a systematic review of the validity of algorithms for identifying cerebrovascular accidents (CVAs) or transient ischemic attacks (TIAs) using administrative and claims data. Methods PubMed and Iowa Drug Information Service (IDIS) searches of the English language literature were performed to identify studies published between 1990 and 2010 that evaluated the validity of algorithms for identifying CVAs (ischemic and hemorrhagic strokes, intracranial hemorrhage and subarachnoid hemorrhage) and/or TIAs in administrative data. Two study investigators independently reviewed the abstracts and articles to determine relevant studies according to pre-specified criteria. Results A total of 35 articles met the criteria for evaluation. Of these, 26 articles provided data to evaluate the validity of stroke, 7 reported the validity of TIA, 5 reported the validity of intracranial bleeds (intracerebral hemorrhage and subarachnoid hemorrhage), and 10 studies reported the validity of algorithms to identify the composite endpoints of stroke/TIA or cerebrovascular disease. Positive predictive values (PPVs) varied depending on the specific outcomes and algorithms evaluated. Specific algorithms to evaluate the presence of stroke and intracranial bleeds were found to have high PPVs (80% or greater). Algorithms to evaluate TIAs in adult populations were generally found to have PPVs of 70% or greater. Conclusions The algorithms and definitions to identify CVAs and TIAs using administrative and claims data differ greatly in the published literature. The choice of the algorithm employed should be determined by the stroke subtype of interest. PMID:22262598

An extended protocol for usability validation of medical devices: Research design and reference model.

PubMed

Schmettow, Martin; Schnittker, Raphaela; Schraagen, Jan Maarten

2017-05-01

This paper proposes and demonstrates an extended protocol for usability validation testing of medical devices. A review of currently used methods for the usability evaluation of medical devices revealed two main shortcomings. Firstly, the lack of methods to closely trace the interaction sequences and derive performance measures. Secondly, a prevailing focus on cross-sectional validation studies, ignoring the issues of learnability and training. The U.S. Federal Drug and Food Administration's recent proposal for a validation testing protocol for medical devices is then extended to address these shortcomings: (1) a novel process measure 'normative path deviations' is introduced that is useful for both quantitative and qualitative usability studies and (2) a longitudinal, completely within-subject study design is presented that assesses learnability, training effects and allows analysis of diversity of users. A reference regression model is introduced to analyze data from this and similar studies, drawing upon generalized linear mixed-effects models and a Bayesian estimation approach. The extended protocol is implemented and demonstrated in a study comparing a novel syringe infusion pump prototype to an existing design with a sample of 25 healthcare professionals. Strong performance differences between designs were observed with a variety of usability measures, as well as varying training-on-the-job effects. We discuss our findings with regard to validation testing guidelines, reflect on the extensions and discuss the perspectives they add to the validation process. Copyright © 2017 Elsevier Inc. All rights reserved.

Validity of administrative data claim-based methods for identifying individuals with diabetes at a population level.

PubMed

Southern, Danielle A; Roberts, Barbara; Edwards, Alun; Dean, Stafford; Norton, Peter; Svenson, Lawrence W; Larsen, Erik; Sargious, Peter; Lau, David C W; Ghali, William A

2010-01-01

This study assessed the validity of a widely-accepted administrative data surveillance methodology for identifying individuals with diabetes relative to three laboratory data reference standard definitions for diabetes. We used a combination of linked regional data (hospital discharge abstracts and physician data) and laboratory data to test the validity of administrative data surveillance definitions for diabetes relative to a laboratory data reference standard. The administrative discharge data methodology includes two definitions for diabetes: a strict administrative data definition of one hospitalization code or two physician claims indicating diabetes; and a more liberal definition of one hospitalization code or a single physician claim. The laboratory data, meanwhile, produced three reference standard definitions based on glucose levels +/- HbA1c levels. Sensitivities ranged from 68.4% to 86.9% for the administrative data definitions tested relative to the three laboratory data reference standards. Sensitivities were higher for the more liberal administrative data definition. Positive predictive values (PPV), meanwhile, ranged from 53.0% to 88.3%, with the liberal administrative data definition producing lower PPVs. These findings demonstrate the trade-offs of sensitivity and PPV for selecting diabetes surveillance definitions. Centralized laboratory data may be of value to future surveillance initiatives that use combined data sources to optimize case detection.

Research Methods in Healthcare Epidemiology and Antimicrobial Stewardship: Use of Administrative and Surveillance Databases.

PubMed

Drees, Marci; Gerber, Jeffrey S; Morgan, Daniel J; Lee, Grace M

2016-11-01

Administrative and surveillance data are used frequently in healthcare epidemiology and antimicrobial stewardship (HE&AS) research because of their wide availability and efficiency. However, data quality issues exist, requiring careful consideration and potential validation of data. This methods paper presents key considerations for using administrative and surveillance data in HE&AS, including types of data available and potential use, data limitations, and the importance of validation. After discussing these issues, we review examples of HE&AS research using administrative data with a focus on scenarios when their use may be advantageous. A checklist is provided to help aid study development in HE&AS using administrative data. Infect Control Hosp Epidemiol 2016;1-10.

Validity and reliability of the Bahasa Melayu version of the Migraine Disability Assessment questionnaire.

PubMed

Shaik, Munvar Miya; Hassan, Norul Badriah; Tan, Huay Lin; Bhaskar, Shalini; Gan, Siew Hua

2014-01-01

The study was designed to determine the validity and reliability of the Bahasa Melayu version (MIDAS-M) of the Migraine Disability Assessment (MIDAS) questionnaire. Patients having migraine for more than six months attending the Neurology Clinic, Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia, were recruited. Standard forward and back translation procedures were used to translate and adapt the MIDAS questionnaire to produce the Bahasa Melayu version. The translated Malay version was tested for face and content validity. Validity and reliability testing were further conducted with 100 migraine patients (1st administration) followed by a retesting session 21 days later (2nd administration). A total of 100 patients between 15 and 60 years of age were recruited. The majority of the patients were single (66%) and students (46%). Cronbach's alpha values were 0.84 (1st administration) and 0.80 (2nd administration). The test-retest reliability for the total MIDAS score was 0.73, indicating that the MIDAS-M questionnaire is stable; for the five disability questions, the test-retest values ranged from 0.77 to 0.87. The MIDAS-M questionnaire is comparable with the original English version in terms of validity and reliability and may be used for the assessment of migraine in clinical settings.

Validity and Reliability of the Bahasa Melayu Version of the Migraine Disability Assessment Questionnaire

PubMed Central

Shaik, Munvar Miya; Hassan, Norul Badriah; Bhaskar, Shalini; Gan, Siew Hua

2014-01-01

Background. The study was designed to determine the validity and reliability of the Bahasa Melayu version (MIDAS-M) of the Migraine Disability Assessment (MIDAS) questionnaire. Methods. Patients having migraine for more than six months attending the Neurology Clinic, Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia, were recruited. Standard forward and back translation procedures were used to translate and adapt the MIDAS questionnaire to produce the Bahasa Melayu version. The translated Malay version was tested for face and content validity. Validity and reliability testing were further conducted with 100 migraine patients (1st administration) followed by a retesting session 21 days later (2nd administration). Results. A total of 100 patients between 15 and 60 years of age were recruited. The majority of the patients were single (66%) and students (46%). Cronbach's alpha values were 0.84 (1st administration) and 0.80 (2nd administration). The test-retest reliability for the total MIDAS score was 0.73, indicating that the MIDAS-M questionnaire is stable; for the five disability questions, the test-retest values ranged from 0.77 to 0.87. Conclusion. The MIDAS-M questionnaire is comparable with the original English version in terms of validity and reliability and may be used for the assessment of migraine in clinical settings. PMID:25121099

The Team Climate Inventory as a Measure of Primary Care Teams' Processes: Validation of the French Version

PubMed Central

Beaulieu, Marie-Dominique; Dragieva, Nataliya; Del Grande, Claudio; Dawson, Jeremy; Haggerty, Jeannie L.; Barnsley, Jan; Hogg, William E.; Tousignant, Pierre; West, Michael A.

2014-01-01

Purpose: Evaluate the psychometric properties of the French version of the short 19-item Team Climate Inventory (TCI) and explore the contributions of individual and organizational characteristics to perceived team effectiveness. Method: The TCI was completed by 471 of the 618 (76.2%) healthcare professionals and administrative staff working in a random sample of 37 primary care practices in the province of Quebec. Results: Exploratory factor analysis confirmed the original four-factor model. Cronbach's alphas were excellent (from 0.88 to 0.93). Latent class analysis revealed three-class response structure. Respondents in practices with professional governance had a higher probability of belonging to the “High TCI” class than did practices with community governance (36.7% vs. 19.1%). Administrative staff tended to fall into the “Suboptimal TCI” class more frequently than did physicians (36.5% vs. 19.0%). Conclusion: Results confirm the validity of our French version of the short TCI. The association between professional governance and better team climate merits further exploration. PMID:24726073

A validated case definition for chronic rhinosinusitis in administrative data: a Canadian perspective.

PubMed

Rudmik, Luke; Xu, Yuan; Kukec, Edward; Liu, Mingfu; Dean, Stafford; Quan, Hude

2016-11-01

Pharmacoepidemiological research using administrative databases has become increasingly popular for chronic rhinosinusitis (CRS); however, without a validated case definition the cohort evaluated may be inaccurate resulting in biased and incorrect outcomes. The objective of this study was to develop and validate a generalizable administrative database case definition for CRS using International Classification of Diseases, 9th edition (ICD-9)-coded claims. A random sample of 100 patients with a guideline-based diagnosis of CRS and 100 control patients were selected and then linked to a Canadian physician claims database from March 31, 2010, to March 31, 2015. The proportion of CRS ICD-9-coded claims (473.x and 471.x) for each of these 200 patients were reviewed and the validity of 7 different ICD-9-based coding algorithms was evaluated. The CRS case definition of ≥2 claims with a CRS ICD-9 code (471.x or 473.x) within 2 years of the reference case provides a balanced validity with a sensitivity of 77% and specificity of 79%. Applying this CRS case definition to the claims database produced a CRS cohort of 51,000 patients with characteristics that were consistent with published demographics and rates of comorbid asthma, allergic rhinitis, and depression. This study has validated several coding algorithms; based on the results a case definition of ≥2 physician claims of CRS (ICD-9 of 471.x or 473.x) within 2 years provides an optimal level of validity. Future studies will need to validate this administrative case definition from different health system perspectives and using larger retrospective chart reviews from multiple providers. © 2016 ARS-AAOA, LLC.

Validity of peptic ulcer disease and upper gastrointestinal bleeding diagnoses in administrative databases: a systematic review protocol.

PubMed

Montedori, Alessandro; Abraha, Iosief; Chiatti, Carlos; Cozzolino, Francesco; Orso, Massimiliano; Luchetta, Maria Laura; Rimland, Joseph M; Ambrosio, Giuseppe

2016-09-15

Administrative healthcare databases are useful to investigate the epidemiology, health outcomes, quality indicators and healthcare utilisation concerning peptic ulcers and gastrointestinal bleeding, but the databases need to be validated in order to be a reliable source for research. The aim of this protocol is to perform the first systematic review of studies reporting the validation of International Classification of Diseases, 9th Revision and 10th version (ICD-9 and ICD-10) codes for peptic ulcer and upper gastrointestinal bleeding diagnoses. MEDLINE, EMBASE, Web of Science and the Cochrane Library databases will be searched, using appropriate search strategies. We will include validation studies that used administrative data to identify peptic ulcer disease and upper gastrointestinal bleeding diagnoses or studies that evaluated the validity of peptic ulcer and upper gastrointestinal bleeding codes in administrative data. The following inclusion criteria will be used: (a) the presence of a reference standard case definition for the diseases of interest; (b) the presence of at least one test measure (eg, sensitivity, etc) and (c) the use of an administrative database as a source of data. Pairs of reviewers will independently abstract data using standardised forms and will evaluate quality using the checklist of the Standards for Reporting of Diagnostic Accuracy (STARD) criteria. This systematic review protocol has been produced in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocol (PRISMA-P) 2015 statement. Ethics approval is not required given that this is a protocol for a systematic review. We will submit results of this study to a peer-reviewed journal for publication. The results will serve as a guide for researchers validating administrative healthcare databases to determine appropriate case definitions for peptic ulcer disease and upper gastrointestinal bleeding, as well as to perform outcome research using administrative healthcare databases of these conditions. CRD42015029216. 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/

42 CFR 456.655 - Validation of showings.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 4 2013-10-01 2013-10-01 false Validation of showings. 456.655 Section 456.655... Showing of an Effective Institutional Utilization Control Program § 456.655 Validation of showings. (a) The Administrator will periodically validate showings submitted under § 456.654. Validation procedures...

42 CFR 456.655 - Validation of showings.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 4 2012-10-01 2012-10-01 false Validation of showings. 456.655 Section 456.655... Showing of an Effective Institutional Utilization Control Program § 456.655 Validation of showings. (a) The Administrator will periodically validate showings submitted under § 456.654. Validation procedures...

42 CFR 456.655 - Validation of showings.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false Validation of showings. 456.655 Section 456.655... Showing of an Effective Institutional Utilization Control Program § 456.655 Validation of showings. (a) The Administrator will periodically validate showings submitted under § 456.654. Validation procedures...

42 CFR 456.655 - Validation of showings.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 4 2011-10-01 2011-10-01 false Validation of showings. 456.655 Section 456.655... Showing of an Effective Institutional Utilization Control Program § 456.655 Validation of showings. (a) The Administrator will periodically validate showings submitted under § 456.654. Validation procedures...

Development and Validation of an Algorithm to Identify Patients with Multiple Myeloma Using Administrative Claims Data.

PubMed

Princic, Nicole; Gregory, Chris; Willson, Tina; Mahue, Maya; Felici, Diana; Werther, Winifred; Lenhart, Gregory; Foley, Kathleen A

2016-01-01

The objective was to expand on prior work by developing and validating a new algorithm to identify multiple myeloma (MM) patients in administrative claims. Two files were constructed to select MM cases from MarketScan Oncology Electronic Medical Records (EMR) and controls from the MarketScan Primary Care EMR during January 1, 2000-March 31, 2014. Patients were linked to MarketScan claims databases, and files were merged. Eligible cases were age ≥18, had a diagnosis and visit for MM in the Oncology EMR, and were continuously enrolled in claims for ≥90 days preceding and ≥30 days after diagnosis. Controls were age ≥18, had ≥12 months of overlap in claims enrollment (observation period) in the Primary Care EMR and ≥1 claim with an ICD-9-CM diagnosis code of MM (203.0×) during that time. Controls were excluded if they had chemotherapy; stem cell transplant; or text documentation of MM in the EMR during the observation period. A split sample was used to develop and validate algorithms. A maximum of 180 days prior to and following each MM diagnosis was used to identify events in the diagnostic process. Of 20 algorithms explored, the baseline algorithm of 2 MM diagnoses and the 3 best performing were validated. Values for sensitivity, specificity, and positive predictive value (PPV) were calculated. Three claims-based algorithms were validated with ~10% improvement in PPV (87-94%) over prior work (81%) and the baseline algorithm (76%) and can be considered for future research. Consistent with prior work, it was found that MM diagnoses before and after tests were needed.

Cross-cultural adaptation of the Oral Health Impact Profile (OHIP) for the Malaysian adult population.

PubMed

Saub, R; Locker, D; Allison, P; Disman, M

2007-09-01

The aim of this project was to develop an oral health related-quality of life measure for the Malaysian adult population aged 18 and above by the cross-cultural adaption the Oral Health Impact Profile (OHIP). The adaptation of the OHIP was based on the framework proposed by Herdman et al (1998). The OHIP was translated into the Malay language using a forward-backward translation technique. Thirty-six patients were interviewed to assess the conceptual equivalence and relevancy of each item. Based on the translation process and interview results a Malaysian version of the OHIP questionnaire was produced that contained 45 items. It was designated as the OHIP(M). This questionnaire was pre-tested on 20 patients to assess its face validity. A short 14-item version of the questionnaire was completed by 171 patients to assess the suitability of the Likert-type response format. Field-testing was conducted in order to assess the suitability of two modes of administration (mail and interview) and to establish the psychometric properties of the adapted measure. The pre-testing revealed that the OHIP(M) has good face validity. It was found that the five-point frequency Likert scale could be used for the Malaysian population. The OHIP(M) was reliable, where the scale Cronbach's alpha was 0.95 and the ICC value for test-retest reliability was 0.79. Three out four construct validity hypotheses tested were confirmed. OHIP(M) works equally well as the English version. OHIP(M) was found to be reliable and valid regardless of the mode of administration. However, this study only provides initial evidence for the reliability and validity of the measure. Further study is recommended to collect more evidence to support these results.

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.

Multidisciplinary strategy to reduce errors with the use of medical gases.

PubMed

Amor-García, Miguel Ángel; Ibáñez-García, Sara; Díaz-Redondo, Alicia; Herranz Alonso, Ana; Sanjurjo Sáez, María

2018-05-01

Lack of awareness of the risks associated with the use of medical  gases amongst health professionals and health organizations is concerning. The  objective of this study is to redefine the use process of medical gases in a  hospital setting. A sentinel event took place in a clinical unit, the incorrect administration of a medical gas to an inpatient. A multidisciplinary  causeroot analysis of the sentinel event was carried out. Different improvement points were identified for each error detected and so we defined a  good strategy to ensure the safe use of these drugs. 9 errors were identified and the following improvement actions were  defined: storage (gases of clinical use were separated from those of industrial  use and proper identification signs were placed), prescription (6 protocols were  included in the hospital´s Computerized Physician Order Entry software),  validation (pharmacist validation of the prescription to ensure appropriate use of  these), dispensation (a new protocol for medical gases dispensation and  transportation was designed and implemented) and administration (information  on the pressure gauges used for each type of gas was collected and reviewed).  72 Signs with recommendations for medical gases identification and  administration were placed in all the clinical units. Specific training on the safe  use of medical gases and general safety training was imparted. The implementation of a process that integrates all phases of use  of medical gases and applies to all professionals involved is presented here as a  strategy to increase safety in the use of these medicines. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Developing a Scale for Innovation Management at Schools: A Study of Validity and Reliability

ERIC Educational Resources Information Center

Bulbul, Tuncer

2012-01-01

The purpose of this study is to develop a valid and reliable assessment tool for use in determining the competency beliefs of school administrators about innovation management. The scale applied to a study group of 216 school administrators, after work Centered on assessing intelligibility and specialized opinion. Exploratory and confirmatory…

A systematic review of validated methods to capture acute bronchospasm using administrative or claims data.

PubMed

Sharifi, Mona; Krishanswami, Shanthi; McPheeters, Melissa L

2013-12-30

To identify and assess billing, procedural, or diagnosis code, or pharmacy claim-based algorithms used to identify acute bronchospasm in administrative and claims databases. We searched the MEDLINE database from 1991 to September 2012 using controlled vocabulary and key terms related to bronchospasm, wheeze and acute asthma. We also searched the reference lists of included studies. Two investigators independently assessed the full text of studies against pre-determined inclusion criteria. Two reviewers independently extracted data regarding participant and algorithm characteristics. Our searches identified 677 citations of which 38 met our inclusion criteria. In these 38 studies, the most commonly used ICD-9 code was 493.x. Only 3 studies reported any validation methods for the identification of bronchospasm, wheeze or acute asthma in administrative and claims databases; all were among pediatric populations and only 2 offered any validation statistics. Some of the outcome definitions utilized were heterogeneous and included other disease based diagnoses, such as bronchiolitis and pneumonia, which are typically of an infectious etiology. One study offered the validation of algorithms utilizing Emergency Department triage chief complaint codes to diagnose acute asthma exacerbations with ICD-9 786.07 (wheezing) revealing the highest sensitivity (56%), specificity (97%), PPV (93.5%) and NPV (76%). There is a paucity of studies reporting rigorous methods to validate algorithms for the identification of bronchospasm in administrative data. The scant validated data available are limited in their generalizability to broad-based populations. Copyright © 2013 Elsevier Ltd. All rights reserved.

Automatic address validation and health record review to identify homeless Social Security disability applicants.

PubMed

Erickson, Jennifer; Abbott, Kenneth; Susienka, Lucinda

2018-06-01

Homeless patients face a variety of obstacles in pursuit of basic social services. Acknowledging this, the Social Security Administration directs employees to prioritize homeless patients and handle their disability claims with special care. However, under existing manual processes for identification of homelessness, many homeless patients never receive the special service to which they are entitled. In this paper, we explore address validation and automatic annotation of electronic health records to improve identification of homeless patients. We developed a sample of claims containing medical records at the moment of arrival in a single office. Using address validation software, we reconciled patient addresses with public directories of homeless shelters, veterans' hospitals and clinics, and correctional facilities. Other tools annotated electronic health records. We trained random forests to identify homeless patients and validated each model with 10-fold cross validation. For our finished model, the area under the receiver operating characteristic curve was 0.942. The random forest improved sensitivity from 0.067 to 0.879 but decreased positive predictive value to 0.382. Presumed false positive classifications bore many characteristics of homelessness. Organizations could use these methods to prompt early collection of information necessary to avoid labor-intensive attempts to reestablish contact with homeless individuals. Annually, such methods could benefit tens of thousands of patients who are homeless, destitute, and in urgent need of assistance. We were able to identify many more homeless patients through a combination of automatic address validation and natural language processing of unstructured electronic health records. Copyright © 2018. Published by Elsevier Inc.

Assessing self-care and social function using a computer adaptive testing version of the pediatric evaluation of disability inventory.

PubMed

Coster, Wendy J; Haley, Stephen M; Ni, Pengsheng; Dumas, Helene M; Fragala-Pinkham, Maria A

2008-04-01

To examine score agreement, validity, precision, and response burden of a prototype computer adaptive testing (CAT) version of the self-care and social function scales of the Pediatric Evaluation of Disability Inventory compared with the full-length version of these scales. Computer simulation analysis of cross-sectional and longitudinal retrospective data; cross-sectional prospective study. Pediatric rehabilitation hospital, including inpatient acute rehabilitation, day school program, outpatient clinics; community-based day care, preschool, and children's homes. Children with disabilities (n=469) and 412 children with no disabilities (analytic sample); 38 children with disabilities and 35 children without disabilities (cross-validation sample). Not applicable. Summary scores from prototype CAT applications of each scale using 15-, 10-, and 5-item stopping rules; scores from the full-length self-care and social function scales; time (in seconds) to complete assessments and respondent ratings of burden. Scores from both computer simulations and field administration of the prototype CATs were highly consistent with scores from full-length administration (r range, .94-.99). Using computer simulation of retrospective data, discriminant validity, and sensitivity to change of the CATs closely approximated that of the full-length scales, especially when the 15- and 10-item stopping rules were applied. In the cross-validation study the time to administer both CATs was 4 minutes, compared with over 16 minutes to complete the full-length scales. Self-care and social function score estimates from CAT administration are highly comparable with those obtained from full-length scale administration, with small losses in validity and precision and substantial decreases in administration time.

VALIDATION OF ANALYTICAL METHODS AND INSTRUMENTATION FOR BERYLLIUM MEASUREMENT: REVIEW AND SUMMARY OF AVAILABLE GUIDES, PROCEDURES, AND PROTOCOLS

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

Ekechukwu, A

Method validation is the process of evaluating whether an analytical method is acceptable for its intended purpose. For pharmaceutical methods, guidelines from the United States Pharmacopeia (USP), International Conference on Harmonisation (ICH), and the United States Food and Drug Administration (USFDA) provide a framework for performing such valications. In general, methods for regulatory compliance must include studies on specificity, linearity, accuracy, precision, range, detection limit, quantitation limit, and robustness. Elements of these guidelines are readily adapted to the issue of validation for beryllium sampling and analysis. This document provides a listing of available sources which can be used to validatemore » analytical methods and/or instrumentation for beryllium determination. A literature review was conducted of available standard methods and publications used for method validation and/or quality control. A comprehensive listing of the articles, papers and books reviewed is given in the Appendix. Available validation documents and guides are listed therein; each has a brief description of application and use. In the referenced sources, there are varying approches to validation and varying descriptions of the valication process at different stages in method development. This discussion focuses on valication and verification of fully developed methods and instrumentation that have been offered up for use or approval by other laboratories or official consensus bodies such as ASTM International, the International Standards Organization (ISO) and the Association of Official Analytical Chemists (AOAC). This review was conducted as part of a collaborative effort to investigate and improve the state of validation for measuring beryllium in the workplace and the environment. Documents and publications from the United States and Europe are included. Unless otherwise specified, all referenced documents were published in English.« less

Simultaneous determination of paeoniflorin, albiflorin, ferulic acid, tetrahydropalmatine, protopine, typhaneoside, senkyunolide I in Beagle dogs plasma by UPLC-MS/MS and its application to a pharmacokinetic study after Oral Administration of Shaofu Zhuyu Decoction.

PubMed

Huang, Xiaochen; Su, Shulan; Cui, Wenxia; Liu, Pei; Duan, Jin-ao; Guo, Jianming; Li, Zhenhao; Shang, Erxin; Qian, Dawei; Huang, Zhijun

2014-07-01

In this present study, a sensitive and rapid UPLC-MS/MS method was developed for simultaneous quantification of paeoniflorin, albiflorin, ferulic acid, tetrahydropalmatine, protopine, typhaneoside and senkyunolide I in Beagle dog plasma after oral administration of the Shao-Fu-Zhu-Yu Decoction. Chloramphenicol and clarithromycin were used as internal standards. Plasma samples were processed by protein precipitation with methanol. The separation was performed on an Acquity BEH C18 column (100mm×2.1mm, 1.7μm) at a flow-rate of 0.4mL/min, using 0.1% formic acid-acetonitrile as mobile phase. Method validation was performed as per Food and Drug Administration guidelines and the results met the acceptance criteria. After validation, this method was successfully applied to a pharmacokinetic study. The results showed that the apparent plasma clearance of paeoniflorin, albiflorin, typhaneoside and senkyunolide I were significantly higher than others. Double peak was observed in plasma concentration curves of tetrahydropalmatine, the ferulic acid had a good absorption in Beagle dog plasma, and senkyunolide I was detected in plasma from the first blood sampling time (15min) and rapidly reached Tmax. The compound of typhaneoside has a low bioavailability according to the results. Copyright © 2014. Published by Elsevier B.V.

Post eLetter Solutions: Healthy Results for Improving Patient Communication Processes at the Royal Hobart Hospital.

PubMed

Boulter, Rhonda

2009-06-01

The primary objective of the Australia Post eLetter project 1 was to determine the feasibility of using the eLetter service with the Patient Administration System Appointment Scheduling Module to provide a fully automated mailing function that would eliminate the need for manual processing of mail delivery. Issues with timely delivery of letters throughout all outpatient sites at the Royal Hobart Hospital (RHH) have been identified as being mainly due to limited human resources being available to perform mailing duties and the like. This new desktop service enables staff to transmit data electronically in conjunction with the appointment software for large quantity mail postings to Australia Post via a secure line. Australia Post then validates the address, appends a barcode, prints the letter, envelopes it and inserts it into the mail distribution network in the state of the recipient. This article depicts the process that has eliminated the manual processing of a letter via the traditional Microsoft application, Wordmate, a system at RHH that was always difficult to use. With the introduction of eLetter, the RHH's Specialist Clinics have significantly improved the timeliness and quality of communication with patients as well as reducing administration tasks for staff.

Interlaboratory validation of an improved U.S. Food and Drug Administration method for detection of Cyclospora cayetanensis in produce using TaqMan real-time PCR

USDA-ARS?s Scientific Manuscript database

A collaborative validation study was performed to evaluate the performance of a new U.S. Food and Drug Administration method developed for detection of the protozoan parasite, Cyclospora cayetanensis, on cilantro and raspberries. The method includes a sample preparation step in which oocysts are re...

Analysis of the Federal Aviation Administration’s Host Computer Acquisition Process and Potential Application in Department of Defense Acquisitions

DTIC Science & Technology

1988-09-01

defense programs lost far more to inefficient procedures than to fraud and dishonesty * (President’s Commission, l986c:15). Based on the Commission...recommendations from current studies, lessons learned from a successful program, and DOD expert opinions to develop an acquisition management strategy that...established for the alternative(s) selected in the preceding phase. 5. In the concept demonstration/validation phase the technical risk and economic

Joint Test Protocol for Validation of Alternative Low-Emission Surface Preparation/Depainting Technologies for Structural Steel

NASA Technical Reports Server (NTRS)

Lewis, Pattie

2005-01-01

Headquarters National Aeronautics and Space Administration (NASA) chartered the Acquisition Pollution Prevention (AP2) Office to coordinate agency activities affecting pollution prevention issues identified during system and component acquisition and sustainment processes. The primary objectives of the AP2 Office are to: (1) Reduce or eliminate the use of hazardous materials (HazMats) or hazardous processes at manufacturing, remanufacturing, and sustainment locations. (2) A void duplication of effort in actions required to reduce or eliminate HazMats through joint center cooperation and technology sharing. This project will identify, evaluate and approve alternative surface preparation technologies for use at NASA and Air Force Space Command (AFSPC) installations. Materials and processes will be evaluated with the goal of selecting those processes that will improve corrosion protection at critical systems, facilitate easier maintenance activity, extend maintenance cycles, eliminate flight hardware contamination and reduce the amount of hazardous waste generated. This Joint Test Protocol (JTP) contains the critical requirements and tests necessary to qualify alternative Low-Emission Surface Preparation/Depainting Technologies for Structural Steel Applications. These tests were derived from engineering, performance, and operational impact (supportability) requirements defined by a consensus of NASA and Air Force Space Command (AFSPC) participants. The Field Test Plan (FTP), entitled Joint Test Protocol for Validation of Alternative Low Emission Surface Preparation/Depainting Technologies for Structural Steel, prepared by ITB, defines the field evaluation and testing requirements for validating alternative surface preparation/depainting technologies and supplements the JTP.

Validation of the Female Sexual Function Index (FSFI) for web-based administration.

PubMed

Crisp, Catrina C; Fellner, Angela N; Pauls, Rachel N

2015-02-01

Web-based questionnaires are becoming increasingly valuable for clinical research. The Female Sexual Function Index (FSFI) is the gold standard for evaluating female sexual function; yet, it has not been validated in this format. We sought to validate the Female Sexual Function Index (FSFI) for web-based administration. Subjects enrolled in a web-based research survey of sexual function from the general population were invited to participate in this validation study. The first 151 respondents were included. Validation participants completed the web-based version of the FSFI followed by a mailed paper-based version. Demographic data were collected for all subjects. Scores were compared using the paired t test and the intraclass correlation coefficient. One hundred fifty-one subjects completed both web- and paper-based versions of the FSFI. Those subjects participating in the validation study did not differ in demographics or FSFI scores from the remaining subjects in the general population study. Total web-based and paper-based FSFI scores were not significantly different (mean 20.31 and 20.29 respectively, p = 0.931). The six domains or subscales of the FSFI were similar when comparing web and paper scores. Finally, intraclass correlation analysis revealed a high degree of correlation between total and subscale scores, r = 0.848-0.943, p < 0.001. Web-based administration of the FSFI is a valid alternative to the paper-based version.

Brief International Cognitive Assessment for MS (BICAMS): international standards for validation.

PubMed

Benedict, Ralph H B; Amato, Maria Pia; Boringa, Jan; Brochet, Bruno; Foley, Fred; Fredrikson, Stan; Hamalainen, Paivi; Hartung, Hans; Krupp, Lauren; Penner, Iris; Reder, Anthony T; Langdon, Dawn

2012-07-16

An international expert consensus committee recently recommended a brief battery of tests for cognitive evaluation in multiple sclerosis. The Brief International Cognitive Assessment for MS (BICAMS) battery includes tests of mental processing speed and memory. Recognizing that resources for validation will vary internationally, the committee identified validation priorities, to facilitate international acceptance of BICAMS. Practical matters pertaining to implementation across different languages and countries were discussed. Five steps to achieve optimal psychometric validation were proposed. In Step 1, test stimuli should be standardized for the target culture or language under consideration. In Step 2, examiner instructions must be standardized and translated, including all information from manuals necessary for administration and interpretation. In Step 3, samples of at least 65 healthy persons should be studied for normalization, matched to patients on demographics such as age, gender and education. The objective of Step 4 is test-retest reliability, which can be investigated in a small sample of MS and/or healthy volunteers over 1-3 weeks. Finally, in Step 5, criterion validity should be established by comparing MS and healthy controls. At this time, preliminary studies are underway in a number of countries as we move forward with this international assessment tool for cognition in MS.

ARM Radiosondes for National Polar-Orbiting Operational Environmental Satellite System Preparatory Project Validation Field Campaign Report

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

Borg, Lori; Tobin, David; Reale, Anthony

This IOP has been a coordinated effort involving the U.S. Department of Energy (DOE) Atmospheric Radiation (ARM) Climate Research Facility, the University of Wisconsin (UW)-Madison, and the JPSS project to validate SNPP NOAA Unique Combined Atmospheric Processing System (NUCAPS) temperature and moisture sounding products from the Cross-track Infrared Sounder (CrIS) and the Advanced Technology Microwave Sounder (ATMS). In this arrangement, funding for radiosondes was provided by the JPSS project to ARM. These radiosondes were launched coincident with the SNPP satellite overpasses (OP) at four of the ARM field sites beginning in July 2012 and running through September 2017. Combined withmore » other ARM data, an assessment of the radiosonde data quality was performed and post-processing corrections applied producing an ARM site Best Estimate (BE) product. The SNPP targeted radiosondes were integrated into the NOAA Products Validation System (NPROVS+) system, which collocated the radiosondes with satellite products (NOAA, National Aeronautics and Space Administration [NASA], European Organisation for the Exploitation of Meteorological Satellites [EUMETSAT], Geostationary Operational Environmental Satellite [GOES], Constellation Observing System for Meteorology, Ionosphere, and Climate [COSMIC]) and Numerical Weather Prediction (NWP forecasts for use in product assessment and algorithm development. This work was a fundamental, integral, and cost-effective part of the SNPP validation effort and provided critical accuracy assessments of the SNPP temperature and water vapor soundings.« less

Experimental study of tensile strength of pharmaceutical tablets: effect of the diluent nature and compression pressure

NASA Astrophysics Data System (ADS)

Juban, Audrey; Briançon, Stéphanie; Puel, François; Hoc, Thierry; Nouguier-Lehon, Cécile

2017-06-01

In the pharmaceutical field, tablets are the most common dosage form for oral administration in the world. Among different manufacturing processes, direct compression is widely used because of its economics interest and it is a process which avoids the steps of wet granulation and drying processes. Tablets are composed of at least two ingredients: an active pharmaceutical ingredient (API) which is mixed with a diluent. The nature of the powders and the processing conditions are crucial for the properties of the blend and, consequently, strongly influence the mechanical characteristics of tablets. Moreover, tablets have to present a suitable mechanical strength to avoid crumbling or breaking when handling, while ensuring an appropriate disintegration after administration. Accordingly, this mechanical property is an essential parameter to consider. Experimental results showed that proportion of the diluent, fragmentary (DCPA) or plastic (MCC), had a large influence on the tensile strength evolution with API content as well as the compression load applied during tableting process. From these results a model was developed in order to predict the tensile strength of binary tablets by knowing the compression pressure. The validity of this model was demonstrated for the two studied systems and a comparison was made with two existing models.

42 CFR 456.655 - Validation of showings.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Administrator will not find an agency's showing satisfactory if the information obtained through his validation... 42 Public Health 4 2010-10-01 2010-10-01 false Validation of showings. 456.655 Section 456.655... Showing of an Effective Institutional Utilization Control Program § 456.655 Validation of showings. (a...

Assessing self-care and social function using a computer adaptive testing version of the Pediatric Evaluation of Disability Inventory Accepted for Publication, Archives of Physical Medicine and Rehabilitation

PubMed Central

Coster, Wendy J.; Haley, Stephen M.; Ni, Pengsheng; Dumas, Helene M.; Fragala-Pinkham, Maria A.

2009-01-01

Objective To examine score agreement, validity, precision, and response burden of a prototype computer adaptive testing (CAT) version of the Self-Care and Social Function scales of the Pediatric Evaluation of Disability Inventory (PEDI) compared to the full-length version of these scales. Design Computer simulation analysis of cross-sectional and longitudinal retrospective data; cross-sectional prospective study. Settings Pediatric rehabilitation hospital, including inpatient acute rehabilitation, day school program, outpatient clinics; community-based day care, preschool, and children’s homes. Participants Four hundred sixty-nine children with disabilities and 412 children with no disabilities (analytic sample); 38 children with disabilities and 35 children without disabilities (cross-validation sample). Interventions Not applicable. Main Outcome Measures Summary scores from prototype CAT applications of each scale using 15-, 10-, and 5-item stopping rules; scores from the full-length Self-Care and Social Function scales; time (in seconds) to complete assessments and respondent ratings of burden. Results Scores from both computer simulations and field administration of the prototype CATs were highly consistent with scores from full-length administration (all r’s between .94 and .99). Using computer simulation of retrospective data, discriminant validity and sensitivity to change of the CATs closely approximated that of the full-length scales, especially when the 15- and 10-item stopping rules were applied. In the cross-validation study the time to administer both CATs was 4 minutes, compared to over 16 minutes to complete the full-length scales. Conclusions Self-care and Social Function score estimates from CAT administration are highly comparable to those obtained from full-length scale administration, with small losses in validity and precision and substantial decreases in administration time. PMID:18373991

QA/QC in the laboratory

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

Hood, F.C.

1992-05-01

Quality assurance and quality control (QA/QC) of analytical chemistry laboratory activities are essential to the validity and usefulness of resultant data. However, in themselves, conventional QA/QC measures will not always ensure that fraudulent data are not generated. Conventional QA/QC measures are based on the assumption that work will be done in good faith; to assure against fraudulent practices, QA/QC measures must be tailored to specific analyses protocols in anticipation of intentional misapplication of those protocols. Application of specific QA/QC measures to ensure against fraudulent practices result in an increased administrative burden being placed on the analytical process; accordingly, in keepingmore » with graded QA philosophy, data quality objectives must be used to identify specific points of concern for special control to minimize the administrative impact.« less

QA/QC in the laboratory. Session F

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

Hood, F.C.

1992-05-01

Quality assurance and quality control (QA/QC) of analytical chemistry laboratory activities are essential to the validity and usefulness of resultant data. However, in themselves, conventional QA/QC measures will not always ensure that fraudulent data are not generated. Conventional QA/QC measures are based on the assumption that work will be done in good faith; to assure against fraudulent practices, QA/QC measures must be tailored to specific analyses protocols in anticipation of intentional misapplication of those protocols. Application of specific QA/QC measures to ensure against fraudulent practices result in an increased administrative burden being placed on the analytical process; accordingly, in keepingmore » with graded QA philosophy, data quality objectives must be used to identify specific points of concern for special control to minimize the administrative impact.« less

Assessment of substance abuse liability in rodents: self-administration, drug discrimination, and locomotor sensitization.

PubMed

Paterson, Neil E

2012-09-01

Assessing abuse liability is a crucial step in the development of a novel chemical entity (NCE) with central nervous system (CNS) activity or with chemical or pharmacological properties in common with known abused substances. Rodent assessment of abuse liability is highly attractive due to its relatively low cost and high predictive validity. Described in this unit are three rodent assays commonly used to provide data on the potential for abuse liability based on the acute effects of NCEs: specifically, self-administration, drug discrimination, and locomotor sensitization. As these assays provide insight into the potential abuse liability of NCEs as well as in vivo pharmacological mechanism(s) of action, they should form a key part of the development process for novel therapeutics aimed at treating CNS disorders.

Validation of a Best-Fit Pharmacokinetic Model for Scopolamine Disposition after Intranasal Administration

NASA Technical Reports Server (NTRS)

Wu, L.; Chow, D. S-L.; Tam, V.; Putcha, L.

2015-01-01

An intranasal gel formulation of scopolamine (INSCOP) was developed for the treatment of Motion Sickness. Bioavailability and pharmacokinetics (PK) were determined per Investigative New Drug (IND) evaluation guidance by the Food and Drug Administration. Earlier, we reported the development of a PK model that can predict the relationship between plasma, saliva and urinary scopolamine (SCOP) concentrations using data collected from an IND clinical trial with INSCOP. This data analysis project is designed to validate the reported best fit PK model for SCOP by comparing observed and model predicted SCOP concentration-time profiles after administration of INSCOP.

Measuring Work Values of Public School Administrators.

ERIC Educational Resources Information Center

Hales, Loyde W.; Waggoner, Jacqueline

This paper presents the results of research investigating (1) the reliability and validity of the Ohio Work Values Inventory (OWVI) when used with public school administrators; (2) the work values of public school administrators; (3) differences in work values of male and female administrators; and (4) differences in work values of individuals at…

78 FR 5866 - Pipeline Safety: Annual Reports and Validation

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-28

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket ID PHMSA-2012-0319] Pipeline Safety: Annual Reports and Validation AGENCY: Pipeline and Hazardous Materials... 2012 gas transmission and gathering annual reports, remind pipeline owners and operators to validate...

28 CFR 25.5 - Validation and data integrity of records in the system.

Code of Federal Regulations, 2010 CFR

2010-07-01

... INFORMATION SYSTEMS The National Instant Criminal Background Check System § 25.5 Validation and data integrity... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Validation and data integrity of records... verify that the information provided to the NICS Index remains valid and correct. (b) Each data source...

Integrated analysis of long noncoding RNA and mRNA profiling ox-LDL-induced endothelial dysfunction after atorvastatin administration.

PubMed

Jiang, Ling-Yu; Jiang, Yue-Hua; Qi, Ying-Zi; Shao, Lin-Lin; Yang, Chuan-Hua

2018-06-01

Long noncoding RNAs (lncRNAs) play a key role in the development of endothelial dysfunction. However, few lncRNAs associated with endothelial dysfunction after atorvastatin administration have been reported. In the present study, differentially expressed (DE) genes in ox-LDL versus control and ox-LDL + atorvastatin versus control were detected. Bioinformatics analysis and integrated analysis of mRNAs and lncRNAs were conducted to study the mechanisms of endothelial dysfunction after atorvastatin administration and to explore the regulation functions of lncRNAs. Here, 532 DE mRNAs and 532 DE lncRNAs were identified (among them, 195 mRNAs and 298 lncRNAs were upregulated, 337 mRNAs and 234 lncRNAs were downregulated) after ox-LDL treatment for 24 hours (fold change ≥2.0, P < .05). After ox-LDL treatment following atorvastatin administration, 750 DE mRNAs and 502 DE lncRNAs were identified (among them, 149 mRNAs and 218 lncRNAs were upregulated and 601 mRNAs and 284 lncRNAs were downregulated). After atorvastatin administration, 167 lncRNAs and 262 mRNAs were still DE. Q-PCR validated the results of microarrays. Chronic inflammatory response, nitric oxide biosynthetic process, microtubule cytoskeleton, cell proliferation and cell migration are regulated by lncRNAs, which also participated in the mainly molecular function and biological processes underlying endothelial dysfunction. Atorvastatin partly improved endothelial dysfunction, but the aspects beyond recovery were mainly concentrated in cell cycle, mitosis, and metabolism. Further exploration is required to explicit the mechanism by which lncRNAs participate in endothelial dysfunction.

Validation of the early childhood attitude toward women in science scale (ECWiSS): A pilot administration

NASA Astrophysics Data System (ADS)

Mulkey, Lynn M.

The intention of this research was to measure attitudes of young children toward women scientists. A 27-item instrument, the Early Childhood Women in Science Scale (ECWiSS) was validated in a test case of the proposition that differential socialization predicts entry into the scientific talent pool. Estimates of internal consistency indicated that the scale is highly reliable. Known groups and correlates procedures, employed to determine the validity of the instrument, revealed that the scale is able to discriminate significant differences between groups and distinguishes three dimensions of attitude (role-specific self-concept, home-related sex-role conflict, and work-related sex-role conflict). Results of the analyses also confirmed the anticipated pattern of correlations with measures of another construct. The findings suggest the utility of the ECWiSS for measurement of early childhood attitudes in models of the ascriptive and/or meritocratic processes affecting recruitment to science and more generally in program and curriculum evaluation where attitude toward women in science is the construct of interest.

Complete Versus Staged Repair for Neonates With Tetralogy of Fallot: Establishment and Validation of a Cohort of 2235 Patients Using Detailed Surgery Sequence Review of Health Care Administrative Data.

PubMed

Savla, Jill J; Fisher, Brian T; Faerber, Jennifer A; Huang, Yuan-Shung V; Mercer-Rosa, Laura

2017-12-12

The surgical strategy for neonates with tetralogy of Fallot (TOF) consists of complete or staged repair. Assessing the comparative effectiveness of these approaches is facilitated by a large multicenter cohort. We propose a novel process for cohort assembly using the Pediatric Health Information System (PHIS), an administrative database that contains clinical and billing data for inpatient and emergency department stays from tertiary children's hospitals. A 4-step process was used to identify neonates with TOF: (1) screen neonates in PHIS with International Classification of Diseases-9 (ICD-9) diagnosis or procedure codes for TOF; (2) include patients with TOF procedures before 30 days of age; (3) exclude patients with missing 2-year follow-up data; (4) analyze patients' 2-year surgery sequence patterns, exclude patients inconsistent with a treatment strategy for TOF, and designate patients as complete or staged repair. Manual chart review at 1 PHIS center was performed to validate this process. Between January 2004 and March 2015, 5862 patients were identified in step 1. Step 2 of cohort assembly excluded 3425 patients (58%); step 3 excluded 148 patients (3%); and step 4 excluded 54 patients (1%). The final cohort consisted of 2235 neonates with TOF from 45 hospitals. Manual chart review of 336 patients showed a positive predictive value for accurate PHIS identification of 44% after step 1 and 97% after step 4. This systematic cohort identification algorithm resulted in a high positive predictive value to appropriately categorize patients. This carefully assembled cohort offers a unique opportunity for future studies in neonatal TOF outcomes.

Validating abortion procedure coding in Canadian administrative databases.

PubMed

Samiedaluie, Saied; Peterson, Sandra; Brant, Rollin; Kaczorowski, Janusz; Norman, Wendy V

2016-07-12

The British Columbia (BC) Ministry of Health collects abortion procedure data in the Medical Services Plan (MSP) physician billings database and in the hospital information Discharge Abstracts Database (DAD). Our study seeks to validate abortion procedure coding in these databases. Two randomized controlled trials enrolled a cohort of 1031 women undergoing abortion. The researcher collected database includes both enrollment and follow up chart review data. The study cohort was linked to MSP and DAD data to identify all abortions events captured in the administrative databases. We compared clinical chart data on abortion procedures with health administrative data. We considered a match to occur if an abortion related code was found in administrative data within 30 days of the date of the same event documented in a clinical chart. Among 1158 abortion events performed during enrollment and follow-up period, 99.1 % were found in at least one of the administrative data sources. The sensitivities for the two databases, evaluated using a gold standard, were 97.7 % (95 % confidence interval (CI): 96.6-98.5) for the MSP database and 91.9 % (95 % CI: 90.0-93.4) for the DAD. Abortion events coded in the BC health administrative databases are highly accurate. Single-payer health administrative databases at the provincial level in Canada have the potential to offer valid data reflecting abortion events. ClinicalTrials.gov Identifier NCT01174225 , Current Controlled Trials ISRCTN19506752 .

The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore

PubMed Central

Mashaki Ceyhan, Emel; Gürsöz, Hakki; Alkan, Ali; Coşkun, Hacer; Koyuncu, Oğuzhan; Walker, Stuart

2018-01-01

Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK) with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP) in order to facilitate the TITCK progress toward agency goals. Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australia's Therapeutic Goods Administration (TGA), Health Canada, Singapore's Health Science Authority (HSA), and the Saudi Arabia Food and Drug Administration (SFDA). Results: The TITCK performs a full review for all new active substance (NAS) applications. Submission of a Certificate of Pharmaceutical product (CPP) with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agency's overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized. Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP) process by sharing GMP inspection outcomes and certificates issued by other authorities, thus avoiding the delays by the current process; removing the requirement for prior approval or CPP; introducing shared or joint reviews with other similar regulatory authorities; formally implementing and monitoring GRevP; defining target timing for each review milestone; redefining the pricing process; and improving transparency by developing publicly available summaries for the basis of approval. PMID:29422861

The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore.

PubMed

Mashaki Ceyhan, Emel; Gürsöz, Hakki; Alkan, Ali; Coşkun, Hacer; Koyuncu, Oğuzhan; Walker, Stuart

2018-01-01

Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK) with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP) in order to facilitate the TITCK progress toward agency goals. Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australia's Therapeutic Goods Administration (TGA), Health Canada, Singapore's Health Science Authority (HSA), and the Saudi Arabia Food and Drug Administration (SFDA). Results: The TITCK performs a full review for all new active substance (NAS) applications. Submission of a Certificate of Pharmaceutical product (CPP) with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agency's overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized. Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP) process by sharing GMP inspection outcomes and certificates issued by other authorities, thus avoiding the delays by the current process; removing the requirement for prior approval or CPP; introducing shared or joint reviews with other similar regulatory authorities; formally implementing and monitoring GRevP; defining target timing for each review milestone; redefining the pricing process; and improving transparency by developing publicly available summaries for the basis of approval.

Implementation of a Medication Reconciliation Assistive Technology: A Qualitative Analysis

PubMed Central

Wright, Theodore B.; Adams, Kathleen; Church, Victoria L.; Ferraro, Mimi; Ragland, Scott; Sayers, Anthony; Tallett, Stephanie; Lovejoy, Travis; Ash, Joan; Holahan, Patricia J.; Lesselroth, Blake J.

