Health claims and other health-related statements in the labeling and advertising of alcohol beverages (99R-199P). Final rule, Treasury decision.

PubMed

2003-03-03

TTB is amending the regulations to prohibit the appearance on labels or in advertisements of any health-related statement, including a specific health claim, that is untrue in any particular or tends to create a misleading impression. A specific health claim on a label or in an advertisement is considered misleading unless the claim is truthful and adequately substantiated by scientific evidence; properly detailed and qualified with respect to the categories of individuals to whom the claim applies; adequately discloses the health risks associated with both moderate and heavier levels of alcohol consumption; and outlines the categories of individuals for whom any levels of alcohol consumption may cause health risks. In addition, TTB will consult with the Food and Drug Administration (FDA), as needed, on the use of specific health claims on labels. If FDA determines that a specific health claim is a drug claim that is not in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act, TTB will not approve the use of such statement on a label. Health-related statements that are not specific health claims or health-related directional statements will be evaluated on a case-by-case basis to determine if they tend to mislead consumers. The final rule provides that health-related directional statements (statements that direct or refer consumers to a third party or other source for information regarding the effects on health of alcohol consumption) will be presumed misleading unless those statements include a brief disclaimer advising consumers that the statement should not encourage consumption of alcohol for health reasons, or some other appropriate disclaimer to avoid misleading consumers. TTB believes that the final regulations will ensure that labels and advertisements do not contain statements or claims that would tend to mislead the consumer about the significant health consequences of alcohol consumption.

Australian and New Zealand Fish Oil Products in 2016 Meet Label Omega-3 Claims and Are Not Oxidized.

PubMed

Nichols, Peter D; Dogan, Lalen; Sinclair, Andrew

2016-11-05

We provide new fish oil product results to assist industry in Australia and New Zealand and, ultimately, consumers in understanding the high product quality assurance protocols in place, together with the high product quality that has been determined by both industry and independent laboratories. Fish oil capsule products common to Australia and New Zealand were purchased in May 2016 in Richmond, Victoria, Australia. Products were from two groups; five standard fish oil products and five fish oil concentrates. Noting Therapeutic Goods Administration (TGA) requirement for use of standard methods, for all analyses undertaken a laboratory was selected that met the TGA criteria, including with accreditation. Total n -3 content exceeded the label-claimed content for all 10 products, with supplements containing on average 124% of the claimed content (range 115%-136%); eicosapentaenoic acid and docosahexaenoic acid (EPA + DHA) content averaged 109% of the label claim (range 99%-119%). All 10 products (100%) similarly met the international recommended peroxide value (PV) level. Anisidine value (pAV) met the international recommended level for eight of the 10 products, with two products known to contain flavorings that interfere with the pAV test. When accredited laboratories and standard protocols are used, Australian and New Zealand fish oil products have been shown to clearly meet their label claims for EPA + DHA content, and are not oxidized.

Australian and New Zealand Fish Oil Products in 2016 Meet Label Omega-3 Claims and Are Not Oxidized

PubMed Central

Nichols, Peter D.; Dogan, Lalen; Sinclair, Andrew

2016-01-01

We provide new fish oil product results to assist industry in Australia and New Zealand and, ultimately, consumers in understanding the high product quality assurance protocols in place, together with the high product quality that has been determined by both industry and independent laboratories. Fish oil capsule products common to Australia and New Zealand were purchased in May 2016 in Richmond, Victoria, Australia. Products were from two groups; five standard fish oil products and five fish oil concentrates. Noting Therapeutic Goods Administration (TGA) requirement for use of standard methods, for all analyses undertaken a laboratory was selected that met the TGA criteria, including with accreditation. Total n-3 content exceeded the label-claimed content for all 10 products, with supplements containing on average 124% of the claimed content (range 115%–136%); eicosapentaenoic acid and docosahexaenoic acid (EPA + DHA) content averaged 109% of the label claim (range 99%–119%). All 10 products (100%) similarly met the international recommended peroxide value (PV) level. Anisidine value (pAV) met the international recommended level for eight of the 10 products, with two products known to contain flavorings that interfere with the pAV test. When accredited laboratories and standard protocols are used, Australian and New Zealand fish oil products have been shown to clearly meet their label claims for EPA + DHA content, and are not oxidized. PMID:27827947

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…

Health claim evidence requirements in Japan.

PubMed

Yamada, Kazuhiko; Sato-Mito, Natsuko; Nagata, Junichi; Umegaki, Keizo

2008-06-01

In the early 1980s the Japanese scientific academy defined a functional food as a food having a tertiary or physiologically active function. The current Japanese "Food with Health Claims" include 2 categories. For the first category, "Food with Nutrient Function Claims," the label may be freely used if a product satisfies the standard for the minimum and maximum levels per daily portion usually consumed. The second category is defined as "Food for Specified Health Uses" (FOSHU). FOSHU foods are those that contain dietary ingredients that have beneficial effects on the physiological functions of the human body, maintain and promote health, and improve health-related conditions. Health claims on these foods correspond to the category of "other" function claims of the Codex Alimentarius. However, claims of disease-risk reduction are not currently allowed under FOSHU with an exception for calcium and folic acid. Manufacturers can emphasize the characteristics of their products and promote sales by labeling or claims. Therefore, the labeling should be clear and correct and avoid any chance of misinterpretation. The labeling of health claims on foods should always be based on scientific evidence. Any manufacturer who applies to the government for approval under the FOSHU code for its product must tabulate both published available publications and internal reports on the effectiveness of the product and/or its ingredients and provide a summary of each available publication or report. The tabulation must include in vitro metabolic and biochemical studies, in vivo studies, and randomized controlled trials on Japanese people. The overall philosophy of the Ministry is to maintain and improve the health status of people and to prevent chronic noncommunicable diseases through an approach that involves a well-balanced diet as well as through the use of "health foods" including "Food with Health Claims."

21 CFR 101.71 - Health claims: claims not authorized.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Health claims: claims not authorized. 101.71 Section 101.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.71 Health...

21 CFR 101.71 - Health claims: claims not authorized.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Health claims: claims not authorized. 101.71 Section 101.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.71 Health...

21 CFR 101.71 - Health claims: claims not authorized.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Health claims: claims not authorized. 101.71 Section 101.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.71 Health...

Do Health Claims and Front-of-Pack Labels Lead to a Positivity Bias in Unhealthy Foods?

PubMed Central

Talati, Zenobia; Pettigrew, Simone; Dixon, Helen; Neal, Bruce; Ball, Kylie; Hughes, Clare

2016-01-01

Health claims and front-of-pack labels (FoPLs) may lead consumers to hold more positive attitudes and show a greater willingness to buy food products, regardless of their actual healthiness. A potential negative consequence of this positivity bias is the increased consumption of unhealthy foods. This study investigated whether a positivity bias would occur in unhealthy variations of four products (cookies, corn flakes, pizzas and yoghurts) that featured different health claim conditions (no claim, nutrient claim, general level health claim, and higher level health claim) and FoPL conditions (no FoPL, the Daily Intake Guide (DIG), Multiple Traffic Lights (MTL), and the Health Star Rating (HSR)). Positivity bias was assessed via measures of perceived healthiness, global evaluations (incorporating taste, quality, convenience, etc.) and willingness to buy. On the whole, health claims did not produce a positivity bias, while FoPLs did, with the DIG being the most likely to elicit this bias. The HSR most frequently led to lower ratings of unhealthy foods than the DIG and MTL, suggesting that this FoPL has the lowest risk of creating an inaccurate positivity bias in unhealthy foods. PMID:27918426

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

Consumers' knowledge, understanding, and attitudes toward health claims on food labels.

PubMed

Fullmer, S; Geiger, C J; Parent, C R

1991-02-01

The purpose of this study was to assess consumers' knowledge of current fiber recommendations and their attitudes, understanding, and awareness of health claims on breakfast cereal labels. An incidental sample of 241 respondents was drawn from four grocery stores of a local chain in Utah. Data were collected using a computerized interviewing system. The results suggested that consumers with higher education levels had a better understanding of diet-disease-related messages and a more positive attitude toward health messages on food labels. Knowledge of fiber was significantly correlated with positive attitudes toward health messages and understanding of health messages. Overall, attitudes toward placing diet-disease-related messages on food labels were positive. On a scale of 1 through 250, the mean score was 182.5 +/- 37.5 standard deviation (73%). Consumer knowledge of fiber was low. Out of 15 possible points, the mean score for fiber knowledge questions was 8.8 +/- 2.1 (59%). Consumers were more familiar with the role fiber may play in the prevention or treatment of certain diseases or conditions than with sources, classifications, and recommended intakes of fiber. Understanding of health messages was relatively low (45%). Whereas consumer attitudes toward health messages on food labels were positive, consumers (especially less-educated consumers) did not appear to understand the messages well. These results reiterate the concern for public policymakers to exercise caution and ensure that health messages on food labels are responsible and accurate. The results should also remind dietetic practitioners, who are the nutrition experts, of their continual role in providing and ensuring accurate nutrition education to the public.

The regulation of patient-reported outcome claims: need for a flexible standard.

PubMed

Morris, Louis A; Miller, David W

2002-01-01

We review the FDA's policies for the regulation of patient-reported outcome (PRO) claims such as quality of life, productivity, satisfaction and symptom reports and suggest alternative standards for substantiation. We base our review on FDA regulatory activities and public statements in the field of advertising substantiation. We compare these activities to the FDA's label substantiation policies and policies for health-economic (HE) claim substantiation. There is an overt inconsistency between the FDA's policies for substantiation of PRO claims in product labels and substantiation for such claims in advertising materials. This results in a higher standard for PRO claims in promotional vehicles than in product labels. Rather than relying on a "substantial evidence" standard, the FDA should consider a more flexible standard, such as the one currently applied to information included in the Clinical Trials section of product labels, or adopting a "competent and reliable scientific evidence" standard as set forth in Section 114 of the Food and Drug Administration Modernization Act (FDAMA) for HE data. We conclude that there needs to be greater consistency for substantiation in product labels and promotional materials. Furthermore, reconceptualizing most PRO claims as benefit extrapolations as opposed to efficacy information suggests a less rigorous standard is necessary.

The role of nutrition labels and advertising claims in altering consumers' evaluation and choice.

PubMed

Bialkova, Svetlana; Sasse, Lena; Fenko, Anna

2016-01-01

Despite policy efforts, consumers' well-informed healthful choice is a challenge. Due to increasing number of benefit claims advertising taste or health front of pack (FOP), consumers face the dilemma to trade taste for health. To understand the mechanisms underlying food evaluation, this study investigates the health-pleasure trade-off and its effect on consumers' choice. 240 EU consumers took part in a taste experiment, after being presented with the product FOP. Half of the products carried a nutrition label FOP, respectively, reduced fat for potato chips, reduced sugar for cereal bars. Further, one third of the products carried health benefit claim, one third taste benefit claim, and one third no additional claim FOP. Attention to information and its effect on experienced taste, health perception and the buying intention were measured. The results show that the message displayed FOP altered consumers evaluation and choice. The effectiveness of the FOP message further depended on consumers' health motivation and the healthfulness perception of carrier products. The outcomes are summarized in a framework of health-pleasure trade-off. Current findings call for the establishment of standards to avoid the use of misleading information FOP. Copyright © 2015 Elsevier Ltd. All rights reserved.

A tale of three labels: translating the JUPITER trial data into regulatory claims.

PubMed

Ridker, Paul M

2011-08-01

Whether a pivotal randomized trial will be interpreted in a similar and consistent manner by different regulatory agencies is uncertain as policy perspectives may play a role in data interpretation and the translation of trial results into clinical practice. Using a contemporary example, to compare and contrast regulatory claims in the United States, Europe, and Canada that derive from a pivotal clinical trial. The recently completed JUPITER trial of rosuvastatin as compared to placebo conducted among 17,802 men and women with LDL-C <130 mg/dL and hsCRP ≥ 2 mg/L, provides the only available data on rosuvastatin for primary prevention of cardiovascular disease. Thus, the JUPITER trial provides an opportunity to compare and contrast how regulatory agencies in the United States, Canada, and Europe chose to interpret an identical database. Labeling indications based on earlier statin trials of primary and secondary prevention were also reviewed. JUPITER demonstrated a 44% reduction (p < 0.000001) in the trial pre-specified primary endpoint (nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, coronary revascularization, or cardiovascular death) with no evidence of heterogeneity across geographic regions. In response to these data, the US Food and Drug Administration label for rosuvastatin in primary prevention came closest to the actual JUPITER trial population by stipulating that those eligible for treatment should be older men and women with hsCRP >2 mg/L, plus one additional risk factor for heart disease. The Canadian label is silent on age and hsCRP (the major trial inclusion criterion), stipulating instead that treatment can be considered for those with 'at least two conventional risk factors for cardiovascular disease,' a group more inclusive than that studied. In contrast, the European Medicines Agency label limits treatment only to 'high risk individuals' ignoring hsCRP and using instead a post hoc definition of 'high risk

Claims-Based Definition of Death in Japanese Claims Database: Validity and Implications

PubMed Central

Ooba, Nobuhiro; Setoguchi, Soko; Ando, Takashi; Sato, Tsugumichi; Yamaguchi, Takuhiro; Mochizuki, Mayumi; Kubota, Kiyoshi

2013-01-01

Background For the pending National Claims Database in Japan, researchers will not have access to death information in the enrollment files. We developed and evaluated a claims-based definition of death. Methodology/Principal Findings We used healthcare claims and enrollment data between January 2005 and August 2009 for 195,193 beneficiaries aged 20 to 74 in 3 private health insurance unions. We developed claims-based definitions of death using discharge or disease status and Charlson comorbidity index (CCI). We calculated sensitivity, specificity and positive predictive values (PPVs) using the enrollment data as a gold standard in the overall population and subgroups divided by demographic and other factors. We also assessed bias and precision in two example studies where an outcome was death. The definition based on the combination of discharge/disease status and CCI provided moderate sensitivity (around 60%) and high specificity (99.99%) and high PPVs (94.8%). In most subgroups, sensitivity of the preferred definition was also around 60% but varied from 28 to 91%. In an example study comparing death rates between two anticancer drug classes, the claims-based definition provided valid and precise hazard ratios (HRs). In another example study comparing two classes of anti-depressants, the HR with the claims-based definition was biased and had lower precision than that with the gold standard definition. Conclusions/Significance The claims-based definitions of death developed in this study had high specificity and PPVs while sensitivity was around 60%. The definitions will be useful in future studies when used with attention to the possible fluctuation of sensitivity in some subpopulations. PMID:23741526

Sunscreen sun protection factor claim based on in vivo interlaboratory variability.

PubMed

Miksa, S; Lutz, D; Guy, C; Delamour, E

2016-12-01

The SPF (sun protection factor) is the best known reference in the world for expressing UVB protection. The SPF is used for labelling purposes for consumer guidance. The determination of the SPF is often accomplished using an in vivo method that has been standardized. Only one in vivo SPF value from one laboratory is required for claiming an SPF value. The aim of this study was to determine the relevance of the in vivo SPF value in terms of interlaboratory variability for claiming purposes and to determine whether some minimum number of different in vivo SPF values from different laboratories would improve the reliability of the final SPF claimed. A large population of 44 different commercially available sunscreen formulations from the European market has been investigated, covering various product types. The majority of the SPF values claimed ranged from 15 to 50+. For each product, at least three different in vivo SPF values tested in different laboratories have been gathered, and a variety of statistical analyses have been performed. For each SPF category from the average of all samples, the minimum and maximum in vivo-measured SPF values from the different laboratories would lead to labels claiming different levels of SPF for the same product. Indeed, with coefficients of variation for in vivo SPF determinations that exceed 50% in some cases, as an example, the same product could in reality be claimed to be SPF 30, SPF 50 or SPF 50+. In this study, the authors demonstrated that using only one in vivo SPF value from one laboratory may actually challenge the reliability of the final SPF claim significantly. To reduce the consumer health risk by ensuring the reliability of the SPF claim, an average from at least 3 (ideally 4) different in vivo SPF values should be compulsory. © 2016 Society of Cosmetic Scientists and the Société Française de Cosmétologie.

Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier.

PubMed

Revicki, Dennis A; Gnanasakthy, Ari; Weinfurt, Kevin

2007-05-01

The Food and Drug Administration (FDA) and European Medicines Agency (EMEA) are willing to consider including information on patient reported outcomes (PROs) in product labeling and advertising. Pharmaceutical industry researchers must provide sufficient evidence supporting PRO benefit before an approval may be granted. This report describes the purpose and content of a PRO Evidence Dossier, which consists of important information supporting PRO claims. The dossier should be completed by pharmaceutical industry or other researchers to document the planning of the PRO assessment strategy, psychometric evidence, desired target labeling statements, and the clinical trial evidence of PRO benefits. The systematic reporting and documentation of information on the rationale for including PROs, rationale for the selection of specific PRO instruments, evidence on the psychometric qualities of the PRO measures, and guidelines for interpreting PRO findings will facilitate achieving a PRO labeling or promotional claim. Combining all the relevant information into a single document will facilitate the review and evaluation process for clinical and regulatory reviewers. The PRO Evidence Dossier may also be helpful to industry and academic researchers in identifying further information that will need to be developed to support the clinical development program and the PRO endpoints.

Development of functional agricultural products utilizing the new health claim labeling system in Japan.

PubMed

Maeda-Yamamoto, Mari; Ohtani, Toshio

2018-04-01

In April 2015, Consumer Affairs Agency of Japan launched a new food labeling system known as "Foods with Function Claims (FFC)." Under this system, the food industry independently evaluates scientific evidence on foods and describes their functional properties. As of May 23, 2017, 1023 FFC containing 8 fresh foods have been launched. Meanwhile, to clarify the health-promoting effects of agricultural products, National Agriculture and Food Research Organization (NARO) implemented the "Research Project on Development of Agricultural Products" and demonstrated the risk reduction of osteoporosis of β-cryptoxanthin rich Satsuma mandarins and the anti-allergic effect of the O-methylated catechin rich tea cultivar Benifuuki. These foods were subsequently released as FFC. Moreover, NARO elucidated the health-promoting effects of various functional agricultural products (β-glucan rich barley, β-conglycinin rich soybean, quercetin rich onion, etc.) and a healthy boxed lunch. This review focuses on new food labeling system or research examining functional aspects of agricultural products.

78 FR 47154 - Food Labeling; Gluten-Free Labeling of Foods

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-05

...The Food and Drug Administration (FDA or we) is issuing a final rule to define the term ``gluten-free'' for voluntary use in the labeling of foods. The final rule defines the term ``gluten-free'' to mean that the food bearing the claim does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat); an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or an ingredient that is derived from a gluten-containing grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). A food that bears the claim ``no gluten,'' ``free of gluten,'' or ``without gluten'' in its labeling and fails to meet the requirements for a ``gluten-free'' claim will be deemed to be misbranded. In addition, a food whose labeling includes the term ``wheat'' in the ingredient list or in a separate ``Contains wheat'' statement as required by a section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and also bears the claim ``gluten-free'' will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a ``gluten-free'' claim. Establishing a definition of the term ``gluten-free'' and uniform conditions for its use in food labeling will help ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. We are issuing the final rule under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

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.

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.

Nutrition labelling: purpose, scientific issues and challenges.

PubMed

Van den Wijngaart, Annoek W E M

2002-01-01

Nutrition labels describe the nutrient content of a food and are intended to guide the consumer in food selection. The nutrition information provided must be selected on the basis of consistency with dietary recommendations. Selection of the specific nutrients or food components to be listed should further take into account label space, the analytical feasibility of measuring the particular nutritional component within the food matrix, and the relative costs of such analyses. Nutrition information provided on labels should be truthful and not mislead consumers. At the same time, labelling regulations should provide incentives to manufacturers to develop products that promote public health and assist consumers in following dietary recommendations. It is likely that in many countries, there would be some segments of the population that would benefit from information about the composition of foods. In these cases, countries should consider the need to provide for appropriate labelling and its presentation relative to existing guidelines and approaches. As nutrition-labelling efforts have evolved, different approaches and legal requirements have been established. These create difficulties in developing and harmonizing nutrition information listings, which have broad international applications. For these reasons, the Codex Guidelines on Nutrition Labeling play an important role to provide guidance to member countries when they want to develop or update their national regulations and to encourage harmonization of national standards with international standards. These Guidelines are based on the principle that no food should be described or presented in a manner that is false, misleading or deceptive. The Guidelines include provisions for voluntary nutrient declaration, calculation and presentation of nutrient information. The Guidelines on Claims establish general principles to be followed and leave the definition of specific claims to national regulations. Definitions

9 CFR 317.356 - Nutrient content claims for “light” or “lite.”

Code of Federal Regulations, 2014 CFR

2014-01-01

... âlite.â 317.356 Section 317.356 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... Labeling § 317.356 Nutrient content claims for “light” or “lite.” (a) General requirements. A claim using... claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317...

9 CFR 317.356 - Nutrient content claims for “light” or “lite.”

Code of Federal Regulations, 2013 CFR

2013-01-01

... âlite.â 317.356 Section 317.356 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... Labeling § 317.356 Nutrient content claims for “light” or “lite.” (a) General requirements. A claim using... claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317...

9 CFR 317.356 - Nutrient content claims for “light” or “lite.”

Code of Federal Regulations, 2011 CFR

2011-01-01

... âlite.â 317.356 Section 317.356 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... Labeling § 317.356 Nutrient content claims for “light” or “lite.” (a) General requirements. A claim using... claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317...

9 CFR 317.356 - Nutrient content claims for “light” or “lite.”

Code of Federal Regulations, 2012 CFR

2012-01-01

... âlite.â 317.356 Section 317.356 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... Labeling § 317.356 Nutrient content claims for “light” or “lite.” (a) General requirements. A claim using... claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317...

16 CFR 460.21 - Government claims.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 1 2012-01-01 2012-01-01 false Government claims. 460.21 Section 460.21 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.21 Government claims. Do not say or imply that a government agency uses, certifies...

16 CFR 460.21 - Government claims.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Government claims. 460.21 Section 460.21 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.21 Government claims. Do not say or imply that a government agency uses, certifies...

16 CFR 460.21 - Government claims.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Government claims. 460.21 Section 460.21 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.21 Government claims. Do not say or imply that a government agency uses, certifies...

16 CFR 460.21 - Government claims.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 1 2014-01-01 2014-01-01 false Government claims. 460.21 Section 460.21 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.21 Government claims. Do not say or imply that a government agency uses, certifies...

16 CFR 460.21 - Government claims.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 1 2013-01-01 2013-01-01 false Government claims. 460.21 Section 460.21 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.21 Government claims. Do not say or imply that a government agency uses, certifies...

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.

9 CFR 412.1 - Label approval.

Code of Federal Regulations, 2014 CFR

2014-01-01

... foreign language or printing labels that bear a statement of the quantity of contents in accordance with... Policy Book, (except for “natural” and negative claims (e.g., “gluten free”)), health claims, ingredient and processing method claims (e.g., high-pressure processing), structure-function claims, claims...

Naturally good: Front-of-package claims as message cues.

PubMed

Skubisz, Christine

2017-01-01

Excess bodyweight is a significant public health problem in the United States, increasing the risk of adverse health conditions including hypertension, diabetes, heart disease, stroke, and cancer. Americans are consuming more calories than their bodies need each day and making purchasing decisions using heuristic cues, rather than caloric information. A recent trend in food and beverage labeling is the placement of a natural claim on a product's package. Unfortunately, the United States has not established clear requirements for natural claims and manufacturers are using this term liberally. Using models of information processing as a framework, the goal of this study was to predict the effects of natural claims on message processing and evaluations. It was predicted that natural claims would be perceived as heuristics for healthfulness. A 6 (product) x 2 (claim) experimental design was carried out. Support for the prediction that natural labeled products are evaluated as more healthful was found. Despite the fact that natural products contained the same number of calories as their regular counterparts, participants estimated that natural products contained 18% fewer calories. Implications of these findings for food labeling and public health are discussed. Copyright © 2016 Elsevier Ltd. All rights reserved.

16 CFR 460.22 - Tax claims.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Tax claims. 460.22 Section 460.22 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.22 Tax claims. Do not say or imply that your product qualifies for a tax benefit unless it is true. ...

16 CFR 460.22 - Tax claims.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Tax claims. 460.22 Section 460.22 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.22 Tax claims. Do not say or imply that your product qualifies for a tax benefit unless it is true. ...

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.

Effects of Categorical Labels on Similarity Judgments: A Critical Analysis of Similarity-Based Approaches

ERIC Educational Resources Information Center

Noles, Nicholaus S.; Gelman, Susan A.

2012-01-01

Our goal in the present study was to evaluate the claim that category labels affect children's judgments of visual similarity. We presented preschool children with discriminable and identical sets of animal pictures and asked them to make perceptual judgments in the presence or absence of labels. Our findings indicate that children who are asked…

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...

The Basis of Structure/Function Claims of Nutraceuticals.

PubMed

Borchers, Andrea T; Keen, Carl L; Gershwin, M Eric

2016-12-01

In the United States, as in most of the world, there are large numbers of nutraceuticals that are sold and which people take to boost their immune response. There are, in addition, almost an equal number of products sold to reduce allergies. However, very few consumers, and indeed physicians, are aware of what a structure/function claim is. Structure/function claims are labeling claims that can be used to describe the potential effects of a dietary ingredient or similar substance on the structure or function of the human body. This category of claims was created by legislation contained in the Dietary Supplement Health and Education Act. The intent was to supply consumers with reasonably substantiated information that would allow them to make educated choices about their diet and health. They were not intended to have the same weight and substantiation as the claims made for conventional prescription pharmaceuticals. Rather, they were proposed to fill the gap between consumer desire for over-the-counter supplements and foods, and rigorous and generally more potent and potentially "toxic" prescription medications. The legally mandated disclaimer, stating that the U.S. Food and Drug Administration has not evaluated the structure/function claim, often leads to misinterpretation. While there should be a biologic premise underlying the claim, there is not an absolute requirement for a conventional rigorous placebo-controlled dose response trial. While this may not be the clinical standard that a typical scientific oriented society might desire, it reflects the attempts of the FDA to find common grounds and to allow consumers to use products that are generally considered as safe based on historical use and biologic comparisons. The logic of, indeed need for, structure/function claims is straightforward; however, of equal importance is that nutraceuticals should be properly labeled, have accuracy in their ingredients, be free of contamination, be safe, and have a

16 CFR 260.11 - Ozone-safe and ozone-friendly claims.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 1 2013-01-01 2013-01-01 false Ozone-safe and ozone-friendly claims. 260.11... THE USE OF ENVIRONMENTAL MARKETING CLAIMS § 260.11 Ozone-safe and ozone-friendly claims. It is... friendly to, the ozone layer or the atmosphere. Example 1: A product is labeled “ozone-friendly.” The claim...

16 CFR 260.11 - Ozone-safe and ozone-friendly claims.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 1 2014-01-01 2014-01-01 false Ozone-safe and ozone-friendly claims. 260.11... THE USE OF ENVIRONMENTAL MARKETING CLAIMS § 260.11 Ozone-safe and ozone-friendly claims. It is... friendly to, the ozone layer or the atmosphere. Example 1: A product is labeled “ozone-friendly.” The claim...

A Critical Review of the Marketing Claims of Infant Formula Products in the United States.

PubMed

Belamarich, Peter F; Bochner, Risa E; Racine, Andrew D

2016-05-01

A highly competitive infant formula market has resulted in direct-to-consumer marketing intended to promote the sale of modified formulas that claim to ameliorate common infant feeding problems. The claims associated with these marketing campaigns are not evaluated with reference to clinical evidence by the Food and Drug Administration. We aimed to describe the language of claims made on formula labels and compare it with the evidence in systematic reviews. Of the 22 product labels we identified, 13 product labels included claims about colic and gastrointestinal symptoms. There is insufficient evidence to support the claims that removing or reducing lactose, using hydrolyzed or soy protein or adding pre-/probiotics to formula benefits infants with fussiness, gas, or colic yet claims like "soy for fussiness and gas" encourage parents who perceive their infants to be fussy to purchase modified formula. Increased regulation of infant formula claims is warranted. © The Author(s) 2015.

9 CFR 317.360 - Nutrient content claims for calorie content.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Nutrient content claims for calorie content. 317.360 Section 317.360 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... Labeling § 317.360 Nutrient content claims for calorie content. (a) General requirements. A claim about the...

21 CFR 101.14 - Health claims: general requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Health claims: general requirements. 101.14 Section 101.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.14 Health claims: general...

21 CFR 101.14 - Health claims: general requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Health claims: general requirements. 101.14 Section 101.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.14 Health claims: general...

21 CFR 101.14 - Health claims: general requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Health claims: general requirements. 101.14 Section 101.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.14 Health claims: general...

21 CFR 101.14 - Health claims: general requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Health claims: general requirements. 101.14 Section 101.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.14 Health claims: general...

Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.

PubMed

2006-10-11

This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably

Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance

PubMed Central

2006-01-01

This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably

21 CFR 101.70 - Petitions for health claims.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Petitions for health claims. 101.70 Section 101.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.70 Petitions for...

21 CFR 101.70 - Petitions for health claims.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Petitions for health claims. 101.70 Section 101.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.70 Petitions for...

21 CFR 101.70 - Petitions for health claims.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Petitions for health claims. 101.70 Section 101.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.70 Petitions for...

21 CFR 101.70 - Petitions for health claims.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Petitions for health claims. 101.70 Section 101.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.70 Petitions for...

21 CFR 101.70 - Petitions for health claims.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Petitions for health claims. 101.70 Section 101.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.70 Petitions for...

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.

Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness.

PubMed

Boyce, Richard D; Horn, John R; Hassanzadeh, Oktie; Waard, Anita de; Schneider, Jodi; Luciano, Joanne S; Rastegar-Mojarad, Majid; Liakata, Maria

2013-01-26

Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug's efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File - Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug

Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness

PubMed Central

2013-01-01

Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug’s efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File – Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug

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

9 CFR 317.354 - Nutrient content claims for “good source,” “high,” and “more.”

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Nutrient content claims for âgood... Nutrition Labeling § 317.354 Nutrient content claims for “good source,” “high,” and “more.” (a) General... nutrient content claims in § 317.313; and (3) The product for which the claim is made is labeled in...

9 CFR 381.454 - Nutrient content claims for “good source,” “high,” and “more.”

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Nutrient content claims for âgood... Nutrition Labeling § 381.454 Nutrient content claims for “good source,” “high,” and “more.” (a) General... nutrient content claims in § 381.413; and (3) The product for which the claim is made is labeled in...

21 CFR 101.65 - Implied nutrient content claims and related label statements.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., physiological, pathological, or other condition, where the claim identifies the special diet of which the food... certain amount (e.g., “high in oat bran”) are implied nutrient content claims and must comply with... the ingredient or type of preparation. If a more specific level is claimed (e.g., “high in ___), that...

21 CFR 101.65 - Implied nutrient content claims and related label statements.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., physiological, pathological, or other condition, where the claim identifies the special diet of which the food... certain amount (e.g., “high in oat bran”) are implied nutrient content claims and must comply with... the ingredient or type of preparation. If a more specific level is claimed (e.g., “high in ___), that...

21 CFR 101.65 - Implied nutrient content claims and related label statements.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., physiological, pathological, or other condition, where the claim identifies the special diet of which the food... certain amount (e.g., “high in oat bran”) are implied nutrient content claims and must comply with... the ingredient or type of preparation. If a more specific level is claimed (e.g., “high in ___), that...

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...

21 CFR 101.74 - Health claims: sodium and hypertension.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Health claims: sodium and hypertension. 101.74 Section 101.74 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.74 Health...

21 CFR 101.74 - Health claims: sodium and hypertension.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Health claims: sodium and hypertension. 101.74 Section 101.74 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.74 Health...

9 CFR 381.454 - Nutrient content claims for “good source,” “high,” and “more.”

Code of Federal Regulations, 2010 CFR

2010-01-01

... labeling of the product if: (1) The claim uses one of the terms defined in this section in accordance with... nutrient content claims in § 381.413; and (3) The product for which the claim is made is labeled in accordance with § 381.409. (b) “High” claims. (1) The terms “high,” “rich in,” or “excellent source of” may...

9 CFR 317.354 - Nutrient content claims for “good source,” “high,” and “more.”

Code of Federal Regulations, 2013 CFR

2013-01-01

... labeling of the product if: (1) The claim uses one of the terms defined in this section in accordance with... nutrient content claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317.309. (b) “High” claims. (1) The terms “high,” “rich in,” or “excellent source of” may...

9 CFR 317.354 - Nutrient content claims for “good source,” “high,” and “more.”

Code of Federal Regulations, 2010 CFR

2010-01-01

... labeling of the product if: (1) The claim uses one of the terms defined in this section in accordance with... nutrient content claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317.309. (b) “High” claims. (1) The terms “high,” “rich in,” or “excellent source of” may...

9 CFR 381.454 - Nutrient content claims for “good source,” “high,” and “more.”

Code of Federal Regulations, 2013 CFR

2013-01-01

... labeling of the product if: (1) The claim uses one of the terms defined in this section in accordance with... nutrient content claims in § 381.413; and (3) The product for which the claim is made is labeled in accordance with § 381.409. (b) “High” claims. (1) The terms “high,” “rich in,” or “excellent source of” may...

Two efficient label-equivalence-based connected-component labeling algorithms for 3-D binary images.

PubMed

He, Lifeng; Chao, Yuyan; Suzuki, Kenji

2011-08-01

Whenever one wants to distinguish, recognize, and/or measure objects (connected components) in binary images, labeling is required. This paper presents two efficient label-equivalence-based connected-component labeling algorithms for 3-D binary images. One is voxel based and the other is run based. For the voxel-based one, we present an efficient method of deciding the order for checking voxels in the mask. For the run-based one, instead of assigning each foreground voxel, we assign each run a provisional label. Moreover, we use run data to label foreground voxels without scanning any background voxel in the second scan. Experimental results have demonstrated that our voxel-based algorithm is efficient for 3-D binary images with complicated connected components, that our run-based one is efficient for those with simple connected components, and that both are much more efficient than conventional 3-D labeling algorithms.

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...

Comparison of the nutritional content of products, with and without nutrient claims, targeted at children in Brazil.

PubMed

Rodrigues, Vanessa Mello; Rayner, Mike; Fernandes, Ana Carolina; de Oliveira, Renata Carvalho; Proença, Rossana Pacheco da Costa; Fiates, Giovanna Medeiros Rataichesck

2016-06-01

Many children's food products highlight positive attributes on their front-of-package labels in the form of nutrient claims. This cross-sectional study investigated all retailed packaged foods (n 5620) in a major Brazilian supermarket, in order to identify the availability of products targeted at children, and to compare the nutritional content of products with and without nutrient claims on labels. Data on energy, carbohydrate, protein, fibre, Na and total and SFA content, along with the presence and type of nutrient claims, were obtained in-store from labels of all products. Products targeted at children were identified, divided into eight food groups and compared for their nutritional content per 100 g/ml and the presence of nutrient claims using the Mann-Whitney U test (P<0·05). Of the 535 food products targeted at children (9·5 % of all products), 270 (50·5 %) displayed nutrient claims on their labels. Children's products with nutrient claims had either a similar or worse nutritional content than their counterparts without nutrient claims. The major differences among groups were found in Group 8 (e.g. sauces and ready meals), in which children's products bearing nutrient claims had higher energy, carbohydrate, Na and total and SFA content per 100 g/ml than products without nutrient claims (P<0·05). This suggests that, to prevent misleading parents who are seeking healthier products for their children, the regulation on the use of nutrient claims should be revised, so that only products with appropriate nutrient profiles are allowed to display them.

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...

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.

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

9 CFR 317.309 - Nutrition label content.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Nutrition label content. 317.309... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.309 Nutrition... program qualify for nutrition claims. (3) The declaration of nutrient and food component content shall be...

9 CFR 317.309 - Nutrition label content.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Nutrition label content. 317.309... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.309 Nutrition... only through a weight-control program qualify for nutrition claims. (3) The declaration of nutrient and...

9 CFR 317.309 - Nutrition label content.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Nutrition label content. 317.309... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.309 Nutrition... only through a weight-control program qualify for nutrition claims. (3) The declaration of nutrient and...

9 CFR 317.309 - Nutrition label content.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Nutrition label content. 317.309... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.309 Nutrition... program qualify for nutrition claims. (3) The declaration of nutrient and food component content shall be...

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...

Are foods with fat-related claims useful for weight management?

PubMed

Schermel, Alyssa; Wong, Christina L; L'Abbé, Mary R

2016-01-01

Many consumers believe that foods labelled with fat claims (e.g. low fat) are lower in calories than comparable regular foods and are therefore helpful for weight management. However, it is unknown whether such foods are actually lower in calories. Our aims were to determine 1) the relative proportion of foods carrying fat claims among various food categories within the Canadian marketplace; and 2) whether foods with fat claims are actually lower in calories than comparable foods without claims. The Food Label Information Program 2010, a database of Canadian foods developed at the University of Toronto, was used to compare the calorie content of products with and without fat claims within a given food subcategory, as defined by Schedule M of the Food and Drug Regulations. Median differences of 25% or greater were deemed nutritionally significant, as that is the minimum difference required for comparative claims such as "reduced" and "lower" in the Food and Drug Regulations. Fat claims were present on up to 68% of products in a given food subcategory. Products with fat claims were not significantly lower in both fat and calories compared to comparable products without fat claims in more than half of the subcategories (24 out of 40) analyzed. Conversely, in 16 subcategories, foods with fat claims were at least 25% lower in calories; however, for many of these foods, the absolute difference in calories was small, i.e., for 9 of the 16 subcategories, the absolute difference between foods with and without fat claims was <50 calories, even though the relative percent difference was high. This research suggests that foods with fat claims may be misleading consumers and undermining their efforts to manage body weight or prevent obesity. Copyright © 2015 Elsevier Ltd. All rights reserved.

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.

Korean consumers' perceptions of health/functional food claims according to the strength of scientific evidence

PubMed Central

Kim, Ji Yeon; Kang, Eun Jin; Kwon, Oran

2010-01-01

In this study, we investigated that consumers could differentiate between levels of claims and clarify how a visual aid influences consumer understanding of the different claim levels. We interviewed 2,000 consumers in 13 shopping malls on their perception of and confidence in different levels of health claims using seven point scales. The average confidence scores given by participants were 4.17 for the probable level and 4.07 for the possible level; the score for the probable level was significantly higher than that for the possible level (P < 0.05). Scores for confidence in claims after reading labels with and without a visual aid were 5.27 and 4.43, respectively; the score for labeling with a visual aid was significantly higher than for labeling without a visual aid (P < 0.01). Our results provide compelling evidence that providing health claims with qualifying language differentiating levels of scientific evidence can help consumers understand the strength of scientific evidence behind those claims. Moreover, when a visual aid was included, consumers perceived the scientific levels more clearly and had greater confidence in their meanings than when a visual aid was not included. Although this result suggests that consumers react differently to different claim levels, it is not yet clear whether consumers understand the variations in the degree of scientific support. PMID:21103090

21 CFR 101.67 - Use of nutrient content claims for butter.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Use of nutrient content claims for butter. 101.67 Section 101.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Nutrient Content Claims § 101...

21 CFR 101.67 - Use of nutrient content claims for butter.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Use of nutrient content claims for butter. 101.67 Section 101.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Nutrient Content Claims § 101...

21 CFR 101.67 - Use of nutrient content claims for butter.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Use of nutrient content claims for butter. 101.67 Section 101.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Nutrient Content Claims § 101...

21 CFR 101.67 - Use of nutrient content claims for butter.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Use of nutrient content claims for butter. 101.67 Section 101.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Nutrient Content Claims § 101...

Influence of Food Labels on Adolescent Diet.

ERIC Educational Resources Information Center

Misra, Ranjita

2002-01-01

Provides information on food nutrition labels and discusses the benefits of adolescents' using them to plan healthy diets. Suggests that teachers and educators should encourage appropriate label reading education for adolescents to promote healthy eating practices. Provides definitions of nutrient content claims. (SG)

Composition, disintegrative properties, and labeling compliance of commercially available taurine and carnitine dietary products.

PubMed

Bragg, Rebecca R; Freeman, Lisa M; Fascetti, Andrea J; Yu, Zengshou

2009-01-15

To test the quality, disintegration properties, and compliance with labeling regulations for representative commercially available taurine and carnitine dietary products. Evaluation study. 11 commercially available taurine and 10 commercially available carnitine products. For each product, the amount of taurine or carnitine was determined and compared with the label claim. All products were evaluated for concentrations of mercury, arsenic, and selenium. Disintegration properties of 5 taurine and 8 carnitine products were determined in vitro. Labels were evaluated for compliance with FDA guidelines. 10 of 11 taurine and 10 of 10 carnitine products were within 10% of the stated label claim. Three of 11 taurine and 6 of 10 carnitine products were within 5% of the stated label claim. The median percentage difference between laboratory analysis and label claim was -5.7% (range, -26.3% to 2.5%) for taurine and 3.6% (range, -2.6% to 8.8%) for carnitine. No substantial amount of contamination with mercury, arsenic, or selenium was found in any of the products. During disintegration testing, 1 of 5 taurine products and 5 of 8 carnitine products did not disintegrate within 45 minutes during at least 1 test. Disintegration time for those that did disintegrate ranged from 1.7 to 37.0 minutes. All product labels conformed with FDA regulations. Taurine and carnitine products evaluated in this study closely adhered to manufacturer claims and labeling guidelines. However, disintegration testing suggested high variability in some products, possibly limiting uptake and use by animals that receive them.

9 CFR 381.462 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Nutrition Labeling § 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content. (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be... fat. (iv) A synonym for “___ percent fat free” is “___ percent lean.” (c) Fatty acid content claims...

9 CFR 317.362 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Nutrition Labeling § 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be.... (iv) A synonym for “___ percent fat free” is “___ percent lean.” (c) Fatty acid content claims. (1...

Consumers' Exposure to Nutrition and Health Claims on Pre-Packed Foods: Use of Sales Weighting for Assessing the Food Supply in Slovenia.

PubMed

Pravst, Igor; Kušar, Anita

2015-11-12

Insights into the use of health-related information on foods are important for planning studies about the effects of such information on the consumer's understanding, purchasing, and consumption of foods, and also support further food policy decisions. We tested the use of sales data for weighting consumers' exposure to health-related labeling information in the Slovenian food supply. Food labeling data were collected from 6342 pre-packed foods available in four different food stores in Slovenia. Consumers' exposure was calculated as the percentage of available food products with particular food information in the food category. In addition, 12-month sales data were used to calculate sales weighted exposure as a percentage of sold food products with certain food information in the food category. The consumer's in-store and sales-weighted exposure to nutrition claims was 37% and 45%, respectively. Exposure to health claims was much lower (13%, 11% when sales-weighted). Health claims were mainly found in the form of general non-specific claims or function claims, while children's development and reduction of disease risk claims were present on only 0.1% and 0.2% of the investigated foods, respectively. Sales data were found very useful for establishing a reliable estimation of consumers' exposure to information provided on food labels. The high penetration of health-related information on food labels indicates that careful regulation of this area is appropriate. Further studies should focus on assessing the nutritional quality of foods labeled with nutrition and health claims, and understanding the importance of such labeling techniques for consumers' food preferences and choices.

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.

21 CFR 101.82 - Health claims: Soy protein and risk of coronary heart disease (CHD).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Health claims: Soy protein and risk of coronary... HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.82 Health claims: Soy protein and risk of coronary heart disease (CHD). (a...

Testing consumer perception of nutrient content claims using conjoint analysis.

PubMed

Drewnowski, Adam; Moskowitz, Howard; Reisner, Michele; Krieger, Bert

2010-05-01

The US Food and Drug Administration (FDA) proposes to establish standardized and mandatory criteria upon which front-of-pack (FOP) nutrition labelling must be based. The present study aimed to estimate the relative contribution of declared amounts of different nutrients to the perception of the overall 'healthfulness' of foods by the consumer. Protein, fibre, vitamin A, vitamin C, calcium and iron were nutrients to encourage. Total fat, saturated fat, cholesterol, total and added sugar, and sodium were the nutrients to limit. Two content claims per nutrient used the FDA-approved language. An online consumer panel (n 320) exposed to multiple messages (n 48) rated the healthfulness of each hypothetical food product. Utility functions were constructed using conjoint analysis, based on multiple logistic regression and maximum likelihood estimation. Consumer perception of healthfulness was most strongly driven by the declared presence of protein, fibre, calcium and vitamin C and by the declared total absence of saturated fat and sodium. For this adult panel, total and added sugar had lower utilities and contributed less to the perception of healthfulness. There were major differences between women and men. Conjoint analysis can lead to a better understanding of how consumers process information about the full nutrition profile of a product, and is a powerful tool for the testing of nutrient content claims. Such studies can help the FDA develop science-based criteria for nutrient profiling that underlies FOP and shelf labelling.

9 CFR 381.409 - Nutrition label content.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Nutrition label content. 381.409... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.409 Nutrition... program qualify for nutrition claims. (3) The declaration of nutrient and food component content shall be...

9 CFR 381.409 - Nutrition label content.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Nutrition label content. 381.409... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.409 Nutrition... that are available only through a weight-control program qualify for nutrition claims. (3) The...

9 CFR 381.409 - Nutrition label content.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Nutrition label content. 381.409... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.409 Nutrition... program qualify for nutrition claims. (3) The declaration of nutrient and food component content shall be...

9 CFR 381.409 - Nutrition label content.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Nutrition label content. 381.409... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.409 Nutrition... that are available only through a weight-control program qualify for nutrition claims. (3) The...

Medical-legal issues in headache: penal and civil Italian legislation, working claims, social security, off-label prescription.

PubMed

Aguggia, M; Cavallini, M; Varetto, L

2006-05-01

Primary headaches can be considered simultaneously as symptom and disease itself, while secondary headaches are expressions of a pathological process that can be systemic or locoregional. Because of its subjective features, headache is often difficult to assess and quantify by severity, frequency and invalidity rate, and for these reasons it has often been implicated in legal controversies. Headache has seldom been considered in the criminal law, except when it represents a typical symptom of a disease whose existence can be objectively assessed (i. e. raised intracranial pressure). Therefore, in civil legislation it is not yet coded to start claiming for invalidity compensation. In particular, one of the most debated medical-legal questions is represented by headaches occurring after head injury. Headache is often the principal symptom at the beginning of several toxic chronic syndromes, with many implications, especially in working claims, and, more recently, it may be referred to as one of the most frequent symptoms by victims of mobbing (i. e. psychological harassment in the workplace). The National Institute for Industrial Accident Insurance (INAIL) scales (instituted by the law 38/2000) mention the "Subjective cranial trauma syndrome" and give an invalidity rate evaluation. With reference to other headache forms, no legislation really exists at the present time, and headache is only considered as a symptom of a certain coded disease. Requests for invalidity social pension and the question of off-label prescriptions (drug prescription for a disease, without formal indication for it) are other controversial matters.

9 CFR 317.362 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2012 CFR

2012-01-01

... acids, and cholesterol content. 317.362 Section 317.362 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. Link to..., and cholesterol in a product may only be made on the label or in labeling of products if: (1) The...

9 CFR 381.462 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2012 CFR

2012-01-01

... acids, and cholesterol content. 381.462 Section 381.462 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content. Link to..., and cholesterol in a product may only be made on the label or in labeling of products if: (1) The...

Consumers’ Exposure to Nutrition and Health Claims on Pre-Packed Foods: Use of Sales Weighting for Assessing the Food Supply in Slovenia

PubMed Central

Pravst, Igor; Kušar, Anita

2015-01-01

Insights into the use of health-related information on foods are important for planning studies about the effects of such information on the consumer’s understanding, purchasing, and consumption of foods, and also support further food policy decisions. We tested the use of sales data for weighting consumers’ exposure to health-related labeling information in the Slovenian food supply. Food labeling data were collected from 6342 pre-packed foods available in four different food stores in Slovenia. Consumers’ exposure was calculated as the percentage of available food products with particular food information in the food category. In addition, 12-month sales data were used to calculate sales weighted exposure as a percentage of sold food products with certain food information in the food category. The consumer’s in-store and sales-weighted exposure to nutrition claims was 37% and 45%, respectively. Exposure to health claims was much lower (13%, 11% when sales-weighted). Health claims were mainly found in the form of general non-specific claims or function claims, while children’s development and reduction of disease risk claims were present on only 0.1% and 0.2% of the investigated foods, respectively. Sales data were found very useful for establishing a reliable estimation of consumers’ exposure to information provided on food labels. The high penetration of health-related information on food labels indicates that careful regulation of this area is appropriate. Further studies should focus on assessing the nutritional quality of foods labeled with nutrition and health claims, and understanding the importance of such labeling techniques for consumers’ food preferences and choices. PMID:26569301

Nutritional quality of packaged foods targeted at children in Brazil: which ones should be eligible to bear nutrient claims?

PubMed

Rodrigues, V M; Rayner, M; Fernandes, A C; de Oliveira, R C; Proença, R P C; Fiates, G M R

2017-01-01

This study aimed to assess the nutritional quality of food products marketed at children, with and without nutrient claims, using two different approaches. Analyses were performed based on a data set with food composition and labelling data from every packaged food marketed at children sold in a major Brazilian supermarket (n=535). Foods were classified as 'healthier' and 'less healthy' according to the UK/Ofcom nutrient profile model and to the NOVA classification based on the level of food processing. Pearson's χ 2 test was used to compare proportions between models. Agreement was assessed using Cohen's κ-statistic (P<0.05). The NOVA model was stricter than the UK/Ofcom model, classifying more products as 'less healthy' (91.4%) compared with the nutrient profile-based model (75.0%; P<0.001). Agreement between models was 79.4% (k=0.30), because 72.9% (n=390) of products were categorised as 'less healthy' by both models, and 6.5% (n=35) as 'healthier'. Half of the food products marketed at children from the database (270; 50.5%) bore nutrient claims. From these products with nutrient claims, 95.9% (92.8-98.0) were classified as 'less healthy' by the NOVA model, whereas this percentage was 74.1% (68.4-79.2) according to the UK/Ofcom model (P<0.05). The high number of foods with low nutritional quality being marketed at children via product packaging and nutrient claims should be of concern to policy makers wanting to improve children's diets and to tackle childhood obesity. The implementation of nutritional quality criteria to ensure that foods targeted at children should be eligible to bear nutrient claims on their labels could avoid a situation where claims mask the overall nutritional status of a food.

Validation of an administrative claims-based diagnostic code for pneumonia in a US-based commercially insured COPD population.

PubMed

Kern, David M; Davis, Jill; Williams, Setareh A; Tunceli, Ozgur; Wu, Bingcao; Hollis, Sally; Strange, Charlie; Trudo, Frank

2015-01-01

To estimate the accuracy of claims-based pneumonia diagnoses in COPD patients using clinical information in medical records as the reference standard. Selecting from a repository containing members' data from 14 regional United States health plans, this validation study identified pneumonia diagnoses within a group of patients initiating treatment for COPD between March 1, 2009 and March 31, 2012. Patients with ≥1 claim for pneumonia (International Classification of Diseases Version 9-CM code 480.xx-486.xx) were identified during the 12 months following treatment initiation. A subset of 800 patients was randomly selected to abstract medical record data (paper based and electronic) for a target sample of 400 patients, to estimate validity within 5% margin of error. Positive predictive value (PPV) was calculated for the claims diagnosis of pneumonia relative to the reference standard, defined as a documented diagnosis in the medical record. A total of 388 records were reviewed; 311 included a documented pneumonia diagnosis, indicating 80.2% (95% confidence interval [CI]: 75.8% to 84.0%) of claims-identified pneumonia diagnoses were validated by the medical charts. Claims-based diagnoses in inpatient or emergency departments (n=185) had greater PPV versus outpatient settings (n=203), 87.6% (95% CI: 81.9%-92.0%) versus 73.4% (95% CI: 66.8%-79.3%), respectively. Claims-diagnoses verified with paper-based charts had similar PPV as the overall study sample, 80.2% (95% CI: 71.1%-87.5%), and higher PPV than those linked to electronic medical records, 73.3% (95% CI: 65.5%-80.2%). Combined paper-based and electronic records had a higher PPV, 87.6% (95% CI: 80.9%-92.6%). Administrative claims data indicating a diagnosis of pneumonia in COPD patients are supported by medical records. The accuracy of a medical record diagnosis of pneumonia remains unknown. With increased use of claims data in medical research, COPD researchers can study pneumonia with confidence that claims

9 CFR 381.462 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2011 CFR

2011-01-01

... acids, and cholesterol content. 381.462 Section 381.462 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content. Link to... level of fat, fatty acid, and cholesterol in a product may only be made on the label or in labeling of...

9 CFR 317.362 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2011 CFR

2011-01-01

... acids, and cholesterol content. 317.362 Section 317.362 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. Link to... level of fat, fatty acid, and cholesterol in a product may only be made on the label or in labeling of...

Interpreting labels of abuse-deterrent opioid analgesics.

PubMed

Webster, Lynn R

To provide an overview of available abuse-deterrent opioids (ADOs) and the labeling text that describes abuse-deterrent (AD) properties. A nonsystematic review of ADO literature and regulatory documents guiding their development. A critical assessment and discussion of common routes of opioid abuse, AD methods and properties, US Food and Drug Administration (FDA) study requirements to achieve AD labeling, and brief guide to understanding AD labels. The FDA has issued guidance as incentive and direction to industry to develop ADOs as one component of a multi-pronged public-health strategy to combat opioid abuse and misuse. The guidance describes separate categories of premarket and postmarket studies and makes recommendations for claims that may be made based on study findings. Ten ADOs have FDA-approved labeling attesting to AD properties. Available formulations that fail to conform to FDA guidance in study and labeling recommendations cannot be considered ADO. Formulations with AD properties are expected to reduce risk compared to the same agents without AD properties but cannot prevent all abuse and adverse clinical outcomes.

16 CFR 460.20 - R-value per inch claims.

Code of Federal Regulations, 2014 CFR

2014-01-01

... HOME INSULATION § 460.20 R-value per inch claims. In labels, fact sheets, ads, or other promotional... here, you can petition to amend the order. (b) You can do this if actual test results prove that the R...

16 CFR 460.20 - R-value per inch claims.

Code of Federal Regulations, 2012 CFR

2012-01-01

... HOME INSULATION § 460.20 R-value per inch claims. In labels, fact sheets, ads, or other promotional... here, you can petition to amend the order. (b) You can do this if actual test results prove that the R...

16 CFR 460.20 - R-value per inch claims.

Code of Federal Regulations, 2013 CFR

2013-01-01

... HOME INSULATION § 460.20 R-value per inch claims. In labels, fact sheets, ads, or other promotional... here, you can petition to amend the order. (b) You can do this if actual test results prove that the R...

16 CFR 460.20 - R-value per inch claims.

Code of Federal Regulations, 2011 CFR

2011-01-01

... HOME INSULATION § 460.20 R-value per inch claims. In labels, fact sheets, ads, or other promotional... here, you can petition to amend the order. (b) You can do this if actual test results prove that the R...

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...

A transversal approach for patch-based label fusion via matrix completion

PubMed Central

Sanroma, Gerard; Wu, Guorong; Gao, Yaozong; Thung, Kim-Han; Guo, Yanrong; Shen, Dinggang

2015-01-01

Recently, multi-atlas patch-based label fusion has received an increasing interest in the medical image segmentation field. After warping the anatomical labels from the atlas images to the target image by registration, label fusion is the key step to determine the latent label for each target image point. Two popular types of patch-based label fusion approaches are (1) reconstruction-based approaches that compute the target labels as a weighted average of atlas labels, where the weights are derived by reconstructing the target image patch using the atlas image patches; and (2) classification-based approaches that determine the target label as a mapping of the target image patch, where the mapping function is often learned using the atlas image patches and their corresponding labels. Both approaches have their advantages and limitations. In this paper, we propose a novel patch-based label fusion method to combine the above two types of approaches via matrix completion (and hence, we call it transversal). As we will show, our method overcomes the individual limitations of both reconstruction-based and classification-based approaches. Since the labeling confidences may vary across the target image points, we further propose a sequential labeling framework that first labels the highly confident points and then gradually labels more challenging points in an iterative manner, guided by the label information determined in the previous iterations. We demonstrate the performance of our novel label fusion method in segmenting the hippocampus in the ADNI dataset, subcortical and limbic structures in the LONI dataset, and mid-brain structures in the SATA dataset. We achieve more accurate segmentation results than both reconstruction-based and classification-based approaches. Our label fusion method is also ranked 1st in the online SATA Multi-Atlas Segmentation Challenge. PMID:26160394

16 CFR 260.9 - Free-of claims.

Code of Federal Regulations, 2014 CFR

2014-01-01

... intentionally to the product. Example 1: A package of t-shirts is labeled “Shirts made with a chlorine-free bleaching process.” The shirts, however, are bleached with a process that releases a reduced, but still... substantiated claim, however, that the shirts were “bleached with a process that releases 50% less of the...

16 CFR 260.9 - Free-of claims.

Code of Federal Regulations, 2013 CFR

2013-01-01

... intentionally to the product. Example 1: A package of t-shirts is labeled “Shirts made with a chlorine-free bleaching process.” The shirts, however, are bleached with a process that releases a reduced, but still... substantiated claim, however, that the shirts were “bleached with a process that releases 50% less of 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...

Validation of an administrative claims-based diagnostic code for pneumonia in a US-based commercially insured COPD population

PubMed Central

Kern, David M; Davis, Jill; Williams, Setareh A; Tunceli, Ozgur; Wu, Bingcao; Hollis, Sally; Strange, Charlie; Trudo, Frank

2015-01-01

Objective To estimate the accuracy of claims-based pneumonia diagnoses in COPD patients using clinical information in medical records as the reference standard. Methods Selecting from a repository containing members’ data from 14 regional United States health plans, this validation study identified pneumonia diagnoses within a group of patients initiating treatment for COPD between March 1, 2009 and March 31, 2012. Patients with ≥1 claim for pneumonia (International Classification of Diseases Version 9-CM code 480.xx–486.xx) were identified during the 12 months following treatment initiation. A subset of 800 patients was randomly selected to abstract medical record data (paper based and electronic) for a target sample of 400 patients, to estimate validity within 5% margin of error. Positive predictive value (PPV) was calculated for the claims diagnosis of pneumonia relative to the reference standard, defined as a documented diagnosis in the medical record. Results A total of 388 records were reviewed; 311 included a documented pneumonia diagnosis, indicating 80.2% (95% confidence interval [CI]: 75.8% to 84.0%) of claims-identified pneumonia diagnoses were validated by the medical charts. Claims-based diagnoses in inpatient or emergency departments (n=185) had greater PPV versus outpatient settings (n=203), 87.6% (95% CI: 81.9%–92.0%) versus 73.4% (95% CI: 66.8%–79.3%), respectively. Claims-diagnoses verified with paper-based charts had similar PPV as the overall study sample, 80.2% (95% CI: 71.1%–87.5%), and higher PPV than those linked to electronic medical records, 73.3% (95% CI: 65.5%–80.2%). Combined paper-based and electronic records had a higher PPV, 87.6% (95% CI: 80.9%–92.6%). Conclusion Administrative claims data indicating a diagnosis of pneumonia in COPD patients are supported by medical records. The accuracy of a medical record diagnosis of pneumonia remains unknown. With increased use of claims data in medical research, COPD researchers

FDA: polyurethane condom carries "extremely misleading" label. Federal agency allows distribution for public health's sake.

PubMed

1995-02-01

The labeling of the Avanti polyurethane condom selling in 10 Western states makes misleading claims about protection from pregnancy and sexually transmitted diseases (STDs) according to officials at the US Food and Drug Administration (FDA). Avanti is sold in a foil package printed with the claim that it is effective against pregnancy, HIV, and STDs. However, polyurethane condoms have not undergone clinical efficacy testing for contraception or STDs, according to officials. The manufacturer of the condom refuted this allegation, stating that latex condoms have the same claims on them. In early 1995 the FDA met with the manufacturer and other companies developing plastic condoms, and concluded that these condoms could not make such claims, nor any claims about slippage and breakage rates. Despite warnings in 1993 to the manufacturer of Avanti about labeling restrictions, the company printed pregnancy and STD efficacy claims on the boxes and individual packages. The FDA later worked out a compromise with the firm in which only the boxes had to be reprinted with the generic label. The FDA had to weigh the risk of the public health cost of delaying sale of the condom, which is the first impermeable condom proven safe for people with latex allergies. In 1991 the FDA was defining standards for clinical testing and labeling of polyurethane condoms under congressional mandate, but the manufacturer of Avanti began mass production based on a preliminary approval determining that the condom was equivalent to latex condoms already on the market. 7000 Avanti condoms were subsequently tested in five countries, but these user tests did not compare Avanti to latex condoms and did not test for pregnancy and STD protection. Test results submitted to the FDA by the company indicated that, although Avanti is more than 1/3 less elastic than latex condoms, it did not break more frequently in an in-use study involving 187 couples.

Consumer attitudes and understanding of low-sodium claims on food: an analysis of healthy and hypertensive individuals.

PubMed

Wong, Christina L; Arcand, JoAnne; Mendoza, Julio; Henson, Spencer J; Qi, Ying; Lou, Wendy; L'Abbé, Mary R

2013-06-01

Sodium-related claims on food labels should facilitate lower-sodium food choices; however, consumer attitudes and understanding of such claims are unknown. We evaluated consumer attitudes and understanding of different types of sodium claims and the effect of having hypertension on responses to such claims. Canadian consumers (n = 506), with and without hypertension, completed an online survey that contained a randomized mock-package experiment, which tested 4 packages that differed only by the claims they carried as follows: 3 sodium claims (disease risk reduction, function, and nutrient-content claims) and a tastes-great claim (control). Participants answered the same questions on attitudes and understanding of claims after seeing each package. Food packages with any sodium claim resulted in more positive attitudes toward the claim and the product healthfulness than did packages with the taste control claim, although all mock packages were identical nutritionally. Having hypertension increased ratings related to product healthfulness and purchase intentions, but there was no difference in reported understanding between hypertensives and normotensives. In general, participants attributed additional health benefits to low-sodium products beyond the well-established relation of sodium and hypertension. Sodium claims have the potential to facilitate lower-sodium food choices. However, we caution that consumers do not seem to differentiate between different types of claims, but the nutritional profiles of foods that carry different sodium claims can potentially differ greatly in the current labeling environment. Additional educational efforts are needed to ensure that consumers do not attribute inappropriate health benefits to foods with low-sodium claims. This trial was registered at clinicaltrials.gov as NCT01764724.

9 CFR 317.362 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2013 CFR

2013-01-01

... acids, and cholesterol content. 317.362 Section 317.362 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be...

9 CFR 381.462 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2013 CFR

2013-01-01

... acids, and cholesterol content. 381.462 Section 381.462 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content. (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be...

9 CFR 381.462 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2014 CFR

2014-01-01

... acids, and cholesterol content. 381.462 Section 381.462 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content. (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be...

9 CFR 317.362 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2014 CFR

2014-01-01

... acids, and cholesterol content. 317.362 Section 317.362 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be...

What's in a name: the Vermont Genetically Engineered Food Labeling Act

PubMed Central

McPherson, Malia J.

2014-01-01

On May 8, 2014, Vermont passed the Vermont Genetically Engineered Food Labeling Act (Act) requiring labels on certain genetically engineered foods. Once the bill takes effect July 1, 2016, all Vermont-retailed foods with more than 0.9% of their total weight in genetically modified ingredients must be labeled with language stating, “may be partially produced with genetic engineering.” As genetically engineered food are considered scientifically equivalent to their traditional counterparts and are not subject to federal labeling by the FDA, the Act presents several legal questions. Several of the legal questions have been raised in a recent lawsuit filed by the Grocery Manufactures Association that claims the Act violates the First Amendment, Supremacy Clause, and Commerce Clause. This paper will discuss why the Second Circuit could strike down the Act as unconstitutional as to each claim. PMID:27774175

Focus on Food Labeling. An FDA Consumer Special Report.

ERIC Educational Resources Information Center

Food and Drug Administration (DHHS/PHS), Washington, DC.

This special issue is designed for those who want to know all they can about the new federal requirements for nutrition information on food labels. Nine articles are included. "Good Reading for Good Eating" (Paula Kurtzweil) addresses mandatory nutrition labeling, the nutrition panel, nutrient content and health claims, and ingredient…

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.

Food claims and nutrition facts of commercial infant foods.

PubMed

Koo, Yu-Chin; Chang, Jung-Su; Chen, Yi Chun

2018-01-01

Composition claim, nutrition claim and health claim are often found on the commercial complementary food packaging. The introduction of complementary foods (CFs) to infants is a turning point in the development of their eating behavior, and their commercial use for Taiwanese infants is growing. In Taiwan, lots of the advertisements for CFs employed health or nutrition claims to promote the products, but the actual nutritional content of these CFs is not clear. The aim of this study was to compare the food claims of commercial complementary food products with their actual nutrition facts. A sample of 363 commercial CFs was collected from websites, local supermarkets, and other food stores, and their nutrition-related claims were classified into composition, nutrition, and health categories. Although the World Health Organization recommends that infants should be exclusively breastfed for the first 6 months, 48.2% of the commercial CFs were targeted at infants younger than 6 months. Therefore, marketing regulations should be implemented to curb early weaning as a result of products targeted at infants younger than 6 months. More than 50% of Taiwanese commercial CFs have high sugar content and more than 20% were high in sodium. Products with health claims, such as "provides good nutrition to children" or "improves appetite," have higher sodium or sugar content than do those without such claims. Moreover, products with calcium or iron content claims did not contain more calcium or iron than products without such claims. Additionally, a significantly greater proportion of the products with "no added sugar" claims were classified as having high sugar content as compared to those without such claims. Parents cannot choose the healthiest food products for their children by simply focusing on food claims. Government should regulate the labeling of nutrition facts and food claims for foods targeted at infants younger than 12 months.

Food claims and nutrition facts of commercial infant foods

PubMed Central

Koo, Yu-Chin; Chang, Jung-Su

2018-01-01

Composition claim, nutrition claim and health claim are often found on the commercial complementary food packaging. The introduction of complementary foods (CFs) to infants is a turning point in the development of their eating behavior, and their commercial use for Taiwanese infants is growing. In Taiwan, lots of the advertisements for CFs employed health or nutrition claims to promote the products, but the actual nutritional content of these CFs is not clear. The aim of this study was to compare the food claims of commercial complementary food products with their actual nutrition facts. A sample of 363 commercial CFs was collected from websites, local supermarkets, and other food stores, and their nutrition-related claims were classified into composition, nutrition, and health categories. Although the World Health Organization recommends that infants should be exclusively breastfed for the first 6 months, 48.2% of the commercial CFs were targeted at infants younger than 6 months. Therefore, marketing regulations should be implemented to curb early weaning as a result of products targeted at infants younger than 6 months. More than 50% of Taiwanese commercial CFs have high sugar content and more than 20% were high in sodium. Products with health claims, such as “provides good nutrition to children” or “improves appetite,” have higher sodium or sugar content than do those without such claims. Moreover, products with calcium or iron content claims did not contain more calcium or iron than products without such claims. Additionally, a significantly greater proportion of the products with “no added sugar” claims were classified as having high sugar content as compared to those without such claims. Parents cannot choose the healthiest food products for their children by simply focusing on food claims. Government should regulate the labeling of nutrition facts and food claims for foods targeted at infants younger than 12 months. PMID:29489848

21 CFR 101.91 - Gluten-free labeling of food.

Code of Federal Regulations, 2014 CFR

2014-04-01

... that has not been processed to remove gluten (e.g., wheat flour); or (3) An ingredient that is derived... is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). (b) Requirements. (1) A food that... Nutrient Content Claims nor Health Claims § 101.91 Gluten-free labeling of food. (a) Definitions. (1) The...

[Health claims made about foods: the new European regulation].

PubMed

Baelde, D

2008-01-01

Pursuant to the regulation harmonized relating to labelling, the presentation of the foodstuffs and publicity on them, the health claims made on these products should not be likely to mislead the consumer, must be able to be scientifically substantiated and it cannot be stated nor be evoked a property relating to the prevention, the treatment or the cure of a human disease. The recent publication of the European regulation concerning nutrition and health claims made on foods is a specific text, which supplements this device. The scientific evaluation of health claims allegations is centralized at the European Food Safety Authority and is preliminary to the launching of the food products. The food supplements, defined in the lawful plan in the field of the food right, are also subjected to these provisions.

Persistent use of against-label statin-fibrate combinations from 2003-2009 despite United States Food and Drug Administration dose restrictions.

PubMed

Alford, Julie C; Saseen, Joseph J; Allen, Richard R; Nair, Kavita V

2012-07-01

To describe the prevalence of prescribing against-label statin-fibrate combination therapy. Retrospective cohort study. Medstat MarketScan Commercial Claims and Encounter database. Adults (aged 18-89 yrs) who were prescribed statin-fibrate combination therapy between January 1, 2003, and June 30, 2009, had pharmacy claims demonstrating two or more concurrently filled prescriptions for a statin and a fibrate, and had continuous insurance enrollment for at least 12 months. Claims data were used to identify patients with dyslipidemia based on International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes. National Drug Codes were used to describe concurrent statin-fibrate combination therapy. The primary outcome was recent use of against-label statin-fibrate combination therapy, defined as use during the last 18 months (January 1, 2008-June 30, 2009) of the study period. Patients were stratified according to statin and dosage to identify against-label combination use (e.g., simvastatin > 10 mg/day with gemfibrozil). Within the recent-use period, 131,394 patients were prescribed concurrent statin-fibrate combination therapy; of these patients, 13,420 (10.2%) had against-label therapy. Simvastatin-gemfibrozil accounted for 8978 (66.9%) of all against-label combinations. Of all 9877 simvastatin-gemfibrozil combinations prescribed in the recent-use period (both on-label and against-label use), 8978 (90.9%) were against label. The secondary outcome was prevalence of against-label statin-fibrate combination therapy on an annual basis: 15.5% in 2003, 18.7% in 2004, 9.1% in 2005, 8.3% in 2006, 9.2% in 2007, and 9.8% in 2008. Against-label statin-fibrate combination therapy continues to be prescribed despite established United States Food and Drug Administration (FDA) dose restrictions. Nearly every time the simvastatin-gemfibrozil combination was prescribed, it was against label because simvastatin exceeded the maximum dose restriction

Toddler drinks, formulas, and milks: Labeling practices and policy implications.

PubMed

Pomeranz, Jennifer L; Romo Palafox, Maria J; Harris, Jennifer L

2018-04-01

Toddler drinks are a growing category of drinks marketed for young children 9-36 months old. Medical experts do not recommend them, and public health experts raise concerns about misleading labeling practices. In the U.S., the toddler drink category includes two types of products: transition formulas, marketed for infants and toddlers 9-24 months; and toddler milks, for children 12-36 months old. The objective of this study was to evaluate toddler drink labeling practices in light of U.S. food labeling policy and international labeling recommendations. In January 2017, we conducted legal research on U.S. food label laws and regulations; collected and evaluated toddler drink packages, including nutrition labels and claims; and compared toddler drink labels with the same brand's infant formula labels. We found that the U.S. has a regulatory structure for food labels and distinct policies for infant formula, but no laws specific to toddler drinks. Toddler drink labels utilized various terms and images to identify products and intended users; made multiple health and nutrition claims; and some stated there was scientific or expert support for the product. Compared to the same manufacturer's infant formula labels, most toddler drink labels utilized similar colors, branding, logos, and graphics. Toddler drink labels may confuse consumers about their nutrition and health benefits and the appropriateness of these products for young children. To support healthy toddler diets and well-informed decision-making by caregivers, the FDA can provide guidance or propose regulations clarifying permissible toddler drink labels and manufacturers should end inappropriate labeling practices. Copyright © 2018 Elsevier Inc. All rights reserved.

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

Multi-label literature classification based on the Gene Ontology graph.

PubMed

Jin, Bo; Muller, Brian; Zhai, Chengxiang; Lu, Xinghua

2008-12-08

The Gene Ontology is a controlled vocabulary for representing knowledge related to genes and proteins in a computable form. The current effort of manually annotating proteins with the Gene Ontology is outpaced by the rate of accumulation of biomedical knowledge in literature, which urges the development of text mining approaches to facilitate the process by automatically extracting the Gene Ontology annotation from literature. The task is usually cast as a text classification problem, and contemporary methods are confronted with unbalanced training data and the difficulties associated with multi-label classification. In this research, we investigated the methods of enhancing automatic multi-label classification of biomedical literature by utilizing the structure of the Gene Ontology graph. We have studied three graph-based multi-label classification algorithms, including a novel stochastic algorithm and two top-down hierarchical classification methods for multi-label literature classification. We systematically evaluated and compared these graph-based classification algorithms to a conventional flat multi-label algorithm. The results indicate that, through utilizing the information from the structure of the Gene Ontology graph, the graph-based multi-label classification methods can significantly improve predictions of the Gene Ontology terms implied by the analyzed text. Furthermore, the graph-based multi-label classifiers are capable of suggesting Gene Ontology annotations (to curators) that are closely related to the true annotations even if they fail to predict the true ones directly. A software package implementing the studied algorithms is available for the research community. Through utilizing the information from the structure of the Gene Ontology graph, the graph-based multi-label classification methods have better potential than the conventional flat multi-label classification approach to facilitate protein annotation based on the literature.

Simvastatin prescribing patterns before and after FDA dosing restrictions: a retrospective analysis of a large healthcare claims database.

PubMed

Tuchscherer, Rhianna M; Nair, Kavita; Ghushchyan, Vahram; Saseen, Joseph J

2015-02-01

Muscle-related events, or myopathies, are a commonly reported adverse event associated with statin use. In June 2011, the US FDA released a Drug Safety Communication that provided updated product labeling with dosing restrictions for simvastatin to minimize the risk of myopathies. Our objective was to describe prescribing patterns of simvastatin in combination with medications known to increase the risk of myopathies following updated product labeling dosing restrictions in June 2011. A retrospective observational analysis was carried out, in which administrative claims data were utilized to identify prescribing patterns of simvastatin in combination with calcium channel blockers (CCBs) and other pre-specified drug therapies. Prescribing patterns were analyzed on a monthly basis 24 months prior to and 9 months following product label changes. Incidence of muscle-related events was also analyzed. In June 2011, a total of 60% of patients with overlapping simvastatin-CCB claims and 94% of patients with overlapping simvastatin-non-CCB claims were prescribed an against-label combination. As of March 2012, a total of 41% and 93% of patients continued to be prescribed against-label simvastatin-CCB and simvastatin-non-CCB combinations, respectively. The most commonly prescribed dose of simvastatin was 20 mg (39%). Against-label combinations were most commonly prescribed at a simvastatin dose of 40 mg (56%). Amlodipine was the most commonly prescribed CCB in combination with simvastatin (70%) and the most common CCB prescribed against-label (67%). Despite improvements in prescribing practices, many patients are still exposed to potentially harmful simvastatin combinations. Aggressive changes in simvastatin prescribing systems and processes are needed to improve compliance with FDA labeling to improve medication and patient safety.

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.

21 CFR 101.10 - Nutrition labeling of restaurant foods.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Nutrition labeling of restaurant foods. 101.10... restaurant foods. Nutrition labeling in accordance with § 101.9 shall be provided upon request for any restaurant food or meal for which a nutrient content claim (as defined in § 101.13 or in subpart D of this...

Label propagation algorithm for community detection based on node importance and label influence

NASA Astrophysics Data System (ADS)

Zhang, Xian-Kun; Ren, Jing; Song, Chen; Jia, Jia; Zhang, Qian

2017-09-01

Recently, the detection of high-quality community has become a hot spot in the research of social network. Label propagation algorithm (LPA) has been widely concerned since it has the advantages of linear time complexity and is unnecessary to define objective function and the number of community in advance. However, LPA has the shortcomings of uncertainty and randomness in the label propagation process, which affects the accuracy and stability of the community. For large-scale social network, this paper proposes a novel label propagation algorithm for community detection based on node importance and label influence (LPA_NI). The experiments with comparative algorithms on real-world networks and synthetic networks have shown that LPA_NI can significantly improve the quality of community detection and shorten the iteration period. Also, it has better accuracy and stability in the case of similar complexity.

Effects of alternative label formats on choice of high- and low-sodium products in a New Zealand population sample.

PubMed

McLean, Rachael; Hoek, Janet; Hedderley, Duncan

2012-05-01

Dietary sodium reduction is a cost-effective public health intervention to reduce chronic disease. In response to calls for further research into front-of-pack labelling systems, we examined how alternative sodium nutrition label formats and nutrition claims influenced consumers' choice behaviour and whether consumers with or without a diagnosis of hypertension differed in their choice patterns. An anonymous online experiment in which participants viewed ten choice sets featuring three fictitious brands of baked beans with varied label formats and nutritional profiles (high and low sodium) and indicated which brand in each set they would purchase if shopping for this product. Participants were recruited from New Zealand's largest online nationwide research panel. Five hundred people with self-reported hypertension and 191 people without hypertension aged 18 to 79 years. The addition of a front-of-pack label increased both groups' ability to discriminate between products with high and low sodium, while the Traffic Light label enabled better identification of the high-sodium product. Both front-of-pack formats enhanced discrimination in the presence of a reduced salt claim, but the Traffic Light label also performed better than the Percentage Daily Intake label in moderating the effect of the claim for the high-sodium product. Front-of-pack labels, particularly those with simple visual cues, enhance consumers' ability to discriminate between high- and low-sodium products, even when those products feature nutrition claims.

Unwarranted claims of drug efficacy in pharmaceutical sales visits: are drugs approved on the basis of surrogate outcomes promoted appropriately?

PubMed

Habibi, Roojin; Lexchin, Joel; Mintzes, Barbara; Holbrook, Anne

2017-11-01

This study compares physicians' recall of the claims of benefits on cardiovascular disease and diabetes made by pharmaceutical sales representatives for drugs approved on the basis of a surrogate outcome, i.e., an off-label claim, compared with those approved on the basis of a serious morbidity or mortality (clinical) outcome. Physicians in primary care practices in Montreal, Vancouver, Sacramento and Toulouse, who saw sales representatives as part of their usual practice and served a non-referral population, were contacted in blocks of 25 from a randomized list of all physicians practising in the relevant metropolitan area. We compared how frequently physicians reported that sales reps made claims of serious morbidity or mortality (clinically meaningful) benefits for drugs approved on the basis of surrogate outcomes vs. drugs approved on the basis of clinical outcomes. There were 448 promotions for 58 unique brand name cardiovascular and diabetes drugs. Claims of clinically meaningful benefit were reported in 156 (45%) of the 347 promotions for surrogate outcome drugs, constituting unwarranted efficacy claims, i.e., off-label promotion. Claims of clinical benefit were reported in 72 of the 101 promotions (71%) for drugs approved on the basis of clinical outcomes, adjusted OR = 0.3 (95% CI 0.2, 0.6), P < 0.001. Claims of efficacy made in sales visit promotions for drugs approved only on the basis of surrogate outcomes extended beyond the regulator-approved efficacy information for the product in almost half of promotions. Unapproved claims of drug efficacy constitute a form of off-label promotion and merit greater attention from regulators. © 2017 The British Pharmacological Society.

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.

PRN 96-4: Label Statements Involving Product Efficacy and Potential for Harm to Property

EPA Pesticide Factsheets

This notice explains EPA procedures in approving pesticide labels that include claims relating to the efficacy of agricultural pesticides and provides a warning to growers regarding reliance on label statements regarding pesticide efficacy.

Interpretive front-of-pack nutrition labels. Comparing competing recommendations.

PubMed

Maubach, Ninya; Hoek, Janet; Mather, Damien

2014-11-01

Many stakeholders support introducing an interpretive front-of-pack (FOP) nutrition label, but disagree over the form it should take. In late 2012, an expert working group established by the New Zealand government recommended the adoption of an untested summary rating system: a Star label. This study used a best-worst scaling choice experiment to estimate how labels featuring the new Star rating, the Multiple Traffic Light (MTL), Daily Intake Guide (DIG), and a no-FOP control affected consumers' choice behaviours and product perceptions. Nutrient-content and health claims were included in the design. We also assessed whether respondents who used more or less information during the choice tasks differed in their selection patterns. Overall, while respondents made broadly similar choices with respect to the MTL and Star labels, the MTL format had a significantly greater impact on depressing preference as a food's nutritional profile became less healthy. Health claims increased rankings of less nutritious options, though this effect was less pronounced when the products featured an MTL. Further, respondents were best able to differentiate products' healthiness with MTL labels. The proposed summary Stars system had less effect on choice patterns than an MTL label and our findings highlight the need for policy makers to ensure that decisions to introduce FOP labels are underpinned by robust research evidence. These results suggest that the proposed summary Stars system will have less effect on shifting food choice patterns than interpretive FOP nutrition label featuring traffic light ratings. Copyright © 2014 Elsevier Ltd. All rights reserved.

Hydrogen sulfide deactivates common nitrobenzofurazan-based fluorescent thiol labeling reagents.

PubMed

Montoya, Leticia A; Pluth, Michael D

2014-06-17

Sulfhydryl-containing compounds, including thiols and hydrogen sulfide (H2S), play important but differential roles in biological structure and function. One major challenge in separating the biological roles of thiols and H2S is developing tools to effectively separate the reactivity of these sulfhydryl-containing compounds. To address this challenge, we report the differential responses of common electrophilic fluorescent thiol labeling reagents, including nitrobenzofurazan-based scaffolds, maleimides, alkylating agents, and electrophilic aldehydes, toward cysteine and H2S. Although H2S reacted with all of the investigated scaffolds, the photophysical response to each scaffold was significantly different. Maleimide-based, alkylating, and aldehydic thiol labeling reagents provided a diminished fluorescence response when treated with H2S. By contrast, nitrobenzofurazan-based labeling reagents were deactivated by H2S addition. Furthermore, the addition of H2S to thiol-activated nitrobenzofurazan-based reagents reduced the fluorescence signal, thus establishing the incompatibility of nitrobenzofurazan-based thiol labeling reagents in the presence of H2S. Taken together, these studies highlight the differential reactivity of thiols and H2S toward common thiol-labeling reagents and suggest that sufficient care must be taken when labeling or measuring thiols in cellular environments that produce H2S due to the potential for both false-positive and eroded responses.

A label distance maximum-based classifier for multi-label learning.

PubMed

Liu, Xiaoli; Bao, Hang; Zhao, Dazhe; Cao, Peng

2015-01-01

Multi-label classification is useful in many bioinformatics tasks such as gene function prediction and protein site localization. This paper presents an improved neural network algorithm, Max Label Distance Back Propagation Algorithm for Multi-Label Classification. The method was formulated by modifying the total error function of the standard BP by adding a penalty term, which was realized by maximizing the distance between the positive and negative labels. Extensive experiments were conducted to compare this method against state-of-the-art multi-label methods on three popular bioinformatic benchmark datasets. The results illustrated that this proposed method is more effective for bioinformatic multi-label classification compared to commonly used techniques.

Method for rapid base sequencing in DNA and RNA with two base labeling

DOEpatents

Jett, James H.; Keller, Richard A.; Martin, John C.; Posner, Richard G.; Marrone, Babetta L.; Hammond, Mark L.; Simpson, Daniel J.

1995-01-01

Method for rapid-base sequencing in DNA and RNA with two-base labeling and employing fluorescent detection of single molecules at two wavelengths. Bases modified to accept fluorescent labels are used to replicate a single DNA or RNA strand to be sequenced. The bases are then sequentially cleaved from the replicated strand, excited with a chosen spectrum of electromagnetic radiation, and the fluorescence from individual, tagged bases detected in the order of cleavage from the strand.

37 CFR 1.75 - Claim(s).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Claim(s). 1.75 Section 1.75 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Specification § 1.75 Claim(s). (a...

37 CFR 1.75 - Claim(s).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Claim(s). 1.75 Section 1.75 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Specification § 1.75 Claim(s). (a...

38 CFR 3.313 - Claims based on service in Vietnam.

Code of Federal Regulations, 2013 CFR

2013-07-01

... in Vietnam. 3.313 Section 3.313 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS... Evaluations; Service Connection § 3.313 Claims based on service in Vietnam. (a) Service in Vietnam. Service in Vietnam includes service in the waters offshore, or service in other locations if the conditions of...

38 CFR 3.313 - Claims based on service in Vietnam.

Code of Federal Regulations, 2012 CFR

2012-07-01

... in Vietnam. 3.313 Section 3.313 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS... Evaluations; Service Connection § 3.313 Claims based on service in Vietnam. (a) Service in Vietnam. Service in Vietnam includes service in the waters offshore, or service in other locations if the conditions of...

38 CFR 3.313 - Claims based on service in Vietnam.

Code of Federal Regulations, 2010 CFR

2010-07-01

... in Vietnam. 3.313 Section 3.313 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS... Evaluations; Service Connection § 3.313 Claims based on service in Vietnam. (a) Service in Vietnam. Service in Vietnam includes service in the waters offshore, or service in other locations if the conditions of...

38 CFR 3.313 - Claims based on service in Vietnam.

Code of Federal Regulations, 2014 CFR

2014-07-01

... in Vietnam. 3.313 Section 3.313 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS... Evaluations; Service Connection § 3.313 Claims based on service in Vietnam. (a) Service in Vietnam. Service in Vietnam includes service in the waters offshore, or service in other locations if the conditions of...

38 CFR 3.313 - Claims based on service in Vietnam.

Code of Federal Regulations, 2011 CFR

2011-07-01

... in Vietnam. 3.313 Section 3.313 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS... Evaluations; Service Connection § 3.313 Claims based on service in Vietnam. (a) Service in Vietnam. Service in Vietnam includes service in the waters offshore, or service in other locations if the conditions of...

Dietary Supplements for Musculoskeletal Pain: Science Versus Claims.

PubMed

Crawford, Cindy; Saldanha, Leila; Costello, Rebecca; Deuster, Patricia A

2018-01-01

Special Operations Forces (SOF) face unique challenges that manifest themselves both mentally and physically. The extremes of training and combat can affect the readiness to perform at peak levels, especially when confronted with musculoskeletal pain. Many SOF Operators turn to dietary supplements in hopes of gaining an edge. Although some supplements are now being marketed for pain, decisions to use these products need to be driven by information that is evidence based. We describe SOF-specific evidence-based recommendations for the use of dietary ingredients for pain that emerged from a rigorous scientific evaluation. These recommendations are compared with the label claims made in the commercial market by companies selling products to combat musculoskeletal pain. This information can be used by the SOF medical community to assist Operators in making informed decisions when considering or selecting dietary supplements for maintaining and optimizing performance. 2018.

Method for rapid base sequencing in DNA and RNA with two base labeling

DOEpatents

Jett, J.H.; Keller, R.A.; Martin, J.C.; Posner, R.G.; Marrone, B.L.; Hammond, M.L.; Simpson, D.J.

1995-04-11

A method is described for rapid-base sequencing in DNA and RNA with two-base labeling and employing fluorescent detection of single molecules at two wavelengths. Bases modified to accept fluorescent labels are used to replicate a single DNA or RNA strand to be sequenced. The bases are then sequentially cleaved from the replicated strand, excited with a chosen spectrum of electromagnetic radiation, and the fluorescence from individual, tagged bases detected in the order of cleavage from the strand. 4 figures.

A concept taxonomy and an instrument hierarchy: tools for establishing and evaluating the conceptual framework of a patient-reported outcome (PRO) instrument as applied to product labeling claims.

PubMed

Erickson, Pennifer; Willke, Richard; Burke, Laurie

2009-01-01

To facilitate development and evaluation of a PRO instrument conceptual framework, we propose two tools--a PRO concept taxonomy and a PRO instrument hierarchy. FDA's draft guidance on patient reported outcome (PRO) measures states that a clear description of the conceptual framework of an instrument is useful for evaluating its adequacy to support a treatment benefit claim for use in product labeling the draft guidance, however does not propose tools for establishing or evaluating a PRO instrument's conceptual framework. We draw from our review of PRO concepts and instruments that appear in prescription drug labeling approved in the United States from 1997 to 2007. We propose taxonomy terms that define relationships between PRO concepts, including "family,"compound concept," and "singular concept." Based on the range of complexity represented by the concepts, as defined by the taxonomy, we propose nine instrument orders for PRO measurement. The nine orders range from individual event counts to multi-item, multiscale instruments. This analysis of PRO concepts and instruments illustrates that the taxonomy and hierarchy are applicable to PRO concepts across a wide range of therapeutic areas and provide a basis for defining the instrument conceptual framework complexity. Although the utility of these tools in the drug development, review, and approval processes has not yet been demonstrated, these tools could be useful to improve communication and enhance efficiency in the instrument development and review process.

Accuracy of claims-based algorithms for epilepsy research: Revealing the unseen performance of claims-based studies.

PubMed

Moura, Lidia M V R; Price, Maggie; Cole, Andrew J; Hoch, Daniel B; Hsu, John

2017-04-01

To evaluate published algorithms for the identification of epilepsy cases in medical claims data using a unique linked dataset with both clinical and claims data. Using data from a large, regional health delivery system, we identified all patients contributing biologic samples to the health system's Biobank (n = 36K). We identified all subjects with at least one diagnosis potentially consistent with epilepsy, for example, epilepsy, convulsions, syncope, or collapse, between 2014 and 2015, or who were seen at the epilepsy clinic (n = 1,217), plus a random sample of subjects with neither claims nor clinic visits (n = 435); we then performed a medical chart review in a random subsample of 1,377 to assess the epilepsy diagnosis status. Using the chart review as the reference standard, we evaluated the test characteristics of six published algorithms. The best-performing algorithm used diagnostic and prescription drug data (sensitivity = 70%, 95% confidence interval [CI] 66-73%; specificity = 77%, 95% CI 73-81%; and area under the curve [AUC] = 0.73, 95%CI 0.71-0.76) when applied to patients age 18 years or older. Restricting the sample to adults aged 18-64 years resulted in a mild improvement in accuracy (AUC = 0.75,95%CI 0.73-0.78). Adding information about current antiepileptic drug use to the algorithm increased test performance (AUC = 0.78, 95%CI 0.76-0.80). Other algorithms varied in their included data types and performed worse. Current approaches for identifying patients with epilepsy in insurance claims have important limitations when applied to the general population. Approaches incorporating a range of information, for example, diagnoses, treatments, and site of care/specialty of physician, improve the performance of identification and could be useful in epilepsy studies using large datasets. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

Label and label-free based surface-enhanced Raman scattering for pathogen bacteria detection: A review.

PubMed

Liu, Yu; Zhou, Haibo; Hu, Ziwei; Yu, Guangxia; Yang, Danting; Zhao, Jinshun

2017-08-15

Rapid, accurate detection of pathogen bacteria is a highly topical research area for the sake of food safety and public health. Surface-enhanced Raman scattering (SERS) is being considered as a powerful and attractive technique for pathogen bacteria detection, due to its sensitivity, high speed, comparatively low cost, multiplexing ability and portability. This contribution aims to give a comprehensive overview of SERS as a technique for rapid detection of pathogen bacteria based on label and label-free strategies. A brief tutorial on SERS is given first of all. Then we summarize the recent trends and developments of label and label-free based SERS applied to detection of pathogen bacteria, including the relatively complete interpretation of SERS spectra. In addition, multifunctional SERS platforms for pathogen bacteria in matrix are discussed as well. Furthermore, an outlook of the work done and a perspective on the future directions of SERS as a reliable tool for real-time pathogen bacteria detection are given. Copyright © 2017 Elsevier B.V. All rights reserved.

Homogeneous Biosensing Based on Magnetic Particle Labels

PubMed Central

Schrittwieser, Stefan; Pelaz, Beatriz; Parak, Wolfgang J.; Lentijo-Mozo, Sergio; Soulantica, Katerina; Dieckhoff, Jan; Ludwig, Frank; Guenther, Annegret; Tschöpe, Andreas; Schotter, Joerg

2016-01-01

The growing availability of biomarker panels for molecular diagnostics is leading to an increasing need for fast and sensitive biosensing technologies that are applicable to point-of-care testing. In that regard, homogeneous measurement principles are especially relevant as they usually do not require extensive sample preparation procedures, thus reducing the total analysis time and maximizing ease-of-use. In this review, we focus on homogeneous biosensors for the in vitro detection of biomarkers. Within this broad range of biosensors, we concentrate on methods that apply magnetic particle labels. The advantage of such methods lies in the added possibility to manipulate the particle labels by applied magnetic fields, which can be exploited, for example, to decrease incubation times or to enhance the signal-to-noise-ratio of the measurement signal by applying frequency-selective detection. In our review, we discriminate the corresponding methods based on the nature of the acquired measurement signal, which can either be based on magnetic or optical detection. The underlying measurement principles of the different techniques are discussed, and biosensing examples for all techniques are reported, thereby demonstrating the broad applicability of homogeneous in vitro biosensing based on magnetic particle label actuation. PMID:27275824

Block-Based Connected-Component Labeling Algorithm Using Binary Decision Trees

PubMed Central

Chang, Wan-Yu; Chiu, Chung-Cheng; Yang, Jia-Horng

2015-01-01

In this paper, we propose a fast labeling algorithm based on block-based concepts. Because the number of memory access points directly affects the time consumption of the labeling algorithms, the aim of the proposed algorithm is to minimize neighborhood operations. Our algorithm utilizes a block-based view and correlates a raster scan to select the necessary pixels generated by a block-based scan mask. We analyze the advantages of a sequential raster scan for the block-based scan mask, and integrate the block-connected relationships using two different procedures with binary decision trees to reduce unnecessary memory access. This greatly simplifies the pixel locations of the block-based scan mask. Furthermore, our algorithm significantly reduces the number of leaf nodes and depth levels required in the binary decision tree. We analyze the labeling performance of the proposed algorithm alongside that of other labeling algorithms using high-resolution images and foreground images. The experimental results from synthetic and real image datasets demonstrate that the proposed algorithm is faster than other methods. PMID:26393597

Claims-based proxies of patient instability among commercially insured adults with schizophrenia

PubMed Central

Ruetsch, Charles; Un, Hyong; Waters, Heidi C

2018-01-01

Objective Schizophrenia (Sz) patients are among the highest utilizers of hospital-based services. Prevention of relapse is in part a treatment goal in order to reduce hospital admissions. However, predicting relapse is a challenge, particularly for payers and disease management firms with only access to claims data. Understandably, such organizations have had little success predicting relapse. A tool that allows payers to identify patients at elevated risk of relapse could facilitate targeted interventions prior to relapse and avoid rehospitalization. In this study, a series of proxy measures of patient instability, calculated from claims data were examined for their utility in identifying Sz patients at elevated risk of relapse. Methods Aetna claims were used to assess the relationship between instability of Sz patients and valence and magnitude of antipsychotic (AP) medication change during a 2-year period. Six proxies of instability including hospital admissions, emergency department visits, medication utilization patterns, and use of outpatient services were identified. Results were replicated using claims data from Truven MarketScan®. Results Patients who switched AP ingredient had the highest overall instability at the point of switch and the second steepest decline in instability following switch. Those who changed to a long-acting injectable AP showed the second highest level of instability and the steepest decrease in instability following the change. Patients augmented with a second AP showed the smallest increase in instability, up to the switch. Results were directionally consistent between the two data sets. Conclusion Using claims-based proxy measures to estimate instability may provide a viable method to better understand Sz patient markers of change in disease severity. Also, such proxies could be used to identify those individuals with the greatest need for treatment modification preventing relapse, improving patient outcomes, and reducing the

9 CFR 317.354 - Nutrient content claims for “good source,” “high,” and “more.”

Code of Federal Regulations, 2014 CFR

2014-01-01

... broccoli in this meal is high in vitamin C”). (c) “Good Source” claims. (1) The terms “good source... that nutrient (excluding total carbohydrate) in § 317.309(c), may only be made on the label or in... defined in paragraph (c)(1) of this section may be used on the label or in labeling of a meal-type product...

9 CFR 381.454 - Nutrient content claims for “good source,” “high,” and “more.”

Code of Federal Regulations, 2012 CFR

2012-01-01

... broccoli in this meal is high in vitamin C”). (c) “Good Source” claims. (1) The terms “good source... that nutrient (excluding total carbohydrate) in § 381.409(c), may only be made on the label or in... defined in paragraph (c)(1) of this section may be used on the label or in labeling of a meal-type product...

9 CFR 317.354 - Nutrient content claims for “good source,” “high,” and “more.”

Code of Federal Regulations, 2012 CFR

2012-01-01

... broccoli in this meal is high in vitamin C”). (c) “Good Source” claims. (1) The terms “good source... that nutrient (excluding total carbohydrate) in § 317.309(c), may only be made on the label or in... defined in paragraph (c)(1) of this section may be used on the label or in labeling of a meal-type product...

9 CFR 381.454 - Nutrient content claims for “good source,” “high,” and “more.”

Code of Federal Regulations, 2014 CFR

2014-01-01

... broccoli in this meal is high in vitamin C”). (c) “Good Source” claims. (1) The terms “good source... that nutrient (excluding total carbohydrate) in § 381.409(c), may only be made on the label or in... defined in paragraph (c)(1) of this section may be used on the label or in labeling of a meal-type product...

Controlling for Frailty in Pharmacoepidemiologic Studies of Older Adults: Validation of an Existing Medicare Claims-based Algorithm.

PubMed

Cuthbertson, Carmen C; Kucharska-Newton, Anna; Faurot, Keturah R; Stürmer, Til; Jonsson Funk, Michele; Palta, Priya; Windham, B Gwen; Thai, Sydney; Lund, Jennifer L

2018-07-01

Frailty is a geriatric syndrome characterized by weakness and weight loss and is associated with adverse health outcomes. It is often an unmeasured confounder in pharmacoepidemiologic and comparative effectiveness studies using administrative claims data. Among the Atherosclerosis Risk in Communities (ARIC) Study Visit 5 participants (2011-2013; n = 3,146), we conducted a validation study to compare a Medicare claims-based algorithm of dependency in activities of daily living (or dependency) developed as a proxy for frailty with a reference standard measure of phenotypic frailty. We applied the algorithm to the ARIC participants' claims data to generate a predicted probability of dependency. Using the claims-based algorithm, we estimated the C-statistic for predicting phenotypic frailty. We further categorized participants by their predicted probability of dependency (<5%, 5% to <20%, and ≥20%) and estimated associations with difficulties in physical abilities, falls, and mortality. The claims-based algorithm showed good discrimination of phenotypic frailty (C-statistic = 0.71; 95% confidence interval [CI] = 0.67, 0.74). Participants classified with a high predicted probability of dependency (≥20%) had higher prevalence of falls and difficulty in physical ability, and a greater risk of 1-year all-cause mortality (hazard ratio = 5.7 [95% CI = 2.5, 13]) than participants classified with a low predicted probability (<5%). Sensitivity and specificity varied across predicted probability of dependency thresholds. The Medicare claims-based algorithm showed good discrimination of phenotypic frailty and high predictive ability with adverse health outcomes. This algorithm can be used in future Medicare claims analyses to reduce confounding by frailty and improve study validity.

37 CFR 1.75 - Claim(s).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Claim(s). 1.75 Section 1.75... GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Specification § 1.75 Claim(s). (a.... (35 U.S.C. 6; 15 U.S.C. 1113, 1126) [31 FR 12922, Oct. 4, 1966, as amended at 36 FR 12690, July 3...

Are Front of Pack Claims Indicators of Nutrition Quality? Evidence from 2 Product Categories.

PubMed

Schaefer, Debra; Hooker, Neal H; Stanton, John L

2016-01-01

American grocery shoppers face an array of front of pack (FOP) nutrition and health claims when making food selections. Such systems have been categorized as summary or nutrient specific. Either type should help consumers make judgments about the nutrition quality of a product. This research tests if the type or quantity of FOP claims are indeed good indicators of objective nutrition quality. Claim and nutrition information from more than 2200 breakfast cereals and prepared meals launched between 2006 and 2010 were analyzed using binary and multinomial logistic regression models. Results suggest that no type or number of front of pack claims could distinguish "healthy" foods. However, some types and frequencies of FOP claims were significant predictors of higher or lower levels of certain key nutrients. Given the complex and crowded label environment in which these FOP claims reside, one may be concerned that such cues are not closely related to objective measures of nutrition quality. © 2015 Institute of Food Technologists®

Comparison of two data mining techniques in labeling diagnosis to Iranian pharmacy claim dataset: artificial neural network (ANN) versus decision tree model.

PubMed

Rezaei-Darzi, Ehsan; Farzadfar, Farshad; Hashemi-Meshkini, Amir; Navidi, Iman; Mahmoudi, Mahmoud; Varmaghani, Mehdi; Mehdipour, Parinaz; Soudi Alamdari, Mahsa; Tayefi, Batool; Naderimagham, Shohreh; Soleymani, Fatemeh; Mesdaghinia, Alireza; Delavari, Alireza; Mohammad, Kazem

2014-12-01

This study aimed to evaluate and compare the prediction accuracy of two data mining techniques, including decision tree and neural network models in labeling diagnosis to gastrointestinal prescriptions in Iran. This study was conducted in three phases: data preparation, training phase, and testing phase. A sample from a database consisting of 23 million pharmacy insurance claim records, from 2004 to 2011 was used, in which a total of 330 prescriptions were assessed and used to train and test the models simultaneously. In the training phase, the selected prescriptions were assessed by both a physician and a pharmacist separately and assigned a diagnosis. To test the performance of each model, a k-fold stratified cross validation was conducted in addition to measuring their sensitivity and specificity. Generally, two methods had very similar accuracies. Considering the weighted average of true positive rate (sensitivity) and true negative rate (specificity), the decision tree had slightly higher accuracy in its ability for correct classification (83.3% and 96% versus 80.3% and 95.1%, respectively). However, when the weighted average of ROC area (AUC between each class and all other classes) was measured, the ANN displayed higher accuracies in predicting the diagnosis (93.8% compared with 90.6%). According to the result of this study, artificial neural network and decision tree model represent similar accuracy in labeling diagnosis to GI prescription.

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...

32 CFR 536.120 - Claims payable as maritime claims.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 3 2010-07-01 2010-07-01 true Claims payable as maritime claims. 536.120... ACCOUNTS CLAIMS AGAINST THE UNITED STATES Maritime Claims § 536.120 Claims payable as maritime claims. A claim is cognizable under this subpart if it arises in or on a maritime location, involves some...

The evidence base for 'own label' resin-based dental restoratives.

PubMed

Burke, F J Trevor

2013-01-01

There is anecdotal evidence that sales of 'own-label' (OL) or 'private label' dental products is increasing, as dentists become more cost conscious in times of economic downturn. However, the purchase of such (less expensive) products could be a false economy if their performance falls below accepted standards. So, while the examination of a resin-based product under research conditions alone may not guarantee success, it could be considered that a material which has been subjected to testing under research conditions will demonstrate its effectiveness under laboratory conditions or reveal its shortcomings; either of these being better than the material not being examined in any way. It was therefore considered appropriate to determine the materials on which research was carried out, with particular reference to OL brands. To determine whether there is a research base behind OL resin-based restorative dental materials.

Probabilistic atlas based labeling of the cerebral vessel tree

NASA Astrophysics Data System (ADS)

Van de Giessen, Martijn; Janssen, Jasper P.; Brouwer, Patrick A.; Reiber, Johan H. C.; Lelieveldt, Boudewijn P. F.; Dijkstra, Jouke

2015-03-01

Preoperative imaging of the cerebral vessel tree is essential for planning therapy on intracranial stenoses and aneurysms. Usually, a magnetic resonance angiography (MRA) or computed tomography angiography (CTA) is acquired from which the cerebral vessel tree is segmented. Accurate analysis is helped by the labeling of the cerebral vessels, but labeling is non-trivial due to anatomical topological variability and missing branches due to acquisition issues. In recent literature, labeling the cerebral vasculature around the Circle of Willis has mainly been approached as a graph-based problem. The most successful method, however, requires the definition of all possible permutations of missing vessels, which limits application to subsets of the tree and ignores spatial information about the vessel locations. This research aims to perform labeling using probabilistic atlases that model spatial vessel and label likelihoods. A cerebral vessel tree is aligned to a probabilistic atlas and subsequently each vessel is labeled by computing the maximum label likelihood per segment from label-specific atlases. The proposed method was validated on 25 segmented cerebral vessel trees. Labeling accuracies were close to 100% for large vessels, but dropped to 50-60% for small vessels that were only present in less than 50% of the set. With this work we showed that using solely spatial information of the vessel labels, vessel segments from stable vessels (>50% presence) were reliably classified. This spatial information will form the basis for a future labeling strategy with a very loose topological model.

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...

The motivational and informational basis of attitudes toward foods with health claims.

PubMed

Žeželj, Iris; Milošević, Jasna; Stojanović, Žaklina; Ognjanov, Galjina

2012-12-01

This research explored the effects of food choice motives, nutritional knowledge, and the use of food labels, on attitude toward food with health claims. Food with health claims was chosen as a relatively novel category of products designed to be beneficial for health. We identified eight motives served by food in general, and tested if they serve as motivations to positively evaluate functional food. Questionnaire was administered on nationally representative samples of 3085 respondents from six Western Balkan countries. We proposed two structural models relating an extensive list of eight and, alternatively, restricted list of three food-choice motives (health, mood and sensory appeal) to attitude toward functional food. We also expected the indirect association between the health motive and attitude, through nutritional knowledge and use of food labels. The results revealed highly positive, although undifferentiated attitude toward functional food, with no significant differences between the countries. The restricted model provided a better fit then the exhaustive model; the health motive was proven to have indirect influence on attitude through knowledge and label use. The implications of these findings for functional approach to attitudes, understanding the demand for functional food and overcoming barriers to dietary change are discussed. Copyright © 2012 Elsevier Ltd. All rights reserved.

Stable isotope labelling methods in mass spectrometry-based quantitative proteomics.

PubMed

Chahrour, Osama; Cobice, Diego; Malone, John

2015-09-10

Mass-spectrometry based proteomics has evolved as a promising technology over the last decade and is undergoing a dramatic development in a number of different areas, such as; mass spectrometric instrumentation, peptide identification algorithms and bioinformatic computational data analysis. The improved methodology allows quantitative measurement of relative or absolute protein amounts, which is essential for gaining insights into their functions and dynamics in biological systems. Several different strategies involving stable isotopes label (ICAT, ICPL, IDBEST, iTRAQ, TMT, IPTL, SILAC), label-free statistical assessment approaches (MRM, SWATH) and absolute quantification methods (AQUA) are possible, each having specific strengths and weaknesses. Inductively coupled plasma mass spectrometry (ICP-MS), which is still widely recognised as elemental detector, has recently emerged as a complementary technique to the previous methods. The new application area for ICP-MS is targeting the fast growing field of proteomics related research, allowing absolute protein quantification using suitable elemental based tags. This document describes the different stable isotope labelling methods which incorporate metabolic labelling in live cells, ICP-MS based detection and post-harvest chemical label tagging for protein quantification, in addition to summarising their pros and cons. Copyright © 2015 Elsevier B.V. All rights reserved.

21 CFR 101.65 - Implied nutrient content claims and related label statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., physiological, pathological, or other condition, where the claim identifies the special diet of which the food... that is useful in creating a diet that is consistent with dietary recommendations if: (i) The food... must contain... (A) A raw fruit or vegetable Low fat as defined in § 101.62(b)(2) Low saturated fat as...

Impact of Health Labels on Flavor Perception and Emotional Profiling: A Consumer Study on Cheese

PubMed Central

Schouteten, Joachim J.; De Steur, Hans; De Pelsmaeker, Sara; Lagast, Sofie; De Bourdeaudhuij, Ilse; Gellynck, Xavier

2015-01-01

The global increase of cardiovascular diseases is linked to the shift towards unbalanced diets with increasing salt and fat intake. This has led to a growing consumers’ interest in more balanced food products, which explains the growing number of health-related claims on food products (e.g., “low in salt” or “light”). Based on a within-subjects design, consumers (n = 129) evaluated the same cheese product with different labels. Participants rated liking, saltiness and fat flavor intensity before and after consuming four labeled cheeses. Even though the cheese products were identical, inclusion of health labels influenced consumer perceptions. Cheese with a “light” label had a lower overall expected and perceived liking compared to regular cheese. Although cheese with a “salt reduced” label had a lower expected liking compared to regular cheese, no lower liking was found when consumers actually consumed the labeled cheese. All labels also influenced the perceived intensities of the attributes related to these labels, e.g., for example salt intensity for reduced salt label. While emotional profiles of the labeled cheeses differed before tasting, little differences were found when actual tasting these cheeses. In conclusion, this study shows that health-related labels might influence the perceived flavor and emotional profiles of cheese products. PMID:26690211

Consumer awareness of salt and sodium reduction and sodium labeling.

PubMed

Kim, M K; Lopetcharat, K; Gerard, P D; Drake, M A

2012-09-01

Reduction of dietary sodium by reduction of sodium in foods is a current industry target. Quantitative information on consumer knowledge of sodium and reduction of dietary sodium is limited. The objectives of this study were to characterize consumer knowledge and awareness of sodium and salt reduction in foods. Consumers (n = 489) participated in a quantitative internet survey designed to gather knowledge and attitudes towards dietary sodium, sodium in foods, and health. Eating habits and food consumption characteristics, knowledge of salt and sodium, and interest in health and wellness were probed. Saltiness believe and sodium knowledge indices were calculated based on correct responses to salt levels in food products. Kano analysis was conducted to determine the role of nutrition labels and satisfaction/dissatisfaction of foods. Consumers were aware of the presence of sodium in "salty" foods, and that sodium was part of salt. People who had a family history of certain diseases associated with a higher intake of dietary sodium did not necessarily have more knowledge of the relationship between sodium intake and a specific disease compared to consumers with no family history. Sodium content on the food label panel did not influence consumer dissatisfaction; however, sodium content did not necessarily increase consumer product satisfaction either. The addition of a healthy nutrient (that is, whole grain, fiber) into a current food product was appealing to consumers. For nutrient labeling, a "reduced" claim was more appealing to consumers than a "free" claim for "unhealthy" nutrients such as fat, sodium, and sugar. This study demonstrated the current state of consumer knowledge on sodium and salt reduction, and consumer perception of the relationship between diets high in sodium and many chronic diseases. Information that may contribute to consumer satisfaction on nutrition panel labeling was also determined. © 2012 Institute of Food Technologists®

Label fusion based brain MR image segmentation via a latent selective model

NASA Astrophysics Data System (ADS)

Liu, Gang; Guo, Xiantang; Zhu, Kai; Liao, Hengxu

2018-04-01

Multi-atlas segmentation is an effective approach and increasingly popular for automatically labeling objects of interest in medical images. Recently, segmentation methods based on generative models and patch-based techniques have become the two principal branches of label fusion. However, these generative models and patch-based techniques are only loosely related, and the requirement for higher accuracy, faster segmentation, and robustness is always a great challenge. In this paper, we propose novel algorithm that combines the two branches using global weighted fusion strategy based on a patch latent selective model to perform segmentation of specific anatomical structures for human brain magnetic resonance (MR) images. In establishing this probabilistic model of label fusion between the target patch and patch dictionary, we explored the Kronecker delta function in the label prior, which is more suitable than other models, and designed a latent selective model as a membership prior to determine from which training patch the intensity and label of the target patch are generated at each spatial location. Because the image background is an equally important factor for segmentation, it is analyzed in label fusion procedure and we regard it as an isolated label to keep the same privilege between the background and the regions of interest. During label fusion with the global weighted fusion scheme, we use Bayesian inference and expectation maximization algorithm to estimate the labels of the target scan to produce the segmentation map. Experimental results indicate that the proposed algorithm is more accurate and robust than the other segmentation methods.

OpenCL based machine learning labeling of biomedical datasets

NASA Astrophysics Data System (ADS)

Amoros, Oscar; Escalera, Sergio; Puig, Anna

2011-03-01

In this paper, we propose a two-stage labeling method of large biomedical datasets through a parallel approach in a single GPU. Diagnostic methods, structures volume measurements, and visualization systems are of major importance for surgery planning, intra-operative imaging and image-guided surgery. In all cases, to provide an automatic and interactive method to label or to tag different structures contained into input data becomes imperative. Several approaches to label or segment biomedical datasets has been proposed to discriminate different anatomical structures in an output tagged dataset. Among existing methods, supervised learning methods for segmentation have been devised to easily analyze biomedical datasets by a non-expert user. However, they still have some problems concerning practical application, such as slow learning and testing speeds. In addition, recent technological developments have led to widespread availability of multi-core CPUs and GPUs, as well as new software languages, such as NVIDIA's CUDA and OpenCL, allowing to apply parallel programming paradigms in conventional personal computers. Adaboost classifier is one of the most widely applied methods for labeling in the Machine Learning community. In a first stage, Adaboost trains a binary classifier from a set of pre-labeled samples described by a set of features. This binary classifier is defined as a weighted combination of weak classifiers. Each weak classifier is a simple decision function estimated on a single feature value. Then, at the testing stage, each weak classifier is independently applied on the features of a set of unlabeled samples. In this work, we propose an alternative representation of the Adaboost binary classifier. We use this proposed representation to define a new GPU-based parallelized Adaboost testing stage using OpenCL. We provide numerical experiments based on large available data sets and we compare our results to CPU-based strategies in terms of time and

Composition, labelling, and safety of food supplements based on bee products in the legislative framework of the European Union - Croatian experiences.

PubMed

Vujić, Mario; Pollak, Lea

2015-12-01

The European Union market is overflown by food supplements and an increasing number of consumers prefer those where bee products play an important part in their composition. This paper deals with complex European Union legislation concerning food supplements based on bee products, placing a special emphasis on their composition, labelling, and safety. Correct labelling of food supplements also represents a great challenge since, in spite of legal regulations in force, there are still open issues regarding the statements on the amount of propolis, which is not clearly defined by the legal framework. One of the key issues are the labels containing health claims from the EU positive list approved by the European Food Safety Authority. Emphasis will also be placed on informing consumers about food, as statements which imply the healing properties of food supplements and their capacity to cure diseases are forbidden. One of the key elements of product safety is HACCP based on the EU Regulations EC 178/02 and 852/2004. Health safety analyses of food supplements with bee products used as raw materials, which are standardised by legal regulations will also be discussed. In the future, attention should also be paid to establishing the European Union "nutrivigilance" system. Croatian experiences in addressing challenges faced by producers, supervisory entities, and regulatory and inspection bodies may serve as an example to countries aspiring to become part of the large European family.

Healthfulness and nutritional composition of Canadian prepackaged foods with and without sugar claims.

PubMed

Bernstein, Jodi T; Franco-Arellano, Beatriz; Schermel, Alyssa; Labonté, Marie-Ève; L'Abbé, Mary R

2017-11-01

The objective of this study was to evaluate differences in calories, nutrient content, overall healthfulness, and use of sweetener ingredients between products with and without sugar claims. Consumers assume products with sugar claims are healthier and lower in calories. It is therefore important claims be found on comparatively healthier items. This study is a cross-sectional analysis of the University of Toronto's 2013 Food Label Database. Subcategories where at least 5% of products (and n ≥ 5) carried a sugar claim were included (n = 3048). Differences in median calorie content, nutrient content, and overall healthfulness, using the Food Standards Australia/New Zealand Nutrient Profiling Scoring criterion, between products with and without sugar claims, were determined. Proportion of products with and without claims that had excess free sugar levels (≥10% of calories from free sugar) and that contained sweeteners was also determined. Almost half (48%) of products with sugar claims contained excess free sugar, and a greater proportion contained sweeteners than products without such claims (30% vs 5%, χ 2 = 338.6, p < 0.0001). Overall, products with sugar claims were "healthier" and had lower median calorie, free sugar, total sugar, and sodium contents than products without claims. At the subcategory level, reductions in free sugar contents were not always met with similar reductions in calorie contents. This study highlights concerns with regards to the nutritional composition of products bearing sugar claims. Findings can support educational messaging to assist consumer interpretation of sugar claims and can inform changes in nutrition policies, for example, permitting sugar claims only on products with calorie reductions and without excess free sugar.

Normative Beliefs, Discursive Claims, and Implementation of Reform-Based Science Standards

ERIC Educational Resources Information Center

Veal, William R.; Riley Lloyd, Mary E.; Howell, Malia R.; Peters, John

2016-01-01

Reform-based science instruction is guided by teachers' normative beliefs. Discursive claims are how teachers say they teach science. Previous research has studied the change in teachers' beliefs and how beliefs influence intended practice and action in the classroom. Few studies have connected what teachers believe, how they say they teach, and…

Agreement between Internet-based self- and proxy-reported health care resource utilization and administrative health care claims.

PubMed

Palmer, Liisa; Johnston, Stephen S; Rousculp, Matthew D; Chu, Bong-Chul; Nichol, Kristin L; Mahadevia, Parthiv J

2012-05-01

Although Internet-based surveys are becoming more common, little is known about agreement between administrative claims data and Internet-based survey self- and proxy-reported health care resource utilization (HCRU) data. This analysis evaluated the level of agreement between self- and proxy-reported HCRU data, as recorded through an Internet-based survey, and administrative claims-based HCRU data. The Child and Household Influenza-Illness and Employee Function study collected self- and proxy-reported HCRU data monthly between November 2007 and May 2008. Data included the occurrence and number of visits to hospitals, emergency departments, urgent care centers, and outpatient offices for a respondent's and his or her household members' care. Administrative claims data from the MarketScan® Databases were assessed during the same time and evaluated relative to survey-based metrics. Only data for individuals with employer-sponsored health care coverage linkable to claims were included. The Kappa (κ) statistic was used to evaluate visit concordance, and the intraclass correlation coefficient was used to describe frequency consistency. Agreement for presence of a health care visit and the number of visits were similar for self- and proxy-reported HCRU data. There was moderate to substantial agreement related to health care visit occurrence between survey-based and claims-based HCRU data for inpatient, emergency department, and office visits (κ: 0.47-0.77). There was less agreement on health care visit frequencies, with intraclass correlation coefficient values ranging from 0.14 to 0.71. This study's agreement values suggest that Internet-based surveys are an effective method to collect self- and proxy-reported HCRU data. These results should increase confidence in the use of the Internet for evaluating disease burden. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Label-free electrical detection using carbon nanotube-based biosensors.

PubMed

Maehashi, Kenzo; Matsumoto, Kazuhiko

2009-01-01

Label-free detections of biomolecules have attracted great attention in a lot of life science fields such as genomics, clinical diagnosis and practical pharmacy. In this article, we reviewed amperometric and potentiometric biosensors based on carbon nanotubes (CNTs). In amperometric detections, CNT-modified electrodes were used as working electrodes to significantly enhance electroactive surface area. In contrast, the potentiometric biosensors were based on aptamer-modified CNT field-effect transistors (CNTFETs). Since aptamers are artificial oligonucleotides and thus are smaller than the Debye length, proteins can be detected with high sensitivity. In this review, we discussed on the technology, characteristics and developments for commercialization in label-free CNT-based biosensors.

Labeling of trans fatty acid content in food, regulations and limits-the FDA view.

PubMed

Moss, Julie

2006-05-01

With the scientific evidence associating trans fatty acid (TFA) intake with an increased risk of coronary heart disease (CHD), the U.S. Food and Drug Administration (FDA) issued a final rule that requires the declaration of the amount of TFA present in foods, including dietary supplements, on the nutrition label by January 1, 2006. The addition of TFA to the nutrition label will lead to the prevention of 600 to 1200 cases of CHD and 240-480 deaths each year saving Dollars 900 million to Dollars 1.8 billion per year in medical costs, lost productivity, and pain and suffering. For the purpose of nutrition labeling, TFA are defined as the sum of all unsaturated fatty acids that contain one or more isolated (i.e. non-conjugated) double bonds in a trans configuration. There are many issues that FDA has yet to resolve: (1) defining nutrient content claims for "free" and "reduced" levels of trans fat, (2) placing limits on the amount of TFA in conjunction with saturated fat limits for nutrient content claims, health claims, and disclosure and disqualifying levels, (3) a daily value, and (4) a possible footnote or disclosure statement to enhance consumer understanding of cholesterol raising lipids. FDA issued an Advanced Notice of Proposed Rulemaking (ANPR) requesting comments on the unresolved issues. FDA will also be conducting consumer research to determine consumer understanding of various TFA labeling possibilities. Comments to the ANPR, results of consumer research and current science will be used by FDA to resolve these issues and to determine future rulemaking for TFA labeling.

FDA preemption of drug and device labeling: who should decide what goes on a drug label?

PubMed

Valoir, Tamsen; Ghosh, Shubha

2011-01-01

The Supreme Court decided an issue that is critical to consumer health and safety last year. In April 2009, the Supreme Court held that extensive FDA regulation of drugs did not preempt a state law claim that an additional warning on the label was necessary to make the drug reasonably safe for use. Thus, states--and even courts and juries--are now free to cast their vote on what a drug label should say. This is in direct contrast to medical devices, where the federal statute regulating medical devices expressly provides that state regulations are preempted. This Article discusses basic preemption principles and drugs, and explores the policy ramifications of pro- and anti-preemption policy in the healthcare industry.

Chemical biology-based approaches on fluorescent labeling of proteins in live cells.

PubMed

Jung, Deokho; Min, Kyoungmi; Jung, Juyeon; Jang, Wonhee; Kwon, Youngeun

2013-05-01

Recently, significant advances have been made in live cell imaging owing to the rapid development of selective labeling of proteins in vivo. Green fluorescent protein (GFP) was the first example of fluorescent reporters genetically introduced to protein of interest (POI). While GFP and various types of engineered fluorescent proteins (FPs) have been actively used for live cell imaging for many years, the size and the limited windows of fluorescent spectra of GFP and its variants set limits on possible applications. In order to complement FP-based labeling methods, alternative approaches that allow incorporation of synthetic fluorescent probes to target POIs were developed. Synthetic fluorescent probes are smaller than fluorescent proteins, often have improved photochemical properties, and offer a larger variety of colors. These synthetic probes can be introduced to POIs selectively by numerous approaches that can be largely categorized into chemical recognition-based labeling, which utilizes metal-chelating peptide tags and fluorophore-carrying metal complexes, and biological recognition-based labeling, such as (1) specific non-covalent binding between an enzyme tag and its fluorophore-carrying substrate, (2) self-modification of protein tags using substrate variants conjugated to fluorophores, (3) enzymatic reaction to generate a covalent binding between a small molecule substrate and a peptide tag, and (4) split-intein-based C-terminal labeling of target proteins. The chemical recognition-based labeling reaction often suffers from compromised selectivity of metal-ligand interaction in the cytosolic environment, consequently producing high background signals. Use of protein-substrate interactions or enzyme-mediated reactions generally shows improved specificity but each method has its limitations. Some examples are the presence of large linker protein, restriction on the choice of introducible probes due to the substrate specificity of enzymes, and competitive

Is nutritional labeling associated with individual health? The effects of labeling-based awareness on dyslipidemia risk in a South Korean population.

PubMed

Kim, Jong Yeob; Kweon, Ki Hong; Kim, Min Jae; Park, Eun-Cheol; Jang, Suk-Yong; Kim, Woorim; Han, Kyu-Tae

2016-09-15

In 1995, the South Korean government made nutrition labeling compulsory, which has positively impacted patients with certain chronic diseases, such as dyslipidemia. We investigated the association between nutrition labeling-based awareness and the risk of dyslipidemia among individuals not yet diagnosed. Our study used data from the fifth Korea National Health and Nutrition Examination Surveys administered during 2010-2014 (n = 17,687). We performed multiple or logistic regression analysis to examine the association between nutritional analysis and various outcome variables. Approximately 70 % of the respondents (n = 11,513) were familiar with nutrition labeling, of which 20 % (n = 3172) decided what food to buy based on that information. This awareness yielded mostly positive results on outcome indicators, such as triglyceride and high-density lipoprotein cholesterol levels. In general, individuals who used nutritional labels to make decisions regarding food purchases had a lower risk of dyslipidemia than individuals who did not (OR: 0.806, 95 % CI: 0.709-0.917). Utilizing nutrition labels for making food choices correlated with a lower risk of dyslipidemia in certain subgroups. Based on our findings, we recommend that health policymakers and medical professionals consider promoting nutrition labeling as an alternative method for managing certain chronic diseases in South Korean patients.

Nutrition and health claims in products directed at children via television in Spain in 2012.

PubMed

Royo-Bordonada, Miguel Ángel; Bosqued-Estefanía, María José; Damián, Javier; López-Jurado, Lázaro; Moya-Geromini, María Ángeles

2016-01-01

To describe the use of nutrition and health claims in products directed at children via television in Spain and to analyse their nutrient profile. A cross-sectional study of television food advertisements over 7 days in five Spanish television channels popular among children. The products were classified as core, non-core or miscellaneous, and as either healthy or less healthy, according to the United Kingdom Nutrient Profile Model. We registered all claims contained on the product (packaging and labelling) and its advertisement. We calculated the frequency distributions of health and nutrition claims. During the 420hours of broadcasting, 169 food products were identified, 28.5% in the dairy group and 60.9% in the non-core category. A total of 53.3% of products contained nutrition claims and 26.6% contained health claims; 62.2% of the products with claims were less healthy. Low-fat dairy products were the food category containing the highest percentage of health and nutrition claims. Over half of all food products marketed to children via television in Spain made some type of nutrition or health claim. Most of these products were less healthy, which could mislead Spanish consumers. Copyright © 2016 SESPAS. Published by Elsevier Espana. All rights reserved.

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

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 1 2013-01-01 2013-01-01 false Claims based on negligence, wrongful act or omission. 1.51 Section 1.51 Agriculture Office of the Secretary of Agriculture ADMINISTRATIVE REGULATIONS... Department of Agriculture (USDA) may, subject to the provisions of the FTCA and DOJ regulations, consider...

Characterization and relative quantification of phospholipids based on methylation and stable isotopic labeling[S

PubMed Central

Cai, Tanxi; Shu, Qingbo; Liu, Peibin; Niu, Lili; Guo, Xiaojing; Ding, Xiang; Xue, Peng; Xie, Zhensheng; Wang, Jifeng; Zhu, Nali; Wu, Peng; Niu, Lili; Yang, Fuquan

2016-01-01

Phospholipids (PLs), one of the lipid categories, are not only the primary building blocks of cellular membranes, but also can be split to produce products that function as second messengers in signal transduction and play a pivotal role in numerous cellular processes, including cell growth, survival, and motility. Here, we present an integrated novel method that combines a fast and robust TMS-diazomethane-based phosphate derivatization and isotopic labeling strategy, which enables simultaneous profiling and relative quantification of PLs from biological samples. Our results showed that phosphate methylation allows fast and sensitive identification of the six major PL classes, including their lysophospholipid counterparts, under positive ionization mode. The isotopic labeling of endogenous PLs was achieved by deuterated diazomethane, which was generated through acid-catalyzed hydrogen/deuterium (H/D) exchange and methanolysis of TMS-diazomethane during the process of phosphate derivatization. The measured H/D ratios of unlabeled and labeled PLs, which were mixed in known proportions, indicated that the isotopic labeling strategy is capable of providing relative quantitation with adequate accuracy, reproducibility, and a coefficient of variation of 9.1%, on average. This novel method offers unique advantages over existing approaches and presents a powerful tool for research of PL metabolism and signaling. PMID:26733148

Consumer and health literacy: The need to better design tobacco-cessation product packaging, labels, and inserts.

PubMed

Weiss, Stephanie M; Smith-Simone, Stephanie Y

2010-03-01

Tobacco-cessation product packaging and instruction materials may not be appropriate for some smokers and may contribute to the underuse and misuse of evidence-based treatments. The dual goals of this project are to analyze literacy levels of Food and Drug Administration (FDA)-approved and non-approved tobacco-cessation product packaging, directions, and claims, and to identify and categorize claims found on product packaging. The Campaign for Tobacco Free Kids (CTFK) maintains the Quitting and Reducing Tobacco Use Inventory of Products (QuiTIP) database, which catalogs products marketed and sold to consumers to reduce or quit use of tobacco products. It also includes all medications approved by the FDA for tobacco cessation as well as a sample of non-approved products such as homeopathic, herbal, nutritional, or dietary supplements commonly marketed as either cessation aids or alternative tobacco/nicotine products. This paper assesses the reading levels required to understand product packaging, labeling, and instructions using the Simple Measure of Gobbledygook (SMOG) and identifies claims on the product package labels using standard qualitative methods. Key findings show that the average reading levels needed to understand instructions for both FDA-approved and non-approved cessation products are above the reading levels recommended to ensure maximum comprehension. Improving the packaging and directions of evidence-based tobacco-cessation products so that they are preferably at or below a fifth-grade reading level, along with using consumer-based design principles to develop packaging, may help smokers take advantage of and correctly use products that will greatly increase their chances of successful quitting. 2010 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Flow-aggregated traffic-driven label mapping in label-switching networks

NASA Astrophysics Data System (ADS)

Nagami, Kenichi; Katsube, Yasuhiro; Esaki, Hiroshi; Nakamura, Osamu

1998-12-01

Label switching technology enables high performance, flexible, layer-3 packet forwarding based on the fixed length label information mapped to the layer-3 packet stream. A Label Switching Router (LSR) forwards layer-3 packets based on their label information mapped to the layer-3 address information as well as their layer-3 address information. This paper evaluates the required number of labels under traffic-driven label mapping policy using the real backbone traffic traces. The evaluation shows that the label mapping policy requires a large number of labels. In order to reduce the required number of labels, we propose a label mapping policy which is a traffic-driven label mapping for the traffic toward the same destination network. The evaluation shows that the proposed label mapping policy requires only about one tenth as many labels compared with the traffic-driven label mapping for the host-pair packet stream,and the topology-driven label mapping for the destination network packet stream.

Couple Graph Based Label Propagation Method for Hyperspectral Remote Sensing Data Classification

NASA Astrophysics Data System (ADS)

Wang, X. P.; Hu, Y.; Chen, J.

2018-04-01

Graph based semi-supervised classification method are widely used for hyperspectral image classification. We present a couple graph based label propagation method, which contains both the adjacency graph and the similar graph. We propose to construct the similar graph by using the similar probability, which utilize the label similarity among examples probably. The adjacency graph was utilized by a common manifold learning method, which has effective improve the classification accuracy of hyperspectral data. The experiments indicate that the couple graph Laplacian which unite both the adjacency graph and the similar graph, produce superior classification results than other manifold Learning based graph Laplacian and Sparse representation based graph Laplacian in label propagation framework.

Effect of low-carbohydrate claims on consumer perceptions about food products' healthfulness and helpfulness for weight management.

PubMed

Labiner-Wolfe, Judith; Jordan Lin, Chung-Tung; Verrill, Linda

2010-01-01

Evaluate effect of low-carbohydrate claims on consumer perceptions about food products' healthfulness and helpfulness for weight management. Experiment in which participants were randomly assigned 1 of 12 front-of-package claim conditions on bread or a frozen dinner. Seven of the 12 conditions also included Nutrition Facts (NF) information. Internet. 4,320 members of a national on-line consumer panel. Exposure to images of a food package. Ratings on Likert scales about perceived healthfulness, helpfulness for weight management, and caloric content. Mean ratings by outcome measure, condition, and product were calculated. Ratings were also used as the dependent measure in analysis of variance models. Participants who saw front-of-package-only conditions rated products bearing low-carbohydrate claims as more helpful for weight management and lower in calories than the same products without a claim. Those who saw the bread with low-carbohydrate claims also rated it as more healthful than those who saw no claim. When the NF label was available and products had the same nutrition profile, participants rated products with low-carbohydrate claims the same as those with no claim. Consumers who do not use the NF panel may interpret low-carbohydrate claims to have meaning beyond the scope of the claim itself. Published by Elsevier Inc.

Mindtagger: A Demonstration of Data Labeling in Knowledge Base Construction.

PubMed

Shin, Jaeho; Ré, Christopher; Cafarella, Michael

2015-08-01

End-to-end knowledge base construction systems using statistical inference are enabling more people to automatically extract high-quality domain-specific information from unstructured data. As a result of deploying DeepDive framework across several domains, we found new challenges in debugging and improving such end-to-end systems to construct high-quality knowledge bases. DeepDive has an iterative development cycle in which users improve the data. To help our users, we needed to develop principles for analyzing the system's error as well as provide tooling for inspecting and labeling various data products of the system. We created guidelines for error analysis modeled after our colleagues' best practices, in which data labeling plays a critical role in every step of the analysis. To enable more productive and systematic data labeling, we created Mindtagger, a versatile tool that can be configured to support a wide range of tasks. In this demonstration, we show in detail what data labeling tasks are modeled in our error analysis guidelines and how each of them is performed using Mindtagger.

32 CFR 536.85 - Claims payable under the Federal Tort Claims Act.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 3 2013-07-01 2013-07-01 false Claims payable under the Federal Tort Claims Act... AND ACCOUNTS CLAIMS AGAINST THE UNITED STATES Claims Cognizable Under the Federal Tort Claims Act § 536.85 Claims payable under the Federal Tort Claims Act. (a) Unless otherwise prescribed, claims for...

Development of an electronic claim system based on an integrated electronic health record platform to guarantee interoperability.

PubMed

Kim, Hwa Sun; Cho, Hune; Lee, In Keun

2011-06-01

We design and develop an electronic claim system based on an integrated electronic health record (EHR) platform. This system is designed to be used for ambulatory care by office-based physicians in the United States. This is achieved by integrating various medical standard technologies for interoperability between heterogeneous information systems. The developed system serves as a simple clinical data repository, it automatically fills out the Centers for Medicare and Medicaid Services (CMS)-1500 form based on information regarding the patients and physicians' clinical activities. It supports electronic insurance claims by creating reimbursement charges. It also contains an HL7 interface engine to exchange clinical messages between heterogeneous devices. The system partially prevents physician malpractice by suggesting proper treatments according to patient diagnoses and supports physicians by easily preparing documents for reimbursement and submitting claim documents to insurance organizations electronically, without additional effort by the user. To show the usability of the developed system, we performed an experiment that compares the time spent filling out the CMS-1500 form directly and time required create electronic claim data using the developed system. From the experimental results, we conclude that the system could save considerable time for physicians in making claim documents. The developed system might be particularly useful for those who need a reimbursement-specialized EHR system, even though the proposed system does not completely satisfy all criteria requested by the CMS and Office of the National Coordinator for Health Information Technology (ONC). This is because the criteria are not sufficient but necessary condition for the implementation of EHR systems. The system will be upgraded continuously to implement the criteria and to offer more stable and transparent transmission of electronic claim data.

The ban on "off-label" pharmaceutical promotion: constitutionally permissible prophylaxis against false or misleading commercial speech?

PubMed

Greenwood, Kate

2011-01-01

Critics of the Food & Drug Administration's ban on off-label promotion often claim that it violates the First Amendment because it suppresses pharmaceutical manufacturers' truthful speech about their legal--and beneficial--products. Characterizing the ban on off-label promotion in this way has more than rhetorical significance. Bans on truthful, non-misleading speech elicit special skepticism because of the belief that they "usually rest solely on the offensive assumption that the public will respond 'irrationally' to the truth." The legislative history of the provisions of the Food Drug and Cosmetic Act that underlie the ban on off-label promotion, however, reveals that Congress was concerned that physicians were responding rationally to false and misleading promotional claims. In this Article, I explore the doctrinal questions raised by conceiving of the ban on off-label promotion not as a ban on "truthful speech to physicians" but instead as a prophylaxis against false and misleading pharmaceutical promotion. I review the evidence that false and misleading claims were commonplace before the ban's adoption and persist today, along with the enforcement challenges the FDA confronted at that time and would confront were the ban lifted, and conclude the government likely could develop the factual record necessary to establish that Congress' rejection of an after-the-fact case-by-case approach to combating false and misleading prescription drug promotion is constitutional.

The role of health-related claims and health-related symbols in consumer behaviour: Design and conceptual framework of the CLYMBOL project and initial results.

PubMed

Hieke, S; Kuljanic, N; Wills, J M; Pravst, I; Kaur, A; Raats, M M; van Trijp, H C M; Verbeke, W; Grunert, K G

2015-03-01

Health claims and symbols are potential aids to help consumers identify foods that are healthier options. However, little is known as to how health claims and symbols are used by consumers in real-world shopping situations, thus making the science-based formulation of new labelling policies and the evaluation of existing ones difficult. The objective of the European Union-funded project R ole of health-related   CLaims   and   sYMBOLs   in consumer behaviour (CLYMBOL) is to determine how health-related information provided through claims and symbols, in their context, can affect consumer understanding, purchase and consumption. To do this, a wide range of qualitative and quantitative consumer research methods are being used, including product sampling, sorting studies ( i.e. how consumers categorise claims and symbols according to concepts such as familiarity and relevance), cross-country surveys, eye-tracking ( i.e. what consumers look at and for how long), laboratory and in-store experiments, structured interviews, as well as analysis of population panel data. EU Member States differ with regard to their history of use and regulation of health claims and symbols prior to the harmonisation of 2006. Findings to date indicate the need for more structured and harmonised research on the effects of health claims and symbols on consumer behaviour, particularly taking into account country-wide differences and individual characteristics such as motivation and ability to process health-related information. Based on the studies within CLYMBOL, implications and recommendations for stakeholders such as policymakers will be provided.

Model-based morphological segmentation and labeling of coronary angiograms.

PubMed

Haris, K; Efstratiadis, S N; Maglaveras, N; Pappas, C; Gourassas, J; Louridas, G

1999-10-01

A method for extraction and labeling of the coronary arterial tree (CAT) using minimal user supervision in single-view angiograms is proposed. The CAT structural description (skeleton and borders) is produced, along with quantitative information for the artery dimensions and assignment of coded labels, based on a given coronary artery model represented by a graph. The stages of the method are: 1) CAT tracking and detection; 2) artery skeleton and border estimation; 3) feature graph creation; and iv) artery labeling by graph matching. The approximate CAT centerline and borders are extracted by recursive tracking based on circular template analysis. The accurate skeleton and borders of each CAT segment are computed, based on morphological homotopy modification and watershed transform. The approximate centerline and borders are used for constructing the artery segment enclosing area (ASEA), where the defined skeleton and border curves are considered as markers. Using the marked ASEA, an artery gradient image is constructed where all the ASEA pixels (except the skeleton ones) are assigned the gradient magnitude of the original image. The artery gradient image markers are imposed as its unique regional minima by the homotopy modification method, the watershed transform is used for extracting the artery segment borders, and the feature graph is updated. Finally, given the created feature graph and the known model graph, a graph matching algorithm assigns the appropriate labels to the extracted CAT using weighted maximal cliques on the association graph corresponding to the two given graphs. Experimental results using clinical digitized coronary angiograms are presented.

Evaluation of a complex, population-based injury claims management intervention for improving injury outcomes: study protocol

PubMed Central

Collie, Alex; Gabbe, Belinda; Fitzharris, Michael

2015-01-01

Introduction Injuries resulting from road traffic crashes are a substantial cause of disability and death worldwide. Injured persons receiving compensation have poorer recovery and return to work than those with non-compensable injury. Case or claims management is a critical component of injury compensation systems, and there is now evidence that claims management can have powerful positive impacts on recovery, but can also impede recovery or exacerbate mental health concerns in some injured people. This study seeks to evaluate the impact of a population-based injury claims management intervention in the State of Victoria, Australia, on the health of those injured in motor vehicle crashes, their experience of the compensation process, and the financial viability of the compensation system. Methods and analysis Evaluation of this complex intervention involves a series of linked but stand-alone research projects to assess the anticipated process changes, impacts and outcomes of the intervention over a 5-year time frame. Linkage and analysis of routine administrative and health system data is supplemented with a series of primary studies collecting new information. Additionally, a series of ‘action’ research projects will be undertaken to inform the implementation of the intervention. A program logic model designed by the state government Transport Accident Commission in conjunction with the research team provides the evaluation framework. Ethics and dissemination Relatively few studies have comprehensively examined the impact of compensation system processes on the health of injured persons, their satisfaction with systems processes, and impacts on the financial performance of the compensation scheme itself. The wholesale, population-based transformation of an injury claims management model is a rare opportunity to document impacts of system-level policy change on outcomes of injured persons. Findings will contribute to the evidence base of information on the

Academic Radiologist Subspecialty Identification Using a Novel Claims-Based Classification System.

PubMed

Rosenkrantz, Andrew B; Wang, Wenyi; Hughes, Danny R; Ginocchio, Luke A; Rosman, David A; Duszak, Richard

2017-06-01

The objective of the present study is to assess the feasibility of a novel claims-based classification system for payer identification of academic radiologist subspecialties. Using a categorization scheme based on the Neiman Imaging Types of Service (NITOS) system, we mapped the Medicare Part B services billed by all radiologists from 2012 to 2014, assigning them to the following subspecialty categories: abdominal imaging, breast imaging, cardiothoracic imaging, musculoskeletal imaging, nuclear medicine, interventional radiology, and neuroradiology. The percentage of subspecialty work relative value units (RVUs) to total billed work RVUs was calculated for each radiologist nationwide. For radiologists at the top 20 academic departments funded by the National Institutes of Health, those percentages were compared with subspecialties designated on faculty websites. NITOS-based subspecialty assignments were also compared with the only radiologist subspecialty classifications currently recognized by Medicare (i.e., nuclear medicine and interventional radiology). Of 1012 academic radiologists studied, the median percentage of Medicare-billed NITOS-based subspecialty work RVUs matching the subspecialty designated on radiologists' own websites ranged from 71.3% (for nuclear medicine) to 98.9% (for neuroradiology). A NITOS-based work RVU threshold of 50% correctly classified 89.8% of radiologists (5.9% were not mapped to any subspecialty; subspecialty error rate, 4.2%). In contrast, existing Medicare provider codes identified only 46.7% of nuclear medicine physicians and 39.4% of interventional radiologists. Using a framework based on a recently established imaging health services research tool that maps service codes based on imaging modality and body region, Medicare claims data can be used to consistently identify academic radiologists by subspecialty in a manner not possible with the use of existing Medicare physician specialty identifiers. This method may facilitate

Medical Malpractice Claims in Radiation Oncology: A Population-Based Study 1985-2012

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

Marshall, Deborah C.; Punglia, Rinaa S.; Fox, Dov

Purpose: The purpose of this study was to determine trends in radiation oncology malpractice claims and expenses during the last 28 years and to compare radiation oncology malpractice claims to those of other specialties. Methods and Materials: We performed a retrospective analysis of closed malpractice claims filed from 1985 to 2012, collected by a nationwide medical liability insurance trade association. We analyzed characteristics and trends among closed claims, indemnity payments (payments to plaintiff), and litigation expenses. We also compared radiation oncology malpractice claims to those of 21 other medical specialties. Time series dollar amounts were adjusted for inflation (2012 was themore » index year). Results: There were 1517 closed claims involving radiation oncology, of which 342 (22.5%) were paid. Average and median indemnity payments were $276,792 and $122,500, respectively, ranking fifth and eighth, respectively, among the 22 specialty groups. Linear regression modeling of time trends showed decreasing total numbers of claims (β = −1.96 annually, P=.003), increasing average litigation expenses paid (β = +$1472 annually, P≤.001), and no significant changes in average indemnity payments (β = −$681, P=.89). Conclusions: Medical professional liability claims filed against radiation oncologists are not common and have declined in recent years. However, indemnity payments in radiation oncology are large relative to those of many other specialties. In recent years, the average indemnity payment has been stable, whereas litigation expenses have increased.« less

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

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...

US Dietary Supplement Labeling Rules and the Possibility of Medical Cost Reduction.

PubMed

Amagase, Harunobu

2015-01-01

US dietary supplements classified as foods are regulated under the Dietary Supplement Health and Education Act (DSHEA) and other rules. After the DSHEA established in 1994, the supplement market grew by about 4 times and reached $32 billion as of 2012. One of the major reasons for this market expansion is that consumers can recognize functions of the supplements by the structure/function (S/F) claims. S/F claims must not be false or misleading, and must be based upon reliable scientific evidence, especially clinical studies. At the same time, disclaimers must be shown on the package, which are "These statements have not been evaluated by the Food and Drug Administration (FDA). These products are not intended to diagnose, treat, cure or prevent any disease." Both the FDA and Federal Trade Commission (FTC) are responsible for label claims and advertisement of dietary supplements. S/F claims are not medical claims, but these may have impact on people's mindset to be healthier. Recent research shows utilizing dietary supplements in 4 major areas with 10 popular ingredients could hypothetically reduce medical costs by over $50 billion in the US in the period of 2013-2020. Predicted fewer health problems and reduced medical cost information will further increase awareness of supplement usage and thus may raise quality of life. These may reduce the medical cost significantly, if the products are used appropriately with sufficient consumer education.

Defining hip fracture with claims data: outpatient and provider claims matter.

PubMed

Berry, S D; Zullo, A R; McConeghy, K; Lee, Y; Daiello, L; Kiel, D P

2017-07-01

Medicare claims are commonly used to identify hip fractures, but there is no universally accepted definition. We found that a definition using inpatient claims identified fewer fractures than a definition including outpatient and provider claims. Few additional fractures were identified by including inconsistent diagnostic and procedural codes at contiguous sites. Medicare claims data is commonly used in research studies to identify hip fractures, but there is no universally accepted definition of fracture. Our purpose was to describe potential misclassification when hip fractures are defined using Medicare Part A (inpatient) claims without considering Part B (outpatient and provider) claims and when inconsistent diagnostic and procedural codes occur at contiguous fracture sites (e.g., femoral shaft or pelvic). Participants included all long-stay nursing home residents enrolled in Medicare Parts A and B fee-for-service between 1/1/2008 and 12/31/2009 with follow-up through 12/31/2011. We compared the number of hip fractures identified using only Part A claims to (1) Part A plus Part B claims and (2) Part A and Part B claims plus discordant codes at contiguous fracture sites. Among 1,257,279 long-stay residents, 40,932 (3.2%) met the definition of hip fracture using Part A claims, and 41,687 residents (3.3%) met the definition using Part B claims. 4566 hip fractures identified using Part B claims would not have been captured using Part A claims. An additional 227 hip fractures were identified after considering contiguous fracture sites. When ascertaining hip fractures, a definition using outpatient and provider claims identified 11% more fractures than a definition with only inpatient claims. Future studies should publish their definition of fracture and specify if diagnostic codes from contiguous fracture sites were used.

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...

Microbial status and product labelling of 58 original tattoo inks.

PubMed

Høgsberg, T; Saunte, D M; Frimodt-Møller, N; Serup, J

2013-01-01

European Council resolutions on tattoo ink introduce sterility and preservation of inks to protect customers. Inks used in Denmark are typically purchased over the internet from international suppliers and manufacturers from the US and the UK. In Denmark tattoo inks are regulated and labelled according to REACH as if they were plain chemicals. The objective of this study was to check the microbial product safety of unopened and opened tattoo ink stock bottles. Packaging, labelling, preservation, sterility and contamination with micro-organisms were studied. Physical inspection and culture of bacteria and fungi. Six of 58 unopened stock bottles (10%) were contaminated with bacteria and one of six samples (17%) of previously used stock bottles was contaminated. The bacterial species represented bacteria considered pathogenic in humans as well as non-pathogenic environmental bacteria. Yeast or moulds were detected in none of the samples. A total of 31% of the manufacturers informed only about the brand name. No information about content, sterility, risks or expiry date was indicated on the label. A total of 42% claimed sterility of their inks. A total of 54% labelled a maximum period of durability of typically 2-3 years. The physical sealing was leaking in 28% of the products. The European Council resolutions regarding safety of tattoo inks are not effective. Stock bottles of tattoo ink may contain bacteria pathogenic to humans and environmental bacteria, and packaging, labelling and preservation of inks are of inadequate quality. Claim of sterility can be erroneous. © 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.

Chronic disease management items in general practice: a population-based study of variation in claims by claimant characteristics.

PubMed

Douglas, Kirsty A; Yen, Laurann E; Korda, Rosemary J; Kljakovic, Marjan; Glasgow, Nicholas J

2011-08-15

To describe how Medical Benefits Schedule (MBS) chronic disease (CD) item claims vary by sociodemographic and health characteristics in people with heart disease, asthma or diabetes. A cross-sectional analysis of linked unit-level MBS and survey data from the first 102,934 participants enrolled in the 45 and Up Study, a large-scale cohort study in New South Wales, who completed the baseline survey between January 2006 and July 2008. Claim for any general practitioner CD item within 18 months before enrolment, ascertained from MBS records. The proportion of individuals making claims for MBS CD items was 18.5% for asthma, 22.3% for heart disease, and 44.9% for diabetes. Associations between participant characteristics and a claim for a CD item showed similar patterns across the three diseases. For heart disease and asthma, people most likely to claim a CD item were women, older, of low income and education levels, with multiple chronic conditions, fair or poor self-rated health, obesity and low physical activity levels. The pattern of claims was slightly different for participants with diabetes in that there was no significant association with number of chronic conditions, smoking or physical activity. Many individuals with self-reported CD do not claim CD items. People with diabetes and individuals with greatest need based on health, socioeconomic and lifestyle risk factors are the most likely to claim CD items.

Effects of comparative claims in prescription drug direct-to-consumer advertising on consumer perceptions and recall.

PubMed

O'Donoghue, Amie C; Williams, Pamela A; Sullivan, Helen W; Boudewyns, Vanessa; Squire, Claudia; Willoughby, Jessica Fitts

2014-11-01

Although pharmaceutical companies cannot make comparative claims in direct-to-consumer (DTC) ads for prescription drugs without substantial evidence, the U.S. Food and Drug Administration permits some comparisons based on labeled attributes of the drug, such as dosing. Researchers have examined comparative advertising for packaged goods; however, scant research has examined comparative DTC advertising. We conducted two studies to determine if comparative claims in DTC ads influence consumers' perceptions and recall of drug information. In Experiment 1, participants with osteoarthritis (n=1934) viewed a fictitious print or video DTC ad that had no comparative claim or made an efficacy comparison to a named or unnamed competitor. Participants who viewed print (but not video) ads with named competitors had greater efficacy and lower risk perceptions than participants who viewed unnamed competitor and noncomparative ads. In Experiment 2, participants with high cholesterol or high body mass index (n=5317) viewed a fictitious print or video DTC ad that had no comparative claim or made a comparison to a named or unnamed competitor. We varied the type of comparison (of indication, dosing, or mechanism of action) and whether the comparison was accompanied by a visual depiction. Participants who viewed print and video ads with named competitors had greater efficacy perceptions than participants who viewed unnamed competitor and noncomparative ads. Unlike Experiment 1, named competitors in print ads resulted in higher risk perceptions than unnamed competitors. In video ads, participants who saw an indication comparison had greater benefit recall than participants who saw dosing or mechanism of action comparisons. In addition, visual depictions of the comparison decreased risk recall for video ads. Overall, the results suggest that comparative claims in DTC ads could mislead consumers about a drug's efficacy and risk; therefore, caution should be used when presenting

Experimental demonstration of tunable multiple optical orthogonal codes sequences-based optical label for optical packets switching

NASA Astrophysics Data System (ADS)

Zhang, Chongfu; Qiu, Kun; Zhou, Heng; Ling, Yun; Wang, Yawei; Xu, Bo

2010-03-01

In this paper, the tunable multiple optical orthogonal codes sequences (MOOCS)-based optical label for optical packet switching (OPS) (MOOCS-OPS) is experimentally demonstrated for the first time. The tunable MOOCS-based optical label is performed by using fiber Bragg grating (FBG)-based optical en/decoders group and optical switches configured by using Field Programmable Gate Array (FPGA), and the optical label is erased by using Semiconductor Optical Amplifier (SOA). Some waveforms of the MOOCS-based optical label, optical packet including the MOOCS-based optical label and the payloads are obtained, the switching control mechanism and the switching matrix are discussed, the bit error rate (BER) performance of this system is also studied. These experimental results show that the tunable MOOCS-OPS scheme is effective.

Small-molecule-based protein-labeling technology in live cell studies: probe-design concepts and applications.

PubMed

Mizukami, Shin; Hori, Yuichiro; Kikuchi, Kazuya

2014-01-21

The use of genetic engineering techniques allows researchers to combine functional proteins with fluorescent proteins (FPs) to produce fusion proteins that can be visualized in living cells, tissues, and animals. However, several limitations of FPs, such as slow maturation kinetics or issues with photostability under laser illumination, have led researchers to examine new technologies beyond FP-based imaging. Recently, new protein-labeling technologies using protein/peptide tags and tag-specific probes have attracted increasing attention. Although several protein-labeling systems are com mercially available, researchers continue to work on addressing some of the limitations of this technology. To reduce the level of background fluorescence from unlabeled probes, researchers have pursued fluorogenic labeling, in which the labeling probes do not fluoresce until the target proteins are labeled. In this Account, we review two different fluorogenic protein-labeling systems that we have recently developed. First we give a brief history of protein labeling technologies and describe the challenges involved in protein labeling. In the second section, we discuss a fluorogenic labeling system based on a noncatalytic mutant of β-lactamase, which forms specific covalent bonds with β-lactam antibiotics such as ampicillin or cephalosporin. Based on fluorescence (or Förster) resonance energy transfer and other physicochemical principles, we have developed several types of fluorogenic labeling probes. To extend the utility of this labeling system, we took advantage of a hydrophobic β-lactam prodrug structure to achieve intracellular protein labeling. We also describe a small protein tag, photoactive yellow protein (PYP)-tag, and its probes. By utilizing a quenching mechanism based on close intramolecular contact, we incorporated a turn-on switch into the probes for fluorogenic protein labeling. One of these probes allowed us to rapidly image a protein while avoiding washout. In

A new label dosimetry system based on pentacosa-diynoic acid monomer for low dose applications

NASA Astrophysics Data System (ADS)

Abdel-Fattah, A. A.; Abdel-Rehim, F.; Soliman, Y. S.

2012-01-01

The dosimetric characteristics of γ-radiation sensitive labels based on polyvinyl butyral (PVB) and a conjugated diacetylene monomer, 10,12-pentacosa-diynoic acid (PCDA) have been investigated using reflectance colorimeter. Two types of labels (colourless and yellow) based on PCDA monomer were prepared using an Automatic Film Applicator System. Upon γ-ray exposure, the colourless label turns progressively blue, while the yellow colour label turns to green then to dark blue. The colour intensity of the labels is proportional to the radiation absorbed dose. The useful dose range was 15 Gy-2 kGy depending on PCDA monomer concentration. The expanded uncertainty of dose measurement of the colourless label was 6.06 (2 σ).

Recent advances in stable isotope labeling based techniques for proteome relative quantification.

PubMed

Zhou, Yuan; Shan, Yichu; Zhang, Lihua; Zhang, Yukui

2014-10-24

The large scale relative quantification of all proteins expressed in biological samples under different states is of great importance for discovering proteins with important biological functions, as well as screening disease related biomarkers and drug targets. Therefore, the accurate quantification of proteins at proteome level has become one of the key issues in protein science. Herein, the recent advances in stable isotope labeling based techniques for proteome relative quantification were reviewed, from the aspects of metabolic labeling, chemical labeling and enzyme-catalyzed labeling. Furthermore, the future research direction in this field was prospected. Copyright © 2014 Elsevier B.V. All rights reserved.

Mass spectrometry–based relative quantification of proteins in precatalytic and catalytically active spliceosomes by metabolic labeling (SILAC), chemical labeling (iTRAQ), and label-free spectral count

PubMed Central

Schmidt, Carla; Grønborg, Mads; Deckert, Jochen; Bessonov, Sergey; Conrad, Thomas; Lührmann, Reinhard; Urlaub, Henning

2014-01-01

The spliceosome undergoes major changes in protein and RNA composition during pre-mRNA splicing. Knowing the proteins—and their respective quantities—at each spliceosomal assembly stage is critical for understanding the molecular mechanisms and regulation of splicing. Here, we applied three independent mass spectrometry (MS)–based approaches for quantification of these proteins: (1) metabolic labeling by SILAC, (2) chemical labeling by iTRAQ, and (3) label-free spectral count for quantification of the protein composition of the human spliceosomal precatalytic B and catalytic C complexes. In total we were able to quantify 157 proteins by at least two of the three approaches. Our quantification shows that only a very small subset of spliceosomal proteins (the U5 and U2 Sm proteins, a subset of U5 snRNP-specific proteins, and the U2 snRNP-specific proteins U2A′ and U2B′′) remains unaltered upon transition from the B to the C complex. The MS-based quantification approaches classify the majority of proteins as dynamically associated specifically with the B or the C complex. In terms of experimental procedure and the methodical aspect of this work, we show that metabolically labeled spliceosomes are functionally active in terms of their assembly and splicing kinetics and can be utilized for quantitative studies. Moreover, we obtain consistent quantification results from all three methods, including the relatively straightforward and inexpensive label-free spectral count technique. PMID:24448447

Food labels, autonomy, and the right (not) to know.

PubMed

Bonotti, Matteo

2014-12-01

Food labelling has been overlooked in the emerging body of literature concerning the normative dimensions of food and drink policies. In this paper, I argue that arguments normally advanced in bioethics and medical ethics regarding the "right to know" and the "right not to know" can provide useful normative guidelines for critically assessing existing and proposed food labelling regimes. More specifically, I claim that food labelling ought to respect the legitimate interests and the autonomy of both consumers who seek knowledge about their food in order to make informed dietary choices and consumers who prefer to remain ignorant about the contents and effects of their food in order to avoid the emotional and psychological harm, or more simply the loss of enjoyment, which may result from receiving that information.

Influence of time orientation on food choice: Case study with cookie labels.

PubMed

Tórtora, Giuliana; Ares, Gastón

2018-04-01

Time orientation can influence health-related behaviors, including food consumption. The aim of the present work was to study the influence of time orientation on food choice, using cookie labels as case study. A choice-conjoint task was designed using labels differing in type of cookie (chocolate chips vs. granola), front-of-pack nutrition information (nutritional warnings vs. Facts Up Front system) and nutritional claim (no claim vs. "0% cholesterol. 0% trans fat"). An online study was conducted, in which 155 participants evaluated 8 pairs of cookie labels and selected the one they would buy if they were in the supermarket. Then, they were asked to complete a consideration of future consequences scale (CFC) adapted to eating habits, as well as a questionnaire about socio-demographic characteristics. Time orientation influenced participants' choices of cookies labels; particularly the importance attached to type of cookie. Participants with greater consideration of future consequences preferred the granola cookies, associated with health, while those who prioritized immediate consequences preferred chocolate chip cookies. In addition, nutritional warnings discouraged choice regardless of participants' time orientation. Results from the present work provide additional evidence of the influence of time preferences on food choices and suggest that strategies to stimulate and generate a more future-oriented perspective on eating habits could contribute to more healthful food choices. Copyright © 2018 Elsevier Ltd. All rights reserved.

The role of health-related claims and health-related symbols in consumer behaviour: Design and conceptual framework of the CLYMBOL project and initial results

PubMed Central

Hieke, S; Kuljanic, N; Wills, J M; Pravst, I; Kaur, A; Raats, M M; van Trijp, H C M; Verbeke, W; Grunert, K G

2015-01-01

Health claims and symbols are potential aids to help consumers identify foods that are healthier options. However, little is known as to how health claims and symbols are used by consumers in real-world shopping situations, thus making the science-based formulation of new labelling policies and the evaluation of existing ones difficult. The objective of the European Union-funded project Role of health-related CLaims and sYMBOLs in consumer behaviour (CLYMBOL) is to determine how health-related information provided through claims and symbols, in their context, can affect consumer understanding, purchase and consumption. To do this, a wide range of qualitative and quantitative consumer research methods are being used, including product sampling, sorting studies (i.e. how consumers categorise claims and symbols according to concepts such as familiarity and relevance), cross-country surveys, eye-tracking (i.e. what consumers look at and for how long), laboratory and in-store experiments, structured interviews, as well as analysis of population panel data. EU Member States differ with regard to their history of use and regulation of health claims and symbols prior to the harmonisation of 2006. Findings to date indicate the need for more structured and harmonised research on the effects of health claims and symbols on consumer behaviour, particularly taking into account country-wide differences and individual characteristics such as motivation and ability to process health-related information. Based on the studies within CLYMBOL, implications and recommendations for stakeholders such as policymakers will be provided. PMID:25750587

PSEA-Quant: a protein set enrichment analysis on label-free and label-based protein quantification data.

PubMed

Lavallée-Adam, Mathieu; Rauniyar, Navin; McClatchy, Daniel B; Yates, John R

2014-12-05

The majority of large-scale proteomics quantification methods yield long lists of quantified proteins that are often difficult to interpret and poorly reproduced. Computational approaches are required to analyze such intricate quantitative proteomics data sets. We propose a statistical approach to computationally identify protein sets (e.g., Gene Ontology (GO) terms) that are significantly enriched with abundant proteins with reproducible quantification measurements across a set of replicates. To this end, we developed PSEA-Quant, a protein set enrichment analysis algorithm for label-free and label-based protein quantification data sets. It offers an alternative approach to classic GO analyses, models protein annotation biases, and allows the analysis of samples originating from a single condition, unlike analogous approaches such as GSEA and PSEA. We demonstrate that PSEA-Quant produces results complementary to GO analyses. We also show that PSEA-Quant provides valuable information about the biological processes involved in cystic fibrosis using label-free protein quantification of a cell line expressing a CFTR mutant. Finally, PSEA-Quant highlights the differences in the mechanisms taking place in the human, rat, and mouse brain frontal cortices based on tandem mass tag quantification. Our approach, which is available online, will thus improve the analysis of proteomics quantification data sets by providing meaningful biological insights.

PSEA-Quant: A Protein Set Enrichment Analysis on Label-Free and Label-Based Protein Quantification Data

PubMed Central

2015-01-01

The majority of large-scale proteomics quantification methods yield long lists of quantified proteins that are often difficult to interpret and poorly reproduced. Computational approaches are required to analyze such intricate quantitative proteomics data sets. We propose a statistical approach to computationally identify protein sets (e.g., Gene Ontology (GO) terms) that are significantly enriched with abundant proteins with reproducible quantification measurements across a set of replicates. To this end, we developed PSEA-Quant, a protein set enrichment analysis algorithm for label-free and label-based protein quantification data sets. It offers an alternative approach to classic GO analyses, models protein annotation biases, and allows the analysis of samples originating from a single condition, unlike analogous approaches such as GSEA and PSEA. We demonstrate that PSEA-Quant produces results complementary to GO analyses. We also show that PSEA-Quant provides valuable information about the biological processes involved in cystic fibrosis using label-free protein quantification of a cell line expressing a CFTR mutant. Finally, PSEA-Quant highlights the differences in the mechanisms taking place in the human, rat, and mouse brain frontal cortices based on tandem mass tag quantification. Our approach, which is available online, will thus improve the analysis of proteomics quantification data sets by providing meaningful biological insights. PMID:25177766

Evaluation of a complex, population-based injury claims management intervention for improving injury outcomes: study protocol.

PubMed

Collie, Alex; Gabbe, Belinda; Fitzharris, Michael

2015-05-12

Injuries resulting from road traffic crashes are a substantial cause of disability and death worldwide. Injured persons receiving compensation have poorer recovery and return to work than those with non-compensable injury. Case or claims management is a critical component of injury compensation systems, and there is now evidence that claims management can have powerful positive impacts on recovery, but can also impede recovery or exacerbate mental health concerns in some injured people. This study seeks to evaluate the impact of a population-based injury claims management intervention in the State of Victoria, Australia, on the health of those injured in motor vehicle crashes, their experience of the compensation process, and the financial viability of the compensation system. Evaluation of this complex intervention involves a series of linked but stand-alone research projects to assess the anticipated process changes, impacts and outcomes of the intervention over a 5-year time frame. Linkage and analysis of routine administrative and health system data is supplemented with a series of primary studies collecting new information. Additionally, a series of 'action' research projects will be undertaken to inform the implementation of the intervention. A program logic model designed by the state government Transport Accident Commission in conjunction with the research team provides the evaluation framework. Relatively few studies have comprehensively examined the impact of compensation system processes on the health of injured persons, their satisfaction with systems processes, and impacts on the financial performance of the compensation scheme itself. The wholesale, population-based transformation of an injury claims management model is a rare opportunity to document impacts of system-level policy change on outcomes of injured persons. Findings will contribute to the evidence base of information on the public health effects of injury claims management policy and

"Weekend effect" on stroke mortality revisited: Application of a claims-based stroke severity index in a population-based cohort study.

PubMed

Hsieh, Cheng-Yang; Lin, Huey-Juan; Chen, Chih-Hung; Li, Chung-Yi; Chiu, Meng-Jun; Sung, Sheng-Feng

2016-06-01

Previous studies have yielded inconsistent results on whether weekend admission is associated with increased mortality after stroke, partly because of differences in case mix. Claims-based studies generally lack sufficient information on disease severity and, thus, suffer from inadequate case-mix adjustment. In this study, we examined the effect of weekend admission on 30-day mortality in patients with ischemic stroke by using a claims-based stroke severity index.This was an observational study using a representative sample of the National Health Insurance claims data linked to the National Death Registry. We identified patients hospitalized for ischemic stroke, and examined the effect of weekend admission on 30-day mortality with vs without adjustment for stroke severity by using multilevel logistic regression analysis adjusting for patient-, physician-, and hospital-related factors. We analyzed 46,007 ischemic stroke admissions, in which weekend admissions accounted for 23.0%. Patients admitted on weekends had significantly higher 30-day mortality (4.9% vs 4.0%, P < 0.001) and stroke severity index (7.8 vs 7.4, P < 0.001) than those admitted on weekdays. In multivariate analysis without adjustment for stroke severity, weekend admission was associated with increased 30-day mortality (odds ratio (OR), 1.20; 95% confidence interval [CI], 1.08-1.34). This association became null after adjustment for stroke severity (OR, 1.07; 95% CI, 0.95-1.20).The "weekend effect" on stroke mortality might be attributed to higher stroke severity in weekend patients. While claims data are useful for examining stroke outcomes, adequate adjustment for stroke severity is warranted.

Small Claims Court.

ERIC Educational Resources Information Center

McKitric, Eloise; Davis, Janet

The study examined individuals and companies who used small claims courts and the results of decisions reached in small claims cases. A review of studies including an empirical study of two Ohio small claims courts monitored for 12 months made it clear that small claims courts need to be examined to determine if utilization and accessibility to…

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...

High-throughput screening based on label-free detection of small molecule microarrays

NASA Astrophysics Data System (ADS)

Zhu, Chenggang; Fei, Yiyan; Zhu, Xiangdong

2017-02-01

Based on small-molecule microarrays (SMMs) and oblique-incidence reflectivity difference (OI-RD) scanner, we have developed a novel high-throughput drug preliminary screening platform based on label-free monitoring of direct interactions between target proteins and immobilized small molecules. The screening platform is especially attractive for screening compounds against targets of unknown function and/or structure that are not compatible with functional assay development. In this screening platform, OI-RD scanner serves as a label-free detection instrument which is able to monitor about 15,000 biomolecular interactions in a single experiment without the need to label any biomolecule. Besides, SMMs serves as a novel format for high-throughput screening by immobilization of tens of thousands of different compounds on a single phenyl-isocyanate functionalized glass slide. Based on the high-throughput screening platform, we sequentially screened five target proteins (purified target proteins or cell lysate containing target protein) in high-throughput and label-free mode. We found hits for respective target protein and the inhibition effects for some hits were confirmed by following functional assays. Compared to traditional high-throughput screening assay, the novel high-throughput screening platform has many advantages, including minimal sample consumption, minimal distortion of interactions through label-free detection, multi-target screening analysis, which has a great potential to be a complementary screening platform in the field of drug discovery.

32 CFR 536.74 - Scope for claims under the Military Claims Act.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (normally a resident) of the United States at the time of the incident giving rise to the claim. See § 536... AND ACCOUNTS CLAIMS AGAINST THE UNITED STATES Claims Cognizable Under the Military Claims Act § 536.74... claims against the United States for death or personal injury, or damage to, or loss or destruction of...

32 CFR 536.74 - Scope for claims under the Military Claims Act.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (normally a resident) of the United States at the time of the incident giving rise to the claim. See § 536... AND ACCOUNTS CLAIMS AGAINST THE UNITED STATES Claims Cognizable Under the Military Claims Act § 536.74... claims against the United States for death or personal injury, or damage to, or loss or destruction of...

Hip Arthroplasty Malpractice Claims in the Netherlands: Closed Claim Study 2000-2012.

PubMed

Zengerink, Imme; Reijman, Max; Mathijssen, Nina M C; Eikens-Jansen, Manon P; Bos, P Koen

2016-09-01

A total hip arthroplasty (THA) is a successful and reliable operation with few complications. These complications however, do form a potential source for compensation claims. In the Netherlands, there are no studies available concerning filed claims after THA. The aim of this study was to determine the incidence of claims related to THAs in the Netherlands and the reasons to claim, which claims lead to compensation, the costs involved for the insurer, and the demographics of the claimants. In this observational study, we analyzed all closed claims from 2000 to 2012 from the national largest insurer of medical liability and compared it to data from our national implant registry in the Netherlands. With the intention to contribute to prevention, we have identified the demographics of the claimant, the reasons for filing claims, and the outcome of claims. Overall, 516 claims were expressed in 280 closed claim files after THA. Claims were most often related to sciatic nerve injury (19.6%). Most claimants were women (71.6%) with an average age of 63.1 years. The median cost per compensated claim is €5.921. The claimant is more likely to be female and to be younger than the average patient receiving a THA. The incidence of a claim after a THA is 0.14%-0.30%. Nerve damage is the most common reason to file for compensation. The distribution in reasons to claim does not resemble the complication rate in literature after a THA. The outcome of this study can be used to improve patient care, safety, and costs. Copyright © 2016 Elsevier Inc. All rights reserved.

Effects of an icon-based menu labelling initiative on consumer food choice.

PubMed

Kerins, Claire; Cunningham, Katie; Finucane, Francis M; Gibson, Irene; Jones, Jenni; Kelly, Colette

2017-01-01

The purpose of this study was to examine the impact of an icon-based menu labelling initiative on consumer buying behaviour. This quasi-experimental study recruited a convenience sample of eight food service establishments, all with at least one menu item meeting the heart healthy criteria. Data from sales of all menu items sold over an 8-week period were collated 4 weeks prior to and 4 weeks during the display of information icons related to healthy food choices on menus. The absolute change in menu item sales showed a non-significant trend towards an increase in healthier menu item selections. Furthermore, there was no association between the type of food service establishment and the percentage change in labelled menu item sales. The study did not find a statistically significant influence of the icon-based menu labels on consumer food choice. Given the limited amount of research that examines alternative menu labelling formats in real-world settings, more studies are necessary to confirm these results. Further research is needed to identify the optimal format, content and impact of menu labels on consumer behaviour.

Effects of School-Based Educational Interventions for Enhancing Adolescents Abilities in Critical Appraisal of Health Claims: A Systematic Review.

PubMed

Nordheim, Lena V; Gundersen, Malene W; Espehaug, Birgitte; Guttersrud, Øystein; Flottorp, Signe

2016-01-01

Adolescents are frequent media users who access health claims from various sources. The plethora of conflicting, pseudo-scientific, and often misleading health claims in popular media makes critical appraisal of health claims an essential ability. Schools play an important role in educating youth to critically appraise health claims. The objective of this systematic review was to evaluate the effects of school-based educational interventions for enhancing adolescents' abilities in critically appraising health claims. We searched MEDLINE, Embase, PsycINFO, AMED, Cinahl, Teachers Reference Centre, LISTA, ERIC, Sociological Abstracts, Social Services Abstracts, The Cochrane Library, Science Citation Index Expanded, Social Sciences Citation Index, and sources of grey literature. Studies that evaluated school-based educational interventions to improve adolescents' critical appraisal ability for health claims through advancing the students' knowledge about science were included. Eligible study designs were randomised and non-randomised controlled trials, and interrupted time series. Two authors independently selected studies, extracted data, and assessed risk of bias in included studies. Due to heterogeneity in interventions and inadequate reporting of results, we performed a descriptive synthesis of studies. We used GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) to assess the certainty of the evidence. Eight studies were included: two compared different teaching modalities, while the others compared educational interventions to instruction as usual. Studies mostly reported positive short-term effects on critical appraisal-related knowledge and skills in favour of the educational interventions. However, the certainty of the evidence for all comparisons and outcomes was very low. Educational interventions in schools may have beneficial short-term effects on knowledge and skills relevant to the critical appraisal of health claims. The small

Effects of School-Based Educational Interventions for Enhancing Adolescents Abilities in Critical Appraisal of Health Claims: A Systematic Review

PubMed Central

Espehaug, Birgitte; Guttersrud, Øystein; Flottorp, Signe

2016-01-01

Background and Objective Adolescents are frequent media users who access health claims from various sources. The plethora of conflicting, pseudo-scientific, and often misleading health claims in popular media makes critical appraisal of health claims an essential ability. Schools play an important role in educating youth to critically appraise health claims. The objective of this systematic review was to evaluate the effects of school-based educational interventions for enhancing adolescents’ abilities in critically appraising health claims. Methods We searched MEDLINE, Embase, PsycINFO, AMED, Cinahl, Teachers Reference Centre, LISTA, ERIC, Sociological Abstracts, Social Services Abstracts, The Cochrane Library, Science Citation Index Expanded, Social Sciences Citation Index, and sources of grey literature. Studies that evaluated school-based educational interventions to improve adolescents’ critical appraisal ability for health claims through advancing the students’ knowledge about science were included. Eligible study designs were randomised and non-randomised controlled trials, and interrupted time series. Two authors independently selected studies, extracted data, and assessed risk of bias in included studies. Due to heterogeneity in interventions and inadequate reporting of results, we performed a descriptive synthesis of studies. We used GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) to assess the certainty of the evidence. Results Eight studies were included: two compared different teaching modalities, while the others compared educational interventions to instruction as usual. Studies mostly reported positive short-term effects on critical appraisal-related knowledge and skills in favour of the educational interventions. However, the certainty of the evidence for all comparisons and outcomes was very low. Conclusion Educational interventions in schools may have beneficial short-term effects on knowledge and skills relevant

Structure of the knowledge base for an expert labeling system

NASA Technical Reports Server (NTRS)

Rajaram, N. S.

1981-01-01

One of the principal objectives of the NASA AgRISTARS program is the inventory of global crop resources using remotely sensed data gathered by Land Satellites (LANDSAT). A central problem in any such crop inventory procedure is the interpretation of LANDSAT images and identification of parts of each image which are covered by a particular crop of interest. This task of labeling is largely a manual one done by trained human analysts and consequently presents obstacles to the development of totally automated crop inventory systems. However, development in knowledge engineering as well as widespread availability of inexpensive hardware and software for artificial intelligence work offers possibilities for developing expert systems for labeling of crops. Such a knowledge based approach to labeling is presented.

Assessment of health claims, content, and safety of herbal supplements containing Ginkgo biloba

PubMed Central

Fransen, Heidi P.; Pelgrom, Sylvia M.G.J.; Stewart-Knox, Barbara; de Kaste, Dries; Verhagen, Hans

2010-01-01

Background European Regulation 1924/2006 states that all health claims made on foods need to be substantiated scientifically. Objective To apply the PASSCLAIM criteria for the scientific substantiation of health claims on foods to herbal supplements containing Ginkgo biloba. Evaluation of three selected claimed health effects for G. biloba (improvement of blood circulation, improvement of symptoms of old age, and improvement of memory) was achieved through review of publicly available scientific data. A total of 35 human intervention studies were evaluated. Commercially available products claimed to contain mainly G. biloba (N=29) were randomly sampled in the Netherlands and analyzed for their content on ginkgo extract. Also, a toxicological risk assessment was performed. Results The three selected health claims investigated could not be substantiated. This was mainly because of a lack of data from studies in healthy volunteers. In most studies results performed with a 24% standardized G. biloba extract were described. However, our chemical analysis showed that 25 of the 29 sampled products did not contain the required minimum 24% standardized extract. Moreover, in most preparations the content of substances typical for G. biloba did not conform to what was declared on the label. Since toxicity data for G. biloba are very limited, a safety limit could not be established. Conclusions Evidence is lacking for three health claims of herbal products with G. biloba. Neither safety nor efficacy can be guaranteed at the recommended daily dose. The multidisciplinary approach described in this paper provides good insight into issues that are relevant for the evaluation of health claims for herbal food supplements. PMID:20927202

Selective Chemical Labeling of Proteins with Small Fluorescent Molecules Based on Metal-Chelation Methodology

PubMed Central

Soh, Nobuaki

2008-01-01

Site-specific chemical labeling utilizing small fluorescent molecules is a powerful and attractive technique for in vivo and in vitro analysis of cellular proteins, which can circumvent some problems in genetic encoding labeling by large fluorescent proteins. In particular, affinity labeling based on metal-chelation, advantageous due to the high selectivity/simplicity and the small tag-size, is promising, as well as enzymatic covalent labeling, thereby a variety of novel methods have been studied in recent years. This review describes the advances in chemical labeling of proteins, especially highlighting the metal-chelation methodology. PMID:27879749

Systematic Comparison of Label-Free, Metabolic Labeling, and Isobaric Chemical Labeling for Quantitative Proteomics on LTQ Orbitrap Velos

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

Li, Zhou; Adams, Rachel M; Chourey, Karuna

2012-01-01

A variety of quantitative proteomics methods have been developed, including label-free, metabolic labeling, and isobaric chemical labeling using iTRAQ or TMT. Here, these methods were compared in terms of the depth of proteome coverage, quantification accuracy, precision, and reproducibility using a high-performance hybrid mass spectrometer, LTQ Orbitrap Velos. Our results show that (1) the spectral counting method provides the deepest proteome coverage for identification, but its quantification performance is worse than labeling-based approaches, especially the quantification reproducibility; (2) metabolic labeling and isobaric chemical labeling are capable of accurate, precise, and reproducible quantification and provide deep proteome coverage for quantification. Isobaricmore » chemical labeling surpasses metabolic labeling in terms of quantification precision and reproducibility; (3) iTRAQ and TMT perform similarly in all aspects compared in the current study using a CID-HCD dual scan configuration. Based on the unique advantages of each method, we provide guidance for selection of the appropriate method for a quantitative proteomics study.« less

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...

Behavior Based Social Dimensions Extraction for Multi-Label Classification

PubMed Central

Li, Le; Xu, Junyi; Xiao, Weidong; Ge, Bin

2016-01-01

Classification based on social dimensions is commonly used to handle the multi-label classification task in heterogeneous networks. However, traditional methods, which mostly rely on the community detection algorithms to extract the latent social dimensions, produce unsatisfactory performance when community detection algorithms fail. In this paper, we propose a novel behavior based social dimensions extraction method to improve the classification performance in multi-label heterogeneous networks. In our method, nodes’ behavior features, instead of community memberships, are used to extract social dimensions. By introducing Latent Dirichlet Allocation (LDA) to model the network generation process, nodes’ connection behaviors with different communities can be extracted accurately, which are applied as latent social dimensions for classification. Experiments on various public datasets reveal that the proposed method can obtain satisfactory classification results in comparison to other state-of-the-art methods on smaller social dimensions. PMID:27049849

Pediatric radiology malpractice claims - characteristics and comparison to adult radiology claims.

PubMed

Breen, Micheál A; Dwyer, Kathy; Yu-Moe, Winnie; Taylor, George A

2017-06-01

Medical malpractice is the primary method by which people who believe they have suffered an injury in the course of medical care seek compensation in the United States and Canada. An increasing body of research demonstrates that failure to correctly diagnose is the most common allegation made in malpractice claims against radiologists. Since the 1994 survey by the Society of Chairmen of Radiology in Children's Hospitals (SCORCH), no other published studies have specifically examined the frequency or clinical context of malpractice claims against pediatric radiologists or arising from pediatric imaging interpretation. We hypothesize that the frequency, character and outcome of malpractice claims made against pediatric radiologists differ from those seen in general radiology practice. We searched the Controlled Risk Insurance Co. (CRICO) Strategies' Comparative Benchmarking System (CBS), a private repository of approximately 350,000 open and closed medical malpractice claims in the United States, for claims related to pediatric radiology. We further queried these cases for the major allegation, the clinical environment in which the claim arose, the clinical severity of the alleged injury, indemnity paid (if payment was made), primary imaging modality involved (if applicable) and primary International Classification of Diseases, 9th revision (ICD-9) diagnosis underlying the claim. There were a total of 27,056 fully coded claims of medical malpractice in the CBS database in the 5-year period between Jan. 1, 2010, and Dec. 31, 2014. Of these, 1,472 cases (5.4%) involved patients younger than 18 years. Radiology was the primary service responsible for 71/1,472 (4.8%) pediatric cases. There were statistically significant differences in average payout for pediatric radiology claims ($314,671) compared to adult radiology claims ($174,033). The allegations were primarily diagnosis-related in 70% of pediatric radiology claims. The most common imaging modality implicated in

32 CFR 842.120 - Asserting the claim.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 6 2010-07-01 2010-07-01 false Asserting the claim. 842.120 Section 842.120 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE CLAIMS AND LITIGATION... include the facts and legal basis for liability. Bases for liability could include local foreign law, US...

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. ...

Performing label-fusion-based segmentation using multiple automatically generated templates.

PubMed

Chakravarty, M Mallar; Steadman, Patrick; van Eede, Matthijs C; Calcott, Rebecca D; Gu, Victoria; Shaw, Philip; Raznahan, Armin; Collins, D Louis; Lerch, Jason P

2013-10-01

Classically, model-based segmentation procedures match magnetic resonance imaging (MRI) volumes to an expertly labeled atlas using nonlinear registration. The accuracy of these techniques are limited due to atlas biases, misregistration, and resampling error. Multi-atlas-based approaches are used as a remedy and involve matching each subject to a number of manually labeled templates. This approach yields numerous independent segmentations that are fused using a voxel-by-voxel label-voting procedure. In this article, we demonstrate how the multi-atlas approach can be extended to work with input atlases that are unique and extremely time consuming to construct by generating a library of multiple automatically generated templates of different brains (MAGeT Brain). We demonstrate the efficacy of our method for the mouse and human using two different nonlinear registration algorithms (ANIMAL and ANTs). The input atlases consist a high-resolution mouse brain atlas and an atlas of the human basal ganglia and thalamus derived from serial histological data. MAGeT Brain segmentation improves the identification of the mouse anterior commissure (mean Dice Kappa values (κ = 0.801), but may be encountering a ceiling effect for hippocampal segmentations. Applying MAGeT Brain to human subcortical structures improves segmentation accuracy for all structures compared to regular model-based techniques (κ = 0.845, 0.752, and 0.861 for the striatum, globus pallidus, and thalamus, respectively). Experiments performed with three manually derived input templates suggest that MAGeT Brain can approach or exceed the accuracy of multi-atlas label-fusion segmentation (κ = 0.894, 0.815, and 0.895 for the striatum, globus pallidus, and thalamus, respectively). Copyright © 2012 Wiley Periodicals, Inc.

Capillary electrophoretic separation-based approach to determine the labeling kinetics of oligodeoxynucleotides

PubMed Central

Kanavarioti, Anastassia; Greenman, Kevin L.; Hamalainen, Mark; Jain, Aakriti; Johns, Adam M.; Melville, Chris R.; Kemmish, Kent; Andregg, William

2014-01-01

With the recent advances in electron microscopy (EM), computation, and nanofabrication, the original idea of reading DNA sequence directly from an image can now be tested. One approach is to develop heavy atom labels that can provide the contrast required for EM imaging. While evaluating tentative labels for the respective nucleobases in synthetic oligodeoxynucleotides (oligos), we developed a streamlined capillary electrophoresis (CE) protocol to assess the label stability, reactivity, and selectivity. We report our protocol using osmium tetroxide 2,2′-bipyridine (Osbipy) as a thymidine (T) specific label. The observed rates show that the labeling process is kinetically independent of both the oligo length, and the base composition. The conditions, i.e. temperature, optimal Osbipy concentration, and molar ratio of reagents, to promote 100% conversion of the starting oligo to labeled product were established. Hence the optimized conditions developed with the oligos could be leveraged to allow osmylation of effectively all Ts in single-stranded (ss) DNA, while achieving minimal mislabeling. In addition, the approach and methods employed here may be adapted to the evaluation of other prospective contrasting agents/labels to facilitate next-generation DNA sequencing by EM. PMID:23147698

Characteristics of claims in the management of septic arthritis in Japan: Retrospective analyses of judicial precedents and closed claims.

PubMed

Otaki, Yasuhiro; DaSilva, Makiko Ishida; Saito, Yuichi; Oyama, Yasuaki; Oiso, Giichiro; Yoshida, Tomohiko; Fukuhara, Masakazu; Moriyama, Mitsuru

2018-03-01

Septic arthritis (SA) cases can result in claims or litigation because of poor prognosis even if it is unavoidable. Although these claims or litigation are useful for understanding causes and background factors of medical errors, the characteristics of malpractice claims associated with SA remain undetermined in Japan. This study aimed to increase our understanding of malpractice claims in the clinical management of SA. We analyzed 6 civil precedents and 16 closed claims of SA from 8530 malpractice claims processed between July 2004 and June 2014 by the Tokyo office of Sompo Japan Nipponkoa Insurance, Incorporated. We also studied 5 accident and 21 incident reports of SA based on project data compiled by the Japan Council for Quality Health Care. The rate of negligence was 83.3% in the precedents and 75.0% in closed claims. Two main malpractice claim patterns were revealed: SA in a lower extremity joint following sepsis caused by methicillin-resistant Staphylococcus aureus in newborns and SA in an injection site following joint injection. These two patterns accounted for 83.3% and 56.3% of judicial cases and closed claim cases, respectively. Breakdowns in care process of accident and incident reports were clearly differentiated from judicial cases or closed claim cases (Fisher's exact test, p < 0.001). It is important to pay particular attention to SA following sepsis in newborns and to monitor for any signs of SA after joint injection to ensure early diagnosis. Analysis of both malpractice claims and accident and incident reports is essential to ensure a full understanding of the situation in Japan. Copyright © 2017. Published by Elsevier Taiwan LLC.

Effects of Categorical Labels on Similarity Judgments: A Critical Evaluation of a Critical Analysis--Comment on Noles and Gelman (2012)

ERIC Educational Resources Information Center

Sloutsky, Vladimir M.; Fisher, Anna V.

2012-01-01

Noles and Gelman (2012) attempt to critically reevaluate the claim that linguistic labels affect children's judgments of visual similarity. They report results of an experiment that used a modified version of Sloutsky and Fisher's (2004) task and conclude that "labels do not generally affect children's perceptual similarity judgments; rather,…

Modeling number of claims and prediction of total claim amount

NASA Astrophysics Data System (ADS)

Acar, Aslıhan Şentürk; Karabey, Uǧur

2017-07-01

In this study we focus on annual number of claims of a private health insurance data set which belongs to a local insurance company in Turkey. In addition to Poisson model and negative binomial model, zero-inflated Poisson model and zero-inflated negative binomial model are used to model the number of claims in order to take into account excess zeros. To investigate the impact of different distributional assumptions for the number of claims on the prediction of total claim amount, predictive performances of candidate models are compared by using root mean square error (RMSE) and mean absolute error (MAE) criteria.

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

Origins of the prohibition against off-label promotion.

PubMed

Coleman, Terry S

2014-01-01

The statute and regulations administered by the Food and Drug Administration ("FDA") do not explicitly prohibit the promotion of drugs and medical devices for unapproved uses, yet the government has collected billions of dollars in penalties for such "off-label" promotion. The statutory interpretations and regulatory provisions relied on by the government to take enforcement action against off-label promotion are the incidental by-products of initiatives undertaken by FDA through administrative action and litigation early in its implementation of the Federal Food, Drug, and Cosmetic Act. The actions were designed to obtain FDA authority over therapeutic claims made in advertising, even though Congress had assigned authority over advertising to the Federal Trade Commission, and to establish a prescription-only drug system, even though FDA lacked statutory authority for such a system. The principal purpose of both efforts was to prevent inappropriate self-medication. This article describes the history of those strategies, including expansion of the definition of the term "labeling" to encompass matter that was initially regarded as advertising; creation of the rule that the labeling of drugs must have adequate directions for all "intended" uses; and construction of the prescription-only drug system in a manner that allowed FDA to use the statutory requirement for labeling to have "adequate directions for use" to prohibit the off-label promotion of prescription drugs.

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.

Weighted compactness function based label propagation algorithm for community detection

NASA Astrophysics Data System (ADS)

Zhang, Weitong; Zhang, Rui; Shang, Ronghua; Jiao, Licheng

2018-02-01

Community detection in complex networks, is to detect the community structure with the internal structure relatively compact and the external structure relatively sparse, according to the topological relationship among nodes in the network. In this paper, we propose a compactness function which combines the weight of nodes, and use it as the objective function to carry out the node label propagation. Firstly, according to the node degree, we find the sets of core nodes which have great influence on the network. The more the connections between the core nodes and the other nodes are, the larger the amount of the information these kernel nodes receive and transform. Then, according to the similarity of the nodes between the core nodes sets and the nodes degree, we assign weights to the nodes in the network. So the label of the nodes with great influence will be the priority in the label propagation process, which effectively improves the accuracy of the label propagation. The compactness function between nodes and communities in this paper is based on the nodes influence. It combines the connections between nodes and communities with the degree of the node belongs to its neighbor communities based on calculating the node weight. The function effectively uses the information of nodes and connections in the network. The experimental results show that the proposed algorithm can achieve good results in the artificial network and large-scale real networks compared with the 8 contrast algorithms.

Food label usage and reported difficulty with following a gluten-free diet among individuals in the USA with coeliac disease and those with noncoeliac gluten sensitivity.

PubMed

Verrill, L; Zhang, Y; Kane, R

2013-10-01

Individuals with coeliac disease (CD) and those with noncoeliac gluten sensitivity (GS) have reported difficulty following a gluten-free diet (GFD); however, few studies have explored the link between the food label, gluten-free (GF) claims and the difficulty associated with following a GFD. The present study surveyed adults with CD (n = 1,583) and adults with GS (n = 797) about their reported difficulty following a GFD, including assessing the role of food labels and GF claims, as well as other factors known to contribute to this difficulty. A two-sample t-test and chi-squared tests for equality of means or proportions were used for the descriptive data and ordinal logistic regression (OLR) was used to model associations. On average, individuals with GS reported slightly more difficulty following the GFD than did participants with CD. According to the OLR results, reading the food label often was significantly associated with less reported difficulty following a GFD, whereas consuming packaged processed foods and looking for GF claims more often were significantly associated with more reported difficulty for both respondent groups. Individuals with GS may rely more heavily on the GF claim for information about a product's gluten content. Individuals with CD, on the other hand, may be more experienced food label readers and may rely more on the ingredient list for finding GF foods. More studies are needed aiming to understand the role of the food label in facilitating consumers' ability to follow a GFD. Published 2013. This article is a U.S. Government work and is in the public domain in the USA.

Linking individual medicare health claims data with work-life claims and other administrative data.

PubMed

Mokyr Horner, Elizabeth; Cullen, Mark R

2015-09-30

Researchers investigating health outcomes for populations over age 65 can utilize Medicare claims data, but these data include no direct information about individuals' health prior to age 65 and are not typically linkable to files containing data on exposures and behaviors during their worklives. The current paper is a proof-of-concept, of merging employers' administrative data and private, employment-based health claims with Medicare data. Characteristics of the linked data, including sensitivity and specificity, are evaluated with an eye toward potential uses of such linked data. This paper uses a sample of former manufacturing workers from an industrial cohort as a test case. The dataset created by this integration could be useful to research in areas such as social epidemiology and occupational health. Medicare and employment administrative data were linked for a large cohort of manufacturing workers (employed at some point during 1996-2008) who transitioned onto Medicare between 2001-2009. Data on work-life health, including biometric indicators, were used to predict health at age 65 and to investigate the concordance of employment-based insurance claims with subsequent Medicare insurance claims. Chronic diseases were found to have relatively high levels of concordance between employment-based private insurance and subsequent Medicare insurance. Information about patient health prior to receipt of Medicare, including biometric indicators, were found to predict health at age 65. Combining these data allows for evaluation of continuous health trajectories, as well as modeling later-life health as a function of work-life behaviors and exposures. It also provides a potential endpoint for occupational health research. This is the first harmonization of its kind, providing a proof-of-concept. The dataset created by this integration could be useful for research in areas such as social epidemiology and occupational health.

9 CFR 381.480 - Label statements relating to usefulness in reducing or maintaining body weight.

Code of Federal Regulations, 2014 CFR

2014-01-01

... criteria set forth for such foods in § 381.460. (d) “Reduced calorie” foods and other comparative claims. A... misleading, and the product is labeled “low calorie” or “reduced calorie” or bears another comparative...

Validation of Medicaid claims-based diagnosis of myocardial infarction using an HIV clinical cohort

PubMed Central

Brouwer, Emily S.; Napravnik, Sonia; Eron, Joseph J; Simpson, Ross J; Brookhart, M. Alan; Stalzer, Brant; Vinikoor, Michael; Floris-Moore, Michelle; Stürmer, Til

2014-01-01

Background In non-experimental comparative effectiveness research using healthcare databases, outcome measurements must be validated to evaluate and potentially adjust for misclassification bias. We aimed to validate claims-based myocardial infarction algorithms in a Medicaid population using an HIV clinical cohort as the gold standard. Methods Medicaid administrative data were obtained for the years 2002–2008 and linked to the UNC CFAR HIV Clinical Cohort based on social security number, first name and last name and myocardial infarction were adjudicated. Sensitivity, specificity, positive predictive value, and negative predictive value were calculated. Results There were 1,063 individuals included. Over a median observed time of 2.5 years, 17 had a myocardial infarction. Specificity ranged from 0.979–0.993 with the highest specificity obtained using criteria with the ICD-9 code in the primary and secondary position and a length of stay ≥ 3 days. Sensitivity of myocardial infarction ascertainment varied from 0.588–0.824 depending on algorithm. Conclusion: Specificities of varying claims-based myocardial infarction ascertainment criteria are high but small changes impact positive predictive value in a cohort with low incidence. Sensitivities vary based on ascertainment criteria. Type of algorithm used should be prioritized based on study question and maximization of specific validation parameters that will minimize bias while also considering precision. PMID:23604043

"Off Label" Use of FDA-Approved Devices and Digital Breast Tomosynthesis.

PubMed

Kopans, Daniel B

2015-11-01

The purpose of this article is to clarify for radiologists the meaning of U.S. Food and Drug Administration (FDA) approval with respect to Digital Breast Tomosynthesis (DBT). DBT is a major improvement over 2D mammography in the detection of cancers (sensitivity) and the reduction in recalls resulting from screening (specificity). Most imaging systems that have been approved by the FDA are used "off label" for breast imaging. Although the FDA determines which claims a manufacturer can make for a device, physicians may use approved devices, such as DBT, off label to provide better patient care.

Label inspection of approximate cylinder based on adverse cylinder panorama

NASA Astrophysics Data System (ADS)

Lin, Jianping; Liao, Qingmin; He, Bei; Shi, Chenbo

2013-12-01

This paper presents a machine vision system for automated label inspection, with the goal to reduce labor cost and ensure consistent product quality. Firstly, the images captured from each single-camera are distorted, since the inspection object is approximate cylindrical. Therefore, this paper proposes an algorithm based on adverse cylinder projection, where label images are rectified by distortion compensation. Secondly, to overcome the limited field of viewing for each single-camera, our method novelly combines images of all single-cameras and build a panorama for label inspection. Thirdly, considering the shake of production lines and error of electronic signal, we design the real-time image registration to calculate offsets between the template and inspected images. Experimental results demonstrate that our system is accurate, real-time and can be applied for numerous real- time inspections of approximate cylinders.

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...

Comparing model-based and model-free analysis methods for QUASAR arterial spin labeling perfusion quantification.

PubMed

Chappell, Michael A; Woolrich, Mark W; Petersen, Esben T; Golay, Xavier; Payne, Stephen J

2013-05-01

Amongst the various implementations of arterial spin labeling MRI methods for quantifying cerebral perfusion, the QUASAR method is unique. By using a combination of labeling with and without flow suppression gradients, the QUASAR method offers the separation of macrovascular and tissue signals. This permits local arterial input functions to be defined and "model-free" analysis, using numerical deconvolution, to be used. However, it remains unclear whether arterial spin labeling data are best treated using model-free or model-based analysis. This work provides a critical comparison of these two approaches for QUASAR arterial spin labeling in the healthy brain. An existing two-component (arterial and tissue) model was extended to the mixed flow suppression scheme of QUASAR to provide an optimal model-based analysis. The model-based analysis was extended to incorporate dispersion of the labeled bolus, generally regarded as the major source of discrepancy between the two analysis approaches. Model-free and model-based analyses were compared for perfusion quantification including absolute measurements, uncertainty estimation, and spatial variation in cerebral blood flow estimates. Major sources of discrepancies between model-free and model-based analysis were attributed to the effects of dispersion and the degree to which the two methods can separate macrovascular and tissue signal. Copyright © 2012 Wiley Periodicals, Inc.

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...

"Organic," "natural," and "additive-free" cigarettes: Comparing the effects of advertising claims and disclaimers on perceptions of harm.

PubMed

Baig, Sabeeh A; Byron, M Justin; Lazard, Allison J; Brewer, Noel T

2018-02-26

The U.S. Tobacco Control Act restricts advertising or labeling that suggests one tobacco product is less harmful than another. We sought to examine how "organic," "natural," and "additive-free" advertising claims and corresponding disclaimers affect perceptions of cigarettes' harm. Participants were a national probability sample of adults in the U.S. (n = 1,114, including 344 smokers). We conducted a 5 (claim) × 2 (disclaimer) between-subjects factorial experiment. Participants viewed a Natural American Spirit cigarettes ad claiming they were "organic," "natural," "additive-free," "light," or "regular;" and with or without a corresponding disclaimer. The outcome was perceived harm of the advertised cigarettes. Among smokers, we also assessed interest in switching within their current brand to cigarettes with this characteristic (e.g., "additive-free"). Claims in the ad had a large effect on perceived harm (Cohen's d = 0.87, 95% CI: 0.47-1.29). Claims of cigarettes being "organic," "natural," or "additive-free" reduced perceived harm from the advertised cigarettes, as compared to "regular" and "light" claims. Disclaimers had a small effect, increasing perceived harm (d = 0.25, 95% CI: 0.08-0.41). The problematic claims also increased smokers' interest in switching. Disclaimers had no effect on smokers' interest in switching. "Organic," "natural," and "additive-free" claims may mislead people into thinking that the advertised cigarettes are less harmful than other cigarettes. Disclaimers did not offset misperceptions of harm created by false claims. The U.S. Food and Drug Administration should restrict the use of these misleading claims in tobacco advertising.

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

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...

Segmentation and labeling of the ventricular system in normal pressure hydrocephalus using patch-based tissue classification and multi-atlas labeling

NASA Astrophysics Data System (ADS)

Ellingsen, Lotta M.; Roy, Snehashis; Carass, Aaron; Blitz, Ari M.; Pham, Dzung L.; Prince, Jerry L.

2016-03-01

Normal pressure hydrocephalus (NPH) affects older adults and is thought to be caused by obstruction of the normal flow of cerebrospinal fluid (CSF). NPH typically presents with cognitive impairment, gait dysfunction, and urinary incontinence, and may account for more than five percent of all cases of dementia. Unlike most other causes of dementia, NPH can potentially be treated and the neurological dysfunction reversed by shunt surgery or endoscopic third ventriculostomy (ETV), which drain excess CSF. However, a major diagnostic challenge remains to robustly identify shunt-responsive NPH patients from patients with enlarged ventricles due to other neurodegenerative diseases. Currently, radiologists grade the severity of NPH by detailed examination and measurement of the ventricles based on stacks of 2D magnetic resonance images (MRIs). Here we propose a new method to automatically segment and label different compartments of the ventricles in NPH patients from MRIs. While this task has been achieved in healthy subjects, the ventricles in NPH are both enlarged and deformed, causing current algorithms to fail. Here we combine a patch-based tissue classification method with a registration-based multi-atlas labeling method to generate a novel algorithm that labels the lateral, third, and fourth ventricles in subjects with ventriculomegaly. The method is also applicable to other neurodegenerative diseases such as Alzheimer's disease; a condition considered in the differential diagnosis of NPH. Comparison with state of the art segmentation techniques demonstrate substantial improvements in labeling the enlarged ventricles, indicating that this strategy may be a viable option for the diagnosis and characterization of NPH.

Banning front-of-package food labels: first Amendment constraints on public health policy.

PubMed

Lytton, Timothy D

2011-06-01

In recent months, the FDA has begun a crackdown on misleading nutrition and health claims on the front of food packages by issuing warning letters to manufacturers and promising to develop stricter regulatory standards. Leading nutrition policy experts Marion Nestle and David Ludwig have called for an even tougher approach: a ban on all nutrition and health claims on the front of food packages. Nestle and Ludwig argue that most of these claims are scientifically unsound and misleading to consumers and that eliminating them would 'aid educational efforts to encourage the public to eat whole or minimally processed foods and to read the ingredients list on processed foods'. Nestle and Ludwig are right to raise concerns about consumer protection and public health when it comes to front-of-package food labels, but an outright ban on front-of-package nutrition and health claims would violate the First Amendment. As nutrition policy experts develop efforts to regulate front-of-package nutrition and health claims, they should be mindful of First Amendment constraints on government regulation of commercial speech.

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...

Structured prediction models for RNN based sequence labeling in clinical text.

PubMed

Jagannatha, Abhyuday N; Yu, Hong

2016-11-01

Sequence labeling is a widely used method for named entity recognition and information extraction from unstructured natural language data. In clinical domain one major application of sequence labeling involves extraction of medical entities such as medication, indication, and side-effects from Electronic Health Record narratives. Sequence labeling in this domain, presents its own set of challenges and objectives. In this work we experimented with various CRF based structured learning models with Recurrent Neural Networks. We extend the previously studied LSTM-CRF models with explicit modeling of pairwise potentials. We also propose an approximate version of skip-chain CRF inference with RNN potentials. We use these methodologies for structured prediction in order to improve the exact phrase detection of various medical entities.

Structured prediction models for RNN based sequence labeling in clinical text

PubMed Central

Jagannatha, Abhyuday N; Yu, Hong

2016-01-01

Sequence labeling is a widely used method for named entity recognition and information extraction from unstructured natural language data. In clinical domain one major application of sequence labeling involves extraction of medical entities such as medication, indication, and side-effects from Electronic Health Record narratives. Sequence labeling in this domain, presents its own set of challenges and objectives. In this work we experimented with various CRF based structured learning models with Recurrent Neural Networks. We extend the previously studied LSTM-CRF models with explicit modeling of pairwise potentials. We also propose an approximate version of skip-chain CRF inference with RNN potentials. We use these methodologies1 for structured prediction in order to improve the exact phrase detection of various medical entities. PMID:28004040

Venous thromboembolism incidence, recurrence, and mortality based on Women's Health Initiative data and Medicare claims.

PubMed

Burwen, Dale R; Wu, Chunyuan; Cirillo, Dominic; Rossouw, Jacques E; Margolis, Karen L; Limacher, Marian; Wallace, Robert; Allison, Matthew; Eaton, Charles B; Safford, Monika; Freiberg, Matthew

2017-02-01

Our objective was to compare Medicare claims to physician review and adjudication of medical records for identifying venous thromboembolism (VTE), and to assess VTE incidence, recurrence, and mortality in a large national cohort of post-menopausal women followed up to 19years. We used detailed clinical data from the Women's Health Initiative (WHI) linked to Medicare claims. Agreement between data sources was evaluated among 16,003 women during 1993-2010. A claims-based definition was selected to analyze VTE occurrence and impact among 71,267 women during 1993-2012. Our VTE definition had 83% sensitivity. Positive predictive value was 69% when all records were included, and 94% after limiting Medicare records to those with a WHI hospitalization adjudicated. Annualized VTE incidence was 4.06/1000person-years (PY), recurrence was 5.30/100PY, and both rates varied by race/ethnicity. Post-VTE mortality within 1year was 22.49% from all causes, including 1.01% from pulmonary embolism, 10.40% from cancer, and 11.08% from other causes. Cancer-related VTE compared to non-cancer VTE had significantly (p<0.001) higher recurrence (9.86/100PY vs. 4.43/100PY) and mortality from all causes (45.89% vs. 12.28%), but not from pulmonary embolism (0.40% vs. 1.27%). Medicare claims compared reasonably well to physician adjudication. The combined data sources provided new insights about VTE burden and prognosis in older women. Published by Elsevier Ltd.

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...

A label-free fluorescent aptamer sensor based on regulation of malachite green fluorescence

PubMed Central

Xu, Weichen; Lu, Yi

2009-01-01

We report a label-free fluorescent aptamer sensor for adenosine based on the regulation of malachite green (MG) fluorescence, with comparable sensitivity and selectivity to other labeled adenosine aptamer-based sensors. The sensor consists of free MG, an aptamer strand containing an adenosine aptamer next to an MG aptamer, and a bridging strand that partially hybridizes to the aptamer strand. Such a hybridization prevents MG from binding to MG aptamer, resulting in low fluorescence of MG in the absence of adenosine. Addition of adenosine causes the adenosine aptamer to bind adenosine, weakening the hybridization of the aptamer strand with the bridging strand, making it possible for MG to bind to the aptamer strand and exhibits high fluorescence intensity. Since this design is based purely on nucleic acid hybridization, it can be generally applied to other aptamers for the label-free detection of a broad range of analytes. PMID:20017558

EBprot: Statistical analysis of labeling-based quantitative proteomics data.

PubMed

Koh, Hiromi W L; Swa, Hannah L F; Fermin, Damian; Ler, Siok Ghee; Gunaratne, Jayantha; Choi, Hyungwon

2015-08-01

Labeling-based proteomics is a powerful method for detection of differentially expressed proteins (DEPs). The current data analysis platform typically relies on protein-level ratios, which is obtained by summarizing peptide-level ratios for each protein. In shotgun proteomics, however, some proteins are quantified with more peptides than others, and this reproducibility information is not incorporated into the differential expression (DE) analysis. Here, we propose a novel probabilistic framework EBprot that directly models the peptide-protein hierarchy and rewards the proteins with reproducible evidence of DE over multiple peptides. To evaluate its performance with known DE states, we conducted a simulation study to show that the peptide-level analysis of EBprot provides better receiver-operating characteristic and more accurate estimation of the false discovery rates than the methods based on protein-level ratios. We also demonstrate superior classification performance of peptide-level EBprot analysis in a spike-in dataset. To illustrate the wide applicability of EBprot in different experimental designs, we applied EBprot to a dataset for lung cancer subtype analysis with biological replicates and another dataset for time course phosphoproteome analysis of EGF-stimulated HeLa cells with multiplexed labeling. Through these examples, we show that the peptide-level analysis of EBprot is a robust alternative to the existing statistical methods for the DE analysis of labeling-based quantitative datasets. The software suite is freely available on the Sourceforge website http://ebprot.sourceforge.net/. All MS data have been deposited in the ProteomeXchange with identifier PXD001426 (http://proteomecentral.proteomexchange.org/dataset/PXD001426/). © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Malpractice claims for endoscopy

PubMed Central

Hernandez, Lyndon V; Klyve, Dominic; Regenbogen, Scott E

2013-01-01

AIM: To summarize the magnitude and time trends of endoscopy-related claims and to compare total malpractice indemnity according to specialty and procedure. METHODS: We obtained data from a comprehensive database of closed claims from a trade association of professional liability insurance carriers, representing over 60% of practicing United States physicians. Total payments by procedure and year were calculated, and were adjusted for inflation (using the Consumer Price Index) to 2008 dollars. Time series analysis was performed to assess changes in the total value of claims for each type of procedure over time. RESULTS: There were 1901 endoscopy-related closed claims against all providers from 1985 to 2008. The specialties include: internal medicine (n = 766), gastroenterology (n = 562), general surgery (n = 231), general and family practice (n = 101), colorectal surgery (n = 87), other specialties (n = 132), and unknown (n = 22). Colonoscopy represented the highest frequencies of closed claims (n = 788) and the highest total indemnities ($54 093 000). In terms of mean claims payment, endoscopic retrograde cholangiopancreatography (ERCP) ranked the highest ($374  794) per claim. Internists had the highest number of total claims (n = 766) and total claim payment ($70  730  101). Only total claim payments for colonoscopy and ERCP seem to have increased over time. Indeed, there was an average increase of 15.5% per year for colonoscopy and 21.9% per year for ERCP after adjusting for inflation. CONCLUSION: There appear to be differences in malpractice coverage costs among specialties and the type of endoscopic procedure. There is also evidence for secular trend in total claim payments, with colonoscopy and ERCP costs rising yearly even after adjusting for inflation. PMID:23596540

16 CFR 306.12 - Labels.

Code of Federal Regulations, 2010 CFR

2010-01-01

... biodiesel, biomass-based diesel, biodiesel blends, and biomass-based diesel blends. The label is 3 inches (7... the black band. Directly underneath the black band, the label shall read “contains biomass-based... the side edges of the label. (5) For biomass-based diesel blends containing more than 5 percent and no...

32 CFR 537.16 - Scope for maritime claims.

Code of Federal Regulations, 2010 CFR

2010-07-01

... claims for damage to: (1) DA-accountable properties of a kind that are within the federal maritime jurisdiction. (2) Property under the DA's jurisdiction or DA property damaged by a vessel or floating object... services (including contract salvage and towage) performed by the DA. Claims for salvage services are based...

A novel all-optical label processing for OPS networks based on multiple OOC sequences from multiple-groups OOC

NASA Astrophysics Data System (ADS)

Qiu, Kun; Zhang, Chongfu; Ling, Yun; Wang, Yibo

2007-11-01

This paper proposes an all-optical label processing scheme using multiple optical orthogonal codes sequences (MOOCS) for optical packet switching (OPS) (MOOCS-OPS) networks, for the first time to the best of our knowledge. In this scheme, the multiple optical orthogonal codes (MOOC) from multiple-groups optical orthogonal codes (MGOOC) are permuted and combined to obtain the MOOCS for the optical labels, which are used to effectively enlarge the capacity of available optical codes for optical labels. The optical label processing (OLP) schemes are reviewed and analyzed, the principles of MOOCS-based optical labels for OPS networks are given, and analyzed, then the MOOCS-OPS topology and the key realization units of the MOOCS-based optical label packets are studied in detail, respectively. The performances of this novel all-optical label processing technology are analyzed, the corresponding simulation is performed. These analysis and results show that the proposed scheme can overcome the lack of available optical orthogonal codes (OOC)-based optical labels due to the limited number of single OOC for optical label with the short code length, and indicate that the MOOCS-OPS scheme is feasible.

Carbon nanotube-based labels for highly sensitive colorimetric and aggregation-based visual detection of nucleic acids

NASA Astrophysics Data System (ADS)

Lee, Ai Cheng; Ye, Jian-Shan; Ngin Tan, Swee; Poenar, Daniel P.; Sheu, Fwu-Shan; Kiat Heng, Chew; Meng Lim, Tit

2007-11-01

A novel carbon nanotube (CNT) derived label capable of dramatic signal amplification of nucleic acid detection and direct visual detection of target hybridization has been developed. Highly sensitive colorimetric detection of human acute lymphocytic leukemia (ALL) related oncogene sequences amplified by the novel CNT-based label was demonstrated. Atomic force microscope (AFM) images confirmed that a monolayer of horseradish peroxidase and detection probe molecules was immobilized along the carboxylated CNT carrier. The resulting CNT labels significantly enhanced the nucleic acid assay sensitivity by at least 1000 times compared to that of conventional labels used in enzyme-linked oligosorbent assay (ELOSA). An excellent detection limit of 1 × 10-12 M (60 × 10-18 mol in 60 µl) and a four-order wide dynamic range of target concentration were achieved. Hybridizations using these labels were coupled to a concentration-dependent formation of visible dark aggregates. Targets can thus be detected simply with visual inspection, eliminating the need for expensive and sophisticated detection systems. The approach holds promise for ultrasensitive and low cost visual inspection and colorimetric nucleic acid detection in point-of-care and early disease diagnostic application.

32 CFR 538.6 - Claims.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 3 2014-07-01 2014-07-01 false Claims. 538.6 Section 538.6 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY CLAIMS AND ACCOUNTS MILITARY PAYMENT CERTIFICATES § 538.6 Claims. Claims for conversion of military payment certificates, as well as claims arising out of...

Recognizing and labeling sex-based and sexual harassment in the health care workplace.

PubMed

Madison, J; Minichiello, V

2000-01-01

To explore how registered nurses (RNs) recognized and labeled incidents of sex-based and sexual harassment in the Australian health care workplace. Qualitative, using 16 unstructured interviews with registered nurses in Australia. Verbatim transcripts were analyzed largely by inductive analysis. Key categories were identified as themes or concepts for analysis. RNs reported several indicators of sexual harassment, including the invasion of space, confirmation from others, lack of respect, the deliberate nature of the behavior, perceived power or control, overly friendly behavior, and a sexualized workplace. RNs rarely labeled harassing behaviors as sex-based or sexual harassment. Many forces reduce the likelihood that RNs will correctly recognize and label unwelcome sexualized behavior as sexual harassment. Recognition is associated with a variety of workplace behaviors that sometimes precede harassment. Implications for the health care workplace are discussed.

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.

Label-free measurements on cell apoptosis using a terahertz metamaterial-based biosensor

NASA Astrophysics Data System (ADS)

Zhang, Caihong; Liang, Lanju; Ding, Liang; Jin, Biaobing; Hou, Yayi; Li, Chun; Jiang, Ling; Liu, Weiwei; Hu, Wei; Lu, Yanqing; Kang, Lin; Xu, Weiwei; Chen, Jian; Wu, Peiheng

2016-06-01

Label-free, real-time, and in-situ measurement on cell apoptosis is highly desirable in cell biology. We propose here a design of terahertz (THz) metamaterial-based biosensor for meeting this requirement. This metamaterial consists of a planar array of five concentric subwavelength gold ring resonators on a 10 μm-thick polyimide substrate, which can sense the change of dielectric environment above the metamaterial. We employ this sensor to an oral cancer cell (SCC4) with and without cisplatin, a chemotherapy drug for cancer treatment, and find a linear relation between cell apoptosis measured by Flow Cytometry and the relative change of resonant frequencies of the metamaterial measured by THz time-domain spectroscopy. This implies that we can determine the cell apoptosis in a label-free manner. We believe that this metamaterial-based biosensor can be developed into a cheap, label-free, real-time, and in-situ detection tool, which is of significant impact on the study of cell biology.

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...

21 CFR 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.

Code of Federal Regulations, 2010 CFR

2010-04-01

... an exhaustive review of labeling claims made for drugs marketed under new-drug and antibiotic drug... classification in lieu of the Academy's classification. (d) For new drugs and antibiotics, supplements to provide... purchaser or prescriber is not misled by being left unaware through the sponsor's silence that a basic...

Framing and Claiming: How Information-Framing Affects Expected Social Security Claiming Behavior.

PubMed

Brown, Jeffrey R; Kapteyn, Arie; Mitchell, Olivia S

2016-03-01

This paper provides evidence that Social Security benefit claiming decisions are strongly affected by framing and are thus inconsistent with expected utility theory. Using a randomized experiment that controls for both observable and unobservable differences across individuals, we find that the use of a "breakeven analysis" encourages early claiming. Respondents are more likely to delay when later claiming is framed as a gain, and the claiming age is anchored at older ages. Additionally, the financially less literate, individuals with credit card debt, and those with lower earnings are more influenced by framing than others.

32 CFR 536.120 - Claims payable as maritime claims.

Code of Federal Regulations, 2014 CFR

2014-07-01

... claim is cognizable under this subpart if it arises in or on a maritime location, involves some... scope of employment. This class of claims includes, but is not limited to: (a) Damage to a ship, boat, barge, or other watercraft; (b) An injury that involves a ship, boat, barge, or other watercraft; (c...

32 CFR 536.120 - Claims payable as maritime claims.

Code of Federal Regulations, 2012 CFR

2012-07-01

... claim is cognizable under this subpart if it arises in or on a maritime location, involves some... scope of employment. This class of claims includes, but is not limited to: (a) Damage to a ship, boat, barge, or other watercraft; (b) An injury that involves a ship, boat, barge, or other watercraft; (c...

32 CFR 536.120 - Claims payable as maritime claims.

Code of Federal Regulations, 2013 CFR

2013-07-01

... claim is cognizable under this subpart if it arises in or on a maritime location, involves some... scope of employment. This class of claims includes, but is not limited to: (a) Damage to a ship, boat, barge, or other watercraft; (b) An injury that involves a ship, boat, barge, or other watercraft; (c...

78 FR 19632 - Administrative Claims Under the Federal Tort Claims Act and Related Statutes

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-02

... Administration 20 CFR Parts 638 and 670 RIN 1290-AA25 Administrative Claims Under the Federal Tort Claims Act and... governing administrative claims under the Federal Tort Claims Act and related statutes. DATES: Effective... (this is not a toll-free number). Individuals with hearing or speech impairments may access this...

Semi-Supervised Sparse Representation Based Classification for Face Recognition With Insufficient Labeled Samples

NASA Astrophysics Data System (ADS)

Gao, Yuan; Ma, Jiayi; Yuille, Alan L.

2017-05-01

This paper addresses the problem of face recognition when there is only few, or even only a single, labeled examples of the face that we wish to recognize. Moreover, these examples are typically corrupted by nuisance variables, both linear (i.e., additive nuisance variables such as bad lighting, wearing of glasses) and non-linear (i.e., non-additive pixel-wise nuisance variables such as expression changes). The small number of labeled examples means that it is hard to remove these nuisance variables between the training and testing faces to obtain good recognition performance. To address the problem we propose a method called Semi-Supervised Sparse Representation based Classification (S$^3$RC). This is based on recent work on sparsity where faces are represented in terms of two dictionaries: a gallery dictionary consisting of one or more examples of each person, and a variation dictionary representing linear nuisance variables (e.g., different lighting conditions, different glasses). The main idea is that (i) we use the variation dictionary to characterize the linear nuisance variables via the sparsity framework, then (ii) prototype face images are estimated as a gallery dictionary via a Gaussian Mixture Model (GMM), with mixed labeled and unlabeled samples in a semi-supervised manner, to deal with the non-linear nuisance variations between labeled and unlabeled samples. We have done experiments with insufficient labeled samples, even when there is only a single labeled sample per person. Our results on the AR, Multi-PIE, CAS-PEAL, and LFW databases demonstrate that the proposed method is able to deliver significantly improved performance over existing methods.

76 FR 49707 - Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease; Reopening of the...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-11

...; (8) allow for the use of the health claim on phytosterol ester-containing dietary supplements (esterified with food- grade fatty acids) but not on nonesterified phytosterol-containing dietary supplements... regarding the cholesterol- lowering efficacy of nonesterified phytosterols in dietary supplements. FDA did...

Framing and Claiming: How Information-Framing Affects Expected Social Security Claiming Behavior

PubMed Central

Brown, Jeffrey R.; Kapteyn, Arie; Mitchell, Olivia S.

2017-01-01

This paper provides evidence that Social Security benefit claiming decisions are strongly affected by framing and are thus inconsistent with expected utility theory. Using a randomized experiment that controls for both observable and unobservable differences across individuals, we find that the use of a “breakeven analysis” encourages early claiming. Respondents are more likely to delay when later claiming is framed as a gain, and the claiming age is anchored at older ages. Additionally, the financially less literate, individuals with credit card debt, and those with lower earnings are more influenced by framing than others. PMID:28579641

Label-free density difference amplification-based cell sorting.

PubMed

Song, Jihwan; Song, Minsun; Kang, Taewook; Kim, Dongchoul; Lee, Luke P

2014-11-01

The selective cell separation is a critical step in fundamental life sciences, translational medicine, biotechnology, and energy harvesting. Conventional cell separation methods are fluorescent activated cell sorting and magnetic-activated cell sorting based on fluorescent probes and magnetic particles on cell surfaces. Label-free cell separation methods such as Raman-activated cell sorting, electro-physiologically activated cell sorting, dielectric-activated cell sorting, or inertial microfluidic cell sorting are, however, limited when separating cells of the same kind or cells with similar sizes and dielectric properties, as well as similar electrophysiological phenotypes. Here we report a label-free density difference amplification-based cell sorting (dDACS) without using any external optical, magnetic, electrical forces, or fluidic activations. The conceptual microfluidic design consists of an inlet, hydraulic jump cavity, and multiple outlets. Incoming particles experience gravity, buoyancy, and drag forces in the separation chamber. The height and distance that each particle can reach in the chamber are different and depend on its density, thus allowing for the separation of particles into multiple outlets. The separation behavior of the particles, based on the ratio of the channel heights of the inlet and chamber and Reynolds number has been systematically studied. Numerical simulation reveals that the difference between the heights of only lighter particles with densities close to that of water increases with increasing the ratio of the channel heights, while decreasing Reynolds number can amplify the difference in the heights between the particles considered irrespective of their densities.

Co-Labeling for Multi-View Weakly Labeled Learning.

PubMed

Xu, Xinxing; Li, Wen; Xu, Dong; Tsang, Ivor W

2016-06-01

It is often expensive and time consuming to collect labeled training samples in many real-world applications. To reduce human effort on annotating training samples, many machine learning techniques (e.g., semi-supervised learning (SSL), multi-instance learning (MIL), etc.) have been studied to exploit weakly labeled training samples. Meanwhile, when the training data is represented with multiple types of features, many multi-view learning methods have shown that classifiers trained on different views can help each other to better utilize the unlabeled training samples for the SSL task. In this paper, we study a new learning problem called multi-view weakly labeled learning, in which we aim to develop a unified approach to learn robust classifiers by effectively utilizing different types of weakly labeled multi-view data from a broad range of tasks including SSL, MIL and relative outlier detection (ROD). We propose an effective approach called co-labeling to solve the multi-view weakly labeled learning problem. Specifically, we model the learning problem on each view as a weakly labeled learning problem, which aims to learn an optimal classifier from a set of pseudo-label vectors generated by using the classifiers trained from other views. Unlike traditional co-training approaches using a single pseudo-label vector for training each classifier, our co-labeling approach explores different strategies to utilize the predictions from different views, biases and iterations for generating the pseudo-label vectors, making our approach more robust for real-world applications. Moreover, to further improve the weakly labeled learning on each view, we also exploit the inherent group structure in the pseudo-label vectors generated from different strategies, which leads to a new multi-layer multiple kernel learning problem. Promising results for text-based image retrieval on the NUS-WIDE dataset as well as news classification and text categorization on several real-world multi

A novel all-optical label processing based on multiple optical orthogonal codes sequences for optical packet switching networks

NASA Astrophysics Data System (ADS)

Zhang, Chongfu; Qiu, Kun; Xu, Bo; Ling, Yun

2008-05-01

This paper proposes an all-optical label processing scheme that uses the multiple optical orthogonal codes sequences (MOOCS)-based optical label for optical packet switching (OPS) (MOOCS-OPS) networks. In this scheme, each MOOCS is a permutation or combination of the multiple optical orthogonal codes (MOOC) selected from the multiple-groups optical orthogonal codes (MGOOC). Following a comparison of different optical label processing (OLP) schemes, the principles of MOOCS-OPS network are given and analyzed. Firstly, theoretical analyses are used to prove that MOOCS is able to greatly enlarge the number of available optical labels when compared to the previous single optical orthogonal code (SOOC) for OPS (SOOC-OPS) network. Then, the key units of the MOOCS-based optical label packets, including optical packet generation, optical label erasing, optical label extraction and optical label rewriting etc., are given and studied. These results are used to verify that the proposed MOOCS-OPS scheme is feasible.

To label or not to label: applications of quantitative proteomics in neuroscience research.

PubMed

Filiou, Michaela D; Martins-de-Souza, Daniel; Guest, Paul C; Bahn, Sabine; Turck, Christoph W

2012-02-01

Proteomics has provided researchers with a sophisticated toolbox of labeling-based and label-free quantitative methods. These are now being applied in neuroscience research where they have already contributed to the elucidation of fundamental mechanisms and the discovery of candidate biomarkers. In this review, we evaluate and compare labeling-based and label-free quantitative proteomic techniques for applications in neuroscience research. We discuss the considerations required for the analysis of brain and central nervous system specimens, the experimental design of quantitative proteomic workflows as well as the feasibility, advantages, and disadvantages of the available techniques for neuroscience-oriented questions. Furthermore, we assess the use of labeled standards as internal controls for comparative studies in humans and review applications of labeling-based and label-free mass spectrometry approaches in relevant model organisms and human subjects. Providing a comprehensive guide of feasible and meaningful quantitative proteomic methodologies for neuroscience research is crucial not only for overcoming current limitations but also for gaining useful insights into brain function and translating proteomics from bench to bedside. Copyright © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

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.

Influence of Label Design on Children's Perception of 2 Snack Foods.

PubMed

Arrúa, Alejandra; Vidal, Leticia; Antúnez, Lucía; Machín, Leandro; Martínez, Joseline; Curutchet, María Rosa; Giménez, Ana; Ares, Gastón

2017-03-01

To evaluate the influence of label design on children's perception of 2 popular snack foods across 3 income levels. Labels of 2 snack products (yogurt and sponge cake) were designed using a fractional factorial design with 3 2-level variables: cartoon character, nutrition claims, and front-of-package nutritional information. A total of 221 children (aged 9-13 years) from Montevideo, Uruguay, with different income levels, participated in the study. Children's attitude toward and liking of 2 food products. Low-income children showed a more positive attitude toward the products than did middle- and high-income children. The inclusion of a cartoon character in sponge cake labels significantly affected hedonic expectations regardless of income. Middle- and high-income children tended to use the term funny more frequently and the term boring less frequently to describe labels that included the cartoon character, compared with those that did not. Results showed that the inclusion of cartoon characters on food labels is associated with fun. Low-income children seem more susceptible to the marketing strategies of food companies than do middle- and high-income children. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

44 CFR 62.20 - Claims appeals.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 44 Emergency Management and Assistance 1 2012-10-01 2011-10-01 true Claims appeals. 62.20 Section... OF CLAIMS Claims Adjustment, Claims Appeals, and Judicial Review § 62.20 Claims appeals. (a.... Decision means the insurer's final claim determination, which is the insurer's written denial, in whole or...

44 CFR 62.20 - Claims appeals.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 44 Emergency Management and Assistance 1 2013-10-01 2013-10-01 false Claims appeals. 62.20 Section... OF CLAIMS Claims Adjustment, Claims Appeals, and Judicial Review § 62.20 Claims appeals. (a.... Decision means the insurer's final claim determination, which is the insurer's written denial, in whole or...

44 CFR 62.20 - Claims appeals.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 44 Emergency Management and Assistance 1 2014-10-01 2014-10-01 false Claims appeals. 62.20 Section... OF CLAIMS Claims Adjustment, Claims Appeals, and Judicial Review § 62.20 Claims appeals. (a.... Decision means the insurer's final claim determination, which is the insurer's written denial, in whole or...

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.

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

A Study of Bicycle and Passenger Car Collisions Based on Insurance Claims Data

PubMed Central

Isaksson-Hellman, Irene

2012-01-01

In Sweden, bicycle crashes are under-reported in the official statistics that are based on police reports. Statistics from hospital reports show that cyclists constitute the highest percentage of severely injured road users compared to other road user groups. However, hospital reports lack detailed information about the crash. To get a more comprehensive view, additional data are needed to accurately reflect the casualty situation for cyclists. An analysis based on 438 cases of bicycle and passenger car collisions is presented, using data collected from insurance claims. The most frequent crash situations are described with factors as to where and when collisions occur, age and gender of the involved cyclists and drivers. Information on environmental circumstances such as road status, weather- and light conditions, speedlimits and traffic environment is also included. Based on the various crash events, a total of 32 different scenarios have been categorized, and it was found that more than 75% were different kinds of intersection related situations. From the data, it was concluded that factors such as estimated impact speed and age significantly influence injury severity. The insurance claims data complement the official statistics and provide a more comprehensive view of bicycle and passenger car collisions by considering all levels of crash and injury severity. The detailed descriptions of the crash situations also provide an opportunity to find countermeasures to prevent or mitigate collisions. The results provide a useful basis, and facilitates the work of reducing the number of bicycle and passenger car collisions with serious consequences. PMID:23169111

Stable isotopic labeling-based quantitative targeted glycomics (i-QTaG).

PubMed

Kim, Kyoung-Jin; Kim, Yoon-Woo; Kim, Yun-Gon; Park, Hae-Min; Jin, Jang Mi; Hwan Kim, Young; Yang, Yung-Hun; Kyu Lee, Jun; Chung, Junho; Lee, Sun-Gu; Saghatelian, Alan

2015-01-01

Mass spectrometry (MS) analysis combined with stable isotopic labeling is a promising method for the relative quantification of aberrant glycosylation in diseases and disorders. We developed a stable isotopic labeling-based quantitative targeted glycomics (i-QTaG) technique for the comparative and quantitative analysis of total N-glycans using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS). We established the analytical procedure with the chemical derivatizations (i.e., sialic acid neutralization and stable isotopic labeling) of N-glycans using a model glycoprotein (bovine fetuin). Moreover, the i-QTaG using MALDI-TOF MS was evaluated with various molar ratios (1:1, 1:2, 1:5) of (13) C6 /(12) C6 -2-aminobenzoic acid-labeled glycans from normal human serum. Finally, this method was applied to direct comparison of the total N-glycan profiles between normal human sera (n = 8) and prostate cancer patient sera (n = 17). The intensities of the N-glycan peaks from i-QTaG method showed a good linearity (R(2) > 0.99) with the amount of the bovine fetuin glycoproteins. The ratios of relative intensity between the isotopically 2-AA labeled N-glycans were close to the theoretical molar ratios (1:1, 1:2, 1:5). We also demonstrated that the up-regulation of the Lewis antigen (~82%) in sera from prostate cancer patients. In this proof-of-concept study, we demonstrated that the i-QTaG method, which enables to achieve a reliable comparative quantitation of total N-glycans via MALDI-TOF MS analysis, has the potential to diagnose and monitor alterations in glycosylation associated with disease states or biotherapeutics. © 2015 American Institute of Chemical Engineers.

32 CFR 842.5 - Claims forms.

Code of Federal Regulations, 2010 CFR

2010-07-01

... certain is sufficient to file a claim. The claimant should use these forms when filing a claim: (a) Claim... of or Damage to Personal Property Incident to Service, or DD Forms 1842, Claim for Personal Property Against the United States, and 1844, Schedule of Property and Claim Analysis Chart, to file the claim. (b...

32 CFR 842.5 - Claims forms.

Code of Federal Regulations, 2011 CFR

2011-07-01

... certain is sufficient to file a claim. The claimant should use these forms when filing a claim: (a) Claim... of or Damage to Personal Property Incident to Service, or DD Forms 1842, Claim for Personal Property Against the United States, and 1844, Schedule of Property and Claim Analysis Chart, to file the claim. (b...

The nutritional quality of foods carrying health-related claims in Germany, The Netherlands, Spain, Slovenia and the United Kingdom

PubMed Central

Kaur, A; Scarborough, P; Hieke, S; Kusar, A; Pravst, I; Raats, M; Rayner, M

2016-01-01

Backgroung/Objectives: Compares the nutritional quality of pre-packaged foods carrying health-related claims with foods that do not carry health-related claims. Subject/Methods: Cross-sectional survey of pre-packaged foods available in Germany, The Netherlands, Spain, Slovenia and the United Kingdom in 2013. A total of 2034 foods were randomly sampled from three food store types (a supermarket, a neighbourhood store and a discounter). Nutritional information was taken from nutrient declarations present on food labels and assessed through a comparison of mean levels, regression analyses and the application of a nutrient profile model currently used to regulate health claims in Australia and New Zealand (Food Standards Australia New Zealand's Nutrient Profiling Scoring Criterion, FSANZ NPSC). Results: Foods carrying health claims had, on average, lower levels, per 100 g, of the following nutrients, energy—29.3 kcal (P<0.05), protein—1.2 g (P<0.01), total sugars—3.1 g (P<0.05), saturated fat—2.4 g (P<0.001), and sodium—842 mg (P<0.001), and higher levels of fibre—0.8 g (P<0.001). A similar pattern was observed for foods carrying nutrition claims. Forty-three percent (confidence interval (CI) 41%, 45%) of foods passed the FSANZ NPSC, with foods carrying health claims more likely to pass (70%, CI 64%, 76%) than foods carrying nutrition claims (61%, CI 57%, 66%) or foods that did not carry either type of claim (36%, CI 34%, 38%). Conclusions: Foods carrying health-related claims have marginally better nutrition profiles than those that do not carry claims; these differences would be increased if the FSANZ NPSC was used to regulate health-related claims. It is unclear whether these relatively small differences have significant impacts on health. PMID:27406158

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...

European consumers and health claims: attitudes, understanding and purchasing behaviour.

PubMed

Wills, Josephine M; Storcksdieck genannt Bonsmann, Stefan; Kolka, Magdalena; Grunert, Klaus G

2012-05-01

Health claims on food products are often used as a means to highlight scientifically proven health benefits associated with consuming those foods. But do consumers understand and trust health claims? This paper provides an overview of recent research on consumers and health claims including attitudes, understanding and purchasing behaviour. A majority of studies investigated selective product-claim combinations, with ambiguous findings apart from consumers' self-reported generic interest in health claims. There are clear indications that consumer responses differ substantially according to the nature of carrier product, the type of health claim, functional ingredient used or a combination of these components. Health claims tend to be perceived more positively when linked to a product with an overall positive health image, whereas some studies demonstrate higher perceived credibility of products with general health claims (e.g. omega-3 and brain development) compared to disease risk reduction claims (e.g. bioactive peptides to reduce risk of heart disease), others report the opposite. Inconsistent evidence also exists on the correlation between having a positive attitude towards products with health claims and purchase intentions. Familiarity with the functional ingredient and/or its claimed health effect seems to result in a more favourable evaluation. Better nutritional knowledge, however, does not automatically lead to a positive attitude towards products carrying health messages. Legislation in the European Union requires that the claim is understood by the average consumer. As most studies on consumers' understanding of health claims are based on subjective understanding, this remains an area for more investigation.

Measuring the labeling efficiency of pseudocontinuous arterial spin labeling.

PubMed

Chen, Zhensen; Zhang, Xingxing; Yuan, Chun; Zhao, Xihai; van Osch, Matthias J P

2017-05-01

Optimization and validation of a sequence for measuring the labeling efficiency of pseudocontinuous arterial spin labeling (pCASL) perfusion MRI. The proposed sequence consists of a labeling module and a single slice Look-Locker echo planar imaging readout. A model-based algorithm was used to calculate labeling efficiency from the signal acquired from the main brain-feeding arteries. Stability of the labeling efficiency measurement was evaluated with regard to the use of cardiac triggering, flow compensation and vein signal suppression. Accuracy of the measurement was assessed by comparing the measured labeling efficiency to mean brain pCASL signal intensity over a wide range of flip angles as applied in the pCASL labeling. Simulations show that the proposed algorithm can effectively calculate labeling efficiency when correcting for T1 relaxation of the blood spins. Use of cardiac triggering and vein signal suppression improved stability of the labeling efficiency measurement, while flow compensation resulted in little improvement. The measured labeling efficiency was found to be linearly (R = 0.973; P < 0.001) related to brain pCASL signal intensity over a wide range of pCASL flip angles. The optimized labeling efficiency sequence provides robust artery-specific labeling efficiency measurement within a short acquisition time (∼30 s), thereby enabling improved accuracy of pCASL CBF quantification. Magn Reson Med 77:1841-1852, 2017. © 2016 International Society for Magnetic Resonance in Medicine Magn Reson Med 77:1841-1852, 2017. © 2016 International Society for Magnetic Resonance in Medicine. © 2016 International Society for Magnetic Resonance in Medicine.

Nutrition labelling and the choices logo in Israel: positions and perceptions of leading health policy makers.

PubMed

Gesser-Edelsburg, A; Endevelt, R; Tirosh-Kamienchick, Y

2014-02-01

Based on the Social Marketing approach and Diffusion of Innovations Theory that indicates the importance of opinion leaders with respect to the spreading of new ideas, concepts or practices within a community, the present study aimed to examine positions and perceptions of Israeli leading dietitians and health officials regarding nutrition labelling and the Choices logo, before it was launched in Israel in February 2011, as well as how they would communicate it to the public as agents of influence. The study involved in-depth face-to-face and telephone interviews with 15 senior dietitians and Health Ministry officials using semi-structured protocols including questions about nutrition labelling and the Choices logo. The respondents considered that the nutrition facts panels usually found on the backs of packages are too complicated for the average consumer. Simiularly, fronts of packages are cluttered with advertisements and health claims, causing confusion. The study participants would like to see an integrative label on the front of the package to facilitate consumers' decisions. However, the Choices logo raises ethical and social questions about the conflict between corporate interests and public health: (i) the label's relativity versus objectivity; (ii) the consumer's responsibility to create a balanced diet; (iii) the label's credibility; and (iv) bias against companies, products and audiences. The results of the present study highlight the importance of a need for an integrated programme of nutrition promotion, including the use of social marketing based on a cooperative effort between the food industry, regulators and professionals, to recommend changes and adjustments in nutritional front of package labelling with the aim of promoting healthier nutrition consumption. © 2013 The Authors Journal of Human Nutrition and Dietetics © 2013 The British Dietetic Association Ltd.

Formalizing Probabilistic Safety Claims

NASA Technical Reports Server (NTRS)

Herencia-Zapana, Heber; Hagen, George E.; Narkawicz, Anthony J.

2011-01-01

A safety claim for a system is a statement that the system, which is subject to hazardous conditions, satisfies a given set of properties. Following work by John Rushby and Bev Littlewood, this paper presents a mathematical framework that can be used to state and formally prove probabilistic safety claims. It also enables hazardous conditions, their uncertainties, and their interactions to be integrated into the safety claim. This framework provides a formal description of the probabilistic composition of an arbitrary number of hazardous conditions and their effects on system behavior. An example is given of a probabilistic safety claim for a conflict detection algorithm for aircraft in a 2D airspace. The motivation for developing this mathematical framework is that it can be used in an automated theorem prover to formally verify safety claims.

32 CFR 536.75 - Claims payable under the Military Claims Act.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., acting within the scope of their employment, that is determined to be negligent or wrongful; or (2..., chapter 11. (c) Maritime claims. Claims that arise on the high seas or within the territorial waters of a...

32 CFR 536.77 - Applicable law for claims under the Military Claims Act.

Code of Federal Regulations, 2011 CFR

2011-07-01

... subpart C claims. (i) Interpretation of meanings and construction of questions of law under the MCA will... 32 National Defense 3 2011-07-01 2009-07-01 true Applicable law for claims under the Military Claims Act. 536.77 Section 536.77 National Defense Department of Defense (Continued) DEPARTMENT OF THE...

Fluorescently labelled multiplex lateral flow immunoassay based on cadmium-free quantum dots.

PubMed

Beloglazova, Natalia V; Sobolev, Aleksander M; Tessier, Mickael D; Hens, Zeger; Goryacheva, Irina Yu; De Saeger, Sarah

2017-03-01

A sensitive tool for simultaneous qualitative detection of two mycotoxins based on use of non-cadmium quantum dots (QDs) is presented for the first time. QDs have proven themselves as promising fluorescent labels for biolabeling and chemical analysis. With an increasing global tendency to regulate and limit the use of hazardous elements, indium phosphide (InP) QDs are highlighted as environmentally-friendly alternatives to the highly efficient and well-studied, but potentially toxic Cd- and Pb-based QDs. Here, we developed water-soluble InP QDs-based fluorescent nanostructures. They consisted of core/shell InP/ZnS QDs enrobed in a silica shell that allowed the water solubility (QD@SiO 2 ). Then we applied the QD@SiO 2 as novel, silica shell-encapsulated fluorescent labels in immunoassays for rapid multiplexed screening. Two mycotoxins, zearalenone and deoxynivalenol, were simultaneously detected in maize and wheat, since the two QD@SiO 2 labelled conjugates emit at two different, individually detectable wavelengths. The cutoff values for the simultaneous determination were 50 and 500μgkg -1 for zearalenone and deoxynivalenol, respectively, in both maize and wheat. Liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) was used to confirm the result. Copyright © 2017 Elsevier Inc. All rights reserved.

Stakeholders' perception of the nutrition and health claim regulation.

PubMed

de Boer, Alie; Bast, Aalt

2015-05-01

In 2007, the Nutrition and Health Claim Regulation (NHCR) entered into force, which required scientific substantiation of health claims. In the field of antioxidants, most proposed claims were negatively assessed by the European Food Safety Authority (EFSA). This study reviews the perception of the NHCR of 14 Dutch stakeholders to unravel the grounds for disproving the putative health claims. Most claims are shown to be refused based on the quality of scientific substantiation, due to usage of scientific methods on which no consensus has been reached and the differences in expectations and requirements. Three themes exemplify the need for improvement in applying the NHCR: (i) enforcement; (ii) methodology; and (iii) perceived impact of the NHCR. With highly diverging perceptions of stakeholders, the current effectiveness of the NHCR can be questioned. The views of different stakeholders on these themes help to focus the discussion on the NCHR in capturing health effects.

Evaluating a Surprising Claim

NASA Astrophysics Data System (ADS)

Hayden, Howard C.

2013-11-01

A television advertisement and a website present an interesting question: can rail company CSX really move a ton of freight 468 miles on a gallon of fuel, or is the claim preposterous? Let us examine the claim, first by understanding what is meant, looking at their data, and then converting units to examine the claim quantitatively.

Evaluating a Surprising Claim

ERIC Educational Resources Information Center

Hayden, Howard C.

2013-01-01

A television advertisement and a website present an interesting question: can rail company CSX "really" move a ton of freight 468 miles on a gallon of fuel, or is the claim preposterous? Let us examine the claim, first by understanding what is meant, looking at their data, and then converting units to examine the claim quantitatively.

32 CFR 536.77 - Applicable law for claims under the Military Claims Act.

Code of Federal Regulations, 2013 CFR

2013-07-01

...) The United States will only be liable for the portion of loss or damage attributable to the fault of... preparation and presentation of the claim. (vi) Punitive or exemplary damages are not payable. (vii) Claims... will be considered as an element of damages under paragraph (b)(3)(ii) of this section. Claims for...

32 CFR 536.77 - Applicable law for claims under the Military Claims Act.

Code of Federal Regulations, 2012 CFR

2012-07-01

...) The United States will only be liable for the portion of loss or damage attributable to the fault of... preparation and presentation of the claim. (vi) Punitive or exemplary damages are not payable. (vii) Claims... will be considered as an element of damages under paragraph (b)(3)(ii) of this section. Claims for...

32 CFR 536.77 - Applicable law for claims under the Military Claims Act.

Code of Federal Regulations, 2014 CFR

2014-07-01

...) The United States will only be liable for the portion of loss or damage attributable to the fault of... preparation and presentation of the claim. (vi) Punitive or exemplary damages are not payable. (vii) Claims... will be considered as an element of damages under paragraph (b)(3)(ii) of this section. Claims for...

Sequential ordering among multicolor fluorophores for protein labeling facility via aggregation-elimination based β-lactam probes.

PubMed

Sadhu, Kalyan K; Mizukami, Shin; Watanabe, Shuji; Kikuchi, Kazuya

2011-05-01

Development of protein labeling techniques with small molecules is enthralling because this method brings promises for triumph over the limitations of fluorescent proteins in live cell imaging. This technology deals with the functionalization of proteins with small molecules and is anticipated to facilitate the expansion of various protein assay methods. A new straightforward aggregation and elimination-based technique for a protein labeling system has been developed with a versatile emissive range of fluorophores. These fluorophores have been applied to show their efficiency for protein labeling by exploiting the same basic principle. A genetically modified version of class A type β-lactamase has been used as the tag protein (BL-tag). The strength of the aggregation interaction between a fluorophore and a quencher plays a governing role in the elimination step of the quencher from the probes, which ultimately controls the swiftness of the protein labeling strategy. Modulation in the elimination process can be accomplished by the variation in the nature of the fluorophore. This diversity facilitates the study of the competitive binding order among the synthesized probes toward the BL-tag labeling method. An aggregation and elimination-based BL-tag technique has been explored to develop an order of color labeling from the equimolar mixture of the labeling probe in solutions. The qualitative and quantitative determination of ordering within the probes toward labeling studies has been executed through SDS-PAGE and time-dependent fluorescence intensity enhancement measurements, respectively. The desirable multiple-wavelength fluorescence labeling probes for the BL-tag technology have been developed and demonstrate broad applicability of this labeling technology to live cell imaging with coumarin and fluorescein derivatives by using confocal microscopy.

45 CFR 504.1 - Claim defined.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Vietnam conflict but were subsequently determined to have been interned, in hiding, or captured by a... receive or consider any other types of claims based on the internment of civilians or the maltreatment of...

Pluvial, urban flood mechanisms and characteristics - Assessment based on insurance claims

NASA Astrophysics Data System (ADS)

Sörensen, Johanna; Mobini, Shifteh

2017-12-01

Pluvial flooding is a problem in many cities and for city planning purpose the mechanisms behind pluvial flooding are of interest. Previous studies seldom use insurance claim data to analyse city scale characteristics that lead to flooding. In the present study, two long time series (∼20 years) of flood claims from property owners have been collected and analysed in detail to investigate the mechanisms and characteristics leading to urban flooding. The flood claim data come from the municipal water utility company and property owners with insurance that covers property loss from overland flooding, groundwater intrusion through basement walls and flooding from the drainage system. These data are used as a proxy for flood severity for several events in the Swedish city of Malmö. It is discussed which rainfall characteristics give most flooding and why some rainfall events do not lead to severe flooding, how city scale topography and sewerage system type influence spatial distribution of flood claims, and which impact high sea level has on flooding in Malmö. Three severe flood events are described in detail and compared with a number of smaller flood events. It was found that the main mechanisms and characteristics of flood extent and its spatial distribution in Malmö are intensity and spatial distribution of rainfall, distance to the main sewer system as well as overland flow paths, and type of drainage system, while high sea level has little impact on the flood extent. Finally, measures that could be taken to lower the flood risk in Malmö, and other cities with similar characteristics, are discussed.

Medical chart validation of an algorithm for identifying multiple sclerosis relapse in healthcare claims.

PubMed

Chastek, Benjamin J; Oleen-Burkey, Merrikay; Lopez-Bresnahan, Maria V

2010-01-01

Relapse is a common measure of disease activity in relapsing-remitting multiple sclerosis (MS). The objective of this study was to test the content validity of an operational algorithm for detecting relapse in claims data. A claims-based relapse detection algorithm was tested by comparing its detection rate over a 1-year period with relapses identified based on medical chart review. According to the algorithm, MS patients in a US healthcare claims database who had either (1) a primary claim for MS during hospitalization or (2) a corticosteroid claim following a MS-related outpatient visit were designated as having a relapse. Patient charts were examined for explicit indication of relapse or care suggestive of relapse. Positive and negative predictive values were calculated. Medical charts were reviewed for 300 MS patients, half of whom had a relapse according to the algorithm. The claims-based criteria correctly classified 67.3% of patients with relapses (positive predictive value) and 70.0% of patients without relapses (negative predictive value; kappa 0.373: p < 0.001). Alternative algorithms did not improve on the predictive value of the operational algorithm. Limitations of the algorithm include lack of differentiation between relapsing-remitting MS and other types, and that it does not incorporate measures of function and disability. The claims-based algorithm appeared to successfully detect moderate-to-severe MS relapse. This validated definition can be applied to future claims-based MS studies.

Adverse Event extraction from Structured Product Labels using the Event-based Text-mining of Health Electronic Records (ETHER)system.

PubMed

Pandey, Abhishek; Kreimeyer, Kory; Foster, Matthew; Botsis, Taxiarchis; Dang, Oanh; Ly, Thomas; Wang, Wei; Forshee, Richard

2018-01-01

Structured Product Labels follow an XML-based document markup standard approved by the Health Level Seven organization and adopted by the US Food and Drug Administration as a mechanism for exchanging medical products information. Their current organization makes their secondary use rather challenging. We used the Side Effect Resource database and DailyMed to generate a comparison dataset of 1159 Structured Product Labels. We processed the Adverse Reaction section of these Structured Product Labels with the Event-based Text-mining of Health Electronic Records system and evaluated its ability to extract and encode Adverse Event terms to Medical Dictionary for Regulatory Activities Preferred Terms. A small sample of 100 labels was then selected for further analysis. Of the 100 labels, Event-based Text-mining of Health Electronic Records achieved a precision and recall of 81 percent and 92 percent, respectively. This study demonstrated Event-based Text-mining of Health Electronic Record's ability to extract and encode Adverse Event terms from Structured Product Labels which may potentially support multiple pharmacoepidemiological tasks.

Ultra-processed family foods in Australia: nutrition claims, health claims and marketing techniques.

PubMed

Pulker, Claire Elizabeth; Scott, Jane Anne; Pollard, Christina Mary

2018-01-01

To objectively evaluate voluntary nutrition and health claims and marketing techniques present on packaging of high-market-share ultra-processed foods (UPF) in Australia for their potential impact on public health. Cross-sectional. Packaging information from five high-market-share food manufacturers and one retailer were obtained from supermarket and manufacturers' websites. Ingredients lists for 215 UPF were examined for presence of added sugar. Packaging information was categorised using a taxonomy of nutrition and health information which included nutrition and health claims and five common food marketing techniques. Compliance of statements and claims with the Australia New Zealand Food Standards Code and with Health Star Ratings (HSR) were assessed for all products. Almost all UPF (95 %) contained added sugars described in thirty-four different ways; 55 % of UPF displayed a HSR; 56 % had nutrition claims (18 % were compliant with regulations); 25 % had health claims (79 % were compliant); and 97 % employed common food marketing techniques. Packaging of 47 % of UPF was designed to appeal to children. UPF carried a mean of 1·5 health and nutrition claims (range 0-10) and 2·6 marketing techniques (range 0-5), and 45 % had HSR≤3·0/5·0. Most UPF packaging featured nutrition and health statements or claims despite the high prevalence of added sugars and moderate HSR. The degree of inappropriate or inaccurate statements and claims present is concerning, particularly on packaging designed to appeal to children. Public policies to assist parents to select healthy family foods should address the quality and accuracy of information provided on UPF packaging.

Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use.

PubMed

Frueh, Felix W; Amur, Shashi; Mummaneni, Padmaja; Epstein, Robert S; Aubert, Ronald E; DeLuca, Teresa M; Verbrugge, Robert R; Burckart, Gilbert J; Lesko, Lawrence J

2008-08-01

To review the labels of United States Food and Drug Administration (FDA)-approved drugs to identify those that contain pharmacogenomic biomarker information, and to collect prevalence information on the use of those drugs for which pharmacogenomic information is included in the drug labeling. Retrospective analysis. The Physicians' Desk Reference Web site, Drugs@FDA Web site, and manufacturers' Web sites were used to identify drug labels containing pharmacogenomic information, and the prescription claims database of a large pharmacy benefits manager (insuring > 55 million individuals in the United States) was used to obtain drug utilization data. Pharmacogenomic biomarkers were defined, FDA-approved drug labels containing this information were identified, and utilization of these drugs was determined. Of 1200 drug labels reviewed for the years 1945-2005, 121 drug labels contained pharmacogenomic information based on a key word search and follow-up screening. Of those, 69 labels referred to human genomic biomarkers, and 52 referred to microbial genomic biomarkers. Of the labels referring to human biomarkers, 43 (62%) pertained to polymorphisms in cytochrome P450 (CYP) enzyme metabolism, with CYP2D6 being most common. Of 36.1 million patients whose prescriptions were processed by a large pharmacy benefits manager in 2006, about 8.8 million (24.3%) received one or more drugs with human genomic biomarker information in the drug label. Nearly one fourth of all outpatients received one or more drugs that have pharmacogenomic information in the label for that drug. The incorporation and appropriate use of pharmacogenomic information in drug labels should be tested for its ability to improve drug use and safety in the United States.

Base pair mismatch recognition using plasmon resonant particle labels.

PubMed

Oldenburg, Steven J; Genick, Christine C; Clark, Keith A; Schultz, David A

2002-10-01

We demonstrate the use of silver plasmon resonant particles (PRPs), as reporter labels, in a microarray-based DNA hybridization assay in which we screen for a known polymorphic site in the breast cancer gene BRCA1. PRPs (40-100 nm in diameter) image as diffraction-limited points of colored light in a standard microscope equipped with dark-field illumination, and can be individually identified and discriminated against background scatter. Rather than overall intensity, the number of PRPs counted in a CCD image by a software algorithm serves as the signal in these assays. In a typical PRP hybridization assay, we achieve a detection sensitivity that is approximately 60 x greater than that achieved by using fluorescent labels. We conclude that single particle counting is robust, generally applicable to a wide variety of assay platforms, and can be integrated into low-cost and quantitative detection systems for single nucleotide polymorphism analysis.

76 FR 35086 - Proposed Information Collection (Fully Developed Claim (Fully Developed Claims-Applications for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-15

... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0747] Proposed Information Collection (Fully Developed Claim (Fully Developed Claims--Applications for Compensation, Pension, DIC, Death Pension, and/or... Claims--Applications for Compensation, Pension, DIC, Death Pension, and/or Accrued Benefits, VA Forms 21...

32 CFR 750.6 - Claims: Presentment.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 5 2013-07-01 2013-07-01 false Claims: Presentment. 750.6 Section 750.6 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY CLAIMS GENERAL CLAIMS REGULATIONS... Claims Act shall be submitted on DD Form 1842. 2 The claim and all other papers requiring the signature...

32 CFR 750.6 - Claims: Presentment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 5 2010-07-01 2010-07-01 false Claims: Presentment. 750.6 Section 750.6 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY CLAIMS GENERAL CLAIMS REGULATIONS... Claims Act shall be submitted on DD Form 1842. 2 The claim and all other papers requiring the signature...

32 CFR 750.6 - Claims: Presentment.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 5 2011-07-01 2011-07-01 false Claims: Presentment. 750.6 Section 750.6 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY CLAIMS GENERAL CLAIMS REGULATIONS... Claims Act shall be submitted on DD Form 1842. 2 The claim and all other papers requiring the signature...

32 CFR 750.6 - Claims: Presentment.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 32 National Defense 5 2012-07-01 2012-07-01 false Claims: Presentment. 750.6 Section 750.6 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY CLAIMS GENERAL CLAIMS REGULATIONS... Claims Act shall be submitted on DD Form 1842. 2 The claim and all other papers requiring the signature...

[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

SOLVENT-BASED TO WATERBASED ADHESIVE-COATED SUBSTRATE RETROFIT - VOLUME III: LABEL MANUFACTURING CASE STUDY: NASHUA CORPORATION

EPA Science Inventory

This volume discusses Nashua Corporation's Omaha facility, a label and label stock manufacturing facility that no longer uses solvent-based adhesives. Information obtained includes issues related to the technical, economic, and environmental barriers and opportunities associated ...

101 Labeled Brain Images and a Consistent Human Cortical Labeling Protocol

PubMed Central

Klein, Arno; Tourville, Jason

2012-01-01

We introduce the Mindboggle-101 dataset, the largest and most complete set of free, publicly accessible, manually labeled human brain images. To manually label the macroscopic anatomy in magnetic resonance images of 101 healthy participants, we created a new cortical labeling protocol that relies on robust anatomical landmarks and minimal manual edits after initialization with automated labels. The “Desikan–Killiany–Tourville” (DKT) protocol is intended to improve the ease, consistency, and accuracy of labeling human cortical areas. Given how difficult it is to label brains, the Mindboggle-101 dataset is intended to serve as brain atlases for use in labeling other brains, as a normative dataset to establish morphometric variation in a healthy population for comparison against clinical populations, and contribute to the development, training, testing, and evaluation of automated registration and labeling algorithms. To this end, we also introduce benchmarks for the evaluation of such algorithms by comparing our manual labels with labels automatically generated by probabilistic and multi-atlas registration-based approaches. All data and related software and updated information are available on the http://mindboggle.info/data website. PMID:23227001

32 CFR 842.103 - Filing a claim.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 6 2011-07-01 2011-07-01 false Filing a claim. 842.103 Section 842.103 National... CLAIMS Claims Under the National Guard Claims Act (32 U.S.C. 715) § 842.103 Filing a claim. This paragraph explains how to file a claim under the National Guard Claims Act. (a) How and when filed. A claim...

32 CFR 842.103 - Filing a claim.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 6 2013-07-01 2013-07-01 false Filing a claim. 842.103 Section 842.103 National... CLAIMS Claims Under the National Guard Claims Act (32 U.S.C. 715) § 842.103 Filing a claim. This paragraph explains how to file a claim under the National Guard Claims Act. (a) How and when filed. A claim...

32 CFR 842.103 - Filing a claim.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 32 National Defense 6 2012-07-01 2012-07-01 false Filing a claim. 842.103 Section 842.103 National... CLAIMS Claims Under the National Guard Claims Act (32 U.S.C. 715) § 842.103 Filing a claim. This paragraph explains how to file a claim under the National Guard Claims Act. (a) How and when filed. A claim...

32 CFR 842.103 - Filing a claim.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 6 2014-07-01 2014-07-01 false Filing a claim. 842.103 Section 842.103 National... CLAIMS Claims Under the National Guard Claims Act (32 U.S.C. 715) § 842.103 Filing a claim. This paragraph explains how to file a claim under the National Guard Claims Act. (a) How and when filed. A claim...

22 CFR 304.6 - Claims investigation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 22 Foreign Relations 2 2011-04-01 2009-04-01 true Claims investigation. 304.6 Section 304.6 Foreign Relations PEACE CORPS CLAIMS AGAINST GOVERNMENT UNDER FEDERAL TORT CLAIMS ACT Procedures § 304.6 Claims investigation. (a) When a claim has been filed with the Peace Corps, the General Counsel will send...

22 CFR 304.6 - Claims investigation.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 22 Foreign Relations 2 2014-04-01 2014-04-01 false Claims investigation. 304.6 Section 304.6 Foreign Relations PEACE CORPS CLAIMS AGAINST GOVERNMENT UNDER FEDERAL TORT CLAIMS ACT Procedures § 304.6 Claims investigation. (a) When a claim has been filed with the Peace Corps, the General Counsel will send...

A label-free and high-efficient GO-based aptasensor for cancer cells based on cyclic enzymatic signal amplification.

PubMed

Xiao, Kunyi; Liu, Juan; Chen, Hui; Zhang, Song; Kong, Jilie

2017-05-15

A label-free and high-efficient graphene oxide (GO)-based aptasensor was developed for the detection of low quantity cancer cells based on cell-triggered cyclic enzymatic signal amplification (CTCESA). In the absence of target cells, hairpin aptamer probes (HAPs) and dye-labeled linker DNAs stably coexisted in solution, and the fluorescence was quenched by the GO-based FÖrster resonance energy transfer (FRET) process. In the presence of target cells, the specific binding of HAPs with the target cells triggered a conformational alternation, which resulted in linker DNA complementary pairing and cleavage by nicking endonuclease-strand scission cycles. Consequently, more cleaved fragments of linker DNAs with more the terminal labeled dyes could show the enhanced fluorescence because these cleaved DNA fragments hardly combine with GOs and prevent the FRET process. Fluorescence analysis demonstrated that this GO-based aptasensor exhibited selective and sensitive response to the presence of target CCRF-CEM cells in the concentration range from 50 to 10 5 cells. The detection limit of this method was 25 cells, which was approximately 20 times lower than the detection limit of normal fluorescence aptasensors without amplification. With high sensitivity and specificity, it provided a simple and cost-effective approach for early cancer diagnosis. Copyright © 2016 Elsevier B.V. All rights reserved.

Fine bakery wares with label claims in Europe and their categorisation by nutrient profiling models.

PubMed

Trichterborn, J; Harzer, G; Kunz, C

2011-03-01

This study assesses a range of commercially available fine bakery wares with nutrition or health related on-pack communication against the criteria of selected nutrient profiling models. Different purposes of the application of nutrient profiles were considered, including front-of-pack signposting and the regulation of claims or advertising. More than 200 commercially available fine bakery wares carrying claims were identified in Germany, France, Spain, Sweden and United Kingdom and evaluated against five nutrient profiling models. All models were assessed regarding their underlying principles, generated results and inter-model agreement levels. Total energy, saturated fatty acids, sugars, sodium and fibre were critical parameters for the categorisation of products. The Choices Programme was the most restrictive model in this category, while the Food and Drug Administration model allowed the highest number of products to qualify. According to all models, more savoury than sweet products met the criteria. On average, qualifying products contained less than half the amounts of nutrients to limit and more than double the amount of fibre compared with all the products in the study. None of the models had a significant impact on the average energy contents. Nutrient profiles can be applied to identify fine bakery wares with a significantly better nutritional composition than the average range of products positioned as healthier. Important parameters to take into account include energy, saturated fatty acids, sugars, sodium and fibre. Different criteria sets for subcategories of fine bakery wares do not seem necessary.

44 CFR 62.21 - Claims adjustment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program SALE OF INSURANCE AND ADJUSTMENT OF CLAIMS Claims Adjustment, Claims Appeals, and Judicial Review § 62.21 Claims adjustment. (a) In...

Environmental performances of coproducts. Application of Claiming-Based Allocation models to straw and vetiver biorefineries in an Indian context.

PubMed

Gnansounou, Edgard; Raman, Jegannathan Kenthorai

2018-04-24

Among the renewables, non-food and wastelands based biofuels are essential for the transport sector to achieve country's climate mitigation targets. With the growing interest in biorefineries, setting policy requirements for other coproducts along with biofuels is necessary to improve the products portfolio of biorefinery, increase the bioproducts perception by the consumers and push the technology forward. Towards this context, Claiming-Based allocation models were used in comparative life cycle assessment of multiple products from wheat straw biorefinery and vetiver biorefinery. Vetiver biorefinery shows promising Greenhouse gas emission savings (181-213%) compared to the common crop based lignocellulose (wheat straw) biorefinery. Assistance of Claiming-Based Allocation models favors to find out the affordable allocation limit (0-80%) among the coproducts in order to achieve the individual prospective policy targets. Such models show promising application in multiproduct life cycle assessment studies where appropriate allocation is challenging to achieve the individual products emission subject to policy targets. Copyright © 2018 Elsevier Ltd. All rights reserved.

32 CFR 536.15 - Claims policies.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Command Claims Service or an ACO, including those which occur in the area of responsibility of a CPO. On... promptly with maximum use of small claims procedures. (2) Consideration under all subparts. Prior to denial... claim is presented. A claim presented as a personnel claim will be considered as a tort prior to denial...

32 CFR 536.15 - Claims policies.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Command Claims Service or an ACO, including those which occur in the area of responsibility of a CPO. On... promptly with maximum use of small claims procedures. (2) Consideration under all subparts. Prior to denial... claim is presented. A claim presented as a personnel claim will be considered as a tort prior to denial...

Off-label use of atypical antipsychotics: cause for concern?

PubMed

McKean, Andrew; Monasterio, Erik

2012-05-01

Licensed indications for medicines were designed to regulate the claims that can be made about a medicine by a pharmaceutical company. Off-label prescribing (i.e. prescribing a drug for an indication outside of that for which it is licensed) is legal and an integral part of medical practice. In psychiatry, off-label prescribing is common and gives clinicians scope to treat patients who are refractory to standard therapy or where there is no licensed medication for an indication. However, efficacy or safety of such off-label use may not be established. There is a growing list of licensed indications for atypical antipsychotics (AAP) beyond schizophrenia and bipolar affective disorder, and also more evidence for other indications where pharmaceutical companies have not obtained a license. Pharmaceutical companies have promoted AAPs for off-label indications to increase sales and consequently have been fined by the US FDA for this. Since the 1990s, AAP use has expanded considerably, for example, the off-label use of quetiapine alone accounted for an estimated 17% of the AAP spend in New Zealand in 2010. There are a number of potential problems with the expanded use of AAPs outside of schizophrenia and related psychoses. A larger population will be exposed to their adverse effects, which include weight gain, type 2 diabetes mellitus, sudden cardiac death and increased mortality rates in the elderly with dementia. There are also concerns with the abuse of these agents, in particular quetiapine. Given that an increasing percentage of the population is being treated with these agents, off-label prescribing of AAPs is a cause for concern; they have a propensity to cause significant side effects and their efficacy and long-term safety for most off-label indications remains largely unknown, and therefore the risks and benefits of their use should be carefully weighed up prior to prescribing these agents off-label.

LPA-CBD an improved label propagation algorithm based on community belonging degree for community detection

NASA Astrophysics Data System (ADS)

Gui, Chun; Zhang, Ruisheng; Zhao, Zhili; Wei, Jiaxuan; Hu, Rongjing

In order to deal with stochasticity in center node selection and instability in community detection of label propagation algorithm, this paper proposes an improved label propagation algorithm named label propagation algorithm based on community belonging degree (LPA-CBD) that employs community belonging degree to determine the number and the center of community. The general process of LPA-CBD is that the initial community is identified by the nodes with the maximum degree, and then it is optimized or expanded by community belonging degree. After getting the rough structure of network community, the remaining nodes are labeled by using label propagation algorithm. The experimental results on 10 real-world networks and three synthetic networks show that LPA-CBD achieves reasonable community number, better algorithm accuracy and higher modularity compared with other four prominent algorithms. Moreover, the proposed algorithm not only has lower algorithm complexity and higher community detection quality, but also improves the stability of the original label propagation algorithm.

Influence of label information on dark chocolate acceptability.

PubMed

Torres-Moreno, M; Tarrega, A; Torrescasana, E; Blanch, C

2012-04-01

The aim of the present work was to study how the information on product labels influences consumer expectations and their acceptance and purchase intention of dark chocolate. Six samples of dark chocolate, varying in brand (premium and store brand) and in type of product (regular dark chocolate, single cocoa origin dark chocolate and high percentage of cocoa dark chocolate), were evaluated by 109 consumers who scored their liking and purchase intention under three conditions: blind (only tasting the products), expected (observing product label information) and informed (tasting the products together with provision of the label information). In the expected condition, consumer liking was mainly affected by the brand. In the blind condition, differences in liking were due to the type of product; the samples with a high percentage of cocoa were those less preferred by consumers. Under the informed condition, liking of dark chocolates varied depending on both brand and type of product. Premium brand chocolates generated high consumer expectations of chocolate acceptability, which were fulfilled by the sensory characteristics of the products. Store brand chocolates created lower expectations, but when they were tasted they were as acceptable as premium chocolates. Claims of a high percentage of cocoa and single cocoa origin on labels did not generate higher expectations than regular dark chocolates. Copyright © 2011 Elsevier Ltd. All rights reserved.

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/.

A Framework for Addressing Skeptics' Claims Using Evidence-Based Argumentation: Lessons Learned from Educational Research

NASA Astrophysics Data System (ADS)

Lambert, J. L.; Bleicher, R. E.; Edwards, A.; Henderson, A.

2012-12-01

In science education, climate change is an issue that is especially useful for teaching concepts spanning several fields of science, as well the nature and practices of science. In response, we are developing a NASA-funded curriculum, titled Climate Science Investigations (CSI): South Florida, that teaches high school and first-year undergraduate level students how to analyze and use scientific data answer questions about climate change. To create an effective curriculum, we integrated lessons learned from our educational research conducted within our elementary science methods courses (Lambert, Lindgren, & Bleicher, 2012). For the past few years, we have been integrating climate science in our courses as a way to teach standards across several science disciplines and assessing our preservice teachers' gains in knowledge over the semesters. More recently, given the media attention and reports on the public's shift in opinion toward being more skeptical (Kellstedt, Zahran, & Vedlitz, 2008; Washington & Cook, 2011), we have assessed our students' perceptions about climate change and implemented strategies to help students use evidence-based scientific argumentation to address common claims of climate skeptics. In our elementary science methods courses, we framed climate change as a crosscutting theme, as well as a core idea, in the Next Generation Science Standards. We proposed that the issue and science of climate change would help preservice teachers not only become more interested in the topic, but also be more prepared to teach core science concepts spanning several disciplines (physical, life, and earth sciences). We also thought that highlighting the "practice of scientific inquiry" by teaching students to develop evidence-based arguments would help the preservice teachers become more analytical and able to differentiate scientific evidence from opinions, which could ultimately influence their perceptions on climate change. Lessons learned from our preservice

Digital mining claim density map for federal lands in Utah: 1996

USGS Publications Warehouse

Hyndman, Paul C.; Campbell, Harry W.

1999-01-01

This report describes a digital map generated by the U.S. Geological Survey (USGS) to provide digital spatial mining claim density information for federal lands in Utah as of March 1997. Mining claim data is earth science information deemed to be relevant to the assessment of historic, current, and future ecological, economic, and social systems. There is no paper map included in this Open-File report. In accordance with the Federal Land Policy and Management Act of 1976 (FLPMA), all unpatented mining claims, mill, and tunnel sites must be recorded at the appropriate BLM State office. BLM maintains a cumulative computer listing of mining claims in the MCRS database with locations given by meridian, township, range, and section. A mining claim is considered closed when the claim is relinquished or a formal BLM decision declaring the mining claim null and void has been issued and the appeal period has expired. All other mining claims filed with BLM are considered to be open and actively held. The digital map (figure 1.) with the mining claim density database available in this report are suitable for geographic information system (GIS)-based regional assessments at a scale of 1:100,000 or smaller.

Digital mining claim density map for federal lands in California: 1996

USGS Publications Warehouse

Hyndman, Paul C.; Campbell, Harry W.

1999-01-01

This report describes a digital map generated by the U.S. Geological Survey (USGS) to provide digital spatial mining claim density information for federal lands in California as of March 1997. Mining claim data is earth science information deemed to be relevant to the assessment of historic, current, and future ecological, economic, and social systems. There is no paper map included in this Open-File report. In accordance with the Federal Land Policy and Management Act of 1976 (FLPMA), all unpatented mining claims, mill, and tunnel sites must be recorded at the appropriate BLM State office. BLM maintains a cumulative computer listing of mining claims in the MCRS database with locations given by meridian, township, range, and section. A mining claim is considered closed when the claim is relinquished or a formal BLM decision declaring the mining claim null and void has been issued and the appeal period has expired. All other mining claims filed with BLM are considered to be open and actively held. The digital map (figure 1.) with the mining claim density database available in this report are suitable for geographic information system (GIS)-based regional assessments at a scale of 1:100,000 or smaller.

Digital mining claim density map for federal lands in Arizona: 1996

USGS Publications Warehouse

Hyndman, Paul C.; Campbell, Harry W.

1999-01-01

This report describes a digital map generated by the U.S. Geological Survey (USGS) to provide digital spatial mining claim density information for federal lands in Arizona as of March 1997. Mining claim data is earth science information deemed to be relevant to the assessment of historic, current, and future ecological, economic, and social systems. There is no paper map included in this Open-File report. In accordance with the Federal Land Policy and Management Act of 1976 (FLPMA), all unpatented mining claims, mill, and tunnel sites must be recorded at the appropriate BLM State office. BLM maintains a cumulative computer listing of mining claims in the MCRS database with locations given by meridian, township, range, and section. A mining claim is considered closed when the claim is relinquished or a formal BLM decision declaring the mining claim null and void has been issued and the appeal period has expired. All other mining claims filed with BLM are considered to be open and actively held. The digital map (figure 1.) with the mining claim density database available in this report are suitable for geographic information system (GIS)-based regional assessments at a scale of 1:100,000 or smaller.

[Approaching the "evidence-practice gap" in pharmaceutical risk management: analysis of healthcare claim data].

PubMed

Nakayama, Takeo

2012-01-01

The concept of evidence-based medicine (EBM) has promulgated among healthcare professionals in recent years, on the other hand, the problem of underuse of useful clinical evidence is coming to be important. This is called as evidence-practice gap. The major concern about evidence-practice gap is insufficient implementation of evidence-based effective treatment, however, the perspective can be extended to measures to improve drug safety and prevention of drug related adverse events. First, this article reviews the characteristics of the database of receipt (healthcare claims) and the usefulness for research purpose of pharmacoepidemiology. Second, as the real example of the study on evidence-practice gap by using the receipt database, the case of ergot-derived anti-Parkinson drugs, of which risk of valvulopathy has been identified, is introduced. The receipt analysis showed that more than 70% of Parkinson's disease patients prescribed with cabergoline or pergolide did not undergo echocardiography despite the revision of the product label recommendation. Afterwards, the issues of pharmaceutical risk management and risk communication will be discussed.

Solar Power Use Claims Guidance

EPA Pesticide Factsheets

The Toolbox for Renewable Energy Project Development's Solar Power Use Claims Guidance page helps electricity consumers understand the legal right that RECs offer their owners when making solar power use claims and provides resources for making claims.

[Visualization and Functional Regulation of Live Cell Proteins Based on Labeling Probe Design].

PubMed

Mizukami, Shin; Kikuchi, Kazuya

2016-01-01

  There are several approaches to understanding the physiological roles of biomolecules: (1) by observing the localization or activities of biomolecules (based on microscopic imaging experiments with fluorescent proteins or fluorescent probes) and (2) by investigating the cellular response via activation or suppression of functions of the target molecule (by using inhibitors, antagonists, siRNAs, etc.). In this context, protein-labeling technology serves as a powerful tool that can be used in various experiments, such as for fluorescence imaging of target proteins. Recently, we developed a protein-labeling technology that uses a mutant β-lactamase (a bacterial hydrolase) as the tag protein. In this protein-labeling technology, also referred to as the BL-tag technology, various β-lactam compounds were used as specific ligands that were covalently labeled to the tag. One major advantage of this labeling technology is that various functions can be carried out by suitably designing both the functional moieties such as the fluorophore and the β-lactam ligand structure. In this review, we briefly introduce the BL-tag technology and describe our future outlook for this technology, such as in fluorescence imaging of biomolecules and functional regulation of cellular proteins in living cells.

Digital mining claim density map for federal lands in Idaho: 1996

USGS Publications Warehouse

Hyndman, Paul C.; Campbell, Harry W.

1999-01-01

This report describes a digital map generated by the U.S. Geological Survey (USGS) to provide digital spatial mining claim density information for federal lands in Idaho as of March 1997. Mining claim data is earth science information deemed to be relevant to the assessment of historic, current, and future ecological, economic, and social systems. There is no paper map included in this Open-File report. In accordance with the Federal Land Policy and Management Act of 1976 (FLPMA), all unpatented mining claims, mill and tunnel sites must be recorded at the appropriate Bureau of Land Management (BLM) State office. BLM maintains a cumulative computer listing of mining claims in the Mining Claim Recordation System (MCRS) database with locations given by meridian, township, range, and section. A mining claim is considered closed when the claim is relinquished or a formal BLM decision declaring the mining claim null and void has been issued and the appeal period has expired. All other mining claims filed with BLM are considered to be open and actively held. The digital map (figure 1.) with the mining claim density database available in this report are suitable for geographic information system (GIS)-based regional assessments at a scale of 1:100,000 or smaller.

Digital mining claim density map for federal lands in Wyoming: 1996

USGS Publications Warehouse

Hyndman, Paul C.; Campbell, Harry W.

1999-01-01

This report describes a digital map generated by the U.S. Geological Survey (USGS) to provide digital spatial mining claim density information for federal lands in Wyoming as of March 1997. Mining claim data is earth science information deemed to be relevant to the assessment of historic, current, and future ecological, economic, and social systems. There is no paper map included in this Open-File report. In accordance with the Federal Land Policy and Management Act of 1976 (FLPMA), all unpatented mining claims, mill, and tunnel sites must be recorded at the appropriate BLM State office. BLM maintains a cumulative computer listing of mining claims in the Mining Claim Recordation System (MCRS) database with locations given by meridian, township, range, and section. A mining claim is considered closed when the claim is relinquished or a formal BLM decision declaring the mining claim null and void has been issued and the appeal period has expired. All other mining claims filed with BLM are considered to be open and actively held. The digital map (figure 1.) with the mining claim density database available in this report are suitable for geographic information system (GIS)-based regional assessments at a scale of 1:100,000 or smaller.

Digital mining claim density map for federal lands in Colorado: 1996

USGS Publications Warehouse

Hyndman, Paul C.; Campbell, Harry W.

1999-01-01

This report describes a digital map generated by the U.S. Geological Survey (USGS) to provide digital spatial mining claim density information for federal lands in Colorado as of March 1997. Mining claim data is earth science information deemed to be relevant to the assessment of historic, current, and future ecological, economic, and social systems. There is no paper map included in this Open-File report. In accordance with the Federal Land Policy and Management Act of 1976 (FLPMA), all unpatented mining claims, mill, and tunnel sites must be recorded at the appropriate BLM State office. BLM maintains a cumulative computer listing of mining claims in the Mining Claim Recordation System (MCRS) database with locations given by meridian, township, range, and section. A mining claim is considered closed when the claim is relinquished or a formal BLM decision declaring the mining claim null and void has been issued and the appeal period has expired. All other mining claims filed with BLM are considered to be open and actively held. The digital map (figure 1.) with the mining claim density database available in this report are suitable for geographic information system (GIS)-based regional assessments at a scale of 1:100,000 or smaller.

Digital mining claim density map for federal lands in Oregon: 1996

USGS Publications Warehouse

Hyndman, Paul C.; Campbell, Harry W.

1999-01-01

This report describes a digital map generated by the U.S. Geological Survey (USGS) to provide digital spatial mining claim density information for federal lands in Oregon as of March 1997. Mining claim data is earth science information deemed to be relevant to the assessment of historic, current, and future ecological, economic, and social systems. There is no paper map included in this Open-File report. In accordance with the Federal Land Policy and Management Act of 1976 (FLPMA), all unpatented mining claims, mill and tunnel sites must be recorded at the appropriate Bureau of Land Management (BLM) State office. BLM maintains a cumulative computer listing of mining claims in the Mining Claim Recordation System (MCRS) database with locations given by meridian, township, range, and section. A mining claim is considered closed when the claim is relinquished or a formal BLM decision declaring the mining claim null and void has been issued and the appeal period has expired. All other mining claims filed with BLM are considered to be open and actively held. The digital map (figure 1.) with the mining claim density database available in this report are suitable for geographic information system (GIS)-based regional assessments at a scale of 1:100,000 or smaller.

Digital mining claim density map for federal lands in Washington: 1996

USGS Publications Warehouse

Hyndman, Paul C.; Campbell, Harry W.

1999-01-01

This report describes a digital map generated by the U.S. Geological Survey (USGS) to provide digital spatial mining claim density information for federal lands in Washington as of March 1997. Mining claim data is earth science information deemed to be relevant to the assessment of historic, current, and future ecological, economic, and social systems. There is no paper map included in this Open-File report. In accordance with the Federal Land Policy and Management Act of 1976 (FLPMA), all unpatented mining claims, mill, and tunnel sites must be recorded at the appropriate BLM State office. BLM maintains a cumulative computer listing of mining claims in the Mining Claim Recordation System (MCRS) database with locations given by meridian, township, range, and section. A mining claim is considered closed when the claim is relinquished or a formal BLM decision declaring the mining claim null and void has been issued and the appeal period has expired. All other mining claims filed with BLM are considered to be open and actively held. The digital map (figure 1.) with the mining claim density database available in this report are suitable for geographic information system (GIS)-based regional assessments at a scale of 1:100,000 or smaller.

31 CFR 535.222 - Suspension of claims eligible for Claims Tribunal.

Code of Federal Regulations, 2014 CFR

2014-07-01

... be presented to the Iran-United States Claims Tribunal under the terms of Article II of the... Iran, dated January 19, 1981, and all claims for equitable or other judicial relief in connection with... or counterclaim in any pending or subsequent judicial proceeding commenced by the Government of Iran...

31 CFR 535.222 - Suspension of claims eligible for Claims Tribunal.

Code of Federal Regulations, 2013 CFR

2013-07-01

... be presented to the Iran-United States Claims Tribunal under the terms of Article II of the... Iran, dated January 19, 1981, and all claims for equitable or other judicial relief in connection with... or counterclaim in any pending or subsequent judicial proceeding commenced by the Government of Iran...

31 CFR 535.222 - Suspension of claims eligible for Claims Tribunal.

Code of Federal Regulations, 2012 CFR

2012-07-01

... be presented to the Iran-United States Claims Tribunal under the terms of Article II of the... Iran, dated January 19, 1981, and all claims for equitable or other judicial relief in connection with... or counterclaim in any pending or subsequent judicial proceeding commenced by the Government of Iran...

31 CFR 535.222 - Suspension of claims eligible for Claims Tribunal.

Code of Federal Regulations, 2010 CFR

2010-07-01

... be presented to the Iran-United States Claims Tribunal under the terms of Article II of the... Iran, dated January 19, 1981, and all claims for equitable or other judicial relief in connection with... or counterclaim in any pending or subsequent judicial proceeding commenced by the Government of Iran...

31 CFR 535.222 - Suspension of claims eligible for Claims Tribunal.

Code of Federal Regulations, 2011 CFR

2011-07-01

... be presented to the Iran-United States Claims Tribunal under the terms of Article II of the... Iran, dated January 19, 1981, and all claims for equitable or other judicial relief in connection with... or counterclaim in any pending or subsequent judicial proceeding commenced by the Government of Iran...

7 CFR 1962.19 - Claims against Commodity Credit Corporation (CCC).

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 14 2013-01-01 2013-01-01 false Claims against Commodity Credit Corporation (CCC... Liquidation of Chattel Security § 1962.19 Claims against Commodity Credit Corporation (CCC). This section is based on a Memorandum of Understanding between CCC and FmHA or its successor agency under Public Law 103...

7 CFR 1962.19 - Claims against Commodity Credit Corporation (CCC).

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 14 2014-01-01 2014-01-01 false Claims against Commodity Credit Corporation (CCC... Liquidation of Chattel Security § 1962.19 Claims against Commodity Credit Corporation (CCC). This section is based on a Memorandum of Understanding between CCC and FmHA or its successor agency under Public Law 103...

7 CFR 1962.19 - Claims against Commodity Credit Corporation (CCC).

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 14 2012-01-01 2012-01-01 false Claims against Commodity Credit Corporation (CCC... Liquidation of Chattel Security § 1962.19 Claims against Commodity Credit Corporation (CCC). This section is based on a Memorandum of Understanding between CCC and FmHA or its successor agency under Public Law 103...

7 CFR 1962.19 - Claims against Commodity Credit Corporation (CCC).

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 14 2010-01-01 2009-01-01 true Claims against Commodity Credit Corporation (CCC... Liquidation of Chattel Security § 1962.19 Claims against Commodity Credit Corporation (CCC). This section is based on a Memorandum of Understanding between CCC and FmHA or its successor agency under Public Law 103...

7 CFR 1962.19 - Claims against Commodity Credit Corporation (CCC).

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 14 2011-01-01 2011-01-01 false Claims against Commodity Credit Corporation (CCC... Liquidation of Chattel Security § 1962.19 Claims against Commodity Credit Corporation (CCC). This section is based on a Memorandum of Understanding between CCC and FmHA or its successor agency under Public Law 103...

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.

Sensitive electrochemical immunoassay for 2,4,6-trinitrotoluene based on functionalized silica nanoparticle labels

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

Wang, Jun; Liu, Guodong; Wu, Hong

2008-03-03

We present a poly(guanine)-functionalized silica nanoparticle (NP) label-based electrochemical immunoassay for sensitively detecting 2,4,6-trinitrotoluene (TNT). This immunoassay takes advantage of magnetic bead–based platform for competitive displacement immunoreactions and separation, and use electroactive nanoparticles as labels for signal amplification. For this assay, anti-TNT-coated magnetic beads interacted with TNT analog-conjugated poly(guanine)-silica NPs and formed analog-anti-TNT immunocomplexes on magnetic beads. The immunocomplexes coated magnetic beads were exposed to TNT samples, which resulted in displacing the analog conjugated poly(guanine) silica NPs into solution by TNT. In contrast, there are no guanine residues releasing into the solution in the absence of TNT. The reaction solutionmore » was then separated from the magnetic beads and transferred to the electrode surface for electrochemical measurements of guanine oxidation with Ru(bpy)32+ as mediator. The sensitivity of this TNT assay was greatly enhanced through dual signal amplifications: 1) a large amount of guanine residues on silica nanoparticles is introduced into the test solution by displacement immunoreactions and 2) a Ru(bpy)32+-induced guanine catalytic oxidation further enhances the electrochemical signal. Some experimental parameters for the nanoparticle label-based electrochemical immunoassay were studied and the performance of this assay was evaluated. The method is found to be very sensitive and the detection limit of this assay is ~ 0.1 ng mL-1 TNT. The electrochemical immunoassay based on the poly[guanine]-functionalized silica NP label offers a new approach for sensitive detection of explosives.« less

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...

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

32 CFR 842.119 - Nonassertable claims.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 6 2010-07-01 2010-07-01 false Nonassertable claims. 842.119 Section 842.119 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE CLAIMS AND LITIGATION... following are considered nonassertable claims and should not be asserted: (1) Claims against any department...

Implementation of Arithmetic and Nonarithmetic Functions on a Label-free and DNA-based Platform

NASA Astrophysics Data System (ADS)

Wang, Kun; He, Mengqi; Wang, Jin; He, Ronghuan; Wang, Jianhua

2016-10-01

A series of complex logic gates were constructed based on graphene oxide and DNA-templated silver nanoclusters to perform both arithmetic and nonarithmetic functions. For the purpose of satisfying the requirements of progressive computational complexity and cost-effectiveness, a label-free and universal platform was developed by integration of various functions, including half adder, half subtractor, multiplexer and demultiplexer. The label-free system avoided laborious modification of biomolecules. The designed DNA-based logic gates can be implemented with readout of near-infrared fluorescence, and exhibit great potential applications in the field of bioimaging as well as disease diagnosis.

Metastasizing patent claims on BRCA1.

PubMed

Kepler, Thomas B; Crossman, Colin; Cook-Deegan, Robert

2010-05-01

Many patents make claims on DNA sequences; some include claims on oligonucleotides related to the primary patented gene. We used bioinformatics to quantify the reach of one such claim from patent 4,747,282 on BRCA1. We find that human chromosome 1 (which does not contain BRCA1) contains over 300,000 oligonucleotides covered by this claim, and that 80% of cDNA and mRNA sequences contributed to GenBank before the patent application was filed also contain at least one claimed oligonucleotide. Any "isolated" DNA molecules that include such 15 bp nucleotide sequences would fall under the claim as granted by the US Patent and Trademark Office. Anyone making, using, selling, or importing such a molecule for any purpose within the United States would thus be infringing the claim. This claim and others like it turn out, on examination, to be surprisingly broad, and if enforced would have substantial implications for medical practice and scientific research. Copyright 2010 Elsevier Inc. All rights reserved.

28 CFR 801.3 - Processing the claim.

Code of Federal Regulations, 2010 CFR

2010-07-01

... TORT CLAIMS ACT PROCEDURE § 801.3 Processing the claim. (a) Will CSOSA/PSA contact you about your claim... acknowledgement indicating the filing date (that is, the date CSOSA/PSA received your claim) and the assigned claim number. Refer to the claim number in any further correspondence you may have with CSOSA/PSA on the...

Claimed Versus Calculated Cue-Weighting Systems for Screening Employee Applicants

ERIC Educational Resources Information Center

Blevins, David E.

1975-01-01

This research compares the cue-weighting system which assessors claimed they used with the cue-weighting system one would infer they used based on multiple observations of their assessing behavior. The claimed cue-weighting systems agreed poorly with the empirically calculated cue-weighting systems for all assessors except one who utilized only…

Digital mining claim density map for federal lands in Nevada: 1996

USGS Publications Warehouse

Hyndman, Paul C.; Campbell, Harry W.

1999-01-01

This report describes a digital map generated by the U.S. Geological Survey (USGS) to provide digital spatial mining claim density information for federal lands in Nevada as of March 1997. Mining claim data is earth science information deemed to be relevant to the assessment of historic, current, and future ecological, economic, and social systems. There is no paper map included in this Open-File report. In accordance with the Federal Land Policy and Management Act of 1976 (FLPMA), all unpatented mining claims, mill, and tunnel sites must be recorded at the appropriate Bureau of Land Management (BLM) State office. BLM maintains a cumulative computer listing of mining claims in the MCRS database with locations given by meridian, township, range, and section. A mining claim is considered closed when the claim is relinquished or a formal BLM decision declaring the mining claim null and void has been issued and the appeal period has expired. All other mining claims filed with BLM are considered to be open and actively held. The digital map (figure 1.) with the mining claim density database available in this report are suitable for geographic information system (GIS)-based regional assessments at a scale of 1:100,000 or smaller.

Food label use and its relation to dietary intake among US adults.

PubMed

Ollberding, Nicholas Jay; Wolf, Randi L; Contento, Isobel

2010-08-01

Rates of diet-related chronic disease combined with the lack of current data on patterns of food label use by the US population warrant re-examination of the use and potential influence of this public health tool. The purpose of this study was to describe the prevalence of food label use and the association between food label use and nutrient intake in a nationally representative sample of US adults who participated in the 2005-2006 National Health and Nutrition Examination Survey. Data on food label use were collected during the interview portion of the survey, and nutrient intake was estimated using the average of two 24-hour dietary recalls. In this sample, 61.6% of participants reported using the Nutrition Facts panel, 51.6% looked at the list of ingredients, 47.2% looked at serving size, and 43.8% reviewed health claims at least sometimes when deciding to purchase a food product. There were significant differences (P<0.05) in food label use across all demographic characteristics examined. Significant differences (P<0.05) in mean nutrient intake of total energy, total fat, saturated fat, cholesterol, sodium, dietary fiber, and sugars were observed between food label users and non-users with label users reporting healthier nutrient consumption. The greatest differences observed were for total energy and fat and for use of specific nutrient information on the food label. Despite food label use being associated with improved dietary factors, label use alone is not expected to be sufficient in modifying behavior ultimately leading to improved health outcomes. 2010 American Dietetic Association. Published by Elsevier Inc. All rights reserved.

38 CFR 21.1030 - Claims.

Code of Federal Regulations, 2010 CFR

2010-07-01

... forms include: (i) DA Form 2171, Request for Tuition Assistance-Army Continuing Education System; (ii... REHABILITATION AND EDUCATION Claims and Applications for Educational Assistance Claims § 21.1030 Claims. (a... administered by VA for pursuit of a program of education, he or she must file an application for educational...

GEO Label: User and Producer Perspectives on a Label for Geospatial Data

NASA Astrophysics Data System (ADS)

Lush, V.; Lumsden, J.; Masó, J.; Díaz, P.; McCallum, I.

2012-04-01

One of the aims of the Science and Technology Committee (STC) of the Group on Earth Observations (GEO) was to establish a GEO Label- a label to certify geospatial datasets and their quality. As proposed, the GEO Label will be used as a value indicator for geospatial data and datasets accessible through the Global Earth Observation System of Systems (GEOSS). It is suggested that the development of such a label will significantly improve user recognition of the quality of geospatial datasets and that its use will help promote trust in datasets that carry the established GEO Label. Furthermore, the GEO Label is seen as an incentive to data providers. At the moment GEOSS contains a large amount of data and is constantly growing. Taking this into account, a GEO Label could assist in searching by providing users with visual cues of dataset quality and possibly relevance; a GEO Label could effectively stand as a decision support mechanism for dataset selection. Currently our project - GeoViQua, - together with EGIDA and ID-03 is undertaking research to define and evaluate the concept of a GEO Label. The development and evaluation process will be carried out in three phases. In phase I we have conducted an online survey (GEO Label Questionnaire) to identify the initial user and producer views on a GEO Label or its potential role. In phase II we will conduct a further study presenting some GEO Label examples that will be based on Phase I. We will elicit feedback on these examples under controlled conditions. In phase III we will create physical prototypes which will be used in a human subject study. The most successful prototypes will then be put forward as potential GEO Label options. At the moment we are in phase I, where we developed an online questionnaire to collect the initial GEO Label requirements and to identify the role that a GEO Label should serve from the user and producer standpoint. The GEO Label Questionnaire consists of generic questions to identify whether

Health and Stress Management and Mental-health Disability Claims.

PubMed