Application of Recursive Partitioning to Derive and Validate a Claims-Based Algorithm for Identifying Keratinocyte Carcinoma (Nonmelanoma Skin Cancer).

PubMed

Chan, An-Wen; Fung, Kinwah; Tran, Jennifer M; Kitchen, Jessica; Austin, Peter C; Weinstock, Martin A; Rochon, Paula A

2016-10-01

Keratinocyte carcinoma (nonmelanoma skin cancer) accounts for substantial burden in terms of high incidence and health care costs but is excluded by most cancer registries in North America. Administrative health insurance claims databases offer an opportunity to identify these cancers using diagnosis and procedural codes submitted for reimbursement purposes. To apply recursive partitioning to derive and validate a claims-based algorithm for identifying keratinocyte carcinoma with high sensitivity and specificity. Retrospective study using population-based administrative databases linked to 602 371 pathology episodes from a community laboratory for adults residing in Ontario, Canada, from January 1, 1992, to December 31, 2009. The final analysis was completed in January 2016. We used recursive partitioning (classification trees) to derive an algorithm based on health insurance claims. The performance of the derived algorithm was compared with 5 prespecified algorithms and validated using an independent academic hospital clinic data set of 2082 patients seen in May and June 2011. Sensitivity, specificity, positive predictive value, and negative predictive value using the histopathological diagnosis as the criterion standard. We aimed to achieve maximal specificity, while maintaining greater than 80% sensitivity. Among 602 371 pathology episodes, 131 562 (21.8%) had a diagnosis of keratinocyte carcinoma. Our final derived algorithm outperformed the 5 simple prespecified algorithms and performed well in both community and hospital data sets in terms of sensitivity (82.6% and 84.9%, respectively), specificity (93.0% and 99.0%, respectively), positive predictive value (76.7% and 69.2%, respectively), and negative predictive value (95.0% and 99.6%, respectively). Algorithm performance did not vary substantially during the 18-year period. This algorithm offers a reliable mechanism for ascertaining keratinocyte carcinoma for epidemiological research in the absence of cancer registry data. Our findings also demonstrate the value of recursive partitioning in deriving valid claims-based algorithms.

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.

43 CFR 3741.1 - Validation of certain mining claims.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Validation of certain mining claims. 3741.1 Section 3741.1 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF... DEVELOPMENT Claims, Locations and Patents § 3741.1 Validation of certain mining claims. The Act in section 1(a...

43 CFR 3741.1 - Validation of certain mining claims.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Validation of certain mining claims. 3741.1 Section 3741.1 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF... DEVELOPMENT Claims, Locations and Patents § 3741.1 Validation of certain mining claims. The Act in section 1(a...

43 CFR 3741.1 - Validation of certain mining claims.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Validation of certain mining claims. 3741.1 Section 3741.1 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF... DEVELOPMENT Claims, Locations and Patents § 3741.1 Validation of certain mining claims. The Act in section 1(a...

43 CFR 3741.1 - Validation of certain mining claims.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Validation of certain mining claims. 3741.1 Section 3741.1 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF... DEVELOPMENT Claims, Locations and Patents § 3741.1 Validation of certain mining claims. The Act in section 1(a...

Commentary on "Validating the Interpretations and Uses of Test Scores"

ERIC Educational Resources Information Center

Brennan, Robert L.

2013-01-01

Kane's paper "Validating the Interpretations and Uses of Test Scores" is the most complete and clearest discussion yet available of the argument-based approach to validation. At its most basic level, validation as formulated by Kane is fundamentally a simply-stated two-step enterprise: (1) specify the claims inherent in a particular interpretation…

A systematic review of validated methods for identifying anaphylaxis, including anaphylactic shock and angioneurotic edema, 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 initially 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 anaphylaxis. PubMed and Iowa Drug Information Service searches were conducted to identify citations applicable to the anaphylaxis health outcome of interest. Level 1 abstract reviews and Level 2 full-text reviews were conducted to find articles using administrative and claims data to identify anaphylaxis and including validation estimates of the coding algorithms. Our search revealed limited literature focusing on anaphylaxis that provided administrative and claims data-based algorithms and validation estimates. Only four studies identified via literature searches provided validated algorithms; however, two additional studies were identified by Mini-Sentinel collaborators and were incorporated. The International Classification of Diseases, Ninth Revision, codes varied, as did the positive predictive value, depending on the cohort characteristics and the specific codes used to identify anaphylaxis. Research needs to be conducted on designing validation studies to test anaphylaxis algorithms and estimating their predictive power, sensitivity, and specificity. Copyright © 2012 John Wiley & Sons, Ltd.

Algorithms to identify colonic ischemia, complications of constipation and irritable bowel syndrome in medical claims data: development and validation.

PubMed

Sands, Bruce E; Duh, Mei-Sheng; Cali, Clorinda; Ajene, Anuli; Bohn, Rhonda L; Miller, David; Cole, J Alexander; Cook, Suzanne F; Walker, Alexander M

2006-01-01

A challenge in the use of insurance claims databases for epidemiologic research is accurate identification and verification of medical conditions. This report describes the development and validation of claims-based algorithms to identify colonic ischemia, hospitalized complications of constipation, and irritable bowel syndrome (IBS). From the research claims databases of a large healthcare company, we selected at random 120 potential cases of IBS and 59 potential cases each of colonic ischemia and hospitalized complications of constipation. We sought the written medical records and were able to abstract 107, 57, and 51 records, respectively. We established a 'true' case status for each subject by applying standard clinical criteria to the available chart data. Comparing the insurance claims histories to the assigned case status, we iteratively developed, tested, and refined claims-based algorithms that would capture the diagnoses obtained from the medical records. We set goals of high specificity for colonic ischemia and hospitalized complications of constipation, and high sensitivity for IBS. The resulting algorithms substantially improved on the accuracy achievable from a naïve acceptance of the diagnostic codes attached to insurance claims. The specificities for colonic ischemia and serious complications of constipation were 87.2 and 92.7%, respectively, and the sensitivity for IBS was 98.9%. U.S. commercial insurance claims data appear to be usable for the study of colonic ischemia, IBS, and serious complications of constipation. (c) 2005 John Wiley & Sons, Ltd.

Assessing the Validity of Discourse Analysis: Transdisciplinary Convergence

ERIC Educational Resources Information Center

Jaipal-Jamani, Kamini

2014-01-01

Research studies using discourse analysis approaches make claims about phenomena or issues based on interpretation of written or spoken text, which includes images and gestures. How are findings/interpretations from discourse analysis validated? This paper proposes transdisciplinary convergence as a way to validate discourse analysis approaches to…

Validation of 2D flood models with insurance claims

NASA Astrophysics Data System (ADS)

Zischg, Andreas Paul; Mosimann, Markus; Bernet, Daniel Benjamin; Röthlisberger, Veronika

2018-02-01

Flood impact modelling requires reliable models for the simulation of flood processes. In recent years, flood inundation models have been remarkably improved and widely used for flood hazard simulation, flood exposure and loss analyses. In this study, we validate a 2D inundation model for the purpose of flood exposure analysis at the river reach scale. We validate the BASEMENT simulation model with insurance claims using conventional validation metrics. The flood model is established on the basis of available topographic data in a high spatial resolution for four test cases. The validation metrics were calculated with two different datasets; a dataset of event documentations reporting flooded areas and a dataset of insurance claims. The model fit relating to insurance claims is in three out of four test cases slightly lower than the model fit computed on the basis of the observed inundation areas. This comparison between two independent validation data sets suggests that validation metrics using insurance claims can be compared to conventional validation data, such as the flooded area. However, a validation on the basis of insurance claims might be more conservative in cases where model errors are more pronounced in areas with a high density of values at risk.

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.

Validation of Diagnostic Groups Based on Health Care Utilization Data Should Adjust for Sampling Strategy.

PubMed

Cadieux, Geneviève; Tamblyn, Robyn; Buckeridge, David L; Dendukuri, Nandini

2017-08-01

Valid measurement of outcomes such as disease prevalence using health care utilization data is fundamental to the implementation of a "learning health system." Definitions of such outcomes can be complex, based on multiple diagnostic codes. The literature on validating such data demonstrates a lack of awareness of the need for a stratified sampling design and corresponding statistical methods. We propose a method for validating the measurement of diagnostic groups that have: (1) different prevalences of diagnostic codes within the group; and (2) low prevalence. We describe an estimation method whereby: (1) low-prevalence diagnostic codes are oversampled, and the positive predictive value (PPV) of the diagnostic group is estimated as a weighted average of the PPV of each diagnostic code; and (2) claims that fall within a low-prevalence diagnostic group are oversampled relative to claims that are not, and bias-adjusted estimators of sensitivity and specificity are generated. We illustrate our proposed method using an example from population health surveillance in which diagnostic groups are applied to physician claims to identify cases of acute respiratory illness. Failure to account for the prevalence of each diagnostic code within a diagnostic group leads to the underestimation of the PPV, because low-prevalence diagnostic codes are more likely to be false positives. Failure to adjust for oversampling of claims that fall within the low-prevalence diagnostic group relative to those that do not leads to the overestimation of sensitivity and underestimation of specificity.

A systematic review of validated methods for identifying erythema multiforme major/minor/not otherwise specified, Stevens-Johnson Syndrome, or toxic epidermal necrolysis 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 (FDA) 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 (HOIs) from administrative and claims data. This paper summarizes the process and findings of the algorithm review of erythema multiforme and related conditions. PubMed and Iowa Drug Information Service searches were conducted to identify citations applicable to the erythema multiforme HOI. Level 1 abstract reviews and Level 2 full-text reviews were conducted to find articles that used administrative and claims data to identify erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis and that included validation estimates of the coding algorithms. Our search revealed limited literature focusing on erythema multiforme and related conditions that provided administrative and claims data-based algorithms and validation estimates. Only four studies provided validated algorithms and all studies used the same International Classification of Diseases code, 695.1. Approximately half of cases subjected to expert review were consistent with erythema multiforme and related conditions. Updated research needs to be conducted on designing validation studies that test algorithms for erythema multiforme and related conditions and that take into account recent changes in the diagnostic coding of these diseases. Copyright © 2012 John Wiley & Sons, Ltd.

Ability Testing for Job Selection: Are the Economic Claims Justified?

ERIC Educational Resources Information Center

Levin, Henry M.

The use of ability testing for job selection has become widespread in the Federal Government and in the U.S. Employment Service, which assists private sector employers. The justification for the practice is based largely on research findings claiming a high level of validity for such tests in predicting job performance. More recently, such claims…

Social Validation Influences Individuals’ Judgments about Ownership

PubMed Central

Casiraghi, Leandro; Faigenbaum, Gustavo; Chehtman, Alejandro; Sigman, Mariano

2018-01-01

In all domains, from informal to formal, there are conflicts about property and ownership which resolution demands consideration of alleged claims from more than one party. In this work we asked adults (N = 359) to judge cases in which a character held a property claim over an item, but is challenged by a second character who holds a different, subsequent claim over it. The specific goal of this work is to investigate how the resolution of such conflicts depends on the social endorsement of ownership claims. To achieve this aim, we designed variations of conflictive situations over property in which we manipulated details regarding the knowledge of the second agent of other third-parties about the first agent’s actions. In essence, our questions were: if an agent claims ownership of something which has a previous property claim on (1) does it matter whether said agent knew of the first’s agent actions or not? And (2) does it matter whether third parties were aware or notified of the first one’s claim? The results confirm that adults resolve the settling of property rights based not only on the nature of ownership claims but also on the social acknowledgment of such claims, in accordance with what is stipulated in legal systems worldwide. Participants considered the second character in the stories to hold a lesser right over the object under dispute when she knew of the first character’s claim. Participants also considered that the first character’s claim was reinforced when there were witnesses for her actions, but not when third parties were merely communicated of such actions. This is the first study to our knowledge that studies how social validation of ownership claims drives adults’ judgments on property claims. PMID:29440998

Social Validation Influences Individuals' Judgments about Ownership.

PubMed

Casiraghi, Leandro; Faigenbaum, Gustavo; Chehtman, Alejandro; Sigman, Mariano

2018-01-01

In all domains, from informal to formal, there are conflicts about property and ownership which resolution demands consideration of alleged claims from more than one party. In this work we asked adults ( N = 359) to judge cases in which a character held a property claim over an item, but is challenged by a second character who holds a different, subsequent claim over it. The specific goal of this work is to investigate how the resolution of such conflicts depends on the social endorsement of ownership claims. To achieve this aim, we designed variations of conflictive situations over property in which we manipulated details regarding the knowledge of the second agent of other third-parties about the first agent's actions. In essence, our questions were: if an agent claims ownership of something which has a previous property claim on (1) does it matter whether said agent knew of the first's agent actions or not? And (2) does it matter whether third parties were aware or notified of the first one's claim? The results confirm that adults resolve the settling of property rights based not only on the nature of ownership claims but also on the social acknowledgment of such claims, in accordance with what is stipulated in legal systems worldwide. Participants considered the second character in the stories to hold a lesser right over the object under dispute when she knew of the first character's claim. Participants also considered that the first character's claim was reinforced when there were witnesses for her actions, but not when third parties were merely communicated of such actions. This is the first study to our knowledge that studies how social validation of ownership claims drives adults' judgments on property claims.

Quantum Fisher information on its own is not a valid measure of the coherence

NASA Astrophysics Data System (ADS)

Kwon, Hyukjoon; Tan, Kok Chuan; Choi, Seongjeon; Jeong, Hyunseok

2018-06-01

We show that contrary to the claim in Feng and Wei (2017), the quantum Fisher information itself is not a valid measure of the coherence based on the resource theory because it can increase via an incoherent operation.

38 CFR 12.23 - Recognition of valid claim against the General Post Fund.

Code of Federal Regulations, 2012 CFR

2012-07-01

... claim against the General Post Fund. 12.23 Section 12.23 Pensions, Bonuses, and Veterans' Relief... claim against the General Post Fund. Effective December 26, 1941, the assets of the estate of a veteran theretofore or thereafter deposited to the General Post Fund are subject to the valid claims of creditors...

38 CFR 12.23 - Recognition of valid claim against the General Post Fund.

Code of Federal Regulations, 2010 CFR

2010-07-01

... claim against the General Post Fund. 12.23 Section 12.23 Pensions, Bonuses, and Veterans' Relief... claim against the General Post Fund. Effective December 26, 1941, the assets of the estate of a veteran theretofore or thereafter deposited to the General Post Fund are subject to the valid claims of creditors...

38 CFR 12.23 - Recognition of valid claim against the General Post Fund.

Code of Federal Regulations, 2011 CFR

2011-07-01

... claim against the General Post Fund. 12.23 Section 12.23 Pensions, Bonuses, and Veterans' Relief... claim against the General Post Fund. Effective December 26, 1941, the assets of the estate of a veteran theretofore or thereafter deposited to the General Post Fund are subject to the valid claims of creditors...

38 CFR 12.23 - Recognition of valid claim against the General Post Fund.

Code of Federal Regulations, 2014 CFR

2014-07-01

... claim against the General Post Fund. 12.23 Section 12.23 Pensions, Bonuses, and Veterans' Relief... claim against the General Post Fund. Effective December 26, 1941, the assets of the estate of a veteran theretofore or thereafter deposited to the General Post Fund are subject to the valid claims of creditors...

38 CFR 12.23 - Recognition of valid claim against the General Post Fund.

Code of Federal Regulations, 2013 CFR

2013-07-01

... claim against the General Post Fund. 12.23 Section 12.23 Pensions, Bonuses, and Veterans' Relief... claim against the General Post Fund. Effective December 26, 1941, the assets of the estate of a veteran theretofore or thereafter deposited to the General Post Fund are subject to the valid claims of creditors...

Development of a claims-based risk score to identify obese individuals.

PubMed

Clark, Jeanne M; Chang, Hsien-Yen; Bolen, Shari D; Shore, Andrew D; Goodwin, Suzanne M; Weiner, Jonathan P

2010-08-01

Obesity is underdiagnosed, hampering system-based health promotion and research. Our objective was to develop and validate a claims-based risk model to identify obese persons using medical diagnosis and prescription records. We conducted a cross-sectional analysis of de-identified claims data from enrollees of 3 Blue Cross Blue Shield plans who completed a health risk assessment capturing height and weight. The final sample of 71,057 enrollees was randomly split into 2 subsamples for development and validation of the obesity risk model. Using the Johns Hopkins Adjusted Clinical Groups case-mix/predictive risk methodology, we categorized study members' diagnosis (ICD) codes. Logistic regression was used to determine which claims-based risk markers were associated with a body mass index (BMI) > or = 35 kg/m(2). The sensitivities of the scores > or =90(th) percentile to detect obesity were 26% to 33%, while the specificities were >90%. The areas under the receiver operator curve ranged from 0.67 to 0.73. In contrast, a diagnosis of obesity or an obesity medication alone had very poor sensitivity (10% and 1%, respectively); the obesity risk model identified an additional 22% of obese members. Varying the percentile cut-point from the 70(th) to the 99(th) percentile resulted in positive predictive values ranging from 15.5 to 59.2. An obesity risk score was highly specific for detecting a BMI > or = 35 kg/m(2) and substantially increased the detection of obese members beyond a provider-coded obesity diagnosis or medication claim. This model could be used for obesity care management and health promotion or for obesity-related research.

Analysis of 23 364 patient-generated, physician-reviewed malpractice claims from a non-tort, blame-free, national patient insurance system: lessons learned from Sweden.

PubMed

Pukk-Härenstam, K; Ask, J; Brommels, M; Thor, J; Penaloza, R V; Gaffney, F A

2009-02-01

In Sweden, patient malpractice claims are handled administratively and compensated if an independent physician review confirms patient injury resulting from medical error. Full access to all malpractice claims and hospital discharge data for the country provided a unique opportunity to assess the validity of patient claims as indicators of medical error and patient injury. To determine: (1) the percentage of patient malpractice claims validated by independent physician review, (2) actual malpractice claims rates (claims frequency / clinical volume) and (3) differences between Swedish and other national malpractice claims rates. DESIGN, SETTING AND MATERIAL: Swedish national malpractice claims and hospital discharge data were combined, and malpractice claims rates were determined by county, hospital, hospital department, surgical procedure, patient age and sex and compared with published studies on medical error and malpractice. From 1997 to 2004, there were 23 364 inpatient malpractice claims filed by Swedish patients treated at hospitals reporting 11 514 798 discharges. The overall claims rate, 0.20%, was stable over the period of study and was similar to that found in other tort and administrative compensation systems. Over this 8-year period, 49.5% (range 47.0-52.6%) of filed claims were judged valid and eligible for compensation. Claims rates varied significantly across hospitals; surgical specialties accounted for 46% of discharges, but 88% of claims. There were also large differences in claims rates for procedures. Patient-generated malpractice claims, as collected in the Swedish malpractice insurance system and adjusted for clinical volumes, have a high validity, as assessed by standardised physician review, and provide unique new information on malpractice risks, preventable medical errors and patient injuries. Systematic collection and analysis of patient-generated quality of care complaints should be encouraged, regardless of the malpractice compensation system in use.

Does Linguistic Analysis Confirm the Validity of Facilitated Communication?

ERIC Educational Resources Information Center

Saloviita, Timo

2018-01-01

Facilitated communication (FC) has been interpreted as an ideomotor phenomenon, in which one person physically supports another person's hand and unconsciously affects the content of the writing. Despite the strong experimental evidence against the authenticity of FC output, several studies claim to support its validity based on idiosyncrasies…

PASSCLAIM - Synthesis and review of existing processes.

PubMed

Richardson, David P; Affertsholt, Tage; Asp, Nils-Georg; Bruce, Ake; Grossklaus, Rolf; Howlett, John; Pannemans, Daphne; Ross, Richard; Verhagen, Hans; Viechtbauer, Volker

2003-03-01

Several approaches to the use of health claims on foods have been made around the world, and the common theme is that any health claim will require scientific validation and substantiation. There is also broad consensus that any regulatory framework should protect the consumer, promote fair trade and encourage innovation in the food industry.This paper is based on a critical evaluation of existing international approaches to the scientific substantiation of health claims, with a view to identifying common new ideas, definitions, best practice and a methodology to underpin current and future developments. There is a clear need to have uniform understanding, terminology and description of types of nutrition and health claims. Two broad categories were defined: Nutrition Claims, i. e. what the product contains, and Health Claims, i. e. relating to health, well-being and/or performance, including well-established nutrient function claims, enhanced function claims and disease risk reduction claims. Such health claims relate to what the food or food components does or do. The categories of health claims are closely and progressively related and are, in practice, part of a continuum. Provision is also made for "generic" or well-established, generally accepted claims and for "innovative" or "product-specific" claims. Special attention was paid to reflect the health-promoting properties of a food or food component in such a way as to facilitate the making of risk reduction claims outside the medical scope of the term prevention. The paper sets out basic principles and guidelines for communication of health claims and principles of nutritional safety. The main body of the work examines the process for the assessment of scientific support for health claims on food and emphasises an evidence-based approach consisting of: Identification of all relevant studies exploring the collection of evidence, data searches, the nature of the scientific evidence, sources of scientific data (including human intervention studies, human observational studies, animal studies and in vitro studies, and the use of biomarkers in human studies. Evaluation of the quality of individual studies to ensure good experimental design and interpretation. Interpretation of the totality of evidence to apply scientific judgement to interpret the weight of evidence as a whole. Assessment of significant scientific agreement on a case-by-case basis to agree within the relevant scientific community that an association between a food or a food component and a health benefit is valid. Annexes include an international comparison of regulatory approaches to health claims, suggestions for the documentation and presentation of evidence, and a procedure for reviewing the evidence.

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.

Commercially marketed supplements for bodybuilding athletes.

PubMed

Grunewald, K K; Bailey, R S

1993-02-01

We conducted a survey of 624 commercially available supplements targeted towards bodybuilding athletes. Over 800 performance claims were made for these supplements. Supplements include amino acids, boron, carnitine, choline, chromium, dibencozide, ferulic acid, gamma oryzanol, medium chain triglycerides, weight gain powders, Smilax compounds and yohimbine. Many performance claims advertised were not supported by published research studies. In some instances, we found no research to validate the claims; in other cases, research findings were extrapolated to inappropriate applications. For example, biological functions of some non-essential compounds were interpreted as performance claims for the supplements. Claims for others were based on their ability to enhance hormonal release or activity. We suggest that more research be conducted on this group of athletes and their nutritional needs. Furthermore, the effectiveness and safety of supplements merit further investigation.

A methodology for collecting valid software engineering data

NASA Technical Reports Server (NTRS)

Basili, Victor R.; Weiss, David M.

1983-01-01

An effective data collection method for evaluating software development methodologies and for studying the software development process is described. The method uses goal-directed data collection to evaluate methodologies with respect to the claims made for them. Such claims are used as a basis for defining the goals of the data collection, establishing a list of questions of interest to be answered by data analysis, defining a set of data categorization schemes, and designing a data collection form. The data to be collected are based on the changes made to the software during development, and are obtained when the changes are made. To insure accuracy of the data, validation is performed concurrently with software development and data collection. Validation is based on interviews with those people supplying the data. Results from using the methodology show that data validation is a necessary part of change data collection. Without it, as much as 50% of the data may be erroneous. Feasibility of the data collection methodology was demonstrated by applying it to five different projects in two different environments. The application showed that the methodology was both feasible and useful.

Do two machine-learning based prognostic signatures for breast cancer capture the same biological processes?

PubMed

Drier, Yotam; Domany, Eytan

2011-03-14

The fact that there is very little if any overlap between the genes of different prognostic signatures for early-discovery breast cancer is well documented. The reasons for this apparent discrepancy have been explained by the limits of simple machine-learning identification and ranking techniques, and the biological relevance and meaning of the prognostic gene lists was questioned. Subsequently, proponents of the prognostic gene lists claimed that different lists do capture similar underlying biological processes and pathways. The present study places under scrutiny the validity of this claim, for two important gene lists that are at the focus of current large-scale validation efforts. We performed careful enrichment analysis, controlling the effects of multiple testing in a manner which takes into account the nested dependent structure of gene ontologies. In contradiction to several previous publications, we find that the only biological process or pathway for which statistically significant concordance can be claimed is cell proliferation, a process whose relevance and prognostic value was well known long before gene expression profiling. We found that the claims reported by others, of wider concordance between the biological processes captured by the two prognostic signatures studied, were found either to be lacking statistical rigor or were in fact based on addressing some other question.

Reliability and validity of electrothermometers and associated thermocouples.

PubMed

Jutte, Lisa S; Knight, Kenneth L; Long, Blaine C

2008-02-01

Examine thermocouple model uncertainty (reliability+validity). First, a 3x3 repeated measures design with independent variables electrothermometers and thermocouple model. Second, a 1x3 repeated measures design with independent variable subprobe. Three electrothermometers, 3 thermocouple models, a multi-sensor probe and a mercury thermometer measured a stable water bath. Temperature and absolute temperature differences between thermocouples and a mercury thermometer. Thermocouple uncertainty was greater than manufactures'claims. For all thermocouple models, validity and reliability were better in the Iso-Themex than the Datalogger, but there were no practical differences between models within an electrothermometers. Validity of multi-sensor probes and thermocouples within a probe were not different but were greater than manufacturers'claims. Reliability of multiprobes and thermocouples within a probe were within manufacturers claims. Thermocouple models vary in reliability and validity. Scientists should test and report the uncertainty of their equipment rather than depending on manufactures' claims.

Statistically Controlling for Confounding Constructs Is Harder than You Think

PubMed Central

Westfall, Jacob; Yarkoni, Tal

2016-01-01

Social scientists often seek to demonstrate that a construct has incremental validity over and above other related constructs. However, these claims are typically supported by measurement-level models that fail to consider the effects of measurement (un)reliability. We use intuitive examples, Monte Carlo simulations, and a novel analytical framework to demonstrate that common strategies for establishing incremental construct validity using multiple regression analysis exhibit extremely high Type I error rates under parameter regimes common in many psychological domains. Counterintuitively, we find that error rates are highest—in some cases approaching 100%—when sample sizes are large and reliability is moderate. Our findings suggest that a potentially large proportion of incremental validity claims made in the literature are spurious. We present a web application (http://jakewestfall.org/ivy/) that readers can use to explore the statistical properties of these and other incremental validity arguments. We conclude by reviewing SEM-based statistical approaches that appropriately control the Type I error rate when attempting to establish incremental validity. PMID:27031707

43 CFR 6305.30 - What are the steps BLM must take in issuing an access authorization to valid occupancies?

Code of Federal Regulations, 2014 CFR

2014-10-01

... issuing an access authorization to mining claims or other valid occupancies wholly surrounded by... permit the reasonable use of the non-Federal land, valid mining claim, or other valid occupancy; and (3) The location, construction, maintenance, and use of the access route that BLM approves will be as...

43 CFR 6305.30 - What are the steps BLM must take in issuing an access authorization to valid occupancies?

Code of Federal Regulations, 2011 CFR

2011-10-01

... issuing an access authorization to mining claims or other valid occupancies wholly surrounded by... permit the reasonable use of the non-Federal land, valid mining claim, or other valid occupancy; and (3) The location, construction, maintenance, and use of the access route that BLM approves will be as...

43 CFR 6305.30 - What are the steps BLM must take in issuing an access authorization to valid occupancies?

Code of Federal Regulations, 2013 CFR

2013-10-01

... issuing an access authorization to mining claims or other valid occupancies wholly surrounded by... permit the reasonable use of the non-Federal land, valid mining claim, or other valid occupancy; and (3) The location, construction, maintenance, and use of the access route that BLM approves will be as...

43 CFR 6305.30 - What are the steps BLM must take in issuing an access authorization to valid occupancies?

Code of Federal Regulations, 2012 CFR

2012-10-01

... issuing an access authorization to mining claims or other valid occupancies wholly surrounded by... permit the reasonable use of the non-Federal land, valid mining claim, or other valid occupancy; and (3) The location, construction, maintenance, and use of the access route that BLM approves will be as...

Providing a Science Base for the Evaluation of Tobacco Products

PubMed Central

Berman, Micah L.; Connolly, Greg; Cummings, K. Michael; Djordjevic, Mirjana V.; Hatsukami, Dorothy K.; Henningfield, Jack E.; Myers, Matthew; O'Connor, Richard J.; Parascandola, Mark; Rees, Vaughan; Rice, Jerry M.

2015-01-01

Objective Evidence-based tobacco regulation requires a comprehensive scientific framework to guide the evaluation of new tobacco products and health-related claims made by product manufacturers. Methods The Tobacco Product Assessment Consortium (TobPRAC) employed an iterative process involving consortia investigators, consultants, a workshop of independent scientists and public health experts, and written reviews in order to develop a conceptual framework for evaluating tobacco products. Results The consortium developed a four-phased framework for the scientific evaluation of tobacco products. The four phases addressed by the framework are: (1) pre-market evaluation, (2) pre-claims evaluation, (3) post-market activities, and (4) monitoring and re-evaluation. For each phase, the framework proposes the use of validated testing procedures that will evaluate potential harms at both the individual and population level. Conclusions While the validation of methods for evaluating tobacco products is an ongoing and necessary process, the proposed framework need not wait for fully validated methods to be used in guiding tobacco product regulation today. PMID:26665160

Using 'big data' to validate claims made in the pharmaceutical approval process.

PubMed

Wasser, Thomas; Haynes, Kevin; Barron, John; Cziraky, Mark

2015-01-01

Big Data in the healthcare setting refers to the storage, assimilation, and analysis of large quantities of information regarding patient care. These data can be collected and stored in a wide variety of ways including electronic medical records collected at the patient bedside, or through medical records that are coded and passed to insurance companies for reimbursement. When these data are processed it is possible to validate claims as a part of the regulatory review process regarding the anticipated performance of medications and devices. In order to analyze properly claims by manufacturers and others, there is a need to express claims in terms that are testable in a timeframe that is useful and meaningful to formulary committees. Claims for the comparative benefits and costs, including budget impact, of products and devices need to be expressed in measurable terms, ideally in the context of submission or validation protocols. Claims should be either consistent with accessible Big Data or able to support observational studies where Big Data identifies target populations. Protocols should identify, in disaggregated terms, key variables that would lead to direct or proxy validation. Once these variables are identified, Big Data can be used to query massive quantities of data in the validation process. Research can be passive or active in nature. Passive, where the data are collected retrospectively; active where the researcher is prospectively looking for indicators of co-morbid conditions, side-effects or adverse events, testing these indicators to determine if claims are within desired ranges set forth by the manufacturer. Additionally, Big Data can be used to assess the effectiveness of therapy through health insurance records. This, for example, could indicate that disease or co-morbid conditions cease to be treated. Understanding the basic strengths and weaknesses of Big Data in the claim validation process provides a glimpse of the value that this research can provide to industry. Big Data can support a research agenda that focuses on the process of claims validation to support formulary submissions as well as inputs to ongoing disease area and therapeutic class reviews.

Annual audits of IDS risk contract settlements improve payment accuracy.

PubMed

Pearce, J W

1999-12-01

Integrated delivery systems (IDSs) should conduct annual audits of payers' settlements under risk contracts to verify that the payer attributed the appropriate amounts of revenue and charged the appropriate claims expenses to the IDS. In particular, IDSs should verify that payers calculated revenues and expenses based on consistent member counts and that the determined commercial revenue was based on the actual premiums paid. IDSs also should determine whether payers have used appropriate demographic factors and countywide rates as a basis for determining Medicare revenue, charged the IDS for claims only for valid members, paid capitated providers the correct capitation amounts, and used appropriate historical data to estimate the amounts of incurred-but-not-reported claims attributed to the IDS.

32 CFR 842.147 - When authorized.

Code of Federal Regulations, 2010 CFR

2010-07-01

... where all of the following exist: (a) The potential claimant could file a valid claim for property damage or personal injury under the Military Claims, Foreign Claims, or National Guard Claims Acts. (b...

Meta-Analysis of Inquiry-Based Instruction Research

NASA Astrophysics Data System (ADS)

Hasanah, N.; Prasetyo, A. P. B.; Rudyatmi, E.

2017-04-01

Inquiry-based instruction in biology has been the focus of educational research conducted by Unnes biology department students in collaboration with their university supervisors. This study aimed to describe the methodological aspects, inquiry teaching methods critically, and to analyse the results claims, of the selected four student research reports, grounded in inquiry, based on the database of Unnes biology department 2014. Four experimental quantitative research of 16 were selected as research objects by purposive sampling technique. Data collected through documentation study was qualitatively analysed regarding methods used, quality of inquiry syntax, and finding claims. Findings showed that the student research was still the lack of relevant aspects of research methodology, namely in appropriate sampling procedures, limited validity tests of all research instruments, and the limited parametric statistic (t-test) not supported previously by data normality tests. Their consistent inquiry syntax supported the four mini-thesis claims that inquiry-based teaching influenced their dependent variables significantly. In other words, the findings indicated that positive claims of the research results were not fully supported by good research methods, and well-defined inquiry procedures implementation.

Claim validity of print advertisements found in otolaryngology journals.

PubMed

Del Signore, Anthony; Murr, Andrew H; Lustig, Lawrence R; Platt, Michael P; Jalisi, Scharukh; Pratt, Loring W; Spiegel, Jeffrey H

2011-08-01

To evaluate the accuracy and scientific evidence supporting product claims made in print advertisements within otolaryngology journals. Cross-sectional survey with literature review and multiple-reviewer evaluation. Fifty claims made within 23 unique advertisements found in prominent otolaryngology journals were selected. References to support the claims were provided within the advertisements or obtained through direct request to the manufacturer. Five academic otolaryngologists with distinct training and geographic practice locations reviewed the claims and supporting evidence. Each physician had substantial experience as an editorial reviewer, and several had specific training in research methodology and scientific methods. Of the 50 claims, only 14 were determined to be based on strong evidence (28%). With regard to the supporting references, 32 references were published sources (76%), while 3 references were package inserts and/or prescribing information (7%). Interobserver agreement among the reviewers overall was poor; however, when 3 or more of the reviewers were in agreement, only 10% of the claims were deemed correct (n = 5). Reviewers also noted that only 6% of the claims were considered well supported (n = 3). Advertisers make claims that appear in respectable journals, but greater than half of the claims reviewed were not supported by the provided reference materials.

Whole grain for whom and why?

PubMed Central

Frølich, Wenche; Åman, Per

2010-01-01

A definition of whole grain is a critical first step in investigating health claims for whole grain and its products. Today, there is no internationally accepted definition of whole grain. Some existing definitions are broad and commodity-based, including grains with similar end uses, while others are more restricted. Scientific knowledge must be the basis for inclusion of certain grains. It is better to start with a restricted list of grains (a precautionary principle) and extend this as more knowledge becomes available. An exact definition of the raw materials (milled, cracked, crushed, rolled, or flaked) and knowledge of the components providing health effects would appear to be crucial issues for the European authorities when approving health claims. It is important that health claims are evidence-based, sustainable, and officially validated. PMID:20300475

A systematic review of validated methods for identifying patients with rheumatoid arthritis using administrative or claims data.

PubMed

Chung, Cecilia P; Rohan, Patricia; Krishnaswami, Shanthi; McPheeters, Melissa L

2013-12-30

To review the evidence supporting the validity of billing, procedural, or diagnosis code, or pharmacy claim-based algorithms used to identify patients with rheumatoid arthritis (RA) in administrative and claim databases. We searched the MEDLINE database from 1991 to September 2012 using controlled vocabulary and key terms related to RA and reference lists of included studies were searched. Two investigators independently assessed the full text of studies against pre-determined inclusion criteria and extracted the data. Data collected included participant and algorithm characteristics. Nine studies reported validation of computer algorithms based on International Classification of Diseases (ICD) codes with or without free-text, medication use, laboratory data and the need for a diagnosis by a rheumatologist. These studies yielded positive predictive values (PPV) ranging from 34 to 97% to identify patients with RA. Higher PPVs were obtained with the use of at least two ICD and/or procedure codes (ICD-9 code 714 and others), the requirement of a prescription of a medication used to treat RA, or requirement of participation of a rheumatologist in patient care. For example, the PPV increased from 66 to 97% when the use of disease-modifying antirheumatic drugs and the presence of a positive rheumatoid factor were required. There have been substantial efforts to propose and validate algorithms to identify patients with RA in automated databases. Algorithms that include more than one code and incorporate medications or laboratory data and/or required a diagnosis by a rheumatologist may increase the PPV. Copyright © 2013 Elsevier Ltd. All rights reserved.

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

Comparing the validity of different sources of information on emergency department visits: a latent class analysis.

PubMed

Dendukuri, Nandini; McCusker, Jane; Bellavance, François; Cardin, Sylvie; Verdon, Josée; Karp, Igor; Belzile, Eric

2005-03-01

Emergency department (ED) use in Quebec may be measured from varied sources, eg, patient's self-reports, hospital medical charts, and provincial health insurance claims databases. Determining the relative validity of each source is complicated because none is a gold standard. We sought to compare the validity of different measures of ED use without arbitrarily assuming one is perfect. Data were obtained from a nursing liaison intervention study for frail seniors visiting EDs at 4 university-affiliated hospitals in Montreal. The number of ED visits during 2 consecutive follow-up periods of 1 and 4 months after baseline was obtained from patient interviews, from medical charts of participating hospitals, and from the provincial health insurance claims database. Latent class analysis was used to estimate the validity of each source. The impact of the following covariates on validity was evaluated: hospital visited, patient's demographic/clinical characteristics, risk of functional decline, nursing liaison intervention, duration of recall, previous ED use, and previous hospitalization. The patient's self-report was found to be the least accurate (sensitivity: 70%, specificity: 88%). Claims databases had the greatest validity, especially after defining claims made on consecutive days as part of the same ED visit (sensitivity: 98%, specificity: 98%). The validity of the medical chart was intermediate. Lower sensitivity (or under-reporting) on the self-report appeared to be associated with higher age, low comorbidity and shorter length of recall. The claims database is the most valid method of measuring ED use among seniors in Quebec compared with hospital medical charts and patient-reported use.

Facet Theory and the Mapping Sentence As Hermeneutically Consistent Structured Meta-Ontology and Structured Meta-Mereology

PubMed Central

Hackett, Paul M. W.

2016-01-01

When behavior is interpreted in a reliable manner (i.e., robustly across different situations and times) its explained meaning may be seen to possess hermeneutic consistency. In this essay I present an evaluation of the hermeneutic consistency that I propose may be present when the research tool known as the mapping sentence is used to create generic structural ontologies. I also claim that theoretical and empirical validity is a likely result of employing the mapping sentence in research design and interpretation. These claims are non-contentious within the realm of quantitative psychological and behavioral research. However, I extend the scope of both facet theory based research and claims for its structural utility, reliability and validity to philosophical and qualitative investigations. I assert that the hermeneutic consistency of a structural ontology is a product of a structural representation's ontological components and the mereological relationships between these ontological sub-units: the mapping sentence seminally allows for the depiction of such structure. PMID:27065932

FDA regulation of labeling and promotional claims in therapeutic color vision devices: a tutorial.

PubMed

Drum, Bruce

2004-01-01

The Food and Drug Administration (FDA) is responsible for determining whether medical device manufacturers have provided reasonable assurance, based on valid scientific evidence, that new devices are safe and effective for their intended use before they are introduced into the U.S. market. Most existing color vision devices pose so little risk that their manufacturers are not required to submit a premarket notification [510(k)] to FDA prior to market. However, even low-risk devices may not be acceptable if they are marketed on the basis of misleading or excessive claims. Although most color vision devices are diagnostic, two types that are therapeutic rather than diagnostic are colored lenses intended to improve deficient color vision and colored lenses intended to improve reading performance. Both of these devices have presented special regulatory challenges to FDA because the intended uses and effectiveness claims initially proposed by the manufacturers were not supported by valid scientific evidence. In each instance, however, FDA worked with the manufacturer to restrict labeling and promotional claims in ways that were consistent with the available device performance data and that allowed for the legal marketing of the device.

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.

Are the claims made in orthopaedic print advertisements valid?

PubMed

Davidson, Donald J; Rankin, Kenneth S; Jensen, Cyrus D; Moverley, Robert; Reed, Mike R; Sprowson, Andrew P

2014-05-01

Advertisements are commonplace in orthopaedic journals and may influence the readership with claims of clinical and scientific fact. Since the last assessment of the claims made in orthopaedic print advertisements ten years ago, there have been legislative changes and media scrutiny which have shaped this practice. The purpose of this study is to re-evaluate these claims. Fifty claims from 50 advertisements were chosen randomly from six highly respected peer-reviewed orthopaedic journals (published July-December 2011). The evidence supporting each claim was assessed and validated by three orthopaedic surgeons. The assessors, blinded to product and company, rated the evidence and answered the following questions: Does the evidence as presented support the claim made in the advertisement and what is the quality of that evidence? Is the claim supported by enough evidence to influence your own clinical practice? Twenty-eight claims cited evidence from published literature, four from public presentations, 11 from manufacturer "data held on file" and seven had no supporting evidence. Only 12 claims were considered to have high-quality evidence and only 11 were considered well supported. A strong correlation was seen between the quality of evidence and strength of support (Spearman r = 0.945, p < 0.0001). The average ICC between the assessors' ratings was strong (r = 0.85) giving validity to the results. Orthopaedic surgeons must remain sceptical about the claims made in print advertisements. High-quality evidence is required by orthopaedic surgeons to influence clinical practice and this evidence should be sought by manufacturers wishing to market a successful product.

Can Medicaid Claims Validly Ascertain Foster Care Status?

PubMed

Raghavan, Ramesh; Brown, Derek S; Allaire, Benjamin T

2017-08-01

Medicaid claims have been used to identify populations of children in foster care in the current literature; however, the ability of such an approach to validly ascertain a foster care population is unknown. This study linked children in the National Survey of Child and Adolescent Well-Being-I to their Medicaid claims from 36 states using their Social Security numbers. Using this match, we examined discordance between caregiver report of foster care placement and the foster care eligibility code contained in the child's Medicaid claims. Only 73% of youth placed in foster care for at least a year displayed a Medicaid code for foster care eligibility. Half of all youth coming into contact with child welfare displayed discordance between caregiver report and Medicaid claims. Children with emergency department utilization, and those in primary care case management health insurance arrangements, had the highest odds of accurate ascertainment. The use of Medicaid claims to identify a cohort of children in foster care results in high rates of underascertainment. Supplementing administrative data with survey data is one way to enhance validity of ascertainment.

A risk-model for hospital mortality among patients with severe sepsis or septic shock based on German national administrative claims data

PubMed Central

Fleischmann-Struzek, Carolin; Rüddel, Hendrik; Reinhart, Konrad; Thomas-Rüddel, Daniel O.

2018-01-01

Background Sepsis is a major cause of preventable deaths in hospitals. Feasible and valid methods for comparing quality of sepsis care between hospitals are needed. The aim of this study was to develop a risk-adjustment model suitable for comparing sepsis-related mortality between German hospitals. Methods We developed a risk-model using national German claims data. Since these data are available with a time-lag of 1.5 years only, the stability of the model across time was investigated. The model was derived from inpatient cases with severe sepsis or septic shock treated in 2013 using logistic regression with backward selection and generalized estimating equations to correct for clustering. It was validated among cases treated in 2015. Finally, the model development was repeated in 2015. To investigate secular changes, the risk-adjusted trajectory of mortality across the years 2010–2015 was analyzed. Results The 2013 deviation sample consisted of 113,750 cases; the 2015 validation sample consisted of 134,851 cases. The model developed in 2013 showed good validity regarding discrimination (AUC = 0.74), calibration (observed mortality in 1st and 10th risk-decile: 11%-78%), and fit (R2 = 0.16). Validity remained stable when the model was applied to 2015 (AUC = 0.74, 1st and 10th risk-decile: 10%-77%, R2 = 0.17). There was no indication of overfitting of the model. The final model developed in year 2015 contained 40 risk-factors. Between 2010 and 2015 hospital mortality in sepsis decreased from 48% to 42%. Adjusted for risk-factors the trajectory of decrease was still significant. Conclusions The risk-model shows good predictive validity and stability across time. The model is suitable to be used as an external algorithm for comparing risk-adjusted sepsis mortality among German hospitals or regions based on administrative claims data, but secular changes need to be taken into account when interpreting risk-adjusted mortality. PMID:29558486

A risk-model for hospital mortality among patients with severe sepsis or septic shock based on German national administrative claims data.

PubMed

Schwarzkopf, Daniel; Fleischmann-Struzek, Carolin; Rüddel, Hendrik; Reinhart, Konrad; Thomas-Rüddel, Daniel O

2018-01-01

Sepsis is a major cause of preventable deaths in hospitals. Feasible and valid methods for comparing quality of sepsis care between hospitals are needed. The aim of this study was to develop a risk-adjustment model suitable for comparing sepsis-related mortality between German hospitals. We developed a risk-model using national German claims data. Since these data are available with a time-lag of 1.5 years only, the stability of the model across time was investigated. The model was derived from inpatient cases with severe sepsis or septic shock treated in 2013 using logistic regression with backward selection and generalized estimating equations to correct for clustering. It was validated among cases treated in 2015. Finally, the model development was repeated in 2015. To investigate secular changes, the risk-adjusted trajectory of mortality across the years 2010-2015 was analyzed. The 2013 deviation sample consisted of 113,750 cases; the 2015 validation sample consisted of 134,851 cases. The model developed in 2013 showed good validity regarding discrimination (AUC = 0.74), calibration (observed mortality in 1st and 10th risk-decile: 11%-78%), and fit (R2 = 0.16). Validity remained stable when the model was applied to 2015 (AUC = 0.74, 1st and 10th risk-decile: 10%-77%, R2 = 0.17). There was no indication of overfitting of the model. The final model developed in year 2015 contained 40 risk-factors. Between 2010 and 2015 hospital mortality in sepsis decreased from 48% to 42%. Adjusted for risk-factors the trajectory of decrease was still significant. The risk-model shows good predictive validity and stability across time. The model is suitable to be used as an external algorithm for comparing risk-adjusted sepsis mortality among German hospitals or regions based on administrative claims data, but secular changes need to be taken into account when interpreting risk-adjusted mortality.

All Validity Is Construct Validity. Or Is It?

ERIC Educational Resources Information Center

Kane, Michael

2012-01-01

Paul E. Newton's article on the consensus definition of validity tackles a number of big issues and makes a number of strong claims. I agreed with much of what he said, and I disagreed with a number of his claims, but I found his article to be consistently interesting and thought provoking (whether I agreed or not). I will focus on three general…

Using Appendicitis to Improve Estimates of Childhood Medicaid Participation Rates.

PubMed

Silber, Jeffrey H; Zeigler, Ashley E; Reiter, Joseph G; Hochman, Lauren L; Ludwig, Justin M; Wang, Wei; Calhoun, Shawna R; Pati, Susmita

2018-03-23

Administrative data are often used to estimate state Medicaid/Children's Health Insurance Program duration of enrollment and insurance continuity, but they are generally not used to estimate participation (the fraction of eligible children enrolled) because administrative data do not include reasons for disenrollment and cannot observe eligible never-enrolled children, causing estimates of eligible unenrolled to be inaccurate. Analysts are therefore forced to either utilize survey information that is not generally linkable to administrative claims or rely on duration and continuity measures derived from administrative data and forgo estimating claims-based participation. We introduce appendectomy-based participation (ABP) to estimate statewide participation rates using claims by taking advantage of a natural experiment around statewide appendicitis admissions to improve the accuracy of participation rate estimates. We used Medicaid Analytic eXtract (MAX) for 2008-2010; and the American Community Survey for 2008-2010 from 43 states to calculate ABP, continuity ratio, duration, and participation based on the American Community Survey (ACS). In the validation study, median participation rate using ABP was 86% versus 87% for ACS-based participation estimates using logical edits and 84% without logical edits. Correlations between ABP and ACS with or without logical edits was 0.86 (P < .0001). Using regression analysis, ABP alone was a significant predictor of ACS (P < .0001) with or without logical edits, and adding duration and/or the continuity ratio did not significantly improve the model. Using the ABP rate derived from administrative claims (MAX) is a valid method to estimate statewide public insurance participation rates in children. Copyright © 2018 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

Does the Test Work? Evaluating a Web-Based Language Placement Test

ERIC Educational Resources Information Center

Long, Avizia Y.; Shin, Sun-Young; Geeslin, Kimberly; Willis, Erik W.

2018-01-01

In response to the need for examples of test validation from which everyday language programs can benefit, this paper reports on a study that used Bachman's (2005) assessment use argument (AUA) framework to examine evidence to support claims made about the intended interpretations and uses of scores based on a new web-based Spanish language…

[Health and nutrition claims made on food: what future?].

PubMed

Laplace, Jean-Paul

2006-11-01

The number of foods bearing health and nutrition claims is growing in line with consumers' expectations. This market offers attractive prospects of profit for industry and commerce. The question is whether such foods really have health effects, and whether the general population or specific groups really benefit from their use. Specific regulations are needed to define the conditions of validation, communication and follow-up of such claims. The European Community's internal market is currently governed by a fragmented set of regulations and enforcement systems. Member states' national regulations differ in substance and application. For these reasons, the European Commission is seeking to create and adopt a common regulation. The following article considers the main stakes relating to consumers' health expectations, public health, and industrial and commercial interests, together with the origins of the concept of "functional foods". In contrast to the 'product based' approach in other cultures (Japan, North America, etc.), Europe has chosen a 'science based' approach focusing on physiological functions. In particular, Europe funded the FUFOSE program (Functional Food Science in Europe) coordinated by ILSI (International Life Science Institute). The bases of true functional food science are considered--how to identify beneficial interactions between food components and specific body functions, and to understand the underlying mechanisms in order to construct hypotheses for testing on volunteers. A methodology based on biological markers has been developed Europe then funded the PASSCLAIM program (Process for the assessment of scientific support for claims on foods) aimed at identifying relationships between a functional effect (normal or enhanced function) and a health benefit or a reduced risk of disease. Selected aspects of these 10-year programs illustrate the scientific bases for a European regulation of nutrition claims and so-called health claims (improved function and reduced risk of disease). The main points of the proposal are summarized The most important questions are the need for prior authorization of health claims, and the possible banning of any claim on some foods, due to their bad "nutritional profile". This implies that such claims will have to be firmly grounded in science. However, these restraints were contested by the European Parliament, which preferred a simple notification procedure and suppressed the reference to "nutritional profiling" for identifying good and bad foods. These recent political episodes reflect the lobbying aimed at preserving innovation and development, mainly by small companies that are unable to support the cost of heavy research files. In addition, there is no scientific agreement on how to determine the nutritional profile of a given food. However, the Council of Europe restored the initial text, which will again be examined by the European Parliament in the coming months. The author emphasizes the fine line that must be drawn between scientific accuracy and regulatory rigidity when validating nutrition claims, which consumers are only too willing to accept at face value.

Validation of a New Risk Measure for Chronic Obstructive Pulmonary Disease Exacerbation Using Health Insurance Claims Data.

PubMed

Stanford, Richard H; Nag, Arpita; Mapel, Douglas W; Lee, Todd A; Rosiello, Richard; Vekeman, Francis; Gauthier-Loiselle, Marjolaine; Duh, Mei Sheng; Merrigan, J F Philip; Schatz, Michael

2016-07-01

Current chronic obstructive pulmonary disease (COPD) exacerbation risk prediction models are based on clinical data not easily accessible to national quality-of-care organizations and payers. Models developed from data sources available to these organizations are needed. This study aimed to validate a risk measure constructed using pharmacy claims in patients with COPD. Administrative claims data were used to construct a risk model to test and validate the ratio of controller (maintenance) medications to total COPD medications (CTR) as an independent risk measure for COPD exacerbations. The ability of the CTR to predict the risk of COPD exacerbations was also assessed. This was a retrospective study using health insurance claims data from the Truven MarketScan database (2006-2011), whereby exacerbation risk factors of patients with COPD were observed over a 12-month period and exacerbations monitored in the following year. Exacerbations were defined as moderate (emergency department or outpatient treatment with oral corticosteroid dispensings within 7 d) or severe (hospital admission) on the basis of diagnosis codes. Models were developed and validated using split-sample data from the MarketScan database and further validated using the Reliant Medical Group database. The performance of prediction models was evaluated using C-statistics. A total of 258,668 patients with COPD from the MarketScan database were included. A CTR of greater than or equal to 0.3 was significantly associated with a reduced risk for any (adjusted odds ratio [OR], 0.91; 95% confidence interval [CI], 0.85-0.97); moderate (OR, 0.93; 95% CI, 0.87-1.00), or severe (OR, 0.87; 95% CI, 0.80-0.95) exacerbation. The CTR, at a ratio of greater than or equal to 0.3, was predictive in various subpopulations, including those without a history of asthma and those with or without a history of moderate/severe exacerbations. The C-statistics ranged from 0.750 to 0.761 for the development set and 0.714 to 0.761 in the validation sets, indicating the CTR performed well in predicting exacerbation risk. The ratio of controller to total medications dispensed for COPD is a measure that can easily be calculated using only pharmacy claims data. A CTR of greater than or equal to 0.3 can potentially be used as a quality-of-care measurement for prevention of exacerbations.

Would a madman have been so wise as this?" The effects of source credibility and message credibility on validation.

PubMed

Foy, Jeffrey E; LoCasto, Paul C; Briner, Stephen W; Dyar, Samantha

2017-02-01

Readers rapidly check new information against prior knowledge during validation, but research is inconsistent as to whether source credibility affects validation. We argue that readers are likely to accept highly plausible assertions regardless of source, but that high source credibility may boost acceptance of claims that are less plausible based on general world knowledge. In Experiment 1, participants read narratives with assertions for which the plausibility varied depending on the source. For high credibility sources, we found that readers were faster to read information confirming these assertions relative to contradictory information. We found the opposite patterns for low credibility characters. In Experiment 2, readers read claims from the same high or low credibility sources, but the claims were always plausible based on general world knowledge. Readers consistently took longer to read contradictory information, regardless of source. In Experiment 3, participants read modified versions of "The Tell-Tale Heart," which was narrated entirely by an unreliable source. We manipulated the plausibility of a target event, as well as whether high credibility characters within the story provided confirmatory or contradictory information about the narrator's description of the target event. Though readers rated the narrator as being insane, they were more likely to believe the narrator's assertions about the target event when it was plausible and corroborated by other characters. We argue that sourcing research would benefit from focusing on the relationship between source credibility, message credibility, and multiple sources within a text.

40 CFR 610.25 - Evaluation of test data.

Code of Federal Regulations, 2012 CFR

2012-07-01

... base; (d) Definition of claims which can be made based on the available data; and (e) Substantiation of... 40 Protection of Environment 31 2012-07-01 2012-07-01 false Evaluation of test data. 610.25... Analysis § 610.25 Evaluation of test data. Valid manufacturer-furnished test data will be evaluated with...

40 CFR 610.25 - Evaluation of test data.

Code of Federal Regulations, 2010 CFR

2010-07-01

... base; (d) Definition of claims which can be made based on the available data; and (e) Substantiation of... 40 Protection of Environment 29 2010-07-01 2010-07-01 false Evaluation of test data. 610.25... Analysis § 610.25 Evaluation of test data. Valid manufacturer-furnished test data will be evaluated with...

40 CFR 610.25 - Evaluation of test data.

Code of Federal Regulations, 2013 CFR

2013-07-01

... base; (d) Definition of claims which can be made based on the available data; and (e) Substantiation of... 40 Protection of Environment 31 2013-07-01 2013-07-01 false Evaluation of test data. 610.25... Analysis § 610.25 Evaluation of test data. Valid manufacturer-furnished test data will be evaluated with...

40 CFR 610.25 - Evaluation of test data.

Code of Federal Regulations, 2014 CFR

2014-07-01

... base; (d) Definition of claims which can be made based on the available data; and (e) Substantiation of... 40 Protection of Environment 30 2014-07-01 2014-07-01 false Evaluation of test data. 610.25... Analysis § 610.25 Evaluation of test data. Valid manufacturer-furnished test data will be evaluated with...

40 CFR 610.25 - Evaluation of test data.

Code of Federal Regulations, 2011 CFR

2011-07-01

... base; (d) Definition of claims which can be made based on the available data; and (e) Substantiation of... 40 Protection of Environment 30 2011-07-01 2011-07-01 false Evaluation of test data. 610.25... Analysis § 610.25 Evaluation of test data. Valid manufacturer-furnished test data will be evaluated with...

The Suitability of the International Certificate of Christian Education as an Examination for University Entrance

ERIC Educational Resources Information Center

Scaramanga, Jonny; Reiss, Michael J.

2017-01-01

Increasing numbers of students are applying to university with the International Certificate of Christian Education (ICCE), an alternative to mainstream qualifications based on a biblically-based, individualised curriculum called Accelerated Christian Education (ACE). No formal validity arguments exist for the ICCE, but it claims to prepare…

43 CFR 2623.2 - Claims protected.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Claims protected. 2623.2 Section 2623.2... Extended To Include Mineral Sections § 2623.2 Claims protected. (a) Valid applications, claims, or rights protected by the provisions of subsection (c) of section 1 of the Act of January 25, 1927, include...

43 CFR 2623.2 - Claims protected.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Claims protected. 2623.2 Section 2623.2... Extended To Include Mineral Sections § 2623.2 Claims protected. (a) Valid applications, claims, or rights protected by the provisions of subsection (c) of section 1 of the Act of January 25, 1927, include...

43 CFR 2623.2 - Claims protected.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Claims protected. 2623.2 Section 2623.2... Extended To Include Mineral Sections § 2623.2 Claims protected. (a) Valid applications, claims, or rights protected by the provisions of subsection (c) of section 1 of the Act of January 25, 1927, include...

43 CFR 2623.2 - Claims protected.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Claims protected. 2623.2 Section 2623.2... Extended To Include Mineral Sections § 2623.2 Claims protected. (a) Valid applications, claims, or rights protected by the provisions of subsection (c) of section 1 of the Act of January 25, 1927, include...

Consumer perceptions of graded, graphic and text label presentations for qualified health claims.

PubMed

Kapsak, Wendy Reinhardt; Schmidt, David; Childs, Nancy M; Meunier, John; White, Christy

2008-03-01

On December 18, 2002, the Food and Drug Administration (FDA) announced the Consumer Health Information for Better Nutrition Initiative. The initiative's goal is to make available more and better information about conventional foods and dietary supplements to help Americans improve their health and reduce risk of disease by making sound dietary decisions. It included a rating system to assess the "weight of the publicly available evidence." It assigns one of four ranked levels to the claim thus resulting in qualified health claims. Two phases of research were conducted by the International Food Information Council (IFIC) Foundation. Qualitative research to assess consumer understanding, vocabulary, and familiarity with claims helped with the design and orientation of the second quantitative research phase. The quantitative phase employed a Web-based survey. The claim formats included: report card graphic, report card text, embedded claim text, point-counterpoint, structure/function claim, and nutrient content claim. Respondents were asked to rate the product for perceived strength of scientific evidence provided to support the claim, and questions about the product's perceived healthfulness, quality, safety, and purchase intent. Consumers found it difficult to discriminate across four levels and showed inclination to project the scientific validity grade onto other product attributes. Consumers showed preference for simpler messages.

20 CFR 670.905 - Are damages that occur to private parties at Job Corps Centers eligible for reimbursement under...

Code of Federal Regulations, 2010 CFR

2010-04-01

... Job Corps Centers eligible for reimbursement under the Tort Claims Act? 670.905 Section 670.905... occur to private parties at Job Corps Centers eligible for reimbursement under the Tort Claims Act? (a... determine if the claim is valid under the Tort Claims Act. If the Regional Solicitor determines a claim is...

[Drug-promoting advertisements in the Dutch Journal of Medicine and Pharmaceutical Weekly: not always evidence based].

PubMed

van Eeden, Annelies E; Roach, Rachel E J; Halbesma, Nynke; Dekker, Friedo W

2012-01-01

To determine and compare the foundation of claims in drug-promoting advertisements in a Dutch journal for physicians and a Dutch journal for pharmacists. A cross-sectional study. We included all the drug-promoting advertisements referring to a randomized controlled trial (RCT) we could find on Medline from 2 volumes of the Dutch Journal of Medicine (Nederlands Tijdschrift voor Geneeskunde; NTvG) and the (also Dutch) Pharmaceutical Weekly (Pharmaceutisch Weekblad; PW). The validity of the advertisements (n = 54) and the methodological quality of the referenced RCTs (n = 150) were independently scored by 250 medical students using 2 standardised questionnaires. The advertisements' sources were concealed from the students. Per journal, the percentage of drug-promoting advertisements having a valid claim and the percentage of high-quality RCT references were determined. Average scores on quality and validity were compared between the 2 journals. On a scale of 0-18 points, the mean quality scores of the RCTs differed 0.3 (95% CI: -0.1-0.7) between the NTvG (score: 14.8; SD: 2.2) and the PW (score: 14.5; SD: 2.6). The difference between the validity scores of drug-promoting advertisements in the NTvG (score: 5.8; SD: 3.3) and the PW (score: 5.6; SD: 3.6) was 0.3 (95% CI: -0.3-0.9) on a scale of 0-10 points. For both journals, an average of 15% of drug-promoting advertisements was valid (defined as a validity score of > 8 points); 35% of the RCTs referred to was of good methodological quality (defined as a quality score of > 16 points). The substantiation of many claims in drug-promoting advertisements in the NTvG and the PW was mediocre. There was no difference between the 2 journals.

21 CFR 314.3 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... studies (including proposals for such studies), assay validation data, final release testing on the last... route of administration; (4) Make a comparative efficacy claim naming another drug product; (5... based on at least one adequate and well-controlled clinical study. FDA means the Food and Drug...

21 CFR 314.3 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... studies (including proposals for such studies), assay validation data, final release testing on the last... route of administration; (4) Make a comparative efficacy claim naming another drug product; (5... based on at least one adequate and well-controlled clinical study. FDA means the Food and Drug...

21 CFR 314.3 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... studies (including proposals for such studies), assay validation data, final release testing on the last... route of administration; (4) Make a comparative efficacy claim naming another drug product; (5... based on at least one adequate and well-controlled clinical study. FDA means the Food and Drug...

21 CFR 314.3 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... studies (including proposals for such studies), assay validation data, final release testing on the last... route of administration; (4) Make a comparative efficacy claim naming another drug product; (5... based on at least one adequate and well-controlled clinical study. FDA means the Food and Drug...

21 CFR 314.3 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... studies (including proposals for such studies), assay validation data, final release testing on the last... route of administration; (4) Make a comparative efficacy claim naming another drug product; (5... based on at least one adequate and well-controlled clinical study. FDA means the Food and Drug...

An external validation study reporting poor correlation between the claims-based index for rheumatoid arthritis severity and the disease activity score.

PubMed

Desai, Rishi J; Solomon, Daniel H; Weinblatt, Michael E; Shadick, Nancy; Kim, Seoyoung C

2015-04-13

We conducted an external validation study to examine the correlation of a previously published claims-based index for rheumatoid arthritis severity (CIRAS) with disease activity score in 28 joints calculated by using C-reactive protein (DAS28-CRP) and the multi-dimensional health assessment questionnaire (MD-HAQ) physical function score. Patients enrolled in the Brigham and Women's Hospital Rheumatoid Arthritis Sequential Study (BRASS) and Medicare were identified and their data from these two sources were linked. For each patient, DAS28-CRP measurement and MD-HAQ physical function scores were extracted from BRASS, and CIRAS was calculated from Medicare claims for the period of 365 days prior to the DAS28-CRP measurement. Pearson correlation coefficient between CIRAS and DAS28-CRP as well as MD-HAQ physical function scores were calculated. Furthermore, we considered several additional pharmacy and medical claims-derived variables as predictors for DAS28-CRP in a multivariable linear regression model in order to assess improvement in the performance of the original CIRAS algorithm. In total, 315 patients with enrollment in both BRASS and Medicare were included in this study. The majority (81%) of the cohort was female, and the mean age was 70 years. The correlation between CIRAS and DAS28-CRP was low (Pearson correlation coefficient = 0.07, P = 0.24). The correlation between the calculated CIRAS and MD-HAQ physical function scores was also found to be low (Pearson correlation coefficient = 0.08, P = 0.17). The linear regression model containing additional claims-derived variables yielded model R(2) of 0.23, suggesting limited ability of this model to explain variation in DAS28-CRP. In a cohort of Medicare-enrolled patients with established RA, CIRAS showed low correlation with DAS28-CRP as well as MD-HAQ physical function scores. Claims-based algorithms for disease activity should be rigorously tested in distinct populations in order to establish their generalizability before widespread adoption.

Assessing the validity of discourse analysis: transdisciplinary convergence

NASA Astrophysics Data System (ADS)

Jaipal-Jamani, Kamini

2014-12-01

Research studies using discourse analysis approaches make claims about phenomena or issues based on interpretation of written or spoken text, which includes images and gestures. How are findings/interpretations from discourse analysis validated? This paper proposes transdisciplinary convergence as a way to validate discourse analysis approaches to research. The argument is made that discourse analysis explicitly grounded in semiotics, systemic functional linguistics, and critical theory, offers a credible research methodology. The underlying assumptions, constructs, and techniques of analysis of these three theoretical disciplines can be drawn on to show convergence of data at multiple levels, validating interpretations from text analysis.

Development and Validation of a Combined Methodology for Assessing the Total Quality Control of Herbal Medicinal Products – Application to Oleuropein Preparations

PubMed Central

Lemonakis, Nikolaos; Gikas, Evagelos; Halabalaki, Maria; Skaltsounis, Alexios-Leandros

2013-01-01

Oleuropein (OE) is a secoiridoid glycoside, which occurs mostly in the Oleaceae family presenting several pharmacological properties, including antioxidant, cardio-protective, anti-atherogenic effects etc. Based on these findings OE is commercially available, as Herbal Medicinal Product (HMP), claimed for its antioxidant effects. As there are general provisions of the medicine regulating bodies e.g. European Medicines Agency, the quality of the HMP’s must always be demonstrated. Therefore, a novel LC-MS methodology was developed and validated for the simultaneous quantification of OE and its main degradation product, hydroxytyrosol (HT), for the relevant OE claimed HMP’s. The internal standard (IS) methodology was employed and separation of OE, HT and IS was achieved on a C18 Fused Core column with 3.1 min overall run time employing the SIM method for the analytical signal acquisition. The method was validated according to the International Conference on Harmonisation requirements and the results show adequate linearity (r2 > 0.99) over a wide concentration range [0.1–15 μg/mL (n=12)] and a LLOQ value of 0.1 μg/mL, for both OE and HT. Furthermore, as it would be beneficial to control the quality taking into account all the substances of the OE claimed HMP’s; a metabolomics-like approach has been developed and applied for the total quality control of the different preparations employing UHPLC-HRMS-multivariate analysis (MVA). Four OE-claimed commercial HMP’s have been randomly selected and MVA similarity-based measurements were performed. The results showed that the examined samples could also be differentiated as evidenced according to their scores plot. Batch to batch reproducibility between the samples of the same brand has also been determined and found to be acceptable. Overall, the developed combined methodology has been found to be an efficient tool for the monitoring of the HMP’s total quality. Only one OE HMP has been found to be consistent to its label claim. PMID:24205178

The role of insurance claims databases in drug therapy outcomes research.

PubMed

Lewis, N J; Patwell, J T; Briesacher, B A

1993-11-01

The use of insurance claims databases in drug therapy outcomes research holds great promise as a cost-effective alternative to post-marketing clinical trials. Claims databases uniquely capture information about episodes of care across healthcare services and settings. They also facilitate the examination of drug therapy effects on cohorts of patients and specific patient subpopulations. However, there are limitations to the use of insurance claims databases including incomplete diagnostic and provider identification data. The characteristics of the population included in the insurance plan, the plan benefit design, and the variables of the database itself can influence the research results. Given the current concerns regarding the completeness of insurance claims databases, and the validity of their data, outcomes research usually requires original data to validate claims data or to obtain additional information. Improvements to claims databases such as standardisation of claims information reporting, addition of pertinent clinical and economic variables, and inclusion of information relative to patient severity of illness, quality of life, and satisfaction with provided care will enhance the benefit of such databases for outcomes research.

20 CFR 404.2121 - Validation reviews.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) General. We will conduct a validation review of a sample of the claims for payment filed by each State VR... by any State VR agency or alternate participant, if we determine that such review is necessary to ensure compliance with the requirements of this subpart. For each claim selected for review, the State VR...

20 CFR 404.2121 - Validation reviews.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) General. We will conduct a validation review of a sample of the claims for payment filed by each State VR... by any State VR agency or alternate participant, if we determine that such review is necessary to ensure compliance with the requirements of this subpart. For each claim selected for review, the State VR...

An Examination of Reliability and Validity Claims of a Foreign Language Proficiency Test

ERIC Educational Resources Information Center

Mircea-Pines, Walter J.

2009-01-01

This dissertation study examined the reliability and validity claims of a modified version of the Spanish Modern Language Association Foreign Language Proficiency Test for Teachers and Advanced Students administered at George Mason University (GMU). The study used the 1999 computerized GMU version that was administered to 277 test-takers via…

20 CFR 404.2121 - Validation reviews.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) General. We will conduct a validation review of a sample of the claims for payment filed by each State VR... by any State VR agency or alternate participant, if we determine that such review is necessary to ensure compliance with the requirements of this subpart. For each claim selected for review, the State VR...

20 CFR 404.2121 - Validation reviews.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) General. We will conduct a validation review of a sample of the claims for payment filed by each State VR... by any State VR agency or alternate participant, if we determine that such review is necessary to ensure compliance with the requirements of this subpart. For each claim selected for review, the State VR...

20 CFR 404.2121 - Validation reviews.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) General. We will conduct a validation review of a sample of the claims for payment filed by each State VR... by any State VR agency or alternate participant, if we determine that such review is necessary to ensure compliance with the requirements of this subpart. For each claim selected for review, the State VR...

Use of a validated algorithm to estimate the annual cost of effective biologic treatment for rheumatoid arthritis.

PubMed

Curtis, Jeffrey R; Schabert, Vernon F; Yeaw, Jason; Korn, Jonathan R; Quach, Caroleen; Harrison, David J; Yun, Huifeng; Joseph, George J; Collier, David

2014-08-01

To estimate biologic cost per effectively treated patient with rheumatoid arthritis (RA) using a claims-based algorithm for effectiveness. Patients with RA aged 18-63 years in the IMS PharMetrics Plus database were categorized as effectively treated if they met all six criteria: (1) a medication possession ratio ≥80% (subcutaneous) or at least as many infusions as specified in US labeling (intravenous); (2) no biologic dose increase; (3) no biologic switch; (4) no new non-biologic disease-modifying anti-rheumatic drug; (5) no new or increased oral glucocorticoid; and (6) ≤1 glucocorticoid injection. Biologic cost per effectively treated patient was defined as total cost of the index biologic (drug plus intravenous administration) divided by the number of patients categorized by the algorithm as effectively treated. Similar methods were used for the index biologic in the second year and for a second biologic after a switch. Rates that the index biologic was categorized as effective in the first year were 31.0% etanercept (2243/7247), 28.6% adalimumab (1426/4991), 28.6% abatacept (332/1160), 27.2% golimumab (71/261), and 20.2% infliximab (474/2352). Mean biologic cost per effectively treated patient, per the algorithm, was $50,141 etanercept, $53,386 golimumab, $56,942 adalimumab, $73,516 abatacept, and $114,089 infliximab. Biologic cost per effectively treated patient, using this algorithm, was lower for patients who continued the index biologic in the second year and higher after switching. When a claims-based algorithm was applied to a large commercial claims database, etanercept was categorized as the most effective and had the lowest estimated 1-year biologic cost per effectively treated patient. This proxy for effectiveness from claims databases was validated against a clinical effectiveness scale, but analyses of the second year or the year after a biologic switch were not included in the validation. Costs of other medications were not included in cost calculations.

The Nature and Significance of Curricular Claims and How They Are Validated.

ERIC Educational Resources Information Center

Lottes, John; McCray, Emajean

This paper is concerned with the clarification and resolution of two basic defects of curricular and instructional research: vagueness as to what is being undertaken, and inattention to the logical aspects of evaluation. It introduces the concepts of curricular claim and instructional claim, clarifies the function and import of curricular claims,…

43 CFR 2650.3-2 - Mining claims.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Mining claims. 2650.3-2 Section 2650.3-2...: Generally § 2650.3-2 Mining claims. (a) Possessory rights. Pursuant to section 22(c) of the Act, on any..., initiated a valid mining claim or location, including millsites, under the general mining laws and recorded...

Claims-based risk model for first severe COPD exacerbation.

PubMed

Stanford, Richard H; Nag, Arpita; Mapel, Douglas W; Lee, Todd A; Rosiello, Richard; Schatz, Michael; Vekeman, Francis; Gauthier-Loiselle, Marjolaine; Merrigan, J F Philip; Duh, Mei Sheng

2018-02-01

To develop and validate a predictive model for first severe chronic obstructive pulmonary disease (COPD) exacerbation using health insurance claims data and to validate the risk measure of controller medication to total COPD treatment (controller and rescue) ratio (CTR). A predictive model was developed and validated in 2 managed care databases: Truven Health MarketScan database and Reliant Medical Group database. This secondary analysis assessed risk factors, including CTR, during the baseline period (Year 1) to predict risk of severe exacerbation in the at-risk period (Year 2). Patients with COPD who were 40 years or older and who had at least 1 COPD medication dispensed during the year following COPD diagnosis were included. Subjects with severe exacerbations in the baseline year were excluded. Risk factors in the baseline period were included as potential predictors in multivariate analysis. Performance was evaluated using C-statistics. The analysis included 223,824 patients. The greatest risk factors for first severe exacerbation were advanced age, chronic oxygen therapy usage, COPD diagnosis type, dispensing of 4 or more canisters of rescue medication, and having 2 or more moderate exacerbations. A CTR of 0.3 or greater was associated with a 14% lower risk of severe exacerbation. The model performed well with C-statistics, ranging from 0.711 to 0.714. This claims-based risk model can predict the likelihood of first severe COPD exacerbation. The CTR could also potentially be used to target populations at greatest risk for severe exacerbations. This could be relevant for providers and payers in approaches to prevent severe exacerbations and reduce costs.

43 CFR 3140.4 - Conversion.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Conversion. 3140.4 Section 3140.4 Public... OF THE INTERIOR MINERALS MANAGEMENT (3000) LEASING IN SPECIAL TAR SAND AREAS Conversion of Existing Oil and Gas Leases and Valid Claims Based on Mineral Locations § 3140.4 Conversion. ...

43 CFR 3140.3 - Time limitations.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Time limitations. 3140.3 Section 3140.3 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND MANAGEMENT... Existing Oil and Gas Leases and Valid Claims Based on Mineral Locations § 3140.3 Time limitations. ...

43 CFR 3140.3 - Time limitations.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Time limitations. 3140.3 Section 3140.3 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND MANAGEMENT... Existing Oil and Gas Leases and Valid Claims Based on Mineral Locations § 3140.3 Time limitations. ...

43 CFR 3140.3 - Time limitations.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Time limitations. 3140.3 Section 3140.3 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND MANAGEMENT... Existing Oil and Gas Leases and Valid Claims Based on Mineral Locations § 3140.3 Time limitations. ...

Positive predictive value between medical-chart body-mass-index category and obesity versus codes in a claims-data warehouse.

PubMed

Caplan, Eleanor O; Kamble, Pravin S; Harvey, Raymond A; Smolarz, B Gabriel; Renda, Andrew; Bouchard, Jonathan R; Huang, Joanna C

2018-01-01

To evaluate the positive predictive value of claims-based V85 codes for identifying individuals with varying degrees of BMI relative to their measured BMI obtained from medical record abstraction. This was a retrospective validation study utilizing administrative claims and medical chart data from 1 January 2009 to 31 August 2015. Randomly selected samples of patients enrolled in a Medicare Advantage Prescription Drug (MAPD) or commercial health plan and with a V85 claim were identified. The claims-based BMI category (underweight, normal weight, overweight, obese class I-III) was determined via corresponding V85 codes and compared to the BMI category derived from chart abstracted height, weight and/or BMI. The positive predictive values (PPVs) of the claims-based BMI categories were calculated with the corresponding 95% confidence intervals (CIs). The overall PPVs (95% CIs) in the MAPD and commercial samples were 90.3% (86.3%-94.4%) and 91.1% (87.3%-94.9%), respectively. In each BMI category, the PPVs (95% CIs) for the MAPD and commercial samples, respectively, were: underweight, 71.0% (55.0%-87.0%) and 75.9% (60.3%-91.4%); normal, 93.8% (85.4%-100%) and 87.8% (77.8%-97.8%); overweight, 97.4% (92.5%-100%) and 93.5% (84.9%-100%); obese class I, 96.9 (90.9%-100%) and 97.2% (91.9%-100%); obese class II, 97.0% (91.1%-100%) and 93.0% (85.4%-100%); and obese class III, 85.0% (73.3%-96.1%) and 97.1% (91.4%-100%). BMI categories derived from administrative claims, when available, can be used successfully particularly in the context of obesity research.

Typologies of Extreme Longevity Myths

PubMed Central

Young, Robert D.; Desjardins, Bertrand; McLaughlin, Kirsten; Poulain, Michel; Perls, Thomas T.

2010-01-01

Purpose. Political, national, religious, and other motivations have led the media and even scientists to errantly accept extreme longevity claims prima facie. We describe various causes of false claims of extraordinary longevity. Design and Methods. American Social Security Death Index files for the period 1980–2009 were queried for individuals with birth and death dates yielding ages 110+ years of age. Frequency was compared to a list of age-validated supercentenarians maintained by the Gerontology Research Group who died during the same time period. Age claims of 110+ years and the age validation experiences of the authors facilitated a list of typologies of false age claims. Results. Invalid age claim rates increase with age from 65% at age 110-111 to 98% by age 115 to 100% for 120+ years. Eleven typologies of false claims were: Religious Authority Myth, Village Elder Myth, Fountain of Youth Myth (substance), Shangri-La Myth (geographic), Nationalist Pride, Spiritual Practice, Familial Longevity, Individual and/or Family Notoriety, Military Service, Administrative Entry Error, and Pension-Social Entitlement Fraud. Conclusions. Understanding various causes of false extreme age claims is important for placing current, past, and future extreme longevity claims in context and for providing a necessary level of skepticism. PMID:21461047

Typologies of extreme longevity myths.

PubMed

Young, Robert D; Desjardins, Bertrand; McLaughlin, Kirsten; Poulain, Michel; Perls, Thomas T

2010-01-01

Purpose. Political, national, religious, and other motivations have led the media and even scientists to errantly accept extreme longevity claims prima facie. We describe various causes of false claims of extraordinary longevity. Design and Methods. American Social Security Death Index files for the period 1980-2009 were queried for individuals with birth and death dates yielding ages 110+ years of age. Frequency was compared to a list of age-validated supercentenarians maintained by the Gerontology Research Group who died during the same time period. Age claims of 110+ years and the age validation experiences of the authors facilitated a list of typologies of false age claims. Results. Invalid age claim rates increase with age from 65% at age 110-111 to 98% by age 115 to 100% for 120+ years. Eleven typologies of false claims were: Religious Authority Myth, Village Elder Myth, Fountain of Youth Myth (substance), Shangri-La Myth (geographic), Nationalist Pride, Spiritual Practice, Familial Longevity, Individual and/or Family Notoriety, Military Service, Administrative Entry Error, and Pension-Social Entitlement Fraud. Conclusions. Understanding various causes of false extreme age claims is important for placing current, past, and future extreme longevity claims in context and for providing a necessary level of skepticism.

Field methods in medical record abstraction: assessing the properties of comparative effectiveness estimates.

PubMed

Cook, Elizabeth A; Schneider, Kathleen M; Robinson, Jennifer; Wilwert, June; Chrischilles, Elizabeth; Pendergast, Jane; Brooks, John

2014-09-15

Comparative effectiveness studies using Medicare claims data are vulnerable to treatment selection biases and supplemental data from a sample of patients has been recommended for examining the magnitude of this bias. Previous research using nationwide Medicare claims data has typically relied on the Medicare Current Beneficiary Survey (MCBS) for supplemental data. Because many important clinical variables for our specific research question are not available in the MCBS, we collected medical record data from a subsample of patients to assess the validity of assumptions and to aid in the interpretation of our estimates. This paper seeks to describe and document the process used to collect and validate this supplemental information. Medicare claims data files for all patients with fee-for-service Medicare benefits who had an acute myocardial infarction (AMI) in 2007 or 2008 were obtained. Medical records were obtained and abstracted for a stratified subsample of 1,601 of these patients, using strata defined by claims-based measures of physician prescribing practices and drug treatment combinations. The abstraction tool was developed collaboratively by study clinicians and researchers, leveraging important elements from previously validated tools. Records for 2,707 AMI patients were requested from the admitting hospitals and 1,751 were received for an overall response rate of 65%; 1,601 cases were abstracted by trained personnel at a contracted firm. Data were collected with overall 96% inter-abstractor agreement across all variables. Some non-response bias was detected at the patient and facility level. Although Medicare claims data are a potentially powerful resource for conducting comparative effectiveness analyses, observational databases are vulnerable to treatment selection biases. This study demonstrates that it is feasible to abstract medical records for Medicare patients nationwide and collect high quality data, to design the sampling purposively to address specific research questions, and to more thoroughly evaluate the appropriateness of care delivered to AMI patients.

Identifying Psoriasis and Psoriatic Arthritis Patients in Retrospective Databases When Diagnosis Codes Are Not Available: A Validation Study Comparing Medication/Prescriber Visit-Based Algorithms with Diagnosis Codes.

PubMed

Dobson-Belaire, Wendy; Goodfield, Jason; Borrelli, Richard; Liu, Fei Fei; Khan, Zeba M

2018-01-01

Using diagnosis code-based algorithms is the primary method of identifying patient cohorts for retrospective studies; nevertheless, many databases lack reliable diagnosis code information. To develop precise algorithms based on medication claims/prescriber visits (MCs/PVs) to identify psoriasis (PsO) patients and psoriatic patients with arthritic conditions (PsO-AC), a proxy for psoriatic arthritis, in Canadian databases lacking diagnosis codes. Algorithms were developed using medications with narrow indication profiles in combination with prescriber specialty to define PsO and PsO-AC. For a 3-year study period from July 1, 2009, algorithms were validated using the PharMetrics Plus database, which contains both adjudicated medication claims and diagnosis codes. Positive predictive value (PPV), negative predictive value (NPV), sensitivity, and specificity of the developed algorithms were assessed using diagnosis code as the reference standard. Chosen algorithms were then applied to Canadian drug databases to profile the algorithm-identified PsO and PsO-AC cohorts. In the selected database, 183,328 patients were identified for validation. The highest PPVs for PsO (85%) and PsO-AC (65%) occurred when a predictive algorithm of two or more MCs/PVs was compared with the reference standard of one or more diagnosis codes. NPV and specificity were high (99%-100%), whereas sensitivity was low (≤30%). Reducing the number of MCs/PVs or increasing diagnosis claims decreased the algorithms' PPVs. We have developed an MC/PV-based algorithm to identify PsO patients with a high degree of accuracy, but accuracy for PsO-AC requires further investigation. Such methods allow researchers to conduct retrospective studies in databases in which diagnosis codes are absent. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

43 CFR 3140.3-1 - Conversion applications.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Conversion applications. 3140.3-1 Section 3140.3-1 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND... Conversion of Existing Oil and Gas Leases and Valid Claims Based on Mineral Locations § 3140.3-1 Conversion...

Commentary: Evaluating the Validity of Formative and Interim Assessment

ERIC Educational Resources Information Center

Shepard, Lorrie A.

2009-01-01

In many school districts, the pressure to raise test scores has created overnight celebrity status for formative assessment. Its powers to raise student achievement have been touted, however, without attending to the research on which these claims were based. Sociocultural learning theory provides theoretical grounding for understanding how…

Modeling the Malaysian motor insurance claim using artificial neural network and adaptive NeuroFuzzy inference system

NASA Astrophysics Data System (ADS)

Mohd Yunos, Zuriahati; Shamsuddin, Siti Mariyam; Ismail, Noriszura; Sallehuddin, Roselina

2013-04-01

Artificial neural network (ANN) with back propagation algorithm (BP) and ANFIS was chosen as an alternative technique in modeling motor insurance claims. In particular, an ANN and ANFIS technique is applied to model and forecast the Malaysian motor insurance data which is categorized into four claim types; third party property damage (TPPD), third party bodily injury (TPBI), own damage (OD) and theft. This study is to determine whether an ANN and ANFIS model is capable of accurately predicting motor insurance claim. There were changes made to the network structure as the number of input nodes, number of hidden nodes and pre-processing techniques are also examined and a cross-validation technique is used to improve the generalization ability of ANN and ANFIS models. Based on the empirical studies, the prediction performance of the ANN and ANFIS model is improved by using different number of input nodes and hidden nodes; and also various sizes of data. The experimental results reveal that the ANFIS model has outperformed the ANN model. Both models are capable of producing a reliable prediction for the Malaysian motor insurance claims and hence, the proposed method can be applied as an alternative to predict claim frequency and claim severity.

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

Validity assessment of self-reported medication use by comparing to pharmacy insurance claims

PubMed Central

Fujita, Misuzu; Sato, Yasunori; Nagashima, Kengo; Takahashi, Sho; Hata, Akira

2015-01-01

Objectives In Japan, an annual health check-up and health promotion guidance programme was established in 2008 in accordance with the Act on Assurance of Medical Care for the Elderly. A self-reported questionnaire on medication use is a required item in this programme and has been used widely, but its validity has not been assessed. The aim of this study was to evaluate the validity of this questionnaire by comparing self-reported usage to pharmacy insurance claims. Setting This is a population-based validation study. Self-reported medication use for hypertension, diabetes and dyslipidaemia is the evaluated measurement. Data on pharmacy insurance claims are used as a reference standard. Participants Participants were 54 712 beneficiaries of the National Health Insurance of Chiba City. Primary and secondary outcome measures Sensitivity, specificity and κ statistics of the self-reported medication-use questionnaire for predicting actual prescriptions during 1 month (that of the check-up) and 3 months (that of the check-up and the previous 2 months) were calculated. Results Sensitivity and specificity scores of questionnaire data for predicting insurance claims covering 3 months were, respectively, 92.4% (95% CI 91.9 to 92.8) and 86.4% (95% CI 86.0 to 86.7) for hypertension, 82.6% (95% CI 81.1 to 84.0) and 98.5% (95% CI 98.4 to 98.6) for diabetes, and 86.2% (95% CI 85.5 to 86.8) and 91.0% (95% CI 90.8 to 91.3) for dyslipidaemia. Corresponding κ statistics were 70.9% (95% CI 70.1 to 71.7), 77.1% (95% CI 76.2 to 77.9) and 69.8% (95% CI 68.9 to 70.6). The specificity was significantly higher for questionnaire data covering 3 months compared with data covering 1 month for all 3 conditions. Conclusions Self-reported questionnaire data on medication use had sufficiently high validity for further analyses. Item responses showed close agreement with actual prescriptions, particularly those covering 3 months. PMID:26553839

Developing leading indicators from OHS management audit data: Determining the measurement properties of audit data from the field.

PubMed

Robson, Lynda S; Ibrahim, Selahadin; Hogg-Johnson, Sheilah; Steenstra, Ivan A; Van Eerd, Dwayne; Amick, Benjamin C

2017-06-01

OHS management audits are one means of obtaining data that may serve as leading indicators. The measurement properties of such data are therefore important. This study used data from Workwell audit program in Ontario, a Canadian province. The audit instrument consisted of 122 items related to 17 OHS management elements. The study sought answers regarding (a) the ability of audit-based scores to predict workers' compensation claims outcomes, (b) structural characteristics of the data in relation to the organization of the audit instrument, and (c) internal consistency of items within audit elements. The sample consisted of audit and claims data from 1240 unique firms that had completed one or two OHS management audits during 2007-2010. Predictors derived from the audit results were used in multivariable negative binomial regression modeling of workers' compensation claims outcomes. Confirmatory factor analyses were used to examine the instrument's structural characteristics. Kuder-Richardson coefficients of internal consistency were calculated for each audit element. The ability of audit scores to predict subsequent claims data could not be established. Factor analysis supported the audit instrument's element-based structure. KR-20 values were high (≥0.83). The Workwell audit data display structural validity and high internal consistency, but not, to date, construct validity, since the audit scores are generally not predictive of subsequent firm claim experience. Audit scores should not be treated as leading indicators of workplace OHS performance without supporting empirical data. Analyses of the measurement properties of audit data can inform decisionmakers about the operation of an audit program, possible future directions in audit instrument development, and the appropriate use of audit data. In particular, decision-makers should be cautious in their use of audit scores as leading indicators, in the absence of supporting empirical data. Copyright © 2017 Elsevier Ltd and National Safety Council. All rights reserved.

Identification of Emergency Department Visits in Medicare Administrative Claims: Approaches and Implications.

PubMed

Venkatesh, Arjun K; Mei, Hao; Kocher, Keith E; Granovsky, Michael; Obermeyer, Ziad; Spatz, Erica S; Rothenberg, Craig; Krumholz, Harlan M; Lin, Zhenqui

2017-04-01

Administrative claims data sets are often used for emergency care research and policy investigations of healthcare resource utilization, acute care practices, and evaluation of quality improvement interventions. Despite the high profile of emergency department (ED) visits in analyses using administrative claims, little work has evaluated the degree to which existing definitions based on claims data accurately captures conventionally defined hospital-based ED services. We sought to construct an operational definition for ED visitation using a comprehensive Medicare data set and to compare this definition to existing operational definitions used by researchers and policymakers. We examined four operational definitions of an ED visit commonly used by researchers and policymakers using a 20% sample of the 2012 Medicare Chronic Condition Warehouse (CCW) data set. The CCW data set included all Part A (hospital) and Part B (hospital outpatient, physician) claims for a nationally representative sample of continuously enrolled Medicare fee-for-services beneficiaries. Three definitions were based on published research or existing quality metrics including: 1) provider claims-based definition, 2) facility claims-based definition, and 3) CMS Research Data Assistance Center (ResDAC) definition. In addition, we developed a fourth operational definition (Yale definition) that sought to incorporate additional coding rules for identifying ED visits. We report levels of agreement and disagreement among the four definitions. Of 10,717,786 beneficiaries included in the sample data set, 22% had evidence of ED use during the study year under any of the ED visit definitions. The definition using provider claims identified a total of 4,199,148 ED visits, the facility definition 4,795,057 visits, the ResDAC definition 5,278,980 ED visits, and the Yale definition 5,192,235 ED visits. The Yale definition identified a statistically different (p < 0.05) collection of ED visits than all other definitions including 17% more ED visits than the provider definition and 2% fewer visits than the ResDAC definition. Differences in ED visitation counts between each definition occurred for several reasons including the inclusion of critical care or observation services in the ED, discrepancies between facility and provider billing regulations, and operational decisions of each definition. Current operational definitions of ED visitation using administrative claims produce different estimates of ED visitation based on the underlying assumptions applied to billing data and data set availability. Future analyses using administrative claims data should seek to validate specific definitions and inform the development of a consistent, consensus ED visitation definitions to standardize research reporting and the interpretation of policy interventions. © 2016 by the Society for Academic Emergency Medicine.

Validating Savings Claims of Cold Climate Zero Energy Ready Homes

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

Williamson, J.; Puttagunta, S.

This report details the validation methods used to analyze consumption at each of these homes. It includes a detailed end-use examination of consumptions from the following categories: 1) Heating, 2) Cooling, 3) Lights, Appliances, and Miscellaneous Electric Loads (LAMELS) along with Domestic Hot Water Use, 4) Ventilation, and 5) PV generation. A utility bill disaggregation method, which allows a crude estimation of space conditioning loads based on outdoor air temperature, was also performed and the results compared to the actual measured data.

Policy Claims and Problem Frames: A Cross-Case Comparison of Evidence-Based Policy in an Australian Context

ERIC Educational Resources Information Center

van Toorn, Georgia; Dowse, Leanne

2016-01-01

This paper explores the signification of evidence-based policy as a new policy-making paradigm in Australia through a cross-case comparison of the role of evidence in two key areas: child protection and illicit drug policy. Although evidence makes certain courses of action appear valid and credible, quality evidence is not necessarily the critical…

Improving medical record retrieval for validation studies in Medicare data.

PubMed

Wright, Nicole C; Delzell, Elizabeth S; Smith, Wilson K; Xue, Fei; Auroa, Tarun; Curtis, Jeffrey R

2017-04-01

The purpose of the study is to describe medical record retrieval for a study validating claims-based algorithms used to identify seven adverse events of special interest (AESI) in a Medicare population. We analyzed 2010-2011 Medicare claims of women with postmenopausal osteoporosis and men ≥65 years of age in the Medicare 5% national sample. The final cohorts included beneficiaries covered continuously for 12+ months by Medicare parts A, B, and D and not enrolled in Medicare Advantage before starting follow-up. We identified beneficiaries using each AESI algorithm and randomly selected 400 women and 100 men with each AESI for medical record retrieval. The Centers for Medicare and Medicaid Services provided beneficiary contact information, and we requested medical records directly from providers, without patient contact. We selected 3331 beneficiaries (women: 2272; men: 559) for whom we requested 3625 medical records. Overall, we received 1738 [47.9% (95%CI 46.3%, 49.6%)] of the requested medical records. We observed small differences in the characteristics of the total population with AESIs compared with those randomly selected for retrieval; however, no differences were seen between those selected and those retrieved. We retrieved 54.7% of records requested from hospitals compared with 26.3% of records requested from physician offices (p < 0.001). Retrieval did not differ by sex or vital status of the beneficiaries. Our national medical record validation study of claims-based algorithms produced a modest retrieval rate. The medical record procedures outlined in this paper could have led to the improved retrieval from our previous medical record retrieval study. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Current and future developments in patents for quantitative trait loci in dairy cattle.

PubMed

Weller, Joel I

2007-01-01

Many studies have proposed that rates of genetic gain in dairy cattle can be increased by direct selection on the individual quantitative loci responsible for the genetic variation in these traits, or selection on linked genetic markers. The development of DNA-level genetic markers has made detection of QTL nearly routine in all major livestock species. The studies that attempted to detect genes affecting quantitative traits can be divided into two categories: analysis of candidate genes, and genome scans based on within-family genetic linkage. To date, 12 patent cooperative treaty (PCT) and US patents have been registered for DNA sequences claimed to be associated with effects on economic traits in dairy cattle. All claim effects on milk production, but other traits are also included in some of the claims. Most of the sequences found by the candidate gene approach are of dubious validity, and have been repeated in only very few independent studies. The two missense mutations on chromosomes 6 and 14 affecting milk concentration derived from genome scans are more solidly based, but the claims are also disputed. A few PCT in dairy cattle are commercialized as genetic tests where commercial dairy farmers are the target market.

Development and Validation of a Predictive Model to Identify Individuals Likely to Have Undiagnosed Chronic Obstructive Pulmonary Disease Using an Administrative Claims Database.

PubMed

Moretz, Chad; Zhou, Yunping; Dhamane, Amol D; Burslem, Kate; Saverno, Kim; Jain, Gagan; Devercelli, Giovanna; Kaila, Shuchita; Ellis, Jeffrey J; Hernandez, Gemzel; Renda, Andrew

2015-12-01

Despite the importance of early detection, delayed diagnosis of chronic obstructive pulmonary disease (COPD) is relatively common. Approximately 12 million people in the United States have undiagnosed COPD. Diagnosis of COPD is essential for the timely implementation of interventions, such as smoking cessation programs, drug therapies, and pulmonary rehabilitation, which are aimed at improving outcomes and slowing disease progression. To develop and validate a predictive model to identify patients likely to have undiagnosed COPD using administrative claims data. A predictive model was developed and validated utilizing a retro-spective cohort of patients with and without a COPD diagnosis (cases and controls), aged 40-89, with a minimum of 24 months of continuous health plan enrollment (Medicare Advantage Prescription Drug [MAPD] and commercial plans), and identified between January 1, 2009, and December 31, 2012, using Humana's claims database. Stratified random sampling based on plan type (commercial or MAPD) and index year was performed to ensure that cases and controls had a similar distribution of these variables. Cases and controls were compared to identify demographic, clinical, and health care resource utilization (HCRU) characteristics associated with a COPD diagnosis. Stepwise logistic regression (SLR), neural networking, and decision trees were used to develop a series of models. The models were trained, validated, and tested on randomly partitioned subsets of the sample (Training, Validation, and Test data subsets). Measures used to evaluate and compare the models included area under the curve (AUC); index of the receiver operating characteristics (ROC) curve; sensitivity, specificity, positive predictive value (PPV); and negative predictive value (NPV). The optimal model was selected based on AUC index on the Test data subset. A total of 50,880 cases and 50,880 controls were included, with MAPD patients comprising 92% of the study population. Compared with controls, cases had a statistically significantly higher comorbidity burden and HCRU (including hospitalizations, emergency room visits, and medical procedures). The optimal predictive model was generated using SLR, which included 34 variables that were statistically significantly associated with a COPD diagnosis. After adjusting for covariates, anticholinergic bronchodilators (OR = 3.336) and tobacco cessation counseling (OR = 2.871) were found to have a large influence on the model. The final predictive model had an AUC of 0.754, sensitivity of 60%, specificity of 78%, PPV of 73%, and an NPV of 66%. This claims-based predictive model provides an acceptable level of accuracy in identifying patients likely to have undiagnosed COPD in a large national health plan. Identification of patients with undiagnosed COPD may enable timely management and lead to improved health outcomes and reduced COPD-related health care expenditures.

Changing the approach to treatment choice in epilepsy using big data.

PubMed

Devinsky, Orrin; Dilley, Cynthia; Ozery-Flato, Michal; Aharonov, Ranit; Goldschmidt, Ya'ara; Rosen-Zvi, Michal; Clark, Chris; Fritz, Patty

2016-03-01

A UCB-IBM collaboration explored the application of machine learning to large claims databases to construct an algorithm for antiepileptic drug (AED) choice for individual patients. Claims data were collected between January 2006 and September 2011 for patients with epilepsy > 16 years of age. A subset of patient claims with a valid index date of AED treatment change (new, add, or switch) were used to train the AED prediction model by retrospectively evaluating an index date treatment for subsequent treatment change. Based on the trained model, a model-predicted AED regimen with the lowest likelihood of treatment change was assigned to each patient in the group of test claims, and outcomes were evaluated to test model validity. The model had 72% area under receiver operator characteristic curve, indicating good predictive power. Patients who were given the model-predicted AED regimen had significantly longer survival rates (time until a treatment change event) and lower expected health resource utilization on average than those who received another treatment. The actual prescribed AED regimen at the index date matched the model-predicted AED regimen in only 13% of cases; there were large discrepancies in the frequency of use of certain AEDs/combinations between model-predicted AED regimens and those actually prescribed. Chances of treatment success were improved if patients received the model-predicted treatment. Using the model's prediction system may enable personalized, evidence-based epilepsy care, accelerating the match between patients and their ideal therapy, thereby delivering significantly better health outcomes for patients and providing health-care savings by applying resources more efficiently. Our goal will be to strengthen the predictive power of the model by integrating diverse data sets and potentially moving to prospective data collection. Crown Copyright © 2015. Published by Elsevier Inc. All rights reserved.

43 CFR 3140.0-5 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-10-01

... for the removal of gas and nongaseous hydrocarbon substances other than coal, oil shale or gilsonite... Existing Oil and Gas Leases and Valid Claims Based on Mineral Locations § 3140.0-5 Definitions. As used in... Sand Areas, as containing substantial deposits of tar sand. (d) Owner of an oil and gas lease means all...

43 CFR 3140.0-5 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... for the removal of gas and nongaseous hydrocarbon substances other than coal, oil shale or gilsonite... Existing Oil and Gas Leases and Valid Claims Based on Mineral Locations § 3140.0-5 Definitions. As used in... Sand Areas, as containing substantial deposits of tar sand. (d) Owner of an oil and gas lease means all...

43 CFR 3140.0-5 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-10-01

... for the removal of gas and nongaseous hydrocarbon substances other than coal, oil shale or gilsonite... Existing Oil and Gas Leases and Valid Claims Based on Mineral Locations § 3140.0-5 Definitions. As used in... Sand Areas, as containing substantial deposits of tar sand. (d) Owner of an oil and gas lease means all...

43 CFR 3140.0-5 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... for the removal of gas and nongaseous hydrocarbon substances other than coal, oil shale or gilsonite... Existing Oil and Gas Leases and Valid Claims Based on Mineral Locations § 3140.0-5 Definitions. As used in... Sand Areas, as containing substantial deposits of tar sand. (d) Owner of an oil and gas lease means all...

Expectation-Based Efficiency and Quality Improvements in Research Administration: Multi-Institutional Case Studies

ERIC Educational Resources Information Center

Saha, Dhanonjoy C.; Ahmed, Abrar; Hanumandla, Shailaja

2011-01-01

Conventional wisdom may support the presumed notion that higher expectations increase efficiency and improve quality. However, this claim may only be validated when workers are equipped with appropriate tools, training, and a conducive work environment. This study implements various interventions, observes outcomes, and analyzes data collected in…

43 CFR 3140.7 - Lands within the National Park System.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Lands within the National Park System... Lands within the National Park System. Conversions of existing oil and gas leases and valid claims based on mineral locations to combined hydrocarbon leases within units of the National Park System shall be...

43 CFR 3140.7 - Lands within the National Park System.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Lands within the National Park System... Lands within the National Park System. Conversions of existing oil and gas leases and valid claims based on mineral locations to combined hydrocarbon leases within units of the National Park System shall be...

43 CFR 3140.7 - Lands within the National Park System.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Lands within the National Park System... Lands within the National Park System. Conversions of existing oil and gas leases and valid claims based on mineral locations to combined hydrocarbon leases within units of the National Park System shall be...

43 CFR 3140.7 - Lands within the National Park System.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Lands within the National Park System... Lands within the National Park System. Conversions of existing oil and gas leases and valid claims based on mineral locations to combined hydrocarbon leases within units of the National Park System shall be...

Another Postmodern Report on Knowledge: Positivism and Its Others

ERIC Educational Resources Information Center

St. Pierre, Elizabeth Adams

2012-01-01

During the first decade of the twenty-first century, neopositivist claims made about the nature and validity of knowledge in the debates about scientifically based research were countered by educators who, decades earlier, had made various turns away from positivism and were surprised by its resurgence. In those debates, positivists often used…

A systematic review of validated methods for identifying acute respiratory failure using administrative and claims data.

PubMed

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

2012-01-01

The Food and Drug Administration's (FDA) Mini-Sentinel pilot program initially 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 (HOIs) from administrative and claims data. This paper summarizes the process and findings of the algorithm review of acute respiratory failure (ARF). PubMed and Iowa Drug Information Service searches were conducted to identify citations applicable to the anaphylaxis HOI. Level 1 abstract reviews and Level 2 full-text reviews were conducted to find articles using administrative and claims data to identify ARF, including validation estimates of the coding algorithms. Our search revealed a deficiency of literature focusing on ARF algorithms and validation estimates. Only two studies provided codes for ARF, each using related yet different ICD-9 codes (i.e., ICD-9 codes 518.8, "other diseases of lung," and 518.81, "acute respiratory failure"). Neither study provided validation estimates. Research needs to be conducted on designing validation studies to test ARF algorithms and estimating their predictive power, sensitivity, and specificity. Copyright © 2012 John Wiley & Sons, Ltd.

Persistent misunderstandings about evidence-based (sorry: informed!) policy-making.

PubMed

Bédard, Pierre-Olivier; Ouimet, Mathieu

2016-01-01

The field of research on knowledge mobilization and evidence-informed policy-making has seen enduring debates related to various fundamental assumptions such as the definition of 'evidence', the relative validity of various research methods, the actual role of evidence to inform policy-making, etc. In many cases, these discussions serve a useful purpose, but they also stem from serious disagreement on methodological and epistemological issues. This essay reviews the rationale for evidence-informed policy-making by examining some of the common claims made about the aims and practices of this perspective on public policy. Supplementing the existing justifications for evidence-based policy making, we argue in favor of a greater inclusion of research evidence in the policy process but in a structured fashion, based on methodological considerations. In this respect, we present an overview of the intricate relation between policy questions and appropriate research designs. By closely examining the relation between research questions and research designs, we claim that the usual points of disagreement are mitigated. For instance, when focusing on the variety of research designs that can answer a range of policy questions, the common critical claim about 'RCT-based policy-making' seems to lose some, if not all of its grip.

Pharmacoepidemiology resources in Ireland-an introduction to pharmacy claims data.

PubMed

Sinnott, Sarah-Jo; Bennett, Kathleen; Cahir, Caitriona

2017-11-01

Administrative health data, such as pharmacy claims data, present a valuable resource for conducting pharmacoepidemiological and health services research. Often, data are available for whole populations allowing population level analyses. Moreover, their routine collection ensures that the data reflect health care utilisation in the real-world setting compared to data collected in clinical trials. The Irish Health Service Executive-Primary Care Reimbursement Service (HSE-PCRS) community pharmacy claims database is described. The availability of demographic variables and drug-related information is discussed. The strengths and limitations associated using this database for conducting research are presented, in particular, internal and external validity. Examples of recently conducted research using the HSE-PCRS pharmacy claims database are used to illustrate the breadth of its use. The HSE-PCRS national pharmacy claims database is a large, high-quality, valid and accurate data source for measuring drug exposure in specific populations in Ireland. The main limitation is the lack of generalisability for those aged <70 years and the lack of information on indication or outcome.

Quantum Locality?

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

Stapp, Henry

Robert Griffiths has recently addressed, within the framework of a ‘consistent quantum theory’ (CQT) that he has developed, the issue of whether, as is often claimed, quantum mechanics entails a need for faster-than-light transfers of information over long distances. He argues, on the basis of his examination of certain arguments that claim to demonstrate the existence of such nonlocal influences, that such influences do not exist. However, his examination was restricted mainly to hidden-variable-based arguments that include in their premises some essentially classical-physics-type assumptions that are fundamentally incompatible with the precepts of quantum physics. One cannot logically prove properties ofmore » a system by attributing to the system properties alien to that system. Hence Griffiths’ rejection of hidden-variable-based proofs is logically warranted. Griffiths mentions the existence of a certain alternative proof that does not involve hidden variables, and that uses only macroscopically described observable properties. He notes that he had examined in his book proofs of this general kind, and concluded that they provide no evidence for nonlocal influences. But he did not examine the particular proof that he cites. An examination of that particular proof by the method specified by his ‘consistent quantum theory’ shows that the cited proof is valid within that restrictive framework. This necessary existence, within the ‘consistent’ framework, of long range essentially instantaneous influences refutes the claim made by Griffiths that his ‘consistent’ framework is superior to the orthodox quantum theory of von Neumann because it does not entail instantaneous influences. An added section responds to Griffiths’ reply, which cites a litany of ambiguities that seem to restrict, devastatingly, the scope of his CQT formalism, apparently to buttress his claim that my use of that formalism to validate the nonlocality theorem is flawed. But the vagaries that he cites do not upset the proof in question. It is show here in detail why the precise statement of this theorem justifies the specified application of CQT. It is also shown, in response to his challenge, why a putative proof of locality that he has proposed is not valid.« less

77 FR 16860 - Certain Mobile Devices, and Related Software Thereof; Notice of Commission Decision To Review in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-22

..., Apple filed a petition for review of certain aspects of the ID's findings concerning claim construction... certain aspects of the ID's findings concerning claim construction infringement, validity, domestic... software by reason of infringement of certain claims of U.S. Patent Nos. 7,812,828 (``the `828 Patent''); 7...

The Reliability and Validity of Tasks Measuring Perception of Rapid Sequences in Children with Dyslexia

ERIC Educational Resources Information Center

Heath, Steve M.; Hogben, John H.

2004-01-01

Background: Claims that children with reading and oral language deficits have impaired perception of sequential sounds are usually based on psychophysical measures of auditory temporal processing (ATP) designed to characterise group performance. If we are to use these measures (e.g., the Tallal, 1980, Repetition Test) as the basis for intervention…

DOD Information Sharing with Domestic Emergency Partners for DSCA Missions

DTIC Science & Technology

2011-06-06

is actually who they claim to be. Public email services, however, such as G- mail or Hotmail ,75 offer no such means to validate user names...service and Hotmail ® is a Microsoft® service. Both provide free web-based email accounts to users. 76 All Partner Access Network was formerly known as the

43 CFR 3140.1-2 - Notice of intent to convert.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Conversion of Existing Oil and Gas Leases and Valid Claims Based on Mineral Locations § 3140.1-2 Notice of intent to convert. (a) Owners of oil and gas leases in Special Tar Sand Areas which are scheduled to... with the State Director, Utah State Office, Bureau of Land Management, 136 E. South Temple, Salt Lake...

43 CFR 3140.1-2 - Notice of intent to convert.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Conversion of Existing Oil and Gas Leases and Valid Claims Based on Mineral Locations § 3140.1-2 Notice of intent to convert. (a) Owners of oil and gas leases in Special Tar Sand Areas which are scheduled to... with the State Director, Utah State Office, Bureau of Land Management, 136 E. South Temple, Salt Lake...

43 CFR 3140.1-2 - Notice of intent to convert.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Conversion of Existing Oil and Gas Leases and Valid Claims Based on Mineral Locations § 3140.1-2 Notice of intent to convert. (a) Owners of oil and gas leases in Special Tar Sand Areas which are scheduled to... with the State Director, Utah State Office, Bureau of Land Management, 136 E. South Temple, Salt Lake...

43 CFR 3140.1-2 - Notice of intent to convert.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Conversion of Existing Oil and Gas Leases and Valid Claims Based on Mineral Locations § 3140.1-2 Notice of intent to convert. (a) Owners of oil and gas leases in Special Tar Sand Areas which are scheduled to... with the State Director, Utah State Office, Bureau of Land Management, 136 E. South Temple, Salt Lake...

Deconstructing climate misinformation to identify reasoning errors

NASA Astrophysics Data System (ADS)

Cook, John; Ellerton, Peter; Kinkead, David

2018-02-01

Misinformation can have significant societal consequences. For example, misinformation about climate change has confused the public and stalled support for mitigation policies. When people lack the expertise and skill to evaluate the science behind a claim, they typically rely on heuristics such as substituting judgment about something complex (i.e. climate science) with judgment about something simple (i.e. the character of people who speak about climate science) and are therefore vulnerable to misleading information. Inoculation theory offers one approach to effectively neutralize the influence of misinformation. Typically, inoculations convey resistance by providing people with information that counters misinformation. In contrast, we propose inoculating against misinformation by explaining the fallacious reasoning within misleading denialist claims. We offer a strategy based on critical thinking methods to analyse and detect poor reasoning within denialist claims. This strategy includes detailing argument structure, determining the truth of the premises, and checking for validity, hidden premises, or ambiguous language. Focusing on argument structure also facilitates the identification of reasoning fallacies by locating them in the reasoning process. Because this reason-based form of inoculation is based on general critical thinking methods, it offers the distinct advantage of being accessible to those who lack expertise in climate science. We applied this approach to 42 common denialist claims and find that they all demonstrate fallacious reasoning and fail to refute the scientific consensus regarding anthropogenic global warming. This comprehensive deconstruction and refutation of the most common denialist claims about climate change is designed to act as a resource for communicators and educators who teach climate science and/or critical thinking.

Validation of current procedural terminology codes for rotavirus vaccination among infants in two commercially insured US populations.

PubMed

Hoffman, Veena; Everage, Nicholas J; Quinlan, Scott C; Skerry, Kathleen; Esposito, Daina; Praet, Nicolas; Rosillon, Dominique; Holick, Crystal N; Dore, David D

2016-12-01

We validated procedure codes used in health insurance claims for reimbursement of rotavirus vaccination by comparing claims for monovalent live-attenuated human rotavirus vaccine (RV1) and live, oral pentavalent rotavirus vaccine (RV5) to medical records. Using administrative data from two commercially insured United States populations, we randomly sampled vaccination claims for RV1 and RV5 from a cohort of infants aged less than 1 year from an ongoing post-licensure safety study of rotavirus vaccines. The codes for RV1 and RV5 found in claims were confirmed through medical record review. The positive predictive value (PPV) of the Current Procedural Terminology codes for RV1 and RV5 was calculated as the number of medical record-confirmed vaccinations divided by the number of medical records obtained. Medical record review confirmed 92 of 104 RV1 vaccination claims (PPV: 88.5%; 95% CI: 80.7-93.9%) and 98 of 113 RV5 vaccination claims (PPV: 86.7%; 95% CI: 79.1-92.4%). Among the 217 medical records abstracted, only three (1.4%) of vaccinations were misclassified in claims-all were RV5 misclassified as RV1. The medical records corresponding to 9 RV1 and 15 RV5 claims contained insufficient information to classify the type of rotavirus vaccine. Misclassification of rotavirus vaccines is infrequent within claims. The PPVs reported here are conservative estimates as those with insufficient information in the medical records were assumed to be incorrectly coded in the claims. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Estimating Anesthesia Time Using the Medicare Claim: A Validation Study

PubMed Central

Silber, Jeffrey H.; Rosenbaum, Paul R.; Even-Shoshan, Orit; Mi, Lanyu; Kyle, Fabienne; Teng, Yun; Bratzler, Dale W.; Fleisher, Lee A.

2012-01-01

Introduction Procedure length is a fundamental variable associated with quality of care, though seldom studied on a large scale. We sought to estimate procedure length through information obtained in the anesthesia claim submitted to Medicare to validate this method for future studies. Methods The Obesity and Surgical Outcomes Study enlisted 47 hospitals located across New York, Texas and Illinois to study patients undergoing hip, knee, colon and thoracotomy procedures. 15,914 charts were abstracted to determine body mass index and initial patient physiology. Included in this abstraction were induction, cut, close and recovery room times. This chart information was merged to Medicare claims which included anesthesia Part B billing information. Correlations between chart times and claim times were analyzed, models developed, and median absolute differences in minutes calculated. Results Of the 15,914 eligible patients, there were 14,369 where both chart and claim times were available for analysis. In these 14,369, the Spearman correlation between chart and claim time was 0.94 (95% CI 0.94, 0.95) and the median absolute difference between chart and claim time was only 5 minutes (95% CI: 5.0, 5.5). The anesthesia claim can also be used to estimate surgical procedure length, with only a modest increase in error. Conclusion The anesthesia bill found in Medicare claims provides an excellent source of information for studying operative time on a vast scale throughout the United States. However, errors in both chart abstraction and anesthesia claims can occur. Care must be taken in the handling of outliers in this data. PMID:21720242

Regulatory science requirements of labeling of genetically modified food.

PubMed

Moghissi, A Alan; Jaeger, Lisa M; Shafei, Dania; Bloom, Lindsey L

2018-05-01

This paper provides an overview of the evolution of food labeling in the USA. It briefly describes the three phases of agricultural development consisting of naturally occurring, cross-bred, and genetically engineered, edited or modified crops, otherwise known as Genetically Modified Organisms (GMO). It uses the Best Available Regulatory Science (BARS) and Metrics for Evaluation of Regulatory Science Claims (MERSC) to evaluate the scientific validity of claims applicable to GMO and the Best Available Public Information (BAPI) to evaluate the pronouncements by public media and others. Subsequently claims on health risk, ecological risk, consumer choice, and corporate greed are evaluated based on BARS/MERSC and BAPI. The paper concludes by suggesting that labeling of food containing GMO should consider the consumer's choice, such as the food used by those who desire kosher and halal food. Furthermore, the consumer choice is already met by the exclusion of GMO in organic food.

Temporal and Geographic variation in the validity and internal consistency of the Nursing Home Resident Assessment Minimum Data Set 2.0.

PubMed

Mor, Vincent; Intrator, Orna; Unruh, Mark Aaron; Cai, Shubing

2011-04-15

The Minimum Data Set (MDS) for nursing home resident assessment has been required in all U.S. nursing homes since 1990 and has been universally computerized since 1998. Initially intended to structure clinical care planning, uses of the MDS expanded to include policy applications such as case-mix reimbursement, quality monitoring and research. The purpose of this paper is to summarize a series of analyses examining the internal consistency and predictive validity of the MDS data as used in the "real world" in all U.S. nursing homes between 1999 and 2007. We used person level linked MDS and Medicare denominator and all institutional claim files including inpatient (hospital and skilled nursing facilities) for all Medicare fee-for-service beneficiaries entering U.S. nursing homes during the period 1999 to 2007. We calculated the sensitivity and positive predictive value (PPV) of diagnoses taken from Medicare hospital claims and from the MDS among all new admissions from hospitals to nursing homes and the internal consistency (alpha reliability) of pairs of items within the MDS that logically should be related. We also tested the internal consistency of commonly used MDS based multi-item scales and examined the predictive validity of an MDS based severity measure viz. one year survival. Finally, we examined the correspondence of the MDS discharge record to hospitalizations and deaths seen in Medicare claims, and the completeness of MDS assessments upon skilled nursing facility (SNF) admission. Each year there were some 800,000 new admissions directly from hospital to US nursing homes and some 900,000 uninterrupted SNF stays. Comparing Medicare enrollment records and claims with MDS records revealed reasonably good correspondence that improved over time (by 2006 only 3% of deaths had no MDS discharge record, only 5% of SNF stays had no MDS, but over 20% of MDS discharges indicating hospitalization had no associated Medicare claim). The PPV and sensitivity levels of Medicare hospital diagnoses and MDS based diagnoses were between .6 and .7 for major diagnoses like CHF, hypertension, diabetes. Internal consistency, as measured by PPV, of the MDS ADL items with other MDS items measuring impairments and symptoms exceeded .9. The Activities of Daily Living (ADL) long form summary scale achieved an alpha inter-consistency level exceeding .85 and multi-item scale alpha levels of .65 were achieved for well being and mood, and .55 for behavior, levels that were sustained even after stratification by ADL and cognition. The Changes in Health, End-stage disease and Symptoms and Signs (CHESS) index, a summary measure of frailty was highly predictive of one year survival. The MDS demonstrates a reasonable level of consistency both in terms of how well MDS diagnoses correspond to hospital discharge diagnoses and in terms of the internal consistency of functioning and behavioral items. The level of alpha reliability and validity demonstrated by the scales suggest that the data can be useful for research and policy analysis. However, while improving, the MDS discharge tracking record should still not be used to indicate Medicare hospitalizations or mortality. It will be important to monitor the performance of the MDS 3.0 with respect to consistency, reliability and validity now that it has replaced version 2.0, using these results as a baseline that should be exceeded.

An in-depth assessment of a diagnosis-based risk adjustment model based on national health insurance claims: the application of the Johns Hopkins Adjusted Clinical Group case-mix system in Taiwan.

PubMed

Chang, Hsien-Yen; Weiner, Jonathan P

2010-01-18

Diagnosis-based risk adjustment is becoming an important issue globally as a result of its implications for payment, high-risk predictive modelling and provider performance assessment. The Taiwanese National Health Insurance (NHI) programme provides universal coverage and maintains a single national computerized claims database, which enables the application of diagnosis-based risk adjustment. However, research regarding risk adjustment is limited. This study aims to examine the performance of the Adjusted Clinical Group (ACG) case-mix system using claims-based diagnosis information from the Taiwanese NHI programme. A random sample of NHI enrollees was selected. Those continuously enrolled in 2002 were included for concurrent analyses (n = 173,234), while those in both 2002 and 2003 were included for prospective analyses (n = 164,562). Health status measures derived from 2002 diagnoses were used to explain the 2002 and 2003 health expenditure. A multivariate linear regression model was adopted after comparing the performance of seven different statistical models. Split-validation was performed in order to avoid overfitting. The performance measures were adjusted R2 and mean absolute prediction error of five types of expenditure at individual level, and predictive ratio of total expenditure at group level. The more comprehensive models performed better when used for explaining resource utilization. Adjusted R2 of total expenditure in concurrent/prospective analyses were 4.2%/4.4% in the demographic model, 15%/10% in the ACGs or ADGs (Aggregated Diagnosis Group) model, and 40%/22% in the models containing EDCs (Expanded Diagnosis Cluster). When predicting expenditure for groups based on expenditure quintiles, all models underpredicted the highest expenditure group and overpredicted the four other groups. For groups based on morbidity burden, the ACGs model had the best performance overall. Given the widespread availability of claims data and the superior explanatory power of claims-based risk adjustment models over demographics-only models, Taiwan's government should consider using claims-based models for policy-relevant applications. The performance of the ACG case-mix system in Taiwan was comparable to that found in other countries. This suggested that the ACG system could be applied to Taiwan's NHI even though it was originally developed in the USA. Many of the findings in this paper are likely to be relevant to other diagnosis-based risk adjustment methodologies.

Teva Pharmaceuticals v. Sandoz: availability of generic glatiramer acetate and the impact to patent litigation claim construction.

PubMed

Fogel, Louis E; Ray, Chad J

2015-01-01

In the upcoming case of Teva Pharmaceuticals v. Sandoz, the U.S. Supreme Court will address how much deference the appellate court should afford to a trial court's claim construction ruling. The effect of this decision will be far-reaching, as how claims are construed can determine whether a patent is infringed or not infringed, valid or invalid.

Is It Believable When It's Scientific? How Scientific Discourse Style Influences Laypeople's Resolution of Conflicts

ERIC Educational Resources Information Center

Bromme, Rainer; Scharrer, Lisa; Stadtler, Marc; Hömberg, Johanna; Torspecken, Ronja

2015-01-01

Scientific texts are a genre in which adherence to specific discourse conventions allows for conclusions on the scientific integrity of the information and thus on its validity. This study examines whether genre-typical features of scientific discourse influence how laypeople handle conflicting science-based knowledge claims. In two experiments…

On Mathematicians' Proof Skimming: A Reply to Inglis and Alcock

ERIC Educational Resources Information Center

Weber, Keith; Mejia-Ramos, Juan Pablo

2013-01-01

n a recent article, Inglis and Alcock (2012) contended that their data challenge the claim that when mathematicians validate proofs, they initially skim a proof to grasp its main idea before reading individual parts of the proof more carefully. This result is based on the fact that when mathematicians read proofs in their study, on average their…

Values-Based Self-Reflective Action Research for Promoting Gender Equality: Some Unexpected Lessons

ERIC Educational Resources Information Center

Wood, Lesley

2014-01-01

The idea of using values as a means of guiding our research decisions and judging the validity of our claims of knowledge is well established in literature on the self-reflective genre of action research. Values in action research should always result in virtuous behaviour--to promote the general social good. However, ideas of what constitutes the…

Identification of Emergency Department Visits in Medicare Administrative Claims: Approaches and Implications

PubMed Central

Venkatesh, Arjun K.; Mei, Hao; Kocher, Keith E.; Granovsky, Michael; Obermeyer, Ziad; Spatz, Erica S.; Rothenberg, Craig; Krumholz, Harlan M.; Lin, Zhenqui

2018-01-01

Objectives Administrative claims data sets are often used for emergency care research and policy investigations of healthcare resource utilization, acute care practices, and evaluation of quality improvement interventions. Despite the high profile of emergency department (ED) visits in analyses using administrative claims, little work has evaluated the degree to which existing definitions based on claims data accurately captures conventionally defined hospital-based ED services. We sought to construct an operational definition for ED visitation using a comprehensive Medicare data set and to compare this definition to existing operational definitions used by researchers and policymakers. Methods We examined four operational definitions of an ED visit commonly used by researchers and policymakers using a 20% sample of the 2012 Medicare Chronic Condition Warehouse (CCW) data set. The CCW data set included all Part A (hospital) and Part B (hospital outpatient, physician) claims for a nationally representative sample of continuously enrolled Medicare fee-for-services beneficiaries. Three definitions were based on published research or existing quality metrics including: 1) provider claims–based definition, 2) facility claims–based definition, and 3) CMS Research Data Assistance Center (ResDAC) definition. In addition, we developed a fourth operational definition (Yale definition) that sought to incorporate additional coding rules for identifying ED visits. We report levels of agreement and disagreement among the four definitions. Results Of 10,717,786 beneficiaries included in the sample data set, 22% had evidence of ED use during the study year under any of the ED visit definitions. The definition using provider claims identified a total of 4,199,148 ED visits, the facility definition 4,795,057 visits, the ResDAC definition 5,278,980 ED visits, and the Yale definition 5,192,235 ED visits. The Yale definition identified a statistically different (p < 0.05) collection of ED visits than all other definitions including 17% more ED visits than the provider definition and 2% fewer visits than the ResDAC definition. Differences in ED visitation counts between each definition occurred for several reasons including the inclusion of critical care or observation services in the ED, discrepancies between facility and provider billing regulations, and operational decisions of each definition. Conclusion Current operational definitions of ED visitation using administrative claims produce different estimates of ED visitation based on the underlying assumptions applied to billing data and data set availability. Future analyses using administrative claims data should seek to validate specific definitions and inform the development of a consistent, consensus ED visitation definitions to standardize research reporting and the interpretation of policy interventions. PMID:27864915

Epistemological Dialogue of Validity: Building Validity in Educational and Social Research

ERIC Educational Resources Information Center

Cakir, Mustafa

2012-01-01

The notion of validity in the social sciences is evolving and is influenced by philosophy of science, critiques of objectivity, and epistemological debates. Methodology for validation of the knowledge claims is diverse across different philosophies of science. In other words, definition and the way to establish of validity have evolved as…

Official statistics and claims data records indicate non-response and recall bias within survey-based estimates of health care utilization in the older population

PubMed Central

2013-01-01

Background The validity of survey-based health care utilization estimates in the older population has been poorly researched. Owing to data protection legislation and a great number of different health care insurance providers, the assessment of recall and non-response bias is challenging to impossible in many countries. The objective of our study was to compare estimates from a population-based study in older German adults with external secondary data. Methods We used data from the German KORA-Age study, which included 4,127 people aged 65–94 years. Self-report questions covered the utilization of long-term care services, inpatient services, outpatient services, and pharmaceuticals. We calculated age- and sex-standardized mean utilization rates in each domain and compared them with the corresponding estimates derived from official statistics and independent statutory health insurance data. Results The KORA-Age study underestimated the use of long-term care services (−52%), in-hospital days (−21%) and physician visits (−70%). In contrast, the assessment of drug consumption by postal self-report questionnaires yielded similar estimates to the analysis of insurance claims data (−9%). Conclusion Survey estimates based on self-report tend to underestimate true health care utilization in the older population. Direct validation studies are needed to disentangle the impact of recall and non-response bias. PMID:23286781

A systematic review of validated methods for identifying pulmonary fibrosis and interstitial lung disease using administrative and claims data.

PubMed

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

2012-01-01

The Food and Drug Administration's Mini-Sentinel pilot program initially aimed 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 (HOIs) from administrative and claims data. This paper summarizes the process and findings of the algorithm review of pulmonary fibrosis and interstitial lung disease. PubMed and Iowa Drug Information Service Web searches were conducted to identify citations applicable to the pulmonary fibrosis/interstitial lung disease HOI. Level 1 abstract reviews and Level 2 full-text reviews were conducted to find articles using administrative and claims data to identify pulmonary fibrosis and interstitial lung disease, including validation estimates of the coding algorithms. Our search revealed a deficiency of literature focusing on pulmonary fibrosis and interstitial lung disease algorithms and validation estimates. Only five studies provided codes; none provided validation estimates. Because interstitial lung disease includes a broad spectrum of diseases, including pulmonary fibrosis, the scope of these studies varied, as did the corresponding diagnostic codes used. Research needs to be conducted on designing validation studies to test pulmonary fibrosis and interstitial lung disease algorithms and estimating their predictive power, sensitivity, and specificity. Copyright © 2012 John Wiley & Sons, Ltd.

"It's all too subjective": scepticism about the possibility or use of philosophical medical ethics.

PubMed

Gillon, R

1985-05-25

In one of a series of articles on philosophical medical ethics, Gillon rebuts the argument that moral claims are essentially different from scientific claims because scientific claims are objective and confirmable or refutable, while moral claims are subjective, unconfirmable, irrefutable, and their differences incapable of resolution. He contends that there is widespread agreement about many moral principles, that moral disagreement may arise from the use of ambiguous terminology, and that progress toward resolution may be accomplished by analysis of the logical validity and consistency of the arguments.

Fun and Games: The Validity of Games for the Study of Conflict

ERIC Educational Resources Information Center

Schlenker, Barry R.; Bonoma, Thomas V.

1978-01-01

Examines claimed advantages and criticisms of the use of games in the study of social conflict, differentiating the advantages and criticisms into questions of internal validity, external validity, and ecological validity. Available from: Sage Publications, Inc., 275 South Beverly Drive, Beverly Hills, California 90212. (JG)

Validity: Applying Current Concepts and Standards to Gynecologic Surgery Performance Assessments

ERIC Educational Resources Information Center

LeClaire, Edgar L.; Nihira, Mikio A.; Hardré, Patricia L.

2015-01-01

Validity is critical for meaningful assessment of surgical competency. According to the Standards for Educational and Psychological Testing, validation involves the integration of data from well-defined classifications of evidence. In the authoritative framework, data from all classifications support construct validity claims. The two aims of this…

Challenges in using medicaid claims to ascertain child maltreatment.

PubMed

Raghavan, Ramesh; Brown, Derek S; Allaire, Benjamin T; Garfield, Lauren D; Ross, Raven E; Hedeker, Donald

2015-05-01

Medicaid data contain International Classification of Diseases, Clinical Modification (ICD-9-CM) codes indicating maltreatment, yet there is a little information on how valid these codes are for the purposes of identifying maltreatment from health, as opposed to child welfare, data. This study assessed the validity of Medicaid codes in identifying maltreatment. Participants (n = 2,136) in the first National Survey of Child and Adolescent Well-Being were linked to their Medicaid claims obtained from 36 states. Caseworker determinations of maltreatment were compared with eight sets of ICD-9-CM codes. Of the 1,921 children identified by caseworkers as being maltreated, 15.2% had any relevant ICD-9-CM code in any of their Medicaid files across 4 years of observation. Maltreated boys and those of African American race had lower odds of displaying a maltreatment code. Using only Medicaid claims to identify maltreated children creates validity problems. Medicaid data linkage with other types of administrative data is required to better identify maltreated children. © The Author(s) 2014.

A profile of anti-vaccination lobbying on the South African internet, 2011-2013.

PubMed

Burnett, Rosemary Joyce; von Gogh, Lauren Jennifer; Moloi, Molelekeng H; François, Guido

2015-11-01

The South African Vaccination and Immunisation Centre receives many requests to explain the validity of internet-based anti-vaccination claims. Previous global studies on internet-based anti-vaccination lobbying had not identified anti-vaccination web pages originating in South Africa (SA). To characterise SA internet-based anti-vaccination lobbying. In 2011, searches for anti-vaccination content were performed using Google, Yahoo and MSN-Bing, limited to English-language SA web pages. Content analysis was performed on web pages expressing anti-vaccination sentiment about infant vaccination. This was repeated in 2012 and 2013 using Google, with the first 700 web pages per search being analysed. Blogs/forums, articles and e-shops constituted 40.3%, 55.2% and 4.5% of web pages, respectively. Authors were lay people (63.5%), complementary/alternative medicine (CAM) practitioners (23.1%), medical professionals practising CAM (7.7%) and medical professionals practising only allopathic medicine (5.8%). Advertisements appeared on 55.2% of web pages. Of these, 67.6% were sponsored by or linked to organisations with financial interests in discrediting vaccines, with 80.0% and 24.0% of web pages sponsored by these organisations claiming respectively that vaccines are ineffective and that vaccination is profit driven. The vast majority of web pages (92.5%) claimed that vaccines are not safe, and 77.6% of anti-vaccination claims originated from the USA. South Africans are creating web pages or blogs for local anti-vaccination lobbying. Research is needed to understand what influence internet-based anti-vaccination lobbying has on the uptake of infant vaccination in SA.

The validated hypoallergenic cosmetics rating system: its 30-year evolution and effect on the prevalence of cosmetic reactions.

PubMed

Verallo-Rowell, Vermén M

2011-01-01

The validated hypoallergenic (vh) rating system was initiated in 1988 to try to objectively validate the "hypoallergenic" claim in cosmetics. To show how the system rates cosmetic hypoallergenicity and to compare the prevalence of cosmetic contact dermatitis (CCD) among users of regular cosmetics versus cosmetics with high VH numbers. (1) Made a VH list based on top allergens from patch-test results published by the North American Contact Dermatitis Group (NACDG) and the European Surveillance System on Contact Allergies (ESSCA); (2) reviewed global regulatory, cosmetic, drug, packaging, and manufacturing practices to show how allergens may contaminate products; (3) compared cosmetic ingredients lists against the VH list to obtain the VH rating (the more allergens absent, the higher the VH rating); and (4) obtained CCD prevalence among users of regular cosmetics versus users of cosmetics with high VH ratings. (1) Two VH lists (1988, 2003) included only cosmetic allergens in the NACDG surveys, the third (2007) included cosmetic and potential contaminant noncosmetic allergens, and the fourth (2010) adds ESSCA patch-test surveys. (2) CCD prevalence is 0.05 to 0.12% (average, 0.08%) among users of cosmetics with high VH ratings versus 2.4 to 36.3% among users of regular cosmetics. The VH rating system is shown to objectively validate the hypoallergenic cosmetics claim.

Reducing medical claims cost to Ghana's National Health Insurance scheme: a cross-sectional comparative assessment of the paper- and electronic-based claims reviews.

PubMed

Nsiah-Boateng, Eric; Asenso-Boadi, Francis; Dsane-Selby, Lydia; Andoh-Adjei, Francis-Xavier; Otoo, Nathaniel; Akweongo, Patricia; Aikins, Moses

2017-02-06

A robust medical claims review system is crucial for addressing fraud and abuse and ensuring financial viability of health insurance organisations. This paper assesses claims adjustment rate of the paper- and electronic-based claims reviews of the National Health Insurance Scheme (NHIS) in Ghana. The study was a cross-sectional comparative assessment of paper- and electronic-based claims reviews of the NHIS. Medical claims of subscribers for the year, 2014 were requested from the claims directorate and analysed. Proportions of claims adjusted by the paper- and electronic-based claims reviews were determined for each type of healthcare facility. Bivariate analyses were also conducted to test for differences in claims adjustments between healthcare facility types, and between the two claims reviews. The electronic-based review made overall adjustment of 17.0% from GHS10.09 million (USD2.64 m) claims cost whilst the paper-based review adjusted 4.9% from a total of GHS57.50 million (USD15.09 m) claims cost received, and the difference was significant (p < 0.001). However, there were no significant differences in claims cost adjustment rate between healthcare facility types by the electronic-based (p = 0.0656) and by the paper-based reviews (p = 0.6484). The electronic-based review adjusted significantly higher claims cost than the paper-based claims review. Scaling up the electronic-based review to cover claims from all accredited care providers could reduce spurious claims cost to the scheme and ensure long term financial sustainability.

An extended model for ultrasonic-based enhanced oil recovery with experimental validation.

PubMed

Mohsin, Mohammed; Meribout, Mahmoud

2015-03-01

This paper suggests a new ultrasonic-based enhanced oil recovery (EOR) model for application in oil field reservoirs. The model is modular and consists of an acoustic module and a heat transfer module, where the heat distribution is updated when the temperature rise exceeds 1 °C. The model also considers the main EOR parameters which includes both the geophysical (i.e., porosity, permeability, temperature rise, and fluid viscosity) and acoustical (e.g., acoustic penetration and pressure distribution in various fluids and mediums) properties of the wells. Extended experiments were performed using powerful ultrasonic waves which were applied for different kind of oils & oil saturated core samples. The corresponding results showed a good matching with those obtained from simulations, validating the suggested model to some extent. Hence, a good recovery rate of around 88.2% of original oil in place (OOIP) was obtained after 30 min of continuous generation of ultrasonic waves. This leads to consider the ultrasonic-based EOR as another tangible solution for EOR. This claim is supported further by considering several injection wells where the simulation results indicate that with four (4) injection wells; the recovery rate may increase up-to 96.7% of OOIP. This leads to claim the high potential of ultrasonic-based EOR as compared to the conventional methods. Following this study, the paper also proposes a large scale ultrasonic-based EOR hardware system for installation in oil fields. Copyright © 2014 Elsevier B.V. All rights reserved.

40 CFR 350.9 - Initial action by EPA.

Code of Federal Regulations, 2011 CFR

2011-07-01

... RIGHT-TO-KNOW INFORMATION: AND TRADE SECRET DISCLOSURES TO HEALTH PROFESSIONALS Trade Secrecy Claims... determine whether chemical identity information claimed as trade secret is entitled to trade secret... disclosure of trade secret chemical identity or if EPA decides to initiate a determination of the validity of...

40 CFR 350.9 - Initial action by EPA.

Code of Federal Regulations, 2013 CFR

2013-07-01

... RIGHT-TO-KNOW INFORMATION: AND TRADE SECRET DISCLOSURES TO HEALTH PROFESSIONALS Trade Secrecy Claims... determine whether chemical identity information claimed as trade secret is entitled to trade secret... disclosure of trade secret chemical identity or if EPA decides to initiate a determination of the validity of...

40 CFR 350.9 - Initial action by EPA.

Code of Federal Regulations, 2012 CFR

2012-07-01

... RIGHT-TO-KNOW INFORMATION: AND TRADE SECRET DISCLOSURES TO HEALTH PROFESSIONALS Trade Secrecy Claims... determine whether chemical identity information claimed as trade secret is entitled to trade secret... disclosure of trade secret chemical identity or if EPA decides to initiate a determination of the validity of...

40 CFR 350.9 - Initial action by EPA.

Code of Federal Regulations, 2014 CFR

2014-07-01

... RIGHT-TO-KNOW INFORMATION: AND TRADE SECRET DISCLOSURES TO HEALTH PROFESSIONALS Trade Secrecy Claims... determine whether chemical identity information claimed as trade secret is entitled to trade secret... disclosure of trade secret chemical identity or if EPA decides to initiate a determination of the validity of...

40 CFR 350.9 - Initial action by EPA.

Code of Federal Regulations, 2010 CFR

2010-07-01

... RIGHT-TO-KNOW INFORMATION: AND TRADE SECRET DISCLOSURES TO HEALTH PROFESSIONALS Trade Secrecy Claims... determine whether chemical identity information claimed as trade secret is entitled to trade secret... disclosure of trade secret chemical identity or if EPA decides to initiate a determination of the validity of...

A Bayesian hierarchical model with spatial variable selection: the effect of weather on insurance claims

PubMed Central

Scheel, Ida; Ferkingstad, Egil; Frigessi, Arnoldo; Haug, Ola; Hinnerichsen, Mikkel; Meze-Hausken, Elisabeth

2013-01-01

Climate change will affect the insurance industry. We develop a Bayesian hierarchical statistical approach to explain and predict insurance losses due to weather events at a local geographic scale. The number of weather-related insurance claims is modelled by combining generalized linear models with spatially smoothed variable selection. Using Gibbs sampling and reversible jump Markov chain Monte Carlo methods, this model is fitted on daily weather and insurance data from each of the 319 municipalities which constitute southern and central Norway for the period 1997–2006. Precise out-of-sample predictions validate the model. Our results show interesting regional patterns in the effect of different weather covariates. In addition to being useful for insurance pricing, our model can be used for short-term predictions based on weather forecasts and for long-term predictions based on downscaled climate models. PMID:23396890

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.

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.

How honest are the signals? A protocol for validating wearable sensors.

PubMed

Kayhan, Varol Onur; Chen, Zheng Chris; French, Kimberly A; Allen, Tammy D; Salomon, Kristen; Watkins, Alison

2018-02-01

There is growing interest among organizational researchers in tapping into alternative sources of data beyond self-reports to provide a new avenue for measuring behavioral constructs. Use of alternative data sources such as wearable sensors is necessary for developing theory and enhancing organizational practice. Although wearable sensors are now commercially available, the veracity of the data they capture is largely unknown and mostly based on manufacturers' claims. The goal of this research is to test the validity and reliability of data captured by one such wearable badge (by Humanyze) in the context of structured meetings where all individuals wear a badge for the duration of the encounter. We developed a series of studies, each targeting a specific sensor of this badge that is relevant for structured meetings, and we make specific recommendations for badge data usage based on our validation results. We have incorporated the insights from our studies on a website that researchers can use to conduct validation tests for their badges, upload their data, and assess the validity of the data. We discuss this website in the corresponding studies.

36 CFR 292.62 - Valid existing rights.

Code of Federal Regulations, 2012 CFR

2012-07-01

... segments. The rights associated with all mining claims on National Forest System lands within the SRNRA in... mining claims on National Forest System lands in that portion of the SRNRA not covered by paragraph (a)(1... Section 292.62 Parks, Forests, and Public Property FOREST SERVICE, DEPARTMENT OF AGRICULTURE NATIONAL...

36 CFR 292.62 - Valid existing rights.

Code of Federal Regulations, 2011 CFR

2011-07-01

... segments. The rights associated with all mining claims on National Forest System lands within the SRNRA in... mining claims on National Forest System lands in that portion of the SRNRA not covered by paragraph (a)(1... Section 292.62 Parks, Forests, and Public Property FOREST SERVICE, DEPARTMENT OF AGRICULTURE NATIONAL...

36 CFR 292.62 - Valid existing rights.

Code of Federal Regulations, 2013 CFR

2013-07-01

... segments. The rights associated with all mining claims on National Forest System lands within the SRNRA in... mining claims on National Forest System lands in that portion of the SRNRA not covered by paragraph (a)(1... Section 292.62 Parks, Forests, and Public Property FOREST SERVICE, DEPARTMENT OF AGRICULTURE NATIONAL...

36 CFR 292.62 - Valid existing rights.

Code of Federal Regulations, 2014 CFR

2014-07-01

... segments. The rights associated with all mining claims on National Forest System lands within the SRNRA in... mining claims on National Forest System lands in that portion of the SRNRA not covered by paragraph (a)(1... Section 292.62 Parks, Forests, and Public Property FOREST SERVICE, DEPARTMENT OF AGRICULTURE NATIONAL...

Recommendations for Practice: Justifying Claims of Generalizability

ERIC Educational Resources Information Center

Hedges, Larry V.

2013-01-01

Recommendations for practice are routinely included in articles that report educational research. Robinson et al. suggest that reports of primary research should not routinely do so. They argue that single primary research studies seldom have sufficient external validity to support claims about practice policy. In this article, I draw on recent…

The Myth of Learning Styles

ERIC Educational Resources Information Center

Riener, Cedar; Willingham, Daniel

2010-01-01

There is no credible evidence that learning styles exist. In this article, the authors begin by defining "learning styles"; then they address the claims made by those who believe that they exist, in the process acknowledging what the authors consider the valid claims of learning-styles theorists. But in separating the wheat from the…

Optimization of space system development resources

NASA Astrophysics Data System (ADS)

Kosmann, William J.; Sarkani, Shahram; Mazzuchi, Thomas

2013-06-01

NASA has had a decades-long problem with cost growth during the development of space science missions. Numerous agency-sponsored studies have produced average mission level cost growths ranging from 23% to 77%. A new study of 26 historical NASA Science instrument set developments using expert judgment to reallocate key development resources has an average cost growth of 73.77%. Twice in history, a barter-based mechanism has been used to reallocate key development resources during instrument development. The mean instrument set development cost growth was -1.55%. Performing a bivariate inference on the means of these two distributions, there is statistical evidence to support the claim that using a barter-based mechanism to reallocate key instrument development resources will result in a lower expected cost growth than using the expert judgment approach. Agent-based discrete event simulation is the natural way to model a trade environment. A NetLogo agent-based barter-based simulation of science instrument development was created. The agent-based model was validated against the Cassini historical example, as the starting and ending instrument development conditions are available. The resulting validated agent-based barter-based science instrument resource reallocation simulation was used to perform 300 instrument development simulations, using barter to reallocate development resources. The mean cost growth was -3.365%. A bivariate inference on the means was performed to determine that additional significant statistical evidence exists to support a claim that using barter-based resource reallocation will result in lower expected cost growth, with respect to the historical expert judgment approach. Barter-based key development resource reallocation should work on spacecraft development as well as it has worked on instrument development. A new study of 28 historical NASA science spacecraft developments has an average cost growth of 46.04%. As barter-based key development resource reallocation has never been tried in a spacecraft development, no historical results exist, and a simulation of using that approach must be developed. The instrument development simulation should be modified to account for spacecraft development market participant differences. The resulting agent-based barter-based spacecraft resource reallocation simulation would then be used to determine if significant statistical evidence exists to prove a claim that using barter-based resource reallocation will result in lower expected cost growth.

Outcome measures for oral health based on clinical assessments and claims data: feasibility evaluation in practice.

PubMed

Hummel, Riët; Bruers, Josef; van der Galiën, Onno; van der Sanden, Wil; van der Heijden, Geert

2017-10-05

It is well known that treatment variation exists in oral healthcare, but the consequences for oral health are unknown as the development of outcome measures is still in its infancy. The aim of this study was to identify and develop outcome measures for oral health and explore their performance using health insurance claims records and clinical data from general dental practices. The Dutch healthcare insurance company Achmea collaborated with researchers, oral health experts, and general dental practitioners (GDPs) in a proof of practice study to test the feasibility of measures in general dental practices. A literature search identified previously described outcome measures for oral healthcare. Using a structured approach, identified measures were (i) prioritized, adjusted and added to after discussion and then (ii) tested for feasibility of data collection, their face validity and discriminative validity. Data sources were claims records from Achmea, clinical records from dental practices, and prospective, pre-determined clinical assessment data obtained during routine consultations. In total eight measures (four on dental caries, one on tooth wear, two on periodontal health, one on retreatment) were identified, prioritized and tested. The retreatment measure and three measures for dental caries were found promising as data collection was feasible, they had face validity and discriminative validity. Deployment of these measures demonstrated variation in clinical practices of GDPs. Feedback of this data to GDPs led to vivid discussions on best practices and quality of care. The measure 'tooth wear' was not considered sufficiently responsive; 'changes in periodontal health score' was considered a controversial measure. The available data for the measures 'percentage of 18-year-olds with no tooth decay' and 'improvement in gingival bleeding index at reassessment' was too limited to provide accurate estimates per dental practice. The evaluated measures 'time to first restoration', 'distribution of risk categories for dental caries', 'filled-and-missing score' and 'retreatment after restoration', were considered valid and relevant measures and a proxy for oral health status. As such, they improve the transparency of oral health services delivery that can be related to oral health outcomes, and with time may serve to improve these oral health outcomes.

Surrogate endpoints and emerging surrogate endpoints for risk reduction of cardiovascular disease.

PubMed

Rasnake, Crystal M; Trumbo, Paula R; Heinonen, Therese M

2008-02-01

This article reviews surrogate endpoints and emerging biomarkers that were discussed at the annual "Cardiovascular Biomarkers and Surrogate Endpoints" symposium cosponsored by the US Food and Drug Administration (FDA) and the Montreal Heart Institute. The FDA's Center for Food Safety and Applied Nutrition (CFSAN) uses surrogate endpoints in its scientific review of a substance/disease relationship for a health claim. CFSAN currently recognizes three validated surrogate endpoints: blood pressure, blood total cholesterol, and blood low-density lipoprotein (LDL) concentration in its review of a health claim for cardiovascular disease (CVD). Numerous potential surrogate endpoints of CVD are being evaluated as the pathophysiology of heart disease is becoming better understood. However, these emerging biomarkers need to be validated as surrogate endpoints before they are used by CFSAN in the evaluation of a CVD health claim.

[Prevalence of Cardiovascular Risk Factors at The Population Level: A Comparison of Ambulatory Physician-Coded Claims Data With Clinical Data From A Population-Based Study].

PubMed

Angelow, Aniela; Reber, Katrin Christiane; Schmidt, Carsten Oliver; Baumeister, Sebastian Edgar; Chenot, Jean-Francois

2018-06-04

The study assesses the validity of ICD-10 coded cardiovascular risk factors in claims data using gold-standard measurements from a population-based study for arterial hypertension, diabetes, dyslipidemia, smoking and obesity as a reference. Data of 1941 participants (46 % male, mean age 58±13 years) of the Study of Health in Pomerania (SHIP) were linked to electronic medical records from the regional association of statutory health insurance physicians from 2008 to 2012 used for billing purposes. Clinical data from SHIP was used as a gold standard to assess the agreement with claims data for ICD-10 codes I10.- (arterial hypertension), E10.- to E14.- (diabetes mellitus), E78.- (dyslipidemia), F17.- (smoking) and E65.- to E68.- (obesity). A higher agreement between ICD-coded and clinical diagnosis was found for diabetes (sensitivity (sens) 84%, specificity (spec) 95%, positive predictive value (ppv) 80%) and hypertension (sens 72%, spec 93%, ppv 97%) and a low level of agreement for smoking (sens 18%, spec 99%, ppv 89%), obesity (sens 22%, spec 99%, ppv 99%) and dyslipidemia (sens 40%, spec 60%, ppv 70%). Depending on the investigated cardiovascular risk factor, medication, documented additional cardiovascular co-morbidities, age, sex and clinical severity were associated with the ICD-coded cardiovascular risk factor. The quality of ICD-coding in ambulatory care is highly variable for different cardiovascular risk factors and outcomes. Diagnoses were generally undercoded, but those relevant for billing were coded more frequently. Our results can be used to quantify errors in population-based estimates of prevalence based on claims data for the investigated cardiovascular risk factors. © Georg Thieme Verlag KG Stuttgart · New York.

Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union

PubMed Central

2014-01-01

Background Metastatic castration-resistant prostate cancer (mCRPC) and its treatment significantly affect health-related quality of life (HRQOL). Our objectives were to evaluate and compare patient-reported outcome (PRO) claims granted by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for 5 recently approved mCRPC treatments and to examine key characteristics, development, and measurement properties of the PRO measures supporting these claims against current regulatory standards. Methods Five products approved for treatment of mCRPC by the FDA and the EMA (2010–2013) were examined: enzalutamide, abiraterone, sipuleucel-T, cabazitaxel, and radium Ra 223 dichloride. United States (US) drug approval packages and European Public Assessment Reports were reviewed. PRO claims in the US labels and European Summaries of Product Characteristics and supporting measures were identified. For PRO measures supporting claims, a targeted literature review was conducted to identify information on key characteristics and measurement properties; this information was compared against FDA PRO guidance criteria. Results Nine PRO “claims” were granted across 4 of 5 products reviewed. The EMA granted more claims (7 claims—4 for pain, 3 for HRQOL) than the FDA (2 claims, both for pain). The Brief Pain Inventory–Short Form (BPI-SF) worst pain item supported most pain claims and was the only measure supporting US claims. EMA pain claims were supported by BPI-SF worst pain (n = 2) and average pain (n = 1) items and the McGill Pain Questionnaire Present Pain Intensity component (n = 1). EMA HRQOL claims were supported by the Functional Assessment of Cancer Therapy–Prostate Module (n = 2) and the EuroQol 5 Dimensions with visual analogue scale (n = 1). Pain and prostate cancer–specific HRQOL measures supporting claims met US regulatory standards for construct validity, reliability, and responsiveness; these properties were strongest for the BPI-SF worst pain item. Only the BPI-SF worst pain item has documented content validity in mCRPC. Conclusions PRO label claims were commonly granted across the mCRPC products reviewed. Among the measures reviewed, only the BPI-SF worst pain item supported US label claims. The BPI-SF worst pain item is recommended for pain assessment for the evaluation of new mCRPC treatments. PMID:24989428

[Food, health claims and drugs. Introduction: why such a session devoted to this topic].

PubMed

Bourlioux, P

2008-01-01

During the ten past years, several countries as Japan, Sweden, Finland, Canada, USA, France ... got involved in the research of foods with positive impact on health. So, new notions as "functionnal foods" and new products with significant names as "alicaments", "nutraceuticals", "foods with health claims" (some of them claiming therapeutic effects) have been created. Since such health claims were developped in different countries of the European Union, a new directive applicable to the Member States from the 1st of July 2007 has been voted by the European Parliament with the following aims: harmonization of health claims and validation of the only claims supported by relevant scientific proofs. Face to such a situation, the French Academy of Pharmacy needed to improve this question, take a clear position, and express necessary recommendations.

Scientists, postmodernists or fascists?

PubMed

Pearson, Alan

2006-12-01

The somewhat frenzied reaction to publication of a provocative, discursive paper titled 'Deconstructing the evidence-based discourse in health sciences: truth, power and fascism' by Holmes et al. in the International Journal of Evidence-Based Healthcare is both surprising and worrying. The paper is essentially a postmodernist critique of evidence-based healthcare. In the same issue of the journal in which the paper was published both the guest editorial and a response to the paper refute its claims. However, media coverage on the paper gave rise to numerous defensive responses that attacked the paper through claiming it represents 'bad science' or by disparaging the International Journal of Evidence-Based Healthcare, its Editor, its peer review processes or the organisation linked to the journal, the Joanna Briggs Institute. It is clear that those who mounted these attacks had no knowledge of the journal (or of the editorial and response refuting the claims made in the paper, published in the same issue) or its parent organisation; and none of them attempted to critique the paper in a scholarly fashion. This paper sets out to construct a scholarly argument to refute these claims and to consider why it is that those who support evidence-based healthcare and/or science chose to disparage a journal and an organisation that promotes and facilitates evidence-based approaches to healthcare - and the value of the Cochrane Collaboration - rather than developing a rigorous critique of the argument developed in the Holmes et al. paper. Although this response appears to be an attempt to silence dissenting views (and may, to some, suggest that the reference to microfascism in the paper in question may, indeed, have some validity) we conclude that the postmodernist critique of evidence-based healthcare embodied in the paper sets out criticisms that, though widespread in healthcare, can be challenged in a considered, scholarly way. The ill-informed, reactionary responses to it by the defenders of science make little contribution to the ongoing development of evidence to improve global health.

Examination of the relationship between theory-driven policies and allowed lost-time back claims in workers' compensation: a system dynamics model.

PubMed

Wong, Jessica J; McGregor, Marion; Mior, Silvano A; Loisel, Patrick

2014-01-01

The purpose of this study was to develop a model that evaluates the impact of policy changes on the number of workers' compensation lost-time back claims in Ontario, Canada, over a 30-year timeframe. The model was used to test the hypothesis that a theory- and policy-driven model would be sufficient in reproducing historical claims data in a robust manner and that policy changes would have a major impact on modeled data. The model was developed using system dynamics methods in the Vensim simulation program. The theoretical effects of policies for compensation benefit levels and experience rating fees were modeled. The model was built and validated using historical claims data from 1980 to 2009. Sensitivity analysis was used to evaluate the modeled data at extreme end points of variable input and timeframes. The degree of predictive value of the modeled data was measured by the coefficient of determination, root mean square error, and Theil's inequality coefficients. Correlation between modeled data and actual data was found to be meaningful (R(2) = 0.934), and the modeled data were stable at extreme end points. Among the effects explored, policy changes were found to be relatively minor drivers of back claims data, accounting for a 13% improvement in error. Simulation results suggested that unemployment, number of no-lost-time claims, number of injuries per worker, and recovery rate from back injuries outside of claims management to be sensitive drivers of back claims data. A robust systems-based model was developed and tested for use in future policy research in Ontario's workers' compensation. The study findings suggest that certain areas within and outside the workers' compensation system need to be considered when evaluating and changing policies around back claims. © 2014. Published by National University of Health Sciences All rights reserved.

Technology Use and Learning Characteristics of Students in Higher Education: Do Generational Differences Exist?

ERIC Educational Resources Information Center

Lai, Kwok-Wing; Hong, Kian-Sam

2015-01-01

As digital technologies form an inextricable part of young people's everyday lives, some commentators claim that the current generation of learners think and learn differently from their predecessors. This study investigated the validity of this claim by surveying 799 undergraduate and 81 postgraduate students at a large research-intensive…

Is Brain Gym[R] an Effective Educational Intervention?

ERIC Educational Resources Information Center

Spaulding, Lucinda S.; Mostert, Mark P.; Beam, Andrea P.

2010-01-01

Brain Gym[R] (BG; BGI, 2008) is a popular commercial program sold by Brain Gym[R] International (BGI). Making extravagant claims for improved intellectual and physical development, it is used in more than 80 countries. While BGI's claims are persuasive, to date there is little empirical evidence validating the approach. We examine some theoretical…

From Command to Constructivism: Canadian Secondary School Physical Education Curriculum and "Teaching Games for Understanding"

ERIC Educational Resources Information Center

Singleton, Ellen

2009-01-01

Canadian physical educators have fought long and hard to be recognized as legitimate contributors to school curricula. In claiming alliances with discourses of medicine and morality, science and psychology, proponents of physical education have sought to be recognized and validated within the educational milieu. These claims have fundamentally…

Assessment and Learning: Some Reflections

ERIC Educational Resources Information Center

Wiliam, Dylan

2017-01-01

In this article, Dylan William states that the central claim in Baird, et al.'s piece is that if theories of assessment take into account theories of learning, assessments will somehow be more valid, and some of the more egregious effects of assessment on learning will be ameliorated. William responds to this claim by arguing that it seems…

Aesthetic Solidarity "after" Kant and Lyotard

ERIC Educational Resources Information Center

Vandenabeele, Bart

2008-01-01

One of the most complex issues in Kant's "Critique of Judgment" is the aesthetic judgment's claim to universal validity and shareability. Kant is not very clear about the exact status of this claim. Kant's distinction between the beautiful and the sublime only complicates the matter, since the universal shareability of the judgment of the sublime…

Re-Operationalizing Established Groups in Brainstorming: Validating Osborn's Claims

ERIC Educational Resources Information Center

Levine, Kenneth J.; Heuett, Kyle B.; Reno, Katie M.

2017-01-01

Since the introduction of brainstorming as an idea-generation technique to address organizational problems, researchers have struggled to replicate some of the claims around the technique. One major concern has been the differences in the number of ideas generated between established groups as found in industry versus the non-established groups…

How Principals Use Research

ERIC Educational Resources Information Center

Biddle, Bruce J.; Saha, Lawrence J.

2006-01-01

Claims that education research is flawed and that it has little or no impact on school practices have been circulating for at least 75 years, and this chorus of criticism has intensified in the past three decades. Yet the validity of such claims has not been investigated, write Biddle and Saha. The authors interviewed 120 school principals (81 in…

Use of health insurance claim patterns to identify patients using nonsteroidal anti-inflammatory drugs for rheumatoid arthritis.

PubMed

Bernard, Marie-Agnès; Bénichou, Jacques; Blin, Patrick; Weill, Alain; Bégaud, Bernard; Abouelfath, Abdelilah; Moore, Nicholas; Fourrier-Réglat, Annie

2012-06-01

To determine healthcare claim patterns associated using nonsteroidal anti-inflammatory drugs (NSAIDs) for rheumatoid arthritis (RA). The CADEUS study randomly identified NSAID users within the French health insurance database. One-year claims data were extracted, and NSAID indication was obtained from prescribers. Logistic regression was used in a development sample to identify claim patterns predictive of RA and models applied to a validation sample. Analyses were stratified on the dispensation of immunosuppressive agents or specific antirheumatism treatment, and the area under the receiver operating characteristic curve was used to estimate discriminant power. NSAID indication was provided for 26,259 of the 45,217 patients included in the CADEUS cohort; it was RA for 956 patients. Two models were constructed using the development sample (n = 13,143), stratifying on the dispensation of an immunosuppressive agent or specific antirheumatism treatment. Discriminant power was high for both models (AUC > 0.80) and was not statistically different from that found when applied to the validation sample (n = 13,116). The models derived from this study may help to identify patients prescribed NSAIDs who are likely to have RA in claims databases without medical data such as treatment indication. Copyright © 2012 John Wiley & Sons, Ltd.

Whose Consensus Is It Anyway? Scientific versus Legalistic Conceptions of Validity

ERIC Educational Resources Information Center

Borsboom, Denny

2012-01-01

Paul E. Newton provides an insightful and scholarly overview of central issues in validity theory. As he notes, many of the conceptual problems in validity theory derive from the fact that the word "validity" has two meanings. First, it indicates "whether a test measures what it purports to measure." This is a factual claim about the psychometric…

Modification of claims-based measures improves identification of comorbidities in non-elderly women undergoing mastectomy for breast cancer: a retrospective cohort study.

PubMed

Nickel, Katelin B; Wallace, Anna E; Warren, David K; Ball, Kelly E; Mines, Daniel; Fraser, Victoria J; Olsen, Margaret A

2016-08-16

Accurate identification of underlying health conditions is important to fully adjust for confounders in studies using insurer claims data. Our objective was to evaluate the ability of four modifications to a standard claims-based measure to estimate the prevalence of select comorbid conditions compared with national prevalence estimates. In a cohort of 11,973 privately insured women aged 18-64 years with mastectomy from 1/04-12/11 in the HealthCore Integrated Research Database, we identified diabetes, hypertension, deficiency anemia, smoking, and obesity from inpatient and outpatient claims for the year prior to surgery using four different algorithms. The standard comorbidity measure was compared to revised algorithms which included outpatient medications for diabetes, hypertension and smoking; an expanded timeframe encompassing the mastectomy admission; and an adjusted time interval and number of required outpatient claims. A χ2 test of proportions was used to compare prevalence estimates for 5 conditions in the mastectomy population to national health survey datasets (Behavioral Risk Factor Surveillance System and the National Health and Nutrition Examination Survey). Medical record review was conducted for a sample of women to validate the identification of smoking and obesity. Compared to the standard claims algorithm, use of the modified algorithms increased prevalence from 4.79 to 6.79 % for diabetes, 14.75 to 24.87 % for hypertension, 4.23 to 6.65 % for deficiency anemia, 1.78 to 12.87 % for smoking, and 1.14 to 6.31 % for obesity. The revised estimates were more similar, but not statistically equivalent, to nationally reported prevalence estimates. Medical record review revealed low sensitivity (17.86 %) to capture obesity in the claims, moderate negative predictive value (NPV, 71.78 %) and high specificity (99.15 %) and positive predictive value (PPV, 90.91 %); the claims algorithm for current smoking had relatively low sensitivity (62.50 %) and PPV (50.00 %), but high specificity (92.19 %) and NPV (95.16 %). Modifications to a standard comorbidity measure resulted in prevalence estimates that were closer to expected estimates for non-elderly women than the standard measure. Adjustment of the standard claims algorithm to identify underlying comorbid conditions should be considered depending on the specific conditions and the patient population studied.

Using Claims Data to Predict Dependency in Activities of Daily Living as a Proxy for Frailty

PubMed Central

Faurot, Keturah R.; Funk, Michele Jonsson; Pate, Virginia; Brookhart, M. Alan; Patrick, Amanda; Hanson, Laura C.; Castillo, Wendy Camelo; Stürmer, Til

2014-01-01

Purpose Estimating drug effectiveness and safety among older adults in population-based studies using administrative healthcare claims can be hampered by unmeasured confounding due to frailty. A claims-based algorithm that identifies patients likely to be dependent, a proxy for frailty, may improve confounding control. Our objective was to develop an algorithm to predict dependency in activities of daily living (ADL) in a sample of Medicare beneficiaries. Methods Community-dwelling respondents to the 2006 Medicare Current Beneficiary Survey, >65 years old, with Medicare Part A, B, home health, and hospice claims were included. ADL dependency was defined as needing help with bathing, eating, walking, dressing, toileting, or transferring. Potential predictors were demographics, ICD-9 diagnosis/procedure and durable medical equipment codes for frailty-associated conditions. Multivariable logistic regression was to predict ADL dependency. Cox models estimated hazard ratios for death as a function of observed and predicted ADL dependency. Results Of 6391 respondents, 57% were female, 88% white, and 38% were ≥80. The prevalence of ADL dependency was 9.5%. Strong predictors of ADL dependency were charges for a home hospital bed (OR=5.44, 95% CI=3.28–9.03) and wheelchair (OR=3.91, 95% CI=2.78–5.51). The c-statistic of the final model was 0.845. Model-predicted ADL dependency of 20% or greater was associated with a hazard ratio for death of 3.19 (95% CI: 2.78, 3.68). Conclusions An algorithm for predicting ADL dependency using healthcare claims was developed to measure some aspects of frailty. Accounting for variation in frailty among older adults could lead to more valid conclusions about treatment use, safety, and effectiveness. PMID:25335470

Feasibility and validity of International Classification of Diseases based case mix indices.

PubMed

Yang, Che-Ming; Reinke, William

2006-10-06

Severity of illness is an omnipresent confounder in health services research. Resource consumption can be applied as a proxy of severity. The most commonly cited hospital resource consumption measure is the case mix index (CMI) and the best-known illustration of the CMI is the Diagnosis Related Group (DRG) CMI used by Medicare in the U.S. For countries that do not have DRG type CMIs, the adjustment for severity has been troublesome for either reimbursement or research purposes. The research objective of this study is to ascertain the construct validity of CMIs derived from International Classification of Diseases (ICD) in comparison with DRG CMI. The study population included 551 acute care hospitals in Taiwan and 2,462,006 inpatient reimbursement claims. The 18th version of GROUPER, the Medicare DRG classification software, was applied to Taiwan's 1998 National Health Insurance (NHI) inpatient claim data to derive the Medicare DRG CMI. The same weighting principles were then applied to determine the ICD principal diagnoses and procedures based costliness and length of stay (LOS) CMIs. Further analyses were conducted based on stratifications according to teaching status, accreditation levels, and ownership categories. The best ICD-based substitute for the DRG costliness CMI (DRGCMI) is the ICD principal diagnosis costliness CMI (ICDCMI-DC) in general and in most categories with Spearman's correlation coefficients ranging from 0.938-0.462. The highest correlation appeared in the non-profit sector. ICD procedure costliness CMI (ICDCMI-PC) outperformed ICDCMI-DC only at the medical center level, which consists of tertiary care hospitals and is more procedure intensive. The results of our study indicate that an ICD-based CMI can quite fairly approximate the DRGCMI, especially ICDCMI-DC. Therefore, substituting ICDs for DRGs in computing the CMI ought to be feasible and valid in countries that have not implemented DRGs.

Testing for purchasing power parity in 21 African countries using several unit root tests

NASA Astrophysics Data System (ADS)

Choji, Niri Martha; Sek, Siok Kun

2017-04-01

Purchasing power parity is used as a basis for international income and expenditure comparison through the exchange rate theory. However, empirical studies show disagreement on the validity of PPP. In this paper, we conduct the testing on the validity of PPP using panel data approach. We apply seven different panel unit root tests to test the validity of the purchasing power parity (PPP) hypothesis based on the quarterly data on real effective exchange rate for 21 African countries from the period 1971: Q1-2012: Q4. All the results of the seven tests rejected the hypothesis of stationarity meaning that absolute PPP does not hold in those African Countries. This result confirmed the claim from previous studies that standard panel unit tests fail to support the PPP hypothesis.

Memory for murder. A psychological perspective on dissociative amnesia in legal contexts.

PubMed

Porter, S; Birt, A R; Yuille, J C; Hervé, H F

2001-01-01

There is currently a complex and inconsistent state in the law relating to dissociation and dissociative amnesia (McSherry, 1998). Although dissociative amnesia in defendants is relevant to both competency to stand trial and criminal responsibility in principle, courts have typically assumed a skeptical stance toward such claims in practice. However, there is considerable evidence from both nonoffender and offender populations to support the validity of dissociative amnesia in defendants. Further, there is information available to aid in the evaluation of amnesia, such as the quality of the report itself and characteristics of the person reporting the amnesia (e.g., psychopathy). When consideration is given to the legal response to reports of dissociative amnesia by complainants, the situation becomes even more complex. While some courts have rejected recovered memory evidence, others have convicted defendants of historical offenses based on such evidence. In some cases, judges have argued that jurors should be left to decide on the validity of recovered memories based on their common sense and experience. The uncritical acceptance of the validity of repressed memories in complainants by many courts stands in stark contrast to the response to claims of amnesia from defendants. It seems apparent that the courts need better guidelines around the issue of dissociative amnesia in both populations. We think that the increasing scientific understanding of memory in the past decade (see Schacter, 1999) can meaningfully contribute to the development of such guidelines. Responsible, nonpartisan expert testimony from mental health professionals would be one step in the direction of rectifying the current state of law in regards to dissociation.

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

PubMed

Idowu, Rachel T; Carnahan, Ryan; Sathe, Nila A; McPheeters, Melissa L

2013-12-30

To identify algorithms that can capture incident cases of myocarditis and pericarditis in administrative and claims databases; these algorithms can eventually be used to identify cardiac inflammatory adverse events following vaccine administration. We searched MEDLINE from 1991 to September 2012 using controlled vocabulary and key terms related to myocarditis. 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 as well as study conduct. Nine publications (including one study reported in two publications) met criteria for inclusion. Two studies performed medical record review in order to confirm that these coding algorithms actually captured patients with the disease of interest. One of these studies identified five potential cases, none of which were confirmed as acute myocarditis upon review. The other study, which employed a search algorithm based on diagnostic surveillance (using ICD-9 codes 420.90, 420.99, 422.90, 422.91 and 429.0) and sentinel reporting, identified 59 clinically confirmed cases of myopericarditis among 492,671 United States military service personnel who received smallpox vaccine between 2002 and 2003. Neither study provided algorithm validation statistics (positive predictive value, sensitivity, or specificity). A validated search algorithm is currently unavailable for identifying incident cases of pericarditis or myocarditis. Several authors have published unvalidated ICD-9-based search algorithms that appear to capture myocarditis events occurring in the context of other underlying cardiac or autoimmune conditions. Copyright © 2013. Published by Elsevier Ltd.

Truth and Evidence in Validity Theory

ERIC Educational Resources Information Center

Borsboom, Denny; Markus, Keith A.

2013-01-01

According to Kane (this issue), "the validity of a proposed interpretation or use depends on how well the evidence supports" the claims being made. Because truth and evidence are distinct, this means that the validity of a test score interpretation could be high even though the interpretation is false. As an illustration, we discuss the case of…

Predictive values of diagnostic codes for identifying serious hypocalcemia and dermatologic adverse events among women with postmenopausal osteoporosis in a commercial health plan database.

PubMed

Wang, Florence T; Xue, Fei; Ding, Yan; Ng, Eva; Critchlow, Cathy W; Dore, David D

2018-04-10

Post-marketing safety studies of medicines often rely on administrative claims databases to identify adverse outcomes following drug exposure. Valid ascertainment of outcomes is essential for accurate results. We aim to quantify the validity of diagnostic codes for serious hypocalcemia and dermatologic adverse events from insurance claims data among women with postmenopausal osteoporosis (PMO). We identified potential cases of serious hypocalcemia and dermatologic events through ICD-9 diagnosis codes among women with PMO within claims from a large US healthcare insurer (June 2005-May 2010). A physician adjudicated potential hypocalcemic and dermatologic events identified from the primary position on emergency department (ED) or inpatient claims through medical record review. Positive predictive values (PPVs) and 95% confidence intervals (CIs) quantified the fraction of potential cases that were confirmed. Among 165,729 patients with PMO, medical charts were obtained for 40 of 55 (73%) potential hypocalcemia cases; 16 were confirmed (PPV 40%, 95% CI 25-57%). The PPV was higher for ED than inpatient claims (82 vs. 24%). Among 265 potential dermatologic events (primarily urticaria or rash), we obtained 184 (69%) charts and confirmed 128 (PPV 70%, 95% CI 62-76%). The PPV was higher for ED than inpatient claims (77 vs. 39%). Diagnostic codes for hypocalcemia and dermatologic events may be sufficient to identify events giving rise to emergency care, but are less accurate for identifying events within hospitalizations.

Validation of a risk stratification tool for fall-related injury in a state-wide cohort.

PubMed

McCoy, Thomas H; Castro, Victor M; Cagan, Andrew; Roberson, Ashlee M; Perlis, Roy H

2017-02-06

A major preventable contributor to healthcare costs among older individuals is fall-related injury. We sought to validate a tool to stratify such risk based on readily available clinical data, including projected medication adverse effects, using state-wide medical claims data. Sociodemographic and clinical features were drawn from health claims paid in the state of Massachusetts for individuals aged 35-65 with a hospital admission for a period spanning January-December 2012. Previously developed logistic regression models of hospital readmission for fall-related injury were refit in a testing set including a randomly selected 70% of individuals, and examined in a training set comprised of the remaining 30%. Medications at admission were summarised based on reported adverse effect frequencies in published medication labelling. The Massachusetts health system. A total of 68 764 hospitalised individuals aged 35-65 years. Hospital readmission for fall-related injury defined by claims code. A total of 2052 individuals (3.0%) were hospitalised for fall-related injury within 90 days of discharge, and 3391 (4.9%) within 180 days. After recalibrating the model in a training data set comprised of 48 136 individuals (70%), model discrimination in the remaining 30% test set yielded an area under the receiver operating characteristic curve (AUC) of 0.74 (95% CI 0.72 to 0.76). AUCs were similar across age decades (0.71 to 0.78) and sex (0.72 male, 0.76 female), and across most common diagnostic categories other than psychiatry. For individuals in the highest risk quartile, 11.4% experienced fall within 180 days versus 1.2% in the lowest risk quartile; 57.6% of falls occurred in the highest risk quartile. This analysis of state-wide claims data demonstrates the feasibility of predicting fall-related injury requiring hospitalisation using readily available sociodemographic and clinical details. This translatable approach to stratification allows for identification of high-risk individuals in whom interventions are likely to be cost-effective. 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/.

Utilization of genetic tests: analysis of gene-specific billing in Medicare claims data.

PubMed

Lynch, Julie A; Berse, Brygida; Dotson, W David; Khoury, Muin J; Coomer, Nicole; Kautter, John

2017-08-01

We examined the utilization of precision medicine tests among Medicare beneficiaries through analysis of gene-specific tier 1 and 2 billing codes developed by the American Medical Association in 2012. We conducted a retrospective cross-sectional study. The primary source of data was 2013 Medicare 100% fee-for-service claims. We identified claims billed for each laboratory test, the number of patients tested, expenditures, and the diagnostic codes indicated for testing. We analyzed variations in testing by patient demographics and region of the country. Pharmacogenetic tests were billed most frequently, accounting for 48% of the expenditures for new codes. The most common indications for testing were breast cancer, long-term use of medications, and disorders of lipid metabolism. There was underutilization of guideline-recommended tumor mutation tests (e.g., epidermal growth factor receptor) and substantial overutilization of a test discouraged by guidelines (methylenetetrahydrofolate reductase). Methodology-based tier 2 codes represented 15% of all claims billed with the new codes. The highest rate of testing per beneficiary was in Mississippi and the lowest rate was in Alaska. Gene-specific billing codes significantly improved our ability to conduct population-level research of precision medicine. Analysis of these data in conjunction with clinical records should be conducted to validate findings.Genet Med advance online publication 26 January 2017.

Scientific evaluation of traditional Chinese medicine under DSHEA: a conundrum. Dietary Supplement Health and Education Act.

PubMed

Chang, J

1999-04-01

In the United States, traditional Chinese medicines (TCM) are currently sold as dietary supplements, as defined by The Dietary Supplement Health and Education Act (DSHEA). This legislation is unique to the United States and while "structure and function" claims are allowable under DSHEA, disease claims are not. The narrow definition, however, poses a challenge to designing appropriate clinical studies that can provide data for "structure and function" claim substantiation. The process of melding Chinese herbal medicines into the dietary supplement category is complex and there is a need to define a clinical trial paradigm carefully that addresses "structure and function claims" without sacrificing scientific rigor. It is frequently not recognized that TCM favors an amalgamation of several herbs to generate the putative clinical effect. Because of this historical multiherb approach, the reliance on retrospective data to support the potential health benefits of an herb extract has severe limitations. Notwithstanding the immense value of identifying the pharmacological activity of a TCM herb to a chemical suitable for pharmaceutical development, another approach to safe and efficacious herbal products is to develop a standardized herbal extract. This article highlights issues related to the latter approach and will discuss a research-based strategy that may be suitable for validating, in part, the putative health benefits of TCM.

An examination of structure-function claims in dietary supplement advertising in the U.S.: 2003-2009.

PubMed

Avery, Rosemary J; Eisenberg, Matthew D; Cantor, Jonathan H

2017-04-01

Dietary supplement advertising cannot claim a causal link between the product and the treatment, prevention, or cure of a disease unless manufacturers seek approval from the FDA for a health claim. Manufacturers can make structure-function (S-F) claims without FDA approval linking a supplement to a body function or system using words such as "may help" or "promotes." These S-F claims are examined in this study in order to determine whether they mimic health claims for which the FDA requires stricter scientific evidence. Data include S-F claims in supplement advertisements (N=6179) appearing in US nationally circulated magazines (N=137) from 2003 to 2009. All advertisements were comprehensively coded for S-F claims, seals of approval, and other claims of guarantee. S-F claims associate supplements with a wide variety of health conditions, many of which are serious diseases and/or ailments. A significant number of the specific verbs used in these S-F claims are indicative of disease treatment/cure effects, thereby possibly mimicking health claims to the average consumer. The strength of the clinical associations made are largely unsubstantiated in the medical literature. Claims that a product is "scientifically proven" or "guaranteed" were largely unsubstantiated by clinical literature. Ads carrying externally validating seals of approval were highly prevalent. S-F claims that strongly mimic FDA-prohibited health claims are likely to create confusion in interpretation and possible public health concerns are discussed. Copyright © 2017 Elsevier Inc. All rights reserved.

Nutrigenetics and personalized nutrition: are we ready for DNA-based dietary advice?

PubMed

Grimaldi, Keith A

2014-05-01

Common genetic variation affects individual nutrient requirements and the use of DNA-based dietary advice, derived from nutrigenetics, has been growing. The growth is about to accelerate as the cost of genotyping continues to fall and research results from major nutrigenetics projects are published. There is still some skepticism; some barriers remain including some commercial tests, which make exaggerated, incorrect claims. There is a need for more public resources dedicated to unbiased, objective review and dissemination of nutrigenetics information; however, nutrigenetics evidence should be assessed in the context of standard nutritional evidence and should not require higher standards. This article argues that we are ready for some DNA-based dietary advice in general nutrition and it can be beneficial. Examples of the scientific validity and health utility of gene-diet interactions will be given and the development of guidelines for assessment and validation of benefits will be discussed.

Epidemiology of Hypersensitivity Pneumonitis among an Insured Population in the United States: A Claims-based Cohort Analysis.

PubMed

Fernández Pérez, Evans R; Kong, Amanda M; Raimundo, Karina; Koelsch, Tilman L; Kulkarni, Rucha; Cole, Ashley L

2018-04-01

Hypersensitivity pneumonitis is a complex lung disease resulting from repeated inhalation of a variety of antigens. Limited data exist regarding its epidemiology. To describe the trends in the annual incidence and prevalence of hypersensitivity pneumonitis in the United States. We developed novel claims-based coding algorithms to identify hypersensitivity pneumonitis, chronic hypersensitivity pneumonitis, and fibrotic hypersensitivity pneumonitis cases using the 2004 to 2013 MarketScan Commercial and Medicare Supplemental healthcare claims databases. Algorithm validity and reliability were assessed with clinical data from National Jewish Health. We calculated yearly cumulative incidence and prevalence overall and by age. For the subgroup with vital status, Kaplan-Meier methods were used to analyze survival stratified by evidence of fibrosis. We identified 7,498 cases that met our hypersensitivity pneumonitis definition over the 10-year study period, including 3,902 with chronic hypersensitivity pneumonitis and 1,852 with fibrotic hypersensitivity pneumonitis. On the basis of the clinical-radiological adjudication of the validation sample, 38 cases (95%) were confirmed as hypersensitivity pneumonitis. The mean age was 52 years, and 58% were women. The 1-year prevalence rates for hypersensitivity pneumonitis ranged from 1.67 to 2.71 per 100,000 persons, and 1-year cumulative incidence rates ranged from 1.28 to 1.94 per 100,000 persons. The prevalence increased with age, ranging from 0.95 per 100,000 among 0- to 9-year-olds to 11.2 per 100,000 among those aged 65 years and older. Between 56 and 68% of hypersensitivity pneumonitis cases in each year were classified as chronic hypersensitivity pneumonitis (prevalence, 0.91-1.70 per 100,000 persons; cumulative incidence, 0.63-1.08 per 100,000 persons). Fewer had fibrotic hypersensitivity pneumonitis (prevalence, 0.41-0.80 per 100,000 persons; cumulative incidence: 0.29-0.43 per 100,000 persons). Most cases (74%) were classified as unspecified hypersensitivity pneumonitis. Older age, male sex, and fibrosis were associated with higher mortality rates in unadjusted analyses. Using U.S. administrative claims-based data, we developed an algorithm with a high sensitivity and specificity for hypersensitivity pneumonitis. Between 2004 and 2013, hypersensitivity pneumonitis was more common among women and those older than 65 years. Most cases were classified as chronic hypersensitivity pneumonitis. Approximately one-fourth met our criteria for fibrotic hypersensitivity pneumonitis, which was associated with a higher mortality rate.

Incidence and Trends of Sepsis in US Hospitals Using Clinical vs Claims Data, 2009-2014

PubMed Central

Dantes, Raymund; Epstein, Lauren; Murphy, David J.; Seymour, Christopher W.; Iwashyna, Theodore J.; Kadri, Sameer S.; Angus, Derek C.; Danner, Robert L.; Fiore, Anthony E.; Jernigan, John A.; Martin, Greg S.; Septimus, Edward; Warren, David K.; Karcz, Anita; Chan, Christina; Menchaca, John T.; Wang, Rui; Gruber, Susan; Klompas, Michael

2017-01-01

Importance Estimates from claims-based analyses suggest that the incidence of sepsis is increasing and mortality rates from sepsis are decreasing. However, estimates from claims data may lack clinical fidelity and can be affected by changing diagnosis and coding practices over time. Objective To estimate the US national incidence of sepsis and trends using detailed clinical data from the electronic health record (EHR) systems of diverse hospitals. Design, Setting, and Population Retrospective cohort study of adult patients admitted to 409 academic, community, and federal hospitals from 2009-2014. Exposures Sepsis was identified using clinical indicators of presumed infection and concurrent acute organ dysfunction, adapting Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) criteria for objective and consistent EHR-based surveillance. Main Outcomes and Measures Sepsis incidence, outcomes, and trends from 2009-2014 were calculated using regression models and compared with claims-based estimates using International Classification of Diseases, Ninth Revision, Clinical Modification codes for severe sepsis or septic shock. Case-finding criteria were validated against Sepsis-3 criteria using medical record reviews. Results A total of 173 690 sepsis cases (mean age, 66.5 [SD, 15.5] y; 77 660 [42.4%] women) were identified using clinical criteria among 2 901 019 adults admitted to study hospitals in 2014 (6.0% incidence). Of these, 26 061 (15.0%) died in the hospital and 10 731 (6.2%) were discharged to hospice. From 2009-2014, sepsis incidence using clinical criteria was stable (+0.6% relative change/y [95% CI, −2.3% to 3.5%], P = .67) whereas incidence per claims increased (+10.3%/y [95% CI, 7.2% to 13.3%], P < .001). In-hospital mortality using clinical criteria declined (−3.3%/y [95% CI, −5.6% to −1.0%], P = .004), but there was no significant change in the combined outcome of death or discharge to hospice (−1.3%/y [95% CI, −3.2% to 0.6%], P = .19). In contrast, mortality using claims declined significantly (−7.0%/y [95% CI, −8.8% to −5.2%], P < .001), as did death or discharge to hospice (−4.5%/y [95% CI, −6.1% to −2.8%], P < .001). Clinical criteria were more sensitive in identifying sepsis than claims (69.7% [95% CI, 52.9% to 92.0%] vs 32.3% [95% CI, 24.4% to 43.0%], P < .001), with comparable positive predictive value (70.4% [95% CI, 64.0% to 76.8%] vs 75.2% [95% CI, 69.8% to 80.6%], P = .23). Conclusions and Relevance In clinical data from 409 hospitals, sepsis was present in 6% of adult hospitalizations, and in contrast to claims-based analyses, neither the incidence of sepsis nor the combined outcome of death or discharge to hospice changed significantly between 2009-2014. The findings also suggest that EHR-based clinical data provide more objective estimates than claims-based data for sepsis surveillance. PMID:28903154

Inferring pregnancy episodes and outcomes within a network of observational databases

PubMed Central

Ryan, Patrick; Fife, Daniel; Gifkins, Dina; Knoll, Chris; Friedman, Andrew

2018-01-01

Administrative claims and electronic health records are valuable resources for evaluating pharmaceutical effects during pregnancy. However, direct measures of gestational age are generally not available. Establishing a reliable approach to infer the duration and outcome of a pregnancy could improve pharmacovigilance activities. We developed and applied an algorithm to define pregnancy episodes in four observational databases: three US-based claims databases: Truven MarketScan® Commercial Claims and Encounters (CCAE), Truven MarketScan® Multi-state Medicaid (MDCD), and the Optum ClinFormatics® (Optum) database and one non-US database, the United Kingdom (UK) based Clinical Practice Research Datalink (CPRD). Pregnancy outcomes were classified as live births, stillbirths, abortions and ectopic pregnancies. Start dates were estimated using a derived hierarchy of available pregnancy markers, including records such as last menstrual period and nuchal ultrasound dates. Validation included clinical adjudication of 700 electronic Optum and CPRD pregnancy episode profiles to assess the operating characteristics of the algorithm, and a comparison of the algorithm’s Optum pregnancy start estimates to starts based on dates of assisted conception procedures. Distributions of pregnancy outcome types were similar across all four data sources and pregnancy episode lengths found were as expected for all outcomes, excepting term lengths in episodes that used amenorrhea and urine pregnancy tests for start estimation. Validation survey results found highest agreement between reviewer chosen and algorithm operating characteristics for questions assessing pregnancy status and accuracy of outcome category with 99–100% agreement for Optum and CPRD. Outcome date agreement within seven days in either direction ranged from 95–100%, while start date agreement within seven days in either direction ranged from 90–97%. In Optum validation sensitivity analysis, a total of 73% of algorithm estimated starts for live births were in agreement with fertility procedure estimated starts within two weeks in either direction; ectopic pregnancy 77%, stillbirth 47%, and abortion 36%. An algorithm to infer live birth and ectopic pregnancy episodes and outcomes can be applied to multiple observational databases with acceptable accuracy for further epidemiologic research. Less accuracy was found for start date estimations in stillbirth and abortion outcomes in our sensitivity analysis, which may be expected given the nature of the outcomes. PMID:29389968

Curb your premium: the impact of monitoring malpractice claims.

PubMed

Amaral-Garcia, Sofia; Grembi, Veronica

2014-02-01

We study a policy aimed at increasing the level of information on medical malpractice costs and the risk exposure of local public healthcare providers. The policy is based on enhanced monitoring of medical malpractice claims by the level of government that rules providers in a multilevel institutional setting. In particular, we implement a difference-in-differences strategy using Italian data at the provider level from 2001 to 2008 to evaluate the impact of monitoring claims on medical liability expenditures, measured as insurance premiums and legal expenditures, which was adopted by only some Regions. Our results show that this information-enhancing policy reduces paid premiums by around 15%. This reduced-form effect might arise by higher bargaining power on the demand side or increased competition on the supply side of the insurance market. Validity tests show that our findings are not driven by differential pre-policy trends between treated and control providers. Moreover, this policy could be cheaply implemented also in other institutional contexts with positive effects. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

38 CFR 3.311 - Claims based on exposure to ionizing radiation.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Department of Defense. (ii) Hiroshima and Nagasaki occupation claims. In all claims based on participation in... requested from the Department of Defense. (iii) Other exposure claims. In all other claims involving... Department of Defense is consistent with the claim that the veteran was present where and when the claimed...

Developing a Validity Argument through Abductive Reasoning with an Empirical Demonstration of the Latent Class Analysis

ERIC Educational Resources Information Center

Wu, Amery D.; Stone, Jake E.; Liu, Yan

2016-01-01

This article proposes and demonstrates a methodology for test score validation through abductive reasoning. It describes how abductive reasoning can be utilized in support of the claims made about test score validity. This methodology is demonstrated with a real data example of the Canadian English Language Proficiency Index Program…

Alternative Vocabularies in the Test Validity Literature

ERIC Educational Resources Information Center

Markus, Keith A.

2016-01-01

Justification of testing practice involves moving from one state of knowledge about the test to another. Theories of test validity can (a) focus on the beginning of the process, (b) focus on the end, or (c) encompass the entire process. Analyses of four case studies test and illustrate three claims: (a) restrictions on validity entail a supplement…

Elaborations for the Validation of Causal Bridging Inferences in Text Comprehension

ERIC Educational Resources Information Center

Morishima, Yasunori

2016-01-01

The validation model of causal bridging inferences proposed by Singer and colleagues (e.g., Singer in "Can J Exp Psychol," 47(2):340-359, 1993) claims that before a causal bridging inference is accepted, it must be validated by existing knowledge. For example, to understand "Dorothy took the aspirins. Her pain went away," one…

On System Engineering a Barter-Based Re-allocation of Space System Key Development Resources

NASA Astrophysics Data System (ADS)

Kosmann, William J.

NASA has had a decades-long problem with cost growth during the development of space science missions. Numerous agency-sponsored studies have produced average mission level development cost growths ranging from 23 to 77%. A new study of 26 historical NASA science instrument set developments using expert judgment to re-allocate key development resources has an average cost growth of 73.77%. Twice in history, during the Cassini and EOS-Terra science instrument developments, a barter-based mechanism has been used to re-allocate key development resources. The mean instrument set development cost growth was -1.55%. Performing a bivariate inference on the means of these two distributions, there is statistical evidence to support the claim that using a barter-based mechanism to re-allocate key instrument development resources will result in a lower expected cost growth than using the expert judgment approach. Agent-based discrete event simulation is the natural way to model a trade environment. A NetLogo agent-based barter-based simulation of science instrument development was created. The agent-based model was validated against the Cassini historical example, as the starting and ending instrument development conditions are available. The resulting validated agent-based barter-based science instrument resource re-allocation simulation was used to perform 300 instrument development simulations, using barter to re-allocate development resources. The mean cost growth was -3.365%. A bivariate inference on the means was performed to determine that additional significant statistical evidence exists to support a claim that using barter-based resource re-allocation will result in lower expected cost growth, with respect to the historical expert judgment approach. Barter-based key development resource re-allocation should work on science spacecraft development as well as it has worked on science instrument development. A new study of 28 historical NASA science spacecraft developments has an average cost growth of 46.04%. As barter-based key development resource re-allocation has never been tried in a spacecraft development, no historical results exist, and an inference on the means test is not possible. A simulation of using barter-based resource re-allocation should be developed. The NetLogo instrument development simulation should be modified to account for spacecraft development market participant differences. The resulting agent-based barter-based spacecraft resource re-allocation simulation would then be used to determine if significant statistical evidence exists to prove a claim that using barter-based resource re-allocation will result in lower expected cost growth.

Avoiding sexual harassment liability in veterinary practices.

PubMed

Lacroix, C A; Wilson, J F

1996-05-15

Harassment based on gender violates the rule of workplace equality established by Title VII of the Civil Rights Act and enforced by the EEOC. In 1986, the US Supreme Court, in Meritor Savings Bank v Vinson, established the criteria that must be met for a claim of hostile environment sexual harassment to be considered valid. Plaintiffs must show that they were subjected to conduct based on their gender, that it was unwelcome, and that it was severe and pervasive enough to alter their condition of employment, resulting in an abusive working environment. There have been few sexual harassment cases involving veterinary professionals, and it is our goal to help keep the number of filed actions to a minimum. The most effective way to avoid hostile environment sexual harassment claims is to confront the issue openly and to adopt a sexual harassment policy for the practice. When it comes to sexual harassment, an ounce of prevention is unquestionably worth a pound of cure.

Transgender Medicare Beneficiaries and Chronic Conditions: Exploring Fee-for-Service Claims Data.

PubMed

Dragon, Christina N; Guerino, Paul; Ewald, Erin; Laffan, Alison M

2017-12-01

Data on the health and well-being of the transgender population are limited. However, using claims data we can identify transgender Medicare beneficiaries (TMBs) with high confidence. We seek to describe the TMB population and provide comparisons of chronic disease burden between TMBs and cisgender Medicare beneficiaries (CMBs), thus laying a foundation for national level TMB health disparity research. Using a previously validated claims algorithm based on ICD-9-CM codes relating to transsexualism and gender identity disorder, we identified a cohort of TMBs using Medicare Fee-for-Service (FFS) claims data. We then describe the demographic characteristics and chronic disease burden of TMBs (N = 7454) and CMBs (N = 39,136,229). Compared to CMBs, a greater observed proportion of TMBs are young (under age 65) and Black, although these differences vary by entitlement. Regardless of entitlement, TMBs have more chronic conditions than CMBs, and more TMBs have been diagnosed with asthma, autism spectrum disorder, chronic obstructive pulmonary disease, depression, hepatitis, HIV, schizophrenia, and substance use disorders. TMBs also have higher observed rates of potentially disabling mental health and neurological/chronic pain conditions, as well as obesity and other liver conditions (nonhepatitis), compared to CMBs. This is the first systematic look at chronic disease burden in the transgender population using Medicare FFS claims data. We found that TMBs experience multiple chronic conditions at higher rates than CMBs, regardless of Medicare entitlement. TMBs under age 65 show an already heavy chronic disease burden which will only be exacerbated with age.

Cost and effectiveness of biologics for rheumatoid arthritis in a commercially insured population.

PubMed

Curtis, Jeffrey R; Chastek, Benjamin; Becker, Laura; Quach, Caroleen; Harrison, David J; Yun, Huifeng; Joseph, George J; Collier, David H

2015-04-01

Administrative claims contain detailed medication, diagnosis, and procedure data, but the lack of clinical outcomes for rheumatoid arthritis (RA) historically has limited their use in comparative effectiveness research. A claims-based algorithm was developed and validated to estimate effectiveness for RA from data for adherence, dosing, and treatment modifications. To implement the claims-based algorithm in a U.S. managed care database to estimate biologic cost per effectively treated patient. The cohort included patients with RA aged 18-63 years in the Optum Research Database who initiated biologic treatment between January 2007 and December 2010 and were continuously enrolled 6 months before through 12 months after the first claim for the biologic (the index date). Patients were categorized as effectively treated by the claims-based algorithm if they met all of the following 6 criteria in the 12-month post-index period: (1) a medication possession ratio ≥ 80% for subcutaneous biologics, or at least as many infusions as specified in U.S. labeling for intravenous biologics; (2) no increase in biologic dose; (3) no switch in biologics; (4) no new nonbiologic disease-modifying antirheumatic drug; (5) no new or increased oral glucocorticoid treatment; and (6) no more than 1 glucocorticoid injection. Drug costs (all biologics) and administration costs (intravenous biologics) were obtained from allowed amounts on claims. Biologic cost per effectively treated patient was defined as total 1-year biologic cost divided by the number of patients categorized by the algorithm as effectively treated with that index biologic. Sensitivity analysis was conducted to examine the total health care costs per effectively treated patient during the first year of biologic therapy. A total of 5,474 individuals were included in the analysis. The index biologic was categorized as effective by the algorithm for 28.9% of patients overall, including 30.6% for subcutaneous biologics and 22.1% for intravenous biologics. The index biologic was categorized as effective in the first year for 32.7% of etanercept (794/2,425), 32.3% of golimumab (40/124), 30.2% of abatacept (89/295), 27.7% of adalimumab (514/1,857), and 19.0% of infliximab (147/773) patients. Mean 1-year biologic cost per effectively treated patient, as defined in the algorithm, was lowest for etanercept ($43,935), followed by golimumab ($49,589), adalimumab ($52,752), abatacept ($62,300), and infliximab ($101,402). The rank order in the sensitivity analysis was the same, except for golimumab and etanercept.  Using a claims-based algorithm in a large commercial claims database, etanercept was the most effective and had the lowest biologic cost per effectively treated patient with RA.

Injury Scheme Claims in Gaelic Games: A Review of 2007–2014

PubMed Central

Roe, Mark; Blake, Catherine; Gissane, Conor; Collins, Kieran

2016-01-01

Context:  Gaelic games (Gaelic football and hurling) are indigenous Irish sports with increasing global participation in recent years. Limited information is available on longitudinal injury trends. Reviews of insurance claims can reveal the economic burden of injury and guide cost-effective injury-prevention programs. Objective:  To review Gaelic games injury claims from 2007–2014 for male players to identify the costs and frequencies of claims. Particular attention was devoted to lower limb injuries due to findings from previous epidemiologic investigations of Gaelic games. Design:  Descriptive epidemiology study. Setting:  Open-access Gaelic Athletic Association Annual Reports from 2007–2014 were reviewed to obtain annual injury-claim data. Patients or Other Participants:  Gaelic Athletic Association players. Main Outcome Measure(s):  Player age (youth or adult) and relationships between lower limb injury-claim rates and claim values, Gaelic football claims, hurling claims, youth claims, and adult claims. Results:  Between 2007 and 2014, €64 733 597.00 was allocated to 58 038 claims. Registered teams had annual claim frequencies of 0.36 with average claim values of €1158.4 ± 192.81. Between 2007 and 2014, average adult claims were always greater than youth claims (6217.88 versus 1036.88), while Gaelic football claims were always greater than hurling claims (5395.38 versus 1859.38). Lower limb injuries represented 60% of all claims. The number of lower limb injury claims was significantly correlated with annual injury-claim expenses (r = 0.85, P = .01) and adult claims (r = 0.96, P = .01) but not with youth claims (r = 0.69, P = .06). Conclusions:  Reducing lower limb injuries will likely reduce injury-claim expenses. Effective injury interventions have been validated in soccer, but whether such changes can be replicated in Gaelic games remains to be investigated. Injury-claim data should be integrated into current elite injury-surveillance databases to monitor the cost effectiveness of current programs. PMID:26967548

How Effective Are Working Memory Training Interventions at Improving Maths in Schools: A Study into the Efficacy of Working Memory Training in Children Aged 9 and 10 in a Junior School?

ERIC Educational Resources Information Center

Cunningham, James; Sood, Krishan

2018-01-01

This study evaluates the validity of claims that Working Memory (WM) training is an effective and legitimate school-based maths intervention. By analysing the current developments in WM in the fields of neurology and cognitive psychology, this study seeks to analyse their relevance to the classroom. This study analyses memory profiles of children…

43 CFR 5511.3-8 - Permits to mining claimants.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Permits to mining claimants. 5511.3-8... § 5511.3-8 Permits to mining claimants. (a) Free-use timber shall be granted under § 5510.0-3(b) to the record owner of a valid mining claim if such claim was located subsequent to July 23, 1955, or if the...

Assessment method for epithermal gold deposits in Northeast Washington State using weights-of-evidence GIS modeling

USGS Publications Warehouse

Boleneus, D.E.; Raines, G.L.; Causey, J.D.; Bookstrom, A.A.; Frost, T.P.; Hyndman, P.C.

2001-01-01

The weights-of-evidence analysis, a quantitative mineral resource mapping tool, is used to delineate favorable areas for epithermal gold deposits and to predict future exploration activity of the mineral industry for similar deposits in a four-county area (222 x 277 km), including the Okanogan and Colville National Forests of northeastern Washington. Modeling is applied in six steps: (1) building a spatial digital database, (2) extracting predictive evidence for a particular deposit, based on an exploration model, (3) calculating relative weights for each predictive map, (4) combining the geologic evidence maps to predict the location of undiscovered mineral resources and (5) measuring the intensity of recent exploration activity by use of mining claims on federal lands, and (6) combining mineral resource and exploration activity into an assessment model of future mining activity. The analysis is accomplished on a personal computer using ArcView GIS platform with Spatial Analyst and Weights-of-Evidence software. In accord with the descriptive model for epithermal gold deposits, digital geologic evidential themes assembled include lithologic map units, thrust faults, normal faults, and igneous dikes. Similarly, geochemical evidential themes include placer gold deposits and gold and silver analyses from stream sediment (silt) samples from National Forest lands. Fifty mines, prospects, or occurrences of epithermal gold deposits, the training set, define the appropriate a really-associated terrane. The areal (or spatial) correlation of each evidential theme with the training set yield predictor theme maps for lithology, placer sites and normal faults. The weights-of-evidence analysis disqualified the thrust fault, dike, and gold and silver silt analyses evidential themes because they lacked spatial correlation with the training set. The decision to accept or reject evidential themes as predictors is assisted by considering probabilistic data consisting of weights and contrast values calculated for themes according to areal correlation with the training sites. Predictor themes having acceptable weights and contrast values are combined into a preliminary model to predict the locations of undiscovered epithermal gold deposits. This model facilitates ranking of tracts as non-permissive, permissive or favorable categories based on exclusionary, passive, and active criteria through evaluation of probabilistic data provided by interaction of predictor themes. The method is very similar to the visual inspection method of drawing conclusions from anomalies on a manually overlain system of maps. This method serves as a model for future mineral assessment procedures because of its objective nature. To develop a model to predict future exploration activity, the locations of lode mining claims were summarized for 1980, 1985, 1990, and 1996. Land parcels containing historic claims were identified either as those with mining claims present in 1980 or valid claims present in 1985. Current claim parcels were identified as those containing valid lode claims in either 1990 or 1996. A consistent parcel contains both historic and current claims. The epithermal gold and mining claim activity models were combined into an assessment (or mineral resource-activity) model to assist in land use decisions by providing a prediction of mineral exploration activity on federal land in the next decade. Ranks in the assessment model are: (1) no activity, (2) low activity, (3) low to moderate activity, (4) moderate activity and (5) high activity.

The MMPI-2 in sexual harassment and discrimination litigants.

PubMed

Long, Barbara; Rouse, Steven V; Nelsen, R Owen; Butcher, James N

2004-06-01

In order to understand patterns of respondents on validity and clinical scales, this study analyzed archival Minnesota Multiphasic Personality Inventory 2s (MMPI-2s) produced by 192 women and 14 men who initiated legal claims of ongoing emotional harm related to workplace sexual harassment and discrimination. The MMPI-2s were administered as a part of a comprehensive psychiatric forensic evaluation of the claimants' current psychological condition. All validity and clinical scale scores were manually entered into the computer, and codetype and cluster analyses were obtained. Among the women, 28% produced a "normal limits" profile, providing no MMPI-2 support for their claims of ongoing emotional distress. Cluster analysis of the validity scales of the remaining profiles produced four distinctive clusters of profiles representing different approaches to the test items. Copyright 2004 Wiley Periodicals, Inc.

Validation of a case definition to define chronic dialysis using outpatient administrative data.

PubMed

Clement, Fiona M; James, Matthew T; Chin, Rick; Klarenbach, Scott W; Manns, Braden J; Quinn, Robert R; Ravani, Pietro; Tonelli, Marcello; Hemmelgarn, Brenda R

2011-03-01

Administrative health care databases offer an efficient and accessible, though as-yet unvalidated, approach to studying outcomes of patients with chronic kidney disease and end-stage renal disease (ESRD). The objective of this study is to determine the validity of outpatient physician billing derived algorithms for defining chronic dialysis compared to a reference standard ESRD registry. A cohort of incident dialysis patients (Jan. 1-Dec. 31, 2008) and prevalent chronic dialysis patients (Jan 1, 2008) was selected from a geographically inclusive ESRD registry and administrative database. Four administrative data definitions were considered: at least 1 outpatient claim, at least 2 outpatient claims, at least 2 outpatient claims at least 90 days apart, and continuous outpatient claims at least 90 days apart with no gap in claims greater than 21 days. Measures of agreement of the four administrative data definitions were compared to a reference standard (ESRD registry). Basic patient characteristics are compared between all 5 patient groups. 1,118,097 individuals formed the overall population and 2,227 chronic dialysis patients were included in the ESRD registry. The three definitions requiring at least 2 outpatient claims resulted in kappa statistics between 0.60-0.80 indicating "substantial" agreement. "At least 1 outpatient claim" resulted in "excellent" agreement with a kappa statistic of 0.81. Of the four definitions, the simplest (at least 1 outpatient claim) performed comparatively to other definitions. The limitations of this work are the billing codes used are developed in Canada, however, other countries use similar billing practices and thus the codes could easily be mapped to other systems. Our reference standard ESRD registry may not capture all dialysis patients resulting in some misclassification. The registry is linked to on-going care so this is likely to be minimal. The definition utilized will vary with the research objective.

Development of vulnerability curves to typhoon hazards based on insurance policy and claim dataset

NASA Astrophysics Data System (ADS)

Mo, Wanmei; Fang, Weihua; li, Xinze; Wu, Peng; Tong, Xingwei

2016-04-01

Vulnerability refers to the characteristics and circumstances of an exposure that make it vulnerable to the effects of some certain hazards. It can be divided into physical vulnerability, social vulnerability, economic vulnerabilities and environmental vulnerability. Physical vulnerability indicates the potential physical damage of exposure caused by natural hazards. Vulnerability curves, quantifying the loss ratio against hazard intensity with a horizontal axis for the intensity and a vertical axis for the Mean Damage Ratio (MDR), is essential to the vulnerability assessment and quantitative evaluation of disasters. Fragility refers to the probability of diverse damage states under different hazard intensity, revealing a kind of characteristic of the exposure. Fragility curves are often used to quantify the probability of a given set of exposure at or exceeding a certain damage state. The development of quantitative fragility and vulnerability curves is the basis of catastrophe modeling. Generally, methods for quantitative fragility and vulnerability assessment can be categorized into empirical, analytical and expert opinion or judgment-based ones. Empirical method is one of the most popular methods and it relies heavily on the availability and quality of historical hazard and loss dataset, which has always been a great challenge. Analytical method is usually based on the engineering experiments and it is time-consuming and lacks built-in validation, so its credibility is also sometimes criticized widely. Expert opinion or judgment-based method is quite effective in the absence of data but the results could be too subjective so that the uncertainty is likely to be underestimated. In this study, we will present the fragility and vulnerability curves developed with empirical method based on simulated historical typhoon wind, rainfall and induced flood, and insurance policy and claim datasets of more than 100 historical typhoon events. Firstly, an insurance exposure classification system is built according to structure type, occupation type and insurance coverage. Then MDR estimation method based on considering insurance policy structure and claim information is proposed and validated. Following that, fragility and vulnerability curves of the major exposure types for construction, homeowner insurance and enterprise property insurance are fitted with empirical function based on the historical dataset. The results of this study can not only help understand catastrophe risk and mange insured disaster risks, but can also be applied in other disaster risk reduction efforts.

The Effect of Complementary and Alternative Medicine Claims on Risk Adjustment

PubMed Central

Lind, Bonnie K.; Abrams, Chad; Lafferty, William E.; Kiehr, Paula K.; Grembowski, David E.

2006-01-01

Objective To assess how the inclusion of diagnoses from complementary and alternative medicine (CAM) providers affects measures of morbidity burden and expectations of health care resource use for insured patients. Methods Claims data from Washington State were used to create two versions of a case-mix index. One version included claims from all provider types; the second version omitted claims from CAM providers who are covered under commercial insurance. Expected resource use was also calculated. The distribution of expected and actual resource use was then compared for the two indices. Results Inclusion of CAM providers shifts many patients into higher morbidity categories; 54% of 61,914 CAM users had higher risk scores in the index which included CAM providers. When expected resource use categories were defined based on all providers, CAM users in the highest morbidity category had average (± s.d.) annual expenditures of $6661 (± $13,863). This was less than those in the highest morbidity category when CAM providers were not included in the index ($8562 ± $16,354), and was also lower than the highest morbidity patients who did not use any CAM services ($8419 ± $18,885). Conclusions Inclusion of services from CAM providers under third party payment increases risk scores for their patients but expectations of costs for this group are lower than expected had costs been estimated based only on services from traditional providers. Additional work is needed to validate risk adjustment indices when adding services from provider groups not included in the development of the index. PMID:17122711

A Validity Agenda for Growth Models: One Size Doesn't Fit All!

ERIC Educational Resources Information Center

Patelis, Thanos

2012-01-01

This is a keynote presentation given at AERA on developing a validity agenda for growth models in a large scale (e.g., state) setting. The emphasis of this presentation was to indicate that growth models and the validity agenda designed to provide evidence in supporting the claims to be made need to be personalized to meet the local or…

Generating Two-Dimensional Repertoire of siRNA Linc-ROR and siRNA mRNA ARF6 from the lincRNA-RoR/miR-145/ARF6 expression Pathway that involved in the progression of Triple Negative Breast Cancer

NASA Astrophysics Data System (ADS)

Aditya Parikesit, Arli; Nurdiansyah, Rizki

2018-01-01

The research for finding the cure for breast cancer is currently entering the interesting phase of the transcriptomics based method. With the application of Next Generation Sequencing (NGS), molecular information on breast cancer could be gathered. Thus, both in silico and wet lab research has determined that the role of lincRNA-RoR/miR-145/ARF6 expression Pathway could not be ignored as one of the cardinal starting points for Triple-Negative Breast Cancer (TNBC). As the most hazardous type of breast cancer, TNBC should be treated with the most advanced approach that available in the scientific community. Bioinformatics approach has found the possible siRNA-based drug candidates for TNBC. It was found that siRNA that interfere with lincRNA-ROR and mRNA ARF6 could be a feasible opportunity as the drug candidate for TNBC. However, this claim should be validated with more thorough thermodynamics and kinetics computational approach as the comprehensive way to comprehend their molecular repertoire. In this respect, the claim was validated using various tools such as the RNAfold server to determine the 2D structure, Barriers server to comprehend the RNA folding kinetics, RNAeval server to validate the siRNA-target interaction. It was found that the thermodynamics and kinetics repertoire of the siRNA are indeed rational and feasible. In this end, our computation approach has proven that our designed siRNA could interact with lincRNA-RoR/miR-145/ARF6 expression Pathway.

Validation of a Screening Risk Index for Serious Prescription Opioid-Induced Respiratory Depression or Overdose in a US Commercial Health Plan Claims Database

PubMed Central

Zedler, Barbara K; Saunders, William B; Joyce, Andrew R; Vick, Catherine C; Murrelle, E Lenn

2018-01-01

Abstract Objective To validate a risk index that estimates the likelihood of overdose or serious opioid-induced respiratory depression (OIRD) among medical users of prescription opioids. Subjects and Methods A case-control analysis of 18,365,497 patients with an opioid prescription from 2009 to 2013 in the IMS PharMetrics Plus commercially insured health plan claims database (CIP). An OIRD event occurred in 7,234 cases. Four controls were selected per case. Validity of the Risk Index for Overdose or Serious Opioid-induced Respiratory Depression (RIOSORD), developed previously using Veterans Health Administration (VHA) patient data, was assessed. Multivariable logistic regression was used within the CIP study population to develop a slightly refined RIOSORD. The composition and performance of the CIP-based RIOSORD was evaluated and compared with VHA-based RIOSORD. Results VHA-RIOSORD performed well in discriminating OIRD events in CIP (C-statistic = 0.85). Additionally, re-estimation of logistic model coefficients in CIP yielded a 0.90 C-statistic. The resulting comorbidity and pharmacotherapy variables most highly associated with OIRD and retained in the CIP-RIOSORD were largely concordant with VHA-RIOSORD. These variables included neuropsychiatric and cardiopulmonary disorders, impaired drug excretion, opioid characteristics, and concurrent psychoactive medications. The average predicted probability of OIRD ranged from 2% to 83%, with excellent agreement between predicted and observed incidence across risk classes. Conclusions RIOSORD had excellent predictive accuracy in a large population of US medical users of prescription opioids, similar to its performance in VHA. This practical risk index is designed to support clinical decision-making for safer opioid prescribing, and its clinical utility should be evaluated prospectively. PMID:28340046

[Disease management programs in Germany: Validity of the medical documentation].

PubMed

Linder, R; Horenkamp-Sonntag, D; Engel, S; Köppel, D; Heilmann, T; Verheyen, F

2014-01-01

The specific documentation for disease management programs (DMP) in Germany with respect to § 137 Social Code Book V is the basis for evaluating the DMP. DMP run up costs of the order of a billion euro without assessing evidence-based benefit so far. Aim of this study was to question if and to which extent this documentation may be suitable for reliable quality assurance in its present form. Data of nearly 300000 insured persons of a German Statutory Health Insurance (Techniker Krankenkasse, TK) which were continuously registered from July 1st 2009 until December 31st 2010 in a DMP were analyzed. We analyzed how items which were components of claims data and of DMP documentation were matched. With regard to prescriptions there were some considerable differences. Prescription of glibenclamid was documented twice as frequently in the DMP documentation compared to prescriptions filled in pharmacies. Only a fraction of emergency hospitalizations documented in the claims data were found in the DMP documentation. Investigations of the fundus oculi for diabetics are mentioned three times more frequently in the DMP documentation than they are accounted by ophthalmologists. There are considerable differences between claims data and DMP specific documentation. The latter shows a plainly reduced validity for investigated fields in the documentation forms. Reasons for this are manifold. Former evaluations of DM Ps carried out just on the basis of DMP documentation are thus highly questionable. Therefore, the DMPs themselves and their documentation have to be reformed. © Georg Thieme Verlag KG Stuttgart · New York.

A New Method to Classify Injury Severity by Diagnosis: Validation using Workers' Compensation and Trauma Registry Data

PubMed Central

Sears, Jeanne M.; Bowman, Stephen M.; Rotert, Mary; Hogg-Johnson, Sheilah

2015-01-01

Purpose Acute work-related trauma is a leading cause of death and disability among U.S. workers. Existing methods to estimate injury severity have important limitations. This study assessed a severe injury indicator constructed from a list of severe traumatic injury diagnosis codes previously developed for surveillance purposes. Study objectives were to: (1) describe the degree to which the severe injury indicator predicts work disability and medical cost outcomes; (2) assess whether this indicator adequately substitutes for estimating Abbreviated Injury Scale (AIS)-based injury severity from workers' compensation (WC) billing data; and (3) assess concordance between indicators constructed from Washington State Trauma Registry (WTR) and WC data. Methods WC claims for workers injured in Washington State from 1998-2008 were linked to WTR records. Competing risks survival analysis was used to model work disability outcomes. Adjusted total medical costs were modeled using linear regression. Information content of the severe injury indicator and AIS-based injury severity measures were compared using Akaike Information Criterion and R2. Results Of 208,522 eligible WC claims, 5% were classified as severe. Among WC claims linked to the WTR, there was substantial agreement between WC-based and WTR-based indicators (kappa=0.75). Information content of the severe injury indicator was similar to some AIS-based measures. The severe injury indicator was a significant predictor of WTR inclusion, early hospitalization, compensated time loss, total permanent disability, and total medical costs. Conclusions Severe traumatic injuries can be directly identified when diagnosis codes are available. This method provides a simple and transparent alternative to AIS-based injury severity estimation. PMID:25900409

Publication bias and the canonization of false facts.

PubMed

Nissen, Silas Boye; Magidson, Tali; Gross, Kevin; Bergstrom, Carl T

2016-12-20

Science is facing a "replication crisis" in which many experimental findings cannot be replicated and are likely to be false. Does this imply that many scientific facts are false as well? To find out, we explore the process by which a claim becomes fact. We model the community's confidence in a claim as a Markov process with successive published results shifting the degree of belief. Publication bias in favor of positive findings influences the distribution of published results. We find that unless a sufficient fraction of negative results are published, false claims frequently can become canonized as fact. Data-dredging, p-hacking, and similar behaviors exacerbate the problem. Should negative results become easier to publish as a claim approaches acceptance as a fact, however, true and false claims would be more readily distinguished. To the degree that the model reflects the real world, there may be serious concerns about the validity of purported facts in some disciplines.

Frontal Lobe Function and Risk of Hip Fracture in Patient With Alzheimer Disease: An Analysis of Linked Data.

PubMed

Roh, Hyun Woong; Hong, Chang Hyung; Lee, SooJin; Lee, Yunhwan; Lee, Kang Soo; Chang, Ki Jung; Oh, Byoung Hoon; Choi, Seong Hye; Kim, Seong Yoon; Back, Joung Hwan; Chung, Young Ki; Lim, Ki Young; Noh, Jai Sung; Son, Sang Joon

2015-11-01

To determine the association between frontal lobe function and risk of hip fracture in patients with Alzheimer disease (AD).Retrospective cohort study using multicenter hospital-based dementia registry and national health insurance claim data was done. Participants who had available data of neuropsychological test, national health insurance claim, and other covariates were included. A total of 1660 patients with AD were included based on Stroop Test results. A total of 1563 patients with AD were included based on the Controlled Oral Word Association Test (COWAT) results. Hip fracture was measured by validated identification criteria using national health insurance claim data. Frontal lobe function was measured by Stroop Test and COWAT at baseline.After adjusting for potential covariates, including cognitive function in other domains (language, verbal and nonverbal memory, and attention), the Cox proportional hazard regression analysis revealed that risk of a hip fracture was decreased with a hazard ratio (HR) of 0.98 per one point of increase in the Stroop Test (adjusted HR = 0.98, 95% confidence interval [CI]: 0.97-1.00) and 0.93 per one point increase in COWAT (adjusted HR = 0.93, 95% CI: 0.88-0.99).The risk of hip fracture in AD patients was associated with baseline frontal lobe function. The result of this research presents evidence of association between frontal lobe function and risk of hip fracture in patients with AD.

Frontal Lobe Function and Risk of Hip Fracture in Patient With Alzheimer Disease

PubMed Central

Roh, Hyun Woong; Hong, Chang Hyung; Lee, SooJin; Lee, Yunhwan; Lee, Kang Soo; Chang, Ki Jung; Oh, Byoung Hoon; Choi, Seong Hye; Kim, Seong Yoon; Back, Joung Hwan; Chung, Young Ki; Lim, Ki Young; Noh, Jai Sung; Son, Sang Joon

2015-01-01

Abstract To determine the association between frontal lobe function and risk of hip fracture in patients with Alzheimer disease (AD). Retrospective cohort study using multicenter hospital-based dementia registry and national health insurance claim data was done. Participants who had available data of neuropsychological test, national health insurance claim, and other covariates were included. A total of 1660 patients with AD were included based on Stroop Test results. A total of 1563 patients with AD were included based on the Controlled Oral Word Association Test (COWAT) results. Hip fracture was measured by validated identification criteria using national health insurance claim data. Frontal lobe function was measured by Stroop Test and COWAT at baseline. After adjusting for potential covariates, including cognitive function in other domains (language, verbal and nonverbal memory, and attention), the Cox proportional hazard regression analysis revealed that risk of a hip fracture was decreased with a hazard ratio (HR) of 0.98 per one point of increase in the Stroop Test (adjusted HR = 0.98, 95% confidence interval [CI]: 0.97–1.00) and 0.93 per one point increase in COWAT (adjusted HR = 0.93, 95% CI: 0.88–0.99). The risk of hip fracture in AD patients was associated with baseline frontal lobe function. The result of this research presents evidence of association between frontal lobe function and risk of hip fracture in patients with AD. PMID:26559259

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

Randomised controlled trials cited in pharmaceutical advertisements targeting New Zealand health professionals: do they support the advertising claims and what is the risk of bias?

PubMed

Ma, Alison; Parkin, Lianne

2015-09-04

To determine whether pharmaceutical advertisement claims targeting health professionals were supported by the randomised controlled trials (RCTs) cited in the advertisements, and to assess the risk of bias in those trials. Pharmaceutical advertisements were obtained from New Zealand Doctor and Pharmacy Today for the period July 2013 to June 2014. All claims made regarding efficacy, safety, and indications were identified and RCTs cited to substantiate these claims were examined. A claim was defined as supported by an RCT if the conclusions drawn in the paper were consistent with the claim. The quality of the RCT was assessed separately, using the Cochrane Risk of Bias Assessment Tool. In 25 (19%) of the 133 instances in which an RCT was cited, the published paper did not support the promotional claim. Moreover, there were only 10 (8%) instances in which the claim was supported by an RCT with a low risk of bias. Of the 78 cited RCTs, only 14% had a low risk of bias, while 49% had an unclear risk and 37% had a high risk. A high proportion of advertisements failed to meet New Zealand regulatory requirements that claims "are valid and have been substantiated".

Validation of electronic medical record-based phenotyping algorithms: results and lessons learned from the eMERGE network.

PubMed

Newton, Katherine M; Peissig, Peggy L; Kho, Abel Ngo; Bielinski, Suzette J; Berg, Richard L; Choudhary, Vidhu; Basford, Melissa; Chute, Christopher G; Kullo, Iftikhar J; Li, Rongling; Pacheco, Jennifer A; Rasmussen, Luke V; Spangler, Leslie; Denny, Joshua C

2013-06-01

Genetic studies require precise phenotype definitions, but electronic medical record (EMR) phenotype data are recorded inconsistently and in a variety of formats. To present lessons learned about validation of EMR-based phenotypes from the Electronic Medical Records and Genomics (eMERGE) studies. The eMERGE network created and validated 13 EMR-derived phenotype algorithms. Network sites are Group Health, Marshfield Clinic, Mayo Clinic, Northwestern University, and Vanderbilt University. By validating EMR-derived phenotypes we learned that: (1) multisite validation improves phenotype algorithm accuracy; (2) targets for validation should be carefully considered and defined; (3) specifying time frames for review of variables eases validation time and improves accuracy; (4) using repeated measures requires defining the relevant time period and specifying the most meaningful value to be studied; (5) patient movement in and out of the health plan (transience) can result in incomplete or fragmented data; (6) the review scope should be defined carefully; (7) particular care is required in combining EMR and research data; (8) medication data can be assessed using claims, medications dispensed, or medications prescribed; (9) algorithm development and validation work best as an iterative process; and (10) validation by content experts or structured chart review can provide accurate results. Despite the diverse structure of the five EMRs of the eMERGE sites, we developed, validated, and successfully deployed 13 electronic phenotype algorithms. Validation is a worthwhile process that not only measures phenotype performance but also strengthens phenotype algorithm definitions and enhances their inter-institutional sharing.

A study in the founding of applied behavior analysis through its publications.

PubMed

Morris, Edward K; Altus, Deborah E; Smith, Nathaniel G

2013-01-01

This article reports a study of the founding of applied behavior analysis through its publications. Our methods included hand searches of sources (e.g., journals, reference lists), search terms (i.e., early, applied, behavioral, research, literature), inclusion criteria (e.g., the field's applied dimension), and (d) challenges to their face and content validity. Our results were 36 articles published between 1959 and 1967 that we organized into 4 groups: 12 in 3 programs of research and 24 others. Our discussion addresses (a) limitations in our method (e.g., the completeness of our search), (b) challenges to the validity of our methods and results (e.g., convergent validity), and (c) priority claims about the field's founding. We conclude that the claims are irresolvable because identification of the founding publications depends significantly on methods and because the field's founding was an evolutionary process. We close with suggestions for future research.

Validity of juvenile idiopathic arthritis diagnoses using administrative health data.

PubMed

Stringer, Elizabeth; Bernatsky, Sasha

2015-03-01

Administrative health databases are valuable sources of data for conducting research including disease surveillance, outcomes research, and processes of health care at the population level. There has been limited use of administrative data to conduct studies of pediatric rheumatic conditions and no studies validating case definitions in Canada. We report a validation study of incident cases of juvenile idiopathic arthritis in the Canadian province of Nova Scotia. Cases identified through administrative data algorithms were compared to diagnoses in a clinical database. The sensitivity of algorithms that included pediatric rheumatology specialist claims was 81-86%. However, 35-48% of cases that were identified could not be verified in the clinical database depending on the algorithm used. Our case definitions would likely lead to overestimates of disease burden. Our findings may be related to issues pertaining to the non-fee-for-service remuneration model in Nova Scotia, in particular, systematic issues related to the process of submitting claims.

A Study in the Founding of Applied Behavior Analysis Through Its Publications

PubMed Central

Morris, Edward K.; Altus, Deborah E.; Smith, Nathaniel G.

2013-01-01

This article reports a study of the founding of applied behavior analysis through its publications. Our methods included hand searches of sources (e.g., journals, reference lists), search terms (i.e., early, applied, behavioral, research, literature), inclusion criteria (e.g., the field's applied dimension), and (d) challenges to their face and content validity. Our results were 36 articles published between 1959 and 1967 that we organized into 4 groups: 12 in 3 programs of research and 24 others. Our discussion addresses (a) limitations in our method (e.g., the completeness of our search), (b) challenges to the validity of our methods and results (e.g., convergent validity), and (c) priority claims about the field's founding. We conclude that the claims are irresolvable because identification of the founding publications depends significantly on methods and because the field's founding was an evolutionary process. We close with suggestions for future research. PMID:25729133

Measuring ability to assess claims about treatment effects: the development of the 'Claim Evaluation Tools'.

PubMed

Austvoll-Dahlgren, Astrid; Semakula, Daniel; Nsangi, Allen; Oxman, Andrew David; Chalmers, Iain; Rosenbaum, Sarah; Guttersrud, Øystein

2017-05-17

To describe the development of the Claim Evaluation Tools, a set of flexible items to measure people's ability to assess claims about treatment effects. Methodologists and members of the community (including children) in Uganda, Rwanda, Kenya, Norway, the UK and Australia. In the iterative development of the items, we used purposeful sampling of people with training in research methodology, such as teachers of evidence-based medicine, as well as patients and members of the public from low-income and high-income countries. Development consisted of 4 processes: (1) determining the scope of the Claim Evaluation Tools and development of items; (2) expert item review and feedback (n=63); (3) cognitive interviews with children and adult end-users (n=109); and (4) piloting and administrative tests (n=956). The Claim Evaluation Tools database currently includes a battery of multiple-choice items. Each item begins with a scenario which is intended to be relevant across contexts, and which can be used for children (from age 10  and above), adult members of the public and health professionals. People with expertise in research methods judged the items to have face validity, and end-users judged them relevant and acceptable in their settings. In response to feedback from methodologists and end-users, we simplified some text, explained terms where needed, and redesigned formats and instructions. The Claim Evaluation Tools database is a flexible resource from which researchers, teachers and others can design measurement instruments to meet their own requirements. These evaluation tools are being managed and made freely available for non-commercial use (on request) through Testing Treatments interactive (testingtreatments.org). PACTR201606001679337 and PACTR201606001676150; Pre-results. 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/.

Absolute and Relative Measures of Instructional Sensitivity

ERIC Educational Resources Information Center

Naumann, Alexander; Hartig, Johannes; Hochweber, Jan

2017-01-01

Valid inferences on teaching drawn from students' test scores require that tests are sensitive to the instruction students received in class. Accordingly, measures of the test items' instructional sensitivity provide empirical support for validity claims about inferences on instruction. In the present study, we first introduce the concepts of…

Exploring the Relationship between Validity and Comparability in Assessment

ERIC Educational Resources Information Center

Crisp, Victoria

2017-01-01

This article discusses how comparability relates to current mainstream conceptions of validity, in the context of educational assessment. Relevant literature was used to consider the relationship between these concepts. The article concludes that, depending on the exact claims being made about the appropriate interpretations and uses of the…

Using Transcripts To Validate Institutional Mission: The Role of the Community College in the Postsecondary Experience of a Generation. ASHE Annual Meeting Paper.

ERIC Educational Resources Information Center

Adelman, Clifford

Information is presented on the use of transcripts to validate institutional mission, proposing that transcript archives can serve as grounds against which the validity of an institution's claimed mission with respect to its primary beneficiaries can be measured. This is done with a focus on the community college. The National Longitudinal Study…

On the Myth and the Reality of the Temporal Validity Degradation of General Mental Ability Test Scores

ERIC Educational Resources Information Center

Reeve, Charlie L.; Bonaccio, Silvia

2011-01-01

Claims of changes in the validity coefficients associated with general mental ability (GMA) tests due to the passage of time (i.e., temporal validity degradation) have been the focus of an on-going debate in applied psychology. To evaluate whether and, if so, under what conditions this degradation may occur, we integrate evidence from multiple…

The challenge of forecasting impacts of flash floods: test of a simplified hydraulic approach and validation based on insurance claim data

NASA Astrophysics Data System (ADS)

Le Bihan, Guillaume; Payrastre, Olivier; Gaume, Eric; Moncoulon, David; Pons, Frédéric

2017-11-01

Up to now, flash flood monitoring and forecasting systems, based on rainfall radar measurements and distributed rainfall-runoff models, generally aimed at estimating flood magnitudes - typically discharges or return periods - at selected river cross sections. The approach presented here goes one step further by proposing an integrated forecasting chain for the direct assessment of flash flood possible impacts on inhabited areas (number of buildings at risk in the presented case studies). The proposed approach includes, in addition to a distributed rainfall-runoff model, an automatic hydraulic method suited for the computation of flood extent maps on a dense river network and over large territories. The resulting catalogue of flood extent maps is then combined with land use data to build a flood impact curve for each considered river reach, i.e. the number of inundated buildings versus discharge. These curves are finally used to compute estimated impacts based on forecasted discharges. The approach has been extensively tested in the regions of Alès and Draguignan, located in the south of France, where well-documented major flash floods recently occurred. The article presents two types of validation results. First, the automatically computed flood extent maps and corresponding water levels are tested against rating curves at available river gauging stations as well as against local reference or observed flood extent maps. Second, a rich and comprehensive insurance claim database is used to evaluate the relevance of the estimated impacts for some recent major floods.

Making Peer-Assisted Content Distribution Robust to Collusion Using Bandwidth Puzzles

NASA Astrophysics Data System (ADS)

Reiter, Michael K.; Sekar, Vyas; Spensky, Chad; Zhang, Zhenghao

Many peer-assisted content-distribution systems reward a peer based on the amount of data that this peer serves to others. However, validating that a peer did so is, to our knowledge, an open problem; e.g., a group of colluding attackers can earn rewards by claiming to have served content to one another, when they have not. We propose a puzzle mechanism to make contribution-aware peer-assisted content distribution robust to such collusion. Our construction ties solving the puzzle to possession of specific content and, by issuing puzzle challenges simultaneously to all parties claiming to have that content, our mechanism prevents one content-holder from solving many others' puzzles. We prove (in the random oracle model) the security of our scheme, describe our integration of bandwidth puzzles into a media streaming system, and demonstrate the resulting attack resilience via simulations.

Antibiotic prescriptions for upper respiratory tract infection in Japan.

PubMed

Higashi, Takahiro; Fukuhara, Shunichi

2009-01-01

The overuse of antibiotics results in the unnecessary spread of resistant strains. A common setting for antibiotic overuse is in the treatment of upper respiratory tract infections (URIs), which are predominantly due to viruses. To investigate the type and frequency of antibiotic prescription for URI without apparent bacterial infection in Japan, based on both visits and facilities. Cross-sectional analysis of insurance claims submitted to an employer-sponsored health insurance plan in Japan between January and March, 2005 for diagnoses of URI. Claims having a potentially valid reason for antibiotic prescription (e.g., secondary diagnosis of pneumonia) were excluded. Antibiotics prescribed for these URI visits. From a total of 24,134 claims, 2,577 claims (non-bacterial URI, one visit per claim) were analyzed; antibiotics were prescribed in 60% of these visits. Third-generation cephalosporins were the most commonly-prescribed drug class (46%), followed by macrolides (27%) and quinolones (16%). In general, visits to physician offices were more likely to result in an antibiotic prescription than visits to hospital outpatient clinics. No statistically significant difference was identified among hospital types, including private and public ownership or teaching hospital status. Analysis of the frequency of antibiotic prescription by facility revealed two peaks in distribution, with one group prescribing to about 90% of URI patients and the second appearing to prescribe to about 40% of patients. Antibiotics are frequently prescribed to URI patients in Japan. Although overuse results from the difficulty in accurately distinguishing viral from bacterial URIs, some facilities appear to attempt to differentiate the underlying cause of the URI while others do not.

Transgender Medicare Beneficiaries and Chronic Conditions: Exploring Fee-for-Service Claims Data

PubMed Central

Guerino, Paul; Ewald, Erin; Laffan, Alison M.

2017-01-01

Abstract Purpose: Data on the health and well-being of the transgender population are limited. However, using claims data we can identify transgender Medicare beneficiaries (TMBs) with high confidence. We seek to describe the TMB population and provide comparisons of chronic disease burden between TMBs and cisgender Medicare beneficiaries (CMBs), thus laying a foundation for national level TMB health disparity research. Methods: Using a previously validated claims algorithm based on ICD-9-CM codes relating to transsexualism and gender identity disorder, we identified a cohort of TMBs using Medicare Fee-for-Service (FFS) claims data. We then describe the demographic characteristics and chronic disease burden of TMBs (N = 7454) and CMBs (N = 39,136,229). Results: Compared to CMBs, a greater observed proportion of TMBs are young (under age 65) and Black, although these differences vary by entitlement. Regardless of entitlement, TMBs have more chronic conditions than CMBs, and more TMBs have been diagnosed with asthma, autism spectrum disorder, chronic obstructive pulmonary disease, depression, hepatitis, HIV, schizophrenia, and substance use disorders. TMBs also have higher observed rates of potentially disabling mental health and neurological/chronic pain conditions, as well as obesity and other liver conditions (nonhepatitis), compared to CMBs. Conclusion: This is the first systematic look at chronic disease burden in the transgender population using Medicare FFS claims data. We found that TMBs experience multiple chronic conditions at higher rates than CMBs, regardless of Medicare entitlement. TMBs under age 65 show an already heavy chronic disease burden which will only be exacerbated with age. PMID:29125908

Piecewise-homotopy analysis method (P-HAM) for first order nonlinear ODE

NASA Astrophysics Data System (ADS)

Chin, F. Y.; Lem, K. H.; Chong, F. S.

2013-09-01

In homotopy analysis method (HAM), the determination for the value of the auxiliary parameter h is based on the valid region of the h-curve in which the horizontal segment of the h-curve will decide the valid h-region. All h-value taken from the valid region, provided that the order of deformation is large enough, will in principle yield an approximation series that converges to the exact solution. However it is found out that the h-value chosen within this valid region does not always promise a good approximation under finite order. This paper suggests an improved method called Piecewise-HAM (P-HAM). In stead of a single h-value, this method suggests using many h-values. Each of the h-values comes from an individual h-curve while each h-curve is plotted by fixing the time t at a different value. Each h-value is claimed to produce a good approximation only about a neighborhood centered at the corresponding t which the h-curve is based on. Each segment of these good approximations is then joined to form the approximation curve. By this, the convergence region is enhanced further. The P-HAM is illustrated and supported by examples.

Face and construct validity of a computer-based virtual reality simulator for ERCP.

PubMed

Bittner, James G; Mellinger, John D; Imam, Toufic; Schade, Robert R; Macfadyen, Bruce V

2010-02-01

Currently, little evidence supports computer-based simulation for ERCP training. To determine face and construct validity of a computer-based simulator for ERCP and assess its perceived utility as a training tool. Novice and expert endoscopists completed 2 simulated ERCP cases by using the GI Mentor II. Virtual Education and Surgical Simulation Laboratory, Medical College of Georgia. Outcomes included times to complete the procedure, reach the papilla, and use fluoroscopy; attempts to cannulate the papilla, pancreatic duct, and common bile duct; and number of contrast injections and complications. Subjects assessed simulator graphics, procedural accuracy, difficulty, haptics, overall realism, and training potential. Only when performance data from cases A and B were combined did the GI Mentor II differentiate novices and experts based on times to complete the procedure, reach the papilla, and use fluoroscopy. Across skill levels, overall opinions were similar regarding graphics (moderately realistic), accuracy (similar to clinical ERCP), difficulty (similar to clinical ERCP), overall realism (moderately realistic), and haptics. Most participants (92%) claimed that the simulator has definite training potential or should be required for training. Small sample size, single institution. The GI Mentor II demonstrated construct validity for ERCP based on select metrics. Most subjects thought that the simulated graphics, procedural accuracy, and overall realism exhibit face validity. Subjects deemed it a useful training tool. Study repetition involving more participants and cases may help confirm results and establish the simulator's ability to differentiate skill levels based on ERCP-specific metrics.

Classification accuracy of claims-based methods for identifying providers failing to meet performance targets.

PubMed

Hubbard, Rebecca A; Benjamin-Johnson, Rhondee; Onega, Tracy; Smith-Bindman, Rebecca; Zhu, Weiwei; Fenton, Joshua J

2015-01-15

Quality assessment is critical for healthcare reform, but data sources are lacking for measurement of many important healthcare outcomes. With over 49 million people covered by Medicare as of 2010, Medicare claims data offer a potentially valuable source that could be used in targeted health care quality improvement efforts. However, little is known about the operating characteristics of provider profiling methods using claims-based outcome measures that may estimate provider performance with error. Motivated by the example of screening mammography performance, we compared approaches to identifying providers failing to meet guideline targets using Medicare claims data. We used data from the Breast Cancer Surveillance Consortium and linked Medicare claims to compare claims-based and clinical estimates of cancer detection rate. We then demonstrated the performance of claim-based estimates across a broad range of operating characteristics using simulation studies. We found that identification of poor performing providers was extremely sensitive to algorithm specificity, with no approach identifying more than 65% of poor performing providers when claims-based measures had specificity of 0.995 or less. We conclude that claims have the potential to contribute important information on healthcare outcomes to quality improvement efforts. However, to achieve this potential, development of highly accurate claims-based outcome measures should remain a priority. Copyright © 2014 John Wiley & Sons, Ltd.

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.

Job strain — Attributable depression in a sample of working Australians: Assessing the contribution to health inequalities

PubMed Central

LaMontagne, Anthony D; Keegel, Tessa; Vallance, Deborah; Ostry, Aleck; Wolfe, Rory

2008-01-01

Background The broad aim of this study was to assess the contribution of job strain to mental health inequalities by (a) estimating the proportion of depression attributable to job strain (low control and high demand jobs), (b) assessing variation in attributable risk by occupational skill level, and (c) comparing numbers of job strain–attributable depression cases to numbers of compensated 'mental stress' claims. Methods Standard population attributable risk (PAR) methods were used to estimate the proportion of depression attributable to job strain. An adjusted Odds Ratio (OR) of 1.82 for job strain in relation to depression was obtained from a recently published meta-analysis and combined with exposure prevalence data from the Australian state of Victoria. Job strain exposure prevalence was determined from a 2003 population-based telephone survey of working Victorians (n = 1101, 66% response rate) using validated measures of job control (9 items, Cronbach's alpha = 0.80) and psychological demands (3 items, Cronbach's alpha = 0.66). Estimates of absolute numbers of prevalent cases of depression and successful stress-related workers' compensation claims were obtained from publicly available Australian government sources. Results Overall job strain-population attributable risk (PAR) for depression was 13.2% for males [95% CI 1.1, 28.1] and 17.2% [95% CI 1.5, 34.9] for females. There was a clear gradient of increasing PAR with decreasing occupational skill level. Estimation of job strain–attributable cases (21,437) versus "mental stress" compensation claims (696) suggest that claims statistics underestimate job strain–attributable depression by roughly 30-fold. Conclusion Job strain and associated depression risks represent a substantial, preventable, and inequitably distributed public health problem. The social patterning of job strain-attributable depression parallels the social patterning of mental illness, suggesting that job strain is an important contributor to mental health inequalities. The numbers of compensated 'mental stress' claims compared to job strain-attributable depression cases suggest that there is substantial under-recognition and under-compensation of job strain-attributable depression. Primary, secondary, and tertiary intervention efforts should be substantially expanded, with intervention priorities based on hazard and associated health outcome data as an essential complement to claims statistics. PMID:18505559

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.

Development and Validation of an Algorithm to Identify Planned Readmissions From Claims Data.

PubMed

Horwitz, Leora I; Grady, Jacqueline N; Cohen, Dorothy B; Lin, Zhenqiu; Volpe, Mark; Ngo, Chi K; Masica, Andrew L; Long, Theodore; Wang, Jessica; Keenan, Megan; Montague, Julia; Suter, Lisa G; Ross, Joseph S; Drye, Elizabeth E; Krumholz, Harlan M; Bernheim, Susannah M

2015-10-01

It is desirable not to include planned readmissions in readmission measures because they represent deliberate, scheduled care. To develop an algorithm to identify planned readmissions, describe its performance characteristics, and identify improvements. Consensus-driven algorithm development and chart review validation study at 7 acute-care hospitals in 2 health systems. For development, all discharges qualifying for the publicly reported hospital-wide readmission measure. For validation, all qualifying same-hospital readmissions that were characterized by the algorithm as planned, and a random sampling of same-hospital readmissions that were characterized as unplanned. We calculated weighted sensitivity and specificity, and positive and negative predictive values of the algorithm (version 2.1), compared to gold standard chart review. In consultation with 27 experts, we developed an algorithm that characterizes 7.8% of readmissions as planned. For validation we reviewed 634 readmissions. The weighted sensitivity of the algorithm was 45.1% overall, 50.9% in large teaching centers and 40.2% in smaller community hospitals. The weighted specificity was 95.9%, positive predictive value was 51.6%, and negative predictive value was 94.7%. We identified 4 minor changes to improve algorithm performance. The revised algorithm had a weighted sensitivity 49.8% (57.1% at large hospitals), weighted specificity 96.5%, positive predictive value 58.7%, and negative predictive value 94.5%. Positive predictive value was poor for the 2 most common potentially planned procedures: diagnostic cardiac catheterization (25%) and procedures involving cardiac devices (33%). An administrative claims-based algorithm to identify planned readmissions is feasible and can facilitate public reporting of primarily unplanned readmissions. © 2015 Society of Hospital Medicine.

Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report.

PubMed

Rothman, Margaret; Burke, Laurie; Erickson, Pennifer; Leidy, Nancy Kline; Patrick, Donald L; Petrie, Charles D

2009-01-01

Patient-reported outcome (PRO) instruments are used to evaluate the effect of medical products on how patients feel or function. This article presents the results of an ISPOR task force convened to address good clinical research practices for the use of existing or modified PRO instruments to support medical product labeling claims. The focus of the article is on content validity, with specific reference to existing or modified PRO instruments, because of the importance of content validity in selecting or modifying an existing PRO instrument and the lack of consensus in the research community regarding best practices for establishing and documenting this measurement property. Topics addressed in the article include: definition and general description of content validity; PRO concept identification as the important first step in establishing content validity; instrument identification and the initial review process; key issues in qualitative methodology; and potential threats to content validity, with three case examples used to illustrate types of threats and how they might be resolved. A table of steps used to identify and evaluate an existing PRO instrument is provided, and figures are used to illustrate the meaning of content validity in relationship to instrument development and evaluation. RESULTS & RECOMMENDATIONS: Four important threats to content validity are identified: unclear conceptual match between the PRO instrument and the intended claim, lack of direct patient input into PRO item content from the target population in which the claim is desired, no evidence that the most relevant and important item content is contained in the instrument, and lack of documentation to support modifications to the PRO instrument. In some cases, careful review of the threats to content validity in a specific application may be reduced through additional well documented qualitative studies that specifically address the issue of concern. Published evidence of the content validity of a PRO instrument for an intended application is often limited. Such evidence is, however, important to evaluating the adequacy of a PRO instrument for the intended application. This article provides an overview of key issues involved in assessing and documenting content validity as it relates to using existing instruments in the drug approval process.

7 CFR 1.51 - Claims based on negligence, wrongful act or omission.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 1 2010-01-01 2010-01-01 false Claims based on negligence, wrongful act or omission. 1.51 Section 1.51 Agriculture Office of the Secretary of Agriculture ADMINISTRATIVE REGULATIONS Claims § 1.51 Claims based on negligence, wrongful act or omission. (a) Authority of the Department...

Validation of International Classification of Diseases coding for bone metastases in electronic health records using technology-enabled abstraction.

PubMed

Liede, Alexander; Hernandez, Rohini K; Roth, Maayan; Calkins, Geoffrey; Larrabee, Katherine; Nicacio, Leo

2015-01-01

The accuracy of bone metastases diagnostic coding based on International Classification of Diseases, ninth revision (ICD-9) is unknown for most large databases used for epidemiologic research in the US. Electronic health records (EHR) are the preferred source of data, but often clinically relevant data occur only as unstructured free text. We examined the validity of bone metastases ICD-9 coding in structured EHR and administrative claims relative to the complete (structured and unstructured) patient chart obtained through technology-enabled chart abstraction. Female patients with breast cancer with ≥1 visit after November 2010 were identified from three community oncology practices in the US. We calculated sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of bone metastases ICD-9 code 198.5. The technology-enabled abstraction displays portions of the chart to clinically trained abstractors for targeted review, thereby maximizing efficiency. We evaluated effects of misclassification of patients developing skeletal complications or treated with bone-targeting agents (BTAs), and timing of BTA. Among 8,796 patients with breast cancer, 524 had confirmed bone metastases using chart abstraction. Sensitivity was 0.67 (95% confidence interval [CI] =0.63-0.71) based on structured EHR, and specificity was high at 0.98 (95% CI =0.98-0.99) with corresponding PPV of 0.71 (95% CI =0.67-0.75) and NPV of 0.98 (95% CI =0.98-0.98). From claims, sensitivity was 0.78 (95% CI =0.74-0.81), and specificity was 0.98 (95% CI =0.98-0.98) with PPV of 0.72 (95% CI =0.68-0.76) and NPV of 0.99 (95% CI =0.98-0.99). Structured data and claims missed 17% of bone metastases (89 of 524). False negatives were associated with measurable overestimation of the proportion treated with BTA or with a skeletal complication. Median date of diagnosis was delayed in structured data (32 days) and claims (43 days) compared with technology-assisted EHR. Technology-enabled chart abstraction of unstructured EHR greatly improves data quality, minimizing false negatives when identifying patients with bone metastases that may lead to inaccurate conclusions that can affect delivery of care.

Cryptanalysis of Chatterjee-Sarkar Hierarchical Identity-Based Encryption Scheme at PKC 06

NASA Astrophysics Data System (ADS)

Park, Jong Hwan; Lee, Dong Hoon

In 2006, Chatterjee and Sarkar proposed a hierarchical identity-based encryption (HIBE) scheme which can support an unbounded number of identity levels. This property is particularly useful in providing forward secrecy by embedding time components within hierarchical identities. In this paper we show that their scheme does not provide the claimed property. Our analysis shows that if the number of identity levels becomes larger than the value of a fixed public parameter, an unintended receiver can reconstruct a new valid ciphertext and decrypt the ciphertext using his or her own private key. The analysis is similarly applied to a multi-receiver identity-based encryption scheme presented as an application of Chatterjee and Sarkar's HIBE scheme.

Triangulation, Respondent Validation, and Democratic Participation in Mixed Methods Research

ERIC Educational Resources Information Center

Torrance, Harry

2012-01-01

Over the past 10 years or so the "Field" of "Mixed Methods Research" (MMR) has increasingly been exerting itself as something separate, novel, and significant, with some advocates claiming paradigmatic status. Triangulation is an important component of mixed methods designs. Triangulation has its origins in attempts to validate research findings…

Use of enzymatic cleaners on US Navy ships. Research report

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

Venkatachalam, R.S.

1996-03-01

The Naval Surface Warfare Center, Carderock Division, conducted a study to determine the feasibility of using enzymatic and bacterial products in cleaning applications aboard U.S. Navy ships. A review of the most recent technical literature and a survey of potential suppliers were conducted. In addition, shipboard systems, subsystems and housekeeping processes were evaluated to identify suitable applications for enzymatic and bacterial cleaners. The study identified numerous commercial products that, based on manufacturers` claims, would be effective and safe for use aboard ship to clean walls, floors, galley work surfaces, engine and machine parts, drains, pipes, grease traps, collection, holding andmore » transfer (CHT) tanks, ballast tanks and bilge areas. However, the study also revealed the absence of standardized test protocols essential for validation of manufacturers` claims, and recommended the cooperative development of such protocols by representatives from the commercial sector, Government and academia. The need to obtain meaningful cost information based on actual use scenarios and to investigate any permitting issues associated with the discharge of related wastes to pierside facilities was also identified.« less

Selected physical and chemical properties of Feverfew (Tanacetum parthenium) extracts important for formulated product quality and performance.

PubMed

Jin, Ping; Madieh, Shadi; Augsburger, Larry L

2008-01-01

The objectives of this research are: (1) to assess selected formulation-relevant physical properties of several commercial Feverfew extracts, including flowability, hygroscopicity, compressibility and compactibility (2) to develop and validate a suitable extraction method and HPLC assay, and (3) to determine the parthenolide content of several commercial Feverfew extracts. Carr's index, minimum orifice diameter and particle-particle interaction were used to evaluate powder flowability. Hygroscopicity was evaluated by determining the equilibrium moisture content (EMC) after storage at various % relative humidities. Heckle analysis and compression pressure-radial tensile strength relationship were used to represent compression and compaction properties of feverfew extracts. An adapted analytical method was developed based on literature methods and then validated for the determination of parthenolide in feverfew. The commercial extracts tested exhibited poor to very poor flowability. The comparatively low mean yield pressure suggested that feverfew extracts deformed mainly plastically. Hygroscopicity and compactibility varied greatly with source. No commercial feverfew extracts tested contained the label claimed parthenolide. Even different batches from the same manufacturer showed significantly different parthenolide content. Therefore, extract manufactures should commit to proper quality control procedures that ensure accurate label claims, and supplement manufacturers should take into account possible differences in physico-chemical properties when using extracts from multiple suppliers.

Nutrition-related claims on children's cereals: what do they mean to parents and do they influence willingness to buy?

PubMed

Harris, Jennifer L; Thompson, Jacqueline M; Schwartz, Marlene B; Brownell, Kelly D

2011-12-01

To examine parents' beliefs about the meaning of common front-of-package nutrition-related claims on children's cereals and determine whether the claims would make them more willing to buy the cereals. Parents viewed images of box fronts for children's cereals of below-average nutritional quality, as assessed by a validated nutrient profiling model. These boxes featured various nutrition-related claims including 'supports your child's immunity', 'whole grain', 'fibre', 'calcium and vitamin D' and 'organic'. Participants were provided possible meanings for these claims and asked to select any that applied with the option to write in additional meanings. They also indicated how the claim would affect their willingness to buy the product. Online survey. Parents with children between the ages of 2 and 11 years (n 306) recruited through an online panel. The majority of parents misinterpreted the meaning of claims commonly used on children's cereals. They inferred that cereals with claims were more nutritious overall and might provide specific health-related benefits for their children; and these beliefs predicted greater willingness to buy the cereals. These findings indicate that common front-of-package nutrition-related claims are potentially misleading, especially when placed on products with high levels of nutrients to limit (e.g. sugar, sodium) and low levels of other nutrients to encourage (e.g. fibre, protein). Additional regulation is needed to protect consumers in the USA.

A reconceptualization of the somatoform disorders.

PubMed

Noyes, Russell; Stuart, Scott P; Watson, David B

2008-01-01

Since its introduction in DSM-III, the Somatoform Disorders category has been a subject of controversy. Critics of the grouping have claimed that it promotes dualism, assumes psychogenesis, and that it contains heterogeneous disorders that lack validity. The history of these disorders is one of shifting conceptualizations and disputes. A number of changes in the classification have been proposed, but few address problems that arise with the current formulation. The authors propose a dimensional reconceptualization based on marked and persistent somatic distress and care-eliciting behavior. This formulation is based on the interpersonal model of somatization. The authors propose testing of this conceptualization and indicate how this might be done.

Lessons to be learned from a contentious challenge to mainstream radiobiological science (the linear no-threshold theory of genetic mutations).

PubMed

Beyea, Jan

2017-04-01

There are both statistically valid and invalid reasons why scientists with differing default hypotheses can disagree in high-profile situations. Examples can be found in recent correspondence in this journal, which may offer lessons for resolving challenges to mainstream science, particularly when adherents of a minority view attempt to elevate the status of outlier studies and/or claim that self-interest explains the acceptance of the dominant theory. Edward J. Calabrese and I have been debating the historical origins of the linear no-threshold theory (LNT) of carcinogenesis and its use in the regulation of ionizing radiation. Professor Calabrese, a supporter of hormesis, has charged a committee of scientists with misconduct in their preparation of a 1956 report on the genetic effects of atomic radiation. Specifically he argues that the report mischaracterized the LNT research record and suppressed calculations of some committee members. After reviewing the available scientific literature, I found that the contemporaneous evidence overwhelmingly favored a (genetics) LNT and that no calculations were suppressed. Calabrese's claims about the scientific record do not hold up primarily because of lack of attention to statistical analysis. Ironically, outlier studies were more likely to favor supra-linearity, not sub-linearity. Finally, the claim of investigator bias, which underlies Calabrese's accusations about key studies, is based on misreading of text. Attention to ethics charges, early on, may help seed a counter narrative explaining the community's adoption of a default hypothesis and may help focus attention on valid evidence and any real weaknesses in the dominant paradigm. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Psychiatry's new manual (DSM-5): ethical and conceptual dimensions.

PubMed

Blumenthal-Barby, J S

2014-08-01

The introduction of the Diagnostic and statistical manual of mental disorders (DSM-5) in May 2013 is being hailed as the biggest event in psychiatry in the last 10 years. In this paper I examine three important issues that arise from the new manual:(1) Expanding nosology: Psychiatry has again broadened its nosology to include human experiences not previously under its purview (eg, binge eating disorder, internet gaming disorder, caffeine use disorder, hoarding disorder, premenstrual dysphoric disorder). Consequence-based ethical concerns about this expansion are addressed, along with conceptual concerns about a confusion of "construct validity" and "conceptual validity" and a failure to distinguish between "disorder" and "non disordered conditions for which we help people."(2) The role of claims about societal impact in changes in nosology: Several changes in the DSM-5 involved claims about societal impact in their rationales. This is due in part to a new online open comment period during DSM development. Examples include advancement of science, greater access to treatment, greater public awareness of condition, loss of identify or harm to those with removed disorders, stigmatization, offensiveness, etc. I identify and evaluate four importantly distinct ways in which claims about societal impact might operate in DSM development. (3) Categorisation nosology to spectrum nosology: The move to "degrees of severity" of mental disorders, a major change for DSM-5, raises concerns about conceptual clarity and uniformity concerning what it means to have a severe form of a disorder, and ethical concerns about communication. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Identifying Social Learning in Animal Populations: A New ‘Option-Bias’ Method

PubMed Central

Kendal, Rachel L.; Kendal, Jeremy R.; Hoppitt, Will; Laland, Kevin N.

2009-01-01

Background Studies of natural animal populations reveal widespread evidence for the diffusion of novel behaviour patterns, and for intra- and inter-population variation in behaviour. However, claims that these are manifestations of animal ‘culture’ remain controversial because alternative explanations to social learning remain difficult to refute. This inability to identify social learning in social settings has also contributed to the failure to test evolutionary hypotheses concerning the social learning strategies that animals deploy. Methodology/Principal Findings We present a solution to this problem, in the form of a new means of identifying social learning in animal populations. The method is based on the well-established premise of social learning research, that - when ecological and genetic differences are accounted for - social learning will generate greater homogeneity in behaviour between animals than expected in its absence. Our procedure compares the observed level of homogeneity to a sampling distribution generated utilizing randomization and other procedures, allowing claims of social learning to be evaluated according to consensual standards. We illustrate the method on data from groups of monkeys provided with novel two-option extractive foraging tasks, demonstrating that social learning can indeed be distinguished from unlearned processes and asocial learning, and revealing that the monkeys only employed social learning for the more difficult tasks. The method is further validated against published datasets and through simulation, and exhibits higher statistical power than conventional inferential statistics. Conclusions/Significance The method is potentially a significant technological development, which could prove of considerable value in assessing the validity of claims for culturally transmitted behaviour in animal groups. It will also be of value in enabling investigation of the social learning strategies deployed in captive and natural animal populations. PMID:19657389

The morality of abortion and the deprivation of futures

PubMed Central

Brown, M.

2000-01-01

In an influential essay entitled Why abortion is wrong, Donald Marquis argues that killing actual persons is wrong because it unjustly deprives victims of their future; that the fetus has a future similar in morally relevant respects to the future lost by competent adult homicide victims, and that, as consequence, abortion is justifiable only in the same circumstances in which killing competent adult human beings is justifiable.1 The metaphysical claim implicit in the first premise, that actual persons have a future of value, is ambiguous. The Future Like Ours argument (FLO) would be valid if "future of value" were used consistently to mean either "potential future of value" or "self-represented future of value", and FLO would be sound if one or the other interpretation supported both the moral claim and the metaphysical claim, but if, as I argue, any interpretation which makes the argument valid renders it unsound, then FLO must be rejected. Its apparent strength derives from equivocation on the concept of "a future of value". Key Words: Abortion • Future Like Ours • Donald Marquis • potentiality • pro-choice PMID:10786320

Measuring ability to assess claims about treatment effects: a latent trait analysis of items from the ‘Claim Evaluation Tools’ database using Rasch modelling

PubMed Central

Austvoll-Dahlgren, Astrid; Guttersrud, Øystein; Nsangi, Allen; Semakula, Daniel; Oxman, Andrew D

2017-01-01

Background The Claim Evaluation Tools database contains multiple-choice items for measuring people’s ability to apply the key concepts they need to know to be able to assess treatment claims. We assessed items from the database using Rasch analysis to develop an outcome measure to be used in two randomised trials in Uganda. Rasch analysis is a form of psychometric testing relying on Item Response Theory. It is a dynamic way of developing outcome measures that are valid and reliable. Objectives To assess the validity, reliability and responsiveness of 88 items addressing 22 key concepts using Rasch analysis. Participants We administrated four sets of multiple-choice items in English to 1114 people in Uganda and Norway, of which 685 were children and 429 were adults (including 171 health professionals). We scored all items dichotomously. We explored summary and individual fit statistics using the RUMM2030 analysis package. We used SPSS to perform distractor analysis. Results Most items conformed well to the Rasch model, but some items needed revision. Overall, the four item sets had satisfactory reliability. We did not identify significant response dependence between any pairs of items and, overall, the magnitude of multidimensionality in the data was acceptable. The items had a high level of difficulty. Conclusion Most of the items conformed well to the Rasch model’s expectations. Following revision of some items, we concluded that most of the items were suitable for use in an outcome measure for evaluating the ability of children or adults to assess treatment claims. PMID:28550019

The influence of weight-of-evidence strategies on audience perceptions of (un)certainty when media cover contested science.

PubMed

Kohl, Patrice Ann; Kim, Soo Yun; Peng, Yilang; Akin, Heather; Koh, Eun Jeong; Howell, Allison; Dunwoody, Sharon

2016-11-01

Controversy in science news accounts attracts audiences and draws attention to important science issues. But sometimes covering multiple sides of a science issue does the audience a disservice. Counterbalancing a truth claim backed by strong scientific support with a poorly backed argument can unnecessarily heighten audience perceptions of uncertainty. At the same time, journalistic norms often constrain reporters to "get both sides of the story" even when there is little debate in the scientific community about which truth claim is most valid. In this study, we look at whether highlighting the way in which experts are arrayed across truth claims-a strategy we label "weight-of-evidence reporting"-can attenuate heightened perceptions of uncertainty that can result from coverage of conflicting claims. The results of our study suggest weight-of-evidence strategies can indeed play a role in reducing some of the uncertainty audiences may perceive when encountering lop-sided truth claims. © The Author(s) 2015.

Publication bias and the canonization of false facts

PubMed Central

Nissen, Silas Boye; Magidson, Tali; Gross, Kevin; Bergstrom, Carl T

2016-01-01

Science is facing a “replication crisis” in which many experimental findings cannot be replicated and are likely to be false. Does this imply that many scientific facts are false as well? To find out, we explore the process by which a claim becomes fact. We model the community’s confidence in a claim as a Markov process with successive published results shifting the degree of belief. Publication bias in favor of positive findings influences the distribution of published results. We find that unless a sufficient fraction of negative results are published, false claims frequently can become canonized as fact. Data-dredging, p-hacking, and similar behaviors exacerbate the problem. Should negative results become easier to publish as a claim approaches acceptance as a fact, however, true and false claims would be more readily distinguished. To the degree that the model reflects the real world, there may be serious concerns about the validity of purported facts in some disciplines. DOI: http://dx.doi.org/10.7554/eLife.21451.001 PMID:27995896

Validating Savings Claims of Cold Climate Zero Energy Ready Homes

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

Williamson, J.; Puttagunta, S.

This study was intended to validate actual performance of three ZERHs in the Northeast to energy models created in REM/Rate v14.5 (one of the certified software programs used to generate a HERS Index) and the National Renewable Energy Laboratory’s Building Energy Optimization (BEopt™) v2.3 E+ (a more sophisticated hourly energy simulation software). This report details the validation methods used to analyze energy consumption at each home.

Psychomotor developmental delay and epilepsy in an offspring of father-daughter incest: quantification of the causality probability.

PubMed

Schmidtke, Jörg; Krawczak, Michael

2010-09-01

A 20-year-old offspring of father-daughter incest, who has been suffering from serious psychomotoric health problems since early childhood, is seeking financial compensation under the German federal act of victim indemnification. For her appeal to be valid, the probability X that the incest was causal for her disorder must exceed 50%. Based upon the available medical records, we show that this is indeed the case and that X is even likely to exceed 65%, thereby rendering the victim's claim scientifically and legally justified.

Planning outstanding reserves in general insurance

NASA Astrophysics Data System (ADS)

Raeva, E.; Pavlov, V.

2017-10-01

Each insurance company have to ensure its solvency through presentation of accounts for its own reserves in the start of the year. Usually the task of the actuary is to estimate the state of the company on an annual basis and the expectation of the status of the company for a future period. One of the major problem when calculating the liabilities of the incurred claims, is related to the delay of payments. Object of consideration in the present note are the outstanding claim reserves, which are set aside to cover claims, occurred before the date of the annual account, but still not paid, and related with them expenses. There may be different reasons for the delay of claims settlement. For example, continuation the process of the liquidation of the damage waiting for necessary documents or the presence of controversial cases whose permission takes time, etc. Thus the claims, which determine the outstanding reserves could be divided in the following types: claims, which are reported, but not settled (RBNS); claims, which are incurred but not reported (IBNR); claims, whose case is finished, but it is possible to be reopened. When calculating the reserves for IBNR claims, most widely used is the Chain-ladder method and its modification presented by the Bornhuetter - Ferguson method. For modeling the outstanding claims, the available data should be presented in so called run-off triangle, which underlies in the basis of such methods. The present work provides a review of the algorithm for calculating insurance outstanding claim reserves according to the Chain-ladder method. Using available data for claims related to liability of drivers, registered in Bulgaria an example is constructed to illustrate the methodology of the Chain-Ladder method. Back-testing approach is used for validating the results.

Validating agent oriented methodology (AOM) for netlogo modelling and simulation

NASA Astrophysics Data System (ADS)

WaiShiang, Cheah; Nissom, Shane; YeeWai, Sim; Sharbini, Hamizan

2017-10-01

AOM (Agent Oriented Modeling) is a comprehensive and unified agent methodology for agent oriented software development. AOM methodology was proposed to aid developers with the introduction of technique, terminology, notation and guideline during agent systems development. Although AOM methodology is claimed to be capable of developing a complex real world system, its potential is yet to be realized and recognized by the mainstream software community and the adoption of AOM is still at its infancy. Among the reason is that there are not much case studies or success story of AOM. This paper presents two case studies on the adoption of AOM for individual based modelling and simulation. It demonstrate how the AOM is useful for epidemiology study and ecological study. Hence, it further validate the AOM in a qualitative manner.

Turning Back the Title VII Clock: The Resegregation of the American Work Force through Validity Generalization.

ERIC Educational Resources Information Center

Goldstein, Barry L.; Patterson, Patrick O.

1988-01-01

Refers to Title VII of the Civil Rights Act of 1964 and the Supreme Court's disparate impact interpretation of Title VII in Griggs versus Duke Power Company. Contends that attacks on the Griggs decision are legally unsound and that claims made by advocates of validity generalization are scientifically unsupported. (Author/NB)

Conflicting Discourses in Qualitative Research: The Search for Divergent Data within Cases

ERIC Educational Resources Information Center

Antin, Tamar M. J.; Constantine, Norman A.; Hunt, Geoffrey

2015-01-01

The search for disconfirming evidence, or negative cases, is often considered a valuable strategy for assessing the credibility or validity of qualitative research claims. This article draws on a multimethod qualitative research project to illustrate how a search for disconfirming evidence evolved from a check on the validity of findings to a…

Confirmatory Factor Analysis of the TerraNova Comprehensive Tests of Basic Skills/5

ERIC Educational Resources Information Center

Stevens, Joseph J.; Zvoch, Keith

2007-01-01

Confirmatory factor analysis was used to explore the internal validity of scores on the TerraNova Comprehensive Tests of Basic Skills/5 using samples from a southwestern school district and standardization samples reported by the publisher. One of the strengths claimed for battery-type achievement tests is provision of reliable and valid samples…

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.

Determination of colonoscopy indication from administrative claims data.

PubMed

Ko, Cynthia W; Dominitz, Jason A; Neradilek, Moni; Polissar, Nayak; Green, Pam; Kreuter, William; Baldwin, Laura-Mae

2014-04-01

Colonoscopy outcomes, such as polyp detection or complication rates, may differ by procedure indication. To develop methods to classify colonoscopy indications from administrative data, facilitating study of colonoscopy quality and outcomes. We linked 14,844 colonoscopy reports from the Clinical Outcomes Research Initiative, a national repository of endoscopic reports, to the corresponding Medicare Carrier and Outpatient File claims. Colonoscopy indication was determined from the procedure reports. We developed algorithms using classification and regression trees and linear discriminant analysis (LDA) to classify colonoscopy indication. Predictor variables included ICD-9CM and CPT/HCPCS codes present on the colonoscopy claim or in the 12 months prior, patient demographics, and site of colonoscopy service. Algorithms were developed on a training set of 7515 procedures, then validated using a test set of 7329 procedures. Sensitivity was lowest for identifying average-risk screening colonoscopies, varying between 55% and 86% for the different algorithms, but specificity for this indication was consistently over 95%. Sensitivity for diagnostic colonoscopy varied between 77% and 89%, with specificity between 55% and 87%. Algorithms with classification and regression trees with 7 variables or LDA with 10 variables had similar overall accuracy, and generally lower accuracy than the algorithm using LDA with 30 variables. Algorithms using Medicare claims data have moderate sensitivity and specificity for colonoscopy indication, and will be useful for studying colonoscopy quality in this population. Further validation may be needed before use in alternative populations.

Phonology, reading, and Chomsky and Halle's optimal orthography.

PubMed

Steinberg, D D

1973-09-01

Chomsky and Halle claim that an orthography based on their underlying phonological representations (UPR) of lexical items would be optimal for English. This paper challenges three of C & H's basic phonological assumptions, that their vowel shift rule is valid, that the UPR is the only sound representation to be listed in the lexicon, and that derived words do not appear as wholes in the lexicon. A less abstract phonological representation level based on the conscious perceptions of speakers, the surface phonemic (SPR), is proposed. An SPR-based orthography has advantages which a UPR-based orthography would not: it is easy to learn and teach, it can be learned at an early age, and it permits rapid detection of rhyme. It is concluded that an orthography based on SPRs, and not UPRs, would be optimal.

42 CFR § 512.307 - Subsequent calculations.

Code of Federal Regulations, 2010 CFR

2017-10-01

... (CONTINUED) HEALTH CARE INFRASTRUCTURE AND MODEL PROGRAMS EPISODE PAYMENT MODEL Pricing and Payment § 512.307... the initial NPRA, using claims data and non-claims-based payment data available at that time, to account for final claims run-out, final changes in non-claims-based payment data, and any additional...

Health benefits and health claims of probiotics: bridging science and marketing.

PubMed

Rijkers, Ger T; de Vos, Willem M; Brummer, Robert-Jan; Morelli, Lorenzo; Corthier, Gerard; Marteau, Philippe

2011-11-01

Health claims for probiotics are evaluated by the Panel on Dietetic Products, Nutrition and Allergies of the European Food Safety Authority. Despite a substantial amount of basic and clinical research on the beneficial effects of probiotics, all of the evaluated claim applications thus far have received a negative opinion. With the restrictions on the use of clinical endpoints, validated biomarkers for gut health and immune health in relation to reduction in disease risk are needed. Clear-cut criteria for design as well as evaluation of future studies are needed. An open dialogue between basic and clinical scientists, regulatory authorities, food and nutrition industry, and consumers could bridge the gap between science and marketing of probiotics.

Understanding current causes of women's underrepresentation in science.

PubMed

Ceci, Stephen J; Williams, Wendy M

2011-02-22

Explanations for women's underrepresentation in math-intensive fields of science often focus on sex discrimination in grant and manuscript reviewing, interviewing, and hiring. Claims that women scientists suffer discrimination in these arenas rest on a set of studies undergirding policies and programs aimed at remediation. More recent and robust empiricism, however, fails to support assertions of discrimination in these domains. To better understand women's underrepresentation in math-intensive fields and its causes, we reprise claims of discrimination and their evidentiary bases. Based on a review of the past 20 y of data, we suggest that some of these claims are no longer valid and, if uncritically accepted as current causes of women's lack of progress, can delay or prevent understanding of contemporary determinants of women's underrepresentation. We conclude that differential gendered outcomes in the real world result from differences in resources attributable to choices, whether free or constrained, and that such choices could be influenced and better informed through education if resources were so directed. Thus, the ongoing focus on sex discrimination in reviewing, interviewing, and hiring represents costly, misplaced effort: Society is engaged in the present in solving problems of the past, rather than in addressing meaningful limitations deterring women's participation in science, technology, engineering, and mathematics careers today. Addressing today's causes of underrepresentation requires focusing on education and policy changes that will make institutions responsive to differing biological realities of the sexes. Finally, we suggest potential avenues of intervention to increase gender fairness that accord with current, as opposed to historical, findings.

[The added value of information summaries supporting clinical decisions at the point-of-care.

PubMed

Banzi, Rita; González-Lorenzo, Marien; Kwag, Koren Hyogene; Bonovas, Stefanos; Moja, Lorenzo

2016-11-01

Evidence-based healthcare requires the integration of the best research evidence with clinical expertise and patients' values. International publishers are developing evidence-based information services and resources designed to overcome the difficulties in retrieving, assessing and updating medical information as well as to facilitate a rapid access to valid clinical knowledge. Point-of-care information summaries are defined as web-based medical compendia that are specifically designed to deliver pre-digested, rapidly accessible, comprehensive, and periodically updated information to health care providers. Their validity must be assessed against marketing claims that they are evidence-based. We periodically evaluate the content development processes of several international point-of-care information summaries. The number of these products has increased along with their quality. The last analysis done in 2014 identified 26 products and found that three of them (Best Practice, Dynamed e Uptodate) scored the highest across all evaluated dimensions (volume, quality of the editorial process and evidence-based methodology). Point-of-care information summaries as stand-alone products or integrated with other systems, are gaining ground to support clinical decisions. The choice of one product over another depends both on the properties of the service and the preference of users. However, even the most innovative information system must rely on transparent and valid contents. Individuals and institutions should regularly assess the value of point-of-care summaries as their quality changes rapidly over time.

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

Oncology patient-reported claims: maximising the chance for success.

PubMed

Kitchen, H; Rofail, D; Caron, M; Emery, M-P

2011-01-01

To review Patient Reported Outcome (PRO) labelling claims achieved in oncology in Europe and in the United States and consider the benefits, and challenges faced. PROLabels database was searched to identify oncology products with PRO labelling approved in Europe since 1995 or in the United States since 1998. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) websites and guidance documents were reviewed. PUBMED was searched for articles on PRO claims in oncology. Among all oncology products approved, 22 were identified with PRO claims; 10 in the United States, 7 in Europe, and 5 in both. The language used in the labelling was limited to benefit (e.g. "…resulted in symptom benefits by significantly prolonging time to deterioration in cough, dyspnoea, and pain, versus placebo") and equivalence (e.g. "no statistical differences were observed between treatment groups for global QoL"). Seven products used a validated HRQoL tool; two used symptom tools; two used both; seven used single-item symptom measures (one was unknown). The following emerged as likely reasons for success: ensuring systematic PRO data collection; clear rationale for pre-specified endpoints; adequately powered trials to detect differences and clinically significant changes; adjusting for multiplicity; developing an a priori statistical analysis plan including primary and subgroup analyses, dealing with missing data, pooling multiple-site data; establishing clinical versus statistical significance; interpreting failure to detect change. End-stage patient drop-out rates and cessation of trials due to exceptional therapeutic benefit pose significant challenges to demonstrating treatment PRO improvement. PRO labelling claims demonstrate treatment impact and the trade-off between efficacy and side effects ultimately facilitating product differentiation. Reliable and valid instruments specific to the desired language, claim, and target population are required. Practical considerations include rationale for study endpoints, transparency in assumptions, and attention to subtle variations in data.

Oncology patient-reported claims: maximising the chance for success

PubMed Central

Kitchen, H; Rofail, D; Caron, M; Emery, M-P

2011-01-01

Objectives/purpose: To review Patient Reported Outcome (PRO) labelling claims achieved in oncology in Europe and in the United States and consider the benefits, and challenges faced. Methods: PROLabels database was searched to identify oncology products with PRO labelling approved in Europe since 1995 or in the United States since 1998. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) websites and guidance documents were reviewed. PUBMED was searched for articles on PRO claims in oncology. Results: Among all oncology products approved, 22 were identified with PRO claims; 10 in the United States, 7 in Europe, and 5 in both. The language used in the labelling was limited to benefit (e.g. “…resulted in symptom benefits by significantly prolonging time to deterioration in cough, dyspnoea, and pain, versus placebo”) and equivalence (e.g. “no statistical differences were observed between treatment groups for global QoL”). Seven products used a validated HRQoL tool; two used symptom tools; two used both; seven used single-item symptom measures (one was unknown). The following emerged as likely reasons for success: ensuring systematic PRO data collection; clear rationale for pre-specified endpoints; adequately powered trials to detect differences and clinically significant changes; adjusting for multiplicity; developing an a priori statistical analysis plan including primary and subgroup analyses, dealing with missing data, pooling multiple-site data; establishing clinical versus statistical significance; interpreting failure to detect change. End-stage patient drop-out rates and cessation of trials due to exceptional therapeutic benefit pose significant challenges to demonstrating treatment PRO improvement. Conclusions: PRO labelling claims demonstrate treatment impact and the trade-off between efficacy and side effects ultimately facilitating product differentiation. Reliable and valid instruments specific to the desired language, claim, and target population are required. Practical considerations include rationale for study endpoints, transparency in assumptions, and attention to subtle variations in data. PMID:22276055

A critical review of biologic mesh use in ventral hernia repairs under contaminated conditions.

PubMed

Primus, F E; Harris, H W

2013-02-01

We used an evidence-based approach to determine whether the promotions and claims of superiority of biologic mesh over synthetic mesh use in ventral hernia repairs (VHRs) under contaminated conditions were sound and valid. We searched the Medline database to specifically identify review articles relating to biologic mesh and VHR and critically reviewed these studies using an evidence-based approach. For the past 45 years, four clinical reviews and one systematic review have included biologic meshes as part of a larger discussion on available prosthetics for VHR. All reviews supported biologic mesh use, especially in the setting of contaminated fields. Yet, the primary literature included in these reviews and served as the basis for these conclusions consisted entirely of case series and case reports, which have the lowest level of evidence in determining scientific validity. Furthermore, the FDA has neither cleared nor approved this particular use. The cumulative data regarding biologic mesh use in VHRs under contaminated conditions does not support the claim that it is better than synthetic mesh used under the same conditions. The highly promoted and at least moderately utilized practice of placing biologic mesh in contamination is being done outside of the original intended use, and a re-evaluation of or possible moratorium on biologic mesh use in hernia surgery is seriously warranted. Alternatively, an industry-sponsored national registry of patients in whom ventral hernia repairs involved biologic mesh would substantively add to our understanding regarding how these intriguing biomaterials are being used and their overall clinical efficacy.

Developing a Science Process Skills Test for Secondary Students: Validity and Reliability Study

ERIC Educational Resources Information Center

Feyzioglu, Burak; Demirdag, Baris; Akyildiz, Murat; Altun, Eralp

2012-01-01

Science process skills are claimed to enable an individual to improve their own life visions and give a scientific view/literacy as a standard of their understanding about the nature of science. The main purpose of this study was to develop a test for measuring a valid, reliable and practical test for Science Process Skills (SPS) in secondary…

Measuring ability to assess claims about treatment effects: a latent trait analysis of items from the 'Claim Evaluation Tools' database using Rasch modelling.

PubMed

Austvoll-Dahlgren, Astrid; Guttersrud, Øystein; Nsangi, Allen; Semakula, Daniel; Oxman, Andrew D

2017-05-25

The Claim Evaluation Tools database contains multiple-choice items for measuring people's ability to apply the key concepts they need to know to be able to assess treatment claims. We assessed items from the database using Rasch analysis to develop an outcome measure to be used in two randomised trials in Uganda. Rasch analysis is a form of psychometric testing relying on Item Response Theory. It is a dynamic way of developing outcome measures that are valid and reliable. To assess the validity, reliability and responsiveness of 88 items addressing 22 key concepts using Rasch analysis. We administrated four sets of multiple-choice items in English to 1114 people in Uganda and Norway, of which 685 were children and 429 were adults (including 171 health professionals). We scored all items dichotomously. We explored summary and individual fit statistics using the RUMM2030 analysis package. We used SPSS to perform distractor analysis. Most items conformed well to the Rasch model, but some items needed revision. Overall, the four item sets had satisfactory reliability. We did not identify significant response dependence between any pairs of items and, overall, the magnitude of multidimensionality in the data was acceptable. The items had a high level of difficulty. Most of the items conformed well to the Rasch model's expectations. Following revision of some items, we concluded that most of the items were suitable for use in an outcome measure for evaluating the ability of children or adults to assess treatment claims. © 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.

40 CFR 280.112 - Drawing on financial assurance mechanisms.

Code of Federal Regulations, 2010 CFR

2010-07-01

... paid. The certification must be worded as follows, except that instructions in brackets are to be replaced with the relevant information and the brackets deleted: Certification of Valid Claim The...

32 CFR 750.8 - Claims: Responsibility of the Tort Claims Unit Norfolk.

Code of Federal Regulations, 2011 CFR

2011-07-01

... received in proper form. (c) Adjudicating the claim. (1) The Tort Claims Unit Norfolk shall evaluate and... is a narrative summary of the facts upon which the suit is based and has as enclosures the claims...

32 CFR 750.8 - Claims: Responsibility of the Tort Claims Unit Norfolk.

Code of Federal Regulations, 2012 CFR

2012-07-01

... received in proper form. (c) Adjudicating the claim. (1) The Tort Claims Unit Norfolk shall evaluate and... is a narrative summary of the facts upon which the suit is based and has as enclosures the claims...

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

PubMed Central

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

2017-01-01

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

Extending religion-health research to secular minorities: issues and concerns.

PubMed

Hwang, Karen; Hammer, Joseph H; Cragun, Ryan T

2011-09-01

Claims about religion's beneficial effects on physical and psychological health have received substantial attention in popular media, but empirical support for these claims is mixed. Many of these claims are tenuous because they fail to address basic methodological issues relating to construct validity, sampling methods or analytical problems. A more conceptual problem has to do with the near universal lack of atheist control samples. While many studies include samples of individuals classified as "low spirituality" or religious "nones", these groups are heterogeneous and contain only a fraction of members who would be considered truly secular. We illustrate the importance of including an atheist control group whenever possible in the religiosity/spirituality and health research and discuss areas for further investigation.

Patent medicine vendors, community pharmacists and STI management in Abuja, Nigeria.

PubMed

Okonkwo, A D; Okonkwo, U P

2010-09-01

Increasingly, literature indicates that Patent Medicine Vendors (PMVs) and Community Pharmacists (CPs) provide sexual reproductive health services and products to their young patrons. This study explored the validity of literature claims, principally from CPs and PMVs perspective in Abuja, Nigeria. Participants were recruited with convenience sampling based on their willingness to participate in the study and our judgement of their professional competence. They were administered a semi-structured questionnaire, which was modelled after McCracken's long interview. We empirically assessed the validity of CPs and PMVs opinions with an exit interview of seven consenting patrons. Interviews were audio taped, transcribed verbatim and subjected to iterative thematic analysis. Participants' accounts and our observations indicate that PMVs and CPs serve young people's sexual reproductive healthcare needs in Abuja. CPs and PMVs provide young people with a seamless and non-judgemental access to contraceptives, sexual health advice and post-sexual risk exposure care. The study corroborates literature claims that CPs and PMVs provide sexual reproductive health advice, services and products to young people. However, participants contend that the current pharmacy practice laws in Nigeria constrain the scope and quality of services that young unmarried people require. Because it is unlikely that Nigeria will reinvigorate her primary healthcare system soon, we call for the formal co-option of CPs and PMVs into the sexual reproductive health management system to standardize and improve services.

Munchausen Syndrome by Proxy/Fabricated and Induced Illness: does the diagnosis serve economic vested interests, rather than the interests of children?

PubMed

Wrennall, Lynne

2007-01-01

The discourse of Munchausen Syndrome by Proxy/Fabricated and Induced Illness posits the widespread incidence of a highly dangerous form of child abuse in which illness and developmental delay in children, is caused by their parents or carers. The discourse has been linked to false allegations of child abuse, hostile adoptions and miscarriages of justice. It has also stimulated concerns that the children's real medical and developmental needs are neglected when their conditions are misdiagnosed as child abuse. This study examines the critical claims that have been levelled against the Munchausen discourse. They provide explanations of the children's problems that compete with the discourse. The claim of the discourse to scientific validity is thereby shown to be questionable. The explanations have been distilled into specific hypotheses, to stimulate further research. The literature from which the hypotheses were derived, identifies problems in the MSbP/FII discourse in five broad areas of science, regarding: the test validity of techniques; construct validity; statistical methods; evidentiary standards and adverse impacts. The main conclusion is that the detailed critical hypotheses, cohere around the central claim that the discourse of Munchausen Syndrome by Proxy/Fabricated and Induced Illness serves economic vested interests, rather than the interests of children. The hypotheses predict adverse health and social outcomes, as a result of the discourse. Consequently, the continued deployment of the discourse would probably be "unsafe and therefore unwise".

The benefit of lithium carbonate adjunct in refractory depression--fact or fiction?

PubMed

Kantor, D; McNevin, S; Leichner, P; Harper, D; Krenn, M

1986-06-01

Our group attempted to validate previous claims of rapid success with lithium carbonate adjunct therapy in antidepressant-resistant depression. Seven depressed patients volunteered for a study of placebo controlled, double-blind design. During their treatment on general hospital psychiatric wards, these patients received antidepressant medication for a period of at least 21 days. While continuing to receive antidepressant medication after the 21 day period, four of the patients then received lithium carbonate, and three received placebo. This combination pharmacological therapy continued for a 48 hour period. After this time, six of the seven patients showed no significant improvement. The remaining patient, who had received lithium carbonate, improved markedly over the 48 hour period. However, this patient relapsed within one week. A review of the two most extensive studies claiming significant results with the lithium carbonate adjunct therapy was performed. We feel that they, as presented, leave serious doubt as to the validity of their conclusions. We conclude that on the basis of our work up to this point in time and the analysis of previous reports claiming otherwise, no valid evidence exists for a consistent therapeutic effect of lithium carbonate adjunct in antidepressant-resistant depression. It was also found that methodologic contamination necessitated the exclusion of an additional six patients from the double-blind trial. We conclude that in order to objectively examine the rapidly expanding field of biological psychiatry, teaching of clinical staff in basic research procedure should be stressed as a part of routine ward orientation.

Middleware Solutions for Self-organizing Multi-hop Multi-path Internet Connectivity Based on Bluetooth

NASA Astrophysics Data System (ADS)

Bellavista, Paolo; Giannelli, Carlo

The availability of heterogeneous wireless interfaces and of growing computing resources on widespread portable devices pushes for enabling innovative deployment scenarios where mobile nodes dynamically self-organize to offer Internet connectivity to their peers via dynamically established multi-hop multi-path opportunities. We claim the suitability of novel, mobility-aware, and application-layer middleware based on lightweight evaluation indicators to support the complexity of that scenario, involving heterogeneous wireless technologies over differentiated and statically unpredictable execution environments. To validate these claims, we have implemented an innovative middleware that manages the durability/throughput-aware formation and selection of different multi-hop paths simultaneously. This paper specifically focuses on how our middleware effectively exploits Bluetooth for multi-hop multi-path networking, by pointing out the crucial role of i) compliance with standard solutions to favor rapid deployment over off-the-shelf equipment and ii) the reduction of the usual overhead associated with some expensive Bluetooth operations, e.g., device inquiry. In particular, the paper shows how it is possible, on the one hand, to extend JSR-82 to portably access monitoring indicators for lightweight mobility/throughput estimations and, on the other hand, to reduce the time needed to update the set of available Bluetooth-based connectivity opportunities via approximated and lightweight forms of discovery.

Validated Colorimetric Assay of Clonidine Hydrochloride from Pharmaceutical Preparations

PubMed Central

Corciova, Andreia

2016-01-01

Clonidine hydrochloride is an antihypertensive agent used for migraine prophylaxis, attention deficit hyperactivity disorder, menopausal flushing and Tourette syndrome. The quantity of the active substance in pharmaceutical preparations must be within specific limits, in agreement with the respective label claim. Therefore, the aim of this study was to establish the conditions for two spectrophotometric methods for clonidine determination, based on the formation of the ion pair complex between clonidine hydrochloride and thymol blue/bromophenol blue. A Jasco UV-Vis 530 spectrophotometer was used for the analysis and the maxim absorbance was measured at 418 nm/448 nm against blank solution. After validation, the methods were used for quantification of clonidine hydrochloride in two commercial samples (tablets). The recovery of active substance varies between 98.06 and 100.13 % without interferences from the excipients. PMID:27610155

Why Does a Method That Fails Continue To Be Used: The Answer

PubMed Central

Templeton, Alan R.

2009-01-01

It has been claimed that hundreds of researchers use nested clade phylogeographic analysis (NCPA) based on what the method promises rather than requiring objective validation of the method. The supposed failure of NCPA is based upon the argument that validating it by using positive controls ignored type I error, and that computer simulations have shown a high type I error. The first argument is factually incorrect: the previously published validation analysis fully accounted for both type I and type II errors. The simulations that indicate a 75% type I error rate have serious flaws and only evaluate outdated versions of NCPA. These outdated type I error rates fall precipitously when the 2003 version of single locus NCPA is used or when the 2002 multi-locus version of NCPA is used. It is shown that the treewise type I errors in single-locus NCPA can be corrected to the desired nominal level by a simple statistical procedure, and that multilocus NCPA reconstructs a simulated scenario used to discredit NCPA with 100% accuracy. Hence, NCPA is a not a failed method at all, but rather has been validated both by actual data and by simulated data in a manner that satisfies the published criteria given by its critics. The critics have come to different conclusions because they have focused on the pre-2002 versions of NCPA and have failed to take into account the extensive developments in NCPA since 2002. Hence, researchers can choose to use NCPA based upon objective critical validation that shows that NCPA delivers what it promises. PMID:19335340

External validation of a multivariable claims-based rule for predicting in-hospital mortality and 30-day post-pulmonary embolism complications.

PubMed

Coleman, Craig I; Peacock, W Frank; Fermann, Gregory J; Crivera, Concetta; Weeda, Erin R; Hull, Michael; DuCharme, Mary; Becker, Laura; Schein, Jeff R

2016-10-22

Low-risk pulmonary embolism (PE) patients may be candidates for outpatient treatment or abbreviated hospital stay. There is a need for a claims-based prediction rule that payers/hospitals can use to risk stratify PE patients. We sought to validate the In-hospital Mortality for PulmonAry embolism using Claims daTa (IMPACT) prediction rule for in-hospital and 30-day outcomes. We used the Optum Research Database from 1/2008-3/2015 and included adults hospitalized for PE (415.1x in the primary position or secondary position when accompanied by a primary code for a PE complication) and having continuous medical and prescription coverage for ≥6-months prior and 3-months post-inclusion or until death. In-hospital and 30-day mortality and 30-day complications (recurrent venous thromboembolism, rehospitalization or death) were assessed and prognostic accuracies of IMPACT with 95 % confidence intervals (CIs) were calculated. In total, 47,531 PE patients were included. In-hospital and 30-day mortality occurred in 7.9 and 9.4 % of patients and 20.8 % experienced any complication within 30-days. Of the 19.5 % of patients classified as low-risk by IMPACT, 2.0 % died in-hospital, resulting in a sensitivity and specificity of 95.2 % (95 % CI, 94.4-95.8) and 20.7 % (95 % CI, 20.4-21.1). Only 1 additional low-risk patient died within 30-days of admission and 12.2 % experienced a complication, translating into a sensitivity and specificity of 95.9 % (95 % CI, 95.3-96.5) and 21.1 % (95 % CI, 20.7-21.5) for mortality and 88.5 % (95 % CI, 87.9-89.2) and 21.6 % (95 % CI, 21.2-22.0) for any complication. IMPACT had acceptable sensitivity for predicting in-hospital and 30-day mortality or complications and may be valuable for retrospective risk stratification of PE patients.

Impact of electronic health records on malpractice claims in a sample of physician offices in Colorado: a retrospective cohort study.

PubMed

Victoroff, Michael S; Drury, Barbara M; Campagna, Elizabeth J; Morrato, Elaine H

2013-05-01

Electronic health records (EHRs) might reduce medical liability claims and potentially justify premium credits from liability insurers, but the evidence is limited. To evaluate the association between EHR use and medical liability claims in a population of office-based physicians, including claims that could potentially be directly prevented by features available in EHRs ("EHR-sensitive" claims). Retrospective cohort study of medical liability claims and analysis of claim abstracts. The 26 % of Colorado office-based physicians insured through COPIC Insurance Company who responded to a survey on EHR use (894 respondents out of 3,502 invitees). Claims incidence rate ratio (IRR); prevalence of "EHR-sensitive" claims. 473 physicians (53 % of respondents) used an office-based EHR. After adjustment for sex, birth cohort, specialty, practice setting and use of an EHR in settings other than an office, IRR for all claims was not significantly different between EHR users and non-users (0.88, 95 % CI 0.52-1.46; p = 0.61), or for users after EHR implementation as compared to before (0.73, 95 % CI 0.41-1.29; p = 0.28). Of 1,569 claim abstracts reviewed, 3 % were judged "Plausibly EHR-sensitive," 82 % "Unlikely EHR-sensitive," and 15 % "Unable to determine." EHR-sensitive claims occurred in six out of 633 non-users and two out of 251 EHR users. Incidence rate ratios were 0.01 for both groups. Colorado physicians using office-based EHRs did not have significantly different rates of liability claims than non-EHR users; nor were rates different for EHR users before and after EHR implementation. The lack of significant effect may be due to a low prevalence of EHR-sensitive claims. Further research on EHR use and medical liability across a larger population of physicians is warranted.

Analysis of British American Tobacco's questionable use of privilege and protected document claims at the Guildford Depository

PubMed Central

LeGresley, Eric; Lee, Kelley

2017-01-01

Background Tobacco companies have a documented history of attempting to hide information from public scrutiny, including inappropriate privilege claims. The 1998 Minnesota Consent Judgement created two depositories to provide public access to discovered documents. Users raised concerns about the access conditions and ongoing integrity of the Guildford Depository collection operated until 2015 by British American Tobacco (BAT). Methods A metadata search of the Legacy Tobacco Documents Library identified inconsistent privilege claims, and duplicates of documents withheld by BAT from public visitors. A review of the validity of claims, for documents obtained through these searches, was conducted against recognised legal definitions of privilege. Findings BAT has asserted inappropriate privilege claims over 49% of the documents reviewed (n=63). The quantity of such claims and consistency of the stated rationale for the privilege claims suggest a concerted effort rather than human error. Conclusions There was insufficient attention given to the operation of the Guildford Depository by the original plaintiffs, including to the subsequent use of privilege claims. Appropriate access to these documents, commensurate with the terms of legal settlements creating the collection, was critical given their public interest value for enhancing understanding of industry strategies and activities, informing of policy interventions, and for holding the industry to account. Future legal settlements should prevent defendants from subsequently withholding disclosed documents, aside from those legitimately privileged, from public view. Control of publicly disclosed documents should not be placed back into the hands of defendant tobacco companies. Plaintiffs also need to invest adequate resources into policing claims of legal privilege. PMID:27354678

Validating bifidobacterial species and subspecies identity in commercial probiotic products.

PubMed

Lewis, Zachery T; Shani, Guy; Masarweh, Chad F; Popovic, Mina; Frese, Steve A; Sela, David A; Underwood, Mark A; Mills, David A

2016-03-01

The ingestion of probiotics to attempt to improve health is increasingly common; however, quality control of some commercial products can be limited. Clinical practice is shifting toward the routine use of probiotics to aid in prevention of necrotizing enterocolitis in premature infants, and probiotic administration to term infants is increasingly common to treat colic and/or prevent atopic disease. Since bifidobacteria dominate the feces of healthy breast-fed infants, they are often included in infant-targeted probiotics. We evaluated 16 probiotic products to determine how well their label claims describe the species of detectable bifidobacteria in the product. Recently developed DNA-based methods were used as a primary means of identification, and were confirmed using culture-based techniques. We found that the contents of many bifidobacterial probiotic products differ from the ingredient list, sometimes at a subspecies level. Only 1 of the 16 probiotics perfectly matched its bifidobacterial label claims in all samples tested, and both pill-to-pill and lot-to-lot variation were observed. Given the known differences between various bifidobacterial species and subspecies in metabolic capacity and colonization abilities, the prevalence of misidentified bifidobacteria in these products is cause for concern for those involved in clinical trials and consumers of probiotic products.

Teaching argumentation and scientific discourse using the ribosomal peptidyl transferase reaction.

PubMed

Johnson, R Jeremy

2011-01-01

Argumentation and discourse are two integral parts of scientific investigation that are often overlooked in undergraduate science education. To address this limitation, the story of peptide bond formation by the ribosome can be used to illustrate the importance of evidence, claims, arguments, and counterarguments in scientific discourse. With the determination of the first structure of the large ribosomal subunit bound to a transition state inhibitor came an initial hypothesis about the role of the ribosome in peptide bond formation. This initial hypothesis was based on a few central assumptions about the transition state mimic and acid-base catalysis by serine proteases. The initial proposed mechanism started a flurry of scientific discourse in experimental articles and commentaries that tested the validity of the initial proposed mechanism. Using this civil argumentation as a guide, class discussions, assignments, and a debate were designed that allow students to analyze and question the claims and evidence about the mechanism of peptide bond synthesis. In the end, students develop a sense of critical skepticism, and an understanding of scientific discourse, while learning about the current consensus mechanism for peptide bond synthesis. Biochemistry and Molecular Biology Education Vol. 39, No. 3, pp. 185-190, 2011. Copyright © 2011 Wiley Periodicals, Inc.

44 CFR 11.74 - Claims not allowed.

Code of Federal Regulations, 2014 CFR

2014-10-01

... business. Claims are not payable for property normally used for business or profit. (9) Unserviceable... arose during the conduct of personal business are not payable. (2) Subrogation claims. Claims based upon..., insurance policies, money orders, and traveler's checks. (12) Government property. Claims are not payable...

Early Identification of Children at Risk for Academic Difficulties Using Standardized Assessment: Stability and Predictive Validity of Preschool Math and Language Scores

ERIC Educational Resources Information Center

Frans, Niek; Post, Wendy J.; Huisman, Mark; Oenema-Mostert, Ineke C. E.; Keegstra, Anne L.; Minnaert, Alexander E. M. G.

2017-01-01

Despite the claim by several researchers that variability in performance may complicate the identification of "at-risk" children, variability in the academic performance of young children remains an undervalued area of research. The goal of this study is to examine the predictive validity for future scores and the score stability of two…

38 CFR 3.311 - Claims based on exposure to ionizing radiation.

Code of Federal Regulations, 2013 CFR

2013-07-01

... body in the field of health physics, nuclear medicine or radiology and if based on analysis of the... follows: (i) Atmospheric nuclear weapons test participation claims. In claims based upon participation in atmospheric nuclear testing, dose data will in all cases be requested from the appropriate office of the...

38 CFR 3.311 - Claims based on exposure to ionizing radiation.

Code of Federal Regulations, 2014 CFR

2014-07-01

... body in the field of health physics, nuclear medicine or radiology and if based on analysis of the... follows: (i) Atmospheric nuclear weapons test participation claims. In claims based upon participation in atmospheric nuclear testing, dose data will in all cases be requested from the appropriate office of the...

38 CFR 3.311 - Claims based on exposure to ionizing radiation.

Code of Federal Regulations, 2012 CFR

2012-07-01

... body in the field of health physics, nuclear medicine or radiology and if based on analysis of the... follows: (i) Atmospheric nuclear weapons test participation claims. In claims based upon participation in atmospheric nuclear testing, dose data will in all cases be requested from the appropriate office of the...

Caught on Video! Using Handheld Digital Video Cameras to Support Evidence-Based Reasoning

ERIC Educational Resources Information Center

Lottero-Perdue, Pamela S.; Nealy, Jennifer; Roland, Christine; Ryan, Amy

2011-01-01

Engaging elementary students in evidence-based reasoning is an essential aspect of science and engineering education. Evidence-based reasoning involves students making claims (i.e., answers to questions, or solutions to problems), providing evidence to support those claims, and articulating their reasoning to connect the evidence to the claim. In…

Mixed Influence of Electronic Health Record Implementation on Diabetes Order Patterns for Michigan Medicaid Adults.

PubMed

Corser, William; Yuan, Sha

2015-08-20

These 2011-2013 analyses examined the authors' hypothesis that relative diabetes care order changes would be measured after electronic health record (EHR) implementation for 291 Medicaid adults who received all of their office-based care at one midwestern federally qualified health center (FQHC) over a 24-month period (n = 2727 encounters, 2489 claims). Beneficiary sociodemographic, clinical, and claims data were validated with clinic EHR and state Medicaid claims linked to providers' national identifier numbers. Overall pre-post order rate comparisons, and a series of controlled within group binary logistic models were conducted under penalized maximum likelihood estimation terms. After EHR implementation, both the overall order rates and odds ratios of per beneficiary hemoglobin A1C (HbA1C) orders increased significantly (ie, from mean of 0.65 [SD = 1.19] annual tests to 0.96 tests [SD = 1.24] [P < .001]). Although the overall post-EHR order rates of dilated eye exams and microalbumin urine tests appeared fairly stable, the odds of eye exam orders being placed at the claims level decreased significantly (OR = 0.774, P = .0030). These mixed results provide evidence of the varied diabetes care ordering patterns likely seen from increased office use of EHR technologies. The authors attempt to explain these post-EHR differences (or lack of) that generally resemble some of the authors' results from another funded project. Ideally, these findings provide Medicaid and health care officials with a more realistic indication of how EHRs may, or may not, influence diabetes care ordering patterns for vulnerable lower-income primary health care consumers. © 2015 Diabetes Technology Society.

Expanding the use of administrative claims databases in conducting clinical real-world evidence studies in multiple sclerosis.

PubMed

Capkun, Gorana; Lahoz, Raquel; Verdun, Elisabetta; Song, Xue; Chen, Weston; Korn, Jonathan R; Dahlke, Frank; Freitas, Rita; Fraeman, Kathy; Simeone, Jason; Johnson, Barbara H; Nordstrom, Beth

2015-05-01

Administrative claims databases provide a wealth of data for assessing the effect of treatments in clinical practice. Our aim was to propose methodology for real-world studies in multiple sclerosis (MS) using these databases. In three large US administrative claims databases: MarketScan, PharMetrics Plus and Department of Defense (DoD), patients with MS were selected using an algorithm identified in the published literature and refined for accuracy. Algorithms for detecting newly diagnosed ('incident') MS cases were also refined and tested. Methodology based on resource and treatment use was developed to differentiate between relapses with and without hospitalization. When various patient selection criteria were applied to the MarketScan database, an algorithm requiring two MS diagnoses at least 30 days apart was identified as the preferred method of selecting patient cohorts. Attempts to detect incident MS cases were confounded by the limited continuous enrollment of patients in these databases. Relapse detection algorithms identified similar proportions of patients in the MarketScan and PharMetrics Plus databases experiencing relapses with (2% in both databases) and without (15-20%) hospitalization in the 1 year follow-up period, providing findings in the range of those in the published literature. Additional validation of the algorithms proposed here would increase their credibility. The methods suggested in this study offer a good foundation for performing real-world research in MS using administrative claims databases, potentially allowing evidence from different studies to be compared and combined more systematically than in current research practice.

LCA-Based Product Claims

EPA Science Inventory

Product environmental claims include a wide range of marketing claims, labels, declarations, statements and reports that are generally intended to distinguish a product as environmentally friendly or ‘green’. They differ from organizational environmental claims in the...

"Presumed fair: Ironic effects of organizational diversity structures": Correction to Kaiser et al. (2013).

PubMed

2016-06-01

Reports an error in "Presumed fair: Ironic effects of organizational diversity structures" by Cheryl R. Kaiser, Brenda Major, Ines Jurcevic, Tessa L. Dover, Laura M. Brady and Jenessa R. Shapiro (Journal of Personality and Social Psychology, 2013[Mar], Vol 104[3], 504-519). In the article, a raw data merging error in one racial discrimination claim condition from Experiment 6 inadvertently resulted in data analyses on an inaccurate data set. When the error was discovered by the authors and corrected, all analyses reported in Experiment 6 for claim validity, seriousness of the claim, and support for the claimant were inaccurate and none were statistically significant. The conclusions should be altered to indicate that participants with management experience who reflected on their own workplace diversity policies did not show the predicted effects. The literature review, remaining five studies, and remaining conclusions in the article are unaffected by this error. Experiment 6 should also report that 26.4% (not 26.4.7%) of participants had a graduate degree and eight participants (not 8%) did not provide educational data. Experiment 5 should have referred to the claim validity measure as a six-item measure ( .92) rather than a five-item measure; analyses on claim validity are accurate in text. Table 2's note should have said standard errors, not standard deviations. (The following abstract of the original article appeared in record 2012-31077-001.) This research tests the hypothesis that the presence (vs. absence) of organizational diversity structures causes high-status group members (Whites, men) to perceive organizations with diversity structures as procedurally fairer environments for underrepresented groups (racial minorities, women), even when it is clear that underrepresented groups have been unfairly disadvantaged within these organizations. Furthermore, this illusory sense of fairness derived from the mere presence of diversity structures causes high-status group members to legitimize the status quo by becoming less sensitive to discrimination targeted at underrepresented groups and reacting more harshly toward underrepresented group members who claim discrimination. Six experiments support these hypotheses in designs using 4 types of diversity structures (diversity policies, diversity training, diversity awards, idiosyncratically generated diversity structures from participants' own organizations) among 2 high-status groups in tests involving several types of discrimination (discriminatory promotion practices, adverse impact in hiring, wage discrimination). Implications of these experiments for organizational diversity and employment discrimination law are discussed. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

27 CFR 46.252 - Claim based on error on return.

Code of Federal Regulations, 2011 CFR

2011-04-01

... PRODUCTS AND CIGARETTE PAPERS AND TUBES Floor Stocks Tax on Certain Tobacco Products, Cigarette Papers, and Cigarette Tubes Held for Sale on April 1, 2009 Claims § 46.252 Claim based on error on return. If the dealer...

27 CFR 46.252 - Claim based on error on return.

Code of Federal Regulations, 2012 CFR

2012-04-01

... PRODUCTS AND CIGARETTE PAPERS AND TUBES Floor Stocks Tax on Certain Tobacco Products, Cigarette Papers, and Cigarette Tubes Held for Sale on April 1, 2009 Claims § 46.252 Claim based on error on return. If the dealer...

27 CFR 46.252 - Claim based on error on return.

Code of Federal Regulations, 2014 CFR

2014-04-01

... PRODUCTS AND CIGARETTE PAPERS AND TUBES Floor Stocks Tax on Certain Tobacco Products, Cigarette Papers, and Cigarette Tubes Held for Sale on April 1, 2009 Claims § 46.252 Claim based on error on return. If the dealer...

27 CFR 46.252 - Claim based on error on return.

Code of Federal Regulations, 2013 CFR

2013-04-01

... PRODUCTS AND CIGARETTE PAPERS AND TUBES Floor Stocks Tax on Certain Tobacco Products, Cigarette Papers, and Cigarette Tubes Held for Sale on April 1, 2009 Claims § 46.252 Claim based on error on return. If the dealer...

27 CFR 46.252 - Claim based on error on return.

Code of Federal Regulations, 2010 CFR

2010-04-01

... PRODUCTS AND CIGARETTE PAPERS AND TUBES Floor Stocks Tax on Certain Tobacco Products, Cigarette Papers, and Cigarette Tubes Held for Sale on April 1, 2009 Claims § 46.252 Claim based on error on return. If the dealer...

Plant-Based Beverages as Good Sources of Free and Glycosidic Plant Sterols

PubMed Central

Decloedt, Anneleen I; Van Landschoot, Anita; Watson, Hellen; Vanderputten, Dana; Vanhaecke, Lynn

2017-01-01

To address the ever-growing group of health-conscious consumers, more and more nutritional and health claims are being used on food products. Nevertheless, only very few food constituents, including plant sterols, have been appointed an approved health claim (European Commission and Food and Drugs Administration). Plant sterols are part of those limited lists of approved compounds for their cholesterol-lowering properties but have been praised for their anti-inflammatory and anti-carcinogenic properties as well. Despite this indisputable reputation, direct quantitative data is still lacking for naturally present (conjugated) plant sterols in beverages. This study aimed to fill this gap by applying a validated extraction and UPLC-MS/MS detection method to a diverse range of everyday plant-based beverages. β-sitosterol-β-d-glucoside (BSSG) showed to be by far the most abundant sterol in all beverages studied, with concentrations up to 60–90 mg per 100 mL in plant-based milk alternatives and fresh fruit juices. Ergosterol (provitamin D2) could be found in beers (0.8–6.1 µg per 100 mL, from the yeast) and occasionally in juices (17–29 µg per 100 mL). Overall, the results demonstrated that the concentrations of water-soluble sterol conjugates have been underestimated significantly and that specific plant-based beverages can be good, low-fat sources of these plant sterols. PMID:29286348

Optimal Use of Available Claims to Identify a Medicare Population Free of Coronary Heart Disease

PubMed Central

Kent, Shia T.; Safford, Monika M.; Zhao, Hong; Levitan, Emily B.; Curtis, Jeffrey R.; Kilpatrick, Ryan D.; Kilgore, Meredith L.; Muntner, Paul

2015-01-01

We examined claims-based approaches for identifying a study population free of coronary heart disease (CHD) using data from 8,937 US blacks and whites enrolled during 2003–2007 in a prospective cohort study linked to Medicare claims. Our goal was to minimize the percentage of persons at study entry with self-reported CHD (previous myocardial infarction or coronary revascularization). We assembled 6 cohorts without CHD claims by requiring 6 months, 1 year, or 2 years of continuous Medicare fee-for-service insurance coverage prior to study entry and using either a fixed-window or all-available look-back period. We examined adding CHD-related claims to our “base algorithm,” which included claims for myocardial infarction and coronary revascularization. Using a 6-month fixed-window look-back period, 17.8% of participants without claims in the base algorithm reported having CHD. This was reduced to 3.6% using an all-available look-back period and adding other CHD claims to the base algorithm. Among cohorts using all-available look-back periods, increasing the length of continuous coverage from 6 months to 1 or 2 years reduced the sample size available without lowering the percentage of persons with self-reported CHD. This analysis demonstrates approaches for developing a CHD-free cohort using Medicare claims. PMID:26443420

Traditional acupuncturists and higher education in Britain: the dual, paradoxical impact of biomedical alignment on the holistic view.

PubMed

Givati, Assaf; Hatton, Kieron

2015-04-01

Traditional acupuncturists' quest for external legitimacy in Britain involves the standardization of their knowledge bases through the development of training schools and syllabi, formal educational structures, and, since the 1990s, the teaching of undergraduate courses within (or validated by) Higher Education Institutions (HEIs), a process which entails biomedical alignment of the curriculum. However, as holistic discourses were commonly used as a rhetorical strategy by CAM practitioners to distance themselves from biomedicine and as a source of public appeal, this 'mainstreaming' process evoked practitioners' concerns that their holistic claims are being compromised. An additional challenge is being posed by a group of academics and scientists in Britain who launched an attack on CAM courses taught in HEIs, accusing them of being 'unscientific' and 'non-academic' in nature. This paper explores the negotiation of all these challenges during the formalization of traditional acupuncture education in Britain, with a particular focus on the role of HEIs. The in-depth qualitative investigation draws on several data sets: participant observation in a university validated acupuncture course; in-depth interviews; and documentary analysis. The findings show how, as part of the formalization process, acupuncturists in Britain (re)negotiate their holistic, anti-reductionist discourses and claims in relation to contemporary societal, political and cultural forces. Moreover, the teaching and validation of acupuncture courses by HEIs may contribute to broadening acupuncturists' 'holistic awareness' of societal and cultural influences on individuals' and communities' ill-health. This investigation emphasises the dynamic and context-specific (rather than fixed and essentialized) nature of acupuncture practice and knowledge. Copyright © 2015 Elsevier Ltd. All rights reserved.

The cost of adherence mismeasurement in serious mental illness: a claims-based analysis.

PubMed

Shafrin, Jason; Forma, Felicia; Scherer, Ethan; Hatch, Ainslie; Vytlacil, Edward; Lakdawalla, Darius

2017-05-01

To quantify how adherence mismeasurement affects the estimated impact of adherence on inpatient costs among patients with serious mental illness (SMI). Proportion of days covered (PDC) is a common claims-based measure of medication adherence. Because PDC does not measure medication ingestion, however, it may inaccurately measure adherence. We derived a formula to correct the bias that occurs in adherence-utilization studies resulting from errors in claims-based measures of adherence. We conducted a literature review to identify the correlation between gold-standard and claims-based adherence measures. We derived a bias-correction methodology to address claims-based medication adherence measurement error. We then applied this methodology to a case study of patients with SMI who initiated atypical antipsychotics in 2 large claims databases. Our literature review identified 6 studies of interest. The 4 most relevant ones measured correlations between 0.38 and 0.91. Our preferred estimate implies that the effect of adherence on inpatient spending estimated from claims data would understate the true effect by a factor of 5.3, if there were no other sources of bias. Although our procedure corrects for measurement error, such error also may amplify or mitigate other potential biases. For instance, if adherent patients are healthier than nonadherent ones, measurement error makes the resulting bias worse. On the other hand, if adherent patients are sicker, measurement error mitigates the other bias. Measurement error due to claims-based adherence measures is worth addressing, alongside other more widely emphasized sources of bias in inference.

A contemporary approach to validity arguments: a practical guide to Kane's framework.

PubMed

Cook, David A; Brydges, Ryan; Ginsburg, Shiphra; Hatala, Rose

2015-06-01

Assessment is central to medical education and the validation of assessments is vital to their use. Earlier validity frameworks suffer from a multiplicity of types of validity or failure to prioritise among sources of validity evidence. Kane's framework addresses both concerns by emphasising key inferences as the assessment progresses from a single observation to a final decision. Evidence evaluating these inferences is planned and presented as a validity argument. We aim to offer a practical introduction to the key concepts of Kane's framework that educators will find accessible and applicable to a wide range of assessment tools and activities. All assessments are ultimately intended to facilitate a defensible decision about the person being assessed. Validation is the process of collecting and interpreting evidence to support that decision. Rigorous validation involves articulating the claims and assumptions associated with the proposed decision (the interpretation/use argument), empirically testing these assumptions, and organising evidence into a coherent validity argument. Kane identifies four inferences in the validity argument: Scoring (translating an observation into one or more scores); Generalisation (using the score[s] as a reflection of performance in a test setting); Extrapolation (using the score[s] as a reflection of real-world performance), and Implications (applying the score[s] to inform a decision or action). Evidence should be collected to support each of these inferences and should focus on the most questionable assumptions in the chain of inference. Key assumptions (and needed evidence) vary depending on the assessment's intended use or associated decision. Kane's framework applies to quantitative and qualitative assessments, and to individual tests and programmes of assessment. Validation focuses on evaluating the key claims, assumptions and inferences that link assessment scores with their intended interpretations and uses. The Implications and associated decisions are the most important inferences in the validity argument. © 2015 John Wiley & Sons Ltd.

Understanding current causes of women's underrepresentation in science

PubMed Central

Williams, Wendy M.

2011-01-01

Explanations for women's underrepresentation in math-intensive fields of science often focus on sex discrimination in grant and manuscript reviewing, interviewing, and hiring. Claims that women scientists suffer discrimination in these arenas rest on a set of studies undergirding policies and programs aimed at remediation. More recent and robust empiricism, however, fails to support assertions of discrimination in these domains. To better understand women's underrepresentation in math-intensive fields and its causes, we reprise claims of discrimination and their evidentiary bases. Based on a review of the past 20 y of data, we suggest that some of these claims are no longer valid and, if uncritically accepted as current causes of women's lack of progress, can delay or prevent understanding of contemporary determinants of women's underrepresentation. We conclude that differential gendered outcomes in the real world result from differences in resources attributable to choices, whether free or constrained, and that such choices could be influenced and better informed through education if resources were so directed. Thus, the ongoing focus on sex discrimination in reviewing, interviewing, and hiring represents costly, misplaced effort: Society is engaged in the present in solving problems of the past, rather than in addressing meaningful limitations deterring women's participation in science, technology, engineering, and mathematics careers today. Addressing today's causes of underrepresentation requires focusing on education and policy changes that will make institutions responsive to differing biological realities of the sexes. Finally, we suggest potential avenues of intervention to increase gender fairness that accord with current, as opposed to historical, findings. PMID:21300892

29 CFR 1620.20 - Pay differentials claimed to be based on extra duties.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 4 2010-07-01 2010-07-01 false Pay differentials claimed to be based on extra duties. 1620.20 Section 1620.20 Labor Regulations Relating to Labor (Continued) EQUAL EMPLOYMENT OPPORTUNITY COMMISSION THE EQUAL PAY ACT § 1620.20 Pay differentials claimed to be based on extra duties. Additional...

TRICARE revision to CHAMPUS DRG-based payment system, pricing of hospital claims. Final rule.

PubMed

2014-05-21

This Final rule changes TRICARE's current regulatory provision for inpatient hospital claims priced under the DRG-based payment system. Claims are currently priced by using the rates and weights that are in effect on a beneficiary's date of admission. This Final rule changes that provision to price such claims by using the rates and weights that are in effect on a beneficiary's date of discharge.

78 FR 47153 - Claims Under the Federal Tort Claims Act for Loss of or Damage to Property or for Personal Injury...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-05

... on negligence, wrongful act or omission. Authority: 12 U.S.C. 5492(a)(1), (11); 28 U.S.C. 2672; 28 CFR 14.11. Sec. 1076.101 Claims against a Bureau employee based on negligence, wrongful act or... representative may present a claim against a Bureau employee based on negligence, or wrongful act or omission, as...

Strong claims and weak evidence: reassessing the predictive validity of the IAT.

PubMed

Blanton, Hart; Jaccard, James; Klick, Jonathan; Mellers, Barbara; Mitchell, Gregory; Tetlock, Philip E

2009-05-01

The authors reanalyzed data from 2 influential studies-A. R. McConnell and J. M. Leibold and J. C. Ziegert and P. J. Hanges-that explore links between implicit bias and discriminatory behavior and that have been invoked to support strong claims about the predictive validity of the Implicit Association Test. In both of these studies, the inclusion of race Implicit Association Test scores in regression models reduced prediction errors by only tiny amounts, and Implicit Association Test scores did not permit prediction of individual-level behaviors. Furthermore, the results were not robust when the impact of rater reliability, statistical specifications, and/or outliers were taken into account, and reanalysis of A. R. McConnell & J. M. Leibold (2001) revealed a pattern of behavior consistent with a pro-Black behavioral bias, rather than the anti-Black bias suggested in the original study. (c) 2009 APA, all rights reserved.

Intuitive Logic Revisited: New Data and a Bayesian Mixed Model Meta-Analysis

PubMed Central

Singmann, Henrik; Klauer, Karl Christoph; Kellen, David

2014-01-01

Recent research on syllogistic reasoning suggests that the logical status (valid vs. invalid) of even difficult syllogisms can be intuitively detected via differences in conceptual fluency between logically valid and invalid syllogisms when participants are asked to rate how much they like a conclusion following from a syllogism (Morsanyi & Handley, 2012). These claims of an intuitive logic are at odds with most theories on syllogistic reasoning which posit that detecting the logical status of difficult syllogisms requires effortful and deliberate cognitive processes. We present new data replicating the effects reported by Morsanyi and Handley, but show that this effect is eliminated when controlling for a possible confound in terms of conclusion content. Additionally, we reanalyze three studies () without this confound with a Bayesian mixed model meta-analysis (i.e., controlling for participant and item effects) which provides evidence for the null-hypothesis and against Morsanyi and Handley's claim. PMID:24755777

The plaintiff's two-sided mouth: defeating ADA claims based on inconsistent positions taken by the plaintiff on other claims.

PubMed

Connell, D S

1996-01-01

In the typical ADA claim, the plaintiff will claim that he or she has a disability but is nevertheless able to perform the essential functions of his or her job. This position is often in direct conflict with other non-ADA claims that the plaintiff has made or is making, where the plaintiff is claiming total disability and/or that he or she is unable to work. This article examines these phenomena, reviews the numerous recent cases that have found for employers based on these inconsistent positions of the plaintiff, and explains how employers can be develop and present this defense.

Scenario-Testing: Decision Rules for Evaluating Conflicting Probabilistic Claims.

ERIC Educational Resources Information Center

Dudczak, Craig A.; Baker, David

Evaluators of argument are frequently confronted by conflicting claims. While these claims are usually based on probabilities, they are often resolved with the accepted claim treated as though it were "true," while the rejected claim is treated as though it were "false." Scenario testing is the label applied to a set of…

32 CFR 536.35 - Unique issues related to environmental claims.

Code of Federal Regulations, 2010 CFR

2010-07-01

... the United States based on contamination by toxic substances found in the air or the ground must be... geographical jurisdiction over the claim and USARCS. Claims for personal injury from contamination frequently arise at an area that is the subject of claims for cleanup of the contamination site. The cleanup claims...

13 CFR 114.104 - What evidence and information may SBA require relating to my claim?

Code of Federal Regulations, 2010 CFR

2010-01-01

... BUSINESS ADMINISTRATION ADMINISTRATIVE CLAIMS UNDER THE FEDERAL TORT CLAIMS ACT AND REPRESENTATION AND... relevant to the government's alleged liability or the damages you claim. (c) For a claim based on death: (1) An authenticated death certificate or other competent evidence showing cause of death, date of death...

Analysis of British American Tobacco's questionable use of privilege and protected document claims at the Guildford Depository.

PubMed

LeGresley, Eric; Lee, Kelley

2017-05-01

Tobacco companies have a documented history of attempting to hide information from public scrutiny, including inappropriate privilege claims. The 1998 Minnesota Consent Judgement created two depositories to provide public access to discovered documents. Users raised concerns about the access conditions and ongoing integrity of the Guildford Depository collection operated until 2015 by British American Tobacco (BAT). A metadata search of the Legacy Tobacco Documents Library identified inconsistent privilege claims, and duplicates of documents withheld by BAT from public visitors. A review of the validity of claims, for documents obtained through these searches, was conducted against recognised legal definitions of privilege. BAT has asserted inappropriate privilege claims over 49% of the documents reviewed (n=63). The quantity of such claims and consistency of the stated rationale for the privilege claims suggest a concerted effort rather than human error. There was insufficient attention given to the operation of the Guildford Depository by the original plaintiffs, including to the subsequent use of privilege claims. Appropriate access to these documents, commensurate with the terms of legal settlements creating the collection, was critical given their public interest value for enhancing understanding of industry strategies and activities, informing of policy interventions, and for holding the industry to account. Future legal settlements should prevent defendants from subsequently withholding disclosed documents, aside from those legitimately privileged, from public view. Control of publicly disclosed documents should not be placed back into the hands of defendant tobacco companies. Plaintiffs also need to invest adequate resources into policing claims of legal privilege. 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/.

Assessing Medicare Part D Claim Completeness Using Medication Self-reports: The Role of Veteran Status and Generic Drug Discount Programs

PubMed Central

Zhou, Lei; Stearns, Sally C.; Thudium, Emily M.; Alburikan, Khalid A.; Rodgers, Jo Ellen

2015-01-01

Objective Medicare Part D claims are commonly used for research, but missing claims could compromise their validity. This study assessed two possible causes of missing claims: veteran status and Generic Drug Discount Programs (GDDP). Methods We merged medication self-reports from telephone interviews in the Atherosclerosis Risk in Communities Study (ARIC) with Part D claims for six medications (three were commonly in GDDP in 2009). Merged records (4,468) were available for 2,905 ARIC participants enrolled in Part D. Multinomial logit regression provided estimates of the association of concordance (self-report & Part D, self-report only, or Part D only) with veteran and GDDP status, controlling for participant socio-demographics. Results Sample participants were 74±5 years of age, 68% white and 63% female; 19% were male veterans. Compared to females, male veterans were 11% (95% CI: 7%–16%) less likely to have matched medications in self-report & Part D and 11% (95% CI: 7%–16%) more likely to have self-report only. Records for GDDP versus non-GDDP medications were 4% (95% CI: 1%–7%) more likely to be in self-report & Part D and 3% (95% CI: 1%–5%) less likely to be in Part D only, with no difference in self-report only. Conclusions Part D claims were more likely to be missing for veterans, but claims for medications commonly available through GDDP were more likely to match with self-reports. While researchers should be aware of the possibility of missing claims, GDDP status was associated with a higher rather than lower likelihood of claims being complete in 2009. PMID:25793271

Form CMS-2728 data versus erythropoietin claims data: implications for quality of care studies.

PubMed

Beaubrun, Anne C; Kanda, Eiichiro; Bond, T Christopher; McClellan, William M

2013-01-01

Medical Evidence Report Form CMS-2728 data is frequently used to study US dialysis patients, but the validity of these data have been called into question. We compared predialysis erythropoietin use as recorded on Form CMS-2728 with claims data as part of an assessment of quality of care among hemodialysis patients. Medicare claims were linked to Form CMS-2728 data for 18,870 patients. Dialysis patients, 67 years old or older, who started dialysis from 1 June 2005 to 31 May 2007 were eligible. Logistic and multivariate regressions were used to compare the use of either Form CMS-2728 or the corresponding claims data to predict mortality and the probability of meeting target hemoglobin levels. The sensitivity, specificity, and kappa coefficient for the predialysis erythropoietin indicator were 58.0%, 78.4%, and 0.36, respectively. Patients with a predialysis erythropoietin claim were less likely to die compared with patients without a claim (odds ratio = 0.80 and 95% confidence interval = 0.74-0.87), but there was no relationship observed between predialysis care and death using only Form CMS-2728 predictors. At the facility level, a predialysis erythropoietin claim was associated with a 0.085 increase in the rate of meeting target hemoglobin levels compared with patients without a claim (p = 0.041), but no statistically significant relationship was observed when using the Form CMS-2728 indicators. The agreement between Form CMS-2728 and claims data is poor and discordant results are observed when comparing the use of these data sources to predict health outcomes. Facilities with higher agreement between the two data sources may provide greater quality of care.

20 CFR 10.405 - Who is considered a dependent in a claim based on disability or impairment?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 1 2010-04-01 2010-04-01 false Who is considered a dependent in a claim based on disability or impairment? 10.405 Section 10.405 Employees' Benefits OFFICE OF WORKERS... Disability and Impairment § 10.405 Who is considered a dependent in a claim based on disability or impairment...

Development and validation of an algorithm for identifying urinary retention in a cohort of patients with epilepsy in a large US administrative claims database.

PubMed

Quinlan, Scott C; Cheng, Wendy Y; Ishihara, Lianna; Irizarry, Michael C; Holick, Crystal N; Duh, Mei Sheng

2016-04-01

The aim of this study was to develop and validate an insurance claims-based algorithm for identifying urinary retention (UR) in epilepsy patients receiving antiepileptic drugs to facilitate safety monitoring. Data from the HealthCore Integrated Research Database(SM) in 2008-2011 (retrospective) and 2012-2013 (prospective) were used to identify epilepsy patients with UR. During the retrospective phase, three algorithms identified potential UR: (i) UR diagnosis code with a catheterization procedure code; (ii) UR diagnosis code alone; or (iii) diagnosis with UR-related symptoms. Medical records for 50 randomly selected patients satisfying ≥1 algorithm were reviewed by urologists to ascertain UR status. Positive predictive value (PPV) and 95% confidence intervals (CI) were calculated for the three component algorithms and the overall algorithm (defined as satisfying ≥1 component algorithms). Algorithms were refined using urologist review notes. In the prospective phase, the UR algorithm was refined using medical records for an additional 150 cases. In the retrospective phase, the PPV of the overall algorithm was 72.0% (95%CI: 57.5-83.8%). Algorithm 3 performed poorly and was dropped. Algorithm 1 was unchanged; urinary incontinence and cystitis were added as exclusionary diagnoses to Algorithm 2. The PPV for the modified overall algorithm was 89.2% (74.6-97.0%). In the prospective phase, the PPV for the modified overall algorithm was 76.0% (68.4-82.6%). Upon adding overactive bladder, nocturia and urinary frequency as exclusionary diagnoses, the PPV for the final overall algorithm was 81.9% (73.7-88.4%). The current UR algorithm yielded a PPV > 80% and could be used for more accurate identification of UR among epilepsy patients in a large claims database. Copyright © 2016 John Wiley & Sons, Ltd.

Yaruss, Coleman, and Hammer (2006): an exemplar of non-evidence-based practice in stuttering treatment.

PubMed

Ingham, Roger J

2007-07-01

This letter is a response to a recent report by J. S. Yaruss, C. Coleman, and D. Hammer (2006) that described a treatment program for preschool children who stutter. Problems with the Yaruss et al. study fall into four domains: (a) failure to provide clinicians with replicable procedures, (b) failure to collect valid and reliable speech performance data, (c) failure to control for predictable improvement in children who have been stuttering for less than 15 months, and (d) the advocacy of procedures for which there is no credible research evidence. The claims made for the efficacy of this treatment are problematic and essentially violate the principles of evidence-based practice as recommended by the American Speech-Language-Hearing Association (ASHA).

Vaccination coverage among children in Germany estimated by analysis of health insurance claims data

PubMed Central

Rieck, Thorsten; Feig, Marcel; Eckmanns, Tim; Benzler, Justus; Siedler, Anette; Wichmann, Ole

2014-01-01

In Germany, the national routine childhood immunization schedule comprises 12 vaccinations. Primary immunizations should be completed by 24 mo of age. However, nationwide monitoring of vaccination coverage (VC) is performed only at school entry. We utilized health insurance claims data covering ~85% of the total population with the objectives to (1) assess VC of all recommended childhood vaccinations in birth-cohorts 2004–2009, (2) analyze cross-sectional (at 24 and 36 mo) and longitudinal trends, and (3) validate the method internally and externally. Counting vaccine doses in a retrospective cohort fashion, we assembled individual vaccination histories and summarized VC to nationwide figures. For most long-established vaccinations, VC at 24 mo was at moderate levels (~73–80%) and increased slightly across birth-cohorts. One dose measles VC was high (94%), but low (69%) for the second dose. VC with a full course of recently introduced varicella, pneumococcal, and meningococcal C vaccines increased across birth-cohorts from below 10% above 60%, 70%, and 80%, respectively. At 36 mo, VC had increased further by up to 15 percentage points depending on vaccination. Longitudinal analysis suggested a continued VC increase until school entry. Validation of VC figures with primary data showed an overall good agreement. In conclusion, analysis of health insurance claims data allows for the estimation of VC among children in Germany considering completeness and timeliness of vaccination series. This approach provides valid nationwide VC figures for all currently recommended pediatric vaccinations and fills the information gap between early infancy and late assessment at school entry. PMID:24192604

A systematic review of validated methods to capture stillbirth and spontaneous abortion using administrative or claims data.

PubMed

Likis, Frances E; Sathe, Nila A; Carnahan, Ryan; McPheeters, Melissa L

2013-12-30

To identify and assess diagnosis, procedure and pharmacy dispensing codes used to identify stillbirths and spontaneous abortion in administrative and claims databases from the United States or Canada. We searched the MEDLINE database from 1991 to September 2012 using controlled vocabulary and key terms related to stillbirth or spontaneous abortion. 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 and assessed each study's methodological rigor using a pre-defined approach. Ten publications addressing stillbirth and four addressing spontaneous abortion met our inclusion criteria. The International Classification of Diseases, Ninth Revision (ICD-9) codes most commonly used in algorithms for stillbirth were those for intrauterine death (656.4) and stillborn outcomes of delivery (V27.1, V27.3-V27.4, and V27.6-V27.7). Papers identifying spontaneous abortion used codes for missed abortion and spontaneous abortion: 632, 634.x, as well as V27.0-V27.7. Only two studies identifying stillbirth reported validation of algorithms. The overall positive predictive value of the algorithms was high (99%-100%), and one study reported an algorithm with 86% sensitivity. However, the predictive value of individual codes was not assessed and study populations were limited to specific geographic areas. Additional validation studies with a nationally representative sample are needed to confirm the optimal algorithm to identify stillbirths or spontaneous abortion in administrative and claims databases.' Copyright © 2013 Elsevier Ltd. All rights reserved.

A new technique for measuring listening and reading literacy in developing countries

NASA Astrophysics Data System (ADS)

Greene, Barbara A.; Royer, James M.; Anzalone, Stephen

1990-03-01

One problem in evaluating educational interventions in developing countries is the absence of tests that adequately reflect the culture and curriculum. The Sentence Verification Technique is a new procedure for measuring reading and listening comprehension that allows for the development of tests based on materials indigenous to a given culture. The validity of using the Sentence Verification Technique to measure reading comprehension in Grenada was evaluated in the present study. The study involved 786 students at standards 3, 4 and 5. The tests for each standard consisted of passages that varied in difficulty. The students identified as high ability students in all three standards performed better than those identified as low ability. All students performed better with easier passages. Additionally, students in higher standards performed bettter than students in lower standards on a given passage. These results supported the claim that the Sentence Verification Technique is a valid measure of reading comprehension in Grenada.

Different micromanipulation applications based on common modular control architecture

NASA Astrophysics Data System (ADS)

Sipola, Risto; Vallius, Tero; Pudas, Marko; Röning, Juha

2010-01-01

This paper validates a previously introduced scalable modular control architecture and shows how it can be used to implement research equipment. The validation is conducted by presenting different kinds of micromanipulation applications that use the architecture. Conditions of the micro-world are very different from those of the macro-world. Adhesive forces are significant compared to gravitational forces when micro-scale objects are manipulated. Manipulation is mainly conducted by automatic control relying on haptic feedback provided by force sensors. The validated architecture is a hierarchical layered hybrid architecture, including a reactive layer and a planner layer. The implementation of the architecture is modular, and the architecture has a lot in common with open architectures. Further, the architecture is extensible, scalable, portable and it enables reuse of modules. These are the qualities that we validate in this paper. To demonstrate the claimed features, we present different applications that require special control in micrometer, millimeter and centimeter scales. These applications include a device that measures cell adhesion, a device that examines properties of thin films, a device that measures adhesion of micro fibers and a device that examines properties of submerged gel produced by bacteria. Finally, we analyze how the architecture is used in these applications.

Building a citywide, all-payer, hospital claims database to improve health care delivery in a low-income, urban community.

PubMed

Gross, Kennen; Brenner, Jeffrey C; Truchil, Aaron; Post, Ernest M; Riley, Amy Henderson

2013-01-01

Developing data-driven local solutions to address rising health care costs requires valid and reliable local data. Traditionally, local public health agencies have relied on birth, death, and specific disease registry data to guide health care planning, but these data sets provide neither health information across the lifespan nor information on local health care utilization patterns and costs. Insurance claims data collected by local hospitals for administrative purposes can be used to create valuable population health data sets. The Camden Coalition of Healthcare Providers partnered with the 3 health systems providing emergency and inpatient care within Camden, New Jersey, to create a local population all-payer hospital claims data set. The combined claims data provide unique insights into the health status, health care utilization patterns, and hospital costs on the population level. The cross-systems data set allows for a better understanding of the impact of high utilizers on a community-level health care system. This article presents an introduction to the methods used to develop Camden's hospital claims data set, as well as results showing the population health insights obtained from this unique data set.

Unsubstantiated claims in patient brochures from the largest state, provincial, and national chiropractic associations and research agencies.

PubMed

Grod, J P; Sikorski, D; Keating, J C

2001-10-01

To determine the presence or absence of claims for the clinical art of chiropractic that are not currently justified by available scientific evidence or are intrinsically untestable. A survey of patient education and promotional material produced by national, state, and provincial societies and research agencies in Canada and the United States. Patient brochures were solicited from the 3 largest provincial, 3 largest state, and the 3 largest national professional associations in the United States and Canada. Similar requests were made of 2 research agencies supported by the national associations. Brochures were reviewed for the presence or absence of unsubstantiated claims. Of the 11 organizations sampled, 9 distribute patient brochures. Of these 9 organizations, all distribute patient brochures that make claims for chiropractic services that have not been scientifically validated. The largest professional associations in the United States and Canada distribute patient brochures that make claims for the clinical art of chiropractic that are not currently justified by available scientific evidence or that are intrinsically untestable. These assertions are self-defeating because they reinforce an image of the chiropractic profession as functioning outside the boundaries of scientific behavior.

78 FR 39771 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Claim for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-02

... employee, whose death is work-related, uses to prove continued eligibility for benefits, to show... penalty for failing to comply with a collection of information that does not display a valid Control...

Iridology: A systematic review.

PubMed

Ernst, E

1999-02-01

Iridologists claim to be able to diagnose medical conditions through abnormalities of pigmentation in the iris. This technique is popular in many countries. Therefore it is relevant to ask whether it is valid. To systematically review all interpretable tests of the validity of iridology as a diagnostic tool. DATA SOURCE AND EXTRACTION: Three independent literature searches were performed to identify all blinded tests. Data were extracted in a predefined, standardized fashion. Four case control studies were found. The majority of these investigations suggests that iridology is not a valid diagnostic method. The validity of iridology as a diagnostic tool is not supported by scientific evaluations. Patients and therapists should be discouraged from using this method.

Identification of Patients with Statin Intolerance in a Managed Care Plan: A Comparison of 2 Claims-Based Algorithms.

PubMed

Bellows, Brandon K; Sainski-Nguyen, Amy M; Olsen, Cody J; Boklage, Susan H; Charland, Scott; Mitchell, Matthew P; Brixner, Diana I

2017-09-01

While statins are safe and efficacious, some patients may experience statin intolerance or treatment-limiting adverse events. Identifying patients with statin intolerance may allow optimal management of cardiovascular event risk through other strategies. Recently, an administrative claims data (ACD) algorithm was developed to identify patients with statin intolerance and validated against electronic medical records. However, how this algorithm compared with perceptions of statin intolerance by integrated delivery networks remains largely unknown. To determine the concurrent validity of an algorithm developed by a regional integrated delivery network multidisciplinary panel (MP) and a published ACD algorithm in identifying patients with statin intolerance. The MP consisted of 3 physicians and 2 pharmacists with expertise in cardiology, internal medicine, and formulary management. The MP algorithm used pharmacy and medical claims to identify patients with statin intolerance, classifying them as having statin intolerance if they met any of the following criteria: (a) medical claim for rhabdomyolysis, (b) medical claim for muscle weakness, (c) an outpatient medical claim for creatinine kinase assay, (d) fills for ≥ 2 different statins excluding dose increases, (e) decrease in statin dose, or (f) discontinuation of a statin with a subsequent fill for a nonstatin lipid-lowering therapy. The validated ACD algorithm identified statin intolerance as absolute intolerance with rhabdomyolysis; absolute intolerance without rhabdomyolysis (i.e., other adverse events); or as dose titration intolerance. Adult patients (aged ≥ 18 years) from the integrated delivery network with at least 1 prescription fill for a statin between January 1, 2011, and December 31, 2012 (first fill defined the index date) were identified. Patients with ≥ 1 year pre- and ≥ 2 years post-index continuous enrollment and no statin prescription fills in the pre-index period were included. The MP and ACD algorithms were applied to the population, and concordance was examined using individual (i.e., sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) and overall performance measures (i.e., accuracy, Cohen's kappa coefficient, balanced accuracy, F-1 score, and phi coefficient). After applying the inclusion criteria, 7,490 patients were evaluated for statin intolerance. The mean (SD) age of the population was 51.1 (8.5) years, and 55.7% were male. The MP and ACD algorithms classified 11.3% and 5.4% of patients as having statin intolerance, respectively. The concordance of the MP algorithm was mixed, with negative classification of statin intolerance measures having high concordance (specificity 0.91, NPV 0.97) and positive classification of statin intolerance measures having poor concordance (sensitivity 0.45, PPV 0.21). Overall performance measures showed mixed agreement between the algorithms. Both algorithms used a mix of pharmacy and medical claims and may be useful for organizations interested in identifying patients with statin intolerance. By identifying patients with statin intolerance, organizations may consider a variety of options, including using nonstatin lipid-lowering therapies, to manage cardiovascular event risk in these patients. This study was funded by Regeneron Pharmaceuticals and Sanofi US. Boklage is employed by, and owns stock in, Regeneron, and Charland is employed by Sanofi. Bellows has received fees from Avenir for advisory board membership and grants from Myriad Genetics, Biogen, Janssen, and National Institutes of Health. Brixner reports advisory board and consultancy fees and grants from Sanofi. Mitchell reports consultancy fees from Sanofi. Study concept and design were contributed by Bellows, Boklage, Charland, and Brixner. Bellows, Sainski-Nguyen, and Olsen took the lead in data collection, along with Mitchell. Data interpretation was performed by Mitchell, along with the other authors. The manuscript was written by Bellows, Sainski-Nguyen, and Olsen and revised by all the authors.

20 CFR 410.679 - Finality of findings with respect to other claims for benefits based on the disability or death...

Code of Federal Regulations, 2011 CFR

2011-04-01

... claims for benefits based on the disability or death of a miner. 410.679 Section 410.679 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, TITLE IV-BLACK... claims for benefits based on the disability or death of a miner. Findings of fact made in a determination...

20 CFR 410.679 - Finality of findings with respect to other claims for benefits based on the disability or death...

Code of Federal Regulations, 2010 CFR

2010-04-01

... claims for benefits based on the disability or death of a miner. 410.679 Section 410.679 Employees..., Finality of Decisions, and Representation of Parties § 410.679 Finality of findings with respect to other claims for benefits based on the disability or death of a miner. Findings of fact made in a determination...

Sickness benefit claims due to mental disorders in Brazil: associations in a population-based study.

PubMed

Barbosa-Branco, Anadergh; Bültmann, Ute; Steenstra, Ivan

2012-10-01

This study aims to determine the prevalence and duration of sickness benefit claims due to mental disorders and their association with economic activity, sex, age, work-relatedness and income replacement using a population-based study of sickness benefit claims (> 15 days) due to mental disorders in Brazil carried out in 2008. The prevalence of mental disorders was 45.1 claims per 10,000 workers. Prevalence and duration of sickness benefit claims due to mental disorder were higher and longer in workers aged over 40 years. Prevalence of claims was 73% higher in women but duration of sickness benefit claims was longer in men. Prevalence rates for claims differed widely according to economic activity, with sewage, residential care and programming and broadcasting activities showing the highest rates. Claims were deemed to be work-related in 8.5% of cases with mental disorder showing low work-relatedness in Brazil. A wide variation of prevalence and duration between age, economic activity and work-relatedness was observed, suggesting that working conditions are a more important factor in mental disorder work disability than previously assumed.

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.

An Exploratory Assessment of the United States Naval Academy Ethical Decision Making Instrument

DTIC Science & Technology

2007-09-01

diversity in the way institutions approach the problem of teaching ethics to undergraduate engineering students . Some schools require students to take...Rest’s Theory of Moral Development Rest, a first generation student of Kohlberg, also confirmed the validity of developmental, self-constructed...justice. This came about during a study when Carol Gilligan, a student of Kohlberg, questioned the validity of Kohlberg’s claim that his conception of

Transcranial Doppler Screening Among Children and Adolescents With Sickle Cell Anemia.

PubMed

Reeves, Sarah L; Madden, Brian; Freed, Gary L; Dombkowski, Kevin J

2016-06-01

With transcranial Doppler (TCD) screening, we can identify children and adolescents with sickle cell anemia who are at the highest risk of stroke. An accurate claims-based method for identifying children and adolescents with sickle cell anemia was recently developed and validated that establishes the necessary groundwork to enable large population-based assessments of health services utilization among children and adolescents with sickle cell anemia using administrative claims data. To assess the feasibility of using administrative claims data to identify and describe the receipt of TCD screening among children and adolescents with sickle cell anemia and to characterize opportunities for intervention. Retrospective cross-sectional study using Medicaid claims data from 2005 to 2010. Medicaid claims data were obtained from the following states: Florida, Illinois, Louisiana, Michigan, South Carolina, and Texas. Children and adolescents 2 to 16 years of age with sickle cell anemia were identified by the presence of 3 or more Medicaid claims with a diagnosis of sickle cell anemia within a calendar year (2005-2010). A total of 4775 children and adolescents contributed 10 787 person-years throughout the study period. Data were analyzed in 2015. A subset of children and adolescents enrolled for 2 or more consecutive years was identified to examine potential predictors of TCD screening, which included age, sex, previous receipt of TCD screening, state of residence, and health services utilization (well-child visits, outpatient visits, emergency department visits, and inpatient visits). Receipt of TCD screening was assessed by year and state. Using logistic regression with generalized estimating equations, we included associated predictors in a multivariable model to estimate odds of TCD screening. For a total of 4775 children and adolescents 2 to 16 years of age, TCD screening rates increased over the 6-year study period from 22% to 44% (P < .001); rates varied substantially across states. A subset of 2388 children and adolescents with sickle cell anemia (50%) was enrolled for 2 or more consecutive years. Each year of increasing age was associated with 3% lower odds of TCD screening (odds ratio, 0.97 [95% CI, 0.95-0.98]; P = .002). Previous receipt of TCD screening (odds ratio, 2.44 [95% CI, 2.11-2.81]; P < .001) and well-child visits (odds ratio, 1.10 [95% CI, 1.03-1.18]; P = .007) were associated with higher odds of receiving a TCD screening. Despite national recommendations, TCD screening rates remain low. Successful strategies to improve TCD screening rates may capitalize on the numerous health care interactions among children and adolescents with sickle cell anemia.

A Dialogic Path to Evidence-Based Argumentive Writing

ERIC Educational Resources Information Center

Hemberger, Laura; Kuhn, Deanna; Matos, Flora; Shi, Yuchen

2017-01-01

Central to argument are evidence-based claims, requiring coordination of a claim with evidence bearing on it. We advocate a dialogic approach to developing argument skills and in the work reported here examine the further scaffold of prompts that exemplify functions of evidence in relation to a claim. This scaffold was successful in accelerating…

38 CFR 3.208 - Claims based on attained age.

Code of Federal Regulations, 2010 CFR

2010-07-01

... age. 3.208 Section 3.208 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS... Claims based on attained age. In claims for pension where the age of the veteran or surviving spouse is material, the statements of age will be accepted where they are in agreement with other statements in the...

38 CFR 3.208 - Claims based on attained age.

Code of Federal Regulations, 2013 CFR

2013-07-01

... age. 3.208 Section 3.208 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS... Claims based on attained age. In claims for pension where the age of the veteran or surviving spouse is material, the statements of age will be accepted where they are in agreement with other statements in the...

38 CFR 3.208 - Claims based on attained age.

Code of Federal Regulations, 2014 CFR

2014-07-01

... age. 3.208 Section 3.208 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS... Claims based on attained age. In claims for pension where the age of the veteran or surviving spouse is material, the statements of age will be accepted where they are in agreement with other statements in the...

38 CFR 3.208 - Claims based on attained age.

Code of Federal Regulations, 2011 CFR

2011-07-01

... age. 3.208 Section 3.208 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS... Claims based on attained age. In claims for pension where the age of the veteran or surviving spouse is material, the statements of age will be accepted where they are in agreement with other statements in the...

38 CFR 3.208 - Claims based on attained age.

Code of Federal Regulations, 2012 CFR

2012-07-01

... age. 3.208 Section 3.208 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS... Claims based on attained age. In claims for pension where the age of the veteran or surviving spouse is material, the statements of age will be accepted where they are in agreement with other statements in the...

76 FR 4936 - Certain Silicon Microphone Packages and Products Containing the Same; Notice of Commission...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-27

... constructions, and based substantially on those claim constructions argued, inter alia, that the prior art did... ALJ rejected, and made, inter alia, noninfringement arguments based on disputed claim constructions... on the construction of the term ``attached'' in claims 1 and 7 of the '089 patent. The only dispute...

The validity of claims made in orthopaedic print advertisements.

PubMed

Bhattacharyya, Timothy; Tornetta, Paul; Healy, William L; Einhorn, Thomas A

2003-07-01

Orthopaedic surgeons are frequently presented with advertisements for orthopaedic and medical products in which companies make claims of clinical and scientific fact. This study was designed to evaluate the statements made in orthopaedic print advertisements and determine whether they are supported by scientific data. Fifty statements from fifty advertisements were chosen at random from six peer-reviewed orthopaedic journals. The companies that placed the advertisements were contacted to provide supporting data for the statement of clinical or scientific fact. Three senior orthopaedic surgeons evaluated the data for quality and support. A high-quality study was defined as a study that could be published in the peer-reviewed literature. A well-supported statement was defined as a statement with enough supporting evidence to be used in clinical practice. The evaluating surgeons were blinded to product and company identification. The supporting data were from a published source for eighteen claims (36%), from a presentation at a public forum or a scientific meeting for twelve claims (24%), or were "data on file" only at the company for twelve claims (24%). Interobserver agreement among the surgeons evaluating the advertisements for quality and support was good (the average intraclass correlation coefficient was 0.72). Of the fifty claims, twenty-two were considered unsupported by scientific data, seventeen were classified as possibly supported, seven were well supported, and four were from companies that did not respond despite three requests. Claims that were supported by published data were significantly more likely to be rated as well supported (p < 0.001). All twelve claims that were supported purely by "data on file" at the company were considered to be poorly supported. Orthopaedic surgeons should interpret claims made in orthopaedic print advertisements with caution. Approximately half of the claims are not supported by enough data to be used in a clinical decision-making process.

Decision tree analysis of factors influencing rainfall-related building damage

NASA Astrophysics Data System (ADS)

Spekkers, M. H.; Kok, M.; Clemens, F. H. L. R.; ten Veldhuis, J. A. E.

2014-04-01

Flood damage prediction models are essential building blocks in flood risk assessments. Little research has been dedicated so far to damage of small-scale urban floods caused by heavy rainfall, while there is a need for reliable damage models for this flood type among insurers and water authorities. The aim of this paper is to investigate a wide range of damage-influencing factors and their relationships with rainfall-related damage, using decision tree analysis. For this, district-aggregated claim data from private property insurance companies in the Netherlands were analysed, for the period of 1998-2011. The databases include claims of water-related damage, for example, damages related to rainwater intrusion through roofs and pluvial flood water entering buildings at ground floor. Response variables being modelled are average claim size and claim frequency, per district per day. The set of predictors include rainfall-related variables derived from weather radar images, topographic variables from a digital terrain model, building-related variables and socioeconomic indicators of households. Analyses were made separately for property and content damage claim data. Results of decision tree analysis show that claim frequency is most strongly associated with maximum hourly rainfall intensity, followed by real estate value, ground floor area, household income, season (property data only), buildings age (property data only), ownership structure (content data only) and fraction of low-rise buildings (content data only). It was not possible to develop statistically acceptable trees for average claim size, which suggest that variability in average claim size is related to explanatory variables that cannot be defined at the district scale. Cross-validation results show that decision trees were able to predict 22-26% of variance in claim frequency, which is considerably better compared to results from global multiple regression models (11-18% of variance explained). Still, a large part of the variance in claim frequency is left unexplained, which is likely to be caused by variations in data at subdistrict scale and missing explanatory variables.

A Behavioral Commentary on Poplin's Discussion of Reductionistic Fallacy and Holistic/Constructivist Principles.

ERIC Educational Resources Information Center

Kimball, Walter H.; Heron, Timothy E.

1988-01-01

In response to two papers decrying reductionism and advocating holistic constructivism in models of learning disabilities, the article claims that the behavioral paradigm, unlike the holistic paradigm, has provided a validated and documented instructional methodology. (DB)

Methodologic limitations of prescription opioid safety research and recommendations for improving the evidence base.

PubMed

Ranapurwala, Shabbar I; Naumann, Rebecca B; Austin, Anna E; Dasgupta, Nabarun; Marshall, Stephen W

2018-06-03

The ongoing opioid epidemic has claimed more than a quarter million Americans' lives over the past 15 years. The epidemic began with an escalation of prescription opioid deaths and has now evolved to include secondary waves of illicit heroin and fentanyl deaths, while the deaths due to prescription opioid overdoses are still increasing. In response, the Centers for Disease Control and Prevention (CDC) moved to limit opioid prescribing with the release of opioid prescribing guidelines for chronic noncancer pain in March 2016. The guidelines represent a logical and timely federal response to this growing crisis. However, CDC acknowledged that the evidence base linking opioid prescribing to opioid use disorders and overdose was grades 3 and 4. Motivated by the need to strengthen the evidence base, this review details limitations of the opioid safety studies cited in the CDC guidelines with a focus on methodological limitations related to internal and external validity. Internal validity concerns were related to poor confounding control, variable misclassification, selection bias, competing risks, and potential competing interventions. External validity concerns arose from the use of limited source populations, historical data (in a fast-changing epidemic), and issues with handling of cancer and acute pain patients' data. We provide a nonexhaustive list of 7 recommendations to address these limitations in future opioid safety studies. Strengthening the opioid safety evidence base will aid any future revisions of the CDC guidelines and enhance their prevention impact. Copyright © 2018 John Wiley & Sons, Ltd.

Evaluating an ensemble classification approach for crop diversity verification in Danish greening subsidy control

NASA Astrophysics Data System (ADS)

Chellasamy, Menaka; Ferré, Ty Paul Andrew; Greve, Mogens Humlekrog

2016-07-01

Beginning in 2015, Danish farmers are obliged to meet specific crop diversification rules based on total land area and number of crops cultivated to be eligible for new greening subsidies. Hence, there is a need for the Danish government to extend their subsidy control system to verify farmers' declarations to warrant greening payments under the new crop diversification rules. Remote Sensing (RS) technology has been used since 1992 to control farmers' subsidies in Denmark. However, a proper RS-based approach is yet to be finalised to validate new crop diversity requirements designed for assessing compliance under the recent subsidy scheme (2014-2020); This study uses an ensemble classification approach (proposed by the authors in previous studies) for validating the crop diversity requirements of the new rules. The approach uses a neural network ensemble classification system with bi-temporal (spring and early summer) WorldView-2 imagery (WV2) and includes the following steps: (1) automatic computation of pixel-based prediction probabilities using multiple neural networks; (2) quantification of the classification uncertainty using Endorsement Theory (ET); (3) discrimination of crop pixels and validation of the crop diversification rules at farm level; and (4) identification of farmers who are violating the requirements for greening subsidies. The prediction probabilities are computed by a neural network ensemble supplied with training samples selected automatically using farmers declared parcels (field vectors containing crop information and the field boundary of each crop). Crop discrimination is performed by considering a set of conclusions derived from individual neural networks based on ET. Verification of the diversification rules is performed by incorporating pixel-based classification uncertainty or confidence intervals with the class labels at the farmer level. The proposed approach was tested with WV2 imagery acquired in 2011 for a study area in Vennebjerg, Denmark, containing 132 farmers, 1258 fields, and 18 crops. The classification results obtained show an overall accuracy of 90.2%. The RS-based results suggest that 36 farmers did not follow the crop diversification rules that would qualify for the greening subsidies. When compared to the farmers' reported crop mixes, irrespective of the rule, the RS results indicate that false crop declarations were made by 8 farmers, covering 15 fields. If the farmers' reports had been submitted for the new greening subsidies, 3 farmers would have made a false claim; while remaining 5 farmers obey the rules of required crop proportion even though they have submitted the false crop code due to their small holding size. The RS results would have supported 96 farmers for greening subsidy claims, with no instances of suggesting a greening subsidy for a holding that the farmer did not report as meeting the required conditions. These results suggest that the proposed RS based method shows great promise for validating the new greening subsidies in Denmark.

To the core of porcine matter: evaluating arguments against producing transgenic pigs.

PubMed

Ravelingien, A; Braeckman, J

2004-07-01

The production of transgenic pigs for xenotransplantation is based on an urgent human need for transplantable organs. Although the particular genetic modifications are small and do not alter the organism phenotypically, several authors consider it to be morally problematic. In this paper we attempt to establish if there are genuine reasons to refrain from producing 'humanized' pigs. We distinguish between two types of ethical arguments against transgenesis often confused in debating the matter: consequentialist and inherent arguments. Whereas the first type of argument pertains to the potentially negative effects of the procedure, the second type claims that genetic engineering of animals is 'inherently' wrong; that the action itself regardless of the effects - is to be considered immoral. If this is the case, then the discussion need not be taken further. If not, then these arguments do not stand in evaluating the procedure. We demonstrate that none of the claims asserting inherent wrongness of transgenesis is valid as such. Sound resistance to producing transgenic pigs is restricted to concerns regarding the concrete effects of the applications.

Quality of care in patients with atrial fibrillation in primary care: a cross-sectional study comparing clinical and claims data.

PubMed

Preuss, Rebekka; Chenot, Jean-François; Angelow, Aniela

2016-01-01

Objectives: Atrial fibrillation (AF) is a common cardiac arrhythmia with increased risk of thromboembolic stroke. Oral anticoagulation (OAC) reduces stroke risk by up to 68%. The aim of our study was to evaluate quality of care in patients with AF in a primary health care setting with a focus on physician guideline adherence for OAC prescription and heart rate- and rhythm management. In a second step we aimed to compare OAC rates based on primary care data with rates based on claims data. Methods: We included all GP practices in the region Vorpommern-Greifswald, Germany, which were willing to participate (N=29/182, response rate 16%). Claims data was derived from the regional association of statutory health insurance physicians. Patients with a documented AF diagnosis (ICD-10-GM-Code ICD I48.-) from 07/2011-06/2012 were identified using electronic medical records (EMR) and claims data. Stroke and bleeding risk were calculated using the CHA 2 DS 2 -VASc and HAS-BLED scores. We calculated crude treatment rates for OAC, rate and rhythm control medications and adjusted OAC treatment rates based on practice and claims data. Adjusted rates were calculated including the CHA 2 DS 2 -VASc and HAS-BLED scores and individual factors affecting guideline based treatment. Results: We identified 927 patients based on EMR and 1,247 patients based on claims data. The crude total OAC treatment rate was 69% based on EMR and 61% based on claims data. The adjusted OAC treatment rates were 90% for patients based on EMR and 63% based on claims data. 82% of the AF patients received a treatment for rate control and 12% a treatment for rhythm control. The most common reasons for non-prescription of OAC were an increased risk of falling, dementia and increased bleeding risk. Conclusion: Our results suggest that a high rate of AF patients receive a drug therapy according to guidelines. There is a large difference between crude and adjusted OAC treatment rates. This is due to individual contraindications and comorbidities which cannot be documented using ICD coding. Therefore, quality indicators based on crude EMR data or claims data would lead to a systematic underestimation of the quality of care. A possible overtreatment of low-risk patients cannot be ruled out.

Trivial constraints on orbital-free kinetic energy density functionals

NASA Astrophysics Data System (ADS)

Luo, Kai; Trickey, S. B.

2018-03-01

Approximate kinetic energy density functionals (KEDFs) are central to orbital-free density functional theory. Limitations on the spatial derivative dependencies of KEDFs have been claimed from differential virial theorems. We identify a central defect in the argument: the relationships are not true for an arbitrary density but hold only for the minimizing density and corresponding chemical potential. Contrary to the claims therefore, the relationships are not constraints and provide no independent information about the spatial derivative dependencies of approximate KEDFs. A simple argument also shows that validity for arbitrary v-representable densities is not restored by appeal to the density-potential bijection.

Self-efficacy: a predictor but not a cause of behavior.

PubMed

Hawkins, R M

1992-12-01

The concept of self-efficacy, as expounded by Bandura as part of his Social Cognitive Theory, has made considerable impact in the psychological literature. It is argued that self-efficacy is a useful hypothetical construct for predicting behavior, but it has no valid claim to being a cause of behavior. Claims for self-efficacy as a causal agent have failed to acknowledge that self-efficacy itself is an epi-phenomenon of performance. Conventional learning theory explanations of observed performance levels are shown to be more parsimonious than accounts relying on the concept of self-efficacy.

Strategy for a transparent, accessible, and sustainable national claims database.

PubMed

Gelburd, Robin

2015-03-01

The article outlines the strategy employed by FAIR Health, Inc, an independent nonprofit, to maintain a national database of over 18 billion private health insurance claims to support consumer education, payer and provider operations, policy makers, and researchers with standard and customized data sets on an economically self-sufficient basis. It explains how FAIR Health conducts all operations in-house, including data collection, security, validation, information organization, product creation, and transmission, with a commitment to objectivity and reliability in data and data products. It also describes the data elements available to researchers and the diverse studies that FAIR Health data facilitate.

Microalgae Nutraceuticals.

PubMed

Nicoletti, Marcello

2016-08-22

Among the new entries in the food supplements sector, an important place must be assigned to nutraceuticals containing microalgae, nowadays accounting for a large and rapidly expanding market. The marketed products are mainly based on three production strains, i.e., Spirulina and Chlorella, followed at a distance by Klamath. It is a composite situation, since two of them are cyanobacteria and the second one is eukaryotic. The reality is that each presents similarities in shape and appearance concerning the marketed form and several utilizations, and peculiarities that need special attention and adequate studies. First, general information is reported about the current scientific knowledge on each microalga, in particular the nutritional value and properties in prevention and wellbeing. Second, original studies are presented concerning the quality control of marketed products. Quality control is a key argument in nutraceuticals validation. Microalgae are particular organisms that need specific approaches to confirm identity and validate properties. The proposed control of quality is based on microscopic analysis of the morphologic characteristics. The final parts of this paper are dedicated to the need for specificity in uses and claims and to considerations about the future of microalgae in food supplements.

Microalgae Nutraceuticals

PubMed Central

Nicoletti, Marcello

2016-01-01

Among the new entries in the food supplements sector, an important place must be assigned to nutraceuticals containing microalgae, nowadays accounting for a large and rapidly expanding market. The marketed products are mainly based on three production strains, i.e., Spirulina and Chlorella, followed at a distance by Klamath. It is a composite situation, since two of them are cyanobacteria and the second one is eukaryotic. The reality is that each presents similarities in shape and appearance concerning the marketed form and several utilizations, and peculiarities that need special attention and adequate studies. First, general information is reported about the current scientific knowledge on each microalga, in particular the nutritional value and properties in prevention and wellbeing. Second, original studies are presented concerning the quality control of marketed products. Quality control is a key argument in nutraceuticals validation. Microalgae are particular organisms that need specific approaches to confirm identity and validate properties. The proposed control of quality is based on microscopic analysis of the morphologic characteristics. The final parts of this paper are dedicated to the need for specificity in uses and claims and to considerations about the future of microalgae in food supplements. PMID:28231149

20 CFR 405.410 - Selecting claims for Decision Review Board review.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Selecting claims for Decision Review Board review. 405.410 Section 405.410 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ADMINISTRATIVE REVIEW... will not review claims based on the identity of the administrative law judge who decided the claim. (b...

20 CFR 429.103 - Who may file my claim?

Code of Federal Regulations, 2010 CFR

2010-04-01

... authorized agent, or your legal representative may file the claim. (c) Claims based on death. The executor or... behalf as agent, executor, administrator, parent, guardian or other representative. ...

The PMA Scale: A Measure of Physicians' Motivation to Adopt Medical Devices.

PubMed

Hatz, Maximilian H M; Sonnenschein, Tim; Blankart, Carl Rudolf

2017-04-01

Studies have often stated that individual-level determinants are important drivers for the adoption of medical devices. Empirical evidence supporting this claim is, however, scarce. At the individual level, physicians' adoption motivation was often considered important in the context of adoption decisions, but a clear notion of its dimensions and corresponding measurement scales is not available. To develop and subsequently validate a scale to measure the motivation to adopt medical devices of hospital-based physicians. The development and validation of the physician-motivation-adoption (PMA) scale were based on a literature search, internal expert meetings, a pilot study with physicians, and a three-stage online survey. The data collected in the online survey were analyzed using exploratory factor analysis (EFA), and the PMA scale was revised according to the results. Confirmatory factor analysis (CFA) was conducted to test the results from the EFA in the third stage. Reliability and validity tests and subgroup analyses were also conducted. Overall, 457 questionnaires were completed by medical personnel of the National Health Service England. The EFA favored a six-factor solution to appropriately describe physicians' motivation. The CFA confirmed the results from the EFA. Our tests indicated good reliability and validity of the PMA scale. This is the first reliable and valid scale to measure physicians' adoption motivation. Future adoption studies assessing the individual level should include the PMA scale to obtain more information about the role of physicians' motivation in the broader adoption context. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

AN EXAMINATION OF CLAIMS-BASED PREDICTORS OF OVERDOSE FROM A LARGE MEDICAID PROGRAM

PubMed Central

Cochran, Gerald; Gordon, Adam J.; Lo-Ciganic, Wei-Hsuan; Gellad, Walid F.; Frazier, Winfred; Lobo, Carroline; Chang, Joyce; Zheng, Ping; Donohue, Julie M.

2016-01-01

Background Health systems may play an important role in identification of patients at-risk of opioid medication overdose. However, standard measures for identifying overdose risk in administrative data do not exist. Objective Examine the association between opioid medication overdose and 2 validated measures of non-medical use of prescription opioids within claims data. Research Design A longitudinal retrospective cohort study that estimated associations between overdose and non-medical use. Subjects Adult Pennsylvania Medicaid program 2007-2012 patients initiating opioid treatment who were: non-dual eligible, without cancer diagnosis, and not in long-term care facilities or receiving hospice. Measures Overdose (International Classification of Disease, 9th edition, prescription opioid poisonings codes), opioid abuse (opioid use disorder diagnosis while possessing an opioid prescription), opioid misuse (a composite indicator of number of opioid prescribers, number of pharmacies, and days supplied), and dose exposure during opioid treatment episodes. Results A total of 372,347 Medicaid enrollees with 583,013 new opioid treatment episodes were included in the cohort. Opioid overdose was higher among those with abuse (1.5%) compared to those without (0.2%, p<0.001). Overdose was higher among those with probable (1.8%) and possible (0.9%) misuse compared to those without (0.2%, p<0.001). Abuse (adjusted rate ratio [ARR]=1.52, 95% CI=1.10-2.10), probable misuse (ARR=1.98, 95% CI=1.46-2.67), and possible misuse (ARR=1.76, 95% CI=1.48-2.09) were associated with significantly more events of opioid medication overdose compared to those without. Conclusions Claims-based measures can be employed by health systems to identify individuals at-risk of overdose who can be targeted for restrictions on opioid prescribing, dispensing, or referral to treatment. PMID:27984346

Is the tobacco control movement misrepresenting the acute cardiovascular health effects of secondhand smoke exposure? An analysis of the scientific evidence and commentary on the implications for tobacco control and public health practice

PubMed Central

Siegel, Michael

2007-01-01

While chronic exposure to secondhand smoke has been well recognized as a cause of heart disease in nonsmokers, there has been recent speculation about the potential acute cardiovascular effects of transient exposure to secondhand smoke among nonsmokers; in particular, the possibility that such exposure could increase the risk of acute myocardial infarction even in an otherwise healthy nonsmoker. This paper reviews the claims being made by a number of anti-smoking and public health groups regarding the acute cardiovascular effects of secondhand smoke exposure among otherwise healthy adults, analyzes the validity of these claims based on a review of the scientific evidence, and discusses the implications of the findings for tobacco control and public health practice. Based on the analysis, it appears that a large number of anti-smoking organizations are making inaccurate claims that a single, acute, transient exposure to secondhand smoke can cause severe and even fatal cardiovascular events in healthy nonsmokers. The dissemination of inaccurate information by anti-smoking groups to the public in support of smoking bans is unfortunate because it may harm the tobacco control movement by undermining its credibility, reputation, and effectiveness. Disseminating inaccurate information also represents a violation of basic ethical principles that are a core value of public health practice that cannot and should not be sacrificed, even for a noble end such as protecting nonsmokers from secondhand smoke exposure. How the tobacco control movement responds to this crisis of credibility will go a long way towards determining the future effectiveness of the movement and its ability to continue to save lives and protect the public's health. PMID:17927828

Using Bovine Viral Diarrhea Virus (BVDV) As Surrogate for Human Hepatitis C Virus

EPA Pesticide Factsheets

This test is designed to validate virucidal effectiveness claims for a product to be registered as a virucide. It determines the potential of the test agent to disinfect hard surfaces contaminated with human Hepatitis C virus (HCV).

Claims-based studies of oral glucose-lowering medications can achieve balance in critical clinical variables only observed in electronic health records.

PubMed

Patorno, Elisabetta; Gopalakrishnan, Chandrasekar; Franklin, Jessica M; Brodovicz, Kimberly G; Masso-Gonzalez, Elvira; Bartels, Dorothee B; Liu, Jun; Schneeweiss, Sebastian

2018-04-01

To evaluate the extent to which balance in unmeasured characteristics of patients with type 2 diabetes (T2DM) was achieved in claims data, by comparing against more detailed information from linked electronic health records (EHR) data. Within a large US commercial insurance database and using a cohort design, we identified patients with T2DM initiating linagliptin or a comparator agent within class (ie, another dipeptidyl peptidase-4 inhibitor) or outside class (ie, pioglitazone or a sulphonylurea) between May 2011 and December 2012. We focused on comparators used at a similar stage of diabetes to linagliptin. For each comparison, 1:1 propensity score (PS) matching was used to balance >100 baseline claims-based characteristics, including proxies of diabetes severity and duration. Additional clinical data from EHR were available for a subset of patients. We assessed representativeness of the claims-EHR-linked subset, evaluated the balance of claims- and EHR-based covariates before and after PS-matching via standardized differences (SDs), and quantified the potential bias associated with observed imbalances. From a claims-based study population of 166 613 patients with T2DM, 7219 (4.3%) patients were linked to their EHR data. Claims-based characteristics in the EHR-linked and EHR-unlinked patients were similar (SD < 0.1), confirming the representativeness of the EHR-linked subset. The balance of claims-based and EHR-based patient characteristics appeared to be reasonable before PS-matching and generally improved in the PS-matched population, to be SD < 0.1 for most patient characteristics and SD < 0.2 for select laboratory results and body mass index categories, which was not large enough to cause meaningful confounding. In the context of pharmacoepidemiological research on diabetes therapy, choosing appropriate comparison groups paired with a new-user design and 1:1 PS matching on many proxies of diabetes severity and duration improves balance in covariates typically unmeasured in administrative claims datasets, to the extent that residual confounding is unlikely. © 2017 John Wiley & Sons Ltd.

Dietary supplement labeling and advertising claims: are clinical studies on the full product required?

PubMed

Villafranco, John E; Bond, Katie

2009-01-01

Whether labeling and advertising claims for multi-ingredient dietary supplements may be based on the testing of individual, key ingredients--rather than the actual product--has caused a good deal of confusion. This confusion stems from the dearth of case law and the open-endedness of Federal Trade Commission (FTC) and Food and Drug Administration (FDA) guidance on this issue. Nevertheless, the relevant regulatory guidance, case law and self-regulatory case law--when assessed together--indicate that the law allows and even protects "key ingredient claims" (i.e., claims based on efficacy testing of key ingredients in the absence of full product testing). This article provides an overview of the relevant substantiation requirements for dietary supplement claims and then reviews FTC's and FDA's guidance on key ingredient claims; relevant case law; use of key ingredient claims in the advertising of other consumer products; and the National Advertising Division of the Better Business Bureau, Inc.'s (NAD's) approach to evaluating key ingredient claims for dietary supplements. This article concludes that key ingredient claims--provided they are presented in a truthful and non-deceptive manner--are permissible, and should be upheld in litigation and cases subject to industry self-regulation. This article further concludes that the NAD's approach to key ingredient claims provides practical guidance for crafting and substantiating dietary supplement key ingredient claims.

ABEL model: Evaluates corporations` claims of inability to afford penalties and compliance costs (version 3.0.16). Model-simulation

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

NONE

1998-11-01

The easy-to-use ABEL software evaluates for-profit company claims of inability to afford penalties, clean-up costs, or compliance costs. Violators raise the issue of inability to pay in most of EPA`s enforcement actions regardless of whether there is any hard evidence supporting those claims. The program enables Federal, State and local enforcement professionals to quickly determine if there was any validity to those claims. ABEL is a tool that promotes quick settlements by performing screening analyses of defendants and potentially responsible parties (PRP`s) to determine their financial capacity. After analyzing some basic financial ratios that reflect a company`s solvency, ABEL assessesmore » the firm`s ability to pay by focusing on projected cash flows. The model explicitly calculates the value of projected, internally generated cash flows from historical tax information, and compares these cash flows to the proposed environmental expenditure(s). The software is extremely easy to use. Version 3.0.16 updates the standard values for inflation and discount rate.« less

The logic-bias effect: The role of effortful processing in the resolution of belief-logic conflict.

PubMed

Howarth, Stephanie; Handley, Simon J; Walsh, Clare

2016-02-01

According to the default interventionist dual-process account of reasoning, belief-based responses to reasoning tasks are based on Type 1 processes generated by default, which must be inhibited in order to produce an effortful, Type 2 output based on the validity of an argument. However, recent research has indicated that reasoning on the basis of beliefs may not be as fast and automatic as this account claims. In three experiments, we presented participants with a reasoning task that was to be completed while they were generating random numbers (RNG). We used the novel methodology introduced by Handley, Newstead & Trippas (Journal of Experimental Psychology: Learning, Memory, and Cognition, 37, 28-43, 2011), which required participants to make judgments based upon either the validity of a conditional argument or the believability of its conclusion. The results showed that belief-based judgments produced lower rates of accuracy overall and were influenced to a greater extent than validity judgments by the presence of a conflict between belief and logic for both simple and complex arguments. These findings were replicated in Experiment 3, in which we controlled for switching demands in a blocked design. Across all three experiments, we found a main effect of RNG, implying that both instructional sets require some effortful processing. However, in the blocked design RNG had its greatest impact on logic judgments, suggesting that distinct executive resources may be required for each type of judgment. We discuss the implications of our findings for the default interventionist account and offer a parallel competitive model as an alternative interpretation for our findings.

37 CFR 42.204 - Content of petition.

Code of Federal Regulations, 2014 CFR

2014-07-01

... from requesting a post-grant review challenging the patent claims on the grounds identified in the... claim challenged. The statement must identify the following: (1) The claim; (2) The specific statutory grounds permitted under 35 U.S.C. 282(b)(2) or (3) on which the challenge to the claim is based; (3) How...

37 CFR 42.204 - Content of petition.

Code of Federal Regulations, 2013 CFR

2013-07-01

... from requesting a post-grant review challenging the patent claims on the grounds identified in the... claim challenged. The statement must identify the following: (1) The claim; (2) The specific statutory grounds permitted under 35 U.S.C. 282(b)(2) or (3) on which the challenge to the claim is based; (3) How...

The epidemiology of malpractice claims in primary care: a systematic review

PubMed Central

Wallace, E; Lowry, J; Smith, S M; Fahey, T

2013-01-01

Objectives The aim of this systematic review was to examine the epidemiology of malpractice claims in primary care. Design A computerised systematic literature search was conducted. Studies were included if they reported original data (≥10 cases) pertinent to malpractice claims, were based in primary care and were published in the English language. Data were synthesised using a narrative approach. Setting Primary care. Participants Malpractice claimants. Primary outcome Malpractice claim (defined as a written demand for compensation for medical injury). We recorded: medical misadventure cited in claims, missed/delayed diagnoses cited in claims, outcome of claims, prevalence of claims and compensation awarded to claimants. Results Of the 7152 articles retrieved by electronic search, a total of 34 studies met the inclusion criteria and were included in the narrative analysis. Twenty-eight studies presented data from medical indemnity malpractice claims databases and six studies presented survey data. Fifteen studies were based in the USA, nine in the UK, seven in Australia, one in Canada and two in France. The commonest medical misadventure resulting in claims was failure to or delay in diagnosis, which represented 26–63% of all claims across included studies. Common missed or delayed diagnoses included cancer and myocardial infarction in adults and meningitis in children. Medication error represented the second commonest domain representing 5.6–20% of all claims across included studies. The prevalence of malpractice claims in primary care varied across countries. In the USA and Australia when compared with other clinical disciplines, general practice ranked in the top five specialties accounting for the most claims, representing 7.6–20% of all claims. However, the majority of claims were successfully defended. Conclusions This review of malpractice claims in primary care highlights diagnosis and medication error as areas to be prioritised in developing educational strategies and risk management systems. PMID:23869100

Automatable algorithms to identify nonmedical opioid use using electronic data: a systematic review.

PubMed

Canan, Chelsea; Polinski, Jennifer M; Alexander, G Caleb; Kowal, Mary K; Brennan, Troyen A; Shrank, William H

2017-11-01

Improved methods to identify nonmedical opioid use can help direct health care resources to individuals who need them. Automated algorithms that use large databases of electronic health care claims or records for surveillance are a potential means to achieve this goal. In this systematic review, we reviewed the utility, attempts at validation, and application of such algorithms to detect nonmedical opioid use. We searched PubMed and Embase for articles describing automatable algorithms that used electronic health care claims or records to identify patients or prescribers with likely nonmedical opioid use. We assessed algorithm development, validation, and performance characteristics and the settings where they were applied. Study variability precluded a meta-analysis. Of 15 included algorithms, 10 targeted patients, 2 targeted providers, 2 targeted both, and 1 identified medications with high abuse potential. Most patient-focused algorithms (67%) used prescription drug claims and/or medical claims, with diagnosis codes of substance abuse and/or dependence as the reference standard. Eleven algorithms were developed via regression modeling. Four used natural language processing, data mining, audit analysis, or factor analysis. Automated algorithms can facilitate population-level surveillance. However, there is no true gold standard for determining nonmedical opioid use. Users must recognize the implications of identifying false positives and, conversely, false negatives. Few algorithms have been applied in real-world settings. Automated algorithms may facilitate identification of patients and/or providers most likely to need more intensive screening and/or intervention for nonmedical opioid use. Additional implementation research in real-world settings would clarify their utility. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

An Appetite for Modernizing the Regulatory Framework for Protein Content Claims in Canada.

PubMed

Marinangeli, Christopher P F; Foisy, Samara; Shoveller, Anna K; Porter, Cara; Musa-Veloso, Kathy; Sievenpiper, John L; Jenkins, David J A

2017-08-23

The need for protein-rich plant-based foods continues as dietary guidelines emphasize their contribution to healthy dietary patterns that prevent chronic disease and promote environmental sustainability. However, the Canadian Food and Drug Regulations provide a regulatory framework that can prevent Canadian consumers from identifying protein-rich plant-based foods. In Canada, protein nutrient content claims are based on the protein efficiency ratio (PER) and protein rating method, which is based on a rat growth bioassay. PERs are not additive, and the protein rating of a food is underpinned by its Reasonable Daily Intake. The restrictive nature of Canada's requirements for supporting protein claims therefore presents challenges for Canadian consumers to adapt to a rapidly changing food environment. This commentary will present two options for modernizing the regulatory framework for protein content claims in Canada. The first and preferred option advocates that protein quality not be considered in the determination of the eligibility of a food for protein content claims. The second and less preferred option, an interim solution, is a framework for adopting the protein digestibility corrected amino acid score as the official method for supporting protein content and quality claims and harmonizes Canada's regulatory framework with that of the USA.

Administrative Claims Data for Economic Analyses in Hematopoietic Cell Transplantation: Challenges and Opportunities

PubMed Central

Preussler, Jaime M.; Mau, Lih-Wen; Majhail, Navneet S; Meyer, Christa L.; Denzen, Ellen; Edsall, Kristen C.; Farnia, Stephanie H.; Silver, Alicia; Saber, Wael; Burns, Linda J.; Vanness, David J.

2017-01-01

There is an increasing need for the development of approaches to measure quality, costs and resource utilization patterns among allogeneic hematopoietic cell transplant (HCT) patients. Administrative claims data provide an opportunity to examine service utilization and costs, particularly from the payer’s perspective. However, because administrative claims data are primarily designed for reimbursement purposes, challenges arise when using it for research. We use a case study with data derived from the 2007–2011 Truven Health MarketScan Research database to discuss opportunities and challenges for the use of administrative claims data to examine the costs and service utilization of allogeneic HCT and chemotherapy alone for patients with acute myeloid leukemia (AML). Starting with a cohort of 29,915 potentially eligible patients with a diagnosis of AML, we were able to identify 211 patients treated with HCT and 774 treated with chemotherapy only where we were sufficiently confident of the diagnosis and treatment path to allow analysis. Administrative claims data provide an avenue to meet the need for health care costs, resource utilization, and outcome information. However, when using these data, a balance between clinical knowledge and applied methods is critical to identifying a valid study cohort and accurate measures of costs and resource utilization. PMID:27184624

Ideology versus evidence: Investigating the claim that the literature on e-cigarettes is undermined by material conflict of interest.

PubMed

Kosmider, Leon; Anastasi, Natasha

2016-04-01

A review of the health effects of e-cigarettes (EC) by Pisinger and Dossing concluded that any reassuring the evidence on the contents of e-cigarettes cannot be trusted because 'A substantial number of studies were funded or otherwise supported by manufacturers of ECs' and the relevant literature is influenced by 'severe conflicts of interest' (A). The review also asserts that 'Conflict of interest seems to influence the conclusions of these papers' (BC). These claims have been embraced and magnified by EC opponents. The Pisinger and Dossing review included 76 studies and considered 26 (34%) to be 'funded or otherwise supported' by the industry. As the review identifies the 'conflicted' studies, such a claim can be checked. In summary, only 10 (13%) of articles covered by the review were sponsored by the industry and only 5 are published studies. Claim 'A' is misleading. Regarding claim 'B', it appears to have been conceived independent of any empirical support. Recently, anti-EC activists and media started to use conflict of interest accusations to disparage the validity of empirical evidence showing that vaping is much safer than smoking. Evidence needs to be considered on its merits rather than from the perspective of preconceived ideological positions. Copyright © 2016 Elsevier Inc. All rights reserved.

Validation of a patient-level medication regimen complexity index as a possible tool to identify patients for medication therapy management intervention.

PubMed

Hirsch, Jan D; Metz, Kelli R; Hosokawa, Patrick W; Libby, Anne M

2014-08-01

The Medication Regimen Complexity Index (MRCI) is a 65-item instrument that can be used to quantify medication regimen complexity at the patient level, capturing all prescribed and over-the-counter medications. Although the MRCI has been used in several studies, the narrow scope of the initial validation limits application at a population or clinical practice level. To conduct a MRCI validation pertinent to the desired clinical use to identify patients for medication therapy management interventions. An expert panel of clinical pharmacists ranked medication regimen complexity for two samples of cases: a single-disease cohort (diabetes mellitus) and a multiple-disease cohort (diabetes mellitus, hypertension, human immunodeficiency virus infection, geriatric depression). Cases for expert panel review were selected from 400 ambulatory clinic patients, and each case description included data that were available via claims or electronic medical records (EMRs). Construct validity was assessed using patient-level MRCI scores, medication count, and additional patient data. Concordance was evaluated using weighted κ agreement statistic, and correlations were determined using Spearman rank-order correlation coefficient (ρ) or Kendall τ. Moderate to good concordance between patient-level MRCI scores and expert medication regimen complexity ranking was observed (claims data, consensus ranking: single-disease cohort 0.55, multiple disease cohort 0.63). In contrast, only fair to moderate concordance was observed for medication count (single-disease cohort 0.33, multiple-disease cohort 0.48). Adding more-detailed administration directions from EMR data did not improve concordance. MRCI convergent validity was supported by strong correlations with medication count (all cohorts 0.90) and moderate correlations with morbidity measures (e.g., all cohorts; number of comorbidities 0.46, Chronic Disease Score 0.46). Nonsignificant correlation of MRCI scores with age and gender (all cohorts 0.08 and 0.06, respectively) supported MRCI divergent validity. This study used cross-sectional, retrospective patient data for a small number of patients and clinical pharmacists from only two universities; therefore, results may have limited generalizability. The patient-level MRCI is a valid tool for assessing medication regimen complexity that can be applied by using data commonly found in claims and EMR databases and could be useful to identify patients who may benefit from medication therapy management. © 2014 The Authors Pharmacotherapy published by Wiley Periodicals, Inc. on behalf of Pharmacotherapy Publications, Inc.

44 CFR 11.15 - Authority to adjust, determine, compromise and settle.

Code of Federal Regulations, 2010 CFR

2010-10-01

... MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY GENERAL CLAIMS Administrative Claims Under Federal Tort... this part, any claim for $200 or less which is based on alleged negligence or wrongful act or omission...

40 CFR 10.3 - Administrative claims; who may file.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) A claim based on death may be presented by the executor or administrator of the decedent's estate or... to present a claim on behalf of the claimant as agent, executor, administrator, parent, guardian, or...

40 CFR 1620.3 - Administrative claim; who may file.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) A claim based on death may be presented by the executor or administrator of the decedent's estate... that the basis for the representation is documented in writing. (d) A claim for loss totally...

75 FR 18548 - In the Matter of Certain Products and Pharmaceutical Compositions Containing Recombinant Human...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-12

... an investigation under section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) based on a complaint...''), claims 4-9 of U.S. Patent No. 5,618,698 (``the '698 patent''), claims 4 and 6 of U.S. Patent No. 5,621... the '868 patent, claim 3 of the '933 patent, claims 6-9 of the '698 patent, and claim 1 of the '422...

Characterization and stability studies of bioactive compounds and food matrices as evidence in support of health claims.

PubMed

González-Ferrero, Carolina; Sáiz-Abajo, María-José

2015-07-01

The characterization and stability evaluation of food and food constituents (chemical active ingredient/microorganism) for which nutrition or health claims want to be requested are essential for the success of an application to EFSA. This work reviews the requirements that must be fulfilled for a full characterization of the active substance, comprising origin, elaboration, or extraction method, and chemical/microbiological composition, using validated analytical methods. The review focuses not only on establishing the specifications of the final active ingredient or food but also on ensuring homogeneity between batches. In addition, the article discusses the methodologies and conditions of the stability studies that need to be performed on food and food constituents to verify that the relevant compounds--chemical and microbiological active ingredients--will get to the consumer in the intended state and concentration to accomplish the claimed health effect over shelf life.

Does our research tool kit equip us to make generalisable claims about dental education?

PubMed

Chambers, D W

2012-11-01

In this essay on the state of scholarship in dental education, I argue that we are best served by looking at the validity, generalisability and usefulness of claims rather than at the rigour of various research methods. All papers published in 2009 in the European Journal of Dental Education (a quarterly) and the Journal of Dental Education (published monthly), a quarterly journal of the Academy of Management, Learning & Education and the monthly American Journal of Orthodontics and Dentofacial Orthopedics were classified by the type of claim made, method by which evidence was collected and techniques of analysis. The dental education literature, compared with the two other journals, was largely focussed on surveys of opinion or particular practices and lacked scope in generalisability. The dental education literature was thin in use of randomisation, covariable analysis and theory-building. © 2012 John Wiley & Sons A/S.

Evaluating Measurement Tools in Science Education Research

ERIC Educational Resources Information Center

Hayward, Elizabeth O.

2012-01-01

In this paper I explore how Margaret Beier, Lesley Miller, and Shu Wang make claims for the validity and reliability of the instrument they developed to explore the construct of "possible selves" as described in their manuscript, "Science Games and the Development of Scientific Possible Selves."

Evaluating measurement tools in science education research

NASA Astrophysics Data System (ADS)

Hayward, Elizabeth O.

2012-12-01

In this paper I explore how Margaret Beier, Lesley Miller, and Shu Wang make claims for the validity and reliability of the instrument they developed to explore the construct of "possible selves" as described in their manuscript, Science Games and the Development of Scientific Possible Selves.

A Critique of the Research on Learning Styles.

ERIC Educational Resources Information Center

Curry, Lynn

1990-01-01

Learning styles advocates claim long-term improvements in four aspects of teaching and learning: curriculum design, instructional methods, assessment, and student guidance. The application of learning style theory encompasses three pervasive problems: confusion in definitions, weakness in measurement reliability and validity, and identification of…

Developing the Scholarship of Teaching through Transformative Learning

ERIC Educational Resources Information Center

Kreber, Carolin

2006-01-01

Following a cognitive-developmental perspective, the Scholarship of Teaching & Learning is understood as a process of knowledge construction whereby knowledge claims are validated through reflection on teaching experience and educational theory. These reflective processes can be documented and peer reviewed. Teaching portfolios allow for the…

On mathematicians' different standards when evaluating elementary proofs.

PubMed

Inglis, Matthew; Mejia-Ramos, Juan Pablo; Weber, Keith; Alcock, Lara

2013-04-01

In this article, we report a study in which 109 research-active mathematicians were asked to judge the validity of a purported proof in undergraduate calculus. Significant results from our study were as follows: (a) there was substantial disagreement among mathematicians regarding whether the argument was a valid proof, (b) applied mathematicians were more likely than pure mathematicians to judge the argument valid, (c) participants who judged the argument invalid were more confident in their judgments than those who judged it valid, and (d) participants who judged the argument valid usually did not change their judgment when presented with a reason raised by other mathematicians for why the proof should be judged invalid. These findings suggest that, contrary to some claims in the literature, there is not a single standard of validity among contemporary mathematicians. Copyright © 2013 Cognitive Science Society, Inc.

Telephone-Based Cognitive-Behavioral Screening for Frontotemporal Changes in Patients with Amyotrophic Lateral Sclerosis (ALS)

PubMed Central

Christodoulou, Georgia; Gennings, Chris; Hupf, Jonathan; Factor-Litvak, Pam; Murphy, Jennifer; Goetz, Raymond R.; Mitsumoto, Hiroshi

2017-01-01

Objective To establish a valid and reliable battery of measures to evaluate frontotemporal dementia (FTD) in patients with ALS over the phone. Methods Thirty-one subjects were administered either in-person or telephone-based screening followed by the opposite mode of testing two weeks later, using a modified version of the UCSF Cognitive Screening Battery. Results Equivalence testing was performed for in-person and telephone-based tests. The standard ALS Cognitive Behavioral Screen (ALS-CBS) showed statistical equivalence at the 5% significance level when compared to a revised phone-version of the ALS-CBS. In addition, the Controlled Oral Word Association Test (COWAT) and Center for Neurologic Study-Lability Scale (CNS-LS) were also found to be equivalent at the 5% and 10% significance level respectively. Similarly, the Mini-Mental State Examination (MMSE) and the well-established Telephone Interview for Cognitive Status (TICS) were also statistically equivalent. Equivalence could not be claimed for the ALS-Frontal Behavioral Inventory (ALS-FBI) caregiver interview and the Written Verbal Fluency Index (WVFI). Conclusions Our study suggests that telephone-based versions of the ALS-CBS, COWAT, and CNS-LS may offer clinicians valid tools to detect frontotemporal changes in the ALS population. Development of telephone-based cognitive testing for ALS could become an integral resource for population-based research in the future. PMID:27121545

Telephone based cognitive-behavioral screening for frontotemporal changes in patients with amyotrophic lateral sclerosis (ALS).

PubMed

Christodoulou, Georgia; Gennings, Chris; Hupf, Jonathan; Factor-Litvak, Pam; Murphy, Jennifer; Goetz, Raymond R; Mitsumoto, Hiroshi

Our objective was to establish a valid and reliable battery of measures to evaluate frontotemporal dementia (FTD) in patients with ALS over the telephone. Thirty-one subjects were administered either in-person or by telephone-based screening followed by the opposite mode of testing two weeks later, using a modified version of the UCSF Cognitive Screening Battery. Equivalence testing was performed for in-person and telephone based tests. The standard ALS Cognitive Behavioral Screen (ALS-CBS) showed statistical equivalence at the 5% significance level compared to a revised phone version of the ALS-CBS. In addition, the Controlled Oral Word Association Test (COWAT) and Center for Neurologic Study-Lability Scale (CNS-LS) were also found to be equivalent at the 5% and 10% significance level, respectively. Similarly, the Mini-Mental State Examination (MMSE) and the well-established Telephone Interview for Cognitive Status (TICS) were also statistically equivalent. Equivalence could not be claimed for the ALS-Frontal Behavioral Inventory (ALS-FBI) caregiver interview and the Written Verbal Fluency Index (WVFI). In conclusion, our study suggests that telephone-based versions of the ALS-CBS, COWAT, and CNS-LS may offer clinicians valid tools to detect frontotemporal changes in the ALS population. Development of telephone based cognitive testing for ALS could become an integral resource for population based research in the future.

32 CFR 842.121 - Referring a claim to the US Attorney.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 6 2010-07-01 2010-07-01 false Referring a claim to the US Attorney. 842.121 Section 842.121 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE CLAIMS AND... to the US Attorney. Only HQ USAF/JACC authorizes referral of a claim to the US Attorney. The base SJA...

Reciprocal Effects of Self-Concept and Performance From a Multidimensional Perspective: Beyond Seductive Pleasure and Unidimensional Perspectives.

PubMed

Marsh, Herbert W; Craven, Rhonda G

2006-06-01

We (Marsh & Craven, 1997) have claimed that academic self-concept and achievement are mutually reinforcing, each leading to gains in the other. Baumeister, Campbell, Krueger, and Vohs (2003) have claimed that self-esteem has no benefits beyond seductive pleasure and may even be detrimental to subsequent performance. Integrating these seemingly contradictory conclusions, we distinguish between (a) older, unidimensional perspectives that focus on global self-esteem and underpin the Baumeister et al. review and (b) more recent, multidimensional perspectives that focus on specific components of self-concept and are the basis of our claim. Supporting the construct validity of a multidimensional perspective, studies show that academic achievement is substantially related to academic self-concept, but nearly unrelated to self-esteem. Consistent with this distinction, research based on our reciprocal-effects model (REM) and a recent meta-analysis show that prior academic self-concept (as opposed to self-esteem) and achievement both have positive effects on subsequent self-concept and achievement. We provide an overview of new support for the generality of the REM for young children, cross-cultural research in non-Western countries, health (physical activity), and nonelite (gymnastics) and elite (international swimming championships) sport. We conclude that future reviews elucidating the significant implications of self-concept for theory, policy, and practice need to account for current research supporting the REM and a multidimensional perspective of self-concept. © 2006 Association for Psychological Science.

24 CFR 17.3 - Administrative claim; who may file.

Code of Federal Regulations, 2010 CFR

2010-04-01

... representative. (c) A claim based on death may be presented by the executor or administrator of the decedent's... evidence of his authority to present a claim on behalf of the claimant as agent, executor, administrator...

39 CFR 912.6 - Administrative claim; who may file.

Code of Federal Regulations, 2010 CFR

2010-07-01

... claim based on death may be presented by the executor or administrator of the decedent's estate, or by... accompanied by evidence of his authority to present a claim on behalf of the claimant as agent, executor...

Followup Audit: DoD Military Treatment Facilities Continue to Miss Opportunities to Collect on Third Party Outpatient Claims

DTIC Science & Technology

2015-07-24

Business Office Manual at the six MTFs reviewed. Based on the statistical sample, there were 144,930 claims worth $34.8 million that had at least...19 Parameters ______________________________________________________________________________ 19 Statistical ...the UBO Manual at the six MTFs reviewed. Based on the statistical sample, there were 144,930 claims worth $34.8 million that had at least one

Are the correct herbal claims by Hildegard von Bingen only lucky strikes? A new statistical approach.

PubMed

Uehleke, Bernhard; Hopfenmueller, Werner; Stange, Rainer; Saller, Reinhard

2012-01-01

Ancient and medieval herbal books are often believed to describe the same claims still in use today. Medieval herbal books, however, provide long lists of claims for each herb, most of which are not approved today, while the herb's modern use is often missing. So the hypothesis arises that a medieval author could have randomly hit on 'correct' claims among his many 'wrong' ones. We developed a statistical procedure based on a simple probability model. We applied our procedure to the herbal books of Hildegard von Bingen (1098- 1179) as an example for its usefulness. Claim attributions for a certain herb were classified as 'correct' if approximately the same as indicated in actual monographs. The number of 'correct' claim attributions was significantly higher than it could have been by pure chance, even though the vast majority of Hildegard von Bingen's claims were not 'correct'. The hypothesis that Hildegard would have achieved her 'correct' claims purely by chance can be clearly rejected. The finding that medical claims provided by a medieval author are significantly related to modern herbal use supports the importance of traditional medicinal systems as an empirical source. However, since many traditional claims are not in accordance with modern applications, they should be used carefully and analyzed in a systematic, statistics-based manner. Our statistical approach can be used for further systematic comparison of herbal claims of traditional sources as well as in the fields of ethnobotany and ethnopharmacology. Copyright © 2012 S. Karger AG, Basel.

Using Self-reports or Claims to Assess Disease Prevalence: It's Complicated.

PubMed

St Clair, Patricia; Gaudette, Étienne; Zhao, Henu; Tysinger, Bryan; Seyedin, Roxanna; Goldman, Dana P

2017-08-01

Two common ways of measuring disease prevalence include: (1) using self-reported disease diagnosis from survey responses; and (2) using disease-specific diagnosis codes found in administrative data. Because they do not suffer from self-report biases, claims are often assumed to be more objective. However, it is not clear that claims always produce better prevalence estimates. Conduct an assessment of discrepancies between self-report and claims-based measures for 2 diseases in the US elderly to investigate definition, selection, and measurement error issues which may help explain divergence between claims and self-report estimates of prevalence. Self-reported data from 3 sources are included: the Health and Retirement Study, the Medicare Current Beneficiary Survey, and the National Health and Nutrition Examination Survey. Claims-based disease measurements are provided from Medicare claims linked to Health and Retirement Study and Medicare Current Beneficiary Survey participants, comprehensive claims data from a 20% random sample of Medicare enrollees, and private health insurance claims from Humana Inc. Prevalence of diagnosed disease in the US elderly are computed and compared across sources. Two medical conditions are considered: diabetes and heart attack. Comparisons of diagnosed diabetes and heart attack prevalence show similar trends by source, but claims differ from self-reports with regard to levels. Selection into insurance plans, disease definitions, and the reference period used by algorithms are identified as sources contributing to differences. Claims and self-reports both have strengths and weaknesses, which researchers need to consider when interpreting estimates of prevalence from these 2 sources.

Dolphin-Assisted Therapy: Claims versus Evidence

PubMed Central

Fiksdal, Britta L.; Houlihan, Daniel; Barnes, Aaron C.

2012-01-01

The purpose of this paper is to review and critique studies that have been conducted on dolphin-assisted therapy for children with various disorders. Studies have been released claiming swimming with dolphins is therapeutic and beneficial for children with autism, attention deficit hyperactivity disorder, physical disabilities, and other psychological disorders. The majority of the studies conducted supporting the effectiveness of dolphin-assisted therapy have been found to have major methodological concerns making it impossible to draw valid conclusions. Readers will be informed of the history of, theory behind, and variations of dolphin-assisted therapy along with a review and critique of studies published which purportedly support its use. PMID:22928101

Ingredient Consistency of Commercially Available Polyphenol and Tocopherol Nutraceuticals

PubMed Central

Remsberg, Connie M.; Good, Renee L.; Davies, Neal M.

2010-01-01

Label claims of vitamin E succinate and polyphenolic nutraceuticals are assessed. A validated HPLC method was utilized to assess vitamin E succinate products. Three novel LC/MS methods were used to assess the polyphenols, pterostilbene, phloretin, and myricetin, in dietary supplements. The amount of vitamin E succinate varied from 0-130% of the stated label content with two products containing vitamin E acetate rather than vitamin E succinate. Expected polyphenols were found in 7 of the 8 supplement products. None of the polyphenol supplements contained content within 100-120% of label claims. The present study indicates a lack of uniformity in nutraceutical products. PMID:27721342

36 CFR 228.15 - Operations within National Forest Wilderness.

Code of Federal Regulations, 2013 CFR

2013-07-01

...) The United States mining laws shall extend to each National Forest Wilderness for the period specified...) Holders of unpatented mining claims validly established on any National Forest Wilderness prior to... by the United States mining laws as then applicable to the National Forest land involved. Persons...

36 CFR 228.15 - Operations within National Forest Wilderness.

Code of Federal Regulations, 2012 CFR

2012-07-01

...) The United States mining laws shall extend to each National Forest Wilderness for the period specified...) Holders of unpatented mining claims validly established on any National Forest Wilderness prior to... by the United States mining laws as then applicable to the National Forest land involved. Persons...

36 CFR 228.15 - Operations within National Forest Wilderness.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) The United States mining laws shall extend to each National Forest Wilderness for the period specified...) Holders of unpatented mining claims validly established on any National Forest Wilderness prior to... by the United States mining laws as then applicable to the National Forest land involved. Persons...

[Visualisation methods for etheric formative forces].

PubMed

Burkhard, B; Kittel, R

2009-09-01

Rudolf Steiner, the founder of anthroposophy, suggested the development of visualisation methods for "etheric formative forces". The essential methods, their "spiritual scientific" basis and indications are described and their claims critically tested. The methods are not validated, the key criteria for diagnostic tests (reproducibility, sensitivity, specifity) are not given.

31 CFR 346.7 - Judicial proceedings.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 2 2010-07-01 2010-07-01 false Judicial proceedings. 346.7 Section... RETIREMENT BONDS § 346.7 Judicial proceedings. No judicial determination will be recognized which would give... claim against a registered owner will be recognized when established by valid judicial proceedings, but...

Artifact-based reflective interviews for identifying pragmatic epistemological resources

NASA Astrophysics Data System (ADS)

Shubert, Christopher Walden

Physics Education Research studies the science of teaching and learning physics. The process of student learning is complex, and the factors that affect it are numerous. Describing students' understanding of physics knowledge and reasoning is the basis for much productive research; however, such research fails to account for certain types of student learning difficulties. In this dissertation, I explore one source of student difficulty: personal epistemology, students' ideas about knowledge and knowing. Epistemology traditionally answers three questions: What is knowledge? How is knowledge created? And, how do we know what we know? An individual's responses to these questions can affect learning in terms of how they approach tasks involving the construction and application of knowledge. The key issue addressed in this dissertation is the effect of methodological choices on the validity and reliability of claims concerning personal epistemology. My central concern is contextual validity, how what is said about one's epistemology is not identical to how one behaves epistemologically. In response to these issues, I present here a new methodology for research on student epistemology: video artifact-based reflective interview protocols. These protocols begin with video taping students in their natural classroom activities, and then asking the participants epistemological questions immediately after watching selected scenes from their activity, contextually anchoring them in their actual learning experience. The data from these interviews is viewed in the framework of Epistemological Resource Theory, a framework of small bits of knowledge whose coordination in a given context is used to describe personal epistemology. I claim that the privileged data from these interviews allows detailed epistemological resources to be identified, and that these resources can provide greater insight into how student epistemologies are applied in learning activities. This research, situated within an algebra-based physics for life scientists course reform project, focuses on student work in Modeling Informed Instruction (MII) laboratory activities, which are an adaptation of Modeling Instruction. The development of these activities is based on the epistemological foundations of Modeling Instruction, and these foundations are used to describe a potential assessment for the epistemological effectiveness of a curriculum.

12 CFR 793.3 - Administrative claim; who may file.

Code of Federal Regulations, 2010 CFR

2010-01-01

... authorized agent, or his legal representative. (c) A claim based on death may be presented by the executor or... accompanied by evidence of his authority to present a claim on behalf of the claimant as agent, executor...

13 CFR 114.102 - When, where and how do I present a claim?

Code of Federal Regulations, 2010 CFR

2010-01-01

... Office nearest to the site of the action giving rise to the claim and within the same state as the site. If your claim is based on the acts or omissions of an employee of SBA's Disaster Assistance Program, you may present your claim either to the appropriate SBA District Office or to the Disaster Assistance...

76 FR 39898 - In the Matter of Certain Electronic Devices With Multi-Touch Enabled Touchpads and Touchscreens...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

... take no position on the ALJ's claim construction ruling that the ``scanning'' step of independent claim... to review and take no position on the ALJ's finding that the ``scanning'' step of independent claim 1... further determined to adopt the remainder of the ID to the extent it is not based on these claim...

Evaluating promotional claims as false or misleading.

PubMed

Brushwood, David B; Knox, Caitlin A; Liu, Wei; Jenkins, Kevin A

2013-11-01

In light of the "false or misleading" standard resulting from the recent legal ruling, it can be concluded that a true claim is one that is both factually and analytically true. Factual truth could be based on the accuracy of the information and the sufficiency of the information. Analytical truth could be based on the scientific foundation for the claim and whether the information within the claim is presented in a balanced way. Regarding the assessment of whether a truthful claim is misleading, the evaluator could consider the relevance, consistency, and context of the information. Standards are important in medication use and medication regulation. Health care professionals who must decide whether a claim is truthful and not misleading will rely on guidance from FDA in determining how to evaluate promotional claims. As the court suggested in the case reviewed here, FDA could take the lead and provide guidance "in differentiating between misleading and false promotion, exaggerations and embellishments, and truthful or non-misleading information." Existing FDA regulations provide a foundation for such guidance. The next step for the agency would be to expand existing guidance to specifically describe how an off-label claim can be identified as either false or misleading.

The effect of threshold amounts for reporting malpractice payments to the National Practitioner Data Bank: analysis using the closed claims data base of the Office of the Assistant Secretary of Defense (Health Affairs).

PubMed

Metter, E J; Granville, R L; Kussman, M J

1997-04-01

The study determines the extent to which payment thresholds for reporting malpractice claims to the National Practitioner Data Bank identifies substandard health care delivery in the Department of Defense. Relevant data were available on 2,291 of 2,576 medical malpractice claims reported to the closed medical malpractice case data base of the Office of the Assistant Secretary of Defense (Health Affairs). Amount paid was analyzed as a diagnostic test using standard of care assessment from each military Surgeon General office as the criterion. Using different paid threshold amounts per claim as a positive test, the sensitivity of identifying substandard care declined from 0.69 for all paid cases to 0.41 for claims over $40,000. Specificity increased from 0.75 for all paid claims to 0.89 for claims over $40,000. Positive and negative predictive values and likelihood ratio were similar at all thresholds. Malpractice case payment was of limited value for identifying substandard medical practice. All paid claims missed about 30% of substandard care, and reported about 25% of acceptable medical practice.

Assessment of Patient-Reported Outcome Instruments to Assess Chronic Low Back Pain.

PubMed

Ramasamy, Abhilasha; Martin, Mona L; Blum, Steven I; Liedgens, Hiltrud; Argoff, Charles; Freynhagen, Rainer; Wallace, Mark; McCarrier, Kelly P; Bushnell, Donald M; Hatley, Noël V; Patrick, Donald L

2017-06-01

 To identify patient-reported outcome (PRO) instruments that assess chronic low back pain (cLBP) symptoms (specifically pain qualities) and/or impacts for potential use in cLBP clinical trials to demonstrate treatment benefit and support labeling claims.  Literature review of existing PRO measures.  Publications detailing existing PRO measures for cLBP were identified, reviewed, and summarized. As recommended by the US Food & Drug Administration (FDA) PRO development guidance, standard measurement characteristics were reviewed, including development history, psychometric properties (validity and reliability), ability to detect change, and interpretation of observed changes.  Thirteen instruments were selected and reviewed: Low Back Pain Bothersomeness Scale, Neuropathic Pain Symptom Inventory, PainDETECT, Pain Quality Assessment Scale Revised, Revised Short Form McGill Pain Questionnaire, Low Back Pain Impact Questionnaire, Oswestry Disability Index, Pain Disability Index, Roland-Morris Disability Questionnaire, Brief Pain Inventory and Brief Pain Inventory Short Form, Musculoskeletal Outcomes Data Evaluation and Management System Spine Module, Orebro Musculoskeletal Pain Questionnaire, and the West Haven-Yale Multidimensional Pain Inventory Interference Scale. The instruments varied in the aspects of pain and/or impacts that they assessed, and none of the instruments fulfilled all criteria for use in clinical trials to support labeling claims based on recommendations outlined in the FDA PRO guidance.  There is an unmet need for a validated PRO instrument to evaluate cLBP-related symptoms and impacts for use in clinical trials. © 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Non-obvious correlations to disease management unraveled by Bayesian artificial intelligence analyses of CMS data.

PubMed

Vemulapalli, Vijetha; Qu, Jiaqi; Garren, Jeonifer M; Rodrigues, Leonardo O; Kiebish, Michael A; Sarangarajan, Rangaprasad; Narain, Niven R; Akmaev, Viatcheslav R

2016-11-01

Given the availability of extensive digitized healthcare data from medical records, claims and prescription information, it is now possible to use hypothesis-free, data-driven approaches to mine medical databases for novel insight. The goal of this analysis was to demonstrate the use of artificial intelligence based methods such as Bayesian networks to open up opportunities for creation of new knowledge in management of chronic conditions. Hospital level Medicare claims data containing discharge numbers for most common diagnoses were analyzed in a hypothesis-free manner using Bayesian networks learning methodology. While many interactions identified between discharge rates of diagnoses using this data set are supported by current medical knowledge, a novel interaction linking asthma and renal failure was discovered. This interaction is non-obvious and had not been looked at by the research and clinical communities in epidemiological or clinical data. A plausible pharmacological explanation of this link is proposed together with a verification of the risk significance by conventional statistical analysis. Potential clinical and molecular pathways defining the relationship between commonly used asthma medications and renal disease are discussed. The study underscores the need for further epidemiological research to validate this novel hypothesis. Validation will lead to advancement in clinical treatment of asthma & bronchitis, thereby, improving patient outcomes and leading to long term cost savings. In summary, this study demonstrates that application of advanced artificial intelligence methods in healthcare has the potential to enhance the quality of care by discovering non-obvious, clinically relevant relationships and enabling timely care intervention. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Deriving Safety Cases from Machine-Generated Proofs

NASA Technical Reports Server (NTRS)

Basir, Nurlida; Fischer, Bernd; Denney, Ewen

2009-01-01

Proofs provide detailed justification for the validity of claims and are widely used in formal software development methods. However, they are often complex and difficult to understand, because they use machine-oriented formalisms; they may also be based on assumptions that are not justified. This causes concerns about the trustworthiness of using formal proofs as arguments in safety-critical applications. Here, we present an approach to develop safety cases that correspond to formal proofs found by automated theorem provers and reveal the underlying argumentation structure and top-level assumptions. We concentrate on natural deduction proofs and show how to construct the safety cases by covering the proof tree with corresponding safety case fragments.

Insecurity of Detector-Device-Independent Quantum Key Distribution.

PubMed

Sajeed, Shihan; Huang, Anqi; Sun, Shihai; Xu, Feihu; Makarov, Vadim; Curty, Marcos

2016-12-16

Detector-device-independent quantum key distribution (DDI-QKD) held the promise of being robust to detector side channels, a major security loophole in quantum key distribution (QKD) implementations. In contrast to what has been claimed, however, we demonstrate that the security of DDI-QKD is not based on postselected entanglement, and we introduce various eavesdropping strategies that show that DDI-QKD is in fact insecure against detector side-channel attacks as well as against other attacks that exploit devices' imperfections of the receiver. Our attacks are valid even when the QKD apparatuses are built by the legitimate users of the system themselves, and thus, free of malicious modifications, which is a key assumption in DDI-QKD.

Bias in the exchange of arguments: the case of scientists' evaluation of lay viewpoints on GM food.

PubMed

Cuppen, Eefje; Hisschemøller, Matthijs; Midden, Cees

2009-09-01

Most perspectives on public participation share the notion that dialogues should be open, allowing participants to articulate and evaluate different views and knowledge claims. We hypothesize that participants' evaluation of claims may be biased because participants have a preference for a particular type or source of a claim. This would hamper an open dialogue. We tested the effect of three variables on scientists' evaluation of claims of the general public about GM food: the claim's favorability towards GM food, the phrasing, and the source of the claim. Results are based on a survey-experiment among 73 biotechnology-scientists. Biased processing occurred when scientists evaluated claims. Claims that were corresponding with the attitude of the scientists and that were phrased in a cognitive way were evaluated more positively than claims that were contrasting the attitude of the scientists and that were phrased in an affective way. Contrary to our expectation, scientists evaluated claims of the public more positively than claims of experts.

An Appetite for Modernizing the Regulatory Framework for Protein Content Claims in Canada

PubMed Central

Marinangeli, Christopher P. F.; Foisy, Samara; Shoveller, Anna K.; Porter, Cara; Musa-Veloso, Kathy; Sievenpiper, John L.; Jenkins, David J. A.

2017-01-01

The need for protein-rich plant-based foods continues as dietary guidelines emphasize their contribution to healthy dietary patterns that prevent chronic disease and promote environmental sustainability. However, the Canadian Food and Drug Regulations provide a regulatory framework that can prevent Canadian consumers from identifying protein-rich plant-based foods. In Canada, protein nutrient content claims are based on the protein efficiency ratio (PER) and protein rating method, which is based on a rat growth bioassay. PERs are not additive, and the protein rating of a food is underpinned by its Reasonable Daily Intake. The restrictive nature of Canada’s requirements for supporting protein claims therefore presents challenges for Canadian consumers to adapt to a rapidly changing food environment. This commentary will present two options for modernizing the regulatory framework for protein content claims in Canada. The first and preferred option advocates that protein quality not be considered in the determination of the eligibility of a food for protein content claims. The second and less preferred option, an interim solution, is a framework for adopting the protein digestibility corrected amino acid score as the official method for supporting protein content and quality claims and harmonizes Canada’s regulatory framework with that of the USA. PMID:28832556

The Naïve Overfitting Index Selection (NOIS): A new method to optimize model complexity for hyperspectral data

NASA Astrophysics Data System (ADS)

Rocha, Alby D.; Groen, Thomas A.; Skidmore, Andrew K.; Darvishzadeh, Roshanak; Willemen, Louise

2017-11-01

The growing number of narrow spectral bands in hyperspectral remote sensing improves the capacity to describe and predict biological processes in ecosystems. But it also poses a challenge to fit empirical models based on such high dimensional data, which often contain correlated and noisy predictors. As sample sizes, to train and validate empirical models, seem not to be increasing at the same rate, overfitting has become a serious concern. Overly complex models lead to overfitting by capturing more than the underlying relationship, and also through fitting random noise in the data. Many regression techniques claim to overcome these problems by using different strategies to constrain complexity, such as limiting the number of terms in the model, by creating latent variables or by shrinking parameter coefficients. This paper is proposing a new method, named Naïve Overfitting Index Selection (NOIS), which makes use of artificially generated spectra, to quantify the relative model overfitting and to select an optimal model complexity supported by the data. The robustness of this new method is assessed by comparing it to a traditional model selection based on cross-validation. The optimal model complexity is determined for seven different regression techniques, such as partial least squares regression, support vector machine, artificial neural network and tree-based regressions using five hyperspectral datasets. The NOIS method selects less complex models, which present accuracies similar to the cross-validation method. The NOIS method reduces the chance of overfitting, thereby avoiding models that present accurate predictions that are only valid for the data used, and too complex to make inferences about the underlying process.

Health literacy and 30-day hospital readmission after acute myocardial infarction

PubMed Central

Bailey, Stacy Cooper; Fang, Gang; Annis, Izabela E; O'Conor, Rachel; Paasche-Orlow, Michael K; Wolf, Michael S

2015-01-01

Objective To assess the validity of a predictive model of health literacy, and to examine the relationship between derived health literacy estimates and 30-day hospital readmissions for acute myocardial infarction (AMI). Design Retrospective cohort study. Setting and participants A National Institute of Aging (NIA) study cohort of 696 adult, English-speaking primary care patients, aged 55–74 years, was used to assess the validity of derived health literacy estimates. Claims from 7733 Medicare beneficiaries hospitalised for AMI in 2008 in North Carolina and Illinois were used to investigate the association between health literacy estimates and 30-day hospital readmissions. Measures The NIA cohort was administered 3 common health literacy assessments (Newest Vital Sign, Test of Functional Health Literacy in Adults, and Rapid Estimate of Adult Literacy in Medicine). Health literacy estimates at the census block group level were derived via a predictive model. 30-day readmissions were measured from Medicare claims data using a validated algorithm. Results Fair agreement was found between derived estimates and in-person literacy assessments (Pearson Correlation coefficients: 0.38–0.51; κ scores: 0.38–0.40). Medicare enrollees with above basic literacy according to derived health literacy estimates had an 18% lower risk of a 30-day readmission (RR=0.82, 95% CI 0.73 to 0.92) and 21% lower incidence rate of 30-day readmission (IRR=0.79, 95% CI 0.68 to 0.87) than patients with basic or below basic literacy. After adjusting for demographic and clinical characteristics, the risk of 30-day readmission was 12% lower (p=0.03), and the incidence rate 16% lower (p<0.01) for patients with above basic literacy. Conclusions Health literacy, as measured by a predictive model, was found to be a significant, independent predictor of 30-day readmissions. As a modifiable risk factor with evidence-based solutions, health literacy should be considered in readmission reduction efforts. PMID:26068508

Mandatory vaccination: understanding the common good in the midst of the global polio eradication campaign.

PubMed

Gostin, Lawrence O

2018-01-03

The detection of wild poliovirus in Israeli sewage in May 2013 led the health authorities to vaccinate children with OPV (Oral Polio Vaccine). Shelly Kamin-Friedman explored the legal and ethical dimensions of this policy. This commentary makes three claims: (1) Mandatory vaccination is a valid exercise of the state's police powers to protect the common good. (2) A disease eradication campaign is a sufficient ground for the exercise of those powers. (3) The state is obliged to use the least restrictive/invasive measure to achieve community-wide vaccine coverage, but need not use less effective measures; further, determining which measure is most effective is a fact-specific determination. This commentary offers grounds to support state powers to protect the public's health and safety. It shows why governments have both the duty and power to safeguard the collective good. State powers also have limits, whose boundaries are determined by the public health necessity. If the state is reasonably using the least restrictive intervention to achieve an important public health objective, it is well within the limits of its authority. The commentary uses legal and ethical norms and evidence to support its conclusions. Governments have a duty and power to achieve population-based vaccine coverage sufficient to stem the spread of infectious diseases, including in isolated geographical areas with high numbers of individuals claiming religious and/or conscientious exemptions to vaccine requirements. Governments are obliged to reasonably seek the least restrictive/invasive measure to achieve valid public health objectives; and governments are not obliged to use less effective measures simply because they are voluntary or less invasive. Finding the most effective, least invasive intervention is fact-specific. The essence of public health law is to recognize the state's power and duty to safeguard the public's health and safety, and to establish and enforce limits on those powers when the government overreaches-that is, adopts a measure more invasive/restrictive than needed to achieve a valid public health objective.

Measurement of skeletal related events in SEER-Medicare: a comparison of claims-based methods.

PubMed

Aly, Abdalla; Onukwugha, Eberechukwu; Woods, Corinne; Mullins, C Daniel; Kwok, Young; Qian, Yi; Arellano, Jorge; Balakumaran, Arun; Hussain, Arif

2015-08-19

Skeletal related events (SREs) are common in men with metastatic prostate cancer (mPC). Various methods have been used to identify SREs from claims data. The objective of this study was to provide a framework for measuring SREs from claims and compare SRE prevalence and cumulative incidence estimates based on alternative approaches in men with mPC. Several claims-based approaches for identifying SREs were developed and applied to data for men aged [greater than or equal to] 66 years newly diagnosed with mPC between 2000 and 2009 in the SEER-Medicare datasets and followed through 2010 or until censoring. Post-diagnosis SREs were identified using claims that indicated spinal cord compression (SCC), pathologic fracture (PF), surgery to bone (BS), or radiation (suggestive of bone palliative radiation, RAD). To measure SRE prevalence, two SRE definitions were created: 'base case' (most commonly used in the literature) and 'alternative' in which different claims were used to identify each type of SRE. To measure cumulative incidence, we used the 'base case' definition and applied three periods in which claims were clustered to episodes: 14-, 21-, and 28-day windows. Among 8997 mPC patients, 46 % experienced an SRE according to the 'base case' definition and 43 % patients experienced an SRE according to the 'alternative' definition. Varying the code definition from 'base case' to 'alternative' resulted in an 8 % increase in the overall SRE prevalence. Using the 21-day window, a total of 12,930 SRE episodes were observed during follow up. Varying the window length from 21 to 28 days resulted in an 8 % decrease in SRE cumulative incidence (RAD: 10 %, PF: 8 %, SCC: 6 %, BS: 0.2 %). SRE prevalence was affected by the codes used, with PF being most impacted. The overall SRE cumulative incidence was affected by the window length used, with RAD being most affected. These results underscore the importance of the baseline definitions used to study claims data when attempting to understand relevant clinical events such as SREs in the real world setting.

Characteristics of 32 supercentenarians.

PubMed

Schoenhofen, Emily A; Wyszynski, Diego F; Andersen, Stacy; Pennington, Jaemi; Young, Robert; Terry, Dellara F; Perls, Thomas T

2006-08-01

To report phenotypic characteristics of 32 age-validated supercentenarians. Case series. U.S.-based recruitment effort. Thirty-two supercentenarians. Multiple forms of proof were used to validate age claims. Sociodemographic, activities of daily living, and medical history data were collected. Age range was 110 to 119. Fifty-nine percent had Barthel Index scores in the partially to totally dependent range, whereas 41% required minimal assistance or were independent. Few subjects had a history of clinically evident vascular-related diseases, including myocardial infarction (n=2, 6%) and stroke (n=4, 13%). Twenty-two percent (n=7) were taking medications for hypertension. Twenty-five percent (n=8) had a history of cancer (all cured). Diabetes mellitus (n=1, 3%) and Parkinson's disease (n=1, 3%) were rare. Osteoporosis (n=14, 44%) and cataract history (n=28, 88%) were common. Data collected thus far suggest that supercentenarians markedly delay and even escape clinical expression of vascular disease toward the end of their exceptionally long lives. A surprisingly substantial proportion of these individuals were still functionally independent or required minimal assistance.

20 CFR 416.2221 - Validation reviews.

Code of Federal Regulations, 2011 CFR

2011-04-01

... each State VR agency or alternate participant. We will conduct some of these reviews on a prepayment... the claims filed by any State VR agency or alternate participant, if we determine that such review is..., the State VR agency or alternate participant must submit such records of the VR services and costs for...

20 CFR 416.2221 - Validation reviews.

Code of Federal Regulations, 2010 CFR

2010-04-01

... each State VR agency or alternate participant. We will conduct some of these reviews on a prepayment... the claims filed by any State VR agency or alternate participant, if we determine that such review is..., the State VR agency or alternate participant must submit such records of the VR services and costs for...

A case of Munchausen syndrome with claims of trauma and haemophilia.

PubMed Central

Park, G; Huang, A; Wright, S

1996-01-01

A case of Munchausen syndrome presented with both factitious trauma and factitious haemophilia. He was treated inappropriately with factor VIII concentrate before the history of the presenting complaint could be validated. Clinical suspicion remains the most important aid to diagnosis. Images Figure 1 PMID:8832359

Matrix Wings: Continuous Process Improvement an Operator Can Love

DTIC Science & Technology

2016-09-01

could employ the principles in AFSO21 but preferably by em- ploying a version that does not take time away from mission preparation/execution and that...results, the DOD’s director of quality management sent a certified public accountant to Yokota to verify the claims. The CPA validated that

Conceptual Distinctions amongst Generics

ERIC Educational Resources Information Center

Prasada, Sandeep; Khemlani, Sangeet; Leslie, Sarah-Jane; Glucksberg, Sam

2013-01-01

Generic sentences (e.g., bare plural sentences such as "dogs have four legs" and "mosquitoes carry malaria") are used to talk about "kinds" of things. Three experiments investigated the conceptual foundations of generics as well as claims within the formal semantic approaches to generics concerning the roles of prevalence, cue validity and…

Applied Research in a Curriculum Project: Accomplishments and Limitations.

ERIC Educational Resources Information Center

Welch, Wayne W.

The validity of statements by various "national curriculum projects" concerning the availability of research evidence to support their claims for the attainment of their objectives is questioned. Evaluation procedures employed by these various curriculum development groups are criticized for lack of empirical data. Obtaining such data is…

Somewhere between What Is and What If: Fictionalisation and Ethnographic Inquiry

ERIC Educational Resources Information Center

Reed, Malcolm

2011-01-01

Fictionalisation seems to render ethnographic inquiry suspect as research appropriate to the social sciences because it subverts a claim of realism or objectivity. This leads some ethnographers to propose alternative criteria for validation, such as participation and evocation, which offer alignment with realism; others suggest that scientific…

20 CFR 416.2221 - Validation reviews.

Code of Federal Regulations, 2012 CFR

2012-04-01

... each State VR agency or alternate participant. We will conduct some of these reviews on a prepayment... the claims filed by any State VR agency or alternate participant, if we determine that such review is..., the State VR agency or alternate participant must submit such records of the VR services and costs for...

20 CFR 416.2221 - Validation reviews.

Code of Federal Regulations, 2014 CFR

2014-04-01

... each State VR agency or alternate participant. We will conduct some of these reviews on a prepayment... the claims filed by any State VR agency or alternate participant, if we determine that such review is..., the State VR agency or alternate participant must submit such records of the VR services and costs for...

20 CFR 416.2221 - Validation reviews.

Code of Federal Regulations, 2013 CFR

2013-04-01

... each State VR agency or alternate participant. We will conduct some of these reviews on a prepayment... the claims filed by any State VR agency or alternate participant, if we determine that such review is..., the State VR agency or alternate participant must submit such records of the VR services and costs for...

Clinical Utility and "DSM-V"

ERIC Educational Resources Information Center

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

2009-01-01

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

15 CFR 2015.3 - Export certificates.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Export certificates. 2015.3 Section... Export certificates. (a) To claim the in-quota rate of duty on sugar-containing products of a..., in the form and manner determined by the United States Customs Service, that a valid export...

Parent-Child Cultural Marginalization and Depressive Symptoms in Asian American Family Members

ERIC Educational Resources Information Center

Kim, Su Yeong; Gonzales, Nancy A.; Stroh, Kunise; Wang, Jenny Jiun-Ling

2006-01-01

The current study findings refute the recent claim that marginality theory lacks construct validity. Cultural marginalization is significantly related to depressive symptoms in Korean American, Chinese American, and Japanese American parents and adolescents living in the United States. Correlational analyses indicate that adolescents' depressive…

A Habermasian Approach to Critical Reading

ERIC Educational Resources Information Center

Lee, Cheu-jey

2016-01-01

This article explores the connection between critical reading and Jurgen Habermas's theory of communicative action. It proposes that Habermas's criteria used for evaluating validity claims in communicative action can be applied in reading texts critically. Analyses of different types of texts are presented to show how critical reading is done in a…

37 CFR 253.9 - Unknown copyright owners.

Code of Federal Regulations, 2010 CFR

2010-07-01

.... No claim to such royalty fees shall be valid after the expiration of the three year period. Public... ARBITRATION ROYALTY PANEL RULES AND PROCEDURES USE OF CERTAIN COPYRIGHTED WORKS IN CONNECTION WITH... copyright owner who is entitled to receive a royalty payment under this part, they shall retain the required...

Infantile Accountability: When Big Data Meet Small Children

ERIC Educational Resources Information Center

Wrigley, Terry; Wormwell, Louise

2016-01-01

This article examines a government attempt to impose testing of 4-year-olds as a baseline against which to "hold primary schools accountable" for children's subsequent progress. It examines the various forms of baseline testing in this experiment and analyses the misleading claims made for the "predictive validity" of baseline…

From Cognitive-Domain Theory to Assessment Practice

ERIC Educational Resources Information Center

Bennett, Randy E.; Deane, Paul; van Rijn, Peter W.

2016-01-01

This article exemplifies how assessment design might be grounded in theory, thereby helping to strengthen validity claims. Spanning work across multiple related projects, the article first briefly summarizes an assessment system model for the elementary and secondary levels. Next the article describes how cognitive-domain theory and principles are…

Patent Opposition Considerations for the Technology Transfer Professional

ERIC Educational Resources Information Center

Wilson, Mark B.; Alge, Daniel

2007-01-01

Many jurisdictions, including the European Patent Office (EPO), have opposition proceedings in which an interested third party can challenge the validity of the claims of an issued patent. The United States Congress is considering legislation that would introduce opposition proceedings in the USA. This paper reviews the existing EPO and proposed…

Lexical Diversity in Writing and Speaking Task Performances

ERIC Educational Resources Information Center

Yu, Guoxing

2010-01-01

In the rating scales of major international language tests, as well as in automated evaluation systems (e.g. e-rater), a positive relationship is often claimed between lexical diversity, holistic quality of written or spoken discourses, and language proficiency of candidates. This article reports a "posteriori" validation study that analysed a…

Veterinary Homeopathy: The Implications of Its History for Unorthodox Veterinary Concepts and Veterinary Medical Education.

ERIC Educational Resources Information Center

Coulter, Dwight B.

1979-01-01

The history of veterinary homeopathy, its future and implications are discussed. The need for investigation into the validity of both allopathic and homeopathic claims is stressed and it is suggested that maintenance of quality is the key factor in any approach. (BH)

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

Radiation and matter: Electrodynamics postulates and Lorenz gauge

NASA Astrophysics Data System (ADS)

Bobrov, V. B.; Trigger, S. A.; van Heijst, G. J.; Schram, P. P.

2016-11-01

In general terms, we have considered matter as the system of charged particles and quantized electromagnetic field. For consistent description of the thermodynamic properties of matter, especially in an extreme state, the problem of quantization of the longitudinal and scalar potentials should be solved. In this connection, we pay attention that the traditional postulates of electrodynamics, which claim that only electric and magnetic fields are observable, is resolved by denial of the statement about validity of the Maxwell equations for microscopic fields. The Maxwell equations, as the generalization of experimental data, are valid only for averaged values. We show that microscopic electrodynamics may be based on postulation of the d'Alembert equations for four-vector of the electromagnetic field potential. The Lorenz gauge is valid for the averages potentials (and provides the implementation of the Maxwell equations for averages). The suggested concept overcomes difficulties under the electromagnetic field quantization procedure being in accordance with the results of quantum electrodynamics. As a result, longitudinal and scalar photons become real rather than virtual and may be observed in principle. The longitudinal and scalar photons provide not only the Coulomb interaction of charged particles, but also allow the electrical Aharonov-Bohm effect.

Lessons to be learned from a contentious challenge to mainstream radiobiological science (the linear no-threshold theory of genetic mutations)

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

Beyea, Jan, E-mail: jbeyea@cipi.com

There are both statistically valid and invalid reasons why scientists with differing default hypotheses can disagree in high-profile situations. Examples can be found in recent correspondence in this journal, which may offer lessons for resolving challenges to mainstream science, particularly when adherents of a minority view attempt to elevate the status of outlier studies and/or claim that self-interest explains the acceptance of the dominant theory. Edward J. Calabrese and I have been debating the historical origins of the linear no-threshold theory (LNT) of carcinogenesis and its use in the regulation of ionizing radiation. Professor Calabrese, a supporter of hormesis, hasmore » charged a committee of scientists with misconduct in their preparation of a 1956 report on the genetic effects of atomic radiation. Specifically he argues that the report mischaracterized the LNT research record and suppressed calculations of some committee members. After reviewing the available scientific literature, I found that the contemporaneous evidence overwhelmingly favored a (genetics) LNT and that no calculations were suppressed. Calabrese's claims about the scientific record do not hold up primarily because of lack of attention to statistical analysis. Ironically, outlier studies were more likely to favor supra-linearity, not sub-linearity. Finally, the claim of investigator bias, which underlies Calabrese's accusations about key studies, is based on misreading of text. Attention to ethics charges, early on, may help seed a counter narrative explaining the community's adoption of a default hypothesis and may help focus attention on valid evidence and any real weaknesses in the dominant paradigm. - Highlights: • Edward J Calabrese has made a contentious challenge to mainstream radiobiological science. • Such challenges should not be neglected, lest they enter the political arena without review. • Key genetic studies from the 1940s, challenged by Calabrese, were found consistent and unbiased. • A 1956 genetics report did not hide estimates and does not need investigation for misconduct. • The scientific record was strong for a no-threshold, linear genetic response to radiation.« less

Electronic medical record-based multicondition models to predict the risk of 30 day readmission or death among adult medicine patients: validation and comparison to existing models.

PubMed

Amarasingham, Ruben; Velasco, Ferdinand; Xie, Bin; Clark, Christopher; Ma, Ying; Zhang, Song; Bhat, Deepa; Lucena, Brian; Huesch, Marco; Halm, Ethan A

2015-05-20

There is increasing interest in using prediction models to identify patients at risk of readmission or death after hospital discharge, but existing models have significant limitations. Electronic medical record (EMR) based models that can be used to predict risk on multiple disease conditions among a wide range of patient demographics early in the hospitalization are needed. The objective of this study was to evaluate the degree to which EMR-based risk models for 30-day readmission or mortality accurately identify high risk patients and to compare these models with published claims-based models. Data were analyzed from all consecutive adult patients admitted to internal medicine services at 7 large hospitals belonging to 3 health systems in Dallas/Fort Worth between November 2009 and October 2010 and split randomly into derivation and validation cohorts. Performance of the model was evaluated against the Canadian LACE mortality or readmission model and the Centers for Medicare and Medicaid Services (CMS) Hospital Wide Readmission model. Among the 39,604 adults hospitalized for a broad range of medical reasons, 2.8% of patients died, 12.7% were readmitted, and 14.7% were readmitted or died within 30 days after discharge. The electronic multicondition models for the composite outcome of 30-day mortality or readmission had good discrimination using data available within 24 h of admission (C statistic 0.69; 95% CI, 0.68-0.70), or at discharge (0.71; 95% CI, 0.70-0.72), and were significantly better than the LACE model (0.65; 95% CI, 0.64-0.66; P =0.02) with significant NRI (0.16) and IDI (0.039, 95% CI, 0.035-0.044). The electronic multicondition model for 30-day readmission alone had good discrimination using data available within 24 h of admission (C statistic 0.66; 95% CI, 0.65-0.67) or at discharge (0.68; 95% CI, 0.67-0.69), and performed significantly better than the CMS model (0.61; 95% CI, 0.59-0.62; P < 0.01) with significant NRI (0.20) and IDI (0.037, 95% CI, 0.033-0.041). A new electronic multicondition model based on information derived from the EMR predicted mortality and readmission at 30 days, and was superior to previously published claims-based models.

Evaluation of the Present-on-Admission Indicator among Hospitalized Fee-for-Service Medicare Patients with a Pressure Ulcer Diagnosis: Coding Patterns and Impact on Hospital-Acquired Pressure Ulcer Rates.

PubMed

Squitieri, Lee; Waxman, Daniel A; Mangione, Carol M; Saliba, Debra; Ko, Clifford Y; Needleman, Jack; Ganz, David A

2018-01-25

To evaluate national present-on-admission (POA) reporting for hospital-acquired pressure ulcers (HAPUs) and examine the impact of quality measure exclusion criteria on HAPU rates. Medicare inpatient, outpatient, and nursing facility data as well as independent provider claims (2010-2011). Retrospective cross-sectional study. We evaluated acute inpatient hospital admissions among Medicare fee-for-service (FFS) beneficiaries in 2011. Admissions were categorized as follows: (1) no pressure ulcer diagnosis, (2) new pressure ulcer diagnosis, and (3) previously documented pressure ulcer diagnosis. HAPU rates were calculated by varying patient exclusion criteria. Among admissions with a pressure ulcer diagnosis, we observed a large discrepancy in the proportion of admissions with a HAPU based on hospital-reported POA data (5.2 percent) and the proportion with a new pressure ulcer diagnosis based on patient history in billing claims (49.7 percent). Applying quality measure exclusion criteria resulted in removal of 91.2 percent of admissions with a pressure injury diagnosis from HAPU rate calculations. As payers and health care organizations expand the use of quality measures, it is important to consider how the measures are implemented, coding revisions to improve measure validity, and the impact of patient exclusion criteria on provider performance evaluation. © Health Research and Educational Trust.

Brain-(Not) Based Education: Dangers of Misunderstanding and Misapplication of Neuroscience Research

ERIC Educational Resources Information Center

Alferink, Larry A.; Farmer-Dougan, Valeri

2010-01-01

Oversimplification or inappropriate interpretation of complex neuroscience research is widespread among curricula claiming that brain-based approaches are effective for improved learning and retention. We examine recent curricula claiming to be based on neuroscience research, discuss the implications of such misinterpretation for special…

Analysis on traditional fishing grounds in Indonesia`s Natuna waters under International Law

NASA Astrophysics Data System (ADS)

Kurniaty, R.; Ikaningtyas; Ruslijanto, P. A.

2018-04-01

This paper examines the boundary tension between Indonesia and China regarding traditional fishing ground in Natuna. Indonesia`s Natuna island is claimed by the China government as its traditional fishing zone/ground. The inclusion of Natuna territory into China`s traditional fishing zone brings new problems to Indonesia, especially with the Chinese ships docked and entered Indonesia`s exclusive economic zone, as well as several cases of illegal fishing over the territorial waters of Indonesia. Claims on traditional fishing zones have the potential to threaten the sovereignty of the Indonesian territory. This study aims to analyze the claims of the traditional fishing rights of China over the waters of the Natuna Islands under international law, especially UNCLOS 1982. This study revealed that the china`s argument of traditional fishing ground in Natuna to the nine dash line map is a unilateral claim, there is no international legal norm that can be used as the legal basis. Indonesia and some ASEAN countries have Internationally validated bilateral agreement on the continental shelf (i.e. Indonesia-Vietnam and Indonesia-Malaysia) thus the inclusion of Natuna into China`s nine dash line map rejects the legal status of Indonesian water under UNCLOS 1982.

A Review on Plants Used for Improvement of Sexual Performance and Virility

PubMed Central

Chauhan, Nagendra Singh; Sharma, Vikas; Dixit, V. K.; Thakur, Mayank

2014-01-01

The use of plant or plant-based products to stimulate sexual desire and to enhance performance and enjoyment is almost as old as the human race itself. The present paper reviews the active, natural principles, and crude extracts of plants, which have been useful in sexual disorders, have potential for improving sexual behaviour and performance, and are helpful in spermatogenesis and reproduction. Review of refereed journals and scientific literature available in electronic databases and traditional literature available in India was extensively performed. The work reviews correlation of the evidence with traditional claims, elucidation, and evaluation of a plausible concept governing the usage of plants as aphrodisiac in total. Phytoconstituents with known structures have been classified in appropriate chemical groups and the active crude extracts have been tabulated. Data on their pharmacological activity, mechanism of action, and toxicity are reported. The present review provides an overview of the herbs and their active molecule with claims for improvement of sexual behaviour. A number of herbal drugs have been validated for their effect on sexual behavior and fertility and can therefore serve as basis for the identification of new chemical leads useful in sexual and erectile dysfunction. PMID:25215296

“Living proof” and the pseudo-science of alternative cancer treatments

PubMed Central

Vickers, Andrew J.; Cassileth, Barrie R.

2008-01-01

Michael Gearin-Tosh was an English Professor at Oxford University who was diagnosed with multiple myeloma in 1994. He rejected conventional chemotherapeutic approaches and turned to a variety of alternative cancer treatments, particularly those involving nutritional supplements and dietary change. In 2002, Dr Gearin-Tosh published a book, “Living Proof”, recounting his experiences. The book gained significant public and media attention. One chapter was written by Carmen Wheatley, an advocate of alternative cancer treatments. In distinction to Dr Gearin-Tosh’s personal story, Dr Wheatley makes general claims about cancer treatment that are supposedly based on the research literature. This appears to provide scientific validation for a highly unconventional program of cancer care. However, the scientific case made for alternative cancer treatments in “Living Proof” does not bear serious examination. There are numerous inaccuracies, omissions and misrepresentations. Many important claims are either entirely unsubstantiated or not supported by the literature cited. In conclusion, a highly publicized book gives the impression that alternative cancer treatments are supported by scientific research. It also suggests that little progress has been made in the conventional treatment of myeloma. This is highly misleading and may lead to cancer patients rejecting effective treatments. PMID:18302909

Living proof and the pseudoscience of alternative cancer treatments.

PubMed

Vickers, Andrew J; Cassileth, Barrie R

2008-01-01

Michael Gearin-Tosh was an English professor at Oxford University who was diagnosed with multiple myeloma in 1994. He rejected conventional chemotherapeutic approaches and turned to a variety of alternative cancer treatments, particularly those involving nutritional supplements and dietary change. In 2002, Dr. Gearin-Tosh published a book, Living Proof: A Medical Mutiny, recounting his experiences. The book gained significant public and media attention. One chapter was written by Carmen Wheatley, an advocate of alternative cancer treatments. In distinction to Dr. Gearin-Tosh's personal story, Dr. Wheatley makes general claims about cancer treatment that are supposedly based on the research literature. This appears to provide scientific validation for a highly unconventional program of cancer care. However, the scientific case made for alternative cancer treatments in Living Proof does not bear serious examination. There are numerous inaccuracies, omissions, and misrepresentations. Many important claims are either entirely unsubstantiated or not supported by the literature cited. In conclusion, a highly publicized book gives the impression that alternative cancer treatments are supported by scientific research. It also suggests that little progress has been made in the conventional treatment of myeloma. This is highly misleading and may lead to cancer patients rejecting effective treatments.

Chromium picolinate intake and risk of type 2 diabetes: an evidence-based review by the United States Food and Drug Administration.

PubMed

Trumbo, Paula R; Ellwood, Kathleen C

2006-08-01

The labeling of both health claims that meet significant scientific agreement (SSA) and qualified health claims on conventional foods and dietary supplements requires pre-market approval by the US Food and Drug Administration (FDA). Approval by the FDA involves, in part, a thorough review of the scientific evidence to support an SSA or a qualified health claim. This article discusses FDA's evidence-based review of the scientific evidence on the role of chromium picolinate supplements in reducing the risk of type 2 diabetes. Based on this evidence-based review, FDA issued a letter of enforcement discretion for one qualified health claim on chromium picolinate and risk of insulin resistance, a surrogate endpoint for type 2 diabetes. The agency concluded that the relationship between chromium picolinate intake and insulin resistance is highly uncertain.

Consumer attitudes and understanding of cholesterol-lowering claims on food: randomize mock-package experiments with plant sterol and oat fibre claims.

PubMed

Wong, C L; Mendoza, J; Henson, S J; Qi, Y; Lou, W; L'Abbé, M R

2014-08-01

Few studies have examined consumer acceptability or comprehension of cholesterol-lowering claims on food labels. Our objective was to assess consumer attitudes and understanding of cholesterol-lowering claims regarding plant sterols (PS) and oat fibre (OF). We conducted two studies on: (1) PS claims and (2) OF claims. Both studies involved a randomized mock-packaged experiment within an online survey administered to Canadian consumers. In the PS study (n=721), we tested three PS-related claims (disease risk reduction claim, function claim and nutrient content claim) and a 'tastes great' claim (control) on identical margarine containers. Similarly, in the OF study (n=710), we tested three claims related to OF and a 'taste great' claim on identical cereal boxes. In both studies, participants answered the same set of questions on attitudes and understanding of claims after seeing each mock package. All claims that mentioned either PS or OF resulted in more positive attitudes than the taste control claim (P<0.0001), despite all products within each study having the same nutrition profile. How consumers responded to the nutrition claims between the two studies was influenced by contextual factors such as familiarity with the functional food/component and the food product that carried the claim. Permitted nutrition claims are approved based on physiological evidence and are allowed on any food product as long as it meets the associated nutrient criteria. However, it is difficult to generalize attitudes and understanding of claims when they are so highly dependent on contextual factors.

Gluten and gluten-free: issues and considerations of labeling regulations, detection methods, and assay validation.

PubMed

Diaz-Amigo, Carmen; Popping, Bert

2012-01-01

Gluten is a commonly used cereal derivative found in bakery products, among other items. In some susceptible individuals, however, it triggers immune responses of different kinds; there is, to a lesser extent, the wheat allergy that is immunoglobulin E (IgE)-mediated and leads to histamine release and typical allergic symptoms. In this case, other water-soluble proteins, like albumins, are also involved. On the other hand, there is, more frequently, celiac disease (CD), where the gluten causes immune reactions in the intestines of certain individuals, leading to degeneration of villi, which typically leads to malabsorption of nutrients and, consequently, malnutrition. The only currently effective health strategy for affected consumers is avoidance of gluten-containing products, based on clear labeling rules. However, despite unanimously accepted Codex definitions by all member jurisdictions, the national implementation of equivalent laws shows significant differences. In the context of CD and in support of the gluten-free statement, regulatory enforcement, as well as manufacturers' quality controls are mostly based on analytical results. However, numerous methods are available, some of which have been validated better than others, and many provide different results on identical samples. Reasons include detection of different gluten components and variability in extraction efficiency due to different buffer compositions, especially from processed foods. Last but not least, the lack of reference materials is hindering the process of generating comparable data across different ELISA kits, as well as other methods. How can such data still be used to support a gluten-free claim? New methodologies, in particular mass spectrometric analysis of gluten derived peptides, are being introduced in numerous laboratories. This methodology is not only capable of detecting gluten derived peptides but can also differentiate between and quantitate wheat, barley, rye, and oat. This paper presents analytical limitations, as well as promising new approaches in support of industry and enforcement activities to ensure compliance with the gluten-free claim under the current regulatory framework.

31 CFR 902.2 - Bases for compromise.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false Bases for compromise. 902.2 Section 902.2 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) FEDERAL CLAIMS... CLAIMS § 902.2 Bases for compromise. (a) Agencies may compromise a debt if the Government cannot collect...

31 CFR 902.2 - Bases for compromise.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false Bases for compromise. 902.2 Section 902.2 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) FEDERAL CLAIMS... CLAIMS § 902.2 Bases for compromise. (a) Agencies may compromise a debt if the Government cannot collect...

31 CFR 902.2 - Bases for compromise.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false Bases for compromise. 902.2 Section 902.2 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) FEDERAL CLAIMS... CLAIMS § 902.2 Bases for compromise. (a) Agencies may compromise a debt if the Government cannot collect...

School Based Management. OSSC Bulletin Vol. 23, No. 10.

ERIC Educational Resources Information Center

Pierce, Lawrence C.

School-based management is an educational reform intended to reverse the trend toward increasing centralization of school administration. Though it has been claimed that centralization increases financial and educational equity, aids efficiency, and eases administration, examination of these claims reveals them to be based too often on incomplete,…

31 CFR 902.2 - Bases for compromise.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Bases for compromise. 902.2 Section 902.2 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) FEDERAL CLAIMS... CLAIMS § 902.2 Bases for compromise. (a) Agencies may compromise a debt if the Government cannot collect...

Supplemental calcium and risk reduction of hypertension, pregnancy-induced hypertension, and preeclampsia: an evidence-based review by the US Food and Drug Administration.

PubMed

Trumbo, Paula R; Ellwood, Kathleen C

2007-02-01

The labeling of health claims that meet the significant scientific agreement (SSA) standard (authorized health claims) and qualified health claims on conventional foods and dietary supplements requires premarket approval by the US Food and Drug Administration (FDA). FDA conducts an evidence-based review to determine whether there is sufficient evidence to support an authorized or qualified health claim. An evidence-based review was conducted on the human intervention and observational studies evaluating the role of supplemental calcium in reducing the risk of hypertension, pregnancy-induced hypertension, and preeclampsia. This review provides FDA's evaluation of the current scientific evidence on the role of supplemental calcium in reducing the risk of these three end points. Based on this evidence-based review, the agency concluded that the relationship between calcium and risk of hypertension is inconsistent and inconclusive, and the relationship between calcium and risk of pregnancy-induced hypertension and preeclampsia is highly unlikely.

Specificity and Sensitivity of Claims-Based Algorithms for Identifying Members of Medicare+Choice Health Plans That Have Chronic Medical Conditions

PubMed Central

Rector, Thomas S; Wickstrom, Steven L; Shah, Mona; Thomas Greeenlee, N; Rheault, Paula; Rogowski, Jeannette; Freedman, Vicki; Adams, John; Escarce, José J

2004-01-01

Objective To examine the effects of varying diagnostic and pharmaceutical criteria on the performance of claims-based algorithms for identifying beneficiaries with hypertension, heart failure, chronic lung disease, arthritis, glaucoma, and diabetes. Study Setting Secondary 1999–2000 data from two Medicare+Choice health plans. Study Design Retrospective analysis of algorithm specificity and sensitivity. Data Collection Physician, facility, and pharmacy claims data were extracted from electronic records for a sample of 3,633 continuously enrolled beneficiaries who responded to an independent survey that included questions about chronic diseases. Principal Findings Compared to an algorithm that required a single medical claim in a one-year period that listed the diagnosis, either requiring that the diagnosis be listed on two separate claims or that the diagnosis to be listed on one claim for a face-to-face encounter with a health care provider significantly increased specificity for the conditions studied by 0.03 to 0.11. Specificity of algorithms was significantly improved by 0.03 to 0.17 when both a medical claim with a diagnosis and a pharmacy claim for a medication commonly used to treat the condition were required. Sensitivity improved significantly by 0.01 to 0.20 when the algorithm relied on a medical claim with a diagnosis or a pharmacy claim, and by 0.05 to 0.17 when two years rather than one year of claims data were analyzed. Algorithms that had specificity more than 0.95 were found for all six conditions. Sensitivity above 0.90 was not achieved all conditions. Conclusions Varying claims criteria improved the performance of case-finding algorithms for six chronic conditions. Highly specific, and sometimes sensitive, algorithms for identifying members of health plans with several chronic conditions can be developed using claims data. PMID:15533190

Using a Non-Equivalent Groups Quasi Experimental Design to Reduce Internal Validity Threats to Claims Made by Math and Science K-12 Teacher Recruitment Programs

NASA Astrophysics Data System (ADS)

Moin, Laura

2009-10-01

The American Recovery and Reinvestment Act national policy established in 2009 calls for ``meaningful data'' that demonstrate educational improvements, including the recruitment of high-quality teachers. The scant data available and the low credibility of many K-12 math/science teacher recruitment program evaluations remain the major barriers for the identification of effective recruitment strategies. Our study presents a methodology to better evaluate the impact of recruitment programs on increasing participants' interest in teaching careers. The research capitalizes on the use of several control groups and presents a non-equivalent groups quasi-experimental evaluation design that produces program effect claims with higher internal validity than claims generated by current program evaluations. With this method that compares responses to a teaching career interest question from undergraduates all along a continuum from just attending an information session to participating (or not) in the recruitment program, we were able to compare the effect of the program in increasing participants' interest in teaching careers versus the evolution of the same interest but in the absence of the program. We were also able to make suggestions for program improvement and further research. While our findings may not apply to other K-12 math/science teacher recruitment programs, we believe that our evaluation methodology does and will contribute to conduct stronger program evaluations. In so doing, our evaluation procedure may inform recruitment program designers and policy makers.

There is no ``I'' in referee: Why referees should be anonymous

NASA Astrophysics Data System (ADS)

Ucko, Daniel

2015-03-01

From the early days of modern science, it has been recognized that scientific claims must be verified by someone who is not the maker of those claims, and who furthermore has no stake in the matter. In other words, claims need to be evaluated objectively, by the community. The way in which this tends to be done is by peer review conducted by journals. Peer review as currently practiced touches on the themes of trust, where the trust is in institutions and procedures that emerge from expert communities. The practice of peer review is viewed as a citizenly duty of scientists in the scientific community, because all scientists take turns serving either as authors, referees, and editors in the peer review process We lack the resources to have a work evaluated by the entire community, so we substitute with a representative. Yet, in most examples of scientific review, the referee or referees are anonymous. This question is particularly important when the peer review process is brought to bear in order to evaluate matters beyond scientific validity, more ``subjective'' criteria such as relative importance, broadness of interest - criteria that do not appear to have an objective standard of comparison and validation. I will show that the anonymity of referees, far from endangering this trust, actually strengthens it. I will show that this anonymity is crucial in order to maintain any objectivity in scientific peer review, and why authors should not try to unmask the referee. Also at American Physical Society (APS).

Calibration of marginal oscillator sensitivity for use in ICR spectrometry

NASA Technical Reports Server (NTRS)

Anicich, V. G.; Huntress, W. T., Jr.

1977-01-01

A constant-reference load is utilized as Q-spoiler in calibrations of relative sensitivity variations of a marginal oscillator with frequency. Frequency-dependent effects troublesome in earlier Q-spoilers are compensated by employing a pure resistive calibration load with compensation for the small distributed capacitance of large resistors. The validity of the approach is demonstrated for a 2:1 mass ratio range, and validity for a mass ratio range greater than 10:1 is claimed. The circuit and technique were developed for use in ion cyclotron resonance (ICR) spectrometric practice.