2017-01-01

Objective: To aid the implementation of a medication reconciliation process within a hybrid primary-specialty care setting by using qualitative techniques to describe the climate of implementation and provide guidance for future projects. Methods: Guided by McMullen et al’s Rapid Assessment Process1, we performed semi-structured interviews prior to and iteratively throughout the implementation. Interviews were coded and analyzed using grounded theory2 and cross-examined for validity. Results: We identified five barriers and five facilitators that impacted the implementation. Facilitators identified were process alignment with user values, and motivation and clinical champions fostered by the implementation team rather than the administration. Barriers included a perceived limited capacity for change, diverging priorities, and inconsistencies in process standards and role definitions. Discussion: A more complete, qualitative understanding of existing barriers and facilitators helps to guide critical decisions on the design and implementation of a successful medication reconciliation process. PMID:29854251

Development and validation of an instrument to evaluate science teachers' assessment beliefs and practices

NASA Astrophysics Data System (ADS)

Genc, Evrim

The primary purpose of this study was to develop a valid and reliable instrument to examine science teachers' assessment beliefs and practices in science classrooms. The present study also investigated the relationship between teachers' beliefs and practices in terms of assessment issues in science, their perceptions of the factors that influenced their assessment practices and their feelings towards high-stakes testing. The participants of the study were 408 science teachers teaching at middle and high school levels in the State of Florida. Data were collected through two modes of administration of the instrument as a paper-and-pencil and a web-based form. The response rate for paper-and-pencil administration was estimated as 68% whereas the response for the web administration was found to be 27%. Results from the various dimensions of validity and reliability analyses revealed that the 24 item-four-factor belief and practice measures were psychometrically sound and conceptually anchored measures of science teachers' assessment beliefs and self-reported practices. Reliability estimates for the belief measure ranged from .83 to .91 whereas alpha values for the practice measure ranged from .56 to .90. Results from the multigroup analysis supported that the instrument has the same theoretical structure across both administration groups. Therefore, future researchers may use either a paper-and-pencil or web-based format of the instrument. This study underscored a discrepancy between what teachers believe and how they act in classroom settings. It was emphasized that certain factors were mediating the dynamics between the belief and the practice. The majority of teachers reported that instruction time, class size, professional development activities, availability of school funding, and state testing mandates impact their assessment routines. Teachers reported that both the preparation process and the results of the test created unbelievable tension both on students and teachers. Implications of the study indicated that it would be valuable to conduct alignment studies to examine whether state tests are fully aligned with the state standards and classroom assessment. Perhaps, such analyses would assist state level decision makers in reconsidering the current policies and "unintended" influences of mandated tests on classroom practices.

GUILD: GUidance for Information about Linking Data sets†

PubMed Central

Gilbert, Ruth; Lafferty, Rosemary; Hagger-Johnson, Gareth; Zhang, Li-Chun; Smith, Peter; Dibben, Chris; Goldstein, Harvey

2018-01-01

Abstract Record linkage of administrative and survey data is increasingly used to generate evidence to inform policy and services. Although a powerful and efficient way of generating new information from existing data sets, errors related to data processing before, during and after linkage can bias results. However, researchers and users of linked data rarely have access to information that can be used to assess these biases or take them into account in analyses. As linked administrative data are increasingly used to provide evidence to guide policy and services, linkage error, which disproportionately affects disadvantaged groups, can undermine evidence for public health. We convened a group of researchers and experts from government data providers to develop guidance about the information that needs to be made available about the data linkage process, by data providers, data linkers, analysts and the researchers who write reports. The guidance goes beyond recommendations for information to be included in research reports. Our aim is to raise awareness of information that may be required at each step of the linkage pathway to improve the transparency, reproducibility, and accuracy of linkage processes, and the validity of analyses and interpretation of results. PMID:28369581

Reliability and Validity of Inferences about Teachers Based on Student Scores. William H. Angoff Memorial Lecture Series

ERIC Educational Resources Information Center

Haertel, Edward H.

2013-01-01

Policymakers and school administrators have embraced value-added models of teacher effectiveness as tools for educational improvement. Teacher value-added estimates may be viewed as complicated scores of a certain kind. This suggests using a test validation model to examine their reliability and validity. Validation begins with an interpretive…

Performance validity testing in neuropsychology: a clinical guide, critical review, and update on a rapidly evolving literature.

PubMed

Lippa, Sara M

2018-04-01

Over the past two decades, there has been much research on measures of response bias and myriad measures have been validated in a variety of clinical and research samples. This critical review aims to guide clinicians through the use of performance validity tests (PVTs) from test selection and administration through test interpretation and feedback. Recommended cutoffs and relevant test operating characteristics are presented. Other important issues to consider during test selection, administration, interpretation, and feedback are discussed including order effects, coaching, impact on test data, and methods to combine measures and improve predictive power. When interpreting performance validity measures, neuropsychologists must use particular caution in cases of dementia, low intelligence, English as a second language/minority cultures, or low education. PVTs provide valuable information regarding response bias and, under the right circumstances, can provide excellent evidence of response bias. Only after consideration of the entire clinical picture, including validity test performance, can concrete determinations regarding the validity of test data be made.

A single-laboratory validated method for the generation of DNA barcodes for the identification of fish for regulatory compliance.

PubMed

Handy, Sara M; Deeds, Jonathan R; Ivanova, Natalia V; Hebert, Paul D N; Hanner, Robert H; Ormos, Andrea; Weigt, Lee A; Moore, Michelle M; Yancy, Haile F

2011-01-01

The U.S. Food and Drug Administration is responsible for ensuring that the nation's food supply is safe and accurately labeled. This task is particularly challenging in the case of seafood where a large variety of species are marketed, most of this commodity is imported, and processed product is difficult to identify using traditional morphological methods. Reliable species identification is critical for both foodborne illness investigations and for prevention of deceptive practices, such as those where species are intentionally mislabeled to circumvent import restrictions or for resale as species of higher value. New methods that allow accurate and rapid species identifications are needed, but any new methods to be used for regulatory compliance must be both standardized and adequately validated. "DNA barcoding" is a process by which species discriminations are achieved through the use of short, standardized gene fragments. For animals, a fragment (655 base pairs starting near the 5' end) of the cytochrome c oxidase subunit 1 mitochondrial gene has been shown to provide reliable species level discrimination in most cases. We provide here a protocol with single-laboratory validation for the generation of DNA barcodes suitable for the identification of seafood products, specifically fish, in a manner that is suitable for FDA regulatory use.

Validation of an instrument to measure tutor performance in promoting self-directed learning by using confirmatory factor analysis.

PubMed

Amador Fierros, Genoveva; Montesinos-López, Osval Antonio; Alcaráz Moreno, Noemí

2016-04-01

This work sought to validate and propose an instrument to measure the performance of tutors in promoting self-directed learning in students involved in processes of problem-based learning. Confirmatory factor analysis (CFA) was applied to validate the instrument composed of 60 items and six factors (self-assessment of learning gaps within the United Nations specific context: self-assessment, reflexion, critical thinking, administration of information, group skills), using a sample of 207 students from a total of 279, which comprise the student population of the Faculty of Nursing at Universidad de Colima in Mexico. (2007). The CFA results demonstrated that the instrument is acceptable to measure performance of tutors in promoting self-directed learning, given that all the indicators, variances, covariances, and thresholds are statistically significant. The instrument permits obtaining students' opinions on how much professors contribute for them to develop each of the 60 skills described in the scale. Lastly, the results could report if professors are placing more emphasis in some areas than in other areas they should address during the problem-based learning (PBL) process, or if definitely their actions are removed from the premises of PBL, information that will be useful for school management in decision making on the direction of teaching as a whole.

Personalised, predictive and preventive medication process in hospitals—still rather missing: professional opinion survey on medication safety in Czech hospitals (based on professional opinions of recognised Czech health care experts)

PubMed Central

2014-01-01

The survey had the following aims: (1) to rationalise the hypothesis that risks and losses relating to medication process' errors in Czech hospitals are at least comparable with the other developed countries and EU countries especially, (2) to get a valid professional opinion/estimate on the rate of adverse drug events happening in Czech hospitals, (3) to point out that medication errors represent real and serious risks and (4) to induce the hospital management readiness to execute fundamental changes and improvements to medication processes. We read through a lot of studies inquiring into hospitals' medication safety. Then, we selected the studies which brought reliable findings and formulated credible conclusions. Finally, we addressed reputable Czech experts in health care and asked them structured questions whether the studies' findings and conclusions corresponded with our respondents' own experience in the Czech hospital clinical practice and what their own estimates of adverse drug events' consequences were like. Based on the reputable Czech health care expert opinions/estimates, the rate of a false drug administration may exceed 5%, and over 7% of those cause serious health complications to Czech hospital inpatients. Measured by an average length of stay (ALOS), the Czech inpatients, harmed by a false drug administration, stay in hospital for more than 2.6 days longer than necessary. Any positive changes to a currently used, traditional, ways of drug dispensing and administration, along with computerisation, automation, electronic traceability, validation, or verification, must well pay off. Referring to the above results, it seems to be wise to follow the EU priorities in health and health care improvements. Thus, a right usage of the financial means provided by the EC—in terms of its new health programmes for the period 2014–2020 (e.g. Horizon 2020)—has a good chance of a good result in doing the right things right, at the right time and in the right way. All citizens of the EU may benefit using the best practice. PMID:24834138

Validation of an Integrated Airframe and Turbofan Engine Simulation for Evaluation of Propulsion Control Modes

NASA Technical Reports Server (NTRS)

Litt, Jonathan S.; Sowers, T Shane; Liu, Yuan; Owen, A. Karl; Guo, Ten-Huei

2015-01-01

The National Aeronautics and Space Administration (NASA) has developed independent airframe and engine models that have been integrated into a single real-time aircraft simulation for piloted evaluation of propulsion control algorithms. In order to have confidence in the results of these evaluations, the integrated simulation must be validated to demonstrate that its behavior is realistic and that it meets the appropriate Federal Aviation Administration (FAA) certification requirements for aircraft. The paper describes the test procedures and results, demonstrating that the integrated simulation generally meets the FAA requirements and is thus a valid testbed for evaluation of propulsion control modes.

Brief debrisoquin administration to assess central dopaminergic function in children.

PubMed

Riddle, M A; Shaywitz, B A; Leckman, J F; Anderson, G M; Shaywitz, S E; Hardin, M T; Ort, S I; Cohen, D J

1986-03-17

Central dopaminergic (DA) function in children was assessed by monitoring plasma-free homovanillic acid (pHVA) levels after brief (18 hour) administration with debrisoquin sulfate, a peripherally active antihypertensive agent that blocks peripheral, but not central, HVA production. Brief debrisoquin administration resulted in marked reductions in pHVA in each of six patients studied. In five of the six patients, post-debrisoquin pHVA levels remained relatively stable over the six-hour period of observation. No significant cardiovascular or behavioral side effects of debrisoquin were observed. The brief debrisoquin administration method appears to be a safe, simple, and potentially valid peripheral technique for evaluating aspects of central dopaminergic function in children with neuropsychiatric disorders. Additional work is needed to further establish this method's validity and reliability.

Forecasting the Movement of Educational Administrators Through Vacancy Flows

ERIC Educational Resources Information Center

Brown, Daniel J.

1976-01-01

Discusses the problem of forecasting manpower flows in administrative hierarchies of educational organizations, reviews groups of manpower models, discusses characteristics of administrative hierarchies and the vacancy model as it relates to those characteristics, and carries out validation and projective tests of the model. (Author/IRT)

KSC-04pd1139

NASA Image and Video Library

2004-05-13

KENNEDY SPACE CENTER, FLA. -- Adm. Craig E. Steidle (center), NASA’s associate administrator, Office of Exploration Systems, tours the Orbiter Processing Facility on a visit to KSC. At right (hands up) is Conrad Nagel, chief of the Shuttle Project Office. They are standing under the orbiter Discovery. The Office of Exploration Systems was established to set priorities and direct the identification, development and validation of exploration systems and related technologies to support the future space vision for America. Steidle’s visit included a tour of KSC to review the facilities and capabilities to be used to support the vision.

Using the Folstein Mini Mental State Exam (MMSE) to explore methodological issues in cognitive aging research.

PubMed

Monroe, Todd; Carter, Michael

2012-09-01

Cognitive scales are used frequently in geriatric research and practice. These instruments are constructed with underlying assumptions that are a part of their validation process. A common measurement scale used in older adults is the Folstein Mini Mental State Exam (MMSE). The MMSE was designed to screen for cognitive impairment and is used often in geriatric research. This paper has three aims. Aim one was to explore four potential threats to validity in the use of the MMSE: (1) administering the exam without meeting the underlying assumptions, (2) not reporting that the underlying assumptions were assessed prior to test administration, (3) use of variable and inconsistent cut-off scores for the determination of presence of cognitive impairment, and (4) failure to adjust the scores based on the demographic characteristics of the tested subject. Aim two was to conduct a literature search to determine if the assumptions of (1) education level assessment, (2) sensory assessment, and (3) language fluency were being met and clearly reported in published research using the MMSE. Aim three was to provide recommendations to minimalize threats to validity in research studies that use cognitive scales, such as the MMSE. We found inconsistencies in published work in reporting whether or not subjects meet the assumptions that underlie a reliable and valid MMSE score. These inconsistencies can pose threats to the reliability of exam results. Fourteen of the 50 studies reviewed reported inclusion of all three of these assumptions. Inconsistencies in reporting the inclusion of the underlying assumptions for a reliable score could mean that subjects were not appropriate to be tested by use of the MMSE or that an appropriate test administration of the MMSE was not clearly reported. Thus, the research literature could have threats to both validity and reliability based on misuse of or improper reported use of the MMSE. Six recommendations are provided to minimalize these threats in future research.

Reliability and Validity of the Self- and Interviewer-Administered Versions of the Global Physical Activity Questionnaire (GPAQ)

PubMed Central

Chu, Anne H. Y.; Ng, Sheryl H. X.; Koh, David; Müller-Riemenschneider, Falk

2015-01-01

Objective The Global Physical Activity Questionnaire (GPAQ) was originally designed to be interviewer-administered by the World Health Organization in assessing physical activity. The main aim of this study was to compare the psychometric properties of a self-administered GPAQ with the original interviewer-administered approach. Additionally, this study explored whether using different accelerometry-based physical activity bout definitions might affect the questionnaire’s validity. Methods A total of 110 participants were recruited and randomly allocated to an interviewer- (n = 56) or a self-administered (n = 54) group for test-retest reliability, of which 108 participants who met the wear time criteria were included in the validity study. Reliability was assessed by administration of questionnaires twice with a one-week interval. Criterion validity was assessed by comparing against seven-day accelerometer measures. Two definitions for accelerometry-data scoring were employed: (1) total-min of activity, and (2) 10-min bout. Results Participants had similar baseline characteristics in both administration groups and no significant difference was found between the two formats in terms of validity (correlations between the GPAQ and accelerometer). For validity, the GPAQ demonstrated fair-to-moderate correlations for moderate-to-vigorous physical activity (MVPA) for self-administration (r s = 0.30) and interviewer-administration (r s = 0.46). Findings were similar when considering 10-min activity bouts in the accelerometer analysis for MVPA (r s = 0.29 vs. 0.42 for self vs. interviewer). Within each mode of administration, the strongest correlations were observed for vigorous-intensity activity. However, Bland-Altman plots illustrated bias toward overestimation for higher levels of MVPA, vigorous- and moderate-intensity activities, and underestimation for lower levels of these measures. Reliability for MVPA revealed moderate correlations (r s = 0.61 vs. 0.63 for self vs. interviewer). Conclusions Our findings showed comparability between both self- and interviewer-administration modes of the GPAQ. The GPAQ in general but especially the self-administered version may offer a relatively inexpensive method for measuring physical activity of various types and at different domains. However, there may be bias in the GPAQ measurements depending on the overall physical activity. It is advisable to incorporate accelerometers in future studies, particularly when measuring different intensities of physical activity. PMID:26327457

48 CFR 2901.603-72 - Administrative procurement management reviews.

Code of Federal Regulations, 2014 CFR

2014-10-01

... improvement of managerial controls and best practices. (b) The administrative procurement review system is a three-pronged approach that includes self-assessment, statistical data for validation, and flexible...

48 CFR 2901.603-72 - Administrative procurement management reviews.

Code of Federal Regulations, 2011 CFR

2011-10-01

... improvement of managerial controls and best practices. (b) The administrative procurement review system is a three-pronged approach that includes self-assessment, statistical data for validation, and flexible...

48 CFR 2901.603-72 - Administrative procurement management reviews.

Code of Federal Regulations, 2012 CFR

2012-10-01

... improvement of managerial controls and best practices. (b) The administrative procurement review system is a three-pronged approach that includes self-assessment, statistical data for validation, and flexible...

48 CFR 2901.603-72 - Administrative procurement management reviews.

Code of Federal Regulations, 2013 CFR

2013-10-01

... improvement of managerial controls and best practices. (b) The administrative procurement review system is a three-pronged approach that includes self-assessment, statistical data for validation, and flexible...

A Medication Safety Model: A Case Study in Thai Hospital

PubMed Central

Rattanarojsakul, Phichai; Thawesaengskulthai, Natcha

2013-01-01

Reaching zero defects is vital in medication service. Medication error can be reduced if the causes are recognized. The purpose of this study is to search for a conceptual framework of the causes of medication error in Thailand and to examine relationship between these factors and its importance. The study was carried out upon an in-depth case study and survey of hospital personals who were involved in the drug use process. The structured survey was based on Emergency Care Research Institute (ECRI) (2008) questionnaires focusing on the important factors that affect the medication safety. Additional questionnaires included content to the context of Thailand's private hospital, validated by five-hospital qualified experts. By correlation Pearson analysis, the result revealed 14 important factors showing a linear relationship with drug administration error except the medication reconciliation. By independent sample t-test, the administration error in the hospital was significantly related to external impact. The multiple regression analysis of the detail of medication administration also indicated the patient identification before administration of medication, detection of the risk of medication adverse effects and assurance of medication administration at the right time, dosage and route were statistically significant at 0.05 level. The major implication of the study is to propose a medication safety model in a Thai private hospital. PMID:23985110

A medication safety model: a case study in Thai hospital.

PubMed

Rattanarojsakul, Phichai; Thawesaengskulthai, Natcha

2013-06-12

Reaching zero defects is vital in medication service. Medication error can be reduced if the causes are recognized. The purpose of this study is to search for a conceptual framework of the causes of medication error in Thailand and to examine relationship between these factors and its importance. The study was carried out upon an in-depth case study and survey of hospital personals who were involved in the drug use process. The structured survey was based on Emergency Care Research Institute (ECRI) (2008) questionnaires focusing on the important factors that affect the medication safety. Additional questionnaires included content to the context of Thailand's private hospital, validated by five-hospital qualified experts. By correlation Pearson analysis, the result revealed 14 important factors showing a linear relationship with drug administration error except the medication reconciliation. By independent sample t-test, the administration error in the hospital was significantly related to external impact. The multiple regression analysis of the detail of medication administration also indicated the patient identification before administration of medication, detection of the risk of medication adverse effects and assurance of medication administration at the right time, dosage and route were statistically significant at 0.05 level. The major implication of the study is to propose a medication safety model in a Thai private hospital.

Validation of a Pediatric Diabetes Case Definition Using Administrative Health Data in Manitoba, Canada

PubMed Central

Dart, Allison B.; Martens, Patricia J.; Sellers, Elizabeth A.; Brownell, Marni D.; Rigatto, Claudio; Dean, Heather J.

2011-01-01

OBJECTIVE To validate a case definition for diabetes in the pediatric age-group using administrative health data. RESEARCH DESIGN AND METHODS Population-based administrative data from Manitoba, Canada for the years 2004–2006 were anonymously linked to a clinical registry to evaluate the validity of algorithms based on a combination of hospital claim, outpatient physician visit, and drug use data over 1–3 years in youth 1–18 years of age. Agreement between data sources, sensitivity, specificity, negative (NPV) and positive predictive value (PPV) were evaluated for each algorithm. In addition, ascertainment rate of each data source, prevalence, and differences between subtypes of diabetes were evaluated. RESULTS Agreement between data sources was very good. The diabetes definition including one or more hospitalizations or two or more outpatient claims over 2 years provided a sensitivity of 94.2%, specificity of 99.9%, PPV of 81.6% and NPV of 99.9%. The addition of one or more prescription claims to the same definition over 1 year provided similar results. Case ascertainment rates of both sources were very good to excellent and the ascertainment-corrected prevalence for youth-onset diabetes for the year 2006 was 2.4 per 1,000. It was not possible to distinguish between subtypes of diabetes within the administrative database; however, this limitation could be overcome with an anonymous linkage to the clinical registry. CONCLUSIONS Administrative data are a valid source for the determination of pediatric diabetes prevalence that can provide important information for health care planning and evaluation. PMID:21378211

Subarachnoid hemorrhage admissions retrospectively identified using a prediction model

PubMed Central

McIntyre, Lauralyn; Fergusson, Dean; Turgeon, Alexis; dos Santos, Marlise P.; Lum, Cheemun; Chassé, Michaël; Sinclair, John; Forster, Alan; van Walraven, Carl

2016-01-01

Objective: To create an accurate prediction model using variables collected in widely available health administrative data records to identify hospitalizations for primary subarachnoid hemorrhage (SAH). Methods: A previously established complete cohort of consecutive primary SAH patients was combined with a random sample of control hospitalizations. Chi-square recursive partitioning was used to derive and internally validate a model to predict the probability that a patient had primary SAH (due to aneurysm or arteriovenous malformation) using health administrative data. Results: A total of 10,322 hospitalizations with 631 having primary SAH (6.1%) were included in the study (5,122 derivation, 5,200 validation). In the validation patients, our recursive partitioning algorithm had a sensitivity of 96.5% (95% confidence interval [CI] 93.9–98.0), a specificity of 99.8% (95% CI 99.6–99.9), and a positive likelihood ratio of 483 (95% CI 254–879). In this population, patients meeting criteria for the algorithm had a probability of 45% of truly having primary SAH. Conclusions: Routinely collected health administrative data can be used to accurately identify hospitalized patients with a high probability of having a primary SAH. This algorithm may allow, upon validation, an easy and accurate method to create validated cohorts of primary SAH from either ruptured aneurysm or arteriovenous malformation. PMID:27629096

Tobacco Industry Efforts to Defeat the Occupational Safety and Health Administration Indoor Air Quality Rule

PubMed Central

Bryan-Jones, Katherine; Bero, Lisa A.

2003-01-01

Objectives. We describe tobacco industry strategies to defeat the Occupational Safety and Health Administration (OSHA) Indoor Air Quality rule and the implementation of those strategies. Methods. We analyzed tobacco industry documents, public commentary on, and media coverage of the OSHA rule. Results. The tobacco industry had 5 strategies: (1) maintain scientific debate about the basis of the rule, (2) delay deliberation on the rule, (3) redefine the scope of the rule, (4) recruit and assist labor and business organizations in opposing the rule, and (5) increase media coverage of the tobacco industry position. The tobacco industry successfully implemented all 5 strategies. Conclusions. Our findings suggest that regulatory authorities must take into account the source, motivation, and validity of arguments used in the regulatory process in order to make accurately informed decisions. PMID:12660202

A comparative trial of paper-and-pencil versus computer administration of the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire.

PubMed

Kleinman, L; Leidy, N K; Crawley, J; Bonomi, A; Schoenfeld, P

2001-02-01

Although most health-related quality of life questionnaires are self-administered by means of paper and pencil, new technologies for automated computer administration are becoming more readily available. Novel methods of instrument administration must be assessed for score equivalence in addition to consistency in reliability and validity. The present study compared the psychometric characteristics (score equivalence and structure, internal consistency, and reproducibility reliability and construct validity) of the Quality of Life in Reflux And Dyspepsia (QOLRAD) questionnaire when self-administered by means of paper and pencil versus touch-screen computer. The influence of age, education, and prior experience with computers on score equivalence was also examined. This crossover trial randomized 134 patients with gastroesophageal reflux disease to 1 of 2 groups: paper-and-pencil questionnaire administration followed by computer administration or computer administration followed by use of paper and pencil. To minimize learning effects and respondent fatigue, administrations were scheduled 3 days apart. A random sample of 32 patients participated in a 1-week reproducibility evaluation of the computer-administered QOLRAD. QOLRAD scores were equivalent across the 2 methods of administration regardless of subject age, education, and prior computer use. Internal consistency levels were very high (alpha = 0.93-0.99). Interscale correlations were strong and generally consistent across methods (r = 0.7-0.87). Correlations between the QOLRAD and Short Form 36 (SF-36) were high, with no significant differences by method. Test-retest reliability of the computer-administered QOLRAD was also very high (ICC = 0.93-0.96). Results of the present study suggest that the QOLRAD is reliable and valid when self-administered by means of computer touch-screen or paper and pencil.

The Development and Validation of a Special Education Intelligent Administration Support Program. Final Report.

ERIC Educational Resources Information Center

Utah State Univ., Logan. Center for Persons with Disabilities.

This project studied the effects of implementing a computerized management information system developed for special education administrators. The Intelligent Administration Support Program (IASP), an expert system and database program, assisted in information acquisition and analysis pertaining to the district's quality of decisions and procedures…

45 CFR 261.41 - How will we determine the caseload reduction credit?

Code of Federal Regulations, 2010 CFR

2010-10-01

... ASSISTANCE (ASSISTANCE PROGRAMS), ADMINISTRATION FOR CHILDREN AND FAMILIES, DEPARTMENT OF HEALTH AND HUMAN..., or other administrative data sources and analyses. (2) We will accept the information and estimates... closures, or other administrative data sources to validate the accuracy of the State estimates. (b) In...

Assessing Student Understanding of the "New Biology": Development and Evaluation of a Criterion-Referenced Genomics and Bioinformatics Assessment

NASA Astrophysics Data System (ADS)

Campbell, Chad Edward

Over the past decade, hundreds of studies have introduced genomics and bioinformatics (GB) curricula and laboratory activities at the undergraduate level. While these publications have facilitated the teaching and learning of cutting-edge content, there has yet to be an evaluation of these assessment tools to determine if they are meeting the quality control benchmarks set forth by the educational research community. An analysis of these assessment tools indicated that <10% referenced any quality control criteria and that none of the assessments met more than one of the quality control benchmarks. In the absence of evidence that these benchmarks had been met, it is unclear whether these assessment tools are capable of generating valid and reliable inferences about student learning. To remedy this situation the development of a robust GB assessment aligned with the quality control benchmarks was undertaken in order to ensure evidence-based evaluation of student learning outcomes. Content validity is a central piece of construct validity, and it must be used to guide instrument and item development. This study reports on: (1) the correspondence of content validity evidence gathered from independent sources; (2) the process of item development using this evidence; (3) the results from a pilot administration of the assessment; (4) the subsequent modification of the assessment based on the pilot administration results and; (5) the results from the second administration of the assessment. Twenty-nine different subtopics within GB (Appendix B: Genomics and Bioinformatics Expert Survey) were developed based on preliminary GB textbook analyses. These subtopics were analyzed using two methods designed to gather content validity evidence: (1) a survey of GB experts (n=61) and (2) a detailed content analyses of GB textbooks (n=6). By including only the subtopics that were shown to have robust support across these sources, 22 GB subtopics were established for inclusion in the assessment. An expert panel subsequently developed, evaluated, and revised two multiple-choice items to align with each of the 22 subtopics, producing a final item pool of 44 items. These items were piloted with student samples of varying content exposure levels. Both Classical Test Theory (CTT) and Item Response Theory (IRT) methodologies were used to evaluate the assessment's validity, reliability and ability inferences, and its ability to differentiate students with different magnitudes of content exposure. A total of 18 items were subsequently modified and reevaluated by an expert panel. The 26 original and 18 modified items were once again piloted with student samples of varying content exposure levels. Both CTT and IRT methodologies were once again used to evaluate student responses in order to evaluate the assessment's validity and reliability inferences as well as its ability to differentiate students with different magnitudes of content exposure. Interviews with students from different content exposure levels were also performed in order to gather convergent validity evidence (external validity evidence) as well as substantive validity evidence. Also included are the limitations of the assessment and a set of guidelines on how the assessment can best be used.

Evidence of reduced oral bioavailability of paracetamol in rats following multiple ingestion of grapefruit juice.

PubMed

Qinna, Nidal A; Ismail, Obbei A; Alhussainy, Tawfiq M; Idkaidek, Nasir M; Arafat, Tawfiq A

2016-04-01

The aim of the current investigation was to assess the ability GFJ to modulate the pharmacokinetic profile of paracetamol following single or repeated administrations of GFJ in Sprague-Dawley rats. Diclofenac and carbamazepine were both used as positive controls. Rats received single GFJ or single distilled water doses or pretreated with three doses of GFJ prior to test drug administration. Blood samples were collected, processed and analyzed using validated HPLC methods, and pharmacokinetic data were constructed for each group. Increase in the bioavailability of both diclofenac and carbamazepine following multiple GFJ ingestion was revealed. Conversely, the bioavailability of paracetamol was significantly reduced following multiple GFJ administration. The percentage of reduction in the C max and AUC of paracetamol were calculated as 31 and 51 %, respectively, compared to none-GFJ-treated control (P < 0.05). The T(max) was not essentially changed. In conclusion, frequent administration of GFJ was confirmed to modulate the pharmacokinetics of paracetamol in rats by reducing its bioavailability. Meanwhile, it may be advisable not to ingest large amounts of GFJ along with paracetamol to avoid a possible potential loss of the efficacy.

Montreal Accord on Patient-Reported Outcomes (PROs) use series-Paper 7: modern perspectives of measurement validation emphasize justification of inferences based on patient reported outcome scores.

PubMed

Sawatzky, Richard; Chan, Eric K H; Zumbo, Bruno D; Ahmed, Sara; Bartlett, Susan J; Bingham, Clifton O; Gardner, William; Jutai, Jeffrey; Kuspinar, Ayse; Sajobi, Tolulope; Lix, Lisa M

2017-09-01

Obtaining the patient's view about the outcome of care is an essential component of patient-centered care. Many patient-reported outcome (PRO) instruments for different purposes have been developed since the 1960s. Measurement validation is fundamental in the development, evaluation, and use of PRO instruments. This paper provides a review of modern perspectives of measurement validation in relation to the followings three questions as applied to PROs: (1) What evidence is needed to warrant comparisons between groups and individuals? (2) What evidence is needed to warrant comparisons over time? and (3) What are the value implications, including personal and societal consequences, of using PRO scores? Measurement validation is an ongoing process that involves the accumulation of evidence regarding the justification of inferences, actions, and decisions based on measurement scores. These include inferences pertaining to comparisons between groups and comparisons over time as well as consideration of value implications of using PRO scores. Personal and societal consequences must be examined as part of a comprehensive approach to measurement validation. The answers to these three questions are fundamental to the the validity of different types of inferences, actions, and decisions made on PRO scores in health research, health care administration, and clinical practice. Copyright © 2016 Elsevier Inc. All rights reserved.

Adolescent substance use screening in primary care: validity of computer self-administered vs. clinician-administered screening

PubMed Central

Harris, Sion Kim; Knight, John R; Van Hook, Shari; Sherritt, Lon; Brooks, Traci; Kulig, John W; Nordt, Christina; Saitz, Richard

2015-01-01

Background Computer self-administration may help busy pediatricians’ offices increase adolescent substance use screening rates efficiently and effectively, if proven to yield valid responses. The CRAFFT screening protocol for adolescents has demonstrated validity as an interview, but a computer self-entry approach needs validity testing. The aim of this study was to evaluate the criterion validity and time efficiency of a computerized adolescent substance use screening protocol implemented by self-administration or clinician-administration. Methods 12- to 17-year-old patients coming for routine care at three primary care clinics completed the computerized screen by both self-administration and clinician-administration during their visit. To account for order effects, we randomly assigned participants to self-administer the screen either before or after seeing their clinician. Both were conducted using a tablet computer and included identical items (any past-12-month use of tobacco, alcohol, drugs; past-3-months frequency of each; and six CRAFFT items). The criterion measure for substance use was the Timeline Follow-Back, and for alcohol/drug use disorder, the Adolescent Diagnostic Interview, both conducted by confidential research assistant-interview after the visit. Tobacco dependence risk was assessed with the self-administered Hooked on Nicotine Checklist (HONC). Analyses accounted for the multi-site cluster sampling design. Results Among 136 participants, mean age was 15.0±1.5 yrs, 54% were girls, 53% were Black or Hispanic, and 67% had ≥3 prior visits with their clinician. Twenty-seven percent reported any substance use (including tobacco) in the past 12 months, 7% met criteria for an alcohol or cannabis use disorder, and 4% were HONC-positive. Sensitivity/specificity of the screener were high for detecting past-12-month use or disorder and did not differ between computer and clinician. Mean completion time was 49 seconds (95%CI 44-54) for computer and 74 seconds (95%CI 68-87) for clinician (paired comparison p<0.001). Conclusions Substance use screening by computer self-entry is a valid and time-efficient alternative to clinician-administered screening. PMID:25774878

Designing the Nuclear Energy Attitude Scale.

ERIC Educational Resources Information Center

Calhoun, Lawrence; And Others

1988-01-01

Presents a refined method for designing a valid and reliable Likert-type scale to test attitudes toward the generation of electricity from nuclear energy. Discusses various tests of validity that were used on the nuclear energy scale. Reports results of administration and concludes that the test is both reliable and valid. (CW)

Implementation of the 3Rs (refinement, reduction, and replacement): validation and regulatory acceptance considerations for alternative toxicological test methods.

PubMed

Schechtman, Leonard M

2002-01-01

Toxicological testing in the current regulatory environment is steeped in a history of using animals to answer questions about the safety of products to which humans are exposed. That history forms the basis for the testing strategies that have evolved to satisfy the needs of the regulatory bodies that render decisions that affect, for the most part, virtually all phases of premarket product development and evaluation and, to a lesser extent, postmarketing surveillance. Only relatively recently have the levels of awareness of, and responsiveness to, animal welfare issues reached current proportions. That paradigm shift, although sluggish, has nevertheless been progressive. New and alternative toxicological methods for hazard evaluation and risk assessment have now been adopted and are being viewed as a means to address those issues in a manner that considers humane treatment of animals yet maintains scientific credibility and preserves the goal of ensuring human safety. To facilitate this transition, regulatory agencies and regulated industry must work together toward improved approaches. They will need assurance that the methods will be reliable and the results comparable with, or better than, those derived from the current classical methods. That confidence will be a function of the scientific validation and resultant acceptance of any given method. In the United States, to fulfill this need, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and its operational center, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), have been constituted as prescribed in federal law. Under this mandate, ICCVAM has developed a process and established criteria for the scientific validation and regulatory acceptance of new and alternative methods. The role of ICCVAM in the validation and acceptance process and the criteria instituted toward that end are described. Also discussed are the participation of the US Food and Drug Administration (FDA) in the ICCVAM process and that agency's approach to the application and implementation of ICCVAM-recommended methods.

The development of an instrument to measure the self-efficacy of students participating in VEX robotics competitions

NASA Astrophysics Data System (ADS)

Robinson, Trevor P.

The number of robotics competitions has steadily increased over the past 30 years. Schools are implementing robotics competitions to increase student content knowledge and interest in science, technology, engineering, and mathematics (STEM). Companies in STEM-related fields are financially supporting robotics competitions to help increase the number of students pursuing careers in STEM among other reasons. These financial supporters and school administrations are asking what the outcomes of students participating in competitive robotics are. Few studies have been conducted to investigate these outcomes. The studies that have been conducted usually compare students in robotics to students not in robotics. There have not been any studies that compare students to themselves before and after participating in robotics competitions. This may be due to the lack of available instruments to measure student outcomes. This study developed an instrument to measure the self-efficacy of students participating in VEX Robotics Competitions (VRC). The VRC is the world's largest and fastest growing robotics competition available for middle and high school students. Self-efficacy was measured because of its importance to the education community. Students with higher self-efficacy tend to persevere through difficult tasks more frequently than students with low self-efficacy. A person's self-efficacy has major influence over what interests, activities, classes, college majors, and careers he or she will pursue in life. The self-efficacy survey instrument created through this study was developed through an occupational and task analysis (OTA), and initial content and face validity was established through the OTA process. Exploratory and confirmatory factor analyses were also conducted to assist in instrument validation. The reliability was calculated using Cronbach's alpha. Face validity was established through the OTA process. Construct validity was established through the factor analyses. The processes of the OTA and factor analyses have created an instrument that results indicate is reliable and valid to use in further research studies.

Testing the validity, reliability and utility of the Self-Administration of Medication (SAM) tool in patients undergoing rehabilitation.

PubMed

Anderson, Jessica; Manias, Elizabeth; Kusljic, Snezana; Finch, Sue

2014-01-01

Determination of patients' ability to self-administer medications in the hospital has largely been determined using the subjective judgment of health professionals. To examine the validity, reliability and utility of the Self-Administration of Medication (SAM) tool as an objective means to determine patients' ability to self-administer in a rehabilitation unit of a public teaching hospital in Melbourne, Australia. To assess validity of the SAM tool, associations were examined between the total SAM tool score and of the patients' competence to self-administer from the perceptions of the tool administrator, patients and nurses. Validity also was determined from a principal component analysis. Pearson correlations were calculated for how SAM scores related to scores obtained from the Functional Independence Measure (FIM) and Barthel Score Index (BSI). To assess the SAM tool's reliability, a Cronbach's alpha coefficient was calculated. Utility of the SAM tool was evidenced by documenting its administration time. One hundred patients participated in this study. The SAM tool had a Cronbach's alpha coefficient of 0.75 and took a mean time of 5.36 min to complete. The capability to self-medicate section of the SAM tool had strong correlations with the FIM (r = 0.485) and BSI (r = 0.472) data, respectively, and the total SAM tool had moderate and strong correlations with the nurses' (r = 0.315) and tool administrator's (r = 0.632) perceptions of patients' ability to self-administer, respectively. Bland-Altman and ROC curve analyses showed poor agreement between the total SAM tool score and the nurses' perceptions. The SAM tool demonstrated acceptable overall internal consistency. It only requires a short time to be completed and is more objective than seeking out health professionals' perceptions. Additional research is needed to further validate this approach to determining patients' ability to self-medicate. Crown Copyright © 2014. Published by Elsevier Inc. All rights reserved.

Evaluation of a Tracking System for Patients and Mixed Intravenous Medication Based on RFID Technology.

PubMed

Martínez Pérez, María; Vázquez González, Guillermo; Dafonte, Carlos

2016-11-30

At present, one of the primary concerns of healthcare professionals is how to increase the safety and quality of the care that patients receive during their stay in hospital. This is particularly important in the administration of expensive and high-risk medicines with which it is fundamental to minimize the possibility of adverse events in the process of prescription-validation-preparation/dosage-dispensation-administration of intravenous mixes. This work is a detailed analysis of the evaluation, carried out by the health personnel involved in the Radiofrequency Identification (RFID) system developed in the Day Hospital and Pharmacy services of the Complejo Hospitalario Universitario A Coruña (CHUAC). The RFID system is evaluated by analyzing surveys completed by said health personnel, since their questions represent the key indicators of the patient care process (safety, cost, adequacy with the clinical practice). This work allows us to conclude, among other things, that the system tracks the patients satisfactorily and that its cost, though high, is justified in the context of the project context (use of dangerous and costly medication).

Evaluation of a Tracking System for Patients and Mixed Intravenous Medication Based on RFID Technology

PubMed Central

Martínez Pérez, María; Vázquez González, Guillermo; Dafonte, Carlos

2016-01-01

At present, one of the primary concerns of healthcare professionals is how to increase the safety and quality of the care that patients receive during their stay in hospital. This is particularly important in the administration of expensive and high-risk medicines with which it is fundamental to minimize the possibility of adverse events in the process of prescription-validation-preparation/dosage-dispensation-administration of intravenous mixes. This work is a detailed analysis of the evaluation, carried out by the health personnel involved in the Radiofrequency Identification (RFID) system developed in the Day Hospital and Pharmacy services of the Complejo Hospitalario Universitario A Coruña (CHUAC). The RFID system is evaluated by analyzing surveys completed by said health personnel, since their questions represent the key indicators of the patient care process (safety, cost, adequacy with the clinical practice). This work allows us to conclude, among other things, that the system tracks the patients satisfactorily and that its cost, though high, is justified in the context of the project context (use of dangerous and costly medication). PMID:27916915

20 CFR 658.425 - Decision of DOL Administrative Law Judge.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ADMINISTRATIVE PROVISIONS GOVERNING THE JOB SERVICE SYSTEM Job Service Complaint System Federal Js Complaint... jursidiction to consider the validity or constitutionality of JS regulations or of the Federal statutes under...

Process auditing in long term care facilities.

PubMed

Hewitt, S M; LeSage, J; Roberts, K L; Ellor, J R

1985-01-01

The ECC tool development and audit experiences indicated that there is promise in developing a process audit tool to monitor quality of care in nursing homes; moreover, the tool selected required only one hour per resident. Focusing on the care process and resident needs provided useful information for care providers at the unit level as well as for administrative personnel. Besides incorporating a more interdisciplinary focus, the revised tool needs to define support services most appropriate for nursing homes, includes items related to discharge planning and increases measurement of significant others' involvement in the care process. Future emphasis at the ECC will focus on developing intervention plans to maintain strengths and correct deficiencies identified in the audits. Various strategies to bring about desired changes in the quality of care will be evaluated through regular, periodic monitoring. Having a valid and reliable measure of quality of care as a tool will be an important step forward for LTC facilities.

Fluorescence In Situ Hybridization Probe Validation for Clinical Use.

PubMed

Gu, Jun; Smith, Janice L; Dowling, Patricia K

2017-01-01

In this chapter, we provide a systematic overview of the published guidelines and validation procedures for fluorescence in situ hybridization (FISH) probes for clinical diagnostic use. FISH probes-which are classified as molecular probes or analyte-specific reagents (ASRs)-have been extensively used in vitro for both clinical diagnosis and research. Most commercially available FISH probes in the United States are strictly regulated by the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS) the Clinical Laboratory Improvement Amendments (CLIA), and the College of American Pathologists (CAP). Although home-brewed FISH probes-defined as probes made in-house or acquired from a source that does not supply them to other laboratories-are not regulated by these agencies, they too must undergo the same individual validation process prior to clinical use as their commercial counterparts. Validation of a FISH probe involves initial validation and ongoing verification of the test system. Initial validation includes assessment of a probe's technical specifications, establishment of its standard operational procedure (SOP), determination of its clinical sensitivity and specificity, development of its cutoff, baseline, and normal reference ranges, gathering of analytics, confirmation of its applicability to a specific research or clinical setting, testing of samples with or without the abnormalities that the probe is meant to detect, staff training, and report building. Ongoing verification of the test system involves testing additional normal and abnormal samples using the same method employed during the initial validation of the probe.

Healthcare Databases for Drug Safety Research: Data Validity Assessment Remains Crucial.

PubMed

Rawson, Nigel S B; D'Arcy, Carl

2018-04-30

Administrative healthcare utilization databases are frequently used either individually or as a component of aggregated data for evaluating drug safety issues without taking into account their known deficiencies. All too often insufficient evidence is provided about their validity for the purposes for which they are used. The assessment of data validity is a key constituent that should be included in drug safety research studies and should take a broad multifaceted approach that encompasses both diagnostic and drug exposure data. Drug safety researchers need to continue advancing their knowledge of the data resources they use and to ensure that they and the users of their research understand the limitations of the data that are the foundation on which their research is built. Fundamental issues regarding data validity should be addressed in each use of administrative data for drug safety research.

Validation of the conceptual research utilization scale: an application of the standards for educational and psychological testing in healthcare.

PubMed

Squires, Janet E; Estabrooks, Carole A; Newburn-Cook, Christine V; Gierl, Mark

2011-05-19

There is a lack of acceptable, reliable, and valid survey instruments to measure conceptual research utilization (CRU). In this study, we investigated the psychometric properties of a newly developed scale (the CRU Scale). We used the Standards for Educational and Psychological Testing as a validation framework to assess four sources of validity evidence: content, response processes, internal structure, and relations to other variables. A panel of nine international research utilization experts performed a formal content validity assessment. To determine response process validity, we conducted a series of one-on-one scale administration sessions with 10 healthcare aides. Internal structure and relations to other variables validity was examined using CRU Scale response data from a sample of 707 healthcare aides working in 30 urban Canadian nursing homes. Principal components analysis and confirmatory factor analyses were conducted to determine internal structure. Relations to other variables were examined using: (1) bivariate correlations; (2) change in mean values of CRU with increasing levels of other kinds of research utilization; and (3) multivariate linear regression. Content validity index scores for the five items ranged from 0.55 to 1.00. The principal components analysis predicted a 5-item 1-factor model. This was inconsistent with the findings from the confirmatory factor analysis, which showed best fit for a 4-item 1-factor model. Bivariate associations between CRU and other kinds of research utilization were statistically significant (p < 0.01) for the latent CRU scale score and all five CRU items. The CRU scale score was also shown to be significant predictor of overall research utilization in multivariate linear regression. The CRU scale showed acceptable initial psychometric properties with respect to responses from healthcare aides in nursing homes. Based on our validity, reliability, and acceptability analyses, we recommend using a reduced (four-item) version of the CRU scale to yield sound assessments of CRU by healthcare aides. Refinement to the wording of one item is also needed. Planned future research will include: latent scale scoring, identification of variables that predict and are outcomes to conceptual research use, and longitudinal work to determine CRU Scale sensitivity to change.

Patient-Reported Outcome (PRO) Consortium translation process: consensus development of updated best practices.

PubMed

Eremenco, Sonya; Pease, Sheryl; Mann, Sarah; Berry, Pamela

2017-01-01

This paper describes the rationale and goals of the Patient-Reported Outcome (PRO) Consortium's instrument translation process. The PRO Consortium has developed a number of novel PRO measures which are in the process of qualification by the U.S. Food and Drug Administration (FDA) for use in clinical trials where endpoints based on these measures would support product labeling claims. Given the importance of FDA qualification of these measures, the PRO Consortium's Process Subcommittee determined that a detailed linguistic validation (LV) process was necessary to ensure that all translations of Consortium-developed PRO measures are performed using a standardized approach with the rigor required to meet regulatory and pharmaceutical industry expectations, as well as having a clearly defined instrument translation process that the translation industry can support. The consensus process involved gathering information about current best practices from 13 translation companies with expertise in LV, consolidating the findings to generate a proposed process, and obtaining iterative feedback from the translation companies and PRO Consortium member firms on the proposed process in two rounds of review in order to update existing principles of good practice in LV and to provide sufficient detail for the translation process to ensure consistency across PRO Consortium measures, sponsors, and translation companies. The consensus development resulted in a 12-step process that outlines universal and country-specific new translation approaches, as well as country-specific adaptations of existing translations. The PRO Consortium translation process will play an important role in maintaining the validity of the data generated through these measures by ensuring that they are translated by qualified linguists following a standardized and rigorous process that reflects best practice.

Streamlining Software Aspects of Certification: Report on the SSAC Survey

NASA Technical Reports Server (NTRS)

Hayhurst, Kelly J.; Dorsey, Cheryl A.; Knight, John C.; Leveson, Nancy G.; McCormick, G. Frank

1999-01-01

The aviation system now depends on information technology more than ever before to ensure safety and efficiency. To address concerns about the efficacy of software aspects of the certification process, the Federal Aviation Administration (FAA) began the Streamlining Software Aspects of Certification (SSAC) program. The SSAC technical team was commissioned to gather data, analyze results, and propose recommendations to maximize efficiency and minimize cost and delay, without compromising safety. The technical team conducted two public workshops to identify and prioritize software approval issues, and conducted a survey to validate the most urgent of those issues. The SSAC survey, containing over two hundred questions about the FAA's software approval process, reached over four hundred industry software developers, aircraft manufacturers, and FAA designated engineering representatives. Three hundred people responded. This report presents the SSAC program rationale, survey process, preliminary findings, and recommendations.

Measuring Eating Competence: Psychometric Properties and Validity of the ecSatter Inventory

ERIC Educational Resources Information Center

Lohse, Barbara; Satter, Ellyn; Horacek, Tanya; Gebreselassie, Tesfayi; Oakland, Mary Jane

2007-01-01

Objective: Assess validity of the ecSatter Inventory (ecSI) to measure eating competence (EC). Design: Concurrent administration of ecSI with validated measures of eating behaviors using on-line and paper-pencil formats. Setting: The on-line survey was completed by 370 participants; 462 completed the paper version. Participants: Participants…

42 CFR 412.140 - Participation, data submission, and validation requirements under the Hospital Inpatient Quality...

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 2 2014-10-01 2014-10-01 false Participation, data submission, and validation... Payment Systems § 412.140 Participation, data submission, and validation requirements under the Hospital....org, before it begins to report data; (2) Identify and register a QualityNet Administrator as part of...

42 CFR 412.140 - Participation, data submission, and validation requirements under the Hospital Inpatient Quality...

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 2 2011-10-01 2011-10-01 false Participation, data submission, and validation... Payment Systems § 412.140 Participation, data submission, and validation requirements under the Hospital....org, before it begins to report data; (2) Identify and register a QualityNet Administrator as part of...

42 CFR 412.140 - Participation, data submission, and validation requirements under the Hospital Inpatient Quality...

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 2 2012-10-01 2012-10-01 false Participation, data submission, and validation... Payment Systems § 412.140 Participation, data submission, and validation requirements under the Hospital....org, before it begins to report data; (2) Identify and register a QualityNet Administrator as part of...

Ultrasonic inspection of a glued laminated timber fabricated with defects

Treesearch

Robert Emerson; David Pollock; David McLean; Kenneth Fridley; Robert Ross; Roy Pellerin

2001-01-01

The Federal Highway Administration (FHWA) set up a validation test to compare the effectiveness of various nondestructive inspection techniques for detecting artificial defects in glulam members. The validation test consisted of a glulam beam fabricated with artificial defects known to FHWA personnel but not originally known to the scientists performing the validation...

Validation of Linguistic and Communicative Oral Language Tests for Spanish-English Bilingual Programs.

ERIC Educational Resources Information Center

Politzer, Robert L.; And Others

1983-01-01

The development, administration, and scoring of a communicative test and its validation with tests of linguistic and sociolinguistic competence in English and Spanish are reported. Correlation with measures of home language use and school achievement are also presented, and issues of test validation for bilingual programs are discussed. (MSE)

A Severe Sepsis Mortality Prediction Model and Score for Use with Administrative Data

PubMed Central

Ford, Dee W.; Goodwin, Andrew J.; Simpson, Annie N.; Johnson, Emily; Nadig, Nandita; Simpson, Kit N.

2016-01-01

Objective Administrative data is used for research, quality improvement, and health policy in severe sepsis. However, there is not a sepsis-specific tool applicable to administrative data with which to adjust for illness severity. Our objective was to develop, internally validate, and externally validate a severe sepsis mortality prediction model and associated mortality prediction score. Design Retrospective cohort study using 2012 administrative data from five US states. Three cohorts of patients with severe sepsis were created: 1) ICD-9-CM codes for severe sepsis/septic shock, 2) ‘Martin’ approach, and 3) ‘Angus’ approach. The model was developed and internally validated in ICD-9-CM cohort and externally validated in other cohorts. Integer point values for each predictor variable were generated to create a sepsis severity score. Setting Acute care, non-federal hospitals in NY, MD, FL, MI, and WA Subjects Patients in one of three severe sepsis cohorts: 1) explicitly coded (n=108,448), 2) Martin cohort (n=139,094), and 3) Angus cohort (n=523,637) Interventions None Measurements and Main Results Maximum likelihood estimation logistic regression to develop a predictive model for in-hospital mortality. Model calibration and discrimination assessed via Hosmer-Lemeshow goodness-of-fit (GOF) and C-statistics respectively. Primary cohort subset into risk deciles and observed versus predicted mortality plotted. GOF demonstrated p>0.05 for each cohort demonstrating sound calibration. C-statistic ranged from low of 0.709 (sepsis severity score) to high of 0.838 (Angus cohort) suggesting good to excellent model discrimination. Comparison of observed versus expected mortality was robust although accuracy decreased in highest risk decile. Conclusions Our sepsis severity model and score is a tool that provides reliable risk adjustment for administrative data. PMID:26496452

Acute Kidney Injury Risk Prediction in Patients Undergoing Coronary Angiography in a National Veterans Health Administration Cohort With External Validation.

PubMed

Brown, Jeremiah R; MacKenzie, Todd A; Maddox, Thomas M; Fly, James; Tsai, Thomas T; Plomondon, Mary E; Nielson, Christopher D; Siew, Edward D; Resnic, Frederic S; Baker, Clifton R; Rumsfeld, John S; Matheny, Michael E

2015-12-11

Acute kidney injury (AKI) occurs frequently after cardiac catheterization and percutaneous coronary intervention. Although a clinical risk model exists for percutaneous coronary intervention, no models exist for both procedures, nor do existing models account for risk factors prior to the index admission. We aimed to develop such a model for use in prospective automated surveillance programs in the Veterans Health Administration. We collected data on all patients undergoing cardiac catheterization or percutaneous coronary intervention in the Veterans Health Administration from January 01, 2009 to September 30, 2013, excluding patients with chronic dialysis, end-stage renal disease, renal transplant, and missing pre- and postprocedural creatinine measurement. We used 4 AKI definitions in model development and included risk factors from up to 1 year prior to the procedure and at presentation. We developed our prediction models for postprocedural AKI using the least absolute shrinkage and selection operator (LASSO) and internally validated using bootstrapping. We developed models using 115 633 angiogram procedures and externally validated using 27 905 procedures from a New England cohort. Models had cross-validated C-statistics of 0.74 (95% CI: 0.74-0.75) for AKI, 0.83 (95% CI: 0.82-0.84) for AKIN2, 0.74 (95% CI: 0.74-0.75) for contrast-induced nephropathy, and 0.89 (95% CI: 0.87-0.90) for dialysis. We developed a robust, externally validated clinical prediction model for AKI following cardiac catheterization or percutaneous coronary intervention to automatically identify high-risk patients before and immediately after a procedure in the Veterans Health Administration. Work is ongoing to incorporate these models into routine clinical practice. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Predicting non-familial major physical violent crime perpetration in the US Army from administrative data.

PubMed

Rosellini, A J; Monahan, J; Street, A E; Heeringa, S G; Hill, E D; Petukhova, M; Reis, B Y; Sampson, N A; Bliese, P; Schoenbaum, M; Stein, M B; Ursano, R J; Kessler, R C

2016-01-01

Although interventions exist to reduce violent crime, optimal implementation requires accurate targeting. We report the results of an attempt to develop an actuarial model using machine learning methods to predict future violent crimes among US Army soldiers. A consolidated administrative database for all 975 057 soldiers in the US Army in 2004-2009 was created in the Army Study to Assess Risk and Resilience in Servicemembers (Army STARRS). Of these soldiers, 5771 committed a first founded major physical violent crime (murder-manslaughter, kidnapping, aggravated arson, aggravated assault, robbery) over that time period. Temporally prior administrative records measuring socio-demographic, Army career, criminal justice, medical/pharmacy, and contextual variables were used to build an actuarial model for these crimes separately among men and women using machine learning methods (cross-validated stepwise regression, random forests, penalized regressions). The model was then validated in an independent 2011-2013 sample. Key predictors were indicators of disadvantaged social/socioeconomic status, early career stage, prior crime, and mental disorder treatment. Area under the receiver-operating characteristic curve was 0.80-0.82 in 2004-2009 and 0.77 in the 2011-2013 validation sample. Of all administratively recorded crimes, 36.2-33.1% (male-female) were committed by the 5% of soldiers having the highest predicted risk in 2004-2009 and an even higher proportion (50.5%) in the 2011-2013 validation sample. Although these results suggest that the models could be used to target soldiers at high risk of violent crime perpetration for preventive interventions, final implementation decisions would require further validation and weighing of predicted effectiveness against intervention costs and competing risks.

Predicting non-familial major physical violent crime perpetration in the U.S. Army from administrative data

PubMed Central

Rosellini, Anthony J.; Monahan, John; Street, Amy E.; Heeringa, Steven G.; Hill, Eric D.; Petukhova, Maria; Reis, Ben Y.; Sampson, Nancy A.; Bliese, Paul; Schoenbaum, Michael; Stein, Murray B.; Ursano, Robert; Kessler, Ronald C.

2016-01-01

BACKGROUND Although interventions exist to reduce violent crime, optimal implementation requires accurate targeting. We report the results of an attempt to develop an actuarial model using machine learning methods to predict future violent crimes among U.S. Army soldiers. METHODS A consolidated administrative database for all 975,057 soldiers in the U.S. Army in 2004-2009 was created in the Army Study to Assess Risk and Resilience in Servicemembers (Army STARRS). 5,771 of these soldiers committed a first founded major physical violent crime (murder-manslaughter, kidnapping, aggravated arson, aggravated assault, robbery) over that time period. Temporally prior administrative records measuring socio-demographic, Army career, criminal justice, medical/pharmacy, and contextual variables were used to build an actuarial model for these crimes separately among men and women using machine learning methods (cross-validated stepwise regression; random forests; penalized regressions). The model was then validated in an independent 2011-2013 sample. RESULTS Key predictors were indicators of disadvantaged social/socio-economic status, early career stage, prior crime, and mental disorder treatment. Area under the receiver operating characteristic curve was .80-.82 in 2004-2009 and .77 in a 2011-2013 validation sample. 36.2-33.1% (male-female) of all administratively-recorded crimes were committed by the 5% of soldiers having highest predicted risk in 2004-2009 and an even higher proportion (50.5%) in the 2011-2013 validation sample. CONCLUSIONS Although these results suggest that the models could be used to target soldiers at high risk of violent crime perpetration for preventive interventions, final implementation decisions would require further validation and weighing of predicted effectiveness against intervention costs and competing risks. PMID:26436603

Development and validation of an administrative case definition for inflammatory bowel diseases

PubMed Central

Rezaie, Ali; Quan, Hude; Fedorak, Richard N; Panaccione, Remo; Hilsden, Robert J

2012-01-01

BACKGROUND: A population-based database of inflammatory bowel disease (IBD) patients is invaluable to explore and monitor the epidemiology and outcome of the disease. In this context, an accurate and validated population-based case definition for IBD becomes critical for researchers and health care providers. METHODS: IBD and non-IBD individuals were identified through an endoscopy database in a western Canadian health region (Calgary Health Region, Calgary, Alberta). Subsequently, using a novel algorithm, a series of case definitions were developed to capture IBD cases in the administrative databases. In the second stage of the study, the criteria were validated in the Capital Health Region (Edmonton, Alberta). RESULTS: A total of 150 IBD case definitions were developed using 1399 IBD patients and 15,439 controls in the development phase. In the validation phase, 318,382 endoscopic procedures were searched and 5201 IBD patients were identified. After consideration of sensitivity, specificity and temporal stability of each validated case definition, a diagnosis of IBD was assigned to individuals who experienced at least two hospitalizations or had four physician claims, or two medical contacts in the Ambulatory Care Classification System database with an IBD diagnostic code within a two-year period (specificity 99.8%; sensitivity 83.4%; positive predictive value 97.4%; negative predictive value 98.5%). An alternative case definition was developed for regions without access to the Ambulatory Care Classification System database. A novel scoring system was developed that detected Crohn disease and ulcerative colitis patients with a specificity of >99% and a sensitivity of 99.1% and 86.3%, respectively. CONCLUSION: Through a robust methodology, a reproducible set of criteria to capture IBD patients through administrative databases was developed. The methodology may be used to develop similar administrative definitions for chronic diseases. PMID:23061064

Development, validation, and administration of a treatment-satisfaction questionnaire for caregivers of dependent type 2 diabetic patients.

PubMed

García-Aparicio, Judit; Herrero-Herrero, José-Ignacio

2015-01-01

Satisfaction with treatment is considered a relevant factor for assessing results in clinical practice. However, when assessing satisfaction in dependent patients, the opinion of their caregivers becomes crucial, since implicit in satisfaction is the degree of caregiver involvement, of adherence to treatment, and lastly of better care of these patients. The purpose of this study was to develop, validate, and administer two versions of a specific questionnaire to assess satisfaction with blood glucose-lowering treatment in caregivers of dependent type 2 diabetic patients. This was an observational, descriptive, epidemiological study conducted in the Los Montalvos Internal Medicine Department at the University Hospital of Salamanca (Spain). Two versions of the questionnaire to assess caregivers' satisfaction with current treatment and after introducing changes in therapy were created and validated according to model procedures. Once validated, the questionnaires were implemented in 219 cases. Cronbach's α-coefficient, correlation between all the items, intraclass correlation coefficient, and correlation between the obtained scores and satisfaction with blood glucose levels all satisfied the standard for validation. Significant levels of correlation were observed between the degree of satisfaction and the number of daily administrations of the blood glucose-lowering medication (Spearman's r=-0.21, P<0.05). Caregivers of patients receiving more frequent administration of their antidiabetic medication prior to the change were more satisfied with the change (r=0.24, P<0.001). Similarly, significant correlation was found between the number of daily administrations for blood glucose-lowering medication after the change and the degree of satisfaction (r=-0.43, P<0.001). A useful novel instrument to assess caregivers' satisfaction was validated. When applied to our cohort of cases, the obtained data suggest that simplicity in antidiabetic therapy should be considered in the management of dependent type 2 diabetic patients when caregivers' satisfaction is an additional objective.

Implementation strategies influence the structure, process and outcome of quality systems: an empirical study of hospital departments in Sweden.

PubMed

Kunkel, S; Rosenqvist, U; Westerling, R

2009-02-01

To analyse whether the organisation of quality systems (structure, process, and outcome) is related to how these systems were implemented (implementation prerequisites, cooperation between managers and staff, and source of initiative). A questionnaire was developed, piloted and distributed to 600 hospital departments. Questions were included to reflect implementation prerequisites (adequate resources, competence, problem-solving capacity and high expectations), cooperative implementation, source of initiative (manager, staff and purchaser), structure (resources and administration), process (culture and cooperation) and outcome (goal evaluation and competence development). The adjusted response rate was 75%. Construct validity and reliability was assessed by confirmatory factor analysis, and Cronbach alpha scores were calculated. The relationships among the variables were analysed with structural equation modelling with LISREL. Implementation prerequisites were highly related to structure (0.51) and process (0.33). Cooperative implementation was associated with process (0.26) and outcome (0.34). High manager initiative was related to structure (0.19) and process (0.17). The numbers in parentheses can be interpreted as correlations. Construct validity was good, and reliability was excellent for all factors (Cronbach alpha>0.78). The model was a good representation of reality (model fit p value = 0.082). The implementation of organisationally demanding quality systems may require managers to direct and lead the process while assuring that their staff get opportunities to contribute to the planning and designing of the new system. This would correspond to a cooperative implementation strategy rather than to top-down or bottom-up strategies. The results of this study could be used to adjust implementation processes.

Accuracy of Canadian health administrative databases in identifying patients with rheumatoid arthritis: a validation study using the medical records of rheumatologists.

PubMed

Widdifield, Jessica; Bernatsky, Sasha; Paterson, J Michael; Tu, Karen; Ng, Ryan; Thorne, J Carter; Pope, Janet E; Bombardier, Claire

2013-10-01

Health administrative data can be a valuable tool for disease surveillance and research. Few studies have rigorously evaluated the accuracy of administrative databases for identifying rheumatoid arthritis (RA) patients. Our aim was to validate administrative data algorithms to identify RA patients in Ontario, Canada. We performed a retrospective review of a random sample of 450 patients from 18 rheumatology clinics. Using rheumatologist-reported diagnosis as the reference standard, we tested and validated different combinations of physician billing, hospitalization, and pharmacy data. One hundred forty-nine rheumatology patients were classified as having RA and 301 were classified as not having RA based on our reference standard definition (study RA prevalence 33%). Overall, algorithms that included physician billings had excellent sensitivity (range 94-100%). Specificity and positive predictive value (PPV) were modest to excellent and increased when algorithms included multiple physician claims or specialist claims. The addition of RA medications did not significantly improve algorithm performance. The algorithm of "(1 hospitalization RA code ever) OR (3 physician RA diagnosis codes [claims] with ≥1 by a specialist in a 2-year period)" had a sensitivity of 97%, specificity of 85%, PPV of 76%, and negative predictive value of 98%. Most RA patients (84%) had an RA diagnosis code present in the administrative data within ±1 year of a rheumatologist's documented diagnosis date. We demonstrated that administrative data can be used to identify RA patients with a high degree of accuracy. RA diagnosis date and disease duration are fairly well estimated from administrative data in jurisdictions of universal health care insurance. Copyright © 2013 by the American College of Rheumatology.

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.

Development and validation of a liquid chromatography mass spectrometry assay for the simultaneous quantification of methadone, cocaine, opiates and metabolites in human umbilical cord

PubMed Central

de Castro, Ana; Concheiro, Marta; Shakleya, Diaa M.; Huestis, Marilyn A.

2011-01-01

A liquid chromatography mass spectrometric selected reaction monitoring mode (SRM) method for methadone, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), cocaine, benzoylecgonine (BE), 6-acetylmorphine, morphine and codeine quantification in human umbilical cord was developed and fully validated. Analytes were extracted from homogenized tissue (1 g) by solid phase extraction. Linearity was 2.5–500 ng/g, except for methadone (10–2000 ng/g). Method imprecision was <12.7%CV with analytical recovery 85.9–112.7%, extraction efficiency >59.2%, matrix effect 4.5–39.5%, process efficiency 48.6–92.6% and stability >84.6%. Analysis of an umbilical cord following controlled methadone administration and illicit drug use contained in ng/g, 40.3 morphine, 3.6 codeine, 442 BE, 186 methadone and 45.9 EDDP. PMID:19656745

Design and testing of classroom and clinical teaching evaluation tools for nursing education.

PubMed

Emerson, Roberta J; Records, Kathie

2007-01-01

Student evaluations of teaching provide administrators an overall picture of the effectiveness of personnel and contribute data for promotion and merit decisions. These evaluations must be assessed for their relevance, validity, and reliability. This paper describes the development process and psychometric testing for clinical (n = 149) and didactic (n = 148) student evaluation of teaching forms for undergraduate and graduate courses in one college of nursing. Validity and reliability results were quite strong for the instruments, both of which evidenced a one-factor solution with factor loadings ranging from .68-.88 and Cronbach's alphas of .96 (Classroom) and .95 (Clinical). The clinical and classroom evaluation tools are relatively short, decreasing the burden on students who need to complete the instruments for multiple instructors in any one semester. Initial testing of the psychometric properties of the tools supports their continued use in colleges of nursing.

Development of the Nonverbal Communication Skills of School Administrators Scale (NCSSAS): Validity, Reliability and Implementation Study

ERIC Educational Resources Information Center

Uzun, Tevfik

2017-01-01

The main purpose of this study is to develop a scale intended for identifying the school administrators' nonverbal communication skills, and establish the relationship between the nonverbal communication skills of school administrators and job performance of teachers. The study was conducted in three stages. The first stage involved the creation…

Establishing Construct Validity for Integrity Tests

DTIC Science & Technology

1993-06-01

College of Business Administration Department of Management and Organizations University of Iowa Iowa City, IA 52242 FINAL REPORT Establishing...Principal investigator: Deniz S. Ones Thesis Advisor: Frank L. Schmidt College of Business Administration Department of Management and...of Philosophy degree in Business Administration in the Graduate College of The University of Iowa June, 1993 Thesis supervisor: Professor Frank

Development and Validation of an Inductively Coupled Plasma Mass Spectrometry (ICP-MS) Method for Quantitative Analysis of Platinum in Plasma, Urine, and Tissues.

PubMed

Zhang, Ti; Cai, Shuang; Forrest, Wai Chee; Mohr, Eva; Yang, Qiuhong; Forrest, M Laird

2016-09-01

Cisplatin, a platinum chemotherapeutic, is one of the most commonly used chemotherapeutic agents for many solid tumors. In this work, we developed and validated an inductively coupled plasma mass spectrometry (ICP-MS) method for quantitative determination of platinum levels in rat urine, plasma, and tissue matrices including liver, brain, lungs, kidney, muscle, heart, spleen, bladder, and lymph nodes. The tissues were processed using a microwave accelerated reaction system (MARS) system prior to analysis on an Agilent 7500 ICP-MS. According to the Food and Drug Administration guidance for industry, bioanalytical validation parameters of the method, such as selectivity, accuracy, precision, recovery, and stability were evaluated in rat biological samples. Our data suggested that the method was selective for platinum without interferences caused by other presenting elements, and the lower limit of quantification was 0.5 ppb. The accuracy and precision of the method were within 15% variation and the recoveries of platinum for all tissue matrices examined were determined to be 85-115% of the theoretical values. The stability of the platinum-containing solutions, including calibration standards, stock solutions, and processed samples in rat biological matrices was investigated. Results indicated that the samples were stable after three cycles of freeze-thaw and for up to three months. © The Author(s) 2016.

Development and Validation of an Inductively Coupled Plasma Mass Spectrometry (ICP-MS) Method for Quantitative Analysis of Platinum in Plasma, Urine, and Tissues

PubMed Central

Zhang, Ti; Cai, Shuang; Forrest, Wai Chee; Mohr, Eva; Yang, Qiuhong; Forrest, M. Laird

2016-01-01

Cisplatin, a platinum chemotherapeutic, is one of the most commonly used chemotherapeutic agents for many solid tumors. In this work, we developed and validated an inductively coupled plasma mass spectrometry (ICP-MS) method for quantitative determination of platinum levels in rat urine, plasma, and tissue matrices including liver, brain, lungs, kidney, muscle, heart, spleen, bladder, and lymph nodes. The tissues were processed using a microwave accelerated reaction system (MARS) system prior to analysis on an Agilent 7500 ICP-MS. According to the Food and Drug Administration guidance for industry, bioanalytical validation parameters of the method, such as selectivity, accuracy, precision, recovery, and stability were evaluated in rat biological samples. Our data suggested that the method was selective for platinum without interferences caused by other presenting elements, and the lower limit of quantification was 0.5 ppb. The accuracy and precision of the method were within 15% variation and the recoveries of platinum for all tissue matrices examined were determined to be 85–115% of the theoretical values. The stability of the platinum-containing solutions, including calibration standards, stock solutions, and processed samples in rat biological matrices was investigated. Results indicated that the samples were stable after three cycles of freeze–thaw and for up to three months. PMID:27527103

The development of the PARENTS: a tool for parents to assess residents' non-technical skills in pediatric emergency departments.

PubMed

Moreau, Katherine A; Eady, Kaylee; Tang, Kenneth; Jabbour, Mona; Frank, Jason R; Campbell, Meaghan; Hamstra, Stanley J

2017-11-14

Parents can assess residents' non-technical skills (NTS) in pediatric emergency departments (EDs). There are no assessment tools, with validity evidence, for parental use in pediatric EDs. The purpose of this study was to develop the Parents' Assessment of Residents Enacting Non-Technical Skills (PARENTS) educational assessment tool and collect three sources of validity evidence (i.e., content, response process, internal structure) for it. We established content evidence for the PARENTS through interviews with physician-educators and residents, focus groups with parents, a literature review, and a modified nominal group technique with experts. We collected response process evidence through cognitive interviews with parents. To examine the internal structure evidence, we administered the PARENTS and performed exploratory factor analysis. Initially, a 20-item PARENTS was developed. Cognitive interviews led to the removal of one closed-ended item, the addition of resident photographs, and wording/formatting changes. Thirty-seven residents and 434 parents participated in the administration of the resulting 19-item PARENTS. Following factor analysis, a one-factor model prevailed. The study presents initial validity evidence for the PARENTS. It also highlights strategies for potentially: (a) involving parents in the assessment of residents, (b) improving the assessment of NTS in pediatric EDs, and (c) capturing parents' perspectives to improve the preparation of future physicians.

SMAP Verification and Validation Project - Final Report

NASA Technical Reports Server (NTRS)

Murry, Michael

2012-01-01

In 2007, the National Research Council (NRC) released the Decadal Survey of Earth science. In the future decade, the survey identified 15 new space missions of significant scientific and application value for the National Aeronautics and Space Administration (NASA) to undertake. One of these missions was the Soil Moisture Active Passive (SMAP) mission that NASA assigned to the Jet Propulsion Laboratory (JPL) in 2008. The goal of SMAP1 is to provide global, high resolution mapping of soil moisture and its freeze/thaw states. The SMAP project recently passed its Critical Design Review and is proceeding with its fabrication and testing phase.Verification and Validation (V&V) is widely recognized as a critical component in system engineering and is vital to the success of any space mission. V&V is a process that is used to check that a system meets its design requirements and specifications in order to fulfill its intended purpose. Verification often refers to the question "Have we built the system right?" whereas Validation asks "Have we built the right system?" Currently the SMAP V&V team is verifying design requirements through inspection, demonstration, analysis, or testing. An example of the SMAP V&V process is the verification of the antenna pointing accuracy with mathematical models since it is not possible to provide the appropriate micro-gravity environment for testing the antenna on Earth before launch.

Evidence-Based Best Practices for Outpatient Management of Warfarin.

PubMed

Rose, Adam J; Vaiana, Mary

2018-06-01

Many best practices have been described for organizing a clinic to manage warfarin. Although these practices may have face validity, they may not be based on empirical analysis. Here, we describe our decade-long effort to apply the Structure-Process-Outcome model of quality measurement as a basis for measuring and improving outpatient warfarin management in the Veterans Health Administration. The purpose of the article is to raise awareness of this body of work with pharmacists who could potentially incorporate the findings of this work into their own practice settings. We conclude with concrete suggestions for immediate implementation in clinical settings.

KSC-04pd1142

NASA Image and Video Library

2004-05-13

KENNEDY SPACE CENTER, FLA. -- Adm. Craig E. Steidle (center), NASA’s associate administrator, Office of Exploration Systems, tours the Orbiter Processing Facility on a visit to KSC. At left is Conrad Nagel, chief of the Shuttle Project Office. They are standing under the left wing and wheel well of the orbiter Discovery. The Office of Exploration Systems was established to set priorities and direct the identification, development and validation of exploration systems and related technologies to support the future space vision for America. Steidle’s visit included a tour of KSC to review the facilities and capabilities to be used to support the vision.

KSC-04pd1140

NASA Image and Video Library

2004-05-13

KENNEDY SPACE CENTER, FLA. -- Adm. Craig E. Steidle (center), NASA’s associate administrator, Office of Exploration Systems, listens to Conrad Nagel, chief of the Shuttle Project Office (right), during a tour of the Orbiter Processing Facility on a visit to KSC. They are standing under the orbiter Discovery. The Office of Exploration Systems was established to set priorities and direct the identification, development and validation of exploration systems and related technologies to support the future space vision for America. Steidle’s visit included a tour of KSC to review the facilities and capabilities to be used to support the vision.

KSC-04pd1141

NASA Image and Video Library

2004-05-13

KENNEDY SPACE CENTER, FLA. -- Adm. Craig E. Steidle (center), NASA’s associate administrator, Office of Exploration Systems, listens to Conrad Nagel, chief of the Shuttle Project Office (right), during a tour of the Orbiter Processing Facility on a visit to KSC. They are standing under the orbiter Discovery. The Office of Exploration Systems was established to set priorities and direct the identification, development and validation of exploration systems and related technologies to support the future space vision for America. Steidle’s visit included a tour of KSC to review the facilities and capabilities to be used to support the vision.

Content Validation of the Comprehension of Written Grammar Assessment for Deaf and Hard of Hearing Students

ERIC Educational Resources Information Center

Cannon, Joanna E.; Hubley, Anita M.

2014-01-01

Content validation is a crucial, but often neglected, component of good test development. In the present study, content validity evidence was collected to determine the degree to which elements (e.g., grammatical structures, items, picture responses, administration, and scoring instructions) of the Comprehension of Written Grammar (CWG) test are…

[Nurse's competence indicators: linguistic and cultural validation of the Nurse Competence Scale].

PubMed

Finotto, Stefano; Cantarelli, William

2009-01-01

For some years, the clinical performance of new-graduate nurses, has been a leading topic in international scientific literature. In Italy there are many criticisms to basic education; ever since the basic education moved from the regional schools to the university, the main question that the teachers, the clinical nurses and the nursing managers are asking is whether the level of competence of new-graduates is appropriate to the demands of the world of work. Many criticisms have been addressed to the gap between theory and practice and between education and clinic. In Italy this has stimulated a debate towards a shared definition of competence and especially towards defining indicators that can assess/measure this phenomenon. The purposes of this study are: translating the indicators of Nurse Competence Scale (NCS) in the Italian language and test its validity and reliability; provide a tool for evaluating competence in Italian in order to use it in the context of our country. after a research on the Medline and Cinhal electronic data base, the NCS was identified and submitted to a process of linguistic translation (English-Italian-English) and to a process of validation using the test-retest methodology (test of Wilcoxon), the Intraclass Correlation Coefficient (ICC) and Cronbach's alpha. the evaluation given by nurses in the first administration does not differ significantly with those of the second one. For all sections of the NCS the ICC reports values greater than 0.85. the Nurse Competence Scale appears valid in its Italian version and it might be used to measure the competences of Italian nurses.

Validation of a treatment satisfaction questionnaire in non-Hodgkin lymphoma: assessing the change from intravenous to subcutaneous administration of rituximab.

PubMed

Theodore-Oklota, Christina; Humphrey, Louise; Wiesner, Christof; Schnetzler, Gabriel; Hudgens, Stacie; Campbell, Alicyn

2016-01-01

A subcutaneous (SC) formulation of rituximab (MabThera ® /Rituxan ® ) has been developed that could reduce administration time and improve patient satisfaction with treatment. The Rituximab Administration Satisfaction Questionnaire (RASQ) was created to assess patients' perceptions and satisfaction with rituximab SC (RASQ-SC) or rituximab intravenous (RASQ-IV). We assessed the content validity and psychometric properties of RASQ in patients with non-Hodgkin lymphoma. Face and content validity of RASQ-SC and RASQ-IV were qualitatively assessed using 60-minute combined concept elicitation and cognitive debriefing interviews. Psychometric validation of RASQ (item performance and reliability) was assessed quantitatively against the established Cancer Therapy Satisfaction Questionnaire (CTSQ), using questionnaire data from the PrefMab (NCT01724021) and MabCute (NCT01461928) clinical studies. RASQ-IV demonstrated excellent coverage of concepts relevant to patients' (n=10) own treatment experiences and no new concepts were identified. Patients' expectations of rituximab SC were conceptually consistent with items included in the RASQ-SC, suggesting that the tool is also conceptually adequate. In 1,051 patients from PrefMab and MabCute, correlations with domains such as "RASQ: Physical Impacts" and "CTSQ: Feelings About Side Effects", "RASQ: Physical Impacts" and "CTSQ: Satisfaction With Therapy", and "RASQ: Satisfaction" and "CTSQ: Satisfaction With Therapy", achieved moderate-to-high correlations (>0.4) for convergent domains and <0.3 for divergent domains. This study supports the qualitative face and content validity and psychometric validity of RASQ-IV and RASQ-SC. Minor revisions were made to the questionnaires to enhance clarity and aid consistent reporting.

Process evaluation of a primary healthcare validation study of a culturally adapted depression screening tool for use by Aboriginal and Torres Strait Islander people: study protocol.

PubMed

Farnbach, Sara; Evans, John; Eades, Anne-Marie; Gee, Graham; Fernando, Jamie; Hammond, Belinda; Simms, Matty; DeMasi, Karrina; Hackett, Maree

2017-11-03

Process evaluations are conducted alongside research projects to identify the context, impact and consequences of research, determine whether it was conducted per protocol and to understand how, why and for whom an intervention is effective. We present a process evaluation protocol for the Getting it Right research project, which aims to determine validity of a culturally adapted depression screening tool for use by Aboriginal and Torres Strait Islander people. In this process evaluation, we aim to: (1) explore the context, impact and consequences of conducting Getting It Right, (2) explore primary healthcare staff and community representatives' experiences with the research project, (3) determine if it was conducted per protocol and (4) explore experiences with the depression screening tool, including perceptions about how it could be implemented into practice (if found to be valid). We also describe the partnerships established to conduct this process evaluation and how the national Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research is met. Realist and grounded theory approaches are used. Qualitative data include semistructured interviews with primary healthcare staff and community representatives involved with Getting it Right. Iterative data collection and analysis will inform a coding framework. Interviews will continue until saturation of themes is reached, or all participants are considered. Data will be triangulated against administrative data and patient feedback. An Aboriginal and Torres Strait Islander Advisory Group guides this research. Researchers will be blinded from validation data outcomes for as long as is feasible. The University of Sydney Human Research Ethics Committee, Aboriginal Health and Medical Research Council of New South Wales and six state ethics committees have approved this research. Findings will be submitted to academic journals and presented at conferences. ACTRN12614000705684. © 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.

Development and initial validation of an endoscopic part-task training box.

PubMed

Thompson, Christopher C; Jirapinyo, Pichamol; Kumar, Nitin; Ou, Amy; Camacho, Andrew; Lengyel, Balazs; Ryan, Michele B

2014-09-01

There is currently no objective and validated methodology available to assess the progress of endoscopy trainees or to determine when technical competence has been achieved. The aims of the current study were to develop an endoscopic part-task simulator and to assess scoring system validity. Fundamental endoscopic skills were determined via kinematic analysis, literature review, and expert interviews. Simulator prototypes and scoring systems were developed to reflect these skills. Validity evidence for content, internal structure, and response process was evaluated. The final training box consisted of five modules (knob control, torque, retroflexion, polypectomy, and navigation and loop reduction). A total of 5 minutes were permitted per module with extra points for early completion. Content validity index (CVI)-realism was 0.88, CVI-relevance was 1.00, and CVI-representativeness was 0.88, giving a composite CVI of 0.92. Overall, 82 % of participants considered the simulator to be capable of differentiating between ability levels, and 93 % thought the simulator should be used to assess ability prior to performing procedures in patients. Inter-item assessment revealed correlations from 0.67 to 0.93, suggesting that tasks were sufficiently correlated to assess the same underlying construct, with each task remaining independent. Each module represented 16.0 % - 26.1 % of the total score, suggesting that no module contributed disproportionately to the composite score. Average box scores were 272.6 and 284.4 (P = 0.94) when performed sequentially, and average score for all participants with proctor 1 was 297.6 and 308.1 with proctor 2 (P = 0.94), suggesting reproducibility and minimal error associated with test administration. A part-task training box and scoring system were developed to assess fundamental endoscopic skills, and validity evidence regarding content, internal structure, and response process was demonstrated. © Georg Thieme Verlag KG Stuttgart · New York.

Implementation of remaining service interval concept.

DOT National Transportation Integrated Search

2016-10-01

This document is a technical summary of the Federal Highway Administration (FHWA) report, "Application and Validation of RSI Framework to Pavements" (FHWA-HRT-16-053). The goal of this project was to demonstrate and to validate the application of the...

[Aseptic process validation and stability study of an injectable preparation of fructose (5%)-glycerol (10%) as part of a hospital clinical research program on endoscopic curative treatment for early epithelial neoplastic lesions of the gastrointestinal tract].

PubMed

Tall, M L; Salmon, D; Diouf, E; Drai, J; Filali, S; Lépilliez, V; Pioche, M; Laleye, D; Dhelens, C; Ponchon, T; Pivot, C; Pirot, F

2015-03-01

As part of a hospital clinical research program on endoscopic curative treatment for early epithelial neoplastic lesions of the gastrointestinal tract, a new hospital sterile and non-pyrogenic preparation of fructose (5%)-glycerol (10%) was realized. Under pharmaceutical legislation, the provision of this hospital preparation involves of aseptic process validation and achieve a stability study. After the aseptic process validation with Mediafill Test, the preparation was made under aseptic conditions associated with a sterilizing filtration according to the good practices preparation. Prepared flexible bags (100mL of solution) were stored for one year in a climatic chamber (25±2°C). To assess stability, the physicochemical controls (fructose concentration, glycerol concentration, hydroxy-methyl-5 furfural [5-HMF] concentration, sodium concentration, pH measure, osmolality and sub-visible particles count) and microbiological (bioburden, bacterial endotoxin and sterility) were performed at regular intervals for one year. Neither significant decrease of fructose concentration, glycerol concentration and sodium concentration nor pH, 5-HMF, osmolality variations out of specifications were observed for one year. The sub-visible particles count, the bacterial endotoxin and sterility were in accordance with the European pharmacopoeia attesting limpidity, apyrogenicity and sterility of this injectable preparation. The hospital preparation was stable over one year at 25±2°C, ensuring safe administration in humans within the framework of this clinical research. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Determination of growth hormone releasing peptides metabolites in human urine after nasal administration of GHRP-1, GHRP-2, GHRP-6, Hexarelin, and Ipamorelin.

PubMed

Semenistaya, Ekaterina; Zvereva, Irina; Thomas, Andreas; Thevis, Mario; Krotov, Grigory; Rodchenkov, Grigory

2015-10-01

Growth hormone releasing peptides (GHRPs) stimulate secretion of endogenous growth hormone and are listed on the World Anti-Doping Agency (WADA) Prohibited List. To develop an effective method for GHRPs anti-doping control we have investigated metabolites of GHRP-1, GHRP-2, GHRP-6, Hexarelin, and Ipamorelin in urine after nasal administration. Each compound was administrated to one volunteer. Samples were collected for 2 days after administration, processed by solid-phase extraction on weak cation exchange cartridges and analyzed by means of nano-liquid chromatography - high resolution mass spectrometry. Six metabolites of GHRP-1 were identified. GHRP-1 in the parent form was not detected. GHRP-1 (2-4) free acid was detected in urine up to 27 h. GHRP-2, GHRP-2 free acid and GHRP-2 (1-3) free acid were detected in urine up to 47 h after administration. GHRP-6 was mostly excreted unchanged and detected in urine 23 h after administration, its metabolites were detectable for 12 h only. Hexarelin and Ipamorelin metabolized intensively and were excreted as a set of parent compounds with metabolites. Hexarelin (1-3) free acid and Ipamorelin (1-4) free acid were detected in urine samples after complete withdrawal of parent substances. GHRPs and their most prominent metabolites were included into routine ultra-pressure liquid chromatography-tandem mass spectrometry procedure. The method was fully validated, calibration curves of targeted analytes were obtained and excretion curves of GHRPs and their metabolites were plotted. Our results confirm that the detection window after GHRPs administration depends on individual metabolism, drug preparation form and the way of administration. Copyright © 2015 John Wiley & Sons, Ltd.

20 CFR 418.3625 - What is the process for administrative review?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false What is the process for administrative review... Medicare Part D Subsidies Determinations and the Administrative Review Process § 418.3625 What is the process for administrative review? The process for administrative review of initial determinations is...

Training and Proficiency Testing for Commuter and Air Taxi Pilots - Federal Aviation Administration

DOT National Transportation Integrated Search

1996-10-21

The objective of this audit was to determine whether the Federal Aviation : Administration (FAA) has established procedures and oversight controls to assure : that commuter and air taxi pilots, engaged in passenger-carrying operations, : hold valid p...

DoD STINFO Manager Training Course. Training Manual

DTIC Science & Technology

1993-02-01

The Export Control Classification Number ( ECCN ) 2. Types of controls, e.g., COCOM 3. Requirements, such as: a. Country groups for which a validated...see Export Administration Act EAR - see Export Administration Regulations ECCN - Export Control Classification Number ELINT - Electronic

SMAP validation of soil moisture products

USDA-ARS?s Scientific Manuscript database

The Soil Moisture Active Passive (SMAP) satellite will be launched by the National Aeronautics and Space Administration in October 2014. SMAP will also incorporate a rigorous calibration and validation program that will support algorithm refinement and provide users with information on the accuracy ...

Documentation of validity for the AT-SAT computerized test battery. Volume 2

DOT National Transportation Integrated Search

2001-03-01

This document is a comprehensive report on a large-scale research project to develop and validate a : computerized selection battery to hire Air Traffic Control Specialists (ATCSs) for the Federal Aviation : Administration (FAA). The purpose of this ...

Documentation of validity for the AT-SAT computerized test battery. Volume 1

DOT National Transportation Integrated Search

2001-03-01

This document is a comprehensive report on a large-scale research project to develop and validate a : computerized selection battery to hire Air Traffic Control Specialists (ATCSs) for the Federal Aviation : Administration (FAA). The purpose of this ...

The new millennium program: Fast-track procurements

NASA Astrophysics Data System (ADS)

Metzger, Robert M.

1996-11-01

The National Aeronautics and Space Administration's (NASA's) New Millennium Program (NMP) has embarked on a technology flight-validation demonstration program to enable the kinds of missions that NASA envisions for the 21st century. Embedded in this program is the concept of rapid mission development supported by a fast-track procurement process. This process begins with the decision to initiate a procurement very early in the program along with the formation of a technical acquisition team. A close working relationship among the team members is essential to avoiding delays and developing a clear acquisition plan. The request for proposal (RFP) that is subsequently issued seeks a company with proven capabilities, so that the time allotted for responses from proposers and the length of proposals they submit can be shortened. The fast-track procurement process has been demonstrated during selection of NMP's industrial partners and has been proven to work.

Defining a Mechanism of Educational Interface Between NASA Life Sciences the Nation's Students

NASA Technical Reports Server (NTRS)

Chamberland, D.; Dreschel, T.; Coulter, G.

1995-01-01

Harnessing our greatest national resource, as represented by the nation's students, will require a thoughtful, well developed and administered program that includes precise, executable strategies and valid evaluation tools. Responding to a national education outreach priority, the National Aeronautics and Space Administration's Life and Biomedical Sciences and Applications Division has initiated a process or organizing and implementing various strategies through a steering committee that includes representatives from Headquarters and three field centers with major Life Sciences programs. The mandate of the Life Sciences Education Outreach Steering Committee is to develop ways of communicating space life science issues to America's students through the nation's teachers by curriculum enhancement and direct participation in the education process with an emphasis in the primary and secondary schools. Metrics are also developed for each individually defined process so that the mechanis can be continuously refined and improved.

Development and validation of an RP-HPLC method for the quantitation of odanacatib in rat and human plasma and its application to a pharmacokinetic study.

PubMed

Police, Anitha; Gurav, Sandip; Dhiman, Vinay; Zainuddin, Mohd; Bhamidipati, Ravi Kanth; Rajagopal, Sriram; Mullangi, Ramesh

2015-11-01

A simple, specific, sensitive and reproducible high-performance liquid chromatography (HPLC) assay method has been developed and validated for the estimation of odanacatib in rat and human plasma. The bioanalytical procedure involves extraction of odanacatib and itraconazole (internal standard, IS) from a 200 μL plasma aliquot with simple liquid-liquid extraction process. Chromatographic separation was achieved on a Symmetry Shield RP18 using an isocratic mobile phase at a flow rate of 0.7 mL/min. The UV detection wave length was 268 nm. Odanacatib and IS eluted at 5.5 and 8.6 min, respectively with a total run time of 10 min. Method validation was performed as per US Food and Drug Administration guidelines and the results met the acceptance criteria. The calibration curve was linear over a concentration range of 50.9-2037 ng/mL (r(2) = 0.994). The intra- and inter-day precisions were in the range of 2.06-5.11 and 5.84-13.1%, respectively, in rat plasma and 2.38-7.90 and 6.39-10.2%, respectively, in human plasma. The validated HPLC method was successfully applied to a pharmacokinetic study in rats. Copyright © 2015 John Wiley & Sons, Ltd.

JPSS-1 Algorithm Updates and upgrades

NASA Astrophysics Data System (ADS)

Weinrich, J. A.

2017-12-01

The National Oceanic and Atmospheric Administration (NOAA) is acquiring the next-generation weather and environmental satellite system, named the Joint Polar Satellite System (JPSS). The Suomi National Polar-orbiting Partnership (S-NPP) satellite was launched on 28 October, 2011, and is a pathfinder for JPSS and provides continuity for the NASA Earth Observation System and the NOAA Polar-orbiting Operational Environmental Satellite (POES) system. JPSS-1 is scheduled to launch in 2017. NASA is developing the Common Ground System which will process JPSS data and has the flexibility to process data from other satellites. This presentation will review the JPSS readiness from a Calibration/Validation perspective. Examples of JPSS Readiness will be presented including algorithm and table updates. The outcomes will show the Cal/Val planning as we going into Launch in 2017.

Validity and reliability of an online visual-spatial working memory task for self-reliant administration in school-aged children.

PubMed

Van de Weijer-Bergsma, Eva; Kroesbergen, Evelyn H; Prast, Emilie J; Van Luit, Johannes E H

2015-09-01

Working memory is an important predictor of academic performance, and of math performance in particular. Most working memory tasks depend on one-to-one administration by a testing assistant, which makes the use of such tasks in large-scale studies time-consuming and costly. Therefore, an online, self-reliant visual-spatial working memory task (the Lion game) was developed for primary school children (6-12 years of age). In two studies, the validity and reliability of the Lion game were investigated. The results from Study 1 (n = 442) indicated satisfactory six-week test-retest reliability, excellent internal consistency, and good concurrent and predictive validity. The results from Study 2 (n = 5,059) confirmed the results on the internal consistency and predictive validity of the Lion game. In addition, multilevel analysis revealed that classroom membership influenced Lion game scores. We concluded that the Lion game is a valid and reliable instrument for the online computerized and self-reliant measurement of visual-spatial working memory (i.e., updating).

Performance of a Natural Language Processing (NLP) Tool to Extract Pulmonary Function Test (PFT) Reports from Structured and Semistructured Veteran Affairs (VA) Data.

PubMed

Sauer, Brian C; Jones, Barbara E; Globe, Gary; Leng, Jianwei; Lu, Chao-Chin; He, Tao; Teng, Chia-Chen; Sullivan, Patrick; Zeng, Qing

2016-01-01

Pulmonary function tests (PFTs) are objective estimates of lung function, but are not reliably stored within the Veteran Health Affairs data systems as structured data. The aim of this study was to validate the natural language processing (NLP) tool we developed-which extracts spirometric values and responses to bronchodilator administration-against expert review, and to estimate the number of additional spirometric tests identified beyond the structured data. All patients at seven Veteran Affairs Medical Centers with a diagnostic code for asthma Jan 1, 2006-Dec 31, 2012 were included. Evidence of spirometry with a bronchodilator challenge (BDC) was extracted from structured data as well as clinical documents. NLP's performance was compared against a human reference standard using a random sample of 1,001 documents. In the validation set NLP demonstrated a precision of 98.9 percent (95 percent confidence intervals (CI): 93.9 percent, 99.7 percent), recall of 97.8 percent (95 percent CI: 92.2 percent, 99.7 percent), and an F-measure of 98.3 percent for the forced vital capacity pre- and post pairs and precision of 100 percent (95 percent CI: 96.6 percent, 100 percent), recall of 100 percent (95 percent CI: 96.6 percent, 100 percent), and an F-measure of 100 percent for the forced expiratory volume in one second pre- and post pairs for bronchodilator administration. Application of the NLP increased the proportion identified with complete bronchodilator challenge by 25 percent. This technology can improve identification of PFTs for epidemiologic research. Caution must be taken in assuming that a single domain of clinical data can completely capture the scope of a disease, treatment, or clinical test.

Electronic health record use to classify patients with newly diagnosed versus preexisting type 2 diabetes: infrastructure for comparative effectiveness research and population health management.

PubMed

Kudyakov, Rustam; Bowen, James; Ewen, Edward; West, Suzanne L; Daoud, Yahya; Fleming, Neil; Masica, Andrew

2012-02-01

Use of electronic health record (EHR) content for comparative effectiveness research (CER) and population health management requires significant data configuration. A retrospective cohort study was conducted using patients with diabetes followed longitudinally (N=36,353) in the EHR deployed at outpatient practice networks of 2 health care systems. A data extraction and classification algorithm targeting identification of patients with a new diagnosis of type 2 diabetes mellitus (T2DM) was applied, with the main criterion being a minimum 30-day window between the first visit documented in the EHR and the entry of T2DM on the EHR problem list. Chart reviews (N=144) validated the performance of refining this EHR classification algorithm with external administrative data. Extraction using EHR data alone designated 3205 patients as newly diagnosed with T2DM with classification accuracy of 70.1%. Use of external administrative data on that preselected population improved classification accuracy of cases identified as new T2DM diagnosis (positive predictive value was 91.9% with that step). Laboratory and medication data did not help case classification. The final cohort using this 2-stage classification process comprised 1972 patients with a new diagnosis of T2DM. Data use from current EHR systems for CER and disease management mandates substantial tailoring. Quality between EHR clinical data generated in daily care and that required for population health research varies. As evidenced by this process for classification of newly diagnosed T2DM cases, validation of EHR data with external sources can be a valuable step.

Identification of pixels with stray light and cloud shadow contaminations in the satellite ocean color data processing.

PubMed

Jiang, Lide; Wang, Menghua

2013-09-20

A new flag/masking scheme has been developed for identifying stray light and cloud shadow pixels that significantly impact the quality of satellite-derived ocean color products. Various case studies have been carried out to evaluate the performance of the new cloud contamination flag/masking scheme on ocean color products derived from the Visible Infrared Imaging Radiometer Suite (VIIRS) onboard the Suomi National Polar-orbiting Partnership (SNPP). These include direct visual assessments, detailed quantitative case studies, objective statistic analyses, and global image examinations and comparisons. The National Oceanic and Atmospheric Administration (NOAA) Multisensor Level-1 to Level-2 (NOAA-MSL12) ocean color data processing system has been used in the study. The new stray light and cloud shadow identification method has been shown to outperform the current stray light flag in both valid data coverage and data quality of satellite-derived ocean color products. In addition, some cloud-related flags from the official VIIRS-SNPP data processing software, i.e., the Interface Data Processing System (IDPS), have been assessed. Although the data quality with the IDPS flags is comparable to that of the new flag implemented in the NOAA-MSL12 ocean color data processing system, the valid data coverage from the IDPS is significantly less than that from the NOAA-MSL12 using the new stray light and cloud shadow flag method. Thus, the IDPS flag/masking algorithms need to be refined and modified to reduce the pixel loss, e.g., the proposed new cloud contamination flag/masking can be implemented in IDPS VIIRS ocean color data processing.

Interdisciplinary Approach to the Development of Accessible Computer-Administered Measurement Instruments.

PubMed

Magasi, Susan; Harniss, Mark; Heinemann, Allen W

2018-01-01

Principles of fairness in testing require that all test takers, including people with disabilities, have an equal opportunity to demonstrate their capacity on the construct being measured. Measurement design features and assessment protocols can pose barriers for people with disabilities. Fairness in testing is a fundamental validity issue at all phases in the design, administration, and interpretation of measurement instruments in clinical practice and research. There is limited guidance for instrument developers on how to develop and evaluate the accessibility and usability of measurement instruments. This article describes a 6-stage iterative process for developing accessible computer-administered measurement instruments grounded in the procedures implemented across several major measurement initiatives. A key component of this process is interdisciplinary teams of accessibility experts, content and measurement experts, information technology experts, and people with disabilities working together to ensure that measurement instruments are accessible and usable by a wide range of users. The development of accessible measurement instruments is not only an ethical requirement, it also ensures better science by minimizing measurement bias, missing data, and attrition due to mismatches between the target population and test administration platform and protocols. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Does the COPD assessment test (CAT(TM)) questionnaire produce similar results when self- or interviewer administered?

PubMed

Agusti, A; Soler-Cataluña, J J; Molina, J; Morejon, E; Garcia-Losa, M; Roset, M; Badia, X

2015-10-01

The COPD assessment test (CAT) is a questionnaire that assesses the impact of chronic obstructive pulmonary disease (COPD) on health status, but some patients have difficulties filling it up by themselves. We examined whether the mode of administration of the Spanish version of CAT (self vs. interviewer) influences its scores and/or psychometric properties. Observational, prospective study in 49 Spanish centers that includes clinically stable COPD patients (n = 153) and patients hospitalized because of an exacerbation (ECOPD; n = 224). The CAT was self-administered (CAT-SA) or administered by an interviewer (CAT-IA) based on the investigator judgment of the patient's capacity. To assess convergent validity, the Saint George's Respiratory Disease Questionnaire (SGRQ) and the London Chest Activity of Daily Living (LCADL) instrument were also administered. Psychometric properties were compared across modes of administration. A total of 118 patients (31 %) completed the CAT-SA and 259 (69 %) CAT-IA. Multiple regression analysis showed that mode of administration did not affect CAT scores. The CAT showed excellent psychometric properties in both modes of administration. Internal consistency coefficients (Cronbach's alpha) were high (0.86 for CAT-SA and 0.85 for CAT-IA) as was test-retest reliability (intraclass correlation coefficients of 0.83 for CAT-SA and CAT-IA). Correlations with SGRQ and LCADL were moderate to strong both in CAT-SA and CAT-IA, indicating good convergent validity. Similar results were observed when testing longitudinal validity. The mode of administration does not influence CAT scores or its psychometric properties. Hence, both modes of administration can be used in clinical practice depending on the physician judgment of patient's capacity.

Validity of administrative database code algorithms to identify vascular access placement, surgical revisions, and secondary patency.

PubMed

Al-Jaishi, Ahmed A; Moist, Louise M; Oliver, Matthew J; Nash, Danielle M; Fleet, Jamie L; Garg, Amit X; Lok, Charmaine E

2018-03-01

We assessed the validity of physician billing codes and hospital admission using International Classification of Diseases 10th revision codes to identify vascular access placement, secondary patency, and surgical revisions in administrative data. We included adults (≥18 years) with a vascular access placed between 1 April 2004 and 31 March 2013 at the University Health Network, Toronto. Our reference standard was a prospective vascular access database (VASPRO) that contains information on vascular access type and dates of placement, dates for failure, and any revisions. We used VASPRO to assess the validity of different administrative coding algorithms by calculating the sensitivity, specificity, and positive predictive values of vascular access events. The sensitivity (95% confidence interval) of the best performing algorithm to identify arteriovenous access placement was 86% (83%, 89%) and specificity was 92% (89%, 93%). The corresponding numbers to identify catheter insertion were 84% (82%, 86%) and 84% (80%, 87%), respectively. The sensitivity of the best performing coding algorithm to identify arteriovenous access surgical revisions was 81% (67%, 90%) and specificity was 89% (87%, 90%). The algorithm capturing arteriovenous access placement and catheter insertion had a positive predictive value greater than 90% and arteriovenous access surgical revisions had a positive predictive value of 20%. The duration of arteriovenous access secondary patency was on average 578 (553, 603) days in VASPRO and 555 (530, 580) days in administrative databases. Administrative data algorithms have fair to good operating characteristics to identify vascular access placement and arteriovenous access secondary patency. Low positive predictive values for surgical revisions algorithm suggest that administrative data should only be used to rule out the occurrence of an event.

Joint Test Report for Validation of Alternative Low-Emission Surface Preparation/Depainting Technologies for Structural Steel

NASA Technical Reports Server (NTRS)

Lewis, Pattie

2007-01-01

Headquarters National Aeronautics and Space Administration (NASA) chartered the NASA Acquisition Pollution Prevention (AP2) Office to coordinate agency activities affecting pollution prevention issues identified during system and component acquisition and sustainment processes. The primary objectives of the AP2 Office are to: (1) Reduce or eliminate the use of hazardous materials or hazardous processes at manufacturing, remanufacturing, and sustainment locations. (2) Avoid duplication of effort in actions required to reduce or eliminate hazardous materials through joint center cooperation and technology sharing. The objective of this project was to qualify candidate alternative Low-Emission Surface Preparation/Depainting Technologies for Structural Steel applications at NASA facilities. This project compares the surface preparation/depainting performance of the proposed alternatives to existing surface preparation/depainting systems or standards. This Joint Test Report (JTR) contains the results of testing as per the outlines of the Joint Test Protocol (JTP), Joint Test Protocol for Validation of Alternative Low-Emission Surface Preparation/Depainting Technologies for Structural Steel, and the Field Test Plan (FTP), Field Evaluations Test Plan for Validation of Alternative Low-Emission Surface Preparation/Depainting Technologies for Structural Steel, for critical requirements and tests necessary to qualify alternatives for coating removal systems. These tests were derived from engineering, performance, and operational impact (supportability) requirements defined by a consensus of government and industry participants. This JTR documents the results of the testing as well as any test modifications made during the execution of the project. This JTR is made available as a reference for future pollution prevention endeavors by other NASA Centers, the Department of Defense and commercial users to minimize duplication of effort. The current coating removal processes identified herein are for polyurethane, epoxy and other paint systems applied by conventional wet-spray processes. A table summarizes the target hazardous materials, processes and materials, applications, affected programs, and candidate substrates.

Independent verification and validation for Space Shuttle flight software

NASA Technical Reports Server (NTRS)

1992-01-01

The Committee for Review of Oversight Mechanisms for Space Shuttle Software was asked by the National Aeronautics and Space Administration's (NASA) Office of Space Flight to determine the need to continue independent verification and validation (IV&V) for Space Shuttle flight software. The Committee found that the current IV&V process is necessary to maintain NASA's stringent safety and quality requirements for man-rated vehicles. Therefore, the Committee does not support NASA's plan to eliminate funding for the IV&V effort in fiscal year 1993. The Committee believes that the Space Shuttle software development process is not adequate without IV&V and that elimination of IV&V as currently practiced will adversely affect the overall quality and safety of the software, both now and in the future. Furthermore, the Committee was told that no organization within NASA has the expertise or the manpower to replace the current IV&V function in a timely fashion, nor will building this expertise elsewhere necessarily reduce cost. Thus, the Committee does not recommend moving IV&V functions to other organizations within NASA unless the current IV&V is maintained for as long as it takes to build comparable expertise in the replacing organization.

Developing and testing an instrument for identifying performance incentives in the Greek health care sector.

PubMed

Paleologou, Victoria; Kontodimopoulos, Nick; Stamouli, Aggeliki; Aletras, Vassilis; Niakas, Dimitris

2006-09-13

In the era of cost containment, managers are constantly pursuing increased organizational performance and productivity by aiming at the obvious target, i.e. the workforce. The health care sector, in which production processes are more complicated compared to other industries, is not an exception. In light of recent legislation in Greece in which efficiency improvement and achievement of specific performance targets are identified as undisputable health system goals, the purpose of this study was to develop a reliable and valid instrument for investigating the attitudes of Greek physicians, nurses and administrative personnel towards job-related aspects, and the extent to which these motivate them to improve performance and increase productivity. A methodological exploratory design was employed in three phases: a) content development and assessment, which resulted in a 28-item instrument, b) pilot testing (N = 74) and c) field testing (N = 353). Internal consistency reliability was tested via Cronbach's alpha coefficient and factor analysis was used to identify the underlying constructs. Tests of scaling assumptions, according to the Multitrait-Multimethod Matrix, were used to confirm the hypothesized component structure. Four components, referring to intrinsic individual needs and external job-related aspects, were revealed and explain 59.61% of the variability. They were subsequently labeled: job attributes, remuneration, co-workers and achievement. Nine items not meeting item-scale criteria were removed, resulting in a 19-item instrument. Scale reliability ranged from 0.782 to 0.901 and internal item consistency and discriminant validity criteria were satisfied. Overall, the instrument appears to be a promising tool for hospital administrations in their attempt to identify job-related factors, which motivate their employees. The psychometric properties were good and warrant administration to a larger sample of employees in the Greek healthcare system.

Developing and testing an instrument for identifying performance incentives in the Greek health care sector

PubMed Central

Paleologou, Victoria; Kontodimopoulos, Nick; Stamouli, Aggeliki; Aletras, Vassilis; Niakas, Dimitris

2006-01-01

Background In the era of cost containment, managers are constantly pursuing increased organizational performance and productivity by aiming at the obvious target, i.e. the workforce. The health care sector, in which production processes are more complicated compared to other industries, is not an exception. In light of recent legislation in Greece in which efficiency improvement and achievement of specific performance targets are identified as undisputable health system goals, the purpose of this study was to develop a reliable and valid instrument for investigating the attitudes of Greek physicians, nurses and administrative personnel towards job-related aspects, and the extent to which these motivate them to improve performance and increase productivity. Methods A methodological exploratory design was employed in three phases: a) content development and assessment, which resulted in a 28-item instrument, b) pilot testing (N = 74) and c) field testing (N = 353). Internal consistency reliability was tested via Cronbach's alpha coefficient and factor analysis was used to identify the underlying constructs. Tests of scaling assumptions, according to the Multitrait-Multimethod Matrix, were used to confirm the hypothesized component structure. Results Four components, referring to intrinsic individual needs and external job-related aspects, were revealed and explain 59.61% of the variability. They were subsequently labeled: job attributes, remuneration, co-workers and achievement. Nine items not meeting item-scale criteria were removed, resulting in a 19-item instrument. Scale reliability ranged from 0.782 to 0.901 and internal item consistency and discriminant validity criteria were satisfied. Conclusion Overall, the instrument appears to be a promising tool for hospital administrations in their attempt to identify job-related factors, which motivate their employees. The psychometric properties were good and warrant administration to a larger sample of employees in the Greek healthcare system. PMID:16970823

Validation of the conceptual research utilization scale: an application of the standards for educational and psychological testing in healthcare

PubMed Central

2011-01-01

Background There is a lack of acceptable, reliable, and valid survey instruments to measure conceptual research utilization (CRU). In this study, we investigated the psychometric properties of a newly developed scale (the CRU Scale). Methods We used the Standards for Educational and Psychological Testing as a validation framework to assess four sources of validity evidence: content, response processes, internal structure, and relations to other variables. A panel of nine international research utilization experts performed a formal content validity assessment. To determine response process validity, we conducted a series of one-on-one scale administration sessions with 10 healthcare aides. Internal structure and relations to other variables validity was examined using CRU Scale response data from a sample of 707 healthcare aides working in 30 urban Canadian nursing homes. Principal components analysis and confirmatory factor analyses were conducted to determine internal structure. Relations to other variables were examined using: (1) bivariate correlations; (2) change in mean values of CRU with increasing levels of other kinds of research utilization; and (3) multivariate linear regression. Results Content validity index scores for the five items ranged from 0.55 to 1.00. The principal components analysis predicted a 5-item 1-factor model. This was inconsistent with the findings from the confirmatory factor analysis, which showed best fit for a 4-item 1-factor model. Bivariate associations between CRU and other kinds of research utilization were statistically significant (p < 0.01) for the latent CRU scale score and all five CRU items. The CRU scale score was also shown to be significant predictor of overall research utilization in multivariate linear regression. Conclusions The CRU scale showed acceptable initial psychometric properties with respect to responses from healthcare aides in nursing homes. Based on our validity, reliability, and acceptability analyses, we recommend using a reduced (four-item) version of the CRU scale to yield sound assessments of CRU by healthcare aides. Refinement to the wording of one item is also needed. Planned future research will include: latent scale scoring, identification of variables that predict and are outcomes to conceptual research use, and longitudinal work to determine CRU Scale sensitivity to change. PMID:21595888

Validity of Heart Failure Diagnoses in Administrative Databases: A Systematic Review and Meta-Analysis

PubMed Central

McCormick, Natalie; Lacaille, Diane; Bhole, Vidula; Avina-Zubieta, J. Antonio

2014-01-01

Objective Heart failure (HF) is an important covariate and outcome in studies of elderly populations and cardiovascular disease cohorts, among others. Administrative data is increasingly being used for long-term clinical research in these populations. We aimed to conduct the first systematic review and meta-analysis of studies reporting on the validity of diagnostic codes for identifying HF in administrative data. Methods MEDLINE and EMBASE were searched (inception to November 2010) for studies: (a) Using administrative data to identify HF; or (b) Evaluating the validity of HF codes in administrative data; and (c) Reporting validation statistics (sensitivity, specificity, positive predictive value [PPV], negative predictive value, or Kappa scores) for HF, or data sufficient for their calculation. Additional articles were located by hand search (up to February 2011) of original papers. Data were extracted by two independent reviewers; article quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies tool. Using a random-effects model, pooled sensitivity and specificity values were produced, along with estimates of the positive (LR+) and negative (LR−) likelihood ratios, and diagnostic odds ratios (DOR = LR+/LR−) of HF codes. Results Nineteen studies published from1999–2009 were included in the qualitative review. Specificity was ≥95% in all studies and PPV was ≥87% in the majority, but sensitivity was lower (≥69% in ≥50% of studies). In a meta-analysis of the 11 studies reporting sensitivity and specificity values, the pooled sensitivity was 75.3% (95% CI: 74.7–75.9) and specificity was 96.8% (95% CI: 96.8–96.9). The pooled LR+ was 51.9 (20.5–131.6), the LR− was 0.27 (0.20–0.37), and the DOR was 186.5 (96.8–359.2). Conclusions While most HF diagnoses in administrative databases do correspond to true HF cases, about one-quarter of HF cases are not captured. The use of broader search parameters, along with laboratory and prescription medication data, may help identify more cases. PMID:25126761

A European benchmarking system to evaluate in-hospital mortality rates in acute coronary syndrome: the EURHOBOP project.

PubMed

Dégano, Irene R; Subirana, Isaac; Torre, Marina; Grau, María; Vila, Joan; Fusco, Danilo; Kirchberger, Inge; Ferrières, Jean; Malmivaara, Antti; Azevedo, Ana; Meisinger, Christa; Bongard, Vanina; Farmakis, Dimitros; Davoli, Marina; Häkkinen, Unto; Araújo, Carla; Lekakis, John; Elosua, Roberto; Marrugat, Jaume

2015-03-01

Hospital performance models in acute myocardial infarction (AMI) are useful to assess patient management. While models are available for individual countries, mainly US, cross-European performance models are lacking. Thus, we aimed to develop a system to benchmark European hospitals in AMI and percutaneous coronary intervention (PCI), based on predicted in-hospital mortality. We used the EURopean HOspital Benchmarking by Outcomes in ACS Processes (EURHOBOP) cohort to develop the models, which included 11,631 AMI patients and 8276 acute coronary syndrome (ACS) patients who underwent PCI. Models were validated with a cohort of 55,955 European ACS patients. Multilevel logistic regression was used to predict in-hospital mortality in European hospitals for AMI and PCI. Administrative and clinical models were constructed with patient- and hospital-level covariates, as well as hospital- and country-based random effects. Internal cross-validation and external validation showed good discrimination at the patient level and good calibration at the hospital level, based on the C-index (0.736-0.819) and the concordance correlation coefficient (55.4%-80.3%). Mortality ratios (MRs) showed excellent concordance between administrative and clinical models (97.5% for AMI and 91.6% for PCI). Exclusion of transfers and hospital stays ≤1day did not affect in-hospital mortality prediction in sensitivity analyses, as shown by MR concordance (80.9%-85.4%). Models were used to develop a benchmarking system to compare in-hospital mortality rates of European hospitals with similar characteristics. The developed system, based on the EURHOBOP models, is a simple and reliable tool to compare in-hospital mortality rates between European hospitals in AMI and PCI. Copyright © 2015 Elsevier Ireland 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...

A Methionine-Induced Animal Model of Schizophrenia: Face and Predictive Validity.

PubMed

Wang, Lien; Alachkar, Amal; Sanathara, Nayna; Belluzzi, James D; Wang, Zhiwei; Civelli, Olivier

2015-05-19

Modulating the methylation process induces broad biochemical changes, some of which may be involved in schizophrenia. Methylation is in particular central to epigenesis, which is also recognized as a factor in the etiology of schizophrenia. Because methionine administration to patients with schizophrenia has been reported to exacerbate their psychotic symptoms and because mice treated with methionine exhibited social deficits and prepulse inhibition impairment, we investigated whether methionine administration could lead to behavioral changes that reflect schizophrenic symptoms in mice. l-Methionine was administered to mice twice a day for 7 days. We found that this treatment induces behavioral responses that reflect the 3 types of schizophrenia-like symptoms (positive, negative, or cognitive deficits) as monitored in a battery of behavioral assays (locomotion, stereotypy, social interaction, forced swimming, prepulse inhibition, novel object recognition, and inhibitory avoidance). Moreover, these responses were differentially reversed by typical haloperidol and atypical clozapine antipsychotics in ways that parallel their effects in schizophrenics. We thus propose the l-methionine treatment as an animal model recapitulating several symptoms of schizophrenia. We have established the face and predictive validity for this model. Our model relies on an essential natural amino acid and on an intervention that is relatively simple and time effective and may offer an additional tool for assessing novel antipsychotics. © The Author 2015. Published by Oxford University Press on behalf of CINP.

Weight concerns scale applied to college students: comparison between pencil-and-paper and online formats.

PubMed

Dias, Juliana Chioda Ribeiro; Maroco, João; Campos, Juliana Alvares Duarte Bonini

2015-03-01

Online data collection is becoming increasingly common and has some advantages compared to traditional paper-and-pencil formats, such as reducing loss of data, increasing participants' privacy, and decreasing the effect of social desirability. However, the validity and reliability of this administration format must be established before results can be considered acceptable. The aim of this study was to evaluate the validity, reliability, and equivalence of paper-and-pencil and online versions of the Weight Concerns Scale (WCS) when applied to Brazilian university students. A crossover design was used, and the Portuguese version of the WCS (in both paper-and-pencil and online formats) was completed by 100 college students. The results indicated adequate fit in both formats. The simultaneous fit of data for both groups was excellent, with strong invariance between models. Adequate convergent validity, internal consistency, and mean score equivalence of the WCS in both formats were observed. Thus, the WCS presented adequate reliability and validity in both administration formats, with equivalence/stability between answers.

Pitfalls of using administrative data sets to describe clinical outcomes in sickle cell disease.

PubMed

Claster, Susan; Termuhlen, Amanda; Schrager, Sheree M; Wolfson, Julie A; Iverson, Ellen

2013-12-01

Administrative data sets are increasingly being used to describe clinical care in sickle cell disease (SCD). We recently used such an administrative database to look at the frequency of acute chest syndrome (ACS) and the use of transfusion to treat this syndrome in California patients from 2005 to 2010. Our results revealed a surprisingly low rate of transfusion for this life-threatening situation. To validate these results, we compared California OSPHD (Office of Statewide Health Planning and Development) administrative data with medical record review of patients diagnosed with ACS identified by two pediatric and one adult hospital databases during 2009-2010. ACS or a related pulmonary process accounted for one-fifth of the inpatient hospital discharges associated with the diagnosis of SCD between 2005 and 2010. Only 47% of those discharges were associated with a transfusion. However, chart reviews found that hospital databases over-reported visits for ACS. OSHPD underreported transfusions compared to hospital data. The net effect was a markedly higher true rate of transfusion (40.7% vs. 70.2%). These results point out the difficulties in using this administrative data base to describe clinical care for ACS given the variation in clinician recognition of this entity. OSPHD is widely used to inform health care policy in California and contributes to national databases. Our study suggests that using this administrative database to assess clinical care for SCD may lead to inaccurate assumptions about quality of care for SCD patients in California. Future studies on health services in SCD may require a different methodology. © 2013 Wiley Periodicals, Inc.

Improving Efficiency Using Time-Driven Activity-Based Costing Methodology.

PubMed

Tibor, Laura C; Schultz, Stacy R; Menaker, Ronald; Weber, Bradley D; Ness, Jay; Smith, Paula; Young, Phillip M

2017-03-01

The aim of this study was to increase efficiency in MR enterography using a time-driven activity-based costing methodology. In February 2015, a multidisciplinary team was formed to identify the personnel, equipment, space, and supply costs of providing outpatient MR enterography. The team mapped the current state, completed observations, performed timings, and calculated costs associated with each element of the process. The team used Pareto charts to understand the highest cost and most time-consuming activities, brainstormed opportunities, and assessed impact. Plan-do-study-act cycles were developed to test the changes, and run charts were used to monitor progress. The process changes consisted of revising the workflow associated with the preparation and administration of glucagon, with completed implementation in November 2015. The time-driven activity-based costing methodology allowed the radiology department to develop a process to more accurately identify the costs of providing MR enterography. The primary process modification was reassigning responsibility for the administration of glucagon from nurses to technologists. After implementation, the improvements demonstrated success by reducing non-value-added steps and cost by 13%, staff time by 16%, and patient process time by 17%. The saved process time was used to augment existing examination time slots to more accurately accommodate the entire enterographic examination. Anecdotal comments were captured to validate improved staff satisfaction within the multidisciplinary team. This process provided a successful outcome to address daily workflow frustrations that could not previously be improved. A multidisciplinary team was necessary to achieve success, in addition to the use of a structured problem-solving approach. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

36 CFR 218.6 - Reviewing officer.

Code of Federal Regulations, 2010 CFR

2010-07-01

... ADMINISTRATIVE REVIEW PROCESSES Predecisional Administrative Review Process for Hazardous Fuel Reduction Projects... the administrative review processes of other Federal agencies, for authorized hazardous fuel reduction... administrative review. ...

75 FR 33637 - Agency Information Collection Activities: Proposed Collection; Comments Requested: National...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-14

... collection of information, including the validity of the methodology and assumptions used; Enhance the... Intelligence Center, Drug Enforcement Administration, U.S. Department of Justice. (4) Affected public who will... information to the El Paso Intelligence Center, Drug Enforcement Administration, and other Law enforcement...

20 CFR 658.418 - Decision of the State hearing official.

Code of Federal Regulations, 2011 CFR

2011-04-01

... consider the validity or constitutionality of JS regulations or of the Federal statutes under which they... Labor, room N2101, 200 Constitution Avenue, NW., Washington, DC, 20210. The notification to the... the Regional Administrator. The notice shall give the address of the Regional Administrator. Federal...

75 FR 74086 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Benefits...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-30

... Administration (ETA) sponsored information collection request (ICR) titled, ``Benefits Timeliness and Quality... information and analyzes data. BTQ data measure the timeliness and quality of states' administrative actions... of information, including the validity of the methodology and assumptions used; Enhance the quality...

9 CFR 78.40 - Designation of States/areas.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Administrator may approve the division of a State into two brucellosis classification areas upon finding that... State has defined the intrastate boundary by county lines or by recognizable geographic features, such... classification requested. The Administrator may amend § 78.43 to reclassify States as validated brucellosis-free...

36 CFR 218.1 - Purpose and scope.

Code of Federal Regulations, 2010 CFR

2010-07-01

... ADMINISTRATIVE REVIEW PROCESSES Predecisional Administrative Review Process for Hazardous Fuel Reduction Projects... a predecisional administrative review (hereinafter referred to as “objection”) process for proposed...). The objection process is the sole means by which administrative review of a proposed authorized...

Pharmacokinetic study of arctigenin in rat plasma and organ tissue by RP-HPLC method.

PubMed

He, Fan; Dou, De-Qiang; Hou, Qiang; Sun, Yu; Kang, Ting-Guo

2013-01-01

A high-performance liquid chromatography (HPLC) technique was developed for the determination of arctigenin in plasma and various organs of rats after the oral administration of 30, 50 and 70 mgkg(-1) of arctigenin to the Sprague-Dawley rats. Results showed that the validated HPLC method was simple, fast, reproducible and suitable to the determination of arctigenin in rat plasma and organ tissue and one-compartmental model with zero-order absorption process can well describe the changes of arctigenin concentration in the plasma. The concentration of compound was highest in the spleen, less in the liver and the least in the lung.

Does adding clinical data to administrative data improve agreement among hospital quality measures?

PubMed

Hanchate, Amresh D; Stolzmann, Kelly L; Rosen, Amy K; Fink, Aaron S; Shwartz, Michael; Ash, Arlene S; Abdulkerim, Hassen; Pugh, Mary Jo V; Shokeen, Priti; Borzecki, Ann

2017-09-01

Hospital performance measures based on patient mortality and readmission have indicated modest rates of agreement. We examined if combining clinical data on laboratory tests and vital signs with administrative data leads to improved agreement with each other, and with other measures of hospital performance in the nation's largest integrated health care system. We used patient-level administrative and clinical data, and hospital-level data on quality indicators, for 2007-2010 from the Veterans Health Administration (VA). For patients admitted for acute myocardial infarction (AMI), heart failure (HF) and pneumonia we examined changes in hospital performance on 30-d mortality and 30-d readmission rates as a result of adding clinical data to administrative data. We evaluated whether this enhancement yielded improved measures of hospital quality, based on concordance with other hospital quality indicators. For 30-d mortality, data enhancement improved model performance, and significantly changed hospital performance profiles; for 30-d readmission, the impact was modest. Concordance between enhanced measures of both outcomes, and with other hospital quality measures - including Joint Commission process measures, VA Surgical Quality Improvement Program (VASQIP) mortality and morbidity, and case volume - remained poor. Adding laboratory tests and vital signs to measure hospital performance on mortality and readmission did not improve the poor rates of agreement across hospital quality indicators in the VA. Efforts to improve risk adjustment models should continue; however, evidence of validation should precede their use as reliable measures of quality. Published by Elsevier Inc.

49 CFR 1522.3 - Fraud and intentional falsification of records.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 9 2010-10-01 2010-10-01 false Fraud and intentional falsification of records...) TRANSPORTATION SECURITY ADMINISTRATION, DEPARTMENT OF HOMELAND SECURITY SECURITY RULES FOR ALL MODES OF TRANSPORTATION TSA-APPROVED VALIDATION FIRMS AND VALIDATORS General § 1522.3 Fraud and intentional falsification...

A Validation Study of the "School Leader Dispositions Inventory"[C

ERIC Educational Resources Information Center

Melton, Teri Denlea; Tysinger, Dawn; Mallory, Barbara; Green, James

2011-01-01

Although university-based school administrator preparation programs are required by accreditation agencies to assess the dispositions of candidates, valid and reliable methods for doing so remain scarce. "The School Leaders Disposition Inventory"[C] (SDLI) is proposed as an instrument that has promise for identifying leadership…

Development and initial validation of a computer-administered health literacy assessment in Spanish and English: FLIGHT/VIDAS.

PubMed

Ownby, Raymond L; Acevedo, Amarilis; Waldrop-Valverde, Drenna; Jacobs, Robin J; Caballero, Joshua; Davenport, Rosemary; Homs, Ana-Maria; Czaja, Sara J; Loewenstein, David

2013-01-01

Current measures of health literacy have been criticized on a number of grounds, including use of a limited range of content, development on small and atypical patient groups, and poor psychometric characteristics. In this paper, we report the development and preliminary validation of a new computer-administered and -scored health literacy measure addressing these limitations. Items in the measure reflect a wide range of content related to health promotion and maintenance as well as care for diseases. The development process has focused on creating a measure that will be useful in both Spanish and English, while not requiring substantial time for clinician training and individual administration and scoring. The items incorporate several formats, including questions based on brief videos, which allow for the assessment of listening comprehension and the skills related to obtaining information on the Internet. In this paper, we report the interim analyses detailing the initial development and pilot testing of the items (phase 1 of the project) in groups of Spanish and English speakers. We then describe phase 2, which included a second round of testing of the items, in new groups of Spanish and English speakers, and evaluation of the new measure's reliability and validity in relation to other measures. Data are presented that show that four scales (general health literacy, numeracy, conceptual knowledge, and listening comprehension), developed through a process of item and factor analyses, have significant relations to existing measures of health literacy.

21 CFR 820.75 - Process validation.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Process validation. 820.75 Section 820.75 Food and... QUALITY SYSTEM REGULATION Production and Process Controls § 820.75 Process validation. (a) Where the... validated with a high degree of assurance and approved according to established procedures. The validation...

21 CFR 820.75 - Process validation.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Process validation. 820.75 Section 820.75 Food and... QUALITY SYSTEM REGULATION Production and Process Controls § 820.75 Process validation. (a) Where the... validated with a high degree of assurance and approved according to established procedures. The validation...

21 CFR 820.75 - Process validation.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Process validation. 820.75 Section 820.75 Food and... QUALITY SYSTEM REGULATION Production and Process Controls § 820.75 Process validation. (a) Where the... validated with a high degree of assurance and approved according to established procedures. The validation...

21 CFR 820.75 - Process validation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Process validation. 820.75 Section 820.75 Food and... QUALITY SYSTEM REGULATION Production and Process Controls § 820.75 Process validation. (a) Where the... validated with a high degree of assurance and approved according to established procedures. The validation...

21 CFR 820.75 - Process validation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Process validation. 820.75 Section 820.75 Food and... QUALITY SYSTEM REGULATION Production and Process Controls § 820.75 Process validation. (a) Where the... validated with a high degree of assurance and approved according to established procedures. The validation...

A Novel Model for Predicting Rehospitalization Risk Incorporating Physical Function, Cognitive Status, and Psychosocial Support Using Natural Language Processing.

PubMed

Greenwald, Jeffrey L; Cronin, Patrick R; Carballo, Victoria; Danaei, Goodarz; Choy, Garry

2017-03-01

With the increasing focus on reducing hospital readmissions in the United States, numerous readmissions risk prediction models have been proposed, mostly developed through analyses of structured data fields in electronic medical records and administrative databases. Three areas that may have an impact on readmission but are poorly captured using structured data sources are patients' physical function, cognitive status, and psychosocial environment and support. The objective of the study was to build a discriminative model using information germane to these 3 areas to identify hospitalized patients' risk for 30-day all cause readmissions. We conducted clinician focus groups to identify language used in the clinical record regarding these 3 areas. We then created a dataset including 30,000 inpatients, 10,000 from each of 3 hospitals, and searched those records for the focus group-derived language using natural language processing. A 30-day readmission prediction model was developed on 75% of the dataset and validated on the other 25% and also on hospital specific subsets. Focus group language was aggregated into 35 variables. The final model had 16 variables, a validated C-statistic of 0.74, and was well calibrated. Subset validation of the model by hospital yielded C-statistics of 0.70-0.75. Deriving a 30-day readmission risk prediction model through identification of physical, cognitive, and psychosocial issues using natural language processing yielded a model that performs similarly to the better performing models previously published with the added advantage of being based on clinically relevant factors and also automated and scalable. Because of the clinical relevance of the variables in the model, future research may be able to test if targeting interventions to identified risks results in reductions in readmissions.

The Transition from Spacecraft Development Ot Flight Operation: Human Factor Considerations

NASA Technical Reports Server (NTRS)

Basilio, Ralph R.

2000-01-01

In the field of aeronautics and astronautics, a paradigm shift has been witnessed by those in academia, research and development, and private industry. Long development life cycles and the budgets to support such programs and projects has given way to aggressive task schedules and leaner resources to draw from all the while challenging assigned individuals to create and produce improved products of processes. however, this "faster, better, cheaper" concept cannot merely be applied to the design, development, and test of complex systems such as earth-orbiting of interplanetary robotic spacecraft. Full advantage is not possible without due consideration and application to mission operations planning and flight operations, Equally as important as the flight system, the mission operations system consisting of qualified personnel, ground hardware and software tools, and verified and validated operational processes, should also be regarded as a complex system requiring personnel to draw upon formal education, training, related experiences, and heuristic reasoning in engineering an effective and efficient system. Unquestionably, qualified personnel are the most important elements of a mission operations system. This paper examines the experiences of the Deep Space I Project, the first in a series of new technology in-flight validation missions sponsored by the United States National Aeronautics and Space Administration (NASA), specifically, in developing a subsystems analysis and technology validation team comprised of former spacecraft development personnel. Human factor considerations are investigated from initial concept/vision formulation; through operational process development; personnel test and training; to initial uplink product development and test support. Emphasis has been placed on challenges and applied or recommended solutions, so as to provide opportunities for future programs and projects to address and disposition potential issues and concerns as early as possible to reap the benefits associated with learning from other's past experiences.

[Methods for the costing process in the field of economic evaluation of a rehabilitation program for patients with chronic obstructive lung diseases].

PubMed

Hessel, F P; Wittmann, M; Petro, W; Wasem, J

2000-07-01

Studies in health economics especially economic evaluations of health care technologies and programmes are getting more and more important. However, in Germany there are no established, validated and commonly used instruments for the costing process. For the economic evaluation of a rehabilitation programme for patients with chronic lung diseases such as asthma and chronic bronchitis we developed methods for identification, measurement and validation of resource use during the inpatient rehabilitation programme and during the outpatient follow-up period. These methods are based on methodological considerations as well as on practical experience from conducting a pilot study. With regard to the inpatient setting all relevant diagnostic and therapeutic resource uses could be measured basing on routine clinical documentation and validated by using the cost accounting of the clinic. For measuring the use of resources during the follow-up period in an outpatient setting no reliable administrative data are accessible. Hence, we compared a standardised retrospective patient questionnaire used in a 20-minute interview (n = 50) and a cost diary for the continuing documentation by the patient over a period of 4 weeks (n = 50). Both tools were useful for measuring all relevant resource uses in sufficient detail, but because of higher participation rates and lower dropouts the structured interview appears to be more suitable. Average total costs per month were 1591 DM (interview), respectively 1867 DM (cost diary). Besides productivity loss, costs for medication and GP visits caused the relatively highest resource uses. Practicable instruments were developed for the costing process as part of an economic evaluation in a German rehabilitation setting for pulmonary diseases. After individual modification, these could also be used for different indications and in other institutional settings.

Factor analysis and predictive validity of microcomputer-based tests

NASA Technical Reports Server (NTRS)

Kennedy, R. S.; Baltzley, D. R.; Turnage, J. J.; Jones, M. B.

1989-01-01

11 tests were selected from two microcomputer-based performance test batteries because previously these tests exhibited rapid stability (less than 10 min, of practice) and high retest reliability efficiencies (r greater than 0.707 for each 3 min. of testing). The battery was administered three times to each of 108 college students (48 men and 60 women) and a factor analysis was performed. Two of the three identified factors appear to be related to information processing ("encoding" and "throughput/decoding"), and the third named an "output/speed" factor. The spatial, memory, and verbal tests loaded on the "encoding" factor and included Grammatical Reasoning, Pattern Comparison, Continuous Recall, and Matrix Rotation. The "throughput/decoding" tests included perceptual/numerical tests like Math Processing, Code Substitution, and Pattern Comparison. The output speed factor was identified by Tapping and Reaction Time tests. The Wonderlic Personnel Test was group administered before the first and after the last administration of the performance tests. The multiple Rs in the total sample between combined Wonderlic as a criterion and less than 5 min. of microcomputer testing on Grammatical Reasoning and Math Processing as predictors ranged between 0.41 and 0.52 on the three test administrations. Based on these results, the authors recommend a core battery which, if time permits, would consist of two tests from each factor. Such a battery is now known to permit stable, reliable, and efficient assessment.

The Development of Inquiry Learning Materials to Complete Content Life System Organization in Junior High School Students

NASA Astrophysics Data System (ADS)

Mayasari, F.; Raharjo; Supardi, Z. A. I.

2018-01-01

This research aims to develop the material eligibility to complete the inquiry learning of student in the material organization system of junior high school students. Learning materials developed include syllabi, lesson plans, students’ textbook, worksheets, and learning achievement test. This research is the developmental research which employ Dick and Carey model to develop learning material. The experiment was done in Junior High School 4 Lamongan regency using One Group Pretest-Posttest Design. The data collection used validation, observation, achievement test, questionnaire administration, and documentation. Data analysis techniques used quantitative and qualitative descriptive.The results showed that the developed learning material was valid and can be used. Learning activity accomplished with good category, where student activities were observed. The aspects of attitudes were observed during the learning process are honest, responsible, and confident. Student learning achievement gained an average of 81, 85 in complete category, with N-Gain 0, 75 for a high category. The activities and student response to learning was very well categorized. Based on the results, this researcher concluded that the device classified as feasible of inquiry-based learning (valid, practical, and effective) system used on the material organization of junior high school students.

A film set for the elicitation of emotion in research: A comprehensive catalog derived from four decades of investigation.

PubMed

Gilman, T Lee; Shaheen, Razan; Nylocks, K Maria; Halachoff, Danielle; Chapman, Jessica; Flynn, Jessica J; Matt, Lindsey M; Coifman, Karin G

2017-12-01

Emotions are highly influential to many psychological processes. Indeed, research employing emotional stimuli is rapidly escalating across the field of psychology. However, challenges remain regarding discrete evocation of frequently co-elicited emotions such as amusement and happiness, or anger and disgust. Further, as much contemporary work in emotion employs college students, we sought to additionally evaluate the efficacy of film clips to discretely elicit these more challenging emotions in a young adult population using an online medium. The internet is an important tool for investigating responses to emotional stimuli, but validations of emotionally evocative film clips across laboratory and web-based settings are limited in the literature. An additional obstacle is identifying stimuli amidst the numerous film clip validation studies. During our investigation, we recognized the lack of a categorical database to facilitate rapid identification of useful film clips for individual researchers' unique investigations. Consequently, here we also sought to produce the first compilation of such stimuli into an accessible and comprehensive catalog. We based our catalog upon prior work as well as our own, and identified 24 articles and 295 film clips from four decades of research. We present information on the validation of these clips in addition to our own research validating six clips using online administration settings. The results of our search in the literature and our own study are presented in tables designed to facilitate and improve a selection of highly valid film stimuli for future research.

Improvements and Extensions for Joint Polar Satellite System Algorithms

NASA Astrophysics Data System (ADS)

Grant, K. D.

2016-12-01

The National Oceanic and Atmospheric Administration (NOAA) and National Aeronautics and Space Administration (NASA) are jointly acquiring the next-generation civilian weather satellite system: the Joint Polar Satellite System (JPSS). JPSS replaced the afternoon orbit component and ground processing of the old POES system managed by NOAA. JPSS satellites carry sensors designed to collect meteorological, oceanographic, climatological, and solar-geophysical observations of the earth, atmosphere, and space. The ground processing system for JPSS is the Common Ground System (CGS), and provides command, control, and communications (C3), data processing and product delivery. CGS's data processing capability provides environmental data products (Sensor Data Records (SDRs) and Environmental Data Records (EDRs)) to the NOAA Satellite Operations Facility. The first satellite in the JPSS constellation, S-NPP, was launched in October 2011. The second satellite, JPSS-1, is scheduled for launch in January 2017. During a satellite's calibration and validation (Cal/Val) campaign, numerous algorithm updates occur. Changes identified during Cal/Val become available for implementation into the operational system for both S-NPP and JPSS-1. In addition, new capabilities, such as higher spectral and spatial resolution, will be exercised on JPSS-1. This paper will describe changes to current algorithms and products as a result of S-NPP Cal/Val and related initiatives for improved capabilities. Improvements include Cross Track Infrared Sounder high spectral processing, extended spectral and spatial ranges for Ozone Mapping and Profiler Suite ozone Total Column and Nadir Profiles, and updates to Vegetation Index, Snow Cover, Active Fires, Suspended Matter, and Ocean Color. Updates will include Sea Surface Temperature, Cloud Mask, Cloud Properties, and other improvements.

Teachers' Perceptions of Fairness, Well-Being and Burnout: A Contribution to the Validation of the Organizational Justice Index by Hoy and Tarter

ERIC Educational Resources Information Center

Capone, Vincenza; Petrillo, Giovanna

2016-01-01

Purpose: The purpose of this paper is to contribute to the validation of the Organizational Justice Index (OJI) by Hoy and Tarter (2004), a self-report questionnaire for teachers' perceptions of fairness in the operation and administration of schools. Design/methodology/approach: In two studies the authors validated the Italian version of the OJI.…

Is the Acute NMDA Receptor Hypofunction a Valid Model of Schizophrenia?

PubMed Central

Adell, Albert; Jiménez-Sánchez, Laura; López-Gil, Xavier; Romón, Tamara

2012-01-01

Several genetic, neurodevelopmental, and pharmacological animal models of schizophrenia have been established. This short review examines the validity of one of the most used pharmacological model of the illness, ie, the acute administration of N-methyl-D-aspartate (NMDA) receptor antagonists in rodents. In some cases, data on chronic or prenatal NMDA receptor antagonist exposure have been introduced for comparison. The face validity of acute NMDA receptor blockade is granted inasmuch as hyperlocomotion and stereotypies induced by phencyclidine, ketamine, and MK-801 are regarded as a surrogate for the positive symptoms of schizophrenia. In addition, the loss of parvalbumin-containing cells (which is one of the most compelling finding in postmortem schizophrenia brain) following NMDA receptor blockade adds construct validity to this model. However, the lack of changes in glutamic acid decarboxylase (GAD67) is at variance with human studies. It is possible that changes in GAD67 are more reflective of the neurodevelopmental condition of schizophrenia. Finally, the model also has predictive validity, in that its behavioral and transmitter activation in rodents are responsive to antipsychotic treatment. Overall, although not devoid of drawbacks, the acute administration of NMDA receptor antagonists can be considered as a good model of schizophrenia bearing a satisfactory degree of validity. PMID:21965469

Measurement of Global Precipitation: Introduction to International GPM Program

NASA Technical Reports Server (NTRS)

Hwang, P.

2004-01-01

The Global Precipitation Measurement (GPM) Program is an international cooperative effort whose objectives are to (a) obtain better understanding of rainfall processes, and (b) make frequent rainfall measurements on a global basis. The National Aeronautics and Space Administration (NASA) of the United States and the Japanese Aviation and Exploration Agency (JAXA) have entered into a cooperative agreement for the formulation and development of GPM. This agreement is a continuation of the partnership that developed the highly successful Tropical Rainfall Measuring Mission (TRMM) that was launched in November 1997; this mission continues to provide valuable scientific and meteorological information on rainfall and the associated processes. International collaboration on GPM from other space agencies has been solicited, and discussions regarding their participation are currently in progress. NASA has taken lead responsibility for the planning and formulation of GPM. Key elements of the Program to be provided by NASA include a Core satellite instrumented with a multi-channel microwave radiometer, a Ground Validation System and a ground-based Precipitation Processing System (PPS). JAXA will provide a Dual-frequency Precipitation Radar for installation on the Core satellite and launch services. Other United States agencies and international partners may participate in a number of ways, such as providing rainfall measurements obtained from their own national space-borne platforms, providing local rainfall measurements to support the ground validation activities, or providing hardware or launch services for GPM constellation spacecraft.

An initial validation of the Virtual Reality Paced Auditory Serial Addition Test in a college sample.

PubMed

Parsons, Thomas D; Courtney, Christopher G

2014-01-30

Numerous studies have demonstrated that the Paced Auditory Serial Addition Test (PASAT) has utility for the detection of cognitive processing deficits. While the PASAT has demonstrated high levels of internal consistency and test-retest reliability, administration of the PASAT has been known to create undue anxiety and frustration in participants. As a result, degradation of performance may be found on the PASAT. The difficult nature of the PASAT may subsequently decrease the probability of their return for follow up testing. This study is a preliminary attempt at assessing the potential of a PASAT embedded in a virtual reality environment. The Virtual Reality PASAT (VR-PASAT) was compared with a paper-and-pencil version of the PASAT as well as other standardized neuropsychological measures. The two modalities of the PASAT were conducted with a sample of 50 healthy university students, between the ages of 19 and 34 years. Equivalent distributions were found for age, gender, education, and computer familiarity. Moderate relationships were found between VR-PASAT and other putative attentional processing measures. The VR-PASAT was unrelated to indices of learning, memory, or visuospatial processing. Comparison of the VR-PASAT with the traditional paper-and-pencil PASAT indicated that both versions require the examinee to sustain attention at an increasingly demanding, externally determined rate. Results offer preliminary support for the construct validity (in a college sample) of the VR-PASAT as an attentional processing measure and suggest that this task may provide some unique information not tapped by traditional attentional processing tasks. Copyright © 2013 Elsevier B.V. All rights reserved.

21 CFR 200.10 - Contract facilities (including consulting laboratories) utilized as extramural facilities by...

Code of Federal Regulations, 2014 CFR

2014-04-01

... Cosmetic Act specifically authorizes inspection of consulting laboratories as well as any factory... Federal Food, Drug, and Cosmetic Act. The Food and Drug Administration's position is that by the... Administration does not consider results of validation studies of analytical and assay methods and control...

21 CFR 200.10 - Contract facilities (including consulting laboratories) utilized as extramural facilities by...

Code of Federal Regulations, 2011 CFR

2011-04-01

... Cosmetic Act specifically authorizes inspection of consulting laboratories as well as any factory... Federal Food, Drug, and Cosmetic Act. The Food and Drug Administration's position is that by the... Administration does not consider results of validation studies of analytical and assay methods and control...

21 CFR 200.10 - Contract facilities (including consulting laboratories) utilized as extramural facilities by...

Code of Federal Regulations, 2013 CFR

2013-04-01

... Cosmetic Act specifically authorizes inspection of consulting laboratories as well as any factory... Federal Food, Drug, and Cosmetic Act. The Food and Drug Administration's position is that by the... Administration does not consider results of validation studies of analytical and assay methods and control...

21 CFR 200.10 - Contract facilities (including consulting laboratories) utilized as extramural facilities by...

Code of Federal Regulations, 2012 CFR

2012-04-01

... Cosmetic Act specifically authorizes inspection of consulting laboratories as well as any factory... Federal Food, Drug, and Cosmetic Act. The Food and Drug Administration's position is that by the... Administration does not consider results of validation studies of analytical and assay methods and control...

Business Administration Scale for Family Child Care (BAS). Second Edition

ERIC Educational Resources Information Center

Talan, Teri N.; Bloom, Paula Jorde

2018-01-01

The "Business Administration Scale for Family Child Care" (BAS) is the first valid and reliable tool for measuring and improving the overall quality of business and professional practices in family child care settings. It is applicable for multiple uses, including program self-improvement, technical assistance and monitoring, training,…

Benefits of Reflective Practice

ERIC Educational Resources Information Center

Wagner, Kathi

2006-01-01

In this article, the author discusses what she was able to learn from an exercise in self-reflection regarding her teaching. She also discusses the advantages of reflection for administrators: First, a reflective practice is data-driven, making it a more valid way to evaluate administrators' knowledge and skills. Second, a reflective practice…

76 FR 64351 - General Services Administration Acquisition Regulation; Submission for OMB Review; Zero Burden...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-18

...] General Services Administration Acquisition Regulation; Submission for OMB Review; Zero Burden Information... regarding zero burden information collection reports. A notice was published in the Federal Register at 76... our estimate of the public burden of this collection of information is accurate and based on valid...

High salinity relay as a post-harvest processing method for reducing Vibrio vulnificus levels in oysters (Crassostrea virginica).

PubMed

Audemard, Corinne; Kator, Howard I; Reece, Kimberly S

2018-08-20

High salinity relay of Eastern oysters (Crassostrea virginica) was evaluated as a post-harvest processing (PHP) method for reducing Vibrio vulnificus. This approach relies on the exposure of oysters to natural high salinity waters and preserves a live product compared to previously approved PHPs. Although results of prior studies evaluating high salinity relay as a means to decrease V. vulnificus levels were promising, validation of this method as a PHP following approved guidelines is required. This study was designed to provide data for validation of this method following Food and Drug Administration (FDA) PHP validation guidelines. During each of 3 relay experiments, oysters cultured from 3 different Chesapeake Bay sites of contrasting salinities (10-21 psu) were relayed without acclimation to high salinity waters (31-33 psu) for up to 28 days. Densities of V. vulnificus and densities of total and pathogenic Vibrio parahaemolyticus (as tdh positive strains) were measured using an MPN-quantitative PCR approach. Overall, 9 lots of oysters were relayed with 6 exhibiting initial V. vulnificus >10,000/g. As recommended by the FDA PHP validation guidelines, these lots reached both the 3.52 log reduction and the <30 MPN/g densities requirements for V. vulnificus after 14 to 28 days of relay. Densities of total and pathogenic V. parahaemolyticus in relayed oysters were significantly lower than densities at the sites of origin suggesting an additional benefit associated with high salinity relay. While relay did not have a detrimental effect on oyster condition, oyster mortality levels ranged from 2 to 61% after 28 days of relay. Although the identification of the factors implicated in oyster mortality will require further examination, this study strongly supports the validation of high salinity relay as an effective PHP method to reduce levels of V. vulnificus in oysters to endpoint levels approved for human consumption. Copyright © 2018 Elsevier B.V. All rights reserved.

Validated methods for identifying tuberculosis patients in health administrative databases: systematic review.

PubMed

Ronald, L A; Ling, D I; FitzGerald, J M; Schwartzman, K; Bartlett-Esquilant, G; Boivin, J-F; Benedetti, A; Menzies, D

2017-05-01

An increasing number of studies are using health administrative databases for tuberculosis (TB) research. However, there are limitations to using such databases for identifying patients with TB. To summarise validated methods for identifying TB in health administrative databases. We conducted a systematic literature search in two databases (Ovid Medline and Embase, January 1980-January 2016). We limited the search to diagnostic accuracy studies assessing algorithms derived from drug prescription, International Classification of Diseases (ICD) diagnostic code and/or laboratory data for identifying patients with TB in health administrative databases. The search identified 2413 unique citations. Of the 40 full-text articles reviewed, we included 14 in our review. Algorithms and diagnostic accuracy outcomes to identify TB varied widely across studies, with positive predictive value ranging from 1.3% to 100% and sensitivity ranging from 20% to 100%. Diagnostic accuracy measures of algorithms using out-patient, in-patient and/or laboratory data to identify patients with TB in health administrative databases vary widely across studies. Use solely of ICD diagnostic codes to identify TB, particularly when using out-patient records, is likely to lead to incorrect estimates of case numbers, given the current limitations of ICD systems in coding TB.

Can You Trust Self-Report Data Provided by Homeless Mentally Ill Individuals?

ERIC Educational Resources Information Center

Calsyn, Robert J.; And Others

1993-01-01

Reliability and validity of self-report data provided by 178 mentally ill homeless persons were generally favorable. Self-reports of service use also generally agreed with treatment staff estimates, providing further validity evidence. Researchers and administrators can be relatively confident in using such data. (SLD)

Personal Accountability in Education: Measure Development and Validation

ERIC Educational Resources Information Center

Rosenblatt, Zehava

2017-01-01

Purpose: The purpose of this paper, three-study research project, is to establish and validate a two-dimensional scale to measure teachers' and school administrators' accountability disposition. Design/methodology/approach: The scale items were developed in focus groups, and the final measure was tested on various samples of Israeli teachers and…

Shifting the Focus of Validity for Test Use

ERIC Educational Resources Information Center

Moss, Pamela A.

2016-01-01

The conventional focus of validity in educational measurement has been on intended interpretations and uses of test scores. Empirical studies of test use by teachers, administrators and policy-makers show that actual interpretations and uses of test scores in context are invariably shaped by local users' questions, which frequently require…

Development and implementation of an integrated EHR for Homecare Service: a South American experience.

PubMed

Aguilera Díaz, Jerónimo; Arias, Antonio Eduardo; Budalich, Cintia Mabel; Benítez, Sonia Elizabeth; López, Gastón; Borbolla, Damián; Plazzotta, Fernando; Luna, Daniel; de Quirós, Fernán González Bernaldo

2010-01-01

This paper describes the development and implementation of a web based electronic health record for the Homecare Service program in the Hospital Italiano de Buenos Aires. It reviews the process of the integration of the new electronic health record to the hospital information system, allowing physicians to access the clinical data repository from their Pc's at home and with the capability of consulting past and present history of the patient health care, order, tests, and referrals with others professionals trough the new Electronic Health Record. We also discuss how workflow processes were changed and improved for the physicians, nurses, and administrative personnel of the Homecare Services and the educational methods used to improve acceptance and adoption of these new technologies. We also briefly describe the validation of physicians and their field work with electronic signatures.

12 CFR 380.30 - Receivership administrative claims process.

Code of Federal Regulations, 2014 CFR

2014-01-01

... OF GENERAL POLICY ORDERLY LIQUIDATION AUTHORITY Receivership Administrative Claims Process § 380.30 Receivership administrative claims process. The Corporation as receiver of a covered financial company shall... 12 Banks and Banking 5 2014-01-01 2014-01-01 false Receivership administrative claims process. 380...

12 CFR 380.30 - Receivership administrative claims process.

Code of Federal Regulations, 2013 CFR

2013-01-01

... OF GENERAL POLICY ORDERLY LIQUIDATION AUTHORITY Receivership Administrative Claims Process § 380.30 Receivership administrative claims process. The Corporation as receiver of a covered financial company shall... 12 Banks and Banking 5 2013-01-01 2013-01-01 false Receivership administrative claims process. 380...

12 CFR 380.30 - Receivership administrative claims process.

Code of Federal Regulations, 2012 CFR

2012-01-01

... OF GENERAL POLICY ORDERLY LIQUIDATION AUTHORITY Receivership Administrative Claims Process § 380.30 Receivership administrative claims process. The Corporation as receiver of a covered financial company shall... 12 Banks and Banking 5 2012-01-01 2012-01-01 false Receivership administrative claims process. 380...

[Management committees in health services: an empirical study].

PubMed

Cecilio, Luiz Carlos de Oliveira

2010-03-01

The aim of the article, based on field data collected from a continuing education program for primary health clinic administrators, was to analyze the functioning of a health service management strategy called "management committees". Different meanings and operational modalities emerged in the committees. Various antimonies appeared in the way the committees operate (autonomy versus heteronomy, reproduction of "instituted" versus "instituting" processes, and communicative versus instrumental reasoning), thus reflecting the level of complexity in this management mechanism. Healthcare provision per se by the clinics only appeared occasionally on the committees' agenda, which mainly focused on administrative issues. The article suggests that further research is needed on the coordinator's involvement in the field of forces constituting the management committee, besides developing pedagogical strategies to support the clinic coordinators and health teams in building the committees. The primary data were submitted to an epistemological discussion anchored in the idea of double hermeneutics, multiple validation of research results, and the relationship between theory and practice.

76 FR 4360 - Guidance for Industry on Process Validation: General Principles and Practices; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-25

... elements of process validation for the manufacture of human and animal drug and biological products... process validation for the manufacture of human and animal drug and biological products, including APIs. This guidance describes process validation activities in three stages: In Stage 1, Process Design, the...

Infant and toddler disease score was useful for risk of hospitalization based on data from administrative claims.

PubMed

Mikaeloff, Yann; Moride, Yola; Khoshnood, Babak; Weill, Alain; Bréart, Gérard

2007-07-01

To develop the infant and toddler disease score (IDS), a population-based predictive tool of morbidity status in infants and toddlers, based on data from administrative claims. A prospective cohort study was conducted, including 35,580 children less than 2 years of age in June 2003 from the French "ERASME" database (mean follow-up 13 months). The outcome variable was incident hospitalization during the follow-up year, that is, before the second birthday for infants and before the third for toddlers. Risk factors before inclusion (age, health care use, medications) were assessed in a 50% random sample (construction sample) by a logistic regression model. Beta coefficients were summed up to obtain the IDS. The IDS was then validated for the remaining 50% of the study population (validation sample). The major variables significantly associated with the outcome were long-term disability, younger age, and >or=1 hospitalization before inclusion. The risks of hospitalization estimated by the IDS were concordant in the construction and validation samples. The IDS is a useful index for the risk of hospitalization of infants and toddlers in relation to their morbidity status and may be used for adjustment in pharmacoepidemiologic studies using administrative claims databases.

Ensuring Evidence-Based Safe and Effective mHealth Applications.

PubMed

Vallespin, Bárbara; Cornet, Joan; Kotzeva, Anna

2016-01-01

The Internet and the digitalization of information have brought big changes in healthcare, but the arrival of smartphones and tablets represent a true revolution and a new paradigm is opened which completely changes our lives. In order to validate the impact of these new technologies in health care, it is essential to have enough clinical studies that validate their impact in wellbeing and healthcare of the patient. Traditional regulatory organisations are still looking for their role in this area. If they follow the classical path of medical devices, we get to a technical, administration and economic collapse. This contribution first presents the main indicators showing the potential of mHealth adoption. It then proposes a classification of mobile health care apps, and presents frameworks for mHealth evaluation. Regulation of mHealth as part of the evaluation process is discussed. Finally, the necessary steps and challenges that have to be taken into account by the industry to prepare the entrance of these technologies into the EU market is analysed.

[The development and validation of two scales on retribution practices: PRG-13 and PRE-21].

PubMed

Boada-Grau, Joan; Costa-Solé, Jordi; Gil-Ripoll, Carme; Vigil-Colet, Andreu

2012-01-01

The present study outlines the development process of two scales that measure general and specific retribution practices in organisations. Historically, retribution has been the subject of research of other social sciences such as Sociology and Business Administration. In Psychology, and more specifically in Work and Organisational Psychology, there are hardly any studies or inventories designed to evaluate retribution practices. In order to accomplish the objectives, a sample of 237 employees was selected, 42.6% of whom were women and 57.4% were men. We performed and exploratory factorial analysis using principal axis factoring as extraction method and an oblique rotation (oblimin) to analyse the two scales. The former is made up of four factors and the latter is a two-factor scale. The reliability coefficients of the six subscales we obtained ranged between .72 and .89. External validity was analysed using the correlations obtained between the two inventories and the Balanced Scorecard. The two tools were found to be two potentially useful scales to evaluate retribution practices.

Spring 2013 Graduate Engineering Internship Summary

NASA Technical Reports Server (NTRS)

Ehrlich, Joshua

2013-01-01

In the spring of 2013, I participated in the National Aeronautics and Space Administration (NASA) Pathways Intern Employment Program at the Kennedy Space Center (KSC) in Florida. This was my final internship opportunity with NASA, a third consecutive extension from a summer 2012 internship. Since the start of my tenure here at KSC, I have gained an invaluable depth of engineering knowledge and extensive hands-on experience. These opportunities have granted me the ability to enhance my systems engineering approach in the field of payload design and testing as well as develop a strong foundation in the area of composite fabrication and testing for repair design on space vehicle structures. As a systems engineer, I supported the systems engineering and integration team with final acceptance testing of the Vegetable Production System, commonly referred to as Veggie. Verification and validation (V and V) of Veggie was carried out prior to qualification testing of the payload, which incorporated the process of confirming the system's design requirements dependent on one or more validation methods: inspection, analysis, demonstration, and testing.

20 CFR 423.5 - Process against Social Security Administration officials in their individual capacities.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false Process against Social Security Administration officials in their individual capacities. 423.5 Section 423.5 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SERVICE OF PROCESS § 423.5 Process against Social Security Administration officials in their...

20 CFR 423.5 - Process against Social Security Administration officials in their individual capacities.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 20 Employees' Benefits 2 2014-04-01 2014-04-01 false Process against Social Security Administration officials in their individual capacities. 423.5 Section 423.5 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SERVICE OF PROCESS § 423.5 Process against Social Security Administration officials in their...

20 CFR 423.5 - Process against Social Security Administration officials in their individual capacities.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false Process against Social Security Administration officials in their individual capacities. 423.5 Section 423.5 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SERVICE OF PROCESS § 423.5 Process against Social Security Administration officials in their...

20 CFR 423.5 - Process against Social Security Administration officials in their individual capacities.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Process against Social Security Administration officials in their individual capacities. 423.5 Section 423.5 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SERVICE OF PROCESS § 423.5 Process against Social Security Administration officials in their...

Development and validation of a RP-HPLC method for the quantitation of tofacitinib in rat plasma and its application to a pharmacokinetic study.

PubMed

S, Vijay Kumar; Dhiman, Vinay; Giri, Kalpesh Kumar; Sharma, Kuldeep; Zainuddin, Mohd; Mullangi, Ramesh

2015-09-01

A novel, simple, specific, sensitive and reproducible high-performance liquid chromatography (HPLC) assay method has been developed and validated for the estimation of tofacitinib in rat plasma. The bioanalytical procedure involves extraction of tofacitinib and itraconazole (internal standard, IS) from rat plasma with a simple liquid-liquid extraction process. The chromatographic analysis was performed on a Waters Alliance system using a gradient mobile phase conditions at a flow rate of 1.0 mL/min and C18 column maintained at 40 ± 1 °C. The eluate was monitored using an UV detector set at 287 nm. Tofacitinib and IS eluted at 6.5 and 8.3 min, respectively and the total run time was 10 min. Method validation was performed as per US Food and Drug Administration guidelines and the results met the acceptance criteria. The calibration curve was linear over a concentration range of 182-5035 ng/mL (r(2) = 0.995). The intra- and inter-day precisions were in the range of 1.41-11.2 and 3.66-8.81%, respectively, in rat plasma. The validated HPLC method was successfully applied to a pharmacokinetic study in rats. Copyright © 2015 John Wiley & Sons, Ltd.

[VALIDATION OF THE HUNGARIAN UNIFIED DYSKINESIA RATING SCALE].

PubMed

Horváth, Krisztina; Aschermann, Zsuzsanna; Ács, Péter; Bosnyák, Edit; Deli, Gabriella; Pál, Endre; Késmárki, Ildiko; Horvath, Réka; Takacs, Katalin; Balázs, Eva; Komoly, Sámuel; Bokor, Magdolna; Rigó, Eszter; Lajtos, Júlia; Takáts, Annamária; Tóth, Adrián; Klivényi, Péter; Dibó, György; Vecsei, László; Hidasi, Eszter; Nagy, Ferenc; Herceg, Mihály; Imre, Piroska; Kovács, Norbert

2015-05-30

The Unified Dyskinesia Rating Scale (UDysRS) was published in 2008. It was designed to be simultaneous valid, reliable and sensitive to therapeutic changes. The Movement Disorder Society organizing team developed guidelines for the development of official non-English translations consisting of four steps: translation/back-translation, cognitive pretesting, large field testing, and clinimetric analysis. The aim of this paper was to introduce the new UDysRS and its validation process into Hungarian. After the translation of UDysRS into Hungarian and back-translated into English, it was reviewed by the UDysRS translation administration team. Subsequent cognitive pretesting was conducted with ten patients. For the large field testing phase, the Hungarian official working draft version of UDysRS was tested with 256 patients with Parkinson's disease having dyskinesia. Confirmatory factor analyses (CFA) determined whether the factor structure for the valid Spanish UDysRS could be confirmed in data collected using the Hungarian Official Draft Version. To become an official translation, the Comparative Fit Index (CFI) had to be ≥ 0.90 compared to the Spanish-language version. For the Hungarian UDysRS the CFI was 0.98. The overall factor structure of the Hungarian version was consistent with that of the Spanish version based on the high CFIs for the UDysRS in the CFA; therefore, this version was designated as the Official Hungarian Version Of The UDysRS.

Stroke and aphasia quality-of-life scale-39: Reliability and validity of the Turkish version.

PubMed

Noyan-ErbaŞ, AyŞin; Toğram, Bülent

2016-10-01

The aim of this study was to adapt the stroke and aphasia quality-of-life scale-39 (SAQoL-39) to the Turkish language and carry out a reliability and validity study of the instrument in a group of patients with aphasia. The study was a descriptive study and contained three phases: adaptation of the SAQoL-39 to the Turkish language, administration of the scale to 30 aphasia patients and reliability and validity studies of the scale. Internal consistency was assessed with Cronbach's alpha and test-re-test reliability was explored (n = 14). The adaptation process was completed based on inter-rater agreement on the translated items and within the scope of final editing by the authors of the study. The SAQoL-39 in Turkish exhibited high test-re-test reliability (ICC =0.97) as well as acceptability with minimal missing data (0-1.4). This instrument exhibited high internal consistency (Cronbach's α = 0.70-0.97), domain-total correlations (r = 0.76-0.85) and inter-domain correlations (r = 0.40-0.68). The analysis shows that the Turkish version of SAQoL-39 is a scale that is highly acceptable, valid and reliable and can be easily used in evaluating the quality-of-life of Turkish people with aphasia.

Construct validity and reliability of the Single Checking Administration of Medications Scale.

PubMed

O'Connell, Beverly; Hawkins, Mary; Ockerby, Cherene

2013-06-01

Research indicates that single checking of medications is as safe as double checking; however, many nurses are averse to independently checking medications. To assist with the introduction and use of single checking, a measure of nurses' attitudes, the thirteen-item Single Checking Administration of Medications Scale (SCAMS) was developed. We examined the psychometric properties of the SCAMS. Secondary analyses were conducted on data collected from 503 nurses across a large Australian health-care service. Analyses using exploratory and confirmatory factor analyses supported by structural equation modelling resulted in a valid twelve-item SCAMS containing two reliable subscales, the nine-item Attitudes towards single checking and three-item Advantages of single checking subscales. The SCAMS is recommended as a valid and reliable measure for monitoring nurses' attitudes to single checking prior to introducing single checking medications and after its implementation. © 2013 Wiley Publishing Asia Pty Ltd.

Can Touch Screen Tablets be Used to Assess Cognitive and Motor Skills in Early Years Primary School Children? A Cross-Cultural Study.

PubMed

Pitchford, Nicola J; Outhwaite, Laura A

2016-01-01

Assessment of cognitive and motor functions is fundamental for developmental and neuropsychological profiling. Assessments are usually conducted on an individual basis, with a trained examiner, using standardized paper and pencil tests, and can take up to an hour or more to complete, depending on the nature of the test. This makes traditional standardized assessments of child development largely unsuitable for use in low-income countries. Touch screen tablets afford the opportunity to assess cognitive functions in groups of participants, with untrained administrators, with precision recording of responses, thus automating the assessment process. In turn, this enables cognitive profiling to be conducted in contexts where access to qualified examiners and standardized assessments are rarely available. As such, touch screen assessments could provide a means of assessing child development in both low- and high-income countries, which would afford cross-cultural comparisons to be made with the same assessment tool. However, before touch screen tablet assessments can be used for cognitive profiling in low-to-high-income countries they need to be shown to provide reliable and valid measures of performance. We report the development of a new touch screen tablet assessment of basic cognitive and motor functions for use with early years primary school children in low- and high-income countries. Measures of spatial intelligence, visual attention, short-term memory, working memory, manual processing speed, and manual coordination are included as well as mathematical knowledge. To investigate if this new touch screen assessment tool can be used for cross-cultural comparisons we administered it to a sample of children ( N = 283) spanning standards 1-3 in a low-income country, Malawi, and a smaller sample of children ( N = 70) from first year of formal schooling from a high-income country, the UK. Split-half reliability, test-retest reliability, face validity, convergent construct validity, predictive criterion validity, and concurrent criterion validity were investigated. Results demonstrate "proof of concept" that touch screen tablet technology can provide reliable and valid psychometric measures of performance in the early years, highlighting its potential to be used in cross-cultural comparisons and research.

Administering Self-Concept Interventions in Schools: No Training Necessary? A Meta-Analysis

ERIC Educational Resources Information Center

O'Mara, Alison J.; Green, Jasmine; Marsh, Herbert W.

2006-01-01

A meta-analysis of 105 studies reporting 152 self-concept interventions in school settings was conducted. The aims of the study were twofold: to explore the construct validity approach to self-concept interventions, and to examine aspects of the administration of the interventions, namely treatment setting, administrator type, administrator…

Admission to the Master of Business Administration Program: An Alternative for Savannah State University

ERIC Educational Resources Information Center

Dowling, Bill

2009-01-01

Traditionally, graduate programs in business administration have heavily relied on the Graduate Management Aptitude Test prepared and administered by the Educational Testing Service in the decision to admit a candidate to the program. The purpose of this paper is to review the literature regarding the statistical validity and statistical…

Physical Activity Strategies for Improved Cognition: The Mind/Body Connection

ERIC Educational Resources Information Center

Fede, Marybeth H.

2012-01-01

Whether an administrator, faculty member, classroom teacher, or specials teacher (Art, Music, and Physical Education), everyone wants students test scores to improve and know that they contributed to it. These improved scores validate the roles and influence of educators and administrators. The purpose of this article is two-fold: (1) to assist…

21 CFR 1316.92 - Petition for expedited release in an administrative forfeiture action.

Code of Federal Regulations, 2010 CFR

2010-04-01

... for expedited release shall establish the following: (1) The owner has a valid, good faith interest in..., which would be subject to seizure for administrative forfeiture for a violation of law involving... in the property, which shall be supported by title documentation, bills of sale, contracts, mortgages...

Iowa Educators' Perceptions on Talented and Gifted Alternative Education High School Students

ERIC Educational Resources Information Center

Bliven Noll, Laurie J.

2012-01-01

This study examined the teachers' and administrators' perceptions on talented and gifted (TAG) alternative education high school students. Administrators and teachers from alternative high schools (AHS) in the state of Iowa received an email of a validated survey instrument for data collection. The survey was used to analyze the perceptions of…

Determination, Verification and Validation of Competencies of Administrative Office Managers.

ERIC Educational Resources Information Center

Stallard, John J.; And Others

1979-01-01

Survey data compiled from 321 administrative office managers indicated five broad areas of competencies rated as most important: (1) budgeting, (2) employee incentives and relations, (3) standards and job evaluation, (4) human relations and motivation, and (5) recruitment and dismissal. The survey also indicated that more men than women fill…

U.S. National Certification in Literary Braille: History and Current Administration

ERIC Educational Resources Information Center

Bell, Edward

2010-01-01

This article reports on a certification examination for teachers of students with visual impairments--the National Literary Braille Competency Test (NLBCT). It discusses the history, development, pilot testing, and validation of NLBCT and the creation of the National Certification in Literary Braille. Data on the current administration of the test…

77 FR 21783 - Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0691...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... manufacturers of PET drugs meet the requirements for the Agency's current good manufacturing practice...

76 FR 60847 - Draft Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0691... Drugs; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... manufacturing practice regulations for PET drugs. DATES: Although you can comment on any guidance at any time...

21 CFR 589.2000 - Animal proteins prohibited in ruminant feed.

Code of Federal Regulations, 2010 CFR

2010-04-01

... manufacturing method that has been validated by the Food and Drug Administration to deactivate the agent that... Food and Drug Administration; or (iii) Use exclusively a method for controlling the manufacturing... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Animal proteins prohibited in ruminant feed. 589...

Bridging the Gap between the Data Base and User in a Distributed Environment.

ERIC Educational Resources Information Center

Howard, Richard D.; And Others

1989-01-01

The distribution of databases physically separates users from those who administer the database and the administrators who perform database administration. By drawing on the work of social scientists in reliability and validity, a set of concepts and a list of questions to ensure data quality were developed. (Author/MLW)

How Many Batches Are Needed for Process Validation under the New FDA Guidance?

PubMed

Yang, Harry

2013-01-01

The newly updated FDA Guidance for Industry on Process Validation: General Principles and Practices ushers in a life cycle approach to process validation. While the guidance no longer considers the use of traditional three-batch validation appropriate, it does not prescribe the number of validation batches for a prospective validation protocol, nor does it provide specific methods to determine it. This potentially could leave manufacturers in a quandary. In this paper, I develop a Bayesian method to address the issue. By combining process knowledge gained from Stage 1 Process Design (PD) with expected outcomes of Stage 2 Process Performance Qualification (PPQ), the number of validation batches for PPQ is determined to provide a high level of assurance that the process will consistently produce future batches meeting quality standards. Several examples based on simulated data are presented to illustrate the use of the Bayesian method in helping manufacturers make risk-based decisions for Stage 2 PPQ, and they highlight the advantages of the method over traditional Frequentist approaches. The discussions in the paper lend support for a life cycle and risk-based approach to process validation recommended in the new FDA guidance. The newly updated FDA Guidance for Industry on Process Validation: General Principles and Practices ushers in a life cycle approach to process validation. While the guidance no longer considers the use of traditional three-batch validation appropriate, it does not prescribe the number of validation batches for a prospective validation protocol, nor does it provide specific methods to determine it. This potentially could leave manufacturers in a quandary. In this paper, I develop a Bayesian method to address the issue. By combining process knowledge gained from Stage 1 Process Design (PD) with expected outcomes of Stage 2 Process Performance Qualification (PPQ), the number of validation batches for PPQ is determined to provide a high level of assurance that the process will consistently produce future batches meeting quality standards. Several examples based on simulated data are presented to illustrate the use of the Bayesian method in helping manufacturers make risk-based decisions for Stage 2 PPQ, and THEY highlight the advantages of the method over traditional Frequentist approaches. The discussions in the paper lend support for a life cycle and risk-based approach to process validation recommended in the new FDA guidance.

33 CFR Appendix C to Part 331 - Administrative Appeal Process for Approved Jurisdictional Determinations

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 3 2010-07-01 2010-07-01 false Administrative Appeal Process for... ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE ADMINISTRATIVE APPEAL PROCESS Pt. 331, App. C Appendix C to Part 331—Administrative Appeal Process for Approved Jurisdictional Determinations ER28MR00...

20 CFR 423.3 - Other process directed to the Social Security Administration or the Commissioner.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 20 Employees' Benefits 2 2014-04-01 2014-04-01 false Other process directed to the Social Security Administration or the Commissioner. 423.3 Section 423.3 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SERVICE OF PROCESS § 423.3 Other process directed to the Social Security Administration or the...

20 CFR 423.3 - Other process directed to the Social Security Administration or the Commissioner.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Other process directed to the Social Security Administration or the Commissioner. 423.3 Section 423.3 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SERVICE OF PROCESS § 423.3 Other process directed to the Social Security Administration or the...

50 CFR 622.250 - Restrictions on sale/purchase.

Code of Federal Regulations, 2014 CFR

2014-10-01

... ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE FISHERIES OF THE CARIBBEAN, GULF OF MEXICO, AND SOUTH... or from the EEZ or adjoining state waters by a vessel that has a valid commercial vessel permit for South Atlantic golden crab may be sold or transferred only to a dealer who has a valid Gulf and South...

Design and Validation of a Straight-Copy Typewriting Prognostic Test Using Kinesthetic Sensitivity.

ERIC Educational Resources Information Center

Olson, Norma Jean

1979-01-01

Describes the development and application of a kinesthetic sensitivity test to determine whether it is a valid and reliable measure of straight-copy typing speed and accuracy. The author states that this kinesthetic sensitivity instrument may be used as a prognostic aptitude test and recommends administration methods. (MF)

Just Ask Me: Convergent Validity of Self-Reported Measures of Music Participation

ERIC Educational Resources Information Center

Elpus, Kenneth

2017-01-01

The purpose of this study was to determine the convergent validity of self-reported and objective measures of school music ensemble participation. Self-reported survey responses to a question about high school music ensemble participation and administrative data in the form of high school transcript-indicated ensemble enrollments were compared…

Recognition, Accreditation and Validation of Non-Formal and Informal Learning: Prospects for Lifelong Learning in Nepal

ERIC Educational Resources Information Center

Regmi, Kapil Dev

2009-01-01

This study was an exploration on the various issues related to recognition, accreditation and validation of non-formal and informal learning to open up avenues for lifelong learning and continuing education in Nepal. The perceptions, experiences, and opinions of Nepalese Development Activists, Educational Administrators, Policy Actors and…

Validation of the Electronic Portfolio Student Perspective Instrument (EPSPI): Conditions under a Different Integration Initiative

ERIC Educational Resources Information Center

Ritzhaupt, Albert D.; Ndoye, Abdou; Parker, Michele A.

2010-01-01

With the explosive growth of e-portfolios in teacher preparation programs, it is essential for administration and other relevant stakeholders to understand the student perspective of e-portfolios' organizational uses. This article describes the validation of the modified Electronic Portfolio Student Perspective Instrument (EPSPI). The analysis…

75 FR 53371 - Liquefied Natural Gas Facilities: Obtaining Approval of Alternative Vapor-Gas Dispersion Models

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-31

... factors as the approved models, are validated by experimental test data, and receive the Administrator's... stage of the MEP involves applying the model against a database of experimental test cases including..., particularly the requirement for validation by experimental test data. That guidance is based on the MEP's...

Concurrent and Predictive Validity of the Phelps Kindergarten Readiness Scale-II

ERIC Educational Resources Information Center

Duncan, Jennifer; Rafter, Erin M.

2005-01-01

The purpose of this research was to establish the concurrent and predictive validity of the Phelps Kindergarten Readiness Scale, Second Edition (PKRS-II; L. Phelps, 2003). Seventy-four kindergarten students of diverse ethnic backgrounds enrolled in a northeastern suburban school participated in the study. The concurrent administration of the…

A systematic review of validated methods for identifying transfusion-related ABO incompatibility reactions using administrative and claims data.

PubMed

Carnahan, Ryan M; Kee, Vicki R

2012-01-01

This paper aimed to systematically review algorithms to identify transfusion-related ABO incompatibility reactions in administrative data, with a focus on studies that have examined the validity of the algorithms. A literature search was conducted using PubMed, Iowa Drug Information Service database, and Embase. A Google Scholar search was also conducted because of the difficulty identifying relevant studies. Reviews were conducted by two investigators to identify studies using data sources from the USA or Canada because these data sources were most likely to reflect the coding practices of Mini-Sentinel data sources. One study was found that validated International Classification of Diseases (ICD-9-CM) codes representing transfusion reactions. None of these cases were ABO incompatibility reactions. Several studies consistently used ICD-9-CM code 999.6, which represents ABO incompatibility reactions, and a technical report identified the ICD-10 code for these reactions. One study included the E-code E8760 for mismatched blood in transfusion in the algorithm. Another study reported finding no ABO incompatibility reaction codes in the Healthcare Cost and Utilization Project Nationwide Inpatient Sample database, which contains data of 2.23 million patients who received transfusions, raising questions about the sensitivity of administrative data for identifying such reactions. Two studies reported perfect specificity, with sensitivity ranging from 21% to 83%, for the code identifying allogeneic red blood cell transfusions in hospitalized patients. There is no information to assess the validity of algorithms to identify transfusion-related ABO incompatibility reactions. Further information on the validity of algorithms to identify transfusions would also be useful. Copyright © 2012 John Wiley & Sons, Ltd.

Hospital Report Cards for Hospital-Acquired Pressure Ulcers: How good are the grades?

PubMed Central

Meddings, Jennifer A.; Reichert, Heidi; Hofer, Tim; McMahon, Laurence F.

2013-01-01

BACKGROUND Value-based purchasing programs will use administrative data to compare hospitals by rates of hospital-acquired pressure ulcers (HAPUs) for public reporting and financial penalties. Validation of administrative data for these purposes, however, is lacking. OBJECTIVE To assess the validity of the administrative data used to generate HAPU rates to compare hospitals for public reporting and financial penalty, by comparing hospital performance as assessed by HAPU rates generated from administrative and surveillance data. DESIGN Retrospective analysis of 2 million all-payer administrative records for 448 California hospitals and quarterly hospital-wide surveillance data for 213 hospitals from the California Nursing Outcomes and Prevalence Study (as publicly reported on CalHospitalCompare). SETTING 196 acute-care hospitals with >=6 months of available administrative and surveillance data PATIENTS Non-obstetric adults discharged in 2009. MEASUREMENTS Hospital-specific HAPU rates were computed as the percentage of discharged adults (from administrative data) or examined adults (from surveillance data) with >=1 HAPU stage II and above (HAPU2+). Categorization of hospital performance using administrative data was compared to the grade assigned using the surveillance data. RESULTS By administrative data, the mean (CI) hospital-specific HAPU2+ rate was 0.15% (0.13, 0.17); by surveillance data, the mean (CI) hospital-specific HAPU2+ rate was 2.0% (1.8, 2.2). Of the 49 hospitals with HAPU2+ rates from administrative data in the highest (worst) quartile, the surveillance dataset assigned these hospitals performance grades of “Superior” for 3 hospitals, “Above Average” for 14 hospitals, “Average” for 15 hospitals, and “Below Average” for 17 hospitals. LIMITATIONS Data are from 1 state, 1 year. CONCLUSIONS Hospital performance scores generated from HAPU2+ rates varied considerably from administrative data and surveillance data, suggesting administrative data may not be appropriate for comparing hospitals. PMID:24126644

Risk perception and information processing: the development and validation of a questionnaire to assess self-reported information processing.

PubMed

Smerecnik, Chris M R; Mesters, Ilse; Candel, Math J J M; De Vries, Hein; De Vries, Nanne K

2012-01-01

The role of information processing in understanding people's responses to risk information has recently received substantial attention. One limitation of this research concerns the unavailability of a validated questionnaire of information processing. This article presents two studies in which we describe the development and validation of the Information-Processing Questionnaire to meet that need. Study 1 describes the development and initial validation of the questionnaire. Participants were randomized to either a systematic processing or a heuristic processing condition after which they completed a manipulation check and the initial 15-item questionnaire and again two weeks later. The questionnaire was subjected to factor reliability and validity analyses on both measurement times for purposes of cross-validation of the results. A two-factor solution was observed representing a systematic processing and a heuristic processing subscale. The resulting scale showed good reliability and validity, with the systematic condition scoring significantly higher on the systematic subscale and the heuristic processing condition significantly higher on the heuristic subscale. Study 2 sought to further validate the questionnaire in a field study. Results of the second study corresponded with those of Study 1 and provided further evidence of the validity of the Information-Processing Questionnaire. The availability of this information-processing scale will be a valuable asset for future research and may provide researchers with new research opportunities. © 2011 Society for Risk Analysis.

41 CFR 128-48.001-50 - Administrative or summary process.

Code of Federal Regulations, 2010 CFR

2010-07-01

... DISPOSAL OF ABANDONED AND FORFEITED PERSONAL PROPERTY § 128-48.001-50 Administrative or summary process... interpreted to mean by administrative process. ... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Administrative or...

Applying Classification Trees to Hospital Administrative Data to Identify Patients with Lower Gastrointestinal Bleeding

PubMed Central

Siddique, Juned; Ruhnke, Gregory W.; Flores, Andrea; Prochaska, Micah T.; Paesch, Elizabeth; Meltzer, David O.; Whelan, Chad T.

2015-01-01

Background Lower gastrointestinal bleeding (LGIB) is a common cause of acute hospitalization. Currently, there is no accepted standard for identifying patients with LGIB in hospital administrative data. The objective of this study was to develop and validate a set of classification algorithms that use hospital administrative data to identify LGIB. Methods Our sample consists of patients admitted between July 1, 2001 and June 30, 2003 (derivation cohort) and July 1, 2003 and June 30, 2005 (validation cohort) to the general medicine inpatient service of the University of Chicago Hospital, a large urban academic medical center. Confirmed cases of LGIB in both cohorts were determined by reviewing the charts of those patients who had at least 1 of 36 principal or secondary International Classification of Diseases, Ninth revision, Clinical Modification (ICD-9-CM) diagnosis codes associated with LGIB. Classification trees were used on the data of the derivation cohort to develop a set of decision rules for identifying patients with LGIB. These rules were then applied to the validation cohort to assess their performance. Results Three classification algorithms were identified and validated: a high specificity rule with 80.1% sensitivity and 95.8% specificity, a rule that balances sensitivity and specificity (87.8% sensitivity, 90.9% specificity), and a high sensitivity rule with 100% sensitivity and 91.0% specificity. Conclusion These classification algorithms can be used in future studies to evaluate resource utilization and assess outcomes associated with LGIB without the use of chart review. PMID:26406318

Validation of administrative data used for the diagnosis of upper gastrointestinal events following nonsteroidal anti-inflammatory drug prescription.

PubMed

Abraham, N S; Cohen, D C; Rivers, B; Richardson, P

2006-07-15

To validate veterans affairs (VA) administrative data for the diagnosis of nonsteroidal anti-inflammatory drug (NSAID)-related upper gastrointestinal events (UGIE) and to develop a diagnostic algorithm. A retrospective study of veterans prescribed an NSAID as identified from the national pharmacy database merged with in-patient and out-patient data, followed by primary chart abstraction. Contingency tables were constructed to allow comparison with a random sample of patients prescribed an NSAID, but without UGIE. Multivariable logistic regression analysis was used to derive a predictive algorithm. Once derived, the algorithm was validated in a separate cohort of veterans. Of 906 patients, 606 had a diagnostic code for UGIE; 300 were a random subsample of 11 744 patients (control). Only 161 had a confirmed UGIE. The positive predictive value (PPV) of diagnostic codes was poor, but improved from 27% to 51% with the addition of endoscopic procedural codes. The strongest predictors of UGIE were an in-patient ICD-9 code for gastric ulcer, duodenal ulcer and haemorrhage combined with upper endoscopy. This algorithm had a PPV of 73% when limited to patients >or=65 years (c-statistic 0.79). Validation of the algorithm revealed a PPV of 80% among patients with an overlapping NSAID prescription. NSAID-related UGIE can be assessed using VA administrative data. The optimal algorithm includes an in-patient ICD-9 code for gastric or duodenal ulcer and gastrointestinal bleeding combined with a procedural code for upper endoscopy.

Integrating technology to improve medication administration.

PubMed

Prusch, Amanda E; Suess, Tina M; Paoletti, Richard D; Olin, Stephen T; Watts, Starann D

2011-05-01

The development, implementation, and evaluation of an i.v. interoperability program to advance medication safety at the bedside are described. I.V. interoperability integrates intelligent infusion devices (IIDs), the bar-code-assisted medication administration system, and the electronic medication administration record system into a bar-code-driven workflow that populates provider-ordered, pharmacist-validated infusion parameters on IIDs. The purpose of this project was to improve medication safety through the integration of these technologies and decrease the potential for error during i.v. medication administration. Four key phases were essential to developing and implementing i.v. interoperability: (a) preparation, (b) i.v. interoperability pilot, (c) preliminary validation, and (d) expansion. The establishment of pharmacy involvement in i.v. interoperability resulted in two additional safety checks: pharmacist infusion rate oversight and nurse independent validation of the autoprogrammed rate. After instituting i.v. interoperability, monthly compliance to the telemetry drug library increased to a mean ± S.D. of 72.1% ± 2.1% from 56.5% ± 1.5%, and the medical-surgical nursing unit's drug library monthly compliance rate increased to 58.6% ± 2.9% from 34.1% ± 2.6% (p < 0.001 for both comparisons). The number of manual pump edits decreased with both telemetry and medical-surgical drug libraries, demonstrating a reduction from 56.9 ± 12.8 to 14.2 ± 3.9 and from 61.2 ± 15.4 to 14.7 ± 3.8, respectively (p < 0.001 for both comparisons). Through the integration and incorporation of pharmacist oversight for rate changes, the telemetry and medical-surgical patient care areas demonstrated a 32% reduction in reported monthly errors involving i.v. administration of heparin. By integrating two stand-alone technologies, i.v. interoperability was implemented to improve medication administration. Medication errors were reduced, nursing workflow was simplified, and pharmacists became involved in checking infusion rates of i.v. medications.

Approaches to ascertaining comorbidity information: validation of routine hospital episode data with clinician-based case note review.

PubMed

Soo, Martin; Robertson, Lynn M; Ali, Tariq; Clark, Laura E; Fluck, Nicholas; Johnston, Marjorie; Marks, Angharad; Prescott, Gordon J; Smith, William Cairns S; Black, Corri

2014-04-21

In clinical practice, research, and increasingly health surveillance, planning and costing, there is a need for high quality information to determine comorbidity information about patients. Electronic, routinely collected healthcare data is capturing increasing amounts of clinical information as part of routine care. The aim of this study was to assess the validity of routine hospital administrative data to determine comorbidity, as compared with clinician-based case note review, in a large cohort of patients with chronic kidney disease. A validation study using record linkage. Routine hospital administrative data were compared with clinician-based case note review comorbidity data in a cohort of 3219 patients with chronic kidney disease. To assess agreement, we calculated prevalence, kappa statistic, sensitivity, specificity, positive predictive value and negative predictive value. Subgroup analyses were also performed. Median age at index date was 76.3 years, 44% were male, 67% had stage 3 chronic kidney disease and 31% had at least three comorbidities. For most comorbidities, we found a higher prevalence recorded from case notes compared with administrative data. The best agreement was found for cerebrovascular disease (κ = 0.80) ischaemic heart disease (κ = 0.63) and diabetes (κ = 0.65). Hypertension, peripheral vascular disease and dementia showed only fair agreement (κ = 0.28, 0.39, 0.38 respectively) and smoking status was found to be poorly recorded in administrative data. The patterns of prevalence across subgroups were as expected and for most comorbidities, agreement between case note and administrative data was similar. Agreement was less, however, in older ages and for those with three or more comorbidities for some conditions. This study demonstrates that hospital administrative comorbidity data compared moderately well with case note review data for cerebrovascular disease, ischaemic heart disease and diabetes, however there was significant under-recording of some other comorbid conditions, and particularly common risk factors.

Reliability, validity and administrative burden of the community reintegration of injured service members computer adaptive test (CRIS-CAT)".

PubMed

Resnik, Linda; Borgia, Matthew; Ni, Pensheng; Pirraglia, Paul A; Jette, Alan

2012-09-17

The Computer Adaptive Test version of the Community Reintegration of Injured Service Members measure (CRIS-CAT) consists of three scales measuring Extent of, Perceived Limitations in, and Satisfaction with community integration. The CRIS-CAT was developed using item response theory methods. The purposes of this study were to assess the reliability, concurrent, known group and predictive validity and respondent burden of the CRIS-CAT.The CRIS-CAT was developed using item response theory methods. The purposes of this study were to assess the reliability, concurrent, known group and predictive validity and respondent burden of the CRIS-CAT. This was a three-part study that included a 1) a cross-sectional field study of 517 homeless, employed, and Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans; who completed all items in the CRIS item set, 2) a cohort study with one year follow-up study of 135 OEF/OIF Veterans, and 3) a 50-person study of CRIS-CAT administration. Conditional reliability of simulated CAT scores was calculated from the field study data, and concurrent validity and known group validity were examined using Pearson product correlations and ANOVAs. Data from the cohort were used to examine the ability of the CRIS-CAT to predict key one year outcomes. Data from the CRIS-CAT administration study were used to calculate ICC (2,1) minimum detectable change (MDC), and average number of items used during CAT administration. Reliability scores for all scales were above 0.75, but decreased at both ends of the score continuum. CRIS-CAT scores were correlated with concurrent validity indicators and differed significantly between the three Veteran groups (P < .001). The odds of having any Emergency Room visits were reduced for Veterans with better CRIS-CAT scores (Extent, Perceived Satisfaction respectively: OR = 0.94, 0.93, 0.95; P < .05). CRIS-CAT scores were predictive of SF-12 physical and mental health related quality of life scores at the 1 year follow-up. Scales had ICCs >0.9. MDCs were 5.9, 6.2, and 3.6, respectively for Extent, Perceived and Satisfaction subscales. Number of items (mn, SD) administered at Visit 1 were 14.6 (3.8) 10.9 (2.7) and 10.4 (1.7) respectively for Extent, Perceived and Satisfaction subscales. The CRIS-CAT demonstrated sound measurement properties including reliability, construct, known group and predictive validity, and it was administered with minimal respondent burden. These findings support the use of this measure in assessing community reintegration.

Drug-loaded erythrocytes: on the road toward marketing approval

PubMed Central

Bourgeaux, Vanessa; Lanao, José M; Bax, Bridget E; Godfrin, Yann

2016-01-01

Erythrocyte drug encapsulation is one of the most promising therapeutic alternative approaches for the administration of toxic or rapidly cleared drugs. Drug-loaded erythrocytes can operate through one of the three main mechanisms of action: extension of circulation half-life (bioreactor), slow drug release, or specific organ targeting. Although the clinical development of erythrocyte carriers is confronted with regulatory and development process challenges, industrial development is expanding. The manufacture of this type of product can be either centralized or bedside based, and different procedures are employed for the encapsulation of therapeutic agents. The major challenges for successful industrialization include production scalability, process validation, and quality control of the released therapeutic agents. Advantages and drawbacks of the different manufacturing processes as well as success key points of clinical development are discussed. Several entrapment technologies based on osmotic methods have been industrialized. Companies have already achieved many of the critical clinical stages, thus providing the opportunity in the future to cover a wide range of diseases for which effective therapies are not currently available. PMID:26929599

Drug-loaded erythrocytes: on the road toward marketing approval.

PubMed

Bourgeaux, Vanessa; Lanao, José M; Bax, Bridget E; Godfrin, Yann

2016-01-01

Erythrocyte drug encapsulation is one of the most promising therapeutic alternative approaches for the administration of toxic or rapidly cleared drugs. Drug-loaded erythrocytes can operate through one of the three main mechanisms of action: extension of circulation half-life (bioreactor), slow drug release, or specific organ targeting. Although the clinical development of erythrocyte carriers is confronted with regulatory and development process challenges, industrial development is expanding. The manufacture of this type of product can be either centralized or bedside based, and different procedures are employed for the encapsulation of therapeutic agents. The major challenges for successful industrialization include production scalability, process validation, and quality control of the released therapeutic agents. Advantages and drawbacks of the different manufacturing processes as well as success key points of clinical development are discussed. Several entrapment technologies based on osmotic methods have been industrialized. Companies have already achieved many of the critical clinical stages, thus providing the opportunity in the future to cover a wide range of diseases for which effective therapies are not currently available.

Construct Validation of a Multidimensional Computerized Adaptive Test for Fatigue in Rheumatoid Arthritis

PubMed Central

Nikolaus, Stephanie; Bode, Christina; Taal, Erik; Vonkeman, Harald E.; Glas, Cees A. W.; van de Laar, Mart A. F. J.

2015-01-01

Objective Multidimensional computerized adaptive testing enables precise measurements of patient-reported outcomes at an individual level across different dimensions. This study examined the construct validity of a multidimensional computerized adaptive test (CAT) for fatigue in rheumatoid arthritis (RA). Methods The ‘CAT Fatigue RA’ was constructed based on a previously calibrated item bank. It contains 196 items and three dimensions: ‘severity’, ‘impact’ and ‘variability’ of fatigue. The CAT was administered to 166 patients with RA. They also completed a traditional, multidimensional fatigue questionnaire (BRAF-MDQ) and the SF-36 in order to examine the CAT’s construct validity. A priori criterion for construct validity was that 75% of the correlations between the CAT dimensions and the subscales of the other questionnaires were as expected. Furthermore, comprehensive use of the item bank, measurement precision and score distribution were investigated. Results The a priori criterion for construct validity was supported for two of the three CAT dimensions (severity and impact but not for variability). For severity and impact, 87% of the correlations with the subscales of the well-established questionnaires were as expected but for variability, 53% of the hypothesised relations were found. Eighty-nine percent of the items were selected between one and 137 times for CAT administrations. Measurement precision was excellent for the severity and impact dimensions, with more than 90% of the CAT administrations reaching a standard error below 0.32. The variability dimension showed good measurement precision with 90% of the CAT administrations reaching a standard error below 0.44. No floor- or ceiling-effects were found for the three dimensions. Conclusion The CAT Fatigue RA showed good construct validity and excellent measurement precision on the dimensions severity and impact. The dimension variability had less ideal measurement characteristics, pointing to the need to recalibrate the CAT item bank with a two-dimensional model, solely consisting of severity and impact. PMID:26710104

Incremental Validity of Biographical Data in the Prediction of En Route Air Traffic Control Specialist Technical Skills

DTIC Science & Technology

2012-07-01

Incremental Validity of Biographical Data in the Prediction of En Route Air Traffic Control Specialist Technical Skills Dana Broach Civil Aerospace...Medical Institute Federal Aviation Administration Oklahoma City, OK 73125 July 2012 Final Report DOT/FAA/AM- 12 /8 Office of Aerospace Medicine...FAA/AM- 12 /8 4. Title and Subtitle 5. Report Date July 2012 Incremental Validity of Biographical Data in the Prediction of En Route Air

Validation protocol of analytical procedures for quantification of drugs in polymeric systems for parenteral administration: dexamethasone phosphate disodium microparticles.

PubMed

Martín-Sabroso, Cristina; Tavares-Fernandes, Daniel Filipe; Espada-García, Juan Ignacio; Torres-Suárez, Ana Isabel

2013-12-15

In this work a protocol to validate analytical procedures for the quantification of drug substances formulated in polymeric systems that comprise both drug entrapped into the polymeric matrix (assay:content test) and drug released from the systems (assay:dissolution test) is developed. This protocol is applied to the validation two isocratic HPLC analytical procedures for the analysis of dexamethasone phosphate disodium microparticles for parenteral administration. Preparation of authentic samples and artificially "spiked" and "unspiked" samples is described. Specificity (ability to quantify dexamethasone phosphate disodium in presence of constituents of the dissolution medium and other microparticle constituents), linearity, accuracy and precision are evaluated, in the range from 10 to 50 μg mL(-1) in the assay:content test procedure and from 0.25 to 10 μg mL(-1) in the assay:dissolution test procedure. The robustness of the analytical method to extract drug from microparticles is also assessed. The validation protocol developed allows us to conclude that both analytical methods are suitable for their intended purpose, but the lack of proportionality of the assay:dissolution analytical method should be taken into account. The validation protocol designed in this work could be applied to the validation of any analytical procedure for the quantification of drugs formulated in controlled release polymeric microparticles. Copyright © 2013 Elsevier B.V. All rights reserved.

Validation of an algorithm to identify children with biopsy-proven celiac disease from within health administrative data: An assessment of health services utilization patterns in Ontario, Canada

PubMed Central

Chan, Jason; Mack, David R.; Manuel, Douglas G.; Mojaverian, Nassim; de Nanassy, Joseph

2017-01-01

Importance Celiac disease (CD) is a common pediatric illness, and awareness of gluten-related disorders including CD is growing. Health administrative data represents a unique opportunity to conduct population-based surveillance of this chronic condition and assess the impact of caring for children with CD on the health system. Objective The objective of the study was to validate an algorithm based on health administrative data diagnostic codes to accurately identify children with biopsy-proven CD. We also evaluated trends over time in the use of health services related to CD by children in Ontario, Canada. Study design and setting We conducted a retrospective cohort study and validation study of population-based health administrative data in Ontario, Canada. All cases of biopsy-proven CD diagnosed 2005–2011 in Ottawa were identified through chart review from a large pediatric health care center, and linked to the Ontario health administrative data to serve as positive reference standard. All other children living within Ottawa served as the negative reference standard. Case-identifying algorithms based on outpatient physician visits with associated ICD-9 code for CD plus endoscopy billing code were constructed and tested. Sensitivity, specificity, PPV and NPV were tested for each algorithm (with 95% CI). Poisson regression, adjusting for sex and age at diagnosis, was used to explore the trend in outpatient visits associated with a CD diagnostic code from 1995–2011. Results The best algorithm to identify CD consisted of an endoscopy billing claim follow by 1 or more adult or pediatric gastroenterologist encounters after the endoscopic procedure. The sensitivity, specificity, PPV, and NPV for the algorithm were: 70.4% (95% CI 61.1–78.4%), >99.9% (95% CI >99.9->99.9%), 53.3% (95% CI 45.1–61.4%) and >99.9% (95% CI >99.9->99.9%) respectively. It identified 1289 suspected CD cases from Ontario-wide administrative data. There was a 9% annual increase in the use of this combination of CD-associated diagnostic codes in physician billing data (RR 1.09, 95% CI 1.07–1.10, P<0.001). Conclusions With its current structure and variables Ontario health administrative data is not suitable in identifying incident pediatric CD cases. The tested algorithms suffer from poor sensitivity and/or poor PPV, which increase the risk of case misclassification that could lead to biased estimation of CD incidence rate. This study reinforced the importance of validating the codes used to identify cohorts or outcomes when conducting research using health administrative data. PMID:28662204

The Global Precipitation Measurement (GPM) Project

NASA Technical Reports Server (NTRS)

Azarbarzin, Ardeshir; Carlisle, Candace

2010-01-01

The Global Precipitation Measurement (GP!v1) mission is an international cooperative effort to advance the understanding of the physics of the Earth's water and energy cycle. Accurate and timely knowledge of global precipitation is essential for understanding the weather/climate/ecological system, for improving our ability to manage freshwater resources, and for predicting high-impact natural hazard events including floods, droughts, extreme weather events, and landslides. The GPM Core Observatory will be a reference standard to uniformly calibrate data from a constellation of spacecraft with passive microwave sensors. GPM is being developed under a partnership between the United States (US) National Aeronautics and Space Administration (NASA) and the Japanese Aerospace and Exploration Agency (JAXA). NASA's Goddard Space Flight Center (GSFC), in Greenbelt, MD is developing the Core Observatory, two GPM Microwave Imager (GMI) instruments, Ground Validation System and Precipitation Processing System for the GPM mission. JAXA will provide a Dual-frequency Precipitation Radar (DPR) for installation on the Core satellite and launch services for the Core Observatory. The second GMI instrument will be flown on a partner-provided spacecraft. Other US agencies and international partners contribute to the GPM mission by providing precipitation measurements obtained from their own spacecraft and/or providing ground-based precipitation measurements to support ground validation activities. The Precipitation Processing System will provide standard data products for the mission.

Analysis of malondialdehyde in human plasma samples through derivatization with 2,4-dinitrophenylhydrazine by ultrasound-assisted dispersive liquid-liquid microextraction-GC-FID approach.

PubMed

Malaei, Reyhane; Ramezani, Amir M; Absalan, Ghodratollah

2018-05-04

A sensitive and reliable ultrasound-assisted dispersive liquid-liquid microextraction (UA-DLLME) procedure was developed and validated for extraction and analysis of malondialdehyde (MDA) as an important lipids-peroxidation biomarker in human plasma. In this methodology, to achieve an applicable extraction procedure, the whole optimization processes were performed in human plasma. To convert MDA into readily extractable species, it was derivatized to hydrazone structure-base by 2,4-dinitrophenylhydrazine (DNPH) at 40 °C within 60 min. Influences of experimental variables on the extraction process including type and volume of extraction and disperser solvents, amount of derivatization agent, temperature, pH, ionic strength, sonication and centrifugation times were evaluated. Under the optimal experimental conditions, the enhancement factor and extraction recovery were 79.8 and 95.8%, respectively. The analytical signal linearly (R 2  = 0.9988) responded over a concentration range of 5.00-4000 ng mL -1 with a limit of detection of 0.75 ng mL -1 (S/N = 3) in the plasma sample. To validate the developed procedure, the recommend guidelines of Food and Drug Administration for bioanalytical analysis have been employed. Copyright © 2018. Published by Elsevier B.V.

Supercooled Liquid Water Content Instrument Analysis and Winter 2014 Data with Comparisons to the NASA Icing Remote Sensing System and Pilot Reports

NASA Technical Reports Server (NTRS)

King, Michael C.

2016-01-01

The National Aeronautics and Space Administration (NASA) has developed a system for remotely detecting the hazardous conditions leading to aircraft icing in flight, the NASA Icing Remote Sensing System (NIRSS). Newly developed, weather balloon-borne instruments have been used to obtain in-situ measurements of supercooled liquid water during March 2014 to validate the algorithms used in the NIRSS. A mathematical model and a processing method were developed to analyze the data obtained from the weather balloon soundings. The data from soundings obtained in March 2014 were analyzed and compared to the output from the NIRSS and pilot reports.

A quantitative approach to developing Parkinsonian monkeys (Macaca fascicularis) with intracerebroventricular 1-methyl-4-phenylpyridinium injections.

PubMed

Li, Hao; Lei, Xiaoguang; Huang, Baihui; Rizak, Joshua D; Yang, Lichuan; Yang, Shangchuan; Wu, Jing; Lü, Longbao; Wang, Jianhong; Yan, Ting; Li, Hongwei; Wang, Zhengbo; Hu, Yingzhou; Le, Weidong; Deng, Xingli; Li, Jiali; Xu, Lin; Zhang, Baorong; Hu, Xintian

2015-08-15

Non-human primate Parkinson's disease (PD) models are essential for PD research. The most extensively used PD monkey models are induced with 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP). However, the modeling processes of developing PD monkeys cannot be quantitatively controlled with MPTP. Therefore, a new approach to quantitatively develop chronic PD monkey models will help to advance the goals of "reduction, replacement and refinement" in animal experiments. A novel chronic PD monkey models was reported using the intracerebroventricular administration of 1-methyl-4-phenylpyridinium (MPP(+)) in Cynomolgus monkeys (Macaca fascicularis). This approach successfully produced stable and consistent PD monkeys with typical motor symptoms and pathological changes. More importantly, a sigmoidal relationship (Y=8.15801e(-0.245/x); R=0.73) was discovered between PD score (Y) and cumulative dose of MPP(+) (X). This relationship was then used to develop two additional PD monkeys under a specific time schedule (4 weeks), with planned PD scores (7) by controlling the dose and frequency of the MPP(+) administration as an independent validation of the formula. We developed Parkinsonian monkeys within controlled time frames by regulating the accumulated dose of MPP(+) intracerebroventricular administered, while limiting side effects often witnessed in models developed with the peripheral administration of MPTP, makes this model highly suitable for treatment development. This novel approach provides an edge in evaluating the mechanisms of PD pathology associated with environmental toxins and novel treatment approaches as the formula developed provides a "map" to control and predict the modeling processes. Copyright © 2015 Elsevier B.V. All rights reserved.

Administrative data measured surgical site infection probability within 30 days of surgery in elderly patients.

PubMed

van Walraven, Carl; Jackson, Timothy D; Daneman, Nick

2016-09-01

Elderly patients are inordinately affected by surgical site infections (SSIs). This study derived and internally validated a model that used routinely collected health administrative data to measure the probability of SSI in elderly patients within 30 days of surgery. All people exceeding 65 years undergoing surgery from two hospitals with known SSI status were linked to population-based administrative data sets in Ontario, Canada. We used bootstrap methods to create a multivariate model that used health administrative data to predict the probability of SSI. Of 3,436 patients, 177 (5.1%) had an SSI. The Elderly SSI Risk Model included six covariates: number of distinct physician fee codes within 30 days of surgery; presence or absence of a postdischarge prescription for an antibiotic; presence or absence of three diagnostic codes; and a previously derived score that gauged SSI risk based on procedure codes. The model was highly explanatory (Nagelkerke's R 2 , 0.458), strongly discriminative (C statistic, 0.918), and well calibrated (calibration slope, 1). Health administrative data can effectively determine 30-day risk of SSI risk in elderly patients undergoing a broad assortment of surgeries. External validation is necessary before this can be routinely used to monitor SSIs in the elderly. Copyright © 2016 Elsevier Inc. All rights reserved.

Tissue distribution study of periplocin and its two metabolites in rats by a validated LC-MS/MS method.

PubMed

Liu, Huaming; Zhang, Dandan; Tang, Zhidan; Sun, Mengjie; Azietaku, John Teye; Ouyang, Huizi; Chang, Yanxu; Wang, Meng; He, Jun; Gao, Xiumei

2018-05-29

Periplocin is a cardiac glycoside and has been used widely in the clinic for its cardiotonic, anti-inflammatory and anti-tumor effects. Though it was taken frequently by oral administration in clinic, there were no reports demonstrated that periplocin could be detected in vivo after an oral administration of periplocin, so it is badly need of searching the characteristic of periplocin in vivo after an oral administration. In this study, a sensitive and reliable liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated to identify and quantify periplocin and its two metabolites in rat tissue after a single dosage of perplocin at 50 mg/kg. The results demonstrated that periplocin and its two metabolites were detected in all of the selected tissues, periplocin could be reach peak concentration quickly after administration, while periplocymarin and periplogenin reached maximum concentration more than 4.83 h after administration. The tissue distribution of analytes tended to be mostly in the liver, and higher analytes concentrations were found in the heart, liver, spleen, lung, kidney, but a small amount of chemical constituents were distributed into the brain. The consequences obtained using this method might provide a meaningful insight for the clinical investigations and applications. This article is protected by copyright. All rights reserved.

Validation study of an electronic method of condensed outcomes tools reporting in orthopaedics.

PubMed

Farr, Jack; Verma, Nikhil; Cole, Brian J

2013-12-01

Patient-reported outcomes (PRO) instruments are a vital source of data for evaluating the efficacy of medical treatments. Historically, outcomes instruments have been designed, validated, and implemented as paper-based questionnaires. The collection of paper-based outcomes information may result in patients becoming fatigued as they respond to redundant questions. This problem is exacerbated when multiple PRO measures are provided to a single patient. In addition, the management and analysis of data collected in paper format involves labor-intensive processes to score and render the data analyzable. Computer-based outcomes systems have the potential to mitigate these problems by reformatting multiple outcomes tools into a single, user-friendly tool.The study aimed to determine whether the electronic outcomes system presented produces results comparable with the test-retest correlations reported for the corresponding orthopedic paper-based outcomes instruments.The study is designed as a crossover study based on consecutive orthopaedic patients arriving at one of two designated orthopedic knee clinics.Patients were assigned to complete either a paper or a computer-administered questionnaire based on a similar set of questions (Knee injury and Osteoarthritis Outcome Score, International Knee Documentation Committee form, 36-Item Short Form survey, version 1, Lysholm Knee Scoring Scale). Each patient completed the same surveys using the other instrument, so that all patients had completed both paper and electronic versions. Correlations between the results from the two modes were studied and compared with test-retest data from the original validation studies.The original validation studies established test-retest reliability by computing correlation coefficients for two administrations of the paper instrument. Those correlation coefficients were all in the range of 0.7 to 0.9, which was deemed satisfactory. The present study computed correlation coefficients between the paper and electronic modes of administration. These correlation coefficients demonstrated similar results with an overall value of 0.86.On the basis of the correlation coefficients, the electronic application of commonly used knee outcome scores compare variably to the traditional paper variants with a high rate of test-retest correlation. This equivalence supports the use of the condensed electronic outcomes system and validates comparison of scores between electronic and paper modes. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Challenges in application of bioanalytical method on different populations and effect of population on PK.

PubMed

Kale, Prashant; Shukla, Manoj; Soni, Gunjan; Patel, Ronak; Gupta, Shailendra

2014-01-01

Prashant Kale has 22 years of immense experience in the analytical and bioanalytical domain. He is Senior Vice President, Bioequivalence Operations of Lambda Therapeutic Research, India which includes Bioanalytical, Clinics, Clinical data management, Pharmacokinetics and Biostatistics, Protocol writing, Clinical lab and Quality Assurance departments. He has been with Lambda for over 14 years. By qualification he is a M.Sc. and an MBA. Mr. Kale is responsible for the management, technical and administrative functions of the BE unit located at Ahmedabad and Mumbai, India. He is also responsible for leading the process of integration between bioanalytical laboratories and services offered by Lambda at global locations (India and Canada). Mr. Kale has faced several regulatory audits and inspections from leading regulatory bodies including but not limited to DCGI, USFDA, ANVISA, Health Canada, UK MHRA, Turkey MoH, WHO. There are many challenges involved in the application of bioanalytical method on different populations. This includes difference in equipment, material and environment across laboratories, variations in the matrix characteristics in different populations, differences in techniques between analysts such as sample processing and handling and others. Additionally, there is variability in the PK of a drug in different populations. This article shows the effect of different populations on validated bioanalytical method and on the PK of a drug. Hence, the bioanalytical method developed and validated for a specific population may need required modification when applied to another population. Critical consideration of all such aspects is the key to successful implementation of a validated method on different populations.

The strange case of the [13N]NH3: validation of the production process for human use.

PubMed

Statuto, Massimo; Galli, Elisa; Bertagna, Francesco; Migliorati, Elena; Zanella, Isabella; Di Lorenzo, Diego; De Agostini, Antonio; Rodella, Carlo; Apostoli, Pietro; Caimi, Luigi; Giubbini, Raffaele; Biasiotto, Giorgio

2016-04-01

PET radiopharmaceuticals are often injected in patients before all quality controls are performed and before sterility results are available. We propose a process validation to produce very safe and pure [N]NH3 for human use. [N]NH3 was produced in the cyclotron target. Online purification was performed by anionic exchange resin. All the production steps were subjected to a sterility test. Some additional controls were added to those required by the monograph. The radiochemical yield of the syntheses was 26.3 and 61.5% corrected for decay, with a radiochemical purity of 100%. In addition to quality controls requested by the European Pharmacopeia monograph, we carefully analyzed the product for the presence of possible contaminants. Some elements, mainly metals, were found in very low amounts at concentrations in the range of ppb. The radionuclidic purity was verified. The achievement of the parameters of osmolality, by addition of saline solution to the preparation, made the analysis of chemical purity difficult and worsened the measurement of radiochemical purity by high performance liquid chromatography. Only pH control is necessary before administration to patients and therefore a safe production process was set up to prevent microbiological contamination. All phases were carefully standardized, starting from in-target production of [N]NH3, to final splitting in the syringes. Sterility tests showed no bacterial growth, indicating the safety of the production process. All our syntheses followed the monograph indications and were optimal to obtain PET imaging of a patient's myocardium.

33 CFR Appendix A to Part 331 - Administrative Appeal Process for Permit Denials and Proffered Permits

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 3 2010-07-01 2010-07-01 false Administrative Appeal Process for... ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE ADMINISTRATIVE APPEAL PROCESS Pt. 331, App. A Appendix A to Part 331—Administrative Appeal Process for Permit Denials and Proffered Permits ER28MR00.000 ...

Current Protocols in Pharmacology

PubMed Central

2016-01-01

Determination of drug or drug metabolite concentrations in biological samples, particularly in serum or plasma, is fundamental to describing the relationships between administered dose, route of administration, and time after dose to the drug concentrations achieved and to the observed effects of the drug. A well-characterized, accurate analytical method is needed, but it must also be established that the analyte concentration in the sample at the time of analysis is the same as the concentration at sample acquisition. Drugs and metabolites may be susceptible to degradation in samples due to metabolism or to physical and chemical processes, resulting in a lower measured concentration than was in the original sample. Careful examination of analyte stability during processing and storage and adjustment of procedures and conditions to maximize that stability are a critical part of method validation for the analysis, and can ensure the accuracy of the measured concentrations. PMID:27960029

caBIG compatibility review system: software to support the evaluation of applications using defined interoperability criteria.

PubMed

Freimuth, Robert R; Schauer, Michael W; Lodha, Preeti; Govindrao, Poornima; Nagarajan, Rakesh; Chute, Christopher G

2008-11-06

The caBIG Compatibility Review System (CRS) is a web-based application to support compatibility reviews, which certify that software applications that pass the review meet a specific set of criteria that allow them to interoperate. The CRS contains workflows that support both semantic and syntactic reviews, which are performed by the caBIG Vocabularies and Common Data Elements (VCDE) and Architecture workspaces, respectively. The CRS increases the efficiency of compatibility reviews by reducing administrative overhead and it improves uniformity by ensuring that each review is conducted according to a standard process. The CRS provides metrics that allow the review team to evaluate the level of data element reuse in an application, a first step towards quantifying the extent of harmonization between applications. Finally, functionality is being added that will provide automated validation of checklist criteria, which will further simplify the review process.

Adaptation and validation of the Spanish version of the graded chronic pain scale.

PubMed

Ferrer-Peña, Raúl; Gil-Martínez, Alfonso; Pardo-Montero, Joaquín; Jiménez-Penick, Virginia; Gallego-Izquierdo, Tomás; La Touche, Roy

2016-01-01

To adapt the Graded Chronic Pain Scale for use in Primary care patients in Spain, and to assess its psychometric properties. Clinical measures observational study investigating the severity of chronic pain. The methodology included a process of translation and back-translation following the international guidelines. Study participants were 75 patients who experienced lower back pain for more than six months and were sent to Primary Care physiotherapy units. Internal consistency, construct validity, test-retest reliability, floor and ceiling effects, and answering capacity were analysed. The Spanish version of the Graded Chronic Pain Scale had a high internal consistency, with a Cronbach's alpha of 0.87 and intraclass correlation coefficient of 0.81. Regarding construct validity, it was identified that two factors explained 72.37% of the variance. Convergent validity showed a moderate positive correlation with the Visual Analogue Scale, the activity avoidance subscale of the Tampa Scale of Kinesophobia, the Pain Catastrophizing Scale, the Roland-Morris Low Back Pain and Disability Questionnaire, and the FearAvoidance Beliefs Questionnaire. A moderate negative correlation was identified with the Chronic Pain Self-Efficacy Scale. The mean time of questionnaire administration was 2minutes and 28seconds. The Spanish version of the Graded Chronic Pain Scale appears to be a valid, reliable, and useful tool for measuring chronic pain at an early stage in Primary Care settings in Spain. Copyright © 2015 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part IV - postanalytic considerations.

PubMed

Barnett, David; Louzao, Raaul; Gambell, Peter; De, Jitakshi; Oldaker, Teri; Hanson, Curtis A

2013-01-01

Flow cytometry and other technologies of cell-based fluorescence assays are as a matter of good laboratory practice required to validate all assays, which when in clinical practice may pass through regulatory review processes using criteria often defined with a soluble analyte in plasma or serum samples in mind. Recently the U.S. Food and Drug Administration (FDA) has entered into a public dialogue in the U.S. regarding their regulatory interest in laboratory developed tests (LDTs) or so-called home brew assays performed in clinical laboratories. The absence of well-defined guidelines for validation of cell-based assays using fluorescence detection has thus become a subject of concern for the International Council for Standardization of Haematology (ICSH) and International Clinical Cytometry Society (ICCS). Accordingly, a group of over 40 international experts in the areas of test development, test validation, and clinical practice of a variety of assay types using flow cytometry and/or morphologic image analysis were invited to develop a set of practical guidelines useful to in vitro diagnostic (IVD) innovators, clinical laboratories, regulatory scientists, and laboratory inspectors. The focus of the group was restricted to fluorescence reporter reagents, although some common principles are shared by immunohistochemistry or immunocytochemistry techniques and noted where appropriate. The work product of this two year effort is the content of this special issue of this journal, which is published as 5 separate articles, this being Validation of Cell-based Fluorescence Assays: Practice Guidelines from the ICSH and ICCS - Part IV - Postanalytic considerations. © 2013 International Clinical Cytometry Society.

Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part II - preanalytical issues.

PubMed

Davis, Bruce H; Dasgupta, Amar; Kussick, Steven; Han, Jin-Yeong; Estrellado, Annalee

2013-01-01

Flow cytometry and other technologies of cell-based fluorescence assays are as a matter of good laboratory practice required to validate all assays, which when in clinical practice may pass through regulatory review processes using criteria often defined with a soluble analyte in plasma or serum samples in mind. Recently the U.S. Food and Drug Administration (FDA) has entered into a public dialogue in the U.S. regarding their regulatory interest in laboratory developed tests (LDTs) or so-called "home brew" assays performed in clinical laboratories. The absence of well-defined guidelines for validation of cell-based assays using fluorescence detection has thus become a subject of concern for the International Council for Standardization of Haematology (ICSH) and International Clinical Cytometry Society (ICCS). Accordingly, a group of over 40 international experts in the areas of test development, test validation, and clinical practice of a variety of assay types using flow cytometry and/or morphologic image analysis were invited to develop a set of practical guidelines useful to in vitro diagnostic (IVD) innovators, clinical laboratories, regulatory scientists, and laboratory inspectors. The focus of the group was restricted to fluorescence reporter reagents, although some common principles are shared by immunohistochemistry or immunocytochemistry techniques and noted where appropriate. The work product of this two year effort is the content of this special issue of this journal, which is published as 5 separate articles, this being Validation of Cell-based Fluorescence Assays: Practice Guidelines from the ICSH and ICCS - Part II - Preanalytical issues. © 2013 International Clinical Cytometry Society. © 2013 International Clinical Cytometry Society.

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

PubMed

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

2017-02-01

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

"Less Success than Meets the Eye?" The Impact of Master of Business Administration Education on Graduates' Careers

ERIC Educational Resources Information Center

Zhao, Jensen J.; Truell, Allen D.; Alexander, Melody W.; Hill, Inga B.

2006-01-01

Some negative rumblings about Master of Business Administration (MBA) education have lately been circulating among business journals and magazines. To test the validity of such rumblings, the authors surveyed 309 graduates who obtained MBAs between 1996 and 2002 from an Association to Advance Collegiate Schools of Business (AACSB)…

75 FR 35305 - Local Number Portability Porting Interval and Validation Requirements; Telephone Number Portability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-22

... database administrators proceed in a clear and orderly fashion so that porting requests can be handled in... communications between service providers and database administrators proceed in a clear and orderly fashion so... Bureau data for 2002 show that there were a total of 371 firms that operated for the entire year. Of this...

The Americans with Disabilities Act: A Decision Tree for Social Services Administrators

ERIC Educational Resources Information Center

O'Brien, Gerald V.; Ellegood, Christina

2005-01-01

The 1990 Americans with Disabilities Act has had a profound influence on social workers and social services administrators in virtually all work settings. Because of the multiple elements of the act, however, assessing the validity of claims can be a somewhat arduous and complicated task. This article provides a "decision tree" for…

Online Proctored versus Unproctored Low-Stakes Internet Test Administration: Is There Differential Test-Taking Behavior and Performance?

ERIC Educational Resources Information Center

Rios, Joseph A.; Liu, Ou Lydia

2017-01-01

Online higher education institutions are presented with the concern of how to obtain valid results when administering student learning outcomes (SLO) assessments remotely. Traditionally, there has been a great reliance on unproctored Internet test administration (UIT) due to increased flexibility and reduced costs; however, a number of validity…

Utility and Validity of NAEP Linking Efforts

ERIC Educational Resources Information Center

Linn, Robert L.; McLaughlin, Donald; Thissen, David

2009-01-01

There are a number of practical situations in which it would be desirable to be able to use the results of the administration of one assessment to estimate what the results would have been if another assessment had been administered. Test linking refers to the idea that results obtained from the administration of one test might be used to infer…

Diversity Leadership Skills of School Administrators: A Scale Development Study

ERIC Educational Resources Information Center

Polat, Soner; Arslan, Yaser; Ölçüm, Dinçer

2017-01-01

The aim of this study is to develop a valid and reliable instrument to determine the level of school administrators' diversity leadership based on teachers' perceptions. For this purpose, an item pool was created which includes 68 questions based on the literature, and data were obtained from 343 teachers. Exploratory factor analysis (EFA) was…

Adaptation from Paper-Pencil to Web-Based Administration of a Parent-Completed Developmental Questionnaire for Young Children

ERIC Educational Resources Information Center

Yovanoff, Paul; Squires, Jane; McManus, Suzanne

2013-01-01

Adapting traditional paper-pencil instruments to computer-based environments has received considerable attention from the research community due to the possible administration mode effects on obtained measures. When differences due to mode of completion (i.e., paper-pencil, computer-based) are present, threats to measurement validity are posed. In…

Computer validation in toxicology: historical review for FDA and EPA good laboratory practice.

PubMed

Brodish, D L

1998-01-01

The application of computer validation principles to Good Laboratory Practice is a fairly recent phenomenon. As automated data collection systems have become more common in toxicology facilities, the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency have begun to focus inspections in this area. This historical review documents the development of regulatory guidance on computer validation in toxicology over the past several decades. An overview of the components of a computer life cycle is presented, including the development of systems descriptions, validation plans, validation testing, system maintenance, SOPs, change control, security considerations, and system retirement. Examples are provided for implementation of computer validation principles on laboratory computer systems in a toxicology facility.

Implementing the space shuttle data processing system with the space generic open avionics architecture

NASA Technical Reports Server (NTRS)

Wray, Richard B.; Stovall, John R.

1993-01-01

This paper presents an overview of the application of the Space Generic Open Avionics Architecture (SGOAA) to the Space Shuttle Data Processing System (DPS) architecture design. This application has been performed to validate the SGOAA, and its potential use in flight critical systems. The paper summarizes key elements of the Space Shuttle avionics architecture, data processing system requirements and software architecture as currently implemented. It then summarizes the SGOAA architecture and describes a tailoring of the SGOAA to the Space Shuttle. The SGOAA consists of a generic system architecture for the entities in spacecraft avionics, a generic processing external and internal hardware architecture, a six class model of interfaces and functional subsystem architectures for data services and operations control capabilities. It has been proposed as an avionics architecture standard with the National Aeronautics and Space Administration (NASA), through its Strategic Avionics Technology Working Group, and is being considered by the Society of Aeronautic Engineers (SAE) as an SAE Avionics Standard. This architecture was developed for the Flight Data Systems Division of JSC by the Lockheed Engineering and Sciences Company, Houston, Texas.

Open and Distance Education Accreditation Standards Scale: Validity and Reliability Studies

ERIC Educational Resources Information Center

Can, Ertug

2016-01-01

The purpose of this study is to develop, and test the validity and reliability of a scale for the use of researchers to determine the accreditation standards of open and distance education based on the views of administrators, teachers, staff and students. This research was designed according to the general descriptive survey model since it aims…

Evidences of Validity of the Brazilian Scale of Learner's Attitude towards Distance Education Programs

ERIC Educational Resources Information Center

Coelho, Francisco Antonio, Jr.; Cortat, Mariane; Flores, Clarissa Leite; Santos, Flávio Augusto Mendes; Alves, Gleidilson Costa; Faiad, Cristiane; Ramos, Wilsa Maria; Rodrigues da Silva, Alan

2018-01-01

Online learning is one of the fastest growing trends in educational uses of technology. In this study, an instrument to measure the social attitudes of the Brazilian students based on distance education was developed and validated. The study population consisted of public administration undergraduate students that has been providing by distance…

Concurrent Validity of the "Working with Others Scale" of the ICIS Employment Interview System

ERIC Educational Resources Information Center

Cassidy, Martha W.

2011-01-01

The purpose of this study was to determine if the Working with Others Scale from the American Association of School Personnel Administrators (AASPA) Interactive Computer Interview System (ICIS) was a valid predictor of practicing teachers' interpersonal skills and abilities to work well with colleagues. Participants in the study were all employed…

Validation of the Offending-Related Attitudes Questionnaire of CRIME-PICS II Scale (Chinese)

ERIC Educational Resources Information Center

Chui, Wing Hong; Wu, Joseph; Kwok, Yan Yuen; Liu, Liu

2017-01-01

This study examined the factor structure, reliability, and validity of the first part of the Chinese version of the CRIME-PICS II Scale, a self-administrated instrument assessing offending-related attitudes. Data were collected from three samples: male Hong Kong young offenders, female Mainland Chinese prisoners, and Hong Kong college students.…

Specifying and Pilot Testing Quality Measures for the American Society of Addiction Medicine's Standards of Care.

PubMed

Harris, Alex H S; Weisner, Constance M; Chalk, Mady; Capoccia, Victor; Chen, Cheng; Thomas, Cindy Parks

2016-01-01

In 2013, the American Society of Addiction Medicine (ASAM) approved its Standards of Care for the Addiction Specialist Physician. Subsequently, an ASAM Performance Measures Panel identified and prioritized the standards to be operationalized into performance measures. The goal of this study is to describe the process of operationalizing 3 of these standards into quality measures, and to present the initial measure specifications and results of pilot testing these measures in a large health care system. By presenting the process rather than just the end results, we hope to shed light on the measure development process to educate, and also to stimulate debate about the decisions that were made. Each measure was decomposed into major concepts. Then each concept was operationalized using commonly available administrative data sources. Alternative specifications examined and sensitivity analyses were conducted to inform decisions that balanced accuracy, clinical nuance, and simplicity. Using data from the US Veterans Health Administration (VHA), overall performance and variation in performance across 119 VHA facilities were calculated. Three measures were operationalized and pilot tested: pharmacotherapy for alcohol use disorder, pharmacotherapy for opioid use disorder, and timely follow-up after medically managed withdrawal (aka detoxification). Each measure was calculable with available data, and showed ample room for improvement (no ceiling effects) and wide facility-level variability. Next steps include conducting feasibility and pilot testing in other health care systems and other contexts such as standalone addiction treatment programs, and also to study the specification and predictive validity of these measures.

A Problem Based Learning Project Analyzing Rubrics Used to Evaluate Elementary STEM Immersion Programs

NASA Astrophysics Data System (ADS)

Pearson, Roxanne N.

In 2010, the President's Council of Advisors on Science and Technology recommended that eight hundred new STEM focused elementary and middle schools be established. Unfortunately, districts may be slow to implement STEM at the elementary level because they do not understand how to do so effectively (Zimny, 2017). School administrators need a framework for decision-making and supervisory feedback related to the process of managing these programs (Zimny, 2017). To support administrators in implementing elementary STEM immersion programs, this project explored three questions: What criteria are common among existing STEM immersion program rubrics? What criteria should be included in a comprehensive rubric for managing elementary STEM immersion programs at the district level? What do district documents show about how elementary STEM immersion programs develop, implement, and evaluate those programs? The team developed a comprehensive STEM program review instrument including criteria for effective elementary STEM curriculum and the professional development and administrative support necessary to implement such curriculum. These criteria were organized into three stages, including the planning and development of elementary STEM immersion programs, the implementation of these programs, and the evaluation of these programs after they had been implemented for a significant period of time. The team synthesized best practice indicators relevant to elementary STEM programs from existing K-12 guides, then validated those indicators against current best practice research and feedback from STEM education experts. District documents from seven elementary STEM immersion programs in Missouri and Colorado were examined using the team's rubric. Scores were higher in the areas of program planning, content alignment, and ongoing refinement of curriculum, and lower in the areas of professional development for professional skills and STEM-specific pedagogy, two-way communication with stakeholders, and data collection for program refinement. Scores were lowest for those schools with inadequate documentation of their program management processes. The team recommended districts institute a more rigorous documentation process for managing innovative programs such as STEM immersion. Communication plans should include procedures for two-way communication with all stakeholders. Data collection and refinement efforts should increase, as should professional development opportunities related to professional skills and STEM-specific pedagogy; this should include administrators.

Enablers and inhibitors of the implementation of the Casalud Model, a Mexican innovative healthcare model for non-communicable disease prevention and control.

PubMed

Tapia-Conyer, Roberto; Saucedo-Martinez, Rodrigo; Mujica-Rosales, Ricardo; Gallardo-Rincon, Hector; Campos-Rivera, Paola Abril; Lee, Evan; Waugh, Craig; Guajardo, Lucia; Torres-Beltran, Braulio; Quijano-Gonzalez, Ursula; Soni-Gallardo, Lidia

2016-07-22

The Mexican healthcare system is under increasing strain due to the rising prevalence of non-communicable diseases (especially type 2 diabetes), mounting costs, and a reactive curative approach focused on treating existing diseases and their complications rather than preventing them. Casalud is a comprehensive primary healthcare model that enables proactive prevention and disease management throughout the continuum of care, using innovative technologies and a patient-centred approach. Data were collected over a 2-year period in eight primary health clinics (PHCs) in two states in central Mexico to identify and assess enablers and inhibitors of the implementation process of Casalud. We used mixed quantitative and qualitative data collection tools: surveys, in-depth interviews, and participant and non-participant observations. Transcripts and field notes were analyzed and coded using Framework Analysis, focusing on defining and describing enablers and inhibitors of the implementation process. We identified seven recurring topics in the analyzed textual data. Four topics were categorized as enablers: political support for the Casalud model, alignment with current healthcare trends, ongoing technical improvements (to ease adoption and support), and capacity building. Three topics were categorized as inhibitors: administrative practices, health clinic human resources, and the lack of a shared vision of the model. Enablers are located at PHCs and across all levels of government, and include political support for, and the technological validity of, the model. The main inhibitor is the persistence of obsolete administrative practices at both state and PHC levels, which puts the administrative feasibility of the model's implementation in jeopardy. Constructing a shared vision around the model could facilitate the implementation of Casalud as well as circumvent administrative inhibitors. In order to overcome PHC-level barriers, it is crucial to have an efficient and straightforward adaptation and updating process for technological tools. One of the key lessons learned from the implementation of the Casalud model is that a degree of uncertainty must be tolerated when quickly scaling up a healthcare intervention. Similar patient-centred technology-based models must remain open to change and be able to quickly adapt to changing circumstances.

Meeting the ambition of measuring the quality of hospitals' stroke care using routinely collected administrative data: a feasibility study.

PubMed

Palmer, William L; Bottle, Alex; Davie, Charlie; Vincent, Charles A; Aylin, Paul

2013-09-01

To examine the potential for using routinely collected administrative data to compare the quality and safety of stroke care at a hospital level, including evaluating any bias due to variations in coding practice. A retrospective cohort study of English hospitals' performance against six process and outcome indicators covering the acute care pathway. We used logistic regression to adjust the outcome measures for case mix. Hospitals in England. Stroke patients (ICD-10 I60-I64) admitted to English National Health Service public acute hospitals between April 2009 and March 2010, accounting for 91 936 admissions. The quality and safety were measured using six indicators spanning the hospital care pathway, from timely access to brain scans to emergency readmissions following discharge after stroke. There were 182 occurrences of hospitals performing statistically differently from the national average at the 99.8% significance level across the six indicators. Differences in coding practice appeared to only partially explain the variation. Hospital administrative data provide a practical and achievable method for evaluating aspects of stroke care across the acute pathway. However, without improvements in coding and further validation, it is unclear whether the cause of the variation is the quality of care or the result of different local care pathways and data coding accuracy.

Administering Cognitive Tests Through Touch Screen Tablet Devices: Potential Issues.

PubMed

Jenkins, Amy; Lindsay, Stephen; Eslambolchilar, Parisa; Thornton, Ian M; Tales, Andrea

2016-10-04

Mobile technologies, such as tablet devices, open up new possibilities for health-related diagnosis, monitoring, and intervention for older adults and healthcare practitioners. Current evaluations of cognitive integrity typically occur within clinical settings, such as memory clinics, using pen and paper or computer-based tests. In the present study, we investigate the challenges associated with transferring such tests to touch-based, mobile technology platforms from an older adult perspective. Problems may include individual variability in technical familiarity and acceptance; various factors influencing usability; acceptability; response characteristics and thus validity per se of a given test. For the results of mobile technology-based tests of reaction time to be valid and related to disease status rather than extraneous variables, it is imperative the whole test process is investigated in order to determine potential effects before the test is fully developed. Researchers have emphasized the importance of including the 'user' in the evaluation of such devices; thus we performed a focus group-based qualitative assessment of the processes involved in the administration and performance of a tablet-based version of a typical test of attention and information processing speed (a multi-item localization task), to younger and older adults. We report that although the test was regarded positively, indicating that using a tablet for the delivery of such tests is feasible, it is important for developers to consider factors surrounding user expectations, performance feedback, and physical response requirements and to use this information to inform further research into such applications.

Brazilian adaptation of the Hotel Task: A tool for the ecological assessment of executive functions.

PubMed

Cardoso, Caroline de Oliveira; Zimmermann, Nicolle; Paraná, Camila Borges; Gindri, Gigiane; de Pereira, Ana Paula Almeida; Fonseca, Rochele Paz

2015-01-01

Over recent years, neuropsychological research has been increasingly concerned with the need to develop more ecologically valid instruments for the assessment of executive functions. The Hotel Task is one of the most widely used ecological measures of executive functioning, and provides an assessment of planning, organization, self-monitoring and cognitive flexibility. The goal of this study was to adapt the Hotel Task for use in the Brazilian population. The sample comprised 27 participants (three translators, six expert judges, seven healthy adults, ten patients with traumatic brain injuries and one hotel manager). The adaptation process consisted of five steps, which were repeated until a satisfactory version of the task was produced. The steps were as follows:(1) Translation;(2) Development of new stimuli and brainstorming among the authors;(3) Analysis by expert judges;(4) Pilot studies;(5) Assessment by an expert in business administration and hotel management. The adapted version proved adequate and valid for the assessment of executive functions. However, further research must be conducted to obtain evidence of the reliability, as well as the construct and criterion validity, sensitivity and specificity, of the Hotel Task. Many neurological and/or psychiatric populations may benefit from the adapted task, since it may make significant contributions to the assessment of dysexecutive syndromes and their impact on patient functioning.

A new kid on the block: The Memory Validity Profile (MVP) in children with neurological conditions.

PubMed

Brooks, Brian L; Fay-McClymont, Taryn B; MacAllister, William S; Vasserman, Marsha; Sherman, Elisabeth M S

2018-06-06

Determining the validity of obtained data is an inherent part of a neuropsychological assessment. The purpose of this study was investigate the failure rate of the Memory Validity Profile (MVP) in a large clinical sample of children and adolescents with neurological diagnoses. Data were obtained from 261 consecutive patients (mean age = 12.0, SD = 3.9, range = 5-19) who were referred for a neuropsychological assessment in a tertiary care pediatric hospital and were administered the MVP. In this sample, 4.6% of youth failed the MVP. Mean administration time for the MVP was 7.4 min, although time to complete was not associated with failure rates. Failure rates were held relatively consistent at approximately 5% across age ranges, diagnoses, and psychomotor processing speed abilities. Having very low, below normal, or above normal intellectual abilities did not alter failure rate on the MVP. However, those with intellectual disability (i.e., IQ<70) had a higher fail rate at 12% on MVP Total Score, but only 6% on the MVP Visual portion. Failure rates on the MVP were associated with lower scores on memory tests. This study provides support for using the MVP in children as young as 5 years with neurological diagnoses.

78 FR 18481 - Project-Level Predecisional Administrative Review Process

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-27

... Administrative Review Process AGENCY: Forest Service, USDA. ACTION: Final rule. SUMMARY: The United States... process by which the public may file objections seeking predecisional administrative review for proposed... for a predecisional objection process. Section 428 further directs the Secretary to apply these...

Self-administration of cocaine, cannabis and heroin in the human laboratory: benefits and pitfalls.

PubMed

Haney, Margaret

2009-01-01

The objective of this review is to describe self-administration procedures for modeling addiction to cocaine, cannabis and heroin in the human laboratory, the benefits and pitfalls of the approach, and the methodological issues unique to each drug. In addition, the predictive validity of the model for testing treatment medications will be addressed. The results show that all three drugs of abuse are reliably and robustly self-administered by non-treatment-seeking research volunteers. In terms of pharmacotherapies, cocaine use is extraordinarily difficult to disrupt either in the laboratory or in the clinic. A range of medications has been shown to significantly decrease cocaine's subjective effects and craving without decreasing either cocaine self-administration or cocaine abuse by patients. These negative data combined with recent positive findings with modafinil suggest that self-administration procedures are an important intermediary step between pre-clinical and clinical studies. In terms of cannabis, a recent study suggests that medications that improve sleep and mood during cannabis withdrawal decrease the resumption of marijuana self-administration in abstinent volunteers. Clinical data on patients seeking treatment for their marijuana use are needed to validate these laboratory findings. Finally, in contrast to cannabis or cocaine dependence, there are three efficacious Food and Drug Administration-approved medications to treat opioid dependence, all of which decrease both heroin self-administration and subjective effects in the human laboratory. In summary, self-administration procedures provide meaningful behavioral data in a small number of individuals. These studies contribute to our understanding of the variables maintaining cocaine, marijuana and heroin intake, and are important in guiding the development of more effective drug treatment programs.

Validation of key behaviourally based mental health diagnoses in administrative data: suicide attempt, alcohol abuse, illicit drug abuse and tobacco use.

PubMed

Kim, Hyungjin Myra; Smith, Eric G; Stano, Claire M; Ganoczy, Dara; Zivin, Kara; Walters, Heather; Valenstein, Marcia

2012-01-23

Observational research frequently uses administrative codes for mental health or substance use diagnoses and for important behaviours such as suicide attempts. We sought to validate codes (International Classification of Diseases, 9th edition, clinical modification diagnostic and E-codes) entered in Veterans Health Administration administrative data for patients with depression versus a gold standard of electronic medical record text ("chart notation"). Three random samples of patients were selected, each stratified by geographic region, gender, and year of cohort entry, from a VHA depression treatment cohort from April 1, 1999 to September 30, 2004. The first sample was selected from patients who died by suicide, the second from patients who remained alive on the date of death of suicide cases, and the third from patients with a new start of a commonly used antidepressant medication. Four variables were assessed using administrative codes in the year prior to the index date: suicide attempt, alcohol abuse/dependence, drug abuse/dependence and tobacco use. Specificity was high (≥ 90%) for all four administrative codes, regardless of the sample. Sensitivity was ≤75% and was particularly low for suicide attempt (≤ 17%). Positive predictive values for alcohol dependence/abuse and tobacco use were high, but barely better than flipping a coin for illicit drug abuse/dependence. Sensitivity differed across the three samples, but was highest in the suicide death sample. Administrative data-based diagnoses among VHA records have high specificity, but low sensitivity. The accuracy level varies by different diagnosis and by different patient subgroup.

Validation of Carotid Artery Revascularization Coding in Ontario Health Administrative Databases.

PubMed

Hussain, Mohamad A; Mamdani, Muhammad; Saposnik, Gustavo; Tu, Jack V; Turkel-Parrella, David; Spears, Julian; Al-Omran, Mohammed

2016-04-02

The positive predictive value (PPV) of carotid endarterectomy (CEA) and carotid artery stenting (CAS) procedure and post-operative complication coding were assessed in Ontario health administrative databases. Between 1 April 2002 and 31 March 2014, a random sample of 428 patients were identified using Canadian Classification of Health Intervention (CCI) procedure codes and Ontario Health Insurance Plan (OHIP) billing codes from administrative data. A blinded chart review was conducted at two high-volume vascular centers to assess the level of agreement between the administrative records and the corresponding patients' hospital charts. PPV was calculated with 95% confidence intervals (CIs) to estimate the validity of CEA and CAS coding, utilizing hospital charts as the gold standard. Sensitivity of CEA and CAS coding were also assessed by linking two independent databases of 540 CEA-treated patients (Ontario Stroke Registry) and 140 CAS-treated patients (single-center CAS database) to administrative records. PPV for CEA ranged from 99% to 100% and sensitivity ranged from 81.5% to 89.6% using CCI and OHIP codes. A CCI code with a PPV of 87% (95% CI, 78.8-92.9) and sensitivity of 92.9% (95% CI, 87.4-96.1) in identifying CAS was also identified. PPV for post-admission complication diagnosis coding was 71.4% (95% CI, 53.7-85.4) for stroke/transient ischemic attack, and 82.4% (95% CI, 56.6-96.2) for myocardial infarction. Our analysis demonstrated that the codes used in administrative databases accurately identify CEA and CAS-treated patients. Researchers can confidently use administrative data to conduct population-based studies of CEA and CAS.

Applying Rasch analysis to evaluate measurement equivalence of different administration formats of the Activity Limitation scale of the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR).

PubMed

Twiss, J; McKenna, S P; Graham, J; Swetz, K; Sloan, J; Gomberg-Maitland, M

2016-04-09

Electronic formats of patient-reported outcome (PRO) measures are now routinely used in clinical research studies. When changing from a validated paper and pen to electronic administration it is necessary to establish their equivalence. This study reports on the value of Rasch analysis in this process. Three groups of US pulmonary hypertension (PH) patients participated. The first completed an electronic version of the CAMPHOR Activity Limitation scale (e-sample) and this was compared with two pen and paper administrated samples (pp1 and pp2). The three databases were combined and analysed for fit to the Rasch model. Equivalence was evaluated by differential item functioning (DIF) analyses. The three datasets were matched randomly in terms of sample size (n = 147). Mean age (years) and percentage of male respondents were as follows: e-sample (51.7, 16.0 %); pp1 (50.0, 14.0 %); pp2 (55.5, 40.4 %). The combined dataset achieved fit to the Rasch model. Two items showed evidence of borderline DIF. Further analyses showed the inclusion of these items had little impact on Rasch estimates indicating the DIF identified was unimportant. Differences between the performance of the electronic and pen and paper administrations of the CAMPHOR Activity Limitation scale were minor. The results were successful in showing how the Rasch model can be used to determine the equivalence of alternative formats of PRO measures.

20 CFR 423.5 - Process against Social Security Administration officials in their individual capacities.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ADMINISTRATION SERVICE OF PROCESS § 423.5 Process against Social Security Administration officials in their... capacities must be served in compliance with the requirements for service of process on individuals who are... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Process against Social Security...

Review of surface steam sterilization for validation purposes.

PubMed

van Doornmalen, Joost; Kopinga, Klaas

2008-03-01

Sterilization is an essential step in the process of producing sterile medical devices. To guarantee sterility, the process of sterilization must be validated. Because there is no direct way to measure sterility, the techniques applied to validate the sterilization process are based on statistical principles. Steam sterilization is the most frequently applied sterilization method worldwide and can be validated either by indicators (chemical or biological) or physical measurements. The steam sterilization conditions are described in the literature. Starting from these conditions, criteria for the validation of steam sterilization are derived and can be described in terms of physical parameters. Physical validation of steam sterilization appears to be an adequate and efficient validation method that could be considered as an alternative for indicator validation. Moreover, physical validation can be used for effective troubleshooting in steam sterilizing processes.

Success, failures and costs of implementing standards in the USA--lessons for infection control.

PubMed

McGowan, J E

1995-06-01

In the US, extensive standards for performance and 'guidelines for practice' have been instituted by a number of governmental and non-governmental agencies. New governmental plans for health care depend heavily on practice guidelines, and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has been especially enthusiastic about continuous quality improvement. Monitoring the appropriateness of care and altering physician practice appeals to insurance carriers and health care management organizations. Some initial data exist to show that the quality of health care has been enhanced by these regulations. The total cost for health care administration in 1990 in the USA was 24.8% of each hospital's spending for health care. Much of this was associated with spending for new initiatives in practice guidelines, physician profiling, quality assurance, and the like. Few data exist to show that the quality of health care or hospital infection control has been enhanced by these expenditures. Regulations and guidelines also have proliferated in infection control. Guides from the JCAHO have been expanded, and recent mandates from the Occupational Health and Safety Administration (OSHA) for protecting employees from blood-borne and respiratory pathogens promise to be especially costly for health care organizations to implement. Little data exist to show that the quality of infection control has been enhanced by these regulations. Standards are difficult to develop, because the science to back them up often is lacking, interpretation of validating data is imprecise, and inherent biological variation makes exceptions common. Seven lessons are important for those developing standards today. These include focusing on objective measures of the impact of the standard, clearly indicating the degree of scientific validity, making the development process inclusive, allowing for local variation, making sure that funding is provided for mandated standards, considering non-scientific implications of standards, and remaining involved in the process after the guideline is developed. Infection control workers should make sure that standards developed take the lessons above into account before they are promulgated.

A Population Pharmacokinetic Model for Disposition in Plasma, Saliva and Urine of Scopolamine after Intranasal Administration to Healthy Human Subjects

NASA Technical Reports Server (NTRS)

Wu, L.; Tam, V. H.; Chow, D. S. L.; Putcha, L.

2014-01-01

An intranasal gel formulation of scopolamine (INSCOP) was developed for the treatment of Space Motion Sickness. The bioavailability and pharmacokinetics (PK) were evaluated under the Food and Drug Administration guidelines for clinical trials with an Investigative New Drug (IND) protocol. The aim of this project was to develop a PK model that can predict the relationship between plasma, saliva and urinary scopolamine concentrations using data collected from the IND clinical trials with INSCOP. Methods: Twelve healthy human subjects were administered three dose levels (0.1, 0.2 and 0.4 mg) of INSCOP. Serial blood, saliva and urine samples were collected between 5 min and 24 h after dosing and scopolamine concentrations were measured by using a validated LC-MS-MS assay. Pharmacokinetic Compartmental models, using actual dosing and sampling times, were built using Phoenix (version 1.2). Model selection was based on the likelihood ratio test on the difference of criteria (-2LL) and comparison of the quality of fit plots. Results: The best structural model for INSCOP (minimal -2LL= 502.8) was established. It consisted of one compartment each for plasma, saliva and urine, respectively, which were connected with linear transport processes except the nonlinear PK process from plasma to saliva compartment. The best-fit estimates of PK parameters from individual PK compartmental analysis and Population PK model analysis were shown in Tables 1 and 2, respectively. Conclusion: A population PK model that could predict population and individual PK of scopolamine in plasma, saliva and urine after dosing was developed and validated. Incorporating a non-linear transfer from plasma to saliva compartments resulted in a significantly improved model fitting. The model could be used to predict scopolamine plasma concentrations from salivary and urinary drug levels, allowing non-invasive therapeutic monitoring of scopolamine in space and other remote environments.

Validation of PROMIS ® Physical Function computerized adaptive tests for orthopaedic foot and ankle outcome research.

PubMed

Hung, Man; Baumhauer, Judith F; Latt, L Daniel; Saltzman, Charles L; SooHoo, Nelson F; Hunt, Kenneth J

2013-11-01

In 2012, the American Orthopaedic Foot & Ankle Society(®) established a national network for collecting and sharing data on treatment outcomes and improving patient care. One of the network's initiatives is to explore the use of computerized adaptive tests (CATs) for patient-level outcome reporting. We determined whether the CAT from the NIH Patient Reported Outcome Measurement Information System(®) (PROMIS(®)) Physical Function (PF) item bank provides efficient, reliable, valid, precise, and adequately covered point estimates of patients' physical function. After informed consent, 288 patients with a mean age of 51 years (range, 18-81 years) undergoing surgery for common foot and ankle problems completed a web-based questionnaire. Efficiency was determined by time for test administration. Reliability was assessed with person and item reliability estimates. Validity evaluation included content validity from expert review and construct validity measured against the PROMIS(®) Pain CAT and patient responses based on tradeoff perceptions. Precision was assessed by standard error of measurement (SEM) across patients' physical function levels. Instrument coverage was based on a person-item map. Average time of test administration was 47 seconds. Reliability was 0.96 for person and 0.99 for item. Construct validity against the Pain CAT had an r value of -0.657 (p < 0.001). Precision had an SEM of less than 3.3 (equivalent to a Cronbach's alpha of ≥ 0.90) across a broad range of function. Concerning coverage, the ceiling effect was 0.32% and there was no floor effect. The PROMIS(®) PF CAT appears to be an excellent method for measuring outcomes for patients with foot and ankle surgery. Further validation of the PROMIS(®) item banks may ultimately provide a valid and reliable tool for measuring patient-reported outcomes after injuries and treatment.

Validation of a brief telephone battery for neurocognitive assessment of patients with pulmonary arterial hypertension.

PubMed

Taichman, Darren B; Christie, Jason; Biester, Rosette; Mortensen, Jennifer; White, Joanne; Kaplan, Sandra; Hansen-Flaschen, John; Palevsky, Harold I; Elliott, C Gregory; Hopkins, Ramona O

2005-04-25

The effects of pulmonary arterial hypertension on brain function are not understood, despite patients' frequent complaints of cognitive difficulties. Using clinical instruments normally administered during standard in-person assessment of neurocognitive function in adults, we assembled a battery of tests designed for administration over the telephone. The purpose was to improve patient participation, facilitate repeated test administration, and reduce the cost of research on the neuropsychological consequences of acute and chronic cardiorespiratory diseases. We undertook this study to validate telephone administration of the tests. 23 adults with pulmonary arterial hypertension underwent neurocognitive assessment using both standard in-person and telephone test administration, and the results of the two methods compared using interclass correlations. For most of the tests in the battery, scores from the telephone assessment correlated strongly with those obtained by in-person administration of the same tests. Interclass correlations between 0.5 and 0.8 were observed for tests that assessed attention, memory, concentration/working memory, reasoning, and language/crystallized intelligence (p < or = 0.05 for each). Interclass correlations for the Hayling Sentence Completion test of executive function approached significance (p = 0.09). All telephone tests were completed within one hour. Administration of this neurocognitive test battery by telephone should facilitate assessment of neuropsychological deficits among patients with pulmonary arterial hypertension living across broad geographical areas, and may be useful for monitoring changes in neurocognitive function in response to PAH-specific therapy or disease progression.

21 CFR 1271.230 - Process validation.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Process validation. 1271.230 Section 1271.230 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.230 Process validation. (a... validation activities and results must be documented, including the date and signature of the individual(s...

21 CFR 1271.230 - Process validation.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Process validation. 1271.230 Section 1271.230 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.230 Process validation. (a... validation activities and results must be documented, including the date and signature of the individual(s...

21 CFR 1271.230 - Process validation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Process validation. 1271.230 Section 1271.230 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.230 Process validation. (a... validation activities and results must be documented, including the date and signature of the individual(s...

21 CFR 1271.230 - Process validation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Process validation. 1271.230 Section 1271.230 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.230 Process validation. (a... validation activities and results must be documented, including the date and signature of the individual(s...

21 CFR 1271.230 - Process validation.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Process validation. 1271.230 Section 1271.230 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.230 Process validation. (a... validation activities and results must be documented, including the date and signature of the individual(s...

The Revalidation of an Instrument to Measure Zones of Indifference of Teachers to Directives Issued by Administrators.

ERIC Educational Resources Information Center

Wilkes, Sam T.; Blackbourn, Joe M.

This project attempts to refine the Zones of Indifference Instrument, (included in appendix) that measures zones of indifference of teachers to typical directives issued by administrators. As a result of the original validation study, a 78-item, two-factor instrument was developed. These two factors explained 52 percent of the variance. The…

Standardized ADOS Scores: Measuring Severity of Autism Spectrum Disorders in a Dutch Sample

ERIC Educational Resources Information Center

de Bildt, Annelies; Oosterling, Iris J.; van Lang, Natasja D. J.; Sytema, Sjoerd; Minderaa, Ruud B.; van Engeland, Herman; Roos, Sascha; Buitelaar, Jan K.; van der Gaag, Rutger-Jan; de Jonge, Maretha V.

2011-01-01

The validity of the calibrated severity scores on the ADOS as reported by Gotham et al. (J Autism Dev Disord 39: 693-705, "2009"), was investigated in an independent sample of 1248 Dutch children with 1455 ADOS administrations (modules 1, 2 and 3). The greater comparability between ADOS administrations at different times, ages and in…

Active Aeroelastic Wing Aerodynamic Model Development and Validation for a Modified F/A-18A Airplane

NASA Technical Reports Server (NTRS)

Cumming, Stephen B.; Diebler, Corey G.

2005-01-01

A new aerodynamic model has been developed and validated for a modified F/A-18A airplane used for the Active Aeroelastic Wing (AAW) research program. The goal of the program was to demonstrate the advantages of using the inherent flexibility of an aircraft to enhance its performance. The research airplane was an F/A-18A with wings modified to reduce stiffness and a new control system to increase control authority. There have been two flight phases. Data gathered from the first flight phase were used to create the new aerodynamic model. A maximum-likelihood output-error parameter estimation technique was used to obtain stability and control derivatives. The derivatives were incorporated into the National Aeronautics and Space Administration F-18 simulation, validated, and used to develop new AAW control laws. The second phase of flights was used to evaluate the handling qualities of the AAW airplane and the control law design process, and to further test the accuracy of the new model. The flight test envelope covered Mach numbers between 0.85 and 1.30 and dynamic pressures from 600 to 1250 pound-force per square foot. The results presented in this report demonstrate that a thorough parameter identification analysis can be used to improve upon models that were developed using other means. This report describes the parameter estimation technique used, details the validation techniques, discusses differences between previously existing F/A-18 models, and presents results from the second phase of research flights.

The usefulness of administrative databases for identifying disease cohorts is increased with a multivariate model.

PubMed

van Walraven, Carl; Austin, Peter C; Manuel, Douglas; Knoll, Greg; Jennings, Allison; Forster, Alan J

2010-12-01

Administrative databases commonly use codes to indicate diagnoses. These codes alone are often inadequate to accurately identify patients with particular conditions. In this study, we determined whether we could quantify the probability that a person has a particular disease-in this case renal failure-using other routinely collected information available in an administrative data set. This would allow the accurate identification of a disease cohort in an administrative database. We determined whether patients in a randomly selected 100,000 hospitalizations had kidney disease (defined as two or more sequential serum creatinines or the single admission creatinine indicating a calculated glomerular filtration rate less than 60 mL/min/1.73 m²). The independent association of patient- and hospitalization-level variables with renal failure was measured using a multivariate logistic regression model in a random 50% sample of the patients. The model was validated in the remaining patients. Twenty thousand seven hundred thirteen patients had kidney disease (20.7%). A diagnostic code of kidney disease was strongly associated with kidney disease (relative risk: 34.4), but the accuracy of the code was poor (sensitivity: 37.9%; specificity: 98.9%). Twenty-nine patient- and hospitalization-level variables entered the kidney disease model. This model had excellent discrimination (c-statistic: 90.1%) and accurately predicted the probability of true renal failure. The probability threshold that maximized sensitivity and specificity for the identification of true kidney disease was 21.3% (sensitivity: 80.0%; specificity: 82.2%). Multiple variables available in administrative databases can be combined to quantify the probability that a person has a particular disease. This process permits accurate identification of a disease cohort in an administrative database. These methods may be extended to other diagnoses or procedures and could both facilitate and clarify the use of administrative databases for research and quality improvement. Copyright © 2010 Elsevier Inc. All rights reserved.

Validity of four approaches of using repeaters' MCAT scores in medical school admissions to predict USMLE Step 1 total scores.

PubMed

Zhao, Xiaohui; Oppler, Scott; Dunleavy, Dana; Kroopnick, Marc

2010-10-01

This study investigated the validity of four approaches (the average, most recent, highest-within-administration, and highest-across-administration approaches) of using repeaters' Medical College Admission Test (MCAT) scores to predict Step 1 scores. Using the differential predication method, this study investigated the magnitude of differences in the expected Step 1 total scores between MCAT nonrepeaters and three repeater groups (two-time, three-time, and four-time test takers) for the four scoring approaches. For the average score approach, matriculants with the same MCAT average are expected to achieve similar Step 1 total scores regardless of whether the individual attempted the MCAT exam one or multiple times. For the other three approaches, repeaters are expected to achieve lower Step 1 scores than nonrepeaters; for a given MCAT score, as the number of attempts increases, the expected Step 1 decreases. The effect was strongest for the highest-across-administration approach, followed by the highest-within-administration approach, and then the most recent approach. Using the average score is the best approach for considering repeaters' MCAT scores in medical school admission decisions.

The development of a science process assessment for fourth-grade students

NASA Astrophysics Data System (ADS)

Smith, Kathleen A.; Welliver, Paul W.

In this study, a multiple-choice test entitled the Science Process Assessment was developed to measure the science process skills of students in grade four. Based on the Recommended Science Competency Continuum for Grades K to 6 for Pennsylvania Schools, this instrument measured the skills of (1) observing, (2) classifying, (3) inferring, (4) predicting, (5) measuring, (6) communicating, (7) using space/time relations, (8) defining operationally, (9) formulating hypotheses, (10) experimenting, (11) recognizing variables, (12) interpreting data, and (13) formulating models. To prepare the instrument, classroom teachers and science educators were invited to participate in two science education workshops designed to develop an item bank of test questions applicable to measuring process skill learning. Participants formed writing teams and generated 65 test items representing the 13 process skills. After a comprehensive group critique of each item, 61 items were identified for inclusion into the Science Process Assessment item bank. To establish content validity, the item bank was submitted to a select panel of science educators for the purpose of judging item acceptability. This analysis yielded 55 acceptable test items and produced the Science Process Assessment, Pilot 1. Pilot 1 was administered to 184 fourth-grade students. Students were given a copy of the test booklet; teachers read each test aloud to the students. Upon completion of this first administration, data from the item analysis yielded a reliability coefficient of 0.73. Subsequently, 40 test items were identified for the Science Process Assessment, Pilot 2. Using the test-retest method, the Science Process Assessment, Pilot 2 (Test 1 and Test 2) was administered to 113 fourth-grade students. Reliability coefficients of 0.80 and 0.82, respectively, were ascertained. The correlation between Test 1 and Test 2 was 0.77. The results of this study indicate that (1) the Science Process Assessment, Pilot 2, is a valid and reliable instrument applicable to measuring the science process skills of students in grade four, (2) using educational workshops as a means of developing item banks of test questions is viable and productive in the test development process, and (3) involving classroom teachers and science educators in the test development process is educationally efficient and effective.

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

Predicting reading outcomes with progress monitoring slopes among middle grade students

PubMed Central

Tolar, Tammy D.; Barth, Amy E.; Fletcher, Jack M.; Francis, David J.; Vaughn, Sharon

2013-01-01

Effective implementation of response-to-intervention (RTI) frameworks depends on efficient tools for monitoring progress. Evaluations of growth (i.e., slope) may be less efficient than evaluations of status at a single time point, especially if slopes do not add to predictions of outcomes over status. We examined progress monitoring slope validity for predicting reading outcomes among middle school students by evaluating latent growth models for different progress monitoring measure-outcome combinations. We used multi-group modeling to evaluate the effects of reading ability, reading intervention, and progress monitoring administration condition on slope validity. Slope validity was greatest when progress monitoring was aligned with the outcome (i.e., word reading fluency slope was used to predict fluency outcomes in contrast to comprehension outcomes), but effects varied across administration conditions (viz., repeated reading of familiar vs. novel passages). Unless the progress monitoring measure is highly aligned with outcome, slope may be an inefficient method for evaluating progress in an RTI context. PMID:24659899

Towards an Operational Definition of Effective Co-Teaching: Instrument Development, Validity, and Reliability

ERIC Educational Resources Information Center

La Monte, Michelle Evonne

2012-01-01

This study focused on developing a valid and reliable instrument that can not only identify successful co-teaching, but also the professional development needs of co-teachers and their administrators in public schools. Two general questions about the quality of co-teaching were addressed in this study: (a) How well did descriptors within each of…

Development of a Three-Tier Test as a Valid Diagnostic Tool for Identification of Misconceptions Related to Carbohydrates

ERIC Educational Resources Information Center

Milenkovic, Dusica D.; Hrin, Tamara N.; Segedinac, Mirjana D.; Horvat, Sasa

2016-01-01

This study describes the development and application of a three-tier test as a valid and reliable tool in diagnosing students' misconceptions regarding some basic concepts about carbohydrates. The test was administrated to students of the Pharmacy Department at the University of Bijeljina (Serb Republic). The results denoted construct and content…

Examining the Reliability and Validity of Clinician Ratings on the Five-Factor Model Score Sheet

ERIC Educational Resources Information Center

Few, Lauren R.; Miller, Joshua D.; Morse, Jennifer Q.; Yaggi, Kirsten E.; Reynolds, Sarah K.; Pilkonis, Paul A.

2010-01-01

Despite substantial research use, measures of the five-factor model (FFM) are infrequently used in clinical settings due, in part, to issues related to administration time and a reluctance to use self-report instruments. The current study examines the reliability and validity of the Five-Factor Model Score Sheet (FFMSS), which is a 30-item…

Associations between MMPI-2-RF validity scale scores and extra-test measures of personality and psychopathology.

PubMed

Forbey, Johnathan D; Lee, Tayla T C; Ben-Porath, Yossef S; Arbisi, Paul A; Gartland, Diane

2013-08-01

The current study explored associations between two potentially invalidating self-report styles detected by the Validity scales of the Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF), over-reporting and under-reporting, and scores on the MMPI-2-RF substantive, as well as eight collateral self-report measures administered either at the same time or within 1 to 10 days of MMPI-2-RF administration. Analyses were conducted with data provided by college students, male prisoners, and male psychiatric outpatients from a Veterans Administration facility. Results indicated that if either an over- or under-reporting response style was suggested by the MMPI-2-RF Validity scales, scores on the majority of the MMPI-2-RF substantive scales, as well as a number of collateral measures, were significantly affected in all three groups in the expected directions. Test takers who were identified as potentially engaging in an over- or under-reporting response style by the MMPI-2-RF Validity scales appeared to approach extra-test measures similarly regardless of when these measures were administered in relation to the MMPI-2-RF. Limitations and suggestions for future study are discussed.

Validity and Reproducibility of a Self-Administered Semi-Quantitative Food-Frequency Questionnaire for Estimating Usual Daily Fat, Fibre, Alcohol, Caffeine and Theobromine Intakes among Belgian Post-Menopausal Women

PubMed Central

Bolca, Selin; Huybrechts, Inge; Verschraegen, Mia; De Henauw, Stefaan; Van de Wiele, Tom

2009-01-01

A novel food-frequency questionnaire (FFQ) was developed and validated to assess the usual daily fat, saturated, mono-unsaturated and poly-unsaturated fatty acid, fibre, alcohol, caffeine, and theobromine intakes among Belgian post-menopausal women participating in dietary intervention trials with phyto-oestrogens. The relative validity of the FFQ was estimated by comparison with 7 day (d) estimated diet records (EDR, n 64) and its reproducibility was evaluated by repeated administrations 6 weeks apart (n 79). Although the questionnaire underestimated significantly all intakes compared to the 7 d EDR, it had a good ranking ability (r 0.47–0.94; weighted κ 0.25–0.66) and it could reliably distinguish extreme intakes for all the estimated nutrients, except for saturated fatty acids. Furthermore, the correlation between repeated administrations was high (r 0.71–0.87) with a maximal misclassification of 7% (weighted κ 0.33–0.80). In conclusion, these results compare favourably with those reported by others and indicate that the FFQ is a satisfactorily reliable and valid instrument for ranking individuals within this study population. PMID:19440274

Specificity rates for non-clinical, bilingual, Mexican Americans on three popular performance validity measures.

PubMed

Gasquoine, Philip G; Weimer, Amy A; Amador, Arnoldo

2017-04-01

To measure specificity as failure rates for non-clinical, bilingual, Mexican Americans on three popular performance validity measures: (a) the language format Reliable Digit Span; (b) visual-perceptual format Test of Memory Malingering; and (c) visual-perceptual format Dot Counting, using optimal/suboptimal effort cut scores developed for monolingual, English-speakers. Participants were 61 consecutive referrals, aged between 18 and 65 years, with <16 years of education who were subjectively bilingual (confirmed via formal assessment) and chose the language of assessment, Spanish or English, for the performance validity tests. Failure rates were 38% for Reliable Digit Span, 3% for the Test of Memory Malingering, and 7% for Dot Counting. For Reliable Digit Span, the failure rates for Spanish (46%) and English (31%) languages of administration did not differ significantly. Optimal/suboptimal effort cut scores derived for monolingual English-speakers can be used with Spanish/English bilinguals when using the visual-perceptual format Test of Memory Malingering and Dot Counting. The high failure rate for Reliable Digit Span suggests it should not be used as a performance validity measure with Spanish/English bilinguals, irrespective of the language of test administration, Spanish or English.

29 CFR 4041.42 - Administration of plan during termination process.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 9 2010-07-01 2010-07-01 false Administration of plan during termination process. 4041.42... TERMINATIONS TERMINATION OF SINGLE-EMPLOYER PLANS Distress Termination Process § 4041.42 Administration of plan during termination process. (a) General rule. Except to the extent specifically prohibited by this...

The Subjective Sexual Arousal Scale for Men (SSASM): preliminary development and psychometric validation of a multidimensional measure of subjective male sexual arousal.

PubMed

Althof, Stanley E; Perelman, Michael A; Rosen, Raymond C

2011-08-01

Sexual arousal is a multifaceted process that involves both mental and physical components. No instrument has been developed and validated to assess subjective aspects of male sexual arousal. To develop and psychometrically validate a self-administered scale for assessing subjective male sexual arousal. Using recommendations of the Food and Drug Administration (FDA) guidance on patient-reported outcome instruments, important aspects of male sexual arousal were identified via qualitative research (focus groups and interviews) of U.S. men with erectile dysfunction (ED) and healthy controls. After a preliminary questionnaire was developed by a panel of experts, a quantitative study of men with ED and controls was conducted to psychometrically validate the Subjective Sexual Arousal Scale for Men (SSASM). To develop a male sexual arousal scale and determine its factor structure, reliability, and construct validity. Five aspects of male sexual arousal were identified from the qualitative focus groups and cognitive interviews. Men's preferred language for describing sexual arousal and preferred response formats were incorporated into the questions. Factor analysis of data from the quantitative study of 304 men aged 21 to 70 years identified five domains with eigenvalues >1: sexual performance (six items), mental satisfaction (five items), sexual assertiveness (three items), partner communication (three items), and partner relationship (three items). The five domains had a high degree of internal consistency (Cronbach's alpha values 0.88-0.94). Test-retest reliability over a 2- to 4-week period was high-moderately high (r values 0.75-0.88) for the five domain scores. Correlations between SSASM domain scores and standardized scale scores for social desirability, general health, life satisfaction, and sexual function demonstrated the construct validity of the scale. Preliminary validation data suggest that the 20-item SSASM scale may be useful as a multidimensional, reliable, self-administered instrument for assessing subjective sexual arousal in men of different ages. © 2011 International Society for Sexual Medicine.

Eye-Tracking as a Tool in Process-Oriented Reading Test Validation

ERIC Educational Resources Information Center

Solheim, Oddny Judith; Uppstad, Per Henning

2011-01-01

The present paper addresses the continuous need for methodological reflection on how to validate inferences made on the basis of test scores. Validation is a process that requires many lines of evidence. In this article we discuss the potential of eye tracking methodology in process-oriented reading test validation. Methodological considerations…

Full-Scaled Advanced Systems Testbed: Ensuring Success of Adaptive Control Research Through Project Lifecycle Risk Mitigation

NASA Technical Reports Server (NTRS)

Pavlock, Kate M.

2011-01-01

The National Aeronautics and Space Administration's Dryden Flight Research Center completed flight testing of adaptive controls research on the Full-Scale Advance Systems Testbed (FAST) in January of 2011. The research addressed technical challenges involved with reducing risk in an increasingly complex and dynamic national airspace. Specific challenges lie with the development of validated, multidisciplinary, integrated aircraft control design tools and techniques to enable safe flight in the presence of adverse conditions such as structural damage, control surface failures, or aerodynamic upsets. The testbed is an F-18 aircraft serving as a full-scale vehicle to test and validate adaptive flight control research and lends a significant confidence to the development, maturation, and acceptance process of incorporating adaptive control laws into follow-on research and the operational environment. The experimental systems integrated into FAST were designed to allow for flexible yet safe flight test evaluation and validation of modern adaptive control technologies and revolve around two major hardware upgrades: the modification of Production Support Flight Control Computers (PSFCC) and integration of two, fourth-generation Airborne Research Test Systems (ARTS). Post-hardware integration verification and validation provided the foundation for safe flight test of Nonlinear Dynamic Inversion and Model Reference Aircraft Control adaptive control law experiments. To ensure success of flight in terms of cost, schedule, and test results, emphasis on risk management was incorporated into early stages of design and flight test planning and continued through the execution of each flight test mission. Specific consideration was made to incorporate safety features within the hardware and software to alleviate user demands as well as into test processes and training to reduce human factor impacts to safe and successful flight test. This paper describes the research configuration, experiment functionality, overall risk mitigation, flight test approach and results, and lessons learned of adaptive controls research of the Full-Scale Advanced Systems Testbed.

Reliability, validity and administrative burden of the community reintegration of injured service members computer adaptive test (CRIS-CAT)”

PubMed Central

2012-01-01

Background The Computer Adaptive Test version of the Community Reintegration of Injured Service Members measure (CRIS-CAT) consists of three scales measuring Extent of, Perceived Limitations in, and Satisfaction with community integration. The CRIS-CAT was developed using item response theory methods. The purposes of this study were to assess the reliability, concurrent, known group and predictive validity and respondent burden of the CRIS-CAT. The CRIS-CAT was developed using item response theory methods. The purposes of this study were to assess the reliability, concurrent, known group and predictive validity and respondent burden of the CRIS-CAT. Methods This was a three-part study that included a 1) a cross-sectional field study of 517 homeless, employed, and Operation Enduring Freedom / Operation Iraqi Freedom (OEF/OIF) Veterans; who completed all items in the CRIS item set, 2) a cohort study with one year follow-up study of 135 OEF/OIF Veterans, and 3) a 50-person study of CRIS-CAT administration. Conditional reliability of simulated CAT scores was calculated from the field study data, and concurrent validity and known group validity were examined using Pearson product correlations and ANOVAs. Data from the cohort were used to examine the ability of the CRIS-CAT to predict key one year outcomes. Data from the CRIS-CAT administration study were used to calculate ICC (2,1) minimum detectable change (MDC), and average number of items used during CAT administration. Results Reliability scores for all scales were above 0.75, but decreased at both ends of the score continuum. CRIS-CAT scores were correlated with concurrent validity indicators and differed significantly between the three Veteran groups (P < .001). The odds of having any Emergency Room visits were reduced for Veterans with better CRIS-CAT scores (Extent, Perceived Satisfaction respectively: OR = 0.94, 0.93, 0.95; P < .05). CRIS-CAT scores were predictive of SF-12 physical and mental health related quality of life scores at the 1 year follow-up. Scales had ICCs >0.9. MDCs were 5.9, 6.2, and 3.6, respectively for Extent, Perceived and Satisfaction subscales. Number of items (mn, SD) administered at Visit 1 were 14.6 (3.8) 10.9 (2.7) and 10.4 (1.7) respectively for Extent, Perceived and Satisfaction subscales. Conclusion The CRIS-CAT demonstrated sound measurement properties including reliability, construct, known group and predictive validity, and it was administered with minimal respondent burden. These findings support the use of this measure in assessing community reintegration. PMID:22984850

The US Food and Drug Administration's expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements.

PubMed

Wallach, Joshua D; Ross, Joseph S; Naci, Huseyin

2018-06-01

The US Food and Drug Administration has several regulatory programs and pathways to expedite the development and approval of therapeutic agents aimed at treating serious or life-debilitating conditions. A common feature of these programs is the regulatory flexibility, which allows for a customized approval approach that enables market authorization on the basis of less rigorous evidence, in exchange for requiring postmarket evidence generation. An increasing share of therapeutic agents approved by the Food and Drug Administration in recent years are associated with expedited programs. In this article, we provide an overview of the evidentiary standards required by the Food and Drug Administration's expedited development and review programs, summarize the findings of the recent academic literature demonstrating some of the limitations of these programs, and outline potential opportunities to address these limitations. Recent evidence suggests that therapeutic agents in the Food and Drug Administration's expedited programs are approved on the basis of fewer and smaller studies that may lack comparator groups and random allocation, and rather than focusing on clinical outcomes for study endpoints, rely instead on surrogate markers of disease. Once on the market, agents receiving expedited approvals are often quickly incorporated into clinical practice, and evidence generated in the postmarket period may not necessarily address the evidentiary limitations at the time of market entry. Furthermore, not all pathways require additional postmarket studies. Evidence suggests that drugs in expedited approval programs are associated with a greater likelihood that the Food and Drug Administration will take a safety action following market entry. There are several opportunities to improve the timeliness, information value, and validity of the pre- and postmarket studies of therapeutic agents receiving expedited approvals. When use of nonrandomized and uncontrolled studies cannot be avoided prior to market entry, randomized trials should be mandatory in the postmarket period, unless there are strong justifications for not carrying out such studies. In the premarket period, validity of the surrogate markers can be improved by more rigorously evaluating their correlation with patient-relevant clinical outcomes. Opportunities to reduce the duration, complexity, and cost of postmarket randomized trials should not compromise their validity and instead incorporate pragmatic "real-world" design elements. Despite recent enthusiasm for widely using real-world evidence, adaptive designs, and pragmatic trials in the regulatory setting, caution is warranted until large-scale empirical evaluations demonstrate their validity compared to more traditional trial designs.

Developing a stroke severity index based on administrative data was feasible using data mining techniques.

PubMed

Sung, Sheng-Feng; Hsieh, Cheng-Yang; Kao Yang, Yea-Huei; Lin, Huey-Juan; Chen, Chih-Hung; Chen, Yu-Wei; Hu, Ya-Han

2015-11-01

Case-mix adjustment is difficult for stroke outcome studies using administrative data. However, relevant prescription, laboratory, procedure, and service claims might be surrogates for stroke severity. This study proposes a method for developing a stroke severity index (SSI) by using administrative data. We identified 3,577 patients with acute ischemic stroke from a hospital-based registry and analyzed claims data with plenty of features. Stroke severity was measured using the National Institutes of Health Stroke Scale (NIHSS). We used two data mining methods and conventional multiple linear regression (MLR) to develop prediction models, comparing the model performance according to the Pearson correlation coefficient between the SSI and the NIHSS. We validated these models in four independent cohorts by using hospital-based registry data linked to a nationwide administrative database. We identified seven predictive features and developed three models. The k-nearest neighbor model (correlation coefficient, 0.743; 95% confidence interval: 0.737, 0.749) performed slightly better than the MLR model (0.742; 0.736, 0.747), followed by the regression tree model (0.737; 0.731, 0.742). In the validation cohorts, the correlation coefficients were between 0.677 and 0.725 for all three models. The claims-based SSI enables adjusting for disease severity in stroke studies using administrative data. Copyright © 2015 Elsevier Inc. All rights reserved.

Introducing the Postsecondary Instructional Practices Survey (PIPS): A Concise, Interdisciplinary, and Easy-to-Score Survey

PubMed Central

Walter, Emily M.; Henderson, Charles R.; Beach, Andrea L.; Williams, Cody T.

2016-01-01

Researchers, administrators, and policy makers need valid and reliable information about teaching practices. The Postsecondary Instructional Practices Survey (PIPS) is designed to measure the instructional practices of postsecondary instructors from any discipline. The PIPS has 24 instructional practice statements and nine demographic questions. Users calculate PIPS scores by an intuitive proportion-based scoring convention. Factor analyses from 72 departments at four institutions (N = 891) support a 2- or 5-factor solution for the PIPS; both models include all 24 instructional practice items and have good model fit statistics. Factors in the 2-factor model include (a) instructor-centered practices, nine items; and (b) student-centered practices, 13 items. Factors in the 5-factor model include (a) student–student interactions, six items; (b) content delivery, four items; (c) formative assessment, five items; (d) student-content engagement, five items; and (e) summative assessment, four items. In this article, we describe our development and validation processes, provide scoring conventions and outputs for results, and describe wider applications of the instrument. PMID:27810868

Validation and Verification (V&V) of Safety-Critical Systems Operating Under Off-Nominal Conditions

NASA Technical Reports Server (NTRS)

Belcastro, Christine M.

2012-01-01

Loss of control (LOC) remains one of the largest contributors to aircraft fatal accidents worldwide. Aircraft LOC accidents are highly complex in that they can result from numerous causal and contributing factors acting alone or more often in combination. Hence, there is no single intervention strategy to prevent these accidents. Research is underway at the National Aeronautics and Space Administration (NASA) in the development of advanced onboard system technologies for preventing or recovering from loss of vehicle control and for assuring safe operation under off-nominal conditions associated with aircraft LOC accidents. The transition of these technologies into the commercial fleet will require their extensive validation and verification (V&V) and ultimate certification. The V&V of complex integrated systems poses highly significant technical challenges and is the subject of a parallel research effort at NASA. This chapter summarizes the V&V problem and presents a proposed process that could be applied to complex integrated safety-critical systems developed for preventing aircraft LOC accidents. A summary of recent research accomplishments in this effort is referenced.

Mission description and in-flight operations of ERBE instruments on ERBS, NOAA 9, and NOAA 10 spacecraft

NASA Technical Reports Server (NTRS)

Weaver, William L.; Bush, Kathryn A.; Degnan, Keith T.; Howerton, Clayton E.; Tolson, Carol J.

1992-01-01

Instruments of the Earth Radiation Budget Experiment (ERBE) are operating on three different Earth-orbiting spacecraft. The Earth Radiation Budget Satellite (ERBS) is operated by NASA, and NOAA 9 and NOAA 10 weather satellites are operated by the National Oceanic and Atmospheric Administration (NOAA). This paper is the second in a series that describes the ERBE mission, and data processing and validation procedures. This paper describes the spacecraft and instrument operations for the second full year of in-orbit operations, which extend from February 1986 through January 1987. Validation and archival of radiation measurements made by ERBE instruments during this second year of operation were completed in July 1991. This period includes the only time, November 1986 through January 1987, during which all ERBE instruments aboard the ERBE, NOAA 9, and NOAA 10 spacecraft were simultaneously operational. This paper covers normal and special operations of the spacecraft and instruments, operational anomalies, and the responses of the instruments to in-orbit and seasonal variations in the solar environment.

The Role of Structural Models in the Solar Sail Flight Validation Process

NASA Technical Reports Server (NTRS)

Johnston, John D.

2004-01-01

NASA is currently soliciting proposals via the New Millennium Program ST-9 opportunity for a potential Solar Sail Flight Validation (SSFV) experiment to develop and operate in space a deployable solar sail that can be steered and provides measurable acceleration. The approach planned for this experiment is to test and validate models and processes for solar sail design, fabrication, deployment, and flight. These models and processes would then be used to design, fabricate, and operate scaleable solar sails for future space science missions. There are six validation objectives planned for the ST9 SSFV experiment: 1) Validate solar sail design tools and fabrication methods; 2) Validate controlled deployment; 3) Validate in space structural characteristics (focus of poster); 4) Validate solar sail attitude control; 5) Validate solar sail thrust performance; 6) Characterize the sail's electromagnetic interaction with the space environment. This poster presents a top-level assessment of the role of structural models in the validation process for in-space structural characteristics.

Earth Science Enterprise Scientific Data Purchase Project: Verification and Validation

NASA Technical Reports Server (NTRS)

Jenner, Jeff; Policelli, Fritz; Fletcher, Rosea; Holecamp, Kara; Owen, Carolyn; Nicholson, Lamar; Dartez, Deanna

2000-01-01

This paper presents viewgraphs on the Earth Science Enterprise Scientific Data Purchase Project's verification,and validation process. The topics include: 1) What is Verification and Validation? 2) Why Verification and Validation? 3) Background; 4) ESE Data Purchas Validation Process; 5) Data Validation System and Ingest Queue; 6) Shipment Verification; 7) Tracking and Metrics; 8) Validation of Contract Specifications; 9) Earth Watch Data Validation; 10) Validation of Vertical Accuracy; and 11) Results of Vertical Accuracy Assessment.

Cross-cultural adaptation and validation of the Sinus and Nasal Quality of Life Survey (SN-5) into Brazilian Portuguese.

PubMed

Uchoa, Priscila Regina Candido Espinola; Bezerra, Thiago Freire Pinto; Lima, Élcio Duarte; Fornazieri, Marco Aurélio; Pinna, Fabio de Rezende; Sperandio, Fabiana de Araújo; Voegels, Richard Louis

The concept of quality of life is subjective and variable definition, which depends on the individual's perception of their state of health. Quality of life questionnaires are instruments designed to measure quality of life, but most are developed in a language other than Portuguese. Questionnaires can identify the most important symptoms, focus on consultation, and assist in defining the goals of treatment. Some of these have been validated for the Portuguese language, but none in children. To validate the translation with cross-cultural adaptation and validation of the Sinus and Nasal Quality of Life Survey (SN-5) into Portuguese. Prospective study of children aged 2-12 years with sinonasal symptoms of over 30 days. The study comprised two stages: (I) translation and cross-cultural adaptation of the SN-5 into Portuguese (SN-5p); and (II) validation of the SN5-p. Statistical analysis was performed to assess internal consistency, test-retest reliability, and sensitivity, as well as construct and discriminant validity and standardization. The SN-5 was translated and adapted into Portuguese (SN-5p) and the author of the original version approved the process. Validation was carried out by administration of the SN-5p to 51 pediatric patients with sinonasal complaints (mean age, 5.8±2.5 years; range, 2-12 years). The questionnaire exhibited adequate construct validity (0.62, p<0.01), internal consistency (Cronbach's alpha=0.73), and discriminant validity (p<0.01), as well as good test-retest reproducibility (Goodman-Kruskal gamma=0.957, p<0.001), good correlation with a visual analog scale (r=0.62, p<0.01), and sensitivity to change. This study reports the successful translation and cross-cultural adaptation of the SN-5 instrument into Brazilian Portuguese. The translated version exhibited adequate psychometric properties for assessment of disease-specific quality of life in pediatric patients with sinonasal complaints. Copyright © 2016 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

Topical Administration of Oxygenated Hemoglobin Improved Wound Healing in an Ischemic Rabbit Ear Model.

PubMed

Xie, Ping; Jia, Shengxian; Tye, Ross; Xu, Wei; Zhong, Aimei; Hong, Seok J; Galiano, Robert D; Mustoe, Thomas A

2016-02-01

Localized oxygen deficiency plays a central role in the pathogenesis of chronic wounds; thus, rectifying localized ischemia with oxygen therapy has been postulated to be an integral aspect of the management of chronic wounds. The efficacy of a novel approach for oxygen therapy on chronic wound healing was evaluated. Oxygen was delivered to ischemic wounds by means of the topical application of oxygenated, chemically modified bovine hemoglobin (IKOR 2084) in a validated rabbit ear ischemic wound model. The wound healing was evaluated histologically by measuring epithelial gap and neo-granulation tissue area. In situ expression of endothelial cells (CD31) and proliferative cells (Ki-67) was examined by immunohistochemistry analysis. The mRNA of vascular endothelial growth factor, endothelial nitric oxide synthase, and matrix metalloproteinase-9 was quantified by real-time reverse-transcriptase polymerase chain reaction. The collagen was detected by Sirius red staining. In comparison with topical application of saline, the administration of oxygenated IKOR 2084 increases wound reepithelialization and formation of neo-granulation tissue in a dose-dependent manner, and cellular proliferation (Ki-67). Conversely, the administration of deoxygenated IKOR 2084 aggravated the ischemic wound healing process. Moreover, the topical administration of oxygenated IKOR 2084 induces angiogenesis as evidenced by concomitant increases in CD31 protein and vascular endothelial growth factor and endothelial nitric oxide synthase mRNA expression in treated wounds. Oxygenated IKOR 2084 administration also increased collagen deposition in wounds, with decreases in the expression of matrix metalloproteinase-9 mRNA. This study suggests that the topical application of oxygenated IKOR 2084 ameliorates the reparative progress of ischemic wounds through enhanced angiogenesis, cellular proliferation, and collagen deposition.

A Computer Adaptive Testing Version of the Addiction Severity Index-Multimedia Version (ASI-MV): The Addiction Severity CAT

PubMed Central

Butler, Stephen F.; Black, Ryan A.; McCaffrey, Stacey A.; Ainscough, Jessica; Doucette, Ann M.

2017-01-01

The purpose of this study was to develop and validate a computer adaptive testing (CAT) version of the Addiction Severity Index-Multimedia Version (ASI-MV®), the Addiction Severity CAT. This goal was accomplished in four steps. First, new candidate items for Addiction Severity CAT domains were evaluated after brainstorming sessions with experts in substance abuse treatment. Next, this new item bank was psychometrically evaluated on a large non-clinical (n =4419) and substance abuse treatment sample (n =845). Based on these results, final items were selected and calibrated for the creation of the Addiction Severity CAT algorithms. Once the algorithms were developed for the entire assessment, a fully functioning prototype of an Addiction Severity CAT was created. CAT simulations were conducted and optimal termination criteria were selected for the Addiction Severity CAT algorithms. Finally, construct validity of the CAT algorithms was evaluated by examining convergent/discriminant validity and sensitivity to change. The Addiction Severity CAT was determined to be valid, sensitive to change, and reliable. Further, the Addiction Severity CAT’s time of administration was found to be significantly less than the average time of administration for the ASI-MV composite scores. This study represents the initial validation of an IRT-based Addiction Severity CAT, and further exploration of the Addiction Severity CAT is needed. PMID:28230387

Advances in the Validation of Satellite-Based Maps of Volcanic Sulfur Dioxide Plumes

NASA Astrophysics Data System (ADS)

Realmuto, V. J.; Berk, A.; Acharya, P. K.; Kennett, R.

2013-12-01

The monitoring of volcanic gas emissions with gas cameras, spectrometer arrays, tethersondes, and UAVs presents new opportunities for the validation of satellite-based retrievals of gas concentrations. Gas cameras and spectrometer arrays provide instantaneous observations of the gas burden, or concentration along an optical path, over broad sections of a plume, similar to the observations acquired by nadir-viewing satellites. Tethersondes and UAVs provide us with direct measurements of the vertical profiles of gas concentrations within plumes. This presentation will focus on our current efforts to validate ASTER-based maps of sulfur dioxide plumes at Turrialba and Kilauea Volcanoes (located in Costa Rica and Hawaii, respectively). These volcanoes, which are the subjects of comprehensive monitoring programs, are challenging targets for thermal infrared (TIR) remote sensing due the warm and humid atmospheric conditions. The high spatial resolution of ASTER in the TIR (90 meters) allows us to map the plumes back to their source vents, but also requires us to pay close attention to the temperature and emissivity of the surfaces beneath the plumes. Our knowledge of the surface and atmospheric conditions is never perfect, and we employ interactive mapping techniques that allow us to evaluate the impact of these uncertainties on our estimates of plume composition. To accomplish this interactive mapping we have developed the Plume Tracker tool kit, which integrates retrieval procedures, visualization tools, and a customized version of the MODTRAN radiative transfer (RT) model under a single graphics user interface (GUI). We are in the process of porting the RT calculations to graphics processing units (GPUs) with the goal of achieving a 100-fold increase in the speed of computation relative to conventional CPU-based processing. We will report on our progress with this evolution of Plume Tracker. Portions of this research were conducted at the Jet Propulsion Laboratory, California Institute of Technology, under contract to the National Aeronautics and Space Administration.

10 CFR 905.21 - What is the administrative appeal process?

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false What is the administrative appeal process? 905.21 Section... § 905.21 What is the administrative appeal process? (a) Filing written appeals with Western. If a... while an appeal process is pending. However, if the appeal is unsuccessful for the customer, Western...

[Computerized system validation of clinical researches].

PubMed

Yan, Charles; Chen, Feng; Xia, Jia-lai; Zheng, Qing-shan; Liu, Daniel

2015-11-01

Validation is a documented process that provides a high degree of assurance. The computer system does exactly and consistently what it is designed to do in a controlled manner throughout the life. The validation process begins with the system proposal/requirements definition, and continues application and maintenance until system retirement and retention of the e-records based on regulatory rules. The objective to do so is to clearly specify that each application of information technology fulfills its purpose. The computer system validation (CSV) is essential in clinical studies according to the GCP standard, meeting product's pre-determined attributes of the specifications, quality, safety and traceability. This paper describes how to perform the validation process and determine relevant stakeholders within an organization in the light of validation SOPs. Although a specific accountability in the implementation of the validation process might be outsourced, the ultimate responsibility of the CSV remains on the shoulder of the business process owner-sponsor. In order to show that the compliance of the system validation has been properly attained, it is essential to set up comprehensive validation procedures and maintain adequate documentations as well as training records. Quality of the system validation should be controlled using both QC and QA means.

Validation of a 30-year-old process for the manufacture of L-asparaginase from Erwinia chrysanthemi.

PubMed

Gervais, David; Allison, Nigel; Jennings, Alan; Jones, Shane; Marks, Trevor

2013-04-01

A 30-year-old manufacturing process for the biologic product L-asparaginase from the plant pathogen Erwinia chrysanthemi was rigorously qualified and validated, with a high level of agreement between validation data and the 6-year process database. L-Asparaginase exists in its native state as a tetrameric protein and is used as a chemotherapeutic agent in the treatment regimen for Acute Lymphoblastic Leukaemia (ALL). The manufacturing process involves fermentation of the production organism, extraction and purification of the L-asparaginase to make drug substance (DS), and finally formulation and lyophilisation to generate drug product (DP). The extensive manufacturing experience with the product was used to establish ranges for all process parameters and product quality attributes. The product and in-process intermediates were rigorously characterised, and new assays, such as size-exclusion and reversed-phase UPLC, were developed, validated, and used to analyse several pre-validation batches. Finally, three prospective process validation batches were manufactured and product quality data generated using both the existing and the new analytical methods. These data demonstrated the process to be robust, highly reproducible and consistent, and the validation was successful, contributing to the granting of an FDA product license in November, 2011.

Safeguarding the process of drug administration with an emphasis on electronic support tools

PubMed Central

Seidling, Hanna M; Lampert, Anette; Lohmann, Kristina; Schiele, Julia T; Send, Alexander J F; Witticke, Diana; Haefeli, Walter E

2013-01-01

Aims The aim of this work is to understand the process of drug administration and identify points in the workflow that resulted in interventions by clinical information systems in order to improve patient safety. Methods To identify a generic way to structure the drug administration process we performed peer-group discussions and supplemented these discussions with a literature search for studies reporting errors in drug administration and strategies for their prevention. Results We concluded that the drug administration process might consist of up to 11 sub-steps, which can be grouped into the four sub-processes of preparation, personalization, application and follow-up. Errors in drug handling and administration are diverse and frequent and in many cases not caused by the patient him/herself, but by family members or nurses. Accordingly, different prevention strategies have been set in place with relatively few approaches involving e-health technology. Conclusions A generic structuring of the administration process and particular error-prone sub-steps may facilitate the allocation of prevention strategies and help to identify research gaps. PMID:24007450

A Washback Study of the "Test for English Majors for Grade Eight" (TEM8) in China--From the Perspective of University Program Administrators

ERIC Educational Resources Information Center

Zou, Shen; Xu, Qian

2017-01-01

Washback and fairness are interrelated in validity research, and thus an investigation into washback inevitably involves fairness. This article reports Phase One of a washback study of "Test for English Majors for Grade Eight" (TEM8). Phase One was a questionnaire survey administered to university program administrators. Two research…

Validity of ICD-9-CM codes for breast, lung and colorectal cancers in three Italian administrative healthcare databases: a diagnostic accuracy study protocol.

PubMed

Abraha, Iosief; Serraino, Diego; Giovannini, Gianni; Stracci, Fabrizio; Casucci, Paola; Alessandrini, Giuliana; Bidoli, Ettore; Chiari, Rita; Cirocchi, Roberto; De Giorgi, Marcello; Franchini, David; Vitale, Maria Francesca; Fusco, Mario; Montedori, Alessandro

2016-03-25

Administrative healthcare databases are useful tools to study healthcare outcomes and to monitor the health status of a population. Patients with cancer can be identified through disease-specific codes, prescriptions and physician claims, but prior validation is required to achieve an accurate case definition. The objective of this protocol is to assess the accuracy of International Classification of Diseases Ninth Revision-Clinical Modification (ICD-9-CM) codes for breast, lung and colorectal cancers in identifying patients diagnosed with the relative disease in three Italian administrative databases. Data from the administrative databases of Umbria Region (910,000 residents), Local Health Unit 3 of Napoli (1,170,000 residents) and Friuli--Venezia Giulia Region (1,227,000 residents) will be considered. In each administrative database, patients with the first occurrence of diagnosis of breast, lung or colorectal cancer between 2012 and 2014 will be identified using the following groups of ICD-9-CM codes in primary position: (1) 233.0 and (2) 174.x for breast cancer; (3) 162.x for lung cancer; (4) 153.x for colon cancer and (5) 154.0-154.1 and 154.8 for rectal cancer. Only incident cases will be considered, that is, excluding cases that have the same diagnosis in the 5 years (2007-2011) before the period of interest. A random sample of cases and non-cases will be selected from each administrative database and the corresponding medical charts will be assessed for validation by pairs of trained, independent reviewers. Case ascertainment within the medical charts will be based on (1) the presence of a primary nodular lesion in the breast, lung or colon-rectum, documented with imaging or endoscopy and (2) a cytological or histological documentation of cancer from a primary or metastatic site. Sensitivity and specificity with 95% CIs will be calculated. Study results will be disseminated widely through peer-reviewed publications and presentations at national and international conferences. 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/

Measurement properties of comorbidity indices in maternal health research: a systematic review.

PubMed

Aoyama, Kazuyoshi; D'Souza, Rohan; Inada, Eiichi; Lapinsky, Stephen E; Fowler, Robert A

2017-11-13

Maternal critical illness occurs in 1.2 to 4.7 of every 1000 live births in the United States and approximately 1 in 100 women who become critically ill will die. Patient characteristics and comorbid conditions are commonly summarized as an index or score for the purpose of predicting the likelihood of dying; however, most such indices have arisen from non-pregnant patient populations. We sought to systematically review comorbidity indices used in health administrative datasets of pregnant women, in order to critically appraise their measurement properties and recommend optimal tools for clinicians and maternal health researchers. We conducted a systematic search of MEDLINE and EMBASE to identify studies published from 1946 and 1947, respectively, to May 2017 that describe predictive validity of comorbidity indices using health administrative datasets in the field of maternal health research. We applied a methodological PubMed search filter to identify all studies of measurement properties for each index. Our initial search retrieved 8944 citations. The full text of 61 articles were identified and assessed for final eligibility. Finally, two eligible articles, describing three comorbidity indices appropriate for health administrative data remained: The Maternal comorbidity index, the Charlson comorbidity index and the Elixhauser Comorbidity Index. These studies of identified indices had a low risk of bias. The lack of an established consensus-building methodology in generating each index resulted in marginal sensibility for all indices. Only the Maternal Comorbidity Index was derived and validated specifically from a cohort of pregnant and postpartum women, using an administrative dataset, and had an associated c-statistic of 0.675 (95% Confidence Interval 0.647-0.666) in predicting mortality. Only the Maternal Comorbidity Index directly evaluated measurement properties relevant to pregnant women in health administrative datasets; however, it has only modest predictive ability for mortality among development and validation studies. Further research to investigate the feasibility of applying this index in clinical research, and its reliability across a variety of health administrative datasets would be incrementally helpful. Evolution of this and other tools for risk prediction and risk adjustment in pregnant and post-partum patients is an important area for ongoing study.

Administrator Training and Development: Conceptual Model.

ERIC Educational Resources Information Center

Boardman, Gerald R.

A conceptual model for an individualized training program for school administrators integrates processes, characteristics, and tasks through theory training and application. Based on an application of contingency theory, it provides a system matching up administrative candidates' needs in three areas (administrative process, administrative…

An overview of self-administered health literacy instruments.

PubMed

O Neill, Braden; Gonçalves, Daniela; Ricci-Cabello, Ignacio; Ziebland, Sue; Valderas, Jose

2014-01-01

With the increasing recognition of health literacy as a worldwide research priority, the development and refinement of indices to measure the construct is an important area of inquiry. Furthermore, the proliferation of online resources and research means that there is a growing need for self-administered instruments. We undertook a systematic overview to identify all published self-administered health literacy assessment indices to report their content and considerations associated with their administration. A primary aim of this study was to assist those seeking to employ a self-reported health literacy index to select one that has been developed and validated for an appropriate context, as well as with desired administration characteristics. Systematic searches were carried out in four electronic databases, and studies were included if they reported the development and/or validation of a novel health literacy assessment measure. Data were systematically extracted on key characteristics of the instruments: breadth of construct ("generic" vs. "content- or context- specific" health literacy), whether it was an original instrument or a derivative, country of origin, administration characteristics, age of target population (adult vs. pediatric), and evidence for validity. 35 articles met the inclusion criteria. There were 27 original instruments (27/35; 77.1%) and 8 derivative instruments (8/35; 22.9%). 22 indices measured "general" health literacy (22/35; 62.9%) while the remainder measured condition- or context- specific health literacy (13/35; 37.1%). Most health literacy measures were developed in the United States (22/35; 62.9%), and about half had adequate face, content, and construct validity (16/35; 45.7%). Given the number of measures available for many specific conditions and contexts, and that several have acceptable validity, our findings suggest that the research agenda should shift towards the investigation and elaboration of health literacy as a construct itself, in order for research in health literacy measurement to progress.

Design and validation of a model to predict early mortality in haemodialysis patients.

PubMed

Mauri, Joan M; Clèries, Montse; Vela, Emili

2008-05-01

Mortality and morbidity rates are higher in patients receiving haemodialysis therapy than in the general population. Detection of risk factors related to early death in these patients could be of aid for clinical and administrative decision making. Objectives. The aims of this study were (1) to identify risk factors (comorbidity and variables specific to haemodialysis) associated with death in the first year following the start of haemodialysis and (2) to design and validate a prognostic model to quantify the probability of death for each patient. An analysis was carried out on all patients starting haemodialysis treatment in Catalonia during the period 1997-2003 (n = 5738). The data source was the Renal Registry of Catalonia, a mandatory population registry. Patients were randomly divided into two samples: 60% (n = 3455) of the total were used to develop the prognostic model and the remaining 40% (n = 2283) to validate the model. Logistic regression analysis was used to construct the model. One-year mortality in the total study population was 16.5%. The predictive model included the following variables: age, sex, primary renal disease, grade of functional autonomy, chronic obstructive pulmonary disease, malignant processes, chronic liver disease, cardiovascular disease, initial vascular access and malnutrition. The analyses showed adequate calibration for both the sample to develop the model and the validation sample (Hosmer-Lemeshow statistic 0.97 and P = 0.49, respectively) as well as adequate discrimination (ROC curve 0.78 in both cases). Risk factors implicated in mortality at one year following the start of haemodialysis have been determined and a prognostic model designed. The validated, easy-to-apply model quantifies individual patient risk attributable to various factors, some of them amenable to correction by directed interventions.

Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part I - rationale and aims.

PubMed

Davis, Bruce H; Wood, Brent; Oldaker, Teri; Barnett, David

2013-01-01

Flow cytometry and other technologies of cell-based fluorescence assays are as a matter of good laboratory practice required to validate all assays, which when in clinical practice may pass through regulatory review processes using criteria often defined with a soluble analyte in plasma or serum samples in mind. Recently the U.S. Food and Drug Administration (FDA) has entered into a public dialogue in the U.S. regarding their regulatory interest in laboratory developed tests (LDTs) or so-called "home brew" assays performed in clinical laboratories. The absence of well-defined guidelines for validation of cell-based assays using fluorescence detection has thus become a subject of concern for the International Council for Standardization of Haematology (ICSH) and International Clinical Cytometry Society (ICCS). Accordingly, a group of over 40 international experts in the areas of test development, test validation, and clinical practice of a variety of assay types using flow cytometry and/or morphologic image analysis were invited to develop a set of practical guidelines useful to in vitro diagnostic (IVD) innovators, clinical laboratories, regulatory scientists, and laboratory inspectors. The focus of the group was restricted to fluorescence reporter reagents, although some common principles are shared by immunohistochemistry or immunocytochemistry techniques and noted where appropriate. The work product of this two year effort is the content of this special issue of this journal, which is published as 5 separate articles, this being Validation of Cell-based Fluorescence Assays: Practice Guidelines from the ICSH and ICCS - Part I - Rationale and aims. © 2013 International Clinical Cytometry Society. © 2013 International Clinical Cytometry Society.

Assessment of the Reliability and Validity of a Stress Questionnaire for Pharmacy Administration Graduate Students

ERIC Educational Resources Information Center

Konduri, Niranjan; Gupchup, Gireesh V.; Borrego, Matthew E.; Worley-Louis, Marcia

2006-01-01

The purpose of this study was to test and assess the reliability and validity of a modified stress scale in a sample of pharmacy graduate students. The modified stress scale was used as part of a larger, nationwide, study whose aim was to investigate the association of stress, perceived academic success and health-related quality of life among…

The use of administrative health care databases to identify patients with rheumatoid arthritis

PubMed Central

Hanly, John G; Thompson, Kara; Skedgel, Chris

2015-01-01

Objective To validate and compare the decision rules to identify rheumatoid arthritis (RA) in administrative databases. Methods A study was performed using administrative health care data from a population of 1 million people who had access to universal health care. Information was available on hospital discharge abstracts and physician billings. RA cases in health administrative databases were matched 1:4 by age and sex to randomly selected controls without inflammatory arthritis. Seven case definitions were applied to identify RA cases in the health administrative data, and their performance was compared with the diagnosis by a rheumatologist. The validation study was conducted on a sample of individuals with administrative data who received a rheumatologist consultation at the Arthritis Center of Nova Scotia. Results We identified 535 RA cases and 2,140 non-RA, noninflammatory arthritis controls. Using the rheumatologist’s diagnosis as the gold standard, the overall accuracy of the case definitions for RA cases varied between 68.9% and 82.9% with a kappa statistic between 0.26 and 0.53. The sensitivity and specificity varied from 20.7% to 94.8% and 62.5% to 98.5%, respectively. In a reference population of 1 million, the estimated annual number of incident cases of RA was between 176 and 1,610 and the annual number of prevalent cases was between 1,384 and 5,722. Conclusion The accuracy of case definitions for the identification of RA cases from rheumatology clinics using administrative health care databases is variable when compared to a rheumatologist’s assessment. This should be considered when comparing results across studies. This variability may also be used as an advantage in different study designs, depending on the relative importance of sensitivity and specificity for identifying the population of interest to the research question. PMID:27790047

A novel approach to scavenging anesthetic gases in rodent surgery.

PubMed

Nesbitt, Jeffrey C; Krageschmidt, Dale A; Blanco, Michael C

2013-01-01

Laboratory animal procedures using gas anesthetics may amass elevated waste gas concentrations in operating rooms if controls are not implemented for capturing and removing the vapors. Area sampling using an infrared analyzer indicated isoflurane concentrations likely to exceed occupational exposure guidelines. Our study showed environmental concentrations of oxygen as high as 40% and isoflurane concentrations >100 ppm when no controls or merely passive controls were utilized. These extraneous isoflurane emissions were determined to be originating from the pre-procedural induction process as well as the gas delivery nose cone. A novel waste gas collection cylinder was designed to enclose the gas delivery nose cone and animal head during the administration of anesthetic gases. The vented cylinder utilized a house vacuum to remove the waste anesthetic gases from the surgical field. A commercially available induction chamber designed to be actively and externally exhausted was used to lower concentrations during the induction process. With implementation of local exhaust ventilation controls, waste anesthetic gas concentrations decreased to below recommended occupational exposure levels. In vitro (sham) testing compared favorably to in vivo measurements validating the reduction capability of active ventilation during rodent anesthetic administration. In vivo isoflurane reductions for the induction chamber emissions, the operating room, and the surgeon's breathing zone were 95%, 60%, and 53%, respectively. The same measurements for an in vitro procedure were 98%, 84%, and 87%, respectively.

Validation of the Version 1 NOAA/NASA Pathfinder Sea Surface Temperature Data Set

NASA Technical Reports Server (NTRS)

Smith, Elizabeth A.

1998-01-01

A high-resolution, global satellite-derived sea surface temperature (SST) data set called Pathfinder, from the Advanced Very High Resolution Radiometer (AVHRR) aboard the NOAA Polar Orbiters, is available from the Jet Propulsion Laboratory Physical Oceanography Distributed Active Archive Center (JPL PO.DAAC). Suitable for research as well as education, the Pathfinder SST data set is a result of a collaboration between the National Oceanographic and Atmospheric Administration (NOAA), the National Aeronautics and Space Administration (NASA) and investigators at several universities. NOAA and NASA are the sponsors of the Pathfinder Program, which takes advantage of currently archived Earth science data from satellites. Where necessary, satellite sensors have been intercalibrated, algorithms improved and processing procedures revised, in order to produce long time-series, global measurements of ocean, land and atmospheric properties necessary for climate research. Many Pathfinder data sets are available to researchers now, nearly a decade before the first launch of NASA's Earth Observing System (EOS). The lessons learned from the Pathfinder programs will facilitate the processing and management of terabytes of data from EOS. The Oceans component of Pathfinder has undertaken to reprocess all Global Area Coverage (GAC) data acquired by the 5-channel AVHRRs since 1981. The resultant data products are consistent and stably calibrated [Rao, 1993a, Rao, 1993b, Brown et al., 1993], Earth-gridded SST fields at a variety of spatial and temporal resolutions.

"May I Buy a Pack of Marlboros, Please?" A Systematic Review of Evidence to Improve the Validity and Impact of Youth Undercover Buy Inspections.

PubMed

Lee, Joseph G L; Gregory, Kyle R; Baker, Hannah M; Ranney, Leah M; Goldstein, Adam O

2016-01-01

Most smokers become addicted to tobacco products before they are legally able to purchase these products. We systematically reviewed the literature on protocols to assess underage purchase and their ecological validity. We conducted a systematic search in May 2015 in PubMed and PsycINFO. We independently screened records for inclusion. We conducted a narrative review and examined implications of two types of legal authority for protocols that govern underage buy enforcement in the United States: criminal (state-level laws prohibiting sales to youth) and administrative (federal regulations prohibiting sales to youth). Ten studies experimentally assessed underage buy protocols and 44 studies assessed the association between youth characteristics and tobacco sales. Protocols that mimicked real-world youth behaviors were consistently associated with substantially greater likelihood of a sale to a youth. Many of the tested protocols appear to be designed for compliance with criminal law rather than administrative enforcement in ways that limited ecological validity. This may be due to concerns about entrapment. For administrative enforcement in particular, entrapment may be less of an issue than commonly thought. Commonly used underage buy protocols poorly represent the reality of youths' access to tobacco from retailers. Compliance check programs should allow youth to present themselves naturally and attempt to match the community's demographic makeup.

"May I Buy a Pack of Marlboros, Please?" A Systematic Review of Evidence to Improve the Validity and Impact of Youth Undercover Buy Inspections

PubMed Central

Lee, Joseph G. L.; Gregory, Kyle R.; Baker, Hannah M.; Ranney, Leah M.; Goldstein, Adam O.

2016-01-01

Most smokers become addicted to tobacco products before they are legally able to purchase these products. We systematically reviewed the literature on protocols to assess underage purchase and their ecological validity. We conducted a systematic search in May 2015 in PubMed and PsycINFO. We independently screened records for inclusion. We conducted a narrative review and examined implications of two types of legal authority for protocols that govern underage buy enforcement in the United States: criminal (state-level laws prohibiting sales to youth) and administrative (federal regulations prohibiting sales to youth). Ten studies experimentally assessed underage buy protocols and 44 studies assessed the association between youth characteristics and tobacco sales. Protocols that mimicked real-world youth behaviors were consistently associated with substantially greater likelihood of a sale to a youth. Many of the tested protocols appear to be designed for compliance with criminal law rather than administrative enforcement in ways that limited ecological validity. This may be due to concerns about entrapment. For administrative enforcement in particular, entrapment may be less of an issue than commonly thought. Commonly used underage buy protocols poorly represent the reality of youths' access to tobacco from retailers. Compliance check programs should allow youth to present themselves naturally and attempt to match the community’s demographic makeup. PMID:27050671

Moderate Resolution Imaging Spectroradiometer (MODIS) Overview

USGS Publications Warehouse

,

2008-01-01

The Moderate Resolution Imaging Spectroradiometer (MODIS) is an instrument that collects remotely sensed data used by scientists for monitoring, modeling, and assessing the effects of natural processes and human actions on the Earth's surface. The continual calibration of the MODIS instruments, the refinement of algorithms used to create higher-level products, and the ongoing product validation make MODIS images a valuable time series (2000-present) of geophysical and biophysical land-surface measurements. Carried on two National Aeronautics and Space Administration (NASA) Earth Observing System (EOS) satellites, MODIS acquires morning (EOS-Terra) and afternoon (EOS-Aqua) views almost daily. Terra data acquisitions began in February 2000 and Aqua data acquisitions began in July 2002. Land data are generated only as higher-level products, removing the burden of common types of data processing from the user community. MODIS-based products describing ecological dynamics, radiation budget, and land cover are projected onto a sinusoidal mapping grid and distributed as 10- by 10-degree tiles at 250-, 500-, or 1,000-meter spatial resolution. Some products are also created on a 0.05-degree geographic grid to support climate modeling studies. All MODIS products are distributed in the Hierarchical Data Format-Earth Observing System (HDF-EOS) file format and are available through file transfer protocol (FTP) or on digital video disc (DVD) media. Versions 4 and 5 of MODIS land data products are currently available and represent 'validated' collections defined in stages of accuracy that are based on the number of field sites and time periods for which the products have been validated. Version 5 collections incorporate the longest time series of both Terra and Aqua MODIS data products.

Xerostomia Quality of Life Scale (XeQoLS) questionnaire: validation of Italian version in head and neck cancer patients.

PubMed

Lastrucci, Luciana; Bertocci, Silvia; Bini, Vittorio; Borghesi, Simona; De Majo, Roberta; Rampini, Andrea; Gennari, Pietro Giovanni; Pernici, Paola

2018-01-01

To translate the Xerostomia Quality-of-Life Scale (XeQoLS) into Italian language (XeQoLS-IT). Xerostomia is the most relevant acute and late toxicity in patients with head and neck cancer treated with radiotherapy (RT). Patient-reported outcome (PRO) instruments are subjective report on patient perception of health status. The XeQoLS consists of 15 items and measures the impact of salivary gland dysfunction and xerostomia on the four major domains of oral health-related QoL. The XeQoLS-IT was created through a linguistic validation multi-step process: forward translation (TF), backward translation (TB) and administration of the questionnaire to 35 Italian patients with head and neck cancer. Translation was independently carried out by two radiation oncologists who were Italian native speakers. The two versions were compared and adapted to obtain a reconciled version, version 1 (V1). V1 was translated back into English by an Italian pro skilled in teaching English. After review of discrepancies and choice of the most appropriate wording for clarity and similarity to the original, version 2 (V2) was reached by consensus. To evaluate version 2, patients completed the XeQoLS-IT questionnaire and also underwent a cognitive debriefing. The questionnaire was considered simple by the patients. The clarity of the instructions and the easiness to answer questions had a mean value of 4.5 (± 0.71) on a scale from 1 to 5. A valid multi-step process led to the creation of the final version of the XeQoLS-IT, a suitable instrument for the perception of xerostomia in patients treated with RT.

Mapping cognitive overlaps between practice-based learning and improvement and evidence-based medicine: an operational definition for assessing resident physician competence.

PubMed

Chatterji, Madhabi; Graham, Mark J; Wyer, Peter C

2009-12-01

The complex competency labeled practice-based learning and improvement (PBLI) by the Accreditation Council for Graduate Medical Education (ACGME) incorporates core knowledge in evidence-based medicine (EBM). The purpose of this study was to operationally define a "PBLI-EBM" domain for assessing resident physician competence. The authors used an iterative design process to first content analyze and map correspondences between ACGME and EBM literature sources. The project team, including content and measurement experts and residents/fellows, parsed, classified, and hierarchically organized embedded learning outcomes using a literature-supported cognitive taxonomy. A pool of 141 items was produced from the domain and assessment specifications. The PBLI-EBM domain and resulting items were content validated through formal reviews by a national panel of experts. The final domain represents overlapping PBLI and EBM cognitive dimensions measurable through written, multiple-choice assessments. It is organized as 4 subdomains of clinical action: Therapy, Prognosis, Diagnosis, and Harm. Four broad cognitive skill branches (Ask, Acquire, Appraise, and Apply) are subsumed under each subdomain. Each skill branch is defined by enabling skills that specify the cognitive processes, content, and conditions pertinent to demonstrable competence. Most items passed content validity screening criteria and were prepared for test form assembly and administration. The operational definition of PBLI-EBM competence is based on a rigorously developed and validated domain and item pool, and substantially expands conventional understandings of EBM. The domain, assessment specifications, and procedures outlined may be used to design written assessments to tap important cognitive dimensions of the overall PBLI competency, as given by ACGME. For more comprehensive coverage of the PBLI competency, such instruments need to be complemented with performance assessments.

Mapping Cognitive Overlaps Between Practice-Based Learning and Improvement and Evidence-Based Medicine: An Operational Definition for Assessing Resident Physician Competence

PubMed Central

Chatterji, Madhabi; Graham, Mark J.; Wyer, Peter C.

2009-01-01

Purpose The complex competency labeled practice-based learning and improvement (PBLI) by the Accreditation Council for Graduate Medical Education (ACGME) incorporates core knowledge in evidence-based medicine (EBM). The purpose of this study was to operationally define a “PBLI-EBM” domain for assessing resident physician competence. Method The authors used an iterative design process to first content analyze and map correspondences between ACGME and EBM literature sources. The project team, including content and measurement experts and residents/fellows, parsed, classified, and hierarchically organized embedded learning outcomes using a literature-supported cognitive taxonomy. A pool of 141 items was produced from the domain and assessment specifications. The PBLI-EBM domain and resulting items were content validated through formal reviews by a national panel of experts. Results The final domain represents overlapping PBLI and EBM cognitive dimensions measurable through written, multiple-choice assessments. It is organized as 4 subdomains of clinical action: Therapy, Prognosis, Diagnosis, and Harm. Four broad cognitive skill branches (Ask, Acquire, Appraise, and Apply) are subsumed under each subdomain. Each skill branch is defined by enabling skills that specify the cognitive processes, content, and conditions pertinent to demonstrable competence. Most items passed content validity screening criteria and were prepared for test form assembly and administration. Conclusions The operational definition of PBLI-EBM competence is based on a rigorously developed and validated domain and item pool, and substantially expands conventional understandings of EBM. The domain, assessment specifications, and procedures outlined may be used to design written assessments to tap important cognitive dimensions of the overall PBLI competency, as given by ACGME. For more comprehensive coverage of the PBLI competency, such instruments need to be complemented with performance assessments. PMID:21975994

10 CFR 26.137 - Quality assurance and quality control.

Code of Federal Regulations, 2013 CFR

2013-01-01

... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

10 CFR 26.137 - Quality assurance and quality control.

Code of Federal Regulations, 2010 CFR

2010-01-01

... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

10 CFR 26.137 - Quality assurance and quality control.

Code of Federal Regulations, 2011 CFR

2011-01-01

... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

10 CFR 26.137 - Quality assurance and quality control.

Code of Federal Regulations, 2012 CFR

2012-01-01

... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

10 CFR 26.137 - Quality assurance and quality control.

Code of Federal Regulations, 2014 CFR

2014-01-01

... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

[Design of a risk matrix to assess sterile formulations at health care facilities].

PubMed

Martín de Rosales Cabrera, A M; López Cabezas, C; García Salom, P

2014-05-01

To design a matrix allowing classifying sterile formulations prepared at the hospital with different risk levels. i) Literature search and critical appraisal of the model proposed by the European Resolution CM/Res Ap(2011)1, ii) Identification of the risk associated to the elaboration process by means of the AMFE methodology (Modal Analysis of Failures and Effects), iii) estimation of the severity associated to the risks detected. After initially trying a model of numeric scoring, the classification matrix was changed to an alphabetical classification, grading each criterion from A to D.Each preparation assessed is given a 6-letter combination with three possible risk levels: low, intermediate, and high. This model was easier for risk assignment, and more reproducible. The final model designed analyzes 6 criteria: formulation process, administration route, the drug's safety profile, amount prepared, distribution, and susceptibility for microbiological contamination.The risk level obtained will condition the requirements of the formulation area, validity time, and storing conditions. The matrix model proposed may help health care institutions to better assess the risk of sterile formulations prepared,and provides information about the acceptable validity time according to the storing conditions and the manufacturing area. Its use will increase the safety level of this procedure as well as help in resources planning and distribution. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Recommendations for elaboration, transcultural adaptation and validation process of tests in Speech, Hearing and Language Pathology.

PubMed

Pernambuco, Leandro; Espelt, Albert; Magalhães, Hipólito Virgílio; Lima, Kenio Costa de

2017-06-08

to present a guide with recommendations for translation, adaptation, elaboration and process of validation of tests in Speech and Language Pathology. the recommendations were based on international guidelines with a focus on the elaboration, translation, cross-cultural adaptation and validation process of tests. the recommendations were grouped into two Charts, one of them with procedures for translation and transcultural adaptation and the other for obtaining evidence of validity, reliability and measures of accuracy of the tests. a guide with norms for the organization and systematization of the process of elaboration, translation, cross-cultural adaptation and validation process of tests in Speech and Language Pathology was created.

The Difficulties of Female Primary School Administrators in the Administration Process and Solution Suggestions

ERIC Educational Resources Information Center

Kosar, Didem; Altunay, Esen; Yalçinkaya, Mu¨nevver

2014-01-01

The aim of this research is to determine the administration experiences of female administrators, find out the troubles they have had during their administration process, and suggest some solutions according to these experiences. The qualitative method was used in this research and data was collected via the semi-structured interview form…

Validity of administrative coding in identifying patients with upper urinary tract calculi.

PubMed

Semins, Michelle J; Trock, Bruce J; Matlaga, Brian R

2010-07-01

Administrative databases are increasingly used for epidemiological investigations. We performed a study to assess the validity of ICD-9 codes for upper urinary tract stone disease in an administrative database. We retrieved the records of all inpatients and outpatients at Johns Hopkins Hospital between November 2007 and October 2008 with an ICD-9 code of 592, 592.0, 592.1 or 592.9 as one of the first 3 diagnosis codes. A random number generator selected 100 encounters for further review. We considered a patient to have a true diagnosis of an upper tract stone if the medical records specifically referenced a kidney stone event, or included current or past treatment for a kidney stone. Descriptive and comparative analyses were performed. A total of 8,245 encounters coded as upper tract calculus were identified and 100 were randomly selected for review. Two patients could not be identified within the electronic medical record and were excluded from the study. The positive predictive value of using all ICD-9 codes for an upper tract calculus (592, 592.0, 592.1) to identify subjects with renal or ureteral stones was 95.9%. For 592.0 only the positive predictive value was 85%. However, although the positive predictive value for 592.1 only was 100%, 26 subjects (76%) with a ureteral stone were not appropriately billed with this code. ICD-9 coding for urinary calculi is likely to be sufficiently valid to be useful in studies using administrative data to analyze stone disease. However, ICD-9 coding is not a reliable means to distinguish between subjects with renal and ureteral calculi. Copyright (c) 2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Model-based methods for case definitions from administrative health data: application to rheumatoid arthritis

PubMed Central

Kroeker, Kristine; Widdifield, Jessica; Muthukumarana, Saman; Jiang, Depeng; Lix, Lisa M

2017-01-01

Objective This research proposes a model-based method to facilitate the selection of disease case definitions from validation studies for administrative health data. The method is demonstrated for a rheumatoid arthritis (RA) validation study. Study design and setting Data were from 148 definitions to ascertain cases of RA in hospital, physician and prescription medication administrative data. We considered: (A) separate univariate models for sensitivity and specificity, (B) univariate model for Youden’s summary index and (C) bivariate (ie, joint) mixed-effects model for sensitivity and specificity. Model covariates included the number of diagnoses in physician, hospital and emergency department records, physician diagnosis observation time, duration of time between physician diagnoses and number of RA-related prescription medication records. Results The most common case definition attributes were: 1+ hospital diagnosis (65%), 2+ physician diagnoses (43%), 1+ specialist physician diagnosis (51%) and 2+ years of physician diagnosis observation time (27%). Statistically significant improvements in sensitivity and/or specificity for separate univariate models were associated with (all p values <0.01): 2+ and 3+ physician diagnoses, unlimited physician diagnosis observation time, 1+ specialist physician diagnosis and 1+ RA-related prescription medication records (65+ years only). The bivariate model produced similar results. Youden’s index was associated with these same case definition criteria, except for the length of the physician diagnosis observation time. Conclusion A model-based method provides valuable empirical evidence to aid in selecting a definition(s) for ascertaining diagnosed disease cases from administrative health data. The choice between univariate and bivariate models depends on the goals of the validation study and number of case definitions. PMID:28645978

Moderate sensitivity and high specificity of emergency department administrative data for transient ischemic attacks.

PubMed

Yu, Amy Y X; Quan, Hude; McRae, Andrew; Wagner, Gabrielle O; Hill, Michael D; Coutts, Shelagh B

2017-09-18

Validation of administrative data case definitions is key for accurate passive surveillance of disease. Transient ischemic attack (TIA) is a condition primarily managed in the emergency department. However, prior validation studies have focused on data after inpatient hospitalization. We aimed to determine the validity of the Canadian 10th International Classification of Diseases (ICD-10-CA) codes for TIA in the national ambulatory administrative database. We performed a diagnostic accuracy study of four ICD-10-CA case definition algorithms for TIA in the emergency department setting. The study population was obtained from two ongoing studies on the diagnosis of TIA and minor stroke versus stroke mimic using serum biomarkers and neuroimaging. Two reference standards were used 1) the emergency department clinical diagnosis determined by chart abstractors and 2) the 90-day final diagnosis, both obtained by stroke neurologists, to calculate the sensitivity, specificity, positive and negative predictive values (PPV and NPV) of the ICD-10-CA algorithms for TIA. Among 417 patients, emergency department adjudication showed 163 (39.1%) TIA, 155 (37.2%) ischemic strokes, and 99 (23.7%) stroke mimics. The most restrictive algorithm, defined as a TIA code in the main position had the lowest sensitivity (36.8%), but highest specificity (92.5%) and PPV (76.0%). The most inclusive algorithm, defined as a TIA code in any position with and without query prefix had the highest sensitivity (63.8%), but lowest specificity (81.5%) and PPV (68.9%). Sensitivity, specificity, PPV, and NPV were overall lower when using the 90-day diagnosis as reference standard. Emergency department administrative data reflect diagnosis of suspected TIA with high specificity, but underestimate the burden of disease. Future studies are necessary to understand the reasons for the low to moderate sensitivity.

Validation of Living Donor Nephrectomy Codes

PubMed Central

Lam, Ngan N.; Lentine, Krista L.; Klarenbach, Scott; Sood, Manish M.; Kuwornu, Paul J.; Naylor, Kyla L.; Knoll, Gregory A.; Kim, S. Joseph; Young, Ann; Garg, Amit X.

2018-01-01

Background: Use of administrative data for outcomes assessment in living kidney donors is increasing given the rarity of complications and challenges with loss to follow-up. Objective: To assess the validity of living donor nephrectomy in health care administrative databases compared with the reference standard of manual chart review. Design: Retrospective cohort study. Setting: 5 major transplant centers in Ontario, Canada. Patients: Living kidney donors between 2003 and 2010. Measurements: Sensitivity and positive predictive value (PPV). Methods: Using administrative databases, we conducted a retrospective study to determine the validity of diagnostic and procedural codes for living donor nephrectomies. The reference standard was living donor nephrectomies identified through the province’s tissue and organ procurement agency, with verification by manual chart review. Operating characteristics (sensitivity and PPV) of various algorithms using diagnostic, procedural, and physician billing codes were calculated. Results: During the study period, there were a total of 1199 living donor nephrectomies. Overall, the best algorithm for identifying living kidney donors was the presence of 1 diagnostic code for kidney donor (ICD-10 Z52.4) and 1 procedural code for kidney procurement/excision (1PC58, 1PC89, 1PC91). Compared with the reference standard, this algorithm had a sensitivity of 97% and a PPV of 90%. The diagnostic and procedural codes performed better than the physician billing codes (sensitivity 60%, PPV 78%). Limitations: The donor chart review and validation study was performed in Ontario and may not be generalizable to other regions. Conclusions: An algorithm consisting of 1 diagnostic and 1 procedural code can be reliably used to conduct health services research that requires the accurate determination of living kidney donors at the population level. PMID:29662679

Prediction Models for 30-Day Mortality and Complications After Total Knee and Hip Arthroplasties for Veteran Health Administration Patients With Osteoarthritis.

PubMed

Harris, Alex Hs; Kuo, Alfred C; Bowe, Thomas; Gupta, Shalini; Nordin, David; Giori, Nicholas J

2018-05-01

Statistical models to preoperatively predict patients' risk of death and major complications after total joint arthroplasty (TJA) could improve the quality of preoperative management and informed consent. Although risk models for TJA exist, they have limitations including poor transparency and/or unknown or poor performance. Thus, it is currently impossible to know how well currently available models predict short-term complications after TJA, or if newly developed models are more accurate. We sought to develop and conduct cross-validation of predictive risk models, and report details and performance metrics as benchmarks. Over 90 preoperative variables were used as candidate predictors of death and major complications within 30 days for Veterans Health Administration patients with osteoarthritis who underwent TJA. Data were split into 3 samples-for selection of model tuning parameters, model development, and cross-validation. C-indexes (discrimination) and calibration plots were produced. A total of 70,569 patients diagnosed with osteoarthritis who received primary TJA were included. C-statistics and bootstrapped confidence intervals for the cross-validation of the boosted regression models were highest for cardiac complications (0.75; 0.71-0.79) and 30-day mortality (0.73; 0.66-0.79) and lowest for deep vein thrombosis (0.59; 0.55-0.64) and return to the operating room (0.60; 0.57-0.63). Moderately accurate predictive models of 30-day mortality and cardiac complications after TJA in Veterans Health Administration patients were developed and internally cross-validated. By reporting model coefficients and performance metrics, other model developers can test these models on new samples and have a procedure and indication-specific benchmark to surpass. Published by Elsevier Inc.

Validation of a Case Definition for Pediatric Brain Injury Using Administrative Data.

PubMed

McChesney-Corbeil, Jane; Barlow, Karen; Quan, Hude; Chen, Guanmin; Wiebe, Samuel; Jette, Nathalie

2017-03-01

Health administrative data are a common population-based data source for traumatic brain injury (TBI) surveillance and research; however, before using these data for surveillance, it is important to develop a validated case definition. The objective of this study was to identify the optimal International Classification of Disease , edition 10 (ICD-10), case definition to ascertain children with TBI in emergency room (ER) or hospital administrative data. We tested multiple case definitions. Children who visited the ER were identified from the Regional Emergency Department Information System at Alberta Children's Hospital. Secondary data were collected for children with trauma, musculoskeletal, or central nervous system complaints who visited the ER between October 5, 2005, and June 6, 2007. TBI status was determined based on chart review. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for each case definition. Of 6639 patients, 1343 had a TBI. The best case definition was, "1 hospital or 1 ER encounter coded with an ICD-10 code for TBI in 1 year" (sensitivity 69.8% [95% confidence interval (CI), 67.3-72.2], specificity 96.7% [95% CI, 96.2-97.2], PPV 84.2% [95% CI 82.0-86.3], NPV 92.7% [95% CI, 92.0-93.3]). The nonspecific code S09.9 identified >80% of TBI cases in our study. The optimal ICD-10-based case definition for pediatric TBI in this study is valid and should be considered for future pediatric TBI surveillance studies. However, external validation is recommended before use in other jurisdictions, particularly because it is plausible that a larger proportion of patients in our cohort had milder injuries.

42 CFR 493.602 - Scope of subpart.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Administration § 493.602 Scope of subpart. This... (the PHS Act) and the Federal validation of accredited laboratories and of CLIA-exempt laboratories...

42 CFR 493.602 - Scope of subpart.

Code of Federal Regulations, 2011 CFR

2011-10-01

...) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Administration § 493.602 Scope of subpart. This... (the PHS Act) and the Federal validation of accredited laboratories and of CLIA-exempt laboratories...

Experimental investigation and oral bioavailability enhancement of nano-sized curcumin by using supercritical anti-solvent process.

PubMed

Anwar, Mohammed; Ahmad, Iqbal; Warsi, Musarrat H; Mohapatra, Sharmistha; Ahmad, Niyaz; Akhter, Sohail; Ali, Asgar; Ahmad, Farhan J

2015-10-01

The biomedical applications of curcumin (CUR) are limited due to its poor oral bioavailability. In this work, CUR nanoparticles were successfully prepared by combining the supercritical anti-solvent (SAS) process with Tween 80 as a solubilizing agent and permeation enhancer. Different processing parameters that can govern the mean particle size and size distribution of nanoparticles were well investigated by manipulating the types of solvents, mixing vessel pressure, mixing vessel temperature, CO2 flow rate, solution flow rate and solution concentration. Solid state characterization was done by Fourier Transform infrared spectroscopy, differential scanning calorimetry, dynamic light scattering, scanning electron microscopy, and powder X-ray diffraction study. Solubility and dissolution profile of SAS-processed CUR were found to be significantly increased in comparison with native CUR. Further, a validated ultra-performance liquid chromatographic method with quadrupole-time of flight-mass spectrometry was developed to investigate the pharmacokinetic parameters after a single oral dose (100mg/kg) administration of CUR (before/after SAS-processed) in male Wistar rats. From the plasma concentration vs. time profile graph, oral bioavailability of SAS-processed CUR was found to be increased approximately 11.6-fold (p<0.001) as compared to native CUR. Copyright © 2015 Elsevier B.V. All rights reserved.

Equivalence of Laptop and Tablet Administrations of the Minnesota Multiphasic Personality Inventory-2 Restructured Form.

PubMed

Menton, William H; Crighton, Adam H; Tarescavage, Anthony M; Marek, Ryan J; Hicks, Adam D; Ben-Porath, Yossef S

2017-06-01

The present study investigated the comparability of laptop computer- and tablet-based administration modes for the Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF). Employing a counterbalanced within-subjects design, the MMPI-2-RF was administered via both modes to a sample of college undergraduates ( N = 133). Administration modes were compared in terms of mean scale scores, internal consistency, test-retest consistency, external validity, and administration time. Mean scores were generally similar, and scores produced via both methods appeared approximately equal in terms of internal consistency and test-retest consistency. Scores from the two modalities also evidenced highly similar patterns of associations with external criteria. Notably, tablet administration of the MMPI-2-RF was substantially longer than laptop administration in the present study (mean difference 7.2 minutes, Cohen's d = .95). Overall, results suggest that varying administration mode between laptop and tablet has a negligible influence on MMPI-2-RF scores, providing evidence that these modes of administration can be considered psychometrically equivalent.

Hospital administrative costs in the US.

PubMed

McGourty, M E; Shulkin, D J

1995-01-01

In a study of administrative costs in US hospitals, Woolhandler et al. reviewed 1990 Medicare cost reports from 6400 hospitals. The intent of this study was to determine the validity of previous administrative cost estimate studies in Californian hospitals, which were extrapolated nationwide. The study found that hospital administrative costs ranged from 20.5 (in Minnesota) to 30.6% (in Hawaii) of each hospital's spending. Furthermore, the investigators found that these administrative costs did not vary according to the level of managed care penetration in a particular US state. Using a health maintenance organisation (HMO) enrolment rate of 20% as the median, the study found hospital administrative costs to be similar to states with an HMO enrolment rate of < 20%. The authors concluded that reducing hospital administrative costs to the Canadian level (9 to 11% of total hospital spending) would result in annual savings of $US50 billion. Thus, the authors suggest that if administrative costs are high, US healthcare reform should follow a system similar to that used in Canada.

Design of a water electrolysis flight experiment

NASA Technical Reports Server (NTRS)

Lee, M. Gene; Grigger, David J.; Thompson, C. Dean; Cusick, Robert J.

1993-01-01

Supply of oxygen (O2) and hydrogen (H2) by electolyzing water in space will play an important role in meeting the National Aeronautics and Space Administration's (NASA's) needs and goals for future space missios. Both O2 and H2 are envisioned to be used in a variety of processes including crew life support, spacecraft propulsion, extravehicular activity, electrical power generation/storage as well as in scientific experiment and manufacturing processes. The Electrolysis Performance Improvement Concept Study (EPICS) flight experiment described herein is sponsored by NASA Headquarters as a part of the In-Space Technology Experiment Program (IN-STEP). The objective of the EPICS is to further contribute to the improvement of the SEF technology, specifially by demonstrating and validating the SFE electromechanical process in microgravity as well as investigating perrformance improvements projected possible in a microgravity environment. This paper defines the experiment objective and presents the results of the preliminary design of the EPICS. The experiment will include testing three subscale self-contained SFE units: one containing baseline components, and two units having variations in key component materials. Tests will be conducted at varying current and thermal condition.

The utility of pain scores obtained during 'regular reassessment process' in premature infants in the NICU.

PubMed

Rohan, A J

2014-07-01

To examine the association of pain assessment scores achieved through regular reassessment practice, as required by the Joint Commission (JC), with painful events and the use of analgesics in premature, ventilated infants. A cross-sectional study was performed in two tertiary level neonatal intensive care units. Pain was assessed at regular intervals at each center using validated multidimensional instruments in accordance with the JC standards. Sample comprised 196 ventilated premature infant patient-days. Overall, 2% of scores suggested the presence of pain, and 0.1% of pain scores were associated with analgesia. Ventilated infants who were exposed to multiple pain-associated procedures in a day never demonstrated pain score elevations despite infrequent preemptive or continuous analgesic administration. Pain assessment scores achieved using regular reassessment processes were poorly correlated with exposure to pain-associated procedures or conditions. Low pain scores achieved through regular reassessment may not correlate to low pain exposure. Resources that are expended on regular reassessment processes may need to be reconsidered in light of the low yield for clinical alterations in care in this setting.

75 FR 57233 - 340B Drug Pricing Program Administrative Dispute Resolution Process

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-20

... Dispute Resolution Process AGENCY: Health Resources and Services Administration, HHS. ACTION: Advance...) to promulgate regulations to establish and implement an administrative dispute resolution process for... does not currently refer to HRSA's plan on how it will resolve any decision made through the new...

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

PubMed

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

2014-04-01

Clinical management is hypothesized to be critical for hospital management and hospital performance. The aims of this study were to develop and validate professional involvement scales for measuring the level of clinical management by physicians and nurses in European hospitals. Testing of validity and reliability of scales derived from a questionnaire of 21 items was developed on the basis of a previous study and expert opinion and administered in a cross-sectional seven-country research project 'Deepening our Understanding of Quality improvement in Europe' (DUQuE). A sample of 3386 leading physicians and nurses working in 188 hospitals located in Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey. Validity and reliability of professional involvement scales and subscales. Psychometric analysis yielded four subscales for leading physicians: (i) Administration and budgeting, (ii) Managing medical practice, (iii) Strategic management and (iv) Managing nursing practice. Only the first three factors applied well to the nurses. Cronbach's alpha for internal consistency ranged from 0.74 to 0.86 for the physicians, and from 0.61 to 0.81 for the nurses. Except for the 0.74 correlation between 'Administration and budgeting' and 'Managing medical practice' among physicians, all inter-scale correlations were <0.70 (range 0.43-0.61). Under testing for construct validity, the subscales were positively correlated with 'formal management roles' of physicians and nurses. The professional involvement scales appear to yield reliable and valid data in European hospital settings, but the scale 'Managing medical practice' for nurses needs further exploration. The measurement instrument can be used for international research on clinical management.

Validation of column-based chromatography processes for the purification of proteins. Technical report No. 14.

PubMed

2008-01-01

PDA Technical Report No. 14 has been written to provide current best practices, such as application of risk-based decision making, based in sound science to provide a foundation for the validation of column-based chromatography processes and to expand upon information provided in Technical Report No. 42, Process Validation of Protein Manufacturing. The intent of this technical report is to provide an integrated validation life-cycle approach that begins with the use of process development data for the definition of operational parameters as a basis for validation, confirmation, and/or minor adjustment to these parameters at manufacturing scale during production of conformance batches and maintenance of the validated state throughout the product's life cycle.

Measurement of Global Precipitation

NASA Technical Reports Server (NTRS)

Flaming, Gilbert Mark

2004-01-01

The Global Precipitation Measurement (GPM) Program is an international cooperative effort whose objectives are to (a) obtain increased understanding of rainfall processes, and (b) make frequent rainfall measurements on a global basis. The National Aeronautics and Space Administration (NASA) of the United States and the Japanese Aviation and Exploration Agency (JAXA) have entered into a cooperative agreement for the formulation and development of GPM. This agreement is a continuation of the partnership that developed the highly successful Tropical Rainfall Measuring Mission (TRMM) that was launched in November 1997; this mission continues to provide valuable scientific and meteorological information on rainfall and the associated processes. International collaboration on GPM from other space agencies has been solicited, and discussions regarding their participation are currently in progress. NASA has taken lead responsibility for the planning and formulation of GPM, Key elements of the Program to be provided by NASA include a Core satellite bus instrumented with a multi-channel microwave radiometer, a Ground Validation System and a ground-based Precipitation Processing System (PPS). JAXA will provide a Dual-frequency Precipitation Radar for installation on the Core satellite and launch services. Other United States agencies and international partners may participate in a number of ways, such as providing rainfall measurements obtained from their own national space-borne platforms, providing local rainfall measurements to support the ground validation activities, or providing hardware or launch services for GPM constellation spacecraft. This paper will present an overview of the current planning for the GPM Program, and discuss in more detail the status of the lead author's primary responsibility, development and acquisition of the GPM Microwave Imager.

Adolescent Risk Screening Instruments for Primary Care: An Integrative Review Utilizing the Donabedian Framework.

PubMed

Hiott, Deanna B; Phillips, Shannon; Amella, Elaine

2017-07-31

Adolescent risk-taking behavior choices can affect future health outcomes. The purpose of this integrative literature review is to evaluate adolescent risk screening instruments available to primary care providers in the United States using the Donabedian Framework of structure, process, and outcome. To examine the literature concerning multidimensional adolescent risk screening instruments available in the United States for use in the primary care setting, library searches, ancestry searches, and Internet searches were conducted. Library searches included a systematic search of the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Academic Search Premier, Health Source Nursing Academic Ed, Medline, PsycINFO, the Psychology and Behavioral Sciences Collection, and PubMed databases with CINAHL headings using the following Boolean search terms: "primary care" and screening and pediatric. Criteria for inclusion consisted of studies conducted in the United States that involved broad multidimensional adolescent risk screening instruments for use in the pediatric primary care setting. Instruments that focused solely on one unhealthy behavior were excluded, as were developmental screens and screens not validated or designed for all ages of adolescents. In all 25 manuscripts reviewed, 16 screens met the inclusion criteria and were included in the study. These 16 screens were examined for factors associated with the Donabedian structure-process-outcome model. This review revealed that many screens contain structural issues related to cost and length that inhibit provider implementation in the primary care setting. Process limitations regarding the report method and administration format were also identified. The Pediatric Symptom Checklist was identified as a free, short tool that is valid and reliable.

Identification of absolute conversion to geraldol from fisetin and pharmacokinetics in mouse.

PubMed

Jo, Jun Hyeon; Jo, Jung Jae; Lee, Jae-Mok; Lee, Sangkyu

2016-12-01

Fisetin (3,3',4',7-tetrahydroxyflavone) is a flavonoid found in several fruits, vegetables, nuts, and wine and has anti-oxidant, anti-inflammatory, and anti-angiogenic properties. Geraldol is the 3'-methoxylated metabolite of fisetin (3,4',7-trihydroxy-3'-methoxyflavone). The concentration of fisetin and geraldol in mouse plasma was determined by LC-MS/MS, following direct protein precipitation. These concentrations were determined after administration of fisetin at doses of 2mg/kg (i.v.) and 100 and 200mg/kg (p.o.). The method was validated in terms of linearity, accuracy, precision, matrix effect, and stability. The pharmacokinetics parameters of fisetin and geraldol were successfully determined using a validated method in mice. Results indicated that fisetin was very rapidly methylated to geraldol in vivo. Following administration of fisetin, it was observed that the C max and AUC values for geraldol were higher than those of fisetin. The absolute bioavailability of fisetin was calculated as 7.8% and 31.7% after oral administration of 100 and 200mg/kg fisetin, respectively. This method was successfully applied to determine the pharmacokinetic parameters of fisetin and its main metabolite geraldol in mouse plasma. Geraldol was the dominant circulating metabolite after fisetin administration in vivo. Copyright © 2016 Elsevier B.V. All rights reserved.

Development and validation of a case definition for epilepsy for use with administrative health data.

PubMed

Reid, Aylin Y; St Germaine-Smith, Christine; Liu, Mingfu; Sadiq, Shahnaz; Quan, Hude; Wiebe, Samuel; Faris, Peter; Dean, Stafford; Jetté, Nathalie

2012-12-01

The objective of this study was to develop and validate coding algorithms for epilepsy using ICD-coded inpatient claims, physician claims, and emergency room (ER) visits. 720/2049 charts from 2003 and 1533/3252 charts from 2006 were randomly selected for review from 13 neurologists' practices as the "gold standard" for diagnosis. Epilepsy status in each chart was determined by 2 trained physicians. The optimal algorithm to identify epilepsy cases was developed by linking the reviewed charts with three administrative databases (ICD 9 and 10 data from 2000 to 2008) including hospital discharges, ER visits and physician claims in a Canadian health region. Accepting chart review data as the gold standard, we calculated sensitivity, specificity, positive, and negative predictive value for each ICD-9 and ICD-10 administrative data algorithm (case definitions). Of 18 algorithms assessed, the most accurate algorithm to identify epilepsy cases was "2 physician claims or 1 hospitalization in 2 years coded" (ICD-9 345 or G40/G41) and the most sensitive algorithm was "1 physician clam or 1 hospitalization or 1 ER visit in 2 years." Accurate and sensitive case definitions are available for research requiring the identification of epilepsy cases in administrative health data. Copyright © 2012 Elsevier B.V. All rights reserved.

Development of a simple and sensitive liquid chromatography triple quadrupole mass spectrometry (LC-MS/MS) method for the determination of cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) and its metabolites in rat whole blood after oral administration of a single high dose of CBD.

PubMed

Palazzoli, Federica; Citti, Cinzia; Licata, Manuela; Vilella, Antonietta; Manca, Letizia; Zoli, Michele; Vandelli, Maria Angela; Forni, Flavio; Cannazza, Giuseppe

2018-02-20

The investigation of the possible conversion of cannabidiol (CBD) into Δ 9 -tetrahydrocannabinol (THC) in vivo after oral administration of CBD is reported herein since recent publications suggested a rapid conversion in simulated gastric fluid. To this end, single high dose of CBD (50mg/kg) was administered orally to rats and their blood was collected after 3 and 6h. A highly sensitive and selective LC-MS/MS method was developed and fully validated in compliance with the Scientific Working Group of Forensic Toxicology (SWGTOX) standard practices for method validation in forensic toxicology. This method also involved the optimization of cannabinoids and their metabolites extraction in order to remove co-eluting phospholipids and increase the sensitivity of the MS detection. Neither THC nor its metabolites were detected in rat whole blood after 3 or 6h from CBD administration. After oral administration, the amount of CBD dissolved in olive oil was higher than that absorbed from an ethanolic solution. This could be explained by the protection of lipid excipients towards CBD from acidic gastric juice. Copyright © 2017 Elsevier B.V. All rights reserved.

An integrated assessment instrument: Developing and validating instrument for facilitating critical thinking abilities and science process skills on electrolyte and nonelectrolyte solution matter

NASA Astrophysics Data System (ADS)

Astuti, Sri Rejeki Dwi; Suyanta, LFX, Endang Widjajanti; Rohaeti, Eli

2017-05-01

The demanding of assessment in learning process was impact by policy changes. Nowadays, assessment is not only emphasizing knowledge, but also skills and attitudes. However, in reality there are many obstacles in measuring them. This paper aimed to describe how to develop integrated assessment instrument and to verify instruments' validity such as content validity and construct validity. This instrument development used test development model by McIntire. Development process data was acquired based on development test step. Initial product was observed by three peer reviewer and six expert judgments (two subject matter experts, two evaluation experts and two chemistry teachers) to acquire content validity. This research involved 376 first grade students of two Senior High Schools in Bantul Regency to acquire construct validity. Content validity was analyzed used Aiken's formula. The verifying of construct validity was analyzed by exploratory factor analysis using SPSS ver 16.0. The result show that all constructs in integrated assessment instrument are asserted valid according to content validity and construct validity. Therefore, the integrated assessment instrument is suitable for measuring critical thinking abilities and science process skills of senior high school students on electrolyte solution matter.

The presentation and preliminary validation of KIWEST using a large sample of Norwegian university staff.

PubMed

Innstrand, Siw Tone; Christensen, Marit; Undebakke, Kirsti Godal; Svarva, Kyrre

2015-12-01

The aim of the present paper is to present and validate a Knowledge-Intensive Work Environment Survey Target (KIWEST), a questionnaire developed for assessing the psychosocial factors among people in knowledge-intensive work environments. The construct validity and reliability of the measurement model where tested on a representative sample of 3066 academic and administrative staff working at one of the largest universities in Norway. Confirmatory factor analysis provided initial support for the convergent validity and internal consistency of the 30 construct KIWEST measurement model. However, discriminant validity tests indicated that some of the constructs might overlap to some degree. Overall, the KIWEST measure showed promising psychometric properties as a psychosocial work environment measure. © 2015 the Nordic Societies of Public Health.

Measuring emotion socialization in schools.

PubMed

Horner, Christy G; Wallace, Tanner L

2013-10-01

Understanding how school personnel can best support students' development of communication skills around feelings is critical to long-term health outcomes. The measurement of emotion socialization in schools facilitates future research in this area; we review existing measures of emotion socialization to assess their applicability to school-based health studies. A content analysis of four emotion socialization measures was conducted. Inclusion criteria included: high frequency of use in prior research, established documentation of validity and reliability, and sufficient description of measurement procedures. Four dimensions emerged as particularly salient to a measure's future relevance and applicability to school-based health studies: (1) methods of measurement; (2) mode and agent of socialization; (3) type of emotion; and (4) structure versus function of socializing behavior. Future measurement strategies should address (1) the structures of emotion socializing processes; (2) diverse socializing agents such as teachers, peers, and administrators; (3) the intended functions of such processes; (4) student perceptions of and responses to such processes; and (5) the complex interactions of these factors across contexts. Strategies attending to these components will permit future studies of school-based emotion socializing processes to determine how they enhance health and reduce health risks. © 2013, American School Health Association.

[Quality Management System in Pathological Laboratory].

PubMed

Koyatsu, Junichi; Ueda, Yoshihiko

2015-07-01

Even compared to other clinical laboratories, the pathological laboratory conducts troublesome work, and many of the work processes are also manual. Therefore, the introduction of the systematic management of administration is necessary. It will be a shortcut to use existing standards such as ISO 15189 for this purpose. There is no standard specialized for the pathological laboratory, but it is considered to be important to a pathological laboratory in particular. 1. Safety nianagement of the personnel and environmental conditions. Comply with laws and regulations concerning the handling of hazardous materials. 2. Pre-examination processes. The laboratory shall have documented procedures for the proper collection and handling of primary samples. Developed and documented criteria for acceptance or rejection of samples are applied. 3. Examination processes. Selection, verification, and validation of the examination procedures. Devise a system that can constantly monitor the traceability of the sample. 4. Post-examination processes. Storage, retention, and disposal of clinical samples. 5. Release of results. When examination results fall within established alert or critical intervals, immediately notify the physicians. The important point is to recognize the needs of the client and be aware that pathological diagnoses are always "the final diagnoses".

Alternative to Nitric Acid for Passivation of Stainless Steel Alloys

NASA Technical Reports Server (NTRS)

Lewis, Pattie L.; Kolody, Mark; Curran, Jerry

2013-01-01

Corrosion is an extensive problem that affects the Department of Defense (DoD) and National Aeronautics and Space Administration (NASA). The deleterious effects of corrosion result in steep costs, asset downtime affecting mission readiness, and safety risks to personnel. Consequently, it is vital to reduce corrosion costs and risks in a sustainable manner. The DoD and NASA have numerous structures and equipment that are fabricated from stainless steel. The standard practice for protection of stainless steel is a process called passivation. Typical passivation procedures call for the use of nitric acid; however, there are a number of environmental, worker safety, and operational issues associated with its use. Citric acid offers a variety of benefits including increased safety for personnel, reduced environmental impact, and reduced operational cost. DoD and NASA agreed to collaborate to validate citric acid as an acceptable passivating agent for stainless steel. This paper details our investigation of prior work developing the citric acid passivation process, development of the test plan, optimization of the process for specific stainless steel alloys, ongoing and planned testing to elucidate the process' resistance to corrosion in comparison to nitric acid, and preliminary results.

CardioNet: a human metabolic network suited for the study of cardiomyocyte metabolism.

PubMed

Karlstädt, Anja; Fliegner, Daniela; Kararigas, Georgios; Ruderisch, Hugo Sanchez; Regitz-Zagrosek, Vera; Holzhütter, Hermann-Georg

2012-08-29

Availability of oxygen and nutrients in the coronary circulation is a crucial determinant of cardiac performance. Nutrient composition of coronary blood may significantly vary in specific physiological and pathological conditions, for example, administration of special diets, long-term starvation, physical exercise or diabetes. Quantitative analysis of cardiac metabolism from a systems biology perspective may help to a better understanding of the relationship between nutrient supply and efficiency of metabolic processes required for an adequate cardiac output. Here we present CardioNet, the first large-scale reconstruction of the metabolic network of the human cardiomyocyte comprising 1793 metabolic reactions, including 560 transport processes in six compartments. We use flux-balance analysis to demonstrate the capability of the network to accomplish a set of 368 metabolic functions required for maintaining the structural and functional integrity of the cell. Taking the maintenance of ATP, biosynthesis of ceramide, cardiolipin and further important phospholipids as examples, we analyse how a changed supply of glucose, lactate, fatty acids and ketone bodies may influence the efficiency of these essential processes. CardioNet is a functionally validated metabolic network of the human cardiomyocyte that enables theorectical studies of cellular metabolic processes crucial for the accomplishment of an adequate cardiac output.

Validation of Rolls-Royce RR-BK01Digital Recording and 1/3 Octave Analysis System for Use in Support of Aircraft Noise Certification Efforts in Compliance with 14 CFR Part 36; Letter Report: V324-FB48B3-LR4

DOT National Transportation Integrated Search

2017-10-23

In support of the Federal Aviation Administrations Office of Environment and Energy, the Volpe Center Environmental Measurement and Modeling Division (Volpe) has completed validation of the digital recording and 1/3 octave band analysis components...

Two Validity Studies of CLEP Subject Examination in Elementary Computer Programming: Fortran IV, U. T. Austin, Spring 1979 and Spring 1982. Research Bulletin 82-8.

ERIC Educational Resources Information Center

Appenzellar, Anne B.; Kelley, H. Paul

Two validity studies of the College Board College-Level Examination Program (CLEP) Subject Examination in Elementary Computer Programming: Fortran IV determined that CLEP scores are appropriate for granting examination credit at the University of Texas at Austin. The standard-setting administration was in the spring of 1979, with a re-evaluation…

Brazilian adaptation of the Hotel Task: A tool for the ecological assessment of executive functions

PubMed Central

Cardoso, Caroline de Oliveira; Zimmermann, Nicolle; Paraná, Camila Borges; Gindri, Gigiane; de Pereira, Ana Paula Almeida; Fonseca, Rochele Paz

2015-01-01

Over recent years, neuropsychological research has been increasingly concerned with the need to develop more ecologically valid instruments for the assessment of executive functions. The Hotel Task is one of the most widely used ecological measures of executive functioning, and provides an assessment of planning, organization, self-monitoring and cognitive flexibility. Objective The goal of this study was to adapt the Hotel Task for use in the Brazilian population. Methods The sample comprised 27 participants (three translators, six expert judges, seven healthy adults, ten patients with traumatic brain injuries and one hotel manager). The adaptation process consisted of five steps, which were repeated until a satisfactory version of the task was produced. The steps were as follows: (1) Translation; (2) Development of new stimuli and brainstorming among the authors; (3) Analysis by expert judges; (4) Pilot studies; (5) Assessment by an expert in business administration and hotel management. Results The adapted version proved adequate and valid for the assessment of executive functions. However, further research must be conducted to obtain evidence of the reliability, as well as the construct and criterion validity, sensitivity and specificity, of the Hotel Task. Conclusion Many neurological and/or psychiatric populations may benefit from the adapted task, since it may make significant contributions to the assessment of dysexecutive syndromes and their impact on patient functioning. PMID:29213957

Nursing intellectual capital theory: operationalization and empirical validation of concepts.

PubMed

Covell, Christine L; Sidani, Souraya

2013-08-01

To present the operationalization of concepts in the nursing intellectual capital theory and the results of a methodological study aimed at empirically validating the concepts. The nursing intellectual capital theory proposes that the stocks of nursing knowledge in an organization are embedded in two concepts, nursing human capital and nursing structural capital. The theory also proposes that two concepts in the work environment, nurse staffing and employer support for nursing continuing professional development, influence nursing human capital. A cross-sectional design. A systematic three-step process was used to operationalize the concepts of the theory. In 2008, data were collected for 147 inpatient units from administrative departments and unit managers in 6 Canadian hospitals. Exploratory factor analyses were conducted to determine if the indicator variables accurately reflect their respective concepts. The proposed indicator variables collectively measured the nurse staffing concept. Three indicators were retained to construct nursing human capital: clinical expertise and experience concept. The nursing structural capital and employer support for nursing continuing professional development concepts were not validated empirically. The nurse staffing and the nursing human capital: clinical expertise and experience concepts will be brought forward for further model testing. Refinement for some of the indicator variables of the concepts is indicated. Additional research is required with different sources of data to confirm the findings. © 2012 Blackwell Publishing Ltd.

PILATES (Physical Activity and Diet Survey): An Italian Self-Administered Questionnaire Evaluating Diet Habits of Gym-Goers. Validation Process.

PubMed

Gianfredi, Vincenza; Nucci, Daniele; Ceccarelli, Francesco; Villarini, Milena; Moretti, Massimo

2018-04-19

PILATES study aims are to assess the main characteristics related to food habits, diet behaviors, and nutrition knowledge and how and where gym-goers get information on dietary supplementation. We present evidence for the reliability, feasibility, and construct validity of the PILATES questionnaire. Cohen's kappa statistic (k) for dichotomous variables was used to assess the agreement between the two administrations (interrater agreement). The nutrient composition and energy of food were derived from the Food Composition Database for Epidemiological Studies in Italy (Banca Dati di Composizione degli Alimenti per Studi Epidemiologici in Italia - BDA). Because of energy intake, waist circumference and weight are continuous variables; we calculate the agreement between the two interviews using Spearman's rho coefficient (nonparametric measure of rank correlation). An Italian 21-item self-administered questionnaire was designed and pretested on 28 students in food science and human nutrition at the University of Perugia who were enrolled on a voluntary basis. After verifying the feasibility of the questionnaire, pretest evaluation showed a generally high concordance with an 87.32% of agreement and k value = 0.71 ± 0.23. In addition, weight, daily energy intake, and waist circumference confirmed a statistically significant agreement (p <.001, Spearman rho coefficient). PILATES questionnaire is a valid tool to estimate dietary intakes in a fairly simple, cost-effective, and timesaving manner